bioihbjkbjnl/mcl2 huggingface dataset:
Activation of Young Men - Population-Based Randomised Controlled Trial
Condition: Obesity; Well-being; Quality of Life; Depression
Study type: Interventional

Summary: 
      The aim of the study is to investigate different novel IC technologies for promoting physical
      activity and health and preventing obesity in young men. The purpose is to provide new
      evidence-based knowledge on the effectiveness of an ICT-based physical activation and to
      identify factors predicting a positive response.

      Specific objectives

        -  to identify the factors associated with physical activity and physical activity
           relationship in young men

        -  to develop an interactive method, based on peer networks, aimed at activating young men
           with use of their own skills, participation and modern ICT

        -  to assess the effectiveness of the chosen activation on the physical activity, weight,
           fitness, health, and relationship towards physical activity among young men

      The study population consists of all conscription aged men in the Oulu area in 2011-2013
      (n=4000). Conscription-aged men provide a large, population based representative sample of
      young men. In Finland military service is mandatory and annually all 18-year old men are
      called for military service. In the call-ups fitness for service is determined based on
      medical examination.

      All those who are determined fit for service or who are granted postponement due to obesity
      will be invited for the activation intervention study. Those with severe obesity are exempted
      from service, but will also participate in the trial. After the call-up, the men will be
      randomised to an intervention group and a control group. The primary outcome variable is
      change in physical activity.

      The study will be conducted during 2011-2015. The study includes technology development (ICT
      platform), collection of cross-sectional data at the call-ups, and a 6-month physical
      activity intervention (a randomized controlled trial) implemented between the call-up and
      start of military service. Game mechanics are integrated into the ICT platform to increase
      user engagement and participation.

      Physical activity, fitness (aerobic and muscular), body composition,lifestyle and
      psychological and physical health will be followed. In addition, the subjects' entry into
      military service and its course will be followed.
    


Intervention name(s): physical, psychological and social activation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Volume-challenge in Morbid Obesity
Condition: Anomaly; Venous Return
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      Preoperative venous return stability and euvolemia is essential in management of morbidly
      obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on
      preoperative management, are rare and not in consensus.The aim of this study was to evaluate
      preoperative effects of a standardized, ideal body weight (IBW) based volume-challenge on
      hemodynamics, stroke volume and level of venous return to the heart.
    

Detailed description: 
      34 morbidly obese patients scheduled for bariatric surgery underwent a preoperative
      three-week preparation by rapid-weight-loss-diet (RWL) to be accepted for bariatric surgery.
      Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and
      after volume-challenge (VC) based on 6ml colloids /kg IBW. Feasibility of standardized VC was
      evaluated by TTE. Dynamic and non-dynamic echocardiographic indices for VC were studied.

      Main outcome measures: Volume-responsiveness and level of venous return before and after
      volume-challenge were assessed by TTE. An increase of stroke volume ≥ 13% was considered as a
      volume-responder.
    

Intervention name(s): preoperative venous return optimizing
Intervention type(s): Other
Intervention description(s): Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume challenge based on 6ml colloids /kg ideal body weight.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Morbidly obese patients scheduled for bariatric surgery in Northern part of Sweden;
        Norrbotten county council.
      
Keywords: morbidly obese patients,; preoperative volume-challenge,; transthoracic echocardiography,; TTE,; rapid weight loss,; venous return,; bariatric surgery,; left ventricular outflow tract,; stroke volume,; diastolic function,; hypervolemia,; hypovolemia
Postoperative Analgesia Impact of Narcotic Free Anesthesia
Condition: Pain, Postoperative; Breast Cancer; Postoperative Nausea and Vomiting
MeSH terms: Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol
      during general anesthesia for patients undergoing mastectomy will result in less pain and
      less narcotic consumption in the recovery room. The investigators will also verify the impact
      of that substitution on nausea and vomiting, on the time spent in the recovery room and on
      chronic postsurgical pain (3 and 6 months).

      Finally, the investigators will see the impact on breast cancer recurrence 5 years after the
      surgery.
    


Intervention name(s): fentanyl; beta-blocker (esmolol, metropolol)
Intervention type(s): Drug; Drug
Intervention description(s): Use of esmolol and metoprolol compared to use of fentanyl for hemodynamic control during general anesthesia. At induction, fentanyl (2 mcg/kg) is replaced by esmolol (1 mg/kg). During the case, with a standardised anesthesia, response to surgical stimulation will be medicated either by fentanyl (50 mcg aliquot) or metropolol (2.5 mg), for a maximum of 6 doses. After this, fentanyl will be given unblindly.; esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.
Intervention MeSH terms: Fentanyl; Adrenergic beta-Antagonists; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Narcotic; Opioid; betablocking drug; postoperative pain; postoperative nausea and vomiting; breast cancer; hyperalgesia; cancer recurrence; anesthesia; mastectomy; chronic postsurgical pain syndrome; acute postoperative pain; postmastectomy pain syndrome; pain; ambulatory surgery
Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain
Condition: Pain, Acute; Pain, Chronic; Pain, Neuropathic
MeSH terms: Neuralgia; Acute Pain; Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative pain after thoracic surgery is associated with adverse outcomes. The current
      strategy to prevent postoperative pain is the use of regional anesthesia and analgesic
      agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become
      the standard analgesic regimen which results in decreased postoperative pain and opioid
      consumption.

      The investigator would like to study the analgesic efficacy of low dose intravenous ketamine
      infusion during surgery in combination with thoracic paravertebral block on postoperative
      pain after VATS in a randomized study.
    

Detailed description: 
      Inadequate pain control after thoracic surgery is associated with adverse events such as
      postoperative pulmonary complications (PPC), and chronic post surgical pain.

      Although the less invasive video-assisted thoracic surgery (VATS) has been used extensively
      as it produces optimal surgical outcomes and possible less postoperative pain, there are
      reports of inadequate pain control.

      Thoracic paravertebral block (TPVB) has been introduced as an effective method in
      postoperative pain management after VATS. It is associated with improved pain control and the
      reduction of opioid analgesic consumption in several studies.

      The use of intravenous low dose ketamine infusion during and after surgery has been shown to
      produce superior postoperative pain control in upper abdominal surgery and thoracotomy.

      The aim of the present study is to study the efficacy of intravenous low dose ketamine
      infusion during surgery on acute and chronic pain after VATS.
    

Intervention name(s): Ketamine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml); normal saline infusion
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anesthesia; thoracic surgery; thoracic paravertebral block; ketamine
The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Tension-Type Headache
Condition: Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of manual acupuncture between 2
      types of points in decreasing tension-type headache symptoms of healthcare workers in
      Dr.Cipto Mangunkusumo hospital
    

Detailed description: 
      The purpose of this study is to compare the effectiveness of manual acupuncture therapy
      between auricular points and body points in improving tension-type headache symptoms based on
      a headache diary which is consisting of intensity and frequency of headache days, a short
      form-36 questionnaire, and an examination of the press pressure threshold on eight
      pericranial muscles. If the use of auricular points is proven to be superior, then this
      method will benefit the patient more because it is more efficient and can be used as a
      protocol for providing therapy to patients with tension-type headache.
    

Intervention name(s): filiform needle
Intervention type(s): Procedure
Intervention description(s): Manual acupuncture using filiform needles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Auricular acupuncture; Tension-type headache; Healthcare worker
Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death
Condition: Nonfatal Myocardial Infarction; Coronary Death
MeSH terms: Heart Diseases; Myocardial Infarction; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Infarction; Death
Study type: Observational

Summary: 
      The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary
      death associated with use of monotherapy low dose ASA (single antiplatelet) as well as
      concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in patients
      with serious coronary heart disease using two UK primary care databases.
    

Detailed description: 
      Number of Anticipated Subjects: In case-control analysis: 10.000-15.000 participants
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals aged 50-84 years who from 1 January 2000 to 31 December 2007 had a documented
        evidence of a hospitalization for a serious acute coronary event (MI, revascularization of
        coronary arteries or unstable angina) and who were alive 1 month after this event in two
        primary care clinical practice databases in the UK: General Practice Research Database
        (GPRD) and The Health Improvement Network (THIN).
      
Keywords: MI; low dose aspirin; PPI; epidemiology; Nonfatal MI and coronary death
Predictors of Individual Training Effectiveness in Preventive Exercise
Condition: Primary Prevention
Study type: Interventional

Summary: 
      Physical exercise elicits beneficial changes in the body. These concern physical performance
      but also improvements in virtually all known risk factors for cardiovascular disease. Yet,
      the extent of individual benefit differs considerably even within homogenous groups and the
      prediction of individual training effectiveness is not yet possible. This study aims to find
      predictors of individual training effectiveness.
    


Intervention name(s): Endurance training
Intervention type(s): Behavioral
Intervention description(s): running / walking at 60 % heart rate reserve 4 times per week for 4 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; healthy subjects
A Study of Safety, Pharmacokinetics (Including Food Effect) And Pharmacodynamics of RO5545965 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, Investigator/Subject-blind, adaptive single-ascending-dose,
      placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics
      (including the effect of food), and pharmacodynamics of RO5545965 following oral
      administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts
      to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2
      doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period
      of approximately 2 weeks between treatment periods.
    


Intervention name(s): Placebo; RO5545965; RO5545965
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single ascending dose; Single ascending dose; Single dose, in fed and fasted state
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Clinical Evaluation of Monolithic Zirconia FPDs
Condition: Dental Materials
Study type: Interventional

Summary: 
      The objectives of the present study are to compare the survival rates and possible biological
      and technical complications of metal-ceramic, veneered and monolithic zirconia posterior
      three-unit fixed partial dentures. The null hypothesis is that no differences would be found
      between the parameters studied for each type of restoration.
    

Detailed description: 
      Ninety patients requiring at least one 3-unit Fixed partial denture (FPD) in the posterior
      region of the maxilla or mandible were included in this study. All subjects were recruited
      from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University
      Complutense of Madrid, Spain). Before treatment, patients were informed of the study
      objectives, clinical procedures, materials used, advantages and possible risks of the ceramic
      material, and other therapeutic alternatives. Prior to the study, participants were asked to
      provide written informed consent. Ninety posterior FPDs were produced and allocated in
      parallel and randomly to either monolithic zirconia, veneered zirconia or MC restorations.
      The clinical procedures were performed by two experienced clinicians. All participants
      received oral hygiene instructions and a professional tooth cleaning prior to prosthetic
      treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer,
      an axial reduction of 1 mm and an occlusal reduction of 1.5- to 2.0-mm. A 10- to 15- degree
      angle of convergence was achieved for the axial walls. Tooth preparations were scanned with
      an intraoral scanner and the FPDs were designed using specific software. The restorations
      were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts
      were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The
      90 FPDs were examined at 1week (baseline),1, 2 and 2 years by 2 researchers who were not
      involved in the restorative treatment.
    

Intervention name(s): Monolithic zirconia; Veneered zirconia; Metal-ceramic
Intervention type(s): Drug; Other; Other
Intervention description(s): To assess the clinical performance and survival of posterior monolithic zirconia fixed partial dentures; To assess the clinical performance and survival of posterior veneered zirconia fixed partial dentures; To assess the clinical performance and survival of posterior metal-ceramic fixed partial dentures
Other intervention name(s): Zenostar T; Wieland Dental; IPS e.max ZirCAD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fixed partial dentures; clinical evaluation; monolithic zirconia; veneered zirconia; survival
Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant
      administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy
      study participants.
    


Intervention name(s): Padsevonil (UCB0942); Erythromycin
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical Form: film-coated tablet
Route of Administration: Oral use; Pharmaceutical Form: film-coated tablet
Route of Administration: Oral use
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Padsevonil
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Padsevonil
Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      This post coital test study is a Phase I multi-center, randomized, crossover, non-significant
      risk device study to be carried out at two clinical sites/centers. The products to be tested
      are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with
      ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of
      product use, with a goal of 10 participants completing the study.
    

Detailed description: 
      Each participant will be seen in approximately nine visits, over a period of 6-8 months, and
      will be contacted approximately 7 days after the final visit. Volunteers will be consented at
      Visit 1 and undergo procedures to confirm they are eligible to continue in the study.

      Each participant will undergo four postcoital test (PCT) cycles:

        1. The first PCT cycle will be a baseline cycle, done without the use of any product, in
           order to demonstrate the participant's ability to undergo normal ovulatory events and to
           produce receptive, midcycle cervical mucus. The partner's ability to produce motile
           sperm capable of penetrating the cervical mucus is also evaluated in this cycle.

        2. Test PCT cycles will be carried out during the subsequent menstrual cycles using either
           the SILCS diaphragm with 3% N-9, the SILCS diaphragm with ContraGel, or the SILCS
           diaphragm alone following a sequence of randomized treatment. Cycles may need to be
           repeated depending on the characteristics of the cervical mucus and the number of sperm
           found in the vaginal pool and endocervical specimens.
    

Intervention name(s): SILCS diaphragm used with ContraGel; SILCS diaphragm used with 3% Nonoxynol-9; SILCS diaphragm
Intervention type(s): Other; Other; Other
Intervention description(s): SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. ContraGel is a clear, water soluble greaseless gel packed in a metal tube.; SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. 3% Nonoxynol-9 (branded as Gynol II) is clear, unscented water soluble greaseless gel packed in plastic tubes with a vaginal applicator.; SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring
Intervention MeSH terms: Nonoxynol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Post coital test; Vaginal; Diaphragm
Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
Condition: Colorectal Lesions
Study type: Interventional

Summary: 
      This pilot, multi center study will establish the effectiveness of Given PillCam® Platform
      with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with
      polyps, compared to standard colonoscopy.

      This study will also use to evaluate the administrative feasibility and data management of
      study design.
    


Intervention name(s): PillCam Colon 2; Colonoscopy
Intervention type(s): Device; Device
Intervention description(s): Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE).
Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.; The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Device Feasibility
Keywords: polyps; capsule endoscopy; colonoscopy