bioihbjkbjnl/mcl2 huggingface dataset:
Optimalization of Nephroprotection Using Agents Inhibiting Renin-Angiotensin-Aldosterone System
Condition: Chronic Kidney Disease; Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional

Summary: 
      The main purpose of the study is find whether the addition of aldosterone antagonist,
      spironolactone to dual renin-angiotensin-aldosterone system blockade involving angiotensin
      converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction
      of proteinuria, main prognostic marker of chronic kidney disease progression.
    

Detailed description: 
      The renin-angiotensin-aldosterone system (RAAS) plays an important role in the progression of
      chronic kidney diseases (CKD), and inhibition of the RAAS with angiotensin-converting enzyme
      inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB) may retard CKD
      progression. Dual pharmacological blockade of the RAAS with ACEI and ARB is recommended as a
      standard renoprotective management at least in patients with nondiabetic proteinuric CKD.
      However, neither ACEI nor ARB, even in high doses or in concomitant usage, abrogate the
      progression of CKD completely. Innovative approaches are needed to keep patients with CKD off
      dialysis. Additional blockade of the aldosterone pathway may prove to be such beneficial
      therapeutic concept.Aldosterone, a final effector of RAAS plays a significant role in the
      pathogenesis of CKD independently of angiotensin II through direct cellular action. This
      includes promoting an inflammatory response, endothelial dysfunction, and fibrosis by
      increasing plasminogen activator inhibitor (PAI-1) and transforming growth factor beta-1
      (TGF-beta-1) expression and stimulation reactive oxygen species.A number of observations
      suggest nongenomic vasoconstrictor action of aldosterone leading to raise arterial and
      glomerular capillary pressure.Given these facts additional administration of aldosterone
      antagonist to combination treatment with ACEI and ARB, so called triple RAAS blockade may
      provide additional renal protection. To shed more light on this issue, we performed a
      randomised open controlled study to evaluate the influence of triple RAAS therapy on
      surrogate markers of kidney injury, i.e. proteinuria, markers of tubular involvement and
      kidney fibrosis.
    

Intervention name(s): Spironolactone (Spironol) 25 mg
Intervention type(s): Drug
Intervention description(s): In the 8-weeks run-in period ACEI, cilazapril (5 mg), telmisartan (80 mg) and hydrochlorotiazyd (12.5 mg) were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 25 mg of spironolactone in two active treatment periods lasting 8 weeks each.
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proteinuria; Renin-Angiotensin-Aldosterone System; Aldosterone Antagonists
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Condition: Acute Lymphoblastic Leukemia, in Relapse
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum
      Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and
      pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
    


Intervention name(s): CARCIK-CD19
Intervention type(s): Biological
Intervention description(s): Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia; CAR-T; CARCIK; Transposon
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fasting Condition
Condition: Fasting State
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fasting condition in
      normal, healthy, adult, human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Ondansetron Tablets USP 8 mg of M/s Ipca Laboratories Limited, India and the corresponding
      Reference Product: Zofran® (Ondansetron hydrochloride) 8 mg Tablets of M/s GlaxoSmithKline,
      under fasting condition in normal, healthy, adult, human subjects in a randomized crossover
      study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single 8 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Ondansetron Tablets USP 8 mg; Ondansetron Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg tablet once a day; 8 mg tablet once a day
Other intervention name(s): Test Product; Zofran®
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood
      Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to
      determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes
      management.
    


Intervention name(s): SMBG to guide clinical decisions; SMBG and CGM
Intervention type(s): Other; Other
Intervention description(s): The investigator will base clinical decisions on A1c and modal day analysis of SMBG.; The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; A1c; Continuous Glucose Monitoring; Blood Glucose
Estimation of Pain During Epidural Analgesia During Labor
Condition: Labor, Obstetric; Pain
Study type: Interventional

Summary: 
      Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric
      labor and childbirth. It consists in establishing a catheter into the epidural space and to
      block the transmission of pain sensations by injecting a local anesthetic and an opioid. In
      10-25% of cases the epidural does not give perfect results, causing it to test its
      effectiveness, which is mainly done by questioning the patient on mitigation or disappearance
      of pain. This collaboration of patients is sometimes limited in our care structure by the
      inability to assess or express the pain, mainly due to cultural differences or language
      barriers, which can represent up to 15% of women in our institution. This led to develop
      objective measures of pain techniques used at the bedside.

      Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of
      the pupil, and parasympathetic system (pΣ).

      The PD increases in response to painful stimulation, in proportion to the intensity of the
      nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain
      in patients under general anesthesia, but has been little studied in conscious subjects.

      There are other permanent changes in the PD, due to constant interaction between Σ and pΣ
      systems. Few data have been published to date on this PD variability (PDV).
    


Intervention name(s): Portable video pupillometer
Intervention type(s): Device
Intervention description(s): Portable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Labor, Obstetric; pain; pupil diameter; Visual Analogic Scale (VAS)
Safety and Efficacy of Autologous Cardiopoietic Cells for Treatment of Ischemic Heart Failure.
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to
      standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.
    


Intervention name(s): Injection of C3BS-CQR-1; Sham, no injection
Intervention type(s): Biological; Biological
Intervention description(s): Injection of the C3BS-CQR-1 using the C-Cath® injection catheter.; Mimic the injection procedure trough insertion of a sham catheter. No injection actually performed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Heart Failure of Ischemic Origin
Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation
Condition: Kidney Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      Varicella zoster virus is part of the herpesvirus group and causes chickenpox in exposed
      individuals. The majority of the population is seropositive for this virus. Reactivation of
      varicella zoster virus occurs in up to 30% of the general population over 60 years old.

      Solid organ transplant recipients receive lifelong immunosuppression drugs and are at great
      risk of reactivation of all herpesviruses including the varicella zoster virus regardless of
      age. The vaccine has been shown to be effective in preventing shingles in the general
      population. The investigators' purpose is to determine how well the vaccine works in patients
      on renal replacement therapy and post-transplant.
    


Intervention name(s): Zostavax (Live attenuated herpes zoster vaccine); Placebo vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.6 mL subcutaneous; 0.65 mL subcutaneous
Other intervention name(s): Zostavax
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
Condition: Migraine With or Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study was to compare the efficacy, toleration and safety of eletriptan
      40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with
      an acute migraine.
    


Intervention name(s): Placebo; Eletriptan 40 mg; Eletriptan 80 mg; Sumatriptan 25 mg; Sumatriptan 50 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Matching Placebo; 40mg oral; 80mg oral; 25mg oral; 50mg oral
Intervention MeSH terms: Sumatriptan; Eletriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy
Condition: Pancreatic Neoplasm
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications.
      No score is currently available to help identify the patient's surgical risk. The purpose of
      this study was to develop and validate a prognostic score to predict major postoperative
      complications after PD.
    

Detailed description: 
      The investigators prospectively collected in an electronic database preoperative,
      intraoperative and outcome data of 700 patients undergoing PD in our Institution from 2002 to
      2010. The investigators used a multivariate logistic regression analysis to create a new
      score to predict severe complications defined as Clavien-Dindo classification III, IV and V.
      The score was developed using a random two-thirds of the population (469 patients), and was
      then validated and calibrated in the remaining third of the patients (231).
    

Intervention name(s): Pancreaticoduodenectomy
Intervention type(s): Procedure
Intervention description(s): Resection of pancreatic lesion
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        700 patients undergoing pancreaticoduodenectomy in our Institution from 2002 to 2010
      
Keywords: pancreas, pancreaticoduodenectomy, major complications
Prevention of Alcohol Intolerance
Condition: Alcohol Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine whether Asians who are especially sensitive to alcohol
      exposure can be protected by boosting their activities of an alcohol disposing enzyme. This
      will be accomplished by administering broccoli sprouts that are rich in an agent that
      increases protective enzyme activity. The test system involves applying alcohol patches to
      the skin and measuring skin redness.
    


Intervention name(s): Broccoli Sprout Extract; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge; 80% acetone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Broccoli sprouts; alcohol sensitivity; sulforaphane; alcohol metabolism; in the Asian Community
A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
Condition: Human; Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the safety, tolerability, and immune response of an investigational
      vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma
      Virus (HPV).
    

Detailed description: 
      The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and
      -06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the
      base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

      The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term
      Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6,
      11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of
      Age" to allow a follow-up period to Month 126.
    

Intervention name(s): V501; Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL intramuscular injection of V501; 0.5 mL intramuscular injection of placebo
Other intervention name(s): GARDASIL™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Sublingual Immunotherapy in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the effect and safety of sublingual Dermatophagoides Farinae Drops in adult
      patients with atopic dermatitis and allergic sensitization to house dust mites.240 adults age
      18 to 60 years with atopic dermatitis(Objective Scoring Atopic Dermatitis, Objective SCORAD
      from 10 to 40) are going to be enrolled in a randomized,double-blind,placebo-controlled
      study.Sublingual Dermatophagoides Farinae Drops or placebo is given for 9 months in addition
      to standard therapy.SCORAD,average anesis interval,rescue medicine and DLQI will be recorded.
    

Detailed description: 
      SCORAD is composed of skin rash area,severity and subjective symptom including pruritus and
      sleeping quality.Skin rash area and severity score are objective SCORAD(range from 0 to
      83).Subjective SCORAD range from 0 to 20 and total SCORAD range from 0 to 103.
    

Intervention name(s): Dermatophagoides Farinae Drops Group 1; Dermatophagoides Farinae Drops Group 2; Dermatophagoides Farinae Drops Group 3; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.; Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drop of placebo.; Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.; Placebo Group is the group with maintenance dose of 3 drops of placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sublingual immunotherapy; atopic dermatitis; Dermatophagoides Farinae Drops
Traveler's Constipation
Condition: Constipation; Travel-Related Illness
MeSH terms: Constipation; Travel-Related Illness
Study type: Interventional

Summary: 
      The occurence of traveler's constipation is sparsely covered in the medical litterature. This
      study aims to determine the gastrointestinal-related discomforts related to traveling on a
      trip to Turkey.
    

Detailed description: 
      Traveler's constipation, which is characterized by the more hard and less frequent stools, is
      sparsely covered in the medical litterature. Only a few studies have examined this problem
      and the actual occurrence and extent of this problem is not known. Hypotheses about why
      travel constipation occurs are, among other things, about changed circadian rhythm due to jet
      lag, changed schedules and tight sanitary conditions. Other factors such as dehydration,
      change in cabin pressure and the content of the in-flight food in connection with flights
      have not been investigated.

      The research project aims to clarify changes in the test subjects' bowel habits as well as
      other gastrointestinal-related discomforts in connection with a flight abroad with only an
      hour's time difference and without the consumption of flight food.
    

Intervention name(s): Flight
Intervention type(s): Behavioral
Intervention description(s): The participants are flying to turkey and back home. The flights are the intervention.
Intervention model: Single Group Assignment
Intervention model description: The investigators are investigating wether a flight abroad is causing a decrease in stools.
Masking: None (Open Label)
Primary purpose: Prevention
OPUS School Meal Study - Cross Sectional Analyses From Baseline Investigations
Condition: Metabolic Syndrome X
MeSH terms: Microvascular Angina; Metabolic Syndrome
Study type: Observational

Summary: 
      The present study is based on cross-sectional data from the baseline investigations carried
      out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools
      in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th grades (8-12
      year olds) took part in these baseline investigations of socioeconomic status, pubertal
      status, growth status, learning abilities, well-being, sleep, physical activity and risk
      markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        School children participating in OPUS School Meal Study (registered as an intervention
        study with protocol number: NCT01457794)
      
Biospecimen description: 
      serum and white cells
    
Keywords: Metabolic Syndrome X; Fatty Acids, Omega-3; Learning; Attention; Nutritional Status; Nutrition Assessments; Body Weight; Physical Activity; Sleep; Child Nutrition Sciences
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of almotriptan malate (a
      migraine headache medication) in the treatment of migraine headaches in adolescents for up to
      one year.
    

Detailed description: 
      Almotriptan malate, and several other treatments for migraine headaches, known as triptans,
      are approved for the treatment of migraine headaches in adults. To date, none of these have
      been approved by the Food and Drug Administration (FDA) for use in adolescents. This is an
      open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years
      old with a history of one to 14 migraines per month for the 6 months prior to entering the
      study. The total study duration will be up to one year. There is a screening phase to
      determine if the patient is eligible for study entry, followed by an open-label treatment
      phase that can last up to one year. Almotriptan malate 12.5 mg tablets will be used to treat
      all migraine headaches during the study, as needed. The primary outcome of the study is an
      assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers.
      The study hypothesis is that the almotriptan malate will be safe and well tolerated in the
      treatment of adolescent migraine headaches. Safety measurements will be performed at set time
      points during the study and will include laboratory tests, physical and neurological exams,
      electrocardiograms (ECGs) and the incidence of adverse events. A diary will be completed by
      the patient for each migraine headache for which they take almotriptan malate. Migraine pain
      information and almotriptan malate use will be recorded in the headache diary. An equal
      number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be
      enrolled. Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset
      of migraine headache pain. The dose may be repeated once if the pain continues 2 hours after
      the first dose, but no more than 2 doses can be taken within a 24-hour period. Study
      medication will be taken for up to one year.
    

Intervention name(s): Almotriptan Malate
Intervention type(s): Drug
Intervention description(s): Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Intervention MeSH terms: Almotriptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Almotriptan Malate; Headache; Triptan