bioihbjkbjnl/mcl2 huggingface dataset:
Weight Loss Among Adults in Beijing, China
Condition: Obesity; Hypertension
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to test the effect of a mobile phone-assisted lifestyle
      intervention on weight loss at 6 months among overweight/obese Chinese adults, as compared to
      a control group.
    

Detailed description: 
      The rapid gains in China's economic development during the past two decades have been
      accompanied by similar gains in the population's waistline. Over 25% of Chinese adult females
      and more than a third of males are overweight or obese and rates are highest in urban areas
      such as Beijing. By 2015, overweight/obesity prevalence in China may reach 50% , thus
      imposing a heavy toll on chronic disease rates and health care costs. Despite these pressing
      public health challenges, very few obesity intervention studies have been conducted among
      Chinese adults.

      Duke University and Peking University have partnered to implement an intervention to address
      these rapid changes in weight. 124 participants in Beijing will be randomly assigned to
      either: (1) usual care (UC), or; (2) a 6-month weight loss (WL) intervention condition. The
      primary outcome is weight change (kg) at 6 months post-baseline. Secondary outcomes include
      change in blood pressure, weight circumference, dietary intake, physical activity, and
      psychosocial mediators at 6 months post-baseline.

      Participants randomized to the intervention arm will receive a series of components,
      delivered over 6 months: personalized behavior change goals to be self-monitored via text
      messaging, group "starter" counseling sessions, and personalized individual counseling. Each
      participant will also receive a pedometer to facilitate self-monitoring. These are
      evidence-based approaches, drawn from the investigators' collective research experience.
    

Intervention name(s): Text Messaging and Behavior Counseling
Intervention type(s): Behavioral
Intervention description(s): Participants randomized to the intervention arm will receive a series of components, delivered over 6 months: personalized behavior change goals to be self-monitored via text messaging, group "starter" counseling sessions, and personalized individual counseling. Each participant will also receive a pedometer to facilitate self-monitoring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
Condition: Sarcoma
MeSH terms: Sarcoma; Hemangiosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with
      locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be
      removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the 2-month objective response rate in patients with locally advanced or
           metastatic, unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with
           paclitaxel.

      Secondary

        -  Determine the 4- and 6-month response rate in patients treated with this drug.

        -  Determine tolerability of this drug in these patients.

        -  Determine the time to disease progression and overall survival of patients treated with
           this drug.

        -  Determine the clinical criteria predicting response in patients treated with this drug.

        -  Correlate the efficacy of this drug with the expression of genes involved in
           angiogenesis regulation in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive paclitaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for up
      to 6 courses.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
    

Intervention name(s): paclitaxel
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult angiosarcoma; recurrent adult soft tissue sarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma
Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe
      and effective in the treatment of generalized anxiety disorder.
    


Intervention name(s): AZD7325; AZD7325; Lorazepam; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 tablets and 1 capsule taken twice a day for 28 days; 4 tablets and 1 capsule taken twice a day for 28 days; 4 tablets and 1 capsule taken twice a day for 28 days; 4 tablets and 1 capsule taken twice a day for 28 days
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder; GAD; Anxiety
A Study To Compare Effects Of GSK189075 In Combination With Either Furosemide Or Hydrochlorothiazide
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Many patients with type 2 diabetes also have conditions that are treated with diuretics. The
      patients may also be treated with GSK189075 for their diabetes. This study is planned to
      assess possible effects of administering GSK189075 in combination with two frequently used
      diuretics.
    


Intervention name(s): Hydrochlorothiazide (HCTZ); Remogliflozin etabonate (GSK189075); Furosemide
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Remogliflozin etabonate (GSK189075); Hydrochlorothiazide (HCTZ)
Intervention MeSH terms: Remogliflozin etabonate; Hydrochlorothiazide; Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Interaction,; Diabetes,; healthy male subjects; GSK189075,; Diuretics,
The Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic
      stroke
    

Detailed description: 
      The limited therapeutic time window for neuroprotection has prevented all clinical trials
      using NMDA receptor antagonists in subjects with ischemic stroke from showing efficacy. In
      animal models of ischemic stroke, antioxidants showed a longer neuroprotective time window
      than NMDA receptor antagonists, and also showed therapeutic potential in clinical trials in
      subjects with ischemic stroke. Sophadil showed good neuroprotective effects against NMDA and
      free-radical mediated cell death, NR2B-selectivity, moderate NMDA receptor antagonism, and
      effective cellular osmotic antioxidant activity even at nanoscale molarity. Non-clinical and
      phase I human clinical studies have shown that Sofadil is helpful in treating ischemic stroke
      subjects with better efficacy and therapeutic time windows. So we designed the clinical trial
      to evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic
      stroke
    

Intervention name(s): sofadil【Neu2000KW】; Sofadil; Sofadil; placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours; 750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours; 1500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours; Saline was administered intravenously
Other intervention name(s): low dose; Medium dose; high dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sofadil; Acute ischemic stroke
A Clinical Trial to Study the Effects of a Fixed Dose Combination of Diclofenac and Eperisone Hydrochloride With Plain Eperisone Hydrochloride in Patients With Low Back Pain
Condition: Acute Musculoskeletal Spasm Due to Low Back Pain
MeSH terms: Spasm; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effects of a fixed dose combination of
      diclofenac and eperisone hydrochloride compared with plain eperisone hydrochloride in
      patients with low back pain.
    

Detailed description: 
      This study is an observer-blind, prospective randomized, controlled study to evaluate
      efficacy and safety of fixed dose combination of eperisone hydrochloride 50 mg and diclofenac
      sodium 50 mg three times daily with plain eperisone hydrochloride 50 mg three times daily in
      patients with musculoskeletal spasm associated with low back pain. A total of 240 adult
      patients of either sex, 120 patients in each arm, who fulfill the inclusion and exclusion
      criteria will be included in this study. The patients will be evaluated at Days 3, 7 and 10
      of the study visit for efficacy and safety. The efficacy evaluation includes objective
      parameters like Finger-to-Floor distance, Lasegue's sign, tenderness of par vertebral
      muscles, lumbar and dorsal hypermyotonia, leg tendon reflexes, need for rescue medication and
      subjective parameters like improvement in lumbar cinesalgia, pain in lower extremities,
      sensory disturbances of lower limb, and Global Assessment of Response to Therapy (PGART).
      Patients will be evaluated for safety on the clinical adverse events reported during the
      study period, sedation on drowsy alert scale and Global Assessment of Tolerability to Therapy
      (PGATT). The patients will also be evaluated for laboratory safety as assessed by measuring
      laboratory parameters for hemogram, renal and hepatic parameters.
    

Intervention name(s): Eperisone hydrochloride and Diclofenac sodium; Eperisone hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given 3 times a day after meals for 7 to 10 days; eperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days
Intervention MeSH terms: Diclofenac; Eperisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: eperisone; diclofenac; low back pain
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites
Condition: Rhinoconjunctivitis With or Without Allergic Asthma
Study type: Observational

Summary: 
      Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy
      With Beltavac® Polymerised With House Dust Mite in pediatric allergic patients
    

Detailed description: 
      This prospective open multi-center non-interventional study assess the safety and
      effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac
      polymerized with house dust mite pediatric allergic patients in routine medical care.

      Patients receive a rush schedule administration every month for a year. They attend at least
      5 study visits to inform about the adverse reactions, the self reported symptoms and the
      medication intake.
    

Intervention name(s): Beltavac® Polymerized with house dust mites
Intervention type(s): Biological
Intervention description(s): Adminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients from 3 to 11 years, who suffer from allergic rhinitis or rhinoconjunctivitis
        associated with or not with asthma caused by house dust mites
      
Biospecimen description: 
      Serum
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects
      with Functional Dyspepsia, focusing on the assessment of subjective symptoms.
    


Intervention name(s): Z-338; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Intervention MeSH terms: Z 338
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acotiamide
Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if intravenous micronutrient therapy (IVMT) is
      effective in the treatment of fibromyalgia, as assessed by validated functional and pain
      measures.
    

Detailed description: 
      As per Brief Summary
    

Intervention name(s): Intravenous micronutrient therapy
Intervention type(s): Drug
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Fibromyalgia; Intravenous micronutrient therapy; IVMT; alternative medicine; complementary medicine; vitamins; vitamin supplements
Penicillin De-labeling in the Pediatric Primary Care Setting
Condition: Penicillin Allergy; Penicillin Reaction
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      While reported adverse reactions to penicillins are common, most patients with a penicillin
      allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy
      has been recommended. For low-risk patients, direct oral challenge may be an optimal approach
      as a delabeling strategy. However, there is a vast disparity between the number of patients
      with a penicillin allergy label and practicing allergists in the United States, and
      implementing outpatient primary care-based delabeling strategies in low-risk patients may
      increase access to delabeling assessments. However, a recent survey of pediatricians
      identified perceived barriers to implementing penicillin allergy evaluations into their
      routine care. Significant gaps in knowledge exist regarding the feasibility of this approach
      involving risk stratification evaluation of reported penicillin adverse reactions and direct
      amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting.
      With this, the primary aim of this study is to evaluate the number of patients for which
      risk-stratification and direct amoxicillin challenge are successfully completed in an
      outpatient pediatric primary care clinic.
    


Intervention name(s): Amoxicillin
Intervention type(s): Drug
Intervention description(s): Two-dose amoxicillin challenge
Intervention MeSH terms: Amoxicillin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: penicillin; allergy
Cryotherapy and Doppler in Inflammatory Rheumatic Diseases
Condition: Rheumatoid Arthritis; Crystal-induced Arthritides; Spondyloarthritis
MeSH terms: Spondylitis; Arthritis; Rheumatic Diseases; Spondylarthritis; Collagen Diseases
Study type: Interventional

Summary: 
      The primary aim of the study is to evaluate the effects of two local cryotherapy (ice or cold
      gas) applications on arthritic knees.

      Evaluation criteria (before/after treatment):

        -  synovial power-Doppler semi-quantitative score

        -  pain VAS (mm)

        -  cytokine levels in synovial fluid

        -  leukocyte count in synovial fluid
    

Detailed description: 
      After informed consent, patients suffering from inflammatory rheumatic diseases (rheumatoid
      arthritis, spondyloarthritis, crystal-induced arthritides) with non-septic arthritides were
      randomized to receive either local ice (30 minutes twice a day) or cold gas (2 minutes twice
      a day - pulsed hyperbaric CO2). Local cryotherapy was applied at 9 AM and 17 PM.

      Skin temperature was monitored Knee power Doppler ultrasonography was performed before
      cryotherapy (9 AM), just after, 2 min after, 2 hours after, before and after the second cold
      application (8 hours after the first cold application), then the day after at 9 A.M (24 hours
      after the first cold application).

      Synovial fluid was also analysed after join arthrocentesis (just before the first cold
      application, then 24 hours later, after the last ultrasonographic examination. A
      corticosteroid injection was performed after the second arthrocentesis when necessary.

      Power Doppler semi-quantitative scores (0-3) were then blindly assessed by a second trained
      ultrasonographist at the different times of the study.

      Pain VAS evolution was also monitored throughout the study. Clinical characteristics of
      patients were collected at baseline. 20 patients suffering from ankle/wrist arthritides were
      also included in order to evaluate power Doppler score evolution under cold gas or
      ice-cryotherapy.

      15 patients suffering from knee arthritides were treated by local cold gas. 31 patients
      suffering from knee arthritides were treated by ice. When both knees were arthritic,
      contralateral synovial fluid and power Doppler score were used as non-treated controls.
    

Intervention name(s): ice; cold gas
Intervention type(s): Device; Device
Intervention description(s): local ice application for 30 minutes; local cold gas application for 2 minutes
Other intervention name(s): ice pack; Cryo+ (pulsed hyperbaric CO2)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cryotherapy; power Doppler score; synovial fluid cytokines; pain VAS
Study Comparing Paclitaxel Plus Carboplatin Versus Anthracyclines Followed by Docetaxel as Adjuvant Chemotherapy for Triple Negative Breast Cancer (PATTERN)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, multisite, randomized, open-lable Phase III clinical trial (PATTERN
      study) comparing Paclitaxel Plus Carboplatin versus Anthracyclines followed by docetaxel as
      adjuvant chemotherapy for triple negative breast cancer
    


Intervention name(s): Paclitaxel; Carboplatin; Epirubicin; Cyclophosphamide; 5-fluorouracil; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Paclitaxel chemotherapy (injection); Carboplatin chemotherapy (injection); Epirubicin chemotherapy (injection); Cyclophosphamide chemotherapy (injection); 5-fluorouracil chemotherapy (injection); Docetaxel chemotherapy (injection)
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Carboplatin; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1：6 cycles of PC (Paclitaxel 80 mg/m2 ivgtt d1,8,15+ Carboplatin Auc = 2 ivgtt d1,8,15, 28 days per cycle).
Arm 2：3 cycles of FEC (epirubicin100 mg/m2 ivgtt d1+Cyclophosphamide 500 mg/m2 iv d1+ 5-fluorouracil 500 mg/m2 iv d1, 21 days per cycle) followed by 3 cycles of Docetaxel (Docetaxel 100mg/m2, ivgtt d1, 21 days per cycle)
Masking: None (Open Label)
Primary purpose: Treatment
Angiographic and IVUS Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals (AIFSIDDES)
Condition: Percutaneous Coronary Angioplasty
Study type: Observational

Summary: 
      The safety and efficacy of drug-eluting stents (DES) with a biocompatible polymer have been
      demonstrated in randomized clinical trials as well as in real world practice. Theoretically,
      a new DES with a biodegradable polymer should reduce the incidence of late in-stent
      thrombosis, however, the long-term safety and efficacy of these stents remains unknown. This
      study was aimed to compare the safety and efficacy of the Excel DES with a biodegradable
      polymer to the Endeavor DES with a biocompatible polymer in same individuals.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patiemts who underwent simultaneous implantation of one or more Endeavor stents and one
        or more Excel stents during the same index procedure and were evaluated with coronary
        angiography and intravascular ultrasound (IVUS) at least one year post-procedure.
      
Keywords: percutaneous coronary angioplasty; zotarolimus-eluting stent; sirolimus-eluting stent; biodegradable polymer; biocompatible polymer