louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03226769: Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
Official title: Prospective, Open-Label, Randomized, Proof of Concept Study Exploring Application of TrueTear™ for the Treatment of Meibomian Gland Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Glands
Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-07-24
Enrollment: 57
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).


Eligibility criteria: Inclusion Criteria:

* Dry eye disease or Meibomian Gland Disease as evaluated by Standard Participant Evaluation for Dryness (SPEED) score, Schirmer test, Tear film breakup time and other applicable objective measures at the Screening and Baseline Visits.
* Use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics for the treatment of dry eye disease or Meibomian Gland Disease within one year of the Screening Visit.

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding.
* History of nasal or sinus surgery.
* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit.
* Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit.
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head.

Primary outcomes:
measure: Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
timeFrame: Baseline (Day 0) to Day 30
measure: Change From Baseline in MGD Symptoms Questionnaire Score
timeFrame: Baseline (Day 0) to Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: mdlasik@comcast.net
name: Gail Torkildsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671969: Very Low Calorie Diet for Diabetic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Kidney Disease
Keywords: determine effects of diet on renal and other parameters
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 10
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 purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* Age \> 18
* Body mass index ≥ 30
* Presumed or biopsy-proven diabetic nephropathy
* Estimated GFR \< 40 ml/min/1.73 meters squared
* Proteinuria \> 0.5 gm/day
* Motivated to lose weight
* Stable medical co-morbidities
* Using an ACE inhibitor or angiotensin receptor blocker agent (unless contraindicated)

Exclusion Criteria:

* Inability to sign informed consent
* Life expectancy of \< 1 year
* Expected need for initiation of dialysis within 9 months
* Type 1 Diabetes
* Recent myocardial infarction or stroke (past 3 months)
* Unstable angina
* Active cancer
* Pregnancy/lactation
* Serious psychiatric diseases
* Substance abuse
* Uncontrolled hypertension (\> 180/110)
* Ineligible for VLCD based on laboratory data

Primary outcomes:
measure: Urinary albumin excretion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
Study officials:
References:
citation: Friedman AN, Chambers M, Kamendulis LM, Temmerman J. Short-term changes after a weight reduction intervention in advanced diabetic nephropathy. Clin J Am Soc Nephrol. 2013 Nov;8(11):1892-8. doi: 10.2215/CJN.04010413. Epub 2013 Aug 8.
Clinical trial NCT01801969: Return to Work and QOL Following TBI. Impact of Rehabilitation Service.
Official title: Return to Work and QOL Following TBI. Impact of Rehabilitation Service.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries
Return to Work
Quality of Life
Keywords: Brain injuries
Rehabilitation services
Return to Work
Quality of life
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 653
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals suffering from severe TBI (GCS\<9) from the Danish Head Trauma Database

Brief summary: The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services.

In Denmark rehabilitation services vary been regions and municipalities. Hospital based rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized by the municipalities

The first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life.

The second purpose is to investigate whether municipality size affects quality of life and return to work after severe TBI.

Data on return to work are derived from a national register on labor market attachment. Data on quality of life are derived from a questionnaire.

The study population is identified from the Danish Head Trauma Database. The completeness and accuracy of the database will be investigated as the first part of the project.


Eligibility criteria: Inclusion Criteria:

* age 18-64

Exclusion Criteria:

-

Primary outcomes:
measure: time to return to work
timeFrame: up to 11 years post-injury
Secondary outcomes:
measure: Quality of life
timeFrame: 1-10 years post-injury
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation and Research Centre
Study officials:
affiliation: Research Unit (Forskningsenheden), Hammel Neurorehabilitation and Research Centre
name: Lene Odgaard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293369: Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy
Official title: Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy and Their Effect on Female Sexual Function and Vaginal Length
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Laparoscopic Hysterectomy
Benign Conditions
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: University of Surrey
First posted: 2014-11-18
Enrollment: 58
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs.

Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length.

Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only

Exclusion Criteria:

* Suspicion of malignancy
* Presence of large adnexal masses (maximum diameter \>10 cm at preoperative ultrasonography)

Primary outcomes:
measure: Female Sexual Function
timeFrame: Three months
measure: Vaginal length
timeFrame: One months
Secondary outcomes:
measure: Vaginal cuff granulation/infection
timeFrame: One month
measure: Vaginal cuff closure time
timeFrame: One day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Obstetrics and Gynecology, Istanbul University School of Medicine
Study officials:
affiliation: Istanbul University School of Medicine
name: Faruk Buyru, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02255669: Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction
Official title: Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Tract Neoplasms
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.

Detailed description: Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.

The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.

Eligibility criteria: Inclusion Criteria:

* 1.\> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal

Exclusion Criteria:

* 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR\>1.5, Platelet\<50000) 4.expected survival \> 3 months based on Karnofsky performance score 5.duodenal stricture

Primary outcomes:
measure: duration of stent patency
timeFrame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
Secondary outcomes:
measure: overall survival
timeFrame: From the date of randomization until the date of death from any cause, assessed upto 12 months
measure: stent occlusion rate
timeFrame: From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months
measure: stent related complication
timeFrame: From the date of randomization until the date of first documented stent related complication, assessed up to 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Cencer
Study officials:
affiliation: Samsung Medical Cencer
name: Jong Kyun Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05971069: Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging
Official title: Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging: Prospective Study to Develop Decision Algorithm to Define the Preservation/Ligation of an Aberrant Left Hepatic Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasm
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: " Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.

There has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.

This prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery
2. Patients aged between 20 to 80
3. Patients with an ECOG 0 or 1
4. Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery

Exclusion Criteria:

1. Patients with abnormal liver function test befor surgery
2. Patients who diagnosed liver cirrhosis or infectious liver disease
3. Patients who underwent liver resection, or chemotherapy for gastric cancer
4. Patients planned for combined liver resection or cholecystectomy during gastrectomy

Primary outcomes:
measure: The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging
timeFrame: Real time near-infrared fluorescence image will be obtained during the surgery.
Secondary outcomes:
measure: Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)
timeFrame: Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT01301469: Comparison of HES 130 in Balanced and in Unbalanced Solution
Official title: Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Decreased and Nonspecific Blood Pressure Disorders and Shock
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.


Eligibility criteria: Inclusion:

* Male or female (non pregnant) patients; between 18 and 70 years
* Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer
* General anesthesia
* Voluntary consent

Exclusion:

* Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV
* BMI \< 18 or \> 29
* Patients with daily urine output \< 1L
* Patients on hemodialysis
* Abnormal liver or renal function (i. e. above upper limit of normal range)
* Abnormal coagulation function (prothrombin time (PT) 3 seconds higher than normal or activated partial thromboplastin time (APTT) 10 seconds higher than normal)
* Hgb \< 10g/dl or HCT \< 30%
* Potassium, sodium or chloride above the upper limit of normal of the laboratory
* History of diabetes mellitus
* Known history of a mental or neurological disorder, such as epileptic seizures.
* History of hypertension and/or taking a beta-receptor blocker or history of atrial fibrillation
* Patients with known hypersensitivity and with contraindications to HES or any of the excipients

Primary outcomes:
measure: Maximum difference of the mean arterial blood pressure
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 2 Hospitals
city: Guangzhou
country: China
facility: Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Hospital
Study officials:
affiliation: Ruijin Hospital
name: Buwei Yu, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03014869: High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation
Official title: Comparison of High Flow Nasal Cannula and Noninvasive Positive Ventilation(NPPV) in Moderate Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
Keywords: COPD Exacerbation
High Flow Oxygen
Noninvasive Positive Ventilation
moderate
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 351
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: TREATMENT

Brief summary: For moderate AECOPD(pH\<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.

Detailed description: Recently, many clinical studies have showed that HFNC can be successfully used in patients with hypoxemic respiratory failure to improve the comfort, to attenuate respiratory failure and to decrease the rate of tracheal intubation and mortality. Although theoretically HFNC is a potential and ideal treatment for AECOPD patients, the related clinical researches are very few. It still needs to further evaluate the safety and efficacy of HFNC in patients with AECOPD. For moderate AECOPD(pH\<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.

Eligibility criteria: Inclusion Criteria:

* AECOPD; 7.35\>pH≥7.25，PaCO2\>50 mmHg

Exclusion Criteria:

* contraindications for NPPV, such as thick sputum, cough weakness, hemodynamic instability, etc.; need to be intubated immediately; refuse to engage in the study; severe organ dysfunction

Primary outcomes:
measure: endotracheal intubation demand rate
timeFrame: 90days
Secondary outcomes:
measure: actual endotracheal intubation rate
timeFrame: 90days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Qingyuan Zhan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03021369: Comparison of Two Different Pleural Drainage Systems
Official title: Vergleich Zweier Thoraxdrainage-Systeme in Der Herzchirurgie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Air Leak From Lung
Lead sponsor: Kerckhoff Klinik
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 374
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: The digital pleural drainage system Topaz+ by Medela is compared to the analogue system Atrium OCEAN by Maquet in patients undergoing cardiac surgery.

The study is prospectively randomized with an all-comer setup. The patients are randomly selected for one of the systems. The surgery is performed in the standard fashion and chest tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32 French drain is placed in every patient and pericardial and/or pleural drains are optional.

The postoperative course does not vary from the clinical standard and the chest tubes are removed according to institutional standard. The clinical data about fluid amount, time of removal, air leaks, tamponade are routinely collected in a digital patient documentation system.


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing cardiac surgery
* capability to give informed consent

Exclusion Criteria:

* no specific exclusion criteria

Primary outcomes:
measure: Detection of air leak due to lung leakage or injury during surgery by the pleural drainage system.
timeFrame: Occurrence of air leak is until the drain is removed (usually postoperative day 2 or 3)
Secondary outcomes:
measure: Time of chest drain removal
timeFrame: Number of days until the chest drains are removed (usually postoperative day 2 or 3, depending on air leak and amount of fluid).
measure: Fluid amount
timeFrame: Total amount of fluid at the time of chest drain removal (usually postoperative day 2 or 3, depending on air leak and amount of fluid).
measure: Number of patients with pericardial tamponade that has to be treated by puncture or surgically
timeFrame: Occurrence through hospital stay (an average of 1 week).
measure: Number of patients with pleural effusion at discharge echo, without intervention
timeFrame: Occurrence through hospital stay (an average of 1 week).
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
Study officials:
References: