bioihbjkbjnl/mcl2 huggingface dataset:
Weight Loss and Physical Activity in Overweight/Obese Individuals With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Overweight; Weight Loss
Study type: Observational

Summary: 
      This is a substudy to a randomised trial investigating the effect of liraglutide on body
      weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In
      the parent trial, patients will be subjected to an 8-week diet intervention phase including a
      low-calorie diet and dietetic counselling, after which.they will be randomised to receive
      either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on
      re-introducing regular foods and a focus on continued motivation to engage in a healthy
      lifestyle.

      This substudy aims to investigate any changes in physical activity associated with the
      initial 8-week weight loss intervention.
    

Detailed description: 
      The investigators aim to describe changes in physical activity associated with a significant
      weight loss among overweight/obese individuals with knee OA. The investigators will take
      advantage of the planned trial "Effect of liraglutide on body weight and pain in overweight
      patients with knee osteoarthritis: A randomised, double blind, placebo-controlled, parallel
      group, single-centre trial" (the parent trial) in which a significant weight loss is sought
      achieved over 8 weeks by means of intensive dietary counseling and meal replacement in
      overweight/obese individuals with knee OA.

      The investigators hypothesize that weight loss is associated with a decrease in daily time
      spent physically inactive.

      Physical activity is measured using accelerometer based recordings using a wearable sensor
      that continuously records physical activity over the entire weight loss program (8 weeks).
      The sensor is miniaturised, discretely worn on the thigh, and is waterproof. Thus the
      measurements interfere minimally with the participants daily life.
    

Intervention name(s): Intensive dietary intervention
Intervention type(s): Dietary Supplement
Intervention description(s): Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals
        with knee osteoarthritis
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Chinese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the dosages of recombinant human serum
      albumin/interferon alpha2b fusion protein injection in healthy subjects.
    

Detailed description: 
      This is an open-label study that will be conducted at a single site in China to characterize
      the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon
      alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of
      Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator
      Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each
      subject. Subjects will complete a follow-up visit at Day 28 after the dosing.
    

Intervention name(s): Human Serum Albumin/interferon alpha2b; Peginterferon 180 μg single dose S.C.
Intervention type(s): Biological; Biological
Intervention description(s): Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0; Pegasys 180 mcg S.C. single dose on Day 0
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness
Condition: Chronic Dizziness
MeSH terms: Vertigo; Dizziness
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of group acceptance and commitment
      therapy with vestibular rehabilitation for chronic dizziness, in comparison with
      self-treatment vestibular rehabilitation in addition to clinical management.
    

Detailed description: 
      The purpose of this study is to examine whether group acceptance and commitment therapy
      combined with vestibular rehabilitation in addition to clinical management for patients with
      persistent postural-perceptual dizziness is more effective than treatment-as-usual(TAU),
      which is self-treatment vestibular rehabilitation in addition to clinical management.
    

Intervention name(s): ACT with VR; self-treatment VR; clinical management
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): 6 weekly 120-minute group sessions of acceptance and commitment therapy with vestibular rehabilitation, and brief (approximately 15 minute) individual follow-up sessions at 1 and 3 months after the group treatment; booklet written on vestibular rehabilitation for self-treatment; clinical management and pharmacotherapy as usual for chronic dizziness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic dizziness; persistent postural-perceptual dizziness; acceptance and commitment therapy; behavior therapy; vestibular rehabilitation
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
Condition: Detrusor Muscle Hyperactivity
MeSH terms: Multiple Sclerosis; Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of a single dose of 750 U
      of Dysport compared to placebo for the improvement in the daily incontinence episode
      frequency for each administration mode in subjects suffering from neurogenic detrusor
      overactivity following spinal cord injury or multiple sclerosis.
    


Intervention name(s): Botulinum toxin type A; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 750 U intra detrusor injection on Day 1 (single dose); Intra detrusor injection on Day 1 (single dose)
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Detrusor Muscle Overactivity
Chest Shielding in Premature Infants During Phototherapy
Condition: Patent Ductus Arteriosus in Premature Infants
MeSH terms: Premature Birth; Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      This is a feasibility study where Infants will be randomized to either chest shielding with
      aluminum foil or chest shielding without aluminum foil while undergoing phototherapy for
      premature infants. The primary outcome is patent ductus arteriosus.
    


Intervention name(s): Chest shield with aluminum foil (CALF); SHIELD
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: PDA; Jaundice; Phototherapy
Clinical Trial of Cross-linked Hyaluronic Acid Dermal Filler
Condition: Hyaluronic Acid; Dermal Fillers
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Young
      Dermal Filler Injection, which is a hyaluronic acid dermal filler injected into the mid to
      deep dermis for the correction of moderate-to-severe nasolabial fold facial wrinkles.

      The main questions it aims to answer are:

        -  The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.

        -  The treatment improvement assessed by Global Aesthetic Improvement Scale (GAIS).

        -  Safety Indicators of which incidences on the day of the injection or after the
           injection.

      Participants will be blinded and randomized into either experiment group or control group,
      and re-visited on 1, 3, 6, 9 and 12 month after injection.

      Researchers will compare if the test product is non-inferiority to Restylane.
    

Detailed description: 
      A prospective, parallel, two-center, non-inferior, randomized, double-blind trial was
      conducted in this study. It was planned to recruit 157 subjects for each group, considering a
      10% dropout rate that would lead to 320 subjects overall.

      Subjects eligible in the screening will be enrolled. Each patient will receive the same
      treatment, either Formaderm Young Dermal Filler Injection or Restylane, to correct both sides
      of the nasolabial fold through randomization.

      Clinical efficacy will be assessed by the blinded physician using the WSRS and GAIS, as well
      as by subjects using GAIS. The safety issue of Formaderm Young or Restylane will be
      identified and recorded during the course of the study.
    

Intervention name(s): Formaderm Young; Restylane
Intervention type(s): Device; Device
Intervention description(s): Dermal filler injection to facial areas.; Dermal filler injection to facial areas.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria
Condition: Malaria, Cerebral
MeSH terms: Malaria; Malaria, Cerebral; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether computerised cognitive rehabilitation
      training improves cognition in children who have had cerebral malaria.
    

Detailed description: 
      Cerebral malaria affects several children in sub-Saharan Africa leaving some survivors with
      cognitive problems especially in attention and memory. There are currently no tested
      interventions for such deficits resulting from infectious diseases like malaria or other
      causes. Providing such interventions will go a long way in helping these children achieve
      their full potential.
    

Intervention name(s): Cognitive rehabilitation training
Intervention type(s): Behavioral
Intervention description(s): A computerised cognitive training package where children will be required to complete several cognitive tasks. The aim is to strengthen the different cognitive processes during these tasks which in turn may lead to improve cognitive processes.
Children will complete these tasks in 16 session for 8 weeks.
Other intervention name(s): Intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria, Cerebral
The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases
Condition: Crowding, Tooth
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Patients who have severe crowding that requires four premolars extraction will be treated in
      this study. The efficacy and effectiveness of in-house clear aligners therapy compared with
      vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring
      the extraction of first premolars will be evaluated using Little's irregularity index (LII),
      Peer assessment rating index (PAR), and treatment duration.

      There are two groups:

      First group (Experimental): the patients in this group will be treated using clear aligners.

      Second group (Control): the patients in this group will be treated using fixed appliances.
    

Detailed description: 
      For years, orthodontists and dentists have used removable appliances for orthodontic
      treatment. With the CAD/CAM technology, clear aligners treat a broader range of cases with
      greater precision. They consist of a series of plastic aligners that are intended to replace
      conventional wire and bracket technology for many orthodontic cases. Each custom-manufactured
      aligner exerts gentle, continuous forces to move teeth incrementally from their original
      state to a final, treated state. Each aligner is worn for about two weeks, then replaced by
      the next in the series until the final position is achieved.
    

Intervention name(s): Clear aligners; Fixed appliances
Intervention type(s): Device; Device
Intervention description(s): Each aligner will be worn for about two weeks, and then replaced by the next in the series until the final position is achieved.; Conventional wires and brackets will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clear aligners; PAR index; Vestibular fixed appliances; Orthodontics; Crowding; Treatment duration
Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal
      pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
    


Intervention name(s): Hydeal-D vaginal pessaries
Intervention type(s): Device
Intervention description(s): One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.
Other intervention name(s): Hyalogyn vaginal pessaries
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyaluronic acid; Post-menopause
The Effect of Combined Robotic Hand Therapy and Conventional Therapy in Stroke Patients
Condition: Stroke; Robot Assisted Therapy; Robotic Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      RAT is an innovative approach that includes intensive, repeatable, interactive and
      personalized applications.The aim of tihis study is to investigate the effect of robotic hand
      therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients.
    

Detailed description: 
      Effective therapy in stroke rehabilitation should include repetitive, functional and
      task-specific exercises with high intensity and duration. In this context, in addition to
      traditional treatments, many new treatment approaches have come up in recent years.
      Robot-assisted therapy (RAT) is one of these new treatment approaches. RAT is an innovative
      approach that includes intensive, repeatable, interactive and personalized applications. It
      is seen that robotic systems are very suitable for the patient to receive more intense and
      task-oriented motor training by integrating with other rehabilitation approaches. Considering
      the scarcity of studies on robotic hand therapy, it was seen that larger scale and long-term
      studies are needed. In this study, investigators aimed to investigate the effect of robotic
      hand therapy added to conventional rehabilitation on motor functions and quality of life in
      stroke patients. Patients will be evaluated pretreatment, posttreatment and 3 months later
      after treatment. Evaluation parameters consist of Brunnstrom Staging, Modified Ashworth Scale
      (MAS), Fugl Meyer Assessment of The Upper Extremity, Functional Independence Measure Scale
      (FIM) and ABILHAND Questionnaire, Stroke Impact Scale (SIS), Stroke-Specific Quality of Life
      Scale (SS-QOL) and SF-36 Quality of Life Questionnaire. We think that robot-assisted therapy
      will contribute to the improvement of hand functions and quality of life in stroke patients.
    

Intervention name(s): Robot assisted therapy; Conventional Therapy Group
Intervention type(s): Procedure; Procedure
Intervention description(s): In addition to the conventional treatment for 60 minutes in the RYT group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes, accompanied by a physiotherapist who is trained in the field of robotic rehabilitation and has at least 5 years of experience; An exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) and 15 minutes of NMES was planned, accompanied by a physiotherapist experienced for at least 5 years in stroke rehabilitation, in the conventional therapy group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This extension study of was designed to evaluate the long-term safety, tolerability, and
      efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was
      an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
    


Intervention name(s): Fingolimod 0.5 mg; Fingolimod 1.25 mg
Intervention type(s): Drug; Drug
Intervention description(s): Patients self-administered fingolimod 0.5 mg capsules orally once daily.; Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Other intervention name(s): FTY720; FTY720
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multiple sclerosis.; Relapse-remitting; Fingolimod
Evaluation Of Linezolid Pk Profile In Burns Patients
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of linezolid pk profile in burns patients
    


Intervention name(s): linezolid
Intervention type(s): Drug
Intervention MeSH terms: Linezolid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
Condition: Oral Health
Study type: Interventional

Summary: 
      -  Randomized double-blind, placebo-controlled trial on the effects of an oral probiotic
           intervention with or without a novel ADP-1 toothpaste Objective

        -  Determine the safety and effectiveness of oral probiotic intervention with or without a
           novel toothpaste and compare with placebo
    

Detailed description: 
      Hypotheses:

        1. Subjects using oral probiotics will have better oral health than subjects using placebo
           toothpaste and placebo lozenges.

        2. Subjects using oral probiotics and ADP-1 toothpaste will have better oral health than
           subjects using oral probiotics and regular toothpaste, and subjects using regular
           toothpaste and placebo lozenges.
    

Intervention name(s): Oral probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): an oral probiotic intervention with or without a novel ADP1 toothpaste; placebo without Oral probiotic or toothpaste
Other intervention name(s): ADP1 toothpaste
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of an oral probiotic intervention with or without a novel toothpaste and compared with placebo toothpaste and placebo lozenges.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical
      product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety
      of MYCAPSSA™ treatment in patients with acromegaly.
    

Detailed description: 
      The study consisted of 2 periods, a Core Treatment Period of up to 7 months and an optional
      Extension Treatment Period of up to 6 months, for a total study duration of up to 13 months.
      The Core Treatment Period consisted of 2 phases, a Dose Escalation Phase of at least 2 months
      to identify the therapeutic dose for each study participant and a Fixed Dose Phase of 2 to 5
      months during which the therapeutic dose was maintained.

      Participants were eligible to enter the Fixed Dose Phase of the Core Treatment Period if they
      were clinically and biochemically controlled. The same criteria were used to allow entry into
      the voluntary 6-month Extension Treatment Period.

      The Core Treatment Period of the study was completed if the participant had at least 2 months
      of treatment in the Fixed Dose Phase and a total treatment duration of at least 7 months.
      Participants who elected to continue into the Extension Treatment Period maintained their
      therapeutic dose during this period. At the end of the study (after the last dose of MYCAPSSA
      in either the Core Treatment Period or the Extension Treatment Period), there was a 2-week
      follow-up period for safety assessments.
    

Intervention name(s): Octreotide capsules
Intervention type(s): Drug
Intervention description(s): Octreotide was provided in hard gelatin capsules.
Other intervention name(s): MYCAPSSA™; Formerly known as Octreolin™
Intervention MeSH terms: Octreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acromegaly; IGF-1; growth hormone; Octreolin; octreotide; somatostatin analog