bioihbjkbjnl/mcl2 huggingface dataset:
Psychosocial Group Interventions for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      A total of 384 patients suffering from chronic depressive disorder will be randomized to
      receive treatment as usual, CBASP, or befriending for a period of five months. The primary
      outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes
      in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and
      neurophysiological parameters. The data gathering is performed at pre- and post intervention
      stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the
      participants six months after the intervention.
    

Detailed description: 
      The efficacy of 20-week group-CBASP as compared to TAU is evaluated by RCT in a psychiatric
      outpatient clinics. The recruition is completed.
    

Intervention name(s): CBASP; Befriending; Treatment as usual
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Cognitive behavioral group intervention for individuals suffering from chronic depression; Social support intervention, sessions once per week; Conventional psychiatric outpatient treatment (individual counseling)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; treatment as usual; CBASP; befriending
The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
Condition: Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      Sedation for catheter ablation of atrial fibrillation should be performed to achieve
      analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as
      propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However,
      propofol and midazolam causes respiratory depression and dexmedetomidine occasionally
      accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that
      does not induce respiratory depression with stable hemodynamics is needed.

      Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and 1st
      line drug for fever and pain. In a previous study, paracetamol reduced morphine consumption
      after surgery. And paracetamol does not cause respiratory depression. Thus, the investigators
      hypothesized that addition of propacetamol to previously used sedatives
      midazolam-remifentanil will reduce opioid consumption during the catheter ablation.

      Therefore, the investigators designed this study to investigate the role of addition of
      propacetamol to previous used midazolam-remifentanil sedation. This study will compare the
      opioid consumption and respiratory effect of propacetamol with placebo-control for catheter
      ablation of atrial fibrillation.
    


Intervention name(s): Propacetamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.; Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.
Other intervention name(s): Propacetamol (Denogan®, Yungjin, Seoul, Korea); Normal Saline
Intervention MeSH terms: Acetaminophen; Propacetamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211
      when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes
      Mellitus.
    


Intervention name(s): LX4211; Januvia®
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg of LX4211 administered as two 200 mg tablets; 100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet
Intervention MeSH terms: Sitagliptin Phosphate; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diagnosing Respiratory Disease in Children Using Cough Sounds 2
Condition: Pneumonia; Bronchiolitis; Asthma Exacerbation; Croup; Reactive Airway Disease; Upper Respiratory Disease; Viral Lower Respiratory Tract Infections; Lower Respiratory Disease
MeSH terms: Bronchiolitis; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software
      application in the diagnosis of childhood acute respiratory disease, including pneumonia,
      bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease
      (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease
      (URTD).
    


Intervention name(s): Recordings of Infants and Children's Cough Sounds
Intervention type(s): Device
Intervention description(s): Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with signs or symptoms of respiratory disease presenting to participating
        Emergency Departments, Urgent Care Clinics, Outpatient Clinics or an Inpatient Ward within
        24 hours of admission.
Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      To compare the single-dose oral bioavailability of clarithromycin 250 mg/5 mL powder for oral
      suspension of Ranbaxy Laboratories with Biaxin 250 mg/5 mL granules for oral suspension in
      healthy, adult, human, male subjects under fed conditions
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, four-period,
      two-sequence, single-dose, crossover fully replicated, bioavailability study on
      clarithromycin formulations comparing clarithromycin 250 mg/5 mL powder for oral suspension
      of Ranbaxy Laboratories with Biaxin® granules 250 mg/5 mL oral suspension in healthy, adult,
      human, male subjects under fed conditions

      A single oral dose of clarithromycin 250 mg/5 mL was administered during each period under
      supervision of a trained Medical Officer.

      During the course of study, the safety parameters including vital signs, physical
      examination, medical history, clinical laboratory and safety tests (haematology, biochemical
      parameters) were assessed and, clinical laboratory safety tests (hematology & biochemical
      parameters) were performed again at the end of the study.
    

Intervention name(s): Clarithromycin 250mg/5mL
Intervention type(s): Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study of clarithromycin 250mg/5mL powdder
Physiology of GERD and Treatment Response
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      This study is designed to assess the physiologic and behavioral mechanisms associated with
      enhanced medication effects in adult patients with functional GERD-related symptoms.
    

Detailed description: 
      Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit
      with a study clinician regarding their symptoms. Heart rate variability and galvanic skin
      response will be measured in the patient-provider dyads and the visits video recorded.
      Subjects will receive a two-month supply of amitriptyline (10 mg/day), along with
      instructions for taking it. Subjects will complete a daily GERD symptom diary during the
      first and eighth weeks of the study. At the end of the 8-week observation period, subjects
      will complete follow-up measures of GERD symptom severity and quality of life.
    

Intervention name(s): Amitriptyline
Intervention type(s): Drug
Intervention description(s): Amitriptyline tablet
Intervention MeSH terms: Amitriptyline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diuretics In the Management of Essential Hypertension (DIME) Study
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic
      adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose
      diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is
      metabolically safe when used with other appropriate antihypertensives, effective in reduction
      of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an
      equivalence trial.
    

Detailed description: 
      There has been substantial evidence from clinical trials to support the rationale of use of
      thiazide diuretics in patients with essential hypertension. Diuretics may be more effective
      in reduction of blood pressure in Japanese patients than Caucasian because of higher salt
      intake. Moreover, given a large number of hypertensive population here, diuretics may be the
      most cost-effective antihypertensive agent. Japanese physicians, however, tend to avoid
      diuretics even in elderly hypertensive patients because of much concern over metabolic
      adverse events including new onset diabetes, which is deemed to increase cardiovascular risk.
      Although it is unlikely that use of low dose (12.5 mg of HCTZ or less) diuretics is
      associated with metabolic adverse events when they are given with any other appropriate
      antihypertensive agents (e.g. Ca antagonist, ACE inhibitor, ARB, K sparing diuretics) other
      than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of
      new onset diabetes in Japanese, who are assumed to be "diabetes prone" based upon thrifty
      gene hypothesis.
    

Intervention name(s): Thiazide diuretics; No diuretics
Intervention type(s): Drug; Drug
Intervention description(s): Any dosage, frequency, and duration; Any antihypertensive regimen other than diuretics
Intervention MeSH terms: Diuretics; Sodium Chloride Symporter Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Thiazide diuretics; Essential hypertension; Type 2 diabetes; Randomized clinical trial; Cost-effectiveness
Xenograft and Posterior Mandibular Socket Filling
Condition: Xenograft Model
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the volume of madibular bone after placement of a
      xenograft in a fresh extraction socket in human. The surgery protocol is flapless, and the
      teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3
      walls intact and the buccal wall at 80% . This study will include 35 patients.
    

Detailed description: 
      Primary objective :

      Estimate the percentage of loss of bone volume and the percentage thickness loss of the
      buccal and palatal cortical for patients who underwent bone volume preservation technology
      and conservation of the vestibular cortical by guided bone regeneration using a material slow
      absorption in the molar areas and premolar.

      Secondary objectives:

      Compare the percentage of loss of bone volume and the percentage loss of thickness of the
      buccal and palatal cortical patients who underwent a preservation technique, the upgrading
      data of mandibular posterior region without fillers described in the literature.

      Methods :

      After tooth extraction of a premolar or molar in mandibular flapless technique, guided bone
      regeneration is carried out. The cell is filled by a slow absorption material (Xenograft
      common use). The regeneration space is maintained by a resorbable membrane. To protect the
      membrane without tissue motion (technical flapless) placing a three-dimensional collagen
      matrix graft substitute gingival (Muccograft®) will be used. A CBCT preoperative be performed
      to verify the integrity of cortical and measure the height and width of the residual cavity.
      caliper measurements at the foot will also be performed during surgery in order to integrate
      also the thickness of the bone tables and gingival thickness.

      After healing of the graft, the pre-implant scan performed at six months postoperatively will
      measure the height and width of the grafted cell, to compare measurements and evaluate the
      dynamics of alveolar resorption
    

Intervention name(s): xenograft material to slow resorption
Intervention type(s): Other
Intervention description(s): xenograft material to slow resorption (Bio-Oss®)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Guided Bone; Pre-implant referred; Regeneration
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Condition: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate
      to severe lateral canthal lines in adults.
    

Detailed description: 
      This multi-center study evaluates the safety and efficacy of four different doses of RT001
      compared to vehicle applied as a single, bilateral topical application in at least 60
      subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of
      the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28
      days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be
      assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or
      treatment regimens need to be evaluated.
    

Intervention name(s): RT001; RT001; RT001; RT001; Vehicle Comparator
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): RT001; RT001; RT001; RT001; Vehicle Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Ovarian Mesial Incision: a New Safe and Fertility-sparing Technique
Condition: Dermoid Ovarian Cysts
MeSH terms: Ovarian Cysts; Dermoid Cyst
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and
      fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.
    


Intervention name(s): Laparoscopic dermoid cystectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopy will be performed by pneumoperitoneum with CO2. A complete pelvic examination will be performed to exclude malignant disease. Ovarian capsule will be incised by scissors on mesial side in study group and antimesial side in control group. After cleavage plane identification the cyst enucleation will be completed by atraumatic dissection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prospective Multicentre Cohort Study PROREPAIR-B (mCRPC)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      PROREPAIR is a prospective multicenter observational cohort study of unselected patients with
      metastatic Castration Resistant Prostate Cancer (mCRPC) with unknown germline mutational
      status at study entry and who are candidates to start 1st line treatment with any approved
      survival-prolonging agent.

      The study aims to evaluate the impact of aberrations in DNA-repair genes,(BRCA1, BRCA2, ATM
      and PALB2 and other genes) on cause-specific survival from the diagnosis of the metastatic
      castration resistant status and other outcomes.
    

Detailed description: 
      This is a non-interventional study in which eligible patients are prospectively followed-up
      until death or the end-of-study, whichever happens first.

      Patients are enrolled after mCRPC diagnosis and before or within the 6 first months of
      starting a first-line treatment with any approved survival-prolonging agent for mCRPC. First
      and subsequent treatment lines will be chosen according to the patients and their treating
      physicians preferences and will not be dictated by this study.

      A whole blood sample for germline DNA extraction as well as any available archival prostate
      cancer tissue samples will be collected at baseline. Optional plasma, serum and whole blood
      samples will be collected at baseline and at different time points along the evolution of the
      disease. A sample will be collected within the last 6 months of life.

      Survival and treatment outcomes including biochemical, radiological and clinical progression
      with standard approved agents abiraterone, enzalutamide, docetaxel, cabazitaxel and
      radium-223 will be prospectively collected.

      Primary aim is to evaluate the prevalence and impact of DNA repair germline mutations in the
      BRCA1, BRCA2, ATM and PALB2 genes on cause-specific survival from mCRPC. Secondary aims will
      include the correlation of additional germline alterations in DNA-repair with survival and
      treatment outcomes; the analyses of the survival and treatment outcomes impact of somatic
      alterations in these genes and the role of germline and somatic defects in the clonal
      evolution of prostate cancer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Recently diagnosed castration resistant prostate cancer without known mutation carrier
        status at study entry
      
Biospecimen description: 
      Whole blood, plasma, serum, archival FFPE and fresh tumour samples
    
Keywords: Castration-Resistant Prostate Cancer; DNA-repair; BRCA1; BRCA2; ATM; PALB2
Efficacy and Safety of Dapagliflozin in Children With Proteinuria
Condition: Proteinuria
MeSH terms: Proteinuria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in
      children with proteinuria.
    


Intervention name(s): Dapagliflozin
Intervention type(s): Drug
Intervention description(s): Dapagliflozin will be given 5mg per day (weight≤30kg) or 10mg per day (weight>30kg), for 12 weeks
Intervention MeSH terms: Dapagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: proteinuria; SGLT2i
Efficacy of BNG-1 to Treat Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to investigate the efficacy and safety of BNG-1 in patients
      with ischemic stroke. The efficacy assessment will be based on the functional outcome while
      the safety will be reviewed by the adverse events and laboratory examinations.
    

Detailed description: 
      The primary endpoint will be performed on the 12 weeks after study drug administered and will
      compare the favorable rate between treatment with Aspirin alone and combination treatment
      with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be
      determined if all of the following occurs: alive, Modified Rankin Scale (MRS) < 3, Barthel
      Index (BI) >= 60.

      Secondary objectives are to compare the following:

        1. Compare the favorable rate at one week after study drug administered and the end of
           treatment (Week 4) and 4 weeks of follow-up (Week 8) of either Aspirin alone or
           combination treatment with BNG-1 and Aspirin.

        2. Compare the mean change in Barthel Index (BI), at each evaluation time-point of either
           Aspirin alone or combination treatment with BNG-1 and Aspirin.

        3. Compare the mean change in National Institute of Health Stroke Scale (NIHSS) at each
           evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and
           Aspirin.

        4. Compare the Modified Rankin Scale (MRS) at each evaluation time-point of either Aspirin
           alone or combination treatment with BNG-1 and Aspirin.

        5. Compare the change in Extended Glasgow Outcome Scale (GOS-E) at each evaluation
           time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
    

Intervention name(s): BNG-1; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): BNG-1 3 grams TID for 4 weeks; Aspirin 100 mg QD for 4 weeks
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic stroke; Traditional Chinese Medication; Aspirin
A Study to Find Out How YM150 is Absorbed Into and Eliminated From the Body in Healthy Male Subjects
Condition: Pharmacokinetics; Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with
      a radio labeled drinking solution.
    

Detailed description: 
      Healthy male subjects are admitted on Day 0. Subjects receive a single oral dose of
      14C-labeled YM150 in the morning of Day 1 and remain in the unit for 7 days (6 nights).
      Blood, plasma, urine and feces samples are collected until 120 hrs after dosing for analysis
      of 14C-labeled radioactivity, YM150, YM-222714 and other metabolites. Expired air is
      collected as well for assessment of 14C-radioactivity.
    

Intervention name(s): YM150
Intervention type(s): Drug
Intervention description(s): 14C-labeled YM150, oral solution
Other intervention name(s): darexaban
Intervention MeSH terms: Darexaban
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Phase 1; 14C-labeled