bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
Condition: Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: IdB 1016 (Siliphos); Matched placebo
Intervention description: 1 pill 3 times daily x 6 weeks; 1 pill 3 times daily x 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clinical Trials; Pilot Projects; Milk Thistle; Liver Function Tests

Summary:

      The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from
      milk thistle, to determine whether it is safe and well-tolerated in adults who have
      non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether
      Siliphos may be beneficial in treatment of NASH as indicated by improvement in liver enzymes
      (ALT and AST). The study hypothesis is that Siliphos will be safe and well-tolerated in
      people with NASH and will result in a decrease in the liver enzymes ALT and AST.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver biopsy within 12 months demonstrating NASH

          -  Abnormal ALT

        Exclusion Criteria:

          -  Uncontrolled diabetes

          -  Hepatitis B, hepatitis C, or other chronic liver conditions

          -  Abnormal kidney function

          -  Excess alcohol consumption
Phase II Study of HMPL-004 in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: HMPL-004; Placebo
Intervention description: HMPL-004 1200 mg/d; Placebo 1200 mg/d
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A double blind, randomized, multi-center, placebo-controlled study to evaluate the efficacy
      and safety of HMPL-004 in patients with active moderate Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or
             histologically), with a CDAI of 220-400 at baseline screen

        Exclusion Criteria:

          -  They have received anti-TNF-α antibody within 3 months of starting study medication,
             or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of
             starting study medication
The Safety and Efficacy of Recombinant Human Prolactin
Condition: Healthy
Intervention: Recombinant Human Prolactin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: galactorrhea; prolactin; bone turnover; menstrual cycle; Control Groups; Women

Summary:

      Medications used to increase breast milk production increase prolactin secretion, the main
      hormone of lactation. There are no FDA approved medications used to improve breast feeding,
      but metoclopramide is used off-label and can have intolerable side effects. We examined the
      biological activity and safety of recombinant human prolactin (r-hPRL) as a potential
      medication to augment lactation. In this study, the effect of r-hPRL on breast milk
      production in women who did not recently deliver a baby and its effect on the bones and
      menstrual cycle were tested.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy Subjects will meet the following criteria:

          1. 18 to 40 years of age

          2. Normal weight (BMI 17 to £ 30 kg/m2)

          3. Good general health

          4. On no medications for at least 3 months before the study

          5. Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase
             progesterone level

          6. No evidence of androgen excess

          7. Normal TSH, prolactin and hematocrit

          8. No current interest in conception

          9. No history of osteoporosis

         10. No use of medications known to affect bone turnover

         11. No alcoholism

         12. No smoking

         13. No history of medical problems or treatment known to affect bone turnover.

        Exclusion Criteria:

        Subjects will be excluded for pregnancy or evidence of breast masses.
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Condition: Exocrine Pancreatic Insufficiency (EPI); Cystic Fibrosis (CF)
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: MS1819; Porcine PERT
Intervention description: MS1819, an oral, non-systemic, that is non-enterically-coated. It is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.; Porcine PERT is being used as a comparator to MS1819 as a second drug/intervention
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2x2 Crossover
Masking: None (Open Label)
Masking description: Unblinded
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Exocrine pancreatic insufficiency; EPI; Cystic Fibrosis; CF; Pancreatic enzyme replacement therapy (PERT); Lipase

Summary:

      The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs
      porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic
      insufficiency (EPI) due to cystic fibrosis (CF).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cystic fibrosis, based on 2 clinical features consistent with CF, plus initial
             diagnostic sweat chloride ≥ 60 mmol/L

          2. Under stable dose of porcine PERT

          3. A fair or better nutritional status

          4. Fecal elastase <100 µg/g

          5. Standard-of-care medications including Cystic Fibrosis Transmembrane Conductance
             Regulator (CFTR) modulators are allowed

        Exclusion Criteria:

          1. History or diagnosis of fibrosing colonopathy

          2. Any chronic diarrheal illness unrelated to pancreatic insufficiency

          3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper
             limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit

          4. Feeding via an enteral tube during 6 months before screening

          5. Forced expiratory volume ≤30% at the Screening visit
Vitamin C in Atrial Fibrillation Ablation
Condition: Atrial Fibrillation Ablation
MeSH terms: Atrial Fibrillation
Intervention: Vitamin C; Placebo
Intervention description: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W; 50mL infused over 30 minutes
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of
      high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered
      every six hours with a 30 minute IV infusion time per dose, compared to matched placebo
      infusion
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >/= 21 years

          2. Diagnosis of atrial fibrillation with plans for a catheter-based ablation procedure

          3. Ability to provide informed consent and willingness to be included in the study

        Exclusion Criteria:

          1. Known allergy to Vitamin C

          2. Inability to obtain informed consent

          3. Diabetes mellitus either requiring the use of insulin therapy or not requiring the use
             of insulin therapy but which is uncontrolled, defined as a glycosylated hemoglobin of
             greater than or equal to 8%

          4. Prior catheter-based ablation for atrial fibrillation

          5. Pregnancy or breast feeding

          6. Active renal calculus

          7. Active acute or chronic infection (including HIV or hepatitis C)

          8. Active or recent (within 5 years) malignancy

          9. Autoimmune or autoinflammatory disease

         10. Recent or active use of immunosuppressive medications

         11. Non-English speaking

         12. Ward of the state (inmate, other)
Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Chlorhexidine gluconate (0.12%); Sodium Fluoride (0.05%); Paraffin wax chewing gum (sugar-free); Deionized water
Intervention description: 30 second oral rinse of 10mL of solution; 30 second oral rinse of 10mL of solution; Approximately two minutes of chew time; 30 second oral rinse of 10mL of solution
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Listerine; Fluorides; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus Mutans; Saliva

Summary:

      This study compared four mouth rinses/chews for their ability to reduce Streptococcus Mutans
      after usage. The four that were compared were chlorhexidine gluconate (0.12%), sodium
      fluoride (0.05%), paraffin wax chewing gum (sugar free), and deionized water. The paraffin
      wax chewing gum replaced the originally planned coconut oil and served as a placebo
      comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting to the dental clinic for routine dental treatment (including
             recall exams, new patient exams, and operative appointments) who are American Society
             of Anesthesia (ASA) class I or II

          -  Cooperative patients classified as 3 or 4 according to the Frankl Behavioral Rating
             Scale,

          -  No known allergies or sensitivities to products or ingredients being tested

          -  Had untreated cavities

          -  Nothing to eat/drink for 1 hour prior to dental appointment

        Exclusion Criteria:

          -  Patients who are ASA class III, IV, V or VI

          -  Known allergies or sensitivities to any of the mouth rinses or any of the ingredients
             in the mouth rinses to be tested

          -  Non-English speaking parent/participant

          -  Patient presenting to the clinic as a walk in or emergency appointment

          -  Patient experiencing any pain or sensitivity

          -  Precooperative or uncooperative behavior or behavior classified as 1 or 2 according to
             the Frankl Behavioral Rating Scale
5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
Condition: Vulvar Vestibulitis
MeSH terms: Vulvar Vestibulitis
Intervention: 5% topical lidocaine ointment; Placebo cream
Intervention description: Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.; hydrophilic petrolatum, dime-sized amount, applied nightly.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vulvar vestibulitis; vestibulitis

Summary:

      -  Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability
           to have sexual intercourse and decreased pain scores in women with vestibulitis when
           compared to placebo.

        -  This is a study to assess if topical lidocaine will improve symptoms in women with
           vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo
           ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total
           of 56 women in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women with the clinical diagnosis of vvs who have dyspareunia as their primary
             complaint. They must have a current sexual partner.

        Exclusion Criteria:

          -  postmenopausal

          -  pure vaginismus

          -  generalized vulvodynia

          -  pudendal neuralgia

          -  pregnant, breastfeeding

          -  less than 2 months post delivery

          -  diagnosis of dermatologic condition on biopsy

          -  positive fungal culture

          -  currently on treatment for vvs

          -  history of lidocaine treatment for vvs
Evaluating Simvastatin's Potential Role in Therapy
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Simvastatin; Placebo
Intervention description: 40 mg tablet each night for one month, then 80 mg for 8 months; Matching tablet each night for 9 months
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 35 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: amyloid protein; apolipoprotein; cerebrospinal fluid; cerebrovascular circulation; inflammation; magnetic resonance imaging; prevention & control

Summary:

      The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects
      processes related to the development of Alzheimer's disease, including: 1) levels of a
      substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood
      flow in the brain, 3) inflammation in the brain, and 4) cognitive function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 35 to 69

          -  Parent with Alzheimer's disease

        Exclusion Criteria:

          -  Current use of cholesterol-lowering medication

          -  Active liver disease

          -  History of adverse reaction to statins

          -  Contraindication to lumbar puncture

          -  Elevated lab values (creatine kinase and creatinine)

          -  Use of medications known to interact with statins

          -  History of dementia

          -  Currently pregnant or planning to become pregnant

          -  Use of large quantities of grapefruit juice (more than 1 quart per day)

          -  Current involvement in another investigational drug study

          -  Contraindications to MRI (for MRI sub-study)

          -  Ethical contraindication to placebo (persons with high vascular risk)
Simvastatin in Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: Simvastatin
Intervention description: Oral tablets taken daily
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: simvastatin

Summary:

      This research study seeks to find new ways to treat people with Waldenstrom's
      Macroglobulinemia (WM). The study is for participants with slow growing WM who otherwise
      might not need therapy for at least 3-6 months. Simvastatin is a drug approved by the FDA for
      lowering cholesterol. In test tube studies the study drug appears to have direct anti-cancer
      effect against WM tumor cells and mast cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Clinicopathological diagnosis of Waldenstrom's macroglobulinemia

          -  Measurable disease

          -  Slowly progressing disease not requiring therapy for at least 3-6 months and who do
             not meet consensus panel criteria for initiation of therapy

          -  ECOG Performance status of 0 or 1

          -  Adequate organ function as defined in the protocol

          -  Patients should agree to avoid grapefruit juice which is a major inhibitor of CYP 3A4

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering
             the study, or those who have not recovered from adverse events due to agents
             administered more than four weeks earlier

          -  Patients who have had rituximab within 3 months prior to entering the study

          -  Patients who have taken any Statin in the past

          -  Patients who take cyclosporin, danazol, or gemfibrozil will be excluded

          -  Prior history of rhabdomyolysis

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             the study requirements

          -  Pregnant or breastfeeding women

          -  HIV-positive

          -  Patients who take verapamil will be excluded

          -  Patients with active or history of liver disease

          -  Patients who consume more than three alcoholic beverages per day
Intravenous Tapentadol in Post-Bunionectomy Pain
Condition: Bunion; Pain
MeSH terms: Bunion
Intervention: Tapentadol; Matching Placebo
Intervention description: 30 mg per administration, maximum 12 administrations over 48 hours; Maximum 12 administrations over 48 hours
Intervention MeSH terms: Tapentadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bunionectomy; Postsurgical Pain; Acute Pain

Summary:

      The purpose of this trial is to established the safety and efficacy of multiple dose
      treatment with tapentadol IV in an adult population with moderate to severe pain following
      bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to undergo primary unilateral first metatarsal bunionectomy

          -  Female patients must be postmenopausal, surgically sterile, or practicing an effective
             method of birth control if they are sexually active

          -  Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch)
             and Baseline pain intensity (last pain score measured within 10 minutes before dosing)
             5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).

        Exclusion Criteria:

          -  History of malignancy within the past 2 years

          -  Current or history of alcohol or drug abuse.

          -  Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological,
             psychiatric disorders (resulting in disorientation, memory impairment or inability to
             report accurately

          -  History of seizure disorder, epilepsy, or any condition that would put the subject at
             risk of seizures

          -  Severely impaired renal function

          -  Moderately or severely impaired hepatic function

          -  Contraindications, or a history of allergy or hypersensitivity, to tapentadol,
             ibuprofen, or excipients

          -  Use of prohibited concomitant medication, or not allowed use of restricted concomitant
             medication
Effects of Leptin Replacement in Children
Condition: Obesity; Metabolic Syndrome; Diabetes
MeSH terms: Metabolic Syndrome
Intervention: Recombinant methionyl human leptin
Intervention description: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Congenital leptin deficiency; Obesity; Metabolic Syndrome; Diabetes

Summary:

      To assess the endocrine and immune effects of leptin replacement in leptin-deficient
      children, from a consanguineous family. The hypothesis is that leptin replacement will have
      significant effects on endocrine function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with a functional leptin gene mutation from a consanguineous Turkish family.
             Only one leptin-naïve child from this family is alive and eligible.

        Exclusion Criteria:

          -  N/A
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
Condition: Atrial Fibrillation; Stroke
MeSH terms: Atrial Fibrillation
Intervention: DU-176b tablets; DU-176b tablets; Warfarin tablets
Intervention description: DU-176b tablets taken once daily for up to 3 months; DU-176b tablets taken once daily for up to 3 months; Warfarin tablets taken once daily for up to 3 months
Intervention MeSH terms: Warfarin; Edoxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with
      non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient
      basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind
      DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses.
      Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the
      Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary
      endpoints are incidence of major, clinically relevant non-major and minor bleeding events
      (all bleeding).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 18 to 80 years of age

          -  Non-valvular AF supported by abnormal ECG documented for two times (interval of more
             than 1 week) within 6 months prior to randomization.

          -  CHADS2 Score of at least 1.

        Exclusion Criteria:

          -  Subjects with mitral valve disease

          -  Subjects with previous valvular heart surgery

          -  Contraindication for anticoagulants

          -  Conditions associated with high risk of bleeding

          -  Acute coronary syndromes (ACS), percutaneous coronary intervention (PCI), MI, stroke,
             transient ischemic attack (TIA) or coronary artery/cardiac/other major surgery within
             the previous 30 days

          -  Active infective endocarditis or life-expectancy < 12 months