louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01781416: Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk
Official title: Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk
Keywords: cardiovascular risk
SCORE
cardiovascular primary prevention
risk factors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 799
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults aged 50 and over who :

* are currently in primary prevention for a cardiovascular event,
* are usually treated by the general practitioner,
* and have a medical visit during the study period.

Brief summary: This is a national, non interventional, prospective study performed in the general practice setting.

The study has been designed :

* to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians,
* and to evaluate the impact of patients' exposure to a medical information leaflet on patients' cardiovascular risk perception.

Detailed description: LEVEL OF CONCORDANCE BETWEEN PATIENTS PERCEPTION AND PHYSICIANS EVALUATION OF CARDIOVASCULAR RISK

Eligibility criteria: Inclusion Criteria:

* Currently in primary prevention for a cardiovascular event (patient with no known history of acute cardiovascular or cerebrovascular event)
* Usually treated by the GP
* Having signed the information and consent form

Exclusion Criteria:

* Patient with a pathologic vascular ultrasound exam (atheromatous plaque or stenosis)
* Patient unable to read and complete the study documentation

Primary outcomes:
measure: Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet)
timeFrame: Baseline
measure: Cardiovascular risk assessed by physicians
timeFrame: Baseline
Secondary outcomes:
measure: Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet
timeFrame: Baseline
measure: Actual cardiovascular risk calculated using SCORE
timeFrame: Baseline
measure: Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR
timeFrame: Baseline
measure: Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR
timeFrame: Baseline
measure: Risk factors considered by patients in self-assessing their CVR
timeFrame: Baseline
Other outcomes:
Locations:
city: PARIS Cedex 15
country: France
facility: Research Site
Study officials:
affiliation: Service de Pharmacologie Clinique - Unite INSERM U 1048 - Faculte de Medecine - 37 Allees Jules Guesde -31073 Toulouse- FRANCE
name: Atul PATHAK, Professor
role: STUDY_CHAIR
affiliation: Unite des Maladies Coronaires - Hopital Europeen Georges Pompidou - 20 Rue Leblanc - 75015 Paris - FRANCE
name: Nicolas DANCHIN, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05375916: Comparison of Short-term Sustained-release Opioid in Open Abdominal Urologic Surgeries
Official title: Comparison of Short-term Sustained-release Opioid With Immediate-release Opioid for Acute Pain Management Following Open Abdominal Urologic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Opioid Use
Keywords: Postoperative pain
Opioid
Sustained-release opioid
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The advantage of slow-release opioid allows for less fluctuation in drug (pain killer) levels in the blood and an extended period within the effective range for pain relief. The slow-release opioids have been preferred over the short-acting opioids because of the longer duration of action, which lessens the frequency and severity of end-of-dose pain.

Herein, the investigators propose the use of low dose slow-release opioid formulation offers better pain control in the first 48 hours post-operatively in open abdominal urologic surgeries.

Detailed description: This will be a randomized, double-blind, controlled trial looking at all adult patients undergoing open abdominal urologic surgeries. After assessing the inclusion/exclusion criteria, the patients will be randomized into one of two groups:

Group 1: Sustained-release (long-acting) opioid on a regular basis for 2 days with immediate-release (short-acting) opioid available on an 'as required' basis

Group 2: Immediate-release (short-acting) opioid on an 'as required' basis only.

All patients will have a general anesthetic at the discretion of the anesthesiologist in the operating room and intravenous opioid will be administered in accordance with the anesthesiologists' discretion.

Pain score and analgesic consumption are the outcome measures.

Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing open abdominal urologic surgeries
* ASA 1-3

Exclusion Criteria:

* Patient refusal
* history of chronic pain
* allergy to hydromorphone
* cannot swallow tablets

Primary outcomes:
measure: Time to Mobilization
timeFrame: Time to mobilize postoperatively up to 5 days
Secondary outcomes:
measure: Opioid consumption of hydromorphone
timeFrame: Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively
measure: Pain score
timeFrame: postoperatively day 1, 2, 3
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References:
Clinical trial NCT01856816: Effect of Meal Patterning on Carotenoid Absorption From Vegetables
Official title: Effect of Meal Patterning on Carotenoid Absorption From Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotenoid
Bioavailability
Dietary Modification
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this research study is to determine how different meal patterns influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is that carotenoid absorption will be lower when daily vegetables are consumed in one meal compared two smaller meals throughout the day.


Eligibility criteria: Inclusion criteria:

* Age range: 18-50 years
* Body mass index (BMI: weight (kg)/height (m2)) ranging from 20-29 kg/m²
* Weight stable (\<4.5 kg change within the last 3 months)
* Constant habitual activity pattern, not to exceed activities of a recreational level over the past 3 months
* Have clinically normal blood profiles (specifically normal liver and kidney functions and fasting blood glucose of ≤110 mg/dl)
* Non-smoking
* Non-diabetic
* No current use of medication affecting lipid profile
* No intestinal disorders including lipid malabsorption, lactose intolerance
* No heavy consumption of alcohol (\>2 drinks per day)
* No current use of dietary supplements that affect cholesterol, (e.g. Benocol or fiber supplements) or a willingness to discontinue their use during the study

Exclusion criteria:

* Diabetic
* Use of lipid altering medications

Primary outcomes:
measure: Area under the concentration (AUC) vs time curve for carotenoids in the triglyceride-rich lipoprotein (TRL) fraction of plasma.
timeFrame: 0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Purdue University
name: Mario Ferruzzi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Wayne Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00391716: Gabapentin Treatment of Alcohol Dependence
Official title: Gabapentin Treatment of Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Alcohol Dependence
Keywords: Alcohol
Alcohol treatment
Alcoholism
Alcohol Dependence
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2006-10-24
Enrollment: 150
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: Gabapentin treatment for alcohol dependence

Detailed description: This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.

Eligibility criteria: Inclusion Criteria:

* Men and women over age 18 with alcohol dependence

Exclusion Criteria:

* Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances
* Significant medical disorders that will increase potential risk or interfere with study participation
* Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
* Treatment with an investigational drug in the last month.

Primary outcomes:
measure: Drinking
timeFrame: 12-week
Secondary outcomes:
measure: Mood
timeFrame: 12-week
measure: Sleep
timeFrame: 12-week
measure: Craving
timeFrame: 12-week
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute
state: California
Study officials:
affiliation: The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
name: Barbara J. Mason, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.
Clinical trial NCT02418416: Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor
Official title: Calcium Ionophore Together With Strontium Chloride Would Likely Have a Positive But Non-traumatic Impact on Human Embryo Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Al Baraka Fertility Hospital
name: Banon IVF Center Assiut, Egypt
First posted: 2015-04-16
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.

Detailed description: In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.

We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.

Eligibility criteria: Inclusion Criteria:

* poor sperm
* poor quality Oocytes
* previous failed fertilization
* previous poor embryogenesis

Exclusion Criteria:

* normal patient
* previous successful outcome

Primary outcomes:
measure: Clinical Pregnancy rate ( % )
timeFrame: 3 months
Secondary outcomes:
measure: Blastocyst rate ( % )
timeFrame: 3 months
Other outcomes:
Locations:
city: Bahrain
country: Bahrain
facility: Al Barka fertility center
city: Assiut
country: Egypt
facility: Banon fertility center
city: Sohag
country: Egypt
facility: IbnSina IVF unit, IbnSina Hospital, El Areef Square
Study officials:
References:
Clinical trial NCT01518816: Role of Serum Total Antioxidant Level in Preterm Labor
Official title: the Role of Serum Total Antioxidant Level in Preterm Labor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Labor
Keywords: antioxidant preterm labor
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women attending the outpatient obstetric clinic and inpatient of Obstetrics and Gynecology department or when they will be admitted to the delivary room of Ain Shams university hospital.

Brief summary: The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.

Detailed description: Study design:

This is a prospective case-control study.

Setting:

The study will be conducted at Ain Shams University Maternity Hospital.

Population of the study:

A total of 70 pregnant women attending the outpatient obstetric clinic and inpatient of Obstetrics and Gynecology department or when they will be admitted to the delivary room of Ain Shams university hospital.

Patient will be divided in to two groups. Group A: 35 pregnant women diagnosed with preterm labor(Preterm labor pain at least 3 contraction every 20 minutes ,cervical dilatation \< 2cm and effacement\< 50%) which will deliver within one week maximum after hospitalization.

Group B: 35 pregnant women( controls )with uncomplicated pregnancies at a similar gestational ages followed routinely in the antenatal care unit.

Every case will be subjected to:-

1. Written informed consent before the study.
2. Complete history .
3. Complete general and abdominal examination.
4. Infection markers(CRP,WBCs count, urine analysis ).
5. Gestational age determination by the last menstrual date or Ultrasonography.
6. Local pelvic examination.

Eligibility criteria: Inclusion Criteria:

* Preterm labor(pregnant between 28th and 37th week).
* Singleton pregnancy.
* Amnion membranes were intact

Exclusion Criteria:

* Past history of preterm labor or premature delivery.
* Urinary tract infections and any other infections.
* Poly- or oligohydramnios.
* Fetal distress, fetal or uterine anomaly.
* Membranes rupture and placenta pathology.
* Preeclampsia or intrauterine growth retardation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
state: Tertiary
Study officials:
affiliation: Ain Shams Maternity Hospital
name: ABDALLAH s ABDELATIF, residant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03110016: Smartphone Intervention for Subthreshold Depression
Official title: Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subthreshold Depression
Lead sponsor: Kibi International University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study aimed to examine the feasibility, usability, user satisfaction, safety, and preliminary efficacy of a smartphone application intervention for young adults with subthreshold depression.


Eligibility criteria: Inclusion Criteria:

* Aged 18-24 years
* Has a Center for Epidemiologic Studies Depression Scale score of ≥16
* Owns a smartphone with the iOS® operating system

Exclusion Criteria:

* Lifetime history of major depressive disorder
* Lifetime history of bipolar disorder
* Currently receiving treatment for a mental health problem from a mental health professional
* Experience of a major depressive episode in the 2 weeks prior to the study, as ascertained using the Mini-International Neuropsychiatric Interview

Primary outcomes:
measure: Feasibility, as measured by adherence to the smartphone application intervention.
timeFrame: 5 weeks after initiating the intervention
Secondary outcomes:
measure: Usability and user satisfaction
timeFrame: 5 weeks after initiating the intervention
measure: Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview.
timeFrame: baseline and 1, 2, 3, 4, and 5 weeks after initiating the intervention
measure: Depressive symptoms
timeFrame: baseline and 5 weeks after initiating the intervention
measure: Inflammatory biomarker
timeFrame: baseline and 5 weeks after initiating the intervention
measure: General self-efficacy
timeFrame: baseline and 5 weeks after initiating the intervention
measure: Social anxiety
timeFrame: baseline and 5 weeks after initiating the intervention
measure: Mental health
timeFrame: baseline and 5 weeks after initiating the intervention
Other outcomes:
Locations:
city: Takahashi
country: Japan
facility: Kibi International University
state: Okayama
Study officials:
affiliation: Kibi International University
name: Kazuki Hirao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05931016: Impact of Surgical Mask, FFP2 Mask and FFP3 Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy
Official title: Impact of Surgical Mask, FFP2 (Filtering Face Piece Class 2) Mask and FFP3 (Filtering Face Piece Class 3) Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Face Mask
Longterm Oxygen Therapy
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known lung disease hospitalized at normal wards.

Brief summary: The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy.

In particular, the question arises whether patients become hypoxemic or hypercapnic by using a mask. Or whether wearing a mask increases oxygen saturation by its reservoir function.


Eligibility criteria: Inclusion Criteria:

* Known lung disease and
* LTOT
* informed consent

Exclusion Criteria:

* Severe disease with contraindication for stress testing (e.g. myocardial infarction, acute pulmonary embolism, acute heart failure)
* Acute exacerbation of lung disease

Primary outcomes:
measure: Increase in capillary oxygen partial pressure
timeFrame: At the end of 6-MWT or spiroergometry
measure: Increase in capillary carbon dioxide partial pressure
timeFrame: At the end of 6-MWT or spiroergometry
Secondary outcomes:
Other outcomes:
Locations:
city: Donaustauf
country: Germany
facility: Klinik Donaustauf
state: Bavaria
Study officials:
References:
Clinical trial NCT01054716: Evaluation of a Noninvasive Fetal RHD Genotyping Test
Official title: Evaluation of a Noninvasive Fetal RHD Genotyping Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhesus D Genotype
Keywords: RhD negative
RhD disease
fetal nucleic acid
fetal DNA
cell free fetal DNA
Fetal RHD genotype
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sequenom Center for Molecular Medicine
First posted: 2010-01-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.

Brief summary: This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.


Eligibility criteria: Inclusion Criteria:

* Subject is 18-64 years of age
* Subject is female
* Subject is pregnant
* Subject is RhD negative
* Subject is between 10 and 28 weeks gestation
* Subject provides informed consent
* Subject agrees to provide neonatal RHD and sex outcome

Exclusion Criteria:

* None

Primary outcomes:
measure: Fetal RHD determination from maternal whole blood
timeFrame: Between 10 and 28 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Grossmont Hospital
state: California
city: San Diego
country: United States
facility: West Coast OBGYN
state: California
city: San Diego
country: United States
facility: Women's Health Care, Inc
state: California
city: San Diego
country: United States
facility: Scripps Hospitals (5 San Diego locations)
state: California
city: Grand Rapids
country: United States
facility: Spectrum Health Research
state: Michigan
Study officials:
References: