bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of
      safety and efficacy of ReHub, a telerehabilitation system made up of a cloud platform and an
      exercise kit with smart sensors, for performing rehabilitation exercises after a primary
      Total Knee Arthroplasty.

      Primary TKA patients are allocated randomly to the control arm or the experimental arm with a
      1:1 ratio. Both arms follow the usual rapid recovery protocol for TKA surgeries at Hospital
      Clínic de Barcelona, which includes discharge after 2-3 days from the surgery, the
      prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary
      visits by a physiotherapist starting approximately 2 weeks after the surgery. The
      experimental arm participants use ReHub to do their exercises instead of working
      independently and physiotherapists monitor their performance and adherence remotely.

      Outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks
      after baseline) and 2 weeks after stitch removal (4 weeks after baseline).
    


Intervention name(s): Rapid Recovery Rehabilitation Programme; ReHub
Intervention type(s): Other; Device
Intervention description(s): Usual intervention at Hospital Clínic de Barcelona for post-operative rehabilitation of TKA patients. Participants, already at home after hospital discharge, must perform 5 different exercises 4 times a day (twice in the morning, twice in the afternoon).
Participants are also encouraged to walk and stretch their legs. Domiciliary visits by a physiotherapist start at approximately 2 weeks after the surgery to help participants do the exercises.; Participants use a telerehabilitation platform, ReHub, as a guide to perform the TKA rehabilitation exercises of the Rapid Recovery Rehabilitation Programme intervention.
The exercise plan in ReHub is carried out by a site physiotherapist on the first day after discharge by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor that transmits data to the platform.
The wearable inertial sensor participants must wear tracks movement while they do the TKA rehabilitation exercises. Movement is analysed and feedback is given in real time. At the end of each exercise, participants can select if they have felt pain in a scale from 1 to 10. A physiotherapist monitors the participants' progress remotely.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
Condition: Cystic Fibrosis in Children
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This study aims to assess the effects of a resistance exercise training program on heart rate
      variability in a group of children and adolescents with cystic fibrosis. The study design is
      a randomized controlled trial.
    

Detailed description: 
      A randomized controlled study will be carried out in children diagnosed with cystic fibrosis
      aged 6 to 18 years. Individuals will be divided into two groups: control group (CON) and
      strength training (ST). Heart rate variability will be analyzed using KUBIOS and measured
      using a Suunto watch, with subjects in lying position without movements or speaking for 5
      minutes. Patients in the ST group will complete an individualized guided strength program for
      8 weeks (3 sessions of 60 min/week). Training prescription will be individualized and based
      on the 5 repetition maximum test (60-80%). Upper and lower limbs exercises will be used,
      including seated bench press, seated lateral row and leg press. Outcome measures will be
      performed at baseline and after 8 weeks.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Heart Rate Variability; Exercise
Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme
Condition: Glioblastoma Multiforme of Brain
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of brain tumors.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma
      Multiforme.
    

Detailed description: 
      OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with
      newly diagnosed Glioblastoma Multiforme receive gradually escalating doses of intravenous
      Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
      Treatment continues for at least 12 months in the absence of disease progression or
      unacceptable toxicity.

      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with
           newly diagnosed Glioblastoma Multiforme, as measured by an objective response to therapy
           (complete response, partial response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in adults (≥ 18 years of
           age) with newly diagnosed Glioblastoma Multiforme.

        -  To determine objective response, tumor size is measured utilizing MRI scans, which are
           performed every 8 weeks for the first two years, every 3 months for the third and fourth
           years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult glioblastoma
Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of
      hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid
      component (long-chain fatty acids). The goal of this combination is to achieve long-acting
      delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release
      of satiety-signals from intestinal cells, and consequently reducing appetite and lowering
      food intake in humans.

      Over a period of 6 weeks, volunteers will ingest SATIOSTAT as meal replacement at lunch and
      as first course at dinner. Once before and after these 6 weeks the investigators will carry
      out an oral glucose challenge, measure satiation hormones and examine faeces (gut
      microbiota). Volunteers will fill in a food diary and a questionnaire for gastrointestinal
      symptoms and quality of life. The whole study will take approximately 8-10 weeks.
    


Intervention name(s): Control; SATIOSTAT
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Control granulates (maize starch and long-chain fatty acids) with powder; SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder
Other intervention name(s): The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.; The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether treatment with multiple injections of
      GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have
      been recently diagnosed with type 1 diabetes mellitus (T1DM).
    

Detailed description: 
      Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part
      of the body which helps fight infections) mistakenly attacks and destroys the cells that
      produce insulin (islet cells found in the pancreas called islet cells). As these cells are
      destroyed, the body's ability to produce insulin decreases. Glutamic acid decarboxylase (GAD)
      is one of the major autoantigens (a protein that the immune system is reacting to) involved
      in the autoimmune process underlying T1DM.

      GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator.
      Previous studies have shown that it may slow or prevent autoimmune destruction of pancreatic
      islet cells by introducing "immune tolerance". By administering excess autoantigen, the body
      may stop its attack on its own cells that produce insulin. If the immune system's attack can
      be halted in a patient with recent onset T1DM, than residual insulin secretion may be
      maintained. This may be beneficial in decreasing acute and long-term diabetic complications
      as well as improving glucose control.
    

Intervention name(s): GAD-Alum; GAD-Alum and Aluminum hydroxide; Aluminum hydroxide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.; Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.; Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
Other intervention name(s): Diamyd; Diamyd; Alhydrogel
Intervention MeSH terms: Aluminum Hydroxide; Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: immune tolerance; immunotherapy; antigen-specific tolerance; vaccine induced tolerance; Beta-cell function; T-cells; DPT-1; treatment of type 1 diabetes; new onset type 1 diabetes; juvenile diabetes; T1D; diabetes mellitus; Type 1 diabetes TrialNet; TrialNet
Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics
Condition: Healthy; Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is carried out to evaluate the safety, tolerability and pharmacokinetics of
      AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.
    

Detailed description: 
      The study has three main objectives:

        -  To evaluate the safety, and tolerability of AeroVanc inhalation powder in healthy
           volunteers, and in patients with CF.

        -  To determine the systemic bioavailability of vancomycin in healthy volunteers following
           single dose pulmonary administration of 16 mg, 32 mg, and 80 mg doses of AeroVanc in
           comparison with a 250 mg dose of vancomycin administered intravenously.

        -  To estimate the lung sputum concentrations of vancomycin in patients with cystic
           fibrosis (CF) following single dose pulmonary administration of 32 mg and 80 mg doses of
           AeroVanc.
    

Intervention name(s): AeroVanc; IV vancomycin hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Vancomycin hydrochloride dry powder for inhalation; Vancomycin hydrochloride solution for intravenous administration
Intervention MeSH terms: Vancomycin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?
Condition: Mood Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Wellbutrin (bupropion) is an effective antidepressant (Thase, M 2005). It exists in instant
      release (IR), sustained release (SR) and extended release (XL) forms. The IR formulation was
      never approved for use in Canada. The XL formulation allows for once daily dosing.

      Wellbutrin is both a norepinephrine and dopamine reuptake inhibitor, and as such increases
      the synaptic concentration of both neurotransmitters. This adds to its positive effects on
      cognition, apathy, tiredness and executive functioning. The increased activation may be also
      responsible for some of its side effects such as initial insomnia and reduced sleep
      efficiency, especially when taken at night.
    

Detailed description: 
      Wellbutrin SR formulation cannot be given as more than 150 mg as a single dose and higher
      doses are commonly required for the treatment of depression; they also have to be given at
      least 8 hours apart in order to avoid peak plasma concentrations and to reduce the risk of
      seizures (incidence of 0.1% at doses £ 300 mg). The twice a day dosing may result in
      complaints of insomnia and may necessitate discontinuing the medication or adding a sleep
      promoting agent. The benefit of once-daily dosing cannot be understated given treatment
      adherence is typically lower in depressed patients than their non-depressed counterparts;
      further, the 8 h dosing interval of bupropion SR is likely to have lower adherence compared
      with traditional bid dosing (i.e., morning and evening); thus, it is not difficult to imagine
      patients missing 30-50% of their second dose given the difficulty of recalling to take the
      second dose at work or school. The review of Fava et al. (2005) plots the relative PK
      profiles of XL and SR and notes the significantly lower bupropion concentration at bedtime,
      which is likely to reduce the occurrence of insomnia. Therefore, Wellbutrin XL may improve
      adherence by eliminating the second dose and Wellbutrin XL also avoids the high plasma drug
      concentrations at bedtime, as seen with bupropion SR, which are associated with insomnia.
      Further, the smoother pharmacokinetic profile of Wellbutrin XL may improve overall
      tolerability compared with Wellbutrin SR.
    

Intervention name(s): Wellbutrin XL
Intervention type(s): Drug
Intervention description(s): Wellbutrin XL 300mg daily
Other intervention name(s): Bupropion
Intervention MeSH terms: Bupropion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wellbutrin SR
Bevacizumab in Extensive Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Despite the fact that a substantial response rate may be obtained in small-cell lung cancers
      (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More
      aggressive regimens remain controversial and recent attempts at increasing dose-intensity
      have been restricted to patients with a more favourable presentation.

      Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial
      Growth Factor). In association with double-drug standard chemotherapies, it has been proven
      that bevacizumab can improve survival of previously untreated advanced non-small-cell lung
      cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on
      NSCLC deserve to be tested on small-cell lung cancers.

      In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to
      experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC
      patients.
    


Intervention name(s): Standard Chemotherapy (PCDE or PE); Experimental Treatment (PCDE or PE + bevacizumab); Prerandomization Chemotherapy (PCDE or PE)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PCDE: cisPlatin 75 mg/m² D2 ; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 4 cycles
PE: cisPlatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 4 cycles; PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 4 cycles Bevacizumab 7.5 mg/kg, D1, until progression
PE: cisPlatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 4 cycles Bevacizumab 7.5 mg/kg, D1, until progression; PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 2 cycles
PE: cisplatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 2 cycles
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extensive-Disease Small-Cell Lung Cancer
A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      This is a randomized, paralleled, control trial to validate the effectiveness and safety of
      Lando® absorbable collagen membrane for oral bone repair.
    


Intervention name(s): Lando® absorbable collagen membrane; Geistlich Bio-Gide resorbable bilayer membrane
Intervention type(s): Device; Device
Intervention description(s): Subjects who are fit for the study will be randomized to either intervention arms.; Subjects who are fit for the study will be randomized to either intervention arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Circadian Clocks and Eating Patterns (Cohort)
Condition: Postpartum Women; Diabetes, Gestational
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      For women of reproductive age, the overall postpartum weight retention (weight gain between
      pregnancies) plays a significant role in long-term obesity. With 20% of women retaining ≥ 5
      kg at 12 months postpartum, the risk of developing conditions, such as gestational diabetes
      mellitus (GDM), metabolic syndrome (MS) and subsequently diabetes and cardiovascular
      diseases, is substantially increased. In post-GDM mothers (women who had GDM in their recent
      pregnancy), postpartum weight retention is also an essential predictor of future diabetes.

      Recent studies have identified the impact of circadian rhythms (influencing sleep/wake
      cycles) and diurnal rhythm of eating (when and how often calories are consumed over a 24h
      period) on cardio-metabolic disorders. In women, one remarkable feature of the postpartum
      period is an 'externally imposed' circadian misalignment of both sleep and eating rhythms,
      because most babies take several weeks to months to establish their daily pattern of activity
      and feeding, which is particularly relevant for breastfeeding women, as the responsibility is
      generally on the mother.

      The overarching goal of this project is to explore the interplay between the diurnal rhythm
      of eating, circadian and metabolic parameters in humans. The potential postpartum effects of
      circadian disruption will be unraveled in women who had GDM during their pregnancy and those
      with an uneventful pregnancy. These women are subject to a circadian misalignment due to
      their 'externally imposed' changes in sleep/wake cycles and eating times in the postpartum
      period.

      With a comprehensive approach combining molecular characterization of in vivo and in vitro
      circadian clock parameters along with metabolic, endocrine, transcriptomic, and lipidomic
      studies, the investigators will assess if eating duration and/or circadian misalignment
      impact on circadian clock parameters of postpartum women in a prospective cohort of 6 months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Postpartum women followed at the Lausanne University Hospital (CHUV)
      
Biospecimen description: 
      Blood, serum and plasma Skin biopsy
    
Keywords: Circadian rhythms; Metabolic syndrome; Eating duration; Sleep/wake cycles
Umblical Incision for Neonatal Surgery
Condition: Neonatal Surgery
Study type: Interventional

Summary: 
      Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can
      solve the problem to some extent by making a smaller scar but takes more time and need
      special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy
      and avoid the drawbacks of both.
    

Detailed description: 
      six cases were subjected to the study 2 cases have duodenal atresia, one case has annular
      pancreas, one case has jujenal atresia chritmas tree, one case has jujenal web and a case of
      malrotation. all of them had made exploration by the umbilical incision, and no drains had
      been used.
    

Intervention name(s): umbilical incision
Intervention type(s): Procedure
Intervention description(s): exploration through umbilical incision
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment