bioihbjkbjnl/mcl2 huggingface dataset:
Local Study of Akatinol Memantine in VaD in Russia
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates the clinical efficacy and safety of Akatinol Memantine 20 mg
      (single-doses) vs. Akatinol Memantine 10 mg (double-doses) in patients suffering from
      moderate and moderately severe vascular dementia.
    


Intervention name(s): Akatinol Memantine 20 mg; Akatinol Memantine 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day; Akatinol Memantine 10 mg to be taken orally, twice daily
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer
Condition: Breast Neoplasms; Heart Injuries; Radiation Toxicity
MeSH terms: Breast Neoplasms; Unilateral Breast Neoplasms; Wounds and Injuries; Heart Injuries
Study type: Interventional

Summary: 
      This study is to prospectively investigate the cardiac dose-sparing effect and clinical
      benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast
      cancer treated with breast conserving surgery followed by radiotherapy is enrolled.
      Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH)
      technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and
      the dose-effect relationship is analyzed.
    

Detailed description: 
      Patients with left-sided breast cancer treated with breast conserving surgery are
      prospectively enrolled. Two types of radiation treatment are delivered based on attending
      physician's preferences: radiation to whole breast +- regional nodal areas with
      free-breathing technique, or with deep inspiration breath-hold (DIBH) technique. The cardiac
      dose parameters including heart dose and the dose to left anterior coronary artery are
      assessed, and the cardiac toxicities regularly assessed with cardiac
      enzymes,electrocardiogram(ECG) and normal gated single-photon emission computed
      tomography-myocardial perfusion imaging before, during and after radiation.The dose-effect
      relationship of heart injuries is analyzed.
    

Intervention name(s): free-breathing; deep inspiratory breath-holding
Intervention type(s): Radiation; Radiation
Intervention description(s): patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery; patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Polarstem Cementless Hip Stem
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant
      in terms of radiographic, clinical performance and long-term survivorship.
    

Detailed description: 
      The goal of this multicenter clinical observation is to validate short-, mid-, and long-term
      outcome (efficacy and safety) of the POLARSTEM™.

      Efficacy evaluations:

        -  Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score,
           Hip disability and osteoarthritis outcome score (HOOS) [7, 8], an extension of the
           Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

        -  Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy,
           implant loosening or migration

      Safety evaluations:

        -  Intra- and perioperative device-related adverse events (AE) and complications up to
           discharge

        -  Postoperative AE up to 10 years
    

Intervention name(s): Osteoarthritis
Intervention type(s): Device
Intervention description(s): Total Hip Arthroplasty
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients enrolled in this multicenter clinical observation will have at least one of the
        indications listed below and meet all of the inclusion criteria. Patients meeting any of
        the exclusion criteria are not eligible for this study.

        Indications

          -  Primary or secondary coxarthrosis

          -  Rheumatoid arthritis

          -  Developmental dysplasia of the hip (Crowe type I and II)

          -  Fracture or avascular necrosis of the femoral head
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
Condition: Lymphoid Leukemia; Myeloid Leukemia; Monocytic Leukemia; Myelodysplasia
MeSH terms: Leukemia; Preleukemia; Leukemia, Lymphoid; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after
      myeloablative allogeneic stem cell transplant.
    

Detailed description: 
      Vitamin C is a nutritional supplement that can help fight inflammation. Most patients who
      have a stem cell transplant have lower than normal levels of vitamin C in their blood.
      Patients will receive intravenous Vitamin C the day after transplant for two weeks, followed
      by oral vitamin C until six months after transplant. The effect of the Vitamin C on
      non-relapse mortality (NRM), time to engraftment, rate of acute graft-versus-host disease and
      to characterize the safety and tolerability of the vitamin C regimen.
    

Intervention name(s): Intravenous (IV) and oral Vitamin C
Intervention type(s): Drug
Intervention description(s): Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours
• After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Other intervention name(s): L-ascorbic acid
Intervention MeSH terms: Ascorbic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin C; Hematopoietic cell transplant (HCT); Non-relapse mortality; Graft versus Host Disease (GVHD)
Phosphate in Blood Pressure Regulation
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      High dietary phosphate intake in the general population is associated with a higher risk for
      developing kidney disease and cardiovascular disease with an increased overall mortality.
      Whereas the effects of high phosphate intake on general health become clearer, almost nothing
      is known about underlying mechanisms. More recently, the investigators and others found in
      animal models that FGF23 stimulates the renal NaCl cotransporter NCC, the target of thiazide
      diuretics, and that increased NCC activity may increase blood pressure. The investigators
      could also show that increasing dietary phosphate intake in mice, increases FGF23 and NCC
      activity within 3 days. Thus, the objective of this single-centre observational cross-over
      study including 20-45 year old healthy male probands is to elucidate the role of dietary
      phosphate on blood pressure regulation and renal handling of sodium chloride in healthy
      subjects. Further the impact of dietary phosphate intake on the regulation of phosphaturic
      hormones and other factors regulation blood pressure will be investigated. In addition, the
      investigators will examine whether phosphate intake modulates gut microbiome composition. The
      primary outcome in this study is the change in blood pressure in healthy subjects on
      low-phosphate diet compared to healthy subjects on high-phosphate diet. In addition, to
      assess changes in NCC activity as the main mechanism of phosphate-sensitive blood pressure
      regulation, renal sodium chloride excretion after administration of hydrochlorothiazide will
      be measured. The secondary outcomes of this study are: changes in renal phosphate, calcium
      and potassium excretion, changes in phosphate regulation hormones such as 25-OH-Vit. D,
      1,25-(OH)2-Vit. D, PTH, FGF23, dopamine in plasma and urine, changes in plasma and urinary
      aldosterone levels, changes in sodium/chloride-cotransporter NCC and NaPi-IIa assessed from
      urinary exosomes, and changes in stool phosphate excretion and gut microbiome composition.
    


Intervention name(s): sodium phosphate; sevelamer, sodium bicarbonate, sodium chloride
Intervention type(s): Dietary Supplement; Drug
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
PTSD Prevention Using Escitalopram
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Assessing the efficacy of escitalopram in preventing the development of PTSD, or or reducing
      its severeness, after exposure to a traumatic event.
    


Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 to 20 mg / day; 1-2 capsules
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Condition: Postoperative Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this randomized clinical trial is to evaluate the interaction of intravenous
      fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The
      hypothesis is that perioperative supplemental intravenous fluid administration reduces the
      incidence of postoperative vomiting.
    

Detailed description: 
      Postoperative vomiting is a common complication on pediatric surgery, especially
      otorhinolaryngological surgery. Is one of the main reasons of prolonged hospital stay, and
      also a cause of patient´s discomfort and an increase on hospitalization cost.

      There are studies in adults with inconclusive results related to supplemental fluid therapy
      and decrease of postoperative nausea and vomiting. But, in recent years a study in children
      showed favorable results in strabismus surgery. The foundation of this study consist in that
      hypovolemia may possibly cause a decrease in perfusion causing intestinal hypoxia, which in
      turn increase the incidence of nausea and vomiting. The objective of this study is to observe
      the effect of supplemental fluid therapy on postoperative vomiting on otorhinolaryngological
      surgery.
    

Intervention name(s): Intraoperative lactated Ringer's solution
Intervention type(s): Other
Intervention description(s): After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during
      robot assisted laparoscopic radical prostatectomy for preservation of erectile function.
    

Detailed description: 
      Using NIM-Eclipse monitoring instrument (Medtronic), we will check action potential of
      cavernous nerve, bulbocavernosus reflex and pudendal nerve somatosensory evoked potential in
      real time during robot assisted laparoscopic radical prostatectomy for preservation of
      erectile function. In this feasibility and protocol setting phase I/II study, we will
      evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping using
      NIM-Eclipse monitoring instrument.
    

Intervention name(s): NIM-Eclipse
Intervention type(s): Device
Intervention description(s): Using NIM-Eclipse, nerve monitoring and mapping are performed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate cancer, robot, nerve mapping and monitoring
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the dose-proportionality of palbociclib pharmacokinetics in
      healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will
      receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days
      between doses. Additionally, this study will investigate the effect of Japanese ethnicity of
      palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level
      between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian
      subjects.
    


Intervention name(s): Palbociclib 75mg; Palbociclib 125mg; Palbociclib 100mg; Palbociclib; Palbociclib 125mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): In Period 1, Japanese subjects will receive a single oral 75mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.; In Period 2, Japanese subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.; In Period 3, Japanese subjects will receive a single oral 100mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.; In Period 4, Japanese subjects will receive a single oral dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. The amount of the dose will be determined based on an interim analysis of the PK data from Periods 1 and 2.; In Period 1, healthy non-Asian subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
Other intervention name(s): PD-0332991; PD-0332991; PD-0332991; PD-0332991; PD-0332991
Intervention MeSH terms: Palbociclib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Japanese PK-Bridging Study; dose-proportionality study; Palbociclib; PD-0332991; healthy volunteers
Dopaminergic Function and Food Reward
Condition: Adiposity; Weight Loss
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      The broad aim of the study is to obtain a better understanding of alterations in mesolimbic
      reward pathways in adiposity based on the hypothesis of a hypofunctioning reward system in
      obesity.

      This will be achieved by integrating a functional neuroimaging (fMRI) with behavioral reward
      tasks and the modulation of the dopamine level by dopamine depletion.
    


Intervention name(s): Dopamine depletion vs. Balanced aminoacid drink
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Dopamine
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
Condition: Peripheral Arterial Disease (PAD)
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral®
      drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery,
      as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides
      the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel)
      from the balloon surface into the vessel walls. This drug absorption is intended to limit the
      chances and the entity of artery re-narrowing over time.
    

Detailed description: 
      The efficacy of the IN.PACT Admiral balloon will be evaluated by assessing the primary
      patency rate of the treated arteries in the thighs of all patients included in the Study.
      Primary patency is a measure of the durability up to 1 year of the free lumen in the artery
      as restored during the procedure and is based on:

        -  the need for re-dilatation of the previously treated vessel segment

        -  an ultrasound examination The safety of the IN.PACT Admiral will be assessed by
           evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated
           arteries in all patients included in the Study.

      The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient
      IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with
      congruent design and protocol. Aggregate data from the two phases is intended to provide
      statistical power for the 12-month primary safety and effectiveness endpoints.
    

Intervention name(s): Drug-Coated Balloon (DCB); PTA Balloon: Balloon Angioplasty
Intervention type(s): Device; Device
Intervention description(s): balloon dilatation and provisional stenting with IN.PACT DCB; balloon dilatation and provisional stenting with standard non-coated PTA balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modulation of Cognitive Control by Transcranial Direct Current Stimulation
Condition: Major Depression
MeSH terms: Depressive Disorder, Major
Study type: Interventional

Summary: 
      Insufficient cognitive control over emotional distracters is characteristic for major
      depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is
      associated with this deficit. In this study the investigators assess the effect of an
      enhancement of dlPFC activity in MDD patients by anodal transcranial direct current
      stimulation (tDCS) on cognitive control.

      In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators
      determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD
      patients and healthy controls. To assess the cognitive control the investigators use a
      delayed response working memory (DWM) task with pictures of varying valence presented during
      the delay period.
    


Intervention name(s): Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
SCALE: Small Changes and Lasting Effects
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The goal of this study is to translate basic behavioral and social science discoveries into
      effective behavioral interventions that reduce obesity and obesity related morbidity in Black
      and Latino communities. This intervention will focus on promoting small changes in eating
      behavior and increasing physical activity among Black and Latino participants in Harlem and
      the South Bronx. The desired result from these activities is individual weight loss that will
      be sustained years after participation in the study.
    

Detailed description: 
      SCALE is a five year study (October 1, 2009 through June 30, 2014) funded by NHLBI. The study
      will examine the possibility and acceptance of a mindful eating intervention in African
      American and Latino participants. We will test whether positive thinking can protect
      participants against the negative impact that stress and depression can have on making
      positive behavior changes such as mindful eating and physical activity.

      Currently, the SCALE study is in the trial phase. Among overweight or obese Black or Latino
      adults who live in Harlem or the South Bronx, the primary goal of this project is to achieve
      weight loss of 7% or more over 12 months by making small sustained changes in eating behavior
      coupled with sustained increases in physical activity. Participants are enrolled for 12
      months and are randomized to one of two study groups.

      Group 1: Will choose one of ten small change eating strategies, a physical activity goal and
      will receive the positive affect/self affirmation component.

      Group 2: Will choose one of ten small change eating strategies and a physical activity goal

      For inquiries regarding potential enrollment in this study, please contact Rosio Ramos at
      646-962-5070 or email ror2023@med.cornell.edu
    

Intervention name(s): Group 1; Group 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.; Subjects will be randomized to the small change eating strategy and a physical activity goal.
Other intervention name(s): eating/physical activity/positive affect/self-affirmation; eating strategy and physical activity goal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase
      for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with
      hormone responsive prostate cancer will be randomized and will receive either intermittent or
      continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will
      enter a long-term follow-up period for 48 months.
    


Intervention name(s): leuprorelin acetate
Intervention type(s): Drug
Intervention description(s): LHRH antagonist
Other intervention name(s): ELIGARD 22.5 mg
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer; Prostate Specific Antigen