bioihbjkbjnl/mcl2 huggingface dataset:
Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
Condition: Stress Disorders; Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Risperidone; Placebo
Intervention description: Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time.; Placebo
Intervention MeSH terms: Risperidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTSD

Summary:

      The purpose of this research of 400 participants is to determine whether a drug called
      risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a
      placebo-controlled study, meaning that half of the participants will be assigned to receive a
      pill that contains no drug. The treatment phase of the study will last for 6 months, during
      which time participants will continue to receive all their usual treatments in addition to
      the study treatment and will be asked to complete procedures and assessments (questionnaires,
      interviews, laboratory tests, physical exams, etc.) related to their PTSD symptoms at various
      points within the 6-month treatment phase. At the end of the 6-month study, participants will
      discontinue the study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Military service related chronic PTSD

          -  CAPS score >50

          -  Participant in VA outpatient PTSD clinic

          -  History of non-response to two or more antidepressants

        Exclusion Criteria:

          -  Comorbid Axis I diagnosis requiring antipsychotic medication

          -  Substance dependence diagnosis (excluding nicotine)

          -  Hepatic or renal problems

          -  Incompatible medical diagnosis or medication (i.e., coumadin, insulin)

          -  Unstable living arrangements

          -  Assault or suicide gesture within 1 year
A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: sacubitril/valsartan (LCZ696); olmesartan; placebo to sacubitril/valsartan (LCZ696); placebo to olmesartan; Amlodipine (Optional)
Intervention description: 200 mg tablets; placebo; placebo; If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen
Intervention MeSH terms: Amlodipine; Valsartan; Olmesartan; Olmesartan Medoxomil; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LCZ696,; Hypertension,; Aortic stiffness,; Central blood pressure,; Cardiovascular MRI

Summary:

      This was the first evaluation of the effects of LCZ696 on local and regional measures of
      aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure.
      The results of this exploratory study will help to understand the mechanism of action of
      LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with
      cardiovascular diseases.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects with essential hypertension, untreated or currently taking antihypertensive
             therapy

        Key exclusion Criteria:

          -  women of child bearing potential (WOCBP) if not on highly effective contraception

          -  Malignant or severe hypertension (grade 3 of WHO classification)

          -  History or evidence of a secondary form of hypertension

          -  Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or
             any history of stroke.

          -  Previous or current diagnosis of heart failure (New York Heart Association Class
             II-IV).
Memantine in the Treatment of Kleptomania
Condition: Kleptomania
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Intervention: Memantine
Intervention description: 10-30mg, daily for 8 weeks
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Compulsive Stealing; Compulsive Shoplifting

Summary:

      The goal of the proposed study is to evaluate the efficacy and safety of memantine in
      kleptomania.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age 18-65

          2. current KM using the clinician-administered Structured Clinical Interview for
             Kleptomania (SCI-K)

          3. stealing behavior within 2 weeks prior to enrollment.

        Exclusion Criteria:

          1. infrequent stealing (i.e. less than one time per week) that does not meet proposed
             criteria for kleptomania (KM)

          2. unstable medical illness or clinically significant abnormalities on laboratory tests
             or physical examination at screen

          3. history of seizures

          4. myocardial infarction within 6 months

          5. current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          6. a need for medication other than memantine with possible psychotropic effects or
             unfavorable interactions

          7. clinically significant suicidality

          8. current Axis I disorder determined by the Structured Clinical Interview for the DSM
             (SCID) and SCID-compatible modules for impulse control disorders (Grant et al., 2005),
             except for nicotine dependence

          9. lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any
             psychotic disorder determined by SCID

         10. current or recent (past 3 months) DSM-IV substance abuse or dependence

         11. positive urine drug screen at screening

         12. initiation of psychotherapy or behavior therapy within 3 months prior to study
             baseline

         13. previous treatment with memantine; and 14) treatment with investigational medication
             or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other
             psychotropics within 2 weeks prior to study baseline.
Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma
Condition: Ewing's Sarcoma
MeSH terms: Sarcoma; Sarcoma, Ewing
Intervention: Olaparib
Intervention description: 400mg PO BID Continuous
Intervention MeSH terms: Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent; Metastatic

Summary:

      This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult
      participants with recurrent/metastatic Ewing's Sarcoma following failure of prior
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Ewing's sarcoma

          -  Normal organ and bone marrow function

          -  Life expectancy of at least 16 weeks

          -  Not pregnant or breastfeeding

          -  Willing and able to comply with the protocol for the duration of the study

          -  Presence of measurable disease

        Exclusion Criteria:

          -  Involvement in the planning and/or conduct of ths study

          -  Previous enrollment in the present study

          -  Participation in another clinical study with an investigational product during the 21
             days prior to first dose of study drug

          -  Previous exposure to any PARP inhibitor

          -  Receiving systemic chemotherapy or radiotherapy within 2 weeks of beginning study
             treatment

          -  Receiving prohibited classes of inhibitors of CYP3A4

          -  Persistent clinically significant toxicities caused by previous cancer therapy

          -  Known myelodysplastic syndrome or acute myeloid leukemia

          -  Symptomatic, uncontrolled brain metastases

          -  Major surgery within 14 days of starting study treatment

          -  Considered a poor medical risk due to a serious, uncontrolled medical disorder,
             non-malignant systemic disorder or active, uncontrolled infection

          -  Unable to swallow orally administered medication or with gastrointestinal disorders
             likely to interfere with absorption of the study medication

          -  Known to be serologically positive for HIV and receiving antiretroviral therapy

          -  Known active Hepatitis B or C

          -  Known hypersensitivity to olaparib or any of the excipients of the product

          -  Uncontrolled seizures
Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Condition: Depersonalization Disorder
MeSH terms: Depersonalization
Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention description: Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Dissociative; Dissociation; Depersonalization; Depersonalization Disorder; Transcranial Magnetic Stimulation; TMS; Depersonalization Disorder (DPD); rTMS

Summary:

      The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic
      stimulation in the treatment of Depersonalization Disorder (DPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients, 18 to 70 years of age.

          -  Primary diagnosis of Depersonalization Disorder.

          -  Duration of the index episode of at least a year.

          -  Patients currently on DPD medication must be at the same stable dose(s) at least 2
             months and be to continue at the same dose(s) through the duration of the study.

          -  Capable and willing to provide informed consent

        Exclusion Criteria:

          -  Individuals with a neurological disorder including, but not limited to: brain lesion;
             history of seizures; history of cerebrovascular accident; history of stroke; cerebral
             aneurysm, Dementia; Parkinson's Disease; Huntington's chorea; Multiple Sclerosis.

          -  Increased risk of seizure for any reason, including prior head trauma with loss of
             consciousness for 5 minutes or more.

          -  Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable
             cardiac disease.

          -  Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants,
             or electrodes) or any other metal object within or near the head, excluding the mouth,
             that cannot be safely removed.

          -  If participating in psychotherapy, must have been in stable treatment for at least
             three months prior to entry into the study, with no anticipation of change in
             frequency of therapeutic sessions, or the therapeutic focus over the duration of the
             rTMS trial.

          -  Known or suspected pregnancy.

          -  Women who are breast-feeding
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
Condition: Pancreatic Neoplasm; Pituitary Neoplasm; Nelson Syndrome; Ectopic ACTH Syndrome
MeSH terms: Neoplasms; Pancreatic Neoplasms; Pituitary Neoplasms; Nelson Syndrome; ACTH Syndrome, Ectopic; Pituitary Diseases; Cushing Syndrome; Syndrome
Intervention: pasireotide LAR
Intervention description: Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rare tumors of neuroendocrine origin; NETs of the pancreatic; Pituitary NETs; EAS Tumors; Nelson's Syndrome; Pancreatic neoplasm; pituitary neoplasm; Nelson Syndrome; ectopic ACTH syndrome; pasireotide LAR; PNETs; PiNETS

Summary:

      This study will assess the effectiveness and safety of pasireotide long-acting release in
      patients who have rare tumors of neuroendocrine origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female Patients at least 18 years old

          -  Patient who have rare tumors of neuroendocrine origin, such as tumors of the:

               1. pancreas

               2. pituitary glands

               3. Nelson syndrome

               4. ectopic-ACTH secreting tumor

          -  Patients who have failed standard of care treatment or for whom no standard of care
             treatment exist

          -  Signed Informed Consent

        Exclusion Criteria:

          -  Patients with active gallbladder disease

          -  Patients with any ongoing or planned anti-neoplastic or interferon therapy

          -  Poorly controlled diabetes mellitus

          -  Female patients who are pregnant or lactating, or are of childbearing potential and
             not practicing a medically acceptable method of birth control

        Other protocol-defined inclusion/exclusion criteria may apply.
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Condition: Excessive Daytime Sleepiness; Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Intervention: BEN-2001; Placebo
Intervention description: Bavisant dihydrochloride monohydrate for oral use; 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: 244.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This phase 2b study is designed as multicentre, multinational, randomized, double blind,
      parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in
      subjects with excessive daytime sleepiness with Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either sex aged 50 to 80 years *Subjects with previous diagnosis of
             Parkinson's disease (following the UK Parkinson's disease society brain bank clinical
             diagnostic criteria)*

          -  Subjects capable of understanding and complying with protocol requirements

          -  Subjects with medical history of excessive daytime sleepiness

        Exclusion Criteria:

          -  Subjects with excessive daytime sleepiness due to conditions other than Parkinson's
             disease (including narcolepsy)

          -  Subjects with clinical evidence of depression with significant psychiatric
             comorbidities (Hamilton Rating Scale for Depression - HAM-D score greater than or
             equal to 17; with or without treatment)

          -  Subjects with evidence of significant fatigue (Fatigue Severity Scale - FSS greater
             than or equal to 36

          -  Subjects with known history of abuse of alcohol or other addictive substances in the 6
             months prior to inclusion.

          -  Subjects with known allergies or hypersensitivity to Bavisant or any of its
             excipients.

          -  Subjects who are pregnant or lactating.
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Obese; Overweight
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Intervention: Gastric Emptying test; Mixed Oral Glucose Tolerance test; Conjugated bile acids sodium; Placebo
Intervention description: participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.; Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.; 500 mg tablets taken orally twice daily for 28 (+/- 4) days; Placebo tablets taken orally twice daily for 28 (+/- 4) days
Intervention MeSH terms: Bile Acids and Salts
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:

      To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity,
      postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum
      FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on
      therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in
      combination with metformin.
    

Eligibility criteria:

        Inclusion criteria:

          1. Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking
             DPP4 inhibitors alone or in combination with metformin.

          2. Women of childbearing potential will have a negative pregnancy test before initiation
             of medication and within 48 hours of receiving radioisotope.

        Exclusion criteria:

          1. Structural of metabolic diseases/conditions that affect the gastrointestinal system,
             or functional gastrointestinal disorders.

          2. Irritable bowel syndrome

          3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.

          4. Subjects with other treatment for type 2 diabetes mellitus.

          5. Subjects with HbA1c > 8%

          6. Females who are pregnant or breastfeeding

          7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or
             lorcaserin.

          8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal,
             hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes
             mellitus), and unstable psychiatric disease.

          9. Subjects who have donated blood or plasma in the past 8 weeks.

         10. Subjects who have participated in another study within the past 30 days.
Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
Condition: Pain
MeSH terms: Pain, Postoperative
Intervention: Fentanyl; Placebo
Intervention description: Fentanyl delivered via sublingual spray; Matching placebo delivered via sublingual spray
Intervention MeSH terms: Fentanyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual
      Spray compared with placebo in participants with postoperative pain after a bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification and contraception

          -  Willing and able to remain confined in the study unit for the entire duration of each
             treatment period and comply with restrictions related to food, drink and medications

          -  Voluntarily consents to participate and provides written informed consent prior to any
             protocol-specific procedures

        Exclusion Criteria:

          -  History or current use of over-the-counter medications, dietary supplements, or drugs
             (including nicotine and alcohol) outside protocol-specified parameters

          -  Signs, symptoms or history of any condition that, per protocol or in the opinion of
             the investigator, might compromise:

               1. the safety or well-being of the participant or study staff;

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding);

               3. the analysis of results
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Intervention: lisdexamfetamine dimesylate (SPD489); lisdexamfetamine dimesylate (SPD489); lisdexamfetamine dimesylate (SPD489); Placebo
Intervention description: SPD489-30mg capsules taken once daily for up to 11 weeks; SPD489 50mg capsules taken once-daily for up to 11 weeks; SPD489 70mg capsule taken once-daily for up to 11 weeks; Placebo capsule taken once daily for up to 11 weeks
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 271.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe
      binge eating disorder as measured by the number of binge days per week
    

Eligibility criteria:

        Inclusion

          -  Subject meets the following Diagnostic and Statistical Manual of Mental Disorders
             Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of binge eating
             disorder (BED).

          -  Binge eating disorder is of at least moderate severity in which subjects report at
             least 3 binge eating days per week.

          -  Subject has a body mass index (BMI) of >24 and <46.

        Exclusion

          -  Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.

          -  Subject is considered a suicide risk or risk to harm others.