bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of
      NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will
      enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette
      Syndrome.
    


Intervention name(s): NBI-98854; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Correlation Between the Retrobulbar Hemodynamics and Intrarenal Hemodynamics in T2DM Patients During the Early Period
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Objective: The main target of this study was to research the early changes of retrobulbar and
      intrarenal hemodynamics, then to research the correlation between them in type 2 diabetes
      (T2DM) patients without diabetic kidney disease (DKD) and diabetic retinopathy (DR).

      Method: 35 T2DM patients (diabetes group) without vascular complications and 30 healthy
      people (control group) were recruited to research the early changes of renal function,
      retrobulbar and intrarenal hemodynamics, and then to research the correlation between them.
      The primary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral
      interlobular renal arteries were evaluated using Doppler Sonographic; the secondary endpoints
      were the retrobulbar hemodynamics RI in the bilateral central retinal artery (CRA), posterior
      ciliary artery (PCA), and arteria ophthalmica (OA) were evaluated using color doppler imaging
      (CDI); the tertiary endpoints were the biochemical endpoints: blood-fat (TC, HDL-C, LDL-C,
      and TG), FPG, 2hPG, HbA1c, and renal function parameters (BUN, Cr, and GFR); in addition, the
      albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.
    


Intervention name(s): Color doppler imaging
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators selected 45 T2DM patients (25 males, 20 females) without microangiopathy
        (DR and DKD) as diabetes group and 38 healthy people (21 males, 17 females) as control
        group from the diabetic outpatient clinic in Shenyang the Fourth Hospital of People, but
        only 34 patients (19 males, 15 females) in the diabetes group and 32 healthy people (17
        males, 15 females) can be researched in our study, all the participants were the Chinese
        Hans. All patients were provided a diet and exercise program by professional nutritionists.
Palatability (Energy I Pilot)
Condition: Energy Density
Study type: Interventional

Summary: 
      A pilot study was conducted to develop the study menus that were similar in appearance,
      aroma, and taste.
    

Detailed description: 
      The aim of the pilot study was to test for differences in palatability ratings of the four
      menus that will be administered during the ENERGY I project. During the pilot study,
      palatability ratings were collected for each meal (breakfast, lunch, and dinner) from four
      different menus that were served to participants during the main ENERGY I trial. The menus
      consist of three diets that vary in dietary fat and energy density: 1) high fat/high energy
      density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. In
      addition to these three menus, the menu from the baseline period of the trial will also be
      tested for palatability.
    

Intervention name(s): Breakfast (1-2 hours, in the morning); Lunch (1-2 Hours, at midday); Dinner (1-2 hours, in the afternoon)
Intervention type(s): Other; Other; Other
Intervention description(s): You will be required to taste small portions (1 to 2 bites) of 4 different breakfast meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy density is the ammount of enregy of kilocalories in one gram of the food.; You will be required to taste small portions of 4 different lunch meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy densityis the ammount of enregy of kilocalories in one gram of the food.; You will be required to taste small portions of 4 different dinner meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy densityis the ammount of enregy of kilocalories in one gram of the food.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Palatability; Taste
Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Children With Unilateral Cerebral Palsy
Condition: Cerebral Palsy, Spastic Hemiplegic
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This study evaluates the therapeutic effects of constraint-induced movement therapy (CIMT)
      with home-based hand-arm bimanual intensive therapy (H-HABIT) with unilateral cerebral palsy.
      Half of the participants will receive CIMT and H-HABIT and others will only receive CIMT.
    


Intervention name(s): CIMT; H-HABIT
Intervention type(s): Other; Other
Intervention description(s): CIMT : Constraint-Induced Movement Therapy (CIMT) is a deviation from traditional treatments, used to treat hemiplegia. Its aim is to stimulate the functional use of the affected limb and reverse the process developmental is disregard. In this method, the unaffected or less affected limb is restrained, so the person has to use the affected limb.; H-HABIT : Hand-Arm Bimanual Intensive Therapy (HABIT) in children with hemiplegia is a new intervention developed at Columbia University. HABIT aims to improve the use and coordination of both arms in daily function. Unlike CIMT, HABIT focuses on improving the ability to perform bimanual activities. Participants will be monitored via webcam-based software (i.e. ZOOM) while they performed the activities in their own home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Constraint-Induced Movement Therapy; Home-based Hand-arm Bimanual Intensive Therapy; Unilateral Cerebral Palsy
Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, pharmacokinetics and pharmacodynamics of TS-143 when administered
      3 times a day for 10 days to healthy Japanese adult males using placebo-controlled,
      double-blind, dose escalation study design.
    


Intervention name(s): TS-143; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2.; Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Homocysteine After Laparoscopic Roux-enY Gastric Bypass
Condition: Obesity, Morbid; Homocystine; Metabolic Disorder; Bariatric Surgery Candidate; Folate Deficiency; Vitamin B 12 Deficiency
MeSH terms: Obesity, Morbid; Metabolic Diseases; Vitamin B 12 Deficiency; Folic Acid Deficiency
Study type: Observational

Summary: 
      Changes in homocysteine values after bariatric surgery remain controversially discussed. This
      is the first comprehensive summary to depict timeline changes in homocysteine levels
      following laparoscopic roux-en-Y gastric bypass.
    

Detailed description: 
      Homocysteine is an independent risk factor for cardiovascular disease. Changes in
      homocysteine levels following bariatric surgery remain controversially discussed.

      708 consecutive patients underwent laparoscopic roux-en-Y gastric bypass over a 6 year
      period. Throughout their routine follow-up, demographic data as well as homocysteine, folate
      and vitamin B12 were retrospectively collected at the timepoints: preoperatively, at 3, 6, 9,
      12, 18, 24, 36, 48, 60, 72, 84, and 96 months postoperatively.

      In order to reveal clinical relevance of the results, patients were sent a special
      questionnaire accompanied by an informed consent form for participation and asked for
      cardiovascular disease events (myocardial infarction, stroke, deep venous thrombosis) or any
      other hospital stay after the surgery and cross checked with two region wide databases which
      account for approx. 80% of all hospital contacts in the region. Additionally, the database
      was networked with the statewide death registry in order to reveal deceased subjects and data
      about their demise through the beforementioned databases was collected.
    

Intervention name(s): laparoscopic long limb roux-en-Y gastric bypass
Intervention type(s): Procedure
Intervention description(s): standard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm)
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive patients eligible for bariatric surgery according to the american society
        of metabolic and bariatric surgery criteria.
      
Biospecimen description: 
      Collection of blood samples during routine pre- and postoperative visits.
    
Keywords: bariatric surgery; gastric bypass; homocysteine; folate; vitamin b12
Inflammatory Markers in Exhaled Breath (Condensate) in Childhood Asthma
Condition: Asthma; Healthy; Children
MeSH terms: Asthma
Study type: Observational

Summary: 
      Background:

      Exhaled nitric oxide and inflammatory biomarkers in exhaled breath condensate may be useful
      to diagnose and monitor childhood asthma. Their ability to indicate an asthma diagnosis, and
      to assess asthma severity and control, is largely unknown.

      Objective:

      To study 1) the ability of exhaled nitric oxide and inflammatory markers in exhaled breath
      condensate (nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis
      factor-α, interleukin-2,-4,-5,-10, acidity) to discriminate between childhood asthma and
      controls. 2) the ability of these biomarkers to indicate asthma severity and control.

      Methods:

      114 Children were included: 64 asthmatics (10.7±3.0 years, 67.2% atopic) and 50 controls
      (10.0±0.4 years). Condensate was collected using a glass condenser
    


Time perspective: Other
Keywords: inflammometry; exhaled breath condensate; fractional exhaled nitric oxide; asthma; children
Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
Condition: Healthy; Hypoxia
MeSH terms: Hypoxia
Study type: Interventional
Phase: Phase 3

Summary: 
      To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject
      population during motion over a specified saturation range.
    

Detailed description: 
      Use an investigational oximetry system to evaluate the triggering of the "sensor off" status
      with marketed, off-the-shelf sensors.
    

Intervention name(s): Arterial line; Motion
Intervention type(s): Device; Device
Intervention description(s): Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601; The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.
Other intervention name(s): CO-Oximeter SaO2 value
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Intestinal Dysmotility: Effect of Colonic Load
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Abnormal motility patterns in the jejunum can be detected in patients with prominent colonic
      distension, and it is not clear whether these abnormalities reflect a primary jejunal
      dysfunction or are due to a reflex distortion. The aim of the study is to determine the
      effect of colonic filling on jejunal postprandial motility using high-resolution manometry.

      Healthy subjects will be studied following a controlled, parallel, randomized, single-blind
      experimental design. On the study day, nutrients will be continuously infused in the proximal
      jejunum (2 Kcal/min) during a 2-h period to induce a steady-state postprandial motor pattern.
      Jejunal motility will be concomitantly recorded using a water-perfused, high-resolution
      manometry catheter. After 1 hour of postprandial recording (basal period), a gas mixture will
      be infused during 7.5 minutes via a rectal tube (720 mL or sham infusion), and jejunal
      motility will be recorded for another hour.
    


Intervention name(s): Colonic gas load; Sham load
Intervention type(s): Other; Other
Intervention description(s): Colonic infusion of gas via an anal cannula; Sham infusion of gas via an anal cannula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Oral Nitrite Synthesis and Post-exercise Hypotension
Condition: Blood Pressure; Sports Physical Therapy
MeSH terms: Post-Exercise Hypotension; Hypotension
Study type: Interventional

Summary: 
      Exercise is probably the most effective approach to reduce blood pressure. In fact, a single
      bout of exercise induces a physiological response known as Post-Exercise Hypotension (PEH)
      where a prolonged decrease in resting blood pressure occurs in the minutes and hours after
      exercise. However, it is not fully understood how this response triggers. Recent evidence
      suggests that oral bacteria may play a key role in blood pressure control by enhancing
      nitrite, and then nitric oxide (NO) bioavailability under resting conditions in humans.
      However, no previous study has investigated whether this is a key mechanism involve in PEH.
      Thus, the main aim of this study was to investigate if the oral nitrate/nitrite pathway is a
      key regulator of PEH and vasodilation in healthy humans.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Four sets of 7 minutes at 65% of VO2peak interspersed with 3 min of passive recovery
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
Condition: Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
Study type: Observational

Summary: 
      The purpose of the study to evaluate Five-Dimensional Ultrasound in automated measurement of
      the fetal femur length at third trimester of pregnancy.
    

Detailed description: 
      This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams
      University Maternity Hospital.

      Ninety pregnant women will be recruited from the the Fetal Care Unit who will fulfill the
      inclusion criteria. They will be counseled to be included into the study.

      All cases will be subjected to:

        1. Full history taking including patient's age, parity, last menstrual period, estimated
           gestational age by dates, past history of medical disorders, clinical examinations
           (General and abdominal).

        2. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases
           for assessment of fetal femur length .

      The FL at Two-Dimensional Ultrasound (Gold standard) will be made from the center of the 'U'
      shape at each end of the bone.

      The FL at Five-Dimensional Ultrasound will be measured by Pressing Five-Dimensional
      Ultrasound long bone Button to extract Fetal Long Bones automatically.

      The estimation of gestational age by femur length by Two-Dimensional Ultrasound and
      Five-Dimensional Ultrasound will be compared to gestational age calculated by accurate dates
      of the last menstrual period.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain
        Shams University Maternity Hospital.

        Ninety pregnant women will be recruited from the the Fetal Care Unit who will fulfill the
        inclusion criteria. They will be counseled to be included into the study.
Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the efficacy and safety of Anlotinib plus Icotinib as the first-line treatment in
      patients with sensitive EGFR mutations advanced non-small cell lung cancer.
    

Detailed description: 
      Anlotinib Hydrochloride is a kind of innovative medicines approved by State Food and Drug
      Administration（CFDA:2011L00661） which was developed by Jiangsu Chia-tai Tianqing
      Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with
      multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
    

Intervention name(s): Anlotinib Plus Icotinib
Intervention type(s): Drug
Intervention description(s): Anlotinib：12mg/capsule, take once when limosis in the morning. If patients suffer from AEs, they can get declined dosage (10mg or 8mg).
Icotinib：125 mg/tablet，three times a day，fasting or serving with food. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent.
Other intervention name(s): A+T
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sensitive EGFR mutations; anlotinib; icotinib; first line; cancer; non-squamous NSCLC
Functional Assessment of Ashwagandaha Root Extract During Weight Loss
Condition: Stress Reaction; Sleep Disturbance; Craving; Obesity
MeSH terms: Dyssomnias; Parasomnias; Weight Loss; Fractures, Stress
Study type: Interventional

Summary: 
      Patients who are involved in a clinical protocol driven 12 week medical weight loss
      intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root
      extract. The study endpoints are primarily the patients self-reported perception of life
      stress and sleep quality. The working hypothesis of this study is that the addition of
      aschwagandha to .the medical weight loss program will improve the self-reported perception of
      life stress and sleep quality
    

Detailed description: 
      During this 12-week medical weight loss program, the randomized patients will also have a
      baseline measurements and final measurements of blood for selected adipokines , cytokines,
      and telomerase measurements
    

Intervention name(s): Ashwagandha Root Extract Capsule; Placebo Capsule
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.; Participants will take one placebo capsule orally twice a day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: If the PSS score is than 20, those patients who are interested in participating are consented to the Ashwagandha study. The patients will then be randomized in a double-blind fashion to receive a 31 day supply of study capsules which will be either Ashwagandha 300mg twice a day or identical placebo capsules in a 1:1 ratio. They will be given careful directions into the use of the study capsules and will be asked to mark a daily log (See addendum #3: Treatment Log) of taking the capsules in the morning and at night.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional
Phase: Phase 2

Summary: 
      This study builds on data that high-density lipoprotein (HDL) has a number of potentially
      beneficial effects including directly modulating glucose metabolism through multiple
      mechanisms. The primary objective of this study is to determine the effects of RVX000222 on
      postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or
      impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test
      (OGTT).
    


Intervention name(s): RVX000222; Placebo, RVX000222
Intervention type(s): Drug; Drug
Intervention description(s): capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days; capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days
Other intervention name(s): RVX-208; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PROMES: A Clinical Study in Which Researchers Want to Learn More About the Safety Profile of MESIGYNA (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) Used as a Medication to Prevent Pregnancy for Adult Women in Reproductive Age in the Peruvian Population at the Outpatient Clinic.
Condition: Contraceptive
Study type: Observational

Summary: 
      Clinical study in which researchers want to learn more about the safety profile of MESIGYNA
      used as a medication in routine clinical practice to prevent pregnancy. In order to find this
      out researchers will collect historic and treatment related data during initial visit and
      follow-up visits of adult women in reproductive age in the Peruvian population at the
      outpatient clinic. Mesigyna is a combined injectable birth control medication (norethindrone
      ethanate (50 mg) and estradiol valerate (5 mg)) for women given monthly.
    


Intervention name(s): Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)
Intervention type(s): Drug
Intervention description(s): Follow clinical administration
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Norethindrone enanthate; Estradiol; Polyestradiol phosphate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who have been prescribed Mesigyna in Peru.