bioihbjkbjnl/mcl2 huggingface dataset:
Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy
Condition: Laparoscopic Cholecystectomy; Gall Stone Disease; Biliary Tract Anatomy; Common Bile Duct Stones.
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be
      difficult, time consuming and bile duct injury may be caused by attempts to cannulate the
      cystic duct. Operative cholangiography performed by direct puncture of the gall bladder
      fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.
    

Detailed description: 
      This study was conducted on 60 patients with symptomatic gall bladder stones undergoing
      laparoscopic cholecystectomy. Patients were randomized into two groups: Group (1) was
      evaluated by cholecyst-cholangiography by puncture through the gall bladder fundus. Group (2)
      was evaluated for the standard cystic duct cholangiography.Cholangiography was considered
      successful if it could be performed with complete delineation of the biliary tree with flow
      of the dye through the duodenum occurred. It is to be noted that inability to cannulate the
      cystic duct for example, is considered a failure.
    

Intervention name(s): cholecystocholangiography; cystic duct cholangiography
Intervention type(s): Procedure; Procedure
Intervention description(s): a central venous pressure catheter was introduced through the anterior abdominal wall subcostally in a direction parallel to the gallbladder bed under direct vision so that it emerges close to the gall bladder. Then the catheter was advanced into the fundus of the gall bladder . The dye was prepared by diluting 20ml of 76% urografin with 20ml normal saline in a 50ml syringe; Then a 14G cannula was introduced through the anterior abdominal wall subcostally, (size 4F), was introduced through this cannula. The catheter was inserted into the cystic duct no more than 1 cm, by a grasper Then a 50ml syringe with the diluted urografin dye, as above, was attached to the catheter and cholangiography was performed by slowly injecting the dye under control of C-arm image intensifier.
Other intervention name(s): cholangiography via gallbladder; cholangiography via cystic dict
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Laparoscopic cholecystectomy; Intra-operative cholangiography
Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      This single-group, small-scale, open-label study (N= 25 to 50) will evaluate the impact of
      combination zonisamide and bupropion on the process of switching from combustible cigarettes
      (CC) to an e-cigarette. There will be a data collection period of at least five days to
      obtain baseline data on use of combustible cigarettes. Participants enrolled in the study
      will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette
      use, (at V3) participants will be given zonisamide (100 mg/daily) and will begin
      extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) in
      addition to continued use of the G6. At each visit, participants will receive enough
      zonisamide, bupropion, and Halo G6 cartomizers to last until their next study visit. Halo G6
      and combination zonisamide and bupropion use will continue until the participant returns for
      the End-of-Study visit (V7).
    


Intervention name(s): Zonisamide; Bupropion; Halo G6 e-cigarette
Intervention type(s): Drug; Drug; Other
Intervention description(s): Zonisamide (100 mg/daily) for 12 weeks.; Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.; G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.
Other intervention name(s): zonegran; wellbutrin; Zyban; e-cigarette
Intervention MeSH terms: Zonisamide; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: e-cigarette; zonisamide; bupropion; combustible cigarettes
Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery
Condition: Arthroplasty, Replacement; Thromboembolism
MeSH terms: Thromboembolism
Study type: Observational

Summary: 
      An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate
      additional data in predefined sub populations of patients at increased risk of bleeding or
      VTE
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subgroups of the general population
Usefulness of Selegiline as an Aid to Quit Smoking - 1
Condition: Tobacco Use Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite the widespread use of nicotine replacement therapies for the treatment of nicotine
      dependence, many smokers are still unable to quit smoking. The purpose of this study is to
      determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.
    

Detailed description: 
      Despite the availability of nicotine replacement therapies and sustained-relapse bupropion
      for the treatment of nicotine dependence, there is still a significant proportion of
      cigarette smokers who are unable to quit smoking. Therefore, new and effective
      pharmacotherapies for smoking cessation are needed. The primary aim of this study is to
      determine the safety and efficacy of selegiline as an aid to smoking cessation.

      In this study, 200 nicotine-dependent cigarette smokers will participate in an 8-week,
      double-blind, placebo-controlled trial and then will be followed over 4 years. Participants
      will be randomly assigned to receive either selegiline or placebo. Selegiline doses of 5 mg
      will be taken once a day during the first week. This will be increased to 5 mg twice daily
      for the remaining 7 weeks. The target smoking "quit date" will be Day 15. All smokers will
      receive brief weekly manualized smoking cessation counseling from the Mayo Clinic's "Smoke
      Free and Livin' It" program. The primary smoking cessation outcome measure will be 7-day
      point prevalence smoking abstinence at the 6-month follow-up. Secondary cessation outcome
      measures will include continuous smoking abstinence during the last four weeks of the trial
      (Days 29-56) and 7-day point prevalence abstinence at the end of the 8-week trial (Days
      49-56).
    

Intervention name(s): Selegiline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
Other intervention name(s): L-deprenyl; Eldepryl®
Intervention MeSH terms: Selegiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tobacco
A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the pharmacokinetics (behavior of the
      compound in the body) of safinamide in patients with different degrees of hepatic (liver)
      impairment in comparison to matched subjects with normal hepatic function.
    


Intervention name(s): safinamide; safinamide; safinamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of 50mg safinamide on Day 1; single dose of 50mg safinamide on Day 1; single dose of 50mg safinamide on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic impairment; Liver diseases; Pharmacokinetics; To Investigate Pharmacokinetics of Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Healthy Subjects With Normal Hepatic Function
Sedation Monitoring During Open Muscle Biopsy in Children
Condition: Sedation Monitoring in Children
Study type: Observational

Summary: 
      The purpose of this study is to compare sedation monitoring by bispectral index and comfort
      score during open muscle biopsies in children.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children aged 1-18 years undergoing open muscle biopsy as diagnostic procedure
      
Keywords: BIS; Comfort; open muscle biopsy
Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can
      provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer
      (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in
      several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's
      disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a
      common neurodegenerative disease characterized by motor dysfunctions, originally described by
      James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss,
      which may correlate with RNFL thinning. Previous studies on this subject, however, reported
      contradicting results. Some investigations reported reductions of the RNFL thickness while
      others did not. In the present study, in order to determine whether RNFL thickness is reduced
      in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness
      measurements with OCT in a series of PD patients and in the healthy control groups.
    


Intervention name(s): Optical coherence tomography
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        PD patients and healthy subjects were included and underwent OCT examinations
      
Keywords: retinal nerve fiber layer thickness; optical coherence tomography; Parkinson disease
Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period.
      Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks
      followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this
      study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine
      alone in patients with chronic hepatitis B infection.
    


Intervention name(s): Clevudine; Purified hepatitis B surface antigen
Intervention type(s): Drug; Biological
Intervention MeSH terms: Clevudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Examination of Operative Approach in pwFSHD (Patient With Facioscapulohumeral Muscular Dystrophy)
Condition: Facio-Scapulo-Humeral Dystrophy
MeSH terms: Muscular Dystrophy, Facioscapulohumeral
Study type: Observational

Summary: 
      Facioscapulohumeral Muscular Dystrophy (FSHD) is one of the most common forms of muscular
      dystrophy, characterized by pronounced skeletal novelistic weakness and with a broad spectrum
      of diseases. It is a hereditary disease seen in 3-5/100,000 of society, usually starting with
      weakness in the facial and shoulder muscles and progressing to the trunk, pelvis and leg
      muscles, giving symptoms in the twenties. In FSHD, which shows slow progression and can lead
      to loss of ambulation ability in about 20% of patients, patients may have difficulty
      performing activities above shoulder level with the influence of the periscapular area.

      Skeletal muscle weakness leads to posture and balance disorders, and postural instability is
      a common problem in patients with FSHD. Weakness of the trunk and lower limb muscles found in
      more than half of patients causes problems with postural balance and walking. The calf,
      iliopsoas, and gluteus maximus muscles together form the main determinants of walking speed
      in healthy people, where kalf muscles are known to contribute the most. Individuals with FSHD
      have been reported to have decreased speed, step length, and step frequency compared to
      healthy controls. Impaired upper body control can compromise the maintenance of dynamic
      stability. In patient with FSHD the effects of muscle tone, motor coordination, loss of joint
      range of motion and muscle weakness on posture, balance control and gait are observed more
      clearly.

      The aim of the study was to compare the effects of scapular management treatments on balance
      and gait in FSHD patients.

      H0: There is no difference in balance and walking parameters of patients with FSHD who have
      had scapulothoracic arthrodesis surgery and have not undergone surgery.

      H1: There is a difference in balance and walking parameters of patients with FSHD who have
      had scapulothoracic arthrodesis surgery and have not undergone surgery.
    

Detailed description: 
      Voluntary patients who have been diagnosed with FSHD will be included in the study. Signed
      voluntary consent will be obtained from participants. Participants will be divided into two
      groups. One group will include patients who have undergone scapulothoracic arthrodesis
      surgery, while the other group will include patients who have not undergone surgery. Both
      groups will undergo some outcome measures to assess their balance and walking.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with FSHD and undergoing scapulothoracic arthrodesis or non-operating
      
Keywords: scapulotorasic arthrodesis; balance; gait; evaluation; usual care
Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage
Condition: Abnormal Uterine Bleeding; Anxiety
MeSH terms: Uterine Hemorrhage; Dilatation, Pathologic; Anxiety Disorders
Study type: Interventional

Summary: 
      Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D&C) will
      be randomized to a multimedia-based education (MME group) or verbal information (Control
      group ) before (D&C). State-Trait Anxiety Inventory will be asked by the nursing staff before
      and after multimedia-based education or verbal information to all patients. Then the patients
      will undergo (D&C) at an office setting. The impact of MME on patient anxiety will be
      evaluated by statistical analysis.
    

Detailed description: 
      Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D&C) with
      diagnostic or treatment purpose will be randomized to two intervention arms.
      Multimedia-education Group (MME group) and verbal information group (Control Group). Both
      groups will receive State-Trait Anxiety Inventory before and after education and then will
      undergo D&C at an office setting. State-Trait Anxiety Inventory will be asked by the nursing
      staff. Multimedia-based education will be carried out using a 5 minutes video explaining the
      details of D&C. D&C will be carried out at office setting by an experienced gynecologist
      under sedation and analgesia.
    

Intervention name(s): Multimedia- based patient education
Intervention type(s): Behavioral
Intervention description(s): Patients will receive a 5 minutes video education before D&C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dilatation and curettage; multimedia based education; anxiety
Comparison of Three Antibiotic Protocols in Prevention of Infection in Dental Implant Surgery
Condition: Dental Implant Failed
MeSH terms: Infections
Study type: Interventional

Summary: 
      Subjects who underwent a dental implant surgery were studied.Subjects randomly were aligned
      into three groups:In group 1, subjects received prophylactic antibiotic orally (Amoxicillin
      2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five
      days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before
      surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin
      500 mg , q8h for five days). The sign and symptom of infection were studied and the incidence
      of infection in each group was determined.
    

Detailed description: 
      Subjects eligible for study inclusion had an edentulous area in the mandible or maxilla and
      underwent a dental implant surgery. Subjects were excluded from study enrollment if they had
      systemic diseases which affect bone metabolism, history of allergy to amoxicillin, refused
      study enrollment or failed to return for follow-up.

      Subjects were randomly divided into three groups : In group 1, subjects received prophylactic
      antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic
      (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic
      (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received
      post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) . An independent researcher
      made random allocation cards using computer-generated random. Then, allocated cases were
      placed in a sealed envelope. All subjects used 0.2% chlorhexidine mouthwash in the treatment
      period. All implants were placed with a two-stage protocol.

      All subjects were followed up for 3 months to assess any infection signs and symptoms.
      Infection was diagnosed based on clinical findings such as pain, redness of the area, and
      discharge around the fixture.An independent dentist who was blind the study groups, evaluated
      all subjects.
    

Intervention name(s): Amoxicillin
Intervention type(s): Drug
Intervention description(s): Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.
Other intervention name(s): GLAXOSMITHKLINE
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: subjects were aligned randomly into three groups.In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) .
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: dental implant; osseointegration; infection
Safety of Non-delayed Weight Bearing After Total Hip Replacement With Non-Cemented Fiber Metal Taper Stem
Condition: Osteoarthritis; Pain
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if full weight bearing following total hip
      replacement can speed recovery when the hip replacement in the long bone of the leg is not
      cemented into the bone. When cement is used, most surgeons allow full or nearly full weight
      bearing following hip replacement. One drawback to cementless implants has been the
      restriction of weight bearing for six to eight weeks after surgery, during which time
      patients are allowed to only put their foot flat on the floor of the operated leg without
      bearing weight on that leg. This study compares the effect of immediate weight bearing on the
      speed of recovery from hip replacement surgery in two groups of patients receiving a
      non-cemented total hip replacement: one group is randomly assigned to not bear weight, and
      the other group is randomly assigned to allowed, tolerated weight bearing from the day of
      surgery forward.
    

Detailed description: 
      Patients undergoing non-cemented total hip arthroplasty with a Zimmer Fiber Metal Taper Stem
      and who meet the inclusion and exclusion criteria are offered the informed consent process.
      Those consenting are randomized following surgery by flip of a coin into one of two groups:
      Weight Bearing as Tolerated or Toe Touch Weight Bearing Only. Each patient is followed for
      two years, and is seen at 6 weeks, 3 months, 1 year and two years. Questionnaires are
      completed including the Harris Hip Score and the SF-36. Patients complete a compliance survey
      to determine behavior related to their study group assignment and compliance with their study
      group. Radiographs are obtained at each post-operative interval and subsidence is evaluated
      and recorded. Range of motion and ambulation are assessed and recorded also.
    

Intervention name(s): Patient may be able to put weight on the operated leg
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight-Bearing; Total Hip Replacement; Non-cemented; Randomized; Fiber-Metal-Taper-Stem; Hip; Osteoarthritis
A Study of Taspoglutide in Type 2 Diabetic Patients
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This crossover study will assess the effect of 2 doses of Taspoglutide on first- and
      second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a
      continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide
      300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or
      b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be
      crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive
      placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion
      patterns will be assessed. The anticipated time on study treatment is <3 months, and the
      target sample size is <100 individuals.
    


Intervention name(s): Placebo; taspoglutide; taspoglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sc for 4 days; 300micrograms/day sc for 2 days; 800 micrograms/day sc for 2 days
Intervention MeSH terms: Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment