bioihbjkbjnl/mcl2 huggingface dataset:
Diet and Plant Sterols in the Control of Cholesterolemia (DESCO)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      DESCO is a randomized clinical trial, controlled against placebo, performed to evaluate the
      effect of a phytosterol-based product (2.5 g/day), after 3 weeks of intake, on the lipid
      profile, also in relation to the quality of the diet, in subjects with moderate
      hypercholesterolemia and low / moderate global cardiovascular risk.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, monocentric cross over clinical study
      conducted in Italy.

      The objective of this study is to evaluate the fasting lipid profile of adults with moderate
      hypercholesterolemia and a low/very low cardiovascular risk, after 3 weeks of supplementation
      with 2.5 g/day of plant sterols, vs placebo, and to assess the relationship between the
      effects of the supplementation and the diet.
    

Intervention name(s): Plant sterols 2.5 g/day; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks; Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Belimumab In Early Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6
      months).
    

Detailed description: 
      This is a single arm, 24 weeks, pilot trial. All patients will be treated with standard of
      care plus Belimumab (at a dose of 10 mg per kilogram of body weight) .

      The primary endpoint is the proportion of LLDAS in week 24.
    

Intervention name(s): Belimumab; Standard of care
Intervention type(s): Biological; Drug
Intervention description(s): Belimumab 10 mg/kg; Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Other intervention name(s): BENLYSTA™
Intervention MeSH terms: Belimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SLE; Belimumab
Advancing Adolescent Bedtime by MI and Text Reminders
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Chronic sleep deprivation among adolescents is a prevalent health problem across the world
      and is associated with a series of short and long term consequences. However, effective
      interventions targeting on this vulnerable adolescent population is very limited. Majority of
      the previous sleep education programme are conducted in a school context which personal
      factors and individualized problems were not addressed. In addition, failure to address
      "knowledge-action gap" may also explain why individual fail to enact health behaviors even
      holding positive motivation. In regard to this, investigators proposed an active and
      person-oriented protocol with the aid of advanced technology in order to improve adolescent
      sleep health.
    

Detailed description: 
      This study will conduct a randomized control trial to evaluate the effectiveness of
      group-based sleep intervention using motivational interviewing plus text reminders in
      changing adolescent sleep deprivation problem with both subjective and objective
      measurements. The intervention will consists of 4 weekly group therapy targeting on
      adolescent with school day sleep duration less than 7 hours.
    

Intervention name(s): Group MI
Intervention type(s): Behavioral
Intervention description(s): refer to the arm description
Other intervention name(s): Motivational interviewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Sleep deprivation; Motivational Interviewing; Text reminders
Muscle Synergies After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The aim of this systematic review was to determine the number of muscle synergies and the
      distribution of muscle weightings in stroke patients during gait.
    

Detailed description: 
      The aim of this systematic review was to determine the number of muscle synergies and the
      distribution of muscle weightings in stroke patients during gait. Although literature has
      suggested that merging of synergies occurs after stroke and that a larger number of is
      associated with increased motor function if compared with healthy adults. IIt is still
      unknown if this hypothesis is also relevant when comparing different functional levels within
      a stroke population and what functional impact of altered synergies on walking behavior is.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers: community sample Stroke: Rehabilitation Hospital RevArte, primary care
        clinic
      
Keywords: muscle synergies; gait; functional ability
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
Condition: Pediatric Cancer; Febrile Neutropenia; Chemotherapy-induced Neutropenia; Oncology
MeSH terms: Neutropenia; Febrile Neutropenia
Study type: Observational

Summary: 
      In this pilot study the feasibility of continous monitoring of health data with a small,
      on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under
      chemotherapy for cancer, is studied. Feasibility is assessed by the number of patients
      wearing the device on seven consecutive days for at least 18h/day, what will be measured by
      monitored heart rate. Study duration for each participant is 14 days.
    

Detailed description: 
      No study has proved feasibility of continuous monitoring of health data with a small wearable
      device such as the device Everion® in pediatric patients. It is not known if children
      tolerate the device and if data quality sustains with smaller arm circumferences or when worn
      on the upper leg. Neither is it known if parents and/or patients can and are willing to
      handle the device in ambulant setting. Therefore, this pilot study assesses the feasibility
      of continous monitoring of health data with a small, on-skin wearable device (the Everion®,
      by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer.
    

Intervention name(s): Everion
Intervention type(s): Device
Intervention description(s): The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients under chemotherapy for any malignancy
      
Keywords: wearable device; Everion®; Fever and Neutropenia; Pediatric Oncology
Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage
Condition: Cancer of Muscle
MeSH terms: Muscle Neoplasms
Study type: Observational

Summary: 
      This study aims to assess the functional ability and health-related quality of life (HRQoL)
      of upper extremity sarcoma patients who have undergone limb salvage surgery.
    

Detailed description: 
      The purpose of this study is to assess the functional capabilities and health-related quality
      of life (HRQoL) of upper-extremity sarcoma patients who have undergone limb salvage surgery.

      Patient hospital records are retrospectively reviewed for demographic and clinical data.

      The patient recruitment takes place at the outpatient clinic of the Comprehensive Cancer
      Center, Helsinki University Hospital, and Tampere University Hospital. The study includes a
      cross-sectional assessment at six months follow-up with five validated questionnaires. A
      follow-up is conducted two and five years after surgery in the outpatient clinic.
    

Intervention name(s): Limb salvage
Intervention type(s): Procedure
Intervention description(s): Local or free flaps
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Upper extremity sarcoma patient who underwent limb-salvage surgery
Treatment of Mature B-cell Lymphoma/Leukaemia
Condition: B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an international trial conducted by three cooperative groups: SFOP (France, Belgium,
      Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature
      B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and
      receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and
      C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and
      C) in terms of event free survival. The reason for the modification is to reduce the long
      term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In
      group B, the modifications of treatment consists of a reduction of cyclophosphamide in
      COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a
      reduction of the doses in the CYVE courses and the elimination of the last 3 courses of
      maintenance treatment
    

Detailed description: 
      Group B: Randomized trial with factorial design. The 4 treatment arms are standard LMB89
      therapy B, reduction of cyclophosphamide (CPM) in COPADM2, deletion of COPADM3, both
      reduction and deletion. Randomization occurs following COPADM1 and is stratified for national
      group, histology (large cell; small non cleaved cell) and stage (Murphy I orII; Murphy
      III+LDH<2N; Murphy III+LDH>2N or Murphy IV).

      The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller
      long-term EFS whether omitting COPADM3 results in a smaller long-term EFS

      Group C: Randomized trial. The 2 treatment arms are standard LMB89 therapy C versus reduction
      of CYVE + deletion of the last 3 maintenance courses. Randomization occurs following COPADM2
      and is stratified for national group, histology (large cell; small non cleaved cell) and CNS
      disease.

      The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance
      courses result in a smaller long-term EFS than standard LMB 89 treatment C
    

Intervention name(s): half cyclophosphamide; without COPADM3; mini CYVE, without 3 maintenance courses; LMB B; LMB C
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-Cell Lymphoma
Spineology Clinical Outcomes Trial: An IDE Investigation
Condition: Lumbar Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System
      (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic
      single-level lumbar degenerative disc disease.
    

Detailed description: 
      This regulated prospective, multi-center, Institutional Review Board (IRB) approved
      single-arm performance goal clinical investigation was conducted at 10 centers with 102
      subjects being enrolled and treated.

      Subjects were actively evaluated from pre-op to 24-months postoperative. Based on enrollment
      duration, some subjects were remotely assessed through self-administered surveys at 36-
      and/or 48-months.

      The primary endpoint, assessed at 24-months postoperative, is a composite score that includes
      pain, function, fusion and safety assessments.
    

Intervention name(s): SIFS graft containment device
Intervention type(s): Device
Intervention description(s): The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.
Other intervention name(s): SIFS mesh
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Classic and Modified CIMT on Quality of Life of Children With Hemiplegic CP
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this research is to see the effect of classic constraint-induced movement
      therapy and its modified form on quality of life of children with hemiplegic cerebral palsy.
      Randomized controlled trials with 2-3 weeks follow-up. The sample size is 40. The subjects
      are divided in two groups, 20 subjects in classical CIMT group and 20 in modified CIMT group.
      Study duration is of 6 months. Sampling technique applied will be purposive non probability
      sampling technique. Only 4-12 years individual with hemiplegic cerebral palsy are included.
      Tools used in the study are Cerebral palsy (quality of life) and Kid Screen 27.
    

Detailed description: 
      Both CCIMT and MCIMT are effective treatments to improve quality of life of children with CP.
      However conflicting evidence is present on which one of these is more effective and no final
      conclusion can be made to date. This study intends to add to the literature and contribute in
      reaching final conclusion about the superiority of either intervention. The purpose of this
      study was to see the psychosocial effect (quality of life) of CIMT and its modified form on
      HCP
    

Intervention name(s): modified constraint induced movement therapy
Intervention type(s): Other
Intervention description(s): Modified CIMT protocol that was based on suggestions made by Dromerick, Edwards, and Hahn (2000) . Modifications were reductions in the duration of mitt wear and massed practice compared with the traditional protocol
Other intervention name(s): classic constaint induced movement therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Constraint induced movement therapy; Cerebral palsy; CPQOL
PRF for Accelerating Palatal Healing
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Backgroung: Various agents are used to reduce post-operative complications associated with
      palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted
      to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.
    

Detailed description: 
      125 patients with isolated recessions were treated. The connective tissue graft was obtained
      by the de-epithelialization of a free gingival graft in both groups. Three different
      hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42),
      cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group,
      n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation
      scores were recorded for different time points.
    

Intervention name(s): Platelet Rich Fibrin; Butyl cyanoacrylate; Wet gauze
Intervention type(s): Other; Other; Other
Intervention description(s): Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.; Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.; Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study to Investigate the Absolute Bioavailability of Oral Sylibin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial phase I in healthy volunteers is intended to describe the oral
      bioavailability of the silybin-phosphatidylcholine complex by calculating the area under the
      curve (AUC0-? and AUC0-12) after administration of the same dose of oral silybin (AUCo) and
      intravenous silybin (AUC iv).
    


Intervention name(s): silybin phosphatidylcholine; Legalón SIL
Intervention type(s): Drug; Drug
Intervention MeSH terms: Silybin; Silymarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical trial; Phase I; Healthy volunteers; Clinical Pharmacology; Bioavailability; Silybin; Liver Trasplantation
Norepinephrine Transporter Blockade as a Pathological Biomarker in Neurogenic Orthostatic Hypotension
Condition: Orthostatic Hypotension; Pure Autonomic Failure; Multiple System Atrophy; Parkinson's Disease
MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Hypotension, Orthostatic; Pure Autonomic Failure; Hypotension; Atrophy
Study type: Observational

Summary: 
      The autonomic or automatic nervous system helps control blood pressure. Diseases of the
      autonomic nervous system may result in a drop in blood pressure on standing in many cases
      leading to fainting. Diseases that affect the autonomic nervous system include pure autonomic
      failure, multiple system atrophy and Parkinson's disease, and can present with very similar
      symptoms and it is sometimes difficult to determine an exact diagnosis. The purpose of the
      study is to find out if the blood pressure response from taking a single dose of the
      medication atomoxetine can help in the diagnosis of these diseases.
    

Detailed description: 
      This is an observational, prospective three-year longitudinal study. The investigators will
      enroll participants with primary neurogenic orthostatic hypotension. All participants will
      undergo an extensive neurological and cardiovascular evaluation, including detailed autonomic
      testing and quality of life assessment. The investigators will then determine the magnitude
      of the pressor effect produced by 18 mg atomoxetine given orally, measured 1 hour after drug
      administration. Participants will be followed annually or more often if there is a
      significant change in their clinical condition. During follow up at year 3, the investigators
      will repeat the initial neurological, cardiovascular and autonomic evaluation. The primary
      endpoint would be the final diagnosis made at year 3 after the initial evaluation (at the end
      of the follow-up period) or if they develop significant worsening of symptoms during
      follow-up phone assessments, based on specific clinical criteria.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        participants with neurogenic orthostatic hypotension, which is a drop in systolic blood
        pressure of at least 30 mmHg within 5 minutes of standing with associated impaired
        autonomic reflexes.
      
Keywords: orthostatic hypotension; Multiple System Atrophy; Pure Autonomic Failure; Parkinson's Disease
Evaluation of Dentifrice Formulations to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind In-Situ Clinical Trial
Condition: Caries
Study type: Interventional

Summary: 
      To compare the remineralization and demineralization inhibition potential of early subsurface
      carious lesions in enamel in situ after rinsing with five different aqueous slurries of
      toothpaste formulations. Percent remineralization (%R), i.e. the % change in ΔZ values
      relative to ΔZd, will be the primary outcome measure.
    


Intervention name(s): 0 ppm Fluoride Dentifrice 1; 1100 ppm NaF Fluoride Dentifrice; 1500 ppm NaMFP Fluoride Dentifrice; 0 ppm Fluoride Dentifrice 2; 0 ppm Fluoride Dentifrice 3
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Each subject will use this product during one of the five treatment periods in the crossover study design.; Each subject will use this product during one of the five treatment periods in the crossover study design.; Each subject will use this product during one of the five treatment periods in the crossover study design.; Each subject will use this product during one of the five treatment periods in the crossover study design.; Each subject will use this product during one of the five treatment periods in the crossover study design.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Energy Flux Study
Condition: Physical Activity
Study type: Interventional

Summary: 
      The focus of this randomized clinical trial study is an examination of the effects of
      maintaining energy balance at different energy fluxes. It will address the primary question:
      Are there increased health benefits related to body composition and metabolic function
      associated with maintaining energy balance at a high energy flux as compared to a low energy
      flux?
    

Detailed description: 
      We will randomly assign 75 sedentary but healthy individuals to one of two exercise groups or
      a non-exercise group. We will follow the individuals for 6 months during the intervention
      period. Both groups will maintain weight by matching energy intake and expenditure (thus the
      exercise group will consume more calories).
    

Intervention name(s): Energy Flux Exercise Intervention
Intervention type(s): Other
Intervention description(s): Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in
      healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of
      food effect by re-dosing at 50 mg and 150 mg
    


Intervention name(s): BI 34021 FU2 solution; BI 34021 FU2 tablet; Placebo; High fat, high calorie breakfast
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): dose group 4 only; only for dose groups 3 and 5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment