bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population
Condition: Plaque; Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is to assess the safety and tolerability of single doses and multiple doses in
      reducing plaque and gingivitis when delivered in a chewing gum formulation.
    

Detailed description: 
      This study is a Phase 1/2a placebo-controlled, double-blind, randomized, dose-escalation
      study to evaluate the safety and proof of concept of Antiplaque Chewing Gum. This is a 2-part
      trial with 9 dosing cohorts in Phase 1 and 7 dosing cohorts in Phase 2a. For both phases, the
      oral soft (OST) and oral hard tissues (OHT) will be examined. Changes from baseline, such as
      soft tissue erythema, ulceration and sloughing, will be noted and assessments will be made by
      the principal investigator as to whether they might be attributable to the antiplaque chewing
      gum.

      In the Phase 2a portion of the study, the efficacy of the antiplaque chewing gum in reducing
      existing supragingival plaque and gingivitis will also be assessed. Plaque will be assessed
      using the Turesky Modification of the Quigley-Hein Plaque Index (PI, Turesky et al-1970) and
      gingivitis will be assessed using both the Modified Gingival Index (MGI, Lobene et al-1986)
      and the percent of bleeding sites on gentle probing (BOP) using the methods described in
      Ainamo and Bay-1975.
    

Intervention name(s): 2 mg KSL-W; 4 mg KSL-W; 6 mg KSL-W; 10 mg KSL-W; 20 mg KSL-W; 30 mg KSL-W; 50 mg KSL-W; 75 mg KSL-W; 100 mg KSL-W; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): Cetylpyridinium chloride (CPC) as an additive, isomalt as a bulk sweetener, peppermint powder for flavoring, sucralose as an intense sweetener, colloidal silicon dioxide is a flow enhancer, magnesium stearate as a process aid, and the proprietary gum base formulation.
Other intervention name(s): Antiplaque Chewing Gum; Antiplaque Chewing Gum; Antiplaque Chewing Gum; Antiplaque Chewing Gum; Antiplaque Chewing Gum; Antiplaque Chewing Gum; Antiplaque Chewing Gum; Antiplaque Chewing Gum; Antiplaque Chewing Gum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Reducing plaque; Reducing gingivitis; safety; proof of concept; antiplaque chewing gum
Effects of Routine Feedback to Clinicians on Youth Mental Health Outcomes: A Randomized Cluster Design
Condition: Mental Health Wellness 1; Psychosocial Problem
Study type: Interventional

Summary: 
      The purpose of this clinical trial was to test the hypothesis that clients of clinicians who
      were scheduled to receive weekly feedback on their clients' progress would improve faster
      than clients of clinicians who were not scheduled to receive weekly feedback.
    

Detailed description: 
      The primary approach to improving psychosocial treatment for youths has been to implement
      evidence-supported treatments (ESTs) in community services. However, this approach has not
      produced clear cut results of effectiveness. A recently developed alternative is to improve
      outcomes through routine measurement and feedback to clinicians and supervisors. The
      investigators used a cluster randomized experiment with 28 sites affiliated with a national
      behavioral health organization to assess whether clients of clinicians who were scheduled to
      receive weekly feedback on their clients' progress would improve faster than clients of
      clinicians who were not scheduled to receive weekly feedback.
    

Intervention name(s): Contextualized Feedback Systems (CFS)tm
Intervention type(s): Behavioral
Intervention description(s): After clinical questionnaires are entered, an automated feedback report is available online weekly to clinicians (and supervisors) in the experimental group. The report shows current mental health status of youths, alerts, and trends over time. Reports also show some clinical data on youths' caregivers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Contextualized Feedback System (CFS); Mental health outcomes; Quality improvement; Feedback; Clinical trial
Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as
      measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic
      impairment and in healthy subjects following a single oral inhaled dose of GW685698X. From
      the study results it should be possible to assess if there is an altered Risk: Benefit in
      patients with moderate hepatic impairment
    


Intervention name(s): GW685698X
Intervention type(s): Drug
Intervention description(s): GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic impairment pharmacokinetics
Food Modification to Alter Glycaemia and Insulinaemia
Condition: Diabetes
Study type: Interventional

Summary: 
      The study specifically aims to determine glycemic and insulinemic response of added low GI
      ingredients, beta-glucan, resistant starch and isomaltulose to foods.
    

Detailed description: 
      There will be a total of 9 test sessions and each session will last up to 3 hours. At each
      test session, the following procedures will be performed: two finger-prick blood samples,
      five minutes apart to measure baseline blood glucose and insulin concentrations. Subject will
      be served the test food and to consume within15 minutes. Following the test meal, blood
      samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and
      180min for glucose measurements and insulin measurements will be collected at 30, 60, 90,
      120, 150 and 180min.
    

Intervention name(s): Glucose Reference 1; Glucose Reference 2; Glucose Reference 3; Wheat Yellow Noodle; Beta-glucan yellow Noodle; Rice Roll; Rice Roll with resistant starch; Sucrose Jelly; Isomaltulose Jelly
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Glucose contains 50g of available carbohydrates; Glucose contains 50g of available carbohydrates; Glucose contains 50g of available carbohydrates; Wheat Yellow Noodle will contain 50g of available carbohydrate; Beta-glucan yellow noodle will contain 50g of available carbohydrate; Rice Roll will contain 50g of available carbohydrate; Rice Roll fortified with resistant starch will contain 50g of available carbohydrate; Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of sucrose; Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of Isomaltulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to compare how safely and how well this medicine works in
      treating children and teenagers between the ages of 6 and 17 years with a diagnosis of
      Bipolar Disorder.
    

Detailed description: 
      There is no accepted, well-studied treatment for Pediatric Bipolar Disorder and treatment has
      often followed from adult studies. The primary objectives for this study are to determine if
      subjects can safely and easily be switched from divalproex sodium to Depakote ER and to
      determine if Depakote ER is both safe and effective for pediatric patients with Bipolar I or
      II. Secondary objectives include determining the serum levels of valproic acid 20 hours after
      administration of Depakote ER at a steady rate and determining if co-administration of
      stimulants will effect the serum levels of valproic acid. Thirty subjects, ages 6-17 years,
      with a diagnosis of Bipolar I or II who are currently asymptomatic, according to a score of
      less than 10 on the Young Mania Rating Scale, or who desire to change to once daily dosing,
      or desire to change because of the likelihood of decreased side-effects, will be recruited
      from our clinic and the community. If subjects have completed baseline evaluations (including
      diagnostic confirmation), labs, and rating scales and are still eligible to participate,
      subjects will be switched in one night from twice-a-day divalproex sodium (DVP) to divalproex
      sodium extended release (DVP ER).

      The potential benefits of the research are that new information will be added to the field of
      child and adolescent psychiatry and the possibility that the medication change may result in
      improved symptoms of mania or side effects of medications related to peak and trough levels.
      The potential benefits of this study outweigh the possible risks.
    

Intervention name(s): Divalproex sodium extended release
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Pediatric Bipolar Disorder; Depakote ER
Bio Equivalence Study of Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets Under Fasting Condition.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets
      40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of
      studies were separated by a washout period of 7 days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Rosuvastatin Calcium Tablets containing Rosuvastatin Calcium 40 mg (
      Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Crestor® 40 mg Tablets
      containing Rosuvastatin Calcium 40 mg (Reference , AstraZeneca Pharmaceuticals LP, USA) in
      Healthy Human Volunteers Under Fasting Condition.
    

Intervention name(s): Torrent's Rosuvastatin Calcium Tablets 40 mg; Crestor 40 mg Tablets of AstraZeneca LP, USA
Intervention type(s): Drug; Drug
Intervention description(s): oral, crossover; oral, crossover
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan
      and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with
      locally advanced or metastatic gastric cancer
    

Detailed description: 
      There is no regimen considered standard in advanced gastric cancer. The reported response
      rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more
      toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of
      approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable
      toxicity.

      Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a
      synergistic activity with LOHP in preclinical trials
    

Intervention name(s): Irinotecan; Oxaliplatin; Fluorouracil; Leucovorin; Oxaliplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles; Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles; Fluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles; Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles; Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles
Other intervention name(s): CPT-11; LoHP; 5-FU; LV; LoHP
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Gastric Cancer; Oxaliplatin; Irinotecan
Food Vouchers and Educational Intervention on Promoting Healthy Eating in Vulnerable Groups.
Condition: Economic Problems
Study type: Interventional

Summary: 
      Cost has been reported as the main barrier to healthy eating in vulnerable groups. We aimed
      to evaluate the effect of food vouchers with a nutrition education intervention on diet
      quality (using NOVA classification) and health. This pilot study has a randomized pre-and
      post-test experimental design. We included 66 vulnerable users from the Red Cross of Zaragoza
      (Spain). Intervention and control group individuals received 120 eu-ros/month during 3 months
      in food vouchers to be spent in supermarkets (60 eu-ros/month if under 12y) plus a 10-week
      nutrition education for the intervention group. Family food purchases were assessed using
      electronically recorded supermarket-obtained transactions. We found the percentage of healthy
      food was higher in the in-tervention group than in the control group. Once the nutrition
      education was over, dif-ferences between groups dissipated. Health parameters improved in the
      intervention group, particularly weight-status, lipid, and liver enzymes. Control
      participants gained weight, although lipid and liver enzymes improved. Blood pressure and
      HbA1c did not improve in either the intervention or the control group. In conclusion,
      providing unrestricted food vouchers to vulnerable groups to increase healthy food
      consumption and reduce the intake of ultra-processed food appears to be insufficient and
      should be accompanied by medium-long term education.
    


Intervention name(s): Food vouchers and education
Intervention type(s): Other
Intervention description(s): Intervention and control group individuals received 120 euros/month during 3 months in food vouchers to be spent in supermarkets (60 euros/month if under 12y) plus a 10-week nutrition education for the intervention group. Family food purchases were assessed using electronically recorded supermarket-obtained transactions.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Condition: Cachexia; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Wasting Syndrome; Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in
      patients with cachexia caused by cancer.

      PURPOSE: This randomized phase I trial is studying whether testosterone administered during
      standard of care chemotherapy and/or radiation works by helping patients with squamous cell
      carcinoma to maintain their body weight and muscle size and strength during treatment.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the effect of testosterone therapy on lean body mass and muscle strength in
           patients with advanced or recurrent squamous cell carcinoma.

        -  To determine the testosterone therapy on inflammatory biomarkers in patients with
           advanced or recurrent squamous cell carcinoma.

      OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized
      to 1 of 2 treatment arms.

        -  Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo
           testosterone intramuscularly (IM) weekly for 7 weeks.

        -  Arm II: Patients receive standard of care chemotherapy and/or radiation and testosterone
           IM weekly for 7 weeks.

      Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope
      metabolic studies, indirect calorimetry studies, and assessment of their physical activity
      level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life
      questionnaires.

      Blood, muscle tissue, and urine samples are collected periodically for laboratory studies.
      Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by
      immunoassay.

      After completion of study treatment, patients are followed periodically for 1 year.
    

Intervention name(s): Placebo Testosterone; Testosterone Enanthate 100 MG/ML
Intervention type(s): Drug; Drug
Intervention description(s): Placebo (Saline) Testosterone given IM once per week.; Testosterone Enanthate 100mg/ml given once per week IM.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: stage IIB cervical cancer; stage III cervical cancer; recurrent cervical cancer; cachexia; advanced head/neck carcinoma; recurrent head/neck carcinoma
Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
Condition: Breast Cancer; Triple Negative Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination
      with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative
      breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study
      to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to
      be used in the randomized Phase II part. The safety and tolerability of AZD2281 in
      combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5
      countries will be enrolled in Phase I.
    


Intervention name(s): AZD2281; Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): Dose finding study to establish the appropriate dose of AZD2281; Intravenous infusion over 1 hour
Other intervention name(s): Olaparib; Taxol
Intervention MeSH terms: Paclitaxel; Olaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; triple negative; metastatic
Study Evaluating the Safety and Tolerability
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The rationale for the current study is to initially evaluate the safety and tolerability of
      B. longum strain in healthy volunteers.
    

Detailed description: 
      The design of the study is based on the aim to study safety and tolerability of B. longum in
      a limited number of healthy volunteers.
    

Intervention name(s): Probiotic
Intervention type(s): Other
Intervention description(s): The study product is probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adouble-blind, randomised, placebo-controlled, parallel-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to study whether addition of different doses of human chorionic
      gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve
      the number of top-quality embryos.
    


Intervention name(s): rFSH; human chorionic gonadotropin; human chorionic gonadotropin; human chorionic gonadotropin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 150 iu/day of rFSH; 50 iu/day of hCG from stimulation day 1; 100 iu/day of hCG from stimulation day 1; 150 iu/day of hCG from stimulation day 1
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hCG; human chorionic gonadotropin
Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR)
Condition: Cardiovascular Risk
Study type: Interventional

Summary: 
      This project seeks to improve health care outcomes in complex patients with cardiovascular
      disease (CVD) or who are at high risk for developing CVD by promoting patient
      self-management. This will be accomplished in 4 diverse, large primary care practices through
      the following 3 aims: (1) develop a patient-specific, active component to an existing
      electronic PHR directed towards patients with complex illnesses that is designed to reduce
      the risk of cardiovascular disease, (2) conduct a randomized controlled trial of the
      effectiveness of passive and active PHRs for improving adherence and clinical outcomes of
      complex patients in an ambulatory environment, and (3) enumerate the barriers and
      facilitators to implementation and use of an PHR among providers and patients in an
      ambulatory setting. To accomplish the aim 1, a users group will be assembled to determine
      which potential features of an 'active PHR' would be most acceptable and useful to them. To
      accomplish the 2nd aim, 1,000 patients with complex chronic disease leading to increased
      cardiovascular risk (i.e., CVD or 2 of the 4 conditions of hypertension (HTN), diabetes
      mellitus (DM), or hyperlipidemia requiring at least one medication for control) will be
      randomized to a passive PHR (n=500), or an active PHR (n=500) at 4 sites where the PHR
      currently is installed and in use. Outcomes to be assessed include improvement in control of
      risk factors (e.g., blood pressure), frequency of compliance with testing guidelines (e.g.,
      annual dilated retinal exams in DM), and clinical outcomes (e.g., myocardial infarction,
      hospitalizations). Aim 3 will be accomplished by surveying all participants using the PHR,
      along with nurses and physicians at the study sites, and by conducting focus groups of PHR
      participants, nurses, and physicians to determine the most useful features of the PHR and to
      barriers and facilitators of use.
    


Intervention name(s): SMART PHR; usual care
Intervention type(s): Other; Other
Intervention description(s): Patient receives an active PHR; Usual passive PHR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: medically complex diseases that increase cardiovascular risk