bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Metoprolol on Thalassemia Cardiomyopathy
Condition: B Thalassemia
MeSH terms: Cardiomyopathies; Thalassemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      effect of B blocker was first evaluated in patient with cardiomyopathy not induced by
      ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on
      Thalassemia cardiomyopathy was evaluated in this study
    

Detailed description: 
      In this clinical trial, 45 patients with thalassemia cardiomyopathy were randomized to
      receive either metoprolol (n = 26) or placebo (n = 19). Echocardiography and 6 minute walk
      test was performed at baseline and repeated after 6 months and the values were compared.
    

Intervention name(s): metoprolol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): using B blocker in patient group; placebo to control group
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thalassemia cardiomyopathy; metoprolol succinate; echocardiography; six minute walk test
Infertile Polycystic Ovary Syndrome (PCOS) Women With Obesity and Lifestyle Changes
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Infertile PCOS women with obesity were included into lifestyle change weight loss program
      prior to inclusion to IVF procedures. They attended group as well as individual workouts and
      they were advised on healthy eating.
    

Detailed description: 
      The weight loss program will consist of dietary change and exercise program which will be
      performed 3 times weekly.
    

Intervention name(s): Weight loss program
Intervention type(s): Behavioral
Intervention description(s): Women with obesity were included to the weight loss program which included physical exercise and dietary guidelines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      The main research objective of this study is whether athletes who have sustained an anterior
      cruciate ligament injury, experience chronic nociplastic pain and psychosocial factors,
      including kinesiophobia and pain catastrophizing, after having been through ACL
      reconstruction surgery and rehabilitation and have returned to sport.
    

Detailed description: 
      This is an observational, cross-sectional study. For the purposes of the study a sample group
      was selected from a clinic specialised in ACL reconstruction and rehabilitation based in
      Athens, Greece. Patients of the specific clinic had received the same surgical technique and
      rehabilitation protocol. Ability to return to sport was examined 9 months after surgery and
      approval was given according to the rehabilitation progress. A list of eligible study
      subjects was formed and, after inclusion and exclusion criteria were screened for, they were
      invited to participate in the study. Study participants, after having declared consent and
      passed the criteria were asked to answer the study questionnaires. Communication with
      participants was done through telephone and email, and all questionnaires were completed
      online.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Athletes that have suffered an ACL rupture and have undergone surgical reconstruction and
        rehabilitation, and have been cleared to return to sport.
      
Keywords: Return to play; Psychosocial; Central sensitization; Chronic pain; Athlete; Reconstruction; Rehabilitation
Focusing on Body Functionality After Bariatric Surgery
Condition: Bariatric Surgery Candidate; Body Image
Study type: Interventional

Summary: 
      This study investigated whether focusing on one's body functionality (i.e., everything the
      body can do, rather than how it looks) would lead to improvements in body image, self-esteem,
      and self-kindness among women who have undergone bariatric surgery.
    


Intervention name(s): Expand Your Horizon
Intervention type(s): Other
Intervention description(s): Expand Your Horizon is an online programme, comprising three 15min writing exercises delivered over the course of 1 week. In each writing exercise, participants are asked to describe the functions of their body, and why those are personally meaningful to them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The objective of the clinical investigation is to assess the performance of the Dreem 3
      System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert
      scoring in a population experiencing insomnia symptoms.
    

Detailed description: 
      Subjects enrolled in the study will come to the sleep laboratory around 8 pm. Their
      involvement in the protocol will only require them to be equipped by the technician with
      Dreem 3 in addition to the PSG reference system. This involves the technician placing all the
      PSG electrodes on the subject's head as per normal practice, and then positioning the Dreem 3
      headband so that both devices can operate simultaneously. The subject will be allowed to go
      to his/her room and do quiet activities (reading, film watching, chatting) prior to sleeping.
      At the end of the night, the technician will remove the Dreem 3 headband and the PSG.

      A technical quality control will be performed on the collected data in accordance with the
      standard operating procedures, as defined in the study protocol. Recordings that do not meet
      the quality control criteria will be excluded from further analysis.

      Subjects will receive the PSG report at the end of the study.
    

Intervention name(s): Dreem 3 System vs PSG
Intervention type(s): Device
Intervention description(s): Dreem 3 System to be worn by each participant while undergoing in-lab sleep study with PSG.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dreem; Insomnia symptoms; Sleep; Polysomnography; Performance; EEG; Sleep monitoring
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The purpose of this study is to assess the impact of patient cost sharing on treatment
      discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Commercial health plan members
Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in
      very young children. The medication being used is methylphenidate (Ritalin); it is being
      studied to determine its safety and how well it works to treat ADHD in preschool-age children
      (3-5.5 year olds).
    

Detailed description: 
      Young children age 3-5.5 years will be studied. The study includes treatment with different
      doses of methylphenidate and placebo; all children will receive active medication during the
      study. Prior to treatment, each child will receive a thorough psychiatric evaluation and each
      guardian will complete a 10-week workshop (2 hours/week). Throughout the study, parents and
      teachers will complete forms that report on the child's behavior and possible side effects.
      Participants will be monitored by regular visits with a study physician. Most participants
      will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and
      monitoring
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: ADHD
A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics
      (the exposure of the trial drug in the body), pharmacodynamics (the effect of the
      investigated drug on the body), safety and tolerability of oral semaglutide in healthy male
      Japanese and Caucasian subjects.
    


Intervention name(s): semaglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily oral administration as tablets. The dose level of oral semaglutide used in the 'Dose escalation period', 'Treatment period 1', 'Treatment period 2' and 'Treatment period 3' will be 5, 10, 20 and 40 mg per day, respectively.; Once-daily oral administration as tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Changes in Power and Cylinder Axis of Toric Soft Contact Lenses (LKL)
Condition: Visual Acuity Reduced Transiently
Study type: Interventional

Summary: 
      Astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a
      toric soft contact lens could be one of the therapy options. Due to the numerous possible
      combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of
      disposable soft toric contact lenses limit their toric lens range, while still aiming to
      cater to the majority of astigmatic patients. Due to that reason, the possibility of
      astigmatism patients getting a different combination of power and axis with toric soft
      contact lenses sold on the market will be high due to SKU limitations. This research aims to
      ascertain the impact of altering cylinder power and axis on visual quality and convenience in
      astigmatism participants using toric soft contact lens. The study was conducted at Kirana
      Ciptomangunkusumo Hospital, Jakarta, starting in April 2020. The study is a prospective,
      randomized, participant-masked, crossover clinical trial where the participants were tested
      for the following conditions on different days using full spherocylinder correction and
      under-correction by 0.25, 0.50, and 0.75 DC while maintaining spherical equivalence. Axis was
      also misaligned between -30° and +30°, in 10° steps. For each visit, the patient was examined
      visual acuity, contrast visual acuity using the Pelli-Robson, and assessed patient comfort
      using the VAS method.
    


Intervention name(s): soft contact lens Toric
Intervention type(s): Other
Intervention description(s): soft contact lens toric with different axis and power that use in human's eye
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Toric soft contact lens
Sensorimotor Exercises in Virtual Reality Platform in Individuals With Human T-lymphotropic Virus
Condition: HTLV-1
Study type: Interventional

Summary: 
      Testing the effectiveness of an exercise protocol engines sensory performed through a virtual
      reality platform in individuals infected with HTLV-1
    

Detailed description: 
      Crossover randomized clinical trial to be conducted with people having a previous diagnosis
      of HTLV-1, they can remain in standing position without assistance. They will be excluded
      from those presenting amputation of the lower limbs, pregnancy, psychiatric disorders,
      rheumatic or orthopedic diseases, other neurological disorders associated and those that are
      experiencing difficulty in understanding the assessment tools used. They will also be
      recruited to a comparative group, healthy individuals, matched for sex, age and education
      level. It will be performed three assessments, before randomization, after 10 weeks and after
      20 weeks, which will be evaluated in balance, functional mobility, gait and posture. The
      participants infected with HTLV-1, will be divided into two groups by random distribution, a
      group will begin the treatment protocol with video game immediately after the first
      evaluation and the other after ten weeks, with the crossing of the groups . Concealment of
      allocation will be guaranteed to the examiners who will have no contact with the
      physiotherapist who will apply the exercise protocol and the team member responsible for
      drawing. Patients will also be instructed to maintain confidentiality of the entry in the
      exercise program to other patients and examiners.
    

Intervention name(s): Video game
Intervention type(s): Other
Intervention description(s): The protocol sensorimotor exercises consist of a virtual game that attaches to the Nintendo Wii and using arrows that are thrown from above, players must perform weight-shifting movements in the Nintendo platform to the target be directed to the trajectory the arrows. The goal is to catch as many arrows.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Inpatient Adolescent Contraception
Condition: Pregnancy Related; Contraception; Contraceptive Usage; Contraception Behavior; Pregnancy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this study is to refine and pilot test the investigators novel
      intervention to offer contraception counseling and initiation for hospitalized female
      adolescents, focusing on long acting reversible contraception (LARC).
    

Detailed description: 
      There are two primary objectives in this study. The first objective is to refine the
      investigators previously developed general sexual risk reduction intervention (SexHealth II)
      to focus on patient-centered contraception counseling and initiation for hospitalized female
      adolescents. The second objective is to conduct an open trial to assess feasibility of the
      investigators SexHealth II intervention among hospitalized females aged 14-21 years (N=75).
      Among key stakeholders (i.e., adolescent participants, parents/guardians, hospitalists and
      nurses), the investigators will assess Bowen's feasibility constructs: acceptability, demand,
      implementation, practicality, integration, and limited-efficacy testing. The investigators
      hypothesize that the SexHealth II intervention will be deemed feasible by female adolescent
      participants (i.e., the median score across all feasibility items will be > 2.5.)
    

Intervention name(s): SexHealth II; Contraceptive
Intervention type(s): Behavioral; Drug
Intervention description(s): SexHealth II is an intervention that will focus exclusively on provision of hormonal contraception counseling and provision for hospitalized female adolescents; The investigators will offer initiation of the following contraceptives:
Ethinyl Estradiol and Etonogestrel 0.015mg-0.12mg vaginal ring (Nuva Ring) Etonogestrel 68mg subcutaneous implant (Nexplanon) Medroxyprogesterone 150mg/ml 150 mg IM injection Ethinyl Estradiol and Norgestimate (Sprintec) 35mcg-0.25mg tablet Norelgestromin/Ethinyl estradiol transdermal patch (Ortho Evra) Norethindrone 0.35mg tablet
Emergency Contraception:
Ulipristal 30 mg tablet Levonorgestrel 1.5mg tablet
Intervention MeSH terms: Contraceptive Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LARC; Long acting reversible contraception
Empowering Rural African American Women and Communities to Improve Diabetes Outcomes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The EMPOWER diabetes program is a year-long, community-based program designed to enhance
      diabetes management in rural African American women with uncontrolled diabetes. The treatment
      is delivered by community peers and follows a relative Small Changes approach.
    

Detailed description: 
      East Carolina University, along with established community partners, is implementing a
      community-based and culturally-tailored intervention to reduce diabetes disparities in 200
      rural African American women with uncontrolled diabetes using our unique
      behaviorally-centered small changes approach to diabetes self-management, delivered by
      community health workers. The focus is on moderation and patient-selected small changes in
      eating, activity, and care management that decrease feelings of deprivation and failure and
      increase feelings of confidence and success. The intervention is specifically tailored to
      overcome psychosocial and environmental barriers to behavioral change through a strong focus
      on emotional, cultural, and social factors related to eating, activity, and medications.
      Objectives for the proposed project are to: 1) implement and evaluate the effectiveness of
      this tailored small changes intervention; 2) examine the impact of this approach on
      psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public
      policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a
      business-sustainable care model. The study will be a randomized prospective trial comparing
      the small changes intervention, delivered in 16 sessions by community health workers, to a
      control group receiving 16 mailings of diabetes educational materials. We hypothesize that
      there will be a greater improvement in behavioral choices and glycemic control in the
      intervention group compared to the control group.
    

Intervention name(s): Lifestyle Counseling; Educational Control Arm
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers; 16 mailings of diabetes educational materials but no regular contact with community health workers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Yoga for Persistent Pain Related to Oncology Surgery
Condition: Persistent Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This randomized controlled trial will evaluate a yoga intervention for individuals who
      experience persistent pain following oncology surgery. The integrated yoga program will
      involve postures, breathing exercises, and concentration practices. Data will be collected at
      several time points (pre-, mid-, and post-intervention) for both the intervention and
      wait-list control conditions. The data will be analysed using linear mixed effects growth
      models. Results will be written up in manuscript format, published in a peer review journal,
      and disseminated at scientific research conferences.
    


Intervention name(s): Yoga Condition
Intervention type(s): Behavioral
Intervention description(s): Participants randomized to the Yoga Condition will participate in an integrated yoga program consisting of yoga postures, breathing exercises, and concentration/meditation practices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers
Condition: Hypertension With Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine
      and JLP-1401 in Healthy Adult Volunteers.
    


Intervention name(s): JLP-1401; Telmisartan/Amlodipine, Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin); Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus, Type 2; Weight Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      The drugs GSK189075 and GW869682 result in increased caloric losses. This study is
      investigating how if taken over 8 weeks that affects weight loss, food intake and the
      composition of the body. The body composition (fat,water, lean mass) is determined using a
      new investigational MR technology.
    


Intervention name(s): GW869682; GSK189075; GSK189075-Placebo; GW869682-Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GW869682 tablet with a dose strength of 250 mg will be available for subjects; GSK189075 tablet with a dose strength of 250 mg will be available for subjects; Placebo tablets to match GSK189075 250 mg will be available for subjects; Placebo tablets to match GW869682 250 mg will be available for subjects
Other intervention name(s): GW869682
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: body composition; obesity; 4C model; hunger; weight loss