louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04128137: Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension
Official title: Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Neurogenic Orthostatic Hypotension
Lead sponsor: H.A.C. PHARMA
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of a 4-week fludrocortisone (FLU) treatment on systolic blood pressure depression after 5 minutes of active orthostatism in patients with neurogenic orthostatic hypotension (HON) symptomatic, despite treatment with non-drug measures with or without midodrine.

Detailed description: The objective of the study is to demonstrate the efficacy of FLU on systolic blood pressure depression in patients with neurogenic orthostatic hypotension. The study is randomised versus placebo.Each patient will be followed for a maximum of 5 months, with no more than 8 visits to the investigator (V0 at Day-7, V1 at D0, V2 at D7, V3 at D+14, V4 at D+21, V5 at D+ 28, V6 at D+56 and V7 only for patients on the FLU arm at D+140.

The presence of a comparator control group with placebo permits to evaluate the efficacy and the tolerance of FLU independently of the natural evolution of the pathology, in patients benefiting from a non-drug or possibly medicated treatment (midodrine) but insufficient.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of orthostatic hypotension (HO), ie a blood pressure drop\> 20 and / or 10 mmHg within 3 minutes after active and symptomatic lifting
* Patient suffering from a neurological disease
* orthostatic neurogenic hypotension persistent and symptomatic despite non-drug measures

Exclusion Criteria:

* Hypersensitivity to FLU or any of its excipients
* non orthostatic neurogenic hypotension
* History of proven heart failure
* History of left ventricular systolic dysfunction
* Uncompensated hypokalemia
* Patient with poorly balanced Grade 3 hypertension
* Pregnant patient at the time of inclusion
* Nursing patient

Primary outcomes:
measure: Systolic BP diminution
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Broca (AP-HP)
Study officials:
affiliation: National Coordinator
name: Jean-Michel SENARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05311137: Study of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population
Official title: Application of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population in the Northern Shanghai Community
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation；closed-loop treatment；
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atrial fibrillation patients in North Shanghai area.

Brief summary: This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy.

Detailed description: This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy, the improvement of disease outcome and the economic value of the atrial fibrillation population in the northern Shanghai community. Improve the disease cognition of patients with atrial fibrillation, and promote the development of the concept of closed-loop treatment of atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* atrial fibrillation patients；Ability to act autonomously, understand and sign informed consent；

Exclusion Criteria:

* none（All patients with atrial fibrillation were enrolled in this study indiscriminately and followed up）

Primary outcomes:
measure: Atrial fibrillation recurrence
timeFrame: 2 years
measure: Heart failure
timeFrame: 5 years
measure: Stroke
timeFrame: 5 years
Secondary outcomes:
measure: bleeding
timeFrame: 2 years
measure: Cardiovascular MACE events
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: No. 301 Yanchang Middle Road, Jing'an District, Shanghai, China
name: WeiYa Xu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05824637: Validation and Reproducibility of S.P.A.T. With Allergens
Official title: Validation and Reproducibility of Type I Hypersensitivity Reaction in the Diagnostic Process of the Skin Prick Test in Allergic and Non-allergic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy to House Dust
Allergy Pollen
Lead sponsor: Hippocreates
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To improve accuracy and take out human error opportunities, Hippo Dx developed S.P.A.T., an automated skin prick test. This study will provide a comparison between manual and automated skin prick test in allergic and non-allergic individuals with a panel of common inhalant allergens.

The primary endpoint is to compare the accuracy of S.P.A.T. to detect sensitization to common aeroallergens compared to a manual skin prick test (SPT).

It is a prospective monocentric study that will include 120 study participants.


Eligibility criteria: Inclusion Criteria:

Adults (18-65y) with presence or absence of self-reported symptoms of inhalant allergy will be included.

Exclusion Criteria:

* Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
* Use of antihistaminic medication \< 7 days before the start of the study
* Use of tricyclic antidepressants (antihistamine activity) \< 7 days before the start of the study
* Use of topical corticoids on the forearm \< 7 days before the start of the study
* Use of Omalizumab \< 6 months before the start of the study
* Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)

Primary outcomes:
measure: Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.
timeFrame: 15 minutes after the diagnostic test
Secondary outcomes:
measure: Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.
timeFrame: day of the diagnostic test
measure: Time (seconds) required to run an automated versus a manual skin prick test.
timeFrame: during the diagnostic test
measure: Amount of allergen solution that is required to run an automated versus a manual skin prick test.
timeFrame: during the diagnostic test
measure: Level of discomfort experienced by the patient as assessed by visual analogue scale after an automated versus a manual skin prick test.
timeFrame: 15 minutes after the diagnostic test
Other outcomes:
Locations:
city: Herentals
country: Belgium
facility: AZ Herentals
Study officials:
affiliation: AZ Herentals
name: Hendrik Sebrechts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04509037: Evaluation of Breast Reduction Techniques
Official title: Breast Reductions: Retrospective Evaluation of Suction Assisted Breast Reduction with Peri-Areolar Mastopexy Compared to Longer Incision Pedicle Breast Reduction Techniques
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Reductions
Keywords: Breast Reductions
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent a breast reduction between 2013 and 2019.

Brief summary: The purpose of this study is to retrospectively evaluate breast reduction techniques in terms of complications, functionality, patient satisfaction, and cosmetic outcomes.

Detailed description: A breast reduction is a common operation with a fairly high complication rate as large incision techniques require undermined skin flaps to be closed under tension. This study is evaluation the open incision breast reduction technique to a liposuction assisted breast reduction. This study will evaluate these two breast reduction techniques in terms of complication rates, functionality, patient satisfaction, and cosmetic outcomes. Participants will be asked to complete the BREAST-Q survey regarding their breast reduction postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent a breast reduction between 2013 and 2019
* All patients who underwent a liposuction assisted or layered skin incision pedicled technique breast reduction.

Exclusion Criteria:

* Patients who underwent additional procedures simultaneously at the time of the breast reduction.

Primary outcomes:
measure: Postoperative Complication Rate
timeFrame: Postoperative Period (Average of 1 year following surgery)
measure: Breast Reduction Success Rate
timeFrame: Postoperative Period (Average of 1 year following surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT01226537: Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients
Official title: Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: it is a Group of Metabolic Diseases in
Which a Person Has High Blood Sugar, Either
Because the Body Does Not Produce Enough Insulin,
or Because Cells do Not Respond to the Insulin That
is Produced.
Keywords: Taurine,Diabetes mellitus,oxidative stress,glycemic control
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes mellitus (DM) and its vascular complications are the one of the most prevalent diseases in the state of Qatar. It is a multifactorial disease associated with the development of retinopathy, nephropathy, neuropathy, cardiomyopathy, and severe vascular dysfunction. The complications of diabetes are caused by either insulin deficiency (type 1 DM) or insulin resistance (type II DM).Unfortunately, effective and sustainable prevention programs of diabetes are limited, and treatment options for type II DM are restricted. Current therapy is based upon control of blood glucose, cholesterol and triglycerides, primarily through insulin replacement in type I diabetes or oral hypoglycemic agents and/or insulin replacement in type II diabetes. New therapies able to prevent vascular complications of diabetes are needed to decrease the occurrence of end organ damage and improve the quality of life of the people. Safe and effective nutritional supplements that could be given along with the regular treatment of the patients that might reduce the need for insulin replacement therapy provide tighter glucose control and protect against oxidative stress and the vascular pathology associated with diabetes mellitus are the need of the hour. Our hypothesis is that supplementation of Taurine in the diets of diabetic patients might reduce the dose or need for insulin replacement therapy and protect them against oxidative stress that is responsible for the complications of diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Above 18-65 Years of old
3. Known diabetic patients with HbA1c\>8.0%
4. People who provide signed informed consent -

Exclusion Criteria:

* 1. Pregnancy 2. Diabetic patients with HbA1c \<8.0 % 3. Recent or prospective surgical interventions 4. Complications of Type I and Type II DM, e.g., Active cardiovascular disease, nephropathy, retinopathy, neuropathy 5. People who do not provide signed informed consent

Primary outcomes:
measure: Fasting glucose 2) HbA1c 3) Lipid profile 4) Taurine 5) Insulin 6) Urine Micro albumin 7) Eye test
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00714337: Formulation and Food Effect Study of AZD1386 in Healthy Volunteers
Official title: A Phase I, Single-Centre, Randomised, Open-Label, Five-Way Cross-Over Formulation- and Food-Effect Study in Healthy Volunteers to Assess the Pharmacokinetics of AZD1386 After Single Doses of Two Oral Solid Formulations and an Oral Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Formulation
pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-14
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.


Eligibility criteria: Inclusion Criteria:

* Females must be non-fertile (Amenorrhea and no pregnancy in the last 12 months prior to enrolment or documentation of being irreversible surgically sterile).
* Healthy male volunteers with BMI between 18 and 30 kg/m2
* Clinical normal physical findings, including blood pressure, pulse rate above 45 bpm, ECG, and laboratory assessments.
* Normal QTc interval on baseline ECG, between 360-450 msec, according to the Fridericia formula.

Exclusion Criteria:

* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity as judged by the Investigator.
* Requirement of concomitant medication during the study, excluding hormone replacement therapy (HRT) or use of drugs with enzyme inducing properties with 3 weeks of first dose
* Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before first administration of study drug
* A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives and who have a QT/QTc \<360 ms

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during study days
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
Study officials:
affiliation: PAREXEL Clinical Pharmacology Research Unit
name: Klaus Francke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00961337: Evaluation of a School-based Influenza Vaccination Program
Official title: Evaluation of a School-based Influenza Vaccination Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Influenza Vaccines
Keywords: school children
influenza vaccination
vaccine effectiveness
influenza attack rate
absenteeism
Influenza vaccine
Lead sponsor: Centers for Disease Control, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Public Health Bureau,Taoyan County Governmnet, Taiwan
name: Education Department,Taoyan County Governmnet, Taiwan
First posted: 2009-08-18
Enrollment: 7854
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether inactivated influenza vaccines are effective to protect school children and their households from getting influenza infection and further prevent student's absenteeism.

Detailed description: School children were found to be the possible spreaders of the influenza. The successful prevention measure on school children was crucial for controlling the epidemic. In Taiwan, the national influenza immunization program on the grade 1-2 students started in winter, 2007. In this intervention study, the two study townships with 27 schools were included as our study population. The three time questionnaires were issued for collecting the health status of the children during the influenza season. The information on the vaccines' safety was also collected after the vaccination. The community collaborative clinics were responsible for taking the specimens.

Eligibility criteria: Inclusion Criteria:

* All elementary and junior high school students living in Shinwu and Guanyin townships were eligible to be enrolled into this study
* Agreed inform consent to participate in this study
* Complete three times questionaire follow-up

Exclusion Criteria:

* One junior high school in Shinwu township because it had both high school and junior high school

Primary outcomes:
measure: Influenza attack rate
timeFrame: Three time points: November, December, 2008; February, 2009
Secondary outcomes:
measure: Children's absenteeism
timeFrame: before and after week 38, 2008
measure: Vaccine effectiveness
timeFrame: From November, 2008 to February, 2009
measure: Side effects after vaccination
timeFrame: within one week after vaccination
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Centers for Disease Control, Taiwan
Study officials:
affiliation: National Health Command Center, Centers for disease control, Department of Health, Taiwan, R.O.C
name: Jen-Hsiang Chunag, MD, MS, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05601037: LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema
Official title: Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema, Breast Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: blinded randomized prospective
Primary purpose: PREVENTION

Brief summary: Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.

Detailed description: The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.

Eligibility criteria: Inclusion Criteria:

* lymph node + breast cancer requiring dissection

Exclusion Criteria:

* previous lymphedema
* BMI \>35

Primary outcomes:
measure: The volume via circumferential measurements: swelling < 5%
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ GENT
state: Oost-Vlaanderen
Study officials:
affiliation: UZ GENT
name: Bernard Depypere, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Depypere B, Vyncke T, Dhooghe N, Claes K, Blondeel P, Van Landuyt K. A Novel Technique for Preventive Lymphovenous Anastomosis: Anastomosing a Ligated Lymphatic Vessel. Plast Reconstr Surg Glob Open. 2021 Mar 22;9(3):e3509. doi: 10.1097/GOX.0000000000003509. eCollection 2021 Mar.
Clinical trial NCT06383637: Antibiotic Use and Resistance KAP Among Dental Interns
Official title: Assessment of Knowledge, Attitude and Practice (KAP) Regarding Antibiotics and Antibiotic Resistance Among Dental Interns: Multicenter Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Antibiotic Side Effect
Antibiotic Resistant Infection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 343
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: dental interns

Brief summary: The study is designed as a cross-sectional online-based questionnaire, and it will be distributed among dental interns. Assess the following among dental interns (1) The knowledge, attitude, and practices (KAP) towards antibiotics and antibiotic resistance; (2) The correlation between their KAP score and where they spend their internship year? (4) Development of the curriculum to provide sufficient training and information about antibiotics and antibiotic resistance.


Eligibility criteria: Inclusion Criteria:

* Dental interns

Exclusion Criteria:

* undergraduates dental students
* postgraduates dental students

Primary outcomes:
measure: Knowledge of dental interns regarding antibiotic use and resistance
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: