bioihbjkbjnl/mcl2 huggingface dataset:
Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
Condition: Chronic Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This
      clinical study is designed to test the hypothesis that lurasidone is effective, tolerable,
      and safe as compared with quetiapine XR long term among schizophrenic outpatients with
      chronic schizophrenia.
    


Intervention name(s): Lurasidone HC1; Quetiapine XR
Intervention type(s): Drug; Drug
Intervention description(s): Lurasidone 40-160 mg/day flexibly dosed.; Quetiapine XR 200-800 mg/day flexibly dosed.
Intervention MeSH terms: Quetiapine Fumarate; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; SM-13496; Latuda; Lurasidone
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
Condition: Postoperative Pain; Breast Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive
      surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new
      defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of
      this study is to compare the analgesic effect of ultrasound guided ESB with thoracic
      paravertebral block - the golden standard method for postoperative regional analgesia
      technique in breast surgery.
    


Intervention name(s): Intravenous morphine patient controlled device; Erector Spinae Plane Block; Thoracic Paravertebral Block
Intervention type(s): Device; Other; Other
Intervention description(s): 24 hour morphine consumption will be recorded; erector spinae plane block will be administered before the surgery; thoracic paravertebral block will be administered before the surgery
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: erector spinae plane block; thoracic paravertebral block; breast surgery; postoperative pain
Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background: Continuous subcutaneous insulin infusion (CSII) has been demonstrated to be an
      effective clinical tool for intensive insulin therapy in Type 1 diabetic patients. Type 2
      diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1)
      levels. Injection of GLP-1 receptor agonists are associated with improved glycemic control.
      Nevertheless, the clinical effects and mechanisms are still unclear when additional
      supplement of GLP-1 analogue in cooperation with intensive CSII treatment for poorly
      controlled Type 2 diabetes patients. This study is designed to understand the complementary
      pharmacological effects of GLP-1 analogue on intensive CSII treatment.

      Methods: Sixty poorly controlled Type 2 diabetes patients will be admitted to the ward for 6
      days CSII intensive treatment. Following the normalization of blood glucose at first 3 days,
      the patients are randomly assigned with combined therapy with exenatide injection or saline
      for another 3 days. The clinical assessments of insulin requirement, insulin secretion,
      insulin resistance glycemic excursions and cytokines will perform immediately during or after
      the study.
    

Detailed description: 
      In the poorly controlled type 2 DM, insulin therapy is the treatment of choice to make sugar
      on target. Actually, however, the general control rate is not good and partially due to the
      complex etiology in type 2 DM. GLP-1 deficiency is the mostly emphasized in modern practice.
      In order to study the effect of GLP-1 analogue in insulinized type 2 DM patients,
      investigators have to optimize the insulin therapy in the first priority. Continuous
      subcutaneous insulin infusion (CSII) or insulin pump is a viable choice for patients with
      type 1 or type 2 DM who want close-to-physiologic insulin treatment. By means of the insulin
      pump therapy, standardized sugar control profile in type 2 DM patients could be achieved in a
      short time. Investigators can further evaluate the clinical response under GLP-1 analogue or
      not.
    

Intervention name(s): Exenatide; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Exenatide 5 microgram bid sc.; Normal saline 2 u bid sc.
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GLP-1 analogue; CSII; insulin; type 2 diabetes mellitus
Japan Statin Treatment Against Recurrent Stroke (J-STARS)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      Although hyperlipidemia is not always the risk factor of stroke, inhibition of
      3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke
      in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol
      lowering should be expected to attenuate inflammation and atherosclerosis. The present study
      hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with
      safety.
    


Intervention name(s): Pravastatin
Intervention type(s): Drug
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stroke; brain ischemia; cerebrovascular accident; statin; hydroxymethylglutaryl-CoA reductase inhibitors; cholesterol; hypercholesterolemia; hyperlipidemia; multicenter studies; prospective studies; endpoint determination; randomized controlled trials; recurrence; pravastatin
Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients
Condition: Gastric Emptying; Mechanically Ventilation; Randomized Controlled Trial; Metoclopramide
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric
      emptying in critically ill mechanically ventilated patients .
    

Detailed description: 
      More than 50% of patients in ICU have gastric dysmotility, which leads to slow gastric
      emptying(GE) and high gastric residual volume (GRV) and is associated with increased
      mortality in these patients
    

Intervention name(s): Metoclopramide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cases will receive 10 mg intravenous metoclopramide every 6 hours.; Cases will receive the same volume of IV placebo / 6 hours.
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Deworming and Enhanced Vitamin A Every 6 Month in Rural Indian Children Aged 1-6
Condition: Village Children
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment
      of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or
      neither. The placebo group get no trial treatment at all and do not receive physical
      placebos.
    


Intervention name(s): Vitamin A; Albendazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin A; Albendazole
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells
      in patients with myocardial infarction.
    


Intervention name(s): Stem cell; Plasmalyte A
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of stem cells; IV infusion
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: mesenchymal stem cells; myocardial infarction
Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      This study aims to develop an effective, brief, family-based intervention targeting quality
      of life and school functioning for youth with sickle cell disease. Utilizing a randomized,
      delayed control group intervention methodology, the present study will systematically
      document the effectiveness of a family-based, one-day intervention plus booster phone calls
      to improve quality of life and increase school functioning for children with sickle cell
      disease transitioning to school and their families.
    

Detailed description: 
      Families Taking Control-School-age Intervention (FTC) will provide education and problem
      solving training for disease management and school functioning. In 4 sessions offered over
      the course of one day, families (patient, caregivers, and school-age siblings) will work
      together and individually to learn and apply the problem solving skills training model to
      relevant examples and family-specific problems, culminating in an outline of family goals to
      target after the intervention. The three booster phone calls will provide support to families
      in implementing the problem-solving model by addressing and refining goals and
      trouble-shooting barriers to implementation. Children and caregivers completed measures at
      baseline (prior to intervention participation) and 6 months later.
    

Intervention name(s): Problem-Solving Skills Training for Disease Management
Intervention type(s): Behavioral
Intervention description(s): Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to determine and compare the rate and extent of absorption of
      norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone
      Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg
      norethindrone acetate) Tablets under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Estradiol/Norethindrone acetate; Activella®
Intervention type(s): Drug; Drug
Intervention description(s): 1/0.5 mg Tablets; 1/0.5 mg Tablets
Other intervention name(s): Mimvey®; Estradiol/Norethindrone acetate (generic name)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; Bioequivalence; Post-Menopausal
Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial is designed to identify an appropriate dose of QAB149 for delivery via a multiple
      dose inhaler for use in the COPD Phase III program.
    


Intervention name(s): QAB149
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: COPD, adults, QAB149
Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Weight Loss
Study type: Interventional

Summary: 
      This is a small exploratory, randomized, controlled trial. Twenty-six older (ages 60-80 yr.),
      obese (BMI 28-40 kg/m2) persons with rheumatoid arthritis (RA) (seropositive or erosive) will
      be randomized to 16 weeks of a counseling health as treatment (CHAT) program or a supervised
      weight loss and exercise training (SWET) program.
    


Intervention name(s): SWET: Supervised Weight loss and Exercise Training; CHAT: Counseling Health As Treatment
Intervention type(s): Other; Other
Intervention description(s): Weight loss will occur via a dietitian-led intervention targeting weight loss over 16 weeks, with weekly weigh-ins and group support sessions. Exercise training will consist of three times per week of an interval-based aerobic program plus twice-weekly resistance training. Both weight loss and exercise training will be supervised to maximize safety and adherence.; Control Arm over 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: RA Seropositive; RA Erosive; Exercise; Diet; Nutrition; Cardiovascular Risk
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy
      and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
    


Intervention name(s): Octagam 10%; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Patients to be treated with Octagam 10%; Patients to be treated with a Placebo
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DM
Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients
Condition: Hypertension; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional

Summary: 
      This project seeks to reduce the disparity in hypertensive heart disease which exists for
      African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure
      (BP). The investigators are targeting a highly vulnerable, often neglected subject population
      which stands to benefit tremendously from better BP control and a corresponding decrease in
      heart damage. HTN occurs early in life and more often in African-Americans, reducing both
      quality and quantity of life. Inner-city African-Americans with HTN utilize the emergency
      department (ED) for chronic BP management. Like cardiovascular disease, vitamin D deficiency
      disproportionately affects African-Americans. Vitamin D is thought to play an important role
      in cardiovascular health. Vitamin D replacement in those who are deficient has been thought
      to reduce the cardiovascular disease, especially if initiated early before irreversible
      damage has occurred, but this has yet to be tested in a prospective clinical trial.
      Accordingly, this proposal was designed to investigate the relationship between vitamin D and
      cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of
      African-American, vitamin D deficient hypertensive patients without prior history of heart
      disease.

      The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in
      vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment, which,
      if shown to be effective could improve the existing approach to a widely accessible,
      cost-effective option.
    


Intervention name(s): cholecalciferol (Vitamin D); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses); chewable wafer every 2 weeks for 52 weeks (27 total doses)
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hypertension; left ventricular hypertrophy; Vitamin D; African-Americans
Autistic Features in Relation to Motor Function and Quality of Life in Children With an Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      Although motor limitations are not currently considered a as clinical manifestation of autism
      spectrum disorder, should not be ignored due to their high incidence and considerable
      influence on life quality functional activity
    


Intervention name(s): assessment
Intervention type(s): Other
Intervention description(s): correlation between Autistic features, motor function and quality of life
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Sample size calculation was performed using G power on the correlation between childhood
        autism rating scale and Quality of life for Spearman's rank correlation coefficient (rs)
        because it was the main outcome variable in the present study. a pilot study was performed
        on 5 patients and showed the correlation value was (r= 0.447226 and p<0.001; and a large
        effect size (f= 0.447226). On the basis of the results of the pilot study (a minimum sample
        size of 34 patients was calculated. A sample size was increased to 34 patients, but the
        number will be increased to 40 to show appropriate results) a minimum sample size of 34
        patients was calculated. A sample size was increased to 34 patients, but it was increased
        to 40 to show appropriate results.
      
Keywords: Autism; Motor function; quality of life; autistic features
Comparison of Short- and Long-time Action Observation Training on Upper Limb Function in Children With Cerebral Palsy
Condition: Cerebral Palsy, Spastic
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      To compared short- and long-time action observation training (AOT) in terms of grip strength,
      the Jebsen Taylor Hand Function Test (JTHF), the Quality of Upper Extremities Skills Test
      (QUEST), and the ABILHAND-Kids test.
    


Intervention name(s): Action observation training
Intervention type(s): Other
Intervention description(s): Each child observed a task video and then performed a task
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cerebral palsy
Evaluation of Analgesia With EMLA and Glucose Oral Solution
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized controlled study the investigators intended to compare analgesic effects
      of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC
      installation.
    

Detailed description: 
      It is a randomised controlled clinical trial, double blinded, with the purpose to compare the
      use of eutectic mixture of local anesthetics (lidocaine and prilocaine) and/or the oral
      solution of glucose 25% in the prevention and treatment of pain in preterm neonates with
      gestational between 28-37 weeks old.

      The pain evaluation will be done using NIPS scale, and also physiologic variables (HR, MAP,
      oxygen saturation level and crie) during two painful procedures performed in the neonatal
      intensive care units:arterial puncture (n=30) and peripherally inserted central catheters
      (n=30). All procedures will have clinical indication and will not be implemented by the
      researcher.The newborns will be randomized into three groups: A (EMLA and glucose; n=20),B
      (EMLA AND placebo; n=20) and C (anesthetic cream placebo and oral glucose; n=20).

      All newborns will be subjected to some kind of therapeutic intervention, the objective of
      this study is validate the application of control measures and treatment of pain for these
      two procedures that cause mild and moderate pain.
    

Intervention name(s): EMLA
Intervention type(s): Drug
Intervention description(s): 0.5g topical EMLA
Other intervention name(s): Lidocaine and prilocaine cream
Intervention MeSH terms: Lidocaine; Prilocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain; preterm neonate; pain assessment; EMLA; oral glucose
Effects of Lutein on Learning and Memory in Chronically Stressed Subjects and in an Acute Stressful Situation (TSST - Trier Social Stress Test): A Randomized, Double-blind, Placebo-controlled Trial)
Condition: Healthy But Chronically Stressed
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study effects of a four months lutein supplementation (in
      form of a lutein fortified nutritional beverage) on general learning and memory performance
      as well as on acute stress-induced changes in learning and memory performance in chronically
      stressed males and females using 2 different lutein doses in comparison to a placebo.
    


Intervention name(s): Nutritional beverage fortified with 6mg lutein/day; Nutritional beverage fortified with 12mg lutein/day; Nutritional beverage fortified with 12mg lutein/day
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 beverages (each containing 3mg lutein) per day (total of 6mg lutein/day) for a total of 4 months; 2 beverages (each containing 6mg lutein) per day (total 12mg lutein/day) for a total of 4 months; 2 beverages (each containing 0mg lutein) per day (total 0mg lutein/day) for a total of 4 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Memory; Cognition; Execute Function; Attention; Mood