bioihbjkbjnl/mcl2 huggingface dataset:
Post-Stroke Improvement of Motor Function
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label clinical study where all new patients presenting with cerebrovascular accidents
      and consenting to treatment are given intravenously a new combination of medications.
      Patients are evaluated neurologically with NIHSS scores before treatment administration and
      at 1 month after the first treatment. Further evaluations at 6 months after treatment by
      NIHSS and Barthel scores are ongoing
    

Detailed description: 
      Patients with cerebrovascular accidents (CVA), ischemic (including those with hemorrhagic
      transformation), are given a new combination of medications which aims to improve neuronal
      survival, stimulate mitochondrial genesis and the formation of new synapses. This combination
      is given as an intravenous perfusion with a 2-hr duration and consists of vitamins B1, B6,
      B12, C, Actovegin, etc.

      Before treatment a NIHSS score is given. Each patient receives 3-4 such perfusions in 1 month
      and afterwards another NIHSS score is obtained.

      Patients are monitored afterwards and those who show improvements receive more such
      treatments, and new NIHSS and Barthel scores are obtained.

      Patients are grouped on the basis of the time interval between CVA occurence and first
      treatment:

        -  Group 1: 0-35 days

        -  Group 2: 36-100 days

        -  Group 3: 101-360 days Improvement of motor function is compared using NIHSS scores
           between groups, and between literature and groups
    

Intervention name(s): Perfusion with New Combination Medication
Intervention type(s): Combination Product
Intervention description(s): Intravenous administration of Actovegin, vitamins B1, B6, B12, C, oxytocin/dexamethasone, calcium gluconate, etc in 250 ml normal saline administered during approximately 2 hours
Intervention model: Single Group Assignment
Intervention model description: The new combination treatment is given to all consecutive patients and compared to literature and between groups (based on the time lapsed between CVA and treatment)
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
Condition: Haemophilus Influenzae Type b
MeSH terms: Influenza, Human; Haemophilus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate safety and reactogenicity of a monovalent conjugated vaccine
      against Haemophilus influenzae type b in healthy children
    


Intervention name(s): Haemophilus influenzae type b
Intervention type(s): Biological
Intervention description(s): 1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; prevention; haemophilus influenzae type b; children
EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)
Condition: Obese
MeSH terms: Obesity
Study type: Observational

Summary: 
      EARLY-MYO-OBESITY-CMR is a prospective, three-center, cardiac imaging study to investigate
      cardiac morphology, function, and tissue phenotypes in a cohort of non-diabetic obese adults,
      and compare with metabolically healthy non-obese controls.
    

Detailed description: 
      1. Transthoracic echocardiography was performed to analyze the LV morphology and function.

        2. CMR was performed within 24 hours of the echocardiographic examination to assess the
           cardiac morphology , cardiac function, and myocardial tissue characteristics. Standard
           cine images were acquired to quantify LV function and volume. T1 mapping-derived ECV
           values were used to detect subtle diffuse fibrosis , and late gadolinium-enhanced (LGE)
           imaging was used to identify focal fibrosis. Native T2 values were obtained to quantify
           myocardial edema . Global longitudinal peak systolic strain (GLS) and e' SR were
           assessed by tissue tracking analysis to detect subclinical systolic and diastolic
           dysfunction.
    

Intervention name(s): cardiac magnetic resonance(CMR)
Intervention type(s): Diagnostic Test
Intervention description(s): CMR was performed to assess myocardial tissue characteristics in the study population
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult obese participants without cardiac symptoms or known cardiac disease
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
Condition: Preterm Premature Rupture of Membrane
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot randomized controlled trial to assess the pharmacokinetics and
      pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature
      rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either
      1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition
      to standard care.
    

Detailed description: 
      This is a pilot randomized controlled trial to assess the pharmacokinetics and
      pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature
      rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either
      1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition
      to standard care. During the course of eight days participants will have serial collection of
      amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After
      delivery, neonatal respiratory samples will be collected as well.
    

Intervention name(s): Azithromycin 500 mg; Azithromycin Oral Product
Intervention type(s): Drug; Drug
Intervention description(s): 500mg azithromycin PO for seven days starting on admission; 1000mg azithromycin PO once at admission
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar
Condition: Smoking
Study type: Observational

Summary: 
      The purpose of this study is to learn about the effects of smoking shisha on the lungs, when
      compared to the effects of smoking cigarettes or of not smoking. The investigators hope to
      learn more about how shisha smokers should be monitored and treated once diseased.
    

Detailed description: 
      Traditional shisha smoking is practiced by ~10% of the Qatari adult population. Although
      based on tobacco leaves, shisha smoking exposes the airway epithelium to a chemical insult of
      intensity and duration different from that of cigarette smoking. This study, a collaboration
      between WCMC-Qatar and WCMC-New York and the Hamad Medical Corporation (HMC), is focused on
      defining the biology of the airway epithelium of shisha smokers compared to non-smokers.
      Using approved protocols, bronchoscopy will be used to sample the airway epithelium, the site
      of the earliest changes associated with smoking. The transcriptome of the recovered
      epithelium will be assessed in the genomic core WCMC-Qatar for gene expression using
      microarrays and complete RNA sequencing using massive parallel sequencing.Based on this
      information, the epithelial DNA will be assessed for relevant SNPs, copy number variations
      and methylation status. Parallel studies will be carried out in cigarette smokers, providing
      a comprehensive catalog of shisha smoking-induced changes compared to cigarette smokers and
      non-smokers in this population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects will be recruited in the pulmonary and smoking cessation clinics of HMC.
      
Biospecimen description: 
      Blood
Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
Condition: Endometrial Carcinoma; Cervix Cancer; Carcinoma of the Uterus
MeSH terms: Carcinoma; Endometrial Neoplasms; Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to investigate the effect of certain variables such as the
      fullness of the patients bladder and the position of the treatment applicator on the dose of
      radiation that other organs such as the bladder and the rectum receive during radiation
      treatment for endometrial carcinoma.
    

Detailed description: 
      -  This study is separated into 2 phases. In phase 1, patients will be asked to have their
           bladder full for the second planned insertion of the brachytherapy applicator and empty
           for the third insertion. For phase 2, the effect of cylinder angle on normal tissue
           dosimetry will be investigated. Of the two bladder states assessed in phase 1 (empty or
           full), the one deemed to give the lower dose to the total amount of bladder tissue will
           be considered the standard and applied to all patients in phase 2.

        -  In phase 1, to standardize bladder filling, patients will be asked to empty their
           bladder, then to drink 32 oz of water one and a half hours before the CT scan. The
           patient will undergo a treatment-planning scan after the brachytherapy cylinder is
           inserted and before brachytherapy treatment.

        -  In phase 2, patients will be asked to fill or empty their bladder according to the
           results of phase 1. The vaginal cylinder will be placed horizontally for the second
           treatment. The cylinder will then be angled at a specific angle for the subsequent
           treatment.

        -  A history and physical exam will be performed within 2 weeks of study entry, then at 14
           days, 90 days, and 180 days following the completion of therapy.
    

Intervention name(s): Radiation therapy
Intervention type(s): Procedure
Intervention description(s): Given as standard therapy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff
        recurrence or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal
        cancer stage I that will be undergoing radiation therapy.
      
Keywords: dosimetric analysis; vaginal cuff brachytherapy
Telmisartan-Induced Reduction in Intra-Myocellular Lipids Trial
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether telmisartan and/or a low-glycemic index
      diet are effective in reducing intra-myocellular lipid (muscle fat) content.
    

Detailed description: 
      The metabolic syndrome currently affects over 20% of the adult population in Canada. Patients
      with abdominal obesity are at markedly increased risk for diabetes and heart disease. Recent
      studies have shown that decreased sensitivity to insulin (insulin resistance), a hallmark of
      the metabolic syndrome, is related to increased storage of fat in muscle cells (muscle fat).
      Several recent studies indicate that blocking the renin-angiotensin system (RAS) may improve
      insulin sensitivity and prevent the development of type 2 diabetes. Other data suggests that
      this effect may be due to the effect of RAS blockade on the recruitment and growth of adipose
      tissue. The primary aim of this study is therefore to explore the role of angiotensin II in
      the development of insulin resistance. Specifically, we will examine the mechanisms
      underlying the putative anti-diabetic effect of RAS blockade by examining the effect of
      angiotensin receptor blockade on muscle fat content in individuals with the abdominal
      obesity. This study will therefore test the hypothesis that treatment with the angiotensin
      receptor blocker telmisartan (Micardis®) will reduce muscle fat, thereby improving insulin
      sensitivity in people with abdominal obesity, with or without additional features of the
      metabolic syndrome. A number of dietary factors can also affect insulin sensitivity and may
      influence muscle fat. Recent studies suggest that increasing the content of low-glycemic
      foods (carbohydrates which are less easily digested), can improve insulin sensitivity and
      lipid profile in patients with insulin resistance. A second aim of this study is therefore to
      test the hypothesis that a low-glycemic diet will reduce muscle fat, thereby improving
      insulin sensitivity in this population.
    

Intervention name(s): Telmisartan (Micardis®) vs. Placebo; Low-Glycemic Index Diet vs. Control Diet
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: insulin resistance, myocellular lipids, adipose tissue
Simultaneous Measurement of Electroencephalography (EEG) and Functional Magnetic Resonance Imaging (fMRI) in Patients With Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      Investigation of inpatients with alcoholism after detoxification with simultaneous
      Electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI).
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with alcohol use disorder
      
Keywords: Patients with alcoholism according to ICD-10 after detoxification
Pharmacokinetics of Lamivudine at Two Different Doses
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to measure the pharmacokinetics (how a drug is absorbed,
      distributed and eliminated from the body) of lamivudine (3TC) and its active component after
      3TC is given at two different doses, 300mg and 150mg once daily.
    

Detailed description: 
      Lamivudine (3TC) has been approved by regulatory authorities for the treatment of HIV
      infection and the current licensed dose is 300 mg once daily. Clinical and pharmacokinetic
      (how a drug is absorbed, distributed and eliminated from your body) data suggest that the
      licensing dose could be reduced without compromising effectiveness. Lower drug doses could
      reduce the side-effects from the medication and would make 3TC more affordable.

      This study will compare the pharmacokinetics, safety and tolerability of two different doses
      of 3TC in healthy volunteers. The study will take place at Chelsea and Westminster Hospital.
      Twenty four healthy HIV negative volunteers will be randomly allocated into two groups.
      Volunteers in Group 1 will start 300mg 3TC once daily for 10 days, followed by 10 days of not
      taking any 3TC (wash-out period). When the wash-out period ends, they will re-start 3TC at a
      dose of 150mg once daily for 10 days. Group 2 is similar except that they will start 150mg
      3TC at the beginning of the study and 300mg 3TC after the wash-out period. Blood samples will
      be taken over a 24-hour period at the end of each dosing phase to measure the levels of 3TC
      in the blood and inside blood cells. Safety and tolerability of 3TC will be assessed by
      questions, physical examination and laboratory parameters. These will be performed at regular
      intervals during the treatment phases.

      Healthy participants as determined by their medical history and physical examination will be
      eligible to participate in the study. HIV-positive participants will not be recruited because
      it is not yet clear if an experimentally reduced dose of 3TC will successfully treat
      HIV-infection. There is no reason to presume that there is any meaningful difference in the
      metabolic processing of 3TC between HIV-infected and HIV-uninfected people.
    

Intervention name(s): Lamivudine (3TC)
Intervention type(s): Drug
Intervention description(s): 3TC 300mg/150mg participants will receive 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days.
3TC 150mg/300mg participants will receive 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days.
Other intervention name(s): Epivir
Intervention MeSH terms: Lamivudine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; HAART; ART; Pharmacokinetic; Healthy volunteers; 3TC; Lamivudine
A Study of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
Condition: Vitamin D Deficiency; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Vitamin D Deficiency
Study type: Observational

Summary: 
      Hypothesis:

      25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than
      those in HD patients with itching

      25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and
      compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of
      patients complaining of itching.
    

Detailed description: 
      25-hydroxy vitamin D levels from non-itching HD patients in this study will be compared to
      25-hydroxy vitamin D levels from our ongoing study in HD patients with itching. The primary
      endpoints for both studies are continuous variables. Student's t test will be used to test
      for statistical significance. Multiple regression analysis will be used for controlling
      covariates and testing the interaction among covariates.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ESRD patients on hemodialysis
      
Keywords: Pruritis in hemodialysis patients; 25-Vitamin D in chronic kidney disease
To Evaluate the Safety, Tolerability, and Pharmacokinetics Profile in Healthy Chinese Volunteers of TG-2349
Condition: Healthy Chinese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers.
    

Detailed description: 
      This study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile in
      healthy Chinese volunteers with single or multiple ascending oral doses of TG-2349
      (Furaprevir capsule). The study is separated into two parts, part A and part B.

      Part A：To evaluate the safety, tolerability, and PK profile of single ascending oral dose
      (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 in healthy Chinese volunteers.

      Part B：To evaluate the safety, tolerability, and PK profile of multiple ascending oral doses
      (200 mg, 400 mg, and 600 mg) of TG-2349 for five days in healthy Chinese volunteers.
    

Intervention name(s): Furaprevir capsule (SAD); Furaprevir capsule (MAD); Placebo (SAD); Placebo (MAD)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): There are four doses in this part, 100 mg, 200 mg, 400 mg, and 600 mg. Each subject will receive the sample once by oral administration.; There are three doses in this part, 200 mg, 400 mg, and 600 mg. Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.; Each subject will receive the sample once by oral administration.; Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.
Other intervention name(s): TG-2349 (SAD); TG-2349 (MAD)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: safety; tolerability; PK; single ascending oral dose; multiple ascending oral doses
Dietary Effects on Weight Loss and Lipid Profile in Sedentary Women
Condition: Obesity; Overweight; Life Style
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Negative-calorie diet is among the popular dieting guides for weight loss; however, there is
      still little knowledge about this method. The present study aimed to determine the effects of
      negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with
      low-calorie diet.
    


Intervention name(s): NCD; LCD
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): negative calorie diet; low calorie diet
Other intervention name(s): group I; group II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Caloric Restriction; Diet; Obesity; Overweight; Sedentary Lifestyle; Weight loss; Women
Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome
Condition: Complex Regional Pain Syndromes
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      This study examines the prevalence of trigger points in muscles in the thorax in upper limb
      Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we
      will examine if adding treatment to muscles in the thoracic area (to the regular physical
      therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.
    

Detailed description: 
      This study examines the prevalence of trigger points in muscles in the thorax in upper limb
      Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. The muscles
      that will be examined are: Subclavius, Pectoralis minor, Rhomboids, Infraspinatus and
      Serratus superior posterior.

      In addition, we will examine if adding treatment to muscles in the thoracic area (to the
      regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb
      in CRPS patients.This will be examined in an A-B-A design: at first the patients will be
      examined. Then they will recieve conventional physiotherapy treatment for a month. After a
      month, they will be examined again, and then they will recieve soft tissue massage to the
      thoracic area for 15 minutes in addition to the conventional physiotherapy treatment. After a
      month of the combined treatment, the patients will be examined a third and final time.
    

Intervention name(s): massage
Intervention type(s): Diagnostic Test
Intervention description(s): a 15 minutes thoracic massage will be added to the regular physical therapy treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The observation stage is a case- control study, the treatment stage is an A-B-A design.
Masking: None (Open Label)
Primary purpose: Treatment