bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Acupuncture for Dizziness and Vertigo in Emergency Department: a Clinical Control Trial
Condition: Dizziness; Vertigo
MeSH terms: Vertigo; Dizziness
Study type: Interventional

Summary: 
      Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department
      (ED). Pharmacological therapy is often solicited for these symptoms, such as vestibular
      suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with
      unavoidable side-effects. To the best of the investigators knowledge, no papers surveyed
      assess the feasibility of applying acupuncture as an emergent intervention means to the
      treatment of dizziness and vertigo. The investigators study targeted on filling in this gap
      by performing a clinical control trial to evaluate the efficacy and safety of traditional
      Chinese medicine - acupuncture - in treating patients with dizziness and vertigo in ED.
    


Intervention name(s): acupuncture
Intervention type(s): Procedure
Intervention description(s): Experiment group received acupuncture at Zusanli (ST36) and Neiguan (PC6) acupuncture points
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: dizziness and vertigo; emergency department (ED); clinical trial; acupuncture
Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response
      study to examine the effects on glucose control of AC2993 as compared to placebo in patients
      with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with
      metformin for at least 3 months prior to screening. Patients whose diabetes management
      consists of diet and exercise will also be eligible for this study.
    


Intervention name(s): Placebo 0.01 mL; Placebo 0.02 mL; Placebo 0.03 mL; Placebo 0.04 mL; AC2993 2.5 mcg; AC2993 5.0 mcg; AC2993 7.5 mcg; AC2993 10.0 mcg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily; 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily; 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily; 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily; 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily; 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily; 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily; 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
Other intervention name(s): synthetic exendin-4; synthetic exendin-4; synthetic exendin-4; synthetic exendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Condition: PFIC1; PFIC2
MeSH terms: Cholestasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and
      safety of low doses and high doses of A4250 compared to placebo in children with progressive
      familial intrahepatic cholestasis (PFIC) types 1 and 2.
    

Detailed description: 
      Up to 50 sites in the following countries will take part in this study:

      Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Spain,
      Sweden, Turkey, United Kingdom, United States, and Saudi Arabia
    

Intervention name(s): A4250 (odevixibat); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A4250 is a small molecule and selective inhibitor of ileal bile acid transporter (IBAT).; Placebo identical in appearance to active drug (A4250).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Randomized, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric; Cholestasis
Contact to a Physician Specialized in Social Medicine and Return to Work
Condition: Return to Work; Musculoskeletal Disease
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The aim of this study was to investigate the impact of a rehabilitation program including a
      physician specialized in social medicine parallel to treatment for suspected spinal disc
      herniation.
    

Detailed description: 
      In a two-year time period (2011 to 2012) 443 patients of suspected of disc herniation and
      risk of low work ability - based on questionnaires participated in a randomized control
      trial. The patients were randomized to either the intervention group (n=220) or control group
      (n=223). The intervention group were invited to the Department of Social Medicine two to four
      weeks after their first contact to Department of Rheumatology for a consultation with a
      physician specialized in social medicine. Together with the patient a return-to-work (RTW)
      schedule was made to ascertain the need for contact to the workplace (to adjust work
      functions), municipality, general practitioner or short-term supportive consultations with a
      psychologist. Throughout the intervention, the patients received their usual treatment from
      the Department of Rheumatology like patients from the control group. Outcome was return to
      the work force at one year follow up using information from a national registry.
    

Intervention name(s): Rehabilitation program
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare pharmacokinetics after single oral administration
      of candesartan and rosuvastatin each separately versus coadministration of candesartan and
      rosuvastatin in healthy male volunteers.
    


Intervention name(s): Candesartan; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
Condition: Hyperkalaemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomised sequence, 2-period, 2-cohort, 2-treatment in
      each cohort, cross-over study in healthy subjects (males and females of non-childbearing
      potential), performed at a single study centre.
    

Detailed description: 
      The study will comprise:

        -  A screening period of maximum 28 days;

        -  Two treatment periods:

             -  Treatment Period 1 starts with admission to the Clinical Unit on Day -1, followed
                by dosing on Day 1 with the assigned treatment (A, B, C, or D) as per assigned
                cohort and treatment sequence, followed by a washout period of at least 14 days.

             -  Treatment Period 2 starts with admission to Clinical Unit on Day -1, followed by
                dosing on Day 1 with cross-over treatment as per assigned cohort, followed by a
                follow-up period of 7 to 10 days.

        -  A follow-up visit/early termination visit at 7 to 10 days after the last investigation
           medicinal product (IMP) administration.

      Subjects will be assigned to either Cohort 1 (tacrolimus) or to Cohort 2 (cyclosporin). Each
      cohort will have 2 treatment periods. Subjects in each cohort will be randomly assigned to
      one of 2 treatment sequences (AB|BA or CD|DC) where,

        -  Treatment A: Tacrolimus

        -  Treatment B: Tacrolimus + SZC

        -  Treatment C: Cyclosporin

        -  Treatment D: Cyclosporin + SZC
    

Intervention name(s): Tacrolimus; Cyclosporin; Sodium Zirconium Cyclosilicate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each subject in this cohort will receive a single dose of oral capsules of tacrolimus on 2 occasions, once alone and once in combination with oral suspension of SZC. Drug administrations will occur after a 12 hour overnight fast.; Each subject will receive a single dose of oral capsules of cyclosporin on 2 occasions, once alone and once in combination with oral suspension of SZC. Drug administrations will occur after a 12 hour overnight fast.; Each subject will receive single oral doses of SZC with tacrolimus (cohort 1) or cyclosporin (cohort 2) under fasted conditions. The doses will be administered after an overnight fast of at least 12 hours.
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Sodium Zirconium Cyclosilicate; Tacrolimus; Cyclosporin; Drug-drug interaction study
The Women's Healthy Lifestyle Study
Condition: Breast Cancer
Study type: Interventional

Summary: 
      This study aims to determine if a motivational interviewing counseling style can help women
      eat a healthy diet and exercise during breast cancer treatment and beyond.
    

Detailed description: 
      Women receiving chemotherapy for early stage breast cancer often gain weight and body fat,
      and this contributes to the health burden that cancer survivors face. Weight gain is a
      concern not only for overall health status, but also as a possible factor for risk of cancer
      recurrence. Unfortunately achieving weight loss, after a gain has occurred, is difficult, and
      there are no satisfactory methods for maintenance of weight loss. This study proposes to
      design and test a novel telephone-based intervention for preventing weight gain during
      treatment for breast cancer in a pilot, randomized study. The 12-month intervention will
      target maintenance of current weight and prevention of body fat gain using counseling for
      moderate exercise and a low-fat, high fruit-vegetable diet. The counseling approach will be
      based on motivational interviewing techniques and will be delivered through telephone
      appointments. Motivational interviewing is a client-centered type of counseling that elicits
      active participation of the patient. By taking a more active role, patients may be more
      likely to follow through with the recommended lifestyle changes. Study endpoints will include
      blood markers of dietary compliance, pedometer steps, self-monitoring logs, questionnaires
      (including quality of life) and anthropometric measures (including body fat by DEXA). An
      important goal of the study is to establish recruitment methods and demonstrate recruitment
      rates in newly diagnosed stage I-IIIA breast cancer patients. The study data also will
      demonstrate implementation of the counseling approach and provide a basis for sample size
      estimates for a larger trial. This type of intervention, namely a combination of exercise and
      diet, has been indicated to have good potential for prevention of recurrence. It is therefore
      necessary to develop effective methods for eliciting these behaviors.
    

Intervention name(s): motivational interviewing; written materials only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): telephone counseling; dietary guidance materials and pedometers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: chemotherapy; exercise; diet; fruit; vegetables; low-fat
Genetics of Ischemic Cardiomyopathy
Condition: Ischemic Cardiomyopathy
MeSH terms: Cardiomyopathies; Ischemia
Study type: Observational

Summary: 
      Background:Ischemic heart disease is one of the heaviest health-related burdens worldwide.We
      aimed to identify the common hub mRNA and pathways that are involved in pathological
      progression of ischemic cardiomyopathy. Methods: To explore potential differentially
      expressed genes (DEGs) of all ischemic heart disease stages, we used chipster and GEO2R tools
      to analyze of retrieved eight high throughput RNA datasets obtained from GEO database. Gene
      Ontology functional annotation and Pathways enrichment analyses were used to obtain the
      common functional enriched DEGs which were visualized in protein-protein interactions (PPI)
      network to explore the hub mRNA according to the interaction scores. Validation qRT-PCR was
      carried out for blood and cardiac biopsies compared with controls to validate the determined
      four hub mRNAs and subsequently reviewed inside comprehensive published meta-analysis
      database. The validated mRNAs were visualized in two interaction modules. Finally screening
      of approved drugs was applied.
    


Intervention name(s): quantitative polymerase chain reaction(QPCR) for four genes; Cardiac biopsy, blood sampling
Intervention type(s): Genetic; Procedure
Intervention description(s): quantitative polymerase chain reaction(QPCR) for four genes; In the studied thirteen peripheral blood subjects, five milliliters blood samples were taken from each patient in potassium EDTA tubes, immediately inserted in liquid nitrogen container and then stored in -80 refrigerators. All studied thirteen cardiac tissue subjects were underwent cardiac biopsy after PCI in order to take two specimens from the left ventricle using judkin right seven french catheters for femoral access and cardiac bioptome 2.3 mm wide. All cardiac specimens were collected in cryotubes, immediately inserted in liquid nitrogen container and then stored in -80 refrigerators.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study subjects were categorized into three control cases who were diagonosed as healthy
        subjects after diagnostic catheterization, three patients with stable coronary artery
        disease undergoing elective PCI who were diagnozed with coronary lesion/s and underwent
        stent implantation without previous history of myocardial infarction, four patients with
        history of myocardial infarction or with acute myocardial infarction undergoing primary PCI
        and three patients with ischaemic cardiomyopathy diagnosed by ejection fraction less than
        35% with history of coronary artery disease or myocardial infarction or those with acute
        myocardial infarction with reduced ejection fraction.
      
Biospecimen description: 
      Cardiac tissue specimens and blood specimens
    
Keywords: Ischemic Cardiomyopathy; qrt-pcr
The Effects of Metformin on Blood Vessel Structure and Function
Condition: Obesity; Hypertension; Hypercholesterolemia; Hyperglycemia
MeSH terms: Hypercholesterolemia; Hyperglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on
      the blood vessels of individuals with the Metabolic Syndrome (MeS).
    

Detailed description: 
      Individuals with the Metabolic Syndrome (MeS) are at increased risk for developing
      cardiovascular diseases. This increased risk may, in part, be related to abnormalities in the
      blood vessels. MeS is defined as having 3 or more of the following 5 criteria:

        -  Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)

        -  Elevated triglycerides (>150 mg/dl)

        -  Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women)

        -  Elevated blood pressure (>130/85) or treatment for high blood pressure

        -  Elevated fasting blood sugar (>100 mg/dl)

      Metformin is a medication that is approved by the Food and Drug Administration (FDA) for the
      treatment of diabetes; however, it can also be safely administered to non-diabetic subjects.
      We are evaluating whether Metformin reduces the stiffness of blood vessels and improves
      endothelial function.

      This study requires 4 visits to the NIA Clinical Research Center (located on the premises of
      Harbor Hospital) over a 5-month period. At the initial visit, patients will be given a
      physical examination with blood and urine tests, and an EKG. They will be randomized into one
      of two groups; one group will receive Metformin (1700 mg per day), while the other group will
      receive a placebo. Participants will take the medication for 4 months. Subsequent visits will
      include additional blood tests, ultrasound and echo exams.

      Taking part in this study is entirely voluntary. All testing and medications will be provided
      at no cost to the participant or their family.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 850mg tablet once a day for one month, then twice a day for 3 months; placebo tablet once a day for one month, then twice a day for 3 months
Other intervention name(s): Fortamet®; Glucophage®; Glumetza™; Riomet™
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; triglycerides; HDL; LDL; High Blood Pressure; High Cholesterol; High Blood Sugar
Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan
Condition: Refractive Error; Myopia; Myopic Astigmatism
MeSH terms: Astigmatism; Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate lens centration and subjective impressions of
      DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in
      ball sports players.
    


Intervention name(s): Nelfilcon A contact lenses; Etafilcon A contact lenses
Intervention type(s): Device; Device
Other intervention name(s): DAILIES® AquaComfort® Plus; DACP; 1-DAY ACUVUE® MOIST®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Soft contact lenses; DACP
Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD
Condition: Neovascular Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the effect of Visudyne® combination therapy (Visudyne®
      [verteporfin for injection] and Lucentis™) on visual acuity outcomes. Study results will be
      submitted for publication to provide data that may help physicians refine the clinical
      management of patients with CNV secondary to age-related macular degeneration (AMD).
    

Detailed description: 
      This will be a single arm study. Patients will be administered Lucentis™ on Day 1, at Months
      1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the
      retreatment criteria algorithm. These patients will also be administered Visudyne® only on
      Day 3.

      Consenting patients will participate in the Screening Period to evaluate study eligibility.
      Patient eligibility assessments will include BCVA, contrast sensibility, speed reading and
      VFQ-25, a standard ophthalmic examination, OCT, color fundus photography, Fluorescein
      Angiography (FA), Green Indocyanine Angiography, Microperimetry and multifocal ERG.

      BCVA and mean central retinal thickness measured by OCT will be repeated at every follow up
      visit.

      Fluorescein Angiography (FA), Green Indocyanine Angiography, contrast sensibility and speed
      reading mean retinal sensitivity measured by microperimetry will repeated at month 3, 6, 9
      and 12 month.

      Color fundus photography at month 1, 3, 6, 9 and 12 month. Multifocal ERG will repeated at
      month 3 and 12 month. VFQ-25 will repeated at month 3 and 12.

      The patient will receive ranibizumab monthly unless the BCVA got worse than 5 letters from
      the baseline BCVA and / or mean central retinal thickness evaluated with OCT increased less
      than 100 µm compared to month 2 visit (last date treatment). The repetition of the dose of
      ranibizumab should not begin before the thirtieth day following the end of the previous
      treatment.
    

Intervention name(s): Ranibizumab; Verteporfin
Intervention type(s): Drug
Intervention description(s): Patients will be administered Lucentis™ 0.5 mg on Day 1, at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.
Intervention MeSH terms: Ranibizumab; Verteporfin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: combination therapy; Lucentis; Visudyne
Safety Study of Oral Edaravone Administered in Subjects With ALS
Condition: ALS
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the long-term safety and tolerability of oral
      edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.
    


Intervention name(s): MT-1186
Intervention type(s): Drug
Intervention description(s): An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.
Other intervention name(s): Oral edaravone
Intervention MeSH terms: Edaravone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment