bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
Condition: Non-alcoholic Steatohepatitis NASH
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: LMB763; Placebo
Intervention description: Hard Gelatin Capsules; Hard Gelatin Capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-alcoholic Steatohepatitis; NASH; Fatty liver disease

Summary:

      The purpose of the present study is to assess the effects of LMB763 with respect to safety,
      tolerability, and on markers of liver inflammation in patients with NASH
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female patients, 18 years or older

          -  Written informed consent

          -  Presence of NASH by histologic evidence (liver biopsy) and elevated alanine
             aminotransferase (ALT), OR phenotypic diagnosis of NASH based on elevated ALT, BMI and
             diagnosis of Type 2 diabetes mellitus

        Exclusion Criteria:

          -  Current use of obeticholic acid (OCA)

          -  New initiation GLP-1 agonists such as liraglutide, exenatide , lixisenatide,
             albiglutide or dulaglutide within 3 months of screening

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, unless they are using highly effective methods of
             contraception during dosing and for 5 days after stopping study medication

          -  Current or history of significant alcohol consumption for a period of more than 3
             consecutive months within 1 year prior to screening

          -  Clinical evidence of hepatic decompensation or severe liver impairment

          -  Previous diagnosis of other forms of chronic liver disease

          -  Uncontrolled diabetes mellitus

          -  History or current diagnosis of ECG abnormalities

          -  Patients with contraindications to MRI imaging
A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
Condition: Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Leucovorin; Fluorouracil - bolus; Bevacizumab; Fluorouracil - infusion; ABT-165; Irinotecan
Intervention description: Intravenous; Intravenous; Intravenous; Intravenous; Intravenous; Intravenous
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; colorectal cancer; ABT-165; FOLFIRI; Bevacizumab; bowel cancer; metastatic colorectal cancer; metastatic colorectal

Summary:

      A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to
      bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of
      the colon or rectum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of
             the colon or rectum.

               -  Primary tumor has been resected > 3 months prior to randomization.

          -  At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance
             imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid
             Tumors (RECIST), Version 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.

          -  Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen
             in the metastatic setting.

          -  Adequate hematologic, renal and hepatic function.

        Exclusion Criteria:

          -  Any prior therapy with irinotecan

          -  Unresolved clinically significant toxicities from prior anticancer therapy, defined as
             any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2

          -  Clinically significant conditions that increase the risk for antiangiogenic therapy.

          -  History of any of the following during first-line therapy with a
             bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel
             perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
Condition: Recurrent C. Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Recurrence
Intervention: Low fecal microbiota dose; Mid fecal microbiota dose; High fecal microbiota dose
Intervention description: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days; receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment; receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in
      the treatment of recurrent C. difficile infection
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually active female subjects of child-bearing potential must agree to use an
             effective method of birth control during the treatment and follow-up period

          -  Female subjects of child-bearing potential must have a negative pregnancy test on the
             day of the procedure.

          -  Subject willing to sign an informed consent form

          -  Subject deemed likely to survive for ≥ 1 year after enrollment

          -  Able to follow study procedure and follow-ups

          -  Subjects' attending physician will provide non-transplant care for the subject

          -  Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of
             recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin

          -  Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of
             vancomycin or metronidazole or fidaxomicin) since last bout of CDI

          -  Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for
             overnight

        Exclusion Criteria:

          -  Unable to take capsules orally

          -  Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT

          -  Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other
             than that found in fortified foods

          -  Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV
             metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT

          -  Severe underlying disease such that the patient is not expected to survive for one or
             more years or unstable medical condition requiring daily change in treatments
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MSTT1041A; Placebo
Intervention description: Participants will receive subcutaneous (SC) MSTT1041A; Participants will receive SC placebo
Intervention MeSH terms: Astegolimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants
      with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a
      16-week treatment period, and an 8-week follow-up period.
    

Eligibility criteria:

        Inclusion criteria

          -  Ability to comply with the study protocol

          -  Chronic AD that has been present for at least 3 years before the screening visit

          -  Documented recent history (within 6 months before the screening visit) of inadequate
             response to treatment with topical medications (medications or treatments applied
             directly to part of the body) or for whom topical treatments are otherwise medically
             inadvisable

        Exclusion criteria

          -  Prior treatment with MSTT1041A

          -  Treatment with any investigational therapy (with the exception of biologics) within 8
             weeks or within 5 half-lives whichever is longer, before screening

          -  Treatment with any cell-depleting agents within 6 months before screening, or until
             lymphocyte count returns to normal, whichever is longer

          -  Treatment with other biologics within 3 months or 5 half-lives before screening,
             whichever is longer

          -  Comorbid conditions that may interfere with evaluation of investigational medicinal
             product

          -  History or evidence of substance abuse that would pose a risk to participant safety,
             interfere with the conduct of the study, have an impact on the study results, or
             affect the participant's ability to participate in the study

          -  History of anaphylaxis, hypersensitivity to a biologic agent, or known
             hypersensitivity to any component of the MSTT1041A or placebo injection

          -  Planned surgical intervention during the course of the study

          -  Pregnant or breastfeeding, or intending to become pregnant during the study

          -  Participant who is a member of the investigational team or his/her immediate family
Comparison of Loss of Resistance Techniques
Condition: Pain Relief
Intervention: Air; Saline
Intervention description: 3 mls used for identifying epidural space; 3 mls of saline used to identify epidural space
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 356.0
Sex: Female
Healthy volunteers: No
Keywords: Quality of pain relief with 2 different methods of identifying epidural space

Summary:

      The purpose of this study is to determine whether there is a difference in success outcome of
      the combined spinal epidural labor analgesia between air versus saline when used to identify
      the epidural space.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant females weighing less than or equal to 250 lbs

          -  Request for neuraxial labor analgesia

        Exclusion Criteria:

          -  ASA physical status greater than II
Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
Condition: Neuromuscular Blockade
Intervention: Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline; Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;
Intervention description: The participants will be randomized to start with "Muscle relaxant #1" in the first study treatment, and will switch to "Muscle relaxant #2" in the second study treatment period.; The participants will be randomized to start with "Muscle relaxant #2" in the first study treatment, and will switch to "Muscle relaxant #1" in the second study treatment period.
Intervention MeSH terms: Rocuronium; Succinylcholine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The participants will be randomized to one of the two drug groups to start with, and will switch to the other group for the next treatment period. For the study, each participant will take two treatments in a random order: (1) rocuronium to be reversed by sugammadex, and (2) succinylcholine plus normal saline placebo.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The randomization of treatment groups will be blinded to the patients themselves, the psychiatrists and outcome assessors, except the anesthesiologists who will administer the drugs.
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Electroconvulsive Therapy, Neuromuscular Blockade

Summary:

      The investigators propose to compare the recovery of neuromuscular blockade from rocuronium
      reversal by sugammadex to succinylcholine in ECT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible and scheduled for ECT

          -  Has the capacity to consent for the study

        Exclusion Criteria:

          -  Any acute major organ failure in the last 30 days

          -  Any known or suspected neuromuscular disorders

          -  Any history of allergic reaction or intolerance to sugammadex, rocuronium, or
             succinylcholine

          -  Any conditions with severe renal impairment, including those requiring dialysis

          -  Anyone currently taking lithium

          -  Anyone currently taking hormonal contraceptives

          -  Anyone taking anti-coagulants, including vitamin K antagonists, unfractionated
             heparin, low molecular weight heparinoids, rivaroxaban, and dabigatran
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
Condition: Obesity; Overweight and Obesity
MeSH terms: Obesity; Overweight
Intervention: LY3502970; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main purpose of the study was to assess the effect of LY3502970 in participants who have
      obesity or are overweight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²)

          -  Have a BMI ≥27 kg/m² and <30 kg/m² with at least 1 of the following weight-related
             comorbidities eg; [Have hypertension, or dyslipidemia, cardiovascular disease]

          -  Have had a stable body weight for the 3 months prior to randomization (not more than
             5% body weight gain and/or loss)

        Exclusion Criteria:

          -  Have any prior diagnosis of diabetes

          -  Have a prior or planned surgical treatment for obesity

          -  Have obesity induced by other endocrinological disorders or diagnosed monogenetic or
             syndromic forms of obesity

          -  Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30
             milliliter (mL)/minute (min)/1.73 m²

          -  Have a history of acute chronic pancreatitis

          -  Have a history of significant active or unstable Major Depressive Disorder (MDD) or
             other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or
             other serious mood or anxiety disorder) within the last 2 years Note: Participants
             with MDD or generalized anxiety disorder whose disease state is considered stable for
             the past 2 years and expected to remain stable throughout the course of the study, may
             be considered for inclusion if they are not on excluded medications.

        Within 3 months prior to screening:

          -  Have poorly controlled hypertension

          -  Have history of acute myocardial infarction

          -  Have history of cerebrovascular accident (stroke)

          -  Had hospitalization due to congestive heart failure (CHF)

          -  Have cancer

          -  Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or
             at screening

          -  Have hepatitis B and/or positive hepatitis B surface antigen
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
Condition: Sarcopenia
MeSH terms: Sarcopenia
Intervention: bimagrumab; Placebo
Intervention description: bimagrumab low dose bimagrumab moderate dose bimagrumab high dose
Patients enrolled prior to the protocol amendment 1 (Population I ), who received bimagrumab in the core study, entered the extension study at Week 25 and were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Study medication was administered as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.; Placebo
Patients enrolled prior to the protocol amendment 1 (Population I), who received placebo in core study, entered the extension study at Week 25 and received placebo as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, lean body mass, gait speed

Summary:

      This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study
      and the main objective was to determine the long-term durability of bimagrumab (BYM338)
      effect after a 6-month treatment period.
    

Eligibility criteria:

        Inclusion criterion:

        - Men and postmenopausal women aged 70 years or older that have participated in, and have
        completed the full study treatment period per protocol (24 weeks/EOT visit) in the
        preceding core study (CBYM338E2202)

        Exclusion criterion:

        - Any condition which should have led to treatment discontinuation per protocol in the core
        study (CBYM338E2202)
Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell; Inflammation
Intervention: alpha-lipoic acid and acetyl-L-carnitine; Control
Intervention description: none to report; none to report
Intervention MeSH terms: Thioctic Acid; Acetylcarnitine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Antioxidant; Inflammation; Sickle Cell Disease; Oxidative Stress; Cytokines; anti-inflammatory; Acetylcarnitine

Summary:

      The purpose of this study is to determine whether alpha-lipoic acid and acetyl-L-carnitine
      will lower systemic inflammation in patients with Sickle Cell Disease by reducing oxidative
      stress, which will result in a decrease in the frequency of vaso-occlusive pain episodes and
      improve their quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta
             zero thalassemia genotype

          -  Age at entry at least 14 years. Younger children will not be included since the
             combination alpha-lipoic acid and acetyl-L-carnitine tablets are not available in a
             smaller dose at this time.

        Exclusion Criteria:

          -  More than 3 packed red blood transfusions in the past 12 months

          -  Coexisting illness that could contribute to inflammation. These include chronic
             hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and
             other similar conditions.

          -  Acute sickle cell disease related symptoms requiring a hospital visit in the past 4
             weeks

          -  Women who are pregnant, attempting to get pregnant, or breast feeding

          -  Active participation in other investigational drug or device studies

          -  Participants who start hydroxyurea or regular transfusion therapy during the course of
             the study on the recommendation of their primary hematologist will be ineligible for
             further participation.