bioihbjkbjnl/mcl2 huggingface dataset:
Gene Expression in Cumulus Cells to Predict Pregnancy
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine the performance of a genetic assay, GemART, in
      cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in
      vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as
      measured by the implantation rate of embryos transferred.
    


Intervention name(s): Morphology; GemART assay
Intervention type(s): Other; Other
Intervention description(s): Embryos selected for transfer will be based upon morphology alone.; Embryos selected for transfer will be based upon morphology and GemART assay.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: In vitro fertilization; Assisted reproduction; pregnancy outcome; cumulus cells
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid
      intima-media thickness in postmenopausal women with moderate hypercholesterolemia.
    


Intervention name(s): Echographic measurements; Blood samples
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but
      severe side effects to the treatment is thrombosis in or outside the central nervous system.

      The aim of this study is to investigate and describe the influence on the coagulation
      parameters during prolonged treatment with asparaginase.

      Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it
      possible to prevent these.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and young adults (age 1-17.9 years) newly diagnosed with ALL in the Nordic
        Countries and treated according to the Nordic ALL-protocol NOPHO ALL-2008.

        Written informed consent has been obtained
      
Keywords: ALL; PEG-asparaginase; prolonged treatment; Thrombosis; Central venous line; Echocardiography
Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg,
      200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days,
      in patients with uncomplicated, smear-positive pulmonary TB.

      The four OPC-67683 treatment groups will comprise 12 patients each and the one standard
      therapy (Rifafour e-275) group six patients.

      Trial 242-06-101 is an exploratory and not a confirmatory trial and as such no hypothesis
      will be tested statistically.

      The control group, six patients treated with Rifafour, will serve as an control to confirm
      the microbiological assessments during the trial.
    


Intervention name(s): OPC-67683; Rifafour e-275
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Cleft Prevention Program
Condition: Cleft Lip; Cleft Palate
MeSH terms: Cleft Palate; Cleft Lip
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception
      and during the first three months of pregnancy decreases the risk of having a child with
      cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have
      had previously child with an oral cleft.
    

Detailed description: 
      Cleft lip and palate is a common and burdensome birth defect that has large health
      ramifications and requires surgical, speech, behavioral, dental, and medical interventions.
      There is some evidence suggesting that taking folic acid particularly at large doses during
      preconception and first trimester of pregnancy may decrease the risk of oral cleft
      recurrence, which is the risk of having a child with an oral cleft for women who have an oral
      cleft or who have had a child with a cleft. However this evidence is based on study designs
      that are incapable of contributing the preventive effects to folic acid with adequate
      confidence, and the real effect of folic acid on cleft recurrence prevention remains to be
      identified. Taking 4 mg of folic acid per day at preconception and first trimester of
      pregnancy has also been shown to prevent the recurrence of neural tube defects by up to 70%,
      providing further support to evaluate this intervention for oral cleft recurrence.

      This study evaluates the effects of supplementation with 4 versus 0.4 mg of folic acid per
      day at preconception and during the first three months of pregnancy on recurrence of cleft
      lip and palate. Up to 6000 women will be randomly assigned to 4 versus 0.4 mg groups. The
      primary aim is to compare the recurrence rates in the offspring of trial mothers in the two
      groups. Secondary aims are to compare the two groups on several outcomes including
      miscarriage, twinning, pre-eclampsia, serum and red cell folate levels, severity of oral
      clefts and occurrence of other birth defects in the offspring of trial mothers, and birth
      weight and gestational age of trial babies, and to compare the recurrence in the two groups
      to that in historic controls.
    

Intervention name(s): Folic acid: 4 mg versus 0.4 mg per day
Intervention type(s): Drug
Intervention description(s): Folic acid
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Reducing Colorectal Cancer Death Through Mailed Outreach Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The main study aim is to develop, implement and disseminate a pilot population-based mailed
      FIT outreach screening program in the Philadelphia VA Medical Center that does not rely on
      having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic
      randomized trial to (1) Compare the effects of usual care (UC), screening invitation +
      reminder (invitation-reminder), or screening invitation + mailed FIT kit + reminder
      (mailed-FIT); (2) Explore whether the FIT completion rate varies by age or race/ethnicity;
      and (3) Explore barriers to use of mailed outreach screening for Veterans.
    

Detailed description: 
      This study seeks to establish the foundation to systematically study and improve the delivery
      and effectiveness of colorectal cancer (CRC) screening in the VA by developing, implementing
      and disseminating a pilot mailed-FIT screening outreach program that does not rely on having
      a clinical office visit. The investigators specifically address the need to identify and
      remediate potential failures to identify and offer screening to eligible Veterans through
      multilevel interventions. The investigators will also create electronic data linkages to, in
      future studies, enable evaluation of FIT performance characteristics and help close critical
      evidence gaps for optimizing screening among Veterans. As this is a pilot study, the focus is
      to assess feasibility of a population-based screening outreach approach through the
      development, implementation and dissemination of a mailed FIT outreach program in the
      Philadelphia VA Medical Center that does not rely on having an office visit.
    

Intervention name(s): Mailed-FIT; Screening invitation-reminder
Intervention type(s): Other; Other
Intervention description(s): The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. Specimens will be analyzed according to manufacturer's instructions to minimize potential degradation of hemoglobin. Results are provided as positive if the hemoglobin concentration is 100ng/dL. The machine records (but does not report) the quantitative results of the hemoglobin concentration in the sample, which we will seek to obtain from the laboratory for future studies.; These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm
Other intervention name(s): Fecal Immunochemical Test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Study the Effects of CYP2C Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide
Condition: Healthy
Study type: Observational

Summary: 
      The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on
      the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.
    

Detailed description: 
      Compared with CYP2C19, CYP2C9 polymorphism appears to have a dominant role in glipizide
      pharmacokinetics and pharmacodynamics in vivo. This indicated that dose adjustment based on
      CYP2C9 genotype may improve antidiabetic treatment.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male Chinese subjects with different geontype of CYP2C9 and CYP2C19 were enrolled in this
        study. They are divided into three groups by different geontype.
      
Biospecimen description: 
      The whole blood samples of each person are stored at -80℃.
    
Keywords: genotype
Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy
Condition: Idiopathic Intracranial Hypertension (IIH)
MeSH terms: Intracranial Hypertension; Pseudotumor Cerebri; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and
      is associated with headache and loss of vision. The medical and surgical management of IIH is
      problematic and many patients are not treated effectively. Some cases of IIH are associated
      with severe stenosis of the large veins of the brain and various researchers have recently
      reported significant improvement in patients with IIH after the narrow veins of the brain
      were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of
      venous sinus stenting in patients with severe IIH refractory to medical management.
    


Intervention name(s): Venous Sinus Stenting
Intervention type(s): Device
Intervention description(s): Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
Condition: Prophylaxis Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is
      to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate
      vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant; Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Herpes simplex; Herpes simplex vaccine
Observational Study in Preterm Infants With Intracranial Hemorrhage
Condition: Intracranial Hemorrhage; Intraventricular Hemorrhage; Cerebral Hypoxia
MeSH terms: Intracranial Hemorrhages; Hypoxia, Brain; Hemorrhage; Hypoxia
Study type: Observational

Summary: 
      Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can
      have considerable effects on neurodevelopmental outcome.

      The investigators showed that preterm infants with severe ICH have decreased cerebral
      oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of
      decreased cerebral oxygenation in preterm infants and the effects on cerebral function are
      unknown.

      This longitudinal observation study will evaluate physiologic parameters to determine trends
      in cerebral oxygenation and function in preterm infants with ICH in comparison to infants
      without ICH.
    


Intervention name(s): No intervention/treatment is given
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants admitted to the newborn intensive care unit at Holtz Children's Hospital of
        the Jackson Memorial Hospital/University of Miami Medical Center.
      
Keywords: Premature infants; Intracranial hemorrhage; Intraventricular hemorrhage; Cerebral oxygenation; Brain function; Cerebral perfusion
Comparison of Anwar and Melles Techniques in Deep Anterior Lamellar Keratoplasty (DALK) for Keratoconus Patients
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      This study will be performed on patients who come to labbafinejad ophthalmic clinic from 20
      March 2008. Keratoconus diagnosis will be determined by clinical finding in slit lamp,
      keratometery and topographic characteristics. Patients will be randomly placed in group A and
      B. In group A, Anwar surgical method and in B, Melles surgical method, will be done. This is
      not a blind study due to surgeons' knowledge. All patients will receive Btamethazone drop and
      Chloramphenicol every 6 hours and will be tapered in two months. In the end anatomical
      results, complications, BCVA, UCVA, astigmatism, endothelial cell numbers will be compared in
      two groups by using specular microscopy. Contrast sensivity, central corneal diameter,
      interface wrinkling and opacity will be measured by metrovison, Confoscan, Photoslit in
      months 3, 6, 12, respectively and will be evaluated afterwards.
    


Intervention name(s): Anwar; Melles
Intervention type(s): Procedure; Procedure
Intervention description(s): Anwar surgical method; Melles surgical method
Keywords: Anwar; Melles; Keratoconus
A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      - To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of
      XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive
      weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment
      cycle).

      Secondary Objectives :

        -  To define the safety profile of the drug

        -  To establish the recommended dose and time interval for future Phase II trials

        -  To determine the pharmacokinetic (PK) profile of XRP6258 in man

        -  To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose
           (following Protocol Amendment No. 2)

        -  To look for evidence of antitumor activity
    

Detailed description: 
      The duration of the study will include the following periods:

        -  Pretreatment: 28 to 7 days before first infusion

        -  Treatment: Weekly for the first four consecutive weeks during 5-week treatment cycle

        -  Post-treatment: 3 - 4 weeks after last infusion.

      Treatment may be continued until disease progression or unacceptable toxicity or patient
      refusal.
    

Intervention name(s): Cabazitaxel (XRP6258)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: infusion solution Route of administration: Intravenous
Other intervention name(s): Jevtana
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prestudy: Lifestyle and Cardiovascular Disease
Condition: Obesity; Diabetes Mellitus; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this pilot study is to optimize conditions for a planned human intervention
      study focusing on how diet predispose for, and influence, lifestyle disease development and
      its consequence in cardiovascular disease development.
    

Detailed description: 
      Common for many of the risk factors of lifestyle diseases is that they are induced by
      improper diet. Recent research has shown that especially total amount and composition of the
      macro nutrients, protein, carbohydrate and fats, is important.

      A time course experiment has been performed where 5 subjects underwent a diet intervention
      for four weeks with a controlled, balanced macro nutrient energy content of every meal. The
      sampling time points were 0, 1, 2, 7, 14 and 28 days. The goals were to determine optimal
      length of intervention with stabilization of gene expression to occur and compare blood and
      subcutaneous abdominal fat tissue as source of biological material for RNA for DNA microarray
      analysis. Microarray analysis were performed on 3 of the 5 subjects.
    

Intervention name(s): Balanced macronutrient diet intervention
Intervention type(s): Other
Intervention description(s): Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.
Other intervention name(s): Microarray study of diet intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dietary Intervention; Nutrigenomics; Diet, Carbohydrate-Restricted; Gene Expression; Gene Expression Profiling; Oligonucleotide Array Sequence Analysis; Biological Markers; Food; Obesity; Blood; Subcutaneous Fat, Abdominal
Resistance Training to Improve Physical Function in the Elderly
Condition: Physical Function
Study type: Interventional

Summary: 
      The primary purpose of this study is to examine the effectiveness of the current resistance
      training guidelines for older adults proposed by ACSM/AHA to improve physical function in
      individuals with reduced physical abilities. A randomized controlled intervention trial will
      be used to compare change in physical function pre- and post-intervention between a treatment
      group receiving the minimum recommendations of the guidelines and a control group asked not
      to change their physical activity participation. To better understand the clinical
      significance of such an occurrence, a secondary purpose was to determine if older adults with
      reduced physical abilities who adhere to the recommended intervention dosage will experience
      a change such that they can be reclassified to a more favorable level of functioning. It is
      hypothesized that the minimum recommended dosage of the guidelines would be sufficient to
      both improve physical function and improve functional classification in older adults with
      reduced physical abilities.
    


Intervention name(s): RT
Intervention type(s): Behavioral
Intervention description(s): 8 week RT Intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Resistance Training; Physical Function; Older Adults
Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic
      acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female
      subjects ages 12-16 years with heavy menstrual bleeding.
    


Intervention name(s): tranexamic acid
Intervention type(s): Drug
Intervention description(s): Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.
Other intervention name(s): Lysteda; modified-immediate release tranexamic acid
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Cyclic Heavy Menstrual Bleed; Menorraghia
A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
      evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of
      participants to achieve lower daily doses of OCS, among those with severe
      corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed.
      Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a
      double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may
      continue into a 32-week active treatment extension (ATE) period, during which all
      participants will receive lebrikizumab treatment. Following completion of the ATE period,
      participants who have both tolerated and derived benefit from treatment with lebrikizumab may
      continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants
      will transition to 24 weeks of safety follow-up upon discontinuation of study drug.
    


Intervention name(s): Lebrikizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.; Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
Other intervention name(s): RO5490255
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment