bioihbjkbjnl/mcl2 huggingface dataset:
Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
Condition: Pervasive Developmental Disorder
MeSH terms: Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to develop a better tolerated and more effective pharmacologic
      treatment with individuals with Pervasive Developmental Disorder. This is a double-blind,
      placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of
      Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be
      more effective than placebo for reducing aggression, tantrum and self-injurious behavior in
      children with Pervasive Developmental Disorder.
    

Detailed description: 
      Pervasive developmental disorders (PDDs) are characterized by severe impairments in social
      interaction and communication in addition to restricted patterns of interests and activities.
      Research suggests that a dysregulation of the dopamine and serotonin systems contributes to
      these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics
      were reported in subjects with PDD, research shifted to the atypical antipsychotics which
      have been shown to be better tolerated and effective in this population. However, the
      atypical antipsychotics have also been associated with adverse effects. Thus there remains a
      need for a novel pharmacotherapy that would be safe and effective for children and
      adolescents with PDDs. The primary objectives of this study are to determine whether
      aripiprazole is effective and well tolerated for irritability in children and adolescents
      with PDD not otherwise specified (NOS) during an 8-week acute phase and whether the
      effectiveness and tolerability of aripiprazole is maintained during a 16-week continuation
      phase.
    

Intervention name(s): Aripiprazole oral product; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.; Placebo will be identical in size and appearance to study drug.
Other intervention name(s): Abilify; Sugar pill
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PDD NOS
Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate antihypertensive (lowering blood pressure)
      effectiveness of three combinations of approved study drugs compared to both study drugs
      being given alone.
    

Detailed description: 
      The duration of treatment is 3.5 months.
    

Intervention name(s): MK0954A, hydrochlorothiazide (+) losartan potassium; Comparator: placebo, losartan, hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
Condition: Restless Legs Syndrome; End-Stage Renal Disease
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Kidney Diseases; Kidney Failure, Chronic; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in
      subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.

      The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to
      investigate the effect of Rotigotine on quality of life and sleep.
    


Intervention name(s): Rotigotine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Transdermal patch; Dose: 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.
Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal.; Transdermal patch; Patches matching to active treatment patches in size and appearance.
Up to 3 weeks of Titration,
2 weeks of Maintenance,
Up to 4 days of Taper Period.
Other intervention name(s): Neupro
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rotigotine; Neupro; Restless Legs Syndrome; RLS; End-Stage Renal Disease
The Anemia Control Program: High or Low Iron Supplementation
Condition: Iron Deficiency Anemia; Cognitive Development; Motor Development
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      The purpose of this clinical trial was to determine if high-iron or low-iron formula,
      containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron
      status in infancy and on development longitudinally.
    

Detailed description: 
      For a detailed description of the clinical trial setting and procedures in infancy, please
      refer to the following:

      Walter T, Pino P, Pizarro F and Lozoff B. Prevention of iron-deficiency anemia: Comparison of
      high- and low-iron formulas in term healthy infants after six months of life. J Pedr
      1998:132:635-40.
    

Intervention name(s): Low-iron formula; High-iron formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Infants randomly assigned at 6 months of age to receive low-iron formula (average 2.3 mg/L, range 1.6 - 2.4 mg/L) until 12 months of age. Low-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.); Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age. High-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: iron deficiency anemia; cognitive development; motor development
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
Condition: Obesity; Sleep
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Enhancing children's sleep may be a novel approach for prevention of obesity and
      cardiovascular (CV) disturbance. Observational studies with children demonstrate that short
      sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with
      children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes
      in eating and activity behaviors and weight status, particularly for children who enhance
      their sleep the most. Enhancing sleep may be particularly important for racial minority
      children and those from lower socioeconomic backgrounds given their increased risk for short
      sleep, obesity and CV risk factors. In this study two active obesity preventive interventions
      will be evaluated: a) enhancing sleep alone (Optimize Sleep [OS]), and b) enhancing sleep
      along with eating and activity behaviors that have demonstrated efficacy for obesity
      prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy
      dense snack foods and beverages, TV viewing, and physical activity) (OS-Plus). Two hundred
      four children 6-11 years old who are primarily African American/black, primarily from low
      socioeconomic backgrounds, and who sleep < 9.5 hours/night into a 12-month study will be
      enrolled. Children will be randomly assigned to either OS or OS-Plus. Over the 6-month
      treatment phase, all children will attend an 8-session treatment; monthly phone contacts will
      occur during maintenance (6-12 months). Primary aim is to determine the efficacy of OS-Plus
      relative to OS on change in body mass index z-score (BMIz) at end of treatment. Secondary
      aims will assess efficacy of OS-Plus relative to OS on additional cardiometabolic risk
      factors, eating and activity behaviors. Exploratory aims will assess maintenance of effects
      at 12 months.
    


Intervention name(s): Optimize Sleep (OS); Optimize Sleep-Plus (OS-Plus)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 "sleep challenges" (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact.; All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 "sleep challenges" (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: obesity prevention; sleep; behavioral intervention
Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions
Condition: Hypertension; Chronic Stable Angina; Vasospastic Angina
MeSH terms: Angina Pectoris; Angina, Stable; Angina Pectoris, Variant
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine
      Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a
      single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Iron Absorption From GDS Capsules
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Slow release iron capsules have been designed based on the gastric delivery system. Iron
      absorption from those capsules administered with and without meals will be measured using
      stable iron isotopes.
    


Intervention name(s): GDS, no meal; GDS, meal; control, no meal; control, meal
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): GDS, no meal; GDS, meal; control, no meal; control, meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study of Ruxolitinib Cream in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label maximum use trial to evaluate ruxolitinib safety, tolerability and
      blood levels after its topical application twice daily to affected areas (≥ 35% BSA) in
      pediatric participants with atopic dermatitis (AD) and to determine if its systemic
      bioavailability results in any adverse events.
    

Detailed description: 
      Open-label, BID application to all affected areas identified at BSLN for 4 weeks (maximum use
      trial (MUsT) period). The next 4 weeks (treatment extension period) will be applied BID to
      active lesions only for the next 4 weeks for a total treatment period of 8 weeks. Eligible
      participants will be offered option to continue into 44-wk LTS period of BID to treat
      as-needed to active lesions. All participants will have 30 day safety follow-up visit.
    

Intervention name(s): Ruxolitinib cream
Intervention type(s): Drug
Intervention description(s): Ruxolitinib 1.5% cream applied twice daily.
Other intervention name(s): INCB018424 phosphate cream
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; Atopic dermatitis; ruxolitinib cream; maximum use; open label
Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      One hundred thirty women with unexplained infertility participated in a prospective clinical
      study. Patients were assigned at random to one of two groups. The first group (n=65) served
      as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno
      Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets.
      The second group (n=65) served as a control and received a placebo tablet in addition to the
      standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was
      performed on all of the patients to assess ovulation.
    

Detailed description: 
      One hundred thirty women with unexplained infertility participated in a prospective clinical
      study. Patients were assigned at random to one of two groups. The first group (n=65) served
      as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno
      Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the
      seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end
      of menstruation through ovulation. The second group (n=65) served as a control and received a
      placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg
      (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess
      ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic
      pregnancy, and multiple pregnancies, were monitored.
    

Intervention name(s): Sildenafil Citrate; Clomiphene Citrate 50mg
Intervention type(s): Drug; Drug
Intervention description(s): oral sildenafil (Respatio® 20mg ); used for ovionulation induct
Other intervention name(s): respatio; technovula
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Efficacy of Probiotics on Physical Performance
Condition: Physical Performance
Study type: Interventional

Summary: 
      Efficacy of probiotics on physical performance
    


Intervention name(s): Probiotic supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic supplement; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the
      way the body takes up, distributes, and gets rid of daridorexant.
    


Intervention name(s): Daridorexant; Famotidine; Efavirenz
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.; Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.; Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.
Intervention MeSH terms: Efavirenz; Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4 treatment arms in 2 sequences, ABCD or BACD.
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
Condition: Mastitis
MeSH terms: Mastitis
Study type: Interventional

Summary: 
      To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis
      incidence.
    

Detailed description: 
      Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously
      isolated from breast milk, can be used as an effective treatment of mastitis and painful
      breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded
      controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and
      Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and
      distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum
      3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The
      intervention period is 16 weeks.
    

Intervention name(s): Lactobacillus fermentum CECT5716; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.; Intervention with a daily capsule containing maltodextrin as placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety,
      tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a
      long acting parenteral (LAP) formulation in healthy subjects. Subjects will be randomized to
      3 monthly dosing cohorts and 1 quarterly dosing cohort with either intramuscular or
      subcutaneous dosing. In the monthly dosing cohorts subjects will receive GSK1265744 alone for
      2 months and then in combination with TMC278 long acting parenteral (LA) for 2 months. For
      the quarterly dosing cohort, 2 quarterly intramuscular doses of GSK1265744 LAP will be given
      alone. Three dose levels of GSK1265744 will be evaluated partly in combination with TMC278 LA
      to adequately characterize the GSK1265744 LAP and TMC278 LA safety, tolerability, and PK
      profile. A total enrolment of approximately 40 healthy subjects is planned for this study.
    


Intervention name(s): GSK1265744 Oral; GSK1265744 LAP 800mg intramuscular injection; GSK1265744 LAP 200mg subcutaneous injection; GSK1265744 LAP 200mg intramuscular injection; GSK1265744 LAP 400mg intramuscular injection; TMC278 LA 1200mg intramuscular injection; TMC278 LA 600mg intramuscular injection; GSK1265744 LAP 800mg intramuscular injection
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30mg tablet; 800mg Loading dose given at month 1 dose; 200mg maintenance dose give at months 2 - 4; 200mg maintenance dose given at months 2 - 4; 400mg maintenance dose given at month 2 - 4; 1200mg Loading dose given at month 3; 600mg Loading dose given at month 4; 800mg dose given quarterly (once every) 12 weeks
Other intervention name(s): GSK1265744; GSK1265744; GSK1265744; GSK1265744; GSK1265744; TMC278 LA; TMC278 LA; GSK1265744
Intervention MeSH terms: Cabotegravir; Rilpivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: GSK1265744 LAP; integrase inhibitor; healthy subjects; TMC278 LA; GSK1265744LAP; long acting retroviral; HIV-1 infection
Genes in Predicting Outcome in Patients With Esophageal Cancer Treated With Cisplatin, Radiation Therapy, and Surgery
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
      It may also help doctors predict a patient's response to treatment.

      PURPOSE: This laboratory study is looking at genes to see if they can predict outcome in
      patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Correlate patient outcomes with neoplastic cell genotypes, specifically 18 single
           nucleotide polymorphisms (SNPs) in 16 major genes involved in platinum metabolism and
           disposition and DNA repair, in patients with esophageal cancer treated with neoadjuvant
           cisplatin-based chemoradiotherapy followed by surgical resection on clinical trial
           ECOG-1201.

        -  Correlate patient outcomes with neoplastic cell genotypes, specifically loss of
           heterozygosity, in these patients.

        -  Correlate patient outcomes with normal (germline) cell genotypes, specifically SNPs
           related to platinum metabolism and disposition and DNA repair.

        -  Compare the predictive ability of neoplastic vs germline cell genotypes.

      OUTLINE: This is a retrospective, cohort, multicenter study.

      Neoplastic and normal (germline) cells are collected from pretreatment and post-treatment
      specimens using laser-capture microdissection. Single nucleotide polymorphisms are examined
      by real-time PCR. Loss of heterozygosity is assessed by analyzing short tandem repeat markers
      in neoplastic and germline tissue.
    

Intervention name(s): loss of heterozygosity analysis; polymerase chain reaction; polymorphism analysis
Intervention type(s): Genetic; Genetic; Genetic
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E1201
      
Biospecimen description: 
      Residuals from analysis
    
Keywords: adenocarcinoma of the esophagus; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; stage I esophageal cancer