bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label Trial to Evaluate Mass Balance of Tavapadon at Steady State in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of
      [14C] tavapadon.
    


Intervention name(s): Tavapadon tablet; Tavapadon [14C] suspension
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive multiple dose titration of Tavapadon (0.25 mg once daily [QD] on Days 1 to 3, 0.5 mg QD on Days 4 to 6, 1.0 mg QD on Days 7 to 9, 1.5 mg QD on Days 10 to 12, and 2.5 mg QD on Days 13 to 15); Following 15-Day multiple dose titration of Tavapadon, participants will receive a single oral dose of Tavapadon 2.5 mg containing approximately 100 μCi of [14C] Tavapadon on Day 16
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if T2-18C3, a true human monoclonal antibody that
      blocks inflammation, is safe to use in patients with type 2 diabetes. The study will also be
      looking at the ability of T2-18C3 to improve control of blood sugar levels in diabetics by
      blocking inflammation in the pancreas.
    

Detailed description: 
      This is a phase I, open label study of the safety and pharmacokinetics of T2-18C3 in patients
      with T2D. Nine patients will receive four biweekly IV infusions of the study drug, T2-18C3,
      at a dose level of 1.25 mg/kg. These patients will be followed for a total of 90 days to
      examine safety, pharmacokinetics, and preliminary efficacy.
    

Intervention name(s): T2-18C3 therapeutic antibody
Intervention type(s): Drug
Intervention description(s): 1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.
Intervention MeSH terms: Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding
Condition: Esophageal Varices; Portal Hypertension; Gastric Varices; Esophageal Bleeding
MeSH terms: Hypertension, Portal; Esophageal and Gastric Varices; Hypertension; Varicose Veins; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to determine the efficacy of early administration of
      Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding.
    

Detailed description: 
      This is a single-arm open-label clinical study with historical controls using Sanvar®
      (vapreotide) administered for 5 days in patients with acute variceal bleeding due to portal
      hypertension.

      Cirrhotic patients with a history of acute hematemesis and/or melena admitted to the
      emergency unit and meeting the eligibility criteria will receive, as soon as possible after
      admission (within a maximum of 24 hours after onset of hemorrhage and within 6 hours after
      admission), Sanvar® (vapreotide acetate) 50 µg IV bolus followed by an IV continuous infusion
      of 50 µg/h for 5 days.

      The diagnostic and therapeutic endoscopy will be performed as soon as possible after the
      initiation of the study drug infusion, but no more than 12 hours after the patient's
      admission to the study center. A final follow up will be performed on Day 42.

      Patients for whom the source of bleeding is determined at endoscopy to be due to a cause
      other than portal hypertension (e.g. gastric ulcer) will be replaced. In addition, in such
      cases the study medication will be discontinued and patients will receive standard treatment
      according to the cause of their bleeding. These patients will be followed up for safety only.

      *Note: There is no provision in this study to have an expanded access program.
    

Intervention name(s): Sanvar® (vapreotide)
Intervention type(s): Drug
Intervention MeSH terms: Vapreotide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal Variceal Bleeding; Portal Hypertension; Hepatic Cirrhosis; Cirrhosis; Liver Cirrhosis; Somatostatin Analog; Vapreotide; Acute Esophageal Variceal Bleeding
A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind,
      placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male
      and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and
      selective antagonist of CCR4.
    


Intervention name(s): RPT193; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Antagonist of the CCR4 chemokine receptor; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Detection in Tandem Endocuff Cap Trial
Condition: Colonic Neoplasms; Adenomas Serrated; Colo-rectal Cancer; Colon Adenoma
MeSH terms: Adenoma; Colonic Neoplasms
Study type: Interventional

Summary: 
      A randomised back to back study comparing cap and Endocuff to detect adenomas during
      colonoscopy
    


Intervention name(s): Endocuff; cap assisted colonoscopy (CAC)
Intervention type(s): Device; Device
Intervention description(s): It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination; cap assisted colonoscopy (CAC)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: colonic adenoma; serrated polyps; caecal intubation time; withdrawal time; polyp miss rate
A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective in this study is to assess if single doses of BMS-986104 that are safe,
      tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte
      count) can be achieved without bradycardia or other adverse events in healthy male subjects.
    


Intervention name(s): BMS-986104; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Epidural Intervention of Spinal Nerves With Tumor Necrosis Factor-Alpha Inhibitor
Condition: Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic; Necrosis
Study type: Interventional

Summary: 
      This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis
      Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal
      stenosis.
    

Detailed description: 
      This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis
      Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal
      stenosis.Ninety patients were diagnosed with lumbar spinal stenosis and were randomly
      assigned to 3 groups, for each group 30 cases. Patients in Group A received epidural
      injection of spinal nerve with 2.0 ml of lidocaine and 10 mg of Tumor Necrosis Factor-Alpha
      Inhibitor (etanercept) onto the affected spinal nerve, Group B patients received epidural
      injection with lidocaine 2ml mixed with 2ml of steroid(Diprospan), and group C patients
      received epidural injections with 4.0 ml of lidocaine only. All the 3 groups were evaluated
      by VAS and ODI, and received 6 months' follow-up.
    

Intervention name(s): Epidural Intervention with TNF-α inhibitor
Intervention type(s): Procedure
Intervention description(s): Epidural administration with TNF-α inhibitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine if short-term adoption of a Westernized lifestyle
      characterized by physical inactivity and increased consumption of fructose will result in
      metabolic and vascular dysfunction. Healthy individuals aged 18-45 years old will undergo an
      acute period of physical inactivity (10 days) coupled with increased fructose consumption.
      Augmented fructose consumption will be achieved via commercially available soda beverages
      which are high in fructose. Vascular and metabolic function measures will be performed before
      and after the 10-day intervention.
    

Detailed description: 
      Men and women who regularly engage in >10,000 steps per day, age 18-45 years, body mass index
      < 30 kg/m2, and with no history of chronic disease will be recruited. Subjects who are
      eligible will undergo an acute period of physical inactivity (10 days) coupled with increased
      fructose consumption (6 cans/day). Physical activity levels will be assessed via a pedometer
      to quantify if individuals achieve <5000 steps/day. Vascular and metabolic function measures
      will be performed before and after the 10-day intervention.
    

Intervention name(s): Fructose and physical inactivity
Intervention type(s): Other
Intervention description(s): Subjects will drink 6 cans of regular sodas daily (divided throughout the day) and will decreased physical activity to less than 5000 steps daily for 10 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: arterial stiffness; endothelial dysfunction; fructose; physical inactivity
Promethazine vs. Lorazepam for Treatment of Vertigo
Condition: Peripheral Vertigo.
MeSH terms: Vertigo; Dizziness
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was a prospective, randomized, double-blind, parallel group clinical trial
      designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the
      treatment of peripheral vertigo in Emergency Department setting.
    


Intervention name(s): Promethazine; Lorazepam
Intervention type(s): Drug; Drug
Intervention MeSH terms: Promethazine; Diphenhydramine; Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
Condition: Pancreas Cancer; Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms; Pancreatic Neoplasms
Study type: Interventional

Summary: 
      This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo
      for pain control in subjects with pancreatic cancer.
    

Detailed description: 
      Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct
      cancer.

      Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with
      ethanol injection versus surgery plus placebo injection. Subjects will be followed every
      three months for survivorship or death to assess pain, quality of life measures, and narcotic
      pain control usage. The primary endpoint of pain control will be determined at one year post
      surgery. Subjects are not required to undergo any additional diagnostic testing procedures
      that are not part of their routine follow-up care.
    

Intervention name(s): Alcohol Injection; Placebo Injection
Intervention type(s): Other; Other
Intervention description(s): Celiac plexus neurolysis by alcohol injection
Other intervention name(s): Ethanol Injection; Normal saline injection
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Pain
A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment
Condition: Hepatic Impairment; Moderate Impaired Hepatic Function
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Quizartinib is a novel oral Class III receptor tyrosine kinase (RTK) inhibitor exhibiting
      highly potent and selective but reversible inhibition of Feline McDonough sarcoma (FMS)-like
      tyrosine kinase 3 (FLT3). Quizartinib is currently being studied alone or in combination with
      other agents as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome
      (MDS) in adult and pediatric populations.
    

Detailed description: 
      The primary objective of this study is to determine the plasma pharmacokinetics (PK) of
      quizartinib and its pharmacologically active metabolite AC886 after a single oral dose of 30
      mg in participants with moderate hepatic impairment (HI) (as defined by National Cancer
      Institute-Organ Dysfunction Working Group [NCI-ODWG] criteria) compared to the healthy
      control participants with normal hepatic function.
    

Intervention name(s): Quizartinib
Intervention type(s): Drug
Intervention description(s): Single oral dose, 30 mg tablet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib
Algae and Cholesterol Absorption
Condition: Intestinal Cholesterol Absorption
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate the effects of wakame and spirulina
      consumption on intestinal cholesterol absorption.
    

Detailed description: 
      Objectives:

      Secondary objectives are to investigate the effects of wakame and spirulina consumption on
      fasting markers for lipid metabolism, glucose metabolism and blood pressure.

      Study design:

      This study is a double-blinded, randomized, placebo-controlled, crossover intervention trial
      consisting of three intervention periods of 17 days each, separated by a minimum washout
      period of 14 days.

      Study population:

      The study population will consist of 37 healthy, non-hypercholesterolemic men and women aged
      between 18 and 70 years.

      Intervention:

      All subjects will receive wakame, spirulina and placebo capsules in randomized order.
      Subjects will be asked to consume 12 capsules per day for 17 days, which is equal to 4.8
      grams of wakame or spirulina a day.
    

Intervention name(s): Wakame; Spirulina; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of 4.8 grams wakame per day for 17 days; Consumption of 4.8 grams spirulina per day for 17 days; Consumption of microcrystalline cellulose for 17 days
Other intervention name(s): Undaria pinnatifida; Arthrospira
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Inflammation
Study type: Observational

Summary: 
      This purpose of this study is to determine if activation of a person's immune system in the
      small intestine could be a contributing cause of Type 1 Diabetes.
    

Detailed description: 
      There is a large body of literature hinting at a role of the gut in Type One Diabetes (T1D)
      pathogenesis. However, to the best of our knowledge there is no definitive evidence to date
      conclusively demonstrating a link. The only way to test this hypothesis is to have access to
      the intestinal tissue of T1D patients at very early stages when beta-islet cell destruction
      is still ongoing. Furthermore, to prepare for large prospective studies it is critical to
      determine whether there is a peripheral blood signature for intestinal inflammation. Finally,
      because enteroviral infections have been implicated in T1D pathogenesis, this study provides
      a unique opportunity to determine whether there is a dysregulated response to innate stimuli
      associated with viral infections and whether evidence of transcriptional signatures
      indicative of viral infections in the gut is correlated with disease. Finally, we will take
      advantage of this pilot study to collect samples that can be used for microbiome, virome and
      metabolic studies.
    

Intervention name(s): Upper endoscopy with small bowel biopsies and brushings.; Blood draw; Stool sample
Intervention type(s): Procedure; Other; Other
Intervention description(s): Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC).; Stool samples will be collected at baseline for future microbiome and virome studies.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 Diabetes, diagnosed within 6 months
      
Biospecimen description: 
      Serum, DNA, RNA extraction, brush biopsies from duodenal mucosa, biopsies of small intestine,
      stool samples
Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of
      Midazolam administered alone and in combination with Vandetanib.
    

Detailed description: 
      A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a
      CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with a
      Single Dose of 800-mg Vandetanib (CAPRELSA)
    

Intervention name(s): Midazolam; vandetanib
Intervention type(s): Drug; Drug
Intervention description(s): Oral syrup 7.5 mg, single dose; Oral tablets, 800 mg, single dose
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; pharmacokinetics; vandetanib; midazolam
Effect of Fasting-Mimicking Diet on Skin Health
Condition: Skin
Study type: Interventional

Summary: 
      This single-center, randomized, controlled clinical trial is being conducted to assess the
      efficacy on facial skin appearance of the Sponsor's 5-day meal kit when consumed monthly for
      3 cycles over the course of 71 days by women with mild to moderate dry fine lines, lack of
      smoothness, uneven skin tone, and lack of radiance on the face.
    

Detailed description: 
      Fasting-mimicking diet (FMD) was developed to mimic the metabolic effects of water-only
      fasting, while providing modest calories and essential nutrients. It consists of 100% natural
      ingredients, which are generally regarded as safe (GRAS). It is comprised of bars, soups, and
      beverages aiming to achieve consistent and effective short-term calorie restriction, while
      providing adequate micronutrients.

      The study will test the efficacy parameters, including clinical grading scores, Corneometer
      measurement, and Antera image analysis and subject self-assessment, of consuming the test
      products in place of other food over a 5 day period, for 3 cycles, over the course of 71 days
      when compared with baseline scores/values, and when compared to the untreated control.
    

Intervention name(s): Fasting mimicking diet (FMD)
Intervention type(s): Other
Intervention description(s): The ProLon(TM) Fasting Mimicking Diet regimen is a meal replacement plan that mimics water only fasting. It consists of 100% natural ingredients, which are generally regarded as safe (GRAS). It is comprised of bars, soups, and beverages aiming to achieve consistent and effective short-term calorie restriction, while providing adequate micronutrients. The very low protein and very low sugar content are essential characteristics of the diet. Complex carbohydrates and polyunsaturated fatty acids are its main components.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
Condition: Hemostasis; Oral Contraceptive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to evaluate the impact of a 91-day extended cycle oral
      contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in
      healthy women.
    


Intervention name(s): 91-day Levonorgestrel Oral Contraceptive; 28-day Levonorgestrel Oral Contraceptive; 28-day Desogestrel Oral Contraceptive
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.; 21 combination tablets containing 150 µg LNG/30 µg EE.; 21 combination tablets containing 150 µg DSG/30 µg EE.
Other intervention name(s): Seasonique®; Minidril®; Marvelon®
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel; Desogestrel; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Contraception; Hemostasis; Blood Coagulation
Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995
      in Subjects with Diabetic Nephropathy
    


Intervention name(s): MT-3995-Low; MT-3995-High; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Nephropathy
Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer
Condition: Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body
      Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer
      (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving
      treatment with a targeted agent such as gefitinib, erlotinib and icotinib.
    


Intervention name(s): SBRT+TKI; TKI
Intervention type(s): Radiation; Drug
Intervention description(s): Received SBRT after three months after EGFR-TKI treatment; Received EGFR-TKI treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment