louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03983122: Outcomes of Laparoscopic Sleeve Gastrectomy
Official title: Long Term Outcomes of Laparoscopic Sleeve Gastrectomy: First Five Years' Results of a Single Center From a Developing Country
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Laparoscopic Sleeve Gastrectomy
Obesity, Morbid
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess 5 year long-term outcomes of laparoscopic sleeve gastrectomy emphasizing weight loss and modification of comorbidities such as type 2 diabetes mellitus, hypertension and gastroesophageal reflux disease from a developing country, Turkey. Prospectively-collected patient data will retrospectively reviewed. To measure the efficacy of the procedure, we will calculate the excess weight loss percentage (EWL %). Effective weight loss after LSG will accepted as more than 50%. The changes in the status of the type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease will be observed.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were, patients between 18 to 65 years old, initial body mass index (BMI) 40 kg/m2 or BMI of 35 kg/m2 in the presence of additional comorbidity and failure of conservative treatment for 2 years.

Exclusion Criteria:

* None

Primary outcomes:
measure: Weight loss
timeFrame: 5 years
Secondary outcomes:
measure: Remision of comorbid diseases
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03381222: Risk Factors of Ascending Aortic Atheromatous
Official title: Risk Factors of of Ascending Aortic Atheromatous Plaque in Thai Cardiac Surgical Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ascending Aortic Atheromatous Plaque
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 239
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age ≥ 18 years and schedule to cardiac surgery with sternotomy.

Brief summary: Background Incidence of perioperative stroke In cardiac surgery is 2.6-5.2%. Ascending aortic atheromatous plaque and stroke are strongly associated.

Propose of study To determine incidence of ascending aortic atheroma in Thai people To identify risk factors which associated with ascending aortic atheroma

Methodology After received standard general anesthesia and start sternotomy. Epiaortic scan will be performed by surgeon use L15-7i Phillips® ultrasound probe cover with sterile cover.

Five standard epiaortic views will be collected. Epiaortic clips will be review and determine about atheroma by two qualified echocardiographers. Atheroma more than third grade will defined to significant. Potential risk factors of atheroma will be gather from medical record

To assess the relationship between risk factors and atheroma a univariate analysis was performed using an unpaired t-test and a Chi-square test.

For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.


Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years Schedule to cardiac surgery with sternotomy

Exclusion Criteria:

Abnormal ascending aortic anatomy such as: dissection, aneurysm

Primary outcomes:
measure: Incidence of ascending aortic atheromatous plaque in Thai population
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: faculty of medicine Siriraj hospital
state: Bangkok
Study officials:
References:
Clinical trial NCT00395122: Optical Coherence Tomography Measurements in Eyes With Band Atrophy
Official title: Evaluation of the Diagnostic Ability of Optical Coherence Tomography With a Normative Database to Detect Band Atrophy of the Optic Nerve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Disorders
Keywords: Band Atrophy
Optical Coherence Tomography
Scanning Laser Polarimetry
Chiasmal Lesions
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2006-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study is designed to evaluate the ability of optical coherence tomography and VCC scanning laser polarimetry to measure and identify the pattern of band atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is that these new technologies are able to identify such pattern. The idea is that by using eyes with band atrophy one is able to investigate the ability of the new technologies in measuring the retinal nerve fiber layer particularly in the nasal and temporal portions of the optic nerve.


Eligibility criteria: Inclusion Criteria:Patients with long standing chiasmal lesions and temporal visual field defect with the following criteria:

1. Visual acuity better than 20/30
2. Refractive error less 5 spherical diopter and 3 cylinder diopter
3. Temporal field defect

Exclusion Criteria:

1. Presence of glaucoma and optic nerve anomalies
2. Anormal nasal field

Primary outcomes:
measure: Retina nerve fiber layer measurements
measure: Macular thickness measurements
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Mário LR Monteiro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moura FC, Costa-Cunha LV, Malta RF, Monteiro ML. Relationship between visual field sensitivity loss and quadrantic macular thickness measured with Stratus-Optical coherence tomography in patients with chiasmal syndrome. Arq Bras Oftalmol. 2010 Sep-Oct;73(5):409-13. doi: 10.1590/s0004-27492010000500004.
Clinical trial NCT01487122: Microwave Diathermy for Treating Nonspecific Chronic Neck Pain
Official title: Microwave Diathermy for Treating Nonspecific Chronic Neck Pain. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Diathermy
Neck Pain
Lead sponsor: Health Service of Andalucia
Sponsor class: OTHER_GOV
First posted: 2011-12-07
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomised controlled trial aims to compare the effect of microwave diathermy (continuous and pulsed modes) with sham microwave diathermy in nonspecific chronic neck pain patients. Every patient will also be treated by exercise and transcutaneous electrical neurostimulation (TENS). The primary endpoint is to establish whether the use of microwaves is justified in terms of pain relief or reduction of disability in this patients.


Eligibility criteria: Inclusion Criteria:

* to be between 18 and 65 years old
* to be diagnosed with chronic nonspecific neck pain (i.e. during more than 3 months in the absence of red flags (unexplained weight loss, fever, neurological signs, history of cancer, history of inflammatory conditions...)

Exclusion Criteria:

* pregnancy
* sick leave
* litigation
* claims because the neck pain.

Primary outcomes:
measure: Change from baseline in pain at six months
timeFrame: Baseline. At three weeks. At six months
measure: Change from baseline in neck disability at six months
timeFrame: Baseline. At three weeks. At six months
measure: Change from baseline in quality of life at six months
timeFrame: Baseline. At three weeks. At six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Juan A Andrade Ortega, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05019222: Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam
Official title: Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During General Anesthesia in the Cervical Spine Surgery Patients: Sevoflurane vs. Remimazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cervical Discectomy and Fusion (ACDF) Surgery
Keywords: Cervical surgery
Quality of Recovery
Remimazolam
sevoflurane
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the cervical spine surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of the investigators study is that, in patients with cervical spine surgery, total intravenous anesthesia based on remimazolam can improve the the quality of recovery compared to inhalation anesthesia based on sevoflurane.


Eligibility criteria: Inclusion Criteria:

* Adult patients who aged 20-70 years
* ASA-PS: 1-3
* BMI \< 30
* Anterior cervical discectomy and fusion surgery

Exclusion Criteria:

* Tolerance or hypersensitivity to benzodiazepine
* Dependence or addiction to psychotropic drugs or alcohol
* Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions

Primary outcomes:
measure: The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores
timeFrame: postoperative day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Myung Hwa Kim
Study officials:
References:
Clinical trial NCT02878122: Study of Predictive Factors of Chemoresistance in Ovarian Cancer
Official title: Study of Predictive Factors of Chemoresistance in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: ovarian cancer
chemo resistance
predictive factors
cohort study
bio bank
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epithelial ovarian cancer

Brief summary: Epithelial ovarian cancer (EOC) has a poor prognosis. EOC management requires debulking surgery and chemotherapy based on taxol and carboplatine. Initial response is often good, but most often a recurrence occurred in the first 18 months. Early recurrence signs chemoresistance and palliative treatment. The study of predictive clinical or biological factors is required to adapt therapeutic and develop new treatments.


Eligibility criteria: Inclusion Criteria:

* patient \> 18 years of age
* patient with histological proven epithelial ovarian cancer

Exclusion Criteria:

* patients who can not give their own consent
* patients without ovarian cancer

Primary outcomes:
measure: Chemoresistance defined by clinical recurrence
timeFrame: 6 months after the end of chemotherapy
measure: Chemoresistance defined by biological recurrence
timeFrame: 6 months after the end of chemotherapy
measure: Chemoresistance defined by radiological recurrence
timeFrame: 6 months after the end of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: LAVOUE
Study officials:
affiliation: Rennes University Hospital
name: LAVOUE Vincent, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01814722: Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)
Official title: Quality of Life of HIV-infected Patients Switched to Raltegravir Versus Other Antiretroviral Regimens
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Human Immunodeficiency Virus
Keywords: HIV Infections
Anti-HIV Agents
Anti-Retroviral Agents
Nucleoside Reverse Transcriptase Inhibitors
Non-nucleoside Reverse Transcriptase Inhibitor
Protease inhibitors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-03-20
Enrollment: 63
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: HIV patients at academic and community-based practices in the United States

Brief summary: This is a multi-center, longitudinal observational study of adult human immunodeficiency virus (HIV) participants at academic and community-based practices in the United States who are switching from first-line to second-line therapy. The study's primary hypothesis is that HIV participants switching to raltegravir-based regimens will have better Medical Outcomes Study-HIV (MOS-HIV) Health Survey scores than participants switched to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based or protease inhibitor (PI)-based regimens.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of HIV
* Switching antiretroviral regimen(s) for the first time at the start of the study

Exclusion Criteria:

* Currently pregnant
* Presence of active tuberculosis, Hepatitis B, and/or Hepatitis C and receiving treatment for the condition(s) during the study period
* Presence of active pneumonia or other signs of opportunistic infections at the start of the study
* Currently participating in a clinical trial

Primary outcomes:
measure: Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores
timeFrame: Week 4 Follow-up
Secondary outcomes:
measure: Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Baseline and Week 4 Follow-up
measure: Change From Baseline in HIV Symptom Index (HIV-SI)
timeFrame: Baseline and Week 4 Follow-up
measure: Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and Week 4 Follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00222222: Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Official title: Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: severe sepsis
prognostic markers
polymorphisms
SIRS
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aims of the study were to find vascular markers of inflammation and endothelial damage during the course of severe sepsis in septic patients and the effects of treatment with anti-inflammatory medication (such as Drotregocin alfa (activated)). Another aim is to find new markers and gene polymorphisms for prognosis and mortality of patients with severe sepsis. The hypothesis is that higher plasma concentrations of certain markers in septic patients are associated with a higher mortality rate.

Detailed description: During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Human activated protein C (Drotrecogin alfa (activated)), an important coagulation inhibitor plays a major role in regulating microvascular coagulation, inflammation and immunology. Little is known about prognostic vascular biomarkers during the time course of patients with severe sepsis.

Eligibility criteria: Inclusion Criteria:

* SIRS-Criteria
* Proven Infection
* One sepsis-induced organ-failure
* Adults \<18 years old

Exclusion Criteria:

* Anemia
* Pregnancy
* Blood donor in the last 3 month

Primary outcomes:
measure: New Prognostic markers for septic patients
timeFrame: until 300 Patients are included
Secondary outcomes:
Other outcomes:
Locations:
city: University hospital Mannheim
country: Germany
facility: 1. Medical Department
state: Mannheim
Study officials:
affiliation: First Department of Medicine, University Medical Centre Mannheim
name: Ursula Hoffmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Centre Mannheim
name: Michael Behnes, MD
role: STUDY_CHAIR
References:
citation: Behnes M, Brueckmann M, Lang S, Putensen C, Saur J, Borggrefe M, Hoffmann U. Alterations of leptin in the course of inflammation and severe sepsis. BMC Infect Dis. 2012 Sep 14;12:217. doi: 10.1186/1471-2334-12-217.
Clinical trial NCT05643222: Performance of Red Tinted Contact Lenses on Colour Defects
Official title: The Performance of Red Tinted Contact Lenses of Various Tones on Colour Deficient Subjects: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Color Vision Defects
Color Blindness
Keywords: Anomalous Trichromats
Color Vision Defect
Contact Lenses
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6 colour defect subjects eye were inserted with 4 different types of red tinted contact lenses at different times and then tested with Ishihara Test and 100 Hue Test to obtain the score values. This was done only on one non dominant eye of subject.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aimed to relate and compare the performance of 4 types of red-tinted contact lenses (CL) with the Total Error Score (TES) from the Farnsworth-Munsell 100 Hue test on colour deficient subjects. Only 6 subject with colour vision defect was tested in this study.

Detailed description: Six congenital CVD subjects were recruited. After colour vision screening using Ishihara plate, the Farnsworth-Munsell 100 Hue test was carried out to determine the type and severity of colour vision deficiency. Four types of red-tinted CL (Type A, B, C and D) were used. The performance of each of these lenses was determined through the comparison of error scores in the Ishihara test before and after wearing tinted contact lens on only the non-dominant eye. Then, the transmittance of each tinted CL was determined using a spectrophotometer. All these lenses were fitted on the subjects in one day where the subjects were given a 30-minute break for each intervention.

Eligibility criteria: Inclusion Criteria:

* Age range 18-40 years
* all sex
* color defect diagnosed with Ishihara Test
* no contraindication in contact lens wear

Exclusion Criteria:

* have ocular and systemic diseases

Primary outcomes:
measure: The lens which gives the best result in TES value
timeFrame: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed.
measure: The lens which gives the best performance in ES value
timeFrame: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Optometry Clinic
Study officials:
affiliation: UKM
name: Haliza Abdul Mutalib, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cole BL, Lian KY, Lakkis C. Using clinical tests of colour vision to predict the ability of colour vision deficient patients to name surface colours. Ophthalmic Physiol Opt. 2007 Jul;27(4):381-8. doi: 10.1111/j.1475-1313.2007.00493.x.
Clinical trial NCT04807322: Reverse Total Shoulder Arthroplasty in Patients Who Exceeded Their Life-expectancy: a Retrospective Study
Official title: Reverse Total Shoulder Arthroplasty in Patients Who Exceeded Their Life-expectancy: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reverse Total Shoulder Arthroplasty
Keywords: reverse total shoulder arthroplasty
RTSA
elderly
proximal humerus fracture
cuff arthropathy
outcome
complications
Lead sponsor: Bürgerspital Solothurn
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 110
Sex: ALL
Minimum age (years): 83
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have already exceeded their life-expectancy (83 years in Switzerland)

Brief summary: Reverse total shoulder arthroplasty (RTSA) has become an established treatment for cuff arthropathy, severe osteoarthritis and in certain fracture cases. Due to the increasingly aging population, patients who have already exceeded their life-expectancy pose a significant challenge to the shoulder surgeon. Therefore, we wanted to investigate patient demographics, hospital stay length, complication rate functional outcome, patient reported outcome scores and mortality retrospectively for patients, who were older than 83 years at time of implantation of a RTSA.

Detailed description: This is a retrospective single institution study. All patients older than 83 years who received a reverse shoulder arthroplasty from 2008 until 2019 are included. Elective cases are compared to fracture cases (patient demographics, length of hospital stay, complication rate, functional outcome, patient reported outcome scores and mortality).

Eligibility criteria: Inclusion Criteria:

* Patients older than 83 years at time of surgery
* Patients who received a reverse total shoulder arthroplasty

Exclusion Criteria:

* Patients younger than 83 years at time of surgery

Primary outcomes:
measure: Patient reported outcome score: ASES
timeFrame: until august 2020
measure: Complication rate
timeFrame: until august 2020
measure: Quality adjusted life year (QALY)
timeFrame: until august 2020
measure: Mortality
timeFrame: until august 2020
measure: Patient reported outcome score: QuickDASH
timeFrame: until august 2020
measure: Patient reported outcome score: VAS
timeFrame: until august 2020
Secondary outcomes:
measure: Patient demographics
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn
Study officials:
affiliation: Bürgerspital Solothurn
name: Mai Lan Dao Trong, MD
role: PRINCIPAL_INVESTIGATOR
References: