bioihbjkbjnl/mcl2 huggingface dataset:
Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty
Condition: Arthroplasty, Replacement, Knee; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Sensitive renal markers have been studied abundantly in connection with open heart, liver and
      transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim
      of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil
      gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty
      acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA
      (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury
      in orthopaedic surgery.
    

Detailed description: 
      Acute renal deterioration is a serious adverse event in elective surgery. Serum creatinine
      based diagnostics of acute kidney injury may delay diagnosis and produce false negative
      results since serum creatinine is affected by diet, muscle mass, used hydration therapy. In
      recent times new markers have been developed and tested in order to find sensitive, fast and
      reliable marker of renal deterioration.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients coming to elective knee arthroplasty
      
Biospecimen description: 
      plasma for measurement of renal markers Urine for measurement of renal markers
    
Keywords: total knee arthroplasty; Kidney function; Renal markers
Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection
Condition: Hypocalcemia
MeSH terms: Hypocalcemia
Study type: Interventional
Phase: Phase 2

Summary: 
      the increased risk of hypocalcemia following total thyroidectomy plus central neck dissection
      can be minimized by routine administration of oral calcium and vitamin D supplements during
      the early postoperative period.
    

Detailed description: 
      Of patients with differentiated papillary thyroid carcinoma, group D underwent total
      thyroidectomy alone and groups A-C underwent total thyroidectomy plus CND. The latter were
      randomized to oral calcium (3 g/day) plus vitamin D (1 mcg/day) (group A, n = 49), calcium
      alone (group B, n = 49), or no supplements (group C, n = 50). Hypocalcemic symptoms, serum
      calcium, and parathyroid hormone (PTH) levels were compared among the groups.
    

Intervention name(s): Oral calcium plus vitamin D; Oral calcium alone
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): calcium supplementation took 3 g/day oral calcium (1 g every 8 h) plus 1 mcg/day vitamin D (0.5 mcg every 12 h), beginning on the night of surgery and continuing for 14 days.; calcium carbonate (3 g/day, 1 g every 8 h)
Other intervention name(s): calcium carbonate and one-alpha (vitamin D); calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Total thyroidectomy; CND; hypocalcemia; calcium; vitamin D
DFN-11 Injection in Episodic Migraine With or Without Aura
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.
    


Intervention name(s): DFN-11; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ibuprofen Bioavailability Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet
      (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be
      taken without water and can be used 'on the go'. Vanquish has an improved organoleptic
      profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as
      a suitable dosage form for children who may be reluctant to swallow tablets. This product has
      the potential for application in both adults and children due to the convenience of the
      format and the ease of administration for both groups.

      This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.
    


Intervention name(s): Test - RB ibuprofen acid orodispersible tablets; Reference - RB Nurofen ibuprofen acid tablets; Comparator - Dolormin ibuprofen lysine tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.; RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.; Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Dietary Acid Load During Pregnancy and Gestational Diabetes Mellitus
Condition: Diabetes, Gestational; Dietary Habits
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      Dietary habits resembling Western style, rich in animal protein and poor in fruit and
      vegetables, increase the body acid load, a predictor of type 2 diabetes risk. Recently, the
      studies related to relationships between dietary acid load and insulin resistance has become
      a growing interest but there are only a few study conducted with gestational diabetes
      mellitus (GDM). Therefore, the aim of this study was to evaluate the potential relationship
      between dietary acid load in second trimester, blood lipid profiles and GDM.
    

Detailed description: 
      This cross-sectional study conducted with 40 women with GDM diagnosed with two-step 100g oral
      glucose tolerance test and 40 healthy women, aged 21-41 years, between weeks of 14-28 of
      pregnancy, who attended the Department of Obstetrics and Gynecology of Gulhane Training and
      Research Hospital. Participants with polycystic ovary syndrome, chronic diseases, pre-GDM, or
      multiple pregnancies were excluded. Sociodemographic information was recorded via
      questionnaire and anthropometrics of women were measured.

      Blood samples were taken after an overnight fasting. Dietary information was obtained by mean
      intakes of a 3-day food records (2 weekdays and 1 weekend day) and analyzed via nutrition
      analysis software. According to the data obtained from software analysis, animal protein
      (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score
      and net endogenous acid production (NEAP; mEq/day) were calculated from established
      algorithms to estimate dietary acid load. All nutrients were age and energy- adjusted before
      being introduced into the equation and tertiles of the scores were used for statistical
      analysis. ANOVA, ANCOVA and Logistic regression test were used. The study plan was approved
      by the Hospital&#39;s Ethics Committee.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant
        between 21-41 years in age, in their 24-28th gestational week applied to Gulhane Education
        and Research Hospital were recruited. This study must recruit 40 women for each group to
        have 80% study power with 5% type I error level to detect a clinically significant
        difference.
      
Keywords: Gestational diabetes mellitus; Dietary acid load; Pregnancy
MK-0524B Lipid Study (MK-0524B-063)
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed
      dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on
      lipid values.
    


Intervention name(s): Comparator: simvastatin; MK-0524A; Placebo; MK-0524B
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
Other intervention name(s): Zocor®; MK0733
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of loperamide on QT/ QT interval corrected
      for heart rate (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and
      supratherapeutic exposures in healthy participants.
    


Intervention name(s): Loperamide; Placebo; Moxifloxacin
Intervention type(s): Drug; Other; Drug
Intervention description(s): Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively.; Matching loperamide placebo capsules will be administered orally.; Moxifloxacin tablets will be administered orally.
Intervention MeSH terms: Moxifloxacin; Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Development of an Innovative Health Ingredient From Marine By-products for the Healthy Aging
Condition: Memory Impairment; Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This interventional, randomised, placebo-controlled and double-blind study aims to evaluate
      the effect of a dietary supplementation with a blue fish hydrolysate derived from marine
      by-products, containing peptides and n-3 polyunsaturated fatty acids, on cognitive
      performance in a healthy older population, between 60 and 73 years old, with lower memory
      performance.
    

Detailed description: 
      The main objective of this study is to evaluate the efficacy of a dietary supplementation
      with a hydrolysate derived from marine by-products compared to a placebo on the evolution of
      episodic memory at 3 months in healthy elderly people with lower memory performance.

      The secondary objectives of this study are to evaluate the efficacy of a dietary
      supplementation with a hydrolysate derived from marine by-products compared to a placebo on
      the evolution at 3 months of verbal recognition memory, working memory, perceived stress
      level, biological markers of nutritional and hormonal status in healthy elderly people with
      lower memory performance. Finally, participants' satisfaction with the product will be
      assessed.

      Participants have to take 4 capsules per day of the hydrolysate containing 770 mg (dose per
      capsule) or of the placebo for 90 days.

      Participants will have a phone screening interview and will attend 5 visits to the Bordeaux
      University Hospital on the Neuro-Psychopharmacological Research Platform.
    

Intervention name(s): Blue fish hydrolysate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The experimental product is a dietary supplement composed of a hydrolysate of fatty blue fish containing low molecular weight peptides and n-3 polyunsaturated fatty acids.
One of the two study groups (28 volunteers) will take 4 capsules of the active product (blue fish hydrolysate), for 90 days.
Each day the capsules will be taken as followed : 2 capsules in the morning and 2 capsules in the evening.; The placebo product containing mainly maltodextrin is presented in the same form as the active product, so that people handling the product cannot distinguish between them. The placebo is flavoured in order to have a fishy smell just like the active product.
One of the two study groups (28 volunteers) will take 4 capsules of placebo per day, for 90 days.Each day the capsules will be taken as followed : 2 capsules in the morning and 2 capsules in the evening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Memory; Cognitive decline; Food supplement; Hydrolysate; Aging
Predictors of AIS Unfavorable Outcomes
Condition: Ischemic Stroke; Alteplase Adverse Reaction
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators evaluated whether the characteristics of ischemic stroke patients,
      door-to-needle time, and stroke risk factors were predictive variables for unfavourable
      outcomes.
    

Detailed description: 
      Investigators conducted a prospective cohort study between January 2022 and June 2023 and
      screened 1184 patients presented with AIS and received alteplase and included 592 AIS
      patients who met the inclusion criteria and were diagnosed based on a thorough clinical
      assessment, including a detailed medical history, physical examination and specific brain
      imaging results and treated with alteplase within four and half hours of stroke onset.

      The investigators assessed mRS after 90 days via a 10-minute telephone interview. With
      patients or their primary caregivers to detect the score, all of our patients had baseline
      mRS of zero. mRS two or less was considered a favourable outcome

      The study consisted of two distinct groups. The first group consisted of 456 patients who
      experienced favourable outcomes, while the second group comprised 136 patients who
      experienced unfavourable outcomes.

      The investigators evaluated whether the characteristics of ischemic stroke patients,
      door-to-needle time, and stroke risk factors were predictive variables for unfavourable
      outcomes.
    

Intervention name(s): Alteplase
Intervention type(s): Drug
Intervention description(s): Following the guidelines set forth by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit.
Intervention MeSH terms: Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consisted of two distinct groups. The first group consisted of 456 patients who experienced favourable outcomes (mRS two or less), while the second group comprised 136 patients who experienced unfavourable outcomes (mRS more than two).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alteplase; acute ischemic stroke; Egypt; Saudi Arabia
Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody
      TNT-1/B (^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them
      without harming normal cells. This may be an effective treatment for glioblastoma multiforme.

      PURPOSE: This phase I trial is studying the side effects and best dose of ^131I MOAB TNT-1/B
      in treating patients with progressive or recurrent glioblastoma multiforme.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in
           patients with progressive or recurrent glioblastoma multiforme.

      Secondary

        -  Determine the biodistribution and radiation dosimetry of this drug in these patients.

        -  Determine the toxicity and tolerability of this drug in these patients.

        -  Determine the overall survival, median time of survival, and 6-month survival of
           patients treated with this drug.

      OUTLINE: This is an open-label, multicenter, dose-escalation study of therapeutic doses of
      iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B).

      The first 12 patients accrued to the study undergo stereotactic placement of 2 catheters
      within the contrast-enhancing tumor on day 0. These patients then receive an imaging dose of
      ^131I MOAB TNT-1/B interstitially over approximately 25 hours on day 1 followed by dosimetry,
      biodistribution evaluations, and whole body imaging over an 8-10 day period. Beginning at
      least 2 weeks, but no more than 4 weeks later, all patients undergo catheter placement as
      above. One day later, patients receive a therapeutic dose of ^131I MOAB TNT-1/B
      interstitially over approximately 25 hours.

      Cohorts of 3-6 patients receive escalating therapeutic doses of ^131I MOAB TNT-1/B until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients
      are treated at the MTD.

      After completion of study treatment, patients are followed weekly for 3 weeks, at 6 weeks, at
      4, 8, and 12 weeks (for the first 12 patients accrued to the study), every 4 weeks until
      disease progression, and then every 8 weeks thereafter.

      PROJECTED ACCRUAL: Approximately 22 patients will be accrued for this study.
    

Intervention name(s): iodine I 131 monoclonal antibody TNT-1/B
Intervention type(s): Radiation
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult glioblastoma; adult gliosarcoma; adult giant cell glioblastoma; recurrent adult brain tumor
A Pilot Study Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning
Condition: Organophosphate Poisoning
MeSH terms: Poisoning; Organophosphate Poisoning
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many
      patients who ingest organophosphates require ventilation; of these patients approximately 50%
      die. Much of the mortality in these ventilated patients is secondary to intermediate
      syndrome. This is because OP pesticides inhibit acetylcholinesterase, causing an excess of
      acetylcholine at nerve synapses and the neuromuscular junction (NMJ). At the NMJ, the excess
      acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest
      or prolonged ventilation and its associated complications.

      The investigators believe that blocking these receptors using a neuromuscular blocking agent
      such as Rocuronium will protect the NMJ from damage and thus prevent intermediate syndrome
      and reduce number of intubated days and mortality.

      In this pilot randomised controlled trial Rocuronium, a competitive nicotinic receptor
      antagonist, will be used to bind to the receptor at the neuromuscular junction and to block
      the effects of the accumulated acetylcholine. The effects of OP pesticide on cholinesterase
      in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is
      eliminated from the body.
    

Detailed description: 
      Primary outcome: Number of days intubated
    

Intervention name(s): Rocuronium; Sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
Other intervention name(s): Esmeron; Bridion
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Organophosphate poisoning; Intermediate syndrome; Rocuronium
HMPL-689 Drug Interaction Study With CYP3A Inhibitor/CYP2C9 Inhibitor/CYP3A Inducer/PPI
Condition: Relapsed or Refractory Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label study to determine effect of Itraconazole, Fluconazole, Rifampin, and
      Rabeprazole on the PK of HMPL-689
    

Detailed description: 
      A phase 1, open-label, 4-part, 2-period, fixed-sequence study to assess the effect of
      Itraconazole, a strong CYP3A inhibitor, the effect of Fluconazole, a moderate CYP3A/2C9
      inhibitor, the effect of Rifampin, a strong CYP3A inducer, and the effect of Rabeprazole, a
      proton pump inhibitor on the pharmacokinetics (PK) of a single oral dose of HMPL-689 in study
      participants. The secondary objective is to evaluate the safety of a single oral dose of
      HMPL-689 administered with and without Itraconazole, Fluconazole, Rifampin, or Rabeprazole in
      study participants.
    

Intervention name(s): Itraconazole 200 mg; Fluconazole 400 mg; Rifampin 600 mg; Rabeprazole 40 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Study participants will be administered 200 mg itraconazole by mouth twice daily after the pharmacokinetic blood draw on Day 3 and once daily on Days 4 to 10, inclusive.; Study participants will be administered 400 mg fluconazole by mouth daily on Day 3 after the pharmacokinetic blood draw, and 200 mg fluconazole by mouth daily on Days 4 to 10, inclusive.; Study participants will be administered 600 mg rifampin by mouth daily starting on Day 3, after the pharmacokinetic blood draw, and on Days 4 to 11, inclusive.; Study participants will be administered 40 mg rabeprazole by mouth daily on Day 3, after the pharmacokinetic blood draw, and on Days 4 to 9, inclusive.
Intervention MeSH terms: Itraconazole; Fluconazole; Rifampin; Rabeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Itraconazole; Fluconazole; Rifampin; Rabeprazole