bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Efficacy of Anacetrapib (MK-0859) Among Participants With Hypercholesterolemia When Added to Ongoing Statin Therapy (MK-0859-022)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effects of anacetrapib on low-density lipoprotein-cholesterol
      (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with
      hypercholesterolemia when added to an existing statin therapy.
    


Intervention name(s): Anacetrapib; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): MK-0859
Intervention MeSH terms: Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transcranial Magnetic Stimulation in Spino-Cerebellar Ataxia
Condition: Spinocerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
Study type: Interventional

Summary: 
      Spinocerebellar Ataxia (SCA) refers to a family of genetic diseases that cause progressive
      problems with gait and balance, as well as other debilitating symptoms. This is a randomized
      controlled pilot study to test a novel therapeutic intervention that uses noninvasive
      magnetic brain stimulation to improve functional outcomes in patients with SCA. The study
      will include quantitative evaluations of gait, balance, and brain physiology to examine
      possible objective end-points for a future, larger multi-site clinical trial. The
      investigators anticipate that patients receiving the real intervention will show a functional
      gain.
    

Detailed description: 
      Spinocerebellar Ataxia (SCA) refers to a family of genetic diseases that cause progressive
      problems with gait and balance, as well as other debilitating symptoms. There is no cure for
      SCA and a lack of an effective symptomatic treatment.

      Investigators will recruit 20 patients with genetically-confirmed SCA to use a novel approach
      - noninvasive transcranial magnetic stimulation (TMS) - to improve balance, gait, and posture
      in patients with SCA. Half will be randomly assigned to a real intervention, and half to a
      sham (control) intervention. The TMS intervention will consist of 20 stimulation sessions
      over a four week period. At baseline and follow-up, patients will undergo comprehensive
      assessments including several SCA rating scales, along with sophisticated tests of balance
      (ie. walking, standing, and muscle coordination). Patients will also complete a series of
      neurophysiologic tests to evaluate the function of the cerebellum and its connections before
      and after the intervention.

      Investigators anticipate patients receiving real TMS will show better balance, fewer falls,
      and improved mobility, while those undergoing sham stimulation will show no benefits. If our
      prediction is correct, this study will provide evidence-based support for a new treatment to
      improve the lives of patients with SCA.
    

Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.
Other intervention name(s): Magstim 200
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinocerebellar Ataxia; SCA; Ataxia; Transcranial Magnetic Stimulation; TMS
Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the
      lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with
      pravastatin in subjects with mixed dyslipidemia.
    


Intervention name(s): Muraglitazar
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Mixed Dyslipidemia
Minimum Effective Volume of Local Anesthetic Using Ultrasound for Brachial Plexus Block
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the minimum effective volume of local anesthetic
      for interscalene brachial plexus block using ultrasound guidance and nerve stimulator
      guidance.
    

Detailed description: 
      This will be a single group assignment, double-blind, up-down sequential allocation study.
      Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are
      undergoing shoulder surgery. This block has a low, but still significant, rate of
      complications. Reducing the volume of local anesthetic given during the block may allow some
      of these complications to be avoided. Participants will undergo ISBPB under ultrasound and
      nerve stimulator guidance. Patients will initially receive 15mL of local anesthetic
      (bupivacaine 0.5% with epinephrine). The volume used for each subsequent patient depends upon
      the success or failure of the previous patient's block - a failure will cause the volume
      given to increase by 1.0 mL, while a success will cause the volume to decrease by the same
      amount.

      The goal of this study is to determine the minimum effective anesthetic volume of bupivacaine
      0.5% providing anesthesia in patients when using ultrasound and nerve stimulator to guide
      placement of the block. The secondary outcome will be the evaluation of diaphragmatic
      function and post-surgery analgesia.
    

Intervention name(s): bupivacaine 0.5%
Intervention type(s): Drug
Intervention description(s): Patients will be given bupivacaine 0.5% in different doses (up-down study).
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this work is to compare two protocols (ketamine-midazolam versus
      fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find
      the most safe protocol with regards to hemodynamic status of patients
    

Detailed description: 
      Induction of anesthesia in hemodynamically compromised patients is a challenge for every
      anesthetist. Most of the intravenous induction agents have a negative effect on arterial
      blood pressure and cardiac output. Theoretically, the "ideal" emergency induction intravenous
      anesthetic should achieve rapid hypnosis and maintain the hemodynamic stability.

      Ketamine has been reported as an induction anesthetic with a sympathomimetic activity. In
      patients with intact autonomic nervous system ketamine increases heart rate, cardiac output,
      and arterial blood pressure (ABP). Despite its sympathomimetic activity in hemodynamically
      stable patients, the hemodynamic response to ketamine in unstable cardiovascular conditions
      is not clear. No studies to the best of our knowledge compared Ketamine-based and
      opioid-based protocols in rapid sequence induction of anesthesia in hemodynamically unstable
      patients.

      In this study, patients with severe sepsis or septic shock scheduled for surgery will be
      assigned to receive either ketamine or fentanyl for induction of anesthesia. After induction
      of anesthesia, endotracheal tube will be inserted aided by succinyl choline. Invasive blood
      pressure will be monitored through a transducer connected to arterial catheter. Electrical
      velocimetry (cardiometry) device will be used for non-invasive monitoring of cardiac output
      and stroke volume.
    

Intervention name(s): Ketamine; Fentanyl; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive :1 mg/Kg ketamine for induction of anesthesia; Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia; Patients will receive 0.05 mg/Kg midazolam
Other intervention name(s): Katalar; Dormicum
Intervention MeSH terms: Midazolam; Fentanyl; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood
Condition: Cognitive Function
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3
      polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory,
      attention, working memory, executive function), subjective mood, alertness and mental fatigue
      after 26 weeks daily supplementation.
    


Intervention name(s): 3 g PronovaPure 150:500 EE EU; 3 g PronovaPure 500:200 EE EU; 3 g Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I
Condition: Diabetes Mellitus, Type 2; Insulin Resistance; Obesity
MeSH terms: Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80%
      (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases.
      The current consensus supports bariatric surgical treatment for diabetic patients with BMI as
      low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the
      surgery as well.

      This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI
      30-35) human volunteers on incretins, insulin production and sensitivity and its clinical
      (diabetic chronic complications) and metabolic impact.
    

Detailed description: 
      Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80%
      (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases;
      most of the remainder achieve better glycemic control, even if they regain weight. The
      current consensus supports bariatric surgical treatment for diabetic patients with BMI as low
      as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery
      as well.

      Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2,
      i.e., any grade of obesity.

      This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella
      technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35)
      human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic
      chronic complications) and metabolic impact.
    

Intervention name(s): Roux-en-Y Bypass Gastroplasty
Intervention type(s): Procedure
Intervention description(s): Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch. A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.
Other intervention name(s): Roux-en-Y Gastric Bypass
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus, type 2; Insulin resistance; Intra-Abdominal Fat; Omentum; duodenal exclusion; bariatric surgery; Glucagon-Like Peptide 1; Gastric Inhibitory Polypeptide; insulin; glucagon; ghrelin; adiponectin; Cytokines
The Effects of Overfeeding on Obesity-Prone (OP) and Obesity-Resistant (OR) Women
Condition: Obesity; Thinness; Weight Gain
MeSH terms: Obesity; Weight Gain; Thinness
Study type: Observational

Summary: 
      This is a longitudinal cohort study of how the responses to a 3 day period of controlled
      overfeeding relate to subsequent weight gain. We hypothesize that thin individuals are
      resistant to weight gain because they respond to periods of overfeeding by increasing fat
      oxidation, reducing food intake, and increasing physical activity relative to those who gain
      weight over time.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects have been recruited through advertisements in local news media and on the internet
      
Biospecimen description: 
      Blood and urine
    
Keywords: obesity; thinness; weight gain; physical activity; diet; fat oxidation; hunger; feeding behavior; overfeeding
Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass
Condition: Analgesics, Opioid
Study type: Interventional

Summary: 
      Opioid free anesthesia is a recent anesthesia technique with the aim to avoid peroperative
      use of morphinics to allow a diminution of secondary morphinics effects in the postoperative
      period.

      There is no robust data on the real benefits of such procedures. Obese patients are
      particular at risk of secondary effects of opioids. The aim of our study is to compare opioid
      free anesthesia to multimodal anesthesia on postoperative morphine consumption after a
      laparoscopic gastric bypass.
    

Detailed description: 
      The aim of the study is to study the impact of an opioid free anesthesia protocol on the
      postoperative morphine consumption in laparoscopic gastric bypass compared to a multimodal
      anesthesia protocol.

      183 morbidly obese patients (Body mass index >40Kg/m2 or >35kg/m2 AND/OR diabete mellitus
      AND/OR sleep apnea syndrome AND/OR arterial hypertension.

      A randomization will allocate two groups of 100 patients in:

        -  Group 1: Multimodal anesthesia without opioids

        -  Group 2: Multimodal anesthesia with opioid The patient, the anesthesist and the data
           evaluator will be all blinded about the allocation of the patient.
    

Intervention name(s): Dexmedetomidine Injection [Precedex]; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): dexmedetomidine or remifentanil during laparoscopic gastric bypass; dexmedetomidine or remifentanil during laparoscopic gastric bypass
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Improving Quality of Primary Care for Patients With Anxiety and/or Panic Disorders
Condition: Panic Disorder; Anxiety Disorder
MeSH terms: Anxiety Disorders; Panic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if primary care patients with panic and/or
      generalized anxiety disorder can benefit from a telephone-based collaborative care
      intervention.
    

Detailed description: 
      Panic and generalized anxiety disorders are serious conditions that often are inadequately
      recognized and treated, responsible for significant morbidity, and associated with excessive
      health services' utilization. More effective treatment interventions that involve both
      primary care physicians (PCPs) and patients are necessary to manage these conditions.

      Patients presenting for primary care services will be screened for panic and generalized
      anxiety disorders using the Primary Care Evaluation of Mental Disorder (PRIME-MD); patients
      and their PCPs will be informed of patients' diagnosis. Participants will then be randomly
      assigned to receive either a telephone-based collaborative care intervention or their PCPs'
      usual care.

      The telephone care intervention will involve a protocol that is based on the American
      Psychiatric Association's and other published guidelines for treating panic disorder (PD) and
      generalized anxiety disorder (GAD). The care manager will assess each patient's treatment
      preferences for either anxiolytic pharmacotherapy, a self-management workbook, referral to a
      community mental health specialist, or some combination of these. The care manager will
      conduct periodic telephone follow-up interviews with intervention participants to inquire
      about anxiety symptoms, treatment adherence, review lesson plans, and any side effects they
      have experienced, as applicable. The care manager maintains correspondence with the PCPs of
      the telephone intervention participants via an electronic medical record system to rapidly
      relay information regarding patients' treatment and obtain the PCPs approval for initiating
      or adjusting pharmacotherapy according to the patient's response to treatment and protocol.

      A blinded research assistant who is unaware of participants' randomization group will conduct
      telephone interviews with all participants to assess the effectiveness of the intervention
      relative to the usual care control condition. These interviews will be conducted at baseline
      and at 2-, 4-, 8-, and 12-months follow-up. Measures assessed include anxiety symptoms,
      functional status, health services utilization, and overall quality of life.
    

Intervention name(s): Telephone-based collaborative care management
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Anxiety; Panic; Generalized Anxiety Disorder
The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill
Condition: Climacteric Syndrome
Study type: Observational

Summary: 
      To investigate the effect of LBFKBRP on climacteric syndrome in women and explore its
      therapeutic mechanism.
    


Intervention name(s): Luo-Bu-Fu-Ke-Bi-RI Pill; tibolone
Intervention type(s): Drug; Drug
Intervention description(s): 10 pills twice daily; 2.5 mg once daily
Intervention MeSH terms: Tibolone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        female
Preliminary Investigation of Novel Methods to Reduce Children's Secondhand Smoke Exposure
Condition: Secondhand Smoke
Study type: Interventional

Summary: 
      The overall aim of the current study is to determine if the use of nicotine containing
      products by caregivers who smoke and who are not interested in quitting, is effective in
      reducing children's secondhand smoke exposure.
    


Intervention name(s): Nicotine polacrilex; Electronic Cigarette; Dissolvable Tobacco Lozenge
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.; Participants were given an e-cigarette starter kit, charging case, and cartridges in either 12mg or 16 mg nicotine, depending on their current amount of cigarettes smoked per day.; Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, >2 packs per day).
Other intervention name(s): Nicorette; Smoke Tip; Ariva, Stonewall
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Methods of Weight Loss in Overweight Coronary Patients
Condition: Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight
      loss counseling would lead to a greater loss of fat mass and a greater improvement in
      cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation
      exercise plus counseling.
    

Detailed description: 
      We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight
      loss counseling would lead to a greater loss of fat mass and a greater improvement in
      cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation
      exercise plus counseling.

      The study population consists of overweight (BMI >27) patients with established coronary
      heart disease. The exercise and counseling program was of 4 months duration with extended
      follow up at 1 year.
    

Intervention name(s): high caloric expenditure exercise; low caloric expenditure exercise plus dietary counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): high caloric expenditure exercise plus dietary counseling; low caloric expenditure exercise plus dietary counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Obesity; coronary heart disease; coronary risk factors; weight loss; exercise
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil
      compared with losartan potassium in patients with mild to moderate essential hypertension.
    


Intervention name(s): olmesartan medoxomil; losartan potassium
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets, once daily for 8 weeks; capsules, once daily for 8 weeks
Intervention MeSH terms: Losartan; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment