louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01680068: Air Tamponade in Macular Hole Surgery
Official title: Air Tamponade in Macular Hole Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Hole
Keywords: Macular hole
Vitreoretinal surgery
Macular surgery
Air tamponade
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
First posted: 2012-09-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used.


Eligibility criteria: Inclusion Criteria:

* Idiopathic stage 2 - 4 macular hole
* Duration of symptoms ≤ 36 months
* Informed consent

Exclusion Criteria:

* Previous vitreomacular surgery
* Myopia ≥ 6 diopters
* Ocular trauma
* Disease affecting visual function

Primary outcomes:
measure: Closure rate of macular hole
timeFrame: 1 month after enrollment
Secondary outcomes:
measure: Closure rate in macular holes larger than 400 micrometer
timeFrame: 1 month after enrollment
Other outcomes:
measure: Visual gain after 6 months of follow up
timeFrame: 6 months after enrollment
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Ophthalmology
Study officials:
affiliation: Helse Stavanger HF
name: Vegard Forsaa, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05615168: Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
Official title: Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension During Surgery
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 34
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: Intraoperative hypotension is linked to increased incidence of perioperative adverse events such as myocardial and cerebrovascular infarction and acute kidney injury. Hypotension prediction index (HPI) is a novel machine learning guided algorithm which can predict hypotensive events using high fidelity analysis of pulse-wave contour. Goal of this trial is to determine whether use of HPI can reduce the number and duration of hypotensive events in patients undergoing major thoracic procedures.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years of age
* patients scheduled for elective major thoracic procedure (lung resection, pleurectomy or resection of the esophagus)
* planned thoracotomy and intraoperative period of one lung ventilation
* planned postoperative admission to the ICU

Exclusion criteria:

* persistent atrial fibrillation
* structural heart defects (shunting or moderate to severe valvular anomalies)
* preoperative serum hemoglobin levels \< 120 g/L
* severe heart failure classified as New York Heart Association (NYHA) grade IV

Primary outcomes:
measure: Time weighted average of area under hypotensive threshold
timeFrame: During surgery
Secondary outcomes:
measure: Cumulative duration of hypotension
timeFrame: During surgery
measure: Number of hypotensive events
timeFrame: During surgery
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
state: Grad Zagreb
Study officials:
References:
Clinical trial NCT01628068: ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)
Official title: Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Adverse Reaction to Drugs Affecting the Gastrointestinal System
Keywords: Left atrial appendage occlusion
gastrointestinal bleeding
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of gastrointestinal bleeding. The investigators propose the percutaneous stop the oral anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in patients receiving anticoagulant therapy for atrial fibrillation without associated valvular heart disease, to reduce significantly the risk of stroke while minimizing the risk of bleeding in a group of patients with high risk for both events.

ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of atrial appendage left versus standard treatment with oral anticoagulants in patients with history of gastrointestinal bleeding and high embolic risk.


Eligibility criteria: Inclusion Criteria:

* documented atrial fibrilation (paroxysmal or permanent) without significant heart valve disease
* \> 18 years
* Classic oral anticoagulation(INR at therapeutic levels: 2-3) or New oral anticoagulants
* CHA2-DS2-VASC score ≥ 3
* prior digestive bleeding without any treatable cause
* Informed consent.

Exclusion Criteria:

* POF
* contraindication to further treatment with dual antiplatelet therapy (aspirin + clopidogrel)
* Intracardiac thrombus
* significant carotid disease
* Cardioversion scheduled within 30 days following the implantation
* AF not controlled by FVM\> 100 bpm
* AF secondary to surgery or ablation
* thrombosis in patients \<40 years
* chronic renal insufficiency with Cr clearance \<30 ml 2
* left appendage sizeappendage with inlet \<12.6 mm or \> 28.5 (ETE)
* depth of the appendage \<10mm in the TEE

Primary outcomes:
measure: Combined overall mortality, major bleeding, stroke or procedure-related complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
state: Mdrid
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barcelona
country: Spain
facility: Fundació Clínic per a la Recerca Biomèdica
city: Madrid
country: Spain
facility: Hospital de La Paz
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
Study officials:
References:
Clinical trial NCT04927468: Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy
Official title: The Management of Large-angle Strabismus in Grave's Ophthalmopathy With Supramaximal Rectus Recession
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Strabismus, Mechanical
Graves Ophthalmopathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy

Detailed description: To evaluate the effectiveness and complications of supramaximal rectus recession for large-angle strabismus in Grave's Ophthalmopathy

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Grave's ophthalmopathy
* angle of deviation more than 20°
* clinically and biochemically euthyroid for at least 3 months;
* a stable orthoptic examination for at least 3 months, for example no greater than five prism dioptre change in primary position and no greater than an 8° change in duction
* monocular and mainly single extraocular muscle restricted motility

Exclusion Criteria:

* Patients with suppression, previously diagnosed and/or treated strabismus not related to the thyroid
* best-corrected visual acuity (BCVA) less than 0.2 in one or both eyes

Primary outcomes:
measure: Postoperative deviations
timeFrame: 6 weeks
measure: Postoperative deviations
timeFrame: 3 months
measure: Postoperative deviations
timeFrame: 6 months
Secondary outcomes:
measure: binocular single vision
timeFrame: 6 weeks
measure: binocular single vision
timeFrame: 3 months
measure: binocular single vision
timeFrame: 6 months
measure: stereoacuity
timeFrame: 6 weeks
measure: stereoacuity
timeFrame: 3 months
measure: stereoacuity
timeFrame: 6 months
measure: ocular motility
timeFrame: 6 weeks
measure: ocular motility
timeFrame: 3 months
measure: ocular motility
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00305968: Evaluation of Patient Education in Irritable Bowel Syndrome
Official title: Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Quality of life
Gastrointestinal symptoms
Health related costs
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Sykehuset Telemark
name: The Hospital of Vestfold
First posted: 2006-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. They often feel frustrated and seek both their family doctors, specialists and alternative medicine for help. Many patients feel they do not know enough about their disease, and the uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information and education in these patients.

Detailed description: The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized to receive intervention now (intervention group) or in 6 months (control group). The intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced gastroenterologist at the local hospital.

Elements in this "school-day" includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices.

The patients are evaluated at time: 0 months and 6 months (intervention group and control group), 12 months (control group) and after 2 years (both groups).

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria
* Must be able to participate in a education-group

Exclusion Criteria:

* Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome
* Serious, untreated psychiatric disorder

Primary outcomes:
measure: Change in Quality of life
timeFrame: 6 months
measure: Change in Gastrointestinal symptom score
timeFrame: 6 months
Secondary outcomes:
measure: Change in health related costs
timeFrame: 6 months
measure: Evaluation of further patient needs after education
timeFrame: 6 months
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Sykehus HF
Study officials:
name: Jostein Sauar, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04462068: ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients
Official title: ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 150
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 with sarcoidosis seen in Department of Respiratory Diseases, Aarhus Denmark

Brief summary: Sarcoidosis is a multisystem granulomatous disease of unknown cause histologically characterized by noncaseating granulomas. Genetic factors affect disease course, which is highly variable and difficult to predict.

This study aims to evaluate the predictive value of ACE and HLA genotypes on disease severity and progression in Danish patients with sarcoidosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoidosis
* Signed informed consent

Exclusion Criteria:

* Inability or unwillingness to adhere to the study
* Inability to give informed consent

Primary outcomes:
measure: Time to initiation of treatment
timeFrame: 1 year from diagnosis
Secondary outcomes:
measure: Number of participants with extrapulmonary organ involvement
timeFrame: 1 year from diagnosis
measure: Change in FEV1
timeFrame: 1 year
measure: Change in FVC
timeFrame: 1 year
measure: Change in diffusion capacity
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology
Study officials:
References:
Clinical trial NCT06187168: Risk Factors of Post-ERCP Sepsis
Official title: Intra-operative Hypotension and Sepsis After Endoscopic Retrograde Cholangiopancreatography: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Intraoperative Hypotension
Bacteremia Sepsis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include 100 adult patients (≥ 18years) undergoing ERCP for obstructive jaundice at the GISC during the study period for obstructive jaundice.

Brief summary: For the treatment of numerous biliary and pancreatic problems, the procedure known as endoscopic retrograde cholangiopancreatography (ERCP) is regarded as a crucial therapeutic intervention. However, ERCP is known to be connected to a variety of issues, including post-ERCP sepsis. This study's goal is to investigate the relationship between unexplained hypotension during or just after surgery and the emergence of sepsis after ERCP.

Detailed description: At the Gastrointestinal Surgery Centre, Mansura University, Egypt, a cohort study will be conducted on a sample of 50 adult (18+) patients who undergoing ERCP. Hypotension that occurred during surgery or shortly after will be classified as exposure when it cannot be linked to a particular cause. In this study, post-ERCP sepsis will be the major outcome measure, while other ERCP-related sequelae will be the supplementary outcome measures.

Discussion:

The findings of this study will significantly advance our understanding of the potential link between intraoperative hypotension and the development of post-ERCP sepsis. This study's goal is to increase knowledge of the challenges presented by ERCP, which will aid in the creation of patient treatment methods that are more effective.

Eligibility criteria: Inclusion Criteria:

* Undergoing ERCP for obstructive jaundice
* Adult (Older than 18 years old)
* Written Informed Consent

Exclusion Criteria:

* Already on sepsis before the ERCP
* Pregnancy

Primary outcomes:
measure: Post-ERCP Sepsis
timeFrame: 24 hours after ERCP
Secondary outcomes:
measure: Hospital readmission
timeFrame: 30 days after ERCP
measure: Post-ERCP ICU admission
timeFrame: 7 days after ERCP
measure: Length of hospital stay
timeFrame: 30 days after ERCP
measure: Postoperative bacteremia
timeFrame: 24 hours after surgery
measure: Post-ERCP pancreatitis
timeFrame: 24 hours after ERCP
measure: Post-ERCP RBCs transfusion
timeFrame: 24 hours after ERCP
measure: 30-day all-cause mortality
timeFrame: 30 days after ERCP
measure: Delayed post-ERCP Sepsis
timeFrame: 7 days after ERCP procedure
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Univesity Faculty of Medicine
state: Aldakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Moataz M Emara, MD, EDAIC
role: STUDY_CHAIR
References:
Clinical trial NCT03765268: Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair
Official title: Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2018-12-05
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a randomized controlled trial in which we are treating inguinal hernia patients with mesh hernioplasty and either neurectomy of iliohypogastric nerve and ilioinguinal neurectomy or preservation comparing post operative acute or chronic pain


Eligibility criteria: Inclusion Criteria:

* patients male, and age between 20 to 70 years Reducible inguinal hernia

Exclusion Criteria:

* Irreducible, obstructed or strangulated hernia uncontrolled diabetes

Primary outcomes:
measure: percentage of patients developing chronic inguinodynia
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital Lahore
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT00870168: Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer
Official title: Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: stage IV breast cancer
estrogen receptor-negative breast cancer
progesterone receptor-negative breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-03-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.

Detailed description: OBJECTIVES:

Primary

* Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.

Secondary

* Assess changes in HER1 and HER2 expression during treatment.

OUTLINE: This is a multicenter study.

Patients receive 6-9 courses of front-line chemotherapy according to the investigator. Patients with estrogen receptor- and/or progesterone receptor-positive disease receive hormone therapy.

Patients undergo biopsy prior to and after completion of chemotherapy for examination of hormone receptors and HER1 and HER2 expression.

After completion of study treatment, patients are followed every 6 months for 5 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the breast

  * Metastatic disease
* No inflammatory breast cancer
* Measurable disease according to RECIST criteria
* Hormone receptor status:

  * Estrogen receptor- and/or progesterone receptor-negative by IHC

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* WHO performance status 0-2
* Life expectancy \> 3 months
* ANC \> 1.5 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Liver transaminases ≤ 3 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 2 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No allergy to xylocaine
* No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency

PRIOR CONCURRENT THERAPY:

* No prior first-line treatment for metastatic disease

Primary outcomes:
measure: Changes in hormone receptor expression
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
affiliation: Centre Jean Perrin
name: Philippe Chollet, MD, PhD
References:
Clinical trial NCT01616368: The Effects of Mindfulness Training on Eating Behaviors and Food Intake
Official title: The Effects of Mindfulness Training on Eating Behaviors and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Feeding Behavior
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2012-06-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators propose to study the effect of mindfulness training on the eating behaviors and dietary intake of overweight or obese persons. Mindfulness skills training involves bringing non-judgmental attention to thoughts, emotions and bodily sensations - including hunger and satiety cues. It is hypothesized that as subjects advance through the 8-week class series, developing their capacity for mindfulness and in effect learn to pay attention to the sensations, assumptions, cognitions, and beliefs that underlie their eating behaviors, that their eating behaviors will improve. Specifically, the investigators hypothesize that 1) there will be significant improvements in the areas of uncontrolled and emotional eating, 2) there will be significant decreases in total caloric intake and significant increases in fruits and vegetables, and 3) there will be a positive significant relationship between the frequency/consistency of mindfulness practice and improvements from baseline to follow-up measures.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) \> 26

Exclusion Criteria:

* Psychotic disorders
* Poorly controlled bipolar disorder
* Borderline or antisocial personality disorder
* A diagnosed eating disorder

Primary outcomes:
measure: Change in Eating behaviors
timeFrame: baseline, 2 months, 5 months
Secondary outcomes:
measure: Change in Nutrition intake
timeFrame: baseline, 2 months, 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Seattle Institute for Biomedical and Clinical Research
name: David Kearney, MD
role: PRINCIPAL_INVESTIGATOR
References: