louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04654715: Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment.
Official title: Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectourethral Fistula
Keywords: rectourethral fistula
Gracilis flap
prostate cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients over 18 that have been treated for a localized prostatic cancer and who were affected with a treatment-induced rectourethral fistula

Brief summary: Prostate cancer is the first cancer amongst men with more than 50000 cases per year in France. Surgical, radiation, frost, or ultrasound induced rectourethral fistula is a rare complication (\<1%) of localized prostatic cancer treatment but hard to manage. Different types of treatment exist: conservatory, trans-sphinteric (York-Masson), transanal, perineal, with or without muscle flap interposition. Gracilis flap interposition for rectourethral fistula management is a promising technique but few cases are described and functional results are scarce.

The aim of this study is to present surgical and functional outcomes of rectourethral fistulas surgery with gracilis flap interposition after treatment of localized prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Male over 18 years old
* Treated for a localized prostatic cancer (Prostatectomy, cryotherapy, HIFU, radiotherapy)
* Affected with a treatment induced Rectourethral fistula

Exclusion Criteria:

* Rectourethral fistula caused by other pelvic diseases (gynecological or digestif cancer, inflammatory bowel disease, other urogenital issues)
* Rectourethral fistula treated by cysto-prostatectomy with urinary tract derivation
* Patient under guardianship
* Non comprehension of written or spoken French

Primary outcomes:
measure: Urinary continence
timeFrame: 3 months after surgery
measure: Fecal continence
timeFrame: 3 months after surgery
measure: Lower extremity functional
timeFrame: 3 months after surgery
measure: Surgical scarring
timeFrame: 3 months after surgery
measure: Global satisfaction of the surgery
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
References:
Clinical trial NCT01949415: An Optional Investigation of Biomarkers of Efficacy
Official title: An Optional Investigation of Biomarkers of Efficacy in TH002 Clinical Study Subjects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinoconjunctivitis
Keywords: House Dust Mite
Rhinoconjunctivitis
ToleroMune
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Topstone Research
First posted: 2013-09-24
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of subjects who completed TH002 and have been dosed with either placebo or the 12 nmol dose in the TH002 study.

Brief summary: House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy.

Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002 study participants


Eligibility criteria: Inclusion Criteria:

* Previously randomised into study TH002, completed the study and received either placebo or the 12 nmol dose in TH002.

Exclusion Criteria:

* Subjects who have received allergen or peptide immunotherapy during the last 12 months (other than TM-HDM)

Primary outcomes:
measure: To identify cellular, proteomic or genetic biomarkers of efficacy to ToleroMune House Dust Mite (TM-HDM) treatment in TH002 study participants.
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Topstone Research
state: Ontario
Study officials:
References:
Clinical trial NCT02756715: The Effect of Anesthetics Agents on Vascular Injury and Level of Syndecan-1 During Knee Surgery
Official title: The Effect of Anesthetics Agents on Vascular Injury and Level of Syndecan-1 During Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx of blood flow. syndecan-1 was a marker of glycocalyx.

The purpose of this study is to prove the variation of level of serum syndecan-1 between preoperative and postoperative period.

Detailed description: The patients were allocated randomly to receive propofol or desflurane. Also, a total of 6ml of blood sample was obtained for total 6 times in consecutive order.

1. Preoperation (immediate before anesthesia induction)
2. Immediate before tourniquet off
3. 5 min after tourniquet off
4. PACU
5. postoperative 6 hours
6. postoperative 24 hours

Serum in blood will be obtained and level of serum cytokine will be evaluated by enzyme-linked immunosorbent assay

Eligibility criteria: Inclusion Criteria:

* patients who was planned to undergo knee surgery.

Exclusion Criteria:

* age \< 20 years old
* history of previous cancer
* history of previous peripheral vascular disease
* Emergency surgery

Primary outcomes:
measure: Syndecan-1
timeFrame: Preoperative time, Immediate before tourniquet off,5 min after tourniquet off,PACU, postoperation after 6hours, postoperation after 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Seong-Hyop Kim, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh CS, Choi JM, Park EH, Piao L, Park HJ, Rhee KY, Kim SH. Impact of Anesthetic Agents on Endothelial Glycocalyx Injury during Total Knee Arthroplasty: Desflurane- vs. Propofol-Based Anesthesia-A Prospective Randomized Controlled Trial. Biomed Res Int. 2021 Jan 23;2021:8880267. doi: 10.1155/2021/8880267. eCollection 2021.
Clinical trial NCT02872337: Pre-operative One-on-One Physical Therapy Education Improves Postoperative Function and Patient Satisfaction After Total Joint Arthroplasty
Official title: One-on-One Physical Therapy Education Improves Postoperative Function and Patient Satisfaction After TJA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to evaluate the efficacy of a one-time, preoperative physical therapy protocol on postoperative (1) discharge disposition, (2) pain, function and stiffness and (3) patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Subjects will be required to meet the following inclusion criteria in order to participate:

  * Unilateral Primary Knee OA or Hip OA
  * Patients at least 18 years old up to 85.
  * Undergoing surgery with one of the following study surgeons
  * Able to independently ambulate ≥ half a block with or without assistive device
  * Able to independently perform non-reciprocal stairs with or without assistive device/rails
  * Patients that plan to D/C home post TKA / THA
  * Patients that speak English only.

Exclusion Criteria:

* Rheumatoid arthritis
* Psoriatic arthritis
* Juvenile rheumatoid arthritis
* Knee or Hip revisions
* Patients under 18 years of age
* Patients unwilling or unable to complete PRO instrument or study questionnaires at the specified study time points pre-operatively or post-operatively
* Bilateral TKA and THA
* Uni-condylar knee arthroplasty or Hip resurfacing
* Patellar reconstruction
* Patient on disability, workman's compensation
* Patients unwilling to participate in PEdPTWP and/or Patient education class and booklet.
* Patients that plan to D/C to rehabilitation center post TKA and THA
* Patients that do not speak English
* Patients that do not have access to computer

Primary outcomes:
measure: Number of In-patient Physical Therapy visits required to meet hospital discharge criteria PT
timeFrame: Through Study Completion, an average of 3 days
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: This standard patient reported outcome was filled out preoperatively or at six weeks postoperatively
measure: Patient Satisfaction Scores
timeFrame: from two weeks prior to surgery until 6 weeks after surgery
measure: Time to meet Physical Therapy discharge criteria
timeFrame: Time from Surgery to meeting PT discharge criteria, an average of 3 days
measure: Hospital Length of Stay
timeFrame: Time from Surgery until Hospital Discharge, an average of 2-3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00519337: Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation
Official title: The Impact of Ascorbic Acid Therapy on Inflammatory Mediators in Cardiothoracic Surgery Patients: The Atrial Fibrillation Suppression Trial IV (AFIST IV) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Inflammation
Keywords: Atrial Fibrillation
cardiac surgery
ascorbic acid
vitamin-c
inflammation
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: The Gustavus and Louise Pfeiffer Research Foundation
First posted: 2007-08-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce inflammation following heart surgery.

Detailed description: Atrial Fibrillation is a significant cause of morbidity following cardiothoracic surgery. Despite prophylactic therapy with beta-blockers and amiodarone, post-operative atrial fibrillation occurs in approximately 22% of patients. We believe that by reducing the inflammation that is caused during CTS, we can see further improvements without any negative effects on hemodynamics. Ascorbic acid, a free radical scavenger has been found to lower inflammation mediators but never in a CTS population. This study will help determine the affect of ascorbic acid on the inflammation associated with CTS.

Eligibility criteria: Inclusion Criteria:

* Cardiothoracic surgery

Exclusion Criteria:

* Pregnancy
* Prior hypersensitivity to ascorbic acid
* Renal Calculi

Primary outcomes:
measure: In CTS patients receiving standard of care therapy,evaluate the effect of ascorbic acid therapy on c-reactive protein (CRP) concentration on post-CTS day 3 and the total post-CTS systemic exposure to CRP over 4 days.
timeFrame: 4 Postoperative Days
Secondary outcomes:
measure: Evaluate the effect of high intensity versus low intensity statin therapy on blood concentrations of fibrinogen, and White blood cell count on post-CTS days 3 and the total post-CTS systemic exposure to these biomarkers over 4 days.
timeFrame: 4 Postoperative Days
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hosptial
state: Connecticut
Study officials:
affiliation: Hartford Hospital, University of Connecticut
name: C. Michael White, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01330537: Exploring the Visual Sensitivity for Topological Properties in Newborn Infants
Official title: Exploring the Visual Sensitivity for Topological Properties in Newborn Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Sensitivity in Newborns
Keywords: perceptual development
topological perception theory
familiarization/novelty preference method
Discriminate a disk and a ring (topologically different),
Discriminate a disk and a triangle (geometrically different)
Detect a change in the number of holes
Detect the size of the hole
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: full-term and healthy newborns

Brief summary: The topological perception theory proposed a precise description for how one organizes the visual world that eliminates the vagueness of subjective phenomenology. In addition, the topological theory challenges the dominant computational view on the part-to-whole hierarchy of visual information processing. Lines of evidence from adult psychophysics, brain imaging data, and even honeybee's behavior have supported the notion that the global topological properties are the very primitives of visual representation. However, the question of how the sensitivity to topological properties originates during development has not been explored much. In a previous study, the investigators found that 2- to 6 month old infants could reliably discriminate stimuli based on topological differences, but failed to do so based on geometric differences. Using familiarization/novelty preference procedure, the present study intends to explore the visual sensitivity for topological properties in newborn infants. Experiment 1 focuses on whether neonates can discriminate a disk (no hole) and a ring (with a hole) that are topologically different, and/or a disk (no hole) and a triangle (no hole) that are geometrically different. Experiment 2 focuses on whether neonates can detect a change in the number of holes and/or the size of the hole. If newborn infants are only sensitive to topological properties and not to geometric properties, this will be a strong proof for the claim that topological property is the very "primitive" visual representation at empirical as well as theoretical level.


Eligibility criteria: Inclusion Criteria:

* full-term and healthy newborns

Exclusion Criteria:

* Eye illnesses or other physical problems

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: Graduate Institute of Neural and Cognitive Sciences, China Medical University, Taiwan
name: Sarina Hui-Lin Chien, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Bai-Horng Su, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01707615: Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use
Official title: Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atherosclerosis of Arteries of the Extremities, Unspecified
Keywords: proanthocyanidin,atherosclerosis, carotid plaque
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2012-10-16
Enrollment: 287
Sex: ALL
Minimum age (years): 43
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use

Detailed description: Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been investigated in clinical use.

Eligibility criteria: Inclusion Criteria:

* (1) carotid ultrasound examination: presence of carotid plaque or abnormal CIMT of between 0.9 and 1.2mm; (2) lipid profile: LDL≦3.12mmol/L, TC≦5.2mmol/L; (3) no lipid-lowering treatment within the past 6 months.

Exclusion Criteria:

* severe cardiomyopathy, acute coronary syndrome, hepatic dysfunction, end-stage renal failure (serum creatinine ≥117mmol/L), prior carotid endarterectomy, and/or patients who did not agree to participate in the present study.

Primary outcomes:
measure: Carotid B-Mode Ultrasound
timeFrame: Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.
Secondary outcomes:
measure: clinical vascular events
timeFrame: after 24 months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Jie Qiu, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02344615: Nerve Stimulator Versus Ultrasound-guided Infraclavicular Block
Official title: A Randomized Comparison of Nerve Stimulator and Ultrasound-guided Infraclavicular Block for Upper Extremity Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: nerve stimulator
ultrasound
Lead sponsor: Cheju Halla General Hospital
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided infraclavicular block for upper extremity surgery.

Detailed description: Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many advantages such as improved success rate, faster onset time, fewer needle passes, shorter performance time, and reduced procedural pain and vascular puncture. However, there is no information about postoperative analgesia.

Therefore, the investigators tested whether ultrasound-guided peripheral nerve block enhanced the postoperative analgesia for upper extremity surgery compared with nerve stimulator (NS) guidance.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical class I - III patients scheduled to undergo upper extremity surgery

Exclusion Criteria:

* coagulopathy, severe pulmonary disease, neuropathy, contralateral diaphragmatic paresis, allergy to study medications

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: at 24h after surgery
Secondary outcomes:
measure: block performance time
timeFrame: at 30 min after block placement
measure: number of needle redirections
timeFrame: at 30 min after block placement
measure: patient discomfort
timeFrame: at 30 min after block placement
measure: paresthesia
timeFrame: at 30 min after block placement
measure: onset time
timeFrame: until 30min after completion of local anesthetic
measure: motor block of hand
timeFrame: at 24h after surgery
measure: postoperative dysesthesia
timeFrame: at 24h after surgery
measure: supplemental analgesia
timeFrame: at 24h after surgery
measure: Pain score
timeFrame: at 24h after surgery
measure: Patient satisfaction
timeFrame: at 24h after surgery
Other outcomes:
Locations:
city: Jeju
country: Korea, Republic of
facility: Cheju Halla General Hopsital
state: Jeju self-governing province
Study officials:
affiliation: Dept. of anesthesia and pain medicine, Cheju Halla General Hospital
name: Chunwoo Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
citation: Koscielniak-Nielsen ZJ. Ultrasound-guided peripheral nerve blocks: what are the benefits? Acta Anaesthesiol Scand. 2008 Jul;52(6):727-37. doi: 10.1111/j.1399-6576.2008.01666.x. Epub 2008 May 12.
Clinical trial NCT00004415: Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Quadriplegia
Keywords: environmental/toxic disorders
neurologic and psychiatric disorders
rare disease
spinal cord injury
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone.

II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.

Detailed description: PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall.

If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Ventilator dependent quadriplegics who are not candidates for phrenic nerve pacing alone

Must have bilateral partial or unilateral phrenic nerve function

Must have been on ventilator support for at least 6 months and unweanable

--Patient Characteristics--

Cardiovascular: No active cardiovascular disease

Pulmonary: No active lung disease

Other: No active brain disease Stable condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University
name: Anthony F. DiMarco
role: STUDY_CHAIR
References: