bioihbjkbjnl/mcl2 huggingface dataset:
Uterocervical Angle: a Screening Tool That Estimates the Latent Phase Duration in Post Term Pregnancies
Condition: Post Term Pregnancy
MeSH terms: Pregnancy, Prolonged
Study type: Interventional

Summary: 
      To evaluate the performance of uterocervical angle (UCA) in the prediction of latent phase
      duration in post term pregnancies
    


Intervention name(s): latent phase duration; uterocervical angle (UCA)
Intervention type(s): Other; Other
Intervention description(s): latent phase duration in post term pregnancies; uterocervical angle is the angle between lower segment of uterus and cervix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia
Condition: Endotoxemia; Inflammation; Multi Organ Dysfunction Syndrome; Sepsis
MeSH terms: Endotoxemia; Inflammation; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Excessive inflammation, production of free radicals and vascular injury are considered the
      main contributors to the development of organ dysfunction in patients with severe infections
      and sepsis. The endogenously produced unconjugated bilirubin is one of the most powerful
      anti-oxidants of the human body and the administration of bilirubin in animal experiments has
      been shown to protect from inflammation-induced death. However, bilirubin for human
      administration is not yet available. Therefore, we wish to exploit one of the side effects of
      atazanavir, a registered drug currently used as a protease inhibitor in HIV infected
      patients. Atazanavir inhibits the enzyme UPD glucuronosyl transferase enzyme (UGT1A1) and
      therefore increases endogenously produced bilirubin levels moderately. To study the effect of
      hyperbilirubinemia during inflammation we will apply the human endotoxemia model. The human
      endotoxemia model permits elucidation of key players in the immune response to a gram
      negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel
      therapeutic strategies in a standardized setting. We hypothesize that atazanavir-induced
      hyperbilirubinemia has beneficial anti-inflammatory and vascular effects during human
      endotoxemia.
    


Intervention name(s): Atazanavir; E. coli endotoxin
Intervention type(s): Drug; Drug
Intervention description(s): capsules of 150 mg, 2 capsules, twice daily on 4 consecutive days; 2 ng/kg E. coli reference endotoxin 11:H 10:K negative intravenously
Other intervention name(s): Reyataz
Intervention MeSH terms: Atazanavir Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Endotoxin; Bilirubin; Inflammation; Sepsis; Multi organ dysfunction syndrome; Oxidative Stress; Heme oxygenase
Web-based Study for Cancer Survivors
Condition: Physical Activity; Dietary Modification
Study type: Interventional

Summary: 
      In this parallel group study, participants were randomized to either 1 of 3 conditions (a)
      fruit and vegetable consumption, (b) dietary fat and added sugars, or (c) physical activity.
    

Detailed description: 
      In this study, the investigators will evaluate the feasibility and preliminary results of a
      3-month web-based lifestyle intervention 500 female cancer survivors.

      Specific aim 1: to determine the rates of recruitment, retention, attendance, satisfaction,
      adverse events, and barriers to participation in the proposed intervention.

      Specific aim 2: to determine whether a home-based intervention is associated with greater
      improvements in mean minutes of moderate to vigorous physical activity, diet quality, body
      size, constructs of Social Cognitive Theory, and health-related quality of life than
      participants randomized to a sedentary behavior reduction condition.
    

Intervention name(s): ALIVE
Intervention type(s): Behavioral
Intervention description(s): ALIVE is an email-based platform designed to help participants increase their physical activity, increase fruit and vegetable consumption, and decrease their intake of saturated and trans fats and added sugars. This automated system contains content and tailoring that is delivered in the form of emails obtained directly from cancer patients. Additional information they will receive included: tips for achieving those goals, health information, and opportunities for interaction and engagement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer; cancer survivorship; dietary intake; physical activity; quality of life
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.
Condition: HER2-ve Metastatic Breast Cancer; Germline BRCA1/2 Mutations; Somatic BRCA1/2 Mutations
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and
      potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve
      metastatic breast cancer associated with germline or somatic breast cancer susceptibility
      gene (gBRCA1/2 or sBRCA1/2) mutations.
    

Detailed description: 
      The study is a phase IIIb, multicenter, single-arm, open-label study designed to evaluate the
      clinical effectiveness in a real-world setting of olaparib monotherapy in patients with
      confirmed germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2)
      mutations. This study will generate additional data to support other olaparib studies, which
      may help inform and guide clinical practice. Physician defined the progression-free survival
      (PFS) for gBRCAm patients is the primary outcome measure. Based on the prevalence of gBRCA1/2
      mutations, it is estimated that up to 1400 patients may require screening in order to
      identify 250 gBRCA mutated patients and 20 sBRCA mutated patients. Patients will be
      administered two olaparib 150mg tablets in morning and evening of every day after a light
      meal. Dose reductions may be required for olaparib treatment related toxicities. Patients
      should continue to receive study treatment until documented physician-defined disease
      progression as assessed by the investigator (gBRCA mutated patients), RECIST1.1 disease
      progression (sBRCA mutated patients) or unacceptable toxicity, or for as long as they do not
      meet any other discontinuation criteria. A positive benefit/risk profile is expected and no
      ethical issues are identified from exposing patients to olaparib within the planned clinical
      study.
    

Intervention name(s): Olaparib
Intervention type(s): Drug
Intervention description(s): Patients will be administered olaparib orally, twice daily at 300 mg. Two (2) 150 mg olaparib tablets should be taken at the same time each morning and evening of every day, approximately 12 hours apart.
Intervention MeSH terms: Olaparib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HER2-ve metastatic breast cancer; Germline BRCA1/2 mutations; Somatic BRCA1/2 mutations; BRCA1; BRCA2
Knowledge Attitudes Beliefs and Practices Regarding HIV Among Teenagers in French Guiana
Condition: HIV
Study type: Observational

Summary: 
      French Guiana is the French territory where the prevalence of HIV is highest. in order to
      determine the knowledge attitudes, beliefs, and practices among the target group of teenagers
      attending the public school system a survey was conducted in 2011. schools and classrooms
      were randomly selected, and a structured questionnaire was administered. Descriptive
      statistics were obtained and multivariate logistic regression was used to determine
      predictors of main outcomes such as age at first sex.

      the results will be used to guide prevention of HIV and sexually transmitted infections
      though the school system.
    


Intervention name(s): observational
Intervention type(s): Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        randomly selected teenagers attending the public school system of french guiana
The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
Condition: Ovulation (Follicular Rupture Yes/no); Menstrual Cycles (Total Length, Bleeding Days); Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor
      will result in premature luteolysis (ovulation failure) in women.
    

Detailed description: 
      Currently available methods of emergency contraception (EC) only work during a very narrow
      time period prior to the hormonal trigger for ovulation or the release of an egg. Women
      having unprotected sex outside this window receive no benefits from this emergency therapy.
      Prostaglandins are critical before, during, and after ovulation, thus their inhibition may
      cause an EC effect that works over a longer time period. We wanted to determine if celecoxib
      might work as an EC with a wider window of action.
    

Intervention name(s): Celebrex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One 400mg tablet daily.; One tablet daily.
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Celebrex; prostaglandin inhibitor; ovulation; menstrual cycles
Music Intervention in the Treatment of Sleep Disorders for Depressed Patients
Condition: Insomnia; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether music hearing in the evening before going
      to sleep can improve sleep quality, depressive symptoms and quality of life in patients with
      affective disorders.
    

Detailed description: 
      Disrupted sleep including Problems of initiating and maintaining sleep are most often
      symptoms in patients with depressive Syndromes and often persist after successful treatment
      of affective symptoms. Normally disrupted sleep in the context of affective disorder is
      treated with sleep medication, which can lead to severe and sometimes intolerable side
      effects.

      A non-pharmacological approach for improving sleep Quality is Hearing Music before going to
      sleep. Classical indian Music can improve sleep Quality in depressed patients. In a danish
      study protocol Western Music improved sleep quality in patients with disturbed sleep and
      posttraumatic stress disorder.

      The investigators want to use western Music to improve sleep . In a three week Intervention
      time, patients shall hear before going to sleep every night for one hour relaxing Music. The
      control group receives Treatment as usual. After the end of Intervention, every participant
      has the possibility to use the sleep inducing Music.

      The aim of the study is to prove whether Hearing Music before going to sleep over three weeks
      improves subjective sleep quality, self rated depressive symptoms and Quality of life and
      objective Parameters such as sleep duration and sleep latency, measured by actigraphy. In a
      follow-up interview four weeks after the Intervention the investigators want to prove if the
      effects continue after end of Intervention.
    

Intervention name(s): Music intervention
Intervention type(s): Other
Intervention description(s): Patient receives Music Intervention before going to sleep. It is composed Music which the Patient hear with maysound Music player.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleep Quality; Depression; Music; quality of life
Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.
Condition: Infertility; Vaginal Flora Imbalance; Genital Disorder
MeSH terms: Infertility; Dysbiosis
Study type: Interventional

Summary: 
      Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of
      the female and male genital tract in couples with fertility problems. Couples who have
      started treatment for artificial insemination or who are on the waiting list for an invitro
      fertilization treatment will be invited to participate. The estimated duration of the study
      will be 7 and a half months.
    

Detailed description: 
      Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of
      the female and male genital tract in couples with fertility problems. Couples who have
      started treatment for artificial insemination or who are on the waiting list for an invitro
      fertilization treatment will be invited to participate. The estimated duration of the study
      will be 7 and a half months.

      Four visits are included in the study period.
    

Intervention name(s): Lactobacillus PS11610
Intervention type(s): Dietary Supplement
Intervention description(s): 7 months and a half intervention study. A 6 months intervention period preceded by a period of sampling and analysis of vaginal, seminal and gland swabs of 6 weeks. During the 6 months of intervention the men participants will intake one capsule that contains 1*10E9 colony forming unit (CFU) of Lactobacillus PS11610 and the women participating will intake two capsules of the same product (each 12 hours). If the couple stay pregnant during the intervention the man will end the product intake and the woman will reduce the dose to one capsule with 1*10E9 CFU of Lactobacillus PS11610 per day during 12 additional weeks.
Intervention model: Single Group Assignment
Intervention model description: Open label intervention study.
Masking: None (Open Label)
Primary purpose: Screening
Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The use of tacrolimus in the long term as part of the immunosuppressive regimen after
      transplantation is associated to complications such as chronic nephrotoxicity, impaired
      glucose metabolism (diabetes mellitus) and an increase of the incidence of neoplasia. The
      conversion from a tacrolimus based therapy to a sirolimus based therapy associated with
      mycophenolate mofetil could improve the incidence of such complications. The aim of this
      study is to assess the risk/benefit ratio of this switch performed in stable renal transplant
      recipient between 12 months and 36 months after transplantation. The incidence of a composite
      endpoint (worsening of GFR evaluated by MDRD formula, incidence of cancer and diabetes) will
      be assessed 24 months after conversion.
    

Detailed description: 
      Two doses of Sirolimus will be evaluated accorded to the CYP 3A5 genotype. Patients carrying
      at least CYP 3A5 *1 allele will receive 4 mg per day whereas the others (CYP 3A5 *3/*3) will
      receive 2 mg.
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention description(s): Sirolimus introduction and tacrolimus withdrawal
Tacrolimus : 33 % decrease of daily dose with complete withdrawal at day 14. Sirolimus daily dose according to CYP3A5 genotype CYP3A5*1/*1 or *1/*3: 4 mg/d CYPY3A5*3/*3 : sirolimus 2 mg/j Adjusted to obtain a trough level between 6 and10 ng/ml
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sirolimus; Tacrolimus; Kidney transplantation; Kidney Transplant Recipients
In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label, sequential, single dose 4-period crossover,
      scintigraphic imaging study in healthy male and non-pregnant, non-lactating female subjects.
    

Detailed description: 
      Subjects will be screened for eligibility to participate in the study up to 28 days before
      dosing. For each treatment period, subjects will be admitted to the clinical unit on the
      evening prior to IMP administration (Day -1) and will fast overnight for a minimum of 8 h. On
      the morning of Day 1, subjects will receive IMP in the fasted state and will remain on site
      until 24 h post-dose. Following Period 2, there will be an interim analysis and review of
      safety and scintigraphy data from dosed regimens in order to determine which formulations
      will be used in subsequent periods. A follow-up phone call will take place 3 to 5 days
      post-final dose to ensure the ongoing wellbeing of the subjects.
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention description(s): single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Intervention MeSH terms: Budesonide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of CAD-9303 in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will consist of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
      cohorts that will be randomized, double-blind, and placebo-controlled to assess the safety,
      tolerability, and pharmacokinetics of CAD-9303. The first SAD cohort will be in healthy
      volunteer subjects. The remaining cohorts will be in participants with schizophrenia.
    

Detailed description: 
      This study will be conducted in two Parts. Part 1 will consist of Single Ascending Dose (SAD)
      cohorts that will be randomized, double-blind, and placebo-controlled to assess the safety,
      tolerability, and pharmacokinetics of CAD-9303. Part 2 will consist of Multiple Ascending
      Dose (MAD) cohorts that will be randomized, double blind, and placebo-controlled to assess
      the safety, tolerability, and pharmacokinetics of CAD-9303. The effects of CAD-9303 will be
      explored on event-related potential (ERP), and on sensory and cognitive function. The first
      SAD cohort will be in healthy volunteer subjects. The remaining cohorts will be in
      participants with schizophrenia. Participants will meet specified eligibility criteria.

      SAD Cohorts will be comprised of 8 subjects; 6 subjects will be administered CAD-9303, and 2
      subjects will be administered matching placebo. MAD Cohorts will be comprised of 12 subjects;
      9 subjects will be administered CAD-9303, and 3 subjects will be administered matching
      placebo.

      Potential subjects will undergo a screening period (up to 28 days), baseline assessments on
      Day -3, -2 and -1, and dosing on Day 1 for SAD and Days 1 - 14 for MAD. A follow-up visit
      will occur 7 days after the last dose. The total duration of individual subject participation
      may be up to 5 weeks for SAD and 7 weeks for MAD, depending on the duration of the screening
      period.

      The study will assess safety by adverse events, vital signs, laboratory parameters (including
      chemistry, hematology and urinalysis) and electroencephalogram (EEG); pharmacokinetics of
      CAD-9303; and exploratory efficacy measures effects on neurophysiological biomarkers,
      cognitive and negative symptoms.
    

Intervention name(s): CAD-9303; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Capsules filled with CAD-9303 from 3 mg up to 1000 mg.; Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind,
      placebo controlled study comparing ubenimex with placebo in patients with pulmonary arterial
      hypertension (PAH) (World Health Organization [WHO] Group 1) and have a WHO/New York Heart
      Association (NYHA) Functional Classification (WHO/NYHA-FC) of II or III.
    

Detailed description: 
      Ubenimex is being developed for the treatment of PAH (WHO Group 1) to improve exercise
      capacity and delay clinical worsening. This proof-of-concept study is designed as a Phase 2,
      multicenter, randomized, double-blind, placebo controlled study comparing ubenimex with
      placebo in patients with PAH (WHO Group 1) and have a WHO/NYHA Functional Classification
      (WHO/NYHA-FC) of II or III. The Primary Objectives for the study are:

        -  To evaluate the efficacy of ubenimex in patients with PAH (WHO Group 1).

        -  To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH.
    

Intervention name(s): ubenimex; placebo
Intervention type(s): Drug; Other
Other intervention name(s): UBX
Intervention MeSH terms: Ubenimex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE
      Ablation System Plus with commercial design devices is both safe and effective for treating
      drug-resistant paroxysmal atrial fibrillation (PAF).
    

Detailed description: 
      This is a prospective, multi-center, single arm safety and effectiveness pilot study.
      Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the
      clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic
      locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and
      12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and
      other relevant outcome measures.
    

Intervention name(s): Catheter ablation to treat paroxysmal atrial fibrillation
Intervention type(s): Device
Intervention description(s): A pulmonary vein isolation will be performed using catheter ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Catheter Ablation; Paroxysmal Atrial Fibrillaltion; Pulmonary Vein Isolation; Atrial Fibrillation