bioihbjkbjnl/mcl2 huggingface dataset:
Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to determine the efficacy and safety of rituximab in Pakistani patients with
      rheumatoid arthritis (RA) who have been inadequately controlled with standard disease
      modifying anti rheumatic drugs (DMARDs).
    

Detailed description: 
      Enrolled subjects with inadequately-controlled RA had their disease activity level assessed
      before initiation of therapy and at intervals of 6 months and 12 months thereafter.
      Standardized disease activity scores like the Disease Activity Score-28 (DAS 28) were used
      for determining remission or otherwise of the disease. The American College of Rheumatology
      (ACR) 20, 50 and 70 response scores and the European League of Associations for Rheumatology
      (EULAR) Response Criteria for RA were used to determine the percentage improvement in the
      individual subject's condition at the same intervals. The former utilizes a set of
      assessments to determine if, after a given therapy, there has been a 20, 50 or 70%
      improvement in the aggregate scores as compared to the baseline and the latter utilizes
      calculated improvements in the DAS 28 score to determine if the response to treatment has
      been good, moderate or none. Both of these have been validated and approved for use by the
      ACR and EULAR respectively.

      The study enrollment period was from 1st January 2010 till 31st December 2010. Observation
      period was 12 months from the enrollment date for each subject. The final results are being
      reported here.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Rituximab was administered as an intravenous infusion as per approved protocol on Day 1 and day 14. The protocol stipulated the administration of intravenous hydrocortisone 100 mg and oral pheniramine maleate 43.5 mg as pre-medication. The Rituximab itself was given as a 1 gm infusion slowly over a period of 4-6 hours.
This was done either by a specialist nurse or a trained doctor.
Other intervention name(s): RTX
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pakistan, Rituximab; RA
Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the
      treatment of non-small cell lung cancer (NSCLC).
    


Intervention name(s): Amrubicin hydrocloride; Docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.; DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.
Intervention MeSH terms: Docetaxel; Amrubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation
      solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over
      12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children
      (6 to 11 years old) with severe persistent asthma.
    


Intervention name(s): Placebo; Tiotropium low dose mcg; Tiotropium high dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 actuations once daily in the evening; 2 actuations once daily in the evening; 2 actuations once daily in the evening
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to determine the mass balance of total radioactivity and
      the routes of elimination by quantifying the urinary and fecal excretion of radioactivity
      following a single oral administration of [14C]-brensocatib, to characterize the
      pharmacokinetics (PK) of brensocatib in plasma and urine, PK of total radioactivity in
      plasma, whole blood, urine and to determine the blood-to-plasma ratios of total
      radioactivity.
    


Intervention name(s): [14C]-brensocatib
Intervention type(s): Drug
Intervention description(s): Oral solution.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: [14C]-brensocatib
Nasal Swab Study to Explore the Nasal Microbia
Condition: Common Cold
MeSH terms: Common Cold
Study type: Observational

Summary: 
      The objective of this study is to evaluate the microbial consortia and the host inflammatory
      factors present in the nasal passages of patients during upper respiratory symptomology and
      when healthy using culture and molecular analysis techniques.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of male and female subjects with common cold symptoms.
      
Biospecimen description: 
      microbiota from nasal samples
The Use of plasmaJet During Operative Laparoscopy for Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Endometriosis is a condition where functional endometrial tissue is present outside the
      uterus. It usually locates in the pelvis, which often includes the ovaries. One of the main
      concerns when performing surgery is to maintain fertility.

      Nevertheless, a disadvantage of using monopolar and bipolar instruments for laparoscopic
      excision or coagulation of endometriosis lesions is the energy / thermal distribution that
      can cause damage to the surrounding healthy tissue. Therefore, the use of ultrasound, laser
      or plasma energy can potentially reduce damage to surrounding tissues and prevent adhesion
      formation. In addition, ablation of the internal surface of endometriomas can be an effective
      alternative to cystectomy.

      The PlasmaJet system uses argon plasma which is released as kinetic, light and / or thermal
      energy. In this way the instrument can be applied within three functions, namely cutting,
      vaporizing and coagulating. Moreover, plasma will dissipate very quickly upon contact with
      tissue which consequently allows a controlled depth of tissue penetration. Thirdly, pure
      plasma energy differs from conventional electrosurgery since no electrical current will be
      spread through the tissue and therefore the thermal effect at surrounding tissues remains
      minimal.

      The aim of this pilot study is to investigate the feasibility, effectiveness and safety of
      plasma energy in the treatment of endometriosis.
    


Intervention name(s): PlasmaJet
Intervention type(s): Device
Intervention description(s): Data will be collected during two contact moments, in particular during her admission for surgical laparoscopy, and during her postoperative check-up. Both of these are standard of care. No additional questionnaires will be taken. During the admission the postoperative pain scoreswill be monitored and collected. The duration of her stay in the hospital will also be recorded. During the postoperative check-up, which takes usually place six weeks after the surgery, complications will registered.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia
Condition: Biliary Atresia Congenital Type 3
MeSH terms: Biliary Atresia
Study type: Interventional

Summary: 
      The peer support WeChat platform for primary caregivers of children with biliary atresia can
      provide social support ,help them adopt positive coping styles to face the disease, and
      reduce negative emotions and caregiver burden.
    

Detailed description: 
      The primary caregivers of children with biliary atresia have a heavy psychological burden,
      but there is a lack of supportive research on this population. Therefore, this study used a
      web-based peer support platform to intervene in the primary caregivers of children with
      biliary atresia to reduce the psychological burden of this population.

      The study consisted of two parts. First, a literature analysis, semi-structured interviews,
      and expert validation are used to form a peer support WeChat platform for primary caregivers
      of children with biliary atresia.

      Second, primary caregivers of children with biliary atresia are selected as the study
      population and divided into intervention and control groups in chronological order at a
      children's hospital in Shanghai. Primary caregivers who visit the hospital between August
      2022 and October 2022 are assigned to the control group and primary caregivers who visit the
      hospital between January 2023 and March 2023 are assigned to the intervention group. The
      intervention group receives a peer support WeChat platform intervention on top of usual care
      from the day of surgery to one postoperative month. The levels of negative emotions and
      caregiver burden are compared between the two groups after the intervention.
    

Intervention name(s): Peer support WeChat platform intervention; Routine nursing care group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Primary caregivers of children with biliary atresia are selected as the study population and divided into intervention and control groups in chronological order at a children's hospital in Shanghai. Primary caregivers who visit the hospital between August 2022 and October 2022 are assigned to the control group and primary caregivers who visit the hospital between January 2023 and March 2023 are assigned to the intervention group. The intervention group will receive a peer support WeChat platform intervention from the day of surgery to one month postoperatively. The level of negative emotions and caregiver burden will be compared between the two groups after the intervention. The intervention group receives the same routine care as the control group.; Provide routine inpatient education and post-discharge follow-up to primary caregivers of biliary atresia.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
Condition: Metabolic Disorder
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five
      Cereal Products in two different ethnic groups.
    

Detailed description: 
      This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five
      Cereal Products in two different ethnic groups. It is a laboratory-based research study,
      conducted in two different ethnic groups, with an open cross-over design, including 24
      healthy non-smoking voluntary subjects, aged from 18 to 45 years. 12 subjects will be
      Caucasian and 12 subjects will be Asian. 8 test sessions per subject are included in the
      study. Foods are consumed in a random order according to a randomisation list. The impact of
      the ethnic group and the products will be determined.
    

Intervention name(s): Product A: NP-0148; Glucose solution; Product B: NP-0149; Product C: NP-0150; Product D: NP-0151; Product E: NP-0152
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.; Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times; Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.; Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.; Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.; Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: glycemic & insulin response; SDS; cereal product; Nutrition; Carbohydrate; Absorption; Intestine
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the long-term maintenance of response, safety and tolerability of repeated
      administration of adalimumab in subjects with Crohn's disease who participated in and
      successfully completed Protocol M02-404 or Protocol M04-691.
    


Intervention name(s): Adalimumab
Intervention type(s): Biological
Intervention description(s): Adalimumab 40 mg by subcutaneous injection every other week or every week
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Absorption of Heme and Non-Heme Iron in Pregnant and Non-pregnant Women and Mechanisms of Fetal Iron Transfer
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Observational

Summary: 
      The three specific aims of this study are 1) to assess the impact of iron status on relative
      differences in absorption of heme and non-heme iron among pregnant women and non-pregnant
      women, 2) to assess the magnitude and the determinants of heme and non-heme iron transfer to
      the fetus over the last trimester of pregnancy, and 3) to characterize relationships between
      placental iron binding proteins with the enrichment of stable iron isotopes in the neonate at
      birth. The investigators hypothesize that there will be up regulation of heme and non-heme
      iron absorption and up regulation of placental iron transport proteins in response to low
      maternal iron stores.
    

Detailed description: 
      To measure the absorption of heme and non-heme iron in women, pregnant and non-pregnant women
      will consume a standardized meal of pork (intrinsically labeled with 58Fe) and a second meal
      of non-heme 57Fe (as ferrous sulfate). Two weeks after ingesting these test meals, a blood
      sample will be collected from each women and the amount of heme (58Fe) and non-heme (57Fe)
      iron incorporated into red blood cells will be measured with magnetic sector thermal
      ionization mass spectrometry. Cord blood samples and placental tissue will be obtained at
      delivery to measure how these two forms of dietary iron were transferred across the placenta
      to the fetus. Maternal and neonatal iron status and placental proteins involved in iron
      transport will also be measured. Data from this study will provide information that aims to
      improve human health by better understanding the iron requirements of a population at high
      risk of iron deficiency.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women and adolescents from Rochester, NY and non-pregnant women from Ithaca, NY.
      
Biospecimen description: 
      For non-pregnant subjects 15 mL of blood are collected. For pregnant subjects two 15 mL blood
      samples are collected. The placenta and up to 30 mL of cord blood are also collected at
      delivery.
    
Keywords: iron; pregnancy; heme iron; non-heme iron; stable isotopes; women/adolescents
ST Elevation in Acute Chest Pain; Could Measurement of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) be Helpful to the Clinician?
Condition: Acute Chest Syndrome
MeSH terms: Acute Chest Syndrome; Syndrome
Study type: Observational

Summary: 
      A blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab
      tests to distinguish between pericarditis accompanied with electrocardiogram (ECG) signs
      mimicking infarction. A test of clinical potential if proven to be able to support either
      origin of acute chest pain etiology.
    

Detailed description: 
      Too many times young patients presenting with acute chest pain are referred to invasive
      angiography or treated with anticoagulation therapy a measure of detrimental effect in those
      inflicted with acute pericarditis.

      A simple blood test (the PLAC test) may have some value in aiding rapid diagnosis saving need
      for cath.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        acute chest pain patients admitted to ICCU with acute ST elevation and elevated troponin
      
Biospecimen description: 
      plasma kept in -80 celsius refrigerator
    
Keywords: LpPLA2; ST elevation; acute pericarditis
Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of combinative induction therapy with
      mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of
      aggressive multiple sclerosis
    


Intervention name(s): plasmapheresis
Intervention type(s): Procedure
Intervention description(s): 3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
Other intervention name(s): novantrone; plasma exchange
Intervention MeSH terms: Mitoxantrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; mitoxantrone; plasmapheresis; induction therapy
A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel
Condition: Central Nervous System
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor
      function, and cognitive effects of perampanel when administered alone and with alcohol.
    


Intervention name(s): alcohol + placebo; alcohol + perampanel; perampanel + alcohol; placebo + alcohol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Part A alcohol + placebo; Part A: alcohol + perampanel; Part B: perampanel + alcohol; Part B: placebo + alcohol
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients
Condition: Supplementation; Bone Health; Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the impact of a 12 month vitamin K supplementation intervention on bone health in
      adult Crohn's disease patients
    

Detailed description: 
      To assess the impact of 12 months of vitamin K1 supplementation (plus vitamin D and calcium
      supplementation to avoid deficiency of these problematic nutrients) at a level which leads to
      dramatically (i.e greater than 70%) reduced levels of undercarboxylated osteocalcin - a
      functional marker of vitamin K status, on vitamin K status, the rate of bone formation and
      bone resorption, using biochemical markers of bone turnover, and bone mineral density in
      adult patients with longstanding Crohn's disease.
    

Intervention name(s): phylloquinone (vitamin K1); placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000 mcg phylloquinone (vitamin K1) once daily for 12 months; placebo oil capsule
Other intervention name(s): Banner Pharmacaps Europe; Banner Pharmacaps Europe
Intervention MeSH terms: Vitamin K; Vitamin K 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: vitamin K; supplementation; bone health indices; adult; Crohn's disease
Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover
      study in healthy male and female subjects. There will be two treatment periods each
      consisting of 7 days. During each treatment period subjects will receive single doses of
      ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the
      morning of Day 5.
    

Detailed description: 
      This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover
      study in healthy male and female subjects. There will be two treatment periods each
      consisting of 7 days. During each treatment period subjects will receive single doses of
      ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the
      morning of Day 5.
    

Intervention name(s): Ketoconazole + GW642444M; Placebo + GW642444M
Intervention type(s): Drug; Drug
Intervention description(s): Ketoconazole 400mg OD days 1-6, GW642444M 25ug single dose on D5; Placebo to match D1-6 + GW642444M 25ug single dose on D5
Other intervention name(s): Placebo
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteer; pharmacodynamics; Ketoconazole; Drug Interaction; pharmacokinetcs; GW642444M; pharmacokinetics