louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03030573: Reconstruction of the Bile Duct With the Round Ligament
Official title: Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bile Duct Obstruction, Extrahepatic
Keywords: Bile duct injury
Bile duct defect
Round ligament
Reconstruction
Lead sponsor: Beaujon Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

Detailed description: Classically, the bile duct defect after bile duct injury or resection is achieved by bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term complications including intrahepatic bile ducts infection, specific complications related to the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts. The investigators had recently developed a new surgical technique to reconstruct the veins with the parietal peritoneum with excellent results. Accordingly the investigators decided to develop a new surgical technique in order to reconstruct the bile duct defects with the vascularized round ligament.

Eligibility criteria: Inclusion Criteria:

1. Radiological or operative diagnosis of bile duct Injury or defect
2. Can underwent surgical procedure

Exclusion Criteria:

1) The absence of the round ligament

Primary outcomes:
measure: Safety - absence of any severe complication or mortality related to the new procedure
timeFrame: at 1 year
Secondary outcomes:
measure: Bile buct patency
timeFrame: at 3 year
Other outcomes:
Locations:
city: Clichy
country: France
facility: Departement HPB surgery, Beaujon Hospital
state: Hauts de seine
Study officials:
affiliation: HBP department, Beaujon hospital, Clichy, France
name: Safi Dokmak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03290573: Site Selection of Short Peripheral Venous Catheters
Official title: Site Selection of Peripheral Venous Access Via Short Peripheral Catheters in Adult Patients (SPECIAL Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Peripheral Venous Catheter
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 1517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous catheters for even small increments of time would further reduce the number of insertions, staff workloads, and costs. In this study, the investigators investigated whether short peripheral venous catheter site of insertion influence the dwell time.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Expected duration of infusion therapy by short peripheral intravenous catheters \>7 days
* Give written informed consent

Exclusion Criteria:

* The peripheral venous catheter was inserted in emergency room or in emergency circumstances
* Bloodstream infection
* Had a peripheral venous catheter already in situ at the baseline
* Altered mental state

Primary outcomes:
measure: Indwelling time
timeFrame: from the cannulae insertion until its removal, usually within 2 weeks
Secondary outcomes:
measure: Phlebitis
timeFrame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Occlusion of the catheter
timeFrame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Infiltration
timeFrame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Accidental catheter removal
timeFrame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Local venous infection
timeFrame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Catheter-related bloodstream infection
timeFrame: from the cannulae insertion until its removal, usually within 2 weeks
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou municipal hospital
state: Anhui
city: Beijing
country: China
facility: Xuanwu Hospital Captial Medical University
state: Beijing
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Fifth Affiliated Hospital of Zhengzhou University
state: Henan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Chuanjie Wu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00551473: Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.
Official title: An Open-Label Study of the Development of Pharmacodynamic Tolerance to 7-days Administration of Lavoltidine 40mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroesophageal Reflux Disease
Reflux, Gastroesophageal
Keywords: pharmacodynamics,
tolerance
H2 antagonist,
AH23844,
lavoltidine,
gastroesophageal reflux disease (GERD), pharmacokinetics,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-31
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Current treatment for gastroesophageal reflux disease(GERD)confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric acid suppression. Clinical data on lavoltidine demonstrates a rapid onset of action, high potency, and prolonged duration of effect after single dose. Since tolerance to the class of compounds to which lavoltidine belongs may be dose dependent, the current study is designed to determine if 40mg lavoltdine given for 7days develops tolerance.


Eligibility criteria: Inclusion Criteria:

* Healthy male, from 18-55 years
* Have BMI from 19-30 kg/m2
* do not present with abnormal clinical lab findings
* are able to tolerate a nasogastric pH electrode.

Exclusion Criteria:

* Helicobacter-positive on a C13 urea breath test
* have a baseline median 24-hour gastric pH\>3

Primary outcomes:
measure: To determine the degree of pharmacodynamic tolerance following seven days administration of lavoltidine 40mg on gastric pH as assessed by percentage of 24hrs pH>4.
timeFrame: seven days
Secondary outcomes:
measure: To determine whether or not significant pharmacodynamic tolerance occurs as early as the second dose of 40mg lavoltidine. Safety and tolerance of seven days administration of lavoltidine 40 mg, in healthy male volunteers.
timeFrame: seven days
Other outcomes:
Locations:
city: Randwick, Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00225173: Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease
Official title: A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hodgkin Disease
Keywords: nodular sclerosis
lymphocyte rich
lymphocyte depleted
mixed cellularity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine and vinorelbine. The introduction of these new agents with their different mechanisms of action into the Stanford V regimen may increase effectiveness while maintaining a favorable toxicity profile with respect to fertility and a low risk of secondary leukemia. On this basis, we propose a new regimen, Stanford VI, for patients with bulky and advanced HD with 3 or more risk factors.

Detailed description: Patients will receive chemotherapy weekly for 19 weeks, alone or followed by irradiation as indicated per protocol guidelines.

* Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
* Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
* Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
* Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
* Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
* Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
* Gemcitabine 1250 mg/m2 IV w 13,15,17,19
* Vinorelbine 25 mg/m2 IV w 13,15,17,19
* Prednisone 40 mg/m2 PO qod w 1-10, taper

Eligibility criteria: Inclusion Criteria:

* Untreated, locally extensive or advanced stage classical Hodgkin's disease
* 3 or more adverse risk factors
* Age \> 18 years and \< 70 years.
* No prior invasive malignancies for \> 5 years except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* ECOG performance status 0 to 2
* WBC \> 4000/µL
* Platelets \> 100,000/µL
* Creatinine \< 2.0mg/dL
* Bilirubin \< 5.0mg/dL

Exclusion Criteria:

* HIV-positive
* Pregnant or currently breast feeding women
* Lymphocyte predominant Hodgkin's disease

Primary outcomes:
measure: Freedom from progression
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Sandra J. Horning, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01613573: Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children
Official title: A Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Growth Hormone Deficiency
Keywords: pegylated Somatropin
PEG-GH
Phase 1 study
Pharmacokinetics
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Huazhong University of Science and Technology
First posted: 2012-06-07
Enrollment: 12
Sex: MALE
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG somatropin, which administered once per week, compared with the daily used somatropin, and to evaluate the safety and possibility to replace daily used somatropin.


Eligibility criteria: Inclusion Criteria:

* have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration \<7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);be in preadolescence (Tanner stage 1) and have a CA \>3 years;have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV; receive no prior GH treatment or stop the GH treatment for more than 4 weeks;sign informed consent

Exclusion Criteria:

* Patients with Liver and kidney dysfunction (ALT\> upper limit of normal 2 times, Cr\> upper limit of normal), hepatitis B virus detection, antigen-HBc, HBsAg and HBeAg are positive
* patients with known to a highly allergic constitution or allergic to the drug of this study
* Patients with diabetes, serious cardiopulmonary, blood system, malignant tumor and other diseases or systemic infection in immunocompromised and mental diseases
* Patients with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, Laron syndrome, GH receptor deficiency, girls with growth delay have not ruled out chromosomal abnormalities
* Participated in clinical trials of other drugs in 3 months
* Other cases that the researchers considered unsuitable for this clinical trial

Primary outcomes:
measure: pharmacokinetics parameter
timeFrame: Somatropin AQ: predose(0),1,2,3,4,6,8,10,12,16,20,24 hours post-dose. PEG somatropin: predose (0),2,4,8,12,18,24,36,48,72,96,120,144,168 hours post-dose
Secondary outcomes:
measure: IGF-1, IGFBP-3
timeFrame: Day I to Day 7 in each treatment period (33 time points) for daily used somatropin, Day I to Day 42 in each treatment period (35 time points) for PEG somatropin
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Luo Xiaoping, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03792373: Hospital Ederly Life Program for Surgical Patients
Official title: Effects of Frailty on Outcomes After Elective Noncardiac Surgery -a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Investigate the Mortality of the Frailty Patients
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ≥65 years

Brief summary: Frailty is the clinically recognizable medical condition, also called syndrome or phenotype, that is, the result of processes leading to an increased vulnerability for serious deteriorations in health and the diminished ability to cope with physical stressors. Recently, frailty has emerged as a significant risk factor for adverse postoperative outcomes. It is related to declines in energy, strength, and function as well as to an increased inflammatory state, including elevated levels of interleukin 6 (IL-6), C-reactive protein (CRP), and anelevated white blood cell count . Frailty, as defined Frailty, as defined in the landmark paper by Fried, included at least three of five of the following criteria: unintentional loss of weight, low physical activity, low energy, low grip strength, and a slowed walking speed. Since then, various frailty scoring lists have been designed to optimize the predictive value. One of these is the Edmonton Frail Scale (EFS), an instrument that can be assessed quickly, using only a simple questionnaire which usually does not require more than five minutes to be completed and which covers most domains of functioning, making it easy and fast to get a reliable impression of the degree of frailty.The aim of this study was to determine which factors,with emphasis on frailty, significantly influence postoperative outcome after elective noncardiac surgery as measured by the Comprehensive Complication Index (CCI).


Eligibility criteria: Inclusion Criteria:

* elective noncardiac surgery

Exclusion Criteria:

* patients who don't cooperate

Primary outcomes:
measure: one-year mortality
timeFrame: 2019.02-2020.02
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gaojun Teng, PhD
role: STUDY_CHAIR
References:
citation: Mao M, Wang LY, Zhu LY, Wang F, Ding Y, Tong JH, Sun J, Sun Q, Ji MH. Higher serum PGE2 is a predicative biomarker for postoperative delirium following elective orthopedic surgery in elderly patients. BMC Geriatr. 2022 Aug 19;22(1):685. doi: 10.1186/s12877-022-03367-y.
Clinical trial NCT05002673: Dental Anaesthesia Affects Pain Level
Official title: Determination of the Effect of Two Different Methods of Dental Anaesthesia on Pain Level in Paediatric Patients: A Cross-over, Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Anesthesia, Local
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2021-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background: Needles are the most feared tools, making anaesthetic injection a worrying practice.

Aim: To compare intraosseous (IOA) and needle-free dental anaesthesia (NFA) methods that painless anaesthesia.

Design: Twenty patients aged 8-10 years were included in this cross-over study. To determine the anxiety levels and pain experienced by the patients, visual and behavior scales were used. The pulse rate (PR) and opiorphin levels (OL) determined. The Friedman and Wilcoxon signed-rank tests were used. p\<0.05 was considered significant.


Eligibility criteria: Inclusion Criteria:

* Patients aged 8-10 years,
* systemically healthy,
* had undergone dental treatment (except for extraction) previously but with at least 1 week passed since then
* were compatible enough to undergo therapy in the clinic in a sitting position,
* had infection between the roots with a rate over 1/3, had 2/3 root formation,
* had been indicated for extraction of the maxillary primary molar teeth (55/65 No. teeth),
* did not have acute and/or subacute infection of the related or other teeth or mouth and surrounding tissues

Exclusion Criteria:

* who scored above 41 in the state anxiety subscale and above 44 in the trait anxiety subscale of the Spielberger State-Trait Anxiety Scale (SSAS-SAAS)
* not meeting the inclusion criteria

Primary outcomes:
measure: Score of scales (wong baker faces pain rating scale)
timeFrame: one year
measure: Score of scales (face, legs, activity, cry, consolability)
timeFrame: one year
measure: Score of scales (frankl behavior rating scale)
timeFrame: one year
measure: heart rate (pulse oximeter)
timeFrame: one year
measure: level of opiorphin (from saliva samples)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Nagehan Yılmaz
state: None Selected
Study officials:
References:
Clinical trial NCT01206673: Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease
Official title: Evaluation of Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Gaucher's Disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed.


Eligibility criteria: Inclusion Criteria:

* Adults (age equal or above 18.
* Patients with Gaucher 's disease treated in the "Grand Ouest" competence center
* patients affiliated to social security
* Informed consent signed

Exclusion Criteria:

- Children (age\<18)

Primary outcomes:
measure: To determine the implication of acquired and inherent immunity in the Gaucher's clinical phenotype at moment of blood sampling
Secondary outcomes:
measure: to find new activity mark for Gaucher's disease by studying macrophagic activation's markers.
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Hospital
city: Rennes
country: France
facility: CHU of Rennes
Study officials:
References:
Clinical trial NCT01223573: Neonatal Pulse Oximetry Compared With Apgar Scores
Official title: Newborn Pulse Oximety as a Predictor for Newborn Status and Future Outcome As Compared With the Apgar Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Newborns Delivered at KMC OB/GYN Department
Lead sponsor: Kern Medical Center
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns delivered at KMC OBGYN dept

Brief summary: Apgar score is a subjective measure to assess prognosis and future outcome of a newborn. Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective times in an goal to assess the usability of pulse oximetry as an added tool in determining the newborn prognosis


Eligibility criteria: Inclusion Criteria:

Newborns delivered vaginaly or by C-section at Kern Medical Center labor and delivery ward

Exclusion Criteria:

known cardiopulmonary disease of the newborn

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04327973: Expanded Access for ATB200/AT2221 for the Treatment of IOPD
Official title: Expanded Use Of Recombinant Human Acid Alpha-Glucosidase/N-butyl-deoxynojirimycin (ATB200/AT2221) For Patients With Infantile-Onset Pompe Disease
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Pompe Disease Infantile-Onset
Keywords: expanded access
compassionate use
Lead sponsor: Amicus Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-03-31
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to ATB200/AT2221.

Detailed description: This program is being offered on a patient by patient basis.

Eligibility criteria: Inclusion Criteria:

1. Patient is male or female and 0 to \< 18 years old.
2. Patient has a diagnosis of Pompe disease, based on documentation of GAA genotyping demonstrating variants associated with IOPD.
3. Patient does not currently qualify for or is unable to enroll (eg, due to location, etc) in any commercial drug-sponsored ongoing clinical trial.
4. Patient is currently being treated with an approved ERT and is declining (eg, worsening in motor function, respiratory function/parameters, cardiac function, etc) based on treating physician's clinical judgement.
5. The patient's legal guardian or representative has given informed consent (and assent when age appropriate for regional requirements) to treatment prior to administering ATB200/AT2221 in a manner consistent with all national requirements.
6. If of reproductive potential and sexually active, female subjects agree to use a highly effective method of contraception throughout the duration of the treatment and for up to 90 days after their last dose of ATB200/AT2221.

Exclusion Criteria:

1. Patient has a hypersensitivity to any of the excipients in ATB200, alglucosidase alfa, or AT2221
2. Patient has a medical or any other extenuating condition or circumstance that may, in the opinion of the investigator and/or Amicus, pose an undue safety risk to the patient.
3. Concomitant use of miglitol (eg, Glyset), non-AT2221 form of miglustat (eg, Zavesca), acarbose (eg, Precose or Glucobay), voglibose (eg, Volix, Vocarb,or Volibo)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: Gainesville
country: United States
facility: UF Health Shands Hospital
state: Florida
city: Padova
country: Italy
facility: University Hospital of Padova
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: