bioihbjkbjnl/mcl2 huggingface dataset:
Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Idiopathic pulmonary fibrosis (IPF), a manifestation of chronic progressive fibrosing
      interstitial pneumonia,ia a rare disease. Current treatment options are limited, and the mean
      survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years. As in
      Europe data are limited on the characteristics and management of such patients, INSIGHTS-IPF
      was initiated as a new registry that documents newly diagnosed (incident) and prevalent
      patients with confirmed IPF diagnosis prospectively.The registry will contribute to the
      optimization of the management of IPF patients in the long term.
    

Detailed description: 
      INSIGHTS-IPF will report current and comprehensive data on Idiopathic Pulmonary Fibrosis
      (IPF) in the long-term.

      Baseline (cross-sectional part): Description of characteristics of IPF patients in terms of

        -  key (socio-) demographic data

        -  IPF risk factors, comorbidities

        -  methods used for IPF diagnosis

        -  IPF disease severity and manifestation (including lung function, cardiopulmonary
           exercise testing and/or exercise capacity if available, laboratory values, biomarkers)

        -  IPF treatment (detailed information on prescribed drugs and doses; non-pharmacological
           treatment; listing and score for lung transplantation)

        -  assessment of patient-related outcomes (PRO) such as quality of life

      Follow-up (prospectively up to at least 2 years after inclusion):

        -  Clinical course of IPF (e.g. in terms of symptoms, lung function, exercise capacity if
           available)

        -  Documentation of treatment pathways (switch/add-on/discontinuation of medication), and
           of non-pharmacological treatment (e.g. start of long term oxygen therapy; new listing
           for lung transplantation)Outcomes/events (such as acute respiratory worsening,
           exacerbations, hospitalisation due to any cause and due to IPF, other complications,
           survival)

        -  Patient-related outcomes such as quality of life, assessed once a year(for comparison
           with baseline)

        -  Resource use for pharmacoeconomic analyses.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current
        ATS/ERS guidelines)
      
Keywords: Drug Treatment; Treatment pathways; Clinical routine; Registry; Outcomes; Survival; Patient-related outcomes; Quality of life; Steroids; Azathioprine; N-Acetylcysteine; Pirfenidone; Tyrosine kinase inhibitors; Nintedanib; multicenter; Germany; Safety; Adverse event
Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The specific objective of this research proposal is to determine the short-term efficacy of a
      primary care-based weight control intervention in which successful volunteer peers deliver a
      group-based program.

      The purpose of the study is to conduct a pilot randomized controlled trial (RCT) of a
      successful volunteer peer-led weight control program compared to a control condition to
      determine intervention efficacy at 3 months. Six peer leaders from 2 primary care clinics
      will be recruited and trained to conduct the intervention. Overweight and obese patients
      (n=80) will be recruited (randomized by individual) to determine weight loss at 3 months
      (primary outcome). The program consists of 12 weekly weight loss sessions led by a successful
      volunteer peer leader using an adaptation of the Diabetes Prevention Program to help
      participants lose weight.
    

Detailed description: 
      The intervention will consist of 12 weekly one-hour weight loss sessions led by successful
      volunteer peers. The initial weight loss session will be conducted by the peer leaders with
      oversight by the PI. This session will serve to introduce the program and give an overview of
      program. The remaining sessions, conducted by co-peer leaders, will utilize an adaptation of
      the Diabetes Prevention Program. This adaptation allows for use in a group setting and
      facilitation by a lay individual.

      Control Condition: Participants in the control condition will be given written information at
      the baseline visit from the NIH website "Aim for a Healthy Weight" to provide a basic
      understanding of weight loss and access to basic online resources. We expect that use of the
      website may result in some weight loss. However, similar information-only interventions have
      had a very small effect, which is accounted for in the sample size calculation.
    

Intervention name(s): Weight loss Groups
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Weight loss
Use of Peanut Labor Ball Following Epidural Anesthesia
Condition: Pregnancy
Study type: Interventional

Summary: 
      The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after
      epidural anesthesia in patients who have never given birth. The study will measure the impact
      on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or
      forceps use), and third or fourth degree laceration rates. This study will determine the
      impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and
      one with traditional wedge and pillow positioning. If benefits related to use of the PLB can
      be demonstrated, it is our intention that each labor room will be stocked with a PBL for use
      as standard of care.

      This study will test the following hypotheses:

        1. The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal
           delivery rate in low risk nulliparous patients who receive epidural anesthesia compared
           to similar cohort using traditional wedge and pillow positioning.

        2. Using the PLB will impact the amount of time from epidural placement to complete
           dilation and the time of second stage of labor, when compared with the control cohort.

        3. Use of the PLB will impact the third and fourth degree laceration rates when compared
           with the control cohort.
    

Detailed description: 
      See above
    

Intervention name(s): Peanut Labor Ball
Intervention type(s): Device
Intervention description(s): Peanut Labor Ball
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: epidural; pregnant; Cesarean Section; forceps; vaginal
Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension.
      Including in this evaluation is the effect PL3994 has on blood pressure.
    

Detailed description: 
      Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is
      commonly seen in emergency rooms and other urgent care settings. Current standards of care
      include intravenously administered drugs, which can be difficult to titrate and require
      ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled
      hypertension who are receiving antihypertensive medications.
    

Intervention name(s): PL3994; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study drug; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hypertension; controlled hypertension; hypertensives
Exposure Therapy Combined With Cortical Interventions for CRPS-II
Condition: Complex Regional Pain Syndromes
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
Study type: Interventional

Summary: 
      Consecutive patients with long-standing complex regional pain syndrome II in a lower limb are
      treated with graded exposure therapy in vivo in combination with methods targeting cortical
      reorganisation.
    

Detailed description: 
      Complex regional pain syndrome, CRPS, is an uncommon but often very handicapping chronic pain
      syndrome. Most often, a single extremity is affected. The diagnosis is subdivided in CRPS
      type I where no nerve injury has been identified, and CRPS type II when a major nerve injury
      has been verified. With the exception of spontaneous pain, several of the symptoms related to
      CRPS may be connected to the inactivity and immobilization often seen in the history of CRPS
      patients.

      Exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with
      the avoided movements and activities, has been shown safe and effective for patients with
      CRPS type I. The present study uses a combination of exposure in vivo and interventions
      targeting a supposed cortical reorganisation with the hypothesis that the functional
      impairments would decrease, independent of possible changes in pain levels.

      Consecutive patients with long-standing CRPS-II, diagnosed according to the Budapest
      criteria, in a lower limb are included. Treatment comprises daily graded exposure therapy in
      vivo, in combination with methods targeting cortical reorganisation: mirror therapy,
      desensibilisation training, and sensory re-education. The treatment is implemented at an
      in-patient ward during four plus four weeks, separated by a home training period of 6-8
      weeks.
    

Intervention name(s): Exposure therapy
Intervention type(s): Behavioral
Intervention description(s): Daily training at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.
Other intervention name(s): Mirror therapy; Desensibilisation training; Sensory re-education
Intervention model: Single Group Assignment
Intervention model description: A series of case-studies
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioural therapy; Exposure in vivo; Cortical reorganisation; Mirror therapy
Mass Balance Study of [14C]LC350189 in Healthy Volunteers
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, single-dose, mass balance study designed to evaluate the
      absorption, metabolism, and excretion of [14C] radiolabeled LC350189 after oral
      administration.
    


Intervention name(s): [14C] LC350189
Intervention type(s): Drug
Intervention description(s): Carbon-14 labelded LC350189
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zika Case Definition and Surveillance Study
Condition: Zika Virus Disease
MeSH terms: Virus Diseases; Zika Virus Infection
Study type: Observational

Summary: 
      This prospective, surveillance study will assess the operational Zika virus definition for
      use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to
      identify Zika virus disease (ZVD) cases among the study cohort.
    

Detailed description: 
      This prospective, multicenter, cohort study will conduct active and passive surveillance for
      ZVD and determine its prevalence and seroconversion incidence in areas of Latin America
      experiencing Zika epidemic activity. A description of the occurrence of dengue virus and
      chikungunya virus infections in the cohort may also be provided as differential diagnosis of
      ZVD.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective, multi-center, cohort study in 2400 subjects aged 15 to 40 years at enrollment
        in 4 countries in Latin America: Colombia, Honduras, Mexico, and Puerto Rico
      
Biospecimen description: 
      Blood samples and urine samples
    
Keywords: Zika virus disease
Pharmacogenetically Based Dosing of Thiopurines in Childhood Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      In a population-based study to explore the impact of TPMT-status on the risk of relapse and
      of second cancer among all patients treated according to the NOPHO ALL2000.
    

Detailed description: 
      The thiopurines 6-mercaptopurine (6MP) and 6-thioguanine (6TG) are widely used in the
      treatment of childhood acute lymphoblastic leukemia (ALL). They primarily exert their
      cytotoxicity through conversion into 6-thioguanine nucleotides (6TGN) that are incorporated
      into DNA. Interindividual variations in response to thiopurine therapy are influenced by
      genetically determined polymorphisms in the activity of the enzyme thiopurine
      methyltransferase (TPMT). TPMT competes with the formation of 6TGN, as it methylates the
      thiopurines (especially 6MP) and some of their metabolites. Approximately ten percent of all
      individuals are TPMT heterozygous, with one wild type and one low activity allele, and one in
      three hundred individuals are TPMT deficient with two low activity alleles. During the
      maintenance therapy phase of the treatment of childhood ALL, which may last several years,
      6MP is given on a daily basis at a starting dose of 75 mg/m.sq./day, which is subsequently
      adjusted to a white blood cell count of 1.5-3.5 x109/L. We have previously demonstrated that
      the risk of relapse is reduced by more than 50%, but the risk of second cancer was increased
      3-fold among TPMT low activity patients. Accordingly, the Nordic ALL2000 protocol recommended
      the dosing of 6MP to be based on the patients TPMT activity. In the present study of almost
      1000 Nordic patients, we will explore whether this strategy of TPMT-based individualised 6MP
      dosing have benefitted the patients by reducing their risk of second cancer while preserving
      their low risk of relapse.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study cohort is based on patients enrolled in the NOPHO ALL2000 protocol.
      
Biospecimen description: 
      whole blood stored for a subset of patients
First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.
Condition: Viral Disease
MeSH terms: COVID-19; Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety,
      tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2
      virus infection.
    

Detailed description: 
      It is a 2-part study in hospitalized COVID-19 patients.

        -  Part 1 is to evaluate safety, tolerability, PK and markers of clinical activity of
           escalating doses of PF-07304814 given as 24-hour IV infusion.

           2 planned and 3 optional cohorts with 8 participants each are planned.

        -  Part 2 is to evaluate safety, tolerability, PK and markers of clinical activity of
           escalating doses of PF- 07304814 given as 120-hour infusion.

           2 planned and 2 optional cohorts with 8 participants each are planned
    

Intervention name(s): PF-07304814; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-07304814 is an anti-viral, formulated for intravenous delivery; Placebo will be formulated for intravenous delivery
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Part 1 will have 2 planned cohorts. Each escalating cohort will be initiated for enrollment after assessment of safety, tolerability and PK data from previous cohorts by an independent IRC and is deemed acceptable.
Part 2 will have 2 planned cohort and each escalating cohort will be initiated after all safety, tolerability and PK data from previous cohort is evaluated and is deemed acceptable by a competent regulatory authority.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; SARS-COV-2
Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects
Condition: Cardiovascular Disease
MeSH terms: Pulmonary Arterial Hypertension; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a Phase IV, open-label, single-arm study to assess the safety and the necessity
      of dose adjustment after switching to FLOLAN injection prepared with the reformulated diluent
      in Japanese patients with PAH who are receiving higher doses of FLOLAN injection than in
      other countries. The objective is to evaluate the safety and tolerability of the thermostable
      formulation of FLOLAN injection (that is [i.e.], FLOLAN injection prepared with the
      reformulated diluent) when switched from the existing FLOLAN injection treatment (i.e.,
      FLOLAN injection prepared with the currently marketed diluent). The study will include a
      screening visit, a run-in period of a maximum of 4 weeks with the existing FLOLAN treatment
      (i.e., FLOLAN injection prepared with the currently marketed diluent), a 4-week treatment
      period with the thermostable formulation of FLOLAN injection (i.e., FLOLAN injection prepared
      with the reformulated diluent) and a one-week follow-up visit. Adequate number of subjects
      will be enrolled in the study in order to have 10 subjects to complete assessments at 4
      weeks, including at least 5 subjects as a subset of subjects who consent to undergo right
      heart catheterisation (RHC) over 24-hour and at Week 4. FLOLAN is a registered trademark of
      the GlaxoSmithKline [GSK] group of companies.
    


Intervention name(s): FLOLAN injection with currently marketed diluent; FLOLAN injection with reformulated diluent
Intervention type(s): Drug; Drug
Intervention description(s): FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the currently marketed diluent (epoprostenol sodium+ powder of hydrogen [pH] 10.2 - 10.8 diluent) for Injection.; FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the reformulated diluent (epoprostenol sodium + pH 11.7 - 12.3 diluent) for Injection.
Intervention MeSH terms: Epoprostenol; Tezosentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension (PAH); safety; FLOLAN; New Thermostable Formulation; dose adjustment; reformulated diluents; currently marketed diluent
Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the safety and tolerability and to determine the
      Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in
      healthy male subjects.
    

Detailed description: 
      BR-A-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to healthy male
      subjects.

      Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times
      from each subjects.

      PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone,
      Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.
    

Intervention name(s): BR-A-657
Intervention type(s): Drug
Intervention description(s): 20, 60, 120, 240, 360, 480mg or placebo tablet
Other intervention name(s): Fimasartan; 20, 60, 120, 240, 360, 480mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: single-dose; pharmacokinetic; pharmacodynamic; safety
Quantitative EEG During Anesthesia Emergence in Children
Condition: Anesthesia, General; Electroencephalography; Brain Waves; Psychology, Children; Child Behavior
Study type: Observational

Summary: 
      Most drugs used in general anesthesia work on various receptors in the human brain, causing
      unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system.
      After the anesthesia, baseline physiological function will be attained by administration of
      some reversal drugs or as the time goes by. In this process, various side effects may occur.

      Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia
      in children and that can cause several problems during the recovery period. Previous EEG
      studies reported that this phenomenon is related to hyperexcitation of the brain, and
      occurrence of epileptiform discharges during anesthesia induction may indicate an increased
      vulnerability for the development of a functional brain disorder in these children.

      However, to the best of our knowledge, there is no studies concern evaluating quantitative
      EEG parameters for prediction of this postoperative negative behavior in children.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study collects subjects from a tertiary university hospital.
Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
Condition: Therapy Resistant Arterial Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This trial is designed to establish invasive and non-invasive measures of arterial stiffness
      as potential predictors of treatment response to renal sympathetic denervation
    

Detailed description: 
      Regardless of the ongoing debate on the general effect of renal sympathetic denervation in
      therapy resistant hypertension, all trials published so far face the problem of a certain
      proportion of nonresponders to treatment. Previous data shows, that to some extent this might
      be attributable to arterial stiffening. Elevated invasive pulse wave velocity as an
      established marker for arterial stiffness has been found to be associated with nonresponse to
      renal denervation treatment in a smaller trial population. This trial attempts to assess the
      predictive value of different invasive and non-invasive markers for arterial stiffness in an
      adequately powered population.
    

Intervention name(s): Renal sympathetic denervation (RDN)
Intervention type(s): Device
Intervention description(s): Catheter based renal sympathetic denervation for therapy resistant arterial hypertension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment