bioihbjkbjnl/mcl2 huggingface dataset:
Implants on Mobile Health Unit
Condition: Contraception
Study type: Observational

Summary: 
      This study explores reasons why adolescents choose to receive a nexplanon implant and remove
      a Nexplanon implant. Nexplanon is provided as part of the standard of care on the University
      of Chicago mobile health unit. This study explores reasons for implantation and removal of
      Nexplanon on this mobile health unit.
    


Intervention name(s): Nexplaon
Intervention type(s): Device
Intervention description(s): This study is an exploratory study of user reasons for Nexplanon implant and removal, and NOT a study on the efficacy or safety of Nexplanon. Nexplanon has already been FDA approved and its efficacy and safety studied.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be adolescent females seeking reproductive healthcare on a mobile
        health unit.
RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
Condition: Stomach Neoplasm
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free
      survival rate (primary end-point) and response rate, toxicity, and overall survival
      (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.

      Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer
      who failed previous first-line standard treatment with fluoropyrimidine and platinum-based
      chemotherapy.

      Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted
      according to the observed clinical toxicities. Treatment will be continued until disease
      progression or patient's intolerability to the study drug.

      Total of 54 patients will be enrolled to decide whether the proportion of patients who are
      free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater
      than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate,
      10%.
    


Intervention name(s): RAD001
Intervention type(s): Drug
Intervention description(s): RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Other intervention name(s): everolimus
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RAD001 (everolimus); second-line treatment; advanced gastric cancer
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
Condition: Hepatitis B; HBV
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2
      mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and
      activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up
      visits are also required periodically through day 43, and potential viral load follow-up
      visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for
      pharmacokinetic, pharmacodynamic, virologic, and safety assessments
    


Intervention name(s): Single Ascending Dose (SAD) Cohorts GS-9620; Multiple Ascending Dose (MAD) Cohorts
Intervention type(s): Drug; Drug
Intervention description(s): This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.; This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses)
Intervention MeSH terms: Vesatolimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis; Hepatitis B; Hepatitis B Virus; HBV; GS-9620; Toll-like receptor (TLR)-7 Agonist
Assessment of vGRF Measurement During Walking With Feetme® Insoles in Healthy Adults
Condition: Healthy Volunteers
Study type: Observational [Patient Registry]

Summary: 
      The objective of the present study is to demonstrate the validity and reliability of vGRF and
      other gait parameters measurement in healthy adults while walking with FeetMe® insoles
      compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and
      MX-T40) .
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Adults between 18 and 85 years old without gait pathologies
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
Condition: Herpes Genitalis
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine
      in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
    

Detailed description: 
      To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA
      vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of
      symptomatic genital herpes for at least one year.
    

Intervention name(s): VCL-HB01; Phosphate-buffered saline
Intervention type(s): Biological; Other
Intervention description(s): Investigational Product; Placebo
Other intervention name(s): PBS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HSV-2; Genital Herpes; Herpes; Herpes Simplex Virus, Type 2
Cognitive Function After Radiation Therapy for Brain Tumours
Condition: Primary Brain Tumor; Radiation Toxicity
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      This study will assess cognitive function in adult patients with a primary brain tumour
      treated with surgical resection with or without radiation therapy (RT). All types of brain
      tumours apart from glioblastoma will be included
    

Detailed description: 
      RT to brain tumours causes cognitive dysfunction. The extent of RT induced changes in
      cognitive function and radio-sensitivity of the brain is unknown. RT with protons instead of
      photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive
      dysfunction. There is modest knowledge on which parts of the brain the investigators need to
      spare, to prevent cognitive dysfunction.

      The study is a cross sectional study assessing cognitive function in patients with brain
      tumours previously treated with RT compared to a similar non irradiated group. 104 patients
      with specified brain tumours from Aarhus University Hospital treated in the period 2006-2016
      will be included. The patients will do patient reported outcome (PRO) and undergo
      neuropsychological assessment with standardized tests: They will do this prior to RT
      treatment and ½, 1, 3 and 5 years afterwards. The PRO's included measures on quality of life,
      fatigue, sleep, depression, anxiety, and socio demografica. The standardized tests are: Trail
      making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word Association Test
      (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV; Paced Auditory Serial Addition
      Test (PASAT). The correlation between cognitive scores and RT dose-volume parameters to
      specific areas in the brain will be tested.
    

Intervention name(s): Cognitive testing
Intervention type(s): Radiation
Intervention description(s): Patients will have their cognitive function tested by the use of standardized cognitive test and fill in questionnaires.
Cognitive function will be assessed by standardized cognitive tests: Hopkins verbal learning test (HVLT), Trail Making Test part A and B (TMT A and TMT B), Pased Auditory Test (PASAT), Wechsler Adult Intelligence Scale coding and digit span (WAIS-IV), Controlled Oral Word Association Test (Cowat) and STROOP colour and word test (STROOP)
Questionnaire include; Quality of life; EORTC QlQ-C30 (QlQ-C30), FACIT-Fatigue Scale (Version 4) (FACIT), Pittsburg Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), Patient's Assessment of Own Functioning Inventory (PAOFI).
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with a primary brain tumour grade I-III
      
Keywords: Cognitive function
Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigation will involve a double-blind, placebo controlled, cross-over study examining
      the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive
      fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1
      standard deviation below the mean on a brief cognitive screen will be given a thorough
      neuropsychological evaluation at two time points. Half of the patients will be randomized to
      receive a single oral dose of lactose placebo prior to the first testing session. After a
      washout period of one week, they will then receive 250mg of armodafinil prior to a second
      testing session (P/A group). The other half of patients will be randomized to receive the
      active drug first. After a washout period of one week, they will receive the placebo prior to
      a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours
      after administration, participants will be asked to take a single 250mg capsule 2 hours prior
      to the scheduled testing sessions.
    


Intervention name(s): armodafinil
Intervention type(s): Drug
Intervention description(s): Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.
Other intervention name(s): NuVigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
Condition: Brain Ischemia; Transient Ischemic Attack; Arteriosclerosis
MeSH terms: Ischemic Attack, Transient; Brain Ischemia; Arteriosclerosis; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a
      combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment
      with aspirin alone after cerebral ischemia of arterial origin.
    

Detailed description: 
      Low-dose aspirin (ASA) (at least 30 mg/day) prevents only 13% of subsequent vascular events
      after minor cerebral ischemia of arterial origin. Anticoagulation (AC) has been proven highly
      effective in preventing vascular events after myocardial infarction and after cerebral
      ischemia in patients with atrial fibrillation. A previous study on the effects of AC after
      cerebral ischemia of arterial origin (SPIRIT) showed that high intensity AC (INR 3.0 to 4.5)
      is not safe, but that mild AC (INR 2.0 to 3.0) was. The 2nd European Stroke Prevention Trial
      (ESPS-2) reported a 22% relative risk reduction of the combination of ASA and dipyridamole
      (DIP) above that of ASA only; its results, however, are subject to debate.

      Study design: ESPRIT was an open randomised controlled trial allocating patients who
      experienced a transient ischemic attack (TIA) or a non-disabling ischemic stroke to either:

      A. oral AC (INR 2.0 to 3.0);

      B. the combination of DIP (400 mg daily) plus ASA (30-325 mg/day); or

      C. ASA only (same dose).

      The mean follow-up was three years. Primary outcome was the composite of vascular death,
      stroke, myocardial infarction or major bleeding. Outcome assessment is blind.
    

Intervention name(s): anticoagulation; aspirin and dipyridamole; aspirin alone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Dipyridamole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: secondary prevention; TIA / minor stroke; atherosclerotic origin; TIA (Transient Ischemic Attack); prevention & control
Analytical Treatment Interruption in HIV Positive Patients
Condition: HIV-1 Infection
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      HIV-1 infected patients with normal peripheral blood CD4+ T-cell counts and undetectable
      viral load will be recruited in four Belgian HIV reference centers. Selected patients will
      undergo a two-step screening in which a viral reservoir measurement will be performed and
      among those with a very low viral reservoir an analytical treatment interruption of their
      longstanding antiretroviral therapy (ART). There is no randomization foreseen. Patients will
      receive an intense clinical and laboratory follow-up during 48 weeks followed by 12 weeks
      post intervention.
    


Intervention name(s): ART interruption
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Treatment interruption; functional cure
Improving Intermediate Risk Management. MARK Study
Condition: Myocardial Infarction; Angina Pectoris; Stroke; Peripheral Arterial Disease
MeSH terms: Myocardial Infarction; Peripheral Arterial Disease; Peripheral Vascular Diseases; Angina Pectoris; Infarction
Study type: Observational

Summary: 
      Cardiovascular risk functions fail to identify more than 50% of patients who develop
      cardiovascular disease. This is especially evident in the intermediate-risk patients in which
      clinical management becomes difficult. The purpose of this study is to analyze if
      ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose,
      glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are
      independently associated to incidence of vascular events and whether they can improve the
      predictive capacity of current risk equations in the intermediate-risk population.
    

Detailed description: 
      Primary prevention of cardiovascular diseases is a priority in public health policy of
      developed and developing countries. The fundamental strategy consists in identifying people
      in a high risk situation in which preventive measures are effective and efficient. However,
      specificity and sensitivity of risk equations are modest, which means that approximately 50%
      of the patients who are likely to develop a vascular event and would benefit from preventive
      measures are not considered at high risk. While 30% of the subjects considered at risk don't
      really benefit from preventive measures. Moreover, decisions which imply thousands of people
      and can determine drug treatment indications are taken every day in primary care centers.
      These decisions are based mostly on the result of estimations about the probability to
      develop a vascular disease in 10 years. Improvement of these predictions in our country will
      have an immediate, clinical and welfare impact and a short term public health effect.

      The purpose of this study is to analyze if ankle-brachial index (ABI), measures of arterial
      stiffness, postprandial glucose, glycosylated hemoglobin, self-measured blood pressure and
      presence of comorbidity are independently associated to incidence of vascular events and
      whether they can improve the predictive capacity of current risk equations in the
      intermediate-risk population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Population aged 35 to 74 which have an intermediate cardiovascular risk.
      
Biospecimen description: 
      Blood sample: Cholesterol and triglycerides concentration, HDL cholesterol, LDL cholesterol,
      Glucose concentration, glycated hemoglobin and creatinine Urine sample:urine albumin, to
      calculate the albumin/creatinine index. Postprandial glucose (mg / dl) will be self-measured
      by patients at home 2 hours after meals (breakfast, lunch and dinner) for one day using an
      Accu-chek ® glucometer.
Insulin Dosing in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis
Condition: Diabetes; Hypoglycemia; Renal Dysfunction; Insulin Dosing
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Hypoglycemia
Study type: Observational

Summary: 
      The purpose of this study is to assess whether the current recommendation for a 50% dose
      reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or
      on hemodialysis results in an increased number of hypoglycemic episodes.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        In patient hospitalized greater than or equal to three days, diabetic with CKD 3-5 or on
        dialysis on insulin therapy
      
Keywords: Diabetes; Renal Failure; Dialysis; End Stage Renal Disease; Hypoglycemia
Core Temperature Afterdrop in Cold-water Swimming
Condition: Hypothermia, Accidental; Cold Water Swimming
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      A significant risk associated with hypothermia during exercise in a cold environment is the
      core temperature (T°core) afterdrop, which corresponds to a continuous fall in T°core during
      rewarming after hypothermia. However, the rate and predictors of the afterdrop are unclear,
      particularly during prolonged cold water swimming.

      The investigators propose to measure the changes in T°core during and after a cold water swim
      at 12.5-13°C qualifying for English Channel swim and to test the impact of anthropometric and
      swimming parameters on the duration of the T°core afterdrop. The hypotheses are that
      afterdrop is common during a prolonged cold water swimming event and that protective factors
      against T°core drop during cold water swimming (increased body fat and BMI) might,
      conversely, be associated with prolonged afterdrop.
    


Intervention name(s): Swimming participants in the 6-hour cold water swim
Intervention type(s): Other
Intervention description(s): The 6-hour cold water swim was the qualifying swim for the English Channel swim during the Channel Swim Camp Dinard 2021 and participants were the swimmers registered for the 6-hour cold water swim who volunteered to participate in this study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Swimmers participating in the 6-hour cold-water swim, qualifying for the English Channel
        swim at the Channel Swim Camp (Dinard, France).
Efficacy of Alkalinized Lidocaine Compared to Remifentanil on the Incidence of Coughing During Emergence of Anesthesia
Condition: Cough; Anesthesia
MeSH terms: Cough
Study type: Interventional

Summary: 
      This study is designed to compare the effects of alkalinized lidocaine in the endotracheal
      tube cuff to a bolus dose of remifentanil given prior to the emergence of anesthesia:

        -  on the incidence of perioperative coughing

        -  on the time needed for the emergence of a desflurane-based anesthesia

        -  on the incidence of sore throat after extubation.

      The investigators hypothesis is that the use of alkalinized lidocaine in the endotracheal
      tube cuff will reduce the incidence of perioperative coughing after a desflurane-based
      anesthesia.
    

Detailed description: 
      Emergence is an important period of general anesthesia during which several problems can
      occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence
      of general anesthesia.

      Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has
      led to earlier discharge and more rapid resumption of normal activities after surgery.
      However, an incidence of coughing around 70% has been reported after a desflurane-based
      anesthesia. Different techniques and drugs have been studied to reduce coughing during
      emergence.

      Among others, the role of lidocaine given intravenously, topically, or intracuff has been
      studied. The use of intracuff alkalinized lidocaine has been proven effective to reduce the
      incidence of coughing during emergence of anesthesia.

      Furthermore, there is some evidence supporting the administration of intravenous opioids
      prior to emergence of general anesthesia to reduce perioperative coughing, agitation and
      hemodynamic stimulation. However, depending on the type of opioids given, this may delay the
      emergence from anesthesia. The effect of a remifentanil infusion given in combination with
      isoflurane as the volatile agent has been shown to reduce the incidence of perioperative
      coughing without delaying the emergence of anesthesia. Bolus doses of remifentanil have also
      been proven effective to reduce the hemodynamic response to extubation.

      The effect of these two modalities (alkalinized lidocaine and remifentanil) have never been
      compared. This study will assess their efficacy to prevent perioperative coughing after a
      desflurane-based anesthesia.
    

Intervention name(s): Remifentanil; Alkalinized lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia; Administration of alkalinized lidocaine in the endotracheal tube cuff
Intervention MeSH terms: Lidocaine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention