bioihbjkbjnl/mcl2 huggingface dataset:
Biological Standardization of Dactylis Glomerata Allergen Extract
Condition: Allergy to Grass Pollen (Dactylis Glomerata)
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biologic activity of a Dactylis glomerata
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
      reference preparation (IHRP).
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Four concentrations of Dactylis glomerata allergen extract, together with a positive and
      negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol
      saline solution, respectively, will be tested in every patient in duplicate on the volar
      surface of the forearm.
    

Intervention name(s): Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control
Intervention type(s): Biological
Intervention description(s): Four concentrations of Dactylis glomerata allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Immunotherapy; Skin prick test; Standardization; Dactylis glomerata
Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as
      assessed by glomerular filtration rate.
    


Intervention name(s): Dapagliflozin; Placebo; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 10 mg, once daily, 12 weeks; Tablets, Oral, 0 mg, once daily, 12 weeks; Tablets, Oral, 25 mg, once daily, 12 weeks
Other intervention name(s): BMS-512148
Intervention MeSH terms: Dapagliflozin; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Interleukin-2 (IL-2) was initially discovered and used as a stimulator of effector T
      lymphocytes (Teffs), but is now viewed as a very promising immunoregulatory drug having the
      capacity to stimulate regulatory T cells (Tregs). At low dose, Il-2 tips the Treg/Teff
      balance towards Tregs. Recently, it has been shown that Tregs of MS patients have reduced
      proliferative potential. MS-IL2 will assess the safety and biological efficacy of low-dose
      IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis (RRMS), with the aim to
      stimulate Treg and define potential clinical benefits
    

Detailed description: 
      In MS-IL2, 30 RRMS patients will be treated in a randomized, double-blind, placebo controlled
      clinical trial. IL-2 will be administered first as an induction course of IL-2 or placebo
      each day for 5 days, followed by a maintenance course at the same dose or placebo every two
      weeks over 6 months.

      The primary efficacy criteria will be the % change from baseline in Treg at day-5, which is
      indicative of the biological response to IL-2.

      The secondary efficacy criteria will be (i) the maintenance of regulatory T cells during the
      6 months of treatment with IL-2 vs. placebo and (ii) the stabilization or regression of the
      disease as determined by disease activity parameters assessed by MRI (cumulative number of
      new lesions in T1 enhanced by gadolinium after 6 months) in the groups treated with IL-2
      compared to placebo.

      Expected impact: MS-IL2 will define which patient respond to IL2 and which doses prevent
      relapses in RRMS. In addition, the deep phenomics studies will further provide the foundation
      for a clinical phase II to define clinical efficacy.
    

Intervention name(s): IL2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Induction period: repeated administration of low-dose IL-2 Maintenance period: treatment with IL-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Interleukin 2, IL2; Relapsing Remitting Multiple Sclerosis; Autoimmune diseases; Regulatory T cells, Tregs
An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia
      (a sleep disorder).
    


Intervention name(s): gaboxadol; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): Duration of Treatment: 3 months; Duration of Treatment: 3 months
Other intervention name(s): MK0928
Intervention MeSH terms: Gaboxadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair
Condition: Femoro Acetabular Impingement; Pain, Postoperative; Hip Labral Tear
MeSH terms: Femoracetabular Impingement; Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to measure whether CPM (continuous passive motion) usage
      improves outcomes following arthroscopic hip surgery that includes labral repair.
      Investigators tested the hypothesis that CPM usage reduces pain levels and pain medication
      use and improves function in individuals who undergo hip arthroscopy.
    

Detailed description: 
      Subjects undergoing primary hip arthroscopy for acetabular labral repair were randomized to
      determine whether they would receive a CPM. Those subjects receiving a CPM were instructed to
      use it for 4-6 hours daily throughout the first two postoperative weeks. The total number of
      pain medications and average pain scores over the two weeks, as well as Hip Outcome Score
      Activity of Daily Living (HOS ADL) scores at standard time points were compared via a two
      sample t-test and intention-to-treat analysis.
    

Intervention name(s): Continuous Passive Motion
Intervention type(s): Device
Intervention description(s): CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: continuous passive motion device; HOS-ADL; hip arthroscopy
Ventilatory Constraint, Breathing Pattern and Ventilatory Responses in Obese Postmenopausal Women
Condition: Obesity; Postmenopausal Women
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this study was to examine the dynamic lung volumes in obese post-menopausal
      women (without hormone replacement therapy) during exercise and their correlations with
      dyspnea.
    

Detailed description: 
      Obesity-related changes in lung volumes have shown to affect breathing mechanisms. During
      exercise, altered breathing mechanisms increase potential for expiratory flow limitation and
      compromise exercise capacity. Estrogen and progesterone are potent respiratory stimulants,
      and their effects in the physiologic regulation of breathing are down-regulated after
      menopause. Therefore, we theorized that the combined obesity and reduced sex hormone levels
      after menopause work as a double jeopardy to cause mechanical ventilatory constraint which
      aggravates dyspnea sensation during exercise, and thus a reduction in exercise capacity. The
      purpose of this study was to exam the dynamic lung volumes in obese post-menopausal women
      (without hormone replacement therapy) during exercise and their correlations with dyspnea.

      From doctoral referral and advertisement, 24 obese (BMI ≧ 27 kg/m2) and 26 lean
      post-menopausal women were recruited for the study. Pulmonary function and body composition
      were measured at rest. A maximal flow volume loop (MFVL) was obtained at baseline. All
      subjects then performed an incremental exercise test on a cycle ergometer with workload
      increasing 25 watts every 3 min. During exercise, at each workload, the tidal exercise FV
      loops were obtained and an inspiratory capacity (IC) maneuver was conducted to assess changes
      in end-expiratory lung volume (EELV) and end inspiratory lung volume (EILV). Dyspnea and leg
      fatigue were assessed using the Borg scale. Analysis of variance with repeated measurements
      was used to test the significance of the mean differences between the two groups during
      exercise. Linear regression analysis was used to determine whether changes in dynamic lung
      volumes during exercise were related to changes in Borg scores. Statistical significance was
      established at p<0.05.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Postmenopausal women (for at least 1 year) who aged below 69 y/o without hormone
        replacement therapy
      
Keywords: Obesity; Postmenopausal women; Mechanical ventilatory constraints; Dynamic lung volume; Expiratory flow limitation
Incentives to Promote Medication Adherence Among HIV-Infected Youth
Condition: HIV
Study type: Observational

Summary: 
      Medication adherence is one of the most salient predictors of patient outcomes in the era
      following development of effective treatment for HIV infection. Evolving strategies to
      improve adherence, specifically incentive interventions and real-time medication monitoring,
      have shown some success in limited studies. Further investigation into incentive
      interventions for HIV-infected adolescents with poor medication adherence is necessary.
    

Detailed description: 
      PRIMARY OBJECTIVE:

        -  To describe the effects of a novel incentive intervention model on HIV-infected youths'
           patterns of antiretroviral medication adherence.

      SECONDARY OBJECTIVES:

        -  To evaluate the feasibility of an outpatient incentive intervention model.

        -  To assess participant satisfaction with the incentive intervention model.

        -  To evaluate the effect of an outpatient incentive intervention model on targeted health
           behaviors (numbers of missed appointments and STI diagnoses).

        -  To measure the effect of the incentive intervention on HIV viral load and CD4+ count.

        -  To determine the overall and per patient cost of the incentive intervention model.

        -  To describe associations between adherence measures: real-time medication monitor data,
           pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio,
           and self-report.

      Upon enrollment, participants will receive education and a real-time medication monitor.
      Participants will be followed monthly in the clinic and will be prescribed thirty-day
      supplies of medication. During weeks 1-4 participants will establish a baseline with the
      real-time medication monitor. During weeks 5-28, participants will receive remote incentives
      based on their level of medication adherence as measured by the real-time medication monitor.
      Additional lottery-style incentives will occur at regular follow-up visits. No incentives
      will be applied during weeks 29-48. Participants will complete the protocol at the week 48
      visit.
    

Intervention name(s): Incentive intervention model
Intervention type(s): Behavioral
Intervention description(s): All participants will receive a real-time electronic medication monitor to monitor daily pill-taking behavior. Participants with qualifying levels of adherence will receive a weekly incentive during the intervention period. At all clinic visits participants will participate in a lottery incentive to reinforce clinic attendance and negative STI screening tests.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Youth with HIV who meet eligibility criteria.
      
Keywords: Medication Adherence; Incentives; Real-time Medication Monitoring
A Study to Evaluate the Use of an Indwelling Catheter to Obtain Cerebrospinal Fluid (CSF) by Low-rate Continuous Sampling (MK-0000-211)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      This is a study to evaluate the feasibility and tolerability of low-rate continuous
      Cerebrospinal Fluid (CSF) sampling and to estimate the number of participants who exhibit
      severe baseline instability of CSF amyloid beta isoform Aß40 concentrations in healthy
      participants.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers from general population
      
Biospecimen description: 
      Cerebrospinal fluid (CSF)
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
Condition: Idiopathic Short Stature
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that an individualized, formula-based Genotropin regimen for children with
      Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th
      percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to
      explore treatment efficiency over four years of two formula-based dose regimens (sub-arms)
      compared to standard treatment
    


Intervention name(s): Genotropin; Genotropin
Intervention type(s): Drug; Drug
Intervention description(s): Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.; Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ISS; human growth hormone
A Study of the Effect of Food on Pirtobrutinib (LOXO-305) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to conduct blood tests to measure how much pirtobrutinib
      (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib
      (LOXO-305) after meals and on an empty stomach. The study will also evaluate the safety and
      tolerability of pirtobrutinib (LOXO-305). Participants will stay in this study for up to 53
      days (screening through follow-up call).
    


Intervention name(s): Pirtobrutinib
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): LOXO-305; LY3527727
Intervention MeSH terms: Pirtobrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of a Midwifery Model in Palestine 2
Condition: Prenatal Care
Study type: Observational [Patient Registry]

Summary: 
      A midwife-led continuity model of care was implemented in governmental maternal facilities in
      Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care
      to women in rural villages clinics and homes. This study investigated if the model had impact
      on important maternal and neonatal health outcomes. A retrospective cohort design was used.
    

Detailed description: 
      Background: A midwife-led continuity model of care was implemented in governmental maternal
      facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and
      postnatal care to women in rural villages clinics and homes. This study investigated if the
      model had impact on important maternal and neonatal health outcomes.

      Method: A retrospective cohort design was used. Nablus governmental hospital, Rafidia's
      medical records were reviewed and data extracted involving 2199 women with singleton
      pregnancies, residing in rural villages, and their new-born babies born between January 2016
      and February 2017. Outcomes were limited to the available information in the hospital's birth
      registry. Important maternal outcomes were postpartum anaemia (Hb <11), mode of delivery and
      induction of labour. Important outcomes for new-borns were premature delivery < 37 weeks,
      birth weight < 2500g and 1500g and referral to neonatal intensive care unit. Outcomes were
      compared between women receiving the midwife-led continuity model of antenatal care and women
      receiving regular care.
    

Intervention name(s): Midwife led continuity model of care
Intervention type(s): Other
Intervention description(s): Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Palestinian women With singleton pregnancies
      
Keywords: Midwifery-led continuity of care; Birth complications
Carnoy's Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: a Randomized Trial
Condition: Rectal Cancer; Gastric Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      This study evaluates the number of lymph nodes dissected in specimens following fixation with
      10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for
      fixation in each solution.
    

Detailed description: 
      Carnoy's solution is a tissue fixative that has alcohol allowing for fat clearing along with
      tissue fixation. Specimens were randomized after the surgical procedure. The perivisceral fat
      was removed from the stomach and the lymph node stations disected and then fixed in formalin
      or carnoy's solution for 24-48h. After dissection the residual fat from the formalin group
      was re-fixed in carnoy and re-disected.
    

Intervention name(s): Carnoy's solution; 10% neutral buffered formaldehyde
Intervention type(s): Other; Other
Intervention MeSH terms: Formaldehyde
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Future Internet Social and Technological Alignment Research
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar disorder patients frequently presents recurring episodes and often experience
      subsyndromal symptoms, cognitive impairment and difficulties in the functioning with a low
      quality of life, relapses of disease and recurring hospitalization. Early diagnosis and
      appropriate intervention may play a role in preventing the neuroprogressive course of bipolar
      illness. The new technologies represent an opportunity to develop psychological standardized
      treatments using internet devices that minimizing the limitations of face to face treatments
      because of its accessibility that allow adjusting to the availability of each user. However,
      although exist many online psychological programs through web and mobile devices for bipolar
      disorder, there is not evidence about their efficacy and effectiveness due to the variability
      in measures and methodology used.
    

Detailed description: 
      Future Internet Social and Technological Alignment Research (FI-STAR) clinical trial is a
      randomized simple blind evaluation within an European project. FISTAR is developed to compare
      this technical solution with treatment as usual. Bipolar disorder patients are to be included
      and randomly assigned to one of two treatment groups: 1) the experimental group (tele-care
      support) and the control group. Participants in both groups will be evaluated at baseline
      (pre-treatment) and at post-treatment.
    

Intervention name(s): Tele-care support; Control group
Intervention type(s): Behavioral; Other
Intervention description(s): Psychoeducation treatment based on telemedicine; Standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Diagnosis of Bile Duct Strictures
Condition: Bile Duct Stricture; Cholangiocarcinoma; Pancreatic Cancer; Chronic Pancreatitis
MeSH terms: Pancreatic Neoplasms; Cholangiocarcinoma; Pancreatitis; Pancreatitis, Chronic; Cholestasis; Constriction, Pathologic
Study type: Observational

Summary: 
      The purpose of this prospective study is to compare the diagnostic utility of two techniques
      (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary
      strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging
      follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this
      the investigators will ask study participants to have a small volume of fluid obtained from
      the bile duct sent for additional testing at RedPATH. In some patients additional brushings
      will be obtained for FISH testing (this adds <2 minutes to ERCP and only associated risk is
      increased procedure duration).

      The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity
      and accuracy when compared to cytology +FISH in patients with biliary strictures.

      Primary aim:

      To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and
      brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology
      for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve
      as the gold standard for diagnosis of malignancy.

      Secondary aims:

        1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH
           and DNA analysis) are used.

        2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with
           cytology, FISH and DNA analysis.
    


Intervention name(s): brushing of bile duct strictures for cytology
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients over the age of 18 undergoing ERCP for the diagnosis and treatment of bile duct
        stricture
      
Keywords: Bile duct stricture; Cholangiocarcinoma; Pancreatic cancer; Chronic pancreatitis