bioihbjkbjnl/mcl2 huggingface dataset:
Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites
Condition: Cirrhosis; Refractory/Recurrent Ascites
MeSH terms: Liver Cirrhosis; Recurrence; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The development of ascites in the natural history of cirrhosis heralds a worsening of the
      prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the
      ascites becomes refractory to medical therapy. Hemodynamic alterations and their relation to
      neurohumoral systems are essential in pathophysiology of ascites formation. The theory that
      best explain the ascites formation and sodium retention in cirrhotics is portal hypertension
      leading to splanchnic arterial vasodilatation leading to underfilling of arterial circulation
      which is sensed by the arterial and the cardiopulmonary receptors leading to sympathetic
      nervous system activation and activation of the anti-natriuretic factors (RAAS and arginine
      vasopressin), resulting in sodium and water retention. The therapeutic options available for
      patients with refractory ascites are serial therapeutic paracentesis, liver transplantation
      and transjugular intrahepatic portosystemic shunts.Vasopressin V2 receptor antagonists
      antagonize the antidiuretic effects of vasopressin at the V2 receptor located in the renal
      collecting duct, they increase free water clearance, and thus may be helpful in mobilizing
      excess water in conditions associated with water retention including cirrhosis. The use of V2
      receptor antagonists in cirrhosis with ascites has been shown to be safe and efficacious.
      Midodrine, an alpha adreno receptor agonist by causing splanchnic vasoconstriction has been
      used in hepatorenal syndrome (HRS) and for control of ascites in patients with refractory or
      recurrent ascites. It is possible that vasoconstrictors and aquaretics (V2 receptor
      antagonists) by acting at different sites in combination may reverse some of the pathogenic
      events that results in refractory or recurrent ascites.There are no reports on the use of
      combination of midodrine and tolvaptan in the patients with cirrhosis with ascites.
      Therefore, we plan to study the role of midodrine, tolvaptan and their combination on
      systemic hemodynamics, renal functions and control of ascites in patients with cirrhosis and
      refractory or recurrent ascites.
    


Intervention name(s): Standard medical therapy; Tolvaptan; Midodrine
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Standard Medical therapy (n-15) with100 to 400mg spironolactone and/or 40 to 160mg furosemide.; Tolvaptan 15 mg twice a day; Midodrine 7.5 mg thrice a day
Intervention MeSH terms: Furosemide; Spironolactone; Tolvaptan; Midodrine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin A Value of Spirulina Carotenoids in Humans
Condition: Intrinsically Labeled Spirulina
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The
      investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A
      reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples
      (10 ml/sample) will be collected from each subject over a two-month period to evaluate the
      bioavailability and bioconversion of spirulina ß-carotene to vitamin A.
    

Detailed description: 
      By utilizing novel stable isotope dilution techniques recently developed in our laboratory,
      we will trace deuterium labeled ß-carotene in intrinsically labeled spirulina, which is
      harvested from a hydroponic system. In the mean time, we will track 13C10 labeled vitamin A
      in humans. In this way we will determine absorption of ß-carotene from spirulina matrix and
      the conversion of the spirulina ß-Carotene to retinol. This will enable us quantitatively
      determine the vitamin A equivalence of spirulina.

      The specific aims of this study are:

        1. To determine labeled ß-C blood response kinetics following an acute dose of
           intrinsically labeled spirulina;

        2. To determine labeled retinol blood response from the intrinsically labeled spirulina;

        3. To determine 13C10 retinol blood response from the isotope reference material 13C10
           retinyl acetate;

        4. To determine s spirulina-vitamin A equivalence.
    

Intervention name(s): spirulina ß-carotene; spirulina ß-carotene
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): an acute dose of spirulina up to 5 g; vitamin A value of spirulina ß-carotene
Other intervention name(s): spirulina VA study; spirulina VA study
Intervention MeSH terms: Carotenoids
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: spirulina; carotenoids
Computerized Treatment for Social Anxiety
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The present study aims to examine the feasibility of a computerized treatment for social
      anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have
      developed in reducing evaluation and social threat biases, they will conduct a two-arm
      randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50)
      will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each
      condition will consist of eight 25 minute treatment sessions. Participants will complete two
      sessions per week for four weeks and will be administered assessments at pre-treatment, one
      week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to
      greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to
      greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to
      greater reductions in threat interpretations and greater increases in benign interpretations
      than the PMR condition; 4) The effects of condition on social anxiety symptoms will be
      mediated by changes in social anxiety-related interpretation bias; and 5) The effects of
      condition will be maintained at the 3-month follow-up assessment.
    


Intervention name(s): Interpretation Bias Modification; Progressive Muscle Relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.; Eight 15-minute sessions of progressive muscle relaxation (PMR).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study aims to explore the effect of narrative enhancement and cognitive therapy in
      improving self-stigma, self-esteem, depression and hope of patients with chronic
      schizophrenia.
    

Detailed description: 
      86 participants with chronic schizophrenia in two different hospitals in northern Taiwan were
      recruited in this study. All participants were randomized into experimental and control
      groups through block randomization. After randomization, the participants in control group
      received routine care and the others in experimental group received Narrative Enhancement and
      Cognitive Therapy(NECT) which contains 20 times group meetings. The research tools include
      demographic data, the Internalized Stigma of Mental Illness Scale (ISMIS), the Discrimination
      and Stigma Scale (DISC), Rosenberg self-Esteem scale (RSES), Beck Depression Inventory
      (BDI-II) and Herth Hope Index (HHI). The questionnaires were collected for three times,
      including before the intervention, 12 weeks after intervention, and after the end of
      intervention. The collected data were analyzed by IBM SPSS 24.0 statistical software. The
      descriptive statistics include mean, standard deviation, minimum, maximum, frequency
      distribution, and percentages; the Generalized estimating equations (GEE) were used to
      explore the effect of Narrative Enhancement and Cognitive Therapy on self-stigma,
      self-esteem, depressive symptoms and hope in patients with schizophrenia after controlling
      demographic data.
    

Intervention name(s): Narrative Enhancement and Cognitive Therapy (NECT)
Intervention type(s): Other
Intervention description(s): Narrative Enhancement and Cognitive Therapy includes two introduction meetings, three psychoeducation meetings, seven cognitive restructuring meetings, seven narrative enhancement meetings and one summing up meeting.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were divided into experimental and control groups through block randomization.
Masking: Single (Participant)
Primary purpose: Other
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The investigators administered a randomized controlled trial (RCT) through random assignment
      of children with ADHD into three different groups to compare the effects of cognitive-motor
      rehabilitation, immediate release methylphenidate, and an active control on the executive
      functioning, learning, and behavioral symptoms of children with ADHD.
    


Intervention name(s): Cognitive-Motor Rehabilitation; Ritalin; Active Control
Intervention type(s): Other; Drug; Other
Intervention description(s): Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises; 2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.; Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
Other intervention name(s): drug therapy
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Cognitive-motor rehabilitation; Active Control Group; Stimulant Medication
Efficacy of YKP3089 in Patients With Photosensitive Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish
      or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy
      patients, and to measure the onset and duration of the effect. Several cohorts will be used,
      to sequentially investigate different doses.
    


Intervention name(s): YKP3089; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dosage form
Intervention MeSH terms: Cenobamate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Epilepsy; Seizures
Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The best format for the delivery of structured education for adults with Type 1 diabetes is
      unclear. Currently some hospitals invite their patients to attend a 5 day outpatient course
      run over one week (Dose Adjustment For Normal Eating (DAFNE)). Other centres offer 1 day a
      week for 3 to 5 weeks. We aim to find out whether or not the benefit of benefits are the same
      then it would mean that the course could routinely be offered to patients in either format,
      thus allowing more patient choice and flexibility.
    

Detailed description: 
      The DAFNE (Dose Adjustment for Normal Eating) course is a 1-week structured education course
      teaching skills in insulin use and dietary freedom to individuals with Type 1 diabetes. At
      the moment, we do not understand enough about why some people get more out of the DAFNE
      programmes than others. Currently DAFNE is always taught over 1 week. We aim to find out
      whether or not the benefit of DAFNE is the same whether it is delivered over 5 consecutive
      days, or one day a week for 5 consecutive weeks. If the benefits are the same then it would
      mean that the course could routinely be offered to patients in either format, thus allowing
      more patient choice and flexibility. At present there have been no RCTs to address

      Approximately 170 people will take part in this study over the next 2 years. Half the people
      who participate will be allocated to attend a DAFNE course over 5 consecutive days, and the
      other halfwill attend one day a week for 5 consecutive weeks. We will perform routine
      biomedical assessments as part of the DAFNE programme and normal diabetes care (e.g. HbA1c (a
      measure of long-term blood glucose control), weight, blood pressure, blood biochemistry), and
      ask patients to recall hypoglycaemic (low blood sugar) events. We will also ask participants
      to fill in some research questionnaires, they will take 45-60 minutes to fill in each time.
      They will include questions about their diabetes, quality of life, well-being and diabetes
      knowledge. These assessments will be made at 3 time points; baseline, 6 and 12 months.

      The main outcome measure is change in HbA1c, with the other biomedical and psychosocial
      parameters being of secondary importance. These evaluations will help us develop the DAFNE
      programme further and inform us how best to deliver the course in the future.
    

Intervention name(s): DAFNE course (Timing of delivery of education)
Intervention type(s): Other
Intervention description(s): Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TCM Differentiation and Treatment Protocol of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu
      Province based on the historical prospective multicenter cohort study.
    

Detailed description: 
      This is a multi-center cross-sectional syndrome investigation study, taking confirmed cases
      as the main observation object, A prospective multicenter cohort study was designed, focusing
      on the common type with the largest number of confirmed cases, to evaluate the intervention
      effect of this project in relieving the disEvaluation of the efficacy and safety of TCM
      differential treatment of COVID-19 inease and preventing disease progressio.

      According to the actual situation of receiving treatment, if the subjects received the
      combination of western medicine and traditional Chinese medicine, it was the exposure group
      (integrated traditional Chinese and western medicine cohort), and if the subjects only
      received western medicine treatment, it was the control group (western medicine cohort). The
      choice of treatment for patients is entirely determined by clinicians according to the
      patient's condition, and patients are free to choose after fully understanding different
      schemes).The choice of control group: COVID-19 (common type) who received routine treatment +
      antiviral therapy；The choice of exposure group: COVID-19 (common type) who received routine
      treatment + TCM.The sample size is tentatively set at 340.
    

Intervention name(s): TCM prescriptions
Intervention type(s): Drug
Intervention description(s): TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        It conforms to the diagnostic criteria of confirmed cases of COVID-19.
      
Keywords: COVID-19; Syndrome investigation; differentiation treatment; multicenter cohort study
Phase III Study Treatment of CLL B and C
Condition: Leukemia, Lymphocytic, Chronic
MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C
      Binet stages B-CLL and on an intent to treat basis two strategies. Conventional chemotherapy
      consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in
      case of response. Experimental arm consisted of high dose therapy with autologous CD34+
      purified progenitor cell support, used as consolidation of Complete Remission or Very Good
      Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses
      of fludarabine in case of insufficient response.
    

Detailed description: 
      The aim of the prospective randomized GOELAMS LLC 98 trial reported here was to compare two
      therapeutic strategies in previously untreated B and C Binet stages B-CLL patients less than
      60 years old. Conventional chemotherapy (Arm A) consisted of six monthly courses of CHOP,
      i.e. vincristin IV 1 mg/m2 on day 1, doxorubicin IV 25 mg/m2 on day 1, cyclophosphamide (Cy)
      300 mg/m2 and prednisone 40 mg/m2 both given orally from day 1 to day 5, followed by 6 CHOP
      courses every other 3 months in case of response. Fludarabine (25 mg/m2 /d IV for 5
      consecutive days) was used in case of non response (stable disease or progression) after 3
      CHOP courses. This conventional therapy was compared to high dose therapy with autologous
      CD34+ purified progenitor cell support (Arm B), used as consolidation of Complete Remission
      (CR) or Very Good Partial Response (VGPR, defined by >50 % tumoral response and bone marrow
      lymphocyte infiltration <30%) obtained after 3 monthly courses of CHOP. In the absence of CR
      or VGPR, 3 to 6 monthly-courses of fludarabine were performed before mobilization with Cy 4
      g/m2 + G-CSF administration. The conditioning regimen included TBI 12 Gy and Cy 60 mg /kg /d
      for 2 days.
    

Intervention name(s): Stem cells autograft
Intervention type(s): Procedure
Intervention description(s): Treatment by Intensive Chemotherapy and autograft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLL
Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis
Condition: Mild Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly
      adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty,
      sweet, sour, astringent, and bitter. It has also been shown to have various effects on the
      anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system,
      endocrine system, and stress protect. Therefore, this study is designed to evaluate the
      efficacy and safety on KO of Omija extract.
    

Detailed description: 
      In the present study, the investigators will assess the efficacy and safety of the
      formulation of Omija extract(1,200 mg administered twice a day) on the symptoms of knee
      osteoarthritis (KO) during a 12-week treatment course. In a randomized, double-blind
      placebo-controlled trial, subjects will be randomly assign to receive oral omija treatment
      group(n=30) or placebo group(n=30). The primary efficacy outcome measure will be score change
      in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) after 12-weeks.
      Secondary parameters will be included the Lysholm index score, hs-CRP, osteocalcin(OSC), and
      deoxypyridinoline(DPYR).
    

Intervention name(s): Omija extract.; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Omija extract 1.2g/day for 12weeks; Placebo 1.2g/day for 12weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Omija; knee osteoarthritis
Proximal Tibial Open Wedge Osteotomy. A Clinical Prospective, Randomized RSA-trial.
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high
      tibial osteotomy is a good choice of treatment for the young and active patient.

      However it leaves an open gap which has to be filled with a bone substitute and requires
      stable fixation.

      Hitherto the golden standard has been autograft taken from iliac crest but there are
      donorsite related problems and limited amount available.

      Recently injectable and resorbable calciumphosphate-cements have been introduced and used
      with promising results in fractures of the distal radius, calcaneus and lateral tibial
      condyle.

      These new cements seem to be a good alternative to other bone substitutes providing high
      initial strength that might promote early mobilisation; it resorbs and promotes
      osteoconduction securing safe healing.

      The aim of the present study is to evaluate whether there is any difference in clinical
      outcome, correction, stability and healing in open-wedge osteotomies with three different
      bone substitutes: Autograft from iliac crest and the injectable calciumphosphate-cement
      Calcibon and as control a group with an empty gap.

      Osteosynthesis is performed with the Dynafix® system (EBI) The investigation is performed as
      a randomised prospective clinical trial including 45 patients with a planned 2 years
      follow-up period.

      Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and
      Lysholm score.

      Routine standing x-rays is performed. Stability is assessed with Roentgen
      Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional
      measuring of eventual loss of correction.

      This combined with urine and serum bone-healing markers gives a very precise picture of the
      healing in the bone-gap.

      To asses the cartilage of the knee MRI is performed and biochemical markers fore Collagen
      type II degradation are measured.
    


Intervention name(s): bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)
Intervention type(s): Procedure
Intervention description(s): Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Osteotomy; Healing; Roentgen Stereometric Analysis