louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06209918: Effect of Bioptron Light on Carpal Tunnel Syndrome(BLCTS)
Official title: Effect of Bioptron Light Therapy on Pregnancy Related Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome Pregnancy
Keywords: Bioptron light therapy
Phototherapy
Carpal tunnel syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 62
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of bioptron light therapy on pregnancy related carpal tunnel syndrome

Detailed description: Carpal tunnel syndrome (CTS) is a symptomatic compression neuropathy of the median nerve at the level of the wrist, characterized by hand pain, numbness, and tingling in the distribution of the median nerve (thumb, index, middle finger, and the radial side of the ring finger) and a reduction in grip strength and hand function. The severity of symptoms can be clinically categorized into mild, moderate, and severe Bioptron phototherapy acts as a "sterile" trigger on human in vitro isolated peripheral blood mononuclear cells (PBMCs), affecting their cytokine production and driving the immune response towards an anti-inflammatory/reparative profile and representing a non-pharmaceutical and non-invasive option for several clinical conditionsA randomized control study, the women will be randomly assigned into two groups, (31 women for each group) equal in number. Group (A) will include 31 women will receive Bioptron light combined with advice and patient education (10 minutes per session, 3 sessions per week, for 4 weeks). Group (B) will be receiving advice only for same duration as group (A)

Eligibility criteria: Inclusion Criteria:

* Pregnant females clinically daignosed with carpal tunnel syndrome at least 1 month
* age will range from (25-35) years.
* body mass index (BMI) will be (BMI ≤ 35 kg/m2)

Exclusion Criteria:

* history of neurologic disease
* hand surgery
* hand trauma,
* diabetes mellitus
* cervical spondylosis
* osteoarthritis of cervical spine and wrist joint
* chronic renal failure
* heart failure
* connective tissue disorders

Primary outcomes:
measure: Nerve conduction studies (NCS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Visual analogue scale
timeFrame: 4 weeks
Other outcomes:
measure: Boston carpal tunnel questionnaire
timeFrame: 4 weeks
Locations:
city: Giza
country: Egypt
facility: Sara Magdy Ahmed
Study officials:
affiliation: Cairo University
name: Sara Ma Ahmed, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05167318: Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Official title: Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Microbial Colonization
Ventilator Associated Pneumonia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.


Eligibility criteria: Inclusion Criteria:

* Gestational age \< 32 weeks
* birth weight \< 1500 grams
* mother is English speaking
* mother is \> 18 years of age.

Exclusion Criteria:

* Congenital anomalies of the face, lungs, or gastrointestinal system
* not expected to survive

Primary outcomes:
measure: Type of of bacterial in the oral cavity
timeFrame: weekly for 4 weeks
Secondary outcomes:
measure: Days of respiratory support
timeFrame: Up to 100 days
measure: Incidence of chronic lung disease
timeFrame: Up to 100 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie Parker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05586919: Treatment of Venous Malformation
Official title: Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Malformation
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with venous malformation of both genders and age above one year.

Exclusion Criteria:

* Age below one year.
* Patients had any other vascular malformations.
* Indication for contrast material or Alcohol and polidocanol injection.
* Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers.
* Pulmonary embolism.
* Acute Ischemia, and acute DVT.

Primary outcomes:
measure: Heaviness questionnaire
timeFrame: 6 months post operative
measure: Disfigurement questionnaire
timeFrame: 6 months post operative
measure: size of venous malformation
timeFrame: 6 months post operative
measure: Degree of satisfaction
timeFrame: 6 months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Walied Khereba
Study officials:
References:
Clinical trial NCT04838119: Preop COVID Testing Patterns
Official title: Preoperative COVID Testing as a Predictor of Community Disease Burden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Testing, preoperative
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 375692
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Publicly reported aggregate data on asymptomatic preoperative COVID tests (no individual patient information)

Brief summary: This study is an investigation of preoperative asymptomatic COVID screening nationwide. The hypothesis is that because these tests are performed without reference to pretest probability of COVID-19 disease, unlike tests based on symptoms or close contact with infected individuals, these studies may represent a more unbiased sample of the local population prevalence of asymptomatic COVID disease burden.

Detailed description: Study will gather publicly reported, aggregated statistics on positive COVID tests over time and across geographically diverse parts of the United States, summarized weekly, from the onset of the pandemic in Spring 2020 to the present time. Study will also gather contemporaneous data on weekly community COVID cases diagnosed, local positive test percentage, hospital admissions and ICU admissions for COVID-19, and deaths from COVID 19. Similar data will be obtained from a coalition of approximately 20 academic medical centers from around the United States, with Wake Forest School of Medicine, Department of Anesthesiology serving as the coordinating center. No individual patient information will be collected. Aggregated testing data, hospital disease burden, and local disease prevalence are all publicly reported.

Data will analyzed as interrupted time series.

Eligibility criteria: Inclusion Criteria:

* having preoperative asymptomatic COVID testing
* \> or = 18 years of age

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of asymptomatic preoperative COVID-19 positive testing
timeFrame: March 2020-February 2021
Secondary outcomes:
measure: Percentage of hospitalization per geographic area
timeFrame: March 2020-February 2021
measure: Percentage of death per geographic area
timeFrame: March 2020-February 2021
measure: ICU census per geographic area
timeFrame: March 2020-February 2021
measure: Percentage of asymptomatic preoperative COVID-19 positive testing per geographic area
timeFrame: March 2020-February 2021
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: B S Segal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005418: Epidemiology of Cardiotoxicity in Children With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Death, Sudden, Cardiac
Heart Failure
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To provide a comprehensive analysis of risk factors for the development of clinical cardiotoxicities in over 6,000 children with cancer who had been treated on standardized protocols involving the use of anthracyclines alone or in combination with other potentially cardiotoxic therapies or with no use of anthracycline therapy.

Detailed description: DESIGN NARRATIVE:

The data were analyzed to estimate the incidence of clinical cardiotoxicity as measured by sudden death, congestive heart failure, or discontinuation of therapy based on cardiac function. Evaluation of patient characteristics (age, anemia) and treatment factors such as drug, dose level, dosing schedule, exposure to irradiation and/or cyclophosphamide identified groups at particularly high risk for development of clinical cardiotoxicity and provided estimates of this risk for future treatment planning. Such estimates of high risk groups should make possible future trials to test the feasibility of using cardioprotectors or alternate dosing schedules to prevent cardiotoxicity. The incidence of clinical cardiotoxicity was calculated using Kaplan- Meier estimates as a function of total cumulative anthracycline dose and also as a function of the time since the end of treatment stratified by dose levels. The estimates were stratified by exposure to cyclophosphamide and radiation therapy. Multivariate methods were used to evaluate the prognostic significance of selected patient characteristics and treatment parameters and to provide estimates of the relative risk of each variable. The method of recursive partitioning was used to identify subpopulations at elevated risk for clinical cardiotoxicity. The data and analytic techniques were accessible through SAS data sets and procedures available to the study at the Pediatric Oncology Group (POG) Statistical Office.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Krischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE. Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol. 1997 Apr;15(4):1544-52. doi: 10.1200/JCO.1997.15.4.1544.
Clinical trial NCT02404818: Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Treated With Radiation Therapy
Official title: UFPTI 1431 - HL02: Investigating Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Survivors Treated With Either Photon or Proton Radiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Lymphoma
Keywords: Radiation
Cardiac
Hodgkin's lymphoma
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hodgkin's lyphoma survivors that have received radiation at UF Health Proton Therapy Institute and also received chemotherapy.

Brief summary: The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma.


Eligibility criteria: Inclusion Criteria:

* Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum.
* Patient must be ≥ 18 years at time of consent.

Exclusion Criteria:

* Pregnant women at time of Cardiac MRI
* Contraindications to Cardiac MRI (contrast allergy, metal implants, medical devices)
* Glomerular filtration rate (GFR) \< 30, unless approved by Radiologist (UF Health Jacksonville Radiology Policy: Administration of Gadolinium-Based Contrast Agents).

Primary outcomes:
measure: Cardiac Abnormalities As Measured By Cardiac MRI
timeFrame: Day 1
measure: Cardiac Abnormalities As Measured By Echocardiogram
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Health Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Health Proton Therapy Institute
name: Bradford S Hoppe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02361918: Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage
Official title: Predicting Value of Serum Procalcitonin, C-reactive Protein, and Drain Fluid Culture, Fluid Il-6 and Tnf-α Levels in Anastomotic Leakage Following Rectal Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leakage in Colon Surgery
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient had colonic resection

Brief summary: Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.

Detailed description: To search for a biomarker, which might be able to predict rectal anastomotic leakage before its clinical presentation. Serum procalcitonin, C-reactive protein, and drain fluid culture, IL-6 and TNF-α levels were evaluated in 50 consecutive patients with rectal cancer who underwent low anterior resection with colorectal anastomosis.

Eligibility criteria: Inclusion Criteria:

* Patient underwent to colonic resection and had drain

Exclusion Criteria:

* other patients

Primary outcomes:
measure: Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage.
timeFrame: 5 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02533518: Ultra-Violet Fluorescence Bronchial Cancer Location
Official title: Ultra-Violet Fluorescence Bronchial Cancer Location
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Diagnose lung cancer at an early stage is crucial for effective treatment. At these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light. These widely distributed autofluorescence methods detect early mucosal abnormalities. They are very sensitive but not specific to recognize the lung cancer. Thanks to European funding (EURIMUS), a new tool with fluorescent UV light has been developed.

The purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in Pneumology of this fluorescence method versus histological analysis of the tissue.


Eligibility criteria: Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme
* Major Patient
* Patient who signed the informed consent document
* Patient with a known primary cancer in bronchial level

Exclusion Criteria:

* Pregnant woman
* Patient with a benign tumor histology
* Patient with an unknown tumor histology.

Primary outcomes:
measure: ultraviolet fluorescence ratio Iodine360 / Iodine450
timeFrame: Day 0
measure: Histology of tissue
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Pneumology departement CHU Saint-Etienne
Study officials:
References:
Clinical trial NCT05661318: AHC Ballana Heart Study
Official title: Aswan Heart Centre - Ballana Heart Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genetic Predisposition to Disease
Keywords: genetics
Cardiovascular risks
Lead sponsor: Magdi Yacoub Heart Foundation
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Residents of Ballana from the 1,200 randomly selected households

Brief summary: This Study is designed to assess CVD incidence, prevalence, progression and related risk factors, including genetic background. It will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy.

Detailed description: Background Population-based longitudinal studies are a cornerstone in understanding current disease landscapes affecting communities and collecting reliable data to guide prevention and treatment strategies. In Egypt there is pressing need of collecting reliable data on cardiovascular disease (CVD) in defined populations.

Objectives Defining the cardiovascular phenotype, genotype as well as OMICS and risk factors for CVD in a defined population in Egypt with follow up for up to 30 years

Methods As a first step, a random representative sample of 1,200 households from the Ballana population will be created. Following inclusion, patients will be screened for their cardiovascular profile and followed up for changes in their profile and cardiovascular events continuously every year in high risk patients and every 3 years for the rest of the participants for a period of 30 years.

Eligibility criteria: Inclusion criteria:

* Residents of Ballana from the 1,200 randomly selected households
* Participants must have a valid National ID card
* Written informed consent

Exclusion criteria:

• Residents who are younger than 18 years

Primary outcomes:
measure: Cardiovascular risk assessment
timeFrame: 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan Heart Centre - Magdi Yacoub Heart Foundation
Study officials:
affiliation: Imperial College London, and Magdi Yacoub Heart Foundation
name: Magdi H Yacoub, FRS OM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keates AK, Mocumbi AO, Ntsekhe M, Sliwa K, Stewart S. Cardiovascular disease in Africa: epidemiological profile and challenges. Nat Rev Cardiol. 2017 May;14(5):273-293. doi: 10.1038/nrcardio.2017.19. Epub 2017 Feb 23.
Clinical trial NCT01987518: French Digestive Polyposis Cohorte Family Adenomatous Polyposis With APC and MYH Gene Mutations , Cowden's Disease With PTEN Gene Mutation, Peutz Jeghers Disease With STK 11 Gene Mutation ,juvénil Polyposis With SMAD 4 Gene Mutation , Serrated and Hyperplastic Polyposis
Official title: French Digestive Polyposis Cohorte
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Digestive Polyposis Cohort

Brief summary: French cohorte about polyposis digestive diseases

Detailed description: Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis

Eligibility criteria: Inclusion Criteria:

* APC Gene mutation
* MYH Homozygote mutation
* COWDEN Disease with PTEN gene mutation
* Peutz Jeghers Disease with STK 11 gene mutation
* Juvenile polyposis with SMAD 4 gene mutation

Exclusion Criteria:

* heterozygote MYH Gene Mutation

Primary outcomes:
measure: genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot
state: Rhone Alpes
Study officials:
affiliation: HEH Hospital
name: jean christophe saurin, msd
role: PRINCIPAL_INVESTIGATOR
References: