louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04197401: Screening & Health Education in Barbershop Centers for Hypertension
Official title: Screening & Health Education in Barbershop Centers for Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Barbershop
Screening
Health Education
Cardiology
DACIMA Clinical Suite
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire
First posted: 2019-12-13
Enrollment: 1536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population to enroll is represented by all men and women who are willing to screen their blood pressure level at the barbershops of Metline Township (located at Bizerte town, in the North of Tunisia).

Brief summary: SALOON-HTN is a cross-sectional, descriptive, non-interventional, multicenter survey aiming to screen high blood pressure by measuring blood pressure in barbershops.

Detailed description: The survey is a screening project for hypertension, which will enroll subjects at the barbershops. The Metline Township (located at Bizerte Town, in the north of Tunisia) will be the geographical area of population enrollment. Barbershops hairdressers will be trained by a medical staff to measure the blood pressure by an ambulatory device.

All subjects willing to participate in the survey will be asked to measure their blood pressure by after at least 5 minutes rest. Three measures will be performed by the Hairdressers, with an interval of 3 minutes between each measure. The mean of the last two measures will be considered. If the mean blood pressure level exceeds 135/85 mmHg the subject will be sent to a physician of his choice.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Informed Consent to participate in the screening study

Exclusion Criteria:

* None

Primary outcomes:
measure: Hypertension frequency
timeFrame: at inclusion
measure: Controlled Hypertensive patients
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Al Matlīn
country: Tunisia
facility: Barbershops (N = 27)
state: Bizerte
Study officials:
affiliation: Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire
name: Faouzi Addad, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00918801: Pilot Study of Hippocampal Function in Type 1 Diabetes Mellitus (T1DM)
Official title: Pilot Study of Hippocampal Function in T1DM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: T1DM
MRI
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 91
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults will be piloted in a sample of diabetic and non-diabetic adolescents ages 13-18.

Brief summary: This study is an expansion of a previous study done to determine how thinking skills relate to hypoglycemia (low blood sugar) and certain regions of the brain in children and adolescents. In this study, the investigators are testing thinking skills and measuring brain activity in adolescents with and without type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Age 13 - 18
* Right handed
* Diagnosis of Type 1 Diabetes OR normal sibling control
* If diabetic, then diagnosis for at least 2 years

Exclusion Criteria:

* Pregnant or lactating
* Chronic disease other than well-controlled asthma, or Hashimoto's thyroiditis.
* Other current serious medical illness
* Co-morbid psychiatric illness
* Co-morbid neurological illness
* Pre-maturity at birth
* Contraindication to MRI scan
* orthodontic braces.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tamara G Hershey, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671601: Application of Deep Learning to Jointly Assess Embryo Development to Improve Pregnancy Outcome of Embryo Transfer
Official title: Application of Deep Learning Automation Based on Time-lapse Imaging to Jointly Assess Embryo Development to Improve Pregnancy Outcome of Single Blastocyst Transfer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reproductive Medicine
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are under 40 years old and need artificial intervention to have children

Brief summary: Aim of this research is to apply the deep learning automation based on Time-lapse imaging to jointly assess embryo development，so that it can ensure the consistency of embryo evaluation and improve the accuracy of evaluation.

Detailed description: This study is an observational prospective study after a retrospective analysis. It is a single-center study without randomization or blindness. In the early stage, 1000 patients are collected from three periods of embryo culture through Time-lapse to establish an automated joint evaluation system for the whole process of embryo development. At the later stage, the patients are divided into two groups: Time-Lapse imaging (TLI) +Artificial Intelligence(AI) assessment group and morphological assessment group. 100 patients with Day 5 single blastocyst transplantation are carried out to follow up the pregnancy outcome.

Eligibility criteria: Inclusion Criteria:

* (1) Age \< 40 years old; (2) Routine IVF cycles; (3) Period number ≤ 2; (4) The number of ova collected is 5-15; (5) BMI: 18-25 kg/m 2, follicle stimulating hormone(FSH) ≤ 12 IU/L on the third day; (6) Patients with more than 3 high-quality embryos on Day3 and performed single blastocyst transplantation on day 5. (7) Patient without endometrial factors.

Exclusion Criteria:

* (1) Preimplantation Genetic Testing(PGT) is needed due to male infertility, ovulation cycle and chromosome abnormalities; (2) there are systemic diseases of clinical significance; (3) Pictures of blastocysts are not formed or available; (4) Incomplete or unclear image collection in prokaryotic, mitotic and blastocyst phases affected AI evaluation.

Primary outcomes:
measure: implantation rate
timeFrame: 2022-2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05158101: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for Stroke
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for the Treatment of Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Stroke
Keywords: Stroke
stem cell treatment
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Stroke

Detailed description: This patient funded trial aims to study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Stroke. Patients will receive intranasal instillations between both nasal cavities of UC-MSC exosomes. The total dose will be 4 CC of AlloEx, approximately 800 billion exosomes, for each day. Patients will receive instillations on back-to-back days totaling 2 doses. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Stroke
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
city: Buenos Aires
country: Argentina
facility: Center for Investigation in Tissue Engineering and Cellular Therapy
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600001: A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
Official title: A Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Idiopathic Constipation
Keywords: Chronic Idiopathic Constipation (CIC)
Constipation
Functional gastrointestinal disorders
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-05-16
Enrollment: 75
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: The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.


Eligibility criteria: Inclusion Criteria:

* The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder
* Patients who have organic constipation
* Patients who received intestinal resection

Primary outcomes:
measure: Improvement of signs and symptoms associated with constipation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
facility: Japan
Study officials:
References:
Clinical trial NCT02212301: Comparison of Two Marketed Lenses in a Controlled Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Dryness
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.


Eligibility criteria: Inclusion Criteria:

1. The subject must be 18 years of age and less than 51 years of age;
2. The subject must have read and understood the Participant Information Sheet;
3. The subject must have read, signed and dated the Informed Consent;
4. The subject must be a current planned replacement soft contact lens wearer;
5. The subject must be a regular user of devices (computer, tablet and/or smart phone) for a minimum average of 5 ± 1 hours per day in a typical week
6. The subject must have a refractive error within the range of correction of both study contact lenses;
7. The subject must have a best-corrected visual acuity of 6/9 (20/30, 0.18 LogMAR) or better in each eye;
8. The subject must demonstrate an acceptable fit with both study contact lenses;
9. The subject must agree to wear their contact lenses as directed for the duration of the study (every day or for at least a minimum of five days per week for a minimum of six hours per day and be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule;
10. The subject must have normal eyes with the exception of the need for visual correction.

Exclusion Criteria:

1. Any known sensitivity or intolerance to any of the contact lenses or adjunct products to be used.
2. Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses).
3. Use of systemic or ocular concomitant medications which, as determined by the investigator, might contraindicate or interfere with contact lens wear.
4. Ocular anterior segment infection, inflammation, abnormality, or active disease, which would contraindicate contact lens wear.
5. Any moderate or severe ocular condition observed during slit lamp examination at the enrollment visit.
6. A history of herpetic keratitis, ocular surgery or irregular cornea(s).
7. Known pregnancy or lactation during the study period.
8. Enrollment of investigator's office staff, relatives, or members of their respective households.
9. Participation in any clinical trial within 30 days of the enrollment visit.

Primary outcomes:
measure: Tear Film Kinetics
timeFrame: 8 hour post insertion
measure: Time Controlled Visual Acuity
timeFrame: 8 hours post insertion
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
References:
Clinical trial NCT00812201: Evaluation of Left Ventricular AutoThreshold
Official title: Evaluation of Left Ventricular AutoThreshold
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
auto threshold
pacing
CRT-P or CRT-D recipients, threshold measurements
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 80
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: Primary care clinic

Brief summary: This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

Detailed description: ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
* Patients who are willing and capable of participating in all testing associated with this study
* Patients who are 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
* Patients with pre-existing leads other than those specified in this investigational plan (unless the Investigator intends to replace them with permitted leads)
* Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
* Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
* Patients with a prosthetic mechanical tricuspid heart valve
* Women who are pregnant

Primary outcomes:
measure: The objective of this study is to collect data to characterize the performance of the LVAT feature.
timeFrame: Implant
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Morgantown
country: United States
facility: Monongalia General Hospital
state: West Virginia
Study officials:
affiliation: Virginia Commonwealth University Health System
name: Kenneth L. Ellenbogen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02048501: Changes in Gut Hormones, Body Composition and Energy Expenditure After Roux-en-Y
Official title: Gut Hormone, Energy Expenditure and Body Composition Change in Subjects Who Succeed or Fail to Sustain Weight Loss After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Weight regain
Sustain weight loss
Weight loss
Gut hormones
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to gain a better understanding of the mechanism of weight regain through gut hormone (substances in the gut that control various functions of the digestive organs) and energy expenditure (the amount of energy a person uses to complete bodily activities).

Our hypothesis is that gut hormone response might be different among subjects who are able to maintain weight loss and subjects with weight regain.

For this study, investigators will measure fasting and postprandial (happening after a meal) gut hormones, bile acid, amino acids, vitamin B, vitamin D, myokines and adipokine levels in obese individuals who are at least 2 years after a Roux-en-Y gastric bypass (RYGB). Investigators will also measure resting metabolic rate (RMR) (the amount of energy expended daily) and body composition (the proportion of fat, muscle, and bone of an individual's body). The subjects body composition will be analyzed, including fat mass and fat free mass, by a Dual-Energy X-ray Absorptiometry (DEXA). This study will provide more information regarding the effect of RYGB on gut hormones, adipokines, bile acids, amino acids, and energy expenditure and body compositions.


Eligibility criteria: Inclusion Criteria:

1. Age between 18-65 years of age
2. Ability and willingness to provide informed consent

Exclusion Criteria:

1. Surgical/anatomical failure such as pouch enlargement, anastomosis dilation, formation of a gastrogastric fistula,
2. Currently on medication that might affect weight gain including GLP-1 analog
3. Inability to provide informed written consent.
4. Any known history of abnormal thyroid function.
5. Females who are pregnant.

Primary outcomes:
measure: Difference in pre and post-prandial plasma Glucagon-like peptide-1 (GLP-1)
timeFrame: Prior to meal stimulation test, 30 minutes, 60 minutes, 90 minutes and 120 after the meal stimulation test.
measure: Difference in pre and post-prandial Peptide YY (PYY)
timeFrame: Priot to the meal stimulation test, 30 minutes,60 minutes, 90 minutes, and 120 minutes after the meal stimulation test.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Metabolic and Weight Loss Surgery
state: North Carolina
Study officials:
affiliation: Duke University
name: Chan Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611701: Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
Official title: Cryoballoon Ablation of Pulmonary Veins After Failed Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2012-06-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized double-blind study was to compare the efficacy and safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after failed first radiofrequency ablation.


Eligibility criteria: Inclusion Criteria:

* Previous failed first radiofrequency ablation procedure (only circumferential PV isolation without linear lesions) in patients referred for second catheter ablation of AF
* \> 3 months after first PVI

Exclusion Criteria:

* Congestive heart failure
* Ejection fraction \<35%
* Left atrial diameter \>60 mm

Primary outcomes:
measure: Recurrence of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a second ablation procedure
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of complication after procedure between two groups
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: The Valley Health System and Columbia University College of Physicians & Surgeons
state: New York
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
citation: Pokushalov E, Romanov A, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS. Cryoballoon versus radiofrequency for pulmonary vein re-isolation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2013 Mar;24(3):274-9. doi: 10.1111/jce.12038. Epub 2012 Dec 4.