louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06822920: Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)
Official title: Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Repair of Dura Mater
Lead sponsor: Collagen Matrix
Sponsor class: INDUSTRY
First posted: 2025-02-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subject device is intended for all patient populations. The following population is excluded from the study:-

* Pregnant Women
* Subjects requiring Legally Authorized Representative
* Subjects under 18 years of age

Brief summary: Monitoring the Use of Collagen Dura Membrane in the Post-market phase

Detailed description: A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.

Eligibility criteria: Inclusion Criteria:

* Patients with a dural defect requiring repair with a dural substitute.

Exclusion Criteria:

* There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.

Primary outcomes:
measure: Measurement of the occurrence of adverse event requiring surgical intervention
timeFrame: 6-9 months
Secondary outcomes:
measure: Adverse events i.e., infection, CSF leak and Pseudomeningocele
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical Collagen of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT01998620: Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
Official title: Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Cholestasis
Keywords: Hepatitis B
Cholestasis
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.

Detailed description: evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

Eligibility criteria: Inclusion Criteria:

1. from 18-65 years old
2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)\>6 months, and now HBsAg or HBV DNA(+)
3. with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP\>1.5ULN and GGT\>3ULN or STB\>2ULN

Exclusion Criteria:

1. liver mass, liver carcinoma
2. liver failure
3. non-hepatic diseases caused jaundice
4. obstructive jaundice

Primary outcomes:
measure: levels of serum total bilirubin declined from baseline
timeFrame: 2 weeks
measure: Alkaline Phosphatase
timeFrame: 10 weeks
measure: Gamma-Glutamyl Transpeptidase
timeFrame: 10 weeks
Secondary outcomes:
measure: level of serum direct bilirubin decline from baseline
timeFrame: 2 weeks, 6 weeks, 10 weeks
measure: level of serum bile acids decline from baseline
timeFrame: 2 weeks, 6 weeks, 10 weeks
measure: glutamic pyruvic transaminase
timeFrame: 2 weeks, 6 weeks, 10 weeks
measure: glutamic oxaloacetic transaminase
timeFrame: 2 weeks, 6 weeks, 10 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Public Health Clinical Center Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Public Health Clinical Center Affiliated to Fudan University
name: Liang Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05292820: Sexual Function of Trans Women After Vaginoplasty
Official title: Exploring Sexual Function and Satisfaction of Trans Women After Vaginoplasty: Results of a Multicentric Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender Dysphoria Vaginoplasty Sexuality
Keywords: Genital gender affirming surgery
Gender dysphoria
Transwomen
Vaginoplasty
Sexuality
Satisfaction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transwomen who underwent vaginoplasty or revision in Lyon, Lille, Limoges between January 2007 and December 2019

Brief summary: Genital feminine affirming surgery may be an important step for transgender women. Vaginoplasty consists in the creation of external female genitalia and an operational vaginal cavity, and thus responds to major functional and aesthetic issues.

Different techniques are available: inversion of penile skin flap for creation of the vulva. The vaginal cavity may come from scrotal skin graft, sigmoid segment, small intestine, or peritoneal flap.

Vaginoplasty has a major place in the the transgender woman pathway, but the specific evaluation of long-term sexuality has not been explored so far.

Multicentric (Lyon, FR - Lille, FR - Limoges, FR), prospective, observational study Patients who underwent vaginoplasty or revision vaginoplasty.

Main objective:

To assess sexuality after sex reassignment surgery in transgender women.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Underwent vaginoplasty or revision in Lyon South Hospital, Lille University Hospital, Limoges University Hospital, between January 2007 and December 2019
* Penile inversion vaginoplasty with scrotal skin graft

Exclusion Criteria:

* \< 18 years old
* Vaginoplasty other than scrotal skin graft : intestinal segment or peritoneal flap

Primary outcomes:
measure: evaluation of FSFI : Female Sexual Function Index
timeFrame: At inclusion
measure: evaluation of FGSIS : Female Genital Self Imaging Scale
timeFrame: At inclusion
measure: evaluation of BIS : Body Image Scale
timeFrame: At inclusion
measure: evaluation of Rosenberg Self-esteem scale
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Lyon
country: France
facility: Lyon South Hospital
Study officials:
References:
Clinical trial NCT05366920: Cholecystectomy Blunt Dissection
Official title: Day-care Laparoscopic Cholecystectomy With Diathermy Hook Versus 5mm Suction Irrigation Blunt Dissection: a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Lead sponsor: Imam Mohammad ibn Saud Islamic University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. 5mm suction irrigation blunt dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with 5mm suction irrigation blunt dissection technique a better same day discharge and a shorter operative time can be achieved.

Detailed description: After initiation of general anaesthesia patients are randomized either to conventional(cautery) or 5mm suction irrigation blunt dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* BMI under 35
* normal liver enzymes
* no bile duct dilatation in ultrasound
* cholecystolithiasis

Exclusion Criteria:

* NSAID allergy
* previous upper gi-surgery
* common bile duct stones in preoperative imaging
* history of severe acute pancreatitis

Primary outcomes:
measure: number of days for discharge after surgery
timeFrame: 30 days
measure: operative time
timeFrame: 30 days
measure: intraoperative bleeding amount
timeFrame: 30 days
Secondary outcomes:
measure: type of analgesic and dose
timeFrame: 30 days
measure: number of events of postoperative nausea and vomiting which require anti emetic drug
timeFrame: 30 day
measure: number of days after surgery when readmission is required
timeFrame: 30 days
measure: presence of a morbidity
timeFrame: 30days
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Central fourth Health Cluster
Study officials:
References:
Clinical trial NCT00922220: A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain
Official title: Immediate Effect of Physical Interventions for Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Back Pain
Keywords: low back pain
spinal manipulation
central sensitization
manual therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 94
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 was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).


Eligibility criteria: Inclusion Criteria:

* ages eighteen to sixty
* currently experiencing low back pain OR currently not experiencing low back pain and have not had an episode for the prior six months

Exclusion Criteria:

* non-English speaking
* systemic medical conditions (e.g. diabetes, hypertension)
* current use of psychiatric medication
* pregnancy
* signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change)
* history of surgery to the low back

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Prior to and immediately following assigned intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida Department of Physical Therapy
name: Steven Z George, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. doi: 10.1186/1471-2474-7-68.
citation: Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.
Clinical trial NCT05309720: Dermal Substitution in Pediatric Burns
Official title: Dermal Substitution in Paediatric Burns: A Prospective Case Series
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Burn Scar
Keywords: Burns
Scar quality
Pediatric
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 20
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective case series
Primary purpose: TREATMENT

Brief summary: The standard treatment of deep dermal to full thickness burns is surgical removal of the burn followed by skin transplantation. Dermal substitutes are increasingly used in the treatment of deep burns to replace lost dermis. Preservation of the collagen and elastin in the acellular human dermal substitute Glyaderm provides a more elastic scar. It is unknown what the effect of Glyaderm on scar quality is in a solely paediatric population.

The objective of this case series is to investigate scar maturation and scar quality when applying Glyaderm in deep dermal to full thickness burns in a pediatric population aged ≤15 years old.


Eligibility criteria: Inclusion Criteria:

1. Age ≤15 years old
2. Burn wounds requiring skin grafting
3. Written informed consent provided by

   1. The participant's parent(s)/guardian (\<12 years of age)
   2. The participant's parent(s)/guardian and the participant itself (12-15 years old)

Exclusion Criteria:

1. Burn wound of ≤30 cm2
2. Infected burn wounds: clinical symptoms in combination with positive wound swabs
3. Patients/parents with insufficient knowledge of the Dutch or English language, since they would not be able to complete the POSAS questionnaire.

Primary outcomes:
measure: Scar quality (clinician)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical assessment of the graft take
timeFrame: 5-7 days after STSG application
measure: Wound epithelialization
timeFrame: 5-7 days after STSG application
measure: Wound healing time
timeFrame: determined in the first several days to weeks after STSG application
measure: Donor site healing time
timeFrame: determined in the first several days to weeks after STSG application
measure: Scar surface area
timeFrame: day of surgery (day 0) and 3, 6 and 12 months post-surgery
measure: Scar quality (participant)
timeFrame: 3, 6 and 12 months post-surgery
measure: Occurrence of scar contractures
timeFrame: Up to 12 months post-surgery
measure: Occurrence of scar hypertrophy
timeFrame: Up to 12 months post-surgery
measure: Range of motion of affected joints
timeFrame: 3, 6 and 12 months post-surgery
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Marielle Vehmeijer-Heeman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138020: Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)
Official title: Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Cognitive Symptoms
Keywords: Rehabilitation Outcome
Cognitive treatment
TBI
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-06-07
Enrollment: 77
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of a structured rehabilitation program on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

Detailed description: The most common impairments following blast-induced traumatic brain injury (bTBI) are cognitive deficits in the domain of executive functioning, learning and memory, and functional and psychosocial disabilities that are closely related to these cognitive deficits. There are no treatment protocols available to address the multiple cognitive impairments in bTBI, but cognitive rehabilitation has proven efficacious in the treatment of non-blast TBI. The cognitive training modules the investigators plan to evaluate have improved organization and memory function in patients with non-blast TBI, but it is unknown whether their efficacy exceeds that of programs that focus only on education and support. This study is a between group comparison of a cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function, and an active control group receiving educational intervention geared at personal management of TBI-related symptoms.

Eligibility criteria: Inclusion Criteria:

* Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) active-duty personnel or Veterans exposed to blast
* Meets criteria for mild TBI
* loss of consciousness (LOC) of 30 min or less
* Age: 21- 50

Exclusion Criteria:

* Evidence of penetrating head injury
* History of previous neurological diagnosis
* History of previous psychotic disorder prior to the blast exposure
* Hearing or vision impairment

Primary outcomes:
measure: Cognitive functioning
timeFrame: Ten weeks
Secondary outcomes:
measure: Daily functioning
timeFrame: Ten weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Yelena Bogdanova, PhD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00356720: Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma
Official title: Clinical Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% (Instilled Twice Daily for 2 or 3 Days) Versus Oral Azithromycin in Treatment of Trachoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Trachoma
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2006-07-26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops, in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure at Day 60 in Per Protocol Set), microbiological evaluation was secondary

Detailed description: The aim of the present study was to compare the efficacy of the dosing regimen which was demonstrated in pharmacokinetic studies to be the best candidate for trachoma treatment (T1225 1.5% eye drops BID for 3 days) with a shorter duration of treatment (T1225 1.5% eye drops BID for 2 days) and with a single oral administration of AZM (20 mg/kg) in patients suffering from active trachoma. The study was to be performed in approximately 600 children (aged 1 to 10 years) from Guinea Conakry and Pakistan.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 1-10 years;
* written informed consent by legally acceptable representative;
* TF+ TI0 (trachomatous inflammation - follicular) or TF+TI+ (trachomatous inflammation - follicular and intense) on simplified World Health Organisation (WHO) grading system

Exclusion Criteria:

* Trichiasis or corneal opacity;
* palpebral deformation;
* clinically significant ocular abnormality;
* ocular infection;
* organic amblyopia;
* hypersensitivity to treatments' components;
* immunosuppressive conditions;
* systemic AZM or steroids;
* topical ophthalmic antibiotics within 3 months;
* other systemic antibiotics within 1 month;
* topical (ocular, nasal, bronchial etc.) treatments within 1 week;
* systemic non-steroidal anti-inflammatory drugs on day before Day 0

Primary outcomes:
measure: Cure at end of study, i.e. TF0 grade on simplified WHO trachoma grading system < 5 follicles ≥ 0.5 mm diameter in upper tarsal conjunctiva) in the worse eye
measure: at the end of the study
Secondary outcomes:
measure: Cure at Days 30 and 60,
measure: cure in both eyes,
measure: trachoma grades at each visit;
measure: microbiological cure;
measure: Ocular signs (bulbar conjunctival hyperaemia, discharge; lachrymation;
measure: Global efficacy assessment by investigator.
measure: Tolerance
Other outcomes:
Locations:
Study officials:
affiliation: CHU d'Angers, France
name: Isabelle COCHEREAU, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05906420: Posterior Circulation ASTRAL Prognostic Score
Official title: Pc-ASTRAL Score for the Prediction of 3 Months Functional Outcome in Acute Ischemic Stroke at the Posterior Circulation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke Ischemic
Stroke Acute
Posterior Circulation Brain Infarction
Risk Score
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: University of Lausanne
name: Centre Hospitalier Universitaire Vaudois
First posted: 2023-06-15
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants included in this study are exclusively patients with acute ischemic stroke of the posterior circulation arriving at the hospital within 24h since last proof of good health. These patients must have a modified Rankin Score \<3 prior the event and available data concerning: age, NIHSS, glucose levels at admission, mRS prior to event and 3 months after the event and acute phase imaging characteristics (CT and/or MRI) including large vessel occlusion, leukoaraiosis and ASPECTS score from the acute CT scan.

Brief summary: The goal of this study is to develop a prognostic score for ischemic posterior circulation strokes, based on our previous work on with the ASTRAL scores (Acute STroke Registry and Analysis of Lausanne) on overall stroke prognosis, intracranial occlusion, recanalization and stroke recurrences. The main question it aims to answer is the modified Rankin score in 3 months after the event.

Participants will be patients with acute ischemic stroke of the posterior circulation with mRS priot to event \<3. All the data will be collected retrospectively from patients included in the ASTRAL registry between January 2003 and December 2021. The ASTRAL registry will be used as the derivation cohort of the score. Demographics, acute glucose, NIHSS score and acute imaging of each participant will be used from the derivation cohort in order to create an integer-based prognostic score. After internal validation, we plan to validate the score in external stroke registries to show its validity.


Eligibility criteria: Inclusion Criteria:

* Isolated posterior circulation strokes based on clinical or/and imaging evidence.
* Arriving within 24h at hospital since last proof of good health.

Exclusion Criteria:

* no available data for 3 months modified Rankin Score
* modified Rankin Score≥3 prior the event

Primary outcomes:
measure: 3 months modified Ranking scale
timeFrame: January 2003-December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: First Propedeutic Department of Internal Medicine & Stroke Unit, AHEPA University Hospital, Aristotle University of Thessaloniki
state: Central Macedonia
city: Lausanne
country: Switzerland
facility: Stroke Center, Department of clinical neurosciences, Lausanne University Hospital and University of Lausanne
state: Vaud canton
Study officials:
References: