bioihbjkbjnl/mcl2 huggingface dataset:
FPA150 in Patients With Advanced Solid Tumors
Condition: Breast Cancer; Ovarian Cancer; Endometrial Cancer; Advanced Solid Tumors
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK),
      pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in
      combination with pembrolizumab an anti-PD1 antibody in patients with advanced solid tumors.
      The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase
      1a Combination (FPA150 and Pembrolizumab) Safety Lead-in and for Phase 1b monotherapy
      cohorts.
    

Detailed description: 
      This is a Phase 1a/1b open-label, multicenter study to evaluate the dosing, safety,
      tolerability, PK, pharmacodynamics, and preliminary efficacy of FPA150 as monotherapy and in
      combination with pembrolizumab, an anti-PD1 antibody, in patients with advanced solid tumors.

      This study includes a Phase 1a FPA150 Monotherapy Dose Escalation, Phase 1a Monotherapy Dose
      Exploration, Phase 1a combination Safety Lead-in (FPA150 + pembrolizumab), a Phase 1b FPA150
      Monotherapy Dose Expansion, and a Phase 1b combination Dose Expansion (FPA150 +
      pembrolizumab).

      The Phase 1a Monotherapy Dose Escalation will include an initial accelerated titration design
      followed by a standard 3+3 dose escalation design until the MTD and/or RD for Phase 1b is
      determined. The Phase 1a combination Safety Lead-In will start enrolling once the FPA150
      monotherapy RD is identified in Phase 1a monotherapy dose escalation and will continue until
      the FPA150 MTD/RD in combination is identified. Phase 1a FPA150 monotherapy Dose Exploration
      may include cohorts that may enroll beyond 3 patients whose tumors express high levels of
      B7-H4 protein and/or have varying levels of B7H4 expression including low (<10% IHC 2+ or 3+
      scores) or no expression on their tumor cells (up to 20 additional patients across all dose
      levels) to further evaluate safety, PK, pharmacodynamics, and clinical activity at that dose
      (to be conditional upon the dose level clearing DLT criteria).

      Phase 1b will be the Dose Expansion (monotherapy and combination) portion of the study.

      Enrollment into Phase 1b Dose Expansion will begin after identification of the MTD and/or RD
      in Phase 1a (monotherapy and Safety Lead-in). Preliminary efficacy will be evaluated in Phase
      1b in planned expansion cohorts that include patients with specific tumor types that are
      B7-H4+ advanced solid tumors.
    

Intervention name(s): FPA150; Pembrolizumab
Intervention type(s): Biological; Biological
Intervention description(s): A monoclonal antibody against B7-H4; An anti-PD1 antibody
Intervention MeSH terms: Pembrolizumab
Intervention model: Single Group Assignment
Intervention model description: Single arm trial with multiple cohorts
Masking: None (Open Label)
Primary purpose: Treatment
R230C and C230C Variants of ABCA1 and Glyburide Response
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to know if the R230C and C230C variants of the ATP-binding
      cassette transporter A1 (ABCA1) gene are associated with a smaller glucose lowering effect
      compared to the wild type allele (R230R) in patients with type 2 diabetes.
    

Detailed description: 
      Specific objectives:

        1. In patients with type 2 diabetes stratified by the existence of the risk alleles
           (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from
           the treatment with glibenclamide on following continuous variables:

             -  Fasting glucose

             -  Percentage reduction

             -  Hemoglobin A1c,

             -  Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol

             -  Weight

        2. In patients with type 2 diabetes stratified by the existence of the risk alleles
           (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from
           the treatment with glibenclamide on following binomial variables:

             -  Number of cases that reach fasting plasma glucose lower than 110 mg/dl

             -  Number of cases that reach an HbA1c less than 7%
    

Intervention name(s): Glyburide
Intervention type(s): Drug
Intervention description(s): Patients in which the fasting glucose persisted above the treatment goal ( fasting plasma glucose above 126 mg/dl) will receive glyburide. The dose of the medication will be adjusted based on the result of blood glucose using the following table:
Fasting glucose 126 to 140 mg/dl: 2.5 mg/day (half tablet in the morning) 141 to 180 mg/dl: 5 mg/day (a tablet in the morning) 181 220 mg/dl: 7.5 mg/day (a tablet in the morning and half tablet per night) 221 to 250 mg/dl: 10 mg/day (a tablet in the morning) and a tablet in the evening.
Intervention MeSH terms: Glyburide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; ABCA1 alleles; Glyburide
9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease
Condition: Crohn´s Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg
      budesonide three-times daily (TID) for the induction of remission in Crohn's disease.
    


Intervention name(s): budesonide; budesonide
Intervention type(s): Drug; Drug
Intervention description(s): 9mg budesonide OD; 3mg budesonide TID
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn´s disease; budesonide; induction of remission
Alcohol Screening and Pre-Operative Intervention Research Study
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This study aims to learn more about how to improve patients' health before and after a
      scheduled surgery by examining acceptability and initial efficacy of pre-operative alcohol
      use reduction interventions.
    

Detailed description: 
      The study is a randomized clinical pilot trial that assesses preliminary intervention
      efficacy of a two-session health coaching intervention relative to brief advice among
      pre-operative elective surgical patients and evaluates intervention acceptability. Study
      subjects will be outpatients at a large health system in the midwestern United States and
      fulfill the study's inclusion criteria. Subjects will be randomized to one of two
      intervention conditions: Health Coaching or Brief Advice.
    

Intervention name(s): Brief advice; Health coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One 10-minute brief advice session; Two 45-minute health coaching sessions will use a non-confrontation motivational interviewing (MI) style. Intervention delivery will include expressing concern about unhealthy drinking, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she is ready to change. We will also include a personalized feedback component to address the links between pre-operative alcohol use and postoperative morbidity/mortality.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Elective Surgery
Bioavailability of BIBR 1048 MS Tablets in Healthy Subjects With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food
    


Intervention name(s): BIBR 1048 MS tablet; BIBR 1048 MS solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MRI Findings of Epiphyseal Growth Plate in Healthy Children
Condition: OCD - Osteochondritis Dissecans
MeSH terms: Osteochondritis; Osteochondritis Dissecans
Study type: Observational

Summary: 
      The purpose of the study is to determine if by using MRI changes can be identified changes
      early on in the knees of young children that may be at risk for developing osteochondritis
      dissecans. If MRI can identify changes then better council can be offered about the risks of
      future activity and treatment options.
    

Detailed description: 
      Each subject will be asked to undergo an MRI at enrollment, six,12, and 18 months. Subjects
      will be monitored for evidence of osteochondritis dissecans in order to determine if we can
      identify it and then create a treatment program to allow these children to avoid developing
      definitive disease
    

Intervention name(s): MRI
Intervention type(s): Device
Intervention description(s): No intervention - observational trial using MRI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        6-10-year-old children with a sibling with known OCD and 6-10-year-old children with a
        known OCD in the contralateral knee
Inflammatory and Microbiologic Markers in Sputum: Comparing Cystic Fibrosis With Primary Ciliary Dyskinesia
Condition: Cystic Fibrosis; Primary Ciliary Dyskinesia
MeSH terms: Cystic Fibrosis; Ciliary Motility Disorders; Dyskinesias; Fibrosis
Study type: Interventional

Summary: 
      The objective of this study is to compare the lower airways inflammatory response to
      infection/pulmonary exacerbation among children known to have Primary Ciliary Dyskinesia
      (PCD) with children known to have Cystic Fibrosis (CF) as measured by the presence of
      inflammatory mediators in expectorated/induced sputum.
    

Detailed description: 
      The inflammatory response to infection and pulmonary exacerbation in CF is well documented,
      as is the response to intravenous antibiotic treatment. On the other hand, the inflammatory
      response to infection and treatment in PCD has not been well characterized. Given differences
      in disease progression, we hypothesize that children with CF respond to infection with a more
      exaggerated and prolonged inflammatory response than those with PCD.
    

Intervention name(s): Sputum Collection; Pulmonary Function Testing; Exhaled Nitric Oxide
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Each study participant will be invited to expectorate sputum for culture, sensitivity, cytology and analysis of cytokine levels. Culture and sensitivity will be performed routinely at the beginning of a pulmonary exacerbation, as per standard of care, and will only be performed at subsequent visits if there is clinical indication. A volume of 5ml of sputum will be required at each visit for analysis. If the participant is unable to expectorate this volume of sputum, he/she will be invited to induce sputum instead as per standard protocols.; Participants will perform spirometry at each visit according to the American Thoracic Society and European Respiratory Society guidelines.; The investigators will measure exhaled Nitric Oxide (eNO) at each visit according to the American Thoracic Society and European Respiratory Society guidelines using a chemiluminescence analyzer. Briefly, single breath exhalation are performed in triplicate at flows of 30, 50, 100, 150, 200 and 250 ml/s and eNO is measured at the end of the exhalation. The higher the flow rate the more peripheral the airways that are being sampled.
Intervention MeSH terms: Nitric Oxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; CF; PCD; exacerbation; inflammatory markers; induced sputum
The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids
Condition: Vascular Diseases; Hypercholesterolemia
MeSH terms: Vascular Diseases; Hypercholesterolemia
Study type: Interventional

Summary: 
      The main aim of the study is to investigate the effect of daily consumption of a margarine
      enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.

      The study also aims to investigate the effect of plant sterols and fish oil on fasting total
      cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein
      cholesterol (HDL-C) and non-HDL-C.

      At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations
      will be explored.
    

Detailed description: 
      The main aim of the study is to investigate the effect of daily consumption of a margarine
      enriched with plant sterol esters and fish oil on fasting TG concentrations.

      The study also aims to investigate the effect of plant sterols and fish oil on fasting TC,
      LDL-C, HDL-C and non-HDL-C.

      At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations
      will be explored. This exploratory objective will only be analyzed if a relevant treatment
      effect on fasting triglycerides concentrations is observed.
    

Intervention name(s): Margarine enriched with plant sterols and fish oil; Placebo margarine
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Plant sterols; Fish oil; Blood lipids
Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the current trial is to investigate safety, tolerability,
      pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4
      weeks in patients with COPD.
    


Intervention name(s): BI 1026706; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): For blinding purposes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease
Condition: Hepatitis; Liver Cirrhosis; Hepatocellular Carcinoma
MeSH terms: Liver Diseases; Liver Cirrhosis
Study type: Observational

Summary: 
      BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell
      growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1
      (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone
      (HGH) in the progression of chronic liver disease remain to be elucidated and investigated.

      METHODS The subjects in the present study included 60 healthy controls, 30 hepatitis
      patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients.
      Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations
      between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical
      parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1,
      HGH and IGFBP-3 in serum.
    

Detailed description: 
      healthy controls:one blood sample (7.5 cc) hepatitis: three blood samples, at admission, at
      3rd and 7-10th day of admission liver cirrhosis: two blood samples, at 1-2 years interval
      (7.5 cc/each session) hepatocellular carcinoma: three blood samples, before, 1 day after and
      at the 7th day of transcatheter arterial chembolizatiom
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Acute hepatitis liver cirrhosis hepatocellular carcinoma
      
Biospecimen description: 
      serum
    
Keywords: GH,IGF-1, IGFBP-3
A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease; Dementia of Alzheimer Type
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to
      moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.
    

Detailed description: 
      This study is designed to assess the correlation of the functional translational biomarker
      P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized,
      double-blind treatment.
    

Intervention name(s): ATH-1017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe; Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Cognition; Dementia; ATH-1017; Memory Loss
Effect of Surgical Therapy on RANKL/OPG (Osteoprotegerin) System
Condition: Chronic Periodontitis; Aggressive Periodontitis; RANKL/OPG Ratio; Gingival Crevicular Fluid
MeSH terms: Periodontitis; Chronic Periodontitis; Aggressive Periodontitis; Aggression
Study type: Observational

Summary: 
      In the present clinical study including chronic, aggressive periodontitis and healthy
      individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG),
      Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after
      surgical periodontal treatment and search out the relationship of clinical parameters with
      these cytokine levels.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individulas that applied to periodontology clinic in faculty of dentistry, Hacettepe
        University.
      
Biospecimen description: 
      Gingival Crevicular fluid (GCF) is collected at baseline and 3 months after the surgical
      treatment.
    
Keywords: Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG ratio, Gingival crevicular fluid
Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared
      to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)
    


Intervention name(s): Pramipexole; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Lansoprazole on Bone Turnover Markers
Condition: Bone Turnover Rate Disorder; Calcium Metabolism Disorders
MeSH terms: Gastroesophageal Reflux; Metabolic Diseases; Calcium Metabolism Disorders
Study type: Observational

Summary: 
      Use of proton pump inhibitors (PPI) has increased in recent years. There are concerns that
      PPIs have possible negative effects on bone metabolism. It has been suggested that PPIs may
      reduce the absorption of calcium from the small intestine and lead to bone resorption by
      affecting osteoclastic activity. In this study, it is planned to investigate the effects of
      lansoprazole, a proton pump inhibitor, on bone turnover markers in pediatric patients with
      gastroesophageal reflux or gastroesophageal reflux disease.
    

Detailed description: 
      This study is planned to be conducted with children who are diagnosed with gastroesophageal
      reflux or gastroesophageal reflux disease aged 2-18 years and healthy volunteers. The
      diagnosis of gastroesophageal reflux will be made in accordance with the guidelines of North
      American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and
      European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). Written
      and verbal consent will be obtained from patients/healthy volunteers and/or parents who want
      to participate in the study. Serum calcium, magnesium, alkaline phosphatase, parathormone,
      25-OH vitamin D and osteocalcin and urine calcium, creatinine, deoxypyridinoline, C-terminal
      telopeptides type-1 collagen and N- terminal telopeptides type-1 collagen levels will be
      measured at baseline and second month in study group and once in control groups.
    

Intervention name(s): Blood and urine specimens
Intervention type(s): Diagnostic Test
Intervention description(s): Blood and urine samples will be taken at baseline and at the end of the second month. For this purpose, 5 ml of blood samples will be taken to plain blood tubes for evaluation of calcium, magnesium, alkaline phosphatase, parathormone, 25-OH vitamin D and osteocalcin quantities. And 3 ml of urine for calcium, creatinine, deoxypyridinoline, C-terminal telopeptides type-1 collagen and N- terminal telopeptides type-1 collagen.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years
        who were treated in Pediatric Gastroenterology Department of Ataturk University Hospital
        included to the study.
      
Biospecimen description: 
      5ml EDTA blood and 3 ml urine specimens will be collected for each case.
    
Keywords: Lansoprazole; Bone turnover; Gastroesophageal reflux