louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01829906: Suboptimal Weight Loss After Gastric Bypass Surgery
Official title: Evaluation of the Efficacy of Two Lifestyle Interventions for Suboptimal Weight Loss After Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Morbid
Keywords: weight loss
bariatric surgery
gastric bypass
health education
nutrition therapy
diet
exercise
cognitive therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-04-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bariatric surgery is the only long-term established treatment for morbid obesity. However, some patients experience suboptimal weight loss after surgery and/or experience a significant weight regain. Unfortunately there are very few studies in this area and little is known about the causes for lack of success or the best approach to treat this group of patients. The main aim of this study is to compare the efficacy of two different lifestyle treatment programs in this group of patients: 1) Hospital-based outpatient program or 2) an inpatient treatment program consisting of 3 - 3-week stays at a rehabilitation center over a 1-year period. Secondary aim is to determine potential reasons for suboptimal weight loss after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \>40kg/m2, or BMI\>35kg/m2 with comorbidities
* healthy volunteers with suboptimal weight loss
* health with significant weight regain after Roux-n-Y Gastric Bypass, defined as failure to lose at least 40% Excess Weight Loss by 12 months postoperatively.

Significant weight regain: Regain of ≥15% of total weight lost after the first postoperative year.

Exclusion Criteria:

* Pregnancy
* enrollment in another obesity treatment
* previous revisional bariatric surgery
* planned bariatric surgery
* past or ongoing drug or alcohol abuse
* physical or mental impairment that interferes with the ability to comply to treatment
* history of severe psychological disorder
* history of severe eating disorder
* current medication known to affect appetite or induce weight loss

Primary outcomes:
measure: Weight loss change
timeFrame: from baseline to 1 year
Secondary outcomes:
measure: Risk factors
timeFrame: One year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Bård Kulseng, md phd
role: STUDY_DIRECTOR
References:
citation: Amundsen T, Strommen M, Martins C. Suboptimal Weight Loss and Weight Regain after Gastric Bypass Surgery-Postoperative Status of Energy Intake, Eating Behavior, Physical Activity, and Psychometrics. Obes Surg. 2017 May;27(5):1316-1323. doi: 10.1007/s11695-016-2475-7.
Clinical trial NCT02217306: Contrast Sensitivity and Diabetic Macular Edema
Official title: Contrast Sensitivity and Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DIABETES MELLITUS
DIABETIC RETINOPATHY
MACULAR EDEMA
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2014-08-15
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients attended at Ophthalmology service in a general hospital

Brief summary: Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be modified by different pathologies or by age. The purpose of this study is to identify the changes that could be in relationship with the course of diabetic retinopathy comparing with diabetic patient without retinopathy and in patients with diabetic macular edema so if it is a difference, research for therapeutic strategies to improve it in this patients.

Detailed description: Contrast sensitivity is defined as a subjective measurement, it is the ability to separate the image between figure and background, taking into account the minimum amount of light required; it is evaluated by the contrast threshold, which is the smallest amount of contrast needed to be able to see a target and solve their characteristics, would be his reciprocal value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where \> 51 years have decreased compared to contrast sensitivity studies international; further that contrast sensitivity in older groups of 41 years is decreased high frequency.

Eligibility criteria: Inclusion Criteria:

* DIABETIC PATIENTS
* 40-60 YEARS OLD
* ANY GENDER
* VISUAL ACUITY \>0.25 IN DECIMAL EQUIVALENT,

Exclusion Criteria:

* PATIENTS WITH CATARACTS OR OTHER MACULOPATHY
* PATIENTS WITH CONTACT LENSES
* PATIENTS WITH REFRACTIVE ERROR \>6.00DP
* PATIENTS WITH PREVIOUS OCULAR SURGERY

Primary outcomes:
measure: Contrast Sensitivity
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Juarez de Mexico
Study officials:
affiliation: Hospital Juarez de Mexico
name: DULCE MI RAZO BLANCO HERNANDEZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSTITUTO POLITECNICO NACIONAL
name: SURISADAI SERAFIN SOLIS, MSc
role: STUDY_CHAIR
affiliation: INSTITUTO POLITECNICO NACIONAL
name: LOURDES CA ORTEGA LUNA, MSc
role: STUDY_CHAIR
affiliation: Hospital Juarez de Mexico
name: VIRGILIO LIMA GOMEZ, MD, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT03366506: Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)
Official title: Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ALS
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population referred to ALS clinic with suspected, possible, probable ,definite ALS

Brief summary: Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

1. Differences between ethnic subgroups
2. Differences between immigrant and native-born populations
3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

Detailed description: Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

1. Differences between ethnic subgroups
2. Differences between immigrant and native-born populations
3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

The clinical features will include pattern of onset, details of full clinical exam ( including ALSFRS-R score, power, reflexes, and other signs of upper or lower-motor neuron dysfunction.

Correlations between different clinical parameters themselves will be made, as well as correlation between clinical parameters and other epidemiological factors.

Eligibility criteria: Inclusion Criteria:

- Suspected, possible, probable ,definite ALS

Exclusion Criteria:

-

Primary outcomes:
measure: Progression rate
timeFrame: up to 10 years
Secondary outcomes:
measure: Appearance of clinical features of UMN or LMN dysfunction
timeFrame: 10 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organisation
Study officials:
affiliation: Hadassah Medical Organization
name: Marc Gotkine, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214006: Carotid Atherosclerotic Plaque Study
Official title: Carotid Atherosclerotic Plaque Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing carotid endarectomy

Brief summary: First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the genetic and environmental variables that cause those plaques to become symptomatic. Second, to differentiate between vulnerable plaque and other types of plaque using ultrasound elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of back-scattered ultrasonic echoes.

Detailed description: This is a multi-investigator study based on the pathophysiology of carotid atherosclerosis and the variables that cause certain plaques to become symptomatic.Patients enrolled in this study will be those patients undergoing a carotid endarterectomy. This will include both symptomatic and asymptomatic patients, and there are a variety of atherosclerotic risk factors representing this patient population.Patients may or may not have had strokes or transient ischemic attacks (TIAs).Pre-operatively patients will be reviewed for their medical history and atherosclerotic risk factors. Plaque removed during routine carotid endarterectomy will be examined for study purposes.

Eligibility criteria: Inclusion Criteria:

* Male and Female patients aged 18-80 presenting for carotid endarterectomy

Exclusion Criteria:

* Patients not felt suitable for carotid endarterectomy and those with impaired decision-making capacity

Primary outcomes:
measure: Lipid protein analysis and cognitive status comparison
timeFrame: 2008-2011
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert J. Dempsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05511506: Cytokines in Femtosecond Laser-assisted Cataract Surgery
Official title: Comparison Between Cytokines During First and Second Eye Surgeries in Patients With Bilateral Femtosecond Laser-assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract; cytokine; pain; miosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The investigators performed the current study to compare: 1) the pain scores by Visual Analogue Scale; 2) the cytokines concentrations in aqueous humor by human cytokine antibody array; 3) the prostaglandin E2 (PGE2) concentrations by enzyme linked immunosorbent assay (ELISA); 4) the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential femtosecond laser-assisted cataract surgery (FLACS). To our knowledge, this is the first intraindividual study investigating contralateral effect in FLACS. The findings from the current study may broaden our understanding on the mechanism of sympathetic reaction, help to improve clinical performances, and provide strong clinical guidance for cataract surgeons.


Eligibility criteria: Inclusion Criteria:

* Consecutive cataract patients aged 40-80 years, regardless of gender, with bilateral similar grades of lens opacity, and scheduled for sequential FLACS were enrolled in this study.

Exclusion Criteria:

* history of ocular or systematic inflammatory diseases like uveitis, rheumatism or other autoimmune diseases;
* previous ocular surgery or trauma;
* preoperative glaucoma, zonular weakness, lens dislocation, or poor pupil dilation (measured pupil diameter \<5.0 mm) or synechiae;
* use of systemic or topical steroids, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-adrenergic antagonist, or pain relief medications within 1 month prior to surgery;
* patients with baseline eye pain, having anxiety, muscle spasm around the eye or involuntary eye movement disorders which may influence the pain score;
* eyes needing for any other type of anesthesia, failed to obtain \> 100 μl aqueous humor (AH) or encountered intra-operative complications like posterior capsule rupture

Primary outcomes:
measure: pain scores
timeFrame: through study completion, an average of 1 year
measure: cytokines concentrations
timeFrame: through study completion, an average of 1 year
measure: pupil behaviors
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China
Study officials:
affiliation: Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China
name: yu yinhui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257606: Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial
Official title: Robot-assisted Training on the Upper Limb in Persons With MS: an RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
name: Expertise Centre for digital Media
name: tUL
name: iMinds
name: Interreg
First posted: 2014-10-06
Enrollment: 17
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: With this randomised intervention study, the investigators want to investigate the training effect of an 8 week training regime, using a robot-assisted training system in persons with MS. Besides conventional therapy, study participants in the experimental group will train 3 times per week during 30 minutes, using the haptic master. Research questions focus on the effects of additional robot assisted training on range of motion, movement quality and clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16 weeks of follow-


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to muscle weakness (Motricity Index \<80), age \> 18 years

Exclusion Criteria:

* MS relapse or glucocorticosteroid treatment in the last month before the start of the study, upper limb paralysis (Motricity Index \< 18), other sever limitations, influencing participation (cognitive, visual)

Primary outcomes:
measure: Motricity index
timeFrame: 2.5 min (pre-post)
measure: Fugl-Meyer
timeFrame: 30 min (pre-post)
measure: Action Research arm test
timeFrame: 15-20 min (pre-post)
measure: Motor Activity log
timeFrame: 45 min (pre-post)
measure: Jamar handgrip strength
timeFrame: 2.5 min (pre-post)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Feys P, Coninx K, Kerkhofs L, De Weyer T, Truyens V, Maris A, Lamers I. Robot-supported upper limb training in a virtual learning environment : a pilot randomized controlled trial in persons with MS. J Neuroeng Rehabil. 2015 Jul 23;12:60. doi: 10.1186/s12984-015-0043-3.
Clinical trial NCT05460806: The Effect of Aerobic Exercise in Alexithymic Individuals With Chronic Pain
Official title: The Effect of Aerobic Exercise on Pain, Alexithymia Level and Quality of Life in Alexithymic Individuals With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Quality of Life
Alexithymia
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It was aimed to investigate the effect of aerobic exercise on pain, alexithymia level and quality of life in young alexithymic individuals with chronic pain. There is no study in the literature comparing the effectiveness of aerobic exercise on alexithymia and chronic pain. Since our study will be the first study to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, it is planned to make national or international papers and publications after the study is completed.

Detailed description: In the study, after the necessary permissions are obtained, the Graded Chronic Pain Scale (ECAS) and Toronto Alexithymia Scale-20 (TAS-20) will be sent to the students who are studying at KTO Karatay University and whose age range is between 18-25 years. Among the students who fill out the form voluntarily, individuals who mark the 3rd or 4th option in the first question in the DKAS and who have a total score of 52 and above in the TAS-20 scale will be identified. Among these individuals, a total of 40 people will be included in the study randomly with a computer program. These participants will again be randomly divided into two groups as the control group (n=20) and the exercise group (n=20).

Eligibility criteria: Inclusion Criteria:

* To be between the ages of 18-25
* To mark the 3rd or 4th option in the first question in the DKAS
* To have a TAS-20 total score of 61 and above

Exclusion Criteria:

* Presence of any physiological or psychological disease that may interfere with the exercise protocol to be applied

Primary outcomes:
measure: Alexithymia
timeFrame: Change from Baseline Alexithymia after 8 week exercise
Secondary outcomes:
measure: Pain levels
timeFrame: Change from Baseline pain after 8 week exercise
measure: Quality of Life levels
timeFrame: Change from Baseline quality of life after 8 week exercise
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT03562806: MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
Official title: MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: MRI 3D UTE Hyper-Cones \& ZTE for PET/MR lung attenuation correction \& for lung diagnostic imaging

Detailed description: The primary objective is to clinically test the feasibility of 3D UTE Hyper-Cones \& ZTE in capturing lung density of patients with lung diseases at reasonable clinical imaging times compared to standard MR lung protocols (LAVA-Flex, PROPELLER). Secondly, we want to investigate if Hyper-Cones \& ZTE can be used for lung imaging such as vessels and air-pathways, oncological patients, lung nodules and lung infiltration \& parenchyma pathophysiology such as chronic obstructive pulmonary disease.

Eligibility criteria: Inclusion Criteria:

* informed consent and signature
* clinical PET/CT planned and performed at Wagi site in Schlieren
* male or female patients
* from 18 to 80 years of age.

Exclusion Criteria:

- same exclusion criteria as for the clinical PET/CT exam (i.e. pregnant women).

Additional exclusion criteria:

- standard exclusion criteria for clinical MRI (evaluated by clinical standard determined by MRI questionnaire).

Primary outcomes:
measure: Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Nuclear Medicine
Study officials:
affiliation: University Hospital, Zürich
name: Martin Huellner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04212806: French Validation of Axial Spondyloarthritis Questionnaires (Val-SpA)
Official title: French Linguistic Validation of Questionnaires for Patients With Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Ankylosing Spondylitis
Keywords: Validation
BASFI
Dougados Functional Index
BAS-G
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
First posted: 2019-12-30
Enrollment: 5
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: Patient with Ankylosing Spondylitis or Axial Spondyloarthritis at any stage of disease evolution followed at the Rhumatology unit of Grenoble University Hospital

Brief summary: The aim is to do a French linguistic validation of three questionnaires used in axial Spondyloarthritis (BASFI, BAS-G, Dougados Functional Index).

In order to validate the questionnaires, a prospective, qualitative, observational and monocentric study will be conducted.

Detailed description: Axial spondyloarthritis (SpA) is a chronic rheumatic diseases affecting axial skeleton and sacro-iliac joints. SpA can have functional consequences, often assessed with the Bath Ankylosing Spondylitis Functional Index (BASFI), the Dougados functional index, or more globally with the Bath Ankylosing Spondylitis Global (BAS-G). If these questionnaires are validated in English, there are not validated in French. The aim is to do a french linguistic validation of these questionnaires.

A translation, reconciliation and retro-translation will be conducted for each of the questionnaires by two bilingual translators. The last version of each questionnaire will be then validated by clinicians experts in SpA. The version will be further validated by 5 patients. If necessary and if changes occured on the version of the questionnaire, another version will be validated by 5 other patients until full understanding is obtained.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with axial spondyloarthritis or ankylosing spondylitis

Exclusion Criteria:

* Patients who do not understand French
* Patients with cognitive impairments
* People protected by law
* People who do not want to participate

Primary outcomes:
measure: BASFI validity in French
timeFrame: Day 0
measure: BAS-G validity in French
timeFrame: Day 0
measure: Dougados validity in French
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
References:
citation: Soulard J, Vaillant J, Baillet A, Vuillerme N. Translation and French Linguistic Validation of the Bath Ankylosing Spondylitis Functional Index and the Bath Ankylosing Spondylitis Global Score in Patients with Axial Spondyloarthritis. Curr Rheumatol Rev. 2023;19(4):449-454. doi: 10.2174/1573397118666220829124234.