bioihbjkbjnl/mcl2 huggingface dataset:
MC-5A for Chemotherapy Induced Peripheral Neuropathy
Condition: Neuropathy, Paraneoplastic
MeSH terms: Paraneoplastic Polyneuropathy; Peripheral Nervous System Diseases
Intervention: MC-5A; Sham device
Intervention description: 45 minutes daily x 10 treatments (given over the course of 2 weeks); Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuropathy,paraneoplastic; paraneoplastic peripheral neuropathy; pain; hyperalgesia

Summary:

      Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer
      therapy with few treatment options. CIPN is a complex side effect that varies between
      individuals and can be difficult to describe, difficult to treat and can significantly effect
      quality of life for patients.

      The purpose of this study is to determine if patients with painful CIPN will have a decrease
      in pain scores after treatment with the MC-5A device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  painful peripheral neuropathy resulting from chemotherapy

          -  pain must be present for minimum of 6 months

          -  must be able to read/understand English

          -  stable analgesics regimens allowed (no change for past 7 days)

        Exclusion Criteria:

          -  painful peripheral neuropathy that is not the result of chemotherapy

          -  pregnant women

          -  patients unable to wean off anti-epileptics

          -  patients currently receiving chemotherapy known to cause peripheral neuropathy

          -  patients with pacemakers or implanted defibrillators

          -  patients with vena cava or aneurysm clips

          -  patients with a history of epilepsy
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: MIV-711; Placebo
Intervention description: MIV-711 administered orally once daily; Placebo manufactured to mimic MIV-711 capsule.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel,
      Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with
      knee osteoarthritis (OA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current average knee pain, defined as pain in either knee, within 1 week before visit
             1, for which the patient gives a severity score of ≥4, <10 on a 0-10 NRS (Numeric
             Rating Scale).

          -  Inclusive of 40-80 years old.

          -  Diagnosis of primary knee osteoarthritis

        Exclusion Criteria:

          -  The presence of any inflammatory arthritis

          -  Any generalized pain condition that may interfere with the evaluation of the target
             knee pain (e.g., fibromyalgia) as judged by the investigator.

          -  Any clinically severe or significant uncontrolled concurrent illness, which, in the
             opinion of the Investigator, would impair ability to give informed consent or take
             part in or complete this clinical study.

          -  Known or suspected intolerance or hypersensitivity to the investigational product,
             closely related compounds, or any of the stated ingredients.
BI 671800 ED in Steroid-naive Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: BI 671800; Fluticasone propionate placebo; Fluticasone propionate; BI 671800 Placebo
Intervention description: BI 671800; Placebo matching Fluticasone propionate; Fluticasone propionate; Placebo matching BI 671800
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 389.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in
      patients with asthma who do not take inhaled corticosteroids.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed informed consent consistent with ICH-GCP

          2. Three month history of reversible (12% with 200 mL) asthma (according to GINA) with
             following spirometry at randomization: FEV1 60%-85%.

          3. No ICS previous 3 months prior to screening.

          4. Diagnosis of asthma prior to 40 years.

          5. ACQ at least 1.5 at randomization.

          6. Male or female, 18 to 65 years.

          7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine
             screen.

          8. Able to perform PFT

        Exclusion criteria:

          1. Significant diseases other than asthma or allergic rhinitis.

          2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.

          3. Hospitalizations for asthma or asthma related intubation within 3 months.

          4. Uncontrolled asthma.

          5. Respiratory tract infection or exacerbation within 4 weeks.

          6. FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or
             asthma exacerbation during the run-in period.

          7. Participation in another interventional study.

          8. Pregnant or nursing women.

          9. Women of child bearing potential nor using appropriate methods of birth control as
             defined by protocol
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Combination Product: BCI-024 + BCI-049
Intervention description: BCI-024 and BCI-049 once a day at bedtime for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: depression; combination

Summary:

      The objective of this study is to allow patients who have participated in the precursor study
      of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01)
      to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination
      with an increased dose of BCI-049.

      The safety and tolerability of this higher dose of the combination will be evaluated, as will
      the treatment effect in reducing symptoms of depression in patients with MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are willing to provide written informed consent and who have completed
             participation in Protocol CBM-IT-01 are eligible for the study.

          -  Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol
             requirements.

        Exclusion Criteria:

        - Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible
        for the study.
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Condition: Alopecia; Alopecia, Androgenetic; Baldness
MeSH terms: Alopecia; Alopecia Areata
Intervention: bimatoprost Formulation A; bimatoprost Formulation B; bimatoprost Formulation C; bimatoprost vehicle solution; minoxidil 5% solution
Intervention description: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Intervention MeSH terms: Bimatoprost; Minoxidil; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 307.0
Sex: Male
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared
      with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic
      alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5%
      solution which will be provided open-label.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss
             for at least 1 year

          -  Willingness to have micro-dot-tattoo applied to scalp

          -  Willingness to maintain same hair style, length and hair color during study

        Exclusion Criteria:

          -  Drug or alcohol abuse within 12 months

          -  HIV positive

          -  Received hair transplants or had scalp reductions

          -  Use of hair weaves, hair extensions or wigs within 3 months

          -  Oral or topical minoxidil treatment within 6 months

          -  Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to
             scalp within 4 weeks
Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Ecopipam; Placebo
Intervention description: Ecopipam HCI tablets administered PO to establish 2 mg/kg/day; Matching Placebo
Intervention MeSH terms: Ecopipam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 153.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study evaluates the effect of ecopipam tablets in children and adolescents in the
      treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam
      tablets, while the other half will receive matching placebo tablets
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 6 and < 18 years of age

          -  ≥ 18 kg (~ 40 lbs.)

          -  TS diagnosis and both motor and vocal tics that cause impairment with normal routines

          -  Minimum score of 20 on the YGTSS-Total Tic Score

          -  May not be taking any medications used to treat motor or vocal tics for at least 14
             days prior to Baseline.

          -  Effective contraception during the study and 30 days after last study dose for
             sexually active subjects

        Exclusion Criteria:

          -  Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder,
             schizophrenia, major depressive disorder)

          -  Unstable medical illness or clinically significant lab abnormalities

          -  Risk of suicide

          -  Pregnant or lactating women

          -  Moderate to severe renal insufficiency

          -  Hepatic insufficiency

          -  Positive urine drug screen

          -  Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity
             Disorder

          -  Certain medications that would lead to drug interactions

          -  Recent behavioral therapy
Early Propranolol After Traumatic Brain Injury: Phase II
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: Propranolol
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine in patients with traumatic brain injury
      (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia
      (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or
      decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive
      to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the
      number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to
      treatment that occur without propranolol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who present within 6 hours of traumatic brain injury who have 1) a Glasgow
             Coma Scale (GCS) score of ≤8 or a GCS of 9-12 with computerized tomography brain scans
             demonstrating brain injury.

        Exclusion Criteria:

          -  pregnancy,

          -  patients already treated with beta-blockers,

          -  patients treated for antiarrhythmic, immunosuppressive or antiinfective treatment,

          -  myocardial infarction during the last 3 months,

          -  unstable or severe heart disease,

          -  severe chronic obstructive pulmonary disease,

          -  serious liver disease,

          -  cardiac ischemia that prevents the initiation of vasopressors,

          -  signs of cardiac arrhythmia or heart block on EKG,

          -  ischemic limb disease that prevents the initiation of vasopressors, vasopressors at
             maximum dose defined as norepinephrine at 40µg/min or neosynephrine at 300µg/min.
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: BIM 23A760
Intervention description: Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin)
      injections at different doses of BIM 23A760 on growth hormone and insulin-like growth
      factor-1 levels in patients with acromegaly after 6 months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  IGF-1 ≥1.3 x upper limit normal (ULN)

          -  Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)

          -  Patient must have documentation supporting the diagnosis of acromegaly, including
             elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.

        Exclusion Criteria:

          -  The patient has received long acting somatostatin analogues within 6 months of study
             entry

          -  The patient has undergone radiotherapy at any time prior to study entry

          -  The time between pituitary surgery (if any) and study entry is less than 6 weeks

          -  The patient suffers from macroadenoma with visual field defects due to chiasmatic
             compression
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab [Herceptin]
Intervention description: Initial loading dose of 4 mg/kg i.v. infusion, followed by weekly doses of 2 mg/kg for up to 18 weeks.
Intervention MeSH terms: Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm, multicenter, open-label study will evaluate the efficacy and safety of
      Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in
      patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg
      (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on
      study treatment is 18 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Diagnosis of breast carcinoma with HER-2 overexpression

          -  At least one measurable brain metastasis

          -  Patients for whom, according to investigator assessment, whole brain radiotherapy is
             the best therapeutic option

          -  Performance status (WHO) </=2

          -  Life expectancy >/=3 months

        Exclusion Criteria:

          -  Presence of neoplastic meningitis

          -  Any prior radiotherapy to the brain

          -  Patients for whom, according to investigator assessment, stereotactic radiotherapy is
             the best therapeutic option

          -  Previous neoplasms, other than breast carcinoma, within 5 years since enrolment
The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly
Condition: Treatment; Placebo
Intervention: d-cycloserine; Sugar Pill
Intervention description: single oral administration of 250 mg d-cycloserine; Single oral administration 250 mg Sugar Pill
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: d-cycloserine; geriatric; neuropsychology; cognition; cognitive-enhancer; aging; neuropsychological functioning

Summary:

      The goal of this study is to determine whether a study medication (d-cycloserine) improves
      the ability of older adults to perform on tests of neuropsychological functioning. Tests of
      neuropsychological functioning assess attention, memory, and executive functioning skills
      (for example, problem-solving, planning and organizing skills). It was hypothesized that
      participants who received study medication would perform better on neuropsychological tests
      than would participants who received the sugar pill.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 60 or older

          -  native English speaker

        Exclusion Criteria:

          -  diagnosis of current psychiatric disorder

          -  substance abuse past 3 months

          -  cognitive impairment

          -  neurological disorder

          -  poor health or unstable medical condition

          -  positive toxicology screen

          -  current use of isoniazid

          -  current use of trecator

          -  severe renal insufficiency
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
Condition: Non-alcoholic Fatty Liver Disease (NAFLD; Hypertriglyceridemia
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight; Hypertriglyceridemia
Intervention: Placebo; Omega-3 carboxylic acid; Fenofibrate 200mg; Placebo
Intervention description: Placebo matching to Omega-3 carboxylic acids (olive oil); 4 g administered as 4 x 1 g capsules; 200mg capsule administered once daily; Placebo matching to fenofibrate 200mg
Intervention MeSH terms: Fenofibrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: omega-3 carboxylic acid

Summary:

      This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study
      performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and
      fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with
      over-weight and hypertriglyceridemia.
    

Eligibility criteria:

        Inclusion Criteria: - Provision of informed consent

          -  Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated
             venepuncture

          -  Have serum triglycerides ≥1.7 mM

          -  Have liver fat content as assessed by MRI >5.5%

          -  Have a body mass index (BMI) >25 and ≤40 kg/m2

             , Exclusion Criteria: - History of or presence of any clinically significant disease
             or disorder which, in the opinion of the investigator, may either put the subject at
             risk because of participation in the study, or influence the results or the subject's
             ability to participate in the study.

          -  Creatinine clearance <60 mL/min at screening (Cockcroft-Gault formula).

          -  Severe hepatic insufficiency and/or significant abnormal liver function defined as
             aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine
             aminotransferase (ALT) >3x ULN

          -  Total bilirubin >2.0 mg/dL (34.2 µmol/L)

          -  Type 2 diabetes, as defined by WHO criteria e.g. fasting plasma Glucose >7.0 mM or use
             of antidiabetic therapy

          -  Any clinically significant abnormalities in clinical chemistry, haematology or
             urinalysis results as judged by the investigator. This includes signs of liver disease
             other than NAFLD that motivates further investigations of treatment based on clinical
             judgement

          -  Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse was to
             be defined as >14 drinks per week (1 drink = 35 cl beer, 14 cl wine, or 4 cl hard
             liquor) or as judged by the investigator