bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes
Condition: Heat Therapy; Perineal Tear; Pain; Labor
Study type: Interventional

Summary: 
      The goal of the clinical trial is to determine the effect of second-stage warm compress
      application on perineal pain and trauma among primiparous women. The main questions may
      reveal the pain intensity and the perineal outcome of the warm compress which might be
      helpful to the women during labor and related authority of the hospital.

      The intervention with warm perineal compression will be done among primiparous mothes during
      second stage of labor
    

Detailed description: 
      Participants

        -  After full dilatation of the cervix, assign participants in a 1:1 ratio to the study and
           control groups randomly.

        -  Ask women to select one closed envelope containing a card with the group allocation
           (study or control groups)

        -  Provide usual care according to the unit protocol to all the women until the second
           stage of labor.

        -  Provide the participants of the study group with a warm perineal compress during the
           whole second stage of labor

        -  Provide usual care according to the unit protocol to the participants of control group
           during the whole second stage of labor.

      The process of applying the warm perineal compress

        -  Fill a clean container with warm water (45-59°C)

        -  Soak a clean pad in the water, squeeze then place gently on the perineum during each
           uterine contraction.

        -  Maintain the temperature between 38-44°C during its application.

        -  Re-soak the pad in warm water between contractions, to maintain warmth and then reapply.

        -  Replace the water in the container every 15 minutes until delivery or if the temperature
           drop below 45°C
    

Intervention name(s): Perineal warm compression Technique
Intervention type(s): Procedure
Intervention description(s): There will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care to asses the pain intensity and perineal tear
Other intervention name(s): Perineal heat therapy
Intervention model: Single Group Assignment
Intervention model description: there are two groups randomly selected. intervention and control group, One group will be used perineal heat application and the control group will be received standardized care.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: perineal warm compression, Tear, Pain
Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)
Condition: End-Stage Renal Disease; Type 2 Diabetes
MeSH terms: Kidney Failure, Chronic; Hypoglycemia
Study type: Interventional

Summary: 
      The study is conducted to assess the efficacy of real-time CGM data in preventing
      hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated
      with insulin therapy and receiving hemodialysis.
    

Detailed description: 
      The study is conducted to assess the efficacy of real-time CGM data in preventing
      hypoglycemia among patients with type 2 diabetes (DM2), treated with insulin and receiving
      hemodialysis. The study will provide novel insights into the glycemic exposure patterns among
      dialysis patients and will provide preliminary data for future outcomes-based studies
      determining the best glycemic targets for this group.
    

Intervention name(s): Dexcom real-time G6 Continuous Glucose Monitoring System (CGM); POC BG
Intervention type(s): Device; Diagnostic Test
Intervention description(s): Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective "urgent low soon" alarm, with proven prediction of hypoglycemia within 20 minutes in advance. The sensor uses a novel semi-permeable membrane that blocks interference with most clinically relevant substances, including high levels of urea and creatinine, and commonly used medications. Dexcom G6 CGM is a commercially-available, minimally invasive sensor, with a flexible and thin wire that is inserted into the abdominal subcutaneous tissue. Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the "urgent low soon" alarm (predictive of hypoglycemia < 55 mg/dL within the preceding 20 minutes).; POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks; and vice versa (Control-Intervention Group).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ESRD; Continuous Glucose Monitoring; Diabetes
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
Condition: Bacteremia
MeSH terms: Bacteremia
Study type: Observational

Summary: 
      To assure the uniform collection, handling, storage and transport of patient whole blood
      specimens and associated information to support validation of the T2 Bacteremia Assay.
    

Detailed description: 
      This protocol is intended for use by external sites collecting clinical research specimens
      for T2 Biosystems' use in developing the T2Bacterial Assay. Specimens and information on
      patients' medical history, blood properties, medications, and blood culture history/results
      are required from the T2Bacterial Assay's target patient population (i.e., candidates for
      blood culture). Ideally, clinical specimens for use in developing the T2Bacterial Assay will
      be collected from negative blood culture, positive non-bacteria blood culture and positive
      bacteria blood culture patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with blood culture results are eligible to participate
      
Biospecimen description: 
      Whole blood specimens, in addition to bacterial isoaltes
    
Keywords: Bacteremia; Sepsis; Acinetobacter baumannii; Staphylococcus aureus; Klebsiella pneumonia; Pseudomonas aeruginosa; Enterococcus faecalis; Magnetic Relaxation Detection; Nuclear Magnetic Resonance Detection; Blood culture
MOVE UP Lifestyle Intervention for Caregivers
Condition: Body Weight; Healthy Diet; Physical Activity; Health Behavior; Healthy Aging
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      In prior research the Mobility and Vitality Lifestyle Program for healthy aging and weight
      management (MOVE UP) was effective in producing a mean loss of >= 5% body weight, with
      increased physical activity and reduced fatigue. This research will pilot a modified and
      streamlined version to see if it will be similarly effective for caregivers of family members
      or friends who have dementia, physical and/or developmental issues, or health problems.
    

Detailed description: 
      The investigators aim to test the feasibility of delivery of a modified and streamlined
      lifestyle program in volunteer community settings and to provide pilot data to inform the
      design of future randomized controlled trials that may improve physical and mental health in
      older adults (50-75) who are providing care for a family member or friend who has dementia,
      physical and/or developmental issues, or health problems. Current objectives include:

      1 . Adapt and pilot the previously studied 32-session, 13-month MOVE UP intervention to a
      streamlined 12-session (4-month) community-based translational behavioral weight management
      program. The pilot program will be delivered by a staff interventionist.

      2. Implement and evaluate the program's impact on weight and healthy lifestyle changes,
      including physical performance outcomes, at 2 sites, each with at least 6 eligible obese and
      caregiving adults ages 50-75 years old.
    

Intervention name(s): MOVE UP
Intervention type(s): Behavioral
Intervention description(s): Each of the 12 group sessions will focus on incremental behavioral strategies for maintaining healthy eating, activity, and weight loss.behaviors. Body weight will be measured in-person session and participants will also to measure their body weight on their in Session 3, participants are given physical activity goal of 10 minutes/day, 50 minutes/week. The goal is raised by 5 minutes/day, 25 minutes/week every other session, the final goal being 30 minutes/day, 150 minutes/week. All subjects will be recommended to engage in an energy restricted dietary intervention that evidence demonstrates has effectively reduced body weight by 5-7% within the initial 4 months of the intervention. This will include reducing energy intake to 1200 to 1800 kcal/d based on initial body weight (<200 pounds = 1200 kcal/d; 200 to 250 pounds = 1500 kcal/d; >250 pounds = 1800 kcal/d).
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment Implementation research for adapted effective intervention
Masking: None (Open Label)
Primary purpose: Prevention
Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)
Condition: Dilated Cardiomyopathy
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the safety and tolerability of Cardiac Repair Cells (CRCs)
      compared to standard-of-care in patients with dilated cardiomyopathy (DCM).
    

Detailed description: 
      Heart failure remains a major public health problem, affecting 5 million patients in the US
      with 550,000 new diagnoses made each year. Heart failure is the leading cause of
      hospitalization in persons over 65 years of age with cost exceeding $29 billion annually.
      Prognosis is very poor once a patient has been hospitalized with heart failure. The mortality
      risk after heart failure hospitalization is 11.3% at 30 days, 33.1% at 1 year and well over
      50% within 5 years (Hunt SA; et al., 2005). These numbers emphasize the need to develop and
      implement more effective treatments to manage heart failure.

      This study is targeting a subset of heart failure patient population, namely those diagnosed
      with dilated cardiomyopathy (DCM). The World Health Organization (WHO) defines dilated
      cardiomyopathy as a cardiac condition wherein a ventricular chamber exhibits increased
      diastolic and systolic volume and a low (<40%) ejection fraction. DCM is reported to affect
      108,000 to 150,000 patients in the U.S.

      This study is a prospective, stratified, randomized, open-label, controlled, multi-center
      study to assess the safety profile and efficacy of CRCs in treating patients with DCM. It
      will enroll a total of 40 patients at 5 sites in the U.S.
    

Intervention name(s): Ixmyelocel-T; Standard of Care
Intervention type(s): Biological; Other
Intervention description(s): CRCs will be administered via direct injection into the heart muscle.; Because the eligible patients had no other cardiac surgery or percutaneous cardiac interventions that were likely to produce clinical improvement, SOC was limited to pharmacologic therapy, heart transplant, or ventricular assist device therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic Dilated Cardiomyopathy; Non-Ischemic Dilated Cardiomyopathy; ixmyelocel-T
Evaluation of Patients With Suspected Endofibrosis
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Observational

Summary: 
      Define responses to exercise on both arterial bruits and oxymetry in patients referred for
      suspected endofibrosis.
    

Detailed description: 
      Recording of oxymetry during exercise and recovery. Recording of vascular bruits at rest ajnd
      post exercise.
    

Intervention name(s): Auscultation
Intervention type(s): Other
Intervention description(s): Electronic stethoscope
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Athletes referred for exercise tests
Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Observational

Summary: 
      This study is a comparison of multifocal electroretinogram assessment between the laser
      treatment group and the photodynamic therapy group in chronic central serous
      chorioretinopathy.
    

Detailed description: 
      1. Laser Group: extrafoveal focal leakage on FAG

        2. PDT Group: no definite focal leak on FAG subfoveal or juxtafoveal focal leakage on FAG,
           or serous retinal pigmentary epithelial detachment involving foveal center

      Inclusion criteria

        1. Chronic serous chorioretinopathy (over 3 months) when subretinal fluid persisted in the
           subfoveal region demonstrated by clinical examination and OCT

        2. Ability to maintain steady fixation for mfERG

        3. Presence of abnormal dilated choroidal vasculature in ICGA

        4. Symptom duration over 3 months

      Exclusion criteria

        1. previous PDT or laser treatment history

        2. evidence of Choriinal neovascularization in FAG

        3. other chorioretinal disorders that can cause macular exudation such as age-related
           macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases,
           retinal vasculopathies, and hereditary dystrophies

      follow-up Visit

      1)baseline 2)1month 3)3months 4)6 months

      each visit: multifocal electroretinogram, visual acuity, optical coference timography should
      be measured.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Laser Group: extrafoveal focal leakage on FAG

          2. photodynamic therapy Group: no definite focal leak on FAG subfoveal or juxtafoveal
             focal leakage on FAG, or s-RPED involving foveal center
      
Keywords: chronic central serous chorioretinopathy; multifocal electroretinogram; central retinal function after treatment in chronic serous chorioretinopathy
Evaluation of Two Marketed Multifocal Contact Lenses
Condition: Visual Performance
Study type: Interventional

Summary: 
      This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The
      purpose of this clinical study is to evaluate the performance of two marketed multifocal
      lenses.
    


Intervention name(s): Multifocal Contact Lens 1; Multifocal Contact Lens 2; Spherical Contact Lens 2
Intervention type(s): Device; Device; Device
Intervention description(s): Dailies Total 1 Multifocal Contact Lens; Biotrue ONEday for Presbyopia Contact Lenses; BioTrue ONEDay Spherical
Other intervention name(s): Test 1 Multifocal , delefilcon A; Test 2 Multifocal, nesofilcon A; Test 2 Alternative, nesofilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Genetics of Recurrent Early Onset Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      This study will identify specific genes that may cause a predisposition to depression in some
      families.
    

Detailed description: 
      Depression is a serious medical illness that is often difficult to diagnose and treat.
      Studies on patterns of depression within families suggest that inherited genes may cause a
      predisposition to the disorder. People with early onset depression often have more relatives
      with depression than people whose depression does not begin until later in life. It is likely
      that several interacting genes cause this tendency towards the disorder, rather than one
      specific gene. This study will serve to identify particular genes that may cause a
      susceptibility to depression in order to better understand the brain mechanisms involved with
      severe depression. In turn, this may aid in the development of new treatments for depression.

      Participation in this observational study will entail one interview and one blood test.
      Participants will be interviewed, either in person or by telephone, about their personal and
      family psychiatric history. The blood sample will be collected at a time and location that is
      convenient for the participant. Participants may also be asked to invite other family members
      to participate in the study.

      For information on a related study please follow this link:

      http://clinicaltrials.gov/show/NCT00005914
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include participants with a family history of depression.
      
Biospecimen description: 
      Blood samples with DNA
    
Keywords: Depressive Disorder; Family; Genetics
Dance Exercise as Novel Complementary Therapy for Parkinson's Disease
Condition: Parkinsons Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to gather data to see if so-called enriched forms of exercise
      programs such as dance is more effective in improving balance and quality of life in patients
      with idiopathic Parkinson's disease than regular exercise programs that are currently
      provided by physical therapists.
    

Detailed description: 
      Comparison of traditional PT to dance in people who have parkinsons disease to measure which
      is better for gait, balance and QOL.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        To qualify for this study, subject must have been diagnosed with Parkinson's Disease for 3
        years or more, be less than 80 years of age, and have problems with gait and balance
      
Keywords: Gait, balance, Parkinson's Disease
Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to
      evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with
      mild to moderate Atopic Dermatitis
    

Detailed description: 
      This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to
      evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with
      mild to moderate Atopic Dermatitis.

      Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201
      OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive
      blocks in 1:1:1 ratio for the active groups and vehicle.

      Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label
      substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.
    

Intervention name(s): ATx201; ATx201 OINTMENT vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Topical; ATx201 OINTMENT vehicle
Other intervention name(s): ATx201 OINTMENT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned by using Interactive Web Response System (IWRS) to one of three treatment groups
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Mexican healthy volunteers will receive the current form of the drug (under the name of
      Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.
    

Detailed description: 
      Bioequivalence
    

Intervention name(s): Epamin: Reference Drug; Phenytoin: Study Drug
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 75 mg (10 ml in suspension) of Epamin; Single dose of 75 mg (10 ml in suspension) of Phenytoin
Intervention MeSH terms: Phenytoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Phenytoin; Epamin
High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparison of virological breakthrough/relapse rate after dose adjustments and sustained
      virological response rate will be assessed by the type of induction.
    

Detailed description: 
      The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics
      by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU
      interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of
      treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and
      sustained virological response rate will be assessed by the type of induction.
    

Intervention name(s): Peginterferon alfa-2a; Interferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Pegasys; Intron-A; Copegus
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neonatal Outcomes in Instrumental Delivery
Condition: Instrumental Delivery; Nec, Affecting Fetus or Newborn
Study type: Observational

Summary: 
      The aim of this study is to compare the impact of instrumental delivery on newborn head mark
      and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how
      mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and
      height of the fetal presentation, operator, time of birth (day or night) and birth weight
      impact on head mark existence and newborn comfort.
    


Intervention name(s): instrumental delivery
Intervention type(s): Other
Intervention description(s): the birth was assisted with an extractor.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        mature newborns who profit an instrumental delivery or not.