bioihbjkbjnl/mcl2 huggingface dataset:
Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Body Weight
Intervention: Ursodiol
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will evaluate whether bile acids are able to increase insulin sensitivity and
      enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance
      glycemic control. These observations will provide the preliminary data for proposing future
      therapeutic as well as further mechanistic studies of the role of bile acids in the control
      of glycemia in T2DM.
    

Eligibility criteria:

        Overweight or Obese subjects with BMI> 25 Kg/m2 with Type 2 Diabetes mellitus on Metformin,
        receiving standard of care for Type 2 DM. Otherwise individuals who are not currently on
        treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological,
        neurological, endocrine (other than T2DM) and unstable psychiatric disease.

        Men or women. Women of childbearing potential will have a negative pregnancy test before
        initiation of medication.
The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
Condition: Nonproliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: AKB-9778; Placebo
Intervention description: Subcutaneous AKB-9778 15mg; Subcutaneous Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of subcutaneously
      administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with
      moderate to severe non-proliferative diabetic retinopathy (NPDR).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adults 18 through 80 years of age (inclusive)

          -  Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)

          -  No evidence of central involved diabetic macular edema

          -  ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better)

        Key Exclusion Criteria:

          -  Ocular disease other than DR that may cause substantial reduction in visual acuity,
             including iris neovascularization, retinal detachment, visually significant epiretinal
             membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other
             retinal inflammatory or infectious diseases

          -  Evidence of neovascularization on clinical examination or imaging

          -  Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening

          -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality
             that may increase the risk associated with study participation
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: MEDI8897; Placebo
Intervention description: A single IM dose of 50 mg on Day 1 of the study.; A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1453.0
Sex: All
Maximum age: 365 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus, RSV; Preterm Infants; Lower Respiratory Tract Infection

Summary:

      The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and
      antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29
      and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV)
      season.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.

          2. Infants who are entering their first full RSV season at the time of screening.

        Key Exclusion Criteria:

          1. Meets American Academy of Pediatrics (AAP) or other local criteria to receive
             commercial palivizumab.

          2. Any fever (>= 100.4°F [>= 38.0°C], regardless of route) or lower respiratory illness
             within 7 days prior to randomization.

          3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at
             the time of randomization.

          4. Active RSV infection (a child with signs/symptoms of respiratory infection must have
             negative RSV testing) or known prior history of RSV infection.

          5. Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including
             maternal RSV vaccination.
ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: ACT01; Comp01; Comp02; Comp03; Comp04
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether or not ACT01 is effective and tolerable
      alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with
      facial and/or scalp keratosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2
             contiguous area containing at least four lesions that are non-hypertrophic and
             non-hyperkeratotic and not larger than 6 mm in longest diameter.

          2. Age 30-85 years, inclusive.

          3. Good general health as determined by investigator and supported by medical history and
             normal or not clinically significant abnormal vital signs (blood pressure and pulse).

        Exclusion Criteria:

          1. Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological,
             hepatic, neurological, pancreatic, pulmonary or renal disease.

          2. Dermatologic conditions if present on the face such as acne, atopic dermatitis,
             seborrheic dermatitis, eczema, rosacea, or albinism.

          3. Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen
             plus ultraviolet A) therapy, or 5) UVB therapy to the intended treatment area within
             180 days prior to the Baseline Visit.

          4. Use of sun lamps or sun tanning beds or booths during the 14 days prior to the
             Baseline Visit.
A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
Condition: ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: MEDI6012; Placebo
Intervention description: MEDI6012; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: In this study, the participant and sponsor staff will be blinded. Sites will be trained to keep the investigator blinded. However, due to the acute nature of the study, members of the research team and, possibly, the investigator may be unblinded.
Enrollment: 593.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy,
      safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult
      participants presenting with acute STEMI (ST segment elevation myocardial infarction).

      The study will enrol participants presenting with acute STEMI who are planned for primary
      percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be
      performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also
      undergo an index and an end of study CTA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation

          -  Planned for primary PCI (percutaneous coronary intervention)

          -  Men and women without child-bearing potential aged 30-80 years of age

          -  Capable and willing to provide informed consent.

          -  Capable of completing study visits

        Exclusion Criteria:

          -  Fibrinolytic administration for index event

          -  Known prior MI or prior coronary artery bypass graft (CABG) surgery

          -  Known pre-existing cardiomyopathy

          -  History of anaphylaxis

          -  Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo
             cardiomyopathy)
Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
Condition: Pain
Intervention: CA-008; Ketorolac; Acetaminophen IV; Fentanyl; Bupivacaine Hydrochloride; Lidocaine HCl; Celecoxib; Acetaminophen Oral; Lidocaine Hydrochloride; Exparel
Intervention description: Drug: CA-008 4.2 mg reconstituted in saline; 30 mg IV at the onset of anesthesia; 1 g at the onset of anesthesia; 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery; 0.25% 30 mL (75 mg) prior to surgery; 1.5% 12 mL at the end of surgery; 200 mg PO bid each day postoperative; 1 g postoperative; 2% 15 mL at the end of surgery; Bupivacaine liposome injection suspension
Intervention MeSH terms: Acetaminophen; Celecoxib; Ketorolac; Lidocaine; Fentanyl; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult aged 18 - 65 years old

          2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3

          3. Planning elective Bunionectomy repair

          4. For both males and females: using an acceptable method of birth control

          5. If a female: not pregnant or breastfeeding

          6. Have a body mass index ≤ 36 kg/m2

        Exclusion Criteria:

          1. Have another painful condition, other than bunion-related pain, that may require pain
             treatment during the study period

          2. Have active skin disease or another abnormality at the anticipated site of surgery
             that could interfere with the planned surgery.

          3. Have a known allergy to study medications.

          4. Have a history of significant medical, neuropsychiatric or other condition, including
             a clinically significant abnormal clinical laboratory test values

          5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
Condition: Bariatric Surgery
MeSH terms: Weight Loss
Intervention: GLP-1
Intervention description: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bariatric Surgery; Glucose Regulation; Cardiac Function; Body Composition

Summary:

      This study is being conducted to evaluate changes in sugar, metabolism, heart function and
      changes in body composition as patients lose weight following bariatric surgery. The
      investigators will compare improvements of the above changes as a function of the four
      different types of bariatric surgery. The investigators believe the most beneficial and
      safest procedure will be the Roux-en-Y.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female volunteers 21-65 years.

          -  BMI > 40.

          -  Preoperative hematocrit level of at least 34% for women and 38% for men.

          -  Postoperative hematocrit level of at least 34% for women and 36% for men.

        Exclusion Criteria:

          -  Volunteers whose hematocrit level does not meet the above criteria.

          -  Pregnant and or lactating females.
Use of Convalescent Plasma for COVID-19
Condition: COVID
Intervention: Convalescent Plasma
Intervention description: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe
      whether this will result in a significant improvement in clinical outcome in comparison to
      historical experience.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented COVID-19 infection by nasal pharyngeal sampling

          -  COVID-19 disease falling into one of the following groups:

          -  Critical disease: respiratory failure requiring mechanical ventilation, pressor
             support, or multiple organ dysfunction/failure

          -  Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index
             </=300mmHg

          -  High Risk: upper respiratory symptoms but no radiographic evidence of disease,
             immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate
             to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years

          -  Health Care Providers: health care providers at risk to exposure to COVID-19 infection
             or those with mild to non-severe disease

        Exclusion Criteria:

          -  History of IgA deficiency

          -  History of anaphylatic reaction to blood product transfusion including
             hypersensitivity to immunoglobulin therapy
Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder
Condition: HIV Infections; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Depression; Substance Abuse
MeSH terms: Substance-Related Disorders; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Intervention: Twinrix; Enhanced treatment as usual
Intervention description: This vaccine will be given in three parts: at entry and after 3 and 6 months.; Participants will receive comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Serious Mental Illness; Dual Diagnosis; Mental Disorders; Substance-Related Disorders

Summary:

      This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce
      risk, and Refer) intervention in increasing rates of testing, immunization, referral, and
      treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental
      disorder and a substance abuse disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or
             major depression

          -  Diagnosis of a substance use disorder

          -  Enrolled in clinical care at Creative Alternatives or People Encouraging People for at
             least 3 months

        Exclusion Criteria:

          -  Pregnant
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab; CP-690-550; CP-690-550; CP-690-550; CP-690,550; CP-690,550; Placebo
Intervention description: 40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.; 15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10); 10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10); 5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10); 3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10); 1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10); Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)
Intervention MeSH terms: Adalimumab; Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 386.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Janus Kinase 3 Clinical Trial

Summary:

      The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5
      doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of
      seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®)
      and one out of seven will only receive inactive substances (placebo.)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have active rheumatoid arthritis

          -  Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)

          -  Subjects must not be currently taking any DMARD other than an antimalarial

        Exclusion Criteria:

          -  Subjects who discontinued any previous TNF inhibitor therapy for either lack of
             benefit or safety.

          -  Subjects who previously received adalimumab (Humira®) therapy for any reason.

          -  Subjects with evidence of blood disorders, chronic infections or untreated
             tuberculosis
Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents
Condition: Angina
Intervention: Ranolazine; Sugar pill
Intervention description: Ranolazine 500mg tablet
500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks; sugar pill manufactured to mimic ranolazine 500mg tablet
500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: deferred percutaneous coronary intervention; fractional flow reserve

Summary:

      To determine if ranolazine improves angina symptoms at 4 months compared with placebo among
      patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on
      the Fractional Flow Reserve (FFR) measurement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable patients >= 18 years of age referred for cardiac catheterization for evaluation
             of cardiac symptoms ( angina, fatigue, or shortness of breath)

          -  At least 1 indeterminate stenosis (20-80%), fractional flow reserve (FFR) >=0.8 and
             PCI deferred

        Exclusion Criteria:

          -  Coronary revascularization (percutaneous coronary intervention or coronary artery
             bypass grafting) during the index procedure or anticipated within the next month

          -  acute coronary syndrome or cardiogenic shock

          -  use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole,
             clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)

          -  use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital,
             phenytoin, carbamazepine, and St. John's wort)

          -  liver cirrhosis

          -  sever renal insufficience (i.e. creatinine clearance < 30mL/min/1.73 m2)

          -  QTc > 500 milliseconds