bioihbjkbjnl/mcl2 huggingface dataset:
A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in
      healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a
      single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly
      assign participants to receive a single open-label SC dose of ganenerumab at different dose
      levels according to safety assessments from Part I.
    


Intervention name(s): Gantenerumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.; Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Anthocyanin & Phenolic Acids Bioavailability & Antioxidant Capacity After Consumption of Purple Wheat Products in Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This study will determine the bioavailability of anthocyanins and phenolic compounds from two
      purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched
      wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product.
      The purple wheat granola bars are an example of a food product that requires much less
      intensive preparation and cooking, compared to the crackers. A comparison of bioavailability
      between these two products should provide insights about how different processes and food
      matrix influence anthocyanin bioavailability and metabolism.
    

Detailed description: 
      This study will determine the bioavailability of anthocyanins and phenolic compounds from two
      purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched
      wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product.
      The purple wheat granola bars are an example of a food product that requires much less
      intensive preparation and cooking, compared to the crackers. A comparison of bioavailability
      between these two products should provide insights about how different processes and food
      matrix influence anthocyanin bioavailability and metabolism. The study is a crossover
      investigation with 8 men and 8 women who will adhere to a low anthocyanin and low phenolic
      diet for the duration and complete 2 postprandial study visits where, in random order, they
      will consume either the crackers or granola bars. Blood and urine will be collected at
      baseline and postprandially for the analysis of anthocyanins and their metabolites and
      phenolic acids and determination of antioxidant capacity.
    

Intervention name(s): Purple Wheat Crackers; Purple Wheat Granola Bars
Intervention type(s): Other; Other
Intervention description(s): Whole grain crackers manufactured with purple wheat; Whole grain granola bars manufactured with purple wheat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Bioavailability; adults
Efficacy of Hysteroscopic Bubble Test, Flow Test and Peristalsis Test.
Condition: Tubal Patency
Study type: Observational

Summary: 
      Fallopian tube (FT) function is complex. One of the main functions is transport of sperms for
      fertilization and transport of the embry for implantation. Hysteroscopic access to "Darwish
      Hysteroscopic Triad" allows excellent way to assess FT patency. This study compares three
      ways of assessing FT patency separably or in combination: flow test, bubble flow test and
      peristalsis test. Combined bubble flow test and peristalsis test is recently published and
      coined (Darwishscope)1.
    

Detailed description: 
      This study includes infertile women subjected to combined hysteroscopy and laparoscopy UGA.
      During hysteroscopy, on each side, three patency test are done successively: flow test,
      bubble flow test and peristalsis test. Gold standard diagnosis of tubal patency and status is
      concomitant laparoscopy.
    

Intervention name(s): Patency test
Intervention type(s): Diagnostic Test
Intervention description(s): Successive flow test, bubble flow test and peristalsis test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertility women
      
Keywords: hysteroscopy; bubble flow test; Flow test; Peristalsis; Darwishscope
Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study
Condition: Healthy
MeSH terms: Depression
Study type: Interventional

Summary: 
      The primary objective will be to study changes in putamen structural connectivity in healthy
      teens with meditation training. Hypothesis: Putamen structural node strength will increase in
      the training group compared to controls.

      R61 Go/No-Go Criteria. Detect an effect size (a threshold of Cohen's d > 0.20) in changes of
      the primary mechanistic outcome (Putamen structural node strength) by the described
      meditation training in 100 healthy adolescents that are 14-18 years old and retain at least
      80% of randomized participants for primary outcome measurement at the end of the study
      regardless of adherence to the intervention.

      The secondary objective will be to study changes in emotional problems in healthy teens with
      meditation training. Hypothesis: There will be a significant decrease in emotional problems
      measured with the Strengths and Difficulties Questionnaire (SDQ) in the training group
      compared to controls.

      Design and Outcomes: The current research study design will utilize an individually
      randomized group treatment, open-label, waitlist-controlled clinical trial to test the
      efficacy and safety of the investigator's innovative mindfulness meditation intervention
      (Training for Awareness Resilience and Action [TARA]) on the primary outcome (Putamen
      structural node strength) and secondary outcome (emotional problems measured with the
      Strengths and Difficulties Questionnaire [SDQ]) in healthy adolescents between the ages of 14
      to 18 years old.
    


Intervention name(s): Training for Awareness, Resilience, and Action (TARA)
Intervention type(s): Behavioral
Intervention description(s): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in
      the control of blood sugar level by enhancing insulin secretion from the pancreas after
      eating a meal. The purpose of this research study is to evaluate the role of GLP1R in the
      response to elevated glucagon concentrations.
    

Detailed description: 
      Glucagon within the islet can signal the β-cell through GLP1R, and acts as an insulin
      secretagogue. This signaling is blocked by exendin-9,39. The relative importance of glucagon
      signaling through its cognate receptor or through GLP1R is unknown. Despite the lower
      affinity of GLP1R for glucagon, intra-islet concentrations of glucagon are sufficiently high
      to stimulate GLP1R. The other situation where this may occur is in response to pharmacologic
      doses of glucagon as used for β-cell function testing or raising peripheral glucagon
      concentrations above fasting values. The experiments proposed will characterize the role of
      GLP1R in glucagon's actions on the β-cell and the potential therapeutic role of dual (GLP-1R
      and glucagon receptor) agonists for the treatment of T2DM and obesity.
    

Intervention name(s): Exendin-9,39; Saline
Intervention type(s): Biological; Other
Intervention description(s): Exendin-9,39 is a competitive antagonist of GLP-1 actions at the GLP-1 receptor; Placebo comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Metabolomic Response to Meal Ingestion
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators have recently shown that postprandial sensations correlate with changes in
      circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with
      a meal load up to the level of tolerance which involved an unpleasant fullness sensation. The
      aim of the present study is to determine changes in circulating metabolites of a satiating
      pleasurable meal. Healthy men (n = 32) will be evaluated after a 5 h fast. Perception
      measurements and blood samples will be taken before and 20 minutes after ingestion of a
      palatable probe meal (juice and warm ham and cheese sandwich, total 300 ml, 440 kcal). NMR
      spectroscopy will be performed to determine plasmatic Low Molecular Weight Metabolites (LMWM)
      and to characterize lipoprotein profiles (number of particles, lipid content and size of the
      main three lipoprotein classes (VLDL, LDL and HDL). Homeostatic (satiety, fullness) and
      hedonic sensations (digestive well-being, mood) will be measured by 10 cm analogical scales.
    


Intervention name(s): Normal meal
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: meal ingestion; postprandial sensations; circulating metabolites
The Role of Metformin and Colesevelam in Human GLP-1 Secretion
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug
      metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).
    


Intervention name(s): Colesevelam; Metformin; Placebo
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Metformin; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Combination Chemotherapy in Treating Patients With Advanced Stomach Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known which combination chemotherapy regimen is most effective in treating advanced
      stomach cancer.

      PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of
      combination chemotherapy in treating patients who have advanced stomach cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy and tolerability of docetaxel, cisplatin, and fluorouracil (TCF)
           versus docetaxel and cisplatin (TC) versus epirubicin, cisplatin, and fluorouracil (ECF)
           in patients with advanced gastric carcinoma.

        -  Compare the time to treatment failure, time to progression, and survival in this patient
           population treated with these regimens.

        -  Compare the quality of life during the treatment period and after failure in this
           patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      center, performance status (0 vs 1), and liver involvement (yes vs no). Patients are
      randomized to one of three treatment arms.

        -  Arm I: Patients receive epirubicin IV bolus and cisplatin IV over 4 hours on day 1 plus
           fluorouracil IV continuously on days 1-21.

        -  Arm II: Patients receive docetaxel IV over 1 hour and cisplatin IV over 4 hours on day
           1.

        -  Arm III: Patients receive docetaxel and cisplatin as in arm II and fluorouracil as in
           arm I.

      Treatment regimen is repeated every 3 weeks for up to 8 courses in the absence of disease
      progression or unacceptable toxicity.

      Quality of life is assessed before randomization; at day 1 of courses 2, 4, and 6; and one
      month after treatment failure.

      Patients with complete response or partial response are followed monthly for 3 months.

      PROJECTED ACCRUAL: Approximately 111 patients will be accrued for this study.
    

Intervention name(s): cisplatin; docetaxel; epirubicin hydrochloride; fluorouracil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Docetaxel; Fluorouracil; Epirubicin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer
Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
Condition: Keloid
MeSH terms: Keloid; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate how safe and effective AIV001 treatment is on scar formation and/or keloid
      recurrence following keloidectomy.
    


Intervention name(s): AIV001
Intervention type(s): Drug
Intervention description(s): Intradermal
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Scar formation; Keloidectomy
Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency
Condition: Chronic Venous Insufficiency, CVI
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      The objective of the study is to collect clinical data of patients in whom Flebogrif® will
      have been used for mechanochemical ablation of incompetent veins in the follow-up period, as
      related to the safety, clinical effectiveness, properties and advantages of Flebogrif®.

      The proposed study is a prospective, multi-centre clinical trial assessing the safety,
      efficacy and quality of Flebogrif® in a population of patients with the incompetent great
      saphenous vein, who require surgical treatment.
    


Intervention name(s): FLEBOGRIF
Intervention type(s): Device
Intervention description(s): The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Morphine Added to Ropivacaine for FICB for Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      prospective, randomized double blinded study to investigate the effects of morphine as an
      adjuvant to ropivacaine on FICB
    


Intervention name(s): Ropivacaine, Morphine; Ropivacaine, Saline
Intervention type(s): Drug; Drug
Intervention description(s): Morphine added to ropivacaine for fascia iliaca compartment block; Normal saline added to ropivacaine for fascia iliaca compartment block
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Pre-anesthetic Education on Cardiac Surgery Patients' Anxiety Level
Condition: Cardiac Surgery Patients
Study type: Interventional

Summary: 
      The study aims to investigate the effect of pre-anesthetic education on patients undergoing
      cardiac surgery
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study.
      Subjects identification was done using identification form, medical record, Mini Mental State
      Evaluation (MMSE) and Internal Classification of Diseases (ICD) 10. Subjects' anxiety level
      were measured using Amsterdam Preoperative Anxiety and Information Scale (APAIS) with the
      help of the researcher to explain the questions. Then, education were given to the subjects,
      guided by a flow chart made by the researcher, using verbal and emphatic non-verbal language.
      If during education subjects got anxious with or without cardiovascular emergencies,
      education would be stopped, subjects would be eased down. Subject's family would be called
      in. If the subjects agreed to continue, the study would be carried on, otherwise subjects
      were dropped out. Benzodiazepin and midazolam 0.5 mg/kgBW would be considered and consulted
      to a psychiatrist. On the day after the education and discussion, subjects filled in APAIS
      again before entering the operation room. APAIS score recorded before and after anesthesia
      would be presented in the means, and analyzed by SPSS using paired T-test (or Wilcoxon test
      as the alternative test).
    

Intervention name(s): Pre-anesthetic Education
Intervention type(s): Behavioral
Intervention description(s): Education was done before the anesthetic procedure, using a flip chart made by the researchers.
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cardiac surgery, anxiety, education
A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma
Condition: Stomach Neoplasms; Neoadjuvant Therapy; Chemoradiotherapy; Chemotherapy
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This prospective, randomized phase II study is designed to evaluate weather neoadjuvant
      chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and
      postoperative chemotherapy for locally advanced gastric adenocarcinoma.
    


Intervention name(s): SIB-IMRT; S-1; Surgery; SOX
Intervention type(s): Radiation; Drug; Procedure; Drug
Intervention description(s): 45.1Gy and 40.04Gy in 22 fractions using intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor; 40mg/m2, orally twice daily every weekday concurrently with radiotherapy treatment; Surgery, preferred D2 lymphadenectomy; SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
Other intervention name(s): TS-1; TS-1; Oxaliplatin for injection
Intervention MeSH terms: Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Artificial Intelligence for Real-time Detection and Monitoring of Colorectal Polyps
Condition: Adenomatous Polyps
MeSH terms: Adenomatous Polyps; Polyps
Study type: Interventional

Summary: 
      The investigators hypothesize that the clinical implementation of a deep learning AI system
      is an optimal tool to monitor, audit and improve the detection and classification of polyps
      and other anatomical landmarks during colonoscopy. The objectives of this study are to
      generate preliminary data to evaluate the effectiveness of AI-assisted colonoscopy on: a) the
      rate of detection of adenomas; b) the automatic detection of the anatomical landmarks (i.e.,
      ileocecal valve and appendiceal orifice).
    

Detailed description: 
      In this trial, the investigators aim to evaluate the followings:

        1. the accuracy of automatic detection of important anatomical landmarks (i.e., ileocecal
           valve, appendiceal orifice);

        2. the accuracy of automatic detection of polyps/adenomas (PDR/ADR);
    

Intervention name(s): Polyps detection by Artificial Intelligence
Intervention type(s): Diagnostic Test
Intervention description(s): The AI system will capture the live video of the procedure and the AI feedback (polyp detection, tracking, and pathology prediction) will be shown on a second screen installed next to the regular endoscopy screen. Screen A will show the regular endoscopy image and screen B will show the regular endoscopy image together with the areas that might harbor a polyp or the information to predict pathology
Intervention model: Single Group Assignment
Intervention model description: prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Polyps detection; Artificial Intelligence; Adenoma detection; Polyps classification; Quality indicators
Growth and Tolerance of Cow Milk-Based Infant Formulas
Condition: Body Weight
MeSH terms: Body Weight
Study type: Observational

Summary: 
      This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant
      formulas in healthy, term infants.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy, term infants
Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response
      (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.
    

Detailed description: 
      Subjects with Type 1 diabetes will be randomized to either one dose of TI inhaled using the
      Gen2C device, or one dose of subcutaneously injected Rapid Acting Analog (RAA) and crossed
      over.

      Crossover Sequences:

      Sequence #1: Period 1 - one 20 U cartridge of TI; Period 2 - 8 U of RAA

      Sequence #2: Period 1 - 8 U RAA; Period 2 - one 20 U cartridge of TI

      An euglycemic clamp procedure will be performed at each dosing visit. The purpose of this
      study is to characterize the pharmacokinetics (PK) of the one dose of TI Inhalation Powder
      using the Gen2C inhaler as compared to one dose of subcutaneous RAA.
    

Intervention name(s): Technosphere Insulin Inhalation Powder; Rapid Acting Analog
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation Powder using the Gen2C inhaler; Subcutaneous Injection
Other intervention name(s): TI; RAA
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; Hyperglycemia; Insulin