bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder; Tic Disorder
MeSH terms: Tic Disorders; Tics; Tourette Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole
      in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
    

Detailed description: 
      Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance
      of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent,
      non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of
      medications approved for the treatment of Tourette's Disorder. The goal of the current trial
      is to obtain efficacy, safety, and tolerability data in a controlled condition of a
      Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The
      trial has an 8-week long double-blind treatment period after a pretreatment
      (screening/washout phase), and the subjects will be followed up for 1 month after the last
      treatment. The Once-daily tablet formulation that will be evaluated in this trial represents
      a daily dosage regimen that is intended to be administered to children and adolescents.
    

Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily, tablet
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourette Syndrome; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tic Disorders; Tics; Movement Disorders; Mental Disorders; Aripiprazole
Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine
Condition: Measles; Mumps; Rubella; Adverse Event Following Immunisation
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in
      subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to
      4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18
      month-old subjects with one dose immunization with measles-rubella(MR).
    

Detailed description: 
      This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in
      subjects 18 months of age and older.

      The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose
      immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose
      immunization with MR.

      Immune efficacy and safety will be compared among different immunization schedules,including
      inoculation doses,enhanced immunity age,vaccination interval time.

      Antibody persistence of 1 dose of MMR vaccine will be evaluated in this study.
    

Intervention name(s): Measles, mumps and rubella Combined Vaccine, Live
Intervention type(s): Biological
Intervention description(s): Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Other intervention name(s): Beijing Tiantan Biological Products Co., Ltd
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals'
      meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to
      MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with
      Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix
      co-administered with Boostrix.
    


Intervention name(s): Meningococcal vaccine GSK134612; Cervarix®; Boostrix®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One dose administered intramuscularly (IM) in the deltoid of the right arm.; Three doses administered intramuscularly (IM) in the deltoid of the left arm.; One dose administered intramuscularly (IM) in the deltoid of the left arm.
Other intervention name(s): Nimenrix®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pertussis; Meningococcal meningitis; Meningococcal infections; HPV; Neisseria meningitidis; Vaccines, conjugate; tetanus; diphtheria; Meningococcal vaccines; Immunogenicity
Endoscopic Screening on Esophageal Cancer
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
Study type: Interventional

Summary: 
      Importance: There are no global screening recommendations for esophageal squamous cell
      carcinoma (ESCC). Endoscopic screening has been investigated in high incidence areas of China
      since 1970's. But up until now there no apparent evidence that would lead to a reduction in
      disease morbidity and mortality.

      Objective: To evaluate whether endoscopic screening and early intervention program could
      reduce the incidence or mortality of ESCC.

      Design: Community-based, controlled cohort study among 45 386 residents, Endoscopy screening
      was completed from November 1999 to May of 2000. Subjects in intervention group were examined
      once during intervention period. The study follow-up concluded in December 2009.

      Setting: High risk area of ESCC in China

      Participants:Cluster sampling from communities with high rates of esophageal cancer. A set of
      villages with was selected as the study intervention community. Age 40 to 69 years residents
      were selected as an eligible population. Another set of villages was select as the control
      population. Buffer villages were set up between intervention and control group.

      Intervention: Endoscopy with Lugol's iodine staining and early treatment on precancerous
      lesions was undergone for the intervention group.

      Main Outcome(s) and Measure(s): Incidence and mortality ESCC
    


Intervention name(s): Endoscopy examination with iodine staining
Intervention type(s): Procedure
Intervention description(s): Endoscopy examination with Lugol's iodine staining and questionnaire once time and early treatment on precancerous lesions was undergone for the intervention group.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: esophageal cancer; screening; endoscopy; prevention
Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study seeks to evaluate and compare the clinical performance of two daily disposable
      soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.
    


Intervention name(s): etafilcon A; omafilcon A
Intervention type(s): Device; Device
Intervention description(s): 1-day soft contact lens; 1-day soft contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment Trial of Subclinical Hypothyroidism in Down Syndrome
Condition: Down Syndrome; Subclinical Hypothyroidism
MeSH terms: Down Syndrome; Hypothyroidism; Syndrome
Study type: Interventional

Summary: 
      The purpose of this research study is to learn about the effects of treating subclinical
      hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down
      syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will
      improve cardiometabolic health and quality of life.
    

Detailed description: 
      The American Academy of Pediatrics (AAP) recommends yearly screening of thyroid studies in
      DS. Clinical experience suggests that thyroid stimulating hormone (TSH) concentrations in the
      subclinical hypothyroid range (5-10 milli international units(mIU/L)) are not uncommon in DS,
      but the benefits and risks of treating SCH in the DS population are not known. In adults, SCH
      has been associated with increased cardiometabolic risk (CMR) and individuals with DS may be
      at increased cardiometabolic risk as well.

      Data in children with SCH are limited. Despite the recommendations to screen for thyroid
      dysfunction, evidence to guide management of elevated TSH in children with DS is equally
      sparse. In non-DS children, TSH>4.65 mIU/L was associated with lower HDL. One year of
      levothyroxine treatment in short children with subclinical hypothyroidism and short stature
      improved growth velocity. Left ventricular (LV) function and LV mass (by echocardiography)
      was not different in 16 children with DS and subclinical hypothyroidism (TSH>6.5 mIU/L; mean
      TSH = 7.8 mIU/L) vs. 25 children with DS and normal TSH. However, these findings may be
      limited by the small sample size. An intervention study of 7 subjects age 2-42 years with DS
      and hypothyroidism, defined as low T4 and normal or elevated TSH (0.2-18.9 mIU/L) on 8 weeks
      of levothyroxine treatment did not improve developmental or functional outcomes.
      Anthropometrics and CMR factors were not examined. In contrast, increased TSH in the absence
      of overt congenital hypothyroidism is common in neonates with DS and prompted a randomized
      controlled trial (RCT) in 181 neonates with DS. TSH-directed levothyroxine treatment was
      associated with better growth, weight gain, and motor development after 24 months compared to
      placebo. These findings highlight that the "asymptomatic" component of subclinical
      hypothyroidism may have medically-relevant effects. This study will provide potentially
      clinically relevant preliminary evidence for the treatment of subclinical hypothyroidism in
      DS.
    

Intervention name(s): Levothyroxine
Intervention type(s): Drug
Other intervention name(s): Synthroid; Levothroid; Levoxyl; Tirosint; Unithroid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Down syndrome; subclinical hypothyroidism; thyroid; levothyroxine
The Effect of Vitamin D Supplementation in Type 2 Diabetes
Condition: DIABETES MELLITUS
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      In many observational studies, vitamin D deficiency is related to glucose intolerance and
      diabetes. But there little randomized, controlled interventional studies that evaluate the
      effect of vitamin D in type 2 diabetes.

      Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2
      diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and
      bone turnover markers.
    

Detailed description: 
      After informed consent, investigators randomized 180 type 2 diabetes into interventiona group
      (25-hydroxy vitamin d 2000 IU+ elemental calcium 200mg per day) or placebo group (elemental
      calcium 200mg per day). The participants should control diabetes by oral medications or
      lifestyle intervention at the intervention period. Investigators exclude the participants who
      took vitamin D or calcium or anti-osteoporotic drugs. Investigators also exclude renal
      insufficiency (Cr>1.5 in men or Cr>1.4 in women) or heavy alcoholics.

      Investigators followed the participants for 24 weeks. After randomization, investigators
      checked HbA1c,glucose, calcium, 25-hydroxyvitamin d, AST, ALT,Creatinine, Parathyroid
      hormone, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity,
      central blood pressure, and aortic augmentation index, and precontrast liver computed
      tomography. Also investigators checked body weight, height, and peripheral blood pressure.

      At 12 weeks, investigators checked HbA1c, 25-hydroxy vitamin D, AST, ALT, calcium, and
      creatinine.

      At the end of the study(at 24 weeks), investigators checked HbA1c, glucose, AST, ALT,
      Creatinine, calcium, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave
      velocity, central blood pressure, aortic augmentation index, and precontrast liver computed
      tomography.

      After the study completed, investiators compared the data of interventional groups and
      placebo groups.
    

Intervention name(s): Vitamin D3; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2000IU per day; elemental calcium 200mg per day per 24 weeks
Other intervention name(s): dicamax d; calcium
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DIABETES MELLITUS; VITAMIN D; ARTERIAL STIFFNESS; FATTY LIVER; BONE TURNOVER
Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery
Condition: Myocardial Injury; Cardiac Surgery
MeSH terms: Tetralogy of Fallot; Ischemia; Wounds and Injuries
Study type: Interventional

Summary: 
      The study aimed to evaluate the combined effects of cyclosporine and remote ischemic
      preconditioning on MDA, calcium cytosol concentration, and mitochondrial edema in tetralogy
      Fallot patients undergoing corrective surgery.
    

Detailed description: 
      Forty patients undergoing tetralogy Fallot corrective surgery were randomized to RIPC and
      cyclosporine (n=20) and control (n=20). Cyclosporin was administered 2 hour pre induction of
      anesthesia with the dose of 3 mg/kg body weight intravenously. RIPC was performed
      preoperatively after induction of anesthesia by inflating pressure cuff on the extremity 30
      mmHg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes
      reperfusion interval. Blood samples from coronary sinus and biopsies from the myocardial
      infundibulum were obtained three times at the condition of pre ischemic, ischemic, and
      reperfusion. MDA was measured from the blood samples, meanwhile calcium cytosol concentration
      and mitochondrial edema was measured from the biopsy samples.
    

Intervention name(s): Cyclosporin; remote ischemic preconditioning; Placebo
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): Cyclosporin was administered intravenously with the dose of 3 mg/ kg body weight; Performed by inflating pressure cuff on the extremity 30 mmHg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes reperfusion interval; Intravenous placebo
Other intervention name(s): Sandimmun; RIPC
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RIPC; cyclosporine; ischemia reperfusion injury; MDA; calcium cytosol; tetralogy Fallot; mitochondrial edema; infundibulum
Effects of Creatine Supplementation in Breast Cancer Survivors
Condition: Breast Cancer; Chemotherapy Effect; Muscle Weakness; Muscle Loss; Exercise
MeSH terms: Breast Neoplasms; Muscle Weakness
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that creatine will accelerate adaptations
      associated with exercise in breast cancer survivors recently completing chemotherapy.
    

Detailed description: 
      The primary objective of this study is to determine the effects of creatine supplementation
      in modulating strength and physical function in breast cancer survivors that have recently
      completed chemotherapy. The primary hypothesis for this objective is that creatine will lead
      to significantly greater gains in strength and physical function in breast cancer survivors
      compared to exercise alone. The secondary objective is to determine if supplemental creatine
      can increase intramuscular storage of creatine and alter energy storage. The hypothesis for
      this objective is that creatine supplementation will significantly increase intramuscular
      concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in
      the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective
      is that the creatine group will have significantly greater muscle cross-sectional area and
      significantly lower intramuscular fat compared to controls. The final objective for this
      study is to test the hypothesis that creatine supplementation will improve body composition
      in breast cancer survivors.
    

Intervention name(s): Creatine
Intervention type(s): Dietary Supplement
Intervention description(s): Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Patients eligible to participate in this study will be allocated to either the creatine group or the control group (1:1) based on a pre-determined randomization list. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Special Populations; Exercise Oncology; Creatine Supplementation; Magnetic Resonance Spectroscopy
5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This investigation is not only to develop an improved radiation/temozolomide approach, but
      also develop a regimen with potential to form the basis of better combined therapy with
      immune based treatments.
    

Detailed description: 
      Glioblastoma has a poor prognosis with median survival is 14-16 months for patients enrolling
      in clinical trials, and across the United States one year survival is reported in the
      Surveillance, Epidemiology, and End Results (SEER) registry to be only 35%. Radiation
      treatment related lymphopenia has been associated with poor tumor outcome in Glioblastoma and
      a variety of other tumor types. As this lymphopenias is prolonged, it may also reduce
      efficacy of the checkpoint inhibitor lymphocyte mediated immune therapies now approved by the
      FDA for an increasing number of indications. Modeling and clinical studies suggest that
      administering radiation over 5 or fewer days (rather than standard 30 days of treatment) may
      reduce the incidence of lymphopenia.
    

Intervention name(s): Temozolomide
Intervention type(s): Drug
Intervention description(s): 5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide
Other intervention name(s): 5 fraction radiosurgery with temozolomide
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Intervention model description: 5 fraction hypofractionated stereotacic radiosurgery along with standard temozolomide
Masking: None (Open Label)
Primary purpose: Other
Evaluation of a Topical Treatment for Actinic Keratosis
Condition: Actinic Keratosis of Face and Scalp
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic
      keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a
      double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be
      treated by the active component.
    


Intervention name(s): AD17137 topical treatment; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Actinic keratosis; topical; dermatology; treatment; clinical study; double blinded
Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if budesonide with HFA is effective, safe and well
      tolerated compared with budesonide CFC. Budesonide HFA has been already given in other
      research studies, in both healthy volunteers and subjects with asthma.
    


Intervention name(s): Budesonide HFA; Budesonide CFC
Intervention type(s): Drug; Drug
Intervention description(s): standard daily inhaled dose; standard daily inhaled dose
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma hyperreactivity