bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.
Condition: Parkinson Disease; Multiple System Atrophy
MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Intervention: Intranasal Insulin
Intervention description: treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
placebo arm: normal saline, daily, intranasally, for 4 weeks.
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parkinson disease; Multiple system atrophy; Intranasal; Insulin

Summary:

      Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative
      disorders characterized by abnormal accumulation of α-synuclein. There is no effective
      treatment that can slow down the disease progression and both disorders are associated with
      severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and
      memory in healthy and cognitively impaired non-diabetic adults.

      The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322)
      has shown that a single 40 international units dose of intranasal insulin improves
      visuospatial memory in diabetes and control subjects.

      This proposal includes randomized, double blinded, placebo-controlled trial of intranasal
      insulin (40 international units daily) in treatment of PD and MSA.

      The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the
      study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of
      cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of
      the cognitive scale ratings.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females older than 17 years.

          2. Clinical diagnosis of Parkinson disease or multiple system atrophy.

          3. Provide written informed consent to participate in the study.

          4. Understand that they may withdraw their consent at any time.

        Exclusion Criteria:

          1. Women who are pregnant or lactating.

          2. In the investigator's opinion, have significant systemic, hepatic, cardiovascular,
             renal or other illness that can interfere based on investigator judgment with the
             trial.

          3. History of dementia.

          4. Unable to walk without help for at least 1 minute.

          5. History of allergic reaction to insulin.

          6. The presence of inflammation of nasal cavity that may prevents absorption of insulin.
The Effects of Metformin on Blood Vessel Structure and Function
Condition: Obesity; Hypertension; Hypercholesterolemia; Hyperglycemia
MeSH terms: Hypercholesterolemia; Hyperglycemia
Intervention: Metformin; Placebo
Intervention description: 850mg tablet once a day for one month, then twice a day for 3 months; placebo tablet once a day for one month, then twice a day for 3 months
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Metabolic Syndrome; triglycerides; HDL; LDL; High Blood Pressure; High Cholesterol; High Blood Sugar

Summary:

      The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on
      the blood vessels of individuals with the Metabolic Syndrome (MeS).
    

Eligibility criteria:

        Inclusion Criteria:

        Participants with the Metabolic Syndrome, which is defined as having 3 or more of the
        following 5 alterations:

          -  Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)

          -  Elevated triglycerides (>150 mg/dl)

          -  Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women)

          -  Elevated blood pressure (>130/85) or treatment for high blood pressure

          -  Elevated fasting blood sugar (>100 mg/dl)

        Exclusion Criteria:

          -  Diabetes treated with medication

          -  Blood pressure >160/100 mmHg

          -  Clinical Congestive Heart Failure

          -  Anemia with hematocrit <32%

          -  Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring daily medication or
             use of home oxygen therapy

          -  Major surgery planned within the next six months

          -  A recent, unexplained weight loss of >10% of body weight in the past 6 months

          -  A known allergy or hypersensitivity to Metformin

          -  History of hepatitis or cirrhosis

          -  History of kidney disease (defined as serum creatinine >1.4 mg/dL in men, >1.3 mg/dL
             in women)

          -  Pregnancy or the absence of an effective method of contraception

          -  Illicit drug or alcohol abuse

          -  Cancer requiring treatment currently or recently completed treatment in the last 2
             months
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Miricorilant; Placebo
Intervention description: Tablets taken orally; Placebo tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Nonalcoholic Steatohepatitis; NASH; Nonalcoholic Fatty Liver Disease

Summary:

      This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and
      efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis
      (NASH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of NASH based on a biopsy obtained within the last year OR

          -  Have a diagnosis of presumed NASH based on blood tests and scans

        Exclusion Criteria:

          -  Have participated in another clinical trial within the last year and received active
             treatment for NASH

          -  Have participated in another clinical trial for any other indication within the last 3
             months

          -  Are pregnant or lactating women

          -  Have a BMI <18 kg/m^2

          -  Have had liver transplantation or plan to have liver transplantation during the study

          -  Have type 1 diabetes or poorly controlled type 2 diabetes.
Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: NBI-98854; 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: 98.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of
      NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will
      enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette
      Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have at least moderate tic severity

          3. Have TS symptoms that impair school, occupational, and/or social function

          4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          5. Be in good general health

          6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for
             amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
             cannabinoids and a negative alcohol screen

          7. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening

          2. Have a known history of long QT syndrome or cardiac arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening

          7. Have a known history of substance dependence, substance (drug) or alcohol abuse

          8. Have a significant risk of suicidal or violent behavior

          9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the
             screening period or at baseline or plan to initiate CBIT during the study

         10. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study
Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia
Condition: Acute Leukemias
MeSH terms: Leukemia; Acute Disease
Intervention: LDE225
Intervention description: LDE225 will be supplied as 200 mg capsules by Novartis. Patients will receive study treatment on an outpatient basis. LDE225 will be dispensed every two weeks for the first four weeks and at the start of every four weeks thereafter, as needed.
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: acute myeloid leukemia; AML; acute lymphoblastic leukemia; ALL; leukemia; acute; LDE225; adult patients; relapsed/refractory

Summary:

      The study will evaluate the efficacy, safety and tolerability of two dosing schedules of
      LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated
      acute leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have relapsed or primary refractory non-M3 acute myeloid leukemia or
             relapsed or refractory non-T-cell acute lymphoblastic leukemia or untreated acute
             myeloid leukemia in elderly patients.

          -  Performance status of 0, 1 or 2 per WHO classification.

          -  Adequate renal and liver function.

          -  Adequate blood creatine kinase value (CK < 1.5ULN)

        Exclusion Criteria:

          -  Allogeneic stem cell transplantation within the last 4 months and/or active graft
             versus host disease requiring systemic immunosuppressant therapy, or autologous stem
             cell transplantation within the last 4 weeks.

          -  Patient for which immediate allogeneic stem cell transplantation is the treatment of
             choice.

          -  Pregnant or nursing (lactating) women.

          -  Active CNS leukemic involvement
Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Firsocostat; Placebo
Intervention description: Capsules orally once daily.; Placebo matched to firsocostat orally once daily.
Intervention MeSH terms: Firsocostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of firsocostat
      in adults with nonalcoholic steatohepatitis (NASH).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Meets all of the following conditions:

               -  A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)

               -  Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF)
                  with ≥ 8% steatosis

               -  Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kPa

                    -  OR

               -  A historical liver biopsy consistent with NASH and non-cirrhotic fibrosis

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine Clearance (CLcr ) as calculated by the Cockcroft-Gault equation ≥ 60 ml/min

        Key Exclusion Criteria:

          -  Pregnant or lactating females

          -  Alanine aminotransferase (ALT) > 5 x upper limit of the normal range (ULN)

          -  Other causes of liver disease including autoimmune, viral, and alcoholic liver disease

          -  Cirrhosis of the liver

               -  Prior history of decompensated liver disease, including ascites, hepatic
                  encephalopathy or variceal bleeding

          -  Body mass index (BMI) < 18 kg/m^2

          -  International normalized ratio (INR) > 1.2 unless on anticoagulant therapy

          -  Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
Condition: Alagille Syndrome
MeSH terms: Alagille Syndrome; Pruritus; Syndrome
Intervention: LUM001; Placebo
Intervention description: LUM001 administered orally; Placebo administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The study is a randomized, double-blind, placebo-controlled study in children with Alagille
      Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on
      pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with
      ALGS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of Alagille Syndrome

          2. Evidence of cholestasis

          3. Moderate to severe pruritus

          4. Ability to understand and willingness to sign informed consent/assent prior to
             initiation of any study procedures

        Exclusion Criteria:

          1. Surgical disruption of the enterohepatic circulation

          2. Liver transplant

          3. History or presence of other concomitant liver disease

          4. Females who are pregnant or lactating

          5. Known HIV infection
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab; placebo; ICS/LABA therapy; Salbutamol/albuterol; Levosalbutamol/levalbuterol
Intervention description: Solution for injection, Subcutaneous injection; Solution for injection, Subcutaneous injection; Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose; Oral inhalation as needed; Oral inhalation as needed
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 776.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the efficacy of different doses and regimens of dupilumab in participants with
      moderate to severe uncontrolled asthma.

      Secondary Objective:

      To evaluate different doses and regimens of dupilumab in participants with moderate to severe
      uncontrolled asthma, with regard to:

        -  Safety and tolerability

        -  Dupilumab systemic exposure and anti-drug antibodies
    

Eligibility criteria:

        Inclusion criteria:

        Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for >=12
        months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:

          -  Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting
             beta-2 agonist

          -  Forced expiratory volume (FEV1) 40 to 80% of predicted normal

          -  Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5

          -  Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)

          -  Had experienced, within prior year: hospitalization, emergency or urgent care visit or
             systemic corticosteroid treatment for worsening asthma

        Exclusion criteria:

          -  Participants <18 years

          -  Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema,
             idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary
             aspergillosis) which impaired pulmonary function tests

          -  Chest X-ray within 12 months of screening visit or at screening visit with clinically
             significant findings of lung disease(s) other than asthma

          -  Current smoker or cessation of smoking within 6 months prior to Visit 1

          -  Previous smoker with a smoking history >10 pack-years

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension
Condition: Systolic Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension; Systolic Murmurs
Intervention: LCZ696; Valsartan; AHU377; Placebo
Intervention description: LCZ696 was supplied as tablets in blister cards in 100 mg strengths.; Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.; AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.; Placebo was supplied as tablets in blister cards.
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 910.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertension; blood pressure; LCZ696; dual-acting; neprilysin; nep inhibitor; vasopeptidase; angiotensin receptor; angiotensin receptor neprilysin inhibitor (ARNi)

Summary:

      The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses
      of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed
      dose of valsartan (320 mg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed. Patients
             with mild-to-moderate systolic hypertension, untreated or currently taking
             antihypertensive therapy.

          -  Ability to communicate and comply with all study requirements and demonstrate good
             medication compliance (≥ 80% compliance rate) during the run-in period.

        Exclusion Criteria:

          -  Severe hypertension

          -  History of angioedema, drug-related or otherwise, as reported by the patient.

          -  Pregnant or nursing (lactating) women.

          -  Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control
             methods.

          -  History or evidence of a secondary form of hypertension.

          -  Other protocol-defined inclusion/exclusion criteria may apply