bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension
Condition: Genuine Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      When the studies in the literature including the mini-sling procedure and the laparoscopic
      buch colposuspension procedure are examined, it is seen that both methods are successful in
      the surgical treatment of stress urinary incontinence (SUI), but there is no study in which
      both procedures have been found to be superior to each other in terms of efficacy and safety.
      The aim of this study is to compare the minisling suburethral sling and laparoscopic buch
      colposuspension application in terms of efficacy and side effects in patients who will
      undergo surgical treatment due to genuine SUI.
    

Detailed description: 
      When the studies in the literature including the mini-sling procedure and the laparoscopic
      buch colposuspension procedure are examined, it is seen that both methods are successful in
      the surgical treatment of stress urinery incontinence (SUI), but there is no study in which
      both procedures have been found to be superior to each other in terms of efficacy and safety.
      The aim of this study is to compare the minisling suburethral sling and laparoscopic buch
      colposuspension application in terms of efficacy and side effects in patients who will
      undergo surgical treatment due to genuine SUI. Investigators planned to measure patients'
      Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the
      surgery and to determine how the operation affects the quality of life.
    

Intervention name(s): laparoscopic burch colposuspension operation; minisling suburethral sling
Intervention type(s): Procedure; Procedure
Intervention description(s): By pushing the urethra medially, two sutures are placed on the bladder at trigon level and midurethral and suspended on the bilateral iliopectineal ligament and colposuspension is supplied.; A vertical vaginal incision is made 1 cm below the external urethral meatus. It is followed by minimal vaginal dissection from the inferior portion of the ascending ramus of the ischiopubic bone to the obturator muscle. The arms of the mesh are fixed on both sides of the obturator internus muscle with the help of a trocar. After leaving a 1-2 mm gap between the mesh and the urethra, the vaginal wall is closed by suturing.
Other intervention name(s): minisling suburethral sling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genuine Stress Incontinence; minisling; laparoscopic burch
Airway Inflammation and Remodeling in Asthma and COPD.
Condition: Asthma; COPD
MeSH terms: Asthma; Inflammation
Study type: Observational

Summary: 
      Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases.
      Although the clinical features of asthma and COPD may be similar, the pathogenesis of these
      diseases differs in many aspects.

      The aim of this study is:

        -  to evaluate airway inflammation in asthma and COPD,

        -  to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,

        -  to assess the relationship between markers of airway inflammation and airway remodeling
           in asthma and COPD patients.

      Material and methods:

        -  mild to moderate asthma patients diagnosed in accordance with Global Initiative for
           Asthma (GINA) guidelines,

        -  mild to moderate COPD patients diagnosed in accordance with Global initiative for
           chronic Obstructive Lung Disease (GOLD) guidelines,

        -  healthy subjects as controls.

      Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC),
      bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway
      wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial
      ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.

      We plan to compare airway inflammation and features of airway remodeling in asthma and COPD
      patients.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with stable asthma and COPD invited to Clinical Hospital in Warsaw
      
Biospecimen description: 
      induced sputum, BALF, bronchial mucosa samples, exhaled breath condensate, serum
    
Keywords: asthma; COPD; airway inflammation; remodeling; cytokines; airway wall thickness
Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a single injection of
      CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.
    


Intervention name(s): CNTX-4975; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes
      using the Mediterranean diet, intermittent fasting and exercise.
    

Detailed description: 
      The morbidities associated with type 2 diabetes (Db2) are major, including cardiovascular and
      renal complications, but also cognitive impairment. Providing interventions targeting Db2
      reversal has shown great potential to improve healthy aging.

      A Db2 reversal clinic has been established at the Montreal Heart Institute's ÉPIC Center,
      with an approach based on the Mediterranean diet and exercise. First-year results showed a
      0.6% decrease in Hb1Ac and an average weight loss at 3 months of 4.5 kg in diabetic patients.
      This improvement was maintained at 6 and 12 months. Although these results are encouraging,
      the literature in Db2 remission shows that a weight loss of 10 kg is the ideal goal.

      Therefore, to offer the possibility of further metabolic improvement at 6 months, three
      interventions are proposed as additions to the current program: targeting ultra-processed
      food reduction, motivational coaching and intermittent fasting. The main objective of our
      pilot study is to determine the feasibility of this improved program in type 2 diabetic
      patients, aged 18 to 80 years.
    

Intervention name(s): Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting
Intervention type(s): Behavioral
Intervention description(s): Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 36 participants will be taught to follow the Mediterranean diet (40% carbohydrates) and training 3 times a week (HIIT and weight training) for 3 months. At 3 months, there will be a randomization: 12 participants will continue the same interventions while 24 will add Intermittent Fasting Intervention for 3 months.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes
VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases
Condition: Healthy
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      This protocol will screen healthy normal volunteers for participation in studies of vaccines
      under development at NIAID's Vaccine Research Center. Of interest are vaccines for:

        -  Newly identified infectious diseases such as SARS.

        -  Infectious diseases of concern as possible bioweapons, such as smallpox and Ebola virus

        -  Emerging infectious diseases that are more widespread geographically than in the past,
           such as West Nile virus

        -  For preventing diseases such as tuberculosis and malaria.

      Healthy normal volunteers between 18 and 70 years of age may be eligible for this protocol.
      Screening begins about 1 to 6 months before the start of the vaccine study. Participants will
      have a physical examination and health history, including questions about sexual activity and
      drug use. Over the course of the screening visits, participants will be asked to give urine
      and blood samples to test for various infections and other medical problems. Women capable of
      getting pregnant will be given a pregnancy test. Women who are pregnant or breastfeeding will
      not be enrolled in the study.

      At the end of the screening, participants will be informed about which vaccines are currently
      being tested in clinical trials for which they may be eligible. Once participants enroll in a
      vaccine study, their participation in the screening protocol ends.
    

Detailed description: 
      STUDY DESIGN: The purpose of the study is to screen potential study volunteers to determine
      if they are eligible for infectious disease vaccine clinical trials being sponsored by the
      Vaccine Research Center (VRC) at the NIH Clinical Center. All work will be conducted by the
      VRC Clinic of the National Institutes of Health or IRB-approved extramural sites that are
      collaborating with the VRC Clinic. Educational materials on vaccines will be reviewed with
      and provided to subjects before enrollment into the study.

      SUBJECTS: Approximately 3,000 healthy adults; age 18-70 years.

      STUDY DURATION: Duration of participation is variable, and may last from a few weeks to
      several months for each subject. Study participation is complete when the subject enrolls in
      a vaccine study, is found to be ineligible for all vaccine studies or declines to participate
      in any vaccine studies.

      STUDY EVALUATIONS: Evaluations usually include history, physical examinations and laboratory
      tests. Only those evaluations needed to determine eligibility for a particular study will be
      done. Evaluations other than those described in this protocol may be done if necessary for
      eligibility for a study. Blood will also be collected for storage.
    

Keywords: Biodefense; Prevention; Emergent; Virus; Immune Response; Healthy Volunteer; HV
DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants
Condition: Tetanus; Diphtheria; Pertussis; Poliomyelitis; Bacterial Meningitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Meningitis, Bacterial; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

        -  To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP),
           Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3
           antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B:
           DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary
           vaccination (all antigens).

      Secondary objectives:

        -  To describe immune responses against all vaccine antigens with no pre-specified
           hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4)
           in the two study groups (Group A and Group B).

        -  To describe the safety after each dose of each vaccine in the two study groups (Group A
           and Group B).

        -  To describe immune responses against all vaccine antigens with no pre-specified
           hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4
           (Group C)
    

Detailed description: 
      Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll
      Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio.

      After review of the local and systemic adverse events occurring during the 7 Days following
      the first dose administered in these subjects, 2nd vaccination of Cohort 1 participants will
      resume and enrollment of the participants of Cohort number 2 will start. Step two will enroll
      Cohort 2 made of subjects randomized in two groups with a 1:1 ratio.

      A sub-study Group C will be enrolled and will receive the vaccine by intramuscular route.
    

Intervention name(s): DTaP-IPV/Hib Combined vaccine; DTaP-IPV vaccine and Hib vaccine; DTaP-IPV/Hib Combined vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart; 0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart; 0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart
Other intervention name(s): SP0204; DD 687; DF 098; SP0204
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Tetanus; Diphtheria; Pertussis; Poliomyelitis; Bacterial meningitis; DTaP-IPV/Hib Combination vaccine
Study of the Drug Efalizumab (Raptiva), for Adult Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is
      to study the action and the effects of Efalizumab, on psoriasis. This medication has been
      studied extensively and has been found to be effective and safe in the treatment of
      psoriasis. The eligible patient will have 10% of his/her body surface area involved with
      psoriasis vulgaris.
    

Detailed description: 
      The eligible patient will receive the drug Efalizumab, weekly for 12 weeks, by injection. The
      patient will be seen weekly for 12 weeks and every other week for the 12 weeks of follow up.
      At those visits, the patient can expect that a physical and skin exam will be done. At
      specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done.
      Two types of skin biopsies will be done after local anesthesia has been administered. One is
      a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil
      eraser. The second type of skin biopsy is shave biopsy, where a postage sized piece of skin
      will be taken.
    

Intervention name(s): Efalizumab
Intervention type(s): Drug
Intervention description(s): 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
Other intervention name(s): Raptiva
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: skin; psoriasis
A Study to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      CC-90009-CP-001 is a Phase 1, single-center, open-label, clinical pharmacology study to
      measure how much CC 90009 gets into the bloodstream, how much is eliminated in urine and
      stool, and how long it takes the body to get rid of it. In addition, the safety and
      tolerability of CC 90009 will be evaluated.
    

Detailed description: 
      The primary objective of the study is to characterize the biotransformation and excretion of
      [14C]-CC-90009 following a single intravenous (IV) dose of 0.6 mg [14C]-CC-90009 in healthy
      male subjects. The secondary objective of the study is to evaluate the safety and
      tolerability. The total radioactivity of [14C]-CC-90009 will be 2 μCi.
    

Intervention name(s): CC-90009; [14C]
Intervention type(s): Drug; Radiation
Intervention description(s): 0.6 mg [ 14C]-CC-90009 administered IV as a single dose; A single dose of [ 14C]-CC-90009 will contain approximately 2 µCi of radioactivity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CC-90009; Metabolism; Healthy Male
Efficacy of MK0557 in Combination With Sibutramine or Orlistat (0557-015)(COMPLETED)
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Study medicine will be given alone, or in combination with either sibutramine or orlistat, to
      obese subjects to compare the effect on body weight over a six month period.
    


Intervention name(s): MK0557
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      OBJECTIVES: I. Evaluate the effect of bromocriptine on luteinizing hormone (LH) secretion by
      suppression of prolactin and stimulation of dopaminergic receptors in early pubertal boys and
      girls.

      II. Evaluate the effect of baclofen on LH secretion by stimulation of gamma-aminobutyric acid
      receptors in early pubertal boys and girls.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Participants receive bromocriptine or baclofen followed by nocturnal measurements of
      luteinizing hormone, growth hormone, and sex steroids. Pituitary reserve is evaluated with
      the administration of gonadotropin-releasing hormone, and in children undergoing assessment
      of short stature, standard provocative stimuli.
    

Keywords: constitutional growth delay; endocrine disorders; rare disease
Early Childhood Malaria Prevention With Maloprim in The Gambia
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      A trial was conducted in the 1980s to compare two strategies for control of malaria in young
      children aged 3-59 months: treatment with chloroquine versus treatment combined with
      fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was
      assessed at the time, and their cognitive abilities and educational outcomes were assess 14
      years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and
      mortality and would improve cognitive abilities and educational outcomes in the long term
    

Detailed description: 
      Two drug strategies for the control of malaria in children aged 3-59 months have been
      compared in a rural area of The Gambia - treatment of presumptive episodes of clinical
      malaria with chloroquine by village health workers, and treatment combined with fortnightly
      chemoprophylaxis (pyrimethamine/dapsone) which was also given by village health workers.
      Treatment alone did not have any significant effect on mortality or morbidity from malaria.
      In contrast, treatment and chemoprophylaxis reduced overall mortality in children aged 1-4
      years, mortality from probable malaria, and episodes of fever associated with malaria
      parasitaemia. A high level of compliance with chemoprophylaxis was obtained and no harmful
      consequences of chemoprophylaxis were observed. Chemoprophylaxis was offered to all children
      at the end of the trial.

      14 years after the end of the trial, participants cognitive abilities and educational
      attainment were assessed. Associations have been found between malaria infection and poor
      cognitive ability but causality has not yet been demonstrated through preventative trials and
      the long-term impact of malaria has not been investigated. 1190 children who had participated
      in the original trial for at least one year were targetted for follow-up. 579 were traced.
      Those who had received chemoprophylaxis attended school for 0.52 years more than the placebo
      group (p=.069). There was no overall effect on cognitive abilities but there was a
      significant treatment effect for cohorts that had not received chemoprophylaxis at the end of
      the trial or who had received less than one year of post-trial prophylaxis
    

Intervention name(s): Maloprim
Intervention type(s): Drug
Intervention MeSH terms: Maloprim
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Malaria; Cognition; Prevention & control; Anemia; Chemoprophylaxis; Mortality; Children; Randomized controlled trial; Education; Long-term effects; The Gambia; Africa, West
Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling
Condition: Myofascial Pain Syndrome; Neck Pain; Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Neck Pain
Study type: Interventional

Summary: 
      Shear-wave elastography (SWE) is considered as a useful tool for quantifying muscle
      stiffness. Considering that Myofascial Trigger Points (MTrP) are defined as "hyperirritable
      zones in contracted bands of muscle, thought to be caused by muscle overload or stress" and
      the effectiveness of dry needling applied to active MTrP for reducing pain and disability,
      the aim of this study is to assess the effects of sham and real dry needling, applied to
      active MTrP in the upper trapezius muscle in patients with chronic neck pain, on the muscle
      stiffness in two areas: 1) the most symptomatic area and 2) a control point.
    


Intervention name(s): Dry Needling; Sham Dry Needling
Intervention type(s): Other; Other
Intervention description(s): Real Dry Needling in the most active Myofascial Trigger Point; Sham Dry Needling in the same location, but not piercing the skin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blinded, Placebo-Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment