bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Laparoscopically Closing the Hernia Defect in Laparoscopic Ventral Hernia Repair on Postoperative Pain
Condition: Ventral Hernias
MeSH terms: Hernia; Hernia, Ventral
Study type: Interventional

Summary: 
      Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh
      reinforcement has gained increasing acceptance among surgeons despite creating a
      tension-based repair. Beneficial effects of this technique have sporadically been reported
      but no evidence is available from randomized controlled trials.

      The primary purpose is to compare early postoperative activity-related pain in patients
      undergoing ventral hernia repair with closure of the gap with patients undergoing standard
      laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis
      and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence
      and chronic pain after 2 years.

      Material and Methods: A randomized, controlled, double-blinded study is planned. Based on
      power calculation we will include 40 patients in each arm. Patients undergoing elective
      laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre
      Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to
      participate.

      Conclusion: The technique with closure of the gap may induce more postoperative pain, but may
      be superior with regard to other important surgical outcomes. No studies have previously
      investigated closure of the gap in the setting of a randomised controlled trial.
    


Intervention name(s): The hernia gap is sutured intracorporally
Intervention type(s): Procedure
Intervention description(s): The hernia gab is closed with non-absorbable suture (Ethibond Excel 2-0, Ethicon, Johnson & Johnson©) performed by an intracorporally interrupted sutured technique using an Auto Suture© Endo-Slide knot-tying instrument. The stitches are placed with a distance of 0.5 - 1 cm from the fascial edges and with a distance of 0.5-1 cm. between the stitches, performed under a 6-8 mmHg intrabdominal pressure.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2a study to be run in 2-3 countries in European Union involving 5-6 sites. It
      will enroll approximately 80 patients to ensure 40 randomized with active rheumatoid
      arthritis. The treatment period is 2 weeks and total study duration per patient is
      approximately 1 month. The study drugs are AZD9567 40 mg (an oral SGRM) and the comparator is
      prednisolone 20mg. The primary endpoint is DAS28 including evaluation of 28 joints and
      C-reactive protein. Safety parameters will also be evaluated and a biomarker program is
      included for future research.
    

Detailed description: 
      This randomized double blind with double dummy technique phase 2a study will be run in 2-3 EU
      countries, most likely Sweden, Denmark and The Netherlands involving 5-6 sites. It is
      estimated that 80-100 patients have to be enrolled to ensure the randomization target of 40.
      The study population is patients with rheumatoid arthritis on stable treatment with
      conventional disease-modifying anti-rheumatic drugs (DMARDs) with an active flare. It is a
      two-arm parallel study and the randomization ratio is 1:1 to the two weeks of once daily
      treatment of 40 mg of AZD9567 and 20 mg prednisolone.

      The primary objective is to assess the efficacy of AZD9567 40 mg, compared to prednisolone 20
      mg in patients with active rheumatoid arthritis in spite of stable treatment with
      conventional and/or s.c/i.v. biological DMARDs and the primary variable is change from
      baseline in 28 joint Disease Activity Score using CRP (DAS28 - CRP). As secondary variables
      swollen and tenderness of 66-68 joints and safety variables are also included. For
      exploratively purposes there is also a biomarker program, collecting blood samples for future
      research.
    

Intervention name(s): AZD9567; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): oral OD SGRM administered as suspension; oral capsules of 20 mg prednisolone administered OD for two weeks
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind, parallell arm study with two weeks treatment of AZD9567 or prednisolone
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: rheumatoid arthritis, swollen joints, tender joints, autoimmunity
Evaluation of a Tele-Rehabilitation Service Program
Condition: Stroke; Paresis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      Is a unique tele-rehabilitation service directed at treating upper limb weakness due to
      stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the
      clinicians providing the care satisfied with the process?
    

Detailed description: 
      Participants will be identified from Mayo Clinic Division of Brain Rehabilitation's existing
      clinical practice and recruited either in person or by using a phone script.

      Eligible participants will have 2 in-person clinical assessments, one before the intervention
      and one concluding the protocol. The first clinical assessment will involve introducing and
      familiarizing the participant with the study procedure, demonstrating and practicing with the
      system, and obtaining baseline clinical measures. During this first session the participant's
      technical skills and home equipment capabilities will be assessed and any assistance needed
      for establishing the technology in their home will be determined and provided. The second
      clinical assessment will include acquiring post-intervention clinical and outcome measures.
      Intervention duration will be 3 months. During the study period, each participant will
      receive online treatment for up to 45 minutes (in order to have net 30 min clinical time)
      twice per week. During these sessions, the clinician will teach system interaction including
      integrating feedback, instruct in system intervention activities and assure participant
      competence in system use, and adjust the level of difficulty in each activity according to
      the participant's abilities and needs. After the first month of intervention, the participant
      may be given permission by the therapist to train with the system for no more than 40 minutes
      per day. Such self-training opportunities are in addition to the twice weekly online sessions
      with the therapist.
    

Intervention name(s): Tele-motion rehabilitation system
Intervention type(s): Device
Intervention description(s): Tele-motion rehabilitation system: Interventions include functional therapeutic exercise and real-time feedback. Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.
Other intervention name(s): Microsoft XB1 Kinect Sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; remote monitoring; hemiparesis
Skin IaM: An Exploratory Clinical Trial to Evaluate Changes in Skin Appearance, Colour, and/or Texture Following the Induction of a Local Inflammatory Skin Response
Condition: Skin Inflammation
MeSH terms: Dermatitis; Inflammation
Study type: Interventional

Summary: 
      This trial will test the feasibility of various imaging devices to detect local skin
      inflammation prior to clinical manifestation.
    


Intervention name(s): Leukotriene B4; FLIR One; SCIO; MS Band 2; AGE reader; HSI prototype (PARC) hyper-spectral camera; iPhone 7
Intervention type(s): Drug; Device; Device; Device; Device; Device; Device
Intervention description(s): Leukotriene B4 (LTB4); Thermal imaging attachment to iPhone; Handheld near-IR molecular spectroscopy device; Wearable "watch-like" device with multiple sensors; Portable bench top device for in-clinic near UV assessment; Portable bench top device for in-clinic multispectral imaging; Smart phone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Multi-dose Vitamin D Supplementation in Preterm Infants
Condition: Vitamin D Deficiency; Preterm Infants
MeSH terms: Premature Birth; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is
      recommended there is no consensus regarding the adequate dose of supplementation for preterm
      infants.
    

Detailed description: 
      Vitamin D is a fat-soluble vitamin that is either taken by dietary sources or synthesized
      upon exposure to sun light. Although major function is on bone metabolism, in recent years
      other effects of Vitamin D attracted attention. Low neonatal vitamin D levels were reported
      to be associated with increased risk of respiratory distress syndrome (RDS), bronchopulmonary
      dysplasia (BPD) and sepsis.

      Vitamin D level in the fetus and the newborn is mostly dependent on maternal vitamin D
      levels. Most of the vitamin D is transferred to the fetus during third trimester and as a
      result preterm newborns especially those with <32 weeks gestational age are born with lower
      vitamin D stores. But there is no consensus regarding the adequate dose of vitamin D
      supplementation for preterm infants. The American Academy of Pediatrics recommends
      supplementation of 200-400 IU/d vitamin D for preterm infants. And the European Society of
      Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends 800-1000 IU/d
      vitamin D supplementation for preterm infants.
    

Intervention name(s): Devit-3 Oral Drop
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Skin-to Skin Contact on Newborn Temperature
Condition: Pregnancy; Skin to Skin Contact
Study type: Interventional

Summary: 
      This study will compare standard methods of stabilizing a newborn's temperature after birth
      with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will
      look at the effects of each warming method on the timing of newborns' initial bath and the
      effects on newborn initiation and percent weight loss by discharge.

      The study will use a randomized controlled trial (RCT) design to test a clinical intervention
      at TriHealth Good Samaritan Hospital. Study participants will be randomized to the
      intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately
      after vaginal birth, or to the control group (CG), which will receive standard care for
      newborn and mother immediately after vaginal birth.

      This study will test the hypothesis that mother-baby STS contact implemented immediately
      after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS
      (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's
      temperature stabilizes after the initial bath will result in:

        1. Improved newborn temperature stability and thermoregulation for newborns whether breast
           or formula-fed.

        2. Initiation of effective breastfeeding behavior within 90 minutes of birth and the
           addition of at least one more breastfeeding within four hours of birth for breastfed
           newborns.

        3. Avoidance of newborn weight loss of 10% or greater.
    


Intervention name(s): Skin-to-Skin Contact
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Breastfeeding; Newborn; Formula; Temperature; Initial Bath
Berberis Vulgaris Consumption and Blood Pressure
Condition: Blood Pressure; Cardiovascular Risk Factor; Lipid Profile
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of barberry consumption on systolic and
      diastolic blood pressure, serum lipids, and inflammatory status. The study will involve cases
      having elevated BP (129/ < 85) and known hypertensive patients on medical treatment. Seventy
      people will be randomized into two groups, including intervention (barberry) or placebo
      groups.

      Before and after of 8 week intervention, 24-hour ambulatory blood pressure monitoring will be
      done and fasting venous blood sample will be taken to measure plasma lipids. In addition,
      24-hour urine will be collected to measure its sodium content and estimate sodium intake.
    


Intervention name(s): berberis vulgaris=barberry; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 grams of barberry powder will be consumed daily for 8 weeks.; Placebo powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Barberry; Berberis vulgaris; Blood pressure; Lipids; Inflammation
Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being
      developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long
      duration of action of GSK573719 when administered via inhalation in animal models supports
      the potential for use as a once-daily bronchodilator for COPD.
    

Detailed description: 
      A randomised, double blind, placebo-controlled, double dummy, 4-way cross-over, dose
      ascending study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of
      single inhaled doses of GSK573719 (3 escalating mcg doses will be used) and tiotropium
      bromide (18µg) via DPI in COPD patients
    

Intervention name(s): GSK573719; Tiotropium
Intervention type(s): Drug; Drug
Intervention description(s): 250 micrograms (μg) per blister, administered via dry powder inhaler, dose-ascending study doses began at 250 ug, then 500 ug, and 1000 μg; strips of five capsules, each containing 18 μg administered via dry powder inhaler
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic obstructive pulmonary disease,; GSK573719,; muscarinic receptor antagonist
Pharmacokinetic Study of Two Oral Bemiparin Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa
      activity
    


Intervention name(s): Oral bemiparin
Intervention type(s): Drug
Intervention description(s): Bemiparin tablets and bemiparin tablets into hard gelatine capsules
Intervention MeSH terms: Bemiparin
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Healthy volunteers
Low Intensity Aerobic Exercise and Active Exercises in Cancer Patients Receiving Palliative Care
Condition: Cancer
Study type: Interventional

Summary: 
      To compare the effect of low intensity aerobic exercise and active ROM exercises on cancer
      related fatigue and its associated symptoms and quality of life in cancer patients receiving
      palliative care.
    


Intervention name(s): Low Intensity Aerobic Exercises Group; Active Exercises Group
Intervention type(s): Other; Other
Intervention description(s): Intervention Low Intensity Aerobic Exercises i.e. stationary cycle(supervised) Intensity 55-65% of HRmax Frequency 3 times a week Duration 30 min each session; Intervention Upper and lower limb ROM & stretching exercises Intensity As per tolerance Frequency 12 repetition/4sets per exercise 3 times/week Duration 30 minutes each session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Low intensity Aerobic Exercise; ROM Exercise; Palliative Care
Valproate Versus Ketorolac Versus Metoclopramide
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized study is testing 3 different intravenous medications to see which one is best
      for acute migraine. The three medications are metoclopramide, valproate, and ketorolac.
    

Detailed description: 
      One million patients present to US emergency departments (ED) annually for treatment of acute
      migraine headache. A variety of parenteral medications are used to treat acute migraine, but
      none offer rapid and complete headache relief without side effects. Preliminary studies have
      suggested that intravenous valproate, an anti-epileptic medication with established efficacy
      as a migraine preventive, may be useful for the treatment of acute migraine. We propose a
      randomized, comparative efficacy trial in which intravenous valproate is compared to two
      standard parenteral therapies for acute migraine. There will not be a placebo control.
      Included subjects will be adults 64 years and younger who meet International Headache Society
      criteria for acute migraine, who do not have clinical evidence of secondary (organic)
      headache, and who do not have allergy or contra-indication to the investigational
      medications. The investigational medications are 1gm of valproate, 10mg of metoclopramide,
      and 30mg of ketorolac. Patients will be approached for participation and randomized at the
      time of presentation to the ED. Pain will be assessed on an 11 point (0 to 10) verbal pain
      scale, validated for use in acute pain trials. Medication will be infused as a slow
      intravenous drip. The primary outcome will be an improvement in headache intensity one hour
      after initiation of the intravenous drip. Secondary outcomes include assessments of pain,
      functional disability, adverse events, and satisfaction with the investigational medication
      one, two and 24 hours after initiation of the intravenous drip. The primary analysis will use
      a Student's t-test for independent samples and involve three pair-wise comparisons. Using an
      alpha of .017 (to account for the three pairwise comparisons), a standard beta, and a
      validated minimum clinically significant difference on the verbal pain scale, we calculated
      the need for 330 subjects. An interim analysis will be conducted to determine lack of
      efficacy of valproate.
    

Intervention name(s): Metoclopramide; Ketorolac; Valproate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10mg IVSS; 30g IVSS; 1gm IVSS
Intervention MeSH terms: Ketorolac; Valproic Acid; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine; emergency; metoclopramide; ketorolac; valproate
A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of this study is to find out how the body of a healthy adult processes TAK-279
      (pharmacokinetics) when substances that either hinder or help the human metabolism such as
      erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn
      about side effects and how well it is tolerated when TAK-279 is given alone and together with
      substances that impact human metabolism.

      The participants will need to stay at the clinic for up to 26 days.
    

Detailed description: 
      The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the
      effect of a moderate CYP3A4 inhibitor (erythromycin- Part 1), and of strong (phenytoin- Part
      2) and moderate (efavirenz- Part 3) CYP3A4 inducers on the pharmacokinetics of TAK-279 in
      healthy participants.

      The study will enroll approximately 48 patients. Participants will be enrolled in one of the
      three parts to receive a single dose of TAK-279 in both Period 1 and Period 2 along with
      multiple doses of either erythromycin, phenytoin or efavirenz in Period 2 as given below:

        -  Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg

        -  Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg

        -  Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg

      All participants will be monitored for up to 14 days postdose in each Part.

      This single-center trial will be conducted in the United States. The overall study duration
      is approximately 65 days for Part 1, 73 days for Part 2, and 70 days for Part 3.
    

Intervention name(s): TAK-279; Erythromycin; Phenytoin; Efavirenz
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-279 capsules; Erythromycin tablets; Phenytoin capsules; Efavirenz tablets
Intervention MeSH terms: Efavirenz; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Phenytoin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Drug Therapy