bioihbjkbjnl/mcl2 huggingface dataset:
Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Physical exercise has been identified as a major item of many chronic diseases and cancer
      rehabilitation.

      Therefore, physical activity for health is a valid and relevant way to improve quality of
      life and to manage cancer patient fatigue. The aim of the study is the assessment of the
      effects of a physical activity retraining program on aerobic capacity, strength and fatigue,
      in a breast cancer population treated by adjuvant chemotherapy.
    

Detailed description: 
      Physical exercise has been identified as a major item of many chronic diseases and cancer
      rehabilitation. It contributes to an improvement in the quality of life and to a decrease in
      the current treatment side effects and mortality. Cancer in association with treatment
      toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems
      in daily activities. The physical capacity and the tolerance for exercise fall simultaneously
      leading to a deconditioning vicious circle which increases physical, psychological and
      emotional symptoms of fatigue. Therefore, physical activity for health is a valid and
      relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the
      study is the assessment of the effects of a physical activity retraining program on aerobic
      capacity, strength and fatigue, in a breast cancer population treated by adjuvant
      chemotherapy.

      A total of 44 subjects is required. The programme is organised as follows: Arm A (aerobic and
      strength training) and during the 27 weeks of treatment (chemotherapy and radiotherapy); Arm
      B (control group). This study includes 3 assessments phases (T0: before adjuvant
      chemotherapy; T1 (week 27) and T2: final evaluation at the 54th week). These assessments
      include: cardiopulmonary exercise test including maximal oxygen uptake test (VO2max),
      six-minute walk test, muscular testing, assessment of physical activity (IPAQ questionnaire),
      fatigue (MFI20 questionnaire), quality of life (EORTC QLQ C30), anxiety and depression
      symptoms (HADS) and nutritional evaluation: BMI and total body photonic absorption.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adjuvant breast cancer
      
Keywords: Adapted physical activity; breast cancer
Focal Ablation of Cervical Precancer
Condition: High-grade Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      This is a pilot cohort study of women undergoing focal ablation for high-grade cervical
      intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics.
      The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting
      inclusion criteria were recruited for enrollment into the pilot study of focal treatment.
      Upon enrollment, they underwent focal ablational treatment rather than standard ablational
      treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess
      safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be
      calculated.
    


Intervention name(s): Focal treatment
Intervention type(s): Procedure
Intervention description(s): Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Exercise on Metabolic Parameters in Classical Homocystinuria
Condition: Homocystinuria
MeSH terms: Homocystinuria
Study type: Observational

Summary: 
      The aim of this research project is to compare the effect of an aerobic exercise session in
      two different populations. Sampling biological material and collecting health-related
      personal data entails minimal risks and burdens. Participants will be asked to perform 30
      minutes of an aerobic exercise on an ergocycle at a fixed power output to correspond to a
      moderate intensity for a sedentary population.
    

Detailed description: 
      Background Among genetic causes of hyperhomocysteinemia, classical homocystinuria, manifest
      not only with vascular diseases but also with neurological symptoms. This is related to the
      higher homocysteine concentration of up to 150-300 μmol/l without treatment. Recently, some
      articles have shown that mild and temporary hyperhomocysteinemia may follow exercise in a
      healthy population. Investigators hypothesized that increase in homocysteine may be of
      greater importance in patients with classical homocystinuria where cystathionine
      beta-synthase deficiency prevents homocysteine metabolism.

      Objective To investigate the effect of an aerobic exercise in patients with classical
      homocystinuria on metabolic parameters compared to healthy controls.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Endocrinology Clinic
Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048
Condition: Pharmacokinetics; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a proof of concept study to determine whether an extended release vaginal film can
      deliver drug for seven days. Two film formulations containing MK-2048 which differ by
      dissolution and spreadability attributes will be compared for safety and pharmacokinetic
      outcomes.
    

Detailed description: 
      This is a phase I randomized trial assessing the safety, acceptability, and pharmacokinetics
      of two formulations of MK-2048 vaginal film. While the primary objective is to evaluate the
      safety of the product, the overarching objective of this study is to provide proof of concept
      that an antiretroviral drug can be delivered in an extended release film formulation to
      provide drug delivery for 7 days or more after a single application. Forty eight women will
      be randomized with equal frequency to receive a single dose of a vaginal film containing
      MK-2048 (either the high Eudragit® or low Eudragit® formulation). The film will be inserted
      by a clinician on the day of enrollment. Vaginal swabs and plasma will be collected at days
      0, 3, 5, 7, 10, 14 and 28 for all participants. On the day of enrollment, some participants
      may elect to participate in immediate post insertion sample collection (vaginal swab and
      plasma) at one or two time points within 6 hours of insertion. Genital biopsy samples and a
      rectal swab will be obtained on day 7, and cervicovaginal lavage will be collected at
      screening and days 14 and 28. The primary endpoint is the frequency of Grade 2 or higher
      adverse events. The secondary endpoints are: MK-2048 concentrations in plasma, cervical
      tissue homogenate, cervicovaginal lavage fluid, rectal and vaginal swab eluents;
      self-reported assessment of qualities of the experience with the films drawn from existing
      survey on microbicidal films, and general acceptability ratings drawn from market research
      methodology.
    

Intervention name(s): MK-2048 High Eudragit Vaginal Film; MK-2048 Low Eudragit Vaginal Film
Intervention type(s): Combination Product; Combination Product
Intervention description(s): 2" x 2" vaginal film containing 30 mg of MK-2048 and either 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®); 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vagina; Film; Extended Release
ABF Tourette's Disorder Post Marketing Surveillance Study
Condition: Tourette's Disorder
MeSH terms: Tourette Syndrome
Study type: Observational

Summary: 
      This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean
      regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA
      Notification No. 2010-94 dated 27 December 2010).
    

Detailed description: 
      This study will be conducted in a prospective, single-arm, multi-center format. As this study
      is observational in nature, the patient's follow-up is not prescriptive in nature and must be
      left up to the judgment of the physician (investigator), within the period of observation set
      forth in the protocol.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients 6 to 18 years of age with Tourette's Disorder according to the approved
        product market authorization
Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Cocaine addiction is a serious health problem with no available medical treatment for
      preventing relapse. Modafinil, a medication that enhances mood, increases energy, and
      improves concentration, may be useful in preventing relapse among individuals with cocaine
      addiction. This study will evaluate the effectiveness of modafinil, in combination with
      cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.
    

Detailed description: 
      The development of a medication to treat cocaine addiction specifically by lessening
      withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms
      include depression, lack of energy, and poor concentration. Modafinil, a central nervous
      system stimulant, is a medication that can speed up physical and mental processes in the
      brain. It is currently used to treat narcolepsy, a condition that causes excessive
      sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people
      with narcolepsy. Modafinil may also cause the same effects in individuals addicted to
      cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is
      to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating
      cocaine dependence.

      A 2-week screening period will be followed by an 8-week treatment phase. Participants will be
      randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a
      daily basis for the 8 weeks of treatment. During this time, participants will be asked to
      report the number of days that they use and do not use cocaine. This will be confirmed three
      times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine
      withdrawal and cocaine "high" will be evaluated. Compliance with study medication will be
      assessed with urine and blood tests. Medication side effects will be monitored through
      physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will
      occur 4 and 8 weeks following the end of treatment.
    

Intervention name(s): Modafinil; Modafinil; Matching Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200mg Modafinil; 400mg Modafinil; Matching Placebo
Other intervention name(s): Provigil; Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine Dependence
Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma
Condition: MGMT-unmethylated Glioblastoma (GBM); GBM
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single arm, open-label, phase II trial of nivolumab, ipilimumab and short-course
      radiation therapy in adult patients with newly diagnosed, MGMT unmethylated GBM with the
      primary objective of determining the overall survival at 1 year.
    


Intervention name(s): Nivolumab; Ipilimumab; Radiation Therapy (RT)
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): study treatment on Day 1 with one dose of nivolumab 3 mg/kg; study treatment on Day 1 with one dose of ipilimumab 1mg/kg; total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
Intervention MeSH terms: Nivolumab; Ipilimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
      Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more
      tumor cells.

      PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy
      together with QS21 works in treating patients with metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and
           QS21 immunoadjuvant in patients with metastatic breast cancer.

        -  Determine the IgG and IgM antibody response to this regimen in these patients.

        -  Determine the proportion of breast cancer cells expressing this antigen in these
           patients.

      Secondary

        -  Monitor the presence of circulating tumor cells prior to, during, and after this regimen
           in these patients.

      OUTLINE: Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine
      subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the
      absence of disease progression or unacceptable disease.

      Blood samples are collected periodically and evaluated for circulating tumor cells and
      reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot
      assays.

      After completion of study treatment, patients are followed every 3 months.
    

Intervention name(s): QS21; sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine; immunoenzyme technique; immunologic technique; laboratory biomarker analysis
Intervention type(s): Biological; Biological; Other; Other; Other
Intervention MeSH terms: Keyhole-limpet hemocyanin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IV breast cancer; male breast cancer
Enhancing Sleep Slow Waves Using External Stimuli
Condition: Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
Study type: Observational

Summary: 
      This is an observational study to determine if the presentation of sensory stimulation during
      sleep can increase slow-wave activity during non-rapid eye movement sleep
    

Detailed description: 
      This is a single-site,unblinded study at the University of Wisconsin to determine the
      effectiveness of various stimulation modalities and parameters to maximize effectiveness for
      increasing slow waves during both nocturnal sleep and during daytime naps The ongoing study
      is a necessary exploratory step towards the future development of non-pharmacological means
      to improve sleep by increasing SWA.

      Several different stimulation modalities will be examined including: auditory (soft tones
      delivered to the subject through earphones); somatosensory (brief and painless electrical
      pulses delivered to the median nerve through electrodes placed at the wrist); vestibular
      (brief and painless electrical pulses delivered through electrodes placed near the mastoids);
      olfactory (light puffs of air, with or without mild odorants, delivered to the nostril(s)
      and/or mouth; visual (brief light flashes via strobe light). The amplitude (stimulus
      intensity) and frequency (number of stimuli per unit time) of stimulation presentation will
      be systematically varied to identify the ideal parameters for slow wave induction during
      sleep. For each stimulation modality and each subject, we will determine the range of
      stimulus intensity from the minimum level sufficient for perceptual response (e.g. - the
      lowest volume setting for an auditory stimulus that the subject can hear) to a stimulus level
      that the subject deems comfortable to still allow sleep. This is particularly important, as
      sleep maintenance during these experiments requires stimulus intensity low enough to avoid
      awakening the subject. Additionally, based on previous results from our laboratory, the
      effective range of stimulus intensity will vary substantially between subjects - both the
      identified range during wakefulness, as well as the range that induces slow waves but avoids
      waking during the sleep recording. Given this response variability, during the sleep
      recordings stimulus intensity will be adjusted, starting with the range determined in waking,
      to find the optimal intensity to inducing sleep slow waves (based on EEG response patterns),
      and avoiding subject awakening.
    

Intervention name(s): Slow-wave optimization
Intervention type(s): Device
Intervention description(s): employing sensory stimulation to enhance slow waves
Other intervention name(s): enhancing slow waves during non-rapid eye movement sleep
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 healthy volunteers will participatea)
Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants
Condition: Mumps
MeSH terms: Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated
      mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live
      attenuated mumps vaccine as the control vaccine.
    

Detailed description: 
      This study is a randomized, blind, single-center, controlled phase III clinical trial. The
      purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps
      vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control vaccine is
      a commercialized live attenuated mumps vaccine manufactured by Zhejiang VACN
      bio-pharmaceutical Co. Ltd. All participants are healthy infants between 8 - 18 months old,
      and will be randomly assigned into experimental group or control group in the ratio 1:1.
    

Intervention name(s): investigational live attenuated mumps vaccine; control live attenuated mumps vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.; The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: live attenuated mumps vaccine; safety; immunogenicity; infant
Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aims to evaluate and assess the effectiveness and safety of vaginal administration
      of isosorbide mono nitrate (ISMN) to induce cervical ripening and shorten the interval time
      between induction and delivery in women undergoing induction of labor.

      Research Hypothesis:

      In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate
      (IMN) is effective to induce cervical ripening and shorten the interval time between
      induction and delivery.

      .

      Research Questions:

      Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and
      shorten the interval time between induction and delivery in women undergoing induction of
      labor?
    

Detailed description: 
      Patient and methods

      Type of study:

      Prospective double blinded randomized placebo-controlled clinical trial.

      Study setting:

      The study will be conducted at Cairo university in labor ward of Kasr El Ainy Hospital.

      Study period:

      approximately 6 months from June 2018 to December 2018.

      Study population:

      Patients will be recruited in this study those attending labor ward at kasr el ainy hospital
      for induction of labor after 39 weeks of gestation.
    

Intervention name(s): isosorbide mononitrate; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction; 70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.
Other intervention name(s): Effox 40 mg; pyridoxine
Intervention MeSH terms: Pyridoxine; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be divided into 2 groups Group 1: 70 women: patients were induced by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) Group 2: 70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.
Masking: Single (Participant)
Primary purpose: Supportive Care