bioihbjkbjnl/mcl2 huggingface dataset:
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening
Condition: Lifestyle; Diet Habit; Smoking Cessation; Physical Activity; Alcohol Drinking; Body Weight
MeSH terms: Colorectal Neoplasms; Body Weight; Alcohol Drinking
Study type: Interventional

Summary: 
      This randomized controlled trial aims to investigate the effect of an individually tailored
      lifestyle feedback letter and a leaflet on lifestyle in the context of sigmoidoscopy
      screening.
    

Detailed description: 
      Cancer screening may be used as a teachable moment for healthy lifestyle behaviours. This
      study aims to investigate the effect of minimal, but individually tailored lifestyle advice
      and a standard leaflet on healthy lifestyle given at a colorectal cancer screening context on
      one-year changes in these behaviours in a population-based sample of men and women.

      Individuals invited to sigmoidoscopy screening in the piloting of Norwegian Bowel Cancer
      Screening are additionally invited to this lifestyle intervention study. Changes in lifestyle
      are measured by a brief lifestyle questionnaire administered at prescreening and after one
      year. The intervention to the intervention arms is given after completion of the prescreening
      lifestyle questionnaire.
    

Intervention name(s): Individually tailored lifestyle feedback; Standard leaflet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The written, standardized individually tailored lifestyle feedback includes feedback on consumption of fruit, berries and vegetables and alcohol, physical activity, smoking and body mass index.; The leaflet is The Norwegian Cancer Society's one-page information brochure on healthy lifestyle behaviours for low cancer risk, including non-smoking, healthy body weight, physical activity, diet, moderate alcohol consumption, moderate sun exposure etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Lifestyle intervention; Diet; Smoking cessation; Physical activity; Alcohol; Body mass index; colorectal cancer screening; sigmoidoscopy
Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the the study was to evaluate the pharmacokinetic properties of
      minodronic acid tablets following single and multiple oral administration in healthy Chinese
      subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was
      also explored.
    

Detailed description: 
      This was a single-center, phase I study in healthy young (19-30 years) and elderly (60-65
      years) volunteers, which was conducted in four parts. In Part 1, minodronic acid tablets were
      administered to young volunteers at doses of 1, 2, and 4 mg. In Part 2, after a single dose,
      young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once
      daily for 7 days. In Part 3, a single oral dose of minodronic acid 1 mg was administered to
      elderly volunteers. In part 4, after a washout period of 8 days, volunteers in the 4-mg dose
      group received a single dose of 4 mg minodronic acid under fed conditions (administrated 30
      minutes before high-fat breakfast). Plasma samples were collected and plasma concentrations
      of minodronic acid were analyzed by LC-MS/MS. Tolerability was assessed throughout the study
      by physical examinations, vital signs measurement, laboratory analyses, and monitoring of
      adverse effects.
    

Intervention name(s): minodronic acid
Intervention type(s): Drug
Intervention description(s): comparison of different doses, ages and medication conditions
Other intervention name(s): YM529/ONO-5920
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: minodronic acid; pharmacokinetics; tolerability; food; age; Chinese subjects
Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients
Condition: Retinitis Pigmentosa; Retinal Degeneration
MeSH terms: Retinitis; Retinitis Pigmentosa; Retinal Diseases; Retinal Degeneration
Study type: Interventional

Summary: 
      Patients suffering from hereditary retinal degeneration receive a retinal implant to restore
      sight.

      Subretinal implant "ON" results in significant visual acuity improvement, when compared to
      "OFF" condition.
    


Intervention name(s): Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye
Intervention type(s): Device
Intervention description(s): Surgical implantation of medical device named "Retina Implant" into eye to restore vision partially.
Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.
Other intervention name(s): retinal implant; bionic eye; artificial vision; artificial eye; restoration of vision; eye chip; vision prosthesis; eye implant; retinal prosthesis
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Retina implant, Subretinal; Legal blindness; Genetic Diseases, Inborn; Eye Diseases; Retinitis Pigmentosa; Retinitis; Retinal Degeneration; Eye Diseases, Hereditary; Retinal Diseases
Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2
Condition: Ability, Spatial
Study type: Interventional

Summary: 
      A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand
      hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing
      impaired participants. These sound changing principles are enabled by respective hearing
      instrument technologies and hearing instrument algorithms. The aim of the study is to
      investigate and assess strengths and weaknesses of these novel sound changing principles in
      terms of hearing performance to determine their application in hearing instruments (Phase of
      development). Both, objective laboratory measurements as well as subjective evaluations in
      real life environment will be carried out. This will be a controlled, single blinded and
      randomised active comparator clinical evaluation which will be conducted mono centric at the
      University Hospital of Zürich.
    


Intervention name(s): several virtual 3-D complex audio environments
Intervention type(s): Procedure
Intervention description(s): The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.
Intervention model: Single Group Assignment
Intervention model description: a group of hearing-impaired particpants with mild or severe hearing loss
Masking: None (Open Label)
Primary purpose: Other
A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Arteriovenous Fistula; Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study is designed to assess the safety and effectiveness of an experimental
      drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive
      hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new
      access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been
      shown in previous research studies to help keep vessels patent when applied to the outside
      surface of the blood vessels (arteries and veins) in patients who undergo surgery to create
      an arteriovenous fistula (AVF). The purpose of this study is to determine whether
      vonapanitase when applied to a limited segment of your blood vessel (about 2 inches)
      immediately after surgery is safe and improves the patency of your AVF.
    


Intervention name(s): Vonapanitase; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): PRT-201
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: radiocephalic; arteriovenous fistula; AVF; hemodialysis; PRT-201; vonapanitase; vascular access; kidney; renal; PATENCY-2; secondary patency; fistula abandonment; use for hemodialysis
IASLC Grading System as a Predictor for EGFR-TKI Therapy
Condition: Lung Cancer
Study type: Observational

Summary: 
      The investigators previously validated the grading system proposed by International
      Association for the Study of Lung Cancer (IASLC) for invasive nonmucinous lung adenocarcinoma
      (LADC) for its reproducibility, prognostication function and predictive value of adjuvant
      chemotherapy (ACT). In this exploratory study, the investigators aimed to investigate the
      role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either
      as adjuvant or palliative therapy.
    


Intervention name(s): IASLC grading system
Intervention type(s): Diagnostic Test
Intervention description(s): A cohort of 2160 patients with invasive nonmucinous EGFR-mutant LADCs were retrospectively collected and classified according to the IASLC grading system. The role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy was investigated.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2008 to April 2021, we consecutively collected lung adenocarcinoma patients
        who underwent complete resection at the Department of Thoracic Surgery, Fudan University
        Shanghai Cancer Center (FUSCC), Shanghai, China. The 8th TNM staging was used in this
        study. The study included three main subgroups: (1) patients with p-TNM stage Ib-III LADCs
        received adjuvant EGFR-TKI or chemotherapy (ADJUVANT subgroup, N=620), (2) patients
        developed post-operative recurrence and treated with either EGFR-TKI or chemotherapy
        (RECURRENCE subgroup, N=321), and (3) next-generation sequencing (NGS) was carried out
        which provided co-occurring mutation information (NGS subgroup, N=1158).
Strength Training Regimen for Normal Weight Diabetics
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The Strength Training Regimen in Normal Weight Diabetics (STRONG-D) study will examine the
      effectiveness of different exercise regimen types in controlling diabetes for the normal
      weight type 2 diabetes population.
    

Detailed description: 
      In the STRONG-D study, participants are randomly assigned to strength training, aerobic
      training or a combined strength and aerobic training group. Participants in the exercise
      group will attend exercise sessions over the course of 9 months at the YMCA. Participants
      will have opportunities to engage in other activities such as educational run-in visits that
      will allow for measurement of hemoglobin A1c and emphasize the importance of exercise in
      improving Type 2 diabetes.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Low Volume Colon Preparation for IBD
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel
      disease.
    

Detailed description: 
      Low-volume preparations are gaining attention for higher acceptability. This study compares
      efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution
      in patients with inflammatory bowel disease-related colitis.

      This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD
      colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel
      cleansing will be assessed using the Ottawa Scale and rated as adequate if <6. Patient
      acceptance, satisfaction, and related symptoms will be also recorded. The study will also
      focus on the factors affecting quality of preparation in inflammatory bowel disease patients
      such as disease characteristics and administration regimen
    

Intervention name(s): Colon preparation for colonoscopy
Intervention type(s): Drug
Intervention description(s): Colon cleansing prior to perform colonoscopy
Other intervention name(s): Colon cleansing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Colon preparation; Colonoscopy; Inflammatory bowel disease
Study to Investigate Effects of Repeated Administration of Itraconazole on Pharmacokinetics of JNJ-42847922 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of repeated once daily administration of
      200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ
      42847922 in healthy, male participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), fixed-sequence,
      single-center, single-dose study designed to assess the effects of steady-state itraconazole
      exposure on the pharmacokinetics of a single oral dose of JNJ 42847922 in healthy male
      participants. The duration of study will be approximately of 6 weeks per participant. The
      study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1);
      Open-label Treatment (6 days); and Follow-up (7 to 14 days after last dose of study drug or
      early withdrawal).

      All eligible participants will receive single oral doses of 5 milligram (mg) JNJ-42847922 on
      Day 1 and Day 6. A daily dose of 200 mg itraconazole will be administered from Day 2 to Day
      6. Followed by an overnight fast of at least 8 hours participants will be administered with
      study treatment 30 minutes after light breakfast. Participants will not be allowed to have
      food until 4 hours of drug administration. Blood samples will be collected for evaluation of
      pharmacokinetics at pre-dose and post-dose of study treatment. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): JNJ-42847922; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6.; Participants will receive single dose of itraconazole as 200 mg (2*100 mg capsule) from Day 2 to Day 6.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Itraconazole; JNJ-42847922
Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma
      lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic
      parameter following the long term administration of SH T00658ID will be assessed.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): EV/DNG (Qlaira, BAY86-5027, SH T00658K); SH D00264A (Triquilar)
Intervention type(s): Drug; Drug
Intervention description(s): 7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo; 7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo
Intervention MeSH terms: Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque
Condition: Root Resorption
MeSH terms: Root Resorption
Study type: Interventional

Summary: 
      Currently Endodontics looks forward for regeneration rather than repair. Regenerative
      endodontic therapy was limited to pulp revascularization of necrotic pulp in immature teeth ,
      followed by mature teeth. Recently pulp revascularization technique by induction of blood
      clot was applied in the treatment of inflammatory root resorption. So far, no clinical study
      for management of teeth with inflammatory internal root resorption by using injectable PRF
      revascularization has been described in the literature. Thus, this is the first clinical
      attempt to manage inflammatory root resorption in necrotic incisor teeth using injectable PRF
      regenerative approach.
    

Detailed description: 
      13 teeth in a total of 10 patients with inflammatory root resorption will be treated using
      revascualrization technique, iPRF will be prepared and unjected in the canal after previous
      canal disinfection with calcium hydroxide for 2-4 weeks. cBCT will be taken preoperative and
      12 month follow up period, also clinical and radiographic follow uo will be considered every
      3 months for 1 year.
    

Intervention name(s): injectable PRF
Intervention type(s): Biological
Intervention description(s): blood sample and centrifuged to obtain i-PRF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulp revascularization; injectable Platelet rich fibrin; i-PRF; root resorption; CBCT
Drug Interaction Study of Warfarin and MT-3995
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin
    

Detailed description: 
      The purpose of this study is to evaluate the potential effects of multiple once daily doses
      of MT-3995 on the PK of (S)-warfarin and (R)-warfarin after single-dose administration of
      racemic warfarin
    

Intervention name(s): Warfarin; MT-3995
Intervention type(s): Drug; Drug
Intervention MeSH terms: Warfarin
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Use of a Liquid Biopsy Signature to Detect Early-onset Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Early-onset gastric cancer (EOGC) is a lethal malignancy with a poor prognosis. It differs
      from late-onset gastric cancer (LOGC) in clinical and molecular characteristics. The current
      strategies for EOGC detection have certain limitations in diagnostic performance due to the
      rising trend in EOGC. Hence, identifying novel EOGC bioindicators is crucial.
    

Detailed description: 
      Due to widespread gastric cancer (GC) detection efforts and timely interventions (removal of
      precancerous lesions and early-stage GC), the GC-associated mortality rate has declined
      worldwide. However, epidemiological studies show rising GC incidences among young adults (<
      50 years old) without familial or hereditary origin. This illness, known as early-onset GC
      (EOGC), comprises 20-30% of new GC diagnoses, mainly among individuals aged 30-40 years; the
      median overall survival time is 11.7 months. Although the underlying cause behind this trend
      is poorly understood, there is a general understanding that EOGC epidemiologically,
      biologically, and pathologically differs from late-onset GC (LOGC, ≥ 50 years). Therefore,
      EOGC patients require clinical assessment and intervention distinct from those applied in
      LOGC.

      Of note, several population-based epidemiological studies have suggested that EOGC patients
      exhibit significantly different behaviors from LOGC patients. EOGC patients are more likely
      to have earlier lymph node and distal metastasis than LOGC patients during disease
      progression. These tough challenges raise clinical concerns: EOGC is more aggressive than
      LOGC; thus, a delayed diagnosis can severely affect patient survival outcomes. Moreover, the
      current approaches to GC detection, such as CEA, HP serology, and pepsinogen (PG), are
      insufficient for detecting early-stage GC and have yet to be investigated in young
      individuals with EOGC. Accordingly, these limitations strongly underscore the necessity to
      establish potent alternative indicators that facilitate the timely detection of EOGC.
    

Intervention name(s): Measurement of levels of an exosome-based liquid biopsy signature
Intervention type(s): Diagnostic Test
Intervention description(s): Each participant was enrolled to assess the levels of an exosome-based liquid biopsy signature
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample Shanxi - Hospital and community sample Beijing -Hospital
      
Biospecimen description: 
      Blood sample