bioihbjkbjnl/mcl2 huggingface dataset:
Short Term Response of Breast Milk Micronutrient Concentrations to a Lipid Based Nutrient Supplement in Guatemalan Women
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Research goals include evaluating the relative impact of maternal nutritional status versus
      recent dietary intake on breast milk micronutrient composition, and evaluating the impact of
      a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.
    

Detailed description: 
      The study includes a cross sectional and an interventional component. Maternal dietary intake
      and nutritional status will be compared to breast milk micronutrient composition in a cross
      sectional manner.

      The short term effect of maternal dietary intake on breast milk micronutrient composition
      will be examined using an intervention with a controlled diet and LNS. Infants will be
      test-weighed during the LNS intervention in order to calculate the infant micronutrient
      intake from the control and LNS intervention days.

      Mother-infant dyads will be recruited into the study and the order in which they will receive
      the 3 treatments will be randomized. All mothers will receive all treatments.

      The mothers will be invited to the clinic on 4 separate occasions. During the first study
      visit, maternal blood will be collected, anthropometric indices will be assessed, and food
      frequency and demographic characteristic surveys will be administered. During the 2-4 visits,
      the LNS intervention will take place. Mothers will arrive at the clinic fasted, and a fasted
      milk collection will occur. Subsequently, mothers will be provided 3 meals based on local
      foods with low-nutrient density. Milk will be collected for 8 hours at each infant feed (ad
      libitum). A 24 hour dietary recall will be conducted. Mothers will receive 1) no LNS, 2) A
      single dose of LNS with breakfast, or 3) A single dose of LNS split into 3 parts with their
      meals throughout the day. Infants will be test weighed before and after each feed to
      calculate their nutrient intake from breast milk and the impact of the different
      supplementation schemes on their nutrient intake.
    

Intervention name(s): Treatment 1: Control; Treatment 2: Bolus (LNS); Treatment 3: Divided Dose (LNS)
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): No supplement provided.; One LNS supplement provided in a single bolus dose in the morning; One LNS supplement provided in 3 separate portions throughout the study visit
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis; Diabetes Insipidus
Study type: Observational

Summary: 
      Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of
      all 7 year olds. MEN is often leading to psychosocial problems because of its burden and
      stigmatism.

      The only available medical treatment option is the vasopressin analogum Desmopressin®.
      However, according to the literature, only one third of patients shows a good treatment
      response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with
      Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side
      effects like water intoxication and hypertension.

      Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in
      patients with MEN compared to controls and lower in patients with severe bed wetting compared
      to patients with only slight bed wetting.
    


Intervention name(s): blood sampling
Intervention type(s): Other
Intervention description(s): At 4 visits capillary blood sampling for copeptin measurement will be performed with each child.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children at the Age of 5-16 years with monosymptomatic enuresis nocturna
      
Keywords: children; desmopressin; copeptin
A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this dose optimization study is to assess tolerability and efficacy of
      topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive
      or have failed one anti-epileptic drug (AED) treatment in monotherapy.
    

Detailed description: 
      This is an open label (all people know the identity of the intervention), dose optimization
      trial to assess the tolerability and efficacy of topiramate as monotherapy in recently
      (within 5 years) diagnosed patients with epilepsy. Treatment naive patients (patients who
      have never received the treatment before) and patients who failed on their first AED in
      monotherapy are allowed. Failure is defined as a lack of efficacy and/or tolerability of that
      AED and the reason for failure is recorded by the physician. A lack of efficacy is
      characterized when the patient has been treated with AED at target dose but the patient still
      has seizure. Topiramate will first be titrated up to an initial target dose that will be
      reached after 4-6 weeks. Further dose titration is guided by the clinical response of the
      individual patient, but the dose may not exceed a maximum of 400mg/day [9mg/kg/day for
      children]. If the patient uses an AED at entry, the AED will be fully tapered off over a
      period of 3 weeks, starting at the beginning of week 2, in order to have all patients on
      topiramate monotherapy at visit 3. Tapering the AED off may, however, extend this 3-week
      period if clinically indicated. Visits will be performed at baseline and after 2, 4, 8, 12,
      16 weeks. The total duration for each patient in the study will be 4 months.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): The patients will receive topiramate tablet twice daily orally up to 16 weeks.
Intervention MeSH terms: Topiramate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Seizures; Topiramate; Anti-epileptic drug; Nervous disorder
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and effectiveness of
      Thymosin Beta 4 administered topically in patients with Pressure Ulcers
    

Detailed description: 
      The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate
      the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically,
      in patients with Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the
      body in areas prone to moisture and friction. PU affects primarily elderly, bedridden
      patients. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide
      that has wound healing and anti-inflammatory properties and can up-regulate the expression of
      laminin-5.
    

Intervention name(s): Placebo; Thymosin Beta 4
Intervention type(s): Drug; Drug
Intervention description(s): Topical administration of 0.00% thymosin beta 4 qd up to 84 days; Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pressure ulcers; cutaneous wound- healing; chronic wound-healing; Thymosin Beta 4; laminin-5
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
Condition: Diphtheria; Tetanus; Poliomyelitis; Haemophilus Infections; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The present clinical study will assess the immunogenicity and reactogenicity of Sanofi
      Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary
      vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of
      life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.
    


Intervention name(s): Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
Intervention type(s): Biological
Intervention description(s): 0.5 mL, IM
Other intervention name(s): PENTAXIM
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphteria; Tetanus; Pertussis; Poliomyelitis; Haemophilus influenzae type b; acellular
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study consists of a 4-week screening period, a 24-week treatment period for all
      participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a
      subset of at least 60 and up to 80 participants, and a 2-week post-treatment follow-up
      period.
    

Detailed description: 
      This is an outpatient study in people who currently suffer a minimum of 2 migraines per
      month. During the study, participants will be instructed to use no more than 2 doses of the
      study drug INP104 within a 24-hour period, or 3 doses in a 7-day period. Participants will
      self-administer INP104 nasally and record their migraines in an eDiary.
    

Intervention name(s): INP104
Intervention type(s): Combination Product
Intervention description(s): No more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril.
Other intervention name(s): Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device; INP104, POD-DHE
Intervention MeSH terms: Dihydroergotamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The purpose of this trial is to compare the
      pharmacokinetic properties (the exposure of the trial drug in the body) of different
      formulations of NN1218.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).; At one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Other intervention name(s): NN1218
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Endorphin at Labor Pain and Acupressure
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      This study was performed to determine the impact of different acupressure procedures,
      performed on women's hands during labor, on endorphin levels and labor pain perception.

      The sample consisted of 140 pregnant women. The study was conducted with three experimental
      groups and one control group, each including 35 pregnant women. Conventional acupressure and
      warm and cold acupressure procedures were performed on the Large Intestinal 4 energy meridian
      zone acupressure point of the experimental group. No procedures were performed on the women
      in the control group. Data were collected using a "Personal Information Form", "Labor
      Intervention Follow-up Form", "Visual Analog Scale" and "Verbal Category Scale".

      The comparison between the experimental and control groups indicated that the conventional
      acupressure procedure was effective in reducing labor pain and that the warm acupressure
      procedure increased endorphin levels.
    


Intervention name(s): Warm Acupressure, Cold Acupressure , Conventional Acupressure
Intervention type(s): Other
Intervention description(s): Acupressure is non-invasive, safe and effective.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: acupressure; labor pain; Midwifery; pregnant women; endorphins; warm acupressure; cold acupressure
The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury
Condition: Neuropathic Pain; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Neuralgia; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the analgesic effect of transcranial direct current
      stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have
      chronic neuropathic pain.
    

Detailed description: 
      -  anodal stimulation of the primary motor cortex (M1)

        -  anode electrode: C3 (EEG 10/20 system)

        -  cathode electrode: contralateral supraorbital area

        -  constant current of 2mA intensity for 20 min

        -  twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday,
           total 20 treatment session)
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Other intervention name(s): Iomed Phoresor II Auto
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether glaucoma drop aids will be cost-effective
      in delivery of ophthalmic medications by improving medication compliance, visual function,
      and even decreasing medication waste in the patient population at Boston Medical Center
      (BMC).
    

Detailed description: 
      Patients being treated for their glaucoma at BMC's Yawkey Eye Clinic will be selected
      according to the inclusion and exclusion criteria. The three drop aids used in this study
      will be the Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, and the
      Simply Touch Eye Drop Applicator. Patients will be randomly placed on one of these drops aids
      for a total of 3 study groups or the no drop aid control, for a total of 4 groups. Prior to
      use of the drop aid, patients will be instructed on how to use the drop aid by a resident
      physician and a pre- intervention intraocular pressure check will be performed by the
      resident physician using an applicator. Intraocular pressure is the only adjustable risk
      factor for glaucoma; thus, glaucoma treatments slow progression of glaucoma by reducing
      intraocular pressure. In addition, patients will be requested to deliver their drops with the
      drop aid with every use. Furthermore, each patient will record the number of days taken to
      complete the glaucoma medication bottle while using the drop aid. At the 3 and 6 week marks,
      the patient will fill out a satisfaction survey. Patients will need to return to the clinic
      at the 6 week mark and can fill out the satisfaction survey at the clinic in addition to
      checking the intraocular pressure post-intervention. Thus, the number of subject contact will
      be two, pre and post-intervention, the duration of participation for each subject will be 6
      weeks, and the patient will also be required to fill out two satisfaction surveys. The
      effectiveness of the drop aids will be compared to the two controls and measured with any
      changes in intraocular pressure readings, length of time to medication completion, and
      patient satisfaction according to the surveys.
    

Intervention name(s): Eye Drop Aid
Intervention type(s): Device
Intervention description(s): Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: glaucoma drop aid
Dry Needling for Spasticity in Stroke
Condition: Stroke
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      Stroke is the leading cause of physical disability due to the presence of spasticity.
      Different needling techniques, including Botulinum Toxin A are proposed for management of
      spasticity; however results are conflicting. The presence of spasticity in the upper
      extremity implies several impairments for daily life activities. No study has investigated
      the effects of deep dry needling inserted into the targeted spastic musculature of the
      shoulder region in patients who had suffered a stroke. The investigators will conduct a
      randomized controlled trial investigating the effects of the inclusion of deep dry needling
      into a rehabilitation program over the musculature of the shoulder region, pressure pain
      hyperalgesia and range of motion in individuals with chronic stroke. The investigators
      hypothesize that patients receiving dry needling into the spastic shoulder musculature would
      exhibit greater improvements in spasticity, pressure sensitivity and range of motion than
      those who will not receive the intervention.
    


Intervention name(s): Dry needling; Physical Therapy; stainless steel needles (0.3mm x 50mm)
Intervention type(s): Other; Other; Device
Intervention description(s): Patients will receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pect; Patients will receive 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dry needling; spasticity; pain
Does the Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      There are several associated structural changes when dealing with massive rotator cuff
      repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration,
      as well as osteoporosis over the tendon insertion. Those changes may lead to difficult in
      applying double-row repair, suture cutting through the tendon, too much tension over the
      repair and loosening or pull-out of anchors, which may results in poor tendon-bone healing
      and subsequent high re-tear rate. Therefore decreasing the tension over the repair site may
      increase the healing over tendon bone junction as well as decrease the risk of anchors
      loosening. A suture-spanning augmentation with two set of suture loops passing over
      musculotendinous junction medially and fixed with anchor at the lateral cortical wall may
      solve the problem. In order to define the clinical benefit of this adjuvant procedure, a
      prospective randomized control study is designed to compare the adjunctive reinforce suture
      with the single-row simple suture repair in massive rotator cuff tear.

      Around sixty patients were randomized divided into two groups. The study group was used
      adjunctive reinforce suture repair technique, which was one lateral cortical anchor holding 2
      separated set of transverse looping sutures over the medial musculotendinous junction in
      addition to single row repair, while the control group was used single row repair technique
      in simple stitch fashion. All patients will have clinical evaluation in pain (VAS score) and
      functional recovery (ASES and UCLA score) as well as MRI image for the tendon integrity.

      If the suture-spanning augmentation of single-row repair can yield an improved healing rate
      and fewer complications, massive rotator cuff tear should be repaired earlier in order to
      prevent the late development of irreparable tear.
    


Intervention name(s): Suture-bridge augmentation of single-row repair
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arthroscopic surgery; massive rotator cuff repair; single-row repair; suture-spanning augmentation
A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
Condition: Ebola
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3
      consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga
      glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified
      Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo)
      including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval,
      induce an equivalent humoral immune response.
    


Intervention name(s): Ad26.ZEBOV; MVA-BN-Filo; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).; Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.; Participants will receive IM injection (0.5 mL) of placebo (0.9 % saline) as Dose 1 on Day 1, followed by placebo as Dose 2 on Day 57 (Groups 4 and 6) and a booster of matching placebo on Day 177 (Group 6).
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention