bioihbjkbjnl/mcl2 huggingface dataset:
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to provide open label emtricitabine/tenofovir disoproxil
      fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study
      GS-US-203-0107.
    


Intervention name(s): FTC/TDF
Intervention type(s): Drug
Intervention description(s): 200/300 mg tablet administered orally once daily
Other intervention name(s): Truvada®
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prevention of chronic hepatitis B recurrence; post orthotopic liver transplant; prevention of chronic hepatitis B recurrence in patients who have undergone orthotopic liver transplant
Violence Sexual Incidence During the First Year of Residence on Asylum Seekers
Condition: Sexual Violence
Study type: Observational

Summary: 
      Asylum seekers women are particularly exposed to sexual violence. One in seven women in
      France and one in three in the world say they have been a victim of sexual violence at least
      once in her life.

      The main objective of this study is to measure the incidence of sexual violence suffered by
      women in asylum proceedings during their first year of stay on French territory, in Marseille
      and Nice.
    

Detailed description: 
      Introduction: One in seven women in France and one in three in the world say they have been a
      victim of sexual violence at least once in his life. They are exacerbated in vulnerable
      populations, marginalized, in post-conflict situations or population displacement.

      Therefore asylum seekers women are particularly exposed to sexual violence. This is why OFPRA
      and the Ministry of Solidarity and Health have protected these women with regard to sexual
      violence, one of the priority issues for public health. Yet, the investigators do not know
      the proportion of women seeking asylum who have suffered violence on French soil. In
      addition, the investigators did not find an international study of the incidence of violence
      sexual abuse suffered in the host country by women seeking asylum. Objective: Determine the
      incidence of sexual violence that occurred in the year following the arrival on French soil
      of adult women in the asylum process in Marseille and Nice.

      Methodology: Multicentric longitudinal observational study (Marseille and Nice) based on a
      historical cohort of sexual violence among women in the application process asylum. 1,800
      adult women seeking asylum were registered in 2019 in Marseille and Nice. The number of
      subjects required is 450 women (1: 4 sample of the target population).

      Data collection will be carried out by hetero-questionnaire carried out in the presence of
      the questioned.
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Women asylum seekers victims of sexual violence
Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec
Condition: Type 1 Diabetes Mellitus; Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Complications
Study type: Interventional

Summary: 
      To determine and compare the time-to-hypoglycaemia (defined as plasma glucose <3.9mmol/L) in
      individuals with type 1 diabetes treated with ultra-Long acting insulin degludec during
      aerobic exercise with or without prior ingestion of a single oral fructose load.
    

Detailed description: 
      Glycaemic control remains complex and demanding during exercise for type 1 diabetes (T1D)
      patients. Traditional treatment guidelines for exercise emphasizing the reduction of insulin
      doses and/or ingestion of additional carbohydrates are of limited applicability for patients
      treated with ultra-long acting basal insulin analogues. Dose reductions may require two to
      three days for modern basal insulin analogues in order to achieve an adapted steady state,
      hereby increasing the risk of inadequate insulin-following exercise. If T1D patients engage
      in recreational exercise - as recommended by every international treatment guideline -
      current treatment strategies may simply not be sufficient.

      As a consequence for patients treated with modern basal insulin analogues, it seems more
      adequate not to modify insulin doses but to apply alternative strategies for recreational
      exercise. The ingestion of fructose, an insulin-independent carbohydrate, which increases
      lipid oxidation but attenuates the dependency on carbohydrates may offer a novel strategy. Up
      to date, only preliminary data for fructose have been produced regarding clinical
      effectiveness and underlying mechanisms in the prevention of hypoglycaemia. The present
      comprehensive study aims to investigate the clinical efficacy, feasibility, and safety of a
      pre-exercise oral fructose load without modification of insulin degludec in T1D patients.
    

Intervention name(s): Fructose; Plain water
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.; Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 1 Diabetes, Fructose, Exercise, Hypoglycaemia, Degludec
Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence
Condition: Bipolar Disorder; Alcohol Abuse/Dependence
MeSH terms: Alcoholism; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The abuse of alcohol is especially common in people with bipolar disorder. However, very
      little is known about the pharmacotherapy of people with both bipolar disorder and alcohol
      abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are
      decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine
      add-on therapy is associated with greater improvement in mood, impulsivity, functioning and
      decreased alcohol use than placebo.
    

Detailed description: 
      Experimental: After obtaining informed consent, 100 patients with bipolar I, or II disorders
      and alcohol abuse/dependence confirmed by a structured clinical interview (SCID) will be
      enrolled. from referral sources in the community we have developed over the past 3 years. A
      medical history and physical examination, including an eye exam with an ophthalmoscope, will
      also be performed at baseline to rule out serious medical illnesses and cataracts. Baseline
      labs including a liver panel and CBC will be obtained. Women of child-bearing potential will
      be given a urine pregnancy test. Baseline measures of psychiatric symptoms will be assessed
      with the HRSD, YMRS, and Barratt Impulsiveness Scale. Alcohol cravings will be assessed with
      the Obsessive Compulsive Drinking Scale (OCDS). Alcohol use including number of drinks/2
      weeks, days used in the past two weeks, and days of heavy use will be obtained as will a
      urine drug/alcohol screen. Alcohol use and cravings will also be recorded throughout the
      study. Side-effects will be assessed with a general side effects scale, the Abnormal
      Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), and Barnes Akathesia Rating
      Scale (BARS). GGT levels will also be repeated at weeks 6 and 12. The subjects will be
      randomized and receive quetiapine or identical appearing placebo add-on therapy in a
      double-blind fashion for 12 weeks. Subjects will return every two weeks for reevaluation with
      the above outcome measures and for upward titration of study drug. All subjects will be given
      the option of receiving open-label quetiapine for an additional 4 weeks (with continuing
      assessment of mood and alcohol use/cravings every 2 weeks) at the end of the study or
      discontinuing medication.
    

Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women
Condition: Ovulation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect
      of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.
    


Intervention name(s): NES/E2 gel
Intervention type(s): Drug
Intervention description(s): Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: NES/E2; transdermal gel delivery; contraception; ovulation; bleeding patterns
Influenza Vaccine in HIV Study
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The aims of this study are:

        1. to investigate if HIV infection alters the antibody responses to influenza and

        2. to assess the ability of licensed influenza vaccine to induce functional
           non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.
    


Intervention name(s): 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)
Intervention type(s): Biological
Intervention description(s): Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.
Intervention MeSH terms: Vaccines
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are recruited from two sites in Melbourne, Australia:

          -  Melbourne Sexual Health Centre (HIV-positive and HIV-negative subjects)

          -  The University of Melbourne at the Peter Doherty Institute for Infection and Immunity
             (HIV-negative subjects only)
      
Biospecimen description: 
      Serum, plasma, peripheral blood mononuclear cells
Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids
Condition: Postoperative Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Observational

Summary: 
      To explore the effect of daytime variation on postoperative hyperalgesia induced by opioids.
      Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning
      group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia
      maintenance were respectively included. Postoperative hyperalgesia at PACU and 24 hours after
      surgery were assessed through mechanical pain measurement. Comparative analysis of
      postoperative hyperalgesia levels, pain and analgesic requirements between morning group and
      afternoon group were performed.
    


Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): Remifentanil was used for maintenance of anesthesia.
Intervention MeSH terms: Remifentanil
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning
        group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia
        maintenance were included.
      
Biospecimen description: 
      Peripheral blood is collected before and after the surgery.
ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System
Condition: Atherosclerosis; Peripheral Vascular Disease; Claudication
MeSH terms: Atherosclerosis; Vascular Diseases; Intermittent Claudication; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional

Summary: 
      The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance
      of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease
      of the superficial femoral (SFA) or common or external iliac arteries.
    


Intervention name(s): ESPRIT BVS
Intervention type(s): Device
Intervention description(s): Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Urdu Translation of Wayfinding Questionnaire for Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Descriptive analytical study to translate WQ in Urdu Language. The WQ is in English Language
      the name of the author of WQ is Van der Ham Et al and firstly introduced in 2013. The
      reliability of this English tool is 0.70 to 0.80 it has been translated in various Languages
      i.e Hungarian, Dutch and Chinese and suffering from stroke. But it was not translated in Urdu
      Language. No such study has been previously conducted in Pakistan region which translates the
      scale and follows the proper cross-cultural adaptation
    

Detailed description: 
      For resolving such problem WQ play pivotal role in accessing navigation problem of stroke
      patients it is a very reliable tool for accessing navigation issue. The scale consists of 22
      items. All the items dated from 01 to 07 in which stroke patients are accessed. The patients
      who are taken in the study age from 18 to 65 years. As the WQ is a well-developed measurement
      scale for accessing navigation in stroke patients. It is meaningful to validate its Urdu
      version. The translation and cultural adaptation process would start after obtaining approval
      from the developer of the original WQ. This would be done according to bitten guidelines. The
      purpose will be to gain uniformity in the translation of both the target Language and source
      Language. This will involve 5 steps which is forward translation, synthesis 1, back
      translation, synthesis 2 and pallet testing. The second step would be done according to the
      Beaton guidelines in which psychometric properties will be measured that is internal
      consistency, test retest reliability, Discriminant validity, Convergent Validity, Content
      Validity and Factor analysis
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        stroke
      
Keywords: Way finding Questionnaire, Navigation, Cognition.
Relationship Between The Quadriceps Muscle Stiffness And Patellar Alignment For Healthy People
Condition: Patellofemoral Maltracking
Study type: Observational

Summary: 
      Patellofemoral pain is a common disease, and it often couples with patellar malalignment.
      Previously, imbalance of the different quadriceps muscle heads was believed to be a causative
      factor of patellar malignment. However, findings from electromyography studies on quadriceps
      activities and patellar alignment in the last two decades were inconsistent. In order to
      better understand the relationship between quadriceps muscle imbalance and patellar
      malalignment, shear wave elastography (SWE), which can measure the passive and active muscle
      stiffness, may shed some new lights to this area. This study aims to examine whether the
      quadriceps muscle stiffness can predict the patellar position. The healthy young adult will
      be recruited in this study. Active and passive quadriceps muscle stiffness will be measured
      with the SWE in different conditions and the result will be correlated with the patellar
      position measured with magnetic resonance imaging (MRI). Also, electromyography (EMG)
      activity will be measured during the active stiffness measurement so as to establish the
      level of agreement between the EMG and SWE data. Linear regression will be used to calculate
      the relationship between different factors. The total number of subjects needed will be 55 by
      setting an effect size of 0.15 with two predictors, 80% power, and α at 0.05 in the linear
      regression.

      This project will be conducted at PolyU campus and an MRI clinic in Hong Kong. Hopefully, it
      could be started in July 2021 and will last for 1 year.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy subject without patellofemoral joint problem
      
Keywords: muscle stiffness; patellofemoral alignment
Degradation of the Anorexic Hormone Peptide YY
Condition: Healthy
MeSH terms: Anorexia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon
      food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study
      we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a
      C-terminally degraded metabolite, PYY3-34, is formed after infusion of PYY.
    


Intervention name(s): PYY1-36 infusion; PYY1-36 + sitagliptin; PYY3-36 infusion; placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.; Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs. Two doses of 100 mg sitagliptin are administered 10 and 1 hour before start of infusion, respectively.; 0.8 pmol/kg/min infusion of PYY3-36.; Infusion of saline for 2 hrs.
Intervention MeSH terms: Sitagliptin Phosphate
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: PYY; Degradation; kinetics; men
Comparison of Pragmatic Posterior Capsular Stretch and Crossbody Stretch on the Shoulder Mobility
Condition: Shoulder Impingement; Shoulder Pain; Adhesive Capsulitis; Rotator Cuff Tears; Posterior Capsule Tear; Glenohumeral Subluxation; Glenohumeral Dysplasia; Acromioclavicular; Sprain (Strain); Internal Rotation Contracture-shoulder; External Rotation Contracture-Shoulder; Flexion Contracture; Extension Contracture-Shoulder
MeSH terms: Shoulder Pain; Bursitis; Contracture; Shoulder Impingement Syndrome; Shoulder Dislocation; Rotator Cuff Injuries; Sprains and Strains
Study type: Interventional

Summary: 
      Various stretches are used to lengthen the posterior shoulder capsule. No study has reported
      the comparison of the pragmatic posterior capsular stretch and cross body stertch
    

Detailed description: 
      Background: Posterior capsular tightness (PCT) is frequently seen in shoulders in athletic
      population and shoulder disoders. PCT leads to variation in scapular and humeral kinematics.
      Two techniques considered in our study for regaining normal range of motion at shoulder joint
      and improving PCT, one is the pragmatic posterior capsular stretch (PPCS) & the other one is
      cross body stretch (CBS) Objective: The aim of our study id to compare the short
      term/intermediate term effect of PPCS and CBS on range of motion on shoulder joint in healthy
      individuals. And to evaluate the feedback of subjects regarding both the interventions.

      Methodology: Sixty a symtomatic shoulder of 30 subjects (15 males, 15 females) were recruited
      for this restricted randomised control trials. A simple random sampling technique was used.
      Subjects were screen through a functional movement screening tool of shoulder mobility. The
      change in hand behind neck and hand behind back will be measured through measuring tape.
      Shoulder ROM and functional movements for both the stretches will be campared. Particpants
      will be follwed for 4 weeks for the change in their shoulder range of motion.
    

Intervention name(s): pragmatic posterior capsular stretch; cross body stretch
Intervention type(s): Other; Other
Intervention description(s): pragmatic posterior stretch is used to increase the length of the posterior capsule; crossbody stretch performed by an individual
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of Advantage Arrest in Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy
      children to contribute to evidence for the safety of Advantage Arrest, consistent with
      Guidance for Industry--Exposure--Response Relationships (April 2003).
    

Detailed description: 
      This is a topical agent where the active ingredients are applied to the teeth and eventually
      swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed
      through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional
      to the dose of silver and fluoride administered topically to the teeth as part of Advantage
      Arrest. This is an open label exposure-response study with up to 50 healthy children ages
      3-13 years of age. Subjects will be treated with Advantage Arrest and have one blood sample
      withdrawn at a randomly assigned time point. A minimum of 3 subjects per time point at
      2,4,6,24,48,96 and 168 hours. Serum samples will be analyzed for F and Ag.
    

Intervention name(s): Silver Diamine Fluoride
Intervention type(s): Drug
Intervention description(s): 38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7
Other intervention name(s): Advantage Arrest
Intervention MeSH terms: Fluorides
Intervention model: Single Group Assignment
Intervention model description: Open label exposure--response study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child; pharmacokinetics; silver diamine fluoride
Choroidal Thickness Measurements During Central Serous Chorioretinopathy (CSCR) Treatment
Condition: Choroidal Thickness
Study type: Observational

Summary: 
      The purpose of this study is to determine changes in choroidal thickness in patients with
      Central Serous Chorioretinopathy (CSCR) during the first 3 months after initial diagnosis via
      Enhanced-Depth-Imaging-Spectral-Domain-Optical-Coherence-Tomography (EDI-OCT).

      Study hypothesis: Since exudative changes in the choroid seem to constitute the primary
      pathology of CSCR, changes in choroidal thickness compared to healthy eyes should be present
      and be visible using EDI-OCT.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with reduction of vision due to Central Serous Chorioretinopathy