bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Bariatric Surgery in Patients With Morbid Obesity
Condition: Obesity, Morbid; Anal Incontinence; Image, Body
MeSH terms: Fecal Incontinence; Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      The main objective is to compare the prevalence of anal incontinence (AI) before and after
      bariatric surgery in obese patients.

      Inclusion: Patients who are scheduled for a bariatric surgical procedure after a
      multidisciplinary evaluation for about 1 year (following french national recommendations).

      Primary objective: After inclusion, all patients will fill in a specific self-questionnaire
      evaluating AI (PFDI-20 score) before surgery and at 6 months after surgery.

      Investigators will evaluate the prevalence of anal incontinence before and at 6months after
      surgery using this PFDI- 20 score.

      In those patients with preoperative anal incontinence (only in patients with 3 positive
      answers to question n°9,10, and 11 of PFDI-20 score self-questionnaire), a pelvic MRI will be
      performed before and at 6 months after surgery. Consequently, no further imaging exam will be
      performed in patients without preoperative anal incontinence (less than 3 positive answers to
      question n°9,10, and 11),

      Secondary objectives:

        -  to evaluate the AI severity variation before and at 6 months after bariatric surgery
           regarding the percentage of postoperative weight loss.

        -  to compare the quality of life (PFIQ-7 score) related to AI day before and at 6 months
           after bariatric surgery.
    

Detailed description: 
      This study is proposed to all obese patients evaluated for potential bariatric surgery during
      a multidisciplinary evaluation for about 1 year following current french national
      recommendations.

      Demographics are collected from medical records (age, sex, weight, height, diabetes, sleep
      apnea syndrome, hypertension, lipid disorders, distal neuropathy, depression, number of
      pregnancies, history of vaginal delivery, traumatic delivery, caesarean section,
      hysterectomy, urinary incontinence surgery, proctologic surgery, presence of rectal prolapse
      (operated or not), cholecystectomy, digestive resection, menopause, history of urinary or
      fecal or gaseous leakage, current treatments, tobacco consumption, diet.

      Data are collected by self-questionnaire to all included patient during the preoperative
      consultation (about 6 weeks before bariatric surgery) and during the 6-months postoperative
      clinical visit scheduled during the regular follow-up.
    

Intervention name(s): bariatric surgical procedures
Intervention type(s): Procedure
Intervention description(s): gastric bypass, sleeve, banding,biliopancreatic diversion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary
        evaluation for about 1 year (following HAS national recommendations).
Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
Condition: Obesity
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Based on previous findings that mentally ill inpatients are interested in losing treatment
      associate weight gain and are capable of adhering to a weight reduction program, this study
      will investigate the effects of participation in nutrition intervention, physical exercise
      and will monitor measurement of metabolic profiles (cholesterol, triglycerides and glucose).
      Hypothesis: participants will reduce weight, maintain weight loss and experience reduction in
      metabolic values and will experience improved quality of life.
    

Detailed description: 
      Study sample: 50 chronic psychiatric inpatients with DSM_IV diagnosis of schizophrenia or
      schizoaffective disorder, aged 18 or older. Exclusion criteria - pregnancy, severe physical
      illness, refusal to participate.

      Study instruments: Q-LES-Q-18 (quality of life): Positive and Negative Syndrome Scale;
      Laboratory test- glucose levels, metabolic profiles (cholesterol, triglycerides).
      Measurements: Weight, BMI, pulse Intervention: Weekly group therapy, lectures on nutrition,
      physical exercise Duration of study: 3 months
    

Intervention name(s): group therapy, physical exercise, nutrition lectures
Intervention type(s): Behavioral
Intervention description(s): weekly group therapy, physical exercize, nutrition guidance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obesity; weight gain; schizophrenia; schizoaffective disorder; antipsychotic induced weight gain
Comparison of The Effects of Concentric And Eccentric Isokinetic Exercises in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study aims to compare the effects of concentric and eccentric isokinetic exercises on
      proprioception and muscle architecture in 42 patients with knee osteoarthritis enrolled the
      study.
    

Detailed description: 
      This study aims to compare the effects of concentric and eccentric isokinetic exercises on
      proprioception and muscle architecture in patients with knee osteoarthritis. 42 patients will
      be included in this study. Patients will be divided into three groups; concentric exercise
      group (n:14), eccentric exercise group (n:14) and control group (n:14). A conventional
      physiotherapy program and a standard therapeutic exercise program will be applied to all
      subjects. In addition to these exercise and physiotherapy programme, concentric and eccentric
      exercise groups will perform the exercises related to their groups. All three groups will
      participate in this program for a total of 18 sessions 3 times a week for 6 weeks. All groups
      will be subject to re-evaluation after 6 weeks.
    

Intervention name(s): the concentric isokinetic exercise group; the eccentric isokinetic exercise group; the control group
Intervention type(s): Other; Other; Other
Intervention description(s): concentric isokinetic exercises; eccentric isokinetic exercises; conventional physiotherapy and standard therapeutic exercises predetermined by us
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Concentric; Eccentric; Muscle Architecture; Proprioception
Investigating the Pharmacokinetic Characteristics of HIP1402 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the PK charateristics and the effect of food on the PK in healthy male
      volunteers who receive HIP1402 capsule in fed versus fasted condition
    

Detailed description: 
      A randomized, open-label, single dose, three-way crossover clinical trial to investigate the
      pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in
      healthy male volunteers
    

Intervention name(s): HIP1402; HGP0412
Intervention type(s): Drug; Drug
Intervention description(s): Tamsulosin HCl 0.4mg; Tamsulosin HCl 0.2mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      single and multiple intravenous doses of SPR206 when administered to healthy adult
      volunteers.
    

Detailed description: 
      This Phase 1 First in Human study is designed to assess the safety, tolerability, and
      pharmacokinetics of single and multiple intravenous doses of SPR206 when administered to
      healthy adult volunteers. This is a randomized, double-blind, placebo-controlled, ascending
      dose, multi-cohort trial. A total of 104 healthy volunteers will be enrolled in 13 cohorts.
      The study will be conducted in two phases: A single ascending dose (SAD) phase, followed by a
      multiple ascending dose (MAD) phase. In SAD, participants in Cohorts 1 - 8 will receive one
      dose of SPR206 or placebo. In MAD, participants in Cohorts 9 - 12 will receive multiple doses
      of SPR206 or placebo for 7 consecutive days, and a final cohort, Cohort 13, will receive
      multiple doses of SPR206 or placebo for 14 consecutive days at a dose deemed safe and
      tolerable and not to exceed the maximum dose administered to participants in Cohorts 9 - 12.
      In both parts sequential cohorts will be exposed to increasing doses of SPR206.
    

Intervention name(s): SPR206; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAD Cohorts: Double-blind dosing will occur in Cohorts 1 - 8. Six participants will receive single doses of SPR206. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.
MAD Cohorts: Double blind dosing will occur in Cohorts 9 - 13. Six participants in each cohort will receive multiple doses of SPR206. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. Dosing will commence on the morning of Day 1. Three doses will be administered per day at approximately 8 hours apart. Daily dosing will continue for a total of 7 consecutive days for Cohorts 9 - 12 and for a total of 14 consecutive days for Cohort 13.; 0.9% sodium chloride for injection. SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.
Other intervention name(s): 0.9% sodium chloride for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, combined single and multiple ascending dose (SAD and MAD) trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; SPR206
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Condition: Opioid-Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of
      opioid-induced constipation in patients with non-cancer-related pain, including those
      patients that have inadequate response to laxative therapy (LIR).
    


Intervention name(s): NKTR-118; NKTR-118; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12.5 mg oral tablet once daily; 25 mg oral tablet once daily; Placebo to NKTR-118
Intervention MeSH terms: Naloxegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-Cancer-Related Pain; Opioid-Induced Constipation
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this observer blind study is to assess the safety in terms of fever >39°C
      (rectal temperature) and the immunogenicity in terms of antibody response following a booster
      vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children
      previously primed with the same vaccines including a pneumococcal conjugate vaccine
      co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and
      OPV or IPV vaccines. Subjects participating in this study should have received three doses of
      pneumococcal conjugate vaccine in the primary study.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00344318)
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
    

Intervention name(s): Synflorix; Tritanrix-HepB; Hiberix; Polio Sabin; Poliorix; Prevenar (Wyeth)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 1 dose; Intramuscular injection, 1 dose; Reconstituted with Tritanrix-Hep B before injection; Oral, 1 dose; Intramuscular injection, 1 dose; Intramuscular injection, 1 dose
Other intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; DTPw-HBV vaccine; Hib vaccine; OPV; IPV; Pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Booster vaccination.; Immunogenicity; Pneumococcal vaccine; Safety; Pneumococcal disease
Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease
Condition: Type 2 Diabetes Mellitus; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone
      (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well
      as the degree of activation of the immune system, when given on top of an anti-diabetic
      treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic
      control.
    

Detailed description: 
      PPARgamma activation by pioglitazone has shown to be associated with an improvement of
      cardiovascular risk when measured with clinical (assessement of intima-media-thickness) or
      biochemical (hsCRP, MMP-9 etc.) markers. Well controlled patients (HbA1c < 8.0 %) will
      receive either pioglitazone or placebo (randomised, double-blind) for 4 weeks. Blood will be
      drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be
      isolated from circulating mononuclear cells to investiagte the degree of activation of the
      immune system, which is another measure for the risk of atherosclerosis development.
    

Intervention name(s): pioglitazone; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: diabetes mellitus; monocyte activation; cardiovascular risk
Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis
Condition: Subacromial Bursitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The main purpose of this study is to compare treatment efficacy of different concentration
      dextrose injection in chronic subacromial bursitis .
    

Detailed description: 
      Rotator cuff disorder with bursitis is one of the most frequent pathologies of the shoulder,
      which may cause serious restriction of daily activities and reduce quality of life. There are
      many ways in treating rotator cuff disorder with bursitis, including medication, physical
      therapy, kinesiological taping, acupuncture and local injection. Protholotherapy, which
      inject hyperosmolar dextrose to soft tissue, is a novel management in musculoskeletal
      disorders. However, only few trials exist in studying hyperosmolar dextrose injection for
      rotator cuff disorder with bursitis and most of them have small sample size and not
      randomized. The aim of this study was to figure out the effects of sonographically guided
      subacromial bursa injection with hyperosmolar dextrose in rotator cuff disorder with bursitis
      by a randomized controlled trial.
    

Intervention name(s): 15% Dextrose; Normal saline
Intervention type(s): Procedure; Procedure
Intervention description(s): inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance; inject normal saline and xylocaine into subacrominal bursa under sonographically guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      It is a phase IV clinical trial: longitudinal, prospective, evaluator-blind, randomized into
      2 groups of patients with chronic obstructive pulmonary disease (COPD). The intervention
      group was based on the administration of roflumilast 500 mcg per day on alternate days
      (roflumilast 500μg eod) for 2 weeks (phasing). In the control group assigned to undertake the
      treatment according to the standard dosage (roflumilast 500μg od).

      The patient monitoring will be done by one of the sub-investigators fully independent team
      that started the medication keeping the pattern masking by single blind, and since it aims to
      assess the frequency of adverse events (AEs) in both groups were collected systematically
      different AEs and their characteristics at 15 days (V1), and from that moment a month (V2)
      and 2 months (V3). Likewise, other data collected (functional demographic, comorbidities,
      home treatment, anxiety and depression and quality of life).

      The purpose of this study is to assess whether the administration of roflumilast by a gradual
      pattern varies the incidence of discontinuations due to adverse events when compared with the
      usual dosage.
    


Intervention name(s): Roflumilast alternated days; Roflumilast 500 mcg per day
Intervention type(s): Drug; Drug
Intervention description(s): 500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks
Other intervention name(s): schedule change; Standard dosage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: COPD
Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to
      stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
      high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
      removed. It is not yet known if chemotherapy plus radiation therapy is more effective than
      chemotherapy alone before surgery in treating non-small cell lung cancer.

      PURPOSE: This randomized phase III trial is studying docetaxel and cisplatin with or without
      radiation therapy to see how well they work when given before surgery in treating patients
      with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest.
    

Detailed description: 
      The main objective of this trial is to compare feasibility and efficacy of sequential
      neoadjuvant chemoradiotherapy with 44 Gy concomitant boost to neoadjuvant chemotherapy alone.

      Secondary objectives are to assess the value of PET in predicting pathological response and
      eventfree survival in stage IIIA NSCLC, and a health economic analysis of the two regimens.
      Further to compare the amount of serum DNA in patients with stage IIIA, pN2 NSCLC before
      chemotherapy, before surgery and at the second follow-up visit (i.e. four months after
      surgery or treatment failure for patients who can not be operated) in patients randomized
      into the trial SAKK 16/00 and to correlate the DNA variation with tumor response, remission
      duration and overall survival.

      OUTLINE: This is a prospective randomized phase III trial. Patients are stratified according
      to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5% or
      more vs less than 5%), and participating center. Patients are randomized to 1 of 2 treatment
      arms.
    

Intervention name(s): Chemotherapy; Radiotherapy; Surgery
Intervention type(s): Drug; Radiation; Procedure
Intervention description(s): Docetaxel (Taxotere®) 85 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days; Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks; 3-4 weeks after termination of radiotherapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: squamous cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; adenosquamous cell lung cancer
Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized Controlled Phase II study to assess the efficacy of Floreo VR (Virtual reality)
      Building Social Connections as treatment for social skills in children with Autism Spectrum
      Disorder (ASD)
    

Detailed description: 
      In this randomized controlled phase II study, 30 eligible subjects aged 4-10 years old with
      documented ASD diagnoses will be enrolled and randomized in a 1:1 ratio intervention vs
      control group.

      The Floreo VR Building Social Connections intervention is designed to be administered for 12
      weeks, with three treatment visits per week, for a total of 36 treatment visits.
    

Intervention name(s): Floreo VR Building Social Connections; Sham
Intervention type(s): Device; Device
Intervention description(s): Floreo's VR platform consists of a VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) that are seamlessly linked in real time, allowing the therapist (or monitor) to set up lessons, change the interactive environment, and provide live verbal and VR-based guidance, feedback, and rewards to users. The lessons that will be implemented in this intervention are aimed at targeting social skills such as communication, joint attention, and social interactions.; This condition will contain the same VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) as the intervention condition, but instead of social skill lessons, only non-intervention, active VR videos such as underwater fish swimming will be shown.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The two parallel groups include an experimental group that will receive the Floreo VR Building Social Connections program and a control group that will receive non-interventional active VR programing.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASD; Virtual Reality; VR; Social Communication; Applied Behavior Analysis Therapy