louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04885764: Profiling Antibody Status and Vaccine Effectiveness in Post Vaccination With SARS CoV2 in Ain Shams University
Official title: Profiling Antibody Status and Vaccine Effectiveness in Post Vaccination With SARS CoV2 in Ain Shams University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Covid19
Keywords: Egypt
Ain Shams University
Vaccine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective intervention study to assess the effectiveness of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection

Detailed description: This is a prospective intervention study to assess the short-term effectiveness of the first dose of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection by monitoring the antibodies (IgG, IgM and level of neutralizing antibodies) in sera of post-vaccinated persons.

The study also will monitor the incidence of SARS-CoV-2 infection among vaccinees just before the first dose administration, 3 weeks after immunization, at the administration of the second dose, 14 days following the second dose and after 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Candidate for receiving vaccination according to health care authorties prioritaizaton

Exclusion Criteria:

1. SARS-CoV-2 recovered cases \<3 months
2. Individuals who are currently infected with Sars-COV-2 and/or with respiratory symptoms with fever.

Primary outcomes:
measure: Short-term effectiveness
timeFrame: 21 days of the first dose of vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
Study officials:
affiliation: Faculty of Medicine Ain Shams University
name: Samia E Girgis, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02618564: The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
Official title: The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy Preparation Outcome
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

Detailed description: We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

Eligibility criteria: Inclusion Criteria:

* Male and non-pregnant female patients 18 to 75 years of age inclusive
* Patients who require an outpatient colonoscopy with a split dose Pico-Salax prep

Exclusion Criteria:

* Colonoscopy requiring the use of a large volume prep (eg Colyte, PEG)
* Ileus or bowel obstruction
* Previous colorectal surgery
* Ascites
* Recognized renal impairment (defined as GFR less than normal in 3 months prior to enrolment)
* Pregnancy
* Recent (\<6 months) myocardial infarction or unstable angina.

Primary outcomes:
measure: Bowel movements, as measured by patient diary
timeFrame: 2 days
Secondary outcomes:
measure: Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale
timeFrame: 2 days
measure: Tolerability, as measured by patient questionnaire
timeFrame: 2 days
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Lawrence Hookey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01306864: Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding
Official title: Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding Peptic Ulcers
Keywords: Endoscopic Hemostasis
Peptic Ulcer
Recurrent Bleeding
Injection Therapy
Thermal Probe
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care.


Eligibility criteria: Inclusion Criteria:

* Bleeding peptic ulcer

Exclusion Criteria:

* Patient is: \< 18 years of age
* Patient is unable to consent
* Patient is contraindicated to undergo endoscopy
* Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
* Patient is pregnant or lactating
* Patinet has an INR \> 2.5

Primary outcomes:
measure: Proportion of patients with further bleed
timeFrame: 72 Hours
Secondary outcomes:
measure: Proportion of patients with initial hemostasis
timeFrame: At the conclusion of the index procedure
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Science Centre University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital- Civic Campus and General Campus
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Medical Center
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospital NHS Foundation
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
References:
citation: Sung JJY, Moreea S, Dhaliwal H, Moffatt DC, Ragunath K, Ponich T, Barkun AN, Kuipers EJ, Bailey R, Donnellan F, Wagner D, Sanborn K, Lau J. Use of topical mineral powder as monotherapy for treatment of active peptic ulcer bleeding. Gastrointest Endosc. 2022 Jul;96(1):28-35.e1. doi: 10.1016/j.gie.2022.01.020. Epub 2022 Feb 3.
Clinical trial NCT03068364: Biological and Electrocardiographic Biomarkers for Risk Stratification in Hypertension.
Official title: Additive Value of Biological and Electrocardiographic Biomarkers for Risk Stratification in Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Mortality
Hypertension
Left ventricular hypertrophy
NT-proBNP
ECG
Transthoracic echocardiography
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, who had a work-up of their hypertension in the Cardiology Department of Croix-Rousse Hospital (Hospices Civils de Lyon, Lyon, France) from January 1997 to January 2014.

Brief summary: Risk stratification of hypertensive patients includes assessment of traditional cardiovascular risk factors and subclinical target organ damages particularly left ventricular hypertrophy (LVH).

LVH may routinely screened by transthoracic echocardiography by measuring the left ventricular mass (LVM).

However, transthoracic echocardiography suffers from several pitfalls: poor reproducibility, technical limitations and unavailability at a first evaluation by general practitioners.

Other biomarkers may be particularly helpful in hypertension risk stratification. The amplitude of the R wave in aVL lead is a simple validated ECG parameters of LVH and a strong predictor of cardiovascular events and mortality.

Plasma N-terminal pro Brain Natriuretic Peptide (NT-proBNP) is also strongly related to LVM and is an independent predictor of all-cause mortality in hypertension.

The main objective of our study is to determine the additive prognostic value of R wave in aVL and NT proBNP on all-cause and cardiovascular mortality.

Secondary objectives are to determine the addition prognostic value of NT-proBNP and R wave in aVL combined in comparison to each marker taken into account

This study will include 1600 patients who had a work-up of their hypertension in the Cardiology Department of Croix-Rousse Hospital (Hospices Civils de Lyon, Lyon, France) from January 1997 to January 2014.

Their data will be collected in an Access database; their vital status will be obtained by the INSEE unit CépiDC.


Eligibility criteria: * Inclusion Criteria:

  * \>18 years old
  * men or women
  * questionnaire completion and physical exam during their first stay in the Cardiology Department of from January 1997 to January 2014.
* Exclusion Criteria:

  * Patients refusal

Primary outcomes:
measure: All- cause and cardiovascular mortality in hypertension
timeFrame: an average of 7 years
Secondary outcomes:
measure: All-cause and cardiovascular deaths
timeFrame: an average of 7 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hopital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Pierre LANTELME
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02285764: Nutritional Intervention During Gestation and Offspring Health
Official title: NIGO Health- Nutritional Intervention During Gestation and Offspring Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Glycemia
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: European Union
First posted: 2014-11-07
Enrollment: 331
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the potential effects of a modified carbohydrate nutritional product for obese pregnant women to reduce maternal glycemia.


Eligibility criteria: Inclusion Criteria:

* Voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy authorization prior to any participation in the study.
* Obese (BMI ≥ 30) as determined by pre-pregnancy BMI.
* ≥18 years of age.
* ≥15+0 but ≤16+6 weeks gestation with a singleton pregnancy.
* Willing to follow supplementation protocol and follow appropriate nutritional guidance and refrain from consuming other caloric nutritional supplements that are not approved by the study staff, if applicable.
* Willing to provide body composition measures on infant at birth.
* Willing to consider additional measures if follow-up studies are conducted.

Exclusion Criteria:

* Adverse maternal and/or fetal medical history which is expected to alter blood glucose regulations.
* Previously diagnosed diabetes, previous gestational diabetes, systemic lupus erythematodes, anti-phospholipid syndrome, known renal disease, treated hypertension, uncontrolled hypothyroidism and/or cancer.
* Taking medications that can impact blood glucose.
* Previous bariatric surgery.
* Lactose intolerant and/or has milk protein allergy or requires a special diet regime.
* Participating in another clinical trial that would impact participation in this study.

Primary outcomes:
measure: Maternal Oral Glucose Tolerance Test (OGTT)
timeFrame: 27-28 weeks gestation
Secondary outcomes:
measure: Neonatal Body Composition
timeFrame: Birth - 72 hours
measure: Maternal Fasting Blood Glucose
timeFrame: 34-36 weeks gestation
Other outcomes:
Locations:
city: München
country: Germany
facility: Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital
city: Granada
country: Spain
facility: University of Granda
city: Granada
country: Spain
facility: University Clinical Hospital San Cecilio
Study officials:
affiliation: Abbott Nutrition
name: Elena Oliveros Delgado, BSc, MSc
role: STUDY_CHAIR
affiliation: Abbott Nutrition
name: Ricardo Rueda, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03336164: FOP Nutrition Label in Campus Campus University Restaurant
Official title: Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus University Restaurant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Labelling
Lead sponsor: University of Paris 13
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After a control period with no specific front-of-pack labeling, the intervention consists in the apposition of a front-of-pack labeling (Nutri-Score) to individual foods in a campus university restaurant. All foods are individually labeled.
Primary purpose: OTHER

Brief summary: This study evaluates the impact of the introduction of a front-of-pack nutrition label on foods and beverages sold in a campus university restaurant in France on the nutritional quality of purchases.

Detailed description: The introduction of front-of-pack nutrition labelling is thought to help consumers making healthier food choices at the point-of-purchase.

Recently, the French government has selected the Nutri-Score as single front-of-pack nutrition label.

Evaluations of the Nutri-Score suggest it is helping consumers making healthier choices. However, its impact in vulnerable populations has not yet been tested. Students are thought to be a vulnerable population due to their limited resources and to their unhealthy food choices.

The objective of the present study is to investigate the impact of the introduction of the Nutri-Score in campus university restaurant on the nutritional quality of food purchases. The intervention is conducted during several months, with a control period without front-of-pack nutrition labelling at the beginning of the university year.

Data on purchases is collected regularly through receipts, and the nutritional quality of purchases is evaluated over time between the intervention situation and the control situation.

Eligibility criteria: Inclusion Criteria:

* All subjects purchasing foods or beverages in the selected campus university restaurant

Exclusion Criteria:

* None No individual data is collected. Only purchases data is collected (cash register sales data)

Primary outcomes:
measure: Overall nutritional quality of purchases
timeFrame: Every 15 days, up to 6 months
Secondary outcomes:
measure: Energy content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Saturated fat content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Sugar content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Sodium content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Fiber content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Protein content of purchases
timeFrame: Every 15 days, up to 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CROUS Nice - Toulon
Study officials:
References:
Clinical trial NCT05676164: A Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Disorder of Stomach and Duodenum
Lead sponsor: Shandong Branden Med.Device Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Multicenter, Prospective, Randomized Controlled Clinical Study
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.

Detailed description: The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.

Participants will Ultrasound was administered with Oral Contrast Agent for Sonography and observed for 2 days.

The investigators will compare Oral Contrast Agent for Sonography produced by Huzhou East Asia Medical Supplies Co., LTD to see if the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD

Eligibility criteria: Inclusion Criteria:

1. subjects whose physicians recommend oral gastrointestinal CEUS;
2. subjects aged 18-80 years;
3. The subject or guardian can understand the purpose of the study, voluntarily sign the informed consent, and agree to the clinical follow-up;

Exclusion Criteria:

1. Pregnant and lactating women;
2. Subjects with dysphagia;
3. Subjects suspected of gastric bleeding, gastrointestinal perforation, intestinal disorders or gastrointestinal obstruction;
4. Subjects who are expected to receive surgery within 60 hours;
5. Subjects who have received gastroscopy within 24 hours;
6. subjects deemed unsuitable for the study by the researcher;
7. Subjects who have participated in other drug or device clinical trials and have not completed the expected primary endpoint follow-up of the clinical trials in which they participated.

Primary outcomes:
measure: Ultrasonic display rate of stomach and duodenal bulb
timeFrame: 1 hour ± 0.5 hour after examination
Secondary outcomes:
measure: Anti-interference capability of product
timeFrame: 1 hour ± 0.5 hour after examination
measure: Stomach filling and peristaltic emptying
timeFrame: 1 hour ± 0.5 hour after examination
measure: Ease of operation
timeFrame: 1 hour ± 0.5 hour after examination
measure: Incidence of device adverse events
timeFrame: 48 hours ±12 hours after examination
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital Of Shangdong University
state: Shandong
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Huixiong Xu, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT00239564: Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
Official title: An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Idiopathic Parkinson's Disease
Keywords: IPX054
Parkinson disease
Levodopa
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.

Detailed description: IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease
* Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months.
* Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day.

Exclusion Criteria:

* Diagnosed with atypical parkinsonism
* Prior surgical interventions for Parkinson's disease
* Glaucoma
* Undiagnosed skin lesion or history of melanoma
* Epilepsy or history of seizures

Primary outcomes:
measure: Parkinsonian disability at Visits 1 and 5
timeFrame: 36 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Site 101
state: California
city: Lawrence
country: United States
facility: Site 102
state: Kansas
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02465164: Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Ripening
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 26
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.


Eligibility criteria: Inclusion Criteria:

1. singleton pregnancy
2. reassuring fetal status at time of presentation
3. Bishop Score \<6

Exclusion Criteria:

1. Closed cervix
2. Breech presentation
3. Multiple gestations
4. Recent vaginal bleeding
5. Placenta previa
6. non reassuring fetal status
7. Active genital herpes infection

Primary outcomes:
measure: Time to Delivery (in Hours)
timeFrame: Up to 60 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: