bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Placebo; Vilazadone
Intervention description: Viibryd
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; GAD

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      relative to placebo in the treatment of generalized anxiety disorder (GAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female, 18 - 70 Years of age

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)

          -  Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women of
             childbearing potential who are not practicing a reliable method of birth control

          -  Patients with a history of meeting DSM-IV-TR criteria for:

               -  any manic, hypomanic or mixed episode, including bipolar disorder and
                  substance-induced manic, hypomanic, or mixed episode;

               -  any depressive episode with psychotic or catatonic features;

               -  panic disorder with or without agoraphobia;

               -  obsessive-compulsive disorder;

               -  Schizophrenia, schizoaffective, or other psychotic disorder;

               -  bulimia or anorexia nervosa;

               -  presence of borderline personality disorder or antisocial personality disorder;

               -  mental retardation, dementia, amnesia, or other cognitive disorders

          -  Patients who are considered a suicide risk
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Plecanatide; Placebo
Intervention MeSH terms: Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1054.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
      parallel-group clinical trial with 12 weeks of study drug therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        •Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS
        based on ROME III diagnostic criteria and meeting criteria for diagnosis of the
        constipation predominant subtype - IBS-C

        Exclusion Criteria:

          -  Refusal or inability to sign informed consent for the trial

          -  Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day
             daily Calls, and/or complete electronic questionnaires

          -  BMI > 35 or < 18

          -  Women of child bearing potential who refuse to use an acceptable method of birth
             control for the duration of the trial

          -  Women who are pregnant or lactating

          -  Diagnosis of IBS-D or IBS-M

          -  Organic or obstructive disease of the small or large intestine

          -  Use of laxatives other than the study-supplied rescue medication (Dulcolax®,
             bisacodyl)

          -  Use of a prohibited concomitant medication within the time frame prior to screening
             outlined in the study protocol for that medication

          -  Unstable medical illness

          -  Bilirubin > 3X ULN in the absence of a conjugation defect

          -  Any laboratory value > 3X ULN unless discussed and approved by the study Medical
             Monitor
A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib [Tarceva]
Intervention description: Single daily oral dose
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This prospective, double-blind, randomized study will evaluate the safety and efficacy of two
      dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control
      rates and overall survival in patients with advanced or metastatic non-small cell lung cancer
      (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current
      smokers and not intending to stop smoking during the study. Patients will be randomized to
      receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will
      continue until disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients aged ≥18 years

          -  inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node
             metastases or malignant pleural or pericardial effusion) or metastatic (stage IV)
             non-small cell lung cancer (NSCLC)

          -  Disease must be characterized according to Response Evaluation Criteria in Solid
             Tumors (RECIST) criteria

          -  Patients have received one prior platinum-based chemotherapy regimen for advanced
             NSCLC, but must have recovered from any treatment-related toxicity

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy ≥12 weeks

          -  Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and
             currently smoking on average ≥1 cigarette per day), not intending to stop during the
             study

        Exclusion Criteria:

          -  Prior antibody or small molecule therapy against Epidermal growth factor receptor
             (EGFR)

          -  Radiotherapy within 28 days prior to enrollment

          -  Received more than one line of chemotherapy for locally advanced/metastatic NSCLC
             (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is
             allowed)
Betaine and Peroxisome Biogenesis Disorders
Condition: Peroxisome Biogenesis Disorders
MeSH terms: Peroxisomal Disorders
Intervention: Betaine
Intervention description: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:
6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)
12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time).
Intervention MeSH terms: Betaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Healthy volunteers: No
Keywords: Peroxisome Biogenesis Disorder; PBD; neonatal adrenoleukodystrophy; infantile Refsum disease; PEX1 mutation; Betaine

Summary:

      The PBD are a rare group of inherited disorders due to the failure to form functional
      cellular peroxisomes. Most patients have progressive hearing and visual loss, leading to
      deafness and blindness, as well as neurological deterioration. There are no therapies for
      this disorder. A misfolded protein with residual function, PEX1-Gly843Asp, represents one
      third of all mutant alleles. Using patient cell lines with this mutation, we reported the
      recovery of peroxisome functions by treatment with Betaine, acting as a nonspecific chemical
      chaperone for the misfolded PEX1 protein. Betaine, or trimethylglycine, is a Health Canada
      and FDA approved orphan drug for the treatment of homocystinuria and is used by us safely and
      regularly in genetic medicine. We will perform a 6 month pilot study with 12 patients to test
      the hypothesis that Betaine, at recommended doses, can recover peroxisome biochemical
      functions in blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females

          -  Any age

          -  Peroxisome Biogenesis Disorder (PBD) confirmed by biochemical analysis of at least two
             peroxisomal enzyme parameters:

               -  Elevated plasma VLCFA (C26/22) > 0.02

               -  Elevated plasma branched chain pristanic acid > 0.3 μg/ml

               -  Reduced red blood cell plasmalogen levels (C16:0DMA/C16:0 Fatty acid) < 0.07

          -  PBD clinical syndromes: neonatal adrenoleukodystrophy (NALD) or infantile Refsum
             disease (IRD)

          -  Genotype PEX1-G843D/G843D, PEX1-G843D/I700fs, or PEX1-G843D and any second PEX1
             mutation that is predicted to be null

          -  Expected survival of at least 6 months

        Exclusion Criteria:

          -  Genotypes other than PEX1 G843D/G843D, PEX1-G843D//I700fs, or PEX1-G843D and any
             second PEX1 mutation that is predicted to be null

          -  Patient already treated with betaine
Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
Condition: Fatigue
MeSH terms: Fatigue
Intervention: armodafinil 150 mg; Placebo; armodafinil 250 mg
Intervention description: given orally; given orally; given orally
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies armodafinil to see how well it works in reducing
      cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve
      fatigue in patients with high grade glioma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma,
             glioblastoma with oligo features, glioblastoma with primitive neuroectodermal
             tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic
             oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have
             completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24
             months prior to enrollment; NOTE: clinical stability will be defined as a stable or
             improved Karnofsky performance status (KPS) compared to the prior month

          -  >= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question
             3); it is not required for the patient to complete the entire BFI to meet this
             criterion

          -  Undergone surgery (gross total or subtotal resection) or biopsy and will have been
             treated with concurrent radiation therapy and chemotherapy as standard of care for
             glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with
             oligo features, glioblastoma with primitive neuroectodermal tumor-like components
             (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or
             anaplastic oligoastrocytoma patients; Note: radiation must be completed, but
             chemotherapy is allowed; patients who are currently using Optune device will be
             eligible to participate in this trial

          -  Negative serum pregnancy test done =< 7 days prior to registration only for women
             determined to be of childbearing potential by their treating physician

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3

          -  Provide informed written consent

          -  Willing to return to enrolling institution for follow-up (during the Active Monitoring
             Phase of the study)

          -  Stable dose of corticosteroid >= 14 days prior to registration
Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Nutrition Disorders
Intervention: Liraglutide; Placebo
Intervention description: Administered once daily subcutaneously (s.c., under the skin); Administered once daily subcutaneously (s.c., under the skin)
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 251.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to investigate the effect of
      liraglutide for weight management in pubertal adolescent subjects with obesity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  Male or female, age 12 to less than 18 years at the time of signing informed consent
             and less than 18 years at date of randomisation

          -  BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off
             points and equal or above the 95th percentile for age and sex (for diagnosis of
             obesity)

          -  Stable body weight during the previous 90 days before screening V2 (below 5 kg
             self-reported weight change)

          -  History of failing to lose sufficient weight with lifestyle modification as judged by
             the investigator and documented in subject's medical record

        Exclusion Criteria:

          -  Pre-pubertal subjects (Tanner stage 1) at screening V2

          -  Type 1 diabetes mellitus (T1DM)

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN2)

          -  Medullary thyroid carcinoma (MTC)

          -  History of pancreatitis (acute or chronic)

          -  Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine
             causes)

          -  Treatment with medications within 90 days before screening V2 that, based on the
             investigator's judgement, may cause significant weight change. This should also
             include treatment with any of the following medications: pramlintide, orlistat,
             zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like
             peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)

          -  Anti-diabetic treatment other than metformin

          -  History of major depressive disorder within 2 years before screening V2
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation
Condition: Cancer of the Cervix
MeSH terms: Vaginal Neoplasms; Uterine Cervical Neoplasms
Intervention: Granisetron; Ondansetron; Questionnaires; Study Drug Diary
Intervention description: 34.3 mg of granisetron formulated in a transdermal patch replaced every 7 days. At cycle 1, participants receive granisetron by vein prior to IV cisplatin and prior to administration of transdermal patch.; 8 mg of ondansetron by mouth three times a day starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.; Completion of 3 questionnaires at study visits taking about 5 minutes each time.; Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced.
Intervention MeSH terms: Ondansetron; Granisetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of the Cervix; Anti-emetic therapy; Granisetron; Transdermal patch; Ondansetron; Zofran; Questionnaires; Surveys; Study Drug Diary; Nausea and Vomiting

Summary:

      The goal of this clinical research study is to compare granisetron (when given through a
      patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with
      cervical, endometrial, or vaginal cancer having chemoradiation.

      Granisetron and ondansetron are designed to help reduce nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women with cervical, endometrial or vaginal cancer dispositioned to receive primary or
             postoperative adjuvant pelvic radiation therapy with concurrent cisplatin
             administration.

          2. Women must be at least 18 years of age.

          3. Women must be able to read English or Spanish at a sixth grade level.

          4. Women with childbearing potential must have a negative pregnancy test within 1 week of
             starting chemoradiation therapy.

        Exclusion Criteria:

          1. Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy
             and/or radiation therapy for recurrent disease.

          2. Women with cervical, endometrial, or vaginal cancer who are receiving extended field
             radiation therapy.

          3. Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy
             and/or radiation therapy in a palliative setting.

          4. Women with cervical, endometrial, or vaginal cancer who have already received their
             first dose of chemotherapy or radiation for more than 7 days prior to starting
             chemotherapy.
A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Dapsone Gel; Dapsone Gel Vehicle
Intervention description: Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.; Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Intervention MeSH terms: Dapsone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2102.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of dapsone gel versus vehicle control in
      patients with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acne vulgaris

          -  Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight,
             tanning beds) throughout the study

        Exclusion Criteria:

          -  Severe cystic acne, acne conglobata, acne fulminans, or secondary acne

          -  Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive
             cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling,
             comedo extraction) in the past week

          -  Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics,
             antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]),
             retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps
             such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium
             sulfacetamide) in the past 2 weeks

          -  Use of birth control pills strictly for acne control
Botox for Non-surgical Lateral Release in Patellofemoral Pain
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome
Intervention: Botulinum toxin A + exercise; Placebo
Intervention description: Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain; Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Botulinum toxin type A; Patellofemoral pain syndrome; Knee Injuries; Exercise Therapy

Summary:

      The purpose of this study is to determine whether the use of botulinum toxin A injected into
      the lateral thigh muscle improves knee function and reduces knee pain secondary to
      patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises
      will be superior to specific exercises alone in improving knee function and reducing knee
      pain in individuals with patellofemoral syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  retropatellar knee pain

          -  pain with two of: prolonged sitting, climbing stairs, squatting, running, kneeling,
             hopping, jumping

          -  pain with patellar palpation

          -  symptoms minimum 1 month

          -  Visual Analog Scale for pain (VAS) usual pain 4 of 10 on VAS [0-10 scale, anchors 0 =
             no pain, 10 = worst pain imaginable]

        Exclusion Criteria:

          -  history knee surgery

          -  history patellar dislocation

          -  clinical evidence of meniscal lesion, ligamentous instability, traction apophysitis
             around the patellofemoral complex, patellar tendon pathology, chondral damage,
             osteoarthrosis, spinal referred pain