louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06103903: Measure of Acceptance of chRonic Visible sKin conditionS
Official title: Acceptance Des Maladies Chroniques Dermatologiques Visibles : Constitution d'échelles Pour le Patient et Son Cluster Familial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acceptance of Visible Chronic Dermatological Disease
Disease Acceptance
Psychological Well-Being
Social Segregation
Keywords: Chronic dermatological disease
Psychology
Sociology
Disease Acceptance
Vitiligo
port wine stain
hyperpigmentation
alopecia areata
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: INSERM UMR 1246 SPHERE
First posted: 2023-10-27
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with visible chronic dermatological diseases and their family circle

Brief summary: The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).

Detailed description: The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).

The investigator will screen the patients and give them a link to complete the questionnaire (according to the age), that includes a pre-scale of acceptation of 50-55 items.

Eligibility criteria: Inclusion Criteria:

1. Targeted pathologies:

   * Flat angioma
   * Primary hypopigmentation and early vitiligo
   * Primary hyperpigmentation
   * Refractory alopecia areata or congenital alopecia
2. Persons concerned:

   * Children (≥ 6 years old) suffering from one of the aforementioned pathologies
   * Adults suffering from one of the above-mentioned pathologies
   * Parents of children suffering from one of the aforementioned pathologies
   * Parents of young adult patients if they live under the same roof
3. Oral agreement for each person (major/minor) and, where applicable, one of the holders of parental authority (minor)

Exclusion Criteria:

1. Secondary "marks" (post-inflammatory, post-medication, post-traumatic, etc.)
2. Major psychiatric disorders

Primary outcomes:
measure: Questionnaire analysis
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital TOURS
Study officials:
affiliation: University Hospital of TOURS
name: Annabel MARUANI, MD-PhD
role: STUDY_DIRECTOR
affiliation: INSERM UMR 1246 SPHERE
name: Jean-Benoit HARDOUIN, MD-PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00538603: Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)
Official title: Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epithelial Ovarian Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-national, randomized, phase III, GCIG Intergroup study comparing pegylated liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in patients with epithelial ovarian cancer in late relapse. (CALYPSO)


Eligibility criteria: Inclusion Criteria:

* Patients with epithelial Ovarian cancer in late relapse

Primary outcomes:
measure: overall survival
timeFrame: overall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Adnan Munkarah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00654303: OLE Study to Evaluate Safety / Efficacy of ZD4522
Official title: ZD4522 Long Term Extension Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolaemia
Keywords: Cholesterol
Hypercholesterolaemia
Statins
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the long term safety of Crestor.


Eligibility criteria: Inclusion Criteria:

* Completion of previous Crestor study as listed in the protocol.

Exclusion Criteria:

* Pregnant or breast feeding women, or not using appropriate contraception.
* Abnormal lab values as listed in the protocol.

Primary outcomes:
measure: Safety, as determined by adverse events, laboratory data, physical examination and ECG.
timeFrame: 12 weekly
Secondary outcomes:
measure: Success in achieving goals for Cholesterol levels
timeFrame: 12 weekly
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Elinor Miller, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03427203: Assessment of New Ostomy Devices in Subjects Having an Ileostomy
Official title: Assessment of New Enhanced Ostomy Devices in Real-life Set-tings in Subjects Having an Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2018-02-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study investigates the performance of three new adhesives with regard to leakage and the skin condition.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4. Must be able to use custom cut product
5. Can use a product with max cut size 45 mm
6. Self-reported problems with leakage (3 x within 14 days)
7. Get a negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation 4.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP264) protocol.
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
6. Have known hypersensitivity towards any of the products used in the investigation

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
city: Vejle
country: Denmark
facility: CCBR Vejle
city: Groningen
country: Netherlands
facility: QPS Netherlands
Study officials:
affiliation: Medical Director
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854503: Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Diabetic Dyslipidemia
Keywords: Statins administration in diabetic dyslipidemia
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes in good glycemic control, treated with metformin alone.
* Untreated dyslipidemia.
* BMI \<30.

Exclusion Criteria:

* History of cancer.
* History of cardiovascular diseases.
* Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.

Primary outcomes:
measure: Glucose tolerance assessed by HbA1c and fasting glucose
timeFrame: 1, 6, 12 months
Secondary outcomes:
measure: insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.
timeFrame: 1, 6, 12 months.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome Tor Vergata
Study officials:
References:
Clinical trial NCT02042703: Imaging Lens Deposits in Exfoliation Syndrome
Official title: Imaging Lens Changes in Exfoliation Syndrome Using Anterior Segment OCT
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Exfoliation Syndrome
Primary Open Angle Glaucoma
Cataracts
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from Glaucoma and Comparehensive clinics at the duke Eye Center.

Brief summary: The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has many ways of showing up in the eye, including the formation of deposits in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance of developing a type of glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the eye without requiring contact with the eye. We will compare lens images of subjects with exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts. This type of imaging could be used in patients with known diagnosis of exfoliation syndrome to track disease progression and see how they respond to possible treatments. We also hope that with this imaging technology we can detect early changes in currently unaffected eyes, which could be useful for predicting which patients may develop the disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of exfoliation syndrome, primary open angle glaucoma (POAG), or cataracts

Exclusion Criteria:

* Unable to provide or sign consent
* Pseudophakia
* Other prior intraocular surgery
* Other eye diseases other than refractive error

Primary outcomes:
measure: Amount of exfoliation deposits on the lens as measured by AS-OCT
timeFrame: 20 min (length of imaging)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT06210503: PENG Block in Comparison With FICB for Hip Reconstruction in Children
Official title: The Comparison of Pericapsular Nerve Block and Fascia Iliaca Compartment Block in Children With Cerebral Palsy or Spina Bifida for Pain Management in Hip Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perioperative Analgesia
Hip Dislocation, Developmental
Keywords: Anesthesia local
nerve block
postoperative pain
hip dislocation
children
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 86
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the hypothesis that performing a Pericapsular nerve group (PENG) block allows for more effective analgesia in the perioperative period during reconstructive surgery on the hip in children with cerebral palsy and spina bifida compared with Fascia illiaca compartment block (FICB).

Detailed description: The main question it aims to answer is: Is the PENG block an effective and safe method of pain relief for hip surgery in children? Participants will be randomized into two equal groups. The group who underwent US - guided PENG block, and the group who underwent US - guided FICB . In both groups we used 0.5% ropivacaine. The same postoperative analgesia regimen was applied by intravenous acetaminophen , oral ibuprofen . In case of ineffectiveness of the prescribed drugs, promedol was used intramuscularly. The postoperative consumption of promedol, time to first rescue analgesia, numerical pain score (NRS) (for children from 7 years old), FLACC score, measurements of A.N.I. monitor MDMS and the side effects will be recorded

Eligibility criteria: Inclusion Criteria:

* reconstructive surgery on the hip joint
* children with cerebral palsy
* children with spina bifida
* age 3 - 18 years.

Exclusion Criteria:

* contraindications to the use of local anesthetics
* contraindications to performing an invasive procedure
* ASA \> 3

Primary outcomes:
measure: Opioids consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Time to rescue analgesia
timeFrame: 24 hours
measure: Pain level
timeFrame: 2, 6, 12, 24 hours after completing the block
measure: Intraoperative level of analgesia
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University
Study officials:
References:
Clinical trial NCT00355303: Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term
Official title: Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Rupture of Membranes at Term
Keywords: Premature rupture of membranes at term
Induction of labour
Misoprostol
PGE2 gel
Immediate induction with PGE2 gel
Immediate induction with Misoprostol
Lead sponsor: Nilratan Sircar Medical College
Sponsor class: OTHER_GOV
First posted: 2006-07-21
Enrollment: 932
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.


Eligibility criteria: Inclusion Criteria:

* Premature rupture of membranes at 37 or more weeks
* Single live fetus in cephalic presentation

Exclusion Criteria:

* Women in labour
* Women with contraindication of induction of labour
* Women with previous caesarean section or uterine surgery

Primary outcomes:
measure: Caesarean Section rate
timeFrame: 48 hours
Secondary outcomes:
measure: Induction delivery time
timeFrame: 48 hours
measure: Neonatal & maternal infectious morbidity
timeFrame: 14 days following date of delivery
Other outcomes:
Locations:
city: Kolkata
country: India
facility: Nilratan Sircar Medical College, 138,AJC Bose Road,
state: West Bengal
Study officials:
affiliation: Nilratan Sircar Medical College , Kolkata, West bengal , India
name: Snehamay Chaudhuri, MBBS,MD.DNB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592903: Somatic Stem Cells in Leiomyomas?
Official title: Identification and Characterization of Putative Leiomyoma Stem Cells.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leiomyomas
Keywords: Uterine fibroids
somatic stem cell
Side Population
Lead sponsor: Igenomix
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 16
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients from 20 years and older undergoing laparoscopic myomectomy for symptomatic uterine fibroids.

Brief summary: The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC) responsible for the formation and growth of leiomyomas using the Side Population method.

Detailed description: The organ of interest in our study is the myometrium, a muscle layer of the uterus located between the perimetry and the endometrium.

The investigators try to identify, locate and characterize the myometrial stem cell population in the uterine fibroids by isolation of "Side Population" by flow cytometry. Once the investigators achieve the purposes to set out, the investigators would try to maintain "in vitro" stem cell population isolated from myometrial fibroids, for further endocrine characterization. Finally, the investigators would try to induce the formation of fibroids in murine models as a first step to demonstrate that the origin of these formations is due to the abnormal proliferation of myometrial adult stem cells. The results of this study will allow the identification of the cell population in the fibroids. The investigators also can being able to compare with the myometrium in order to establish a relationship that helps us to understand more about the pathophysiology of this disease, using these stem cells as targets therapy in the treatment of this myometrium condition.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis for subserosal, intramural and submucosal fibroids.
* Aged between 20 and 40 years
* Signing of informed consent for collection and storage of biological samples.

Exclusion criteria:

* Contraindications for surgery.
* Failure to sign informed consent for collection and storage of biological samples.

Primary outcomes:
measure: Formation and growth of human leiomyomas
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: Igenomix
name: Carlos Simon, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05430503: Long COVID and Post-exertional Pulmonary Diffusion
Official title: Lung Diffusing Capacities for Nitric Oxide and Carbon Monoxide in Long COVID With Dyspnea at Rest and After Mild Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long COVID
Breathlessness
Exercise Intolerance
Alveolar Lung Disease
Pulmonary Gas Exchange
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Caucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction. They were referred to our pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.

Brief summary: Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and carbon monoxide (DLCO) in long COVID may have a clinical impact in relation to exercise intolerance.

Detailed description: Prolonged recovery from acute coronavirus disease 2019 (long COVID) is characterized in about 30% of subjects from breathlessness and fatigue also during daily activities often associated to decreased lung diffusing capacity for carbon monoxide (DLCO) at rest. Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and DLCO in long COVID may have a clinical impact in relation to exercise intolerance. Combined DLNO and DLCO were simultaneously measured at rest and immediately after a short bout of treadmill walking in 32 dyspneic subjects ≥3 months after the COVID-19 acute phase. A group of healthy subjects served as a control group.

Eligibility criteria: Inclusion Criteria:

* History of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.

Exclusion Criteria:

* History of diseases potentially causing dyspnea or affecting pulmonary gas transport, i.e., bronchial asthma, lung bullous disease, chronic obstructive pulmonary disease, pulmonary interstitial fibrosis or vasculitis, hematological diseases, systemic collagen diseases, congestive heart failure, liver or renal diseases, and morbid obesity.

Primary outcomes:
measure: Combined DLNO and DLCO changes after mild exercise
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Ospedale Policlinico San Martino IRCCS - S.S. Fisiopatologia Respiratoria
Study officials:
References: