bioihbjkbjnl/mcl2 huggingface dataset:
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      People with chronic kidney disease are known to have immune response abnormalities, including
      a diminished response to some vaccinations. Those with chronic kidney disease have a
      disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to
      immune response abnormalities, the CKD population may or may not respond to the recommended
      three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and
      18-related genital tract disease. The objective of this study is to measure the antibody
      response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD)
      (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant.
      Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples
      to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained
      at months 0, 7 and 24.
    


Intervention name(s): Gardasil® Vaccine (FDA-approved vaccination regimen)
Intervention type(s): Drug
Intervention description(s): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: chronic kidney disease; children; dialysis; kidney transplant; human papilloma virus; Gardasil; Chronic kidney disease (non-dialysis, dialysis, and kidney transplant) secondary to any cause.
SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects
Condition: Chemotherapy Induced Peripheral Neuropathy (CIPN)
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double-bline, placebo-controlled, single dose study comparing the
      pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian)
      subjects.
    


Intervention name(s): Calmangafodipir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Eptinezumab in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate how eptinezumab enters, moves through and exits
      the body. Safety and tolerability will also be investigated.
    

Detailed description: 
      The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts
      with 9 subjects in each cohort.
    

Intervention name(s): Eptinezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eptinezumab - single intravenous infusion; Placebo - single intravenous infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions
Condition: Dry Mouth
MeSH terms: Xerostomia
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine
      Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fed conditions using a
      single-dose, 2-treatment, 2-period, crossover design.
    


Intervention name(s): Pilocarpine
Intervention type(s): Drug
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
Condition: Seizures; Epilepsy
MeSH terms: Seizures
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of a potential generic 600 mg
      oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine
      tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.
    


Intervention name(s): Oxcarbazepine
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the study was to examine the immediate effect of positive-word stimuli on the
      limits of stability during multi-direction reach operation in standing position in healthy
      young adults.
    


Intervention name(s): Smartphone Application (SPSRS); Smartphone Application (YouTube)
Intervention type(s): Device; Device
Intervention description(s): Participants use application on iPhone and watch videos showing positive-word stimuli. This application repeats positive-word stimuli every 5 seconds.
The participants watch 3-minute motion picture displaying positive-word stimuli.; Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Stem Cell Fistula Plug in Post Surgical Leak Fistulas
Condition: Surgical Leak Fistula
MeSH terms: Fistula
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators propose to study the safety of autologous mesenchymal stromal cell transfer
      using a biomatrix (The Gore Fistula Plug) in a Phase I study using a single dose of 20
      million cells. 15 adult patients (age 18 and greater) with persistent symptomatic
      post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic
      therapies will be enrolled. The subjects will be subsequently followed for fistula response
      and closure for 18 months. This is an autologous product derived from the patient and used
      only for the same patient.
    

Detailed description: 
      Visit 1: Patients will be evaluated for eligibility (inclusion/exclusion checklist) and
      written, informed consent will be obtained. Patients will undergo general exam with vital
      signs. Patients will be scheduled for a fat biopsy to collect the tissue needed to grow MSC.
      In the event there is no cell growth from the tissue obtained from the first biopsy, one
      further attempt will made from a second tissue sample from this patient. However, if the
      second attempt fails to grow cells, no further attempts will be made, and the subject will
      not continue in the study.

      Visit 2 (Week 0; Day 0): Patients will undergo an interventional endoscopy, the fistula tract
      will be assessed and the stem cell coated will be placed endoscopically.

      Study visit will be as follows:

      Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8;
      Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (week 52; Month 12)
      Visit 10 (Week 78; Month 18)
    

Intervention name(s): MSC Fistula Plug
Intervention type(s): Drug
Intervention description(s): Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell.
Other intervention name(s): mesenchymal stromal cell coated fistula plug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition
Condition: Infant, Premature, Diseases
MeSH terms: Infant, Premature, Diseases
Study type: Interventional

Summary: 
      Oral feeding in the neonatal period requires an accurate coordination between suction,
      swallowing and breathing. In premature new-borns and, depending on their gestational age, the
      coordinated work of those processes becomes jeopardised, being necessary to begin with an
      artificial enteral feeding. This situation results in lengthen their stay at the hospital
      until they are able to respond in a reliable way to their nutritional requirements orally,
      maintaining an adequate daily weight gain and without endangering their cardiorespiratory
      system.

      This project is an experimental, prospective, blinded, randomized study, aimed to determine
      whether the application of a manual oral stimulation protocol in premature infants,
      hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral
      full feeding, while improves quality of feeding and shortens hospitalization time.
    


Intervention name(s): Manual oral stimulation protocol
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oral feeding; oral stimulation; physiotherapy intervention
Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma
Condition: Malignant Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant; Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
      such as cisplatin, work in different ways to stop the growth of tumor cells, either by
      killing the cells or by stopping them from dividing. Giving bortezomib together with
      cisplatin may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib
      together with cisplatin works as first-line therapy in treating patients with malignant
      mesothelioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the activity and safety of bortezomib and cisplatin as first-line treatment in
           patients with malignant mesothelioma.

        -  Validate the use of progression-free survival rate as a primary endpoint for the design
           of phase II mesothelioma trials.

      OUTLINE: This is a nonrandomized, open-label, multicenter study.

      Patients receive cisplatin IV over 1 hour on day 1 and bortezomib IV over 3-5 seconds on days
      1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 6 courses in the absence of
      disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study.
    

Intervention name(s): bortezomib; cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: localized malignant mesothelioma; recurrent malignant mesothelioma; advanced malignant mesothelioma
SUBLIVAC FIX Phleum Pratense DT/DRF
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum
      pratense based on reduction of upper airways reactivity after 5 months of treatment with
      different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety
      and tolerability will be assessed by the number of related Adverse Events of different
      dosages of SUBLIVAC FIX Phleum pratense compared to placebo.
    


Intervention name(s): SUBLIVAC FIX phleum prat.; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Comparison of different dosages to placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Dose range finding; Dose tolerability; grass pollen; Allergic rhinitis/rhinoconjunctivitis; Safety; Immunogenicity
Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to test safety aspects and effects on lung function of a new dry
      powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with
      previous studies which have only used inhalation of the drug as a vapour.
    


Intervention name(s): GSK159797
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: inhaled; asthmatic subjects; GSK159797; safety and tolerability; efficacy; dry powder
Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery
Condition: Bypass Complication; Cardioplegia Solution Adverse Reaction; Endothelial Degeneration; Oxidative Stress; Aortic Valve Stenosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Aortic Valve Stenosis
Study type: Observational [Patient Registry]

Summary: 
      Investigating the myocardial effects of cold blood cardioplegia and del nido cardioplegia
      solution, which are routinely used in clinical practice, will contribute to the studies in
      the literature on the safety and efficacy of these two methods.

      For this purpose, patients with coronary artery disease that going to be Coronary Artery
      Bypass Graft (CABG) surgery will be classified within the scope of the SYNTAX score, the
      level of exposure to cardioplegia change in proportion to their score will be examined. Also,
      left ventricular muscle mass will be calculated in patients who will undergo Aortic Valve
      replacement (AVR) due to Aortic Stenosis, and myocardial protection level proportional to
      muscle mass will be examined, and cardioplegia efficiency will be compared.
    

Detailed description: 
      Endocan, E-Selectin, TNF(Tumor Necrosis Factor)-alpha, Total Oxidant and Antioxidant status
      will be studied on sequential blood samples taken from patients who will undergo Elective
      Coronary Artery Bypass Grafting operation and aortic valve replacement, via retrograde
      cardioplegia cannula before induction, at the beginning of cardiopulmonary bypass and after
      removing the cross-clamp. With routinely used parameters like hemogram, lactate, liver and
      kidney function tests morbidity-mortality rates for specific cardioplegia technique will be
      compared
    

Intervention name(s): Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
Intervention type(s): Diagnostic Test
Intervention description(s): Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress
Intervention MeSH terms: Antioxidants
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with coronary artery disease and aortic valve stenosis irrespectively
      
Biospecimen description: 
      Venous blood specimens taken from peripheral venous cannula and retrograde cardioplegia
      cannula
    
Keywords: Coronary Artery Bypass Grafting; Cardioplegia; Cardiopulmonary Bypass; Aortic Valve Replacement; Endothelial Damage; Oxidative Stress
Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
Condition: Healthy Men
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This study investigates the effect of altitude exposure on sleep, breathing and psychomotor
      performance in healthy subjects.
    

Detailed description: 
      Sleep is essential for well being and performance. Sleep disturbances by recurrent apnea and
      hypoxia in patients with obstructive sleep apnea syndrome impair quality of life, cognitive
      and cardiovascular functions. Similar consequences occur in healthy subjects exposed to
      hypoxia at altitude due to periodic breathing with recurrent central apnea. This project will
      investigate effects of altitude on sleep, breathing, psychomotor performance and on the
      cardiovascular system in healthy subjects and patients with sleep apnea. The results will
      help to better understand mechanisms of sleep disturbances and psychomotor impairment induced
      by hypoxia and to prevent adverse effects of altitude exposure.
    

Intervention name(s): altitude exposure
Intervention type(s): Other
Intervention description(s): exposure to 490m, 1700m and 2590m
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: hypoxia; altitude; sleep; sleep apnea; periodic breathing; vigilance; psychomotor; endothelial function
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)
Condition: Smoking
Study type: Interventional

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and
      amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to
      a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).
    


Intervention name(s): mTHS 2.2; mCC; NNS
Intervention type(s): Other; Other; Other
Intervention description(s): Single use of mTHS 2.2; Single use of subject's own mCC; Single administration of 1 mg of nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Smoking; Nicotine absorption; Candidate modified risk tobacco product; Conventional cigarette; Nicotine replacement therapy: nasal spray
Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis
Condition: Uveitis
MeSH terms: Uveitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A study comparing the safety and efficacy of adalimumab compared with. placebo in adults with
      inactive non-infectious intermediate uveitis, posterior uveitis, or panuveitis.
    


Intervention name(s): Adalimumab; Prednisone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by 40 mg eow starting at Week 1.; Administered orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all subjects continuing in the study were to discontinue prednisone no later than Week 19.; Administered by subcutaneous injection
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Prednisone; Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uveitis
Muscle Energy Technique on Sacroiliac Dysfunction
Condition: Sacroiliac Disorder
Study type: Interventional

Summary: 
      Sacroiliac pain is a huge problem in women during pregnancy and postpartum period. Muscle
      energy technique has potential effect in decreasing the pain and disability
    

Detailed description: 
      A sample of forty women diagnosed with postpartum sacroiliac dysfunction, their ages ranged
      from 20 to 40 years and their BMI was ranged from 25-30 kg / m2 participated in this study,
      they were selected and divided randomly into 2 equal groups (A&B). Group (A) (Control group):
      consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions /
      week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and
      ice for another 20 minutes /session (10 minutes for each). All patients in both group were
      evaluated at the beginning of the study and after 12 sessions through measuring pain
      intensity using visual analog scale and disability using oswestry disability index (ODI)
    

Intervention name(s): muscle energy technique; ice and heat packs
Intervention type(s): Other; Other
Intervention description(s): MET was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles. the limb was taken very slightly beyond the restriction barrier and was held there for 10-30 seconds, it was done 3 times per session for 12 sessions.; Applying 20 minutes: 10 minutes hot,10 minutes cold on sacroiliac area, 3 times per week for 12 sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Muscle energy technique; sacroiliac dysfunction; ice and heat pack
Phase 2 Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and
      safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban
      measuring clotting times using Whole Blood Clotting Time (WBCT).
    

Detailed description: 
      This is a randomized, single-blind, placebo-controlled assessment of the efficacy and safety
      of ciraparantag administered to healthy volunteers measuring clotting times using WBCT as
      determined by the manual testing method. All subjects will undergo screening up to 36 days
      prior to enrollment.

      All enrolled subjects are to receive a single dose of 20 mg rivaroxaban in the morning on
      Days 1-3. On Day 3 (3.75 hours post rivaroxaban), subjects who have a minimum increase in
      clotting time of 25% (as measured by WBCT) are randomized and will receive a single IV dose 4
      hours after the rivaroxaban dose, followed by serial testing of manual WBCT.

      Subjects are enrolled sequentially in up to 4 ciraparantag dose cohorts. There will be a
      safety review after completion of treatment in one cohort and prior to initiation of
      treatment in the subsequent cohort.
    

Intervention name(s): Ciraparantag; Placebo; Rivaroxaban
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ciraparantag (administered over 10 minutes); Saline for injection; Rivaroxaban 20 mg given once per day (QD) in the morning
Other intervention name(s): PER977; AMAG 977; PBO
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: PER977; Ciraparantag; Whole Blood Clotting Time (WBCT); Rivaroxaban