louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04484402: Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
Official title: Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Limbal Stem Cells (Corneal Epithelial Stem Cells) or Adipose-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Corneal Ulcer
Corneal Disease
Corneal Dystrophy
Keywords: Corneal Disease
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
First posted: 2020-07-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells

Detailed description: In order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of cultured autologous stem cells are performed. Corneal (limbal) epithelial stem cells (LSC) or mesenchymal stem cells derived from adipose tissue (ADSC) are mixed with sodium hyaluronate 1%

Eligibility criteria: Inclusion Criteria:

* inflammatory-dystrophic diseases of the cornea:

  1. Epithelial defects of the cornea, ulcerative keratitis of various etiology, resistant to standard methods of treatment
  2. Dystrophic diseases of the cornea, accompanied by edema
  3. Burns of the cornea
  4. Neurotrophic forms of keratitis
  5. Persistent post-traumatic, postoperative, contusion keratitis and keratopathy

Exclusion Criteria:

1. Pregnancy.
2. Viral hepatitis B and C, HIV, tubeculosis and other chronic viral and bacterial infections.
3. Cancer or leukemia
4. Any diseases in the stage of decompensation.
5. Mental disorders.
6. Anomalies of eye refraction

Primary outcomes:
measure: Number of cured patients
timeFrame: 2 month
measure: Number of patients with treatment-related adverse events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
name: Igor Volotovski, Prof
role: STUDY_DIRECTOR
affiliation: Head of the Department of eyes diseases of Belarusian State Medical University
name: Liudmila Marchenko, Prof
role: STUDY_DIRECTOR
affiliation: Leading researcher, Institute of Biophysics and Cell Engineering
name: Zinaida Kvacheva
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00546702: Glulisine + Lantus in Type I Patients
Official title: Multicenter, Open, Non-Randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine During 26 Weeks of Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.


Eligibility criteria: Inclusion Criteria:

* Adult men and women (\>18 years) with type I diabetes mellitus (onset of diabetes under the age of 40)
* An HbA1c range of \>6.5 - \<11%
* And on multiple injection regimen (more than 1 year of continuous insulin treatment)
* Body mass index \<35.

Exclusion Criteria:

* Active proliferative diabetic retinopathy
* Diabetes other than type I diabetes mellitus
* Pancreatectomised subjects
* Subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine
* Hypersensitivity to insulin
* Major systemic diseases
* Impaired hepatic or renal function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change of HbA1c.
timeFrame: from baseline to endpoint.
Secondary outcomes:
measure: Change in HbA1c.
timeFrame: from baseline (week 1) to weeks 12 and 26
measure: Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.
timeFrame: from baseline to endpoint.
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Olga Efremenkova
role: STUDY_DIRECTOR
References:
Clinical trial NCT06812702: Parkinson's Disease Biomarker Study
Official title: A Multi-site Longitudinal Cohort Study of Prodromal and Clinical Parkinson'sDisease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease, Idiopathic
REM Sleep Behavior Disorder
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 295
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male or female over age 40, ability to follow protocol

Brief summary: The primary objective of this study is to determine whether data acquired from a remote monitoring approach can reliably identify and track motor symptoms in prodromal PD and clinical PD.

The study is a one-year longitudinal biomarker study recruiting idiopathic RBD patients, Parkinson's Disease patient and healthy controls. All participants receive a smartphone with the Roche PD Mobile Application, complete a number of active tests daily and their movements will be remotely monitored. Participants will undergo additional neurological exams and DaT-SPECT and MRI imaging in the study.

A second objective of this study will be to validate an immunohistochemistry skin biopsy assay for the detection of pathological alpha-synuclein diagnostic of PD, in the peripheral nerves of the skin.


Eligibility criteria: Inclusion Criteria:

* signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria

Exclusion Criteria:

* participation in interventional clinical study within 3 months of screening, moderate to severe depression in judgement of the investigator, any concomitant disease, condition or treatment which may interfer with the conduct of study (determined by investigator), additional group-specific exclusion criteria

Primary outcomes:
measure: Digital Biomarkers
timeFrame: 12 months
Secondary outcomes:
measure: alpha-synuclein deposition in skin biopsy
timeFrame: 12 months
measure: Changes in sensor-based measurements and passive monitoring
timeFrame: 12 months
measure: Correlation of sensor-based measurements and imaging outcomes
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Pacific Parkinson's Research Centre
state: British Columbia
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: The Neuro
state: Quebec
city: Montreal
country: Canada
facility: The Neuro
state: Quebec
city: Québec
country: Canada
facility: Centre de recherche du CHU de Québec-Université Laval (CHUQ)
Study officials:
References:
Clinical trial NCT04477902: Long-Term Experience and Health Effects of COVID-19
Official title: A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Corona Virus Infection
Quality of Life
Risk Reduction
Keywords: covid-19
corona virus
covid19
coronavirus
SARS-CoV-2
infection
household
transmission
vaccine
clinical trials
online
Altura
outpatient
telemedicine
Lead sponsor: Altura
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone in the USA can participate in this study that meets inclusion criteria. To ensure diversity urban, suburban and rural areas of the country will be included.

Brief summary: The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.

Detailed description: Ths is a longitudinal, observational, descriptive study to gather data needed to support a better understanding of COVID-19 from the perspective of a diverse national population.

This multi-phase study will use an action research approach to identify specific ways that physician groups, federally qualified health centers (FQHCs), public health departments, and other health and social services systems in the United States can address healthcare needs and mitigate the transmission of COVID-19. Email surveys will be used to assess the historical and current status of participants by medical condition, geography, and demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever, loss of sense of taste or smell, etc.) and their current psychosocial needs.

The study will provide the structure for an iterative exploration of trends over time (up to 24 months). The opt-in survey will be posted and available to individuals 18 and older who choose to participate. Survey frequency will be every two weeks.

To analyze broader trends, all survey responses will be de-identified and aggregated. Overall general findings will not be linked to individuals or physician groups when reporting and publishing study results.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Any gender specification
* Has consented to proceed with survey
* Is able to complete the survey via email on a regular basis

Exclusion Criteria:

* none

Primary outcomes:
measure: Longitudinal survey
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Altura
state: California
Study officials:
affiliation: Altura
name: Pete Fronte, MBA
role: STUDY_CHAIR
References:
Clinical trial NCT02793102: Sensory Workshops and Anorexia Nervosa
Official title: Prospective Evaluation of a Year of Therapeutic Impact Sensory Workshops on Body Mass Index in Anorexia Adolescent Mental
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anorexia
Keywords: mental anorexia
sensory workshops
BMI
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: In the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.

Detailed description: As part of the unit that specializes in eating disorders in adolescents, we see patients decreased taste and smell sensory abilities. Since 2006, we have implemented various sensory workshops: olfactory, tactile-kinesthetic and auditory. The establishment of this therapeutic practice that is centered on oral sphere and all respect, it was observed a decrease of 30% of the length of hospitalization. All the data we currently have in the field, suggests a rehabituation food odors and facilitate the recall of memories related to food in anorexic patients. However in the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of anorexia nervosa according to DMS IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria.
* Follow Outpatient care or hospitalization
* Able to respond to the clinical evaluation questionnaires
* Affiliated to the social security system
* Consentement Informed of the legal representative and the patient

Exclusion Criteria:

* Somatic comorbidity associated diabetes, celiac disease, brain tumor.
* Intolerance Odors, predisposition to develop asthma and / or respiratory allergies.
* Pathologie Chronic of nose and sinus.
* Hyposmic Or anosmic.

Primary outcomes:
measure: Assess the impact of sensory workshops on BMI Body Mass Indexat 6 months and 12 months
timeFrame: Comparaison to baseline and 6 month after and maintenance at month 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondation Lenval
name: Florence ASKENAZY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01617902: Hyperbilirubinemia After Cardiac Surgery
Official title: Hyperbilirubinemia After Major Cardiac or Thoracic Aorta Surgery: Predictors and Clinical Significance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Keywords: Hyperbilirubinemia
cardiac
surgery
aorta
prognosis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 1000
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: Patients undergoing elective major cardiac or thoracic aorta surgery

Brief summary: This study aims to evaluate the incidence and risk factors of hyperbilirubinemia following major cardiac or thoracic aorta surgery, and to determine the clinical impacts of the hyperbilirubinemia on postoperative mortality and morbidity.

Detailed description: Patients receiving elective cardiac or thoracic aorta surgery will be monitored for the development of postoperative hyperbilirubinemia. Collection of data will include patient baseline demographic characteristics, laboratory and echocardiographic findings, procedural factors of the surgery, and early postoperative variables. Serial postoperative liver function testings will be done during the hospitalization. Postoperative hyperbilirubinemia is defined as serum bilirubin level of 3mg/dL.

Eligibility criteria: Inclusion Criteria:

Patients aged over 18 years who are scheduled to undergo elective major cardiac or thoracic aorta surgery. Major cardiac surgery includes coronary artery bypass grafting, pericardiectomy and corrections of cardiac diseases using cardiopulmonary bypassing (valve surgery, tumor excision, arrhythmia surgery, heart transplantation, ventricular reconstruction, pulmonary thromboembolectomy, and atrial or ventricular septal defects closure).

Exclusion Criteria:

1. univentricular or one-and-half ventricle repairs
2. presence of known liver cirrhosis or hepatic cancer
3. history of liver transplantation
4. Genetic diseases that affects bilirubin metabolism (i.e. Gilbert syndrome)
5. preoperative bilirubin level of 3mg/dL or more.

Primary outcomes:
measure: All cause-death
timeFrame: Within 30 days after surgery or during postoperative hospitalization
Secondary outcomes:
measure: gastrointestinal or hepatobiliary complications requiring intervention
timeFrame: Within 30 days after surgery or during postoperative hospitalization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joon Bum Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04935502: Home Based Exercises With and Without Posture and Ergonomics Training Among Students During COVID-19
Official title: Effects of Home Based Exercises With and Without Posture and Ergonomics Training on Pain and Physical Activity Level Among Students With Musculoskeletal Pain Due to COVID-19 Pandemic: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Musculoskeletal Pain
posture
ergonomic
exercise
Covid-19
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of exercises with and without postural and ergonomic training among the students returning to university after quarantine due to COVID-19.

Detailed description: Postural awareness and ergonomic trainings are approaches that can help to relive pain among patients with Musculoskeletal complaints. The purpose of this study was to investigate the effects of posture and ergonomics training for students receiving distance education during the Covid-19 pandemic on musculoskeletal pain and physical activity level

Eligibility criteria: Inclusion Criteria:

1. Participant's using gadget like computer, mobile or laptop for online education during quarantine.
2. Participant's having musculoskeletal pain during COVID-19 quarantine.
3. Prolonged sitting and low physical activity during quarantine.
4. Prolonged exposure of screen more than 6 hours per day due online classes during the quarantine.

Exclusion Criteria:

1. Participant's having musculoskeletal pain before the quarantine.
2. Participant's doing any type of physical activity during quarantine.
3. Participant's taking online classes or any online educational program before quarantine.
4. Participant's with known congenital, inflammatory and infectious conditions of spine.
5. Participant's following any ergonomic recommendations or any postural awareness during and after quarantine.

Primary outcomes:
measure: Visual analogue scale (VAS).
timeFrame: 4 Weeks
measure: Extended Nordic Musculoskeletal (NMQ-E).
timeFrame: 4 Weeks
measure: International Physical Activity Questionnaire Short Form (IPAQ-SF).
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT00934102: Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses
Official title: Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2009-07-08
Enrollment: 57
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.


Eligibility criteria: Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
* Has had an ocular examination in the last two years
* Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
* Has clear corneas and no active ocular disease
* Can be successfully fit with the lenses to be used in the study
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* Is pregnant or lactating
* Has undergone corneal refractive surgery
* Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Front Surface Lens Deposits
timeFrame: Period 2, Day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research: University of Waterloo
state: Ontario
Study officials:
References:
Clinical trial NCT05631002: Chemical Shift Encoding-based Water-fat Magnetic Resonance Imaging in Spinal Tumors
Official title: Chemical Shift Encoding-based Water-fat Magnetic Resonance Imaging in Spinal Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Tumor
Bone Tumor
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with spinal tumors

Brief summary: Fat composition of the spinal tumors is positively correlated with classification and differential diagnosis of benign and malignant tumors.

Detailed description: Chemical shift encoding-based water-fat magnetic resonance imaging (MRI) is a non-invasive method that provides quantitative information about the biochemical water-fat composition of bone marrow and skeletal muscle in vivo.

Eligibility criteria: Inclusion Criteria:

* Pathological biopsy of a patient with diagnosed spinal tumor lesion, and preoperative examination Chemical shift encoding-based water-fat MRI was performed.

Exclusion Criteria:

* Recurrent neoplasms; Lesion diameter \< 1 cm; Poor image quality.

Primary outcomes:
measure: Type of tumor
timeFrame: One month before treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Ning Lang
role: STUDY_CHAIR
References: