bioihbjkbjnl/mcl2 huggingface dataset:
Role of Endothelin-1 in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance
      to changes in perfusion pressure. In the eye, several studies have reported that retinal
      blood flow is autoregulated over a wide range of ocular perfusion pressures. The
      investigators could recently show that Endothelin-1 is a key metabolite in the regulation of
      vascular tone in the eye and plays an important role in the blood flow autoregulation of the
      choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the
      present study is designed to test the hypothesis that Endothelin-1 plays also a role in optic
      nerve head blood flow autoregulation.

      Therefore, subjects will perform squatting to increase systemic perfusion pressure during
      administration of either an endothelin A-receptor blocker (BQ-123) or placebo. Optic nerve
      head blood flow will be continuously measured during the procedure to investigate optic nerve
      head autoregulation.
    


Intervention name(s): BQ-123; Physiological saline solution; Laser Doppler Flowmetry; Goldmann Applanation Tonometer; squatting
Intervention type(s): Drug; Drug; Device; Device; Other
Intervention description(s): 60 mcg/min, infusion period: 60 min; infusion period 60 minutes; blood flow measurements at the temporal neuroretinal rim to assess optic nerve head blood flow; intraocular pressure measurements; subjects will perform squatting for 6 minutes while blood flow measurements
Intervention MeSH terms: cyclo(Trp-Asp-Pro-Val-Leu)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: BQ-123; Optic Nerve Head Blood Flow; Intraocular Pressure; Regional Blood Flow; Ocular Physiology; Optic Disk
Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets
Condition: Pharmacokinetic Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Study subjects were screened and enrolled for the study. Subjects were housed in the clinical
      facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each
      period. After maintaining at least 10 hours of overnight fast Test or Reference product was
      administered orally (as per the randomization schedule) to each subject with about 240 mL of
      water at ambient temperature in each period by trained study personnel.

      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were
      collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50,
      10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period
      with a washout period of 7 days between the dosing of two periods. Subjects were continuously
      monitored for well being i.e., blood pressure, radial pulse and oral temperature before
      check-in, prior to drug administration and at regular intervals post dose in each period. The
      concentration of Ropinirole in plasma samples obtained from study subjects was determined
      using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on
      obtained drug concentration data, using appropriate software.
    


Intervention name(s): Test Product (Ropinirole); Reference Product (REQUIP )
Intervention type(s): Drug; Drug
Intervention description(s): one Tablet at "0" hour; one Tablet at "0" hour
Other intervention name(s): Ropinirole HCl Tablets CR 2mg; REQUIP XL Tablets
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization
Condition: Stone, Kidney; Child, Only
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional

Summary: 
      Epidemiological studies have shown a progressive increase in the incidence of pediatric
      urolithiasis over the past few decades.
    

Detailed description: 
      Pediatric stone disease is considered endemic in developing nations including Turkey,
      Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s
      revolutionized the management of upper urinary tract calculus disease.

      Reports of successful SWL in children were first published in 1986; then several reports
      showed safety, and stone-free rates comparable with those of adults. For successful SWL,
      accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS)
      to fully focus the shock waves on the stone
    

Intervention name(s): ultrasonic focus Shock wave lithotripsy; fluoroscopic focus Shock wave lithotripsy
Intervention type(s): Procedure; Procedure
Intervention description(s): successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone; successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pediatric renal stones; ultrasound shock waves; fluoroscope.
Relations Between Pelvic Floor, Diaphragm and Trunk Muscles
Condition: Prostate Cancer; Urinary Incontinence
MeSH terms: Urinary Incontinence
Study type: Interventional

Summary: 
      The present study evaluates the functional relations of pelvic floor, diaphragm, and torso
      muscles, their variation and correlations with urinary incontinence while separately training
      physical characteristics of the mentioned muscles in men after radical prostatectomy.
    

Detailed description: 
      During the last two decades, the connection between pelvic floor muscles (PFM) and abdominal
      muscles or diaphragm has been detected: PFM contract and relax during the inhalation and
      exhalation in pace with the diaphragm; the activity of the PFM increases with the increase of
      intra-abdominal pressure during forced exhalations or cough. The role of pelvic floor is
      essential for the synergy of diaphragm and abdominal muscles in maintenance of
      intra-abdominal pressure. According to the aforementioned physiological functional
      relationships, the investigators have postulated a hypothesis that diaphragm muscles training
      and abdominal muscles training could have similar effect as direct PFM training on pelvic
      floor muscles strength and pelvic floor muscles endurance measured using perineometer in men
      after radical prostatectomy.
    

Intervention name(s): Muscles exercises program
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Prostatectomy; Rehabilitation; Incontinence
Hypopressive Abdominal Exercise in Postpartum Abdominal Diastasis
Condition: Abdominal Diastasis
MeSH terms: Diastasis, Muscle
Study type: Interventional

Summary: 
      The prevalence of abdominal diastasis is high in postpartum. The abdominal diastasis can
      impair the body posture, the of lumbo-pelvic stability and movement, or breathing. Exercises
      focused on the transversus abdominis muscle have been proposed as a therapeutic approach for
      abdominal diastasis.

      Hypopressive abdominal exercises have been used for postpartum recovery, for specific
      pathologies related to pregnancy (low back pain, pelvic floor dysfunction ...) and even for
      the rehabilitation of spinal pathologies. However, there is a lack of studies that determine
      its effectiveness and clinical utility.

      The aim of the study will be to analyze the effects of Hypopressive abdominal exercises on
      postpartum abdominal diastasis, the tone of the transverse abdominal muscle and the pelvic
      floor musculature.

      A case series design will be applied, with weekly assessment of the outcomes after the
      intervention and two months after the intervention.
    


Intervention name(s): Hypopressive abdominal exercises
Intervention type(s): Other
Intervention description(s): Three sessions per week during four consecutive weeks (Total: 12 sessions). Each session time: 30 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postpartum; Hypopressive abdominal exercises; Pelvic floor muscles
A Multiple Ascending Dose Study of BIO89-100 in Subjects With Biopsy Confirmed NASH or NAFLD and at High Risk of NASH
Condition: NASH
MeSH terms: Liver Diseases; Fatty Liver
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Part 1: This is a multi-center evaluation of BIO89-100 (administered weekly or every other
      week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in
      subjects with NASH and NAFLD at high risk of NASH, including a pre-defined number of subjects
      with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled

      Part 2: This is a multi-center, open label evaluation of BIO89-100 at 27 mg administered
      weekly for 20 weeks in subjects with biopsy-poven NASH (NAS ≥4, fibrosis stage F2 or F3)
    


Intervention name(s): BIO89-100; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subcutaneous injection; Subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NASH, NAFLD; Liver diseases; Fatty Liver; Metabolic diseases
Increasing the Variety of Vegetables and Fruits Served to Preschool Children at a Snack
Condition: Obesity; Feeding Behaviors
Study type: Interventional

Summary: 
      Intake of vegetables and fruits in preschool children is less than recommended amounts.
      Although offering a variety of foods has been shown to increase intake, this effect has not
      been well studied for low-energy-dense foods. The purpose of this study was to test whether
      increasing the variety of vegetables and fruits served to preschool children affected the
      amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would
      increase both the amount selected and the amount eaten.
    


Intervention name(s): Cucumber snack; Pepper snack; Tomato snack; Vegetable variety snack; Apple snack; Peach snack; Pineapple snack; Fruit variety snack
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Three 300-g bowls of vegetables per table: three of cucumber slices; Three 300-g bowls of vegetables per table: three of yellow pepper strips; Three 300-g bowls of vegetables per table: three of grape tomatoes; Three 300-g bowls of vegetables per table: one each of cucumber slices, pepper strips, and grape tomatoes; Three 300-g bowls of fruits per table: three of apple wedges; Three 300-g bowls of fruits per table: three of peach slices; Three 300-g bowls of fruits per table: three of pineapple half-rings; Three 300-g bowls of fruits per table: of each of apple wedges, peach slices, and pineapple half-rings
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Dietary variety; Vegetable intake; Fruit intake
Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL
Condition: Multiple Myeloma; Non-Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; Mantle-Cell Lymphoma; Follicular Lymphoma; Indolent B Cell Lymphoma; Primary Mediastinal Lymphoma; Lymphoplasmacytic Lymphoma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Waldenstrom Macroglobulinemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I trial with pilot expansion of HLA-haploidentical or HLA-mismatched related
      donor nicotinamide expanded-natural killer (NAM-NK) cell based therapy for patients with
      relapsed or refractory multiple myeloma (MM) or relapsed/refractory CD20-positive non-Hodgkin
      lymphoma (NHL). The primary endpoint of the study is to determine the maximum tolerated dose
      (MTD) of NAM-NK cells while maintaining safety.
    


Intervention name(s): Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells
Intervention type(s): Biological
Intervention description(s): Cyclophosphamide 40 mg/kg x 1 day on Day -5
Fludarabine 25 mg/m^2 x 3 days (Day -5, Day -4, day-3)
Other intervention name(s): NAM-NK
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MM; NHL; NK Cell; NK Cells
A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and efficacy of rituximab combined with MTX in participants
      with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor
      Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the
      target sample size is 500 participants. Eligible participants may receive re-treatment with
      rituximab under a separate protocol WA17531.
    


Intervention name(s): MabThera/Rituxan; Methotrexate; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 1; 2; 3
Intervention MeSH terms: Methotrexate; Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
ICE T for Post GYN Surgery Pain
Condition: Opioid Substitution Treatment
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized controlled trial is to determine whether, "ICE-T," a
      multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and
      tylenol, has improved pain control compared to the standard narcotic based postoperative pain
      regimen in patients undergoing total laparoscopic gyn surgery.
    


Intervention name(s): Ketorolac; Opioids; Ice Packs; Tylenol; Motrin; dilaudid
Intervention type(s): Drug; Drug; Other; Drug; Drug; Drug
Intervention description(s): Use of non-steroidal anti-inflammatory drug for pain control post operatively; Use of narcotic for pain control post operatively; Placement of Ice packs on surgical sites post operatively; Use of pain medication post operatively; Use of non-steroidal anti-inflammatory drug for pain control post operatively; Use of narcotic for pain control post operatively
Other intervention name(s): Toradol; Oxycodone
Intervention MeSH terms: Acetaminophen; Ketorolac; Oxycodone; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Anti-inflammatory agents non-steroidal
Metastatic Colorectal Cancer. Real-World Data Analysis.
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT)
      Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis
    

Detailed description: 
      In this study, with the given rationale is to reveal treatment approaches, survival data,
      side effect profile and their management in our country in RAS WT mCRC patients by means of
      the real-world data collection.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients who have been diagnosed within 3-years period before March 2019 will be included.
A Study of the Relationship Between Disulfiram and Cocaine Self-administration.
Condition: Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The problem of cocaine dependence remains a major medical, social, and legal concern. Several
      studies have suggested that disulfiram may be beneficial for the treatment of cocaine
      dependence. A common assumption has been that disulfiram treatment, by increasing DA
      availability, enhances the aversive aspects of stimulants. This study aims to measure plasma
      activity in those with the C/C DBH genotype, which is associated with higher DBH activity
      subsequently making the disulfiram treatment more effective, as well as determine the effects
      of treatment with disulfiram on cocaine self-administration using a human laboratory model of
      cocaine self-administration.
    


Intervention name(s): placebo; disulfiram
Intervention type(s): Drug; Drug
Intervention description(s): 0mg daily; 250mg daily
Intervention MeSH terms: Disulfiram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cocaine; disulfiram; antabuse; addiction; stimulant
Cerebrolysin and Neurodevelopment in Preterm Infants
Condition: Infant Development; Cerebral Palsy; Preterm Infant
MeSH terms: Cerebral Palsy; Premature Birth
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall aim of the study is to assess the effect of Cerebrolysin on physical and mental
      development of preterm infants by Denver Scale II at different ages of 5, 7 and 12 months
    

Detailed description: 
      There is an inverse relationship between birth weight or gestational age and risk for
      developmental impairment, with increasing incidence as birth weight or gestational age
      decreases.

      Serious impairment, defined as problems in body function or structure which may be temporary
      or permanent, is generally a more stable condition and typically leads to a disability
      requiring rehabilitation. Mild impairment is a more reversible condition amenable to early
      intervention. Studies that have followed extremely preterm and extremely low birth weight
      infants into school age and early adulthood have shown higher rates of motor, cognitive or
      behavioral impairments as compared with infants born at term. The neurologic consequences of
      extreme prematurity range from mild behavioral and cognitive defects to severe disability.
      Perinatal neuroprotection aims to reduce these outcomes.

      Cerebrolysin is a porcine brain-derived peptide preparation that acts like endogenous
      neurotrophic factors. It is produced by a standardized enzymatic breakdown of lipid-free
      brain protein powder and consists of low molecular weight peptides and free amino acids.

      The pharmacodynamic effects of Cerebrolysin can be categorized in terms of neuronal survival
      (e.g. trophic and survival promoting actions), neuroprotection (e.g. limiting neuronal
      dysfunction, especially in adverse conditions), neuroplasticity (e.g. adaptive responses to
      changing conditions) and neurogenesis (e.g. promoting differentiation of progenitor cells).
      We aim to assess the effect of Cerebrolysin on physical and mental development of preterm
      infants at different ages of life at 5, 7 and 12 months.
    

Intervention name(s): Cerebrolysin
Intervention type(s): Drug
Intervention description(s): Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections).
Intervention MeSH terms: Cerebrolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the addition of tralokinumab to standard
      asthma medication is effective in the treatment of adults with asthma.
    

Detailed description: 
      Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic
      disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in
      improved control of asthma. This study will determine whether the addition of tralokinumab to
      standard asthma medications results in a reduced rate of asthma exacerbations in subjects
      with severe asthma.
    

Intervention name(s): Placebo Q2W; Tralokinumab 300 mg, Q2W; Placebo, Q2/4W; Tralokinumab 300 mg, Q2/4W
Intervention type(s): Other; Biological; Other; Biological
Intervention description(s): Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.; Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.; Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.; Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
Other intervention name(s): CAT-354; CAT-354
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Tralokinumab; CAT-354
Atrasentan Spermatogenesis and Testicular Function
Condition: Nephropathy; Diabetes
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to evaluate the effects of Atrasentan on sperm production and
      testicular function in male subjects with Type 1 or 2 Diabetes and Nephropathy.

      This study included 2 periods: a Treatment Period (up to 26 weeks) followed by an
      Observational Period (up to an additional 52 weeks).
    


Intervention name(s): Atrasentan
Intervention type(s): Drug
Intervention description(s): Atrasentan
Intervention MeSH terms: Atrasentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetic Nephropathies; Kidney Diseases; Urologic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases