bioihbjkbjnl/mcl2 huggingface dataset:
Functional Outcomes After Radial Head Fractures Treated Non-operatively
Condition: Radial Head Fracture
MeSH terms: Fractures, Bone; Radial Head and Neck Fractures; Radius Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of physical therapy as part of the
      non-operative treatment of radial head fractures.There is currently no data to support the
      use of physical therapy in the non-operative treatment of radial head fractures. Likewise,
      there is no data that shows that physical therapy is harmful to patients being treated
      non-operatively for radial head fractures. Investigators believe that prescribing physical
      therapy for patients with non-displaced radial head fractures treated non-operatively is
      unnecessary, and that that it would be equally efficacious to teach patients simple
      stretching exercises that they could perform by themselves. Subjects will be randomized into
      2 groups: Group 1 - Patients will be prescribed physical therapy within the first month
      following fracture; Group 2 - Patients will be given simple stretching exercises to perform
      at home and will not be given a prescription for physical therapy. Patients who agree to
      participate in this study and sign the informed consent will be randomly assigned to one of
      the two groups.
    


Intervention name(s): Outpatient physical therapy in addition to standard follow-up visits; Home exercises in addition to standard follow-up visits
Intervention type(s): Procedure; Behavioral
Intervention description(s): Patients in Group 1 will be given a prescription for outpatient physical therapy.; Patients in Group 2 will be carefully instructed on home exercises for range of motion and strengthening of their affected elbow. All therapy regimens will be prescribed at initial presentation, as is the current practice. All other care will be identical for patients in both groups. This
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
Condition: Patella; Joint Instability; Patellofemoral Joint Dislocation
MeSH terms: Joint Dislocations; Joint Instability; Patellar Dislocation
Study type: Interventional

Summary: 
      About six months after patella stabilizing surgery postoperative restrictions are commonly
      lifted and patients may consider whether a return to activity/sports is feasible. Currently,
      there are no evidence-based criteria to determine a patients readiness for sports and/or
      activity (RTS) following stabilizing surgery. The purpose of this project was therefore to
      investigate the feasibility of a test battery to evaluate knee function in postoperative
      follow-up evaluation - and in RTS decisions - for patients with patellar instability. Banff
      Patellofemoral Instability Instrument 2.0 and Norwich Patellar Instability Score is being
      translated and validatend in a Norwegian population. Furter is patients experience of living
      with patellar instability explored.
    


Intervention name(s): Return to Sport testbattery
Intervention type(s): Other
Intervention description(s): At baseline, approximately 3 weeks before surgery and 6 months after surgery: patients conduct a testbattery consisting of 2 PROMs: the NPI-No and BPII2.0-No together with three physical tests: isokinetic strength tests, hop tests and Y-balance test. For the cross-cultural validation of NPI and BPII2.0 patients also conduct KOOS, IKDC 2000 and Tampa Scale.
Other intervention name(s): Validation of Banff Patellofemoral Instability Instrument 2.0 - No; Validation of Norwich Instability Score - No
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
Condition: Dental Implant
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      The purpose is to place implants in HIV positive and HIV negative patients then follow
      patients over 3 years period of time to evaluate how well dental implants perform in HIV
      positive patients versus HIV negative patients.
    

Detailed description: 
      This study will review the osseointegration of implant supported restorations in HIV positive
      and HIV negative patients, then follow patients over a 3 year period of time. The treatment
      outcome as measured according to Mish criteria for implant success. Patients will be examined
      at each interval for the presence of pain, infection, mobility, and radiographic bone height
      of each implant.
    

Intervention name(s): Astra implants
Intervention type(s): Device
Intervention description(s): Root form OsseoSpeed TX Astra Tech Implant System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Implant; Crown
sST2 and Cardiac Surgery
Condition: Cardiac Surgery
Study type: Observational

Summary: 
      Evaluation of the prognosis value of sST2 dosed before cardiac surgery on prognosis of long
      terme prognosis after cardiac surgery.

      The patients where initialy recruted for another cohort named micro-SIRS and inflammation but
      the gaved their consent to analyse the blood samples for other studies
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients included before cardiac surgery
A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is designed as a multiple-ascending-dose, safety and tolerability study
      with IW-3300. The study drug will be administered as a low-volume [20 mL] enema. Study
      participants will be randomized in a 2:1 ratio to receive IW-3300 or placebo. Up to 3
      different doses of IW-3300 will be studied. Safety reviews will be conducted before
      proceeding to each higher dose.
    

Detailed description: 
      This is a Phase 1, single-center, randomized, double-blind, placebo-controlled,
      multiple-ascending-dose study of IW-3300 administered rectally, once-daily, for 7 days as a
      low-volume enema in healthy adult participants. This study will assess the effect of IW-3300
      on safety and tolerability.

      The study includes up to 4 treatments: placebo and up to 3 dose levels of IW-3300 which will
      be determined after safety reviews of previous cohorts.

      The 9 participants within each cohort will be randomized to receive IW-3300 (6 subjects) or
      placebo (3 participants), administered rectally (as a low-volume [20 mL] enema). Participants
      in each dosing cohort will progress through 3 study periods: (1) Screening Period, (2) Clinic
      Period, and (3) Follow-up Period. Treatment duration will be 7 days; participants will be
      followed in the Phase 1 clinical research unit (CRU) for the duration of dosing, until at
      least 24 hours after the last dose of study drug and contacted by phone for follow-up
      approximately 2 weeks after the last dose. Total participant participation will be 29 to 57
      days, including the Screening, Clinic, and Follow-up Periods.
    

Intervention name(s): IW-3300; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A dose of IW-3300 administered rectally (as a low-volume [20 mL] enema).; A dose of placebo administered rectally (as a low-volume [20 mL] enema).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteers
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987516)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-64-R84-070)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TENS in Optimizer(R) Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart
      failure.

      Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation
      (TENS). It is applied to strengthen the musculature and improve exercise tolerance and
      quality of life.

      It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients
      with Optimizer® pacemaker systems for improvement of heart failure.

      This pilot safety study enrolled 6 patients with chronic heart failure and reduced left
      ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for
      a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to
      the study, and all were in clinically stable condition and willing to participate in this
      study.

      Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF)
      on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients
      were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the
      Optimizer®-system respectively.
    


Intervention name(s): Stimulette r4x
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cross-section Survey of Mechanical Ventilation and Acute Respiratory Distress Syndrome in China
Condition: Respiratory Failure; Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      The characteristics and outcomes of a mixed group of critically ill patients who received
      mechanical ventilation are not known in China.

      A 1 month Cross-section survey will be performed with the aim of describing the
      characteristics and outcomes of conventional mechanical ventilation and treatment of acute
      respiratory distress syndrome in intensive care units in China.
    

Detailed description: 
      From August 31th 2012 to September 30th 2012, all patients admit to ICUs were screened,
      mechanical patients and patients with ARDS be enrolled. The demographic characteristics,
      diagnosis, formerly medical history, Ventilator indications, Ventilator data, other
      respiratory treatments, weaning outcome and 28 day mortality, and the treatment of ARDS will
      be recorded.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A mixed group of critically ill patients who received mechanical ventilation or patient
        with ARDS
      
Keywords: mechanical ventilation, ARDS, Ventilator strategy, outcome
Study the Effect of Acupuncture on Migraine Patient Without Aura Via Functional Magnetic Resonance Imaging.
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional

Summary: 
      This study recruits 30 subjects into three groups, including two experimental groups and one
      control group. The two experimental groups receive acupuncture treatment for 4 weeks and two
      times functional magnetic resonance imaging scans as well as clinical symptom assessments.
      The control group receive one scan without any intervention. The aim of this study is to find
      the whether the effect of acupuncture treatment have diversity among migraineurs with
      different disease course.
    

Detailed description: 
      This study recruits 10 patients with long course (> 5 years) without aura migraine, 10
      patients with short course (< 5 years) without aura migraine and 10 healthy volunteers who
      meet the inclusion and exclusion criteria. Among the study, two migraine patient groups
      receive acupuncture treatment for 4 weeks, the frequency is 30 minutes each time, three times
      a week. According to the national standard of the people's Republic of China (GB / T
      12346-2006) acupoint name and location, the acupuncture treatment includes SJ23 (Si Zhu Kong,
      unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi,
      unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan,
      bilateral) and SJ5 (Wai Guan, bilateral) acupoints. Both migraine patients receive scan in
      functional magnetic resonance imaging (Siemens 3.0T superconducting magnetic resonance
      scanner, Germany) and symptom scale assessment before the first acupuncture stimulation and
      post the last acupuncture stimulation. Healthy volunteers receive only one scanning without
      intervention.
    

Intervention name(s): Acupuncture stimulation
Intervention type(s): Behavioral
Intervention description(s): The intervention is about acupuncture treatment, which has 4 weeks acupoint stimulation and the frequency is 30 minutes each times for 3 times per week. The acupoints include SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two experimental groups with different condition receive identical intervention, with control group as baseline for comparison.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Acupuncture; Functional magnetic resonance imaging
Safety and Local Tolerability of Prevenar in Indian Children
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Observational

Summary: 
      This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian
      children.

      Prevenar is indicated for active immunization of infants and children from 6 weeks of age
      through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia,
      bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and
      23F.

      Prevenar has been marketed in India since June 2006. The Board of Health in India has given
      restricted permission to import and market Prevenar. The present study is a post-approval
      regulatory commitment to the Board of Health in India.

      This is an observational study and the protocol for the study has been approved by the Board
      of Health.
    


Intervention name(s): pneumococcal conjugate vaccine
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Time perspective: Prospective
Keywords: Pneumococcal Infections/PC (Prevention & Control)
A Multistrain Probiotic in Patients With Irritable Bowel Syndrome With Predominant Constipation
Condition: Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional

Summary: 
      Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate
      or global relief, which partly explain contradictory results obtained in clinical trials with
      probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of
      probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate
      due to its non-invasive and discriminating character compared to a healthy population. It is,
      inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and
      intensity of inflammation by regulating the transcription of cytokines, chemokines and their
      receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a
      predictor of probiotic response based on its baseline value.
    

Detailed description: 
      Resolvin D1 levels will be measured in patients with IBS-C as defined by the Rome IV criteria
      before 6 and 12 weeks after supplementation with a mixture of probiotics. The progression of
      IBS-C symptoms will also be assessed throughout the study.

      The correlation with resolvin D1 levels and the severity of IBS symptoms will be
      investigated. The efficacy of the probiotic mixture in relieving the symptoms of IBS-C will
      be measured and compared based on the levels of resolvin D1.
    

Intervention name(s): Probiotics mixture
Intervention type(s): Dietary Supplement
Intervention description(s): 12 weeks of daily supplementation with 1 g of probiotics mixture (4.10exp9 colony forming unit/g) containing:
Bifidobacterium longum LA 101
Lactobacillus helveticus La 102
Lactococcus lactis LA 103
Streptococcus thermophilus LA 104
Intervention model: Single Group Assignment
Intervention model description: Quasi-experimental study: post-treatment versus baseline comparison
Masking: None (Open Label)
Primary purpose: Treatment
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
Condition: Intrahepatic Cholestasis of Pregnancy
MeSH terms: Cholestasis; Cholestasis, Intrahepatic; Pregnancy Complications
Study type: Observational

Summary: 
      Many studies have attempted to find the predictors of adverse neonatal outcome in women with
      Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L
      has been associated with increased risk of meconium staining, low Apgar scores, preterm
      delivery, and stillbirth.Other predictors such as level of transaminases, history of
      cholelithiasis, and hepatitis virus infection have been studied but the results are
      inconclusive.A more comprehensive investigation involving multiple neonatal outcomes and a
      wide variety of outcome predictors is needed in order to establish guidelines for optimal
      timing of delivery in pregnancies complicated by ICP. The aim of our study was to evaluate
      wide variety of predictors of adverse neonatal outcomes in a large cohort of women with ICP .
    

Detailed description: 
      We performed a retrospective cohort study of all women diagnosed with ICP. Pregnancy outcomes
      including delivery gestational age, spontaneous preterm delivery, iatrogenic preterm
      delivery, birth weight, mode of delivery, oligohydramnios, intrauterine growth restriction
      (IUGR), placental abruption, preterm premature rupture of membrane (PPROM), concerning fetal
      heart tracing, chorioamnionitis, endometritis, postpartum hemorrhage, transfusion,
      stillbirth, neonatal intensive care unit (NICU) admission, hyperbilirubinemia, meconium
      stained amniotic fluid, respiratory distress syndrome(RDS) or transient tachypnea of
      newborn(TTN) (transient tachypnea of the newborn), and composite neonatal outcome were
      ascertained. A composite adverse neonatal outcome was created and defined as any of the
      following: NICU admission, hypoglycemia, hyperbilirubinemia, RDS, TTN, mechanical ventilation
      use, oxygen by nasal cannula, pneumonia, and stillbirth. PPROM was defined by rupture of
      membrane before 37 weeks gestation. Concerning fetal heart tracing was defined as recurrent
      variable or late decelerations with moderate variability, prolonged decelerations, or
      category 3 tracing. Providers who were caring for the women reviewed and independently
      characterized fetal heart tracings. Since fetal heart tracings were not accessible to
      authors, authors accepted the providers' interpretation. For analysis of concerning fetal
      heart tracing, women with non-labor cesarean section were excluded. Hyperbilirubinemia was
      defined by neonatal hyperbilirubinemia that required phototherapy. Hypoglycemia was defined
      by neonatal hypoglycemia that required intravenous infusion. Diagnosis of RDS and TTN were
      made by the managing neonatologist and based on standard clinical guidelines.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        neonates
The Safe Teen Study
Condition: Prevention
Study type: Observational

Summary: 
      The study examines (1)the incidence of preventive health services provided by family
      physicians to adolescent patients, and (2)barriers and facilitators of prevention discussions
      between family physicians and their adolescent patients.
    

Detailed description: 
      This study used a card study design to allow volunteer physicians to record research data in
      the context of providing clinical care. The method was brief, simple, and convenient for busy
      practicing clinicians.

      Volunteer resident physicians and faculty carried data collection checklists in their pockets
      and completed one for every adolescent patient seen during a randomly selected two week
      period. Physicians attempted to collect data on ten consecutive encounters with teen patients
      aged 11-21 years. The checklist documented patient characteristics (age, gender and
      ethnicity), reason for visit, parent presence, and types of prevention issues discussed
      during the visit. Patient and visit information was collected to assess its influence on
      physician prevention discussions. Finally, the checklist asked open-ended questions related
      to barriers to and facilitators to teen prevention discussions.

      The study involved five clinical sites comprising approximately 140 faculty and resident
      family physicians. The investigators sought 10-15 volunteer physicians from each site (60-90
      physicians), and asked them to complete data checklists on 10 consecutive adolescent patients
      (600-900 visits). After a training session, each site randomly selected data collection
      periods.

      Physicians provided usual care for adolescent patients and recorded on the checklists any
      prevention discussions during the visit.
    

Time perspective: Other
Keywords: Family Physicians; Adolescents; Preventive Care; Health Behavior