bioihbjkbjnl/mcl2 huggingface dataset:
A Dose Escalation and Safety Study of I5NP in Patients Undergoing Major Cardiovascular Surgery
Condition: Injury of Kidney; Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic
      study. The study will be conducted in approximately 8-10 centers in the United States and
      Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will
      participate. Patients will receive a single IV injection of I5NP or placebo following
      cardiovascular surgery. I5NP will be administered 4 hours (+/- 30 minutes) following removal
      of the cardiopulmonary bypass machine (CBM).

      The duration of the study is approximately 44 days, inclusive of a 14 day screening period.
      Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient
      visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 and Day 7 or hospital
      discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls will be
      made at 6 and 12 months after date of surgery.
    

Detailed description: 
      The drug (I5NP) is a small interfering RNA that is being developed to protect patients from
      acute kidney injury after cardiac bypass surgery. This first-in-man study will test the
      safety of I5NP and measure how long the drug stays in the blood stream after injection. This
      study is not meant to test if I5NP protects kidneys from the damage that may occur in rare
      cases during surgery. Another purpose of this dose escalation study is to find out the right
      dose of the experimental drug to be given to study subjects in future studies. Even though
      there were no harmful effects seen in the animals tested, we do not know what side effects
      the experimental drug might cause in humans.
    

Intervention name(s): I5NP (a small interfering RNA); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single IV injection of experimental drug; Single IV injection of saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Acute Kidney Injury; Acute Renal Failure
Subclinical Atherosclerosis in HIV-infected Patients
Condition: HIV Infections; Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      We will obtain data using multi-slice CT technology to detect subclinical coronary disease in
      the HIV population. Determination of subclinical cardiovascular disease using noninvasive
      technology and elucidation of the associated risk factors will help to guide targeted therapy
      to prevent cardiovascular events in this patient population.

      We will investigate the prevalence of coronary plaque lesions and coronary artery
      calcifications in men and women with HIV disease as determined by 64-row multidetector
      computed tomography (MDCT) and MDCT coronary angiography in comparison to age-matched control
      subjects without HIV infection. We hypothesize that evidence of coronary artery calcification
      and coronary plaque lesions as seen by MDCT will be present in individuals with HIV more than
      non-HIV control subjects of the same age. We also hypothesize the degree of atherosclerosis
      will be increased in HIV patients compared to control subjects.

      We will evaluate the metabolic and inflammatory factors associated with coronary artery
      disease in HIV-infected individuals. We hypothesize that traditional cardiac risk factors as
      well as metabolic and inflammatory changes associated with HIV and its treatment such as
      dyslipidemia, increased secretion of inflammatory markers, decreased adiponectin, increased
      insulin resistance and increased visceral fat may be associated with coronary artery disease
      in HIV-infected individuals.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV infected men and women and non-HIV infected control men and women
      
Biospecimen description: 
      DNA
    
Keywords: HIV; atherosclerosis
Foster With or Without Charcoal Block or Aerochamber Plus
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite
      beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol
      100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique
      or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the
      standard actuator
    


Intervention name(s): charcoal block; Aerochamber Plus spacer; pMDI standard actuator
Intervention type(s): Procedure; Device; Drug
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BDP; Formoterol; pMDI; Aerochamber Plus; Charcoal
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, placebo-controlled, randomised crossover study to investigate the
      efficacy and safety of GW876008
    


Intervention name(s): GW876008; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome safety
Visual Performance After RESTOR Implantation
Condition: Refractive Assessment
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the distance, intermediate, and near vision after
      aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.
    

Detailed description: 
      To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive
      AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

      Prospective study of 50 patients with cataract that had phacoemulsification and AcrySof®
      ReSTOR IOL implantation. Uncorrected distance vision acuity (UDVA), corrected distance visual
      acuity (CDVA), distance-corrected near visual acuity (DCNVA), and distance-corrected
      intermediate visual acuity (DCIVA) were measured postoperatively. A patient-satisfaction and
      visual phenomena questionnaire was administered at the end of the study.
    

Intervention name(s): RESTOR IOL
Intervention type(s): Procedure
Intervention description(s): The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's AcrySof® ReSTOR® intraocular lens (IOL) for cataract patients with and without presbyopia. This innovative lens uses a revolutionary apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly increases their independence from glasses after surgery
Other intervention name(s): RESTOR IQ MULTIFOCAL IOL
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multifocal IOL; ReSTOR IOL
Low Back Pain and Depression: Cohort Study
Condition: Low Back Pain; Pelvic Pain; Depression
MeSH terms: Back Pain; Low Back Pain; Pelvic Pain; Depression; Depressive Disorder
Study type: Observational

Summary: 
      The aims of this study are to investigate whether pelvic pain and low back pain disability
      are associated with postpartum depression and to compare the prevalence between women without
      Low back pain and disability and women with Low Back Pain (LBP) and disability every
      trimester, and correlate postpartum Depression and some clinical and biopsychosocial
      variables: subgroups of LBP, disability, pain intensity, pain widespread and nationality, in
      a cohort of Spanish women at 2 months postpartum.
    

Detailed description: 
      295 pregnant women will formed the cohort, during all pregnancy and two months after
      delivery. The Edinburgh Postnatal Depression Scale was used to evaluate depressive symptoms
      at 2 months postpartum. The LBP will be evaluated based on self-administrated questionnaire,
      and the patients with LBP will be classified in to lumbopelvic groups according to mechanical
      assessment of the lumbar spine, pelvic pain provocation tests, standard history, pain
      intensity on visual analogue scale, spread of pain through pain drawings and Oswestry index
      was used to evaluated the disability. Logistics regression analysis will performed to explain
      the predictors of depression.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The cohort comprised all pregnant women who were registered consecutively at this primary
        health care center
      
Keywords: Low back pain; Oswestry questionnaire; Post-partum Depression; Pelvic pain
User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients
Condition: Asthma Acute; Asthma in Children; Asthma Chronic; Asthma Attack
MeSH terms: Asthma
Study type: Observational

Summary: 
      The primary goal of this proposal is to use an in-home, smartphone-enabled, hand-held
      spirometer to determine the FEV1% predicted ranges that predict the Yellow Zone threshold.
    

Detailed description: 
      The study hypothesizes that objective lung function tracking at-home, using a portable
      spirometer in addition to conventional symptom monitoring (in which asthmatic patients
      self-report and track their own symptoms), will result in more reliable detection of
      exacerbation in children 6-15 years old with asthma.

      This is a 44-week, single arm, blinded nonrandomized trial to determine clinically relevant
      ranges in FEV1% predicted that correlate with the Yellow Zone of the Asthma Action Plan.

      A total of 100 pediatric subjects (between the ages of 6 and 15 years old) with
      physician-diagnosed mild or moderate persistent asthma treated on controller therapy will be
      enrolled from the ED, Inpatient Units, Pulmonary Medicine Clinic, and Allergy/Immunology
      Clinic at UCSF Benioff Children's Hospital San Francisco.

      Primary Specific Aim

      To determine the FEV1% predicted changes that correspond with a change from the Green to
      Yellow Zone.

      The primary outcome will be Yellow Zone episodes, as identified by the occurence of any of
      the following:

      Symptom Diary score > 4 ATAQ score > 1

      Secondary Specific Aim

      To determine the FEV1% predicted changes that correspond with a change from the Yellow to Red
      Zone.

      The secondary outcome will Red Zone episodes, as identified by the occurence of any of the
      following:

      ED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids
      Hospitalization
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 6 to15 years old with mild to moderate persistent asthma seen in the outpatient
        clinic
      
Keywords: asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management
Multiple Dose Study to Evaluate Drug-drug Interactions, Safety and Tolerability of NDC-002 in Healthy Volunteers
Condition: Stroke Sequelae; Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, One-sequence, Three-period, Multiple-dose Study to Evaluate Drug-drug
      Interactions, Safety and Tolerability between NDC-002A/NDC-002B and NDC-002C in Healthy
      Volunteers
    

Detailed description: 
      This is an Open-label, One-sequence, Three-period, Multiple-dose Study and the goal of this
      clinical trial is to evaluate in health Volunteers.

      The main question[s] it aims to answer are:

        -  Drug-drug Interactions

        -  Safety

        -  Tolerability

      The study consisted of Three-period: Period 1 which repeated administration of NDC-002C for 7
      days and Period 2 which repeated administration of NDC-002A for 7 days, followed by
      administration of NDC-002B for 8 days and Period 3 which repeated concomitant administration
      of NDC-002B and NDC-002C for 7 days.
    

Intervention name(s): NDC-002
Intervention type(s): Drug
Intervention description(s): Combination of NDC-002B and NDC-002C
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with characteristic deficits
      in social functioning and presence of stereotypic behavior. Several research studies have
      examined potential deficits in cognitive skills, such as working memory, in this condition. A
      meta-analysis of the studies aimed at evaluating working memory (WM) in autistic population
      suggested deficits in visual and verbal aspects of WM. Working memory training has also been
      studied in other neurodevelopmental disorders such as Attention Deficit Hyperactivity
      Disorder (ADHD). The study includes development of mobile-based games for training WM and
      other cognitive skills in patients and the evaluation of such training in reducing symptoms
      of ASD. These games may also be useful for other neurodevelopmental disorders.
    


Intervention name(s): Game-based cognitive training
Intervention type(s): Behavioral
Intervention description(s): A suite of 5 games is presented to the participants for training working memory
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: digital intervention; serious games
CTRP3 and Progranulin in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Visceral obesity is the one of the major causes of cardiovascular morbidity and mortality in
      industrialized countries. Adipose tissue secretes various kinds of bioactive molecules termed
      adipokines which contribute to the development of obesity-related disorders including
      cardiovascular disease (CVD). Progranulin and CTRP3 are recently discovered novel adipokines.
      Therefore, the investigators tried to compare circulating CTRP-3 and progranulin levels in
      patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated
      with CAD prevalence after adjustment for well-known CAD risk factors.
    

Detailed description: 
      CTRP-3 (synonyms CORS-26, cartducin and cartonectin) is a potent anti-inflammatory adipokine
      that inhibits proinflammatory pathways in monocytes and adipocytes. Using a recently
      developed enzymelinked immunosorbent assay (ELISA), we reported that circulating CTRP-3
      levels were elevated in patients with glucose metabolism dysregulation.

      Progranulin was identified as a key adipokine mediating high fat diet-induced insulin
      resistance and obesity through interleukin-6 (IL-6) in adipose tissue. We previously reported
      that progranulin levels were significantly higher in individuals with type 2 diabetes and
      were associated with macrophage infiltration in omental adipose tissue. Moreover, the
      expression of progranulin reduces inflammation and its degradation into granulins peptides
      enhances inflammation in atherosclerotic plaque, which may contribute to the progression of
      atherosclerosis There has been no previous report on the implication of CTRP-3 or progranulin
      in humans with cardiovascular disease (CAD). In the present study, we compared circulating
      CTRP-3 and progranulin levels in patients with CAD and investigated whether CTRP-3 or
      progranulin is significantly associated with CAD prevalence after adjustment for well known
      CAD risk factors.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Acute coronary syndrome (ACS) patients, who were admitted to the coronary care units of the
        Division of Cardiology at Guro Hospital in Korea University Medical Center.

        Control subjects were recruited from the participants for a routine health check-up in the
        Health Promotion Center of Korea University Guro Hospital.
      
Biospecimen description: 
      Blood samples
    
Keywords: CTRP-3; progranulin; coronary artery disease
Dexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Condition: Dexmedetomidine; Fentanyl; Time to Extubation; Morbid Obesity; Laparoscopic Sleeve Gastrectomy
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general
      anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy.
    

Detailed description: 
      The use of opioids in surgeries for patients with morbid obesity is controversial since they
      are known for having ventilatory depressing effects. Therefore, alternative analgesics are
      needed to improve anesthetic management for patients with obesity.
    

Intervention name(s): Group F (fentanyl group); Group D (dexmedetomidine group)
Intervention type(s): Drug; Drug
Intervention description(s): Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation and was stopped 10 minutes before the end of surgery.; The patients received loading dose of dexmedetomidine (1 μg/kg) (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) intravenously over 15 minutes before induction of anesthesia followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery.
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Comparison of physical activity parameters of the lower extremity muscles in patients who
      received total extraperitoneal repair (TEP) and STOPPA repair.
    

Detailed description: 
      The patients were evaluated during the preoperative period and in the postoperative day 3, to
      achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity
      muscular function changes.
    

Intervention name(s): Stoppa inguinal hernia repair; Total extraperitoneal inguinal hernia repair
Intervention type(s): Procedure; Procedure
Intervention description(s): Stoppa inguinal hernia repair; Total extraperitoneal inguinal hernia repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)
Condition: Chronic Hepatitis Delta
MeSH terms: Hepatitis A; Hepatitis D; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of bulevirtide combination
      with pegylated interferon in participants with chronic hepatitis delta (CHD).
    


Intervention name(s): Bulevirtide; Peginterferon Alfa-2a (PEG-IFN alfa)
Intervention type(s): Drug; Drug
Intervention description(s): Administered via subcutaneous injections; Administered via subcutaneous injections
Other intervention name(s): Myrcludex B; Hepcludex®
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if DiaPep277 can effectively protect the internal
      production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the
      immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the
      immune system and is expected to prevent further destruction of the beta-cells by stimulating
      regulatory responses, without causing immunological suppression.
    


Intervention name(s): DiaPep277; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months; Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia
Condition: Hip Arthroplasty
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      This investigation is planned to compare the incidence and severity of postoperative sore
      throat according to the dose of remifentanil.
    


Intervention name(s): Endotracheal intubation using laryngoscope; High remifentanil; Low remifentanil; High sevoflurane; Low sevoflurane
Intervention type(s): Procedure; Drug; Drug; Drug; Drug
Intervention description(s): Endotracheal intubation was done using laryngoscope for general anesthesia.; Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.; Remifentanil was administered as 0.1 mcg/kg/min.; Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.; Sevoflurane was administered as 0.5 MAC.
Intervention MeSH terms: Remifentanil; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intubation; pharyngitis; remifentanil