louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02242838: Post-Marketing Surveillance of Micardis® (Telmisartan) in Patients With Hypertension
Official title: Post-Marketing Surveillance of Micardis® (Telmisartan) Special Drug Use-results Survey on Long-term Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 6336
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertension patients without telmisartan treatment are selected at medical institutions

Brief summary: The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period


Eligibility criteria: Inclusion Criteria:

* Patients with hypertension

Exclusion Criteria:

Patients with the following conditions

* Patients with a history of hypersensitivity of this product
* Women in pregnancy (included the possibility of pregnancy)
* Patients with severe biliary obstructive disorders or severe hepatic insufficiency

Primary outcomes:
measure: Number of patients with adverse drug reactions
timeFrame: up to 1 year
measure: Incidence of adverse drug reactions
timeFrame: up to 1 year
measure: Change in Mean systolic blood pressure (SBP)
timeFrame: up to 1 year
measure: Change in Mean diastolic blood pressure (DBP)
timeFrame: up to 1 year
Secondary outcomes:
measure: Overall assessment of efficacy by investigator on 4-point scale
timeFrame: at 3 month, after 1 year
measure: Change in pulse rate
timeFrame: up to 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05154643: T1rho Imaging of Liver in Presence of Iron
Official title: Quantitative Rotating Frame Relaxometry for Early Detection of Liver Fibrosis in Presence of Hepatic Iron
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibrosis
Keywords: Quantitative rotating frame relaxometry, T1rho, early detection of liver fibrosis, hepatic iron
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 50
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with liver fibrosis and healthy controls will be screened before receiving MR exam.

Brief summary: Liver T1rho is elevated in response to accumulation of extracellular matrix proteins during fibrosis. The presence of hepatic iron overload; however, can shorten the T1rho value. With proper correction, we can remove this confounding factor and improve the reliability of T1rho for early diagnosis of liver fibrosis.

Patients with early-stage liver fibrosis confirmed by biopsy will be recruited at the Prince of Wales Hospital (Hong Kong). Thirty patients and twenty healthy volunteers will be recruited. The liver iron content will be measured using the established T2\* MRI relaxometry. Breathhold black blood T1rho relaxometry will be used to collect T1rho data. The measured T1rho will be retrospectively corrected to remove the shortening effect caused by iron.

We will use ANOVA to compare the measurement with and without fibrosis. We will use Pearson correlations between the disease state and the imaging measurements, and ROC analysis to determine the diagnostic value of the proposed method.


Eligibility criteria: Inclusion Criteria:

* Between age 18 and age 55
* Informed written consent obtained

Exclusion Criteria:

* Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy

Primary outcomes:
measure: The liver iron content will be measured using the established T2* MRI relaxometry
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong, Prince of Wale Hospital
state: Shatin
Study officials:
References:
Clinical trial NCT01292343: Triclosan Toothpaste and Third Molar Surgery
Official title: Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Socket
Wound Infection
Keywords: third molars
triclosan
toothpaste
dry socket
wound infection
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load.

Detailed description: This study may provide evidence on the effect of triclosan containing dentifrice on oral bacteria and oral inflammation prior to third molar surgery, and on the incidence of inflammatory complications after the surgery. If proven effective, dentifrice containing triclosan may be recommended prior to tooth extractions and replace antibiotics and other antimicrobial products as a prophylactic procedure before oral surgery procedures.

Eligibility criteria: Inclusion Criteria:

* must include at least one mandibular third molar with partial or full bony impaction
* no sign of active pericoronal (around the crown) infections
* must have not taken antibiotics for any reason in the past 30 days
* must be healthy and between 18 and 35 years of age
* must be able to read and sign an informed consent

Exclusion Criteria:

* Subjects with systemic diseases and pregnant or lactating women
* Subjects with advanced periodontal diseases or having two or more untreated caries lesions
* Subjects who cannot read and sign an informed consent
* Subjects with signs of pericoronal infections

Primary outcomes:
measure: dry socket
timeFrame: 3 to 7 days
Secondary outcomes:
measure: wound infection
timeFrame: 3 to 7 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Eastman Dental Center
state: New York
Study officials:
affiliation: University of Rochester Eastman Dental Center
name: Yanfang Ren, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04062643: Obesity Effect on Stroke and Cardiovascular Events
Official title: OBESITY ASSOCIATION WITH RECURRENT STROKE AND CARDIOVASCULAR EVENTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Keywords: obesity
recurrent stroke
ischemic stroke
hemorrhagic stroke
cardiovascular events
vascular death
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 9285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All stroke patients enrolled in the prospective cohort registry in Egeanregion.

Brief summary: The relation between obesity and stroke recurrence is still under debate. In this study it has been sought whether baseline obesity is associated with recurrent stroke and major cardiovascular events in a long-time period.

Detailed description: Five-years follow-up data of Ege Stroke Registry for stroke recurrence and cardiovascular events regarding to obesity were analyzed. Data include age, gender, stroke severity, neuroimaging studies, cardiovascular risk factors. Within the inclusion period, all of the included patients were followed until censoring (10th of December 2011) or readmission because of recurrent stroke, cardiovascular event or death, whichever came first. The Kaplan-Meier method was used for survival analysis. Cox proportional hazard model was applied to identify predictors of recurrent vascular events.

Eligibility criteria: Inclusion Criteria:

* All consecutive stroke patients.

Exclusion Criteria:

* Incomplete baseline information, other factors making them unsuitable for follow-up,undetermined stroke, subarachnoid hemorrhage.

Primary outcomes:
measure: Stroke recurrence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05499143: ImpACT for Developmental Coordination Disorder
Official title: ImpACT for Developmental Coordination Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Coordination Disorder
Keywords: Child
Diagnostics
Early development
Neurodevelopmental disorders
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 491
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who experience movement problems and/or there is a suspicion or diagnosis of DCD

Brief summary: This study investigates the impact of Developmental Coordination Disorder on the child and its environment in Belgium within the following domains: diagnosis, activities and participation, school, therapy/support, and socio-emotional impact.


Eligibility criteria: Inclusion Criteria:

* Parents of children living in Belgium
* Parents of children between 4 and 18 years old
* Parents of children who experience movement problems and/or there is a suspicion or diagnosis of DCD

Exclusion Criteria:

• Parents of children who have another other medical condition that would explain the movement difficulties (e.g. cerebral palsy, muscle disease,...)

Primary outcomes:
measure: Impact of Developmental Coordination Disorder (DCD)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Lynn Bar-On, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Licari MK, Alvares GA, Bernie C, Elliott C, Evans KL, McIntyre S, Pillar SV, Reynolds JE, Reid SL, Spittle AJ, Whitehouse AJO, Zwicker JG, Williams J. The unmet clinical needs of children with developmental coordination disorder. Pediatr Res. 2021 Oct;90(4):826-831. doi: 10.1038/s41390-021-01373-1. Epub 2021 Jan 27.
Clinical trial NCT01596543: The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
Official title: Thr Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: sleep
HTT
heat illness
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: International Diabetes Federation
First posted: 2012-05-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the present study is to evaluate the effect of partial and complete sleep deprivation on exercise heat tolerance. Twelve healthy young male volunteers will participate in the study. They will arrive to our lab four times, in each visit the will undergo VO2 test and Heat Tolerance Test (HTT) after sleeping different amount of hours.

Detailed description: The volunteers will arrive to our lab fout times- During their first visit they will go through a VO2 max test in order to evaluate their aerobic fitness, and their physiological efficiency will be measured. During their second visit they will go through an exercise heat tolerance test according to our validated protocol after a full night sleep. During the third and fourth visit they will go through an exercise heat tolerance test and a measurement of their physiological efficiency after a partial and complete sleep deprivation, respectively. The physiological tests will take place in the heat chamber that is located at the Heller Institute of Medical Research. The results will be then analyzed, and a comparison between the physiological measurements during the heat tolerance tests and the physiological efficiency tests after the various sleep conditions will be performed.

Eligibility criteria: Inclusion Criteria:

* age 18-30
* healthy
* after medical checkup
* after signing concent form

Exclusion Criteria:

* heart disease
* respiratory disease
* baseline bp above 140/90 mmHg
* sleep disorders
* diabetes
* anhydrosis
* skin disease
* acute illness

Primary outcomes:
measure: oxygen consumption
timeFrame: experimental days 1,3,4
Secondary outcomes:
measure: Skin temperature
timeFrame: experimental days 2,3,4
measure: Rectal temperature
timeFrame: experimental days 2,3,4
measure: Heart rate
timeFrame: experimental days 1,2,3,4
Other outcomes:
Locations:
city: Tel-Hashomer, Ramat-Gan
country: Israel
facility: Heller Institute of Medical Research
Study officials:
affiliation: The Institute of Military Physiology
name: Amit Druyan, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muginshtein-Simkovitch E, Dagan Y, Cohen-Zion M, Waissengrin B, Ketko I, Heled Y. Heat tolerance after total and partial acute sleep deprivation. Chronobiol Int. 2015 Jun;32(5):717-24. doi: 10.3109/07420528.2015.1030409. Epub 2015 May 8.
Clinical trial NCT03166943: the Possible Effect of the Antiviral Inhibitors for Treatment of Hepatitis C Virus Infection in Cardiac Function
Official title: An Investigative Study on the Possible Effect of the Antiviral Inhibitors (Sofosbuvir and Daclatasvir) for Treatment of Hepatitis C Virus Infection in Cardiac Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: It has been known for many years that the heart and the liver are intimately related. There is a mutual interaction between the function of the heart and the liver and a broad spectrum of acute and chronic entities that affect both the heart and the liver. Chronic hepatitis C virus infection affects more than 3% (170 million) of the world's population.

Detailed description: Assessment of systolic function by echocardiography will be done to 100 hepatitis C virus infected patients who receive antiviral treatment (sofosbuvir and daclatasvir) by biplane simpson's method and by speckle tracking.

Assessment of diastolic function by echocardiography to 30 hepatitis C virus infected patients who will not receive antiviral treatment, by left atrium volume , mitral inflow pattern , tissue doppler annular early and late diastolic velocities .

Eligibility criteria: Inclusion Criteria:

1. patients on continuous regimen (Sofosbuvir and daclatasvir) for 3 months
2. normal baseline trans thoracic echocardiography
3. normal Electrocardiography

Exclusion Criteria:

1 - Diabetes mellitus, hypertension and chronic kidney disease. 2- Hepatitis C virus patients with any baseline Electrocardiography abnormality.

3- Patients with underlying any structural heart disease.

Primary outcomes:
measure: Percentage of patients with ventricular dysfunction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00347243: Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses
Official title: Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Pseudophakia
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose:To compare visual performance, total and high order wavefront aberrations (coma, spherical aberration and other terms) and contrast sensitivity in eyes implanted with one monofocal aspheric intraocular lens (IOL) and two spherical IOLs (SofPort AO, Soflex,AcrySof®IQ (40 eyes), AcrySof®Natural and AMO®Sensar)


Eligibility criteria: Inclusion Criteria:

* Patients with bilateral visually significant senile cataract, corneal astigmatism less than 2.0 diopters and potential acuity meter (PAM) better than 0.2 LogMar

Exclusion Criteria:

* any other ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, decentration (estimated by retro illumination and digital photo) greater than 0.4mm13 or loss of follow-up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao paulo
state: SP
Study officials:
affiliation: UNIFESP - EPM
name: Paulo Schor, MD
role: STUDY_DIRECTOR
References:
citation: Altmann GE. Wavefront-customized intraocular lenses. Curr Opin Ophthalmol. 2004 Aug;15(4):358-64. doi: 10.1097/00055735-200408000-00013.
Clinical trial NCT00878943: Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
Official title: A Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Pulmonary Arterial Hypertension
Keywords: Open label access
sildenafil
pulmonary arterial hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India.


Eligibility criteria: Inclusion Criteria:

* Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID therapy.
* All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study

Exclusion Criteria:

* Pregnant or lactating women
* Participation in other studies during study participation
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: The Institute of Medical Sciences, CARE Hospital
state: Andra Pradesh
city: Ahmedabad
country: India
facility: Mehta Hospital & Cardiopulmonary Care Center
state: Gujarat
city: Vadodara
country: India
facility: Bankers Heart Institute
state: Gujarat
city: Bangalore
country: India
facility: St Johns Medical College Hospital
state: Karnataka
city: Noida
country: India
facility: Metro Multispeciality Hospital
state: Uttar Pradesh
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04066543: TACE Combined With Anlotinib Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
Official title: A Single-center Randomized Controlled Clinical Trial of TACE Combined With Anlotinib Comparing With TACE in the Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TACE vs.TACE+Anlotinib
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the effectiveness of Anlotinib in middle-advanced Hepatocellular Carcinoma (HCC) Patients.

Detailed description: The aim of this study is to include 40 patients with middle-advanced Hepatocellular Carcinoma .These patients were randomly allocated to TACE treatment group or TACE+Anlotinib treatment group.The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

Eligibility criteria: Inclusion Criteria:

1. Subject has no contraindication to chemotherapy, and has no obvious obstacles in the function of major organs such as heart, lung, liver and kidney;
2. Subject has middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C ;
3. Liver function child-pugh class A or B; Karnofsky (KPS) score \> 60 points;
4. Subject could not accept surgical resection or refuse surgical operation;and who did not receive other treatment before operation.

5.18\~75 years old; ECOG PS score: 0-1 points; expected survival period is more than 3 months.

Exclusion Criteria:

1. Subject has contraindications to chemotherapy;
2. Subject has obstacle in the function of major organs such as heart, lung, liver and kidney;
3. Severe coagulation dysfunction (prothrombin time \> 18 s or hemorrhagic tendency);
4. Uncontrollable hypertension and portal hypertension;
5. Hepatic artery-portal vein or hepatic vein fistula or portal vein trunk cancer thrombus;
6. A large amount of ascites or refractory ascites;
7. With distant metastasis.

Primary outcomes:
measure: PFS
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Guoliang Shao
role: PRINCIPAL_INVESTIGATOR
References: