bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Probiotics and Fibers on Albuminuria in Persons With Type 1 Diabetes
Condition: Type 1 Diabetes; Nephropathy; Albuminuria; Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary objective is to assess the impact of three months' treatment with pre-/probiotic
      mix on markers of nephropathy and other comorbidity related to diabetes. A double blinded,
      randomized, placebo-controlled crossover, single-centre study including 46 patients with type
      1 diabetes and albuminuria. The treatment period is 2 x 12 weeks with 6 weeks washout. The
      primary outcome is to evaluate the effect of pre-/probiotic mix on albuminuria.
    

Detailed description: 
      Recent data has pointed towards a link between gut microbiota and chronic kidney disease
      (CKD). It is hypothesized that defects in the intestinal barrier due to intestinal dysbiosis,
      a microbial imbalance in the intestines, allow bacterial toxins and other proinflammatory
      substances to pass and cause systemic inflammation that damages the endothelium. To
      reestablish the microbial symbiosis and thereby strengthening the gut barrier different
      treatments have been investigated. Fibers serve as substrate for the beneficial bacterial
      strains and probiotics are selected bacteria that exert a beneficial effect on the gut
      environment. It is hypothesized that a supplement of fructo-oligosaccharides and probiotics
      (Pre-/probiotic mix) will strengthen the gut barrier and thereby protect the endothelium and
      kidneys.

      The aim of this study is to test whether af Pre-/probiotic mix, will have a beneficial impact
      on albuminuria in persons with type 1 diabetes and albuminuria.

      46 patients with type 1 diabetes and albuminuria will be recruited from Steno Diabetes Center
      Copenhagen (SDCC) in accordance with the study in- and exclusion criteria.
    

Intervention name(s): Pro-/prebiotic Mix; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Soluble powder for oral use of pre-/probiotic mix 3.0 g twice daily.; Soluble powder for oral use twice daily.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, double blinded, placebo controlled, crossover, single-centre study. A total of 46 participants will be randomly assigned into two groups of 23 to a sequence of treatment (active followed by placebo or vice versa). Allocation will be masked for both participants and investigators.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: probiotics, dietary fibers
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in
      treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
    


Intervention name(s): AAAA; AAPA; PAAA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks); Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks); Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HBV DNA suppression; ALT normalisation; Viral resistance; HBeAg seroconversion
Study of Safety and Efficacy of Durvalumab in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The expression of PD-L1 in breast cancer has been previously demonstrated (Ghebeh et al
      2006). In addition, PD-L1 has been shown to work as a "molecular shield", by protecting
      cancer cells from cytotoxic T-cells and chemotherapy induced apoptosis (Ghebeh et al 2008)
      suggesting to combine PD-L1 blockade with chemotherapy.

      This trial will test Durvalumab in combination with Paclitaxel on metastatic triple-negative
      breast cancer patients. The safety profile of Durvalumab as a monotherapy has been previously
      established (lu et al 2015). In this trial the safety profile and tolerability of Durvalumab
      given in combination of Paclitaxel will be tested. In addition, the efficacy of this
      combination on metastatic breast cancer will be monitored.
    

Detailed description: 
      This open label single arm trial will involve metastatic triple negative PD-L1 positive
      breast cancer patients. The trial will include a dose deescalation phase where three doses of
      paclitaxel will be tried on 3 patients each followed by a dose expansion phase on 25
      patients. Paclitaxel will be given weekly for 1 cycle followed by combination of Paclitaxel
      and Durvalumab. Once 6 cycles of Paclitaxel are completed, Durvalumab will be given alone
      until disease progression or unacceptable toxicity. The toxicity and tolerability of the
      combination will be the main end point while the efficacy will be a secondary end point.
    

Intervention name(s): Paclitaxel; Durvalumab
Intervention type(s): Drug; Drug
Intervention description(s): Paclitaxel will be given weekly for 6 cycles; Durvalumab will be given q2 wks concurrently with paclitaxel.
Other intervention name(s): MEDI4736
Intervention MeSH terms: Paclitaxel; Durvalumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: triple negative; breast cancer; durvalumab; paclitaxel; safety; efficacy; PD-L1; PD-1; Metastatic; AstraZeneca; MEDI4736
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics
      of PUR3100 in Healthy Adults
    

Detailed description: 
      This is a randomized, parallel group, double-blind, double dummy study.

      Following screening and confirmation of eligibility, twenty-four healthy subjects will be
      evenly randomized to 1 of the 4 dose groups of 6 subjects each. Subjects will receive
      intravenous (IV) dihydroergotamine (D.H.E) or IV placebo and dry powder inhalation of 0.5mg
      of PUR3100, 1.0 mg of PUR 3100, 1.5 mg of PUR 3100, or placebo.

      All potential subjects will complete screening between 28 days and 2 days prior to study unit
      check-in on Day -1. Subjects will remain in the study unit for 3 days post check-in and will
      be dosed each day at the study site.

      A follow up visit will occur 4 days after the last dose of study drug, on Day 7 of the study.
    

Intervention name(s): PUR3100; Dihydroergotamine (D.H.E 45); Matching Placebo for PUR3100; Matching Placebo for D.H.E 45
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): PUR3100 is an inhalation powder containing DHE, an anti-migraine treatment with broad spectrum agonist activity against 5-hydroxytryptamine (5-HT), dopamine, and adrenergic receptors. PUR3100 is provided as 500 µg dose strength capsules. Each capsule contains the drug substance, DHE mesylate, with mannitol, leucine, and sodium chloride as excipients.; D.H.E. 45 is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. It is supplied as a clear, colorless solution supplied in sterile ampules for IV, intramuscular, or subcutaneous administration containing (per mL) DHE mesylate, USP 1 mg, ethanol, 94% w/w. 6.2% by volume, glycerin 15% by weight, and water for injection.; Each capsule of matching placebo is filled with iSPERSE powder comprised of mannitol, leucine, and sodium chloride. The PUR3100 inhalation powder is administered using the supplied RS01 inhalation device (RS01 UHR2, Plastiape S.p.A.).; The matching placebo for D.H.E. 45 is 0.9% sterile saline for injection.
Intervention MeSH terms: Dihydroergotamine
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Double Dummy, Double-blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection
Condition: Cerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia
Study type: Interventional

Summary: 
      Background: after resection of medulloblastoma in children they suffer from signs and
      symptoms of ataxia which impedes their activities of daily living. purpose: to investigate
      the effect motor imagery training on balance, severity of ataxia and gait parameters on
      children after resection of medulloblastoma. Methods: Fifty children surfing from cerebellar
      ataxia after medulloblastoma resection were selected from tumors hospital of Cairo
      University, their age ranged from seven to nine years old, they were randomly assigned into
      two matched control and study groups. The control groups received the selected physical
      therapy program while, the study group received motor imaginary training in addition to the
      selected physical therapy program. Both groups were evaluated by ataxic rating scale,
      pediatric berg balance scale and kinematic gait analysis by kinovea software.
    

Detailed description: 
      Motor imagery is an effective method to enhance motor performance applied in rehabilitation
      programs it did not impose a physical load on patients, was confirmed through clinical
      evidence from meta#analysis. Motor imagery means thinking in motor task with executing it to
      activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by
      thinking.
    

Intervention name(s): motor imaginary training; physical therapy training
Intervention type(s): Other; Other
Intervention description(s): Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semi#reclined sitting in quiet room in front the screen. Children then asked to close their eyes and imagine practicing the task like the illustrative video. Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise.; facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Optimalization of Nephroprotection Using Atorvastatin (Sortis)
Condition: Chronic Kidney Disease; Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional

Summary: 
      The main purpose of the study is find whether the addition of statin (Atorvastatin) to dual
      renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme
      inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria,
      main prognostic marker of chronic kidney disease progression.
    

Detailed description: 
      The renin-angiotensin-aldosterone system (RAAS) plays an important role in the progression of
      chronic kidney diseases (CKD), and inhibition of the RAAS with angiotensin-converting enzyme
      inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB) may retard CKD
      progression. Dual pharmacological blockade of the RAAS with ACEI and ARB is recommended as a
      standard renoprotective management at least in patients with nondiabetic proteinuric CKD.
      However, neither ACEI nor ARB, even in high doses or in concomitant usage, abrogate the
      progression of CKD completely. Innovative approaches are needed to keep patients with CKD off
      dialysis. Additional statin (Atorvastatin) pathway may prove to be such beneficial
      therapeutic concept.Given these facts additional administration of statin to combination
      treatment with ACEI and ARB, may provide additional renal protection. To shed more light on
      this issue, we performed a randomised open controlled study to evaluate the influence of
      triple therapy with ACEI and/orARB and statin on surrogate markers of kidney injury, i.e.
      proteinuria, markers of tubular involvement and kidney fibrosis.
    

Intervention name(s): atorvastatin (Sortis) 40 mg
Intervention type(s): Drug
Intervention description(s): In the 8-weeks run-in period angiotensin-converting enzyme inhibitors and angiotensin II type 1 receptor blockers were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 40 mg of atorvastatin in two active treatment periods lasting 8 weeks each
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proteinuria,; atorvastatin
Unloading Induced Effects on Local Glucose Uptake Into m. Soleus
Condition: Local Glucose Uptake; Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      The present study aimed to investigate whether a daily intake of lupin protein and a
      neuromuscular electrical stimulation training twice a day can improve local glucose uptake
      into m. soleus during a 60 day unloading phase with a special unloading device, the
      HEPHAISTOS orthosis (HEP).
    

Detailed description: 
      The 60 day unloading intervention with the HEPHAISTOS unloading device had the following key
      objectives:

      primary hypothesis:

        -  Assesment and evaluation of insulin sensitivity and local glucose uptake in the unloaded
           m. soleus and whether it can be improved by dietary supplementation of lupin seeds and
           neuromuscular electrical stimulation.

      secondary hypotheses:

        -  Assesment and evaluation of unloading-induced reductions in muscle mass and whether they
           can be mitigated by dietary supplementation of lupin seed and neuromuscular electrical
           stimulation.

        -  Assesment and evaluation of whole-body glycemic effects of the interventions.
    

Intervention name(s): lupin protein; Neuromuscular electrical stimulation; HEPHAISTOS unloading orthotic device
Intervention type(s): Dietary Supplement; Other; Device
Intervention description(s): 19g of lupin crunchy every day for the whole duration of the intervention phase (60 days); Individual neuromuscular electrical stimulation training had to be performed twice a day (morning and evening) over the whole duration of the intervention phase (60 days). Subjects were asked to continuously increase the intensity until a maximum intensity of 100mA per training.; Orthotic device which unloads the muscles of the lower leg. Subjects had to wear the device for the whole duration of the intervention phase (60 days).
Other intervention name(s): NMES; HEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lupin Protein; Glucose Metabolism; GLUT4; Muscle Unloading; Neuromuscular Electrical Stimulation
Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
Condition: Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional

Summary: 
      On the basis of published data and the investigators' results indicating that oxidative
      stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD,
      the investigators propose a study to test whether or not an antioxidant supplementation has a
      therapeutic interest for patients with FSHD. Their results have important implications for
      the successful implementation of rational antioxidant therapy in FSHD in which cell loss
      could be linked to oxidative stress.
    

Detailed description: 
      This study will compare the effect of the therapeutic interest of an antioxidant
      supplementation on the functional deficits and the molecular muscle abnormalities into two
      groups of patients affected by FSHD, one treated with the antioxidant supplementation during
      17 weeks. The antioxidant by capsule consisted of:Vitamin E (400 mg /day), Selenium (200
      µg/day in the form of selenomethionine), Vitamin C (500 mg/day), Zinc (25 mg/day in the form
      of gluconate). The second one treated with a placebo during 17 weeks. Patients will be
      assigned to intervention groups by chance, and neither physician, nor patient, will know
      which product is administrated (study in "double blind").
    

Intervention name(s): Taking of blood; needle biopsy of the vastus lateralis muscle; Vit C Vit E Zn Se; Placebo Vit E Placebo Vit C Zn Se
Intervention type(s): Procedure; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Taking venous blood samples to analyse oxidant stress; T0 needle biopsy of the vastus lateralis muscle (analysis of oxidative stress and inflammatory markers)During 17 weeks supplementation by Vit E, C , Zn Se After 17 weeks: veinous blood samples and needle biopsy; T0 venous blood samples and needle biopsy of the vastus lateralis muscle During 17 weeks vit E 400mg/d, Se 200µg/d, Vit C 500mg/day, Zn 25 mg/d After the supplementation of 17 weeks:venous blood samples and needle biopsy of the vastus lateralis muscle; venous blood samples and needle biopsy
Other intervention name(s): FSHD; Antioxidant
Intervention MeSH terms: Ascorbic Acid; Vitamin E; alpha-Tocopherol; Tocopherols; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: FSHD; Antioxidants; Oxidative stress; Muscle function; Quality of life; Activity; (FSHD;4q35)
Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide
Condition: Adverse Effect of Other General Anesthetics; Anesthesia Intubation Complication; Inhalation of Nitrous Oxide; Trachea
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff
      hyperinflation of the endotracheal tube. Furthermore the difference among various types of
      cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.

      TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the
      intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with
      cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical
      study is needed to evaluate the intracuff pressure during general anesthesia with nitrous
      oxide exposure.
    

Detailed description: 
      During 60 minutes after routine anesthetic induction and intubation of the endotracheal
      tubes, intracuff pressures will be measured every 10 minutes with a manometer (VBM, Sulz,
      Germany).

      60% nitrous oxide will be added at time 0. For 60 minutes from the beginning of general
      anesthesia, intracuff pressures will be measured every 10 minutes.

      After 60 minutes, Intracuff pressures will be maintained around 20 cm H2O during the
      remaining period of the surgery.

      The questionnaire for a sore throat, hoarseness, and dysphagia will be questioned at about 1,
      6, and 24 hours after the surgery and the general anesthesia.
    

Intervention name(s): Cylindrical-shape cuff ETT (Group C); Tapered-shape cuff ETT (Group T)
Intervention type(s): Device; Device
Intervention description(s): Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube.; Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube.
Other intervention name(s): Mallinckrodt Hi-Lo(TM) endotracheal tube; Mallinckrodt TaperGuard(TM) endotracheal tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Cuff pressure; Cylindrical cuff; Endotracheal tube; Nitrous oxide; Tapered cuff
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The purpose of this randomized double-blind clinical trial is to determine the effectiveness
      of manual therapy for patients with subacromial impingement syndrome of the shoulder. We
      hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and
      spine will be more effective in reducing pain and shoulder disability at short-term (6 wk)
      and long-term (3, 6, 12 months) as compared to therapeutic exercise only.
    

Detailed description: 
      Subacromial impingement syndrome (SAIS) is a frequent cause of shoulder pain. Clinical trials
      investigating the effectiveness of manual therapy have demonstrated improvements in outcomes
      when manual therapy has been added to a program of therapeutic exercise. However, the these
      clinical trials (3) have significant limitations and generalizability. Two of the three 3
      trials had a small number of subjects (14 & 22 subjects) and all 3 trials had only short term
      follow up (<12 weeks) and used non-validated self report outcome measures. These limitations
      reduce the confidence with which clinicians can apply these results to the patients they
      treat with SAIS. Clear evidence is needed to justify the cost and clinician time required to
      perform manual therapy in the delivery of patient care. Therefore, the purpose of this
      randomized clinical trial is to examine the short-term and long-term effectiveness of manual
      therapy in addition to therapeutic exercise as compared to therapeutic exercise only in
      patients diagnosed with SAIS.
    

Intervention name(s): Manual Therapy and Exercise; Exercise Only
Intervention type(s): Other; Other
Intervention description(s): Manual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function.; A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function
Other intervention name(s): Manual Therapy and Therapeutic Exercise; Therapeutic Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: shoulder pain; shoulder impingement syndrome; manual therapy; rehabilitation