bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      single and repeat doses of 800 mg GSK2586184 in healthy subjects.
    

Detailed description: 
      This is a study in healthy volunteers to investigate the safety, tolerability,
      pharmacokinetics (the body's effect on the drug) and pharmacodynamics (the drug's effect on
      the body) of single and repeat doses of 800 mg GSK2586184. The effect of food and gender on
      pharmacokinetics will also be investigated following single dosing.

      The study is made up of 2 groups of healthy subjects. The first group consists of 6 female
      subjects who will receive a single dose of 800mg GSK2586184 (study medication) during 2
      seperate sessions. One session will involve the female subjects taking the study medication
      with food and the other session will involve study medication being taken without food. The
      safety and tolerability of the study medication in female subjects and the effect of food on
      the pharmacokinetics of the study medication will be investigated.

      The second group will consist of 12 healthy male subjects participating in 2 sessions. 8
      subjects will receive study medication and 4 will receive placebo (dummy medication) during
      the course of the study. Neither they or their study doctor will know which one they are
      given. Each male subject will receive a single dose of study medication or placebo followed
      by 13 days of twice daily dosing of study medication or placebo. Each dose will be taken with
      food.The single dose results from this group of subjects will be compared to the female group
      to investigate the effect of gender on pharmacokinetics. The safety and pharmacokinetics of
      repeat dosing will be investigated. The effect of repeat dosing on kidney function and the
      immune system will also be investigated.

      The study will take place in the SGS Clinical Pharmacology Unit in Antwerp, Belgium. A
      pharmaceutical company, GlaxoSmithKline, is funding the study.
    

Intervention name(s): GSK2586184 800mg single and repeat dose; Placebo-to-match GSK2586184; GSK2586184 single dose taken with food; GSK2586184 single dose taken without food
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): GSK2586184 800mg single dose and then twice daily dosing for 13 days; Placebo-to-match GSK2586184; GSK2586184 single dose taken with FDA approved high fat, high calorie breakfast; GSK2586184 single dose taken in a fasted state
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Simultaneously PET/MRI in Prolonged DOC Patients
Condition: Disorder of Consciousness; Minimally Conscious State; FDG-PET; Rs-fMRI
MeSH terms: Consciousness Disorders; Persistent Vegetative State
Study type: Observational

Summary: 
      Recently introduced hybrid PET/MR scanners provide the opportunity to measure simultaneously,
      and in direct spatial correspondence, both metabolic demand and functional activity of the
      brain, hence capturing complementary information on the brain's physiological state. Here we
      exploited PET/MR simultaneous imaging to explore the relationship between the metabolic
      information provided by resting-state fluorodeoxyglucose-PET (FDG-PET) and fMRI (rs-fMRI) in
      patients with disorders of consciousness.
    


Intervention name(s): Multimodal Neuroimaging
Intervention type(s): Diagnostic Test
Intervention description(s): fludeoxyglucose (FDG-)PET/MR imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Distinguishing patients in unresponsive wakefulness syndrome, UWS [i.e. patients showing
        eyes opening but no behavioral evidence of consciousness ] from patients in minimally
        conscious state, MCS [i.e., patients showing minimal, inconsistent but clearly discernible
        intentional behaviors ] is pivotal for decision making in the entire care pathway of
        patients with DoC.
      
Keywords: Disorder of Consciousness; Unresponsive wakefulness syndrome; Multimodal Neuroimaging
Distribution of Medication Disposal Packets - Acute Opioid Prescribing
Condition: Orthopedic Surgery; Neurosurgery; Surgery; Opioid Use; Opioid Misuse
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Many prescription opioids following surgery are left unused and are at risk of being misused
      or diverted. Encouraging proper disposal is important, yet motivating this behavior remains
      challenging as patients must understand the risks of opioids, the benefits of disposal, and
      identify opportunities and places to dispose of them safely. Alternative disposal techniques
      can improve disposal rates but may be lost or forgotten. Applying behavioral economics
      techniques may lower the barriers and promote disposal. The objective is to test the effect
      of a specifically timed, mailed, at-home kit on disposal rates following surgery.
    

Detailed description: 
      A pragmatic, cluster-randomized quality improvement study embedded in an existing automated,
      post-operative text messaging program to capture patient-reported outcomes (e.g., pain score,
      opioid use, ability to manage pain) and disposal as part of usual care. It was approved by
      the University of Pennsylvania Institutional Review Board with a waiver of informed consent.

      All patients, 18 years or older, undergoing an orthopedic or urologic procedure and
      prescribed an opioid were approached and consented via text messaging. Patients without
      access to a text message capable device or non-English speaking were excluded. Participants
      were block randomized to usual care or a mailed at-home disposal packet. Usual care consisted
      of a text message hyperlink to nearby disposal locations. Intervention participants were
      mailed an at-home disposal packet timed to arrive between post-operative days four and seven
      based on prior data collection on reported use. The disposal packet (DisposeRx Inc.) contains
      a powder that sequesters unused opioids in a polymer gel. Patients self-reported disposal via
      the automated system.
    

Intervention name(s): Medication Disposal Packet
Intervention type(s): Other
Intervention description(s): The disposal packet (DisposeRx Inc.) contains a powder that sequesters unused opioids in a polymer gel. The kits reached patients four days following their surgery based on prior data to leverage availability bias, or a tendency to think or act on things that are most present in one's mind, and provided patients with a disposal technique when they were likely to be finished with their opioids. The process of mailing the disposal packet is simple, low cost (~$1.50/ mailed packet) and scalable.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Opioid Prescribing; Mobile Health; Quality Improvement; Learning Health Systems
Exploratory THS 2.1 Nicotine Pharmacokinetics and Safety Study
Condition: Smoking
Study type: Interventional

Summary: 
      The main goal of this exploratory study is to evaluate the pharmacokinetic profile of
      nicotine for the candidate modified risk tobacco product THS 2.1 and for conventional
      cigarettes (CC).
    

Detailed description: 
      This 2-period 2-sequence cross-over clinical study intends to explore the profile of nicotine
      uptake (rate and extent of nicotine absorbed and associated variability) in healthy smokers
      switching from (CC) to THS 2.1 (single or ad libitum use) compared to smokers continuing to
      use CC, as a comparator. This study will serve to optimize blood sampling schedules and
      sample size estimation for further studies. This study will also provide preliminary
      information on the relationship between nicotine absorption and urge to smoke/withdrawal
      symptoms when using THS 2.1 as compared to CC, as well as the safety profile, which is
      related to the use of THS 2.1.

      After screening, enrolled subjects will be admitted to the clinic for 8 days. This study
      duration includes 2 consecutive periods. Each period consists of 1 day for single use of the
      product preceded by a 24-hour nicotine deprivation, and 1 day for ad libitum product use.
      After leaving the clinic, the subjects will be followed up for safety over a period of 7
      days.

      This clinical study will be conducted in compliance with International Conference on
      Harmonisation of technical requirements for registration of pharmaceuticals for human use
      (ICH Good Clinical Practice), the Declaration of Helsinki as amended in 2008, and the
      applicable regulatory requirements.
    

Intervention name(s): Conventional cigarettes (CC); THS 2.1
Intervention type(s): Other; Other
Intervention description(s): Subjects are randomized in a 1:1 fashion to be assigned to one of the 2 sequences, either A) CC and then THS 2.1, or B) THS 2.1 and then CC.; Subjects are randomized in a 1:1 fashion to be assigned in one of the sequences, either A) CC and then THS 2.1, or B) THS 2.1 and then CC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Modified risk tobacco product (MRTP); Smoking; Nicotine profile
Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe
      and well tolerated.
    

Detailed description: 
      This study is designed to describe the safety, tolerability, immunogenicity, and
      pharmacokinetics of escalating, repeated IM injections (the intended route of administration
      for immunoprophylaxis) of MEDI-524, initially in children £6 months old with a history of
      prematurity (³32 to £35 weeks gestation, without BPD), one of the target populations of
      infants at high risk for serious RSV disease.
    

Intervention name(s): Medi-524
Intervention type(s): Biological
Intervention description(s): IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
Condition: Brain Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      The study is an observational, European, multi-center, prospective assessment of the clinical
      utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms
      deemed appropriate for endovascular treatment.
    

Detailed description: 
      All eligible subjects presenting to the participating Centers will be considered for entry
      into the study. Up to 160 evaluable subjects meeting the study entry criteria will be
      enrolled.

      Subjects will be followed per Institution's standard of care.
    

Intervention name(s): WEB Aneurysm Embolization System
Intervention type(s): Device
Intervention description(s): Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The decision to use a WEB device to treat the patient has been made before and
        independently of the decision to include the patient in this study
Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Condition: Circumcision
Study type: Interventional

Summary: 
      This study will evaluate a new, minimally-invasive surgical circumcision technique for men,
      which is easy to learn and perform, is safe, and is associated with high patient satisfaction
      and excellent cosmetic results.
    

Detailed description: 
      Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV
      transmission. Currently, the most widely used VMMC technique in South Africa is open surgical
      circumcision.

      According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision
      (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a)
      would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than
      current methods and/or might entail less risk of HIV transmission in the post-operative
      period; (c) could be performed safely by health-care providers with a minimal level of
      training; and (d) would be cost-effective compared to standard surgical methods for male
      circumcision scale up."

      This quasi-experimental compares the open surgical technique to an alternative
      minimally-invasive technique using the disposable Unicirc device with tissue adhesive. The
      controls come from a separate randomized controlled trial (Unicirc 001) that was conducted
      just prior to the Unicirc 002 case series of 50 subjects. The investigators postulate that
      VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an
      easier technique to learn and perform, requires less intraoperative time, is safer for both
      surgeons and patients, heals quicker, and is more cost effective than other currently
      available techniques. The disposable nature of the device is an immense advantage as it
      eliminates the need to sterilize and can therefore be used in resource-limited settings. It
      also reduces the chances of infection caused by contaminated instruments.
    

Intervention name(s): Surgical Control; Unicirc with tissue adhesive
Intervention type(s): Procedure; Procedure
Intervention description(s): The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.; Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Circumcision; Voluntary medical male circumcision; Minimally-invasive; HIV prevention
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
Condition: Recurrent Bacterial Vaginosis (BV)
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the
      prevention of recurrence of bacterial vaginosis.
    


Intervention name(s): 1% SPL7013 Gel; 3% SPL7013 Gel; placebo gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): vaginal gel; vaginal gel; vaginal gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: BV; Bacterial vaginosis; recurrent; SPL7013 Gel; VivaGel
Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the use of the drug isradipine for cognitive
      enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.
    

Detailed description: 
      The purpose of this study is to evaluate the use of the drug isradipine for cognitive
      enhancement in patients diagnosed with schizophrenia and schizoaffective disorder. Incomplete
      treatment response can be common in these disorders. While there are medications that are
      effective at treating positive symptoms, some other symptoms of the disorders are often left
      only partially treated (cognitive impairment and negative symptoms). This study will begin to
      address if the medication isradipine might help to treat some of the cognitive problems
      associated with schizophrenia and schizoaffective disorder. Isradipine is a medication that
      acts by blocking a specific type of receptor in the brain called a calcium channel. It is
      currently approved by the FDA for hypertension.
    

Intervention name(s): isradipine
Intervention type(s): Drug
Intervention description(s): Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel
Other intervention name(s): Dynacirc CR
Intervention MeSH terms: Isradipine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cognition; Schizophrenia; Schizoaffective disorder
Clinical Markers of Panic and Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder; Panic Disorder; Duration of Untreated Illness
MeSH terms: Anxiety Disorders; Panic Disorder
Study type: Observational

Summary: 
      The goal of this observational study is to compare socio-demographic and clinical features in
      patients affected by Generalized Anxiety Disorder (GAD) and by Panic Disorder (PD). The main
      questions it aims to answer are:

        -  which socio-demographic/clinical markers are associated to GAD or PD diagnosis?

        -  which factors are associated with a longer duration of untreated illness (DUI) in GAD
           and in PD? Participants will signed a written informed consent and
           socio-demographic/clinical variables will be retrospectively collected. Researchers will
           compare GAD and PD groups in terms of socio-demographic and clinical features, including
           DUI, to better characterize the two disorders and to investigate factors associated to a
           longer DUI.
    


Intervention name(s): Structured Clinical Interview for DSM-5
Intervention type(s): Diagnostic Test
Intervention description(s): A structured interview will be administered to confirm the diagnosis reported in clinical charts
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients suffering from PD or GAD identified from medical records in the pre-pandemic
        period (2016-2019).
"Studio NaVA" - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Observational

Summary: 
      "Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on
      Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio
      Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that
      contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI,
      Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents;
      Rhinasthma; VAS scale), that will be available for the doctors after the registration to the
      web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to
      fill them during the waiting time of the visit.
    


Intervention name(s): Data Collection
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age,
             recruited from Pediatricians of the Italian territory

          -  600 subject (5 for each participant Pediatrician) of the same age range, without
             respiratory pathology (patient family)
      
Keywords: Adolescents; Respiratory Pathology
Differentiation HHD From HCM (EARLY-MYO-HHD)
Condition: Hypertrophic Cardiomyopathy; Hypertensive Heart Disease
MeSH terms: Heart Diseases; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertension; Hypertrophy
Study type: Observational

Summary: 
      Differentiating hypertrophic cardiomyopathy (HCM) from hypertensive heart disease (HHD)
      unavoidably encounters diagnostic challenges especially in patient of suspected HCM with
      history of hypertension. Diverse and overlapping forms of HCM can often lead to ambiguity
      when diagnosis is based on a single genetic or morphological index.

      The investigators have deduced a integrated formula based on cardiac magnetic resonance (CMR)
      imaging and established a differentiating flow-chart between HCM and HHD, the investigators
      aim to identify their method in the current multi-center trial.
    

Detailed description: 
      Both hypertrophic cardiomyopathy (HCM) and hypertensive heart disease (HHD) present left
      ventricular hypertrophy (LVH), but the prognosis varies. Nevertheless, the feasibility of
      distinguishing these two conditions is limited by the fact that overlapping LVH and diverse
      forms of HCM can often lead to diagnostic ambiguity when diagnosis is based on a single
      morphological index. Diagnosis is more difficult in a patient with a history of hypertension
      and with left ventricular wall thickness between 11 and 15 mm. It also puzzles the situation
      when hypertrophy without outflow-track obstruction was found in hypertensive subjects which
      might not be explained solely by the history of hypertension.

      The investigators have deduced an integrated formula based on cardiac magnetic resonance
      (CMR) imaging and established a differentiating flow-chart between HCM and HHD. In this
      study, the investigators aim to explore the applicability of the quantifying scheme for
      distinguishing HCM from HHD in the multi-center trial.
    

Intervention name(s): evaluated by the predetermined differentiating formula
Intervention type(s): Diagnostic Test
Intervention description(s): After recruiting patients, collecting the baseline data, a CMR scan will be carried out and post-processed, a predetermined differentiating formula (including left ventricular morphology, ejection fraction, presence of late gadolinium enhancement, T1 value and strain data) will be used to produce a cardiac values, which is to be input into our differentiating flow.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive subjects were prospectively enrolled into 3 cohorts between July 2017 and June
        2020. The cohorts were divided as follows: the hypertrophic cardiomyopathy, hypertensive
        heart disease and control groups
      
Keywords: hypertrophic Cardiomyopathy; hypertensive Heart Disease; cardiac magnetic resonance