louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04561895: Adipokine Genetic Variations in predictingNAFLD Progression to NASH in Egyptian Patients
Official title: Genetic Variations in Adipokine to Improve Risk Prediction for NAFLD and Its Progression to NASH in Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NAFLD
NASH - Nonalcoholic Steatohepatitis
Keywords: Egyptian population
NAFLD
NASH
DNA extraction
liver enzymes
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Elsahel teaching hospital
First posted: 2020-09-24
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian diabetic patients diagnosed with NAFLD

Brief summary: Due to the limited data concerning Egyptian population. authors aimed to investigate the differentadipokine gene polymorphism related to non alcoholic fatty liver disease incidence, prognosis and progression to steotosis and also to find different related factors including obesitu, diabetes and liver enzymes level


Eligibility criteria: Inclusion Criteria:

Egyptian patients confirmed NAFLD diagnosis diabetic

-

Exclusion Criteria:

* Pregnancy and lactation, history of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day women), cirrhosis, autoimmune hepatitis and other causes of liver disease (viral hepatitis, hemochromatosis, Wilson's disease), drug induced hepatitis, chronic enteropathies, Chronic kidney disease

Primary outcomes:
measure: investigate adipokine dna polymorphism
timeFrame: 1 months
measure: correlations
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El Sahel teaching hospital
state: Shobra
Study officials:
affiliation: professor
name: Amal Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405295: Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
Official title: A Multicentre Prospective Cohort Study: Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Carcinoma
BRCA Mutation
Adjuvant Drug Therapy
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early-stage triple-negative breast cancer with BRCA1/2 mutations treated at multiple hospitals in China with postoperative sequential treatment with capecitabine or olaparib or a combination of both drugs

Brief summary: Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.


Eligibility criteria: Inclusion Criteria:

* ECOG score 0-1
* TNBC
* BRCA1/2 mutation
* No distant metastases assessed by imaging after surgical treatment
* Breast cancer that is non-pCR after neoadjuvant therapy, or postoperative pathology suggestive of ≥pT2, or ≥pN1
* Have completed postoperative adjuvant chemotherapy and/or radiotherapy
* No major organ dysfunction

Exclusion Criteria:

* Patients who are unable to take oral medication, or who refuse this medication regimen
* Already enrolled in another study, or less than or equal to 4 weeks from discontinuation of another medication
* Presence of severe dysfunction of vital organs
* Patients with other malignancies (with the exception of cured non-melanoma skin cancers, carcinoma in situ of the cervix and other tumours that have been cured for at least 5 years)
* Acute infectious disease or active chronic infectious disease
* History of uncontrolled epilepsy, central nervous system disease or mental disorder

Primary outcomes:
measure: iDFS%
timeFrame: 3 years
Secondary outcomes:
measure: DRFS%
timeFrame: 3 years
measure: OS%
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
name: Peng Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195195: Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries
Official title: A Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, "Wrap-up"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplantation
Keywords: Transplantation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transplantation patients treated with sirolimus.

Brief summary: The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.


Eligibility criteria: Inclusion Criteria:

* Transplantation patients treated with sirolimus (Rapamune).

Exclusion Criteria:

* Patients must be able to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03731481: Virtual Lifestyle Medicine Comparative Effectiveness Research
Official title: Comparing the Effectiveness of Two Virtual Lifestyle Medicine Interventions Across Urban and Rural Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Obesity
Sleep Disorder
Depression
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: Live Healthy Appalachia
name: Ardmore Institute of Health
name: OhioHealth
name: Lifestyle Medicine Institute
First posted: 2018-11-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness research of two interventions across four cohorts
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the effectiveness of two online Lifestyle Medicine programs. Participants will be randomized by residence, urban vs. rural, into one of two Lifestyle Medicine programs.

Detailed description: This study compares the effectiveness of two virtual Lifestyle Medicine programs across two settings: urban and rural. Program materials include nutritional education, methods to reduce personal stress, and incorporation of physical activity in daily routine. Bio-marker and subjective/self-reported survey measures will be collected at baseline, 5-weeks and six-months from baseline. Study seeks to measure variations in participant outcomes across two lifestyle interventions, participant engagement and level of adherence.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Able to read and write English
* Access to high-speed Internet
* Taking medication for at least one chronic disease condition such as high blood pressure, OR are overweight (BMI of 25 or greater)
* Willing to provide blood samples at three time points
* Willing to complete online surveys at three time points

Exclusion Criteria:

* Advised by physician to limit physical activity
* Previous experience with lifestyle medicine programs, specifically Lifestyle Medicine Clinic, Complete Health Improvement Program, Full Plate Diet
* Household includes someone who has previous experience with a Lifestyle Medicine program

Primary outcomes:
measure: Level of participant engagement
timeFrame: 6 months
Secondary outcomes:
measure: Chronic disease status
timeFrame: Baseline, 5-weeks, and 6-months from baseline
measure: Psychological status
timeFrame: Baseline, 5-weeks, and 6-months from baseline
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: David Drozek, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06471881: Zirconia Bars for Mandibular Implant Overdentures
Official title: Clinical and Radiographical Performance of Zirconia Bars for Mandibular Implant Overdentures: A 3-year Follow-up Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Mouth
Keywords: Cohort study
Edentulism
Implant overdentures
Zirconia
Prosthodontic maintenance
Dental implants
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: To assess the clinical and radiographic outcomes of computer-aided designed and manufactured (CAD-CAM) zirconia bars supporting mandibular implant-retained overdentures (IODs) after a 3-year follow-up.

Methods: A prospective observational single-center study involving 30 edentulous patients rehabilitated with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design - computer-assisted manufacturing zirconia bar with distal extensions was performed assessing clinical and radiographic parameters.


Eligibility criteria: Inclusion Criteria:

* Edentulous individuals for more than one year.
* Individuals with sufficient anatomical bone conditions in the interforaminal area to place implants of 4.3mm in diameter and at least 10.0mm in length without bone augmentation needs.
* Written consent to participate and to attend the study and the yearly follow-ups.

Exclusion Criteria:

* Individuals suffered from psychiatric problems.
* History of cerebrovascular or cardiovascular accident within the last six months.
* Uncontrolled or insulin-dependent diabetes, immuno-compromised status, current chemotherapy, and leukocyte system diseases.
* Severe systemic health conditions do not allow surgical intervention with local anesthesia.
* Irradiated bone.
* Severe parafunctional habits
* Drugs or alcohol abuse.
* Insufficient oral hygiene.
* Unrealistic treatment demands.
* Smokers were not excluded, but a cessation protocol was suggested before the implant treatment.
* Unwillingness to participate in the study.

Primary outcomes:
measure: Implant Survival
timeFrame: 36 months
measure: Implant Success
timeFrame: 36 months
measure: Prosthetic Survival
timeFrame: 36 months
measure: Prosthetic Success
timeFrame: 36 months
measure: Radiological evaluation
timeFrame: 36 months
measure: Radiological examination
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Joannis Katsoulis, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05626881: Efficacy of Intralesional PRP +/- Topical Silymarin in the Treatment of Melasma
Official title: Evaluation of the Efficacy and Tolerability of Autologous Intralesional Platelet-rich Plasma, Topical Silymarin, and Combined Autologous Intralesional Platelet-rich Plasma With Topical Silymarin in the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melasma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Melasma is an acquired disorder of melanogenesis leading to hyperpigmentation and manifested by symmetrical brown to gray-black macules and patches with serrated irregular edges . It occurs especially in sun-exposed areas and affects young to middle-aged women. It is most commonly seen on the face and less commonly on the neck, arms, and chest . Platelet rich plasma (PRP) is defined as a small volume of autologous plasma that contains a high concentration of platelets obtained by centrifugation of autologous blood and subsequent suspension of platelets


Eligibility criteria: Inclusion Criteria:

* Females in the reproductive age (18 years old and above) presented with melasma confirmed by wood's light.

Exclusion Criteria:

* Pregnant and lactating.
* Systemic diseases that may cause facial hyperpigmentation (e.g: thyroid diseases, renal, hepatic or endocrinal disorders).
* Patients receiving depigmenting drugs oral or topical in previous 3 months, drugs that prolong bleeding as aspirin, hormone replacement therapy or contraceptive pills.
* Patients with anemia, thrombocytopenia, coagulopathies or patient on anticoagulant therapy and patients with iron deficiency.
* Patient with infections in the face e.g. herpes.
* Patients with history of scarring or keloid formation.

Primary outcomes:
measure: Improvement in mMASI SCORE
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Sarkar R, Arora P, Garg VK, Sonthalia S, Gokhale N. Melasma update. Indian Dermatol Online J. 2014 Oct;5(4):426-35. doi: 10.4103/2229-5178.142484.
citation: Cestari TF, Dantas LP, Boza JC. Acquired hyperpigmentations. An Bras Dermatol. 2014 Jan-Feb;89(1):11-25. doi: 10.1590/abd1806-4841.20142353.
citation: Achar A, Rathi SK. Melasma: a clinico-epidemiological study of 312 cases. Indian J Dermatol. 2011 Jul;56(4):380-2. doi: 10.4103/0019-5154.84722.
citation: Sirithanabadeekul P, Dannarongchai A, Suwanchinda A. Platelet-rich plasma treatment for melasma: A pilot study. J Cosmet Dermatol. 2020 Jun;19(6):1321-1327. doi: 10.1111/jocd.13157. Epub 2019 Sep 30.
Clinical trial NCT03572881: Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping
Official title: Assessment of Rhythmic Risk in Patients With Type 1 Brugada Syndrome by Pulmonary Infundibulum Mapping
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brugada Syndrome Type 1
Keywords: Brugada syndrome
ventricular arrhythmia
sudden death
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. The rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. In addition, the predictive value of ventricular pacing remains controversial; There is therefore currently no review to effectively assess rhythmic risk in patients with Brugada type I syndrome.

Investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with Brugada type 1 syndrome with a comparable ECG.

The mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. Only the catheter used differs from the usual procedure.


Eligibility criteria: Inclusion Criteria:

Group 21

* Brugada Type 1 syndrome
* Age : 50-60 years old
* Asymptomatic
* Signed informed consent

Group2

* Brugada Type 1 syndrome
* Age \>18 years old
* Implantable defibrillator
* Having received at least 1 appropriate shock or a sudden sudden death
* Signed informed consent

Groups 1 and 2

Exclusion Criteria:

* Brugada Type 2 or 3 syndrome
* Contraindication to electrophysiological exploration

Primary outcomes:
measure: Identification of different voltage zones by endocardial mapping of the pulmonary infundibulum between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Louis Pradel
Study officials:
References:
Clinical trial NCT05418881: Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)
Official title: Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients - MONITOR 2022
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fitness Trackers
Hemodynamic Monitoring
Internet of Things
Postoperative Complications
Wearable Electronic Devices
Anesthesia
Surgery
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: University of Wuerzburg
First posted: 2022-06-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.Furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. In addition, patients' activity levels are recorded and correlated with various clinical parameters.


Eligibility criteria: Inclusion Criteria:

* Patients with elective surgery (≥ 18 years).
* Written informed consent to participate in the study
* Planned invasive arterial blood pressure measurement

Exclusion Criteria:

* Postoperative invasive ventilation
* American Society of Anaesthesiologists (ASA) Class V
* Outpatient surgical procedure
* Previous participation in this study
* Patients unable to give consent or patients who do not have adequate German language skills
* Suspected lack of compliance
* Skin lesions of the forearms or inability to wear a tracking device
* Known allergy to latex/silicone/nickel

Primary outcomes:
measure: Measurement accuracy
timeFrame: postoperative until hospital discharge up to 21 days
measure: Measurement accuracy
timeFrame: postoperative until hospital discharge up to 21 days
Secondary outcomes:
measure: Patient compliance with mobile tracking devices
timeFrame: postoperative until hospital discharge up to 21 days
measure: Postoperative inertial movement
timeFrame: postoperative until hospital discharge up to 21 days
measure: Postoperative step count
timeFrame: postoperative until hospital discharge up to 21 days
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Wuerzburg University Hospital
state: Bavaria
Study officials:
affiliation: Wuerzburg University Hospital
name: Patrick Meybohm, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05408481: Relation Between COVID-19 Pts and Hyponatremia in Adreno Ortical Insufficient Patients.
Official title: Hyponatremia in COVID-19 Patients With Adrenal Insufficiency and Its Relation to Mortality and Survival Scores.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Hyponatremia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients

Brief summary: Hyponatremia in COVID-19 patients with adrenal insufficiency

Detailed description: Hyponatremia is the most prevalent hydroelectrolytic disorder in clinical practice, and is linked to higher rates of morbidity and mortality. 1, 2.Sodium balance disorder, particularly hyponatremia, is a common condition among hospitalized patients with COVID-19 . and it is associated with a higher risk of morbidity, mortality, and disability. Acute hyponatremia causes serious brain swelling that can lead to permanent disability or death. Chronic hyponatremia causes attention deficit, gait instability, and osteoporosis, Mechanisms of hyponatremia in coronavirus disease 2019 (COVID-19) patients. Osmotic syndrome of inappropriate antidiuretic hormone release (SIADH) as a major mechanism. Also hypovolemic hyponatremia that may have been common in COVID-19 patients since nausea, vomiting, diarrhea.we predict critical illness-related corticosteroid insufficiency (CIRCI) play a role in hyponatremia in COVID-19 , high percentage of critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection in the study were treated with vasopressors (2). Angiotensin-converting enzyme 2 receptor and transmembrane serine protease 2 serine protease were colocalized in adrenocortical cells in the zona fasciculata and zona reticularis (2). plasma cortisol concentrations will be collected in critically ill patients with COVID-19 (2). The cortisol levels of critically ill patients with COVID-19 were low(2).We aimed to identify the previlence and mortality rate of hyponatremia in covid 19 patient with adrenal insufficiency . Our studies will present in Assiut hospital university on patients in isolation ward from October 2021 to October 2022.

Eligibility criteria: Inclusion Criteria:

* 1-Suspected COVID-19 patients come to isolation hospital in Assuit. 2-Hyponatremia. 3- Adrenal insufficiency

Exclusion Criteria:

* Non-cooperative patients

Primary outcomes:
measure: The effect of hyponatremia on mortality of COVID-19 patient with adrenal insufficiency
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: