louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00932984: Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Floral (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd Silver Floral.


Eligibility criteria: Inclusion criteria:

* Phototype Skin II and III Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Concomitant use of photosensitivity drugs
* History of sensitivity or photosensitivity withr topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
timeFrame: From the treatment start to the end of the study (treatment period 5 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT04910984: Developing a Chatbot to Promote HIV Testing
Official title: Developing an Artificial Intelligence Chatbot to Promote HIV Testing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: HIV testing
PrEp
HIV care
Chatbot
MSM
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-06-02
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the feasibility of a Chatbot in promoting HIV testing in a pilot RCT with 80 men who have sex with men in Kuala Lumpur, Malaysia will be studied. Participants will be randomized to Chatbot or treatment as usual (TAU) groups. Participants in the intervention group will receive automated personalized messages containing HIV testing-related information, motivation and skills.

Detailed description: After informed consent, participants will be randomly assigned to Chatbot or TAU groups using stratified randomization by age. Participants in TAU will receive attention-matched educational materials manually sent by the research assistant. Participants in the intervention group will receive an automated personalized question message (root-node message) from the Chabot. In each round of the interactive communication, the Chatbot will provide automated personalized messages containing HIV testing-related information, motivation and skills based on participants' answers and will continuously update over time. Participants will be observed over 180 days with responses and interactions stored on a HIPAA-compliant and protected cloud. An independent assessment of recent testing and reasons why will be sent by link to both TAU and intervention groups using a link to a Qualtrics survey housed on REDCap at baseline and after 90 and 180 days. After 180 days, the RA will send an additional REDCap survey to intervention participants to assess the feasibility of the Chabot to measure 4 key elements: acceptability, practicality, demand, and adaptation.

Eligibility criteria: Inclusion Criteria:

* cis-gender male
* 18+ years;
* had condomless sex with men in the past 6 months
* has a smartphone
* speaks Bahasa Malay or English.

Exclusion Criteria:

* Not able to read Malay or English

Primary outcomes:
measure: Change in HIV testing
timeFrame: 30 days, 60 days, 90 days, 120 days, 150 days, and 180 days
Secondary outcomes:
measure: Recruitment rate
timeFrame: 180 days
measure: Completion rate
timeFrame: 180 days
measure: Interaction time
timeFrame: 180 days
measure: Interaction frequency
timeFrame: 180 days
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
state: Jalan Pantai Baharu
Study officials:
affiliation: Yale University
name: Jeffrey A. Wickersham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04975984: Expectant Management of Ectopic Pregnancy
Official title: Evaluation of Expectant Management in Women Diagnosed With a Tubal Ectopic Pregnancy at Ain-Shams University Maternity Hospital Over the Period From January 1, 2016 to December 31, 2020
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ectopic Pregnancy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants included in this study will have the following criteria:

1. Hemodynamically stable with confirmed diagnosis of ectopic pregnancy on ultrasound scan.
2. No significant pelvic pain.
3. No hemoperitoneum.
4. No fetal heart in the ectopic pregnancy.
5. HCG level \<5000 IU/L.
6. Expectant management was the first line of management offered to the patient after optimal counseling.

Brief summary: The aim of this study is to assess the efficacy and safety of expectant management in the treatment of tubal ectopic pregnancy and identification of different factors that can be used to predict its success.


Eligibility criteria: Inclusion Criteria:

- all women who underwent expectant management as the first line of management offered after optimal counseling during the period from January 1, 2016 to December 31, 2020.

1. Hemodynamically stable with confirmed diagnosis of ectopic pregnancy on ultrasound scan.
2. No significant pelvic pain.
3. No hemoperitoneum.
4. No fetal heart in the ectopic pregnancy.
5. HCG level \<5000 IU/L.
6. Expectant management was the first line of management offered to the patient after optimal counseling.

Exclusion Criteria:

1. all women with non tubal ectopic pregnancy
2. all women with tubal ectopic pregnancy that recieved medical or surgical treatment as 1st line treatment

Primary outcomes:
measure: resolution of hCG level
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university maternity hospital
Study officials:
References:
Clinical trial NCT00004284: Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercalciuria
Kidney Calculi
Keywords: hypercalciuria
nephrolithiasis
rare disease
renal and genitourinary disorders
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Texas
First posted: 1999-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria.

II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

Patients receive potassium phosphate or potassium citrate tablets twice a day for 3 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Absorptive hypercalciuria Intestinal hyperabsorption of calcium, i.e.: Exaggerated calciuric response to oral calcium load OR Fractional calcium-47 absorption greater than 0.61 Calciuria greater than 200 mg/day on random and calcium-restricted diet Normal or high fasting urinary calcium Normal serum calcium Normal serum parathyroid hormone No primary hyperparathyroidism At least 1 calcium oxalate stone within the past 3 years No struvite or carbonate apatite stones No noncalcareous stones No numerous stones making precise quantitation difficult No renal tubular acidosis --Prior/Concurrent Therapy-- No concurrent drug therapy for nephrolithiasis --Patient Characteristics-- Creatinine clearance at least 0.7 mL/min per kilogram No hyperkalemia No hyperphosphatemia No urinary tract infection Other: No predisposition to hyperkalemia, including concurrent use of the following drugs: Potassium-sparing diuretics Angiotensin-converting enzyme inhibitors Nonsteroidal anti-inflammatory drugs No active peptic ulcer disease No chronic diarrhea

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Charles Y. C. Pak
role: STUDY_CHAIR
References:
Clinical trial NCT04306484: 18F-DOPA-PET in Non-tumoral and Tumoral Brain Lesions
Official title: 18F-DOPA-PET in Non-tumoral and Tumoral Brain Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Keywords: tumor
tumoral
non-tumoral
pseudotumoral
3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine
FDOPA
positron emission tomography
PET
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET in our centre between June 2015 and June 2019

Brief summary: Background: 3,4-dihydroxy-6-\[18F\]-fluoro-L-phenylalanine (FDOPA) positron emission tomography (PET) can identify well low and high grade brain tumors. However, increased FDOPA uptake has been reported in non-tumoral brain lesions. The aim was to analyse FDOPA-PET in patients with non-tumoral brain lesions and to compare them with patients with (low and high grade) brain tumors.

Methods: retrospective analyse. Patients consecutively recruited with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET at Nimes university Hospital between June 2015 and June 2019. FDOPA-PET parameters (maximum and mean lesion standardized uptake values \[SUV\] and ratios comparing lesion with different background uptake SUV) and thresholds were analysed in search for those offering optimal discrimination between non-tumoral and tumoral lesions.


Eligibility criteria: Inclusion Criteria:

* presence of defined tumor (histology was required) or non-tumor (diagnosed by histological or other analyses) diagnosis,
* clinical and MRI follow-up of \>24 months,
* FDOPA-PET scan \<2 months before surgery or stereotactic biopsy (when performed)

Primary outcomes:
measure: FDOPA-TEP
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
References:
citation: Renard D, Collombier L, Laurent-Chabalier S, Mura T, Le Floch A, Fertit HE, Thouvenot E, Guillamo JS. 18F-FDOPA-PET in pseudotumoral brain lesions. J Neurol. 2021 Apr;268(4):1266-1275. doi: 10.1007/s00415-020-10269-9. Epub 2020 Oct 21.
Clinical trial NCT05499884: Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis
Official title: Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Keywords: deep pelvic endometriosis
rectal shaving segmental digestive resection
endovaginal ultrasound
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The protocol of this study consists in the inclusion of patients with endometriosic rectal involvement with a scheduled intervention. An endovaginal ultrasound will be performed in the operating room by the radiology team to confirm the operative indication of rectal shaving then in a second step a second ultrasound in the operating room will confirm the complete excision of the lesion or the case will allow to perform a more complete gesture (discoid or segmental resection) if the shaving is not sufficient with ultrasound and / or macroscopically


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Deep pelvic endometriosis with symptomatic rectal involvement
* With surgical indication of rectal shaving validated in "RCP" or during the pre-operative consultation by the surgeon

Exclusion Criteria:

* History of inflammatory digestive pathology

Primary outcomes:
measure: Questioning the choice of surgical technique (performing a more complete procedure, such as discoid or segmental resection, immediately or after shaving)
timeFrame: during the procedure/surgery
Secondary outcomes:
measure: anatomo-pathological analysis of the operating piece.
timeFrame: during the procedure/surgery
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Chrystele RUBOD, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02335684: Effects of Increased CF-LVAD Pump Speed During Sustained Submaximal Exercise
Official title: Improving Functional Capacity in Heart Failure Patients Supported With Continuous-flow Left Ventricular Assist Devices. -Effects of Increased Pump Speed During Sustained Submaximal Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart-assist devices
exercise capacity
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
First posted: 2015-01-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD).

The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD patients can be increased when pump speed is increased soon after the onset of exercise.

Detailed description: To test the hypothesis described above the investigators will study submaximal exercise tests below anaerobic threshold in patients supported with CF-LVADs.Each patient will perform two tests- one with baseline CF-LVAD pump speed and the other with incrementally increased pump speed.

Eligibility criteria: Inclusion Criteria:

* Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent.

Exclusion Criteria:

* Unstable patients, CF-LVAD implantation less than three months ago.

Primary outcomes:
measure: Exercise time
timeFrame: Exercise time will be estimated only on the day of the study. No follow-up.
Secondary outcomes:
measure: Perceived exertion
timeFrame: Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.
Other outcomes:
measure: Heart rate
timeFrame: Heart rate will be measures during exercise.
measure: Anaerobic threshold
timeFrame: Anaerobic threshold is measured during exercise on the study day.
Locations:
city: Copenhagen Oe
country: Denmark
facility: University Hospital of Copenhagen; Rigshospitalet.
Study officials:
affiliation: Rigshospitalet, Denmark
name: Finn Gustafsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03405584: High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment
Official title: Efficacy of High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment：a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.


Eligibility criteria: Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection

Exclusion Criteria:

* Less than 18 years old
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy.
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Hong Lu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387984: YKL-40 and Complications in Type 2 Diabetes
Official title: Association Study of the Plasma Concentration of YKL-40 and Vascular Complications in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Diabetic complications
YKL-40
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2011-07-06
Enrollment: 473
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The type 2 diabetic patient who receives follow-up at NTUH diabetics caring network

Brief summary: In this study, the investigators plan to establish the relationship between plasma concentration of YKL-40 with various vascular complications in the patients of type 2 diabetes.

Detailed description: It is well recognized now that diabetes mellitus is a systemic vasculopathy and causes various micro- and macrovascular complications. Vascular damage and endothelium dysfunction in diabetes mellitus involve a chronic inflammatory process via a complicated mechanism.

YKL-40 is a 40 kD lectin molecule. It is secreted by various cells, including macrophages, vascular smooth muscle cells and giant cells, and the level of YKL-40 is found elevated in both acute (eg. infection) and chronic (eg. rheumatoid arthritis, systemic lupus erythematosus or cirrhosis of the liver) inflammatory processes. The plasma concentration of YKL-40 is elevated in the patients of type 2 diabetes mellitus compared with non-diabetic controls, and is associated with insulin resistance, fasting plasma glucose and plasma IL-6 concentrations. Furthermore, the concentration of YKL-40 is elevated and is associated with the severity of albuminuria in the patients of type 1 diabetes.

The objective of this study is to establish the relationship between plasma concentration of YKL-40 with various vascular complications in the patients of type 2 diabetes, and to evaluate its potential as a biomarker for the vascular diabetic complications in patients with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Clear consciousness
* type 2 diabetic patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Douliu City, Yunlin County
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Chih-Hung Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06766084: Is Total Arterial Revascularization Superior to Multiarterial Grafting in Coronary Artery Bypass Grafting
Official title: Is Total Arterial Revascularization Superior to Multiarterial Grafting in Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CABG
Revascularization
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 7878
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing isolated CABG at Carmel medical center, Beilinson medical center and Soroka medical center at Israel

Brief summary: Retrospective study of adult patients with multivessel disease undergoing isolated coronary artery bypass grafting (CABG) in three centers between January 1st, 2009, and December 31st, 2023. Patients were grouped according to the revascularization strategy (total arterial revascularization vs. multiarterial grafting). Primary outcome was a composite of major adverse cardiac and cerebrovascular events (MACCE).


Eligibility criteria: Inclusion Criteria:

* isolated CABG

Exclusion Criteria:

* single vessel CABG
* CABG with utilization of only one arterial graft

Primary outcomes:
measure: MACCE
timeFrame: through study completion, a median of 101 months
Secondary outcomes:
measure: Mortality
timeFrame: through study completion, a median of 101 months
measure: MI
timeFrame: through study completion, a median of 101 months
measure: CVA
timeFrame: through study completion, a median of 101 months
measure: repeat revascularization
timeFrame: through study completion, a median of 101 months
Other outcomes:
Locations:
Study officials:
References: