bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Combined Psychotherapy and Physiotherapy Group Treatment Program for Survivors of Torture
Condition: Pain Syndrome; Disability Physical
Study type: Interventional

Summary: 
      The aim of this study is to assess the impact and feasibility of an interdisciplinary group
      treatment approach, involving psychotherapy and physiotherapy, with survivors of torture that
      are incarcerated in a prison in Kurdistan, Iraq. The primary aim is to develop initial
      estimates of treatment effects on symptoms and poor functioning consistent with centralized
      pain and post-traumatic stress disorder, anxiety, and/or depression. The secondary aim is to
      assess the feasibility of studying this interdisciplinary treatment program in which local
      Kurdish psychotherapists and physiotherapists provide a 10-week intervention in a prison, in
      the Kurdish Sorani language, and to Kurdish participants that present with mental health
      symptoms, physical complaints, and poor functioning
    

Detailed description: 
      The aim of this randomized wait-list controlled pilot study is to assess the impact and
      feasibility of an interdisciplinary group treatment approach, involving psychotherapy and
      physiotherapy, with survivors of torture that are incarcerated in a prison in Kurdistan,
      Iraq. The primary aim is to develop initial estimates of treatment effects on symptoms and
      poor functioning consistent with centralized pain and post-traumatic stress disorder,
      anxiety, and/or depression. It is hypothesized that participants in the study will present
      with statistically significant improvements in some to all measures of symptoms and function.
      The secondary aim is to assess the feasibility of studying this interdisciplinary treatment
      program in which local Kurdish psychotherapists and physiotherapists provide a 10-week
      intervention in a prison, in the Kurdish Sorani language, and to Kurdish participants that
      present with mental health symptoms, physical complaints, and poor functioning
    

Intervention name(s): Physiotherapy; Psychotherapy
Intervention type(s): Other; Other
Intervention description(s): Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.; Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study design is a randomized, wait-list controlled pilot study. A parallel group study design will be used to compare a treatment group and a wait-list control group. This study design will be effective for addressing the gap in literature by examining both the initial treatment estimates related to health and functioning and the feasibility of performing a similar study on a larger scale.
Masking: None (Open Label)
Primary purpose: Treatment
Integrated Intervention Post-Sexual Assault
Condition: Substance Use Disorders; Posttraumatic Stress Disorder; Sexual Assault
MeSH terms: Substance-Related Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The primary objective of the proposed Stage IA/IB study is to establish feasibility of an
      integrated cognitive-behavioral intervention for reducing SUD and PTSD symptoms among women
      who experienced a sexual assault within the past six weeks. The intervention will be tested
      in an open label trial to make final modifications to evaluate feasibility, acceptability,
      and preliminary efficacy of the five to six week integrated intervention with standardized
      repeated measures during a one-month follow-up.
    


Intervention name(s): Written Exposure and Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Intervention involves writing details about a recent sexual assault and coping skills for substance use.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study to Evaluate the Safety of Dexibuprofen 300mg Under Fasting and Fed Conditions
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I Study to Evaluate the Safety of Dexibuprofen 300mg (Apsen Pharmaceuticals A / S.)
      After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes
      Under Fasting and Fed Conditions.
    

Detailed description: 
      A single oral dose of test medicine will be administered to participants in a practical
      period with the aid of 200 mL of water at room temperature. During administration,
      participants should stay in seated position. Participants will be confined at least 12 hours
      prior to administration and will remain for about 24 hours after the same, totaling about 36
      hours of confinement.

      After 36 hours of confinement the participantes will proceed to the multi-dose use phase for
      seven days in fed conditions.

      To assess safety, an evaluation of the vital signs, laboratory tests and health status of the
      participants will be carried out throughout the study.
    

Intervention name(s): Dexibuprofen
Intervention type(s): Drug
Intervention description(s): Dexibuprofen 300mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Irritation Potential of GSK2894512 Cream on Skin in Healthy Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3
      concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in
      healthy subjects. Results from this study will be considered when selecting the
      concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and
      efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30
      evaluable subjects complete the study. The total duration of subject participation may be up
      to 50 days.
    


Intervention name(s): GSK2894512 cream; Vehicle cream; Positive control; Negative control
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK2894512 is a white to off-white cream that will be applied topically in 3 different concentrations (0.5% [5 milligram (mg)/gram (g)], 1% [10 mg/g], and 2% [20 mg/g]).; Vehicle cream does not contain any active pharmaceutical ingredient.; Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g).; Negative control contains petrolatum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; dermal; GSK2894512; Cumulative irritation
Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a mechanistic randomized controlled trial on the effects of chiropractic spinal
      manipulative therapy on patients with chronic low back pain. It is designed as a mechanistic
      trial, in which the main objective is to identify which variables related to central
      sensitization can help predict the response to spinal manipulation, and the evolution of
      which of these variables can help explain clinical changes in chronic low back pain patients
      receiving spinal manipulative therapy.
    

Detailed description: 
      The study is a mechanistic randomized controlled trials on the effects of chiropractic spinal
      manipulative therapy on patients with chronic low back pain. 100 chronic low back pain
      patients will be randomly allocated to receive 12 sessions over 4 weeks of spinal
      manipulative therapy or placebo spinal manipulation. The main objective is to identify
      variables related to a central sensitization or nociplastic pain phenotype can help predict
      the response to spinal manipulation. Additionally, changes in these variables during the
      treatment period will be used to identify potential pain mechanisms involved in pain relief
      by spinal manipulation. An additional group of 50 healthy volunteers will be used to measure
      the same variables and their evolution during 4 weeks in a healthy control population.
      Response to treatment will be measured according to changes in pain intensity and disability.
    

Intervention name(s): Spinal Manipulation; Placebo
Intervention type(s): Other; Other
Intervention description(s): Manual therapy technique applied by a chiropractor in the form of a high-velocity low-amplitude force to the lumbopelvic spine; Placebo spinal manipulation consisting in the application by a chiropractor of a lower-velocity lower-amplitude force to gluteal muscles in a non-intentional direction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo-controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic low back pain; Spinal manipulation; Central sensitization; Pressure pain thresholds; Cytokines; Chiropractic
Intensive Prevention Program After Myocardial Infarction
Condition: Myocardial Infarction; Prevention Harmful Effects
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      It is unknown, if a modern prevention program, including intense nurse-coordinated education
      sessions, regular telephone contacts and a telephone hotline for 12 months, significantly
      reduces cardiovascular risk factors, clinical events and quality of life in myocardial
      infarction patients compared to usual care. Furthermore, actually no data on the additional
      effects and the feasibility of longterm telemetric care of cardiovascular risk factors exist.

      The primary hypothesis to be tested is that an intensive longterm prevention program compared
      to the standard of medical care, will achieve better risk factor control and consecutively
      less clinical adverse events in patients after myocardial infarctions. The study endpoints
      will be evaluated after 12 months and during long-term course (after 24 months = one year
      after termination of the prevention program).

      In a substudy the effects of short reinterventions ("Prevention Boosts") during long-term
      course are tested (IPP Prevention Boost Study). Patients with at least one insufficiently
      controlled risk factor at 24-months visit are randomly assigned to a short (2-month)
      reintervention vs. no reintervention. The effects of the reinterventions on risk factor
      control are evaluated after 36 months.

      A further substudy focusing on young patients <= 45 years of age at time of MI (IPP-Y = IPP
      in the Young) was added after completion of the pilot IPP study. In this study we focus on
      the prevention program in young MI-patients. A retrospective analysis of individual genetic
      risk (assessed by genetic risk scores) in the young patients is included in this substudy.
    


Intervention name(s): Intensive Prevention Program; Standard medical and interventional therapy
Intervention type(s): Behavioral; Other
Intervention description(s): "Study nurse"-coordinated education sessions, telephone calls, telephone hotline and telemetric care of cardiovascular risk factors (if patient internet connection available).; Medical and interventional therapy following the standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Condition: Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of eplontersen after administration for 65 weeks to
      patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN), as
      compared to the NEURO-TTR trial (NCT01737398). For more information, please visit
      http://www.neuro-ttransform.com/.
    

Detailed description: 
      This is a multicenter, open-label study in up to 140 participants, who will be randomized to
      receive subcutaneous (SC) injections of either eplontersen once every 4 weeks or inotersen
      once a week. Participants will also receive daily supplemental doses of the recommended daily
      allowance of vitamin A. Participants included in the inotersen reference arm will be crossed
      over to eplontersen at Week 37 after completing the Week 35 assessments.
    

Intervention name(s): Eplontersen; Inotersen
Intervention type(s): Drug; Drug
Intervention description(s): Eplontersen by subcutaneous injection; Inotersen by subcutaneous injection
Other intervention name(s): ION-682884; AKCEA-TTR-LRx; IONIS-TTR-LRx; TEGSEDI; ISIS 420915
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polyneuropathy; Amyloidosis; ATTR; TTR
Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India.
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      The 'DHANI randomized controlled trial" seeks to examine the effects of prenatal DHA
      supplementation on newborn anthropometry where in healthy pregnant will be assigned to
      receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery.
    

Detailed description: 
      A double-blinded, randomized, placebo controlled trial would be conducted among pregnant
      women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d
      algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants
      would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be
      taken before the enrollment of the participant in the study. This study would assess the
      effect of maternal DHA supplementation on:

        1. New born anthropometry (birth weight, length and head circumference)

        2. New born APGAR score
    

Intervention name(s): Docosa-hexaenoic acid (DHA); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through delivery.; 400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery.
Other intervention name(s): DHA; Omega 3 fatty acid; Corn/Soy oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: DHA; Omega 3 fatty acid; Decosa hexaenoic acid; Pregnancy; Newborn outcome; Supplementation; Birth size; gestational age; India; Randomized controlled trial; RCT
Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The investigators will randomize smokers to receive 1) Varenicline + smoking
      cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling.
      Neither the participants nor the research therapists/evaluators will know to which condition
      (active or placebo pill) the participants have been assigned i.e., a double-blind study). The
      medication and weekly counseling will occur for 28 days. Participants will complete
      assessment measures just before the start of treatment (baseline), at the end-of-treatment,
      at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use
      between treatment groups.
    


Intervention name(s): Varenicline; Placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.; Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tobacco; nicotine; cigarette smoking
Cyriax Inferior Capsule Stretching in Idiopathic Adhesive Capsulitis
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The objective of study is to find out the effectiveness of cyriax capsular stretching in
      idiopathic adhesive capsulitis and to find out the combined effect of capsular stretching's,
      mobilization and conservative treatment on pain and Range of Motion (ROM) in idiopathic
      adhesive capsulitis.
    

Detailed description: 
      This Randomized study was carried out at Pakistan Railway Hospital Rawalpindi. A total of 28
      patients were screened out as per inclusion criteria and randomly placed into two groups A
      and B through lottery method. The Visual Analogue scale, Shoulder Pain and Disability Index,
      and Range of Motion of shoulder joint were used as outcome measures. All the patients were
      assessed at baseline before intervention and at the completion of 3weeks of treatment.
    

Intervention name(s): Cyriax inferior capsular stretching + Manual Therapy; Manual therapy
Intervention type(s): Other; Other
Intervention description(s): Electro-therapy 10mins Manual therapy : Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Active ROM exercises : 10 reps x 3 sets Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each) Cyriax inferior capsular stretching; Before starting capsule stretching technique, Analgesic short-wave diathermy may be given for 10 minutes.
Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adhesive Capsulitis; Cyriax Manual Therapy; Stretching
SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The safety in the diabetic patient refer so much to the accuracy of the treatment and to the
      handling of the diabetic in security topics. Therefore, is not only an economic question, but
      a more global concept that means to receive an accurate sanitary attention in line with the
      available evidences nowadays.

      OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is
      followed of an improvement in the safety of the diabetic patients.

      METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA)
      with a random distribution of the educative intervention to realize on the sanitary
      professionals (5 intervention/5 control). The intervention is an educative system on adults,
      brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the
      diabetics. The group control follows his usual clinical practice on the diabetics.

      The participation was voluntary. The centres have been matched, being comparable in
      population and other characteristics, except the specific intervention; ranging between the
      6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected
      only between 45 until 75 years old as operative age group of the 45 until the 75 years like
      operative aim.

      Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the
      informatic software for primary care.

      Exclusion criteria: serious or terminal illness or patients controlled exclusively by
      specialists.
    


Intervention name(s): Educational program 6-hour standardized
Intervention type(s): Behavioral
Intervention description(s): 6-hour standardized program for adults ( doctors and nurses )
Other intervention name(s): Standardized educational programs; Patients safety
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Patient's Safety; Diabetes mellitus; Public Health for professionals; Safety; Public health