louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05666206: Efficacy of Fibrin Sealant in Hypospadias Surgery
Official title: Efficacy of Fibrin Sealant in Hypospadias Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypospadias
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2022-12-27
Enrollment: 200
Sex: MALE
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate if application of a fibrin sealant over the urethroplasty suture line for waterproofing instead of a dartos vascularized pedicled flap to reduce complications and improve the outcome in hypospadias repair.

Detailed description: Many procedures have been tried for the sake of proper management of hypospadias and reducing the complications. Of them, tabularized incised plate (TIP) is one of the most convenient technique, which became the most common procedure for hypospadias repair (Elsayem et al., 2022).

Although many surgical modifications and techniques have been prescribed to minimize post-operative complications and improve outcomes, a high percentage of complications still occurs. Urethrocutaneous fistulae are the most common post-operative complication (10%-40%) after hypospadias surgery; other complications being skin flap related complications such as flap necrosis, suture line breakdown, ascent of the testis and penile torsion (Shenoy et al.,2021).

In this thesis a secondary preputial dartos flap will be performed in all cases and we will evaluate the value of usage of fibrin glue on the 1ry suture line .

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria All treatment naïve children with hypospadias.

Exclusion Criteria:

* Adult hypospadias.
* Recurrent cases.
* Prio pelvic trauma or radiation.

Primary outcomes:
measure: Success of surgery
timeFrame: 3 months
Secondary outcomes:
measure: complications of hypospadias surgery
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology department - AlAzhar university
Study officials:
References:
Clinical trial NCT01865006: Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture
Official title: Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Phoniatric Evaluation of Total Thyroidectomy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent to total thyroidectomy.

Brief summary: The purpose of this study is to compare effect of sutureless thyroidectomy with vessel closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric evaluation.


Eligibility criteria: Exclusion Criteria:

* Pre-operative voice problems
* Pre-operative vocal cord paralysis
* Singers and teachers
* Pre-operative known advanced stage malignity
* Previously operated for thyroid diseases.

Primary outcomes:
measure: Voice quality change in relation with operative technique
timeFrame: Postoperative 1st week and 2nd month
Secondary outcomes:
measure: Voice quality change in relation with histopathology.
timeFrame: 1st week and 2nd month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty Department of General Surgery
Study officials:
References:
citation: Uludag SS, Teksoz S, Arikan AE, Tarhan O, Yener HM, Ozcan M, Liddy W, Randolph GW. Effect of energy-based devices on voice quality after total thyroidectomy. Eur Arch Otorhinolaryngol. 2017 May;274(5):2295-2302. doi: 10.1007/s00405-016-4444-0. Epub 2017 Feb 25.
Clinical trial NCT00945399: Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
Official title: Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Knee Chondral
Osteochondral Defect
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial, sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several secondary objectives were determined. The microfracture procedure will be conducted in one operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two operative steps:

1. Arthroscopy to collect cartilage;
2. Implantation following arthrotomy about 6 weeks following arthroscopy.

Both groups will follow the same rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* isolated femoral osteochondral lesion
* aged 18 to 45
* grade 3 or 4 lesion (ICRS) sized 2,5 to 7,5cm2
* lesion depth under 10mm
* IKDC score below 55
* no prior surgical treatment

Exclusion Criteria:

* pregnancy or breastfeeding
* allergy
* arthrosis
* varus or valgus angle greater than 6°
* kissing lesion
* affection of the patella
* excessive laxity
* meniscal pathology history
* severe chronic disease
* BMI \> 30
* HIV, Hepatitis B, C, HTLV, Syphilis

Primary outcomes:
measure: Clinical evaluation scoring system: IKDC
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Gent University Hospital, Dept of Orthopaedic Surgery
Study officials:
References:
Clinical trial NCT04170699: Effects of PECS 1 Block on Venous Cancer Port Catheter
Official title: Effects of Ultrasound Guided Pectoral Blok Type 1 on Subcutaneous Port Catheter Replacement : A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter; Pain (Indwelling Catheter)
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a two-arm parallel assignment. One group will receive PECS 1 block and the other will receive infiltrative anesthesia.
Primary purpose: TREATMENT

Brief summary: In this study our aim is to investigate the effects of ultrasound (USG) guided pectoral block (PECS) type 1 in the administration of an implanted port-a-cath .

Detailed description: Cancer is one of the most important reasons of mortality in the world. There are a lot of different types of treatments for cancer and so far chemotherapy is the most common one. However, chemotherapy damages the peripheral veins, so implanted subcutaneous port-a-caths are used as an alternative. Traditionally this implantation is adminstered with infiltrative anesthesia. Recently, USG is used in anesthesia practice world wide. Blanco R et all (1) defined PECS 1 block as an alternative to paravertebral block. PECS 1 block aims to anesthetize the medial and lateral pectoral nerves. In this study our aim is to investigate the effects of USG guided PECS 1 block in the administiration of an implanted port-a-cath .

Eligibility criteria: Inclusion Criteria:

* Ages between 18- 75
* ASA (American Society of Anesthesiologists) Score I-IV
* Undergoing elective port-a-cath replacemnet

Exclusion Criteria:

* Patients with neurological deficits
* Patients who have major vascular damage at the same side
* Mentally retarded patients
* Patients with alcohol or drug addiction
* Patients who are allergic to local anesthetics
* Pregnancy
* Paitents with coagulopathy
* Patients with skin infection at the side of the procedure
* Patients with pneumothorax at the side of the procedure
* Patient with a pacemaker

Primary outcomes:
measure: Perioperative and postoperative analgesic needs of patients
timeFrame: Change in Visual analog Scale (VAS) scores ( between 1 and 10, a higher score represents greater pain intensity. ) at the 1st, 3rd, 6th, 12th and 24th hours after the procedure.
Secondary outcomes:
measure: Hemodynamic parameters at the perioperative and postoperative period
timeFrame: 1st, 3rd, 6th,12th and 24th hours after the procedure.
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University
Study officials:
affiliation: Bulent Ecevit University
name: OZCAN PISKIN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01068899: Energy Expenditure
Official title: Energy Expenditure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: healthy adults
healthy children
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2010-02-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women and children who do not have any respiratory or pulmonary disorders

Brief summary: The purpose of this study is to standardize methods in measuring a person's energy expenditure. These methods may be used in a larger study in the future.


Eligibility criteria: Inclusion Criteria:

* adults must be 18 years of age or older
* children must be between 6 and 88 pounds

Exclusion Criteria:

* pulmonary or respiratory disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Aline Andres, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05769699: Serum Biomarkers in Parkinson's Disease at Different Stages
Official title: Serum Biomarkers in Parkinson's Disease at Different Stages
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: * Determine clinical characteristics of parkinsonian patients in various stages of disease;
* Measure peripheral neurodegeneration, synaptic, and inflammation biomarkers in a population of parkinsonian patients at various stages of disease.
* Measure vesicular neurodegeneration, synaptic and inflammation biomarkers


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with idiopathic PD according to Movement Disorders Society (MDS) criteria;
* Age: 18-80 years;
* Signature of informed consent to participate in this study

Exclusion criteria.

* Women pregnant
* Inflammatory or autoimmune diseases

Primary outcomes:
measure: Determine clinical characteristics of parkinsonian patients in various stages of disease
timeFrame: 3 years
measure: Determine clinical characteristics of parkinsonian patients in various stages of disease
timeFrame: 3 years
measure: Determine biooogical characteristics of parkinsonian patients in various stages of disease
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Flavia Torlizzi
Study officials:
References:
Clinical trial NCT05066399: Fetal Cardiac Magnetic Resonance in Detection of CHD
Official title: Fetal Cardiac Magnetic Resonance Imaging Using DUS Gating on 3T: Preliminary Experiences in Detection of CHD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Fetal Cardiac Disorder
Heart Defect, Congenital
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic (Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Germany), Prof. Dr. med. Annegret Geipel

Brief summary: The aim of this clinical prospective study is to investigate the value of fetal cardiac magnetic resonance imaging using a new Doppler ultrasound based gating method for the detection of congenital heart desease.


Eligibility criteria: Inclusion Criteria:

* fetuses in third trimenon
* congenital heart defect suspected by obstetric ultrasound

Exclusion Criteria:

* pregnant women with contraindication for native MRI

Primary outcomes:
measure: The number of heart defect characteristics detectable by DUS gated Cine MRI imaging
timeFrame: Up to 3 months after birth, cardiac MRI findings will be compared against fetal ultrasound gainst fetal ultrasounand against findings after birth (reference standard).
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
state: NRW
Study officials:
References:
Clinical trial NCT01642199: Lay Health Coaches for Weight Loss: Peers Versus Mentors
Official title: A Randomized Trial Testing Lay Health Coaches for Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
weight loss
lay health coach
peer coach
mentor coach
reduced intensity weight loss program
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-07-17
Enrollment: 278
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to determine whether reduced intensity behavioral weight loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than rBWL + Mentor Health Coaches and rBWL alone.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index between 30 and 40
* Age between 40 and 60 years
* English speaking

Exclusion Criteria:

* Are unwilling to communicate regularly with a weight loss coach
* Report not being able to walk 2 blocks (1/4 mile) without stopping
* Are currently participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months
* Are pregnant, lactating, less than 6-months post-partum, or plan to become pregnant during the intervention timeframe
* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines
* Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., relocation, dementia, terminal illness, substance abuse).

Primary outcomes:
measure: Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Direction of social comparison between participants and their Peer or Mentor weight loss coach
timeFrame: 2-weeks, 3-months, 6-months, 9-months, and 12-months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital / Warren Alpert Medical School at Brown University
name: Tricia M Leahey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leahey TM, Huedo-Medina TB, Grenga A, Gay L, Fernandes D, Denmat Z, Doyle C, Areny-Joval R, Wing RR. Patient-provided e-support in reduced intensity obesity treatment: The INSPIRE randomized controlled trial. Health Psychol. 2020 Dec;39(12):1037-1047. doi: 10.1037/hea0000996.
Clinical trial NCT03824899: UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer
Official title: The Application of UGT1A1 Genotype Combined With Pharmacokinetics of SN-38 in the Detection of Irinotecan-based Neoadjuvant Chemoradiotherapy in Patients With Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Locally Advanced Rectal Cancer
Keywords: neoadjuvant chemoradiotherapy
irinotecan
SN-38
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.


Eligibility criteria: Inclusion Criteria:

* pathological confirmed adenocarcinoma
* clinical stage T3-4 and/or N+
* the distance from anal verge less than 12 cm
* without distance metastases
* performance status score: 0\~1
* UGT1A1\*28 6/6 or 6/7
* without previous anti-cancer therapy
* sign the inform consent

Exclusion Criteria:

* pregnancy or breast-feeding women
* serious medical illness
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
* DPD deficiency
* UGT1A1\*28 7/7

Primary outcomes:
measure: the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
timeFrame: During the chemoradiation weekly，assessed up to 5 weeks
measure: pathological response rate
timeFrame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhen Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01275599: Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
Official title: A Phase 1, Open-Label, Single-Sequence Study to Examine the Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Opioid-Related Disorders
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Tibotec BVBA
First posted: 2011-01-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose adjustments are necessary for patients who are concomitantly treated with telaprevir.

Telaprevir, in combination with other antiviral agents, is being investigated for the treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for maintainance therapy in patients with opioid dependence.


Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 18 and 64 years, inclusive. Females must be of non-childbearing potential.
* Receiving once daily buprenorphine/naloxone maintenance therapy at a stable dose not exceeding 24 mg/6 mg, respectively, for at least 2 weeks prior to screening.

Exclusion Criteria:

* Illicit use of drugs such as cocaine, amphetamines and methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, tricyclic antidepressants, methadone or opiates/opioids (apart from buprenorphine).
* Treatment with any investigational drug within the last 30 days, or 5 half-lives, whichever is longer.
* Blood donation of 500 mL or more within the last 56 days.
* Infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).

Primary outcomes:
measure: Blood levels of buprenorphine
timeFrame: Day -4 through Day 38
measure: Blood levels of norbuprenorphine
timeFrame: Day -4 through Day 38
measure: Blood levels of naloxone
timeFrame: Day -1 and Day 7
measure: Blood levels of telaprevir
timeFrame: Day 1 through Day 7
Secondary outcomes:
measure: Safety and tolerability
timeFrame: Day -14 through Day 38
measure: Buprenorphine withdrawal symtoms
timeFrame: Day -2 through Day 38
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Scott McCallister, M.D.
role: STUDY_DIRECTOR
References: