bioihbjkbjnl/mcl2 huggingface dataset:
Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy
Condition: Oral Nimodipine; Milrinone; Vascular Spasm After Traumatic Subarachnoidhaemorrhage
MeSH terms: Subarachnoid Hemorrhage; Spasm; Subarachnoid Hemorrhage, Traumatic; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy
      for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.
    

Detailed description: 
      after being informed about the study and potential risks. All patients giving written consent
      will be randomized by double-blind manner into 2groups each one containing 15 patients.

      Group 1(n =15 ):the patients will receive nimodipine (60 mg/4 hours) orally or via
      nasogastric tube In group 2(n =15 ): the patients will receive Oral Nimodipine (60 mg/4) will
      be given orally or in the gastric tube also from the first day of admission, then after the
      diagnosis of vasospasm is confirmed, start milrinone.
    

Intervention name(s): nimodipine; Oral Nimodipine and milrinone
Intervention type(s): Drug; Drug
Intervention description(s): (60 mg/4 hours) orally or via nasogastric tube; Oral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus
Intervention MeSH terms: Nimodipine; Milrinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: milrinone Oral Nimodipine
Jail-Based Use of Smoking Cessation Treatment Study
Condition: Tobacco Use
Study type: Interventional

Summary: 
      Smoking rates remain above 60% for individuals involved in the criminal justice system and
      contribute to elevated mortality rates in this population. Addressing smoking disparities
      among justice-involved individuals is a critical public health issue in Minnesota, one of a
      few states with rising incarceration rates. People who are incarcerated represent the
      intersection of multiple high-priority populations (disproportionately African-American,
      Native American, low-income, homeless, on Medicaid, and suffering from mental illness and
      substance use disorders). This study examines the impact of a smoking cessation intervention
      for individuals discharged from jail to the community on smoking abstinence. Participants
      will be randomized to either 1) guideline-based, in-person smoking cessation counseling
      during incarceration, telephone counseling after incarceration, and nicotine replacement, or
      2) enhanced treatment as usual. This study's findings will be used to develop a larger,
      multi-site study that is fully powered to measure longer-term health and smoking cessation
      outcomes.
    

Detailed description: 
      Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post
      discharge from jail. During these assessments, seven-day point prevalence abstinence will be
      bio-verified with exhaled carbon monoxide, and self-reported general health, physical health,
      mental health, and substance use measures will also be obtained. The analysis is fully
      powered (i.e., power > .8) to detect significant between group effects on the primary outcome
      (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence
      abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to
      treat sample and will utilize pre-specified logistic and linear regression models.
    

Intervention name(s): Nicotine Replacement Therapy; Counseling
Intervention type(s): Drug; Behavioral
Intervention description(s): All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges.; All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Incarceration; Smoking; Counseling; Nicotine Replacement; Disparities
Ergonomic Considerations on Musculoskeletal Disorders and Posture in Software Developers.
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The human and computer interface is becoming increasingly intuitive, but for the
      inexperienced user still poses formidable problems. Musculoskeletal symptoms of VDU users are
      believed to have a multifactorial aetiology. Software developers don't have knowledge of
      ergonomic principles. Faulty postures had an effect on posture.
    

Detailed description: 
      Data will be collected from software developer companies in Lahore at questionnaire include
      demographic data and data collection tools. The software developer will be guided about basic
      ergonomic principles and data will be collected at the start of the study and in 2 stages
      with a 2-week interval. A quasi-experiment study will be used. The sample size will be323
      (margin of error 5%, confidence level 95%, population size 2000, and dist. 50%) by Rao
      software. A convenient sampling technique will be used. Data will be analyzed using SPSS 21
      by comparing mean and correlating variables
    

Intervention name(s): ergonomic principls
Intervention type(s): Other
Intervention description(s): Ergonomic principles for posture correction in office for computer users.
Intervention model: Single Group Assignment
Intervention model description: Quasi-experimental study
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effect of Genetic Polymorphism on Interactions of Clopidogrel and Cilostazol in Healthy Volunteers
Condition: Interaction
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of genetic polymorphisms on
      pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean
      healthy adult volunteers.
    


Intervention name(s): Clopidogrel; Cilostazol; Clopidogrel/Cilostazol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral administration of 300mg of clopidogrel; single oral administration of 100mg cilostazol; single oral administration of 300mg clopidogrel and 100mg cilostazol
Other intervention name(s): Plavix; Pletaal; Plavix/Pletaal
Intervention MeSH terms: Cilostazol; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: CYP2C19; CYP3A5; Clopidogrel; Cilostazol; Healthy
Bacterial Contamination of Healthcare Worker Uniforms
Condition: Bacterial Contamination of Healthcare Worker Uniforms
Study type: Interventional

Summary: 
      Healthcare worker uniforms are frequently contaminated with bacteria known to cause
      infections in humans. These bacteria are acquired during the workday. A new technology of
      antimicrobial textiles have been developed and incorporated into the fabric of health care
      worker uniforms, reportedly with effectiveness rates of > 99% but there is little literature
      describing the effectiveness of Healthcare worker (HCW) uniforms with antimicrobial
      properties in the clinical setting. Because of the potential benefit that such uniforms could
      offer HCWs and patients alike, further investigation into whether these fabrics are effective
      is warranted.

      Up to 140 physicians, nurses, and midlevel providers who work at Denver Health on the general
      internal medicine wards will be invited to participate in this study. Participants will be
      randomized to wear either uniforms (scrubs) that have antimicrobial properties or standard
      scrubs provided by the hospital. At the end of an 8-hour workday, three areas on each uniform
      and each subject's wrist area will be cultured to assess for total bacterial colonization as
      well as for various resistant bacteria such as methicillin-resistant Staphylococcus aureus
      (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant gram-negative rods.

      Primary Hypothesis: HCW uniforms with antimicrobial properties will have less bacterial
      contamination than standard uniforms (scrubs) at the end of an 8-hour workday.

      Specific aim 1a. Demonstrate that antimicrobial uniforms will have less total bacterial
      contamination of sites swabbed compared to standard uniform after an 8-hour workday.

      Specific aim 1b. Demonstrate that antimicrobial uniforms will have less
      antimicrobial-resistant bacterial contamination (specifically looking for MRSA, VRE, and
      resistant gram negatives) of sites swabbed compared to standard uniform after an 8-hour
      workday.
    


Intervention name(s): Antimicrobial Scrubs
Intervention type(s): Other
Intervention description(s): Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: healthcare; worker; uniforms; bacterial; contamination
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Condition: Irritable Bowel Syndrome; Generalized Anxiety Disorder
MeSH terms: Irritable Bowel Syndrome; Syndrome; Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose to evaluate the effectiveness of duloxetine in treating subjects
      with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The
      investigators hypothesize that duloxetine as a single therapeutic agent will effectively
      target pain and other core symptoms of IBS as well as GAD in this patient population with
      both conditions.
    

Detailed description: 
      Generalized Anxiety Disorder (GAD) is commonly associated with Irritable Bowel Syndrome(IBS).
      The etiology of IBS remains unknown and it is often refractory to treatment. Duloxetine has
      demonstrated efficacy in the treatment of GAD as well as other pain disorders including
      fibromyalgia and diabetic neuropathy.

      We plan to study 30 subjects with diagnoses of IBS and GAD between the ages of 18 and 65
      years. There will be a single-blind placebo-run-in for the first 2 weeks, followed by
      open-label duloxetine for 12 weeks flexibly titrated to 120 mg/day. Subjects will be informed
      that they will receive placebo for 2 weeks during the trial. All study visits will be at
      Allegheny General Hospital Department of Psychiatry. The study consists of a total of nine
      office visits.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): All subjects will receive single-blind placebo for the first two weeks, and then duloxetine for the next 12 weeks, followed by an up to 2 week taper off of the duloxetine. After 2 weeks of placebo daily, subjects will receive 30 mg per day of duloxetine for two weeks, then titrated up to 60 mg per day of duloxetine at week 2. A dosage decrease to 30 mg daily is permittable after week 2. This will be a flexible dose study with doses of duloxetine progressively increasing at weeks 4 (90 mg daily) and 6 (120 mg daily) in conjunction with CGI-I scores, to reach 120 mg daily or the maximum tolerated dose, if less than 120 mg daily at Week 12. There will be a post-taper follow up appointment at Week 14. Of Note: Amendment IRB Approved 6/14/11 Study Ending at Week 12 with removal of Week 14 visit as part of study.
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: IBS; Irritable Bowel Syndrome; GAD; Generalized Anxiety Disorder
A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes
Condition: Collaborative Implementation Intentions; Individual Implementation Intentions; Information Only Control Condition
Study type: Interventional

Summary: 
      In a 6-week experimental design, up to 90 adult couples in which one partner has Type 2
      Diabetes (T2D) will be randomly assigned to either the collaborative implementation
      intentions (Collaborative IIs), the Individual Implementation Intentions (Individual IIs)
      condition, or the control condition. As this is a pilot study, randomization for the
      experimental groups vs the control groups will occur at a 2:1 ratio. Thus, the experimental
      conditions will contain up to 36 participants and the control condition will contain up to 18
      participants. Adults with T2D who are living with a romantic partner, not meeting current
      physical activity guidelines but able and willing to begin a new physical activity (PA)
      routine and their partners will be assessed at baseline, 3 weeks and 6 weeks after the
      experimental manipulation. Partners will report on their own investment in the patient's goal
      and patients will report on their own PA self-efficacy. Patient's PA will be measured through
      self-report, partner report and accelerometers for a week prior to each survey assessment.
      These specific aims are planned:

      AIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in
      partner investment in partners of adults with T2D than do individual IIs or control.

      AIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in
      patient PA self-efficacy in adults with T2D than do individual IIs or control.

      AIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in
      patient PA in adults with T2D than do individual IIs or control.
    


Intervention name(s): Collaborative implementation Intentions; Individual implementation Intentions; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): With spouse/romantic partner; Without spouse/romantic partner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kangaroo Care Reduces Infant Pain Caused By Vaccination
Condition: Infant; Pain; Kangaroo Mother Care; Nursing; Evidence-based Practices
Study type: Interventional

Summary: 
      The aim of this randomized controlled study determine the effect of KMC on pain in infants
      during vaccination.
    

Detailed description: 
      Infants undergo many painful procedures from the time they are born. Kangaroo mother care
      (KMC) is one of the nonpharmacological methods that are effective in alleviating pain. The
      aim of this randomized controlled study determine the effect of KMC on pain in infants during
      vaccination. The study subjects were 128 healthy, 1-month-old infants and their mothers. A
      sociodemographic questionnaire, the Neonatal Infant Pain Scale (NIPS), a pulse oximeter, and
      a chronometer were used in collecting the data. This study indicate that KMC reduced crying
      duration, heart rate, and pain in vaccinated infants, whereas it increased oxygen saturation
      levels in the blood.
    

Intervention name(s): İnfant pain management
Intervention type(s): Behavioral
Intervention description(s): Kangaroo mother care was applied to the infants during heel prick. With kangaroo mother care, the pain of infants was reduced.
Intervention model: Single Group Assignment
Intervention model description: The study was conducted between May -September 2016 in FHC. As 1-month-old infants were enrolled for the study, the total number of infants enrolled in FHCs each month was determined. Post-natal infants numbers were recorded in May-June, June-July, July-August, and August-September, for 48, 52, 59, and 57 infants, respectively. A pilot study was conducted on 20 infants born in May. Following the pilot study, monthly randomization was performed by an investigator. Accordingly, the study and control groups were determined monthly. There was no blinding in this study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: infant; pain; kangaroo mother care; nursing; evidence-based practices
Ivacaftor Treatment in 4 Month to 2 Year Old CF Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Observational

Summary: 
      The purpose of this research study is to determine the effects of clinically prescribed
      ivacaftor treatment on 4-24 month old children with CF and gating mutations on sleeping
      energy expenditure, growth status and gut health and function.
    

Detailed description: 
      Ivacaftor is a novel FDA approved therapy for patients with CF and gating mutations who are 4
      months and older. This investigator-Initiated study is designed to evaluate the nutritional,
      growth and GI impact of ivacaftor treatment for the youngest (4-24 months) patient cohort and
      for whom FDA approval has recently been granted. This proposal directly extends the previous
      highly informative nutrition and weight gain investigation of ivacaftor treatment in the
      older patient cohort (1). The primary aims of the study are to evaluate the impact of 12
      weeks of ivacaftor treatment in 4-24 month old subjects with CF and gating mutations on
      sleeping energy expenditure, growth status and gut health and function in 18 children with
      protocol evaluations at baseline (pre-treatment) and 6 and 12 weeks after clinically
      prescribed ivacaftor treatment has begun. Other outcomes of significant clinical interest in
      young subjects with CF will be explored. All subjects will be evaluated at the Children's
      Hospital of Philadelphia (CHOP) and will be recruited both regionally and nationally to
      ensure timely enrollment.
    

Intervention name(s): Ivacaftor
Intervention type(s): Drug
Intervention description(s): Ivacaftor (Kalydeco®, Vertex Pharmaceuticals Inc.) was the first of a new class of drugs that improved CFTR gating dysfunction (2, 3, 4). For such mutations (G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D) that permit CFTR expression at the cell membrane but compromise its activity.
Other intervention name(s): Kalydeco
Intervention MeSH terms: Ivacaftor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        4-24 month old subjects with a diagnosis of cystic fibrosis with at least one CFTR gating
        mutation of these ten (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1439D,
        or R117H) approved for treatment in a usual state of good health with a clinical decision
        to start ivacaftor treatment.
      
Biospecimen description: 
      Blood and stool collections
    
Keywords: CF transmembrane conductance regulator; CFTR; Gating Mutations
Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was designed primarily to assess preliminary efficacy and safety of CJM112 in
      patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate
      clinical profile for further clinical development. In addition, sustainability of response
      and dose relationship were to be explored.
    


Intervention name(s): CJM112; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne, inflammatory acne, efficacy, safety, PK
Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to evaluate the effect of sustained virologic
      response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS)
      and on neurocognition as measured by neurocognitive tests. This study will also evaluate the
      antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose
      combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.

      During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF
      FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit,
      participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12
      weeks.
    


Intervention name(s): LDV/SOF; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 90/400 mg FDC tablet administered orally once daily; Tablet administered orally once daily
Other intervention name(s): Harvoni®; GS-5885/GS-7977
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Merge the data of ultrasound with that of the anatomical and functional MRI is necessary
      since the high dose rate Curietherapy is carried out under ultrasound guidance. The
      investigators will recruit prostate cancer patients to evaluate the quality of the data,
      their sensitivity to exam conditions (patient position, volume of endorectal probe, gold
      grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from
      different sources with the purpose of estimating the opportunities of integration treatment
      plan for Curietherapy broadband.

      The nuclear magnetic resonance imaging provides precise anatomical study, but also provides
      access to a functional approach to the tumor mapping of water diffusion coefficient (DW-MRI),
      for dynamic imaging with injection contrast agent (DCE-MRI) and finally by spectroscopic
      imaging (IRMS). This multimodality imaging project is part of a multidisciplinary context,
      involving close collaboration between clinicians, medical physicists, and physicists of the
      teams participating in this project (Institut Gustave Roussy and U2R2M-CIERM hospital
      Kremlin-Bicetre).
    


Intervention name(s): Functional magnetic resonance imaging; Ultrasound
Intervention type(s): Device; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)