bioihbjkbjnl/mcl2 huggingface dataset:
"ACT" for Parents of Children With Autism Spectrum Disorder
Condition: Stress
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The investigators will develop and pilot test an intervention called "ACT for Parents" which
      aims to decrease stress and improve quality of life in parents of children < 15 years who
      have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be
      conducted to gather initial data on the treatment feasibility and acceptability, detect
      treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine
      the treatment design for a future clinical trial.
    

Detailed description: 
      Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of
      uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued
      behavior in the presence of these emotions. ACT has been successfully applied to parents with
      similar mental health presentations. Using a randomized controlled study design,
      investigators seek to gather initial data on the treatment feasibility and acceptability,
      detect treatment effects in a cohort of parents who have a child (under the age of 15) with
      autism spectrum disorder.
    

Intervention name(s): Acceptance and Commitment Therapy
Intervention type(s): Behavioral
Intervention description(s): Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued behavior in the presence of these emotions. ACT has been successfully applied to parents of children with a variety of mental health presentations.
Other intervention name(s): ACT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Group Therapy; Parents; Autism; Quality of Life
"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
Condition: Renal Transplant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to see if campath-1H can be used in first time renal transplant
      subjects to prevent rejection and reduce the overall amount of anti-rejection medications
      that patients take on a daily basis.
    

Detailed description: 
      Twenty nine primary recipients of either a live donor or deceased donor renal transplant were
      enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody
      therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and
      maintenance sirolimus.

      Subjects were followed for 3 years to compare the incidence and severity of rejection
      episodes, complications related to the immunosuppression, including infections, malignancies
      and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12
      months (unless medically contraindicated).
    

Intervention name(s): Campath-1H
Intervention type(s): Drug
Intervention MeSH terms: Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevent kidney rejection
Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the injection site reaction and injection site pain
      after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different
      autoinjectors.
    

Detailed description: 
      Original French title of the study: Etude de phase IV, multicentrique, randomisée, ouverte,
      comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée
      d'interféron β-1b (Betaferon®) ou interféron β-1a (Rebif®) pendant la période de trois mois
      d'initiation de la thérapie chez des patients atteints d'une forme récurrente/rémittente de
      sclérose en plaques.

      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the
      trial.
    

Intervention name(s): Betaferon/Betaseron; Rebif; Betaferon/Betaseron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250ug administrated with Betaject; 44ug administered with Rebiject II; 250ug administrated with Betaject light
Intervention MeSH terms: Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; RRMS
Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods
Condition: Focus of Study is to Determine Efficacy of Compex
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The purpose of this research study is to determine if the application of ice, control group,
      or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed
      muscle soreness from performing leg extension and flexion. Individuals will complete a health
      history questionnaire to determine if they qualify for this study. We will measure your leg
      girth with a measuring tape and take a pain measurement of your hamstrings by using a spring
      to press down on your leg. Individuals will then warm-up on a bike without resistance for 5
      minutes followed by 10 regular leg extension and flexion exercises. Individuals will then
      perform 6 sets of 10 leg extension and flexion exercises on a biodex machine (similar to leg
      curl machines in the gym). Individuals will perform each set to the maximum effort of their
      capables. After each set of 10 individuals will have a 2 minute rest. We will ask you to rank
      your leg soreness on a scale from 1-10.

      Individuals will then be assigned to a modality of either ice, control group or compex.
      Individuals will perform the modality (ice, control, compex) we assign you to until you are
      no longer sore.

      Over the next five days individuals will return to measure their level of soreness, leg girth
      and pain pressure.

      This study will examine the following hypotheses:

      H1: There will be no difference in pressure pain threshold after using the Compex compared to
      other groups.

      H2: There will be no difference in perceived soreness after using the Compex compared to
      other groups.

      H3: There will be no difference in muscular strength after using the Compex compared to other
      groups.

      H4: There will be no difference in active range of motion after using the Compex compared to
      other groups.
    


Intervention name(s): Compex unit's Active Recovery® program; Ice application
Intervention type(s): Device; Other
Intervention description(s): Compex unit's Active Recovery® program will be performed for 15 minutes once per day.; Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Compex, ice
Habit Reversal Training for Children and Adolescents With Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Study type: Interventional

Summary: 
      The purpose of the current study is:

        1. To evaluate the effectiveness of a habit reversal training (HRT) approach for children
           ages 7 to 17 years of age inclusive with a diagnosis of trichotillomania.

        2. To explore factors that may relate to symptom severity, treatment outcome, and
           psychosocial impairment (e.g., specific symptom presence, co-morbidity, emotional
           regulation).
    

Detailed description: 
      The purpose of this research study is to further investigate how well Habit Reversal Training
      (HRT) works to reduce hair-pulling symptoms in children and adolescents with trichotillomania
      (TTM).

      All children will have the option to receive 8 weekly HRT sessions. Half of all children will
      be chosen at random to receive these sessions immediately following the pre-assessment and
      the remaining half will receive them after eight weeks (TAU condition). These sessions will
      focus developing skills for managing TTM and to decrease hair pulling. Such skills may
      include teaching your child to replace hair-pulling with another behavior. In the TAU
      condition, participants will seek the treatment in the community, with the option of
      receiving HRT treatment sessions at the end of the study.

      Participants in both groups will undergo four assessments in total (1) Pre-Assessment; (2)
      Post-treatment Assessment; (3) One-month Follow-up; (4)Three-month Follow-up. These
      assessments will involve several interviews that ask about different psychological symptoms
      that your child experiences such as sadness, anxiety, and TTM.
    

Intervention name(s): Habit Reversal Training
Intervention type(s): Behavioral
Intervention description(s): 8 weekly therapy sessions lasting 50 minutes based on the protocol outlined by Woods (2001).
The overall focus of treatment is to provide patients with tools to help them manage and reduce hair-pulling.
components:
Session 1. (a) to develop an understanding of the subject's hair-pulling through an initial interview; and (b) to establish a protocol for ongoing assessment.
Session 2. implement habit reversal, including awareness training, competing response training, and social support.
Sessions 3-8. For subjects with a single hair-pulling site, Session 3 will review and practice HRT procedures and name solutions to problems that may have arisen. For those with multiple hair-pulling sites, treatment will be reviewed for the first site in the hierarchy.
Other intervention name(s): Trichotillomania; Hair pulling; TTM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Habit Reversal Training; Hair Pulling; Children; Trich; cognitive behavioral therapy; TTM; psychotherapy
Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Dose Compared to Monocomponents in Healthy Male Volunteers
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the relative bioavailability of a fixed dose combination of tiotropium and
      salmeterol compared to a free dose combination of the marketed products of tiotropium and
      salmeterol (Spiriva® and Serevent® Diskus®).

      Assessment of the relative bioavailability of a fixed dose combination of tiotropium and
      salmeterol compared to tiotropium and salmeterol administered as individual mono substances
      from the marketed products.

      Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol
      in a PE (Polyethylene) capsule administered via the HandiHaler® 2
    


Intervention name(s): Tiotropium/Salmeterol; Serevent® Diskus®; Spiriva®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fixed dose combination of tiotropium 7.5 μg and salmeterol 25 μg inhalation powder, PE capsule via HandiHaler®
Intervention MeSH terms: Tiotropium Bromide; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of nipocalimab versus
      placebo in participants with moderate to severe active rheumatoid arthritis (RA).
    

Detailed description: 
      RA is a chronic autoimmune inflammatory disorder of unknown etiology that occurs in
      approximately 1 percent (%) of the population. Nipocalimab (also referred to as JNJ-80202135
      and M281) is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody designed
      to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal
      fragment crystallizable (Fc) receptor (FcRn). Nipocalimab has a unique mechanism of action
      whereby it blocks the IgG binding site on endogenous FcRn and is expected to decrease
      pathogenic IgG antibody concentrations. A significant involvement of pathogenic IgG
      antibodies has been demonstrated in autoimmune diseases including RA. The primary hypothesis
      is that treatment with nipocalimab intravenously (IV) every 2 weeks (q2w) is superior to
      placebo in participants with moderate to severe active rheumatoid arthritis (RA) as assessed
      by the mean change from baseline in the disease activity index score 28 using C-reactive
      Protein (DAS28-CRP) at Week 12. The study consists of a Screening Period (less than or equal
      to [<=] 6 Weeks), Double-blind Treatment Period (12 Weeks), and a Safety Follow-up Period (6
      Weeks). Key safety assessments will include adverse events (AEs), serious adverse events
      (SAEs), adverse events of special interests (AESIs), clinical laboratory safety tests
      (hematology, chemistry, and lipid profile), vital signs, and physical examination. The total
      duration of the study is up to 24 weeks.
    

Intervention name(s): Placebo; Nipocalimab
Intervention type(s): Other; Drug
Intervention description(s): Placebo infusion will be administered intravenously.; Nipocalimab infusions will be administered intravenously.
Other intervention name(s): JNJ-80202135; M281
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211
      versus a placebo control in subjects with type 2 diabetes mellitus.
    


Intervention name(s): LX4211 Low Dose; LX4211 High Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A low dose of LX4211; daily oral intake for 28 days; A high dose of LX4211; daily oral intake for 28 days; Matching placebo dosing with daily oral intake for 28 days
Intervention MeSH terms: (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: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SPD544 High Strength Bioequivalence Study
Condition: ADHD
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess bioequivalence of 2 capsule strengths.
    

Detailed description: 
      This will be a randomised, open-label, two-period, single dose, crossover bioequivalence
      study in healthy subjects under fasting conditions to assess bioequivalence of 1 x 60 mg
      capsule methylphenidate compared to 2 x 30 mg capsules methylphenidate. Pharmacokinetics and
      safety will be assessed.
    

Intervention name(s): SPD544; Methylphenidate hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): two 30mg capsules, single oral dose; one 60mg capsule, single oral dose
Other intervention name(s): Equasym XL; Metadate CD
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Overnight Closed Loop Study in U.S.
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The
      goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be
      used in an even larger study outside of hospital.
    

Detailed description: 
      Subjects that have met eligibility criteria will undergo treatment with the hybrid closed
      loop system under various experimental conditions.There is no statistically powered study
      hypothesis testing.

      The investigational centers will be encouraged to include subjects of different ethnicities
      including Hispanic, Native American, and African-American.

      The study is anticipated to last no more than 12 months from investigational center
      initiation to finalization of all data entry and monitoring procedures. Subjects are expected
      to participate for approximately 1- 2 months.
    

Intervention name(s): Hybrid Closed Loop
Intervention type(s): Device
Intervention description(s): The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Intervention model: Single Group Assignment
Intervention model description: subjects undergo treatment with the hybrid closed loop system under various experimental conditions
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: HCL; Type 1 Diabetes; Sensor
Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation
Condition: Minimal Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Observational

Summary: 
      This study included 20 patients listed for liver transplantation in addition to 20 age- and
      sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations
      were performed for both patients and controls before and 6 months after liver
      transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B,
      Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver
      transplantation.
    


Intervention name(s): Liver transplantation
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver
        transplantation.
Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effects on Metabolism
Condition: Obesity; Surgery
Study type: Observational

Summary: 
      Severe obesity (SO), defined as BMI≥95th percentile, has increased worldwide among
      adolescents. American studies estimated that 1.3-2.8% of 12-19-year-old individuals have a
      BMI >40 kg/m2 or a BMI >35 kg/m2 with at least one serious co-morbidity. The immediate and
      long-term risks associated with SO in adolescents include cardiovascular and metabolic
      diseases, obstructive sleep apnoea and nonalcoholic fatty liver disease. However, the results
      of sleeve gastrectomy in adolescents are still uncertain.

      Objective and hypotheses: Investigators aimed to assess the long-term safety, efficacy, and
      cardiovascular risk changes of laparoscopic sleeve gastrectomy in adolescents with SO.

      Method: Longitudinal retrospective study of 22 adolescents with SO who underwent laparoscopic
      sleeve gastrectomy. Clinical and metabolic variables immediately before surgery and after 6,
      12, 18 and 24 months were assessed.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Severe obese adolescents who underwent laparoscopic sleeve gastrectomy
      
Keywords: cardiovascular risk; metabolic profile
Three Arm Trial of Immune Effects of Echinacea
Condition: Upper Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      The goal of this study is to determine if either of two, commercially available, Echinacea
      purpurea products stimulate the immune system. For the study, 60 healthy adults will be
      randomized to receive one of the two Echinacea purpurea products or placebo for 10 days.
      Blood will be drawn to assess immune markers just before beginning the study medication,
      during the 10 day course of medication and after completing the course of medication. It is
      postulated that adults receiving either of the Echinacea products will have evidence of
      immune stimulation and those receiving placebo will not.
    


Intervention name(s): Echinacea purpurea product; Echinacea purpurea product; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 5 ml by mouth 3 times per day for 10 days; 1 ml by mouth 3 times per day for 10 days; either 5 ml or 1 ml by mouth three times per day for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Echinacea; immune modulation; prevention
A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once
      daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having
      achieved normokalemia following two days of initial ZS therapy (10g TID).
    


Intervention name(s): Sodium Zirconium Cyclosilicate (ZS) 10g; Sodium Zirconium Cyclosilicate (ZS) 5g; Sodium Zirconium Cyclosilicate (ZS) 10g; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase); Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.; Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.; Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment