bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This primary purpose of this study is to evaluate the safety, tolerability, and
      pharmacokinetic properties of multiple ascending doses of ATN-103 administered subcutaneously
      (below the skin) to Japanese subjects with active rheumatoid arthritis and on a stable
      background of methotrexate. Some subjects will receive ATN-103 while other subjects will
      receive a placebo.
    


Intervention name(s): ATN-103 10 mg q4wks; ATN-103 30 mg q4wks; ATN-103 80 mg q4wks; ATN-103 10 mg q8wks; ATN-103 80 mg q8wks
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.; ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.3 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.; ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.; ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections.; ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TNF inhibitor; Multiple ascending dose study
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the
      efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and
      maintenance treatment of moderately to severely active Crohn's Disease (CD). The target
      population includes participants with CD who are refractory or intolerant to corticosteroids
      (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor
      necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF
      therapies and demonstrated inadequate responses or intolerance to anti-TNFs.

      The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week
      Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14
      (end of Induction Phase), participants achieving a decrease from baseline of at least 70
      points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use
      of rescue therapy will continue to the Maintenance Phase.
    


Intervention name(s): Etrolizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etrolizumab will be administered as per regimen specified in individual arms.; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Other intervention name(s): RO5490261; RG7413
Intervention MeSH terms: Etrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The main hypothesis of the investigators study is that the development of autoimmune diabetes
      may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.
    


Intervention name(s): Mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 1 diabetes; mesenchymal stem cells; intervention
Gastrointestinal Tolerance Evaluation of an Infant Formula
Condition: Healthy, Full-term Infants Who Are Formula-fed
Study type: Interventional

Summary: 
      Prospective, double-blind, randomized study of 2 infant formulas.
    

Detailed description: 
      Exclusively formula-fed infants will participate in a 6-week feeding period of an infant
      formula. Tolerance records will be kept for 2 days at the end of the 6-week period by
      caregivers.
    

Intervention name(s): Routine Infant Formula 1; Routine Infant Formula 2
Intervention type(s): Other; Other
Intervention description(s): Routine infant formula with probiotic; Routine infant formula with probiotic and prebiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
JASPER Intervention in Down Syndrome
Condition: Down Syndrome, Trisomy 21
MeSH terms: Down Syndrome; Syndrome; Trisomy
Study type: Interventional

Summary: 
      The goal of this study is to determine whether JASPER (Joint Attention, Symbolic Play,
      Engagement, Regulation), which is an intensive, targeted early behavioral intervention
      focused on a developmentally based approach for teaching joint engagement, joint attention,
      and play skills can improve behavioral / emotional regulation, social communication skills,
      and developmental trajectories in Down syndrome (DS). The investigators will also explore the
      potential use of EEG and event-related potentials (ERP) as outcome measures, as this approach
      may help elucidate mechanisms of change in behavior and development, and may help explain
      differences in development of social communication skills in individuals with DS. EEG and ERP
      measure may also help to predict treatment outcome.
    


Intervention name(s): JASPER
Intervention type(s): Behavioral
Intervention description(s): JASPER is a therapist and parent-mediated intervention that (1) targets the foundations of social communication, (2) uses naturalistic behavioral strategies to increase the rate and complexity of social communication and (3) includes parents as implementers of the intervention to promote generalization across settings and to ensure maintenance. This intervention is individualized and centered around two key developmental domains critical for social communication function: joint engagement and joint attention.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will initially undergo brief telephone screen to assess eligibility. Parents/guardians will complete surveys during the Baseline assessment and ERP/EEG testing will be done for participants who are able to undergo their assessments in-person. Participants will then be randomly assigned to either the treatment group or the control/waitlist group. The immediate group will start with 3 months of JASPER intervention and then have 3 months of their usual clinical care. The control/waitlist group will start with 3 months of their usual clinical care and then undergo 3 months of JASPER intervention. The 3-month treatment phase will involve weekly sessions with the JASPER interventionist, each 60 minutes long. Surveys and ERP/EEG assessments (as possible) will be repeated at the 3 month and at 6 month research visits for all participants.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Behavioral regulation; Emotional regulation; Social communication; Development
Web-Based Epilepsy Education Program for Adolescents and Parents
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      This study aims to develop a web-based epilepsy education program for adolescents with
      epilepsy and their parents and to evaluate the efficacy of eb-based epilepsy education
      program on health management.eb-based epilepsy education program has been proved to be a
      useful and reliable educational website for the development of knowledge, attitude,
      self-efficacy and e-health literacy of adolescents with epilepsy and their parents.
    

Detailed description: 
      This study aims to develop a web-based epilepsy education program for adolescents with
      epilepsy and their parents and to evaluate the efficacy of web-based epilepsy education
      program on health management.

      This randomized controlled study was conducted with 69 adolescents with epilepsy aged between
      9-18 and their parents (n=71) who were accepted to Pediatric Neurology Policlinic of Antalya
      Training and Research Hospital of Health Science University between November 2017 and April
      2018. The study sample was divided into two groups as study (35 adolescents, 37 parents) and
      control (34 adolescents, 34 parents) groups using simple randomization method. The web-based
      epilepsy training program which was developed during the preparation stage of the study was
      evaluated by 13 experts using the Quality of Criteria for Consumer Health Information
      measurement instrument. The data collection materials (Seizure Self efficacy scale, E-Health
      literacy scale, Child Attitude Toward Illness Scale, Website Analysis and MeasureMent
      Inventory Scale) were administered by the researcher to the adolescents and parents in both
      groups before applying eb-based epilepsy education program. Following the administration of
      eb-based epilepsy education program to the initiative group, all participants were observed
      for three months. The data collection materials were reapplied to all the participants at the
      end of the third month. In addition, the adolescents and their parents in the study group
      were applied Website Analysis and Measurement Inventory measurement tool for the evaluation
      of usability of the site.
    

Intervention name(s): Web based education
Intervention type(s): Other
Intervention description(s): Web based education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Epilepsy; Web based education; Pediatric Nursing; Parent; Adolescence
A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A new tablet form of PF-04531083 has been manufactured. Previously the compound was
      administered as a solution/suspension to healthy volunteers. This study will investigate the
      pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics
      obtained, with the same dosing regimen, with the solution/suspension.
    


Intervention name(s): PF-04531083; PF-04531083
Intervention type(s): Drug; Drug
Intervention description(s): Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days; Dosed as a tablet in 100mg strengths. Dosage in this optional second cohort will be optimised based on the data arising from Cohort 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; tablet performance; healthy volunteers; open label
A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum
      concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and
      ribavirin combination therapy following single and multiple doses in participants with CHC
      infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving
      hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target
      sample size is 48 individuals.
    


Intervention name(s): Peginterferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.; Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.
Other intervention name(s): Pegasys; Copegus
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of Glass Carbomer Performance
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and
      flouroapatite reinforced glass carbomer filling material.
    

Detailed description: 
      The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and
      flouroapatite reinforced glass carbomer filling material.

      In this study, total of 100 (46 class I, 54 class II) restorations were performed in 36
      patients. All cavities were prepared conventionally. Half of the restorations were restored
      with nano composite resin (Tokuyama Estelite, Tokuyama Dental, Japan) and the other half were
      restored with glass carbomer material (GCP Dental, The Netherlands). Rubber-dam was used for
      isolation. Before the replacement of composite restorations, enamel edges were etched
      according to selective etching method. Then universal adhesive system was applied. Composite
      resin was applied to the cavity in 2 mm layers by incramental technique. Glass carbomer was
      placed with bulk technique by applying finger pressure with surface covering. Composite
      restorations were polymerized with LED light curing unit. Glass carbomer restorations were
      cured its own special curing unit. Restorations were evaluated with modified USPHS criteria
      at the end of the first week, 6 months and 12 months. Data were analyzed using Fisher's Exact
      Chi-Square test, Fisher Freeman Halton Test and Continuity (Yates) Correction. Wilcoxon sign
      test was used for intra-group comparisons of the parameters. Statistically significance was
      evaluated at p <0.05.
    

Intervention name(s): Restoration of cavities using glass carbomer material (GCP Dental); Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)
Intervention type(s): Other; Other
Intervention description(s): Detection of caries then restoration of cavities; Detection of caries then restoration of cavities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: glass ionomer, composite, clinical
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is
      effective and save, and to determine the most effective dose, in the treatment of patients
      with acute kidney injury caused by sepsis.
    

Detailed description: 
      Design:

      Adaptive trial with two stages and interim analysis

        -  Stage 1: four arms; three dose groups and placebo. n=30/arm. (n=120)

        -  Interim analysis based on 120 subjects, with continued recruitment, adding 11 subjects
           to Stage 1 safety population (n=131): to evaluate safety and select dose for stage 2

        -  Stage 2: one dose group and placebo. N=85/arm. (n=170) Total n in the study: 301.

      Primary objectives

        -  To investigate the effect of recAP on renal function (measured creatinine clearance
           D1-D7 period, incidence and duration of renal replacement therapy (RRT) over 28 days,
           eGFR at D60 and D90) and related clinical parameters (ICU stay, Hospital stay,
           Mechanical ventilation over 28 days, SOFA and SAPS2 scores 28 days) in patients with
           SA-AKI.

        -  To determine effective therapeutic dose(s) of recAP.

      Secondary objectives

        -  To investigate the safety and tolerability of recAP in patients with SA AKI. (assessed
           by independent Data Monitoring Board, adverse events over 90 days study period,
           laboratory values, ECG, physical examniations, vital signs, Anti Drug Antibodies)

        -  To investigate the pharmacokinetic profile (PK) of recAP in a subset of patients (part
           1, n=120) with SA AKI. (Population PK; AUC D1-7, Cmax, Cmin, Tmax, terminal T1/2)

        -  To investigate the immunogenic potential of recAP in patients with SA AKI. (anti-drug
           antibodies at D14, D28, D60 and D90)

        -  To investigate the effect on quality of life (using the EuroQol, EQ-5D) following study
           inclusion, at ICU discharge, and Day 90.

      Other objectives

      • To evaluate whether specific patient groups can be identified that benefit most from recAP
      treatment or patient groups that are non-responders
    

Intervention name(s): recAP; Placebo
Intervention type(s): Biological; Other
Intervention description(s): One hour infusions once daily for three days; 1 hour IV infusion once daily for 3 days
Other intervention name(s): Recombinant Alkaline Phosphatase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SA-AKI; Sepsis; AKI; Recombinant Alkaline Phosphatase; recAP
Safety Study of F2695 SR in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment
      of adults with major depressive disorder.
    


Intervention name(s): F2695 SR
Intervention type(s): Drug
Intervention description(s): Drug F2695 SR (flexible dose) to be given orally in capsule form once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder
Efficacy of Polyglucosamine for Weight Loss
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The polyglucosamine, specification L112 is a medical device and in this clinical trial used
      for weight reduction of overweight and obese participants. The rationale for this study is to
      show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals
      with the highest fat content.
    

Detailed description: 
      To have a comparable diet condition, all participants in both groups had to follow the
      recommendations of the German clinical practice guidelines on the management and prevention
      of obesity.

      One group had to take the polyglucosamine tablets and the other group placebo tablets for at
      least 24 weeks. It is known, that polyglucosamine is a fat binder acting in a
      physical-chemical manner, the positive charged fiber is bound to the negative charged dietary
      fat and this complex in unable to pass the gut wall into the body but is naturally excreted,
      hence this energy is not available. Therefore, this medical device should show a measurable
      reduction in body weight.
    

Intervention name(s): Polyglucosamine; Placebo
Intervention type(s): Device; Other
Intervention description(s): ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans; Placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: obesity,; body weight,; overweight,; weight loss,; polyglucosamine,; L112; caloric restriction; physical activity
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is multi-center, randomized, placebo-controlled, parallel-group, double-blind,
      dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin
      orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary
      osmolality."
    


Intervention name(s): Desmopressin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.; Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
Other intervention name(s): FE992026; desmopressin melt; Minirin
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Relative Bioavailability of 2 Oral Formulations of Nintedanib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib
      compared to 2 soft gelatine capsules containing 100 mg nintedanib
    


Intervention name(s): Nintedanib; Nintedanib; Nintedanib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 soft gelatine capsule, single dose, oral; Nintedanib, 2 soft gelatine capsules, single dose, oral
Other intervention name(s): Nintedanib, 2 soft gelatine capsules, single dose, oral
Intervention MeSH terms: Nintedanib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment