louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00668486: Dermacyd Delicata Breeze - Photo Evaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Breeze.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Breeze.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Use of drug photosensitizer
* History of sensitivity or irritation for topic products
* Active cutaneous disease which can change the study results
* History or photodermatosis active
* Family or personal antecedent of cutaneous photoinduced neoplasias
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
* Intense solar exposure in the study area
* Use of new drugs or cosmetics during 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: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT01391286: Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
Official title: A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-daily Application of Bimatoprost Solution 0.03% Compared to Vehicle to Treat Chemotherapy-induced Hypotrichosis of the Eyelashes in Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eyelash Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* Have inadequate eyelashes due to chemotherapy treatment
* Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
* Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss

Exclusion Criteria:

* Any disease/infection/abnormality of the eye or area around the eye
* Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
* Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
* Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
* Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
* Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy

Primary outcomes:
measure: Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
timeFrame: Baseline, Month 4
Secondary outcomes:
measure: Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
timeFrame: Baseline, Month 4
measure: Change From Baseline in Eyelash Thickness as Measured by DIA
timeFrame: Baseline, Month 4
measure: Change From Baseline in Eyelash Darkness as Measured by DIA
timeFrame: Baseline, Month 4
Other outcomes:
Locations:
city: Chiba
country: Japan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19.
Clinical trial NCT06934486: Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection
Official title: A Multi-Centre Prospective, Non-Comparative, Open, Post-Marketing Surveillance Study to Obtain Clinical Outcome Data on the Use of Tissue Patch in the Prevention of Air Leaks Following Lung Resection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post-operative Air Leaks
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2025-04-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing lung resection

Brief summary: Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.

Detailed description: Post-market study conducted to assess the continuing effectiveness and safety of TissuePatch SF when used as an adjunct to standard suture/staple closure of clinically significant (Macchiarini Grade ≥1) intra-operative visceral pleural air leaks incurred during lobectomy and segmentectomy (open or minimally invasive), including those performed as video-assisted thoracic surgery (VATS), in adults.

Eligibility criteria: Inclusion Criteria:

1. Is ≥18 and \<80 years of age
2. Undergoing planned (not emergent) video-assisted thoracic surgery pulmonary resection
3. Understands and is willing to comply with all study related procedures
4. Has provided signed informed consent

Exclusion Criteria:

1. Women who are pregnant or lactating or, if of childbearing potential, are unwilling to use birth control for 6-months following surgery
2. Has severe congestive heart failure, pulmonary or renal failure, serious haematological disorder or significant liver disease
3. Has previously undergone a pneumonectomy
4. Has a bronchial fistula
5. Has or is suspected of having an active infection at or near the planned surgical site
6. Has a known allergy or sensitization to TissuePatch SF or its constituent components
7. In the investigator's opinion, has a life expectancy of less than 12 months
8. Has, in the investigator's opinion, any disease or condition, physical or psychological, that could interfere with the evaluation of TissuePatch SF or compliance with study procedures

Intra-Operative Exclusion Criteria:

1. \>3 identified air leaks
2. No air leaks Macchiarini Grade ≥1

Primary outcomes:
measure: Intra-operative air leaks
timeFrame: Prior to the completion of surgery
Secondary outcomes:
measure: Overall device safety
timeFrame: 3-months post surgery
measure: Overall device safety
timeFrame: 6-months post-surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00827086: Influencing Factors in Uveitis
Official title: Evaluation of Influencing Factors in Uveitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Keywords: influencing factors (smoking, nutrition, education)
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 500
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 Uveitis

Brief summary: Environmental factors possibly influencing uveitis are evaluated.

Detailed description: Smoking, nutrition, BMI, education

Eligibility criteria: Inclusion Criteria:

* Patients with Uveitis

Exclusion Criteria:

* Children under 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Ophthalmology at St. Franziskus Hospital
state: Northrhine-Westfalia
Study officials:
affiliation: Department of Ophthalmology at St. Franziskus Hospital
name: Arnd Heiligenhaus, Prof, MD
role: STUDY_CHAIR
affiliation: Department of Ophthalmology at St Franziskus Hospital Muenster
name: Martin Rösel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roesel M, Ruttig A, Schumacher C, Heinz C, Heiligenhaus A. Smoking complicates the course of non-infectious uveitis. Graefes Arch Clin Exp Ophthalmol. 2011 Jun;249(6):903-7. doi: 10.1007/s00417-010-1597-1. Epub 2011 Jan 5.
Clinical trial NCT05599386: Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery
Official title: Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2022-10-31
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: PROBABILITY_SAMPLE
Study population: Public University hospital

Brief summary: The aim of this observational study is to investigate if preoperative quantitative sensory testing, anxiety and depression symptoms, and biological markers are associated with the risk of developing acute and chronic postoperative pain after video-assisted Thoracoscopic surgery (VATS).

Detailed description: This observational study examine acute and chronic postoperative pain in patients undergoing VATS. In the study preoperative biomarkers, quantitative sensory testing and questionnaires are used to create prediction models for acute and chronic postoperative pain. The study will serve as background information on the risk factors and predictive factors as well as an exploration of the impact of surgical stress from VATS on circulation microRNA and inflammatory mediators.

Eligibility criteria: Inclusion Criteria:

* Adults independent of sex with an age of ≥ 18 years
* Patients scheduled for VATS as a part of either examination or radical treatment of lung cancer

Exclusion Criteria:

* Patients who are unable to understand oral and written information.
* Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
* Pregnant and nursing women.
* Patients receiving a planned preoperative epidural blockade during their stay.
* Patients converted to open surgery.

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 48 hours postoperative
measure: Numerical Rating Scale
timeFrame: 365 days postoperative
Secondary outcomes:
measure: Total equipotent opioid dose
timeFrame: Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
measure: Time to first administration of opioid
timeFrame: Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
measure: Mobilisation
timeFrame: 48 hours postoperative
measure: Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish
timeFrame: Measured twice. Once 48 hours after surgery or at non fixed time(on average 4 days and a maximum of 3 months) as well as at 365 days
Other outcomes:
measure: Examination of the level of inflammatory biomarkers (IL-6, IL-8, TNFa, etc.) and circulation microRNA
timeFrame: 48 hours postoperative
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region Of Northern Jutland
Study officials:
affiliation: Aalborg University Hospital
name: Jannie Bisagaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01269086: Family Preventive Visits to Detect Risk Factors in the Family
Official title: Family Preventive Visits to Detect Risk Factors in the Family
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Heath Care
Preventive Medicine
Adolescent Health Services
Family
Family Practice
Keywords: Primary Heath Care
Preventive Medicine
Adolescent Health Services
Spouses
Family
Family Practice
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Fundacion Hispanoamericana de Solidaridad
name: Fundacion MAPFRE
First posted: 2011-01-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine whether a systematic family assessment in adult preventive health visits increases the detection of risk factors in the spouse or adolescent child of the screened person.


Eligibility criteria: Inclusion Criteria:

* Parents of adolescents between 14-17 years.

Exclusion Criteria:

* Living with single parents.
* Does not accept participating in the study.

Primary outcomes:
measure: Composite outcome: Family Risk Factors
timeFrame: 1 month
Secondary outcomes:
measure: Composite outcome: Couple Risk Factors
timeFrame: 1 month
measure: Composite outcome: Adolescent Risk Factors
timeFrame: 1 month
measure: Type of health plan for follow up
timeFrame: 1 month
measure: Diagnostic accuracy of adults to diagnose risk factors in their spouse or adolescent child.
timeFrame: 1 month
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Centro de Salud Familiar San Alberto Hurtado
Study officials:
affiliation: Family Medicine Department, Pontificia Universidad Catolica de Chile
name: Diego Garcia-Huidobro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06842186: A Phase 1 Study of WVE-007 in Adults Living with Overweight or Obesity
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Ascending Doses of WVE-007 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults Living with Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Obesity and Overweight
Lead sponsor: Wave Life Sciences Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of WVE-007 when administered subcutaneously (SC) as single ascending doses in adults who are affected by overweight or obesity.


Eligibility criteria: Inclusion Criteria:

* Male and female participants aged 18 to 60 years
* BMI 28 to 35 kg/m2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records)
* Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments

Exclusion Criteria:

* History or presence of CV disease, including heart failure (New York Heart Association \[NYHA\] Class III or IV), myocardial infarction, angina, or clinically significant abnormal laboratory assessments
* History or presence of thyroid disorders
* Medical history or diagnosis of causes of liver disease
* Use of any siRNA agent in the prior 12 months
* Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study

Primary outcomes:
measure: The proportion of participants with adverse events
timeFrame: Day 1 through end of study
Secondary outcomes:
measure: Maximum concentration of WVE-007 in plasma (Cmax)
timeFrame: Day 1 through 169
measure: Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)
timeFrame: Day 1 through 169
measure: Change over time from baseline levels of serum activin E
timeFrame: Day 1 through 169
Other outcomes:
measure: Percent change of weight (kg) from baseline
timeFrame: Day 1 through 169
measure: Body composition changes as follows: Change in body fat percentage from baseline, percent change of visceral fat (kg) from baseline, and percent change in fat-free mass (kg) from baseline
timeFrame: Day 1 through 169
Locations:
city: Chisinau
country: Moldova, Republic of
facility: ARENSIA Research Clinic
Study officials:
References:
Clinical trial NCT05839886: The Adverse Event of Mitotane Therapy in Patients With Adrenocortical Carcinoma
Official title: The Adverse Event of Mitotane Therapy in Patients With Adrenocortical Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adrenocortical Carcinoma
Keywords: Mitotane
Adverse effect
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with adrenocortical carcinoma treated with mitotane

Brief summary: This work will evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024.

Detailed description: Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex. The annual incidence of ACC is thought to be between 0.5-2.0 cases per million. Adjunctive therapy with mitotane may be offered post- surgically to minimise risk of recurrence.

Aims: Evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024.

Methods: Cortisol, ACTH, Gastrointestinal reactions and CNS Toxicity will be measured. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Patients will be included, within ACC with mitotane. Data will be tested for normality, described as Mean± SD, compared using paired sample t-test with 5% p-value for significance and 95% confidence interval (CI).

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years old and ≤ 75 years Diagnosis of Patients with adrenocortical cancer Gender: males and females Provide written informed consent Satisfactory compliance

Exclusion Criteria:

Patients with renal insufficiency (Cr\>2 times the upper limit of normal). Patients with a history of liver cirrhosis. Patients who are currently using corticosteroids. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF\<50%).

Patients with stroke and acute myocardial infarction in the past 6 months. Patients during pregnancy and lactation

Primary outcomes:
measure: Documentation of adverse effects
timeFrame: from starting mitotane treatment until discontinuation of mitotane (since this is very variable from patient to patient no specific number of days or weeks can be entered (standard therapy would be about 2 years)
Secondary outcomes:
measure: Tumor treatment response
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06508086: Pilonidal Sinus Disease
Official title: LASER ABLATION VERSUS KARYDAKIS TECHNIQUE IN THE TREATMENT OF PILONIDAL SINUS DISEASE: A COMPARATIVE STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pilonidal Sinus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
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 outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure.


Eligibility criteria: Inclusion Criteria:

* All patients with a clinical diagnosis of symptomatic uncomplicated pilonidal sinus, males or females, any age will be included in our study.

Exclusion Criteria:

* Patients with pilonidal abscess and any associated acute condition.
* Patients with hidradenitis suppurativa.
* Refusal.
* Unfit for surgery.
* Recurrence.

Primary outcomes:
measure: recurrence rate in the treatment of pilonidal disease
timeFrame: 6 months after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5.
citation: Doll D, Matevossian E, Wietelmann K, Evers T, Kriner M, Petersen S. Family history of pilonidal sinus predisposes to earlier onset of disease and a 50% long-term recurrence rate. Dis Colon Rectum. 2009 Sep;52(9):1610-5. doi: 10.1007/DCR.0b013e3181a87607.
citation: Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.