louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01367054: Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
Official title: Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutritional and Metabolic Diseases
Keywords: Metformine
adverse events
bioequivalence
Lead sponsor: Biocinese
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective is evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.

Detailed description: OBJECTIVE: To evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.

MATERIAL AND METHODS: The study was approved by research Ethics Committee and all twenty-eight volunteers signed the selected IC. An open, randomized, crossover study with two periods of confinement and an interval of seven days between them was performed. Twenty (20) blood collections were performed between 30 minutes and 36 hours after drug administration. Plasma samples were analyzed by liquid chromatography mass spectrometry (LC-MS/MS). Statistical analysis was conducted based on pharmacokinetic parameters: maximum concentration (Cmax) and area under the curve (AUC 0-te AUC 0-inf). Analysis of variance (ANOVA) model appropriate was employed for the two periods cross under the logarithmically transformed data.

Eligibility criteria: Inclusion Criteria:

* Within 10% of their ideal body weight
* Age between 18 and 50 years
* Healthy conditions
* Ability to understand the written informed consent

Exclusion Criteria:

* Pregnancy
* Smokers
* Alcohol and drugs

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 24 hours. All adverse events observed are analyzed.
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Brazil
facility: Biocinese
state: Pr
Study officials:
affiliation: Biocinese
name: Josélia Manfio, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351754: Detection of Pulmonary Embolism With CECT
Official title: Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Embolism
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA


Eligibility criteria: Inclusion Criteria:

* Patients 18 yrs or older
* With suspected PE
* Referred for MDCTA of pulmonary arteries
* Signed informed consent

Exclusion Criteria:

* Pregnant and lactating females
* History of hypersensitivity to iodinated contrast agents
* Hyperthyroidism or pheochromocytoma
* Severe CHF
* Renal impairment
* Weight greater than 300 lbs
* Pacemaker
* Swan Ganz catheter
* Defibrillator or other intrathoracic metallic vascular device
* Received an investigational compound within 30 days of being in the study

Primary outcomes:
measure: Hounsfield Units (HU) measured at various levels of pulmonary arteries
Secondary outcomes:
measure: Presence of artifacts; global enhancement
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics, Inc.
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics
name: Steve Sireci, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05493254: Enhancing Smoking Cessation Via Telehealth Options in Primary Care
Official title: Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery Via Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-09
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.


Eligibility criteria: Inclusion Criteria:

1. current smoking, defined as 1+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months
2. age 18+
3. enrolled in MyChart or willing to enroll
4. possess a valid e-mail address that is checked daily
5. owner of an iOS or Android smartphone to provide remote CO
6. have a valid mailing address
7. English fluency

Exclusion Criteria:

1) Use of an FDA-approved cessation medication in the last 7 days

Primary outcomes:
measure: Number of participants who utilized smoking cessation treatment
timeFrame: Month 1
measure: Number of participants who utilized smoking cessation treatment
timeFrame: Month 3
measure: Number of participants who utilized smoking cessation treatment
timeFrame: Month 6
measure: Cigarettes smoking
timeFrame: Month 1
measure: Cigarettes smoking
timeFrame: Month 3
measure: Cigarettes smoking
timeFrame: Month 6
measure: Quit attempts
timeFrame: Month 1
measure: Quit attempts
timeFrame: Month 3
measure: Quit attempts
timeFrame: Month 6
measure: Seven-day point prevalence abstinence
timeFrame: Month 1
measure: Seven-day point prevalence abstinence
timeFrame: Month 3
measure: Seven-day point prevalence abstinence
timeFrame: Month 6
measure: E-visit Acceptability
timeFrame: Month 1
measure: E-visit Acceptability
timeFrame: Month 3
measure: E-visit Acceptability
timeFrame: Month 6
measure: E-visit Adoption
timeFrame: Month 1
measure: E-visit Adoption
timeFrame: Month 3
measure: E-visit Adoption
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT06850454: Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy
Official title: A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chemotherapy Induced Nausea and Vomiting
Keywords: olanzapine
moderately emetogenic chemotherapy
carboplatin
irinotecan
oxaliplatin
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy

Detailed description: A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy

Eligibility criteria: Inclusion Criteria:

* histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
* age of \>18 years old

Exclusion Criteria:

* pregnancy or breast feeding
* has emetic episode within 24 hours
* gut obstruction
* uncontrolled brain metastasis
* allergy to or current use of olanzapine
* concomittant moderate or high emetogenic chemotherapy on day 2-5
* Total bilirubin \> 2 mg/dl or creatinine clearance \< 30 ml/min
* unable to swallow drug

Primary outcomes:
measure: total protection rate of nausea and vomiting
timeFrame: 5 days
Secondary outcomes:
measure: no nausea rate
timeFrame: 5 days
measure: severity of nausea and vomiting
timeFrame: 5 days
measure: adverse events
timeFrame: 5 days
measure: rescue therapy
timeFrame: 5 days
measure: quality of life score
timeFrame: 5 days
measure: Cost
timeFrame: 5 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
References:
citation: Shen J, Zhao J, Jin G, Li H, Jiang Y, Wu Y, Gao J, Chen F, Li J, Wang W, Li Q. A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy. J Cancer Res Clin Oncol. 2024 May 28;150(5):283. doi: 10.1007/s00432-024-05712-7.
citation: Yamamoto S, Iihara H, Uozumi R, Kawazoe H, Tanaka K, Fujita Y, Abe M, Imai H, Karayama M, Hayasaki Y, Hirose C, Suda T, Nakamura K, Suzuki A, Ohno Y, Morishige KI, Inui N. Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials. BMC Cancer. 2021 Jul 19;21(1):832. doi: 10.1186/s12885-021-08572-3.
Clinical trial NCT00897754: Gene Expression in Patients With Advanced or Metastatic Colorectal Cancer Receiving Bevacizumab
Official title: Alternative Splice Forms of VEGF in Colorectal Cancer - Possible Value in Anti-VEGF Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
stage III colon cancer
stage IV colon cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients participating in E3200

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.

PURPOSE: This laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.

Detailed description: OBJECTIVES:

* Determine whether the balance of splice form expression alters susceptibility of tumors in vivo to respond to anti-VEGF therapy.

OUTLINE: Tumor tissue samples collected on clinical trial E-3200 are analyzed for laboratory endpoints.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Tumor tissue samples available from patients with advanced or metastatic adenocarcinoma of the colon or rectum

  * Receiving bevacizumab on clinical trial E-3200

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Mean scores for VEGFb and pan-VEGF gene expression by IHC
timeFrame: 1 month
measure: Gene expression as measured by tissue microarrays
timeFrame: 1 month
measure: Splice form expression as measured by reverse transcriptase-PCR
timeFrame: 1 month
measure: VEGF165b protein expression as measured by ELISA
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol Heart Institute at University of Bristol
name: David Bates, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03045354: Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite
Official title: The Effect of Carbohydrate-Containing Foods at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite in Normal Weight and Overweight/Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Breakfast
Keywords: children
dietary carbohydrates
satiety
appetite
blood glucose
solanum tuberosum
obesity
breakfast
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 22
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of carbohydrates of familiar breakfast meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and overweight or obese (OW/OB) children.

Detailed description: Regular breakfast eating NW and OW/OB children, 9-14 years of age, will participate in the experiment. Four isocaloric (450 kcal) breakfasts (eggs with a side of French fries, mashed potatoes, or beans, and control breakfast of milk, cereal and toast) and breakfast skipping will be examined. On five separate mornings, 7 days apart and after a 12 hour overnight fast, each participant will receive one of the four breakfasts or skip breakfast, in a randomized counterbalanced order. Participants will be given an ad libitum lunch 3 hours after breakfast and parents will report the rest of day food record for food intake analysis. Blood glucose will be measured via finger-prick at baseline, and 30, 60, 120, and 180 minutes after breakfast consumption. Subjective appetite will be measured with a visual analogue scale at baseline and every 15 minutes for 1 hour, and every hour for 3 hours.

Eligibility criteria: Inclusion Criteria:

* be between 9 and 14 years of age
* be healthy, and have been born at term
* not be taking any medications
* not have allergies or sensitivities to potatoes, eggs, gluten, dairy, or beans
* NW (between the 5th and 85th BMI percentile for age and gender)
* OW/OB (\>85th BMI percentile for age and gender)

Exclusion Criteria:

* food sensitivities, allergies, or dietary restrictions
* health, learning, emotional, or behavioural problems
* receiving any medications

Primary outcomes:
measure: Short-term food intake (kcal)
timeFrame: 3 hours after breakfast
Secondary outcomes:
measure: Subjective appetite
timeFrame: Baseline, at 15 or 60 minutes intervals for 3 hours
measure: Blood glucose
timeFrame: Baseline, 30, 60, 120 and 180 minutes after breakfast
measure: Rest of day food record
timeFrame: 8-12 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: School of Nutrition, Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Nick Bellissimo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189254: A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ
Official title: A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1487-IMIQ Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratoses
Keywords: 1 year follow up
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: At least 18 years old. Females of childbearing potential, with a negative urine pregnancy test, must have been willing to use a medically acceptable method of contraception during the treatment.

Brief summary: The purpose of the study is to obtain recurrence rates and long-term safety data for patients who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a previous study.


Eligibility criteria: Inclusion Criteria:

* 100% clearance of Actinic Keratosis (AK) lesions in the 1487 IMIQ study

Exclusion Criteria:

* used any treatments in the previous treatment area within 24 hours prior to the follow-up visit

Primary outcomes:
measure: Efficacy
timeFrame: one year after completion of study 1487-Imiq
measure: Safety
timeFrame: one year after completion of study 1487-Imiq
measure: Adverse Events
timeFrame: one year after completion of study 1487-Imiq
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Study Coordinator
role: STUDY_CHAIR
References:
Clinical trial NCT00243854: Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
Official title: Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Resectable Pancreatic Cancer
adenocarcinoma of the pancreas
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-10-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

Detailed description: To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

Eligibility criteria: Inclusion Criteria:

* pathologically confirmed adenocarcinoma of the pancreas
* resectable disease
* tumor \</= 6cm diameter
* ECOG performance 0-1
* Organ system fxn: granulocytes (\>/=1800/uL); plt ct \>/=100K; bili\</=2mg; liver enzymes \<2.5ULN; crt \</=1.5;
* Normal CXR
* Negative pregnancy test

Exclusion Criteria:

* metastatic disease or peritoneal seeding based on cross-sectional imaging
* previous irradiation to the planned field
* prior chemotherapy or immunotherapy
* active infection
* active PUD

Primary outcomes:
measure: To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy
timeFrame: Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Higinia Cardenes, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Gabriela Chiorean, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01461954: FST-100 in the Treatment of Acute Viral Conjunctivitis
Official title: A Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of FST-100 Ophthalmic Suspension in the Treatment of Acute Viral Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Viral Conjunctivitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute viral conjunctivitis. The study intends to show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical resolution of acute viral conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye

Exclusion Criteria:

* Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle

Primary outcomes:
measure: Clinical resolution of acute viral conjunctivitis
timeFrame: 6-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora Clinical Site
state: Massachusetts
city: São Paulo
country: Brazil
facility: Hospital São Paulo/Federal University of São Paulo (UNIFESP)
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: