bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality Rehabilitation in Patients With Total Knee Replacement
Condition: Knee Arthropathy; Total Knee Replacement
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations
      in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies
      on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive
      capacity, postural control and gait. However, literature lacks such studies in TKR patients.
      This preliminary study aims to evaluate the efficacy of a VR system for the enhancement of
      motor skills in TKR patients compared to a traditional approach of rehabilitation.
    

Detailed description: 
      In this randomized controlled trial (RCT), the randomization of the sample will be performed
      by a local software and in a single blind design. Forty patients will be enrolled and after
      giving the informed consent, assigned to two groups :

        -  the experimental group (VRG), which will be undergone to treatment with virtual reality
           for the recovery of load distribution and proper gait pattern;

        -  the control group (CG), which will be undergone to a traditional rehabilitation
           addressed to recovery of correct gait pattern for the same time period as VRG.

      Both treatments consist in 15 sessions, at least 5 per week , each lasting 45 minutes. Both
      VRG or CG will last for 21 days from the start of treatment.

      All patients, in adjunction to Virtual Reality Rehabilitation (EG) or Traditional
      Rehabilitation (CG), will execute a global rehabilitation project, consisting in
      Physiotherapy, Physical Therapies for pain and inflammation control, and Occupational
      Therapy, personalized by a multidisciplinary rehabilitation team for a minimum of 150-180
      minutes per day, and according to their clinical conditions for them.

      The purposes of this study in detail are:

        1. Observing differences in the distribution of the bi-podalic load in the group that
           performs a re-education with virtual reality compared to those who perform the
           traditional treatment.

        2. Observing differences in the recovery time of a correct pattern of gait in the group
           that performs a re-education with virtual reality compared to those who perform a
           traditional treatment.

        3. Observing changes in neurophysiological patterns in the two groups.
    

Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): Virtual Reality Rehabilitation System
Other intervention name(s): VRRS EVO, Khymeia s.r.l., Italy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Virtual Reality; Total Knee Replacement; Proprioception; Balance; Gait
The Weigh Forward, Financial Incentives for Maintenance of Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of financial incentives in improving and
      maintaining weight loss.
    

Detailed description: 
      The study will evaluate the effectiveness of financial incentives in improving maintenance of
      weight loss. The investigators propose a 2-arm randomized controlled trial in which 258
      participants who lose at least 5 kgs in a weight loss program will be randomized to one of
      the following: 1) daily weigh-ins and weekly feedback, 2) daily weigh-ins,weekly feedback,
      and a weekly escalating lottery-based financial incentive.

      Study participants will be obese volunteers recruited from a major community-based weight
      loss program (Weight Watchers), who have lost at least 5kg during the 4-6 months prior to
      enrolling in the study. Upon enrollment, these participants will have an active online
      membership with Weight Watchers. Among these participants, the following will be assessed: 1.
      Assess the effectiveness of escalating lottery rewards, relative to the control group, on
      maintenance of weight loss over the ensuing 6 months (Phase I); 2.The degree to which weight
      loss is maintained in the intervention group relative to usual care during the 6 months
      following the cessation of the interventions (Phase II).

      During Phase I, incentives will be provided to some study participants (escalating lottery
      arm) for the first 6 months and participants will be followed for 6 more months to examine
      effects following cessation of incentives.
    

Intervention name(s): Escalating Lottery
Intervention type(s): Behavioral
Intervention description(s): Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)
Condition: Heart Failure; Heart Transplantation; Heart-Assist Devices
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      End-stage heart failure (ESHF) represents a major burden in terms of quality of life,
      mortality and costs. The current practice in France is to treat patients with ESHF by a
      combination of drugs and lifestyle interventions before proposing heart transplant (HT) if
      there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in
      Germany, patients presenting with ESHF are preferentially managed by ventricular assist
      device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these
      two strategies in the management of ESHF and associated consumption of resources.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients presenting with end-stage heart failure between November 2010 and October 2011
        at the Heart and Diabetes Center of Bad Oeynhausen, and who underwent ventricular assist
        device implantations were included in group I. All patients presenting with end-stage heart
        failure to the Hôpital Européen Georges Pompidou or the Groupe Hospitalier
        Pitié-Salpêtrière, during that same period, were included in group II.
      
Keywords: End Stage Heart Failure; New York Heart Association functional class III or IV; Heart transplantation; Ventricular assisted devices; Cardiogenic shock
Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease
      immune-mediated destruction of beta cells and result in preserved beta-cell function in
      patients with type 1 diabetes of recent onset.
    

Detailed description: 
      Although the presence of autoantibodies is a diagnostic criterion, the immunopathogenesis of
      beta-cell destruction in type 1 diabetes is typically associated with T-lymphocyte
      autoimmunity.

      Many T-lymphocyte-mediated diseases include a B-lymphocyte component. B lymphocytes can play
      a crucial role as antigen-presenting cells, expressing high levels of class II
      major-histocompatibility-complex antigens and generating cryptic peptides to which T
      lymphocytes are not tolerant.

      B lymphocytes can be selectively depleted with the anti-CD20 monoclonal antibody. We will
      test the hypothesis that transient elimination of B lymphocytes with anti-CD20 monoclonal
      antibody would decrease immune-mediated destruction of beta cells and result in preserved
      beta-cell function in patients with type 1 diabetes of recent onset.
    

Intervention name(s): rituximab
Intervention type(s): Drug
Intervention description(s): anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)
Other intervention name(s): anti-CD20 monoclonal antibody
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: type 1 diabetes; age; course of disease; autoantibodies; C-peptide levels
Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease
      progression of prostate cancer.

      PURPOSE: Randomized phase II trial to study the effectiveness of a diet that is low in fat
      and/or high in flaxseed in slowing or preventing disease progression in patients who have
      newly diagnosed prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare tumor proliferation in patients with newly diagnosed prostate cancer eating fat-
           and/or flaxseed-modified diets.

        -  Compare differences in histopathological markers associated with prostate cancer (rates
           of apoptosis, extent of high-grade prostatic intraepithelial neoplasia) among patients
           in these diet groups.

        -  Compare changes in serum prostate specific antigen among patients in these diet groups.

        -  Compare changes in hormone-related factors (total serum testosterone and free androgen
           index, insulin-like growth factor [IGF], and IGF-binding protein-3) among patients in
           these diet groups.

        -  Compare the effects of diet on nutritional biomarkers (levels of lignans in the urine
           and ejaculate, fatty acid profiles of erythrocytes and prostatic tissue) in these
           patients.

        -  Determine associations between dietary modification and changes in dietary biomarkers,
           hormonal intermediates, and study endpoints in these patients.

      OUTLINE: This is a randomized study. Patients are stratified according to Gleason score (less
      than 7 vs at least 7) and race (black vs non-black). Patients are randomized to 1 of 4 diet
      groups.

        -  Arm I (Flaxseed-supplemented diet): Patients are instructed to incorporate ground
           flaxseed into their daily diets.

        -  Arm II (Low-fat diet): Patients are instructed on ways to achieve a diet with no greater
           than 20% of total energy from dietary fat.

        -  Arm III (Flaxseed-supplemented, low-fat diet): Patients are instructed as in arm I and
           arm II.

        -  Arm IV (Control diet): Patients are contacted weekly, but do not receive dietary
           counseling until after surgery.

      All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery.
      After surgery, all patients receive dietary counseling.

      PROJECTED ACCRUAL: A total of 160 patients (40 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): dietary intervention; flaxseed
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer
Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride
Condition: Dental Caries; Molar Incisor Hypomineralization
MeSH terms: Dental Caries; Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the clinical performance of Silver
      diamine Fluoride (SDF) and Silver diamine fluoride + Atraumatic resin restoration (SDF+ARR)
      on molars with MIH
    

Detailed description: 
      SDF and SDF+ARR will be placed on two permanent molar teeth with MIH, in a split mouth
      design. 100 patients will be included in the study. The teeth will be randomized into two
      groups according to the dental restorative material.

      Group 1: SDF only ((Riva Star) 2: SDF (Riva Star) +ARR (Equia Forte). The US Public Health
      Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity,
      marginal discoloration and retention) will be used for clinical evaluation of atraumatic
      resin restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24.
      months. Intra-oral photos will be taken directly after treatment and at control appointments
      to evaluate discoloration and seconder caries under magnification.

      The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and
      Wilcoxon method will be used to estimate survival percentages.
    

Intervention name(s): SDF only; SDF+ARR
Intervention type(s): Device; Device
Intervention description(s): Molar with MIH will be treated with SDF; Molar with MIH will be treated with SDF+ARR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: molar incisor hypomineralization; silver diamine fluoride
A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent
Condition: Nicotine Dependence; Overweight; Obesity
MeSH terms: Overweight; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a combination of naltrexone SR and
      bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and
      obese subjects.
    


Intervention name(s): NB32; Ancillary therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks.; During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
Other intervention name(s): Contrave; Naltrexone SR 32 mg/Bupropion SR 360 mg daily
Intervention MeSH terms: Naltrexone; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nicotine-dependence in overweight and obese subjects
Evaluation of Efficacy and Tolerance of Crystal Peel in the Treatment of Adults Presenting Facial Mild Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The goal of this interventional, confirmatory and post market study is to evaluate the
      efficacy and clinical performance of Crystal Peel in adults suffering mild facial acne
      vulgaris. The principal and secondary aims are:

        -  Principal aim: to evaluate the efficacy and clinical performance of Crystal Peel, a
           salicylic-based peel, for the treatment of acne by lesions counting (front, 2 cheeks,
           the chin above the jaw line (excluding the nose)) using both visual observation and
           palpation.

        -  Secondary aims: pores and texture analysis, visual effect (Standardized anonymized
           photographs, investigator global assessment, patient global assessment, local and
           overall tolerance of the Crystal Peel, subject's self-evaluation and potential adverse
           events collection.

      The primary endpoint of the study will be an objective counting of the acne lesions performed
      on every visit.
    

Detailed description: 
      Total lesions will be defined as the sum of inflammatory lesions (papules and pustules),
      non-inflammatory lesions (whiteheads and blackheads) and other acne lesions (nodules).
    

Intervention name(s): Crystal Peel
Intervention type(s): Device
Intervention description(s): 3 applications performed by a dermatologist.
Intervention MeSH terms: Methamphetamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acne; facial; crystal peel; salicylic acid
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
Condition: Resectable Prancreas Carcinoma
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In this multicenter study, patients with resectable pancreatic carcinoma will be treated with
      (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery
      followed by 4-6 cycles FOLFIRINOX.

      The overall survival between both therapies will be compared as well as other parameters.
    

Detailed description: 
      This is a phase II/III randomized multicenter study. Patients with resectable pancreatic
      carcinoma will be randomized in Arm A (surgery plus adjuvant gemcitabine, 6 cycles) or Arm B
      (4-6 cycles FOLFIRINOX neoadjuvant, 4-6 cycles FOLFIRINOX adjuvant).

      Primary endpoint is the overall survival, secondary endpoints are progression-free survival,
      perioperative morbidity and mortality, rate of R0 resections, tolerability and feasibility of
      neoadjuvant FOLFIRINOX and others.
    

Intervention name(s): Gemcitabine; Oxaliplatin; 5-Fluorouracil; Irinotecan; Natriumfolinate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Gemcitabine; Fluorouracil; Oxaliplatin; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreas cancer; neoadjuvant chemotherapy; Folfirinox; gemcitabine
Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation"
Condition: Alpha-1 Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate different doses of "Kamada-AAT for Inhalation" on the levels of alpha
      1-proteinase inhibitor and other analytes in epithelial lining fluid (ELF) and serum and to
      assess the safety of the treatment in subjects with AAT Deficiency.
    


Intervention name(s): Kamada-AAT for Inhalation, 80mg; Placebo; Kamada-AAT for Inhalation, 160mg
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery
Condition: Caloric Restriction; Exercise
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine whether maintaining a eugonadal state, during
      severe, sustained energy deficit, attenuates physiological decrements, particularly the loss
      of lean body mass.
    

Detailed description: 
      This study will enroll up to 60 physically active men in a 3-phase randomized,
      placebo-controlled trial. After completing a 14-day (free-living, phase 1), energy-adequate,
      diet-acclimation phase (protein, 1.6 g∙kg-1∙d-1; fat 30% total energy intake, with remaining
      energy derived from carbohydrate), participants will be randomized to one of two experimental
      groups and undergo a 28-day (live-in, phase 2), 55% energy deficit phase: energy deficit
      alone (DEF) or energy deficit + exogenous testosterone (DEF+TEST). Recovery (free-living,
      phase 3) will be assessed after completing phase 2 to determine when body mass has been
      recovered within ± 2.5% of initial body mass (duration will vary, 42-day maximum for phase
      3). This study will delineate the contribution of testosterone declines from the physical and
      mental demands encountered by Warfighters during military training and combat operations on
      complex markers of physiological and psychological status, addressing a direct, consistently
      observed, gap in knowledge.
    

Intervention name(s): Sesame Oil; testosterone enanthate
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35; 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain
Condition: Scrotal Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with
      scrotal pain that we found published.

      We proposed a pilot study using Botox to block the nerves on a small group of men with
      chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have
      had temporary relief from a testicular cord block using local anaesthetic drug.

      The encourage results of the pilot study has given us the background information to proceed
      with a formal randomised control trial of Botox vs placebo.

      We hypothesized that Botox injections to block the testicular nerve will be effective in
      providing long term pain relief for men with scrotal pain.
    


Intervention name(s): Botox; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): OnabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Scrotal pain; Botox
Protein Requirements In Active Populations
Condition: Increased Metabolic Requirement; Healthy
Study type: Interventional

Summary: 
      Protein requirements in active individuals have been suggested to be greater than the current
      recommended dietary allowance (RDA).

      Nutritional requirements for dietary amino acids in adults have traditionally been determined
      utilizing the nitrogen balance technique, which is prone to underestimating protein
      requirements. As a result, there is a need to re-evaluate recommendations in order to
      characterize how dietary amino acid needs may be modulated by physical activity.

      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique
      have suggested that protein requirements in young men are at least 50% higher than the RDA
      based on nitrogen balance data.

      The purpose of this study is to measure the protein requirement in active, young adult males
      using the IAAO technique in the presence of a variable intensity exercise stimulus.
    


Intervention name(s): Amino Acid Intake
Intervention type(s): Dietary Supplement
Intervention description(s): Amino acid intakes will be varied at 0.2-2.6 g/kg/day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science