louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05341427: DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
Official title: DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Wound
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients

Detailed description: It will be hypothesized that

1. Age may significantly affect burn wound healing's response to pulsed electromagnetic waves.
2. TBSA may significantly affect burn wound healing's response to pulsed electromagnetic waves
3. Depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves
4. Wound healing stage may significantly affect burn wound healing's response to pulsed electromagnetic waves This study will be conducted at the in-patient burn units. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units.

Pulsed electromagnetic waves will be performed for 60 min 3 times per week till healing (maximum 8 weeks) on the wound area.

PEMF therapy will be as (duration: 60 minutes; frequency: 12 Hz; intensity: 12 Gauss)

Eligibility criteria: Inclusion Criteria Partial thickness Burn wound depth. Age ranges from 20-50 years. TBSA more than 15% Sufficient understanding to perform the tests. Exclusion Criteria Diabetic patients. Patients receiving immunosuppressive drugs. Associated co-morbidities, such as neurological diseases, malnutrition, and other inﬂammatory and/or infectious diseases.

Primary outcomes:
measure: wound healing rate
timeFrame: maximum of 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT06711627: Food Provision in CenteringPregnancy Prenatal Care
Official title: Arkansas Community Engagement Alliance: Delivering Arkansas Perinatal Outcomes for Minority and Rural Women Through Innovative System Improvement to Create Equity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy Complications
Excessive Gestational Weight Gain
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 400
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overarching research question is: "Does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a cluster-randomized controlled trial with 400 pregnant women who are enrolled in CenteringPregnancy classes. CenteringPregnancy classes (clusters) will be randomized to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (\~8 weeks post-partum).


Eligibility criteria: Inclusion Criteria:

* Aged 16-44 years
* Pregnant
* Enrolled in CenteringPregnancy
* Speaks English, Spanish, or Marshallese

Primary outcomes:
measure: Excessive Gestational Weight Gain (EGWG)
timeFrame: Baseline to Post-partum (approx. 40 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06114927: Validation of the Spanish Version of the Conceptualization of Pain Questionnaire
Official title: Validation of the Spanish Version of the Conceptualization of Pain Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development
Pain
Adolescent Behavior
Keywords: survey
children
health knowledge
chronic pain
pain education
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 324
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Schoolchildren aged 8-17 years.

Brief summary: The goal of this observational study is to develop a questionnaire to assess a child's concept of pain and to evaluate its psychometric properties in schoolchildren aged 8-17 years. The main question\[s\] it aims to answer are:

* Validate to Spanish language the Conceptualization of Pain Questionnaire to assess a child's concept of pain.
* Conduct an analysis to evaluate its psychometric properties. Participants will respond a questionnaire of 15 items and asks respondents to respond if they believe the items/statements to be true or false, although they are allowed to respond undecided.

Detailed description: The inclusion criteria were: to be able to read and write in Spanish language and excluded if they suffered from an intellectual disability that, according to the teachers, could interfere with their participation in the study procedures.

The main outcome was: The Conceptualization of Pain Questionnaire - Spanish version.

Eligibility criteria: Inclusion Criteria:

* Were able to read and write in Spanish

Exclusion Criteria:

* If they suffered from an intellectual disability that, according to the teachers, could interfere with their participation in the study procedures.

Primary outcomes:
measure: The Conceptualization of Pain Questionnaire (COPAQ-S) Spanish version.
timeFrame: 1 year
Secondary outcomes:
measure: Age
timeFrame: 1 year
measure: Gender
timeFrame: 1 year
measure: School Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Rovira i Virgili University
Study officials:
References:
Clinical trial NCT05752227: Difference Strain Ratio Ultrasound Elastography Between Benign and Malignant Peripheral Lung Lesions
Official title: Difference In Strain Ratio Ultrasound Elastography Between Benign And Malignant Peripheral Parenchymal Lung Lesions.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Lung Lesions
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are all above age of 18 yrs old without gender discrimination

Brief summary: Diagnostic accuracy study to investigate the sensitivity and specificity of sonographic elastography using strain ratio to differentiate between benign and malignant peripheral lesions in comparison to biopsy, clinically, or radiologically.

Detailed description: This is a diagnostic accuracy study with comparison to gold standard tests e.g., chest computed tomography, transthoracic biopsy, or microbiological analysis. All patients included in this study will give informed consent according to the guidelines of ethics committee, Alexandria Faculty of Medicine. (http://www.med.alexu.edu.eg/wp-content/uploads/2012/04/Checklist-FINAL- 20141.pdf-)

Eligibility criteria: Inclusion Criteria:

* 1) Adult patients above age of 18 years old. 2) Patients with peripheral lung lesion.

Exclusion Criteria:

1. Pure pleural lesions.
2. Clinical instability to reach the final diagnosis.
3. Inaccessibility by ultrasound.

Primary outcomes:
measure: Cut off value strain ratio
timeFrame: 6-9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Ahmed Farag Abouelnour
Study officials:
affiliation: Alexandrian University
name: Ahmed F Abouelnour, Masters
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06745427: A Multi-center Prospective Study on the Oncological and Reproductive Outcomes and Quality of Life in Young Woman After Fertility-sparing Treatment of Endometrial Cancer and Endometrial Intraepithelial Hyperplasia
Official title: A Multi-center Prospective Study on the Oncological and Reproductive Outcomes and Quality of Life in Young Woman After Fertility-sparing Treatment of Endometrial Cancer and Endometrial Intraepithelial Hyperplasia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometrial Cancer
Endometrial Intraepithelial Neoplasia
Fertility-sparing Surgery
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2024-12-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women in Sweden

Brief summary: We will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia

Detailed description: A multi-center prospective study on the oncological and reproductive outcomes and quality of life in young woman after fertility-sparing treatment of endometrial cancer and endometrial intraepithelial hyperplasia

Eligibility criteria: Inclusion Criteria:

* Fertility sparing treatment of EC and EIN.
* 18-45 Years old
* From start study (Jan 2025 - end study Jan 2028)
* All centras in Sweden

Exclusion Criteria:

* Not English och Swedish speaking

Primary outcomes:
measure: Relaps of endometrial cancer or EIN after fertility-sparing treatment
timeFrame: from enrollment to 2 years after fertility-sparing treatment
Secondary outcomes:
measure: Live birth rate in women that has been treated with fertility-sparing treatment for EC or EIN
timeFrame: From start of study to 2 years after fertility-sparing treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02203227: Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia
Official title: Efficacy and Safety Study of Dietary Supplements (BioTurmin, BioTurmin-WD and MaQxan) on Cotinine Level and Oxidative Stress Marker in Chronic Smokers Having Mild to Moderate Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Smokers
Hyperlipidemia
Keywords: Dietary supplements
Cotinine level
Malondialdehyde
Chronic smokers
Hyperlipidemia
Lead sponsor: Olive Lifesciences Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
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 investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.

Detailed description: In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 60 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Eligibility criteria: Inclusion Criteria:

* Men \> 20 years
* Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC \>200 mg/dL and/or HDL-C \<40 mg/dL)
* Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

* Patients with Chronic obstructive pulmonary disease (COPD)
* Women
* Patients with severe liver, renal, cardiac or brain diseases.
* Unable to complete follow up.
* Subjects on any medication like diuretics.
* Allergic to any medication.
* With a history of alcohol and/or drug abuse.

Primary outcomes:
measure: change in urine cotinine and serum oxidative stress marker (malondialdehyde) level
timeFrame: Baseline, on day 30 and on day 60
Secondary outcomes:
measure: Change in serum lipid profile
timeFrame: Baseline, on day 30 and on day 60
Other outcomes:
measure: Safety and tolerability (composite measure)
timeFrame: Baseline, on day 30 and on day 60
Locations:
city: Bangalore
country: India
facility: Sreenivasa Clinic Diabetic Research Center
state: Karnataka
Study officials:
affiliation: Sreenivasa Clinic Diabetic Research Center
name: Venkateshwarlu K, MD (Ayur)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05386927: Early Diagnosis of GDM by Multiomics
Official title: Clinical Study of a New Technology System for Early Diagnosis and Screening of GDM Based on Multiomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.

Brief summary: Gestational diabetes mellitus (GDM) is prone to cause a variety of adverse pregnancy outcomes, and has potential harm to the short-term and long-term health of both mothers and infants. However, its diagnosis mainly relies on oral glucose tolerance test (OGTT) at 24-28 weeks of gestation, so it is often diagnosed in the second and third trimester, and may be too late to intervene. Therefore, advancing the diagnostic window period of GDM is the key to the prevention and treatment of GDM and its complications. It is urgent to establish a new technology for the early diagnosis and screening of GDM with high detection rate and accuracy. Based on literature survey and previous studies, this study found that the combined analysis of metabolomics and lipidomics may have broad clinical application prospects in the early diagnosis and screening of GDM. It is hoped that a set of new techniques based on multi-omics for early diagnosis and screening of GDM can be constructed, providing a feasible and effective tool for early detection and treatment of GDM in clinical.


Eligibility criteria: Inclusion Criteria:

* Plan to have routine prenatal examinations and give birth in the research center
* First trimester
* Singleton pregnancy
* Without pregnancy complications
* Willing to cooperate with the hospital to follow up

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
* Fetus has a known deformity or genetic defects
* Incomplete clinical data

Primary outcomes:
measure: Salivary metabolomics
timeFrame: First trimester (9-14 gestational weeks)
measure: Serum lipidomics
timeFrame: First trimester (9-14 gestational weeks)
measure: Urine metabolomics
timeFrame: First trimester (9-14 gestational weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Zhaoxia Liang, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06321627: Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach
Official title: Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach - ICARUS Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV-Related Carcinoma
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 100
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: Patients with HPV-positive tumors of the oropharynx, uterine cervix, and anus

Brief summary: The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body.

Detailed description: The present study (ICARUS - genomIC RAdiosensitivity viRUS) involves the collection of data (retrospective and prospective) from an extensive cohort of patients with HPV-related tumors of the oropharynx, cervix, and anus.

The aim is to:

1. investigate the role of Cl2 in non-oropharyngeal HPV-related tumors, and
2. compare the Radiation Sensitivity Index (RSI) values of HPV-related tumors in patients who responded to radiotherapy (responders) with those of patients with radioresistant tumors (non-responders).

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years old)
* Diagnosis of HPV-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus
* Curative intent radiation therapy (exclusive, post-operative, with or without chemotherapy)
* Availability of pre-radiation therapy biopsy sample
* No diagnosis of solid neoplasms and/or hematologic malignancies in the previous 5 years
* Possibility of retrospective and prospective data collection and anonymous submission to the referring center of clinical data related to the patient, pathology, and treatment characteristics (including radiation treatment plan in RT.dose format)
* Ability to obtain written informed consent for the use of data anonymously for research purposes

Exclusion Criteria:

* Patients undergoing surgical treatment
* Patients with local and/or locoregional recurrence
* Patients with synchronous distant metastases at diagnosis
* Patients previously treated with oncologic therapies for tumors of the same anatomical site

Primary outcomes:
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: Genetic patterns of radiosensitivity
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Daniela Alterio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00166127: Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery
Official title: Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Keywords: heart failure
cardiac surgery
pharmacokinetics
pharmacodynamics
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2005-09-14
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study protocol is to evaluate the blood concentrations of levosimendan when administered at different doses clinically employed during cardiopulmonary bypass or cardiac manipulation during off pump surgery in patients who require the drug for inotropic support (improved heart function) and the associated hemodynamic variables (vital signs). Levosimendan is one of the first agents in a new class of drugs used to treat heart failure and works via a unique mechanism called calcium sensitization, that makes the heart beat more efficiently. Levosimendan also has unique effects on the blood vessels, as well as causing relaxation, an important therapeutic approach of heart failure therapy.

Detailed description: This is a non-randomized trial, and the patients will be assigned to one of three dose groups following cardiopulmonary bypass or prior to manipulation of the heart in the off pump group. A total of 30 patients will be enrolled into this study, 20 off-pump and 10 subjects on pump. Levosimendan is approved in Europe for the treatment of decompensated heart failure. It improved cardiac function without increasing energy demands. The subject's enrollment ends at Day 7 or day of discharge, whichever comes first.

Eligibility criteria: Inclusion Criteria:

* At least 21 years of age
* Less than 80 years of age
* ASA Class III-IV
* Scheduled for elective cardiac surgery
* Signed informed consent
* History of heart failure, and/or left ventricular ejection fraction \<50%

Exclusion Criteria:

* Emergency surgery
* Withdrawal of consent
* Uncontrollable ventricular arrhythmias
* Obstructive cardiomyopathy
* Confirmed pregnancy test for women of child-bearing potential

Primary outcomes:
measure: pharmacokinetics
timeFrame: day of surgery
Secondary outcomes:
measure: hemodynamics
timeFrame: day of surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Jerrold H Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: