louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01524458: Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
Official title: Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms to patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. The commonest causes of spastic esophageal motility disorders included Achalasia, hypertensive lower esophageal sphincter (LES), Nutcracker esophagus and Diffuse esophageal spasm (DES). Majority of these diseases were diagnosed by manometry. Achalasia is the most common primary esophageal motility disorder in which the LES failed to relax with increased pressure. Currently the standard treatment for Achalasia and spastic motility disorders is Laparoscopic Myotomy. The development of Natural Orifices Transluminal Endoscopic Surgery (N.O.T.E.S.) has lead to a new way to perform myotomy - Peroral Endoscopic Myotomy (P.O.E.M.). Basically, through mucosal incision, a submucosal tunnel is created after identification of the level of gastroesophageal junction. Myotomy will be performed with endoscopic instruments and the entrance site will be closed with clips.


Eligibility criteria: Inclusion Criteria:

* All patients with age ranged 18 to 85 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion Criteria:

1. Pregnancy
2. Informed consent not available
3. Previous history of esophagectomy or mediastinal surgery
4. Previous history of endoscopic resection for early esophageal cancers, inclduing endoscopic mucosal resection and endsocopic submucosal dissection
5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swllow

Primary outcomes:
measure: Relief of Dysphagia
timeFrame: 4 weeks
Secondary outcomes:
measure: Complication
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Dept of Surgery, The Chinese University of Hong Kong
name: Philip WY Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01039558: The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
Official title: Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: gastroesophageal reflux disease
lansoprazole
ecabet sodium
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will estimate the responses of lansoprazole and ecabet sodium combination therapy and compare with lansoprazole and placebo therapy in patients who need additional therapy after standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal reflux disease.


Eligibility criteria: Inclusion Criteria:

* age 19-75 years
* patients with typical gastroesophageal symptom or erosive reflux esophagitis on gastroduodenoscopy
* patients with recurrent gastroesophageal symptom after standard proton pump inhibitor treatment for 4 weeks or more

Exclusion Criteria:

* patients with gastric ulcer or duodenal ulcer
* patients with gastric cancer or esophageal cancer
* pregnant or postpartum women

Primary outcomes:
measure: We will compare the summations of symptoms score and calculate the response rate
timeFrame: after 4 weeks and 8 weeks
Secondary outcomes:
measure: the global response of treatment
timeFrame: after 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Joo Sung Kim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02866058: Outcomes of Cesarean Section vs Vaginal Delivery: Instrumental Variable Adjusted Analysis
Official title: Substantial Variability Between Traditional and Instrumental Variable Estimates of the Risk of Caesarean Section in Canada: a Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Cesarean Section
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: Medical Research Foundation - Memorial University
First posted: 2016-08-15
Enrollment: 1703590
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All obstetrical deliveries in Canada (except the province of Quebec) between April 1, 2006 and March 31, 2009

Brief summary: This study will examine the effect of cesarean section on perinatal mortality, using data provided by the Canadian Institute for Health Information.

Detailed description: This study will examine administrative data provided by the Canadian Institute for Health Information (CIHI). Maternal obstetrical delivery and neonatal hospitalization records provided by CIHI will be linked before analysis. The primary outcome is in-hospital perinatal mortality. The data will be analyzed by traditional multi-variate logistic regression, and the results from this analysis will be compared to the results from instrumental variable adjusted regression using the Generalized Method of Moments. The instrumental variable is the rate of cesarean delivery among women living within the same hospital catchment area. All analyses will be adjusted for maternal, infant, delivery provider, and hospital factors, as well as for clustering at the level of the delivery hospital.

Eligibility criteria: Inclusion Criteria:

* Mothers living in Canada and their infants delivering within the study period at Canadian hospitals outside of the province of Quebec.

Exclusion Criteria:

* Maternal record not linkable to neonatal record.
* Multiple gestation.
* Birthweight \< 500 gm.
* Gestational age at delivery \< 20 weeks.
* Deliveries at hospitals with less than 20 cesarean deliveries during study period.
* Records with missing data for important covariates

Primary outcomes:
measure: Perinatal Mortality
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial University
name: Kris Aubrey-Bassler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03447496: Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children
Official title: Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction
Lead sponsor: The Fuzhou No 2 Hospital
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 100
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.

Brief summary: Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.

Detailed description: The Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children that were treated with closed or open reduction.

Eligibility criteria: Inclusion Criteria:

* Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.

Exclusion Criteria:

* Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.

Primary outcomes:
measure: Radiographic union
timeFrame: Up to 12 weeks.
Secondary outcomes:
measure: Fracture displacement
timeFrame: Up to 12 weeks.
Other outcomes:
measure: Functional clinical scores
timeFrame: Through study completion, an average of 1 year.
Locations:
city: Fuzhou
country: China
facility: Shunyou Chen
state: Fujian
Study officials:
affiliation: The Fuzhou No 2 Hospital
name: Chen Shunyou, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02995096: Tumor Characteristics, Pre-transplant Treatments and Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma
Official title: The Effect of Tumor Characteristics, Pre-transplant Treatments and Immunosuppression on Survival After Liver Transplantation for Hepatocellular Carcinoma - a European Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 23124
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: Patients receiving liver transplantation for hepatocellular carcinoma in European centers reporting to the ELTR database.

Brief summary: Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC.


Eligibility criteria: Inclusion Criteria:

* Hepatocellular carcinoma within transplantation criteria

Exclusion Criteria:

* Disseminated disease

Primary outcomes:
measure: Overall survival
timeFrame: up to 10 year survival
Secondary outcomes:
measure: Hepatocellular carcinoma specific survival
timeFrame: 5 year and 10 year survival
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Surgery and Transplantion, Rigshospitalet, Denmark
name: Hans-Christian Pommergaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02828696: Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
Official title: Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Wear
Keywords: CAD-CAM composites
Worn dentition
minimally invasive treatment
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of a minimally invasive treatment, consisting of partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of rehabilitation of advanced and generalized dental wear over a period of 5 years.


Eligibility criteria: Inclusion Criteria:

* Patients presenting advanced and generalized worn dentition
* All the posterior teeth (minus 2) present wear
* All the anterior teeth (tooth n°13 to n°23) need palatal veneers

Exclusion Criteria:

* More than one missing tooth on each mandible
* Patients with crown(s), bridge(s) or implant(s)
* Patients with non-stabilized parodontite
* Smoker
* Patients suffering from :

  1. Parkinson's Disease
  2. Severe osteoarthritis
  3. Spontaneous pain in the temporomandibular joints, shift of the mandible and an opening limit (25 mm)
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability

Primary outcomes:
measure: Clinical evaluation of minimally-invasive treatment protocol of worn dentition
timeFrame: 5 years
measure: Quality of life evaluation of minimally-invasive treatment protocol of worn dentition
timeFrame: 5 years
Secondary outcomes:
measure: Toxicology evaluation of PICN restorations mechanical and biological behaviour
timeFrame: 5 years
measure: Wear evaluation of PICN restorations mechanical and biological behaviour
timeFrame: 5 years
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Institute of Dentistry University of Liege
Study officials:
affiliation: University Hospital Center (CHU) of Liège
name: Amélie Mainjot
role: STUDY_DIRECTOR
References:
Clinical trial NCT00222196: Oslo Balloon Angioplasty Versus Conservative Treatment
Official title: Oslo Balloon Angioplasty Versus Conservative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: atherosclerosis
quality of life
pain-score
biomarkers
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Aker
name: Pfizer
First posted: 2005-09-22
Enrollment: 200
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. However, the fact remains that the indication for performing PTA are still more based on opinions than on scientific data.

The purpose of the trial was to randomize patients primarily referred for intermittent claudication into two groups: One group was offered conservative treatment; the other group was offered conservative treatment combined with PTA.

Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers


Eligibility criteria: Inclusion Criteria:

* Age below 75 years
* Symptoms of intermittent claudication with duration \> 3 months
* ABPI \<0.9
* A two-year follow-up is possible

Exclusion Criteria:

* Subjective pain-free walking distance \> 400m
* Critical ischemia
* Previous vascular or endovascular surgery
* Diabetes ulcer
* Other physical disability abrogating organised exercise
* Use of warfarin
* Mentally unable to give informed consent
* Renal insufficiency
* Coagulation disorders Duplex or PTA impossible

Primary outcomes:
measure: The patient quality of life.
Secondary outcomes:
measure: Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
Other outcomes:
Locations:
Study officials:
affiliation: Aker and Ullevål University Hospitals, Oslo, Norway
name: Marthe Nylaende, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00127296: Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe
Official title: Comparison of the Accuracy and Precision of NovoLog® Mix 70/30 FlexPen® to Vial and Syringe in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix 70/30 FlexPen® and vial and syringe in subjects with type 2 diabetes mellitus. No insulin is administered in this trial - insulin is dispensed into an empty vial.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Insulin naive
* No previous experience administering injections

Exclusion Criteria:

* Any condition that, in the Investigator and/or Sponsor's opinion, could interfere with the results of this trial

Primary outcomes:
measure: Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference)
Secondary outcomes:
measure: Patient preference
measure: Accuracy (mean relative error)
measure: Precision (coefficient of variation)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Schwartz S, Khutoryansky N, Braceras R. Comparison of resource utilisation, preference and handling of a pre-filled pen and vial/syringe in patients with type 2 diabetes mellitus. Journal of Clinical Research 2007; 10: 1-10
Clinical trial NCT00772096: Septic Encephalopathy and Late Cognitive Dysfunction
Official title: Septic Encephalopathy and Late Cognitive Dysfunction in Patients With Sepsis - the Role of Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Severe Sepsis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 50
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: Delirium and long-term cognitive dysfunction are important problems in intensive care patients. Patients with sepsis are at a high risk of developing delirium (septic encephalopathy), which may be an important risk factor for the development of long-term cognitive dysfunction.

Working hypotheses: 1. Septic encephalopathy and cognitive dysfunction are caused by an unspecific reaction of the brain to an intense inflammatory stimulus. 2. It is possible to therapeutically influence the inflammatory response and its effects on the brain.


Eligibility criteria: Inclusion Criteria:

* Admitted to an intensive care unit for treatment of sepsis, severe sepsis or septic shock
* Age 18 or older

Exclusion Criteria:

* Primary infection of the CNS
* History of cerebrovascular disease
* History of any neoplasia involving the CNS
* History of long-term psychiatric medication
* History of allergy to fish- or egg-protein
* Severe coagulation abnormalities
* Clinical signs of altered coagulation, active bleeding
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Department of Anaesthesia, University Hospital Basel, Switzerland
name: Luzius A Steiner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burkhart CS, Dell-Kuster S, Siegemund M, Pargger H, Marsch S, Strebel SP, Steiner LA. Effect of n-3 fatty acids on markers of brain injury and incidence of sepsis-associated delirium in septic patients. Acta Anaesthesiol Scand. 2014 Jul;58(6):689-700. doi: 10.1111/aas.12313. Epub 2014 Mar 24.
Clinical trial NCT05041296: Cardiac MRI for Detection of Acute and Chronic Cardiac Involvement in Patients With Epilepsy
Official title: The Epileptic Heart - Multiparametric Cardiac Magnetic Resonance Imaging for Detection and Quantification of Acute and Chronic Cardiac Involvement in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Cardiomyopathies
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epilepsy with treatment in the Clinic and Polyclinic for Epileptology of the University Hospital Bonn (Primary care clinic)

Brief summary: The aim of the study is to use multiparametric cardiac MRI to identify any abnormalities in myocardial structure and function in patients with epilepsy. A two-stage study design is planned as part of the study:

1. In the acute setting, cardiac MRI will be performed in patients before and after a tonic-clonic seizure and compared intraindividually. In this study arm, potential acute seizure-induced myocardial damage will be detected.
2. In the chronic setting, cardiac MRI will be performed in patients with known chronic epilepsy during the seizure-free interval to detect potential chronic myocardial damage (myocardial fibrosis) and compared with a control population. Within the group of epilepsy patients, possible associations with various epilepsy-specific characteristics (e.g., form, cause, onset, duration, and severity of epilepsy) will be investigated.


Eligibility criteria: Inclusion criteria:

1. diagnosed epilepsy
2. examination under usual antiepileptic pharmacotherapy or medication up-dosing (if medication was reduced during video-EEG recording)
3. age between 18-60 years

Exclusion criteria:

1. underlying cardiac disease, e.g. coronary artery disease, previous myocardial infarction, previous myocarditis, complex congenital heart defect, known cardiomyopathy of other cause
2. pregnant and breastfeeding women
3. patients who use IUD for contraception
4. patients with a contraindication to contrast enhanced MRI

Primary outcomes:
measure: T1 relaxation time
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
Secondary outcomes:
measure: T2 relaxation time
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Extracellular volume fraction
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Myocardial strain
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn, Clinic and Polyclinic for Epileptology
state: NRW
city: Bonn
country: Germany
facility: University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
state: NRW
Study officials:
References: