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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Clinical Trials of Interest

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A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Squamous Cell Carcinoma of the Head and Neck
    Squamous Cell Carcinoma of the Head and Neck
  • Phase Phase 1
    Phase 1
INTERVENTION

Biological: NG-641, Biological: Pembrolizumab

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Biological: NG-641, Biological: Pembrolizumab

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Cardiff & Vale University LHB, Cardiff, United Kingdom

Brief Summary

A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN).

Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Myocardial Stunning
    Myocardial Stunning
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: IV Diazoxide, Other: Placebo

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: IV Diazoxide, Other: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Johns Hopkins Hospital, Baltimore, Maryland, United States

Brief Summary

This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. The investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.

XEN1101 for Major Depressive Disorder

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Major Depressive Disorder
    Major Depressive Disorder
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: XEN1101, Drug: Placebo

Eligibility
  • Ages: 18 to 65 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: XEN1101, Drug: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Brief Summary

This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a novel treatment target for mood disorders through the administration of the KCNQ-selective channel opener XEN1101 (Xenon Pharmaceuticals).

Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Rhizarthrosis
    Rhizarthrosis
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: Botulinum toxin, Drug: Placebo

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Botulinum toxin, Drug: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

CHU de Nice, Nice, Paca, France

Brief Summary

Only 4 randomized controlled clinical trials have been published to date to assess the short-term effectiveness of intra-articular Botulinum Toxin injection on pain, function and quality of life in patients suffering from chronic knee pain related or not to knee osteoarthritis and also in the context of ankle osteoarthritis. The analgesic properties and the reported safety make intra-articular Botulinum toxin a strong candidate in the treatment of symptomatic manifestations of osteoarthritis disease and more particularly in certain locations such as the trapezo-metacarpal joint. Investigators hypothesize that injection of intra-articular Botulinum toxin into the trapezo-metacarpal joint will be of benefit in reducing pain and improving function in patients with rhizarthrosis. Investigators will begin a monocentric randomized controlled trial comparing intra-articular injections of Botulinum toxin and placebo.

Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Esophagitis
    Esophagitis
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Full dose Pantoprazole plus matching placebo, Drug: Half Dose Pantoprazole plus matching placebo

Eligibility
  • Ages: 1 to 17 Year (Child)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Full dose Pantoprazole plus matching placebo, Drug: Half Dose Pantoprazole plus matching placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Caribbean Clinical Research, LLC, Ponce, Puerto Rico

Brief Summary

The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Refractory Chronic Cluster Headache
    Refractory Chronic Cluster Headache
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: Ketamine + Magnesium sulfate (drug combination)

Eligibility
  • Ages: 18 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Ketamine + Magnesium sulfate (drug combination)

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

CH Annecy Genevois, Annecy, France

Brief Summary

Chronic cluster headache (CCH) is a rare primary headache disorder, defined by episodic attacks that occur for more than one year with no remission period or with remission periods lasting < 3 months (ICHD-3 criteria). In certain cases, CCH patients become drug-resistant and continue to suffer almost daily attacks. Ketamine appears to be effective in a variety of chronic pain conditions, such as refractory headache, and can show an enhanced analgesic effect when combined with magnesium. A single infusion of ketamine-magnesium combination has been described to reduce attacks in 17 patients with rCCH. The main outcome was a comparison of the number of daily attacks two weeks prior to the infusion and one week after (days 7-8). The number of daily attacks decreased from 4.3±2.4 before treatment to 1.3±1.0 after treatment (p<0.001). 13/17 had at least 50% response. Thus, the goal of this placebo-controlled study is to try to confirm these findings.

Study of DP303c Injection in Patients With Advanced or Metastatic Gastric Cancer

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Gastric Cancer
    Gastric Cancer
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: DP303c treatment, Drug: DP303c treatment(second-line of HER2-positive), Drug: DP303c treatment (third-line of HER2-positive), Drug: DP303c treatment(≥second-line of HER2 low expressing), Drug: DP303c + PD-1/PD-L1 treatment

Eligibility
  • Ages: 18 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: DP303c treatment, Drug: DP303c treatment(second-line of HER2-positive), Drug: DP303c treatment (third-line of HER2-positive), Drug: DP303c treatment(≥second-line of HER2 low expressing), Drug: DP303c + PD-1/PD-L1 treatment

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Brief Summary

This study is an open-label, multicenter, phase II study to evaluate the efficacy and safety of DP303c injection in patients with HER2-positive advanced or metastatic gastric cancer.

Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple Sclerosis

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Urinary Bladder, Neurogenic, Multiple Sclerosis
    Urinary Bladder, Neurogenic, Multiple Sclerosis
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: VESIcare 10Mg Tablet, Drug: Botox 100 UNT Injection

Eligibility
  • Ages: 18 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: VESIcare 10Mg Tablet, Drug: Botox 100 UNT Injection

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Brief Summary

Botulinum toxin type A injections into the detrusor at a dose of 200 units (U) of BOTOX® are a recognized second-line treatment for the treatment of adult neurogenic lower urinary tract disorders. Anticholinergics are established as the usual first-line treatment for neurogenic detrusor hyperactivity, but are oft not sufficiently effective and have significant side effects. In patients with multiple sclerosis (MS) suffering from overactive bladder, the 200 U dose of BOTOX® is very effective but induces a risk of urinary retention in 30% of patients requiring the temporary use of self-catheterization1. At 100 U, a recent study shows the efficacy and very good tolerance of botulinum toxin A in terms of probing risk in MS patients with overactive bladder and failure of anticholinergics. Furthermore, the efficacy of anticholinergics in MS has been little studied and is also disputed. The investigators plan to test the therapeutic alternative as the first line of treatment in two groups of randomized MS patients from a homogeneous population suffering from overactive bladder: - a group testing the effectiveness of low doses of botulinum toxin type A (100 U, BOTOX®), - the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®). During this pilot study, the efficacy and side effects profile of each treatment will be analyzed in order to determine the amplitudes of effect and the safety profiles in this population and in order to establish the statistical hypotheses for a subsequent randomized multicenter study. The aim of this study will be to establish the benefit of botulinum toxin at a dose of 100 U as a first-line treatment instead of anticholinergics

MH004 Topical Cream in Healthy Adult Volunteers and Participants With Atopic Dermatitis or Rheumatoid Arthritis

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Atopic Dermatitis, Rheumatoid Arthritis
    Atopic Dermatitis, Rheumatoid Arthritis
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: MH004 Ia(0.1%), Drug: MH004 Ia(0.3%), Drug: MH004 Ia(1%), Drug: MH004 Ia(3%), Drug: MH004 Ib-1(0.1%), Drug: MH004 Ib-1(0.3%), Drug: MH004 Ib-1(1%), Drug: MH004 Ib-2(0.3%), Drug: MH004 Ib-2(1%), Drug: MH004 Ib-2(3%)

Eligibility
  • Ages: 18 to 70 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: MH004 Ia(0.1%), Drug: MH004 Ia(0.3%), Drug: MH004 Ia(1%), Drug: MH004 Ia(3%), Drug: MH004 Ib-1(0.1%), Drug: MH004 Ib-1(0.3%), Drug: MH004 Ib-1(1%), Drug: MH004 Ib-2(0.3%), Drug: MH004 Ib-2(1%), Drug: MH004 Ib-2(3%)

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Brief Summary

This is a Phase Ia/Ib Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis and participants with Mild to Moderate Rheumatoid Arthritis.

Efficacy and Tolerability of Beta Hydroxybutyrate in Patients With Amyotrophic Lateral Sclerosis (ALS)

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Amyotrophic Lateral Sclerosis
    Amyotrophic Lateral Sclerosis
  • Phase Phase 2
    Phase 2
INTERVENTION

Dietary Supplement: Beta Hydroxybutyrate

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Dietary Supplement: Beta Hydroxybutyrate

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Ulm, Ulm, Baden-Wurttemberg, Germany

Brief Summary

Weight loss is a known negative prognostic factor in amyotrophic lateral sclerosis (ALS). One potential mechanism of weight loss in ALS is a disturbance of the mitochondrial complex I which causes an energy deficit in affected cells. Over the last years, various interventional studies targeting the energy deficit in ALS yielded promising results; however,it is still unclear which kind of nutrition or nutritional supplement is most beneficial. Ketone bodies represent a logical therapeutic option in ALS as ketone bodies are an extremely high-energetic substrate which yields the double amount of adenosine triphosphate (ATP) per mole compared to glucose. The human liver is able to synthesize ketone bodies (beta-hydroxybutyrate, acetone, and aceto-acetate) from fat in times of glucose shortage, for example after a prolonged period of fasting. This metabolic shift is the underlying principle of the ketogenic diet, a carbohydrate-free, fat-rich diet which has been successfully tested in other neurodegenerative diseases such as Alzheimer's and Parkinson's disease. In the ALS mouse model, a ketogenic diet was associated with a slower decline of motor function. However, a ketogenic diet is difficult to implement in ALS as it requires a long-term change of eating habits, which is difficult to achieve due to progressive dysphagia, fast worsening of general condition, and limited survival. Therefore, the direct administration of ketone bodies yields a more realistic alternative in ALS as it is easy to apply and allows to maintain the usual eating habits. In this study, we hypothesize that the administration of 3 x 15.6 g beta hydroxybutyrate per day (in addition to normal food intake and the standard medication of 2 x 50 mg riluzole) slows down disease progression as measured by neurofilament light chains (NfL) in serum after 6 months compared to placebo. Power calculation relies on the results of the lipids and calories for ALS (LIPCAL-ALS) study which tested the effect of a high-caloric fatty nutritional supplement in ALS. The study revealed that NfL serum values declined significantly in the intervention group while remaining stable in the placebo group over the course of the study. Assuming a similar effect size for ketone bodies, we calculated that 76 patients had to be included in the current trial.