bioihbjkbjnl/mcl2 huggingface dataset:
Sintilimab in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Therapy for Advanced or Metastatic Squamous NSCLC
Condition: Squamous NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and Safety Evaluation of IBI308 in Patients with Advanced or Recurrent Squamous
      NSCLC
    

Detailed description: 
      The anti-tumor activity of anti-PD-1 therapy in previously untreated Chinese squamous NSCLC
      patients will be investigated in this clinical trial.
    

Intervention name(s): Sintilimab; Gemcitabine; Cisplatin; Placebo; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200mg, Q3W, day1, I.V.; consecutive cycles; 1000mg/m^2, Q3W, day 1and 8, I.V.; first 4 or 6 consecutive cycles.; 75 mg/m^2, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.; NA, Q3W, day1, I.V.; consecutive cycles; AUC 5mg/ml/min, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.
Other intervention name(s): IBI308
Intervention MeSH terms: Carboplatin; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of
      osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of
      diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation
      mediators.
    


Intervention name(s): Diacerhein
Intervention type(s): Drug
Intervention MeSH terms: Diacerein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Osteoarthritis, IL-1
VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the effectiveness of cellular dermal
      replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing
      diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.
    


Intervention name(s): SECONDARY dressing gauze and tape; debridement, irrigation; Dermagraft; Oasis
Intervention type(s): Device; Procedure; Device; Device
Intervention description(s): SECONDARY dressing gauze and tape; debridement, irrigation; Dermagraft per company protocol; Oasis per company protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Foot Ulcer; Chronic wounds; Chronic ulcers; Oasis; Dermagraft; Adaptic
Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Aldosterone and its target the mineralocorticoid receptor are implied in development of
      cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum
      aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or
      not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity.
      The first "candidate biomarker" is Neutrophil gelatinase-associated lipocalin (NGAL) or
      "lipocalin" which being measured in blood or in the urine. According to scientific
      knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary
      samples taken during study.
    

Detailed description: 
      This study is broken up into 5 groups:

      The first is a pre-analytical study to determinate optimum conditions for lipocalin samples.

      The second focuses on intra-individual variations of lipocalin levels in blood and urine.

      The third determinate the normal values of lipocalin in blood and urine. Fourthly, we study
      the role of renal function on serum and urines lipocalin levels.

      Fifthly, we study the role of anti-aldosterone treatment on patients who suffer of primary
      hyperaldosteronism.
    

Intervention name(s): Urinary and blood lipococalin levels determination; Spironolactone
Intervention type(s): Procedure; Drug
Intervention description(s): Blood test on an empty stomach. Urinary taking on arrival in the service; For the group 5, at the time of the V0 visit, a treatment by aldactone will be set up (posology: 1 to 2 mg/kg).
Other intervention name(s): ALDACTONE
Intervention MeSH terms: Spironolactone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lipocalin; mineralocorticoid receptor
Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis
Condition: Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective open-label study to evaluated the efficacy and safety of
      infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS).
      Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th
      week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes
      include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not
      necessary. The adverse events at any time were recorded.
    


Intervention name(s): infliximab
Intervention type(s): Drug
Intervention description(s): 100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
Other intervention name(s): remicade
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spondylitis, Ankylosing; infliximab; Antibodies, Monoclonal
A Pilot Study of Migraine and Appetite Behaviour in Children
Condition: Migraine Disorders; Obesity
MeSH terms: Migraine Disorders; Obesity
Study type: Observational

Summary: 
      The purpose of this study is to determine whether there is an association between migraine in
      children and certain patterns of appetite or eating behaviour that may lead to later obesity.
    

Detailed description: 
      Migraine is a chronic neurological disorder characterized by recurrent episodes of headache
      and associated symptoms. The condition affects approximately 11% of the child population and
      it can impose considerable burdens on the sufferer either due to the headache itself, or
      associated co-morbidities such as psychological stress, obesity, sleep problems, etc.
      Increasing attention is focussing on the shared genetic, environmental and neurobiological
      mechanisms of migraine co-morbidities to gain further insights into improving outcomes.

      We are interested in studying eating behaviours in children with migraine since there is
      evidence that altered patterns of eating behaviour (and underlying changes in appetite) are
      seen in migraineurs although not studied systematically. Altered appetite and eating
      behaviours may be a mechanism for the emerging association between obesity (or degree of
      adiposity) and migraine severity, detected in both adult and paediatric studies to varying
      extents. Studying the putative association between migraine, degree of adiposity and patterns
      of eating behaviour in children may help to tease out causal mechanisms, since both migraine
      and obesity often evolve over the course of childhood.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        New referrals to outpatient general paediatric and paediatric neurology service (both
        accepting primary care referrals) within a single multispecialty children's hospital.
      
Keywords: Migraine; Children; Primary headache disorders; Appetite; Obesity; Feeding Behavior
Effect of Quadratus Lumborum Block in C/S
Condition: Postoperative Pain; Cesarean Section Complications; Block; Patient Satisfaction
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We
      hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S.
    


Intervention name(s): ultrasound guıded quadratus lumborum block
Intervention type(s): Procedure
Intervention description(s): Administering local aneshtetic agent with a block needle using the in-plane technique, bilaterally. Lumbar interfascial triangle, where the middle lumbar fascia joins the deep lamina of the posterior layer on the lateral border of the erector spinae was targeted as the optimal point of injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled
Masking: Single (Participant)
Primary purpose: Prevention
Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid
Condition: Hepatitis C; Liver Cirrhosis
MeSH terms: Hepatitis C; Liver Cirrhosis; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that
      of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver
      transplantation.
    


Intervention name(s): tacrolimus + steroid; tacrolimus + mycophenolate mofetil
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver transplantation,; HCV recurrence,; immunosuppression
Impact of Mobilization on Cardiac Surgery
Condition: Postoperative; Dysfunction Following Cardiac Surgery
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effects of a program of early mobilization
      in the functional capacity in patients undergoing coronary artery bypass grafting in short
      and long- term.
    

Detailed description: 
      The hypotheses this study is that patients if conduct the program of early mobilization
      during hospitalization achieve better performance in the walk test (distance) at hospital
      discharge and 60 days after the surgical procedure compared to patients who only carry out
      the program of respiratory exercises. Intervention and control groups will receive breathing
      exercises up to 24 hours postoperatively, and the intervention group will also receive early
      mobilization exercises.
    

Intervention name(s): Interventional Group; Control group
Intervention type(s): Other; Other
Intervention description(s): Respiratory exercises will be performed and subsequently active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conducted on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned. After positioning the patient, the ergometer is adjusted.; The patients will oriented to maintain sitting position and perform deep breaths (3 sets of 10 repetitions) in each session. They will receive the intervention once a day, for 30 minutes until 7th postoperative day. In addition, non invasive ventilation will be installed after orotracheal extubation for 30 to 60 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Functional Capacity; Physical Exertion; Patient Care; Early mobilization
Effect of Intake of Hydrolyzed Krill Protein Isolate on Plasma Amino Acid Profile
Condition: Human Nutrition
Study type: Interventional

Summary: 
      Purpose: To examine the absorption of three different protein sources: hydrolyzed krill
      protein isolate, whey protein isolate, and soy protein isolate.
    

Detailed description: 
      Design and Method: Randomized, controlled, double-blind cross-study, in which 12 healthy
      adult young men in randomized order ingest 35 g of protein of crude protein from one of the
      three protein sources or water on four different experimental days. Before and up to three
      hours after ingestion of the test beverage, blood samples are collected for 8 time points
      during each experimental day.
    

Intervention name(s): Krill protein hydrolysate; Soy protein isolate; Whey protein isolate; Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Ingestion of 35 g Krill protein hydrolysate; Ingestion of 35 g Soy protein isolate; Ingestion of 35 g Whey protein isolate; Ingestion of water (control)
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Design and Method: Randomized, controlled, double-blind cross-study, in which 12 healthy adult young men in randomized order ingest 35 g of protein of crude protein from one of the three protein sources or water on four different experimental days. Before and up to three hours after ingestion of the test beverage, blood samples are collected for 8 time points during each experimental day.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Protein; Amino Acids; Krill; Whey; Soy; Satiety; Insulin
Effects of Gastric pH on the Pharmacokinetics of Atazanavir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to evaluate the ability of a natural supplement (betaine
      hydrochloride) to affect the absorption of atazanavir in healthy volunteers. The
      investigators predict that betaine hydrochloride will increase the absorption of atazanavir
      in volunteers pre-treated with proton-pump inhibitors (PPIs).
    


Intervention name(s): Ritonavir-boosted Atazanavir; Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1; Rabeprazole (20mg) PO twice daily (Days 1-3); Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 (Day 4); Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 on Day 4
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Rabeprazole; Betaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of SHR4010 in Patients With Hemodialysis
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the safety and pharmacokinetics of SHR0410 in
      patients with hemodialysis.
    


Intervention name(s): SHR0410
Intervention type(s): Drug
Intervention description(s): SHR0410 monotherapy,given intravenously
Other intervention name(s): KOR agonist
Intervention model: Single Group Assignment
Intervention model description: SHR0410 monotherapy
Masking: None (Open Label)
Primary purpose: Treatment
A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The reason for the study is to find out if MEDI5395 and durvalumab will work and be safe for
      the treatment of solid tumors.
    

Detailed description: 
      This is an Phase 1, first-in-human, open-label, dose-escalation, and dose-expansion study to
      assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary
      efficacy of MEDI5395 in combination with durvalumab in participants with selected advanced
      solid tumors.
    

Intervention name(s): MEDI5395; Durvalumab
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.; Participants will receive IV infusion of durvalumab as stated in arm description.
Other intervention name(s): Imfinzi
Intervention MeSH terms: Durvalumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solid tumors; immunotherapy; oncolytic virus; NDV-GMCSF
Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers
Condition: Vaccine
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to explore the safety and tolerability of CoVaccine HT in
      healthy male and female volunteers. In this study volunteers will receive intramuscular
      injections of CoVaccine HT.
    


Intervention name(s): CoVaccine HT
Intervention type(s): Biological
Intervention description(s): intramuscular injection, dose escalation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vaccine, hypertension
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Esomeprazole Magnesium DR Capsules Under Fasting Conditions
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Magnesium DR
      Capsules 40 mg and Nexium® 40 mg DR Capsules of AstraZeneca LP, USA. Dosing periods of
      studies were separated by a washout period of 4 days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Esomeprazole Magnesium DR Capsule containing Esomeprazole Magnesium
      40 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Nexium® 40 mg DR
      Capsules containing Esomeprazole Magnesium 40 mg (Reference , AstraZeneca LP, USA) in Healthy
      Human Volunteers Under Fasting Condition.
    

Intervention name(s): Nexium 40 mg DR Capsules of AstraZeneca LP, USA; Torrent's Esomeprazole Magnesium DR Capsules 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): oral, cross over; oral, cross over
Other intervention name(s): esomeprazole magnesium delayed release capsules; esomeprazole magnesium delayed release capsules
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra®) in Subjects Aged 6 to 35 Months
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      Multi-center, observational, active safety surveillance study in participants aged 6 to 35
      months in Korea under routine clinical practices.
    

Detailed description: 
      The planned duration of each participant's participation in the study will be 21 to 28 days.
    

Intervention name(s): VaxigripTetra®
Intervention type(s): Biological
Intervention description(s): Suspension for injection Injection intramuscular
Other intervention name(s): Quadrivalent influenza vaccine (split-virion, inactivated) - QIV
Intervention MeSH terms: Vaccines
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants aged 6 to 35 months will be enrolled after receipt of one dose of
        VaxigripTetra® during a routine health care visit.

        Participants will be enrolled on the day of vaccination (first or second vaccination) and
        will be followed-up for only one vaccination.

        Planned number of subjects: 670 subjects aged 6 to 35 months Planned number of country: 1
        (Republic of Korea) Planned number of sites: 12
Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
Study type: Interventional

Summary: 
      This randomised-controlled study is undertaken to investigate the effects of a long term low
      intensity outpatient training program on physical fitness and quality of life in moderate to
      severe COPD patients.
    

Detailed description: 
      Broad evidence exists on the beneficial effects of pulmonary rehabilitation on exercise
      capabilities and quality of life in COPD patients. Clinically relevant effects have been
      achieved by training programs of differing design regarding setting (inpatient vs. outpatient
      vs. home-based), duration (short-term vs. long-term) and intensity (high vs. low intensity).

      While there is sufficient evidence to propose pulmonary rehabilitation its use is generally
      low in clinical practice. One reason may be that it is unlikely that costly programs are
      offered to a significant proportion of eligible patients. The ideal training program will
      therefore at the same time accomplish the greatest improvements regarding physical
      capabilities and quality of life and sustain them for the longest period at the lowest cost.

      The purpose of the present study is to evaluate whether a continuous, low-intensity,
      low-cost, physiotherapist-led outpatient pulmonary rehabilitation program is a able to
      achieve significant long-term improvements of exercise tolerance and quality of life in
      moderate to severe COPD patients at a lower cost level than previously published programs.
    

Intervention name(s): pulmonary outpatient rehabilitation
Intervention type(s): Procedure
Intervention description(s): Subjects take part in once weekly training sessions of 60 min duration. Sessions take place in local physiotherapist practice and involve simple training devices (chairs, elastic bands, balls). In addition, subjects take part in a structured and validated educational program concerning COPD (COBRA) of 8 h duration. They are offered counselling regarding nutrition (2 h), psycho-social (2 h) and social (2 h) aspects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; pulmonary rehabilitation