louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02457728: Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate
Official title: Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: St John of God Hospital, Vienna
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.

Detailed description: During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors).

In addition, closure of peritoneum should be accomplished using this device.

Eligibility criteria: Inclusion Criteria:

* Inguinal hernia,
* femoral hernia

Exclusion Criteria:

* pregnancy,
* not able to understand patient information

Primary outcomes:
measure: Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.
timeFrame: During hospitalization and 6 weeks after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: St John of God Hospital
state: Steiermark
Study officials:
affiliation: St John of God Hospital, Vienna
name: Bernhard DAUSER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06161428: Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
Official title: Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vulva Cancer
Sentinel Lymph Node
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-12-07
Enrollment: 100
Sex: FEMALE
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 primary or recurrent vulva cancer

Brief summary: The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with vulva cancer tumour size \>4 cm, multifocal tumors and local recurrences.


Eligibility criteria: Inclusion Criteria:

* Patients with vulva cancer, tumor \> 4 cm, multifocal tumor, or local recurrences in vulva

Exclusion Criteria:

* Previous external irradiation of the vulva or groins
* Former sentinel node or inguinal lymphadenectomy in the relevant groin
* Known allergy to ICG or iodine
* Patient is in active treatment for other cancer and/or disseminated disease

Primary outcomes:
measure: Sensitivity
timeFrame: Three years
Secondary outcomes:
measure: Negative predictive value
timeFrame: Three years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
Study officials:
References:
Clinical trial NCT04249128: Nourishing Hair, Skin & Nails Supplement Study (Derm Aid)
Official title: The Derm Aid Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hair Loss
Skin Laxity
Cosmetic Acne
Nails; Soft
Skin Aging
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Noho Health
First posted: 2020-01-30
Enrollment: 75
Sex: ALL
Minimum age (years): 26
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized into one of eight arms. The arms include four combinations of dietary supplements for skin, hair \& nail health (Keratin, collagen peptides, pro-berry powder, vegan Keratin, and Astaxanthin). Each supplement formation is included in two arms - one arm is paid, the other arm is free.
Primary purpose: PREVENTION

Brief summary: A 90 day eight arm virtual interventional study looking at the impact of various supplement formulations for improves in hair, skin \& nail health via self report, and dermatology assessment via remote dermatologist assessment.

Detailed description: This study is being run entirely on the ProofPilot clinical trial platform. Participants enroll online, submit selfies, and are shipped dietary various dietary supplements containing a one or more of Keratin, Astaxanthin, Collagen Peptides and Pro-berry powder in vegan and non-vegan formats. All participants will receive active ingredients but in various fomulations.

Half the participants will receive the formations for free. The other half will pay a discounted amount for the supplements.

Eligibility criteria: Inclusion Criteria:

* Continental US
* ability and willingness to take selfies

Exclusion Criteria:

* skin diease
* use of retinoids
* known allergies
* significant facial hair
* medically relevant skin disease

Primary outcomes:
measure: Changes in Self-Report Skin, Hair & Nail Health and Satisfaction
timeFrame: Baseline, 30 Day, 60 Day and 90Day
measure: Blinded Dermatology Assessment of Facial Skin health
timeFrame: Baseline 45 day and 90 day
measure: Participant Acceptability
timeFrame: weekly
measure: Paid versus unpaid particpatnt adherence
timeFrame: 30 and 90 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot Online App (https://p.proofpilot.com)
state: New York
Study officials:
References:
Clinical trial NCT04264728: Adult-onset Generalized Morphea
Official title: Adult-onset Generalized Morphea : A Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Generalized Morphea
Keywords: Morphea
Generalized Morphea
Localized Scleroderma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with generalized morphea as defined by criteria established by Laxer and Zulian (4 or more morpheaform plaques larger than 3 centimeters that show tendency to confluence and involve at least 2 different anatomic sites)

Brief summary: This study aimed to describe the demographical and clinical characteristics of a retrospective cohort of adult-onset GM and to investigate whether these findings differ between patients with an isomorphic and a symmetric pattern of lesion distribution.


Eligibility criteria: Inclusion Criteria:

* Age of onset ≥ 18 years
* Patients with generalized morphea as defined by criteria established by Laxer and Zulian (4 or more morpheaform plaques larger than 3 centimeters that show tendency to confluence and involve at least 2 different anatomic sites)
* Availability of good-quality clinical photographs
* Patient who, after being informed, has not expressed his or her opposition to the re-use of his or her data for the purposes of this research

Exclusion Criteria:

* Patients with linear morphea who met criteria for generalized morphea
* Patient's opposition to participate

Primary outcomes:
measure: Retrospective study of generalized morphea in adult patients consulted in dermatology departments
timeFrame: Files analyzed retrospectily from January 1st, 2019 to September 30, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de dermatologie - Hôpital Civil de Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Cédric LENORMAND, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01463228: A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of FDC Tablets of Canagliflozin and Metformin IR (2x150 mg/1000 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR (2x1000 mg) Tablets in Healthy Fed Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Bioequivalence
Canagliflozin (JNJ-28431754)
Metformin IR
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-11-01
Enrollment: 83
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

Detailed description: This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as a fixed dose combination (FDC) tablet (ie, canagliflozin and metformin IR in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Eligibility criteria: Inclusion Criteria:

- Body mass index (BMI) between 18.5 and 30 kg/m² inclusive and a body weight of not less than 50 kg

Exclusion Criteria:

- History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator

Primary outcomes:
measure: Canagliflozin plasma concentrations
timeFrame: Up to 72 hours
measure: Metformin plasma concentrations
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Adverse events
timeFrame: Up to approxmately 23 days
measure: Clinical Laboratory Tests
timeFrame: Up to approximately 23 days
measure: Vital Signs
timeFrame: Up to approximately 23 days
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC L.LC. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT03070028: Minimally Invasive Treatment Methods for Pilonidal Disease
Official title: Randomized Prospective Comparison of Crystallized Phenol and Platelet Rich Plasma Applications in Treatment of Pilonidal Sinus Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 200
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: Patients with pilonidal sinus disease will be randomised to two groups (crystallised phenol and platelet rich plasma). Sinus healing time, patient satisfaction, complications and recurrence rates will be compared.

Detailed description: Patients with pilonidal sinus disease will be treated by either crystallised phenol or platelet rich plasma application. Treatment results, healing time, postprocedural complications, patient satisfaction and recurrences will be compared.

Eligibility criteria: Inclusion Criteria:

* Having pilonidal sinus disease
* accepting to be involved in the study

Exclusion Criteria:

* below the age of 18
* having connective tissue disorders
* diabetes mellitus
* severe anemia

Primary outcomes:
measure: healing time
timeFrame: first 1 year of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Uşak University
Study officials:
affiliation: Uşak University Medical School
name: Barış Sevinç, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sevinc B, Damburaci N, Karahan O. Comparison of Curettage Plus Platelet-Rich Plasma Gel and Curettage Plus Phenol Application in Treatment of Pilonidal Sinus Disease: A Randomized Trial. Dis Colon Rectum. 2022 May 1;65(5):735-741. doi: 10.1097/DCR.0000000000002082.
Clinical trial NCT01014728: Intraoperative Bleeding During Endoscopic Sinus Surgery
Official title: Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-11-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the blood loss during sinus surgery looking at two different types of anesthesia: either intravenous anesthesia with propofol or inhalational anesthesia with sevoflurane.


Eligibility criteria: Inclusion Criteria:

* male or female patients who are 18 years of age or older,
* ASA grade 1 (normal otherwise healthy patient),
* ASA grade 2 (patient with mild systemic disease),
* patients who have chronic sinusitis with or without nasal polyps.

Exclusion Criteria:

* pregnancy,
* abnormal coagulation panel
* preoperative use of NSAIDS or ASA medications within 7 days,
* end-stage renal disease,
* allergy to any of the used medications,
* maximal body mass index over 35

Primary outcomes:
measure: Estimated Blood Loss
timeFrame: from the start of surgery to the end of surgery, up to 6 hours
Secondary outcomes:
measure: Anesthesiologist Numeric Rating Scale (ANRS)
timeFrame: at the end of surgery (up to 6 hours)
measure: Surgeon's Numeric Rating Scale (SNRS)
timeFrame: at the end of surgery (up to 6 hours)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert M Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06720428: Acupoint Therapy Device for Dry Eye
Official title: Development of a Prototype of Acupoint Therapy Device for Dry Eye and Preliminary Verification of Its Clinical Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Acupuncture treatment
Dry Eye Acupoint Therapeutic Instrument
Safety
Validity
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To built a dry eye acupoint therapeutic instrument by stimulating acupoints with low impulse current .And the safety of the dry eye acupoint treatment device will be tested and the initial validation will be verified.


Eligibility criteria: Inclusion Criteria:

1. Patients who meet the diagnostic criteria for dry eye: The diagnostic and classification criteria refer to the Consensus of Chinese dry eye Experts: Definition and Classification (2020);
2. this study included patients with dry eyes can be treated as usual or are using artificial tears, also can be never accepted artificial tears treatment;
3. this research project, informed consent and signed informed consent form, participants are willing to accept treatment.

Those who met the above criteria could be included in the study.

Exclusion Criteria:

1. Patients with other eye diseases, acute inflammation or allergy of the eye or skin around the eye: such as blepharitis, lacrimal duct obstruction, congenital absence or dysplasia of lacrimal gland, anterior ganglia inflammation, such as trachoma, chemical burn and other corneal and conjunctival lesions, extensive scar of the eyelid conjunctival, long-term use of anti-glaucoma eye drops for glaucoma;
2. Those who have undergone external or internal eye surgery in the past 6 months；
3. Patients who have undergone tear punctum embolization or submandibular gland transplantation;
4. Wearing contact lenses within the past 3 months； （5）History of ocular trauma; （6）Active fundus lesions in the past 3 months； （7）People who are allergic to artificial tears; （8）Suffering from diseases that affect tear secretion, such as facial paralysis, diabetes, and hyperthyroidism;

(9)Patients with serious life-threatening primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases, as well as mental illness; (10)Attending other clinical trials.

Primary outcomes:
measure: Schirmer's test (SLT)
timeFrame: baseline and 8 weeks post-treatment
measure: Tear film breakup time (TBUT)
timeFrame: baseline and 8 weeks post-treatment
measure: Ocular Surface Disease Index, OSDI
timeFrame: baseline and 8 weeks post-treatment
measure: Corneal fluorescein staining (CFS)
timeFrame: baseline and 8 weeks post-treatment
Secondary outcomes:
measure: MGD
timeFrame: baseline and 8 weeks post-treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01660828: Exercise Test and Cardiac Injury
Official title: The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Exercise induced (high sensitive) troponin release
Ischemia reperfusion injury
Remote ischemic preconditioning
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 20
Sex: ALL
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: Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin levels. The underlying mechanism is not yet elucidated, but could be explained by changes due to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion injury. If the mechanism underlying the troponin release during exercise is similar to that of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding RIPC.


Eligibility criteria: Inclusion Criteria:

* age: 18-45 year
* willing to sign informed consent
* healthy

Exclusion Criteria:

* hypertension (systolic blood pressure \>140 mmHg or diastolic blood pressure \> 90 mmHg)
* any cardiovascular abnormality in past medical history, physical examination or ECG, including QTc interval
* drug abuse
* alcohol abuse (\> 3 units/day)
* smoking during the last 2 years
* BMI \>30 kg/m2
* inability to perform bicycle test
* the presence of an absolute or relative contra-indication for exercise (table 2 in protocol)
* the presence of diabetes (fasting glucose \> 6.9 mmol/L, non-fasting glucose \>11.0 mmol/L; if non-fasting glucose is \> 6.9 mmol/L, blood glucose measurement will be repeated in fasting condition and should then not exceed 6.9 mmol/L)
* total cholesterol in blood 6.6 mmol/L or higher

Primary outcomes:
measure: serum level of high sensitive troponin at several timepoints
timeFrame: timepoints t= baseline, 0, 1, 2, 3,4 and 8 hours after finishing exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Nijmegen Medial Centre
name: G. Rongen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00641628: Nipple Areola Complex Conservation
Official title: Subcutaneous Mastectomy With Conservation of the Nipple Areola Complex: Broadening the Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Nipple sparing mastectomy
NAC conservation
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2008-03-24
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: 96 patients were offered a nipple sparing mastectomy.

Detailed description: 96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.

Eligibility criteria: Inclusion Criteria:

* breast cancer

Exclusion Criteria:

* inflammatory breast cancer
* clinical skin or nipple involvement

Primary outcomes:
measure: tumour recurrence
timeFrame: 07/2003 - 02/2008
measure: % of nipple areola complex conservation
timeFrame: 07/2003 - 02/2008
Secondary outcomes:
measure: cosmetics
measure: patient's satisfaction
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
Study officials:
affiliation: Technical University of Munich
name: Marion Kiechle, MD
role: STUDY_CHAIR
References:
citation: Paepke S, Schmid R, Fleckner S, Paepke D, Niemeyer M, Schmalfeldt B, Jacobs VR, Kiechle M. Subcutaneous mastectomy with conservation of the nipple-areola skin: broadening the indications. Ann Surg. 2009 Aug;250(2):288-92. doi: 10.1097/SLA.0b013e3181b0c7d8.