louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02390388: Pudendal Block Versus Caudal Block for Hypospadias
Official title: A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pudendal block
Hypospadias
caudal block
child
analgesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Ayse Cigdem Tutuncu
name: Senol Emre
name: Fatis Altindas
name: Kaya, Guner, M.D.
First posted: 2015-03-17
Enrollment: 80
Sex: MALE
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: The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.

Detailed description: In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* aged 1 to 10 years scheduled undergoing hypospadias surgery

Exclusion Criteria:

* history of allergic reactions to local anesthetics
* rash or infection at the injection site
* anatomical abnormality
* bleeding diatheses, coagulopathy, liver diseases

Primary outcomes:
measure: postoperative pain intensity measure
timeFrame: 24 hours
Secondary outcomes:
measure: time to to first use of analgesic
timeFrame: 24 hours
measure: parental satisfaction
timeFrame: 24 hours
measure: the incidence of side effects
timeFrame: 24 hours
measure: intraoperative analgesic requirement
timeFrame: intraoperative
measure: postoperative total analgesic requirements
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: Guner Kaya, Prof.
role: STUDY_DIRECTOR
References:
citation: Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52.
citation: Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
Clinical trial NCT01138488: A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
Collaborators: name: HNEC TEST
First posted: 2010-06-07
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index for children: 15.0-20.0 kg/m\^2 (both inclusive), for adolescents: 18.0-28.0 kg/m\^2 (both inclusive) and for adults maximum 30.0 kg/m\^2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month, or more than 500 mL within 3 months prior to screening
* Not able or willing to refrain from smoking during the inpatient period
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods

Primary outcomes:
measure: Area under the serum insulin degludec concentration-time curve
timeFrame: from 0 to infinity after single-dose
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: from 0 to 12 hours after single-dose
Secondary outcomes:
measure: Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed
timeFrame: from 0 to 57 hours after single-dose
measure: Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed
timeFrame: from 0 to 12 hours after single-dose
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Biester T, Danne T, Blasig S, Remus K, Aschemeier B, Kordonouri O, Bardtrum L, Haahr H. Pharmacokinetic and prandial pharmacodynamic properties of insulin degludec/insulin aspart in children, adolescents, and adults with type 1 diabetes. Pediatr Diabetes. 2016 Dec;17(8):642-649. doi: 10.1111/pedi.12358. Epub 2016 Jan 18.
Clinical trial NCT06759688: Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot
Official title: Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbohydrate Ingestion
Keywords: Diabetic foot wound infections,
Diabetic foot ulcer,
low carbohydrate dietary approaches.
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients complained of diabetic foot infections graded 0 to 4 with absent signs of ischemia.

Brief summary: A low-carbohydrate diet, when combined with standard wound care and diabetes management, appears to accelerate the healing of infected diabetic foot, improve blood glucose control, reduce systemic inflammation and promoting overall patient recovery. This approach could be considered a beneficial adjunct therapy in the treatment of diabetic foot infections.

Detailed description: The research was a case control study. It conducted prospectively from January 2019 to December 2023 in the surgery department of Aswan university hospital. It involving patients with diabetic foot infections. The patients were divided into two groups of patients. The first group committed to not eating carbohydrates in food. The second group ate their daily routine and did not adhere to the carbohydrate's restriction. The diabetic food infection classified from mild, moderate and sever, as per the Infectious Diseases Society of America (IDSA) Infection Severity Classification.

Eligibility criteria: Inclusion Criteria:

Patients complained of diabetic foot infections graded 0 to 4 with absent signs of ischemia.

Exclusion Criteria:

Patients with foot gangrene grade 5 The presence of foot ischemia Those who refused to participate

Primary outcomes:
measure: Change in the wound size and healing
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References:
Clinical trial NCT01848288: Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems
Official title: Intra-Operative Metrics and Clinical Outcomes After Cataract Surgery With the CENTURION® Vision System and the INFINITI® Vision System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Phacoemulsification
Cumulative Dissipated Energy (CDE)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 112
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics after phacoemulsification with the CENTURION® vision system configuration compared with the INFINITI® vision system configuration.


Eligibility criteria: Inclusion Criteria:

* Eligible to undergo cataract extraction via phacoemulsification with primary ACRYSOF Intraocular Lens (IOL) implantation;
* Free of severe disease(s)/condition(s) listed in the "Warnings" and "Precautions" section of implanted ACRYSOF IOL;
* Willing to undergo second eye surgery within 14 days of first eye surgery;
* Willing and able to understand/sign a written Informed Consent Document;
* Willing and able to return for scheduled follow-up examinations;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Planned multiple procedures at the time of surgery or during the course of the study (eg, LASIK, LRI, etc.);
* Previous intraocular or corneal surgery of any kind;
* Poorly dilating pupil;
* Severe retinal disorders (eg, macular degeneration, proliferative diabetic retinopathy);
* Corneal disease (eg, herpes simplex, herpes zoster, etc) or retinal detachment;
* Severe conditions that per Investigator's clinical judgment would increase the operative risk or confound the result of this investigation;
* Female patients who are pregnant, lactating, or planning to be pregnant during the course of the study;
* Currently participating in another drug or device clinical trial, or participated in another drug or device clinical trial within 30 days of enrollment into this trial;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Cumulative Dissipated Energy
timeFrame: Day 0 (operative day), each eye
measure: Aspiration (ASP) Fluid Used
timeFrame: Day 0 (operative day), each eye
Secondary outcomes:
measure: Aspiration Time
timeFrame: Day 0 (operative day), each eye
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Erin Hayes, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01083888: ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
Official title: ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia
Hemodialysis
Renal Impairment
Keywords: FG-4592
ASP1517
Safety and tolerability
Plasma concentration
Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.


Eligibility criteria: Inclusion Criteria:

* Chronic renal failure patients receiving hemodialysis thrice weekly
* Body weight: \>=40.0 and \<80.0 kg
* Mean hemoglobin level \>=10.0 and =\<12.0 g/dL

Exclusion Criteria:

* Patients with severe inflammation or infection
* Patients who have a medical history of gastrointestinal surgery or enterectomy
* Patients who have uncontrolled hypertension
* Patients whose AST, ALT, total bilirubin, GGT exceed the ULN or those who have a medical history of serious liver diseases
* Patients who have a medical history of severe cardiac or cerebrovascular diseases
* Patients who have received blood transfusion or who have had a surgery (except surgery for a shunt) within 4 weeks
* Patients with a medical history of serious drug allergies
* Patients who may be pregnant or lactating, or who refuse to use required birth control during the study period

Primary outcomes:
measure: ASP1517 concentrations in plasma
timeFrame: For 96 hours after dosing
Secondary outcomes:
measure: ASP1517 concentrations in dialysate
timeFrame: For 6 hours after dosing
measure: Plasma EPO level
timeFrame: Pre dosing and for 24 hours after dosing
measure: Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests
timeFrame: For 96 hours after dosing
Other outcomes:
Locations:
city: Chubu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00812188: Treatment Study Comparing Medium or High Dose Uva-1 Treatment 3x/Week Versus Fluocinonide 0.05% Cream in the Treatment of Morphea.
Official title: A Prospective, Open Label Trial of High Dose UVA-1, 3x/Week or Medium Dose UVA-1, 3x/Week vs. Fluocinonide 0.05% Cream Treatment of Morphea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symmetric Limited Morphea
Keywords: Morphea
Plaque morphea
Localized Scleroderma
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18 years of age or older.
* Symmetric limited morphea.

Exclusion Criteria:

* Known sensitivity to fluocinonide 0.05% cream.
* Clinical evidence of superinfected skin.
* Immunocompromised state (including previously documented HIV).
* Generalized Scleroderma.
* Previous history of skin cancer.
* Non-English speaking subjects.

Primary outcomes:
measure: Efficacy of UVA-1 treatment vs. topical steroid.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas - Department of Dermatology Clinical Trials
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Heidi Jacobe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00524888: Suturing vs Biological Adhesive in Simple Lacerations of Hand
Official title: Suturing Vs Adhesion for Hand Lacerations in the ER A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lacerations
Keywords: Hand
Laceration
bioadhesive
ER
Hand laceration distal to the volar wrist crease
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-09-05
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the difference in clinical outcome between lacerations in the hand treated by sutures versus treated by tissue adhesive.


Eligibility criteria: Inclusion Criteria:

* Any age
* Hand laceration distal to the volar wrist crease.

Exclusion Criteria:

* Fracture , tendon, artery involvement, more than 8 hours from laceration to trx,
* Immunosuppression
* Anticoagulation therapy
* Diabetes
* Unable to achieve homeostasis in more than 15 minutes
* Unwilling to participate in the study
* Unable to participate in the follow up or bite of any kind.

Primary outcomes:
measure: Wound appearance
timeFrame: 3 Months
Secondary outcomes:
measure: pain of treatment and time length of treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Michael Icekson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04636788: Circulating Extracellular Exosomal Small RNA as Potential Biomarker for Human Pancreatic Cancer
Official title: Diagnostic and Prognostic Values of EUS-FNA Specimens and Circulating Exosomal Small RNA in Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Adenocarcinoma
Keywords: exosome
snoRNA
endoscopic ultrasound
liquid biopsy
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is for the verification of biomarkers for pancreatic cancer treatment using small RNA liquid biopsy, combined with EUS-FNA tissues.

Detailed description: CA19-9 is the FDA approved biomarker for the diagnosis of pancreatic cancer. However, the specificity of CA19-9 to differentiate between pancreatic cancer, cholangiocarcinoma, or other pancreatic lesions is not satisfying enough.

Tumor cells secret abundant exosomes in the early stage. Circulating tumor cells are detected mainly in the advanced stage. Meanwhile, the role of non-coding RNA draws more and more attention in tumor area. Exosomes protect inside RNA from plasma RNase. Compared with long RNA, small RNA, including miRNA, snoRNA, tRNA, piRNA could exist more stably.

By means of next-generation sequencing, we look forward to finding new exosomal small RNA biomarkers.

Eligibility criteria: Inclusion Criteria:

* age \>18
* pancreatic cancer patients
* pancreatic lesions other than PAAD
* chronic pancreatitis
* cholangiocarcinoma

Exclusion Criteria:

* diagnosed with other pathological types of cancer
* treated with chemo/radio/surgery previously

Primary outcomes:
measure: senstivity
timeFrame: up to 8 weeks
measure: specificity
timeFrame: up to 8 weeks
Secondary outcomes:
measure: survival time
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, HUST
state: Hubei
Study officials:
References:
Clinical trial NCT00699088: A Clinical Investigation of the Balance® Microplasty™ Hip System
Official title: A Prospective, Non-controlled, Clinical Investigation of the Balance® Microplasty™ Hip System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Rheumatoid Arthritis
Avascular Necrosis
Keywords: Total Hip Arthroplasty
Total Hip Replacement
Minimally Invasive
Microplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 70
Sex: ALL
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 requiring relief from painful or disabling joint disease

Brief summary: The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.


Eligibility criteria: Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis.
* Correction of functional deformity.
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
* Revision of previously failed femoral head resurfacing component

Exclusion Criteria:

Absolute contraindications include:

* infection,
* sepsis,
* osteomyelitis.

Relative contraindications include:

* uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* osteoporosis,
* metabolic disorders which may impair bone formation,
* osteomalacia,
* distant foci of infections which may spread to the implant site,
* rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* vascular insufficiency, muscular atrophy, or neuromuscular disease.

Primary outcomes:
measure: Harris Hip Score
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of revisions and removals
timeFrame: 5 Years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Pittsburgh
country: United States
facility: Allegheny Health- Orthopedic Division
state: Pennsylvania
city: Fredericksburg
country: United States
facility: Orthopedic Specialty Clinic
state: Virginia
city: Monroe
country: United States
facility: Orthopaedic & Sports Medicine Clinic of Monroe
state: Wisconsin
Study officials:
affiliation: Director, Clinical Research, Biomet Orthopedics, LLC
name: Russell Schenck, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01700088: The Effect of Nasal Cannulae During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy
Official title: The Effect of Nasal Cannulae During the First 2 Hours Postoperative in Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Post Pulmonary Resection
Keywords: hypoxemia
Post Pulmonary Resection
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing lung resection surgery.

Brief summary: At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via face mask in patient having lung resection surgery. After then if the patient is fine, we'll replace the face mask with nasal cannular untie the next morning. We hypothesized that oxygen mask can be replace by nasal cannular without any hypoxia.


Eligibility criteria: Inclusion Criteria:

* age \>/= 18 years old
* Patient undergoing lobectomy or pneumonectomy or wedge resection
* ASA 1-3
* Preoperative oxygen saturation \< 95 %

Exclusion Criteria:

* Cannot communication

Primary outcomes:
measure: Oxygen saturation
timeFrame: 30 minutes
Secondary outcomes:
measure: Incidence of hypoxemia
timeFrame: 3 days postoperative
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References: