bioihbjkbjnl/mcl2 huggingface dataset:
Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial
Condition: Renal Insufficiency, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Intervention: Chlorthalidone; Bumetanide
Intervention description: Chlorthalidone; Bumetanide
Intervention MeSH terms: Chlorthalidone; Bumetanide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diuretics; Bumetanide; Chlorthalidone; Chronic Kidney Disease; Volume Overload

Summary:

      This study aims to demonstrate the possible benefit of a treatment based on double diuretic
      in patients with chronic kidney disease and severely impaired glomerular filtration rate.
      This is based on previous observations where the investigators found that volume overload is
      a frequent condition within this population and is strongly linked to an increase in
      morbidity and mortality. The investigators consider that this therapy could be beneficial
      given that most of these patients are treated with loop diuretics, however, with the passage
      of time, adaptive changes in the distal nephron occur that promote a decrease in the
      treatment effect. In this sense, thiazide diuretics at appropriate doses could 'break' the
      resistance, since their mechanism of action antagonizes the resistance mechanism.
      Unfortunately, to this day, this treatment has not been fully evaluated. Particularly in this
      type of population.

      The investigators developed a study proposed as a double blind randomized clinical trial,
      where the population will be divided into two groups. A group will be given the standard
      treatment based on loop diuretic (bumetanide), while the other group will receive the
      intervention (bumetanide plus chlorthalidone). After a 30-day follow-up period, the results
      will be measured.

      With respect to the effectiveness of the treatment, the decrease in volume overload by
      bioimpedance will be measured. While the occurrence of adverse effects during the same
      monitoring period will be observed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  glomerular filtration rate less than 30 ml / min / 1.73m

          -  Without replacement therapy (dialysis or hemodialysis)

          -  Volume overload

          -  At least 100 ml per day of residual diuresis

          -  Use of a loop diuretic for at least one month

        Exclusion Criteria:

          -  Allergies known to diuretics

          -  Patients with severe infections

          -  Patients with hemodynamic instability

          -  Amputees

          -  Patients with cognitive impairment

          -  Patients with acute renal failure

          -  Patients with graft loss
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Intervention: SER-109; Placebo
Intervention description: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.; Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will involve administering the study drug as a single dose of study drug or
      placebo. This study is designed to demonstrate the superiority of the experimental drug
      versus placebo in adult patients with recurrent CDI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent, indicating that the patient understands the purpose of and
             procedures required for the study. Patients who are unable to provide informed consent
             will not be included in the study.

          2. Male or female patients ≥ 18 years.

          3. ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode
             with documentation of ≥ 2 episodes.

        Exclusion Criteria:

          1. Female patients who are pregnant, breastfeeding, lactating, or planning to become
             pregnant during the study.

          2. Known or suspected toxic megacolon and/or known small bowel ileus.

          3. Active irritable bowel syndrome with diarrhea within the previous 12 months.

          4. Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3
             months before enrollment (this does not include appendectomy or cholecystectomy) or
             any history of total colectomy or bariatric surgery.

          5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease,
             microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel
             disease in the past 24 months.

          6. Admitted to or expected to be admitted to an acute care facility or intensive care
             unit for medical reasons (not just boarding). Patients discharged from an acute care
             facility before Day 1 or residing in nursing homes or rehabilitation facilities may be
             enrolled.

          7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for
             active malignancy (patients on maintenance chemotherapy may only be enrolled after
             consultation with medical monitor).
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg FDC tablet administered orally once daily; Tablet (s) administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy, safety and tolerability of
      treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks
      in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead
      sponsored study and did not achieve sustained virologic response (SVR).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV genotype determined by the Central Laboratory

          -  HCV RNA > LLOQ at screening

          -  Participated and completed a Gilead sponsored HCV treatment study of direct acting
             antiviral (DAA) containing regimens.

          -  Male and female of childbearing potential must agree to use protocol specified
             method(s) of contraception

        Key Exclusion Criteria:

          -  Current or prior history: Clinically-significant illness (other than HCV) or any other
             major medical disorder that may interfere with treatment, assessment or compliance
             with the protocol; individuals currently under evaluation for a potentially
             clinically-significant illness (other than HCV) are also excluded.

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at screening

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Condition: Heart Failure
MeSH terms: Heart Failure; Cardiotoxicity
Intervention: Placebo; Atorvastatin
Intervention description: A pill taken once a day; A pill taken once a day
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer Treatment Related to Heart Failure

Summary:

      This research study will test whether atorvastatin, a drug commonly prescribed for reducing
      cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin
      is from a family of medications that are commonly called "statins"
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 18 years of age

          -  All patients with newly diagnosed NHL and HL

          -  Scheduled to receive anthracycline-based therapy

        Exclusion Criteria:

          -  Statin use or Statin use is indicated based on guidelines

          -  Pregnancy or breastfeeding

          -  Unable to provide informed consent

          -  Unexplained persistent elevation of transaminases (>3 times upper limits of normal)

          -  Concomitant use of cyclosporine

          -  Renal failure: estimated glomerular filtration <45 mL/min/1.73 m2

          -  Contraindication to a CMR (metallic object, severe claustrophobia, pacemaker, vascular
             clip

          -  LVEF of <50% at baseline
Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
Condition: Opioid Related Disorder
MeSH terms: Opioid-Related Disorders
Intervention: RBP-6000; Subutex
Intervention description: 18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and given on alternate sides of the participant's abdomen.; Participants were inducted and stabilized over a 14-day period (study days -14 to -1) on SUBUTEX sublingual tablets. Tablets are placed under the tongue until dissolved.
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid Dependence, Buprenorphine, Depot, SUBUTEX, RBP-6000

Summary:

      This is an open-label study in treatment seeking opioid-dependent subjects for safety,
      tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of
      subcutaneous injections of depot buprenorphine after induction and stabilization of treatment
      seeking subjects onto Subutex.

      Subjects were planned to receive 4 subcutaneous (SC) injections of RBP-6000 separated by 28
      days (Cohorts 1-5) or 6 SC injections of RBP-6000 separated by 28 days (Cohort 6) after a
      13-day induction and dose stabilisation period on SUBUTEX Sublingual (SL) tablet at dose
      levels of 8-24 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects

          -  Agree not to take any buprenorphine products other than those administered for the
             current study throughout participation in the study

          -  Body mass index (BMI) of >18.0 to < 33.0 kg/m

        Exclusion Criteria:

          -  Participants with a current diagnosis requiring chronic opioid treatment

          -  Participants with a history of risk factors of Torsades de Pointes (e.g., heart
             failure, hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a
             Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF > 470 in females
             at screening

          -  Abuse of buprenorphine or use of buprenorphine within 14 days of informed consent
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tesofensine/Metoprolol; Placebo
Intervention description: Tesofensine 0.5 mg + Metoprolol 100 mg
Intervention MeSH terms: Metoprolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2
      Diabetes Mellitus
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females

          2. Confirmed diagnosis of T2DM

          3. 18-70 years of age

          4. HbA1c ≥7.0%

        Exclusion Criteria:

          1. Hypersensitivity to tesofensine/metoprolol

          2. Heart failure class II or greater according to the New York Heart Association (NYHA)
             or decompensated heart failure

          3. History of myocardial infarction or stroke within 12 months prior to enrolment

          4. History of coronary revascularisation or angioplasty in the last 12 months prior to
             enrolment

          5. Patients reporting angina in the last 6 months prior to enrolment

          6. Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs

          7. Any clinically significant cardiac arrhythmia
Premature Ventricular Contractions (PVCs) and Blood Pressure Control
Condition: Ventricular Premature Complexes; Blood Pressure
MeSH terms: Premature Birth; Ventricular Premature Complexes
Intervention: PVC Suppression using Flecainide; No PVC Suppression using Placebo
Intervention description: Flecainide will be administered to result in a reduction in PVC burden.; Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Intervention MeSH terms: Flecainide
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if reduction in premature ventricular contraction
      (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma
      catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC
      suppression in a randomized, double-blinded, crossover fashion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Frequent symptomatic premature ventricular contractions (PVCs) (>10% of total QRSs on
             a 24-hour Holter)

          -  Willingness to participate in research

        Exclusion Criteria:

          -  Age > 65 years old

          -  Pacemaker implantation

          -  Implantable cardioverter defibrillator implantation requiring pacing

          -  Sick sinus syndrome

          -  Atrio-ventricular (AV) block

          -  Left ventricular dysfunction defined as left ventricular ejection fraction < 50%

          -  History of myocardial infarction or coronary artery disease

          -  Severe left ventricular hypertrophy (wall thickness > 1.5 cm by echocardiography
             performed within 3 months from enrollment)

          -  Severe liver dysfunction

          -  Creatinine clearance of 35 mL/min/1.73 square meters or less

          -  Pregnancy

          -  Known hypersensitivity to the drug

          -  QRS duration > 120 ms

          -  Recent change in blood pressure medication within 30 days of enrollment
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: Psilocybin
Intervention description: Dose-finding
Intervention MeSH terms: Psilocybin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of TRD

        Exclusion Criteria:

          -  Other comorbidities
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective
      treatment for ulcerative colitis after 52 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who completed the APD334-003 (NCT02447302) study

        Exclusion Criteria:

          -  Participants who did not complete the APD334-003 study
A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lu AG09222; Placebo
Intervention description: Lu AG09222 will be administered per schedule specified in the arm.; Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine
      headaches for people who have not been helped by other treatments that are used to prevent
      migraines.

      People who join this trial have tried 2 to 4 other medications to prevent their migraines,
      but these medications have not helped them.

      When the trial is over, researchers will use this information to find out if the number of
      migraine days decreased more for the participants who got either dose of Lu AG09222 than for
      the participants who got the placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The participant has a diagnosis of migraine as defined by International Classification
             of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening
             Visit.

          -  The participant has a history of migraine onset at least 12 months prior to the
             Screening Visit.

          -  The participant has a migraine onset at ≤50 years of age.

          -  The participant has documented evidence of treatment failure in the past 10 years of
             at least 2 to 4 (maximum) different migraine preventive medications.

        Key Exclusion Criteria:

          -  The participant has been previously dosed with an anti-pituitary adenylate
             cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody.

          -  The participant has confounding and clinically significant pain syndromes.

          -  The participant has a diagnosis of acute or active temporomandibular disorder.

          -  The participant has a history or diagnosis of confounding headaches.
Role of Exenatide in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Exenatide; Insulin
Intervention description: In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.; Each subject received a baseline study with insulin alone
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Hypoglycemia; Hyperglycemia

Summary:

      The purpose of this study is to see if giving exenatide and insulin before a meal would lower
      blood sugars after the meal. This study may help in developing new treatments to help control
      high blood sugars after meals. This may help improve overall blood sugar control and prevent
      the long-term effects of diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

        ***Subjects must be patients of the Texas Children's Hospital Diabetes Care Center***.

        All of the following criteria must be met:

          1. Between 12-21 years of age at the time of enrollment.

          2. Have been diagnosed with Type 1 diabetes for at least 1 year and in good control
             (HbA1C less than 8.5%).

          3. Subjects must be otherwise healthy except for the Type 1 Diabetes and treated
             hypothyroidism.

          4. Menstruating women must have a negative pregnancy test.

          5. Hemoglobin equal to or greater than 12 g/dL before each study.

          6. Weight greater than 44 kg.

          7. Tanner stage greater than 3

        Exclusion Criteria:

          1. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis,
             juvenile rheumatoid arthritis etc or on treatment that might directly or indirectly
             affect glucose homeostasis, except for diabetes and hypothyroidism; stable on
             medications.

          2. Lack of a supportive family environment as detected by the clinicians and/or social
             workers.

          3. Positive pregnancy test in menstruating young women.

          4. BMI greater than 90th percentile for age or less than 10th percentile for age.

          5. Lactating and nursing mothers.