louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05733728: Retrospective Register for Uveal Melanoma
Official title: Retrospective Register for Uveal Melanoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveal Melanoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with uveal melanoma

Brief summary: Background: Uveal melanoma (UM) is a common primary ocular malignancy associated with limited overall survival in the advanced stage of the disease. Fundamental breakthrough regarding the management of the disease and the overall-survival have not yet been achieved. Studies with large cohorts are difficult to perform due to limited patient numbers, therefore retrospective analyses are of great potential to gain further knowledge in a disease with high clinical needs.

Aim: The proposed project is a register for patients with UM treated at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021.

Patients and Methods: Patients treated for UM at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021 will be included in the register. Information on the baseline characteristics, survival times and course of the disease will be gathered via retrospective chart review and saved in a password-secured database.


Eligibility criteria: Inclusion Criteria

* Patients 18 - 99 years
* Diagnosis of uveal melanoma Exclusion Criteria
* Patients younger than 18 years of age
* Inadequate or missing information on the clinical course in patient charts

Primary outcomes:
measure: Conduction of a Register providing the basis for
timeFrame: 1997-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01701128: The Effect of Exercise Training on Gait and Quality of Life in Parkinson's Disease
Official title: The Effect of Exercise Training on Gait and Quality of Life in Patients With Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Physical activity, treadmill training, rehabilitation
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and without a strengthening component, on functional mobility, gait and quality of life in patients with Parkinson's disease (PD). The rationale for a study of this type stems from the hypothesis that treadmill training may act as an external "pacemaker" and enhance some properties of gait. There is a need for larger scale randomized controlled trials comparing the effects of treadmill training to control groups that receive similar amounts of attention. To date, no study has combined TT and muscle strengthening, likely the optimal form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of 72 one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill training will considerably improve walking parameters and the well being of people with PD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease
* Stage of II or less on Hoehn and Yahr scale

Exclusion Criteria:

* Having musculoskeletal impairments or having excessive pain in any joint that could limit participation in exercise program
* Dementia (MMSE\<24)
* Having balance problems
* Live beyond 45 minutes from Laval University

Primary outcomes:
measure: Change in Gait speed
timeFrame: Baseline, 3 and 6 months
measure: Change in Endurance walking
timeFrame: Baseline, 3 and 6 months
measure: Change in Quality of life
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Change in Postural Balance
timeFrame: Baseline, 3 and 6 months
measure: Change in Spatiotemporal parameters of walking
timeFrame: Baseline, 3 and 6 months
measure: Change in Cognitive impairment
timeFrame: Baseline, 3 and 6 months
measure: Change in Fear of falling
timeFrame: Baseline, 3 and 6 months
measure: Change in Depression and anxiety level
timeFrame: Baseline, 3 and 6 months
measure: Change in Effects of symptoms and motor impairment
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Quebec Memory and Motor Skills Disorders Research Center
city: Quebec
country: Canada
facility: Laval University
Study officials:
affiliation: Laval University
name: Philippe Corbeil
role: STUDY_DIRECTOR
affiliation: Laval University
name: Alexandra Nadeau
role: STUDY_DIRECTOR
affiliation: Quebec Memory and Motor Skills Disorders Research Center
name: Emmanuelle Pourcher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00905528: TRENDY Follow-up: Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Official title: Prospective Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
endothelial function
renal hemodynamics
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 69
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes mellitus and normo or microalbuminuria

Brief summary: Basal nitric oxide (NO) activity plays a pivotal role in the regulation of glomerular hemodynamics, and in animal experiments its alteration has been associated with morphological changes characteristic of diabetic nephropathy. The investigators aimed to assess in a prospective study: 1. basal NO activity of renal vasculature and 2. renal hemodynamics to examine whether impairment of basal NO activity of the renal vasculature is related to development and progression of diabetic nephropathy and other cardiovascular endpoints.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes mellitus

Exclusion Criteria:

* Macroalbuminuria
* Symptomatic cardiovascular disease

Primary outcomes:
measure: Change in eGFR after 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg
state: Bavaria
Study officials:
affiliation: Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
name: Roland E Schmieder, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ritt M, Ott C, Delles C, Schneider MP, Schmieder RE. Impact of the endothelial nitric oxide synthase gene G894T polymorphism on renal endothelial function in patients with type 2 diabetes. Pharmacogenet Genomics. 2008 Aug;18(8):699-707. doi: 10.1097/FPC.0b013e32830500b1.
citation: Ritt M, Ott C, Raff U, Schneider MP, Schuster I, Hilgers KF, Schlaich MP, Schmieder RE. Renal vascular endothelial function in hypertensive patients with type 2 diabetes mellitus. Am J Kidney Dis. 2009 Feb;53(2):281-9. doi: 10.1053/j.ajkd.2008.10.041. Epub 2008 Dec 19.
Clinical trial NCT01437228: Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Endometritis
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 668
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean delivery rates are increasing in Turkey and a major component of this increase is cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of endomyometritis and wound infection, remains a leading cause of postoperative complications. Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and obstetric variables. Infection following cesarean delivery results in not only increased hospital stay but also increases the cost of care. Strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and altering the uterine position during repair of the uterine incision. Despite these interventions, endometritis is still major problem after cesarean delivery.

Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing an important role. The microbes endogenous to the vagina change throughout the course of pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand, reaching below the infant's head or presenting part, is in direct contact with the vagina. Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95% confidence interval \[CI\] 58%, 100%) of cesareans that follow labor. In these cases, vaginal flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision. Vaginal preparation has been shown to decrease the quantitative load of vaginal microorganisms as well as to remove certain species of bacteria.


Eligibility criteria: Inclusion Criteria:

* Women older than 38 weeks estimated gestational age and required cesarean section.

Exclusion Criteria:

* Highly emergent cesarean
* Allergy to povidone iodine
* Chorioamnionitis on admission
* Fever on admission

Primary outcomes:
measure: rate of postpartum endometritis
timeFrame: 6 weeks
Secondary outcomes:
measure: morbidity
timeFrame: two days
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sisli Etfal Hospital
state: Sisli
Study officials:
References:
citation: Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Clinical trial NCT00458328: The Effect of Z-338 in Subjects With Functional Dyspepsia
Official title: The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Functioanl Dyspepsia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2007-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound


Eligibility criteria: Inclusion Criteria:

* Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1.
* Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1.

Exclusion Criteria:

* Subjects that heartburn should be the most bothersome symptom
* Subjects presenting with primary complaints relieved by stool movements (IBS)
* Subjects with diabetes by treatment
* Subjects that heartburn should be more than moderate

Primary outcomes:
measure: Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index
Secondary outcomes:
Other outcomes:
Locations:
city: Kurashiki
country: Japan
facility: Kawasaki Medical School
state: Okayama
Study officials:
affiliation: Kawasaki Medical School
name: Ken Haruma, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01807728: Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
Official title: Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Quality of life
Participation
Training
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2013-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine the effectiveness of different training programs on outcomes in persons with spinal cord injury (SCI). We are interested to see which programs have the greatest impact.


Eligibility criteria: Inclusion Criteria:

* 18 to 75 years old
* Use either a power or manual wheelchair as a primary means of mobility (\>50% of weekly mobility)
* Living in the community
* Must have a non-progressive spinal cord injury
* Manual wheelchair users must be able to independently propel their wheelchairs
* Manual wheelchair users score ≤90 on the Wheelchair Skills Training Questionnaire (WST-Q)

Exclusion Criteria:

* Cognitive impairment that could interfere with learning

Primary outcomes:
measure: Change from baseline in quality of life at 1 year
timeFrame: Baseline, 1 Year
Secondary outcomes:
measure: Change from baseline in quality of life at 1 month
timeFrame: Baseline, 1 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Florida Spinal Cord Injury System
state: Florida
city: Chicago
country: United States
facility: Midwest Regional Spinal Cord Injury Care System
state: Illinois
city: West Orange
country: United States
facility: Northern New Jersey Spinal Cord System
state: New Jersey
city: Pittsburgh
country: United States
facility: Debbie
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michael Boninger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Worobey LA, McKernan G, Toro M, Pearlman J, Cowan RE, Heinemann AW, Dyson-Hudson TA, Pedersen JP, Mesoros M, Boninger ML. Effectiveness of Group Wheelchair Maintenance Training for People with Spinal Cord Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Apr;103(4):790-797. doi: 10.1016/j.apmr.2021.02.031. Epub 2021 Jun 24.
citation: Worobey LA, Kirby RL, Cowan RE, Dyson-Hudson TA, Shea M, Heinemann AW, Pedersen JP, Hibbs R, Boninger ML. Using remote learning to teach clinicians manual wheelchair skills: a cohort study with pre- vs post-training comparisons. Disabil Rehabil Assist Technol. 2022 Oct;17(7):752-759. doi: 10.1080/17483107.2020.1804633. Epub 2020 Aug 18.
Clinical trial NCT05087693: Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)
Official title: Examining the Effect of Salbutamol Use in Asthma and/or Exercise Induced Bronchoconstriction Whilst Exercising in Ozone Air Pollution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma and/or Exercise Induced Bronchoconstriction
Ozone Air Pollution
Keywords: Asthma
Exercise Induced Bronchoconstriction
Salbutamol
Ozone
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. The purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or EIB exercising in ozone air pollution. To examine this, we are planning a randomized cross over trial where people with asthma and/or EIB complete sub maximal exercise in four conditions on four separate days. The four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.


Eligibility criteria: Inclusion Criteria:

* Have asthma and/or EIB
* Able to perform maximal exercise
* Able to communicate sufficiently using the English language

Exclusion Criteria:

* Allergic to salbutamol (also known as Ventolin)
* Pregnant or potentially pregnant
* Have a history of smoking
* Had an upper respiratory tract infection within the last 4 weeks
* Have a chronic respiratory disease other than asthma or EIB

Primary outcomes:
measure: Measured Before and 30 Minutes After Exercise in Each 1 Day Condition
timeFrame: Measured before and 30 minutes after exercise in each 1 day condition
measure: Change in FVC From Baseline to 30 Minutes After Exercise
timeFrame: Measured before and 30 minutes after exercise in each 1 day condition
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Environmental Physiology Laboratory
state: British Columbia
Study officials:
References:
Clinical trial NCT02647593: The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis
Official title: The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis Showing the High Level of Aminotransferase and the Establishment of New Nomenclature ; Gallstone Hepatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "Patients have been diagnosed as CBD stone under endoscopic retrograde cholangiopancreatography (ERCP). Among patients, patients who displayed above 400 IU/L of aminotransferase without cholangitis (gallstone hepatitis group) and patients who showed the normal value of aminotransferase (control group) were enrolled in this study. We estimated two groups by comparing clinical features, lab finding, radiologic images, and findings under ERCP such as CBD diameter, CBD stone diameter, CBD stone number, periampullary diverticulum.

Brief summary: Laboratory change induced by common bile duct (CBD) stone is in general observed as the higher elevation of alkaline phosphatase (ALP) and gamma-glutamyl transpeptideas (ɤ-GT), in comparison to those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). However, some patients with CBD stone show the marked increased level of aminotransferase, which sometimes leads to misdiagnose those as liver disease caused by viral hepatitis, ischemia, and drug toxicity. The aim of this study is to investigate the clinicopathologic features of patients with CBD stones with the high level of aminotransferase in serum.


Eligibility criteria: Inclusion Criteria:

1. patients were diagnosed with CBD stone under endoscopic retrograde cholangiopancreatography (ERCP)
2. patients showing above 400 IU/L of aminotransferase when at the first admitted into hospital and the control groups is the patients displaying normal AST and ALT.

Exclusion Criteria:

* 1. underlying hepatobiliary disease 2. alcoholics 3. cholangitis

Primary outcomes:
measure: clinicopathologic features of patients with CBD stones with the high level of aminotransferase
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01556893: Creating LASIK Flaps With the LenSx Femtosecond Laser
Official title: Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Hyperopia
Keywords: Flap Creation
Femtosecond Laser
corneal flap prior to LASIK procedure
Lead sponsor: Alcon LenSx, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 20
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 will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.

Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.

Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.


Eligibility criteria: Inclusion Criteria:

1. Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
2. Must be over 18 years of age
3. Must have visual acuity correctable to at least 20/25 in both eyes
4. If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
5. Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
6. Must sign and be given a copy of the written Informed Consent form
7. Postoperative refractive target is emmetropia

Exclusion Criteria:

1. Known sensitivity to planned study concomitant medications
2. Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
3. Presenting any contraindications to femtosecond initiated LASIK
4. Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
5. Irregular astigmatism, based on Investigator's judgment
6. Undergoing monovision LASIK
7. Pregnant, lactating or plan to become pregnant during the course of this study
8. For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.

Primary outcomes:
measure: Ease of Lifting Flaps
timeFrame: Operative
Secondary outcomes:
measure: Stromal Bed Quality
timeFrame: Operative
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Ophthalmology, Semmelweis University
Study officials:
References: