bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy
Condition: Pain, Postoperative; Cholecystectomy, Laparoscopic
MeSH terms: Shoulder Pain; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effect of premedication with pregabalin or
      gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.
    

Detailed description: 
      Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to
      surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and
      vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in
      the intensity of postoperative pain after laparoscopic surgery.
    

Intervention name(s): Pregabalin 75mg; Gabapentin 300mg; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.; In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.; In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
Other intervention name(s): placebo
Intervention MeSH terms: Pregabalin; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: pregabalin; gabapentin; post operative pain; laparoscopic cholecystectomy
A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Observational

Summary: 
      The objective of this research study is to compare the tolerability and effectiveness of
      Combigan(brimonidine tartrate/timolol maleate) and Cosopt (dorzolamide hydrochloride)in the
      treatment of open angle glaucoma or ocular hypertension.
    

Detailed description: 
      Patients between the ages of 40 to 90 years of age, that have been diagnosed with open angle
      glaucoma or ocular hypertension,including pseudo-exfoliation and pigmentary glaucoma with
      definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss, who have
      been receiving a stable treatment regime for at least 4 weeks prior to the study initiation,
      with a Cosopt mono or a Prostaglandin + Cosopt combination are to be included in the
      study.Patients must have an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at
      baseline.

      Patients with any other form of glaucoma other than primary open angle glaucoma, with a
      gonioscopy measured angle grade of less than 2, with a visual field defect not of
      glaucomatous origen and previous cyclodestructive procedures will be excluded.The use of
      ocular non steroidal and anti-inflammatory topical agents which inhibit cyclooxygenase and
      prostaglandin analog synthesis,the use of glucocorticoid therapy, and hypersensitivity to any
      of the study components also precludes involvement in the study. Any ocular laser therapy
      within the past three months, ocular inflammation or infection in the past three months or
      any history of trauma in the last six months will also exclude enrollment in the study.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community sample
      
Keywords: Open angle glaucoma; Ocular hypertension; Parallel comparison; Combigan; Cosopt
Study to Evaluate Novel Gastric Space Occupying Device
Condition: Obesity
Study type: Observational

Summary: 
      This will be an observational, prospective, non-randomized, pilot study to gain initial
      device experience on a novel space-occupying device in persons who are overweight or obese.
      No formal hypothesis testing will be conducted.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be selected from a community sample that satisfy the inclusion/exclusion
        criteria.
      
Keywords: medical device, space-occupying device
A Study of the Safety, Tolerability, and Pharmacodynamics of MK-8931 in Participants With Alzheimer's Disease (MK-8931-010 AM1 [P07820 AM1])
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and pharmacodynamics of three different doses of MK-8931, a
      ß-secretase inhibitor, in participants with mild to moderate Alzheimer's Disease (AD).
    


Intervention name(s): MK-8931; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-8931, capsules, at a dose of 12 or 40 mg, orally, once per day for 7 days; Placebo capsules, orally, once per day for 7 days
Other intervention name(s): SCH 900931
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen
      (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of
      the study vaccine. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Detailed description: 
      The primary study was designed to evaluate the immunogenicity and protective efficacy of
      hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical
      control group.

      The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the
      first vaccine dose and to further investigate the prevalence and incidence of other hepatitis
      B markers and the clinical significance of these at all time points from Year 16-20.

      No additional subjects will be recruited during this long-term follow-up study and no vaccine
      will be administered.
    

Intervention name(s): Engerix™-B
Intervention type(s): Biological
Intervention description(s): In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Long-term follow-up; Hepatitis B antibody persistence
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This study looks at changes in cell proteins in people with chronic hives treated with
      omalizumab.
    

Detailed description: 
      The purpose of this study is to evaluate for changes in the proteins produced in white blood
      cells (basophils) in patients with chronic hives who are treated with and respond to
      omalizumab.
    

Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention description(s): Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Idiopathic Urticaria; CIU; Urticaria; Chronic Hives; Xolair
Tolerance Study of the Dietary Supplement Lipidrive (ECPH1-03)
Condition: Obese
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this clinical study are to determine the tolerance of dietary supplement
      Lipidrive through the evaluation of several parameters :

        -  Various blood biological parameters

        -  Urinary parameters

        -  Hemodynamic indicators

        -  Cardiac function

        -  Anthropometric variables
    

Detailed description: 
      Primary objectives of this study :

      Evaluate the effects of two doses of the product on:

        -  Various blood biological parameters for tolerance (preprandial): blood glucose, insulin,
           HOMA-IR, glycated hemoglobin, fructosamine, total cholesterol, triglycerides,
           HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT,
           alkaline phosphatase, bilirubin, urea.

        -  Urinary parameters: urea, creatinine.

        -  Hemodynamic indicators: heart rate and blood pressure.

        -  Cardiac function: ECG.

        -  Anthropometric variables: weight, waist, hips, waist/hip ratio, body composition using
           bioelectric impendence analysis.

      Secondary objectives of this study:

      Evaluate the effects of the highest dose on:

      - Adiponectin, leptin, TNF-α, and the evolution kinetics of blood glucose and blood insulin
      levels following a standard breakfast, with or without the acute administration of the
      Lipidrive dietary supplement.

      Two questionnaires (one on eating habits over 3 days and another on physical and sports
      activities) will be completed at various times (cf. below). A "satisfaction" questionnaire
      will also be completed at the end of the study.

      A serum bank will be created (ghrelin, resistin, GIP, GLP-1, IL-6, IL-1 beta, CCK), and
      stools will be collected at V2 and V5 for subsequent microbiota analysis (aliquoting
      performed by the AME2P laboratory, which will send the samples to BIOFORTIS Nantes at the end
      of the trial).
    

Intervention name(s): Lipidrive
Intervention type(s): Dietary Supplement
Intervention description(s): LipiDrive, 4 to 8 capsules per day, oral administration. Dose 1: 2.6 g Lipidrive per day Dose 2: 5.2 g Lipidrive per day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oil Consumption and Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      More than 31 million U.S. adults have high total cholesterol and over 73 million U.S. adults
      have high LDL cholesterol. Cottonseed oil (CSO) is found readily in our food supply, and
      recent research has shown improvements in blood lipids following CSO consumption in healthy
      adults with normal cholesterol profiles. To date, however, there are no published studies on
      the effects of CSO-enriched diets on blood lipids and markers of health in an older
      population with hypercholesterolemia. Therefore, the purpose of this study is to test the
      health effects of a diet rich in CSO against a diet rich in olive oil to determine if the
      CSO-enriched diet will show greater improvements in blood lipids and other health markers in
      adults with high cholesterol levels. If CSO in the diet is found to improve these markers,
      these study findings could lead to improvements in health.
    

Detailed description: 
      This was a single-blind, randomized controlled trial. Investigators recruited subjects with
      hypercholesterolemia (high blood cholesterol levels). Subjects were randomized into one of
      two groups: (1) Cottonseed oil (CSO), (2) Olive oil (OO). The interventions consist of
      identical foods that are only different in the respective oil they are prepared with.

      There was a screening visit and 3 testing visits: Baseline (visit 2), mid-visit at week 4
      (visit 6), and post-visit at week 8 (visit 10). Anthropometrics, questionnaires, and a
      fasting blood sample were collected at each visit. At visits 2 and 10 participants
      participated in a saturated fatty acid meal challenge in which additional blood and
      metabolism measurements were collected. Visits 3-9 represent weekly meal pickups, with the
      exception of visit 6 which is also a testing visit.

      Hypothesis: Investigators hypothesized that enrichment of the diet with CSO would result in
      significantly greater improvements in blood lipids, metabolism, and appetite compared to the
      OO group.
    

Intervention name(s): Cottonseed Oil; Olive Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants are provided about 60% of their required energy for 8 weeks as foods from a 5 day cycle menu that are enriched with Cottonseed Oil; Participants are provided about 60% of their required energy for 8 weeks as foods from a 5 day cycle menu that are enriched with Olive Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 8 week parallel feeding trials of diets rich in Cottonseed oil or Olive Oil
Masking: Single (Participant)
Primary purpose: Prevention
Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients
Condition: Carpal Tunnel Syndrome; Chronic Pain; Scleroderma
MeSH terms: Carpal Tunnel Syndrome; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Syndrome; Chronic Pain
Study type: Interventional

Summary: 
      Carpal tunnel syndrome is a common peripheral entrapment neuropathy, this study aims to
      investigate if, and to what extent local ozone therapy could offer symptom improvement in
      scleroderma patients with Carpal tunnel syndrome
    

Detailed description: 
      Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities.
      Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general
      population, 3 and 7.8% in the working population. It occurs at any age, especially in
      individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of
      treatment modalities have been tried to improve the condition, starting from local anesthetic
      injection, steroid, and up to surgical decompression of the nerves.

      Scleroderma patients are a special group which usually sufferers from such problem
    

Intervention name(s): Ozone; methylprednisolone acetate
Intervention type(s): Drug; Drug
Intervention description(s): After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance; After prepping and draping the area, intracarpal injection of methylprednisolone acetate 40mg, and 40 mg lidocaine (20 ml, volume) will be performed under sonographic guidance
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Functional Electrical Stimulation
Condition: Rupture of Anterior Cruciate Ligament
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The purpose of this study is to examine the short term effect of functional electrical
      stimulation treatment versus neuro-muscular electrical stimulation on gait quality for
      patient after anterior cruciate ligament reconstruction.
    

Detailed description: 
      Background: Quadriceps weakness is common following anterior cruciate ligament (ACL)
      reconstruction. The inadequate quadriceps strength contributes to altered gait patterns
      following ACL reconstruction. Neuromuscular electrical stimulation (NMES) has been shown to
      reduce quadriceps atrophy post-ACL reconstruction. However, the effect of functional
      electrical stimulation (FES), a modulation of NMES which enables quadriceps stimulation
      synchronized with gait, has not been tested.

      Objective: The aim of this study is to evaluate the effectiveness of FES to improve the gait
      pattern of patients post ACL reconstruction.

      Methods: Fifty six Individuals post-ACL reconstruction will be randomly placed into FES or
      NMES treatment group. All patients will receive a standard exercise program three sessions
      weekly. In addition, each group will receive a different electrical stimulation treatment:
      Neuromuscular Electrical Stimulation (NMES) or Functional Electrical Stimulation (FES).
      Outcome measures will include spatiotemporal gait measures (e.g., gait speed, single limb
      support, and asymmetry index), as well as isometric quadriceps strength. Measures will be
      taken a week before the surgery, a week after it, and one month from the beginning of
      rehabilitation. Strength and gait pattern will be measured. Isometric Quadriceps strength
      will measured using the Biodex isokinetic system, and gait analysis will be carried out
      through the spatio-temporal Optogait system.
    

Intervention name(s): Functional electrical stimulation; Neuro-muscular electrical stimulation; Active exercises
Intervention type(s): Device; Device; Procedure
Intervention description(s): Electrical stimulation that cause muscle contraction while walking; Electrical stimulation that cause muscle contraction in a stationary position; Subjects will receive training exercise according to ACL reconstruction protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anterior cruciate ligament reconstruction; Functional Electrical stimulation; Gait analysis; Physical therapy
The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on
      the pharmacokinetics of oral calcitriol (ROCALTROL)
    


Intervention name(s): Calcitriol; Lanthanum carbonate + Calcitriol; Sevelamer carbonate + Calcitriol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.; Lanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.; Sevelamer carbonate (2400 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
Other intervention name(s): Rocaltrol; Fosrenol + Rocaltrol; Renvela + Rocaltrol
Intervention MeSH terms: Calcitriol; Sevelamer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
Condition: Lymphoma; Acute Lymphoblastic Leukemia
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effect of a blood thinning drug called Apixaban
      versus no administration of a blood thinning drug, in preventing blood clots in children with
      leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and
      have a central line (a catheter inserted for administration of medications and blood
      sampling)
    


Intervention name(s): Apixaban; No systemic anticoagulant prophylaxis
Intervention type(s): Drug; Other
Intervention MeSH terms: Apixaban; Anticoagulants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Anticoagulation
Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding
Condition: Postmenopausal Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D
      power Doppler ultrasound using the international endometrial tumor analysis group and office
      hysteroscopy with taking samples for histopathological analysis.
    

Detailed description: 
      The aim was to compare the efficiency of the upper mentioned interventions in diagnosing the
      cause of postmenopausal bleeding.
    

Intervention name(s): 2D grey scale vaginal ultrasound; 3D power Doppler vaginal ultrasound; Office hysteroscopy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): To assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform).; To assess the endometrium using the IETA group criteria.; using the vaginoscopic approach to assess the uterine cavity and take sample.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with postmenopausal bleeding
      
Biospecimen description: 
      Sample from the uterine endometrium for histopathological analysis
Psychotherapy for Intermittent Explosive Disorder
Condition: Anger; Intermittent Explosive Disorder
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to examine the effectiveness two forms of psychotherapy (also known
      as "talk therapy" ) for individuals with anger and aggression problems. Anger and aggression
      are everywhere - on the road, in the schools, at little league games, at home, and at work.
      In this study we are testing usefulness of anger management techniques in reducing symptoms
      of Intermittent Explosive Disorder (IED) and impulsive, aggressive behavior.
    

Detailed description: 
      Qualified participants will be randomly assigned to 12 1-hour sessions of either
      cognitive-behavioral therapy or supportive psychotherapy.

      Participation in this study will require 16 visits over approximately 4 months with 3
      follow-up sessions over a 12 month period. Therapy is provided at no cost and each study
      participant will receive a comprehensive psychological assessment. Two types of talk therapy
      are being offered in this study. One form of therapy focuses on thought and behaviors
      associated with anger and aggression. This type of therapy is known as cognitive behavioral
      therapy. The other type of therapy focuses on the individuals' feeling about their anger
      /aggression and the situations that lead to this anger. This is known as supportive therapy.
      The form of therapy you are given will be randomly determined (like by flipping of a coin).
    

Intervention name(s): Cognitive Behavioral Therapy; Supportive Psychotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Twelve weekly therapy sessions, approximately one hour each in duration; Twelve weekly therapy sessions, approximately one hour each in duration
Other intervention name(s): Cognitive Restructuring, Relaxation, and Coping Skills Training
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: anger; intermittent; explosive