bioihbjkbjnl/mcl2 huggingface dataset:
DARE: Diabetes in cArdiac REhabilitation
Condition: Type 2 Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the DARE study is to see whether strict glycemic control during cardiac
      rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak
      workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery
      disease.
    

Detailed description: 
      In a recent study, we showed that the benefit of cardiac rehabilitation on the improvement of
      exercise capacities (VO2 peak, peak workload, ventilatory threshold), after an acute coronary
      event, was significantly reduced in patients with type 2 diabetes. Moreover ,we showed, in
      multivariate analysis, that the worse improvement of the capacities to the effort after
      cardiac rehabilitation, was mainly related to hyperglycemia.

      Because the improvement of exercise capacities after cardiac rehabilitation (in particular
      VO2 peak) has been shown to be an essential factor to reduce short- term and long-term
      morbidity and mortality, we may think that such benefit on reduction of morbidity and
      mortality may be significantly less in patients with diabetes.

      Thus, we propose to carry out a multicentric intervention study, entitled DARE which goal is
      to see whether a strict glycemic control, during cardiac rehabilitation following an acute
      Myocardial Infarction (MI), is likely to improve, the results of cardiac rehabilitation on
      exercise capacities in patients with type 2 diabetes.

      After arrival in cardiac rehabilitation, patients with diabetes, will be randomized into 2
      groups: an "intensive treatment" group, in which the patients will treated by insulin under a
      basal-bolus regimen with strict glycemic control and a "conventional treatment" group, in
      which the previous anti-diabetic treatment will be continued.
    

Intervention name(s): Conventional antidiabetic treatment; Intensive insulin treatment
Intervention type(s): Other; Other
Intervention description(s): No intensive treatment; Intensive insulin treatment
Intervention MeSH terms: Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus; cardiac rehabilitation; insulin
BIIB033 In Acute Optic Neuritis (AON)
Condition: Acute Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with
      their first episode of unilateral acute optic neuritis (AON). The secondary objective of this
      study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this
      study population.
    


Intervention name(s): BIIB033 (anti-LINGO-1 mAb); Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).; via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Other intervention name(s): anti-LINGO-1 monoclonal antibody (mAb); Opicinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Optic Neuritis
Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis
Condition: Periodontitis; Laser
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an
      Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect
      of LANAP on periodontal indexes like BOP, CAL, probing depth
    

Detailed description: 
      this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an
      Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect
      of LANAP on periodontal indexes like BOP, CAL, probing depth in a split mouth design before
      treatment and after follow up sessions.
    

Intervention name(s): LANAP (Laser Assisted New Attachment Procedure); LANAP off
Intervention type(s): Radiation; Radiation
Intervention description(s): radiation of Nd:YAG laser in periodontal pocket; radiation of Nd:YAG laser in off mode in periodontal pocket
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LANAP; Periodontitis
Myocardial Perfusion Study to Detect Coronary Microvascular Abnormality in Diabetic Patients With Nonfatal Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The goal of this study is to use MCE (myocardial contrast/perfusion echocardiography) to
      study and compare short/long term change of myocardial perfusion abnormality and cardiac
      outcome in diabetic patients after nonfatal MI (heart attack), who are treated with different
      glucose control agents.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic and nondiabetic patients will be initially recruited and studied after acute
        nonfatal MI and revascularization with either PCI or CABG
Home Pulmonary Rehabilitation for COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD); Emphysema
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
Study type: Interventional

Summary: 
      Regular physical activity has been found to be important in maintaining health and well-being
      in people with COPD. The purpose of this study is to test new technology and health coaching
      aimed to help people with COPD become more physically active in their daily lives.
    


Intervention name(s): Home Based Pulmonary Rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Twice daily exercise routine six days a week of 3 minutes of personal breathing, 5 exercises with 10 reps each, and 6 minutes of walking with weekly health coach calls.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume [FEV1] <50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale [mMRC] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pulmonary Rehabilitation
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Epelsiban in Healthy Female Volunteers
Condition: Embryo Transfer
Study type: Interventional
Phase: Phase 1

Summary: 
      Epelsiban is a potent and selective oxytocin receptor antagonist in development for enhanced
      implantation rates during in-vitro fertilization (IVF). This study a non-randomized, open
      label study designed to assess the safety, tolerability and pharmacokinetics of additional
      repeat doses of epelsiban in healthy females, and will be the first dosing experience of
      greater than 200 milligram (mg) as a single dose with this compound. Data from this study
      will inform the selection of doses of epelsiban to be used in future clinical studies. This
      study will be composed of 3 periods: Screening, Treatment, and Follow-up. The total duration
      that a subject involved in the study will be up to 6 weeks. At least 2 cohorts of subjects
      will be enrolled in this study and cohorts will be conducted sequentially. Additional cohorts
      will be enrolled if determined necessary. A sufficient number of subjects will be screened
      for the study to obtain approximately 6 evaluable subjects per cohort.
    


Intervention name(s): Epelsiban
Intervention type(s): Drug
Intervention description(s): Epelsiban will be supplied as a 25 mg white to off-white round direct compression oral tablet.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epelsiban; Healthy Female Volunteers; Safety; Tolerability; Oxytocin; Pharmacokinetics
Lifestyle Intervention to Treat Diabetes in the Marshall Islands
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The Republic of the Marshall Islands has the highest prevalence of type 2 diabetes (T2D) in
      the world. This clinical trial tested whether a community-based, intensive, plant-rich
      lifestyle intervention with exercise is more effective for treating and managing T2D in the
      Republic of the Marshall Islands than the standard of diabetes care. The intensive lifestyle
      intervention consisted of a plant-rich diet and moderate exercise. It centered around a
      12-week program of counseling and instruction on healthy eating, exercise, and stress
      management, as well as hands-on cooking classes and prepared meals. Cardiometabolic outcomes
      were assessed throughout the intervention and at 24 weeks. The present study is the first
      randomized clinical trial ever conducted in the Republic of the Marshall Islands and the
      first lifestyle intervention trial conducted in Micronesia.
    


Intervention name(s): Standard of diabetes care; Lifestyle Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The standard of diabetes care consisted of standard treatment protocols used by the MOH Diabetes Clinic. These included placing T2D patients on anti-hyperglycemic agents appropriate to their HbA1c levels (including sulfonylureas, metformin, and insulin) and providing oral and written information about the importance of maintaining a healthy weight, eating a healthy diet, and getting regular exercise. Participants in the control group were instructed not to make changes in their diet and activity levels during the study.; The lifestyle intervention consisted of a high-fiber, low-fat, mostly plant-based diet and 30-60 minutes per day of culturally-relevant, moderate intensity exercise. Participants initially received 12 weeks of group educational classes and some prepared meals and then followed the lifestyle intervention on their own for the remaining 12 weeks. Group classes included informative sessions on healthy eating, exercise (both aerobic and strength training), and stress management, as well as hands-on cooking classes. Classes were delivered as a combination of PowerPoint presentations, practical workshops, dine-outs, shopping tours, and cooking classes with spouses.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-arm study, although the control group was allowed to crossover after completing the control condition.
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess Cardiac Conduction of GSK1349572
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, partial-blind, placebo-controlled, single dose, cross-over trial
      investigating the effect of GSK1349572 on cardiac repolarization as compared to placebo in
      healthy adult males and females. Approximately 42 subjects will be enrolled in this study and
      will be admitted to the clinic for three separate dosing sessions. Subjects will receive
      single dose administrations of placebo, a supratherapeutic dose of GSK1349572 (250 mg), and
      moxifloxacin (400 mg) in random sequence. Safety of subjects will be monitored by clinical
      observation, measures of vital signs, 12-lead ECGs and clinical laboratory measurements.
    


Intervention name(s): GSK1349572 250 mg; Placebo Suspension; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is an experimental HIV medication in the integrase inhibitor class.; Placebo is a liquid with no drug in it.; This is an FDA approved antibiotic in the fluoroquinolone class.
Other intervention name(s): AVELOX. AVELOX is a registered trademark of Bayer Aktiengesellschaft
Intervention MeSH terms: Moxifloxacin; Dolutegravir; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GSK1349572; moxifloxacin; Avelox; QTc
Simo Decoction and Gum Chewing for Bowel Activity
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      Abdominal surgery, including hepatic resection for hepatocellular carcinoma (HCC), is
      inevitably followed by an episode of gastrointestinal hypomotility. A delayed return of
      gastrointestinal function, defined as postoperative ileus (POI), has a great impact on
      patient comfort, morbidity and recovery. POI often results in a prolonged hospital stay and
      contributes significantly to healthcare costs.

      Some prospective studies have revealed that gum chewing can improve the return of
      gastrointestinal function after colorectum surgery, gynaecology and obstetrics, and urinary
      system surgery. Moreover, some retrospective studies also revealed that simo decoction may
      improve the return of gastrointestinal function after hepatic resection of HCC. Therefore,
      the present study compared the effect of gum chewing and simo decoction after hepatic
      resection of HCC on POI, surgical complications, and length of hospital stay.
    


Intervention name(s): simo decoction; gum chewing
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a phase 2, 52-week international, multi-regional, multi-center, randomized,
      double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.
    


Intervention name(s): GLPG1972; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablets of GLPG1972 for oral use.; Film-coated tablets of matching placebo for oral use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Condition: Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to examine the clinical dose range of ASP1585 based on the
      efficacy, safety, and feasibility of treatment in chronic kidney disease patients on
      hemodialysis with hyperphosphatemia.
    


Intervention name(s): ASP1585
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): Bixalomer; Kiklin (R)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dose-finding; Hemodialysis; ASP1585; Chronic kidney disease
Comparison of Hemodynamic Changes by Using the Videolaryngoscope and the Macintosh Laryngoscope
Condition: Anesthesia Intubation Complication
Study type: Interventional

Summary: 
      Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might
      attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs
      comparatively less airway manipulation so, the investigators expect less hemodynamic response
      while using videolaryngoscope.
    

Detailed description: 
      The hemodynamic stress response to tracheal intubation can precipitate adverse cardiovascular
      events in patients with cardiovascular disease. Which is shown to greatly increase the risk
      of myocardial infarction or stroke, especially in elderly patients with hypertension. Direct
      laryngoscopy and laryngoscopic stimulation of pharyngolaryngeal structures may be an
      important factor in the hemodynamic stress response associated with tracheal intubation.

      Patients were randomly allocated to two groups using a permuted block randomization method:
      1) patients intubated by using the videolaryngoscopy 2) patients intubated by using the
      Macintosh laryngoscope . SAP, MAP, and heart rate were measured and recorded in the operating
      room: At baseline, before intubation, immediately after intubation and 1,2,3,4 and 5 minutes
      after tracheal intubation.
    

Intervention name(s): videolaryngoscope; Macintosh laryngoscope
Intervention type(s): Device; Device
Intervention description(s): patients intubated by using the videolaryngoscope; patients intubated by using the Macintosh laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: videolaryngoscope; direct laryngoscope; hemodynamic changes; elderly patients
Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg
      dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to
      clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.
    

Detailed description: 
      An international, multi-center, single-blind, randomized, active-controlled study with two
      parallel groups in patients with bacterial vaginosis. Eligible patients were randomized to
      receive Fluomizin vaginal tablets for 6 days or Clindamycin vaginal cream (2%) for 7 days.
      Control examinations were performed 3 to 14 days and 2 to 6 weeks after the end of the
      therapy.
    

Intervention name(s): Dequalinium chloride; Clindamycin
Intervention type(s): Drug; Drug
Intervention description(s): Vaginal tablet, 10mg, 1 tablet daily for 6 days; vaginal cream, 2%, once daily for 7 days
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Dequalinium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Fluomizin; Dequalinium chloride; Bacterial vaginosis; vaginal therapy
A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The aim of this work is to investigate the clinical performance and subjective acceptance of
      the comfilcon A asphere contact lens when compared to single-vision spectacles in subjects
      who have never worn contact lenses and who use digital devices (such as phones, tablets,
      laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.
    

Detailed description: 
      The aim of this clinical work is to compare the clinical performance and subjective
      acceptance of comfilcon A asphere contact lens when compared to single-vision spectacles in
      subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4
      hours per day on at least 5 days per week. Subjects will be randomized to use either their
      habitual spectacles or the study contact lenses for two months.
    

Intervention name(s): comfilcon A asphere; Spectacles
Intervention type(s): Device; Device
Intervention description(s): Contact Lens; Habitual spectacles
Other intervention name(s): test; Control; Single Vision Spectacles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy
Condition: Cholecystitis
MeSH terms: Cholecystitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal
      invasiveness, less post-operative pain and early recovery when compared to the open
      conventional cholecystectomy. However, patients who have undergone LC still complain of
      postoperative pain. It has been reported that ondansetron produces numbness when injected
      under the skin and has local anesthetic effect that is 15 times more potent than lidocaine
      the most widely used local anesthetic and probably explains its antiemetic action. It
      possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions
      as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have
      a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP
      administration of ondansetron on pain management post LC.
    


Intervention name(s): Ondansetron; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Interperitoneal administration in the gall bladder bed; Interperitoneal administration in the gall bladder bed
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Phase II Multi-Center Study of T89 to Treat Chronic Stable Angina
Condition: Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the anti-angina effect and dose response of T89, a
      2-herb botanical drug product, in patients with chronic stable angina pectoris in the United
      States.
    

Detailed description: 
      T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89
      was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due
      to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993.
      There were more than 2 billion doses have been prescribed or used, in about 10,000,000
      subjects, in short or long-term administration worldwide.

      The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore,
      Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose
      response of T89 in patients with chronic stable angina pectoris in the United States.

      T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN)
      as active constitutes, and using Borneol as transporting enhancer.
    

Intervention name(s): T89
Intervention type(s): Drug
Intervention description(s): A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
Other intervention name(s): Dantonic Capsule; Cardiotonic Pills
Intervention MeSH terms: Cardiotonic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Angina Pectoris Treatment