bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be a randomized, double-blind, placebo-controlled study consisting of a screening
      period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind
      maintenance treatment phase (Phase 3), and a follow up period.

      Subjects may be either outpatients or inpatients between screening and through the time they
      reach stabilization at the end of Phase 2; hospitalization is not a study requirement.
      However, eligible subjects must be outpatients at the beginning of Phase 3.

      Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and
      3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be
      encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any
      tolerability issues. The investigator will also have the option to phone the subjects and
      their guardian(s) at any time to ensure clinical stability.

      A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing
      the interim analysis. One interim analysis is planned after 75% of the total expected number
      of impending relapse events (28 events) are achieved and will be conducted by an independent
      data analysis center. The DMC will make a recommendation about stopping or continuing the
      study based on safety and efficacy reviews. The results of the interim analysis and
      individual subject data will remain blinded to the sponsor during the course of the study
      until the DMC determines that the study will conclude based on the results of the interim
      analysis, or the study is completed after 37 endpoint events.
    


Intervention name(s): Aripiprazole; Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg); Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adolescent; Schizophrenia
Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression
Condition: Depressive Symptoms; Emotion Regulation
MeSH terms: Depression
Study type: Interventional

Summary: 
      The goal of this pilot trial was to test SPARX with Inuit youth in Northern Canada. SPARX is
      an educational video game designed to teach cognitive behavioural therapy strategies and
      techniques. This "serious game" has previously shown promise in addressing symptoms of
      depression with Māori youth in New Zealand. Researchers in this study tested SPARX's
      suitability with Inuit youth in the territory of Nunavut using surveys that youth completed
      before and after gameplay.

      Hypothesis 1: Youth who completed SPARX were expected to experience a decrease in depressive
      symptoms and risk factors related to depression. Hypothesis 2: Youth who completed the SPARX
      program were expected to experience an increase in factors related to resilience.

      A team of Nunavut-based community mental health staff facilitated youth's participation in
      this remote pilot trial with 24 youth aged 13-18 across 11 communities in Nunavut. These
      youth had been identified by community facilitators as showing low mood, depression, and/or
      significant levels of stress.
    


Intervention name(s): SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)
Intervention type(s): Other
Intervention description(s): SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts) is a psychoeducational serious game (an e-intervention that utilizes gaming for serious purposes) that teaches established cognitive behavioural therapy strategies and techniques across seven levels or modules. The game is designed to address depressive symptoms in youth by helping them cope with negative thoughts and feelings, represented in the game as GNATs-Gloomy Negative Automatic Thoughts. SPARX was originally designed and developed at the University of Auckland with the specific needs of certain underserved groups of youth in mind, including Māori rangatahi, the Indigenous young people of Aotearoa, New Zealand.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hopelessness; catastrophizing; rumination; resilience
Evaluation of the Irritation Potential of Products in Human Eyes.
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the human eye irritation potential of two test sunscreen formulation
    


Intervention name(s): Sunscreen Spray SPF50 Z15-034(BAY987516); Shampoo Control; Sunscreen Spray SPF50 Z15-038(BAY987516)
Intervention type(s): Other; Other; Other
Intervention description(s): Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.; Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.; Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare
      the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male
      subjects.

      During the course of the study, the similarity in pharmacokinetics will be assessed by
      sampling the levels of drug in the blood, and by comparing these levels among the different
      administration arms. Pharmacodynamics, safety, tolerability, and immunologic response to the
      administered drugs will also be evaluated throughout.
    

Detailed description: 
      The primary PK parameter endpoints are AUC0-last and Cmax for denosumab. The secondary PK
      endpoints will include all other PK parameters for denosumab, including AUC0-∞, Tmax, CL and
      t1/2.

      For the primary PK Analysis, an analysis of variance (ANOVA) model with treatment and
      stratification factors as fixed effects will be performed on the natural log transformed
      values of Cmax, AUC0 last, and AUC0-∞.

      Estimates of geometric mean ratios together with the corresponding 90% confidence intervals
      (CI) will be derived for the comparisons of the PK parameters as follows:

        -  MB09 versus EU-Xgeva®

        -  MB09 versus US-Xgeva®

        -  EU-Xgeva® versus US-Xgeva®

      Bioequivalence will be concluded if the 90% CIs for the test to reference ratios of the
      geometric least square means for AUC0-last and Cmax are entirely contained within the [80%,
      125%] interval.

      For the PD Analysis, an analysis of covariance (ANCOVA) model with treatment and
      stratification factors as fixed effects and logged pre-dose sCTX concentrations fitted as a
      covariate will be performed on the natural log-transformed values of AUEC0 253 and AUIC0 253.

      Adverse events will be coded using MedDRA Version 24. All AE data will be presented in a data
      listing. Treatment-emergent AEs will be summarised by treatment and overall, as well as by
      severity and relationship to study drug. Serious AEs and AEs leading to discontinuation of
      study drug will also be presented in the data listings and summarised by treatment and
      overall.

      The incidence of ADA to denosumab and the neutralizing potential and titre of positive ADAs
      will be reported. All immunogenicity data will be presented in the data listings.
    

Intervention name(s): MB09 (denosumab biosimilar); US-sourced Xgeva; EU-sourced Xgeva
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of 35mg SC administered; Single dose of 35mg SC administered; Single dose of 35mg SC administered
Other intervention name(s): US-licensed Xgeva; EU-licensed Xgeva
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Recruiting Blood Donor With Allogeneic Natural Killer Cell
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study on manufacture of MG4101 (allogeneic natural killer cell) to use for
      Hepatocellular carcinoma(HCC) after Transarterial Chemoembolization(TACE) will be harvested
      WBC(white blood cell) and plasma from healthy donors, or plasma from healthy donors by
      leukapheresis or plasmapheresis procedure.
    

Detailed description: 
      The purpose of this study is to manufacture MG4101 (allogeneic natural killer cell) which
      will be used for clinical trial in HCC after TACE.

      Manufacturing MG4101 involves WBC(white blood cell) and plasma harvesting from healthy
      donors. Another methodology for plasma harvesting can be performed through the leukapheresis
      procedure.

      Healthy donors were requested to visit the institution twice for receiving either
      leukapheresis or plasmapheresis procedure. During the screening, study participants
      (subjects) were given a written informed consent, which was written in accordance with the
      Declaration of Helsinki and regional laws. Following the screening, study participants
      (subjects) each received a questionnaire for medical examination and a preliminary
      examination to evaluate their suitability as donors.

      If the study subjects' test result is suitable for clinical study standards either
      leukapheresis or plateletpheresis process will be performed for the following three weeks.

      The MG4101 will be manufactured from harvesting WBC and plasma, under the conditions of both
      GMP(Good Manufacturing Practice) at Green Cross Lab Cell Corp. (Korea). Also, the resulting
      MG4101, will be cryopreserved for using clinical trial in HCC after TACE.
    

Intervention name(s): Leukapheresis or Plasmapheresis
Intervention type(s): Other
Intervention description(s): Leukapheresis: Donate 5x10^9 white blood cells and 400 ml of plasma. Plasmapheresis: Donate 400ml of plasma.
Donated white blood cell and plasma will be manufactured MG4101(allogeneic natural killer cell) to use for Hepatocellular carcinoma(HCC) patients after Transarterial Chemoembolization(TACE).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Subjects; Healthy Participants
A Study to Evaluate Chronic Hepatitis C Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and
      ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as
      dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected
      treatment-naïve adults.
    


Intervention name(s): ABT-450/r/ABT-267, ABT-333; Ribavirin; Placebo for ABT-450/r/ABT-267; Placebo for ABT-333; Placebo for ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Capsule (double-blind treatment period), tablet (open-label treatment period); Tablet; Tablet; Capsule
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ABT-333 also known as dasabuvir; Viekira PAK
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C Virus; Hepatitis C Genotype 1; Hepatitis C; Treatment-Naïve; Interferon-Free; Chronic Hepatitis C; Viekira Pak; ombitasvir; paritaprevir; dasabuvir
A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      Overactive bladder is very prevalent in postmenopausal women. The current study is designed
      to investigate whether a new drug may offer safe and effective treatment.
    

Detailed description: 
      Clinical development of MK-0634 was discontinued. Study MK-0634-027 was a safety follow-up
      study to determine if there were any ocular effects of MK-0634 in participants from the
      United Kingdom who were exposed to MK-0634 during the 007 study.
    

Intervention name(s): MK-0634 50 mg; MK-0634 125 mg; Placebo for MK-0634
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one capsule orally, once daily in morning; one or three capsules orally, once daily in morning; one, two, three or four capsules orally once daily in morning
Other intervention name(s): L-000796568; L-000796568
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs
Condition: Drug-Related Side Effects and Adverse Reactions
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the
      association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of
      non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2
      V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the
      sample size planned, a mean difference of total body water delta between groups (control vs.
      polymorphic) of at least allow 10% could be observed.
    


Intervention name(s): Diclofenac; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 50 mg po, b.i.d for 6 days; Placebo po, b.i.d. for 6 days
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)
Condition: Ovarian Cysts
MeSH terms: Ovarian Cysts
Study type: Observational

Summary: 
      The most common endocrine condition in reproductive women is polycystic ovary syndrome. It
      has a prevalence of 5-10%. According to the Rotterdam criteria, oligo/anovulation, clinic or
      biochemical hyperandrogenism, PCOS morphology in ultrasonography, and the presence of these
      two criteria are required for diagnosis.

      The echogenicity of the ovarian stroma, vascularity, ovarian size, cystic pattern density,
      and subcortical organization of cysts are all significant considerations in ultrasonographic
      evaluation.
    

Detailed description: 
      Retrospective archive study.

      In the years 2018-2019, the ultrasonographic archives of PCOS women will be analyzed
      retrospectively in the Radiology department of Usak Education and Research Hospital.
      Ultrasonographic (Two-dimensional ultrasonography , conventional and other doppler)
      measurements of ovaries will be assessed in ultrasonographic data. Patient's data ( Menstrual
      cycle, androgenic findings, age, BMI etc..) will be obtained on the hospital records, PCOS
      patient's phenotype will be evaluated according to National Institutes Health (NIH)
      recommendations.

      The ovarian ultrasonographic findings of PCOS women will be compared.

      This study approved by Usak University Medical Faculty Ethical Committee April,06,2022.

      The Ethical Committee decision number is 57-57-04.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Reproductive period, PCOS women
Effect of Protein-nutrition Beverages on Muscle Protein Synthesis in Women
Condition: Muscle Protein Synthesis
Study type: Interventional

Summary: 
      This study investigates whether a protein-nutrition beverage can increase muscle protein
      synthesis to a similar magnitude as a control beverage.
    

Detailed description: 
      Potential participants will be screened, and if eligible, invited to participate. Body
      composition and physical activity level will be assessed during the initiation visit. During
      the trial visits, women receive a protein-nutrition beverage; muscle protein synthesis is
      assessed via blood analytes and muscle biopsies at rest and after exercise. Statistical
      analysis includes mixed model regression approach with change in muscle protein synthesis as
      the primary outcome.
    

Intervention name(s): Protein-nutrition beverage
Intervention type(s): Other
Intervention description(s): Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Muscle protein synthesis
Exploratory Analysis of Pulmonary Microbiome in Intubated Patients
Condition: Intubation Complication
Study type: Observational

Summary: 
      This prospective, multicentric study investigates the modifications of pulmonary microbiome
      that occur in patients who need mechanical ventilation for non-pulmonary conditions. Genomic
      analysis will be performed by 16S RNA amplification on biological samples (bronchial
      aspirate) collected from patients.
    

Detailed description: 
      The microbiome is defined as a community of microorganisms (such as bacteria, fungi, and
      viruses) that inhabit a particular organ. This prospective, multicentric, observational study
      investigates the bacterial changes that occur in the pulmonary microbiome during the first 72
      hours of mechanical ventilation in patients who have been intubated for non-pulmonary
      conditions in intensive care units (ICU).

      To this aim, genetic analyses will be performed on bronchial aspirate samples that will be
      collected from patients during their staying in ICU. Demographic and clinical information
      will be retrieved from patients' clinical reports and recorded in an apposite clinical report
      forms (CRF) in anonymized way. In particular, the reason for the admission to ICU, absence fo
      concomitant pulmonary diseases, comorbidities, body mass index, hematological examination
      results, concomitant therapies, antibiotic therapy performed in the 30 days prior to the
      admission, ventilation associated pneumonia (VAP)-preventing procedures, complications during
      mechanical ventilation, length of mechanical ventilation will be recorded in the CRF.

      The study will last 24 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Intubated patients with mechanical ventilation for at least 48 hours
      
Biospecimen description: 
      Bronchial aspirate
    
Keywords: ventilation; intubation; pulmonary microbiome
Methylnaltrexone Use for Opioid-induced Postoperative Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the routine use of methylnaltrexone in the
      post-operative pediatric spinal fusion patient will decrease the incidence of constipation.
    

Detailed description: 
      Methylnaltrexone will be given to pediatric patients post-operative from spinal fusion
      surgery on post-operative day number 3 and then again on postoperative day number 4, if no
      laxation achieved. Various outcome measures, safety and efficacy of the drug will be observed
      and recorded.
    

Intervention name(s): Methylnaltrexone; Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
Intervention type(s): Drug; Drug
Intervention description(s): Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.; Standard institutional bowel protocol will begin on post-operative day 1. Miralax,Docusate sodium or senna will be given on a weight-based dosing. If no bowel movement in 72 hours, bisacodyl or magnesium hydroxide will be added.
Other intervention name(s): Relistor; Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol
Intervention MeSH terms: Methylnaltrexone; Bisacodyl; Polyethylene glycol 3350; Magnesium Hydroxide; Bismuth subsalicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid-induced