bioihbjkbjnl/mcl2 huggingface dataset:
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin,
      vincristine and prednisone) the patients are randomized to:

      A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg

      B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
    

Detailed description: 
      The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan
      (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival,
      after induction with chemotherapy and rituximab in folicular lymphoma patients no treated
      previously.

      The other aims are, evaluate the global survival, event free survival, time until next
      treatment, response rate after consolidation or maintenance treatment, quality of life,
      security of two branches and relation cost-efectivity
    

Intervention name(s): Rituximab; Ibritumomab tiuxetan
Intervention type(s): Drug; Drug
Intervention description(s): 375 mg/m2 every 8 weeks during 24 months; One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Folicular Lymphoma; Consolidation; Maintenance
Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
Condition: Contraception
Study type: Interventional

Summary: 
      To evaluate the feasibility and effectiveness of group contraceptive counseling on family
      planning knowledge acquisition, service satisfaction, method uptake and continuation among a
      group of resettled African refugee women.
    

Detailed description: 
      Thousands of women refugees arrive in the United States each year, yet there is very little
      known about reproductive health and family planning needs of these women after resettlement.

      This randomized controlled pilot study, in a population of resettled African refugee women,
      will evaluate differences between group and individual contraceptive counseling on the
      decision to use contraception, satisfaction with counseling method, and modern family
      planning knowledge.

      Participants will arrive to clinic during an assigned "intervention day." An intake and exit
      survey will be performed before and after their counseling session. Demographics, attitudes
      towards contraception, and knowledge regarding contraceptive methods will be assessed via
      questionnaire. Participants will be randomized to either group or individual contraceptive
      counseling. After each session, participants will have the option to privately choose a
      reversible method of contraception free of charge.

      Telephone survey follow-up with participants will occur every three months for one year.
      Follow-up surveys will include questions regarding method continuation, method satisfaction
      and and modern contraceptive knowledge.
    

Intervention name(s): Counseling
Intervention type(s): Other
Intervention description(s): Participants will be randomly assigned to group versus individual contraceptive counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Refugee Health; Resettled Refugee; Family Planning; Contraception; Group Counseling; Group contraceptive counseling
Effects of a Weight Reduction and Lifestyle Program in Older Adults
Condition: Functional Disability; Obesity; Physical Inactivity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This research study will assess the effects of two different programs on weight, body
      composition, mobility and improved health. Measures of health will include functional
      abilities, and physical performance. The 2 programs being tested will be provided the same
      physical activity program which will include aerobic activity and resistance (weight)
      training. The intervention study will last up to 1 year with follow-up at 6 months and yearly
      phone calls thereafter.
    


Intervention name(s): Diet and physical activity; Physical activity control
Intervention type(s): Behavioral; Other
Intervention description(s): lifestyle weight reduction - low fat eating, low calorie and physical activity; physical activity plus successful aging health education
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: obesity; physical activity; older adults; functional disability
Mum Can I Have Vegetables Again? Development of Vegetable Preferences
Condition: Vegetable Intake After Weaning With Vegetables or Fruits; Fruit Intake After Weaning With Vegetables or Fruits
Study type: Interventional

Summary: 
      -  Rationale: Despite the health benefits, children's consumption of vegetables is below
           the recommendations. Most human food preferences are learned through mere exposure,
           imitation, and conditioning principles. During the last years, it has become clear that
           the development of food preferences starts very early in life. Furthermore, preferences
           that are learned early in life, are relatively stable and may track into adulthood.
           However, it is unclear how vegetable preferences develop from infancy until young
           childhood. In order to influence vegetable consumption, it is essential to study the
           opportunities to develop a preference for vegetable products early in childhood.

        -  Objective: The aim of this study is to investigate the effect of repeated exposure to
           vegetables compared to repeated exposure to fruit during weaning on short and long term
           vegetable and fruit intake. Furthermore, the stability of the learned fruit or vegetable
           preferences and the later food preferences are measured (i.e. vegetable, fruits,
           sweets).

        -  Study design:

      In this longitudinal study we will measure the development of preferences for a particular
      vegetable or fruit type within 4 to 6 months old subjects, during a 19 day exposure period to
      fruit or vegetables (of which 9 days exposure to the target fruit or vegetable) and 6 months
      after this exposure period. In addition, we compare the food preferences (fruit, vegetable,
      sweet foods in general), after 6 months, between infants who were weaned with a variety of
      fruits and infants who were weaned with a variety of vegetables.
    


Intervention name(s): green beans group; Artichoke group; Apple group; Plums group
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Infants were weaned with vegetable purees for the first 18 days of weaning. One vegetable type per day. With green beans every other day.; Infants were weaned with vegetable purees for the first 18 days of weaning. One vegetable type per day. With artichoke every other day.; Infants were weaned with fruit purees for the first 18 days of weaning. One fruit type per day. With apple every other day.; Infants were weaned with fruit purees for the first 18 days of weaning. One fruit type per day. With Plums every other day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: weaning; infants; vegetables; repeated-exposure
A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors
Condition: Breast Cancer; Ovarian Cancer; Colon Cancer; Lung Cancer; Gastric Cancer; Solid Tumors
MeSH terms: Ovarian Neoplasms; Stomach Neoplasms; Colonic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an extension study to evaluate the safety of Veliparib monotherapy or in combination
      with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI)
      in subjects with solid tumors.
    


Intervention name(s): Veliparib; Carboplatin; Paclitaxel; FOLFIRI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): combination of Fluorouracil, leucovorin and irinotecan
Other intervention name(s): ABT-888; Taxol
Intervention MeSH terms: Paclitaxel; Carboplatin; Veliparib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Cancer; Lung Cancer; PARP Inhibitor; Ovarian Cancer; Solid Tumors; Breast Cancer; Colon Cancer
Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion
Condition: Hypotension; Pressure Ulcer
MeSH terms: Hypotension; Pressure Ulcer
Study type: Interventional

Summary: 
      Continuous pulse oximetry monitoring is the standard of care in critically ill patients in
      emergency departments, operating rooms and intensive care units. In patients with poor
      peripheral perfusion (low blood flow) due to peripheral vascular disease, low body
      temperature, or shock and the use of medications to raise the blood pressure, clinicians have
      difficulty obtaining an accurate measurement. This study compares the accuracy of forehead
      oximetry sensors to nasal alar sensors to lab oximetry measures and on the rate of device
      related pressure ulcers with both.
    

Detailed description: 
      Continuous pulse oximetry monitoring is the standard of care in critically ill patients in
      emergency departments, operating rooms and intensive care units. In patients with poor
      peripheral perfusion (low blood flow) due to peripheral vascular disease, low body
      temperature, or shock and the use of medications to raise the blood pressure, clinicians have
      difficulty obtaining an accurate measurement. Several studies have demonstrated the utility
      of forehead sensor measurements under these clinical conditions. Forehead sensor measurement
      is considered to be a more central measurement than with digit or ear sensors. However the
      sensor requires a head band for accurate measurement. On a regular basis, the forehead sensor
      has led to pressure ulcer development at Barnes-Jewish Hospital despite following vendor
      recommendations for alternating placement every 8 hours from one side of the forehead to the
      other. An alternate sensor placed on the nose has recently demonstrated rapid detection of
      induced drops in oxygen saturation. It has also demonstrated correlation with arterial oxygen
      saturation measured in a clinical laboratory. The oxygen saturation measurement from the nose
      is also considered a central measurement. However, studies of the nose sensor were conducted
      in healthy subjects or during anesthesia care over several hours. Therefore, research is
      needed to examine the accuracy of the nose sensor in the ICU patient population. In addition,
      due to concerns for sensor related pressure ulcers in patients with decreased perfusion, the
      sensor needs to be evaluated for extended periods of time.
    

Intervention name(s): Nasal alar oxygen sensor
Intervention type(s): Device
Intervention description(s): Application of a nasal alar oxygen sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to validate that the device posts a Sensor-Off message within
      the time frame stated in the proposed claims.
    


Intervention name(s): Nellcor USB Pulse Oximeter Monitor Interface Cable
Intervention type(s): Device
Intervention description(s): Volunteers are subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature. Such conditions include exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Focus of Study: Healthy Volunteers
Relative Bioavailability of Three Oral Formulations Candidates of Rilpivirine for Potential Pediatric Use Compared to Oral Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of rilpivirine in
      healthy adult participants following: 1) administration of a single dose of two different
      oral dispersible tablet formulation candidates and of an oral granules formulation with that
      following administration of a single dose of the 25-milligram (mg) oral tablet (EDURANT),
      after a standardized breakfast; 2) administration of a single dose of one selected oral
      formulation candidate (a dispersible tablet or granules) in different fed conditions
      (standardized breakfast or yoghurt) and in the fasted state and breakfast and 3)
      administration of a single dose of one selected oral formulation candidate (a dispersible
      tablet or granules) dispersed in water or in orange juice, in fed condition (standardized
      breakfast).
    

Detailed description: 
      This is a Phase 1, open-label, randomized, 2-panel, 4-way crossover study in healthy adult
      participants to assess the relative bioavailability of rilpivirine following single dose
      administration of oral pediatric formulation candidates (two dispersible tablet formulations
      and one granules formulation), compared to the commercially available 25-mg tablet (EDURANT)
      and to assess the effect of food and different food constituents on the oral bioavailability
      of rilpivirine following single dose administration of one selected formulation candidate.
      The study will consist of 2 panels: Panel 1 and Panel 2. In each panel, participants will be
      randomized to receive treatment A, B, C, D and E, F, G, H, respectively. Pharmacokinetic
      parameters will be evaluated primarily. Safety will be monitored throughout the study.
    

Intervention name(s): Rilpivirine Oral Tablet; Rilpivirine formulation G007; Rilpivirine formulation G009-01; Rilpivirine formulation G002; Standardized Breakfast
Intervention type(s): Drug; Drug; Drug; Drug; Dietary Supplement
Intervention description(s): Rilpivirine formulated as 25 mg oral tablet.; Rilpivirine G007 formulation as 10*2.5 mg tablets.; Rilpivirine G009-01 formulation as 10*2.5 mg tablets.; Rilpivirine G002 formulation as 10 g of 2.5 milligram per gram (mg/gm) granules.; It will consist of (or its equivalent) 4 slices of bread, 2 slices of ham and/or cheese, butter, fruit preserve and 1 or 2 cups (up to 480 milliliter [mL]) of decaffeinated coffee or decaffeinated tea with milk and/or sugar, if desired (containing approximately fat: 21 gram (gm), carbohydrates: 67 gm, proteins: 19 gm; calories 533 kilocalorie (kcal) [189 kcal from fat, 268 kcal from carbohydrates, and 76 kcal from proteins]).
Other intervention name(s): Edurant
Intervention MeSH terms: Rilpivirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; EUDRANT; Rilpivirine
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Pediatric
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety,
      tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia
      or schizoaffective disorder.
    


Intervention name(s): Lumateperone 42 mg; Lumateperone 28 mg
Intervention type(s): Drug; Drug
Intervention description(s): Lumateperone 42 mg, oral administration; Lumateperone 28 mg, oral administration
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EYP001a Food Effect Study in Subjects With Chronic Hepatitis B Virus (HBV) Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids
      pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of
      hepatitis B.

      This Phase 1 study is designed primarily to assess Pharmacokinetics (PK) under fed and fasted
      conditions, and to assess the safety, tolerability and Pharmacodynamics (PD) of single oral
      doses of EYP001a in subjects with chronic HBV infection.
    

Detailed description: 
      This is a single-center, open-label, randomized, 4-way crossover study.

      A total of 14 chronic HBV subjects will participate. Subjects will receive 4 single dose
      administrations of EYP001a during the study. There will be 2 separate dosing periods: 1
      period with 2 single administrations of EYP001a in the morning, once under fasted conditions
      and once under fed condition (separated by 48.5 hours), and 1 period with 2 single
      administrations of EYP001a in the evening, once under fasted conditions and once under fed
      condition (separated by 48.5 hours).

      The subjects will be randomized to 1 of 4 treatment sequences:

        -  Sequence 1: Period 1 first dose morning fasted, second dose morning fed; Period 2 first
           dose evening fasted, second dose evening fed.

        -  Sequence 2: Period 1 first dose evening fasted, second dose evening fed; Period 2 first
           dose morning fasted, second dose morning fed.

        -  Sequence 3: Period 1 first dose morning fed, second dose morning fasted; Period 2 first
           dose evening fed, second dose evening fasted.

        -  Sequence 4: Period 1 first dose evening fed, second dose evening fasted; Period 2 first
           dose morning fed, second dose morning fasted.

      Participation will include an eligibility screening period of maximally 40 days, clinic stay
      during the treatment periods, and a followup visit 4 to 6 days after the last study drug
      administration.

      The safety and tolerability of EYP001a will be assessed by evaluating vital signs, ECGs,
      liver ultrasound, clinical laboratory and adverse events.
    

Intervention name(s): EYP001a
Intervention type(s): Drug
Intervention description(s): Oral EYP001a capsules - 100 mg strength
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The subjects will be randomized to 1 of 4 treatment sequences.
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
Condition: Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose
      levels study in healthy Caucasian and Japanese male volunteers.

      Following a 4-week screening period, eligible male subjects will be stratified by ethnic
      group and will be randomized to one of six groups. On dosing day, designated as Day 1, each
      subject will receive single SC injection of study medication according to group allocation
      and will be followed up for a month for safety monitoring.
    


Intervention name(s): MOD-4023; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Rescue Intracranial Stenting in Acute Ischemic Stroke
Condition: Acute Stroke; Ischemic Stroke; Intracranial Atherosclerosis; Stent Stenosis; Cerebral Ischemia; Stent Occlusion; Stroke, Ischemic; Intracranial Hemorrhages; Thrombotic Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Intracranial Hemorrhages; Brain Ischemia; Intracranial Arteriosclerosis; Thrombotic Stroke; Atherosclerosis; Ischemia; Hemorrhage
Study type: Interventional

Summary: 
      In acute ischemic stroke caused by intracranial large vessel occlusion, rescue intracranial
      stenting has been recently a treatment option to achieve recanalization in patients with the
      failure of mechanical thrombectomy. Nevertheless, there are few studies supporting this
      beneficial treatment in two cerebral circulations. We aimed to analyse whether the use of
      rescue intracranial stenting would improve prognosis of patients at 3 months.
    

Detailed description: 
      In Asia population, large intracranial arterial stenosis lesion accounts for more than 30% in
      common causes of ischemic stroke, compares with about 10% in Caucasian population every year.
      Normally, in human brain, there are about 130 billion neurons but they are lost equivalent to
      their losses in approximately 3.6 years of normal aging in case of a large vessel ischemic
      stroke untreated each hour. Consequently, after the success of 5 randomized controlled trials
      about the mechanical thrombectomy, which have been done from December 2010 to December 2014,
      all of guidelines recommended this technique as the first-line treatment in acute ischemic
      stroke. However, the HERMES meta-analysis showed that revascularisation failure ratio 28.9%
      in patients older than 80 years. Recently, in case of mechanical thrombectomy failure, many
      studies suggested the rescue intracranial stenting could be alternative urgently needed
      treatment to achieve permanent recanalization which is one of the most important factors
      impacting on clinical outcomes after acute ischemic stroke. Hence, the aims of our study were
      to assess both the "non-poor" outcome at 3 months and the symptomatic intracerebral
      hemorrhage relating to procedure in patients receiving rescue intracranial stenting.
    

Intervention name(s): Rescue intracranial stenting
Intervention type(s): Procedure
Intervention description(s): Rescue Intracranial Stenting in Acute Ischemic Stroke caused by intracranial large vessel occlusion
Other intervention name(s): RIS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute ischemic stroke; Rescue intracranial stenting; Symptomatic intracerebral hemorrhage; MRI 3 Tesla; Rehabilitation