louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01257789: Eliminating Learning Curve Related Morbidity in Fast Track Laparoscopic Roux-en-Y Gastric Bypass
Official title: Structured Bariatric Fellowship Programme Moelholm Private Hospital - Denmark. Learning Laparoscopic RY - Gastric Bypass One Way to do it
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Operative Time
Surgical Volume
Keywords: laparoscopic gastric bypass
learning curve
complications
operative time
Lead sponsor: Private Hospital Moelholm
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 consequtive patients already sceduled for laparoscopic gastric bypass surgery

Brief summary: Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant learning curve. We report the results of a systematic training programme from a high volume bariatric center measuring the outcome by comparing the results with data from a consecutive series of 1000 fast track LRYGB.

Method: Using a stepwise training programme the RY gastric bypass operation was divided into an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic surgeon without experience in upper GI surgery was mentored by an experienced bariatric surgeon. During 6 months full time fellowship 300 operations were performed.

Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in which the mentor surgeon did the other part of the operation. In 110 patients the trainee performed both procedures. Two percent had peri-operative complications compared to 1% of 1000 patients. All were repaired and had an uneventful recovery. Two percent had postoperative complications \< 30 days compared to 2.8% in the clinic. In the trainees series there were no leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for operation 0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic. Concerning time to discharge there was no difference between patients operated by the trainee and the standard of the clinic.

Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery eliminates morbidity of the learning curve without affecting the volume.


Eligibility criteria: Inclusion Criteria:

patients undergoing laparoscopic gastric bypass

Exclusion Criteria:

* super obesity
* male patients

Primary outcomes:
measure: complication rate
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Private Hospital Moelholm
Study officials:
References:
Clinical trial NCT01026389: Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease
Official title: Efficacy Evaluation of Dotarem®-Enhanced MRA Compared to Gadovist®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Limb Arterial Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: MRA-Contrast agent comparison in peripheral disease
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged ≥ 18 years.
* Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy.
* Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.

Exclusion Criteria:

* Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
* Patient who had a major cardiovascular event within 30 days prior to the inclusion.
* Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.

Primary outcomes:
measure: Intra-patient Accuracy (Percent Agreement), On-site Data
timeFrame: up to one month
Secondary outcomes:
measure: Intra-patient Accuracy, in Off-site Readings
timeFrame: up to one month
measure: Specificity
timeFrame: up to one month
measure: Sensitivity
timeFrame: up to one month
Other outcomes:
Locations:
city: Wien
country: Austria
facility: AKH hospital
Study officials:
References:
Clinical trial NCT03557489: Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position
Official title: Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility.

The objectives of our study is to compare the difference in incidence rates of sacral pressure injury in surgical patients with supine position more than 3 hours between those treated with usual preventive care and a sacral foam pad versus a control group receiving usual care.

Detailed description: The incidence of pressure injury in surgical patients about 12% to 45%, though these patients were treated with "gel pad" as routine. Based on the nutritional status of patients, long-term surgery, surgical posture, and anesthesia-induced hypotension, pressure injury still occurred. Sacral foam pad (Mepilex(®) Border Sacrum) is an unique 5-layer design, was designed to protect sacral pressure injury. In this study, we enrolled surgical patients who need to supine over ≧ 3 hours to evalute the effectiveness of sacral foam pad in preventing sacral pressure injury. The patients will randomized to control and intervention groups, both groups recruited 105 patients. In control group, patients use gel pad during surgery; whereas patients use gel pad in addition to sacrum foam pad (Mepilex(®) Border Sacrum) in intervention group. After surgery, the occurrence and severity of sacral pressure injury was evaluated. The results of this study can provide evidence to improve the awareness of operating room medical staff on surgical pressure injury, and find out the risk factors in avoiding of pressure injury, and offer an effective strategy to enhance the quality of surgery throughout the perioperative care.

Eligibility criteria: Inclusion Criteria:

1.20-99 years old surgical patients who need to supine position over ≧ 3 hours 2.Patients have no any skin lesion.

Exclusion Criteria:

1. under 20 years
2. Patients have any skin lesion.

Primary outcomes:
measure: Sacral pressure injury
timeFrame: After 1 hour surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Deputy Director of Nursing Department in Shuang Ho Hospital
name: Chun Mah, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123589: The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill Adults.
Official title: The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sedative Withdrawal Delirium
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was designed to explore the effects of different sedation protocol on incidence rates of delirium and PTSD in severe patients with mechanically ventilation.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Critically ill adults whose expected time of mechanical ventilation is longer than 24 hours
* Aged between 18 years old to 85 years old.

Exclusion Criteria:

* Subjects with brain injury;
* History of cardiopulmonary resuscitation;
* Mental disability;
* Taken neuromuscular blocking drugs;
* Inability to exchange;
* Contraindicated to midazolam or morphine;
* Inconvenience to daily interruption

Primary outcomes:
measure: The incident rate of delirium
timeFrame: From weaning to discharged from ICU,about 7 days.
measure: The incident rates of PTSD
timeFrame: 30th day and 180th day after discharged from ICU
measure: The duration of delirium
timeFrame: From weaning to discharged from ICU,about 7 days.
Secondary outcomes:
measure: Incidence rate of unexpected extubation
timeFrame: From intubation to weaning,about 7 days
measure: Dosage of analgesics and sedatives
timeFrame: From intination of analgesics and sedatives to stopping drug appication,about 7 days
measure: The duration of mechanical ventilation
timeFrame: From intubation to weaning,about 7days
measure: Duration of ICU
timeFrame: From admitted to ICU to discharged from ICU,about 7 days
measure: The whole hospitalization time
timeFrame: From admitted to hospital to discharged from hospital,about 7 days
measure: Patients' death rates within ICU stay
timeFrame: From admitted to ICU to discharged from ICU,about 7 days
measure: Patients' death rates within hospitalized stay
timeFrame: From admitted to hospital to discharged from hospital,about 7 days
measure: The cost in ICU
timeFrame: From admitted to ICU to discharged from ICU,about 7 days
measure: The total cost in hospital
timeFrame: From admitted to hospital to discharged from hospital,about 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03713489: Platelet Transfusion in HBV-related acute-on Chronic Liver Failure
Official title: Platelet Transfusion in HBV-related acute-on Chronic Liver Failure: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Keywords: acute-on-chronic liver failure
platelet
Hepatitis B
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute-on-chronic liver failure (ACLF) is a syndrome that has recently been recognized as encompassing acute deterioration of liver function in patients with pre-existing chronic liver disease. It is associated with multi-organ failure and a high risk of short-term mortality. Thrombocytopenia is common in ACLF. In addition, the function of platelet is also compromised according to our previous data. The aim of this study is to explore whether platelet transfusion could reduce the short-term mortality rate of HBV-related ACLF. This is a single center, open labeled randomized controlled study. There are two arms. Subjects who is assigned to platelet transfusion group will receive both platelet transfusion (9 times/4 weeks, 1 unit each time) and standard medical treatment. While those in standard medical treatment group will receive standard medical treatment only. The major endpoint is 28-day transplant-free mortality rate.


Eligibility criteria: Inclusion Criteria:

* Age 18-60 years old
* Diagnosed with acute-on-chronic liver failure (grade-2) according to EASL-CLIF criteria and grading system.
* Chronic hepatitis B infection.
* ADP inhibition rate ≥70%.

Exclusion Criteria:

* Combined with chronic liver disease other than chronic HBV infection.
* Previous decompensation.
* Intracranial hemorrhage proved by radiological methods, symptoms and physical signs.
* Under anti-platelet or anticoagulants therapy within 4 weeks.
* Esophageal variceal bleeding within 1 week.
* Platelets transfusion within 1 week.
* Hepatocellular carcinoma or other types of malignancies.
* Pregnancy or breastfeeding.
* Severe chronic extra-hepatic disease.
* Comined with situations that researchers considered not suitable for inclusion
* Refusal to sign the informed consent form.

Primary outcomes:
measure: 28-day transplant-free mortality
timeFrame: 28 days
Secondary outcomes:
measure: transplant-free survival time
timeFrame: 90 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03233789: Development and Validation of an ADL-score Based on FIM and EBI
Official title: Entwicklung Und Validierung Eines ADL-Scores (Activities of Daily Life) Auf Basis Von FIM (Functional Independence Measure) Und EBI (Erweiterter Barthel-Index)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Disorder
ICF
Medical Rehabilitation
Assessment
Functional Independence
Observational Study
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Association nationale pour le développement de la qualité dans les hôpitaux et les cliniques (ANQ), Bern, Switzerland
First posted: 2017-07-31
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with neurologic disorders in in-patient rehabilitation

Brief summary: The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation clinics.

The following steps are performed:

1. Development of an ADL-algorithms by experts
2. Validation of the ADL-algorithms in a quantitative approach
3. Finalization of the ADL-algorithms by experts based on study results


Eligibility criteria: Inclusion Criteria:

* Admission to in-patient neurologic rehabilitation clinic

Exclusion Criteria:

* No sufficient language skills (German, French or Italian)

Primary outcomes:
measure: Agreement FIM-based ADL-score vs. EBI-based ADL-score
timeFrame: within 3 days of admission to rehabilitation clinic
Secondary outcomes:
measure: Correlation FIM-based ADL-score vs. EBI-based ADL-score
timeFrame: within 3 days of admission to rehabilitation clinic
measure: Difference in FIM-based ADL-score vs. EBI-based ADL-score
timeFrame: within 3 days of admission to rehabilitation clinic
Other outcomes:
Locations:
Study officials:
affiliation: Charite University, Berlin, Germany
name: Karla Spyra, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03995589: Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
Official title: Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: I. To investigate whether patient characteristics, exercise therapy characteristics, local metabolic exercise response, endothelial function, autonomic function or atherosclerotic lesion location can predict the walking response to a successfully completed semi-supervised exercise intervention in patients with intermittent claudication (WP I) II. To assess the effect of a home-based exercise intervention with remote monitoring and coaching on cardiovascular risk factors in patients with intermittent claudication (WP II)


Eligibility criteria: The study population will comprise patients diagnosed with lower-extremity artery disease (ABI ≤0.9 and/or 20% decrease after a maximal treadmill test) suffering from intermittent claudication (Rutherford 1-3) presenting with new complaints (at least 6 months after previous revascularization) at the Vascular Center of university hospitals Leuven will be included if according to current guidelines their initial treatment should be conservative

Inclusion Criteria:

* age \> 17 yrs
* ABI ≤0.9 and/or 20% decrease after a maximal treadmill test
* intermittent claudication (Rutherford 1-3)
* ability to undertake an exercise test and read and understand Dutch questionnaires

Exclusion criteria

* exercise test induced signs of complex arrhythmias or significant ischemia during baseline testing
* other comorbidity limiting participation in the exercise group

Primary outcomes:
measure: Pain free walking distance
timeFrame: Baseline - 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
citation: Cornelis N, Buys R, Fourneau I, Van den Bosch A, De Wilde C, Goetschalckx K, Cornelissen V. Cardiorespiratory fitness in patients with lower extremity artery disease? It takes more than just some steps! Eur J Prev Cardiol. 2022 May 5;29(5):e190-e192. doi: 10.1093/eurjpc/zwab135. No abstract available.
Clinical trial NCT01724489: Study of Growth Hormone and Bone in Obesity
Official title: Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Osteopenia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Pfizer
First posted: 2012-11-09
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Obesity is an important risk factor for osteoporosis and fractures. With the growing prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this population is of importance to public health. Growth hormone (GH) is a critical mediator of bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of bone loss in obesity. The development of novel imaging techniques provides an opportunity to investigate the effects of GH on skeletal structure and strength, which will provide insights into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone loss in obesity may help identify new treatment targets for this important complication. The investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal health.


Eligibility criteria: Inclusion Criteria:

* Ages 18-65 and generally healthy
* BMI ≥ 25 kg/m2
* Bone mineral density (BMD) T score ≤ -1.0 and \> -2.5 (as measured by DXA)

Exclusion Criteria:

* For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome
* History of diabetes mellitus, cancer or other serious chronic disease
* Use of osteoporosis medications
* Anemia

Primary outcomes:
measure: Bone Mineral Density
timeFrame: baseline and 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Miller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Miriam Bredella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05120089: Muscle Energy Technique Versus Myofacial Release in Adolescents With Spinal Deformity
Official title: Muscle Energy Technique Versus Myofacial Release in Adolescents With Spinal Deformity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Spinal Deformities
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal deformity may not only alter the physical appearance, but may also have a psychological impact on the child, particularly in the adolescent to whom self- image is so important.

This study will investigate the effect of muscle energy technique compared to myofacial release in the adolescent with spinal deformities( scoliosis and/ or kyphosis).


Eligibility criteria: Inclusion Criteria:

* Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles . All children are normal \&perform all activities of daily living
* They were able to understand and follow verbal commands and instructions included in the testing procedures.

Exclusion Criteria:

* All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
* None of them had any surgical intervention .
* None of them had any history of other musculoskeletal deformities or neuromuscular disorders.
* hey had neither visual, auditory defect.

Primary outcomes:
measure: cobb angle for spinal deformities (scoliosis and/or kyphosis)
timeFrame: immediately before the beginning of the intervention procedures
measure: cobb angle for spinal deformities (scoliosis and/or kyphosis)
timeFrame: by the end of successful three month of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AAA
Study officials:
References: