bioihbjkbjnl/mcl2 huggingface dataset:
Lycopene or Green Tea for Men at Risk of Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate
      cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene
      or green tea may be more effective in preventing prostate cancer.

      PURPOSE: This randomized phase II trial is studying lycopene to see how well it works
      compared with green tea in preventing prostate cancer in patients previously enrolled in the
      ProtecT trial
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months
           following randomization in patients with prostate cancer previously enrolled on ProtecT

      Secondary

        -  To evaluate trial recruitment and randomization rates of patients treated with this
           regimen.

        -  To evaluate intervention tolerability in patients treated with this regimen.

        -  To evaluate compliance of patients treated with this regimen.

        -  To evaluate trial retention of patients treated with this regimen.

        -  To assess PSA values in patients treated with this regimen.

        -  To evaluate dietary compliance with recommendations of patients treated with this
           regimen.

        -  To assess weight and body mass index of patients treated with this regimen.

        -  To evaluate attitudes and views of men and their spouses about dietary modification and
           participation in long-term study.

      OUTLINE: Patients are stratified according to PSA test levels obtained from ProtecT study
      recruitment clinic (< 3.0 ng/mL vs 3.0-19.99 ng/mL). Patients are randomized to 1 of 2
      treatment arms.
    

Intervention name(s): Green tea drink; green tea capsules; Green tea placebo capsules; Lycopene capsules; Lycopene placebo capsules; Tomato rich diet
Intervention type(s): Behavioral; Dietary Supplement; Other; Dietary Supplement; Other; Other
Intervention description(s): Green tea drink; green tea capsules; Green tea placebo capsules; Lycopene capsules; Lycopene placebo capsules; Tomato rich diet
Intervention MeSH terms: Lycopene
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prostate cancer
A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer
Condition: Atypical Ductal Breast Hyperplasia; Breast Cancer; Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      Chemoprevention is the use of certain drugs to keep cancer from forming. The use of
      atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying
      the best dose of atorvastatin in preventing breast cancer in women at increased risk for
      breast cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the minimum biological effective dose (MBED) of atorvastatin required to
      induce modulation in the proliferation marker, Ki-67, in breast tissue of women who are at
      high risk to develop breast cancer. We will evaluate pre- and post atorvastatin treatment (4
      dose levels) expression of Ki-67 in samples obtained via FNA from breast tissue of women at
      high risk for breast cancer. This specific aim tests the hypothesis that treatment with
      atorvastatin will induce a decrease in Ki-67.

      SECONDARY OBJECTIVES:

      I. To evaluate atorvastatin induced modulation of breast cancer biomarkers markers (EGFR,
      P-EGFR, ER, p21, p27, bcl-2, CC3, cytology) and drug related markers (LXR, total cholesterol,
      LDL, HDL, CRP) in women who are at high risk to develop breast cancer.

      II. To determine plasma and tissue levels of atorvastatin and two of its hydroxylated
      metabolites (ohydroxyatorvastatin and p-hydroxyatorvastatin) in women who are treated with
      atorvastatin and to correlate these levels with Ki-67 levels. III. To correlate changes in
      Ki-67 and the above-described panel of biomarkers with HMG-CoA reductase genotype.

      OUTLINE: Participants are randomized to 1 of 4 arms.

      ARM I: Participants receive oral atorvastatin once daily for 3 months.

      ARM II: Participants receive oral atorvastatin (at a higher dose than in arm I) once daily
      for 3 months.

      ARM III: Participants receive oral atorvastatin (at a higher dose than in arm II) once daily
      for 3 months.

      ARM IV: Participants do not receive treatment. Participants undergo blood sample collection
      and fine needle aspiration of breast tissue at baseline and at 3 months for correlative
      biomarker studies.
    

Intervention name(s): atorvastatin calcium; laboratory biomarker analysis
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Correlative studies
Other intervention name(s): CI-981; Lipitor
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Primary Obstructive Megaureter Management in Eastern Interregional Area
Condition: Congenital Obstructive Megaureter
Study type: Observational

Summary: 
      Congenital obstructive megaureter is a urinary malformation affecting the ureterovesical
      junction and causing obstruction to the flow of urine. It is the second most common cause of
      hydronephrosis. This malformation affects four times more boys than girls and is bilateral in
      25% of cases. It is also associated with contralateral renal dysplasia in 15% of cases. The
      obstruction is linked to aperistalsis and hypertrophy of the circular muscle bundles and
      increased collagen 1 level. This malformation is accessible to antenatal screening from the
      second trimester. It falls within the scope of CAKUT and requires regular monitoring. Indeed,
      this uropathy can cause repeated pyelonephritis, kidney scarring and affected kidney
      function.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Minor patient (from 1 to 17 years old) treated between January 2010 and December 2017 for
        an obstructive congenital mega-ureter
      
Keywords: Congenital obstructive megaureter; Urinary malformation; Ureterovesical junction; Hydronephrosis; Renal dysplasia
Multimodal IMAgery Characterization of Cardiac Damage and Severity After COVID-19 Infection
Condition: COVID-19 Virus Disease; Cardiac Complication
MeSH terms: COVID-19; Virus Diseases
Study type: Observational

Summary: 
      Coronavirus Disease 2019 (COVID-19) is an infection caused by Severe Acute Respiratory
      Syndrome Coronavirus (SARS-CoV-2), which affects multiple organ system particularly the lung
      and heart. Indeed, SARS CoV-2 has various cardiac manifestations which are associated with
      higher mortality and morbidity. Cardiac involvement, based on elevated levels of myocardial
      enzymes, have been described in 20 to 30% of COVID-19 infection. However, the
      physiopathological mechanisms of myocardial injury remains unclear. Main hypothesis include
      inflammation and cytokine storm, hypercoagulability and vascular thrombosis, inflammation or
      stress leading to coronary plaque rupture (type I myocardial infarction), supply-demand
      mismatch and hypoxemia resulting in myocardial damage (type II myocardial infarction) ...

      Two patterns can be identified : ischemic or non-ischemic pattern including myocarditis,
      stress induced cardiomyopathy, thrombo-embolic disease. However, the consequences of
      myocardial damage after confirmed COVID-19 infection are unknown at medium to long term
      prognosis.

      Data are needed to identify myocardial damage and to guide effective therapies and follow-up
      (use of ACE inhibitor, beta-blockers, steroids...? ) In this study, the investigators
      proposed to collect multimodal cardiac imaging including MRI (Magnetic Resonance Imaging) and
      TTE (Transthoracic echocardiogram) in order to identify and characterize cardiac injury as
      ischemic or non-ischemic pattern, to better assess risk stratification and to guide effective
      therapies if necessary.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients increase troponin level > 50ng/ml or left ventricular dysfunction assessed by
        echocardiography during hospitalization for confirmed COVID-19 infection
Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients
      who have recurrent prostate cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the effect of PSA-3 peptide vaccine emulsified in Montanide ISA-51
      on PSA levels in patients with recurrent prostate cancer. II. Determine the toxicity of this
      regimen in these patients. III. Determine whether the T lymphocyte immune response to PSA-3
      and HLA-A2 antigen-presenting cells that endogenously produce PSA is increased in patients
      treated with this regimen. IV. Determine the duration of the PSA and/or immune responses in
      patients treated with this regimen. V. Correlate immune and PSA responses in patients treated
      with this regimen. VI. Determine the efficacy of a second (boost) vaccination with this
      regimen in patients with a PSA or immune response.

      OUTLINE: This is a multicenter study. Patients receive PSA-3 peptide vaccine emulsified in
      Montanide ISA-51 subcutaneously in 2 sites on days 1, 8, 15, and 22 in the absence of
      unacceptable toxicity. Patients who show an immune or prostate specific antigen (PSA)
      response are followed until disease progression, defined as a diminution or disappearance of
      an immune response or 2 consecutive increases in PSA over the nadir. Patients are eligible
      for a second series of injections at the time of progression.

      PROJECTED ACCRUAL: A total of 14-44 patients will be accrued for this study within 12-18
      months.
    

Intervention name(s): PSA prostate cancer vaccine; incomplete Freund's adjuvant
Intervention type(s): Biological; Biological
Intervention MeSH terms: Freund's Adjuvant
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer
Ketamine + Mindfulness for Depression
Condition: Depression, Unipolar
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this project, the investigators will administer a single infusion of IV ketamine to
      depressed patients and randomize the patients to receive either a) usual/typical infusion
      conditions or b) mindfulness training and exercises in conjunction with the infusion.
      Investigators will test whether the conjunction of ketamine + mindfulness enhances the
      reductions in depression following a single ketamine infusion.
    

Detailed description: 
      NOTE: The study's target sample size was revised after beginning the study, based on a
      revised available budget.
    

Intervention name(s): Intravenous Ketamine; Brief Mindfulness Exercises; Academic Exercises
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min); 30min guided training in mindfulness meditation immediately prior to infusion; 30min of mental math and other academic cognitive puzzles completed silently/mentally
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
Condition: Contraception
MeSH terms: Uterine Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial was to identify at least one next generation ring (NGR)
      that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of
      participants ovulation was observed in less than 15% of the participants at any time during
      the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as
      judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The
      primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and
      cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the
      incidence of BTB-S.
    


Intervention name(s): Nomegestrol acetate (NOMAC); Etonogestrel (ENG); Ethinyl estradiol (EE); Estradiol (E2)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Daily release of 500, 700, or 900 μg.; Daily release of 75, 100, 120 or 125 μg; Daily release of 15 μg; Daily release of 300 μg
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Etonogestrel; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a long-term, open-label study using NPSP558 for the treatment of adult patients
      with Hypoparathyroidism.
    

Detailed description: 
      Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for up
      to 80 months, which will be injected daily in either thigh. During that time they will be
      monitored for safety (specifically calcium levels in blood or urine). In addition, the
      patients' intake of Vitamin D and Calcium will be measured.
    

Intervention name(s): NPSP558
Intervention type(s): Drug
Intervention description(s): All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.
Other intervention name(s): RACE
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTH 1-84; Hypoparathyroidism; Parathyroid Hormone 1-84; NPSP558
Effects of Neurodynamic Mobilization and Stretching Exercises for Chronic Discogenic Sciatica
Condition: Physical Therapy
MeSH terms: Sciatica
Study type: Interventional

Summary: 
      This study compares between neurodynamic mobilization and stretching exercises in treatment
      of chronic dicogenic sciatica
    

Detailed description: 
      This study was conducted at the outpatient clinics, faculty of physical Therapy, Kafrelsheikh
      University to compare between the effects of slider, tensioner neurodynamic mobilization
      techniques and stretching exercises on pain, Range of motion (ROM) and functional disability
      for patients with chronic discogenic sciatica.

      Design of the study:

      A pre-test post-test three-armed comparative study design was used for comparison between the
      effects of slider, tensioner neurodynamic mobilization techniques and stretching exercises
      for patients with chronic discogenic sciatica.

      Selection of patients:

      Sample size:

      Using G-power software program and regarding F test study , alpha level of 0.05, confidence
      interval 95% and effect size of 0.25 (to detect small effects ), three groups and 6 dependent
      variables, the total sample size will be 36 patient (twelve in each group).

      To reach the specific sample size, forty-three patients were screened regarding the
      inclusion/exclusion criteria. Thirty-six patient with unilateral chronic discogenic sciatica
      from both sexes (….male and … female) were recruited from the outpatient clinics, faculty of
      physical Therapy, Kafrelsheikh University. Their age ranged between 21-50 years.

      They were randomly allocated by simple random method; to avoid selection bias, patients were
      asked to choose a card of three wrapped cards representing the three treatment groups:

      Group (A): received Slider technique only. Group (B): received Tensioner technique only.
      Group (C): received Stretching exercises of back extensors, hamstrings and gastrocnemius
      muscles only.
    

Intervention name(s): Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius
Intervention type(s): Other
Intervention description(s): neurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica.
Other intervention name(s): sliders, tensioners and stretching exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: simple random sampling
Masking: None (Open Label)
Primary purpose: Treatment
Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function
Condition: Impaired Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of
      chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias.
      The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701)
      following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly
      subjects and in adult subjects with mild, moderate, severe, and end stage renal disease
      (ESRD) degrees of impaired renal function. The results of this study will characterize the
      pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with
      various degrees of renal impairment, and these data will be compared to healthy adult and
      elderly subjects.
    


Intervention name(s): SSP-004184
Intervention type(s): Drug
Other intervention name(s): SPD602, FBS0701
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phosphorylation of ERK1/2 in Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Levodopa-induced dyskinesia severely limits the use of levodopa in Parkinson's disease and
      constitutes a debilitating complication of dopaminergic treatment in late stage. Among
      several neurobiological mechanisms identified so far, the investigators have established in
      experimental models the key role of D1 receptor hypersensitivity and a"Ras-ERK" signalling
      pathway. As the very same dopamine receptor machinery and the Ras-ERK pathway are present in
      blood lymphocytes, the investigators wish to test the hypothesis that the level of ERK
      phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in Parkinson's
      Disease.

      The study will be performed in dyskinetic levodopa-treated patients and non-Parkinson's
      Disease controls. Blood sampling "off" and "on" levodopa treatment (1 hour post-dose), as
      well as clinical data collection will be done during a scheduled pre-op work-up (deep brain
      stimulation). Subsequently, suspended lymphocytes from blood samples will be immunolabelled
      using an anti-pERK antibody and mean fluorescence intensity and percent of labelled
      lymphocytes will be assessed by flow cytometry. Additionally, plasma and urine samples will
      be collected "on" et "off" for dosage of dopamine. The motor effect of levodopa will be
      assessed through UPRSIII rating scale and eye movement (saccades) speed by non-invasive
      oculometric recordings.
    


Intervention name(s): Clinical variables; Clinical variables; Clinical variables
Intervention type(s): Other; Other; Other
Intervention description(s): Demography, disease duration, treatment duration, current treatment, daily intake of levodopa, Disease stage (Hoehn and Yahr, HY), motor score (UPDRS III) and dyskinesia severity (UPDRS IV). Biological variables.; Demography, Biological variables.; Eye movement recordings : non-invasive infra-red camera oculometry (EyeBrain) before and after (only parkinson's disease group) levodopa(10 to 15 minute/recording)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Consecutive eligible PD in- and outpatients selected at the university hospital of bordeaux
        and subjects without known neurological disorder in a community sample.
      
Biospecimen description: 
      whole blood urine
Methoxyflurane and Fentanyl in LBNP
Condition: Hypovolemia; Cardiac Output, Low; Analgesia
MeSH terms: Cardiac Output, Low; Hypovolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a single-centre, placebo-controlled, crossover study on healthy volunteers
      aiming to explore non-inferiority of methoxyflurane and fentanyl compared to placebo on the
      tolerance to hypovolemia.
    

Detailed description: 
      The study will explore the effects of fentanyl and methoxyflurane versus placebo (NaCl;
      saline) on the hemodynamic response to hypovolemia in healty volunteers. Hypovolemia will be
      induced in the "lower body negative pressure" model. XX healthy volunteers will be exposed to
      inhaled methoxyflurane, 3 ml or intravenous fentanyl, XX mg or placebo in a randomized order
      (cross-over) at least 3 days apart.
    

Intervention name(s): Lower body negative pressure (LBNP)
Intervention type(s): Procedure
Intervention description(s): LBNP is a model of experimental hypovolemia, whereby the lower body is exposed to negative pressure leading to sequestering of blood in the lower body and central hypovolemia. LBNP will be induced stepwise with increments of 10 mmHg, each level lasting 1 min. LBNP will be terminated at symptoms or signs of impending hemodynamic collapse.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, placebo controlled, crossover study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Methoxyflurane; Fentanyl