bioihbjkbjnl/mcl2 huggingface dataset:
Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the extension phase is to evaluate the long-term safety and tolerability of
      buprenorphine transdermal system (BTDS).
    

Detailed description: 
      Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical
      experience indicating it to be safe and effective in a variety of therapeutic situations for
      the relief of moderate to severe pain. Transdermal systems may offer advantages over
      currently indicated oral products including ease and convenience of use, improved compliance,
      possible reduction in patient care, and prolonged and consistent delivery of drug.
    

Intervention name(s): Buprenorphine transdermal patch; Buprenorphine transdermal patch; Buprenorphine transdermal patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear; Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear; Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Intervention MeSH terms: Buprenorphine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Opioid; Transdermal
Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
Condition: Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae Infections
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine
      (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H.
      influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4
      months of age according to the local Expanded Programme on Immunisation (EPI) schedule
    


Intervention name(s): Quinvaxem
Intervention type(s): Biological
Intervention description(s): A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at 2, 3 and 4 months of age
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaccination; Immunisation; Virus; Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae; Immunity
Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess how glimepiride affects the recovery from hypoglycemia in
      participants with type 2 diabetes mellitus. The primary objective is to estimate the time
      taken by participants to recover from hypoglycemia to euglycemia after treatment with either
      2 mg or 4 mg of glimepiride when compared to placebo.
    


Intervention name(s): Placebo; Glimepiride 2 mg; Glimepiride 4 mg; Hypoglycemic Clamp
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.; One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.; Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.; On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.
Intervention MeSH terms: Glimepiride; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Condition: Mild Cognitive Impairment Due to Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD) are at
      high risk to develop Alzheimer´s dementia. The therapeutic agent Contraloid has the potential
      to influence the chronic neurodegenerative process of AD. As Contraloid was so far only
      administered to healthy subjects, the rational of the proposed study is first to collect
      safety data in patients diagnosed with MCI due to AD, as the absorption, distribution,
      metabolism and excretion processes may be altered by disease, aging, comorbidities and
      concomitant drug therapies. Additionally, the design of a subsequent phase II study will be
      based on the data of this study. The results of the exploratory analyses will enable power
      calculations and the identification of the most useful and reliable biomarkers for the
      subsequent proof of concept phase II study.
    


Intervention name(s): Contraloid acetate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of drug substance capsules; Oral administration of placebo without any exipients.
Other intervention name(s): PRI-002; Microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
Condition: Preventive Avian Flu
MeSH terms: Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and reactogenicity of live attenuated
      influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO,
      in Thailand to previously healthy Thais.
    

Detailed description: 
      It is a phase I randomized placebo controlled trial (vaccine and placebo ratio of 2:1). A
      phase II study is planned to be conducted following review of results of this phase.

      Phase I: It is a double blind randomized placebo controlled trial involving 24 participants
      age 18-49 years (16 will receive vaccines and 8 will receive placebo). All will be admitted
      in the isolation ward for 10-14 days after each immunization mainly for safety assessment.
      Two doses of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133
      (H5N2) will be given by intranasal route 21 days apart. Each group of 4 participants will be
      immunized at a time at 30-60 mins interval. All participants will be followed 21 days after
      each immunization. Total follow up is 60 day.
    

Intervention name(s): Avian Flu Vaccine; Placebo
Intervention type(s): Biological; Biological
Keywords: Avian Flu; H5N2
Endoscopy for Assessment of Mucosal Healing in IBD
Condition: Crohn´s Disease; Ulcerative Colitis
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders,
      Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and
      histologic features including patterns of inflammation, crypt abscesses and granulomas.
      i-Scan use an endoscopic image from the video processor and reconstruct virtual images in
      real time, resulting in an improved contrast of the capillary patterns and enhancement of the
      mucosal surface (so called virtual chromoendoscopy).

      The main objective of this study is to determine endoscopic features of mucosal healing in
      patients with IBD and to compare these features to clinical and histological data in order to
      establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing
      as a parameter of remission and relapse.
    


Intervention name(s): High-definition white light endoscopy and i-Scan
Intervention type(s): Device
Intervention description(s): Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Crohn´s disease and ulcerative colitis were prospectively included.
A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Condition: Cancer; Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Study type: Interventional

Summary: 
      A multicentre, open, randomized phase II study comparing a multimodal intervention (oral
      nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer
      care.
    


Intervention name(s): Multimodal intervention; Standard care
Intervention type(s): Other; Other
Intervention description(s): Nutritional supplements aimed at optimal energy balance and protein intake (2 cartons of ProSure per day), nutritional advice, home-based self-assisted exercise program and anti-inflammatory treatment (300 mg celecoxib) for 6 weeks. The aerobic exercise program is performed as self-administered daily walking sessions, aiming for a minimum of two sessions 30 minutes on a weekly basis. Other aerobic activities could be used instead of walking. The resistance exercise program should be performed 3 times weekly and lasts about 20 minutes. The program is targeting major muscle groups in the upper body and legs with use of weights. The intensity of the exercise and performance of the exercises are adapted to the individual patient's disease burden and physical performance.; Standard cancer care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cachexia; neoplasms; complications; combined modality therapy; exercise therapy; diet therapy; anti-inflammatory agents
Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial
Condition: Obesity; Cardiovascular Disease; High Blood Pressure
MeSH terms: Cardiovascular Diseases; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical
      activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The
      investigators are conducting an intervention for 12 weeks that promotes physical activity
      through support groups, group exercise sessions or through information that is given at the
      baseline appointment. Participants will be randomly assigned to a group.
    


Intervention name(s): In Person; At Home
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the In Person group have weekly visits for the 12 weeks to the research office. The first visit can last up to one and a half hours and each subsequent visit can last approximately one hour. Group meetings provide appropriate nutrition and physical activity information as well as behavioral change strategies. Sessions also include some light physical activity (equal to brisk walking).; Participants in the At Home group receive a workbook from the research staff at their baseline visit that outlines an accepted nutrition and physical activity program to complete on their own.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Women; Menopause; Cardiovascular Disease; Physical Activity; Weight Loss
Islet Transplantation for Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with
      stable renal allografts by islet transplantation.
    

Detailed description: 
      We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be
      transplanted into the portal vein of patients with T1DM who have stable renal allografts to
      achieve insulin independence for the recipient. The protocol will employ a defined islet
      isolation procedure, percutaneous islet infusion into the recipient's portal vein via an
      intra-portal catheter, tight glycemic control during the peri-transplant period, and an
      immunosuppressive protocol that avoids glucocorticoids.
    

Intervention name(s): Islet transplantation
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; autoimmunity
Predicting the Efficacy of Resistance Exercise Training for Improving Endurance Performance
Condition: Elite Cyclists
Study type: Interventional

Summary: 
      The overall objective of the study is to identify molecular determinants of the efficacy of
      resistance training for improving endruance performance in elite cyclists
    

Detailed description: 
      For elite endurance athletes, the addition of resistance training to habitual endurance
      training routines generally leads to improved endurance performance. However, this is not
      always the case, with several individuals failing to respond in the expected manner. This
      inter-individual variation is likely associated with inherent cellular and molecular
      charateristics of skeletal muscle. Indeed, responses to resistance training seem to be
      associated with muscle biological characteristics such as muscle fiber composition and
      ribosomal content (during the early phase of resistance training).

      The study will investigate the association between muscle fibre composition (type I vs type
      II muscle fiber proportions) / ribosomal content in m. vastus lateralis and the effects of 10
      weeks of resistance training on endurance performance in 52 elite cyclists. Half the
      participants will perform resistance training in addition to their habitual endurance
      training routines, the other half will perform endurance training-only. Muscle biopsies will
      be sampled from m. vastus lateralis before and after the first two weeks of the intervention.
      For muscle fiber composition, the hypothesis is that larger proportions of type II fibers
      will be associated with more pronounced benefits of resistance training. For ribosomal
      content, the hypothesis is that higher rRNA content at baseline and larger increases in rRNA
      content during the initial part of the intervention will be associated with more pronounced
      benefits of resistance training. No changes are expected in the non-resistance training
      control group.
    

Intervention name(s): Resistance training; Endurance training (habitual)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Resistance training sessions twice a week for ten weeks; Endurance training for ten weeks (habitual routines)
Other intervention name(s): Heavy-load strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cycling; Endurance performance; Skeletal muscle biology; Individualization; Muscle fiber type proportions; Ribosomal RNA
Study to Investigate the Mechanism of Action of an Oral Enzyme Treatment With Bromelain, Trypsin and Rutoside Versus Placebo in Subjects With OsTeoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the pharmacodynamic profile of an oral enzyme
      treatment with Bromelain, Trypsin and Rutoside in subjects with osteoarthritis.
    

Detailed description: 
      This study is a randomised, placebo controlled, two parallel arms, cross over, and
      multicentric trial in 40 male and female subjects suffering from osteoarthritis. While is it
      well established that Wobenzyme is safe and have proven efficacy in painful conditions,
      inflammation and osteoarthritis, little is known about its clear mechanism of action
      underlying its clinical efficacy. This study hypothesises that oral enzyme combination
      therapy with Wobenzyme will lead to systemic pharmacodynamic effects which will be documented
      by a holistic assessment of the inflammasome, innate immune system, cartilage turnover,
      systemic inflammatory markers, as well as potential cellular pathways.
    

Intervention name(s): Wobenzym®; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Wobenzym®; Microcrystalline cellulose
Intervention MeSH terms: Wobenzym
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
Condition: Cocaine Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to assess the efficacy of caffeine compared to placebo in
      detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also
      studied.

      108 with cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.)
      plus biperidene (8 mg b.i.d.) or caffeine (300 - 1200 mg t.i.d.) with placebo or placebo
      during 6 months.

      Primary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology,
      craving for cocaine and mental status during detoxifying period, 2) study retention and 3)
      cocaine use.

      Brain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.
    


Intervention name(s): Caffeine; Biperiden; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d; Biperiden 2-4 mg/d p.o.; Placebo + Placebo
Intervention MeSH terms: Biperiden; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine dependence; cocaine use; cocaine craving
Edmonton Obesity Staging System: Post-operative Outcome and 30-day Mortality
Condition: Postoperative Complications; Other Complications of Other Bariatric Procedure
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related
      diseases and predictor of mortality than BMI or waist circumference. The aim of this study is
      to determine whether the EOSS is also important in predicting post - operative outcome and
      30-day mortality after metabolic surgery.
    

Detailed description: 
      From October 2014 to December 2015 the investigators conducted a prospective data collection
      on patients undergoing either laparoscopic sleeve gastrectomy (LSG) or laparoscopic Gastric
      Bypass (Laparoscopic Roux-en-Y-Gastric Bypass (LRYGB) and Omega-Loop-Gastric-Bypass (LOLGB)),
      being the first surgical treatment for severe obesity. Preoperative EOSS by Sharma et al. was
      applied to all patients by two different evaluators. Data collection included the following:
      gender, age, body mass index, waist circumference, waist to hip ratio, comorbidities, early -
      postoperative complications, readmission rates and 30 - day mortality. Follow-up was
      performed in all patients up to 1 month after surgery.
    

Intervention name(s): LSG and LRYGB
Intervention type(s): Other
Intervention description(s): The role of the Edmonton Obesity Staging System in predicting post-operative outcome and 30-day mortality after metabolic surgery (LSG and LRYGB)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing either LSG, LRYGB or LOLGB, being the first surgical treatment for
        severe obesity
      
Keywords: EOSS; Metabolic Surgery; postoperative outcome; 30 - day mortality
Pilot Study on the Submental Area
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for
      non-invasive reduction of submental fat.
    


Intervention name(s): The Zeltiq System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Lipolysis; Cryolipolysis; Fat Reduction
Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia
Condition: Anesthesia; Surgery
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      The rate of elimination of inhalation agent is directly proportional to the degree of
      alveolar ventilation. Using Isocapnic Hyperpnoea (IH) device, it is possible to maintain
      constant end-tidal CO2 with increased minute ventilation. This is achieved by passively
      adding a flow of CO2 to the inspirate in proportion to increases in ventilation above the
      baseline. In animal and human studies IH shortens the time of awakening from isoflurane and
      sevoflurane anesthesia when manual positive pressure ventilation is applied. IH device could
      be used for spontaneous hyperpnoea as well. The investigators want to compare recovery times
      from sevoflurane anesthesia in patients with application of hypercapnic spontaneous
      hyperpnoea (HSH) versus the standard anesthesia protocol (controls). 44 patients ill be
      randomized to either HSH facilitated recovery, or conventional recovery (controls).The time
      intervals from the end of anesthesia (turning off the vaporizer) until recovery milestones
      will be recorded.
    


Intervention name(s): Standard Anesthesia management for post surgical patients; Hypercarbic Spontaneous Hyperpnoea
Intervention type(s): Other; Device
Intervention description(s): The O2 flow on the anesthetic machine will be set at 15 L/min. Ventilatory assistance will be performed to maintain O2 saturation >97% and end tidal CO2 at 35-45mmHg.; Patient will be disconnected from the anesthetic circuit and connected to the resuscitation bag attached to the IH system. With O2 flow of 2 L/min patient will be gently ventilated until recovery of the spontaneous ventilation. After starting spontaneous ventilation basal O2 flow will be adjusted to keep ETCO2 in range of 50-60 mm Hg or minute ventilation of 15-17 L/min, whichever occurs first.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Isocapnic hyperpnoea (IH); Anesthesia; Accelerate elimination of inhalation agents; Recovery from anesthesia