louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02609295: Effects of α-linolenic Acid Supplementation on Hemostasis in Nondiabetic and Hypercholesterolemic Subjects
Official title: Effects of α-linolenic Acid Supplementation in the Form of Perilla Oil on Collagen-epinephrine Closure Time, Activated Partial Thromboplastin Time and Lp-PLA2 Activities in Nondiabetic and Hypercholesterolemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: α-linolenic acid
perilla oil
aPTT
Collagen-epinephrine closure time
Lp-PLA2
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase A2 (Lp-PLA2) activity.

Detailed description: An 8-week, randomized, double-blind, placebo-controlled study was conducted with 86 nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dL ≤ serum cholesterol ≤ 300mg/dL) subjects, not taking any medications and supplements to affect lipid metabolism, platelet function and inflammation, divided into two groups: an α-linolenic acid (ALA) group \[1.2 g (two capsules) of perilla oil daily; 497 mg ALA\] and a placebo group (1.2 g of medium-chain triglyceride oil daily).

Eligibility criteria: Inclusion Criteria:

* Voluntarily agree to participate and sign in informed consent form
* Adults aged 40-70
* Nondiabetic and hypercholesterolemic subjects (serum cholesterol ≥ 200 mg/dL)

Exclusion Criteria:

* Subjects taking any medication or supplements known to affect lipid metabolism or platelet function, n-3 fatty acid supplementation or n-3 fatty acid-rich fish more than two times per week
* Following diseases: dyslipidemia, hypertension, diabetes, liver disease, renal disease, pancreatitis, cardiovascular disease, gastrointestinal disease, cancer, or any other disease requiring treatment
* Participation in clinical trials of any drug or supplement within 30 days prior to the participation of the study
* Pregnant or lactating women, alcoholic, mental patient
* Judged to be inappropriate for the study by the investigator after reviewing other reasons

Primary outcomes:
measure: Collagen-Epinephrine Closure Time (C-EPI CT)
timeFrame: Baseline
measure: Collagen-Epinephrine Closure Time (C-EPI CT)
timeFrame: 8-week follow up
Secondary outcomes:
measure: Prothrombin Time (PT)
timeFrame: Baseline
measure: Prothrombin Time (PT)
timeFrame: 8-week follow up
measure: Activated partial thromboplastin time (aPTT)
timeFrame: Baseline
measure: Activated partial thromboplastin time (aPTT)
timeFrame: 8-week follow up
measure: Fibrinogen
timeFrame: Baseline
measure: Fibrinogen
timeFrame: 8-week follow up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
References:
Clinical trial NCT03324295: Aqueous Urea Concentration May be Related to Cataract Development
Official title: Aqueous Urea Concentration May be Related to Cataract Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract Cortical
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Assiut university hospital

Brief summary: cataracts could be cured with eye drops. Some studies reported that in chronic renal failure, the occurrence of cataract is rare and the mechanism is unknown. The aim of this research is to describe correlation between urea concentration in the serum and aqueous humor and development of age related cataract.

Detailed description: The study was conducted in the departments of Ophthalmology and internal medicine,

Asyut University hospitals, Egypt. Three groups of subjects were included:

patients with age related cortical cataracts who are otherwise healthy (cases) and two control groups; first systemically healthy subjects with ocular problems other than cataract and a second control group of patients with impaired renal functions and are not on dialysis treatment and thus have elevated serum urea levels. Slit lamp examination was performed to evaluate crystalline lens for opacities. Measurement of serum urea was done for all study subjects. Aqueous humor urea concentration was done only for the group of patients who are planned to have intraocular surgery. For that purpose, 0.1 ml of aqueous humor will be aspirated at the start of routine intraocular surgery.

Eligibility criteria: Inclusion Criteria:

* Senile Cortical cataract.

Exclusion Criteria:

* Senile Nuclear cataract.
* Congenital cataract
* Traumatic cataract

Primary outcomes:
measure: Blood urea level
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Hassan Lotfy
Study officials:
affiliation: Assiut University
name: Hassan Fahmy, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04031495: Image Guidance for Improved Vessel Cannulation in Pediatric Patients
Official title: Image Guidance for Improved Vessel Cannulation in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Vein Cannulation
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: Children's National Research Institute
First posted: 2019-07-24
Enrollment: 4
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios.

Detailed description: Phase I Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios. n=5 patients will be enrolled, and success would be 4 children (80%) successfully cannulated with a single pass using the P-SCENERGY.

Eligibility criteria: Inclusion Criteria:

* pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation

Exclusion Criteria:

* none

Primary outcomes:
measure: Successful Central Vein Cannulation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Karun Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02328495: Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy
Official title: Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Misoprostol, Office hysteroscopy ,Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 76
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Detailed description: Several studies revealed that cervical ripening with misoprostol is effective in reducing pain especially in postmenopausal patients. A recent randomized controlled trial revealed that uterine striating by bladder filling prior to office hysteroscopy is associated with reduced pain perception and easier introduction of hysteroscope through the cervix.

The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Eligibility criteria: Inclusion Criteria:

* Menopausal patients who have an indication for office hysteroscopy

Exclusion Criteria:

* Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.

Primary outcomes:
measure: Intensity of pain [ visual analogue scale ranging from 0 to 10 ]
timeFrame: Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 10 minutes] and 30 minutes after the procedure
Secondary outcomes:
measure: Operative time
timeFrame: From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination[ an expected average 10 minutes]
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obstetrics and Gynecology Department,Cairo university
Study officials:
affiliation: Cairo University
name: Usama M Fouda, M.D,PhD
role: STUDY_CHAIR
References:
citation: Celik C, Tasdemir N, Abali R, Bastu E, Akbaba E, Yucel SH, Gul A. The effect of uterine straightening by bladder distention before outpatient hysteroscopy: a randomised clinical trial. Eur J Obstet Gynecol Reprod Biol. 2014 Sep;180:89-92. doi: 10.1016/j.ejogrb.2014.06.029. Epub 2014 Jul 7.
citation: Fouda UM, Elshaer HS, Elsetohy KA, Youssef MA. Misoprostol versus uterine straightening by bladder distension for pain relief in postmenopausal patients undergoing diagnostic office hysteroscopy: a randomised controlled non-inferiority trial. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:326-30. doi: 10.1016/j.ejogrb.2016.06.024. Epub 2016 Jul 1.
Clinical trial NCT06536595: Validity and Reliability of the Turkish Version of HAnDE
Official title: Validity and Reliability of the Turkish Version of the Hand Scleroderma Lived Experience Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scleroderma
Hand Rheumatism
Keywords: hand
reliability
scale
validation
scleroderma
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: diagnosed with scleroderma

Brief summary: The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.

Detailed description: Objective: The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.

Methods: The HAnDE was cross-culturally adapted according to Beaton's guideline. Participants completed the Turkish version of HAnDE scale (HAnDE-T), The Mouth Handicap in Systemic Sclerosis Scale (MHISS), 36 Item Short Form Survey (SF-36), Health Assessment Questionnaire (HAQ). Internal consistency of the HAnDE-T questionnaire was evaluated by Cronbach's alpha coefficient. Convergent validity was tested using Pearson's correlation coefficient. The construct validity of the HAnDE-T questionnaire was assessed by factor analysis. The construct validity of the HAnDE-T was evaluated by correlating the scores between HAnDE-T and HAQ, SF-36 PCS, SF-36 MCS and MHISS scores.

Eligibility criteria: Inclusion Criteria:

* 1) being 18-65 years of age,
* 2) being diagnosed of SSc according to do 2013 American College of Rheumatology (ACR) criteria and/or European League Against Rheumatism (EULAR) criteria,
* 3) being literate in Turkish,
* 4) being agreed to participate in the research.

Exclusion Criteria:

* 1) being in a psychological or cognitive disorders that would prevent to answer questions.

Primary outcomes:
measure: HAnDE-T
timeFrame: Patients were asked to complete the HAnDE-T when they first came (baseline). After 1 week, they were asked to complete HAnDE-T for retest.
Secondary outcomes:
measure: MHISS
timeFrame: Patients were asked to complete the MHISS when they first came (baseline).
measure: SF-36
timeFrame: Patients were asked to complete the SF-36 when they first came (baseline).
measure: HAQ
timeFrame: Patients were asked to complete the HAQ when they first came (baseline).
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University
Study officials:
affiliation: Gazi University
name: Deran Oskay, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00877695: Motiv82Change: an HIV Prevention Study for Young Latino Men
Official title: Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
HIV Seronegativity
prevention
Hispanic
Latino
MSM
men
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop and pilot test a culturally and developmentally tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).

Detailed description: Stage 1, divided into Stage 1a and Stage 1b, focuses on development, refinement, and pilot testing of interventions. The formative research leading to and including intervention development is completed in Stage 1a. A pilot study to provide acceptability/feasibility data and obtain effect size estimates of the intervention's strength in changing a desired outcome is conducted in Stage 1b. If Stage 1b results are "promising," the intervention moves to full scale efficacy testing in Stage 2 using the classic experimental design of a randomized control trial (RCT). The intervention is ready for Stage 3 effectiveness testing only after its efficacy has been demonstrated in at least two Stage 2 trials.

Eligibility criteria: Inclusion Criteria:

To be eligible, participants must:

1. be male;
2. self-identify as Hispanic/Latino;
3. be 18 - 29 years of age;
4. live in South Florida;
5. have had at least 1 episode of unprotected anal sex with a man in the last 6 months;
6. have had at least 2 male sex partners in the last 6 months;
7. be HIV negative or not known to be HIV positive; and
8. have not previously participated in this study.

Exclusion Criteria:

1. living with HIV infection

Primary outcomes:
measure: The main outcome measure for the Stage 1b trial will be reduction in at least one of the two main outcome variables - number of unprotected anal sex acts and number of sex partners (both in the last 3 months).
timeFrame: 16 months
Secondary outcomes:
measure: acceptability and feasibility of the intervention
timeFrame: 16 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Nova Southeastern University (Miami Office)
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: M. Isabel Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00040495: Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
Official title: An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peptic Ulcer Hemorrhage
Keywords: Peptic
Ulcer
Hemorrhage
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-06-28
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy.


Eligibility criteria: Inclusion Criteria:

* Patients must be men or non-pregnant women at least 18 years of age
* Patients who present with a gastric or duodenal ulcer

Exclusion Criteria:

* Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation
* Patients presenting with active bleeding and/or NBVV at 2 or more separate sites
* Patients with any severe concomitant diseases, eg, end stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06439095: Interleukin-2 (IL-2), Interleukin-5 (IL-5) and Interleukin-17 (IL-17) Levels of Patients With Stainless Steel Crowns
Official title: Evaluation of IL-2, IL-5 and IL-17 Expression Levels in Saliva of Patients Treated With Stainless Steel Crowns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Saliva
Dental Crown
Nickel Sensitivity
Keywords: Saliva
Dental crown
Gene expression
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients living in Van city

Brief summary: The aim of this study is to investigate whether nickel hypersensitivity following stainless steel crown treatment in children aged 3-9 leads to an increase in IL-2, IL-5, and IL-17 levels by analyzing saliva samples. By doing so, the study seeks to prevent potential hypersensitivity reactions after stainless steel crown treatment.

The main question it aims to answer is:

Which interleukin level increases in the controls 1 week after stainless steel crowns are applied? Researchers will investigate whether there is a significant increase in interleukin levels in children's saliva before and after the procedure.

Participants will:

They will provide saliva samples before stainless steel crowns are applied They will visit the clinic after 1 week for check-ups and tests.

Detailed description: Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 3-9 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 5 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure. Also ph value and ion levels of saliva will be measured.

Eligibility criteria: \*\*Inclusion Criteria:\*\*

* Patients with teeth requiring stainless steel crowns due to having caries on two or more surfaces.
* Pediatric patients between 3-9 years old

\*\*Exclusion Criteria:\*\*

* Patients having any dental materials, such as fillings, fissure sealants, root canal treatments, or space maintainers
* Patients with known allergies to various foods and materials.
* Patients with systemic diseases that affect the immune system.
* Patients with a history of chemotherapy or radiotherapy.

Primary outcomes:
measure: IL-2, IL-5, IL-17 Expression Level (Fold Change)
timeFrame: Sample collection at baseline (Day 0) and 7 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yüzüncü Yil University
state: Tuşba
Study officials:
affiliation: Yuzuncu Yıl University
name: Burçin Avcı, DDS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06045195: Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
Official title: Phase II Trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: advanced stage
first line treatment
PD-1 inhibitor
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to estimate efficacy of the novel regimen. The primary endpoint is the 1-year PFS rate after treatment with one dose of pembrolizumab followed by four to six cycles of chemo-immunotherapy with P-BrECADD, and PET-guided radiotherapy as per standard of care


Eligibility criteria: Main Inclusion Criteria:

* age 18-60
* advanced stage classical Hodgkin Lymphoma
* no previous treatment for cHL

Main Exclusion Criteria:

* Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
* Chemotherapy or radiotherapy in medical history
* Prior or concurrent disease that prevents treatment according to protocol

Primary outcomes:
measure: progression free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Department of Medicine, Cologne University Hospital
Study officials:
affiliation: 1st Department of Medicine, Cologne University Hospital
name: Peter Borchmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References: