louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02512432: INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
Official title: INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Keratoconus
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To join established study put on by Addition Technologies, Inc. in the surgical implantation of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.

Detailed description: Use of asymmetrical corneal inserts to reduce or eliminate myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplantation may potentially be deferred.

Eligibility criteria: Inclusion Criteria:

* 21 years of age, or older
* have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
* have clear central corneas
* have a corneal thickness of 450 microns or greater at the proposed incision site
* have corneal transplantation as the only remaining option to improve their visual function

Exclusion Criteria:

* under 21 years of age
* have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
* do not have clear central corneas
* do not have a corneal thickness of 450 microns or greater at the proposed incision site
* do not have corneal transplantation as the only remaining option to improve their visual function

Primary outcomes:
measure: Corneal mapping to measure corneal thickness and steepening
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego, Shiley Eye Institute
name: Christopher Heichel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533337: Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
Official title: Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Injury
Digital Pulp Defect
Keywords: dorsal digital free flap
dorsal branch of proper digital nerve
dorsal branch of proper digital artery
proper digital artery
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2012-02-15
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured.

Detailed description: Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured. The data were compared with those of the contralateral, uninjured hand.

Eligibility criteria: Inclusion Criteria:

1. soft tissue defects in the fingertip, pulp, or volar surface of the digits;
2. a defect \> 2 cm in length;
3. unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and
4. the patient refuses to use tissues from the toe.

Exclusion Criteria:

1. soft tissue defects in the dorsum of the digits;
2. a defect \< 2 cm in length;
3. homodigital and heterodigital island flaps are available.

Primary outcomes:
measure: static 2-point discrimination (2PD) test
timeFrame: 25 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01294137: Sleep Apnea in Frail Elderly
Official title: Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing
Sleep Apnea
Keywords: frail
elderly
hospitalized
sleep apnea
oximetry
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 80
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be different than in the youngest people, and its consequences might be severe and atypical (falls, functional and cognitive decline).

Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this study is to evaluate the accuracy of oximetry for detection of respiratory disturbances in sleep apnea in the hospitalized elderly.

Detailed description: Main goal: to define the more specific and sensitive cut-off of variability index of the oximetry to detect sleep apnea in the hospitalized elderly.

Secondary goals:

* sleep apnea prevalence in the elderly
* accuracy of other oximetry parameters (saturation line, oximetry desaturation index, autonomic arousals) for detection of respiratory disturbances in sleep apnea in the hospitalized elderly
* to determine the clinical and biological data associated with sleep apnea in the hospitalized elderly
* to determine the factors associated with the record failures and its prevalence
* to study the prevalence of the Periodic Limb Movements of Sleep in the hospitalized elderly

Study design: simultaneous records by oximetry and ventilatory polygraphy with tibial EMG in the hospitalized elderly in a geriatric readaptation unit.

Eligibility criteria: Inclusion Criteria:

* age \> 75 ans
* affiliation to the French health care system

Exclusion Criteria:

* hypoxemia with oxygenotherapy
* already known and treated sleep apnea syndrome
* mild to severe dementia (MMSE\<18/30)
* nocturnal neurpsychological disturbances
* acute organic failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Sylvie Maziere, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Gaëtan Gavazzi, MD PhD
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Catherine Bioteau, MD
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Pascal Couturier, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Renaud Tamisier, MD
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Sandrine Launois, MD
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Patrick Lévy, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Jean-Louis Pépin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03138837: Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage
Official title: Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage. Potential Role of the Apparent Diffusion Coefficient (ADC) Value
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Diagnoses Disease
Magnetic Resonance Imaging
Apparent Diffusion Coefficient
Keywords: Bladder cancer
Magnetic Resonance Imaging
Bladder Cancer Superficial
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment of participants from single tertiary centre outpatient clinic of Urology and Nephrology Center in Mansoura

Brief summary: assess diagnostic performance of 3-Tesla DW-MRI in detecting and staging bladder cancer and potential role of the ADC value as a biomarker reflecting histological grade and stage.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 years or older
* Suspected by the out-patient flexible cystoscopy as Non-muscle invasive bladder cancer.
* Patient who will undergo radical cystectomy.
* Patient with history of allergy to iodinated contrast media

Exclusion Criteria:

* Refuse to complete study requirements
* Patient with any of the following:

  1. Any metallic fragment or foreign body
  2. Coronary and peripheral artery stents
  3. Aortic stent graft
  4. Prosthetic heart valves and annuloplasty rings
  5. Cardiac pacemaker
  6. Implanted cardioverter-defibrillator (ICD)
  7. Retained trans venous pacemaker and defibrillator leads
  8. Cochlear, otologic, or other ear implant

Primary outcomes:
measure: assess the diagnostic performance of 3-T DW-MRI in detecting and staging bladder cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Urology and Nephrology center
name: Hassan Abol-Enein, MD
role: STUDY_CHAIR
affiliation: Urology and Nephrology center
name: Mohamed AboElghar, MD
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology center
name: Ahmed O. Mosbah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology and Nephrology center
name: Khaled Sheir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology and Nephrology center
name: Ahmed Elassmy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00087737: Study Evaluating DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-07-16
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with MDD.


Eligibility criteria: Inclusion Criteria:

* Outpatients.
* Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article
* Subjects must have a primary diagnosis of major depressive disorder

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or ER) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00281437: Health First-Study 2
Official title: Health First: Health and Psychological Outcomes of Physical Activity- Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Exercise Adherence
Sedentary Adults
Lifestyle
Traditional
Keywords: exercise
adherence
lifestyle
choice
autonomy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study was designed to investigate the influence of choice of exercise program on exercise adherence. The two exercise programs included 1) traditional exercise at a fitness centre or 2) lifestyle exercise-walking using a pedometer to track steps. Biological and psychological indicators were examined to investigate the effect of choice in a sample of sedentary adults.


Eligibility criteria: Inclusion Criteria:

* 25-65 year old adults
* sedentary (exercise less than twice per month in the last 4 months)

Exclusion Criteria:

* physician non-consent
* too active (exercise more than twice per month in the last 4 months)
* participated in previous studies from this lab

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Wendy M Rodgers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Gordon J Bell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Kerry Courneya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Vicki J Harber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02486237: Complications in Central American Diabetic Patients: Historic Cohort
Official title: Complications in Central American Diabetic Patients: Historic Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus
complications
prevalence
Lead sponsor: Clínica Los Yoses
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2015-07-01
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with type 2 diabetes mellitus

Brief summary: Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients.

Detailed description: This is retrospective observational study aimed to determine the prevalence of complications in Central American diabetic patients. Patients included are treated in the usual outpatient practice setting and we will try to determine the prevalence of diabetic complications in these patients.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus diagnosed between 2004 and 2009
* seen by the attending physician for the first time between January and December 2009.
* male or female patients between 18 and 80 years

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of patients with microvascular and cardiovascular complications
timeFrame: up to 10 years
Secondary outcomes:
measure: Number of participants with at least one episode of hypoglycemia
timeFrame: up to 10 years
measure: Number of patients with microvascular and cardiovascular complications stratified by their glucose control
timeFrame: up to 10 years
measure: Number of patients with microvascular and cardiovascular complications stratified by blood pressure control
timeFrame: up to 10 years
measure: Number of patients with microvascular and cardiovascular complications stratified by cholesterol levels
timeFrame: up to 10 years
measure: Number of patients with microvascular and cardiovascular complications stratified by diabetes pharmacologic treatment
timeFrame: up to 10 years
Other outcomes:
Locations:
city: San Pedro de Montes de Oca
country: Costa Rica
facility: Clínica Los Yoses
state: San José
city: San José
country: Costa Rica
facility: Hospital CIMA
city: San Salvador
country: El Salvador
facility: Centro Panamericano de Ojos
city: San Salvador
country: El Salvador
facility: INSACOR
city: San Salvador
country: El Salvador
facility: Medicentro La Esperanza
city: Guatemala
country: Guatemala
facility: Clínica 1005
city: Guatemala
country: Guatemala
facility: Prevención en Salud S.A
city: Tegucigalpa
country: Honduras
facility: Honduras Medical Center
Study officials:
affiliation: Clínica Los Yoses
name: Chih Hao Chen Ku, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482737: Clinical Impact of Red Cell Storage Age
Official title: Clinical Impact of Red Cell Storage Age: Individual Patient Data Meta-Analysis of Four Recent Large Randomized Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RBC Transfusions
Keywords: RBC transfusions
storage age
meta-analysis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 33000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects in the recent four RCTs who are 18 years or older and have received at least one RBC transfusion.

Brief summary: The recent four RCTs evaluating effects of RBC storage age on morbidity and mortality found no statistically significant adverse effects of longer stored RBC compared to shorter storage ages. Unfortunately, none of these RCTs had sufficient numbers of subjects receiving RBC at either storage age extreme to identify consequences of RBC transfusion at these limits. To better investigate effects of RBC storage age on clinical outcomes, this study will perform secondary meta-analyses of merged common patient data elements -individual patient data (IPD) meta-analysis (IPDMA) - from the nearly 33,000 subjects enrolled in the four RCTs.


Eligibility criteria: Inclusion Criteria:

* Received at least one RBC transfusion
* \>=18 years of age

Exclusion Criteria:

* N/A

Primary outcomes:
measure: All-cause mortality
timeFrame: 28 days after transfusion
measure: Hospital length of stay
timeFrame: after transfusion through 28 days
Secondary outcomes:
measure: All-cause mortality at 28 days for long-storage
timeFrame: 28 days after transfusion
measure: 28 day mortality for short-storage
timeFrame: 28 days after transfusion
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Marie Steiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059837: Clinical Analysis of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery
Official title: Retrospective Study of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Pterygium
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 116
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 116 patients were included. They had pterygium excision and conjunctival autograft surgery and followed by anterior photographs.

Brief summary: This study is conducted to evaluate its morphologic reproliferating patterns in patients with pterygium treated with the excision and conjunctival autograft.

Detailed description: The medical records of 116 eyes of 116 patients with pterygium who had pterygium excision and conjunctival autograft between February 2009 and May 2011 were reviewed. Using consecutively recorded photographs, we evaluated preoperative morphologic characteristics and its growth patterns.

Eligibility criteria: Inclusion Criteria:

* Recurrent pterygium
* Unilateral or bilateral pterygium
* Both male and female
* Consenting to participate in study

Exclusion Criteria:

* Fibrovascular proliferation secondary to injury
* Severe dry eye syndrome
* Pseudopterygium
* Signs of malignancy on pterygium
* Corneoscleral trauma or corneo-limbal scars

Primary outcomes:
measure: Pterygium recurrence pattern
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong Kyun Kim
state: Kyungangpookdo
Study officials:
affiliation: Kyungpook National University Hospital
name: Hong Kyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwon SH, Kim HK. Analysis of recurrence patterns following pterygium surgery with conjunctival autografts. Medicine (Baltimore). 2015 Jan;94(4):e518. doi: 10.1097/MD.0000000000000518.
Clinical trial NCT04980937: Peroneal Nerve Injury: a 20- Year Retrospective Case Series Study
Official title: Ski- and Snowboard Related Open Peroneal Nerve Injury: a 20- Year Retrospective Case Series Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Injury
Peroneal Nerve Injury
Sport Injury
Keywords: Ski accident
traumatic
peroneal nerve injury
reconstructive surgery
case series
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who suffered a peroneal nerve injury caused by the sharp edge of a ski or snowboard and required surgical intervention.

Brief summary: In a 20-year retrospective study, all skiers and snowboarders with a peroneal nerve injury at the fibular head treated surgically at the Department of Plastic, Reconstructive and Aesthetic Surgery at the Medical University of Innsbruck, Austria, were included. Covering a period from 1999/2000 to 2018/2019.

Detailed description: All data were gained in a clinical routine context, and the study design was retrospective. The work was approved by the local ethics committee of the Medical University of Innsbruck, Innsbruck, Austria (EK Nr.: 1300/2019). We reviewed medical charts from over a 20-year period, including all patients with a PNI after a ski- or snowboard-related accident requiring surgical intervention at the Department of Plastic, Reconstructive and Aesthetic Surgery of the Medical University of Innsbruck, Austria.

We analyzed the demographical data, including age, gender, and citizenship, as well as included variables concerning the winter sport activity (i.e., ski or snowboard, owned or rented, self-inflicted without collision or collision caused by another skier or snowboarder, professional or recreational athlete). We also analyzed the injury itself (i.e., PNI as main injury, open or closed, motoric, sensible or both, fracture, muscle injury, complete or incomplete transection), as well as the treatment.

Eligibility criteria: Inclusion Criteria:

* Skiers and snowboarders
* treated with a peroneal nerve injury at the fibular head
* time frame January 1999 to Dicember 2019

Exclusion Criteria:

* Different injury mechanism
* injury of a different nerve than peroneal nerve

Primary outcomes:
measure: Successful nerve reconstruction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: