bioihbjkbjnl/mcl2 huggingface dataset:
Translation of an Intervention for Violence Among Adolescents in Emergency Departments
Condition: Violence
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The translation study aims to refine and package intervention and training materials
      essential to translating an efficacious Emergency Department (ED) based Brief Intervention
      (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist
      remotely. The study will take place in two phases. During the Effectiveness phase, we will
      determine the effectiveness of the interventions [on-site therapist delivered BI + text
      messages (n=133); remote therapy delivered BI + text messages (n=133)], as compared to a
      usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored
      text messages will be delivered daily for the first month post-discharge, and three times per
      week in the second month post-discharge to the BI groups. During the Implementation phase,
      components of the RE-AIM model will be assessed over a 4-month period.
    

Detailed description: 
      Participants who screen positive for the study during the effectiveness phase, will be
      randomized to either the therapy or control at a rate of 2:1. Whether the participant
      receives the on-site therapist or the remote therapist will depend on day of week or shift.
      Over the course of the study, the proportion of shifts covered by on-site verses remote
      therapists will be balanced for seasonality and time of day (evening vs. day time).
    

Intervention name(s): SafERteens
Intervention type(s): Behavioral
Intervention description(s): A 30 minute private on-on-one brief motivational interviewing intervention given during emergency department care. The goal of the intervention was to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Chronic neck pain causes errors in joint position. There are studies in the literature
      suggesting that the application of instrument-assisted soft tissue mobilization improves the
      sense of joint position. There are no studies that acutely examine this practice on joint
      position sense and pain in the cervical region. As a result of our study, we will investigate
      the effects of instrument-assisted soft tissue mobilization in a single session on perception
      of pain and joint position.
    


Intervention name(s): Instrument Assisted Soft Tissue Mobilization; Sham
Intervention type(s): Other; Other
Intervention description(s): Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.; Bilateral sham Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Joint Position Sense; Soft Tissue; Mobilization; Neck Pain
Effects of Whole-Body Vibration and High Impact Exercises in Postmenopausal Women
Condition: Osteoporosis, Postmenopausal; Exercise Therapy
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      We investigated the effects of whole body vibration (WBV) and high-impact (HI) exercises in
      postmenopausal women with low bone mineral density. In summary, WBV exercises are effective
      in preventing bone loss and WBV and HI exercise programs are effective in decreasing fall
      risk, increasing health-related quality of life and improving depressive symptoms
    

Detailed description: 
      Purpose: The aim of this study was to determine the effects of six months of supervised
      whole-body vibration (WBV) and high-impact (HI) exercises on bone mineral density (BMD),
      serum bone turnover markers, fall risk, health-related quality of life (HRQoL) and depressive
      symptoms in postmenopausal women, additionally, to evaluate the advantage of each training
      program to another.

      Methods: In a prospective, randomized controlled 6-month interventional trial 58 eligible
      postmenopausal women were assigned to WBV training group (n=19), HI training group (n=19), or
      control group (n=20). The patients in both training groups participated in a supervised
      training program, which consisted of the one-hour exercise session three times a week for six
      months. The WBV groups received vibration (30-35 Hz, 2-4 mm) in five different static
      positions. The HI group jumped rope (10-50 jumps/day). All patients received calcium (1000
      mg) and vitamin D (880 IU) supplementation per day. In all participants, baseline and
      six-month BMD at the lumbar spine and femur were measured by Dual-energy X-ray Absorptiometry
      (DXA). Serum osteocalcin (OC) and C-terminal telopeptide of type I collagen (CTx) were
      measured at baseline, three- and six-month intervals. Fall risk was assessed by using the
      Timed Up and Go (TUG) test and fall index measured by static posturography at baseline,
      three- and six-month intervals. HRQoL and depressive symptoms were assessed using the Quality
      of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Beck
      Depression Inventory (BDI), respectively, at baseline and six-month of the study.
    

Intervention name(s): Whole-body vibration exercise; High-impact exercise
Intervention type(s): Device; Other
Intervention description(s): The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA).; In the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure; Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single
      intravenous administrations of GGF2 in patients with heart failure.
    

Detailed description: 
      Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety,
      tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of
      GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.
    

Intervention name(s): Glial growth factor 2/ Neuregulin 1β3; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Recombinant Human Glial Growth Factor 2
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
Condition: Periampullary Cancers With Obstructive Jaundice; Pancreas Head Cancer; Bile Duct Cancer; Ampulla of Vater Cancer
MeSH terms: Bile Duct Neoplasms; Cholangiocarcinoma; Head and Neck Neoplasms; Jaundice; Jaundice, Obstructive
Study type: Interventional

Summary: 
      Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage
      (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage
      (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase
      difficulties in determining a proper resection margin. The purpose of this study is to
      compare the clinicopathological outcomes according to the methods of preoperative biliary
      drainage in periampullary cancers causing obstructive jaundice, and to find out a proper
      biliary drainage method.
    


Intervention name(s): biliary drainage
Intervention type(s): Procedure
Intervention description(s): biliary drainage via PTBD or ERBD/ENBD
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Analysis of Different Tests to Evaluate Prognosis of Patients on Liver Transplant Waiting List
Condition: Cirrhosis; Liver Failure; Portal Hypertension
MeSH terms: Liver Failure; Hypertension, Portal; Hypertension
Study type: Observational

Summary: 
      It is a cohort to evaluate the power of different diagnostic tests in predicting the
      prognosis of patients with severe liver disease.

      Patients with decompensated liver cirrhosis on the waiting list for liver transplantation
      will be evaluated with comparison of different diagnostic tests according to the MELD score
      (Model for End-Stage Liver Disease), MELD-Na (Model for End-Stage Liver Disease and sodium),
      indocyanine green clearance test, hepatic venous pressure gradient and transient
      elastography. All patients will be submitted to all the tests and prospectively followed for
      6 months, to establish mortality and complications related to liver disease in order to
      define the value of each method to predict outcomes.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cirrhotic patients on the liver transplantation waiting list of a single center.
      
Keywords: portal hypertension; elastography; Hepatic venous pressure gradient measurement
Validation of the French Adaptation of the RAADS-R Scale : Scale of Asperger Syndrome Diagnosis
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder; Asperger Syndrome
Study type: Interventional

Summary: 
      The diagnosis of developmental disorders in adults is still difficult. Indeed, in France,
      there is not questionnaires to easily and accurately diagnose this disorder. Several
      diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical
      tool that aims to better identify autism spectrum disorders including mild forms in adult
      people and help to diagnose of high-functioning autism . The objective of this study is to
      perform a complete validation of this scale in the french version.
    

Detailed description: 
      The diagnosis of developmental disorders in adults is still difficult. Indeed, in France,
      there is not questionnaires to easily and accurately diagnose this disorder. Several
      diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical
      tool that aims to better identify autism spectrum disorders including mild forms in adult
      people and help to diagnose of high-functioning autism . This scale is a self-administered
      questionnaire completed by the person himself assisted by a clinician (psychiatrist,
      psychologist) which ensures the understanding of issues and the choice of answers. The scale
      contains 80 items including 64 questions describe specific symptoms of autism spectrum
      disorders and 16 questions describe non-symptomatic behaviors. The objective of this study is
      to perform a complete validation of this scale in the french version. 300 adults should be
      included, including 100 adults with high-functioning autism, 100 adults with another
      psychiatric disorder, and 100 adults without developmental disabilities and / or mental.
    

Intervention name(s): RAADS-R scale
Intervention type(s): Other
Intervention description(s): This scale is a self-administered questionnaire completed by the person himself assisted by a clinician
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding
Condition: Gastrointestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      The investigators investigated the rebleeding rate the risk factors for rebleeding after
      long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure
      gastrointestinal bleeding.
    


Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent CE in Shanghai Renji Hospital ( China )from June 2002 to January
        2012 for OGIB
      
Keywords: capsule endoscopy; obscure gastrointestinal bleeding; rebleeding; risk factors
First Time in Human Study
Condition: Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Depression; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male
      volunteers
    

Detailed description: 
      To evaluate the safety, tolerability and pharmacokinetics of single ascending doses of
      GSK356278 and may assess the effect of food on GSK356278 pharmacokinetics. They study will
      assess the compound's effect on nausea, emesis and alertness. Close monitoring of
      cardiovascular parameters will be included.
    

Intervention name(s): GSK356278; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): GSK356278; PLACEBO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: healthy male volunteers; GSK356278; first time in man; major depressive disorder
An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
Condition: Depressive Disorder; Anxiety
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety and tolerability of
      JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who
      have had inadequate response to treatment with a selective serotonin reuptake inhibitor
      (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).
    

Detailed description: 
      This is a multicenter, double-blind (neither physician nor participant knows the treatment
      that the participant receives), placebo-controlled, randomized, parallel-group study in
      participants with Major Depressive Disorder (MDD) with Anxious Distress. Participants who had
      treatment initiated with a SSRI/SNRI allowed by the protocol will be evaluated at the
      investigation site. The site assessment will be reviewed and validated by an independent
      central rater. The review will include the clinical history of MDD, SSRI/SNRI treatment of
      adequate dose and duration for the current episode of depression, and current symptom
      severity on the Hamilton Depression Rating Scale (HDRS17). Enrolled participants will be
      maintained on SSRI/SNRI treatment throughout the study to determine whether additional
      treatment with JNJ-4216579 can reduce the symptoms of MDD with anxious distress.The study
      will consist of 3 phases: a Screening Phase of up to 4 weeks, an 11-week double-blind
      Treatment Phase, and a 3-week post-treatment (follow up) Phase. The double-blind treatment
      Phase of the trial will consist of 3 periods. The first period is a placebo lead-in of
      double-blind duration, after which participants will enter the treatment period when they
      will be randomly assigned to JNJ-42165279 or continuation on placebo for 6 weeks.
      Participants who successfully complete the treatment period prior to the end of Week 11, will
      be treated with placebo for the remaining time of the double-blind phase of the study, which
      will vary depending on the duration of the placebo lead-in for the specific participant. The
      total study duration for each participant will be approximately 18 weeks. Efficacy and safety
      of JNJ-42165279 will be evaluated. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): JNJ-42165279; Placebo
Intervention type(s): Drug; Other
Intervention description(s): JNJ-42165279 will be administered orally at a dose of 25 milligrams (mg) tablet once daily for 6 weeks.; Matching Placebo will be administered orally.
Intervention MeSH terms: JNJ-42165279
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Anxiety symptoms; JNJ-42165279
Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Condition: Acute Bacterial Skin and Skin Structure Infections
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, multi-center, randomized, active-comparator, study in subjects with
      ABSSSI. The study has two subgroups for assessment of efficacy and safety - oral subgroup 1
      and IV subgroup 2. Each subgroup will comprise of two treatment arms.
    

Detailed description: 
      Subjects willing to participate in the study and fulfilling all eligibility criteria will
      receive either oral therapy (subgroup 1) or IV therapy (subgroup 2). The investigator can
      initiate treatment with either oral or IV therapy based on clinical judgement i.e subjects
      who require IV therapy (like subjects with severe ABSSSI or where oral administration is not
      feasible).
    

Intervention name(s): Oral Levonadifloxacin/Linezolid Tablet; Intravenous Levonadifloxacin/Linezolid Infusion
Intervention type(s): Drug; Drug
Intervention description(s): oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID); IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)
Intervention MeSH terms: Linezolid; Levonadifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue
Condition: Brown Adipose Tissue
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing
      the norepinephrine transporter.
    


Intervention name(s): PET imaging
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: brown adipose tissue
Strength Training With Eccentric Arm-cranking
Condition: Strength Training
Study type: Interventional

Summary: 
      The new training device, the eccentric arm-crank, will be examined for its training effect by
      this project. That the training device can be used in athletes and patients with paraplegia
      in the future, the so-called "testing of the applicability of this concept" will be carried
      out during this study. Fourteen volunteer, healthy and trained people are first tested for
      their upper body performance, followed by a training phase over 20 trainings and at the and
      the performance data is collected again. The training intensity and duration is continuously
      increased during the training phase.
    

Detailed description: 
      At the beginning, the study design includes an familiarisation appointment with performance
      tests and training on the eccentric arm-crank device (KREHA). At least one week later, the
      first test sequence including a maximum strength test (bench press), magnetic resonance
      imaging (MRI) to determine the muscle cross-section area of the upper arm and a test to
      determine the anaerobic performance (Wingate test) is conducted. The second test sequence
      takes place one to three days later. This includes a handgrip strength test, an aerobic
      endurance test (ramp test on the arm crank ergometer with ergospirometry) and a further
      familiarisation training on the KREHA. The training phase starts within two weeks after the
      pre-tests have been completed. There are two to a maximum of three trainings per week. These
      take 30 to 60 minutes and take place on the KREHA device under the supervision of the study
      staff. The training phase lasts a maximum of twelve weeks (20 training sessions). The first
      test sequence is repeated five to eight days after the last workout. The second test sequence
      takes place at the same time interval as in the pre-tests.
    

Intervention name(s): eccentric arm-cranking training
Intervention type(s): Other
Intervention description(s): Over the twenty training sessions, able-bodied participants will exercise on the KREHA device. An arm-crank has to be decelerated, which will be rotated by a prematurely defined revolution rate and training duration. During this intervention a certain power has to be applied. During the whole time of training a continous progression in power and training duration is applied
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: eccentric
Haloperidol vs. Valproate in Agitation
Condition: Psychomotor Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare the efficacy of haloperidol and valproate in management
      of people with agitation in emergency department
    


Intervention name(s): Haloperidol; Valproate
Intervention type(s): Drug; Drug
Other intervention name(s): Haldol; Depakene
Intervention MeSH terms: Valproic Acid; Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
myDC/pDC in Stage III Melanoma Patients
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC
      vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.
    

Detailed description: 
      Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined
      pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol:
      2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC
      and myDC. After each vaccination the investigators will examine peripheral blood for
      proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide
      loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients
      remain disease free, the investigators will repeat this cycle with a 6 months interval up to
      a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory
      evaluation.
    

Intervention name(s): A: myDC vaccination; B: pDC vaccination; C: combined myDC/pDC vaccination
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment