bioihbjkbjnl/mcl2 huggingface dataset:
Immunization Via Mosquito Bite With Radiation-attenuated Sporozoites
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety, tolerability, and biomarkers of protection in healthy
      malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either
      infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected
      (mock-immunization).
    

Detailed description: 
      This is a Phase 1 open-labeled study. In addition to safety and tolerability of Plasmodium
      falciparum Sporozoites (PfRAS), this study is a comprehensive, systems biology-based effort
      to identify and validate biomarkers of protection with PfRAS immunization, comparing
      sterility protected to nonprotected study subjects. The goal of the trial design is to
      achieve approximately 50% sterile protection in order to facilitate the identification of
      biomarkers and correlates of protection.

      Following true-immunization or mock-immunization, study subjects and nonimmunized infectivity
      controls will receive a challenge via the bites of 5 An stephensi mosquitoes carrying
      infectious P falciparum sporozoites within a controlled clinical environment (controlled
      human malaria infection, CHMI) to determine the level of sterile protection.
    

Intervention name(s): PfRAS; Placebo; Challenge
Intervention type(s): Biological; Biological; Other
Intervention description(s): Radiation-attenuated Plasmodium falciparum sporozoites (PfRAS) administered by the bite of infected Anopheles stephensi mosquitoes; Administered by the bite of noninfected Anopheles stephensi mosquitoes; 5 infectious Anopheles stephensi mosquito bites carrying infectious Plasmodium falciparum sporozoites within a controlled clinical environment.
Other intervention name(s): True-immunization; PfRAS infected Anopheles stephensi mosquitoes; Mock-immunization; Noninfected Anopheles stephensi mosquites
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
Condition: Urinary Bladder Neurogenic
MeSH terms: Urinary Bladder, Neurogenic
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin
      (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years
      of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology
      stratified into 2 age groups (2 to 7 years and 8 to 16 years).

      The secondary objectives are to investigate the safety and tolerability of the 2 dose
      regimens and to determine the effect of the 2 dose regimens on detrusor LPP.
    


Intervention name(s): alfuzosin (SL770499)
Intervention type(s): Drug
Intervention MeSH terms: Alfuzosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: elevated detrusor leak point pressure
The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
Condition: Fontan Circulation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will test the hypothesis that a single dose of sildenafil can increase the exercise
      capacity of pediatric patients with a Fontan Circulation.
    


Intervention name(s): Sildenafil; Placebo; Sildenafil 2; Placebo 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.; Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.; oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).; Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).
Other intervention name(s): Viagra; Ora-sweet and Ora-plus (1:1 ratio).; Viagra; Ora-sweet and Ora-plus (1:1 ratio).
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fontan; sildenafil; exercise capacity; Patients with Fontan Circulation
The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD
Condition: Bronchiectasis; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchiectasis
Study type: Observational

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways
      and lungs that develops against harmful particles or gases with exacerbations. Coexistence of
      bronchiectasis with COPD may lead to worsening of the functional parameters as well as
      alteration of the microbiological pattern in exacerbations and may negatively affect the
      exacerbation result parameters.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways
      and lungs that develops against harmful particles or gases with exacerbations. COPD
      exacerbations are characterized by worsening of dyspnea, coughing and expectoration.
      Exacerbations requiring hospitalization are the main cause of morbidity and mortality in
      COPD. Bronchiectasis is the irreversible extension of the bronchi. Usually follows with
      chronic sputum cough, airway obstruction and recurrent infection episodes. The association of
      bronchiectasis and COPD has long been known and its incidence is in the range of 30-50%.
      Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as
      well as alteration of the microbiological pattern in exacerbations and may negatively affect
      the exacerbation result parameters.
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with COPD exacerbation
      
Keywords: Bronchiectasis; Chronic Obstructive Pulmonary Disease; Exacerbation; Computed Tomography
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of repeated administration of NurOwn®
      (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived
      mesenchymal stromal cells (MSC), which are enriched from the patient's own bone marrow,
      propagated ex vivo and induced to secrete Neurotrophic factors (NTFs).

      The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally
      by standard lumbar puncture where neurons and glial cells are expected to take up the
      neurotrophic factors secreted by the transplanted cells
    

Detailed description: 
      Neurotrophic factors (NTFs) are potent survival factors for embryonic, neonatal, and adult
      neurons and are considered potential therapeutic candidates for ALS. Delivery of multiple
      NTFs to the immediate environment of afflicted neurons in ALS patients is expected to improve
      their survival and thus slow down disease progression and alleviate symptoms. NTF-secreting
      mesenchymal stromal cells (MSC-NTF cells) are a novel cell-therapeutic approach aimed at
      effectively delivering NTFs directly to the site of damage in ALS patients.

      Participants meeting the inclusion and exclusion criteria will be randomized and will undergo
      bone-marrow aspiration. MSC of the participants randomized to the treatment group will be
      induced into MSC-NTF cells. Participants will undergo a total of three intrathecal (IT)
      transplantations with NurOwn® (MSC-NTF cells) or matching placebo at three bi-monthly
      intervals
    

Intervention name(s): NurOwn® (MSC-NTF cells); Placebo; Bone Marrow aspiration
Intervention type(s): Biological; Other; Other
Intervention description(s): Autologous transplantation of bone marrow derived mesenchymal stem cells propagated ex vivo and induced to secrete neurotrophic factors; Placebo; Bone Marrow aspiration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled Multicenter Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MSC; Autologous; Neurotrophic factors
Physical Activity on Prescription and Enhanced Individual Support by Physiotherapist
Condition: Physical Activity; Sedentary Behavior; Multimorbidity
Study type: Observational

Summary: 
      Multimorbidity is common, especially in the elderly population and is associated with a
      higher risk of mortality and disability, lower quality of life, polypharmacy, increased
      healthcare use and costs. Physical inactivity increases the risk of multimorbidity and
      individuals with multimorbidity are more likely to be physically inactive. Physical activity
      can prevent and treat several diseases. Physical Activity on Prescription (PAP) is an
      evidence-based method used in health care to increase physical activity. The aim of this
      study was to investigate whether self-reported physical activity level increase and sedentary
      time decreases in individuals who have received PAP in health care completed with enhanced
      individual support by physiotherapist at PAP-reception in wellness center for six months and
      to compare individuals with one diagnosis to individuals with multimorbidity.

      The study population consisted of 331 adults who received PAP in health care and enhanced
      individual support by a physiotherapist at PAP-reception during six months. Data has been
      collected retrospectively from a local register with questionnaires from the PAP-reception.
      Self reported physical activity minutes/week and hours of sedentary time/day were measured at
      baseline and at six months. Differences in physical activity minutes and sedentary time from
      baseline to six months have been compared between individuals with one diagnosis and
      individuals with multimorbidity.
    


Intervention name(s): Increased physical activity
Intervention type(s): Behavioral
Intervention description(s): PAP and enhanced individual support by physiotherapist to increase physical activity
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of men and women aged 20-93 years who received PAP from
        health care and enhanced individual support by physiotherapist at PAP-reception in wellness
        centre in central and western Gothenburg in 2015-2016. The majority of the study population
        had a multimorbidity and the most common diagnosis was musculoskeletal disease.
      
Keywords: Physical activity on prescription; Individual support; Enhanced support; Person-centered care; Physiotherapist
A Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion in Patients
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-blind, randomized, active controlled, multi-center, parallel group study comparing
      HSK3486 with Propofol, in patients undergoing a colonoscopy.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): For induction and maintenance of sedation.; For induction and maintenance of sedation.
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Lorazepam on Cognition in APOE e4 Carriers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      We expect the results of this pilot study to justify a larger study that follows people to
      determine if certain tests of memory and attention, performed while sleepiness is induced by
      a single dose of lorazepam (a widely used anti-anxiety medication) could predict an
      individual's risk of developing AD. We plan to compare cognitively normal people who possess
      a common gene that increases risk for AD- the apolipoprotein E (APOE) e4 allele-to
      individuals without this gene. We hypothesize that a single 2 mg dose of lorazepam will cause
      more cognitive impairment in carriers of the APOE e4 allele than in noncarriers, and that the
      carriers will recover more slowly from these impairments than noncarriers.
    

Detailed description: 
      We aim to compare measures of memory and information processing speed at 2.5 hours and 5
      hours after the administration of a 2 mg dose of lorazepam or placebo in cognitively normal,
      50-65 year old APOE e4 carriers and noncarriers, and determine the differential impact of
      lorazepam on cognition at each time point. Twenty carriers and 20 noncarriers matched for
      age, sex, and education will be drawn from a database of persons who have already undergone
      genotyping for an ongoing study at the Mayo Clinic, excluding people with evidence of
      depression or cognitive impairment and other medical, neurological or psychiatric conditions.
      Using a double blind, crossover design, subjects will receive either placebo or a 2 mg dose
      of lorazepam after baseline testing. Equivalent tests will be repeated 2.5 and 5 hours post
      challenge. The data analysis will compare APOE e4 carriers to noncarriers.
    

Intervention name(s): lorazepam; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single 2 mg dose of lorazepam; single dose of placebo
Other intervention name(s): Ativan
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: apolipoprotein E e4; Alzheimer's disease; somnolence; Early detection
Kefir Versus Milk on Time-Trial Performance in Masters Athletes
Condition: Gastrointestinal Complication; Exercise Performance; Aerobic Endurance
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of added probiotic cultures to a
      carbohydrate + protein recovery beverage compared to a similar recovery beverage without
      probiotic cultures, in its ability to impact endurance performance, perceived ratings of
      gastrointestinal symptoms and markers of inflammation and intestinal damage.
    

Detailed description: 
      In a randomized, crossover fashion, the investigators will assess changes in exercise
      performance, gastrointestinal symptom rating scale scores, as well as interleukin-6 and
      intestinal fatty-acid binding protein levels following consumption of either water, kefir or
      flavored milk.
    

Intervention name(s): Water; Flavored Kefir; Flavored Milk
Intervention type(s): Other; Other; Other
Intervention description(s): 340 mL plain tap water consumed immediately following glycogen depleting exercise; 320 mL kefir consumed immediately following glycogen depleting exercise; 240 mL flavored milk consumed immediately following glycogen depleting exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, crossover.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Kefir; Milk; Aerobic Endurance; Exercise Performance; Gastrointestinal Symptoms
The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children
Condition: Anesthesia, General
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Propofol and Sevoflurane affect the
      oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.
    


Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
First in Human Study of CT-1500 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single center, randomized, placebo-controlled, double-blind study of CT-1500
      in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics
      of single ascending doses and multiple ascending doses of orally administered CT-1500
      compared to placebo.
    

Detailed description: 
      This study is a single center, randomized, placebo-controlled, double-blind study of CT-1500
      in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics
      of single ascending doses and multiple ascending doses of orally administered CT-1500
      compared to placebo. It is planned for 5 dose levels to be investigated in the single
      ascending dose (SAD) part (Part 1) of the study, between 5 mg to 120 mg. Three dose levels
      are proposed for investigation in the multiple ascending dose (MAD) part (Part 2) of the
      study.
    

Intervention name(s): CT-1500; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hard Capsule; Hard Capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Ascending Single Doses followed by Ascending Multiple Doses of Study Intervention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Acute Effects of E-Cigarette Aerosol Inhalation
Condition: Endothelial Dysfunction; Biochemical Markers
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to examine the acute effects of nicotine free electronic
      cigarette aerosol on vascular function in healthy, non-smokers.

      This study comprises a portion of a larger study comparing results of vascular function in
      nonsmokers to vascular function in healthy smokers chronically exposed to nicotinized
      electronic cigarette aerosol versus conventional cigarettes.
    

Detailed description: 
      The purpose of this study is 1) to examine the acute effects of nicotine free e-cigarette
      aerosol on vascular function in healthy, non-smokers and 2) to examine and compare vascular
      function in healthy smokers chronically exposed, at baseline and after 12 months, to
      nicotinized e-cigarette aerosol versus conventional cigarettes as compared to age, gender and
      body mass index-matched nonsmokers. Vascular function (microvascular reactivity via dynamic
      femoral oximetry, arterial hyperemia, femoral artery flow-mediated dilation, central
      pulse-wave velocity, neurovascular reactivity) will be assessed as part of a single
      integrated MRI protocol. The outcome of the project will provide new insight into the acute
      and chronic effects of e-cigarette aerosol inhalation in terms of surrogate markers of
      endothelial dysfunction (EDF), the prime promoter of atherosclerotic cardiovascular disease,
      and aid toward establishment of future public health advisories.
    

Intervention name(s): Electronic Cigarette Aerosol
Intervention type(s): Drug
Intervention description(s): 16 two-second-long puffs from a non-nicotinized electronic cigarette.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inflammation
Risedronate in Osteopenic Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare risedronate 35 mg and placebo with respect
      to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in
      osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative
      computed tomography (3D pQCT).

      The secondary objectives are to compare the percent change from Screening/Baseline between
      the 2 treatment groups for the following measurements:

        -  Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total
           proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;

        -  3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12,
           and 24 months; and

        -  Bone turnover markers (BTMs) of:

             -  fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen
                (CTX 1);

             -  serum aminoterminal propeptide of type 1 procollagen (PINP); and

             -  urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.
    


Intervention name(s): risedronate; risedronate placebo
Intervention type(s): Drug; Drug
Intervention description(s): risedronate sodium 35 mg tablets (once a week dose); placebo for risedronate tablets (once a week dose)
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postmenopausal