bioihbjkbjnl/mcl2 huggingface dataset:
Adjunct Inversion for Lower Pole Stone
Condition: Kidney Stone
MeSH terms: Kidney Calculi
Study type: Interventional

Summary: 
      This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL)
      with and without simultaneous adjunct controlled inversion therapy in the treatment of lower
      pole caliceal stone.
    


Intervention name(s): Inversion; Shock Wave Lithotripsy; Hydration
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Patients inverted 30 degree head down in Trendelenburg position; Shock wave lithotripsy; Hydration of patient with 0.5L NaCl and 20mg frusemide IV
Other intervention name(s): ESWL; Frusemide 20mg
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass
Condition: Ischemic Heart Disease; Angina Pectoris
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Angina Pectoris; Blister
Study type: Interventional

Summary: 
      The purpose of this study was to see if the heart-lung machine involved in cardiac surgery
      increases the movement of activated white blood cells from the bloodstream into the patient's
      tissues and also to see if aprotinin usage during surgery reduces this effect.
    

Detailed description: 
      It has long been known that exposure of blood to the heart-lung bypass machine can trigger a
      whole-body inflammatory response in cardiac surgery patients that is linked to activation of
      circulating white blood cells. The investigators propose to use a technique to track the
      movement of white blood cells into the skin of patients during bypass surgery. The skin
      blisters will be elicited by application of the blistering agent cantharidin to the forearm
      of volunteer patients. This will allow the investigators to study the activation state of
      white blood cells that enter tissues during bypass surgery and to determine whether aprotinin
      has any beneficial effect with regards to inflammatory status of these cells.

      The investigators propose that white blood cell trafficking into the blisters will increase
      following the use of the heart-lung machine and that the effect of aprotinin will be to
      ablate this.
    

Intervention name(s): Aprotinin
Intervention type(s): Drug
Intervention MeSH terms: Aprotinin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cardiopulmonary; Surgery; leukocyte; inflammation; Coronary Artery Bypass Grafting
The Validity and Reliability of the Turkish Version of TASC and the Relationship Between SMC and Motor Functions
Condition: Cerebral Palsy, Spastic; Cerebral Palsy; Cerebral Palsy Spastic Diplegia; Cerebral Palsy Quadriplegic; Cerebral Palsy, Monoplegic
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      Selective motor control (SMC) impairment in children with cerebral palsy (CP) includes
      movement patterns dominated by flexor or extensor synergy affecting functional movements. The
      research was designed to investigate the validity and the reliability of the Turkish version
      of the Test of Arm Selective Control (TASC) (which is improved to evaluate SMC in children
      with spastic CP) and in order to provide more understanding of the relationship between SMC
      and upper extremity and gross motor functions. The study included 21 hemiplegic, 11 diplegic
      and 4 quadriplegic children with CP whose ages are 4 to 18 years and Gross Motor Function
      Classification System (GMFCS) level changes from 1 to 4, and their parents. In order to
      evaluate the gross motor function of children, GMFCS and the ability to hold objects with
      their hands in daily activities were evaluated with Manual Ability Classification System
      (MACS). ABILHAND-Kids scale was applied to evaluate upper extremity performance. TASC scale
      was used to evaluate the upper extremity SMC of children.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children in Special Education Centers
      
Keywords: cerebral palsy; selective motor control; upper limb; upper limb functions; gross motor functions
Validity of Smart Cap and Smart Sweat Patch
Condition: Fluid Intake in Athletes; Sweating Rate in Athletes; Sweat Chloride Concentration in Athletes
Study type: Interventional

Summary: 
      The main objectives are to determine the validity of a Smart Cap in measuring fluid intake
      during running and fitness exercise and the validity of a Smart Sweat Patch in measuring
      sweat rate and sweat chloride concentration during outdoor cycling, running, and fitness
      exercise. A secondary objective is to compare regional sweating rate and sweat electrolyte
      concentrations (sodium, chloride, and potassium) on contralateral arms with vs. without
      tattoos.
    


Intervention name(s): Smart Cap, running and fitness exercisers only; Sweat Patch, all subjects- running, fitness, cycling; Reference sweat patch, all subjects - running, fitness, cycling; Bottle Scale, all subjects - running, fitness, cycling
Intervention type(s): Device; Device; Device; Other
Intervention description(s): Bottle cap; Regional contralateral forearm patch; Regional contralateral forearm patch; Bottle weight
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Each subject will serve as his or her own control. We will compare the Test and Reference methods during moderate intensity self-paced training runs, coach-led fitness sessions, and/or group outdoor cycling rides.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sweat; hydration; wearable; exercise
Ibuprofen With or Without Acetaminophen for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized clinical trial comparing two interventions for acute low back pain:

        1. Ibuprofen + acetaminophen

        2. Ibuprofen + placebo

      Participants will include patients who present to an emergency room for management of low
      back pain. Medication will be dispensed to participants at the time of emergency room
      discharge. Data will be collected from participants by telephone for 1 week.
    


Intervention name(s): Acetaminophen; Ibuprofen 600 mg; Educational intervention; Placebo oral capsule
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): Acetaminophen 500-1000mg every 6 hours; Ibuprofen 600mg every 6 hours; Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp); To match acetaminophen, patients will take one or two capsules every 6 hours
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tolerability and Efficacy of Anti-Aging Treatment Regimen in Subjects With Photodamage
Condition: Skin Manifestations
MeSH terms: Skin Manifestations
Study type: Interventional

Summary: 
      The subjects will use the test skincare products. This is a full face, twice daily
      application study, with digital photos and expert grader evaluations at Baseline, 4 and 8
      week periods. If the subject meets the study criteria and is enrolled, they will be
      instructed at screening visit to discontinue the use of any facial products (except dry
      mineral foundation and eye make-up) for seven (7) days before beginning the study (referred
      to as the "washout" period). They will return to the site for the baseline visit 2 after the
      required 7 day washout period (visit can occur within 1 week after screening visit).
    

Detailed description: 
      After the subjects properly consent to participation and are determined eligible, the study
      coordinator will review the subjects' medical history and obtain demographics. The Principal
      Investigator (PI) or designee (expert grader) will examine the subjects to determine their
      appropriateness for study inclusion.

      At the Screening visit (Visit 1, Day -10 to -7), the subjects will be assessed by the PI or
      designee to confirm inclusion into the study. Expert grading and Canfield VISIA CR
      photographic documentation (all flash modes including RBX) will be performed at baseline
      (Visit 2, Day 0), Week 4 (Visit 3, Day 28 ± 7 days), and Week 8 (Visit 4, Day 56 ± 7 days).

      Subjects who, in the PI's or designee's opinion, appear to be experiencing product related
      adverse reactions may be discontinued at any time during the study. The subjects' home care
      treatment products (the items included in the kit) will be performed at home, at the times
      and in the manner described in the instructions provided.
    

Intervention name(s): Three Product Anti-Aging Treatment Regimen
Intervention type(s): Other
Intervention description(s): Cream Skin Cleanser RD04033B, twice daily, 8 weeks; Anti-aging Cream RD04034B, twice daily, 8 weeks; and Sunscreen SPF 50 RD04036, once daily, reapply as needed, 8 weeks
Other intervention name(s): Anti-aging Cream; Sunscreen SPF 50; Cream Skin Cleanser
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: photodamage; fine lines; wrinkles; dyschromia
Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Condition: Diabetes Mellitus; Diabetes Mellitus Complications; Gastroparesis
MeSH terms: Gastroparesis; Diabetes Mellitus; Diabetes Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of RM-131 on gastric emptying,
      gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in
      patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to
      evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131 and
      placebo) will be administered subcutaneously in a blinded fashion.
    


Intervention name(s): RM-131; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.; Placebo given subcutaneously for 35 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Delayed Gastric Emptying; Gastroparesis; Gastrointestinal Motility Disorder
Repeat Antenatal Corticosteroids
Condition: Antenatal Corticosteroids
Study type: Observational

Summary: 
      This study will review records of women who broke their water early who received a repeat
      course of antenatal steroids.
    

Detailed description: 
      Antenatal corticosteroids (ANCS) administered to a mother at risk of preterm delivery have
      been shown to decrease morbidity of prematurity if preterm birth occurs. Although early
      animal studies found that many repeated doses led to growth restriction a single repeat dose
      was found to benefit human neonates without a significant decrease in birth weight.

      Current guidelines recommend two doses of ANCS administered 24 hours apart as a single
      "course." A repeat course of steroids is administered no less than 1-2 weeks after the first
      course if the mother remains at risk of preterm delivery. However, the main studies
      supporting the repeat course of ANCS excluded women with preterm premature rupture of
      membranes (PPROM). These authors designed exclusion criteria this way because of a
      theoretical increased risk of chorioamnionitis with administration of a glucocorticoid, which
      may have immunosuppressant effects. As a result, there is insufficient data to recommend a
      repeat dose of ANCS in women with PPROM.

      One study and its follow up publication did include women with PPROM. It did not find an
      increased incidence of chorioamnionitis between the treatment and the placebo groups,
      although women with PPROM were not analyzed separately.

      The combination of no increased incidence of chorioamnionitis but no clearly studied
      populations creates an opportunity for a randomized controlled trial of repeat doses of ANCS
      including only women with PPROM.
    

Intervention name(s): Antenatal corticosteroids
Intervention type(s): Other
Intervention description(s): Women and neonates with PPROM who received a repeat dose of antenatal corticosteroids, compared to women with PPROM who did not received a repeat course of antenatal corticosteriods
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women preterm premature rupture of membranes All ethnic backgrounds
Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe
Study type: Interventional
Phase: Phase 1

Summary: 
      This research investigates the use of autologous bone marrow stem cells for the treatment of
      medically refractory temporal lobe epilepsy patients.
    

Detailed description: 
      The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a
      safe and potentially beneficial treatment for patients with temporal lobe refractory
      epilepsy. We are mainly evaluating seizure frequency, hippocampal volume an cognitive
      performance
    

Intervention name(s): Stem cell transplantation
Intervention type(s): Procedure
Intervention description(s): Transplantations with autologous bone marrow mononuclear stem cells by selective posterior cerebral artery angiography
Other intervention name(s): BMMSC - Bone Marrow Mononuclear Stem Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizure frequency; Hippocampal volume; Adverse effects
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
Condition: Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover, Phase 2 Clinical Trial
      to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects
      with Chronic Cough
    

Detailed description: 
      A Phase 2, multicenter, randomized, double-blind, placebo controlled, two-period crossover
      trial to evaluate the safety, tolerability, and efficacy of ADX-629 (300 mg) administered
      orally, twice-a-day to eligible participants with refractory or unexplained chronic cough.
      Patients who are interested in participating will be provided detailed information about the
      study including description of study assessments/procedures, possible side-effects,
      alternative treatments, and potential benefits.
    

Intervention name(s): ADX-629; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized to receive both ADX-629 and placebo in one of two treatment sequences: One group of subjects will receive ADX-629 during the 1st treatment period and matching placebo during the 2nd Treatment while subjects the other sequence/group will receive the matching placebo in the 1st treatment period and ADX-629 in the 2nd treatment period.; Subjects will be randomized to receive both ADX-629 and placebo in one of two treatment sequences: One group of subjects will receive ADX-629 during the 1st treatment period and matching placebo during the 2nd Treatment while subjects the other sequence/group will receive the matching placebo in the 1st treatment period and ADX-629 in the 2nd treatment period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: refractory cough; cough hypersensitivity; ADX-629; unexplained cough; reactive aldehyde species; crossover; inflammation
A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare the efficacy, safety and immunogenicity of Leucostim® to those of
      Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a
      myelosuppressive chemotherapy.
    

Detailed description: 
      TAC regimen (docetaxel, doxorubicin and cyclophosphamide) is recommended for the adjuvant
      treatment of breast cancer patients. The TAC regimen is known to lead to significant
      hematological toxicity and induces febrile neutropenia with a rate > 20%. The use of primary
      G-CSF prophylaxis with the TAC regimen is recommended by guidelines. e.g., by the European
      Organisation for Research and Treatment of Cancer as well as by the guideline on myeloid
      growth factors of the National Comprehensive Cancer Network.6,7 This study is to compare the
      efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with
      breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.
    

Intervention name(s): Leucostim 5µg/kg/day; Neupogen 5µg/kg/day
Intervention type(s): Biological; Biological
Intervention description(s): 5µg/kg/day (based on actual body weight) Leucostim®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir; 5µg/kg/day (based on actual body weight) Neupogen®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neutropenia
Impact of Mothers Touch Program on Women's Psychological Functioning
Condition: Psychological Distress; Post Partum Depression; Mood
MeSH terms: Depression, Postpartum
Study type: Observational

Summary: 
      The study investigates the effect of the Mothers Touch program on the psychological
      well-being of new mothers following 5 weeks of child birth. Mothers Touch Program is designed
      based on traditional Indian post-partum care given by trained carer in the family.

      Study was designed as cohort, including a randomised controlled trial.
    


Intervention name(s): Mothers Touch Program
Intervention type(s): Other
Intervention description(s): Combination of diet, massage, body binding methods along with 40 days of rest following the traditional way of delivering
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants giving birth in pre selected 4 hospitals in India.
Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      All study participants will receive both warfarin and a study drug called evacetrapib. The
      main purpose of this study is to look at how much warfarin gets into the blood stream and how
      long it takes the body to get rid of warfarin when given both with and without evacetrapib.
      Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots
      when given with evacetrapib by measuring the time it takes for blood to clot and comparing it
      to an average of the international normalized ratio (INR). INR measures the time it takes for
      blood to clot and compares it to an average.

      The study will last approximately 5 weeks, not including screening.
    


Intervention name(s): Evacetrapib; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Other intervention name(s): LY2484595
Intervention MeSH terms: Warfarin; Evacetrapib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
Condition: Hysterectomy; Genital Diseases, Female; Pain
MeSH terms: Genital Diseases; Genital Diseases, Female
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the effect of four different follow-up strategies
      on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions.
      Furthermore the investigators aim to examine associations between preoperative thresholds for
      pain (thermal and pressure) and postoperative pain and development of chronic pelvic pain
      after benign hysterectomy.
    

Detailed description: 
      Contact sponsor if detailed information is requested.
    

Intervention name(s): Follow-up strategy; No contact after discharge
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Comparison of different follow-up strategies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Benign gynecological disease; Surgery; Postoperative follow-up strategy; Pain threshold; Chronic pelvic pain; [E04.950.300.399]; [C13.351.500]; [F02.463.593.710.560]; [N02.421.585.722.700]; Postoperative Care