bioihbjkbjnl/mcl2 huggingface dataset:
Development of a Marker of Adherence for Tracking Consumption of Nutrient Supplements
Condition: Adherence, Treatment
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether selected adherence markers can be used to
      track daily or intermittent consumption of nutrient supplements.
    

Detailed description: 
      The investigators will assess whether urinary concentrations of selected adherence markers
      can be used to distinguish between daily or intermittent consumption of lipid-based nutrient
      supplements.
    

Intervention name(s): lipid-based nutrient supplement containing adherence markers; lipid-based nutrient supplement containing or not containing adherence markers; lipid-based nutrient supplement not containing adherence markers
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The supplement will be provided once daily for 10 days; The product containing adherence markers will be provided once daily every other day (5 days total); the product not containing adherence markers will be provided on the intervening days for a total of 10 days.; The supplement will be provided once daily for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this first-in-human study is to assess the safety, tolerability, PK and
      exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in
      healthy male subjects to support further clinical development of OMT-28 in the indication of
      atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide
      dosing for Phase II trials.
    

Detailed description: 
      This first-in-human study will be carried out in one study center involving multiple steps.
      Up to 100 healthy male and female subjects will be enrolled. The study consists of 4 parts:

        1. a single ascending dose (SAD) part

        2. a multiple ascending dose (MAD) part

        3. a single dose, double cross-over food effect (FE) part.

        4. a single dose gender effect part (female subjects group) The safety and PK data will be
           evaluated by the DSMC after each cohort to decide on further dose escalation.
    

Intervention name(s): OMT-28; Matching Placebo
Intervention type(s): Drug; Other
Intervention description(s): OMT-28 is a fully synthetic small molecule that belongs to the family of 17,18-epoxyeicosatetraenoic acids (17,18-EEQ) analogs, a natural metabolite of the omega-3 fatty acid eicosapentaenoic acid (EPA).; Microcrystalline cellulose
Other intervention name(s): 17,18-epoxyeicosatetraenoic acid analog; Microcrystalline cellulose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: OMT-28; Atrial Fibrillation; SAD; MAD; First-in-Man; Cardiovascular
Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level
Condition: Progesterone; Contraceptive Methods
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to assess the effect of different progesterone containing
      contraceptive methods on safety and endogenous progesterone level
    

Detailed description: 
      Progestogen-only' contraceptives are presented as injections, implants, oral formulations,
      hormone-releasing intrauterine methods and emergency contraceptives. These substances could
      be used by females who are breastfeeding or have other contraindications to estrogen
      treatment, including those who are immediately postpartum, have thalassemia, sickle-cell
      disease, gallbladder disease, or currently experiencing thrombo-embolic disorders, valvular
      heart disease, ischemic heart disease.

      Intrauterine, injectable methods and contraceptive implants named as long-acting reversible
      contraceptives (LARC) are the more efficient reversible contraceptive approaches are highly
      effective, longer-acting contraceptive methods levels.
    

Intervention name(s): Depo-Provera; Implanon; Norgestrel; Mirena
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Injectable progesterone; Etonogestrel implant; Pill containing progesterone; Levonorgestrel-releasing intra-uterine drug (IUD)
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Etonogestrel; Norgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Among patients attending Tanta University Hospitals
Safety and Pharmacokinetic Study of PF-06700841 in Japanese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1 study of PF-06700841. PF-06700841 is being developed for treatment of
      inflammatory bowel disease. The goal of the study is to assess the safety, tolerability,
      pharmacokinetics and pharmacodynamics of PF-06700841 after multiple oral doses of PF-06700841
      in Japanese healthy volunteers.
    


Intervention name(s): PF-06700841; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-06700841 will be administered as tablet; Matching placebo will be administered as tablet
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Home Blood Pressure Monitoring Project
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The goal of this project is to improve hypertension control at Kaiser Permanente Colorado
      (KPCO) by implementing a population-based multi-factorial intervention that uses home BP
      monitors that can download BP readings to KPCO's health records via internet, interactive
      voice response (IVR) technology, and multidisciplinary care team. Participants will be
      randomized to either the home blood pressure monitoring group receiving the multi-factorial
      intervention or the usual care group who will be receiving Kaiser standard of care. We will
      determine the proportion of patients in each group who achieve their target BP goals at 6
      months, according to national clinical practice guidelines. The study hypothesis is that a
      higher proportion of patients with uncontrolled hypertension in the home blood pressure
      monitoring (HBPM) group will achieve their target blood pressure compared to those in the
      usual care (UC) group.
    

Detailed description: 
      STUDY OBJECTIVES:

      Primary:

      • To determine the proportion of patients in each group who achieve their target BP goals at
      6 months, according to national clinical practice guidelines

      Secondary:

      The following parameters will be evaluated between groups:

        -  Change in BP measures between baseline and at 6 months

        -  Proportion of patients who are receiving antihypertensive treatments in accordance to
           national clinical practice guidelines

        -  Adherence to hypertensive medication regimen during the 6-month follow-up period

        -  Patient satisfaction with the care model.
    

Intervention name(s): Home Blood Pressure Monitoring
Intervention type(s): Behavioral
Intervention description(s): Home blood pressure readings are taken at least 3 times a week, uploaded to a Microsoft Health Vault account through American Heart Association Heart360 at least 1 time per week. Patients are followed by a clinical pharmacist, with physician oversight, who will make adjustments to antihypertensive medications or suggest additional medications using national JNC VII and KPCO hypertension guidelines.
Other intervention name(s): HBPM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension, intervention
Ozonated Water Irrigation as an Adjunct to Periodontal Therapy
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The use of chlorhexidine or ozonized water in periodontal pockets accompanying NPT can
      provide a significant improvement in probing pocket depths compared to conventional
      treatment. However, the effect of subgingival ozonized water applications on VEGF and IGF
      levels, which are thought to play a role in the pathogenesis of periodontal disease and
      periodontal regeneration, should be examined.
    

Detailed description: 
      Background: This study aims to evaluate the effects of subgingival ozonated water irrigation
      as an adjunct to non-surgical periodontal treatment on clinical and biochemical parameters of
      patients with moderate and severe periodontitis.

      Methods: A total of 72 stage II and Stage III periodontitis patients were included in the
      study. The systemically healthy patients which were between the ages of 19 and 58 were
      treated non-surgically. At the end of each visit concerning periodontal treatment, the pocket
      of each tooth was irrigated with a sterile plastic syringe (10 mL per quadrant) with a blunt
      tip containing ozonated water (OW; ozone groups), 0.12% chlorhexidine digluconate (CHX
      groups) or saline (C; control groups) for 30-60 s. Periodontal clinical parameters, gingival
      crevicular fluid (GCF) vascular endothelial growth factor (VEGF) and insulin-like growth
      factor-1 (IGF-1) levels were evaluated at baseline and 8 weeks after periodontal treatment.
      All statistical data were analyzed using SPSS software.
    

Intervention name(s): salin irrigation; ozonated water irrigation; chlorhexidine irrigation
Intervention type(s): Other; Other; Other
Intervention description(s): Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with saline was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.; Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with ozonated water was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.; Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with 0.12% chlorhexidine digluconate was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ozone; periodontitis; chlorhexidine digluconate; root planing
Fat Burning After a Meal
Condition: Postprandial Effect of Carbohydrate Beverage Consumption
Study type: Interventional

Summary: 
      The purpose of the study is to determine how adding a carbohydrate beverage to a meal with
      different protein levels affects the rate at which one's body burns fats, sugars, and
      proteins.
    


Intervention name(s): 15% protein; 30% protein; Sweetened beverage
Intervention type(s): Other; Other; Other
Intervention description(s): Meal to provide 15%en from protein.; Meal to provide 30%en from protein.; Beverage sweetened with either sugar (sucrose) or sucralose (non-nutritive sweetener).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: protein; carbohydrate; lipid; oxidation; fat; sugar; juice; obesity
Evaluation of the Effectiveness of the Utilization of the Kangaroo Care Guide
Condition: Kangaroo Care Trainig
Study type: Interventional

Summary: 
      The aim of this study was to determine the effect of kangaroo care guideline-based training
      for nurses on nurses' knowledge level, kangaroo care practices and Attitude Towards
      Evidence-Based Nursing scale scores.

      The study was parallel group (experimental-control), randomized controlled experimental
      design with pretest-posttest design.

      It was carried out in the neonatal intensive care unit of Selçuk University Faculty of
      Medicine Hospital in Konya province. Study data were collected from 32 newborn nurses between
      October 2022 and January 2023. Premature infants in the intervention (n = 16) and control
      groups (n = 16) were determined by randomization method.
    

Detailed description: 
      Neonatal nurses in the intervention group were trained on the kangaroo care guide, but no
      application was made to the control group. Data were collected using the BP Information Form,
      BP Practice status, and the Attitudes Toward Evidence-Based Nursing Scale. Data were
      collected as a pretest before the application and as a posttest after the application.
      Pearson Chi-Square Test, Yates Correction and Fisher's Exact Test were used to compare
      categorical data according to groups. Two Independent Sample t Test was used to compare
      normally distributed variables and Mann Whitney U Test was used to compare non-normally
      distributed variables. Statistical significance level was accepted as p˂0.05.
    

Intervention name(s): Providing training on kangaroo care guide
Intervention type(s): Other
Intervention description(s): Online training was given to neonatal nurses on the kangaroo care guide created by the researcher in line with the literature.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel group (experimental-control)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Kangaroo Care; trainig; Nurse; NICU
The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination
      with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin
      has been shown to have fewer side effects in the control of blood glucose values.

      Obesity and diabetes are states of increased inflammation and can influence the free radicals
      and inflammatory markers (chemicals in the blood which increase due to inflammation in the
      body) and are also major risk factors for atherosclerotic disease. In this study we want to
      see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an
      anti-inflammatory effect in the human. The purpose of this study is to determine if the
      addition of sitagliptin to diabetic patients will provide added benefit. We believe that
      sitagliptin provides these added benefits by suppressing free radicals (charged substances
      that cause damage to the body) and inflammation.
    


Intervention name(s): Januvia (Sitagliptin) 100 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The first group will be started on 100 mg sitagliptin daily for 12 weeks; will be placed on a placebo for 12 weeks.
Other intervention name(s): januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
First in Man Clinical Study to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of
      single ascending doses of CM3.1-AC100 in healthy male volunteers.
    


Intervention name(s): CM3.1-AC100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for sc injection, single ascending doses; Solution for sc injection
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: First time in man, safety study, Cm3.1-AC100; Male volunteer aged 18 to 50 years at Screening
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
Condition: Prostate Cancer; Neuropathy; Epilepsy; Encephalopathy
MeSH terms: Brain Diseases
Study type: Observational

Summary: 
      Enzalutamide may lead to various adverse reactions. This study investigates reports of
      different neurological toxicities in the World Health Organization's (WHO) global database of
      individual safety case reports (VigiBase).
    

Detailed description: 
      Enzalutamide are responsible of a wide range of side effects.The investigators use VigiBase,
      the World Health Organization (WHO) database of individual safety case reports, to identify
      cases of adverse drug reactions following treatment with enzalutamide
    

Intervention name(s): Enzalutamide
Intervention type(s): Drug
Intervention description(s): Enzalutamide for the treatment of prostate cancer or other solid tumors
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with enzalutamide for prostate cancer or other solid tumors
      
Keywords: Drug-induced neurotoxicity
Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the pathologic complete response rate to preoperative administration of
      Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)
    

Detailed description: 
      Primary objectives: To evaluate the pathologic complete response rate to preoperative
      administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH) Secondary
      objectives: To assess breast conserving rate after preoperative chemotherapyTo evaluate
      clinical response rate, disease free survival (DFS), and overall survival (OS) To assess the
      safety profiles of PGH

      Treatment will be delivered in the outpatient setting. Each three-week cycle consists of
      paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) in addition to
      trastuzumab, which is given at a dose of 4 mg/kg IV on day 1 of the first treatment cycle
      over 90 min, and subsequently given weekly at a dose of 2 mg/kg over 30 min. Patients will
      receive 6 cycles of therapy unless there is any evidence of no response suitable for
      operation(SD or PD) or unacceptable toxicity or noncompliance by patient with protocol
      requirements. Patients who are unsuitable for op due to SD or PD, will undergo XRT. However,
      when patients are still suitable for op even with SD or PD, these patients will undergo
      op.Such decision will be made at physician's discretion at each institution. Also, even
      though there is neither clear evidence of disease progression nor severe toxicity, if patient
      declines the treatment, study treatment can be discontinued. Response will be documented by
      physical examination, sonography and/or chest CT prior to treatment and every three cycles.
      Postoperatively within 1-3 week, trastuzumab 6 mg/kg every 3 weeks x 11 and tamoxifen or AI
      for 5 years will be given as indicated. Radiation therapy will be initiated postoperatively
      in 3-4 weeks according to the standard practice guidelines.
    

Intervention name(s): Paclitaxel/Gemcitabine/Trastuzumab
Intervention type(s): Drug
Intervention description(s): 80 mg/m2 of paclitaxel 1,200 mg/m2 of gemcitabine, day 1, day 8 every 3-week. trastuzumab at a dose of 4 mg/kg IV on D1 of first treatment cycle subsequently given weekly at a dose of 2 mg/kg
Other intervention name(s): Paclitaxel; Gemzar; Herceptin
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patients with HER2 + stage II/III breast cancer
Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With Asthma
Condition: Asthma
MeSH terms: Influenza, Human; Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      - Trial to assess asthma exacerbation through to the end of the study; and to demonstrate
      that the efficacy over one season against culture-confirmed influenza-illness; and finally to
      assess the safety and tolerability of CAIV-T in children with asthma.
    

Detailed description: 
      - To assess asthma exacerbation, being defined as acute wheezing illness associated with
      hospitalization, unscheduled clinic visits, or new prescriptions from study vaccination
      through to the end of the study.
    

Intervention name(s): CAIV-T and TIV
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1, Randomized, Placebo-controlled, Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Chinese Type 2 Diabetic Patients
Condition: Type 2 Diabetic Patients
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, multiple dose escalation study to investigate the
      safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be
      conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be
      randomized in each cohort to receive the study drug or placebo.
    


Intervention name(s): SHR0534; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment