bioihbjkbjnl/mcl2 huggingface dataset:
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The
      Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To
      Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum
      Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo
    

Detailed description: 
      This is a six-week, randomized, double blind, multi-center, parallel group Extension to the
      BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who
      were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high
      dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after
      experiencing an acute exacerbation of schizophrenia. Patients who completed the 6 week
      treatment period and/or all efficacy assessments in Study BL-1020 IIb are eligible to
      continue double-blind treatment in this optional 6 week Extension Study. Approximately 220
      patients will be enrolled in this study: Treatment Group IE (n=82, 10 mg/day BL-1020);
      Treatment Group IIE (n=82: target dose 30 mg/day BL-1020); Treatment Group IIIE (n=55; target
      dose 8 mg/day risperidone). Study drug (BL-1020 or risperidone) will be administered orally,
      once daily, in a doubleblinded manner, during this six-week Extension Study
    

Intervention name(s): BL-1020; BL-1020 10-30 mg; risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg; BL-1020 10-30 mg; risperidone
Other intervention name(s): BL-1020 High Dose
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
A Meditation Intervention on Subconcussive Head Impacts
Condition: Head Injury Trauma
MeSH terms: Craniocerebral Trauma
Study type: Interventional

Summary: 
      The purpose of this research is to explore potential methods of rehabilitating changes
      observed from repetitive head impacts. Participation in this study will involve functional
      magnetic resonance (fMRI) imaging, aerobic testing, heart rate variability (HRV) wrist
      monitor, hypercapnia challenge, a meditation rehabilitation intervention, and filling out
      survey information concerning subjective well-being.
    

Detailed description: 
      COLLEGE ATHLETES:

      At each study visit, participants will undergo an fMRI-cerebrovascular reactivity (CVR)
      challenge scanning session as well as an aerobic exercise test on a stationary bike. During
      the CVR-fMRI scan, the participant will wear a mask that will deliver a blend of oxygen and
      nitrogen at varying amounts while lying in an MRI scanner. During the aerobic stationary bike
      assessment, the participant will pedal at a steady state against applied resistance for 10
      minutes while wearing an ECG heart rate monitor to observe heart rate. A Biostrap heart rate
      variability (HRV) wrist monitor will be provided which will be worn daily. The data from the
      monitor, concerning HRV and sleep, will be collected. The participant will answer a brief
      survey concerning the previous night's sleep. After the conclusion of the sport's season,
      there will be a follow up scanning session. After the post-season scan, the participant will
      participate in a breath work meditation intervention over the following two months, twice a
      week for a 30 minute meditation session.

      HIGH SCHOOL ATHLETES:

      Participants will be given a Biostrap HRV monitor which will be worn daily. The data from the
      monitor, concerning HRV and sleep, will be collected. The participant will answer a brief
      survey concerning the previous night's sleep. High school athletes will be randomized into
      one of two study groups, the control group or the intervention group. The intervention group
      will receive guided meditation over 2 months (twice a week for 30 mins each session), and
      will ride a stationary bike at 3 time points. The control group will proceed about their
      lives normally.
    

Intervention name(s): Guided Meditation
Intervention type(s): Behavioral
Intervention description(s): Participants will meditate in response to the guidance provided by a trained meditation coach in person.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SUB-CONCUSSIVE HEAD IMPACTS; MEDITATION; adolescent athletes; young adult athletes
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and
      immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris
    


Intervention name(s): CTLA4Ig / Abatacept
Intervention type(s): Drug
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine safety, efficacy and tolerability of various doses
      of ITCA 650 in subjects with type 2 diabetes.
    


Intervention name(s): ITCA 650; Exenatide Injection; Ex Inj/ITCA 650
Intervention type(s): Other; Drug; Other
Intervention description(s): ITCA 650 (continuous delivery of exenatide in DUROS); twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks; twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
Other intervention name(s): Byetta; Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acupuncture for Relieving Perimenopausal Symptoms
Condition: Perimenopause
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether acupuncture is effective for relieving
      perimenopausal symptoms.
    

Detailed description: 
      -  A randomised controlled trial with superiority design

        -  A total of 220 participants will be included in 3 centers

        -  2 arms: acupuncture group and Climen® group
    

Intervention name(s): Acupuncture; Climen 21 Tablets
Intervention type(s): Other; Drug
Intervention description(s): Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world.; Climen Tablets are commonly used for menopausal symptoms
Other intervention name(s): Climen Tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: perimenopause; hot flash; palpitation
Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious
      than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized,
      double-blinded, placebo controlled trial
    

Detailed description: 
      Data collection

        1. Baseline characteristics

             -  demographic data; age, gender, BW, height

             -  cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV,
                ascites, hepatic encephalopathy, SBP etc.

             -  comorbidity such as DM, CVA

        2. After randomization

             -  assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy
                index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG
                at day 1,7

             -  blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at
                Day 1,3,7

             -  record adverse effect of drug such as nausea, vomiting, bloating.

             -  record diet, frequency of bowel movement and stool pH

             -  compliance
    

Intervention name(s): L-ornithine-L-aspartate and lactulose; placebo and lactulose
Intervention type(s): Drug; Drug
Intervention description(s): L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days; placebo 3 times a day for 7 days
Intervention MeSH terms: Lactulose; N-Methylaspartate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: L ornithine L aspartate; Lactulose; Hepatic encephalopathy; LOLA
Trial of Aerobic Exercise Training in Stroke Survivors
Condition: Stroke; Insulin Resistance; Sedentary Lifestyle
MeSH terms: Stroke; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of treadmill training on inflammation in
      the skeletal muscle and adipose tissue, insulin action in the skeletal muscle, and whole body
      glucose metabolism in stroke survivors. The fundamental hypothesis of this study is that key
      inflammatory markers in adipose tissue and skeletal muscle are abnormal, skeletal muscle
      insulin signaling is impaired, and systemic insulin sensitivity is reduced in hemiparetic
      stroke patients and that these factors are modifiable and improved by exercise training in
      stroke patients.
    

Detailed description: 
      Many stroke survivors are sedentary and are at risk for the development of diabetes. We will
      study the interactions of adipose tissue and the paretic and non-paretic muscle inflammation,
      insulin signaling and action in hemiparetic stroke patients and the ability to employ
      exercise training to reverse these abnormalities in this ethnically diverse population.
      Participants aged 40-75 years with chronic stroke will be randomized to treadmill training
      versus stretch control group using a one-two-one blocked randomization on race (black vs.
      white), sex (male vs. female), and glucose tolerance status (normal vs. impaired and type 2
      diabetes).

      Stroke occurs in over 780,000 persons each year in the U.S., the vast majority reported in
      persons older than 55 years of age. Following stroke, patients remain at continued high risk
      for recurrent stroke. Inflammatory processes lead to cardiovascular events/stroke and
      contribute to disease risk progression by impacting insulin resistance and the development of
      type 2 diabetes. Interventions that reduce inflammation and improve insulin sensitivity have
      important clinical implications, especially in the stroke population.

      Task-oriented treadmill training is utilized to improve cardiovascular fitness and functional
      mobility in hemiparetic stroke patients. Additionally, preliminary data indicates that
      progressive treadmill training in this population improves glucose tolerance.
    

Intervention name(s): Aerobic Exercise; Stretching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treadmill training- begins at 15 minutes total duration at 40-50% maximal heart rate reserve 3 times per week, increasing to 60-70% maximal heart rate reserve for 45-60 minutes for 6 months; Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Inflammation; Insulin Sensitivity
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure
      and in healthy volunteers will be after two single shot applications.
    

Detailed description: 
      Two single shot applications of i.v. sodium thiosulfate will be given to dialysis patients.
      One application will be given immediately before a dialysis session and the second dose will
      be given after the consecutive dialysis session.

      In healthy volunteers sodium thiosulfate will be given only once. In both groups, dialysis
      patients and healthy volunteers, blood and urinary/dialysate samples will be collected at
      defined time points.
    

Intervention name(s): Sodium thiosulfate
Intervention type(s): Drug
Intervention description(s): 6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
Other intervention name(s): Na2S2O3
Intervention MeSH terms: Sodium thiosulfate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal failure; sodium Thiosulfate; pharmakokinetic
Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective in this pilot study is to explore if asthma patients prescribed fixed
      dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®),
      beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge
      test and the following reversibility test.

      The primary endpoint is to identify asthma patients responding positive or negative to the
      mannitol challenge test and/or the reversibility test.

      The hypothesis is that not all patients are well treated.
    


Intervention name(s): Mannitol challenge test & reversibility test
Intervention type(s): Drug
Intervention description(s): Patients perform an asthma control test (ACT) to establish if they are "well controlled" or "symptomatic". All patients will perform then perform the mannitol challenge test. Aridol™ is an indirect osmotic bronchial challenge test which can be used to identify bronchial hyperresponsiveness
Intervention MeSH terms: Mannitol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; mannitol challenge test; Sweden; primary care
Pentoxifylline for Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive
      destruction of small bile ducts within the liver that can lead to end stage liver disease and
      all its complications.

      Although ursodeoxycholic acid (UDCA) is associated with increased survival in many patients
      with PBC, there is absence of an adequate response to UDCA in a significant proportion of PBC
      patients.

      Tumor necrosis factor alpha (TNF-alpha) is a cytokine that plays an important role in the
      pathogenesis of PBC. Other fibrosis biomarkers such as tissue metallo proteinase 1 (TIMP-1)
      are associated with progression of liver fibrosis in PBC. Pentoxifylline (PTX) is a
      methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown
      anti-fibrotic effects in serum of patients with PBC. Furthermore, PTX has well known clinical
      and safety profiles. The main hypothesis of this study is that therapy with pentoxifylline
      (PTX) will result in improvement of liver disease in PBC patients who are incomplete
      responders to UDCA.

      The focus of this proposal is on the effectiveness of PTX in improving laboratory parameters
      of liver disease and levels of cytokines involved in the pathogenesis of the disease in
      patients with PBC.
    


Intervention name(s): Pentoxifylline
Intervention type(s): Drug
Intervention description(s): Patients will take 400mg of pentoxifylline three times daily for a total duration of 6 months.
Intervention MeSH terms: Pentoxifylline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biliary cirrhosis
Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes
Condition: Obesity; Overweight; Blood Pressure; Hypercholesteremia; Diabetes
MeSH terms: Obesity; Overweight; Hypercholesterolemia
Study type: Interventional

Summary: 
      In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines
      on cardiovascular health and risk reduction in children; among these guidelines were
      screening recommendations for obesity and obesity-related conditions. Following publication
      of this report there was a call for caution and for increased patient (parent, child) input
      on implementing these guidelines. There are limited current studies evaluating
      patient-centered outcomes (PCO) in the well-child setting, however, given the childhood
      obesity epidemic, there is a clear need for such an evaluation. The city of Detroit, MI ranks
      first among 22 cities with data for the prevalence of overweight and obese youth (39.7%),
      making Henry Ford Health System, which is located in Detroit, MI, an ideal setting to study
      childhood obesity related research questions.
    

Detailed description: 
      Within this patient population, our specific aims therefore are to (1) examine current trends
      in screening and management of obesity and obesity-related conditions in a real-world urban
      practice setting; (2) examine the family (patient and parent/guardian) and clinician
      preferences for the identification and management of obesity and obesity-related conditions;
      and (3) design and conduct a Phase II pragmatic cluster randomized trial (PCRT) of an
      educational intervention in providers for guiding screening for obesity and obesity-related
      conditions during the well-child visit that incorporates and leverages PCO. Staff dedicated
      solely to this project will partner with the Henry Ford Health System's proposed
      Patient-Centered Outcomes Research Center's Cores staff members to design, execute and
      disseminate study results in order to affect clinical care. By seeking to understand the
      current screening patterns in pediatrics and by creating an education intervention for
      providers aimed at taking a patient/family centered approach to these preventative health
      screenings, we may increase PCOs which in turn may have meaningful implications for future
      adult health.
    

Intervention name(s): Motivational interviewing to elicit PCO in pediatrics
Intervention type(s): Behavioral
Intervention description(s): A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.
Other intervention name(s): Motivational Interviewing; Patient-Centered Outcomes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
How Virtual Reality is Impacting Balance: An Examination of Postural Stability
Condition: Healthy
Study type: Observational

Summary: 
      There are several studies examining the effects of different sensory stimuli on balance in
      healthy young people. Our study will especially explain how the same environment will affect
      postural control, when projected into VR environment. In this way, we aim to contribute to
      the literature and virtual reality programs used in rehabilitation.
    

Detailed description: 
      Thanks to the development of technology in recent years, virtual reality applications have
      started to be included in physiotherapy. Virtual reality is used in both clinical and
      academic studies for the purpose of training rather than evaluation. In the literature, it
      has been emphasized that traditional balance training does not have any superiority over
      virtual reality and virtual reality training can be used as a practical alternative in the
      long term (12,13). Furthermore, the feedback provided by virtual reality games is effective
      in the patient&#39;s participation in the treatment. Different visual stimuli created using
      virtual reality can affect postural control in different ways (14). In addition, there is no
      study comparing the effect of real image and virtual reality image on postural control by
      transferring the current environment to virtual reality. The aim of this study is to reflect
      the real environment to virtual reality; To explain how postural control is affected by eyes
      closed, eyes open and in virtual reality. Two hypotheses were determined in this study.

      H0: There is no significant difference between the real environment and three virtual
      environment on postural control in healhty subject.

      H1: There is a significant difference between the real environment and three virtual
      environment on postural control in healthy subject.
    

Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): No intervention will be applied to the participants. Postural stability will be evaluated in the virtual reality environment and real environment.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Voluntary heathy adults
      
Keywords: balance; postural control; virtual reality; visual