louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00814411: A Trial of Group Versus Individual Family Planning Counseling in Ghana
Official title: A Randomized Trial of Group vs. Individual Family Planning Counseling in Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: contraception
noninferiority
intention
family planning counseling
post abortion care
Family planning intention among women with unmet need
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Kwame Nkrumah University of Science and Technology
First posted: 2008-12-24
Enrollment: 648
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study uses a randomized, noninferiority design to determine whether group family planning counseling is as effective as individual family planning counseling among gynecological patients with unmet need at two teaching hospitals in Ghana.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* fertile
* desires to delay pregnancy for at least 12 months

Exclusion Criteria:

-

Primary outcomes:
measure: Contraceptive Intention
timeFrame: Follow-up
Secondary outcomes:
measure: Modern contraceptive method knowledge
timeFrame: baseline and follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital
state: Ashanti
city: Accra
country: Ghana
facility: Korle Bu Teaching Hospital
state: Greater Accra
Study officials:
References:
Clinical trial NCT02276911: Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
Official title: Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervical Spondylosis
Lumbar Spondylosis
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, placebo controlled, double-blinded study at a single institution.

Detailed description: Pain medicine literature and the principal investigator's anecdotal experience in posterior cervical and lumbar instrumented spine surgery suggest that pre-incisional IV ibuprofen significantly reduces postoperative pain without increasing surgical complications or fusion rate, which leads to earlier ambulation, less dependence on narcotic medications, shorter hospital stays, and earlier return to work. The purpose of this study is to assess if these anecdotal findings hold true in a randomized clinical trial of patients with cervical or lumbar spondylosis, who are undergoing decompression and instrumented fusion of the spine.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age
* Able to give consent
* Diagnosed with spondylosis, stenosis, and/or instability of the cervical spine
* Diagnosed with spondylosis, stenosis, and/or instability of the lumbar spine
* Require a posterior decompression with internal fixation
* Likely to complete the trial

Exclusion Criteria:

* Patients with previous surgery at the treated spine segment
* Women who are pregnant or plan to become pregnant during the study period Renal/liver disease
* Anemia; coagulopathy
* Thrombocytopenia (\<30,000)
* Coronary artery disease
* Previous coronary artery bypass graft (CABG)
* Patients taking Coumadin, Plavix, Lithium, or ACE-inhibitors plus Lasix; non-steroidal anti-inflammatory drug (NSAID) hypersensitivity
* Gastric ulcers
* Recent stroke
* Traumatic brain injury, or intracranial surgery

Primary outcomes:
measure: Change in pain level
timeFrame: pre-operative, 1-3 weeks post-operative, 6 months post-operative
measure: Change in overall health/function
timeFrame: pre-operative, 1-3 weeks post-operative, 6 months post-operative
measure: Fusion rates
timeFrame: 6 month post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: SJHMC/Barrow Neurosurgical Associates
state: Arizona
Study officials:
affiliation: St. Joseph Hospital and Medical Center
name: Nicholas Theodore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01958411: Correlation Between NAFLD, Epicardial Adipose Tissue and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Non-alcoholic Fatty Liver Disease
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 340
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants who underwent a medical health check in the health promotion center in Korea Guro University

Brief summary: * Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.
* Non-alcoholic fatty liver disease (NAFLD) is closely associated with many cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation using computed tomography (CT).
* Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT) is an independent marker of cardiovascular events in the general population.
* Therefore, the purpose of this investigators study is to compare the NAFLD severity and EAT volume with FDG uptake measured by PET/CT.


Eligibility criteria: Inclusion Criteria:

* Healthy patients for visiting routine medical check in our clinic

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Diabetes
* Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
* Malignancy
* Severe renal or hepatic disease
* Subjects taking medications that might affect inflammation such as nonsteroidal antiinflammatory drug and statin

Primary outcomes:
measure: Correlation between vascular inflammatory status measured by 18FDG PET and NAFLD measured by un-enhanced CT
timeFrame: 12 weeks
measure: Correlation between vascular inflammatory status measured by 18FDG PET and epicardial adipose tissue measured by CT
timeFrame: 12 weeks
Secondary outcomes:
measure: The relationship of NAFLD with carotid intima media thickness
timeFrame: 12 weeks
measure: The relationship of epicardial adipose tissue volume with carotid intima media thickness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
citation: Lee HJ, Lee CH, Kim S, Hwang SY, Hong HC, Choi HY, Chung HS, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. Association between vascular inflammation and non-alcoholic fatty liver disease: Analysis by 18F-fluorodeoxyglucose positron emission tomography. Metabolism. 2017 Feb;67:72-79. doi: 10.1016/j.metabol.2016.11.004. Epub 2016 Nov 6.
Clinical trial NCT01405911: Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
Official title: A Phase II, Randomized, Placebo-Controlled, Parallel-group, Double-Blind, Dose Response Finding Clinical Trial to Study the Efficacy and Safety of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glucose Intolerance
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 242
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.


Eligibility criteria: Inclusion Criteria:

* Impaired glucose tolerance
* On diet/exercise therapy
* Unlikely to conceive
* Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) \<6.1%, Fasting Plasma Glucose \<126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and \<200 mg/dL

Exclusion Criteria:

* History of diabetes mellitus
* Disease or condition of clear or likely glucose tolerance disorder
* Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

Primary outcomes:
measure: Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8
timeFrame: Baseline (Week 0) and Week 8
measure: Percentage of Participants Who Experienced One or More Adverse Events (AEs)
timeFrame: Up to 10 weeks
measure: Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7
timeFrame: Baseline (Week -1) and Week 7
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kaku K, Kadowaki T, Terauchi Y, Okamoto T, Sato A, Okuyama K, Arjona Ferreira JC, Goldstein BJ. Sitagliptin improves glycaemic excursion after a meal or after an oral glucose load in Japanese subjects with impaired glucose tolerance. Diabetes Obes Metab. 2015 Nov;17(11):1033-41. doi: 10.1111/dom.12507. Epub 2015 Jul 17.
Clinical trial NCT02513511: Hypnosis to Perform Awake Intubation
Official title: Hypnosis as a Sole Agent to Perform Awake Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Keywords: difficult airway
awake intubation
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Awake intubation is a recommended safety procedure in specific cases where the intubation or ventilation before general anesthesia is at risk.

Numerous techniques to allow awake intubation have been described, such as pure awake technique, local anesthetics or intravenous sedation for example.

Hypnosis is used for various operating room techniques and surgeries. The investigators aim to analyze the feasibility of awake laryngoscopy and intubations on patients placed under hypnosis alone.

Detailed description: Awake intubation is a recommended safety procedure in specific cases where the intubation or ventilation before general anesthesia is at risk.

Numerous techniques to allow awake intubation have been described, such as pure awake technique, local anesthetics or intravenous sedation for example.

Hypnosis is used for various operating room techniques and surgeries. The investigators aim to analyze the feasibility of awake laryngoscopy and intubations on patients placed under hypnosis alone.

Once patient will consent to be enrolled in the study, the same physician, trained in hypnosis, will accompany the patient in the operating room and place him into a hypnotic state. Once this hypnotic state is achieved, an oro-tracheal laryngoscopy will be performed with an Airtraq videolaryngoscope by an experienced anesthetist, specialised in the management of the difficult airway. If conditions allow it, the laryngoscopy will be followed by an oro-tracheal intubation.

A questionnaire assessing objective and subjective criteria from the patient and from the airway specialist will be collected.

Eligibility criteria: Inclusion Criteria:

* adults
* american society of anesthesiology classification 1-3
* understanding of french language

Exclusion Criteria:

* history of difficult intubation
* patient refusal
* deafness
* uncomfortable with french language understanding

Primary outcomes:
measure: Number of participants in which laryngoscopy is possible under hypnosis
timeFrame: 60 minutes
Secondary outcomes:
measure: Number of participants in which intubation is possible under hypnosis
timeFrame: 60 minutes
measure: comfort assessed by patient
timeFrame: 60 minutes
measure: comfort assessed by doctor
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Dpt of Anesthesiology, University of Lausanne CHUV
state: VD
Study officials:
affiliation: University of Lausanne Hospitals
name: patrick Schoettker, MD, PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02843711: Molecular Analysis of 150 Lung Adenocarcinoma
Official title: Molecular Analysis of 150 Lung Adenocarcinoma With Corresponding Histopathological and Clinical Data Available
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Adenocarcinoma
Keywords: Lungcarta Panel
lung adenocarcinoma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults\>18 years old with diagnosis of lung adenocarcinoma and treatment by surgery

Brief summary: LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery during the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung adenocarcinomas. For all patients, clinical data and histopathological data are available. The objective of this study is to characterize these lung adenocarcinomas by the LungCarta Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA mutations and/or frameshift insert/deletion among 26 oncogenes. Once included in the study, the adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are correlated with clinical, histopathological and molecular data.

Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's expression.


Eligibility criteria: Inclusion Criteria:

* Adults
* lung adenocarcinoma
* Surgical specimen

Exclusion Criteria:

* not adenocarcinoma subtype of lung cancer
* Tumour biopsy
* insufficient material for DNA extraction

Primary outcomes:
measure: Genomic DNA Mutation
timeFrame: at diagnosis (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Anatomie et cytologie pathologiques Groupement hospitalier Est, Institut de cancérologie des Hospices civils de Lyon,
Study officials:
affiliation: Hospices Civils de Lyon
name: Marie BREVET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04434911: Precision Medicine Study on Cardiovascular Disease (PRECISE)
Official title: Precision Medicine Study on Cardiovascular Disease (PRECISE)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Diseases
Keywords: monogenic cardiovascular disease
clinical outcomes
genomics
genetic diagnosis
risk stratification
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2020-06-17
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with monogenic cardiovascular disease from multiple centers in China between October 10, 2020 and October 10, 2025

Brief summary: Cardiovascular diseases are the leading cause of death in China and have become a financial burden on society under the traditional medical model. A new and sustainable medical model is needed to solve this dilemma, for which precision medicine models have great potential. Monogenic cardiovascular disease is the first field to be broken through in precision medicine at this stage, and it is also the field where precision medicine is most likely to be successfully transformed into clinical application, including genetic diagnosis, molecular typing, risk stratification, genetic interruption and individualized treatment.

Detailed description: In this study, patients with monogenic cardiovascular disease are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood, saliva, urine and feces for all patients, and myocardium for patients receive cardio myectomy surgery . Genetic testing will be performed to identify novel disease genes, genetic risk factors and potential therapy targets.

Eligibility criteria: Inclusion Criteria:

* Patients with monogenic cardiovascular diagnosed according current practice guideline.

Exclusion Criteria:

* Patients who refuse to sign the informed consent or decline follow-up.

Primary outcomes:
measure: number of participants with cardiovascular deaths
timeFrame: an average of 5 years
measure: number of participants with all-cause death
timeFrame: an average of 5 years.
Secondary outcomes:
measure: number of participants with heart failure
timeFrame: an average of 5 years
measure: number of participants with stroke
timeFrame: an average of 5 years
measure: number of participants with malignant arrhythmia
timeFrame: an average of 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lei Song, MD. ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876811: Effect of Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers
Official title: Raspberries and Human Health: A Short-term Intervention Trial Investigating the Effect of Daily Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oxidative Stress
Keywords: raspberry
fruit
antioxidants
polyphenols
oxidative stress
dietary intervention
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2009-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is determine whether daily consumption of frozen red raspberries can improve the antioxidant capacity of the blood and reduce the effects of oxidative stress, dose-dependently, in a healthy adult population.

Detailed description: Red raspberries are an excellent source of numerous polyphenolic antioxidants. The bioactivity of these compounds have been implicated in many biological pathways and may function to reduce the risk of numerous chronic diseases. We are conducting an intervention study with frozen red raspberries on a healthy adult population in order to determine if raspberry polyphenols are bioavailable and bioactive in vivo. Twenty-four subjects (12 male and 12 female) will be recruited to participate and consume one-cup frozen red raspberries daily for two weeks, they then will randomly be assigned to consume either one, two or four cups of raspberries for another two weeks, this will be followed by four weeks of non-treatment. Blood samples and 12-hour urine collections will be taken in order to measure the concentration of raspberry polyphenols in response to treatment dose. Dose-dependent treatment effects on blood biomarkers for antioxidant capacity, oxidative stress, inflammation and other chronic disease risk factors will also be measured.

Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* obese (\>30kg/m2)
* high blood pressure (140/90mmHg)
* allergic to raspberries
* pregnant or lactating
* history of chronic disease
* currently taking medication

Primary outcomes:
measure: serum TBARS
timeFrame: end of week 1, 3, 5 and 9
Secondary outcomes:
measure: serum antioxidant capacity (AOC)
timeFrame: end of week 1, 3, 5 and 9
measure: serum thiols
timeFrame: end of week 1, 3, 5 and 9
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Department of Nutritional Sciences, University of Toronto
name: A V Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: