bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress
Condition: Physiological Stress
MeSH terms: Heat Stress Disorders
Study type: Interventional

Summary: 
      Israel ministry of defense is examining a new protective undergarment of GORE company
      (chempark fabric) for the police forces. The goal of this research is to perform a
      comparative experiment in order to evaluate the physiological strain induced by a BC
      protective undergarment under exercise-heat stress conditions.
    

Detailed description: 
      In order to physiologically evaluate a new BC protective garment for the Israeli police use
      under exercise-heat stress conditions, 10 young and healthy civilian volunteers will
      participate in this study.

      The subjects will undergo 5 experiment days: Recruitment day, one day of acclimatization to
      heat, and 3 days of performing experiment protocol, each day dressed with different
      protective garment (Protective garment in current use + NBC mask, new BC protective
      undergarment + standard combat uniforms, new BC protective undergarment + standard combat
      uniforms + NBC mask).

      Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid
      balance will be recorded.the physiological heat strain will be assessed and compared between
      the different protective garments.
    

Intervention name(s): exercise under hot and humid conditions protocol
Intervention type(s): Other
Intervention description(s): acclimatization day protocol: 2 hour effort performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (40 deg. centigrade & 40% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously
experiment days (3 days): 2 hour effort (2 cycles of: 50 min walk and 10 min rest-sitting) performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (30 deg. centigrade & 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia
Condition: Sleep Initiation and Maintenance Disorders; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Hot Flashes; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of estrogen replacement therapy in treating
      depression in menopausal women with hot flashes and insomnia.
    

Detailed description: 
      Estrogen is a hormone that plays an important part in the development of the female
      reproductive system. During menopause, estrogen levels drop significantly. The drop in
      estrogen may cause physiologic and psychological changes in women; common symptoms include
      hot flashes, sweating, insomnia, and irritability. In addition, approximately 10% of
      menopausal women experience depression. Estrogen replacement therapy (ERT) is often
      prescribed to alleviate these symptoms. It is not known, however, exactly how ERT treats
      depression. It may indirectly decrease depression by alleviating insomnia associated with hot
      flashes, or it may directly improve mood and decrease depression by altering chemicals in the
      brain. The purpose of this study is to gain insight into how ERT treats depression and to
      develop strategies to reduce depression in menopausal women. In turn, these findings may help
      categorize populations of women whose depression should be treated with ERT versus
      nonhormonal therapies.

      In this 9-week study, participants will be randomly assigned to receive ERT, a sleeping pill,
      or placebo. Study visits will occur at baseline and Weeks 2, 4, 6, and 9; at each study
      visit, blood pressure will be monitored, and standardized psychological tests and
      questionnaires will be used to assess the participant's level of depression and reported
      quality of life outcomes. Blood will be drawn at baseline and Week 9 to measure estrogen and
      follicle stimulating hormone levels.
    

Intervention name(s): Estrogen Replacement Therapy; Zolpidem; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 17-b-Estradiol Patch, .05 mg/day; applied for 7 days; 10 mg/day, po qhs; placebo
Other intervention name(s): Climara; Ambien
Intervention MeSH terms: Zolpidem; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Women; Menopause; Depression; Hot flash; Insomnia; Sleep Disruption; Estrogen Replacement Therapy
Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsies, Myoclonic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, crossover study of Ataluren for the treatment of nonsense mutation Dravet
      syndrome or cyclin-dependent kinase-like 5 (CDKL5) deficiency, resulting in drug-resistant
      epilepsy. Patients will receive 12 weeks of ataluren or placebo during each treatment period.
      Treatment Period 1 will be followed by a 4-week Washout Period. Based on ataluren PK and
      pharmacodynamic data, the 4-week washout period is deemed an appropriate length of time to
      eliminate any ataluren drug effects. Following the Washout Period, patients will crossover to
      receive the opposite treatment during Treatment Period 2 as follows: Patients receiving
      ataluren during Treatment Period 1 will receive placebo during Treatment Period 2. Patients
      receiving placebo during Treatment Period 1 will receive ataluren during Treatment Period 2.
    

Detailed description: 
      Investigators will try to characterize the safety profile of ataluren in patients with CDKL5
      or Dravet syndrome resulting from a nonsense mutation and evaluate changes in convulsive
      and/or drop seizure frequency from Baseline following ataluren treatment in patients with
      CDKL5 or Dravet syndrome resulting from a nonsense mutation. Investigators will measure
      changes in minor seizure types (absence, myoclonic, complex partial/focal dyscognitive)
      following ataluren treatment in patients with CDKL5 or Dravet syndrome resulting from a
      nonsense mutation and changes from Baseline in cognitive, motor, and behavioral function as
      well as QOL following ataluren treatment in patients with CDKL5 or Dravet syndrome resulting
      from a nonsense mutation.
    

Intervention name(s): ataluren; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder formulation; Powder formulation
Other intervention name(s): PTC124
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      A specifically formulated probiotic product comprised of defined and tested microbial strains
      may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it
      is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the
      potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM)
      as a dietary supplement product for patients undergoing dialysis along with standardized care
      of treatment.
    

Detailed description: 
      Probiotics are increasingly utilized clinically. As their safety and health benefits are
      established, it is reasonable to anticipate that probiotic bacteria will be incorporated into
      a growing number of clinical regimens, as a dietary supplement.

      Extensive in vitro R&D investigations in Kibow's laboratories

      Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus
      thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).

      Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat
      model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University,
      Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr)
      levels.

      Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of
      both genders and varying body weights) with moderate to severe kidney failure. Based on
      positive results, this formulation, marketed and distributed as AzodylTM, is currently
      licensed for veterinary applications to Vetoquinol USA.

      Pilot scale studies, double blind, placebo controlled, cross-over studies for six months
      conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN
      (P>95%) and improved quality of life (P>95%). Decrease in creatinine and uric acid levels
      were also observed. However, these studies were based on correlating the age of geriatric
      cats and dogs with moderate to significant kidney failure to human geriatric conditions.
    

Intervention name(s): Kibow Biotics
Intervention type(s): Dietary Supplement
Intervention description(s): 6 month, double-blind, cross-over, wash-out, placebo controlled study in an outpatient setting. Each patient takes two capsules, three times a day (180 CFU/day).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Out patient hospital setting
      
Biospecimen description: 
      Blood serum, plasma and lymphocytes.
    
Keywords: Probiotics; Kibow Biotics; Dialysis; Gut based uremic toxin removal
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
Condition: Breast Carcinoma; Cancer Survivor; Cognitive Side Effects of Cancer Therapy; Malignant Female Reproductive System Neoplasm
MeSH terms: Breast Neoplasms; Genital Neoplasms, Female
Study type: Interventional

Summary: 
      The purpose of this study is to examine thinking abilities, mood, and quality of life in
      cancer survivors before and after an 8-week group-based memory and thinking skills workshop.
      Research participants will include people treated for cancer in the past. Researchers would
      like to know if there is a relationship between baseline performance on timed attention and
      memory tasks before receiving memory and thinking skills workshop designed to improve
      cognition, and performance on such tasks after the workshop.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To objectively assess changes in cognitive performance and quality of life (QOL) pre and
      post participation in a cognitive rehabilitation intervention in gynecologic and breast
      cancer survivors who have undergone chemotherapy.

      II. To measure changes in neural function as measured by functional magnetic resonance
      imaging (fMRI) blood oxygenation level dependent (BOLD) signal and corresponding behavioral
      responses while performing cognitive tasks.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I (Skills workshop): Patients participate in a memory and thinking skills workshop once
      weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline
      (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).

      ARM II (Education workshop): Patients participate in education workshop for 7 weeks 1-hour
      duration group focusing on the brain and cognition. Patients complete cognitive tests and
      questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
    

Intervention name(s): Cognitive Intervention; Educational Intervention; Functional Magnetic Resonance Imaging; Memory Intervention; Quality-of-Life Assessment; Questionnaire Administration
Intervention type(s): Other; Other; Procedure; Other; Other; Other
Intervention description(s): Participate in memory and thinking skills workshop; Participate in workshops focusing on increasing knowledge and education on the brain and cognition; Undergo functional neuroimaging; Participate in memory and thinking skills workshop; Ancillary studies; Ancillary studies
Other intervention name(s): Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; fMRI; FUNCTIONAL MRI; Quality of Life Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Memory; Attention; Chemo-brain; Survivor; Treatment
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30
      mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing
      fexofenadine hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - aventis U.S. LLC,
      Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditions. To monitor
      adverse events and ensure the safety of subjects.
    

Detailed description: 
      An open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose,
      Crossover, Oral Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrating
      Tablets 30 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of Allegra ®
      (Containing Fexofenadine Hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi -
      Aventis U.S. LLC, Bridgewater, NJ 08807 in Healthy, Adult, Human Subjects Under Fasting
      Conditions.
    

Intervention name(s): Fexofenadine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
Other intervention name(s): ALLEGRA
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults
Condition: Metabolic Syndrome; Diabetes; Aging
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      Increasing physical activity in older adults has important implications for treating obesity
      related metabolic conditions, however the interaction of aging- and obesity-related declines
      in physical function may make adding structured exercise particularly challenging for this
      group. Given these challenges, an alternative prescription to traditional structured
      exercise, may be short bouts of intermittent walking scattered throughout the day - this may
      be an effective strategy to increase physical activity, reduce sedentary behavior, and
      improve glycemic control in overweight/obese older adults. The purpose of this project is to
      determine how interrupting sedentary time with short bouts of moderate intensity walking
      affects important metabolic outcomes in older, overweight adults. It would also be of
      interest to compare the effects of short, frequent interruptions in sedentary behavior to a
      traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes
      (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall aims
      of the proposed research are to 1) Determine the effect of performing short bouts of
      moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to
      uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects of
      interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m
      walk (CW)) on metabolism.

      The investigators hypothesize that interrupting sedentary time with intermittent walking will
      improve glucose and insulin metabolism compared to uninterrupted sitting and it will be as
      effective at improving metabolism as a single continuous 30 min walk.
    


Intervention name(s): US; IW; CW
Intervention type(s): Other; Other; Other
Intervention description(s): US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.; IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.; CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
Other intervention name(s): Uninterrupted sitting; Intermittent Walking; Continuous Walking
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sedentary behavior; physical activity; older adults
Strength Training and Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      People with stroke experience weakness and incoordination. Studies have shown that with
      functional task practice, people can increase motor control and strength to a certain extent.
      This study will investigate whether adding progressive resistance strength training to
      functional task practice modeled after Constraint-Induced Movement Therapy results in greater
      motor function gains than functional task practice alone
    

Detailed description: 
      To date most investigations of UE rehabilitation have examined single interventions. However,
      combining 2 efficacious interventions may enhance effectiveness. Both functional task
      training and strength training are beneficial for promoting improved upper extremity
      function, but they have seldom been studied as a coupled therapy. The research proposed in
      this project will examine the effect on UE function of adding UE resistive exercises to
      functional task training. Secondary aims are to examine the effect of stroke severity on the
      response to therapy, the interrelationship between therapy-induced neural changes and
      movement composition and functional changes with therapy, and test for retention of UE
      function gains over 6 months. Individuals with chronic hemiparesis from stroke will complete
      baseline testing and then be randomly assigned to either the functional task + strength
      training group or the functional task training alone group. Each group will train 4
      hours/day, 3 days/week for 4 weeks. Each will perform 3 hours of functional task training per
      session. The strengthening group will then complete 1 hour of UE progressive resistance
      exercises while the functional task training alone group will complete gravity eliminated
      range of motion exercises for 1 hour. All subjects will be post-tested and then complete
      follow-up testing 6 months later.
    

Intervention name(s): Constraint-Induced Movement Therapy + strength training; Constraint-Induced Movement Therapy + range of motion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises; Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for
Other intervention name(s): forced use, functional task practice, progressive resistive exercise; forced use, functional task practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; upper extremity; motor skills
Smoking Treatment and Anxiety Management Program
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The Smoking Treatment and Anxiety Management Program (STAMP) is a treatment program focused
      on helping people manage their anxiety while quitting smoking. The study involves coming in
      to our clinic for 4 treatment sessions, with follow-ups for up to 2 years (a week 1, week 2,
      month 1, month 3, month 6, year 1, and year 2 follow-up). Participants will be paid $142.50
      for their full participation as well as receive 6 weeks of free nicotine replacement patches.
    


Intervention name(s): Cognitive Behavioral Therapy for smoking cessation; Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Includes anxiety sensitivity (AS) psychoeducation and interoceptive exposure exercises in addition to regular smoking cognitive behavioral therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy; Smoking Cessation
Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
Condition: Chronic Cerebral Ischemia
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia; Cognitive Dysfunction; Cognition Disorders
Study type: Observational

Summary: 
      An open-label, prospective, observational, multicenter study. The study enrolls adult
      outpatients with CCI from 8 federal districts of the Russian Federation.
    

Detailed description: 
      Medical data (demographic and clinical characteristics - diagnosis, MoCA test results) are
      collected from patients to whom Divaza is prescribed to be taken according to the following
      regimen: 2 tablets 3 times per day for 12 weeks.

      Neurologists assess the patients' cognitive functions with MoCA scale before starting therapy
      with Divaza (visit 1) and 12 weeks after the treatment (visit 2).

      The efficacy of Divaza for the treatment of cognitive impairment in patients with chronic
      cerebral ischemia (CCI) is evaluated.

      Safety is assessed based on the frequency and severity of adverse events. In addition, the
      relationship between MoCA test performance and gender or regional social and economic factors
      is evaluated.
    

Intervention name(s): Divaza
Intervention type(s): Drug
Intervention description(s): Oral administration.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult CCI outpatients with cognitive impairment (MoCA score <26) or without one (MoCA score
        ≥ 26) recieving unchanged basic therapy of CCI and underlying vascular disease for a 3
        month previous to the onset of the study. Diagnosis of сhronic cerebral ischemia (CCI) was
        based on the clinical history of underlying vascular disease(atherosclerosis and/or
        arterial hypertension) and neurological signs. Vascular nature of cognitive impairment in
        patients with MoCA<26 was determined according to NINDS-AIREN criteria.