bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with
      carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer,
      and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency
      of neo-adjuvant chemotherapy.
    


Intervention name(s): carboplatin+ paclitaxel; paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): carboplatin AUC 2mg/mL*min/week, 3 week cycle up to 4 cycles; paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles; paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Other intervention name(s): A; B
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antidepressant Use During Pregnancy
Condition: Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      This study will determine the safety of antidepressant use during pregnancy for both the
      mother and the child.
    

Detailed description: 
      Symptoms of major depressive disorder (MDD) include persistent sad mood, feelings of
      hopelessness or guilt, decreased energy, irritability, and more. If untreated, MDD can
      interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities.
      MDD occurs most commonly in females between the ages of 25 and 44. This puts women of
      childbearing age at a particularly high risk for developing the disorder. However, very
      little research has been done to determine the safety of antidepressant use during pregnancy
      and how the medication may affect the baby. This study will determine the safety of
      antidepressant use during pregnancy for both the mother and the child.

      Participants in this observational study will not receive medication or treatment of any
      kind. Pregnant woman who are already taking medication for depression will be recruited, in
      addition to pregnant women who are not taking any medication. The participants will first
      undergo interviews to establish their psychiatric diagnoses. Subsequent interviews will be
      held to monitor levels of depressive symptoms, exposure to other substances that could
      potentially harm the fetus, levels of antidepressants in the blood, and dietary intake during
      pregnancy. Participants will report to the study site for these evaluations at Weeks 20, 30,
      and 36 of pregnancy. From Week 36 to Week 40, interviews will be conducted over the phone.

      At birth, cord blood will be collected and the infant's cries will be recorded. The infant's
      development will be assessed at 2 weeks and 3, 6 ½, 12, 18, and 24 months postpartum. Mothers
      who take selective serotonin reuptake inhibitors (SSRIs) and are breastfeeding their children
      will report to the study site with their children at 1 month postpartum to measure the level
      of SSRIs in the infant's blood. In addition, digital photographs of the infant's face,
      profile, hands, and torso will be taken at 2 weeks and 3, 12, and 24 months postpartum.
      Additional face-only photographs of the infant will be taken at these times and at birth for
      further in-depth analyses of facial characteristics. Mother-child interactions will be
      videotaped at all postpartum assessments.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with or without active depression and with or without SSRI use in pregnancy
      
Keywords: SSRI Exposure; Pregnancy; Infant Development
Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia
Condition: Hemodynamic Instability
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the maternal cardiac output response to rescue
      norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients
      with preeclampsia undergoing cesarean section.
    

Detailed description: 
      Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and
      neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with
      exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia
      are apparently higher than healthy parturients, placental hypoperfusion is more common.
      Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia
      for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous
      blood flow (provided that hypotension is avoided) which contribute to increase placental
      perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia
      hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a
      potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction
      for use in parturients undergoing cesarean section. However, hemodynamic effects of the
      rescue norepinephrine bolus is still unknown. The purpose of this study is to investigate the
      maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for
      postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean
      section.
    

Intervention name(s): Phenylephrine; Norepinephrine
Intervention type(s): Drug; Drug
Intervention description(s): A rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia; A rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia
Other intervention name(s): Vasopressors; Vasopressors
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine; Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Cardiac output response; Norepinephrine; Phenylephrine; Preeclampsia; Cesarean section
Treatment of Osteoporosis - TOP1 Clinical Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      This study investigates the effect of zeolite on bone mineral metabolism. The clinical
      parameters include bone mineral density, bone remodelling markers, fractures and fallings,
      the subjective evaluation of the overall health status and intensity of the musculoskeletal
      pain measured by VAS.
    

Detailed description: 
      Randomized, placebo-controlled, double-blind study. The Study lasts 12 months. Study
      Population: The study population will consist of 100 patients with osteoporosis defined
      according BMD (bone mineral density) criteria: T score -2, 5 on the femoral neck, and, or T
      -2, 5 on L1-L5, who has not been treated before, or in whom privies treatment did not been
      successful, despite a gender or age. Subjects will be randomized in each cohort to receive
      PMA-zeolite (Panaceo) or placebo (1:1). All of them will receive Vit D3 800 j daily.

      The double blind design can be reached by a "third party blinding" where a qualified person,
      not being involved in the assessment of the study, will administer the study treatment.

      Follow up DXA, Ca, P, ALP, Osteocalcin, Cross laps, Creatinin will be done to each subject
      before the treatment, 6 months later and after 12 months. IVA (vertebral deformity
      assessment) will be performed before the treatment and after 12 months.
    

Intervention name(s): zeolite; cellulose
Intervention type(s): Device; Device
Intervention description(s): given for a period of 12 months; given for a period of 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The clinical study is a randomized, double-blinded, controlled study aimed to assess the effect of zeolite-intervention in osteoporotic patients on the bone mineral density and bone turnover in comparison to osteoporotic patients control group that received the placebo over a period of for 12 months. The study population will consist of 100 patients with osteoporosis defined according BMD criteria: T score -2, 5 on the femoral neck, and, or T -2, 5 on L1-L5, who have not been treated before, or in whom privies treatment did not been successful, despite a gender or age. The Panaceo and Placebo groups will be divided into 50 and 50 patients.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to establish the bioequivalence of two different
      tablet formulations containing BAY77-1931. The secondary objectives of this study were to
      assess the safety and tolerability, as well as to Investigate the plasma lanthanum
      concentration after BAY 77-1931 ODT 500 mg administration.
    


Intervention name(s): Fosrenol ODT (Lanthanum Carbonate, BAY77-1931); Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)
Intervention type(s): Drug; Drug
Intervention description(s): Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID; Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 4

Summary: 
      Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is
      the most common indication for heart transplantation worldwide. Despite advances in medical
      and device therapy, the 5-year mortality of patients with DCM remains high.

      Patients diagnosed of dilated cardiomyopathy with a NYHA functional class of II to IV and
      left ventricular ejection fraction(LVEF) <35% were selected for randomized controlled study
      of the efficacy and safety of high dose Renin-angiotensin system (RAS) inhibitor (benazepril
      or valsartan), in comparison with low dose RAS inhibitor(benazepril or valsartan) and
      standard beta-adrenergic blocker therapy (metoprolol). The primary endpoint was all cause
      death or admission for heart failure. Additional prespecified outcomes included all-cause
      death, cardiovascular death, all-cause admission, heart failure admission. Secondary
      cardiovascular outcomes included the changes from baseline to the last available observation
      after treatment in NYHA functional class, quality-of-life scores, LVEF, LVEDD, mitral
      regurgitation and wall-motion score index assessed by ECG. Adverse events were reported
      during in-hospital observation and follow-ups.
    


Intervention name(s): Benazepril; Valsartan; Metoprolol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metoprolol; Valsartan; Benazepril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dilated cardiomyopathy; High dose ACEI/ARB
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
Condition: Osteoporosis; Spinal Fractures
MeSH terms: Osteoporosis; Spinal Fractures
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated
      autologous bone marrow cells as a new therapy in patients with established osteoporosis by a
      prospective, single-center, open, non-randomized and unblinded clinical trial.
    


Intervention name(s): Fucosylated MSC for Osteoporosis
Intervention type(s): Biological
Intervention description(s): Aproximately 30 days before the infusion of the investigational product, patient bone marrow will be obtained according to standard practice of the Haematology University Hospital Virgen de la Arrixaca (HCUVA).
Mononuclear bone marrow cells will be separated and cultured in GMP conditions to purify and obtain mesenchymal cell established dose range. The infusion day BM-MSCs will be fucosylated and resuspended in saline to a concentration of 5 million cells per 1 mL. Then, the final product will be packaged in syringes for intravenous administration to patients through a peripheral venous access.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by
      administering sodium nitrite intravenously in healthy volunteers. The accuracy of a
      noninvasive HbMet sensor will be assessed by comparison to blood measurements from a
      laboratory analyzer.
    


Intervention name(s): Rainbow Universal Pulse Oximeter Sensor
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

      The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog
      beta pegol) during surgical procedures in patients with haemophilia B.
    


Intervention name(s): nonacog beta pegol
Intervention type(s): Drug
Intervention description(s): The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).
Other intervention name(s): NNC-0156-0000-0009
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Parental Permission and Adolescent Assent and Decision-Making in Clinical Research
Condition: Adolescents
Study type: Observational

Summary: 
      This study will evaluate how adolescents enrolled in clinical research and their parents:

        -  Understood the study information presented before they agreed to participate

        -  Made decisions about enrolling in the study

        -  Experienced the process of assent and consent

        -  Perceive the experience of participating in research

      The study will determine how adolescents and their parents evaluate risk and benefit, what
      information they use in making their research enrollment decisions, and how these decisions
      are made.

      In recent years the medical community and the federal government have increasingly recognized
      the need to conduct pediatric research. Several initiatives have resulted in an expanding
      number of studies that include children. With more pediatric research comes the need to
      ensure that protections for the rights and safety of children enrolled in research are
      performing well.

      Adolescent patients between 13 and 18 years of age who are enrolled in a research study at
      the NIH involving cancer, diabetes mellitus, vaccines, obesity, bipolar disorder, and HIV, as
      well as healthy adolescent controls, may be eligible. One parent of each adolescent also
      participates.

      Participants are interviewed at the NIH Clinical Center. Each interview will last about 30
      minutes and consists of questions in the following areas:

        -  Demographics (age, sex, ethnicity, education, socioeconomic status, etc.)

        -  Brief medical history of the adolescent

        -  Experience and satisfaction with the parental permission/assent process

        -  Motivations for participating in clinical research

        -  Decision-making process

        -  Willingness to accept certain types and levels of hypothetical risks in a study,
           including those of side effects and invasive procedures

        -  Willingness to enroll with different chances of possible benefit

        -  Comparison with other activities

        -  General understanding of research
    

Detailed description: 
      This study aims to better understand how adolescents enrolled in clinical research and their
      parents understood the study information presented, made decisions about enrolling,
      experienced the process of assent and consent, and perceive the experience of participating
      in research. Interviews will be conducted with adolescents participating in clinical research
      and with one of their parents. Adolescents with a number of disorders including cancer,
      chronic diseases, bipolar disorder, obesity, and HIV, as well as healthy controls who are
      enrolled in NIH intramural protocols will be interviewed.
    

Time perspective: Prospective
Keywords: Assent; Adolescent; Informed Consent
Dose Linearity Study of Codeine Sulfate Under Fasted Conditions
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg,
      30 mg, and 60 mg codeine sulfate tablets under fasted conditions
    


Intervention name(s): Codeine Sulfate
Intervention type(s): Drug
Intervention description(s): 15 mg, 30 mg, and 60 mg tablets
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pivotal Study for the FLAIR Endovascular Stent Graft
Condition: Stenoses
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients
      with stenoses at the venous anastomosis of a synthetic AV access graft.
    

Detailed description: 
      A total of 227 patients were treated at 16 U.S. investigational sites to evaluate the safety
      and effectiveness of the FLAIR™ Endovascular Stent Graft. This study compared the FLAIR™
      Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous
      anastomosis of a synthetic AV access graft.
    

Intervention name(s): FLAIR Endovascular Stent Graft; PTA; FLAIR Endovascular Stent Graft
Intervention type(s): Device; Procedure; Device
Intervention description(s): Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft; Percutaneous Transluminal Angioplasty; Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
Other intervention name(s): Flair; Stent Graft; Flair; Stent Graft; Flair; Stent Graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Vascular Prosthesis; stenoses; grafts
Prevention of Neurosurgical Wound Infections
Condition: Surgical Wound Infections
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      The goal of this study is to determine whether injecting the antibiotic vancomycin directly
      into surgical wounds can decrease the rate of infection following implantation of
      neurosurgical devices.
    


Intervention name(s): Vancomycin; Placebo (Saline Solution)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.; Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Infection; Vancomycin; Neurosurgery; Stimulator; Pump; Deep Brain Stimulation; Intrathecal Pump
Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Condition: Pregnancy
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The purpose of this study was to assess the effectiveness of a moderated physical exercise
      program called Blooming Exercise Program (BEP) developed during pregnancy in order to control
      excessive maternal weight gain and its consequences. Additionally, other objectives of the
      study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy
      outcomes and on the perception of the pregnant's health
    

Detailed description: 
      BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular,
      an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i)
      different alterations during pregnancy such as gestational diabetes or hypertension, (ii)
      foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour
      and increased number of caesareans) and (iv) future health disorders for the woman
      (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic
      floor health problems, such as urinary incontinence (IU) may arise or worsen.

      OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical
      exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order
      to control excessive maternal weight gain and its consequences. Additionally, other
      objectives of the study were to analyse the influence of BEP on urinary incontinence, on the
      other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's
      health.

      DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women
      were recruited and divided into an intervention group (IG, n=100) and a control group (CG,
      n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions
      through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program
      addressed to pregnant women but received regular health care. Pregnancy outcomes regarding
      the mother and the new born, urinary incontinence and women's habits data were obtained and
      registered through initial interviews, medical records and two specific questionnaires on
      health and urinary incontinency (ICIQ-SF and King's).
    

Intervention name(s): Supervised exercise program
Intervention type(s): Behavioral
Intervention description(s): Intervention group participated in Blooming Exercise Program as from week 10-12 of gestation. At least 56 sessions through 22 weeks. 3 sessions per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregnancy; Exercise; Excessive weight gain; Outcomes; Urinary incontinence