bioihbjkbjnl/mcl2 huggingface dataset:
COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal
MeSH terms: Pneumonia; Streptococcal Infections; Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study in a large number of healthy children less than 3 years old to measure the
      efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate
      vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection)
      likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of
      otitis media (ear infection) in children under 3 years old.
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007. The following vaccines will be offered by the sponsor:

        -  Two doses of hepatitis A vaccine will be offered to all subjects to comply with national
           recommendations.

        -  NeisVac-C vaccine against Neisseria meningitis group C will be offered to all subjects
           in Argentina at 12 months of age.

        -  Varicella vaccine will be offered to all subjects in Colombia and Panama at 12 months of
           age.

        -  Two doses of Rotarix vaccine will be offered to all subjects in Colombia within the
           first six months of life.

      In addition, all subjects will receive a dose of Hepatitis B vaccine at birth according to
      national recommendations and a dose of measles, mumps and rubella (MMR) vaccine at 12 to 15
      months of age according to local Extended Program of Immunization (EPI) .

      These vaccines will not be provided by the sponsor. The protocol posting has been updated
      according to the amendment of the protocol dated 25 Nov 2008. The protocol posting has been
      updated according to the amendment of the protocol dated 14 December 2009. The protocol
      posting has been updated according to the amendment of the protocol dated 09 September 2010.
    

Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; Havrix; Engerix-B; Infanrix hexa; GSK Biologicals' DTPa-IPV/Hib vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 4 doses; Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group; Intramuscular injection, 3 doses; Intramuscular injection,3 doses; Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group
Other intervention name(s): Hepatitis A vaccine; Hepatitis B vaccine; DTPa-HBV-IPV/Hib
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Otitis media; Pneumonia; Community acquired pneumonia (CAP); Pneumococcal disease; Booster vaccination; Immunogenicity; Pneumococcal vaccine; Safety; Efficacy; Carriage
Events Before Death
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      Previous studies of the patients treated in RRI clinics suggest that hemodialysis patients
      undergo a certain consistent predictable pattern at the initiation of dialysis and before
      death. This pattern can be described as a group of patterns of patients' biological markers
      over a few months after starting dialysis and several months prior to death. Additional
      patterns can be observed that occur with changes in seasons or time of day. The aim of this
      study is to compare these patterns in patients treated in FMC-Asia, FMC-Europe, FMC-South
      America, and RRI-US populations. Noting that patterns in patient parameters are similar
      across continents, climates, and geographic variations only further accentuates the
      importance in the models that can predict patients' survival and provide an opportunity for
      timely intervention.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Hemodialysis patients
Calcium for Prevention of Ovarian Hyperstimulation Syndrome
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous
      calcium is a novel protocol. But still there is lack of evidence of it is real effect in
      prevention of OHSS & the mechanism of its action is still questionable . In the study the
      investigators try to search for the evidence for its effect & the real mechanism for its
      action.
    

Detailed description: 
      The study population will be divided into 2groups each containing 100 infertile couples
      candidate for ICSI.

      Group (A)active group: administration of 10% Intravenous calcium gluconate 10 ml in 200 mL of
      physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup.
      Intravenous infusion was performed within 30 minutes.

      Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup,
      day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30
      minutes
    

Intervention name(s): calcium; 0.9 % saline
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group.
Intravenous infusion was performed within 30 minutes; 0.9 % saline intravenous infusion
Other intervention name(s): Calcium intravenous infsuion
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: OHSS; ICSI; calcium injection
A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC)
      with regional lymph node metastasis is still in the area of controversy. The aim of this
      study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional
      5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with
      regional lymph node (LN) metastasis.
    


Intervention name(s): mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin )
Intervention type(s): Drug
Intervention description(s): Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, which is repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.
Intervention MeSH terms: Leucovorin; Folic Acid; Fluorouracil; Oxaliplatin; Levoleucovorin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing
      altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung
      disease travelling from 760 m to 3200 m.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy
      of acetazolamide prophylaxis in reducing the incidence of altitude related adverse health
      effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease travelling to
      altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by
      car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days.
      Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and
      during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

      An interim analysis will be carried out when 90 patients will have completed the study or
      after the first year. The Peto's method will be used to correct the P-values.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: airway disease; bronchitis; emphysema; altitude; prevention; acetazolamide
FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, open-label, randomized, phase III trial. Patients will be stratified
      after breast surgery, as per investigational site; menopausal status; node negative
      diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status
      (positive versus negative).
    

Detailed description: 
      Patients will be randomized to:

        -  Fluorouracil, doxorubicin, and cyclophosphamide (FAC) x 6 (cycles): 5-fluorouracil 500
           mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 6
           cycles.

        -  FAC x 4 (cycles) → Paclitaxel x 8 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50
           mg/m2 + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 4 cycles, followed by 8
           administrations of weekly paclitaxel 100 mg/m2

      Premenopausal women with hormone receptor positive tumors must receive tamoxifen 20 mg daily
      for 5 years, after the end of chemotherapy.

      Postmenopausal women with hormone receptor positive tumors are allowed to receive aromatase
      inhibitors as initial adjuvant hormone therapy or after tamoxifen.

      All patients with breast conservative surgery must receive radiotherapy.

      Estimated 5-year disease-free survival in the control arm (FAC x 6) is expected to be 80%. It
      is expected that disease-free survival will increase by 5% in the experimental arm
      (FAC-paclitaxel). 906 patients per arm must be recruited, to detect this difference with an
      alpha error of 0.05 and 80% power. Assuming a 6% post-randomization drop-out rate, 960
      patients per arm are needed, 1920 in total.
    

Intervention name(s): Fluorouracil; Doxorubicin; Cyclophosphamide; Paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Arm A: FAC Arm B: FAC-wP; Arm A: FAC Arm B: FAC-wP; Arm A: FAC Arm B: FAC-wP; Arm B: FAC-wP
Other intervention name(s): Adrucil; Caelyx; Cytoxan; taxol
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Node negative, high risk breast cancer.; Prognostic gene profile.; Saint Gallen high risk criteria.; Weekly paclitaxel.
Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, randomized, double-blind, placebo-controlled, single ascending dose
      study, in which the safety and pharmacokinetics of laninamivir octanoate administered by
      inhalation via the TwinCaps® DPI will be assessed in adults with mild or moderate chronic
      asthma.
    

Detailed description: 
      32 subjects, as two sequential groups of 16 subjects at each dose level (40 mg and 80 mg),
      will be randomised 3:1 to receive active drug or matching placebo.

      Males and females aged 18 to 65 years inclusive, with mild or moderate chronic asthma.

      Stratum 1: Mild asthma - requiring treatment consistent with Global Initiative for Asthma
      (GINA) Step 2 Stratum 2: Moderate asthma - requiring treatment consistent with GINA Step 3

      Following a screening period of up to 30 days, eligible consenting subjects will be admitted
      to the clinic on the morning of Day 1. Laninamivir octanoate will be administered on Day 1.
      Subjects will remain in the clinic until Day 3 and will return for subsequent outpatient
      visits on Day 5, Day 6 and Day 7. A final follow-up visit for safety evaluations will occur
      on Day 14 ± 1 (or at the time of premature discontinuation). Each subject will participate in
      the study for approximately 7 weeks.
    

Intervention name(s): Laninamivir octanoate
Intervention type(s): Drug
Intervention description(s): 40 mg dose consists of 2 laninamivir octanoate TwinCaps® DPI 80 mg dose consists of 4 laninamivir octanoate TwinCaps® DPI (2 administered 12 hours apart)
Other intervention name(s): CS-8958
Intervention MeSH terms: Laninamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Mild or moderate asthmatics; Adults; Laninamivir
Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA
Condition: Pediatric Obesity; Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of physical exercise, associated or not
      with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper
      airway resistance in obese teenagers. Half of the participants will undergo physical exercise
      and compression socks program, and the other half of subjects will undergo physical exercise
      program without compression socks.
    

Detailed description: 
      Obesity is an important factor of OSA development in children and teenagers, and physical
      activity is a relevant alternative to promote OSA decrease with ou without weight loss.

      Physical activity, beyond the improvement of body composition and exercise cardiorespiratory
      capacity, restricts fluid retaining in the lower limb of the leg by the activation of
      musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid
      shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway
      collapsibility.

      It has been previously shown that venous compression leads to beneficial fluid regulation in
      OSA subjects and appears as an efficient tool in OSA management.

      To the investigators knowledge no study assess the impact of the cumulative effect of
      physical and venous compression program on upper airway resistances in obese teenager with
      OSA.
    

Intervention name(s): Interventional group; Control group
Intervention type(s): Other; Other
Intervention description(s): Venous compression leads to beneficial fluid regulation in OSA participants and appears as an efficient tool in OSA management.
To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.; Standard obesity care with physical activity program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pediatric obesity; obstructive sleep apnea; physical exercise; compression socks; rostral fluid shift
Step Down FSH Approach and Late Follicular Phase in Progesterone Level
Condition: Progesterone Resistance
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Step-down approach and late follicular phase progesterone level
    

Detailed description: 
      The study will be performed using the stimulation medication Gonal-F which is a recombinant
      FSH-preparation. Due to application as pen-device, it allows reduction of the stimulation
      dosage in steps of 12.5IU.

      It is important to evaluate the dynamics of progesterone-rise after final oocyte maturation,
      as this dynamic might also have an influence on the receptivity of the endometrium.
    

Intervention name(s): follicle stimulating hormone
Intervention type(s): Drug
Intervention description(s): Follicle stimulating hormone( will be chosen according to ovarian reserve parameters in the study group the dosage will be reduced in the control group it will remain unchanged
Other intervention name(s): Gonal-F
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometrial receptivity progesterone elevation
Radiation Therapy Using Holmium Ho 166 DOTMP Plus Melphalan and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Radiation therapy using holmium Ho 166 DOTMP may damage cancer cells. Drugs used
      in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
      die. Peripheral stem cell transplantation may be able to replace immune cells that were
      destroyed by chemotherapy or radiation therapy used to kill cancer cells.

      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy using holmium Ho
      166 DOTMP plus melphalan and peripheral stem cell transplantation in treating patients who
      have multiple myeloma.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of targeted radiotherapy using holmium Ho
      166 DOTMP when combined with melphalan and autologous or syngeneic peripheral blood stem cell
      transplantation in patients with multiple myeloma. II. Determine the response rate and time
      to progression in patients treated with this regimen.

      OUTLINE: This is a dose escalation, multicenter study of targeted radiotherapy using holmium
      Ho 166 DOTMP. Phase I: Autologous or syngeneic peripheral blood stem cells (PBSC) are
      harvested and selected for CD34+ cells. Patients receive an initial test dose of holmium Ho
      166 DOTMP IV. Patients with adequate skeletal uptake of the test dose then receive
      therapeutic dose holmium Ho 166 DOTMP IV over 5-10 minutes for 1-3 days beginning 2 days
      after test dose infusion and melphalan IV over 20-30 minutes on day -3. PBSC are reinfused
      beginning a minimum of 24 hours after melphalan infusion and after ongoing radiation to bone
      marrow falls to less than 1 rad/hour. Cohorts of 4-7 patients receive escalating doses of
      targeted radiotherapy using holmium Ho 166 DOTMP until the maximum tolerated dose (MTD) is
      determined. The MTD is defined as the dose preceding that at which 2 of 7 patients experience
      dose limiting toxicity. Phase II: Patients receive holmium Ho 166 DOTMP at the MTD from phase
      I of the study. Patients are followed every 3 months for 1 year.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 1 year.
    

Intervention name(s): melphalan; peripheral blood stem cell transplantation; holmium Ho 166 DOTMP
Intervention type(s): Drug; Procedure; Radiation
Intervention MeSH terms: Melphalan
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans
Condition: Recovery of Lactobacillus Reuteri ATCC PTA 4659; The Safety of Lactobacillus Reuteri ATCC PTA 4659
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a sachet containing Lactobacillus
      Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7,
      14 and 28 days supplementation as well as 14 days wash out compared to the same sachet
      without the probiotic bacteria as placebo control.
    

Detailed description: 
      This study is the first to investigate the relative colonisation of the human GI tract by L
      Reuteri ATCC PTA 4659. Simple demonstration that they survive passage is the first step in
      development of potential new probiotics, which is necessary before these strains can be
      considered for continued testing in probiotic food matrices. The aim of this study will
      evaluate the safety and tolerability of Lactobacillus Reuteri in healthy adult subjects.
    

Intervention name(s): Probiotic strain ATCC PTA 4659
Intervention type(s): Other
Intervention description(s): Placebo control containing no probiotic strain of ATCC PTA 4659 High dose of ATCC PTA 4659 1*10 10 CFU/bag Low dose of ATCC PTA 4659 1*10 8 CFU/bag
Other intervention name(s): ATCC PTA 4659
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Survive; safety; lactobacillus Reuteri