bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Effects of a2 Platinum Stage 1 Infant Formula on Infant Digestion and Comfort
Condition: Healthy Infants
Study type: Interventional

Summary: 
      This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the
      effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2
      β-casein-containing stage 1 infant formula versus breastfeeding on crying, tolerance, gut
      health, and immune function.
    

Detailed description: 
      The protocol was updated from V8.2 to V9.1 and was approved by the Ethical Committee of
      Shanghai First Maternity and Infant Hospital, the main site. The major changes are: from
      "blind to participants" to "non-blind to participants"; from "Single-Centre" to
      "Multi-Centre"; number of subjects from "270" to "180"; trial period from "3 weeks" to "4
      weeks"; and number of visits from "6" to "4".
    

Intervention name(s): a2 Platinum® stage 1 infant formula; Conventional, A1 and A2 β-casein containing stage 1 infant formula
Intervention type(s): Other; Other
Intervention description(s): Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.; Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
Condition: Opioid Abuse
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual
      recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40
      mg alone in subjects with a history of opioid abuse.
    

Detailed description: 
      In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in
      combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects
      were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour
      washout between doses. 15 subjects randomized to receive oxycodone before the
      oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment
      Phase was to assess the abuse liability and abuse deterrence potential of 4 times the
      recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8
      tablets per dose).

      All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to
      dosing on all dose days.
    

Intervention name(s): Acurox 5/30mg taken first; Oxycodone 5mg taken first
Intervention type(s): Drug; Drug
Intervention description(s): followed by oxycodone 5mg with 48 hour washout; followed by Acurox 5/30mg with 48 hour washout
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence
Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy,
      placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of
      tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients
      homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor
      (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be
      randomised into the 16 week double-blind treatment period in which they receive either
      tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily
      administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily.
      After the 16 week treatment period all patients will receive salmeterol MDI twice daily for
      four weeks.

      The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume
      in the First Second (FEV1) measurements with an electronic peak flow meter throughout the
      study. Daily data on asthma control and use of rescue medication are recorded using an
      electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma
      Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure
      and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.
    


Intervention name(s): Tiotropium bromide; Placebo; Salmeterol xinafoate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Bromides; Tiotropium Bromide; Salmeterol Xinafoate
Intervention model: Parallel Assignment
Primary purpose: Treatment
Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Primary Objective: to evaluate the interaction with food after a single oral dose of a
           fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male
           subjects

        -  Secondary Objective: to assess the clinical and biological safety and tolerability of
           Coarsucam™
    


Intervention name(s): Artesunate + Amodiaquine
Intervention type(s): Drug
Intervention MeSH terms: Artesunate; Amodiaquine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg
      subcutaneous weekly injection when co-administered with MTX
    

Detailed description: 
      this study is to evaluate the long-term safety including immunogenicity and efficacy of
      LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX for additional 48
      weeks (a total of 100 weeks including 52 weeks of the treatment period in Study LG-ECCL002)
      in the subjects who have completed the treatment period of phase III clinical study for
      LBEC0101 (Study No. LG-ECCL002).
    

Intervention name(s): LBEC0101
Intervention type(s): Drug
Intervention description(s): Etanercept 50mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at
      sparing the pelvic autonomic nervous system. They were observed prospectively followed and
      interviewed in order to evaluate functional outcomes after surgery.
    

Detailed description: 
      Surgical tretament for deep endometriosis can produce lesions at the level of the pelvic
      autonomic system.

      Before surgery and 3-12 months after the nerve-sparing surgical procedures, patients were
      assessed for urinary, sexual and fecal function, in order to evaluate whether sparing of the
      nerves during the intervention had a beneficial impact on post-operative pelvic function.
    

Intervention name(s): Validated questionnaires
Intervention type(s): Other
Intervention description(s): Patients were administered pre- and post-operatively the three validated questionnaires ((FSFI, ICIQ-UI short form Italian, NBD score) investigating sexual, urinary, and fecal function, respectively.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoimg nerve-sparing surgery for deep endometriosis were enrolled if they
        were operated by a single surgeon with extensive background in minimally-invasive pelvic
        surgery.
      
Keywords: surgery; pelvic function
A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers
Condition: Healthy Volunteer Study; Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to evaluate the safety and tolerability of KNX100
      administered orally as a single and multiple ascending doses in healthy volunteers.
    

Detailed description: 
      This is an adaptive, Phase 1, first-in-human (FIH), single treatment, double blind, placebo
      controlled, randomized, single and multiple ascending dose study of KNX100 administered to
      healthy volunteers. Approximately 64 male and female healthy subjects will be enrolled into
      this study. Healthy subjects who meet all the eligibility criteria will be randomly assigned
      to Cohorts 1-5 for the Single Ascending Dose and Cohorts 1-3 for the Multiple Ascending Dose.
      Each cohort will evaluate 8 subjects; 6 subjects will receive KNX100 (study drug) and 2
      subjects will receive placebo.

      Each cohort will be enrolled sequentially, and dose escalation decisions will be made
      according to protocol by the Cohort Review Committee (CRC) consisting of the investigators
      and medical monitor. Subjects and clinical staff will be blinded to therapy assignment.
      KNX100 will be provided in capsule form as 5, 25 and 100 mg capsules for oral administration
      and the dose range will be 5 to 50mg.
    

Intervention name(s): KNX100
Intervention type(s): Drug
Intervention description(s): KNX100 will be provided in capsule form as 5, 25 and 100 mg capsules for oral administration. Study drug will be encapsulated in hydroxypropyl methylcellulose (HPMC) dark green opaque size 0 capsules and packaged in 100 mL high density polyethylene (HDPE) bottles with polypropylene (PP) twist-off closures.
Other intervention name(s): KNX100 placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dosing will be based on the assigned treatment group. The single ascending dose cohorts will evaluate doses of KNX100 starting with 25 mg and increasing up to a maximum of 50 mg per day. The multiple ascending dose cohorts will evaluate a low-, mid-, and high-dose KNX100 administered for 7 consecutive days. Individual doses will be dispensed by unblinded site pharmacy staff. Dose escalation will progress upon Cohort Review Committee (CRC) approval.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of AAM for Correction of Age Related Volume Deficits in the Face
Condition: Age-Related Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate Allograft Adipose Matrix (AAM) in the face of people
      with age-related volume deficit - fat loss. AAM is a tissue used to correct fat loss.
      Participation in this study requires injections for placing AAM in the bilateral pre-jowl and
      malar areas of the face. The research will tell whether AAM is effective in maintaining
      mid-face fullness and whether the appearance of the skin improves after injection.
    


Intervention name(s): AAM
Intervention type(s): Procedure
Intervention description(s): Subcutaneous injection procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized cohorts
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Efficacy of AIN457 in Noninfectious Uveitis
Condition: Non-infectious Uveitis
MeSH terms: Uveitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was performed to evaluate the efficacy and safety of AIN457 for patients with
      active uveitis that requires systemic immunosuppression.
    


Intervention name(s): AIN457; AIN 457; AIN457
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AIN457 subcutaneous dose; AIN457 low dose (i.v); AIN457 high dose (i.v)
Other intervention name(s): Secukinumab; Secukinumab; Secukinumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Uveitis; eye; IL-17; IL-17A; IL17; AIN457; Vogt-Koyanagi-Harada; Behcet's; Behcet; Sympathetic ophthalmia; Multifocal choroiditis; Birdshot; HLA-B27; Birdshot retinochoroiditis; Retinal vasculitis; Sarcoidosis; Intermediate uveitis; Panuveitis; Posterior uveitis
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
Condition: Chronic Hepatitis B Virus Infection; Chronic Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis B; Hepatitis C, Chronic; Hepatitis B, Chronic; Herpesviridae Infections; Hepatitis; Hepatitis, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of renal impairment on pharmacokinetics
      (PK) of BMS-914143.
    

Detailed description: 
      Primary purpose: Protocol designed to evaluate the effect of renal impairment on
      pharmacokinetics of BMS-914143
    

Intervention name(s): BMS-914143 (Peginterferon Lambda-1a)
Intervention type(s): Biological
Other intervention name(s): Lambda
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models
Condition: Pleural Effusion
MeSH terms: Prostatic Neoplasms; Pleural Effusion
Study type: Observational

Summary: 
      The purpose of this study is to determine whether adding new methods of data visualization to
      routine clinical care will improve (i) surgical planning and (ii) surgical outcomes in
      patients with kidney and prostate tumors.
    

Detailed description: 
      This early phase I trial studies how well indwelling pleural catheters with doxycycline work
      compared to indwelling pleural catheters alone in treating participants with malignant
      pleural effusions. These types of catheters are commonly used to treat pleural effusions
      (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat
      pleural effusions. It is not yet known whether giving doxycycline with indwelling pleural
      catheters works better than indwelling pleural catheters alone in treating participants with
      cancerous pleural effusions.
    

Intervention name(s): Routine CT; Routine imaging CT with a 3D printed model; Routine imaging MRI with a 3D printed model; Routine MRI; Routine imaging CT with a VR model; Routine imaging MRI with a VR model
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions.; CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + 3D Printed Model; will measure post-operative lesion volume as visualized on the post-operative MRI + 3D Printed Model; will measure post-operative lesion volume as visualized on the post-operative MRI; CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + VR Model; will measure post-operative lesion volume as visualized on the post-operative MRI + VR Model
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have scheduled to have kidney or prostate cancer surgery
Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema
Condition: Cardiac Edema
MeSH terms: Edema, Cardiac; Edema
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the
      efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid
      retention caused by congestive heart failure) based on the conventional therapy.

      To evaluate the efficacy and safety of Tolvaptan 15 mg on congestive heart failure patients
      with body fluid retention after current diuretic treatment, after continuous treatment of 7
      days' oral Tolvaptan 15mg or placebo.
    

Detailed description: 
      -  A randomized, double-blind, multicenter, placebo-controlled, parallel study

        -  Study population: The congestive heart failure patients with body fluid retention after
           received current diuretics therapy

        -  Number of patients: Patients will be randomly assigned to Tolvaptan and placebo group in
           1:1 ratio, 120 patients in each group, 240 patients in total

        -  Group assignment method: Tolvaptan 15 mg group: conventional therapy + Tolvaptan 15 mg
           Placebo group: conventional therapy + placebo

        -  Administration and dosage of the study drug: Once daily, 1 tablet be taken orally after
           breakfast, for successive 7 days

        -  Study period:

        -  Screening period (4 days in minimum, 7 days in maximum), including:

      Screening period: from the time the informed consent form is signed to Day -4 Observation
      period: 3 days before drug administration

        -  Treatment period: 7 days

        -  Follow up visits: Day 8 (efficacy evaluation day) and Day 7 (+3) after the last dosing

        -  Post treatment survey: Day 14 (+3) after the last dosing
    

Intervention name(s): Tolvaptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral taken
Other intervention name(s): Samsca
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Way to Safety Cellphone Blocking
Condition: Teen Drivers; Motor Vehicle Accident
Study type: Interventional

Summary: 
      Research participants will be recruited to take part in a randomized control trial.
      Participants' cellphone use will be observed during an initial baseline period. Participants
      will then be randomly assigned to one of four conditions: education only (control), opt-in
      blocking, opt-out blocking, and opt-out blocking with parental notification.
    

Detailed description: 
      Motor vehicle crashes are the leading cause of death in teens in the United State and for
      drivers aged 15-19 involved in fatal crashes, 21% of distracted drivers were distracted by
      the use of cellphones. Nearly 90% of teens expect a response to a text message within 5
      minutes, and the compulsion to respond is stronger for messages from close social contacts.
      This suggests that behavioral-economic interventions such as immediate and frequent
      incentives are needed to offset the disutility caused by not being able to communicate by
      cellphone while driving. If proven to be effective, incentives could be scaled up via auto
      insurance discount contributions, school programs, and parental contributions.
    

Intervention name(s): Cellcontrol DriveID; Education Only
Intervention type(s): Device; Other
Intervention description(s): Technology that blocks incoming and outgoing calls and texts.; No active intervention, educational materials will be provided
Other intervention name(s): DriveID; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Driving; Teens; Texting; Cellphone; DriveID; Motor vehicle accident
Normative Reference Values of Equilibrium Coordination Test Among Children
Condition: Coordination Disorder, Developmental
MeSH terms: Motor Skills Disorders
Study type: Observational

Summary: 
      A cross-sectional study will be conducted recruiting children of age group 8-15 years. Pilot
      study has been conducted for the determination of the sample size. The calculated sample size
      has come out to be, n=378 which can be taken for males and females separately. Stratified
      random sampling will be done according to age. Child will be asked to perform all tests one
      by one and the time taken (in seconds) will be noted required to perform the tests. The mean
      of three readings will be obtained using a mobile-based stop watch.
    

Detailed description: 
      756 children will be recruited of age group 8-15 years. Five equilibrium coordination tests
      i.e. Sideways walking, tandem walking, cross-stepping, heel walking and toe walking will be
      performed by each child and three readings will be recorded. Mean of three readings will be
      considered as normative reference value of each test respectively.
    

Intervention name(s): Reference values
Intervention type(s): Other
Intervention description(s): Normative reference values of coordination tests will be obtained
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Normal healthy children of age group between 8 and 17 years was recruited
      
Keywords: children; coordination; normal range; postural balance; walking