louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01158365: Dermacyd in Odor Reducing.
Official title: Single Center, Open, Cross-over, Phase III Study for Comparative Evaluation of Safety Use and Efficacy in the Odor Reduce and Vaginal Moisturize Increase for Intimates Use Products Dermacyd Femina Delicata, Dermacyd Femina Breeze, Dermacyd Teen Sweet Flower, Dermacyd Teen Fresh Mix and Dermacyd Femina Comparing to the Control Product Glycerine Vegetal Soap Granado Traditional.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-07-08
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary Objective:

- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional

Secondary Objective:

- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.


Eligibility criteria: Inclusion criteria:

* Perfect mucosa in the product analysis region
* Volunteers with active sexual life: normal Papanicolau test performed less than one year is mandatory
* Bacterioscopy describing the vaginal flora
* Negative Trichomonas vaginalis test
* Negative Whiff test
* Willingness in using preservative in the sexual intercourse during the study period
* Use the same category cosmetics products
* 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:

* Use of antiinflammatory / immunosuppression / antihistaminic drugs
* Atopic or allergy history to cosmetic products
* Active cutaneous disease (local and/or disseminated) in the evaluated area
* Disease which can cause immunosuppression, such as diabetes, HIV, etc.
* Endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs
* Intense solar exposure (to get a tan) during the 15 days before the evaluation
* Gynecologic treatment until four weeks before the evaluation
* Any vaginal infection detected during the inclusion
* Other conditions considered by the investigator as reasonable for exclude the patient in the study.

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

Primary outcomes:
measure: Reduction of genital odor and increase hydration in genital mucosa
timeFrame: From the treatment start to the end of the study (day 67)
Secondary outcomes:
measure: Evaluation of the integrity of the mucosa
timeFrame: From the treatment start to the end of the study (day 67)
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT07022665: Influence of Hospital Volume on Mortality and Short-term Postoperative Outcomes in Uncomplex General Surgery in Switzerland
Official title: Influence of Hospital Volume on Mortality and Short-term Postoperative Outcomes in Uncomplex General Surgery in Switzerland: A Retrospective National Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystolithiasis
Cholecystitis
Inguinal Hernia
Femoral Hernia
Umbilical Hernia
Appendicitis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 399701
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with with appendicectomy for appendicitis, cholecystectomy for cholecystolithiasis and/or cholecystitis , umbilical hernia repair, or inguinal and/or femoral hernia repair operated in Switzerland between 2013 and 2022.

Brief summary: The effect of centralisation measures on the operative outcomes after any type of surgery in Switzerland has not been highlighted yet. This study aims to investigate the influence of the annual case-specific hospital volume on uncomplex general surgery. The four operations investigated are appendectomy, cholecystectomy, umbilical hernia repair, and inguinal/femoral hernia repair.


Eligibility criteria: Inclusion Criteria:

* All patients with appendicectomy for appendicitis, cholecystectomy for cholecystolithiasis and/or cholecystitis , umbilical hernia repair, or inguinal and/or femoral hernia repair

Exclusion Criteria:

* incomplete case documentation
* age under 20 years
* other hospitals than general or surgical hospitals
* no index operation

Primary outcomes:
measure: Mortality
timeFrame: Periprocedural
Secondary outcomes:
measure: Reoperation
timeFrame: Periprocedural
measure: Length of hospital stay
timeFrame: Periprocedural
measure: Sociodemographic trends
timeFrame: 2013 - 2022
Other outcomes:
Locations:
city: St.Gallen
country: Switzerland
facility: HOCH Health Ostschweiz, Kantonsspital St.Gallen
Study officials:
References:
Clinical trial NCT06354465: Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews
Official title: Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Use Disorder
Criminal Justice
Treatment Adherence and Compliance
Keywords: addiction
criminal justice
Medications for opioid use disorder
Lead sponsor: Lifespan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-04-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Incarcerated individuals include participants in the RIDOC MOUD program.

Organizational stakeholders inlcude clinicians, Wardens, leadership and/or other staff involved in the MOUD program.

Brief summary: This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders.


Eligibility criteria: Incarcerated individuals, inclusion criteria:

* English speaking
* Over the age of 18
* Diagnosed with opioid use disorder

Incarcerated individuals, Exclusion Criteria:

- Diagnosed with "Severe, Persistent, Mental Illness (SPMI)" Rationale for Exclusion: These individuals suffer from severe mental health disease and therefore warrant greater protection, have greater risk for coercion, and offer insights to severe co-diagnosis treatment that, while important, remain outside the scope of general MAT implementation.

Organizational Stakeholders, Inclusion Criteria:

- Employed or contracted by Rhode Island Department of Corrections (for organizational staff interviews) and involved with the Medication for Addiction Treatment (MAT) program

Organizational Stakeholders, Exclusion Criteria:

- If not permitted by their organizational union to participate

Primary outcomes:
measure: Qualitative Transcripts
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cranston
country: United States
facility: Rhode Island Department of Corrections
state: Rhode Island
Study officials:
affiliation: Lifespan
name: Justin Berk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01561365: Applicability of the Ottawa Ankle Rules
Official title: Applicability of the Ottawa Ankle Rules to Exclude Fractures of the Ankle and Midfoot - Comparison to Orthopedic Residents Routine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fracture
Ankle Sprain
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 92
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this prospective study was to compare outcomes in patients handled by emergency physician according to OAR versus by an orthopedic resident.

92 consecutive patients with ankle injuries attending our emergency department were divided in two groups. The study group comprised 32 patients who arrived during the morning shift and were examined by an emergency physician according to OAR. Patients discharged without an x-ray were followed in the clinic or by telephone communication. The control group constituted 60 patients who were examined during the evening and night shifts by orthopedic residents unaware of this study.

Detailed description: Objective. Ankle and midfoot injuries are common orthopedic complaints, both in general medicine and orthopedic practice. The percentage of fractures among these injuries is small, however many will undergo x-ray. Ottawa ankle rules (OAR) are clinical guidelines for determining whether to use radiography in such cases. The aim of this prospective study was to compare outcomes in patients handled by emergency physician according to OAR versus by an orthopedic resident. Also, we validated the applicability of OAR in an emergency department in our country.

Methods. 92 consecutive patients with ankle injuries attending our emergency department were divided in two groups. The study group comprised 32 patients who arrived during the morning shift and were examined by an emergency physician according to OAR. Patients discharged without an x-ray were followed in the clinic or by telephone communication. The control group constituted 60 patients who were examined during the evening and night shifts by orthopedic residents unaware of this study.

Eligibility criteria: Inclusion Criteria:

* ankle trauma

Exclusion Criteria:

* unwilling to participate

Primary outcomes:
measure: Amount of patients sent to xrays
timeFrame: 2 hours
Secondary outcomes:
measure: missed fractures
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Leonid Kandel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00269165: Adjuvant Radiation in Aortic Valvuloplasty - ARAVA
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Aortic Valve Stenosis
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2005-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effect of external beam radiation therapy in the prevention of restenosis following successful balloon aortic valvuloplasty in severe, symptomatic aortic stenosis.


Eligibility criteria: Inclusion Criteria:

* Severe Aortic Stenosis
* NYHA Class 2-4 CHF Symptoms
* Age \> 75
* EuroSCORE \> 7
* Prohibitively High Risk for Aortic Valve Replacement Surgery as Designated by a Cardiac Surgeon

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02597465: A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
Official title: A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 in Subjects With Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Advanced Biliary Tract Cancer
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open label study to determine the efficacy and safety of SPARC1507

Detailed description: Subjects with advanced Biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.

Eligibility criteria: Inclusion Criteria:

* Evidence of advanced/metastatic biliary tract cancer
* Male or female ≥ 18 years old
* Participants must have measurable disease according to RECIST
* ECOG performance status ≤ 1

Exclusion Criteria:

* Known hypersensitivity to trial treatments, or their excipients
* Prior history of treatment with any taxane therapy
* Cardiovascular disorders as per Investigator's discretion
* The subject has received radiation therapy

Primary outcomes:
measure: Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1
timeFrame: 3 years and 6 months
Secondary outcomes:
measure: Overall survival in subjects treated with SPARC1507 versus Investigators choice
timeFrame: 3 years and 6 months
measure: Overall response rate in subjects treated with PICN versus Investigators choice
timeFrame: 3 years and 6 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 years and 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: SPARC study site
state: Colorado
Study officials:
References:
Clinical trial NCT00802165: Effect of Electroacupuncture on Pain Threshold
Official title: Effect of Electroacupuncture on Pain Threshold
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pain
Keywords: Asymptomatic normals
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate whether or not electroacupuncture can have an effect on the pain threshold of the subject, as compared to sham treatment.

Detailed description: This study is utilized to evaluate the what effectiveness electroacupuncture has on pain threshold as compared to sham. The outcome measurement utilized will be a digital algometer. The electroacupuncture treatment will consist of a total of four electroacupuncture treatments stimulating acupuncture points LI4 and LI11, and will be given on the same upper extremity tested by the algometer. The algometer measurements will occur alone on the first week, prior to the treatments on the second and third week, and the final reading alone on the fourth week.

Eligibility criteria: Inclusion Criteria:

* Normal healthy subjects

Exclusion Criteria:

* Hypertension
* Heart Disease
* Pregnancy
* No spinal manipulation or other treatment or medication that could effect pain threshold

Primary outcomes:
measure: Digital Algometer
timeFrame: Four Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT04496765: Early-onset Rectal Cancer
Official title: Patients With Early-Onset Rectal Cancer Aged 40 Year or Less Have Similar Oncologic Outcomes to Older Patients Despite Presenting in More Advanced Stage; A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 244
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of either gender aged 40 years or less who presented with rectal cancer of any stage

Brief summary: The present study aimed to review the characteristics and outcome of early-onset rectal cancer in a subset of Egyptian patients aged 40 years or less. Since the previous studies assessed this point of research in CRC overall, the investigators opted to focus upon rectal cancer alone since it may represent a separate category, distinct from colon cancer, in this age group with regards to presentation, tumor behavior, and outcome.


Eligibility criteria: Inclusion Criteria:

* Patients of either gender aged 40 years or less who presented with rectal cancer of any stage were included to the study

Exclusion Criteria:

* patients with colon cancer or other gastrointestinal cancer and patients who were lost to follow-up.

Primary outcomes:
measure: Local recurrence
timeFrame: 36 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile
role: STUDY_CHAIR
References:
Clinical trial NCT04889365: COVID-19 Antigen Rapid Test Kit
Official title: The Use of SG Diagnostics COVID-19 Antigen Rapid Test Kit for Self-testing as a Method for Reduction SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV2 Infection
Keywords: SARS-CoV-2
COVID-19
symptoms
test
Lead sponsor: Polish Society of Disaster Medicine
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers with or without COVID-19 symptoms

Brief summary: The SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19.


Eligibility criteria: Inclusion Criteria:

* Adult (aged ≥ 18 years) volunteers

Exclusion Criteria:

* Children (aged \< 18years)

Primary outcomes:
measure: Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
timeFrame: within 1 day
measure: Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
timeFrame: within 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Medical Academy
Study officials:
References:
Clinical trial NCT00825565: Study of Alwextin® Cream in Treating Epidermolysis Bullosa
Official title: Open-label, Pilot Study to Investigate the Safety and Tolerability of Alwextin 3.0% Cream in the Treatment of Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epidermolysis Bullosa
Keywords: Epidermolysis bullosa
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2009-01-21
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how safe and effective allantoin 3% cream (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically to the entire body once daily.

Detailed description: Potential subjects came to the for a screening visit. Eligible subjects had baseline assessments performed and were provided study medication, allantoin 3% cream. Subjects were instructed to apply the study medication to the entire body once daily and to keep daily record of study medication use. Subjects returned every 4 weeks for a total of 12 weeks for repeat assessments.

Eligibility criteria: Inclusion Criteria:

* history of epidermolysis bullosa

Exclusion Criteria:

* use of any skin product containing allantoin for 30 days prior to enrollment

Primary outcomes:
measure: Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage
timeFrame: baseline and then every 4 weeks for a total of 12 weeks
measure: Target Wound Size Reduction or Closure
timeFrame: baseline and then every 4 weeks for a total of 12 weeks
measure: Physician Global Assessment of Severity (PGAS)
timeFrame: baseline and then every 4 weeks for a total of 12 weeks
measure: Physician Assessment of Individual Signs
timeFrame: baseline and at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert and Ann Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy S Paller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00553865: Clinical Trial to Evaluate the Efficacy and the Safety of Antihypertensive Tablets
Official title: A 8-Week, Randomized, Double-blind, Parallel Designed, Phase II Multi-center Clinical Trial to Evaluate the Antihypertensive Efficacy and the Safety of OJP-2028 Tablets in Patients With the Uncomplicated Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine the optimal dosage of the clinical trial which is evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.

Detailed description: Evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.

Eligibility criteria: Inclusion Criteria:

1. Adult men and women (Age 18-75 years)
2. Uncomplicated essential hypertension: Clinic sitting SiDBP between 90 and 109 mmHg after 2 week placebo run-in period

Exclusion Criteria:

1. Secondary hypertension
2. History and/or signs of cardiovascular complications (eg; myocardial infarction, unstable angina)
3. Pregnancy or lactation
4. Contraindications to the antihypertensive drugs to be used during the treatment period

Primary outcomes:
measure: Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.
timeFrame: 8 weeks
Secondary outcomes:
measure: Average SiSBP Differences of each group by comparison with the baseline.
timeFrame: 8 weeks
measure: Responder rate of each group by comparison with the baseline.
timeFrame: 8 weeks
measure: Average SiDBP and SiSBP Differences of each group by comparison with the baseline.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: CHEOL HO KIM
role: PRINCIPAL_INVESTIGATOR
References: