louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01022281: Early Diagnosis in Glaucoma With GDxVcc
Official title: Evaluation of Scanning Laser Polarimetry Findings in Individuals With Exfoliation Syndrome Compared With Normal Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exfoliation Syndrome
Keywords: Exfoliation
Scanning Laser Polarimetry
Corneal Thickness
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with and without exfoliation

Brief summary: To compare the Retina Nerve Fiber Layer thickness, measured with Scanning Laser Polarimetry in subjects with exfoliation syndrome and normal controls and to evaluate the value of scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma

Detailed description: To compare the Scanning Laser Polarimetry findings in subjects with exfoliation syndrome and normal controls and to evaluate the value of scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma. Prospective study in progress. The investigators compare and analyze the scanning laser polarimetry parameters in consecutive subjects with exfoliation syndrome and normal intraocular pressure and compared them with consecutive normal controls. Randomly selected patients with exfoliation syndrome and normal controls undergo a comprehensive ophthalmic exam which includes 3 IOP measurements, corneal pachymetry, automated perimetry and assessment of the retina nerve fiber layer with scanning laser polarimetry. The investigators hypothesize that patients with exfoliation syndrome may show worse scanning laser polarimetry parameters than normal controls and this may prove to be an early sign of exfoliative glaucoma development. Evaluation of retina nerve fiber layer thickness may help us in identifying earlier those individuals with exfoliation syndrome that will develop exfoliative glaucoma.

Eligibility criteria: Inclusion Criteria:

* Exfoliation material on pupil
* Intraocular pressure below 21 mm Hg without therapy
* No glaucomatous damage
* Age between 60-75
* Open angle

Exclusion Criteria:

* Other Ophthalmic diseases
* Dry eye
* Corneal disorders
* Diabetic Retinopathy
* Optic Neuropathy (other than glaucomatous neuropathy)
* Ocular surgery or laser

Primary outcomes:
measure: Scanning laser polarimetry parameters, evaluation of retina nerve fiber layer thickness
timeFrame: Morning measurement (10:00 - 13:00)
Secondary outcomes:
measure: Corneal thickness, exfoliation syndrome subjects that will develop exfoliation glaucoma
timeFrame: 10:00-13:00
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Glaucoma Unit, 1st University Department of Ophthalmology
Study officials:
affiliation: 1st University Department of Ophthalmogy
name: Antonios T Dimopoulos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03080181: Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment
Official title: Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cushing Disease
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Pasireotide treatment is strictly associated with glucose metabolism impairment. The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose function in patients with Cushing's disease (CD).

Methods: Clinical and hormonal parameters, insulin secretion, evaluated by homostasis model assessment (HOMA-β) and by the area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test and insulin sensitivity, evaluated by the euglycemic hyperinsulinemic clamp, were evaluated in 12 patients with active CD before and after 12 months of pasireotide.

Circulating adipokines were evaluated in patients with CD compared to a matched group of 12 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* patients with active Cushing's disease.

Exclusion Criteria:

* pituitary radiotherapy treatment performed less than 5 years before pasireotide,
* pregnancy,
* women taking oral contraceptives,
* diabetes on GLP-1 analogues,
* DPP4 inhibitors or sulphonylureas treatment,
* intolerance to SSA,
* risk conditions for prolonged QT syndrome and severe liver o renal insufficiency.

Primary outcomes:
measure: Change of circulating adipokines levels
timeFrame: Change from baseline to 12 months of therapy
measure: Change of homeostasis model assessment (HOMA-β )
timeFrame: Change from baseline to 6 and 12 months of therapy
measure: Change of area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test
timeFrame: Change from baseline to 6 and 12 months of therapy
measure: Change of M value evaluated by the euglycemic hyperinsulinemic clamp
timeFrame: Change from baseline to 12 months of therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06153381: Virtual Rehabilitation Assistant Via Instant Messaging Communication to Promote Adherence to Rehabilitation After Reverse Shoulder Replacement
Official title: Herramienta de Procesamiento de Lenguaje Natural en Dispositivo móvil Inteligente Para Asegurar la Adherencia a la rehabilitación Domiciliaria en cirugías de Artroplastia Invertida de Hombro (NLP-PTAdherence)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Osteoarthritis
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
First posted: 2023-12-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: reverse shoulder replacement surgery is performed to improve the functionality and reduce pain of the affected shoulder. Now, it is necessary to carry out an appropriate rehabilitation process to optimize surgical results. The lack of health resources makes it essential for the patient to work autonomously once hospital rehabilitation is completed. But lack of adherence is one of the main barriers to recovery

Detailed description: The objective is to evaluate the effectiveness of a Chatbot that interacts with patients via instant messaging to supervise home rehabilitation and increase adherence. Conduct a feasibility study with a pilot sample

Eligibility criteria: Inclusion Criteria:

* Patients undergoing reverse shoulder replacement
* With a personal smartphone
* An instant messaging application installed
* Familiar with the use of such an application (i.e., at least three accessess per week)
* Able to write and read in the Spanish language

Exclusion Criteria:

* Condition, whether cognitive, neurological, integrative or musculoskeletal, that obviously prevents understanding or performing the exercises of the rehabilitation program or may pose a risk to the patient's health.

Primary outcomes:
measure: Shoulder disability
timeFrame: 0 weeks, 12 weeks
Secondary outcomes:
measure: Shoulder functionality
timeFrame: 0 weeks, 12 weeks
measure: Shoulder pain
timeFrame: 0 weeks, 12 weeks
measure: Quality of Life
timeFrame: 0 weeks, 12 weeks
measure: Number of sessions of rehabilitation completed
timeFrame: 12 weeks
Other outcomes:
Locations:
city: València
country: Spain
facility: Hospital Universitario y Politécnico La Fe
state: Valencia
Study officials:
References:
Clinical trial NCT00533481: Efficacy of MK0557 in Combination With Sibutramine or Orlistat (0557-015)(COMPLETED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Study medicine will be given alone, or in combination with either sibutramine or orlistat, to obese subjects to compare the effect on body weight over a six month period.


Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 18-65 who are considered obese (have a body mass index between 30 and 43)

Exclusion Criteria:

* Subject has high blood pressure or is taking any high blood pressure medicine
* History of psychiatric disorder, stroke, or heart disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05331781: Ultrasound-Guided TAP Block and Spinal Morphine for Pain Relief After Caesarean Section
Official title: Comparative Study Between Ultrasound-Guided Transversus Abdominis Plane Block and Spinal Morphine for Pain Relief After Elective Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: Ultrasound-Guided Transversus Abdominis Plane Block, Morphine, Caesarean section
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This interventional double-blind randomized controlled study was carried out on 60 cases underwent elective caesarean section delivery, they were divided into 2 groups; patients were randomly allocated into two equal groups; Group M: received intrathecal 150 microgram morphine in a 0.5 ml volume, mixed with 10 mg of hyperbaric bupivacaine 0.5 % in a 2 ml volume (total volume 2.5 ml). Group B: received intrathecal 10 mg hyperbaric bupivacaine 0.5% 2ml volume + 0.5 saline (Total volume 3ml) and at the end of surgery patient received bilateral TAP block with 20 ml volume of 0.25% bupivacaine on each side.


Eligibility criteria: Inclusion Criteria:

* pregnant females scheduled for elective cesarean section

Exclusion Criteria:

* Patient refusal Patients with known allergies or with past history of allergy to local anesthesia Patients having an infection at the site of injection either in the back or in the abdominal region, Patients with coagulopathy or on systemic anticoagulation, Chronic opioid abuse, significant neurological, psychiatric or neuromuscular disease, Drug abuse and alcoholism, Obesity (BMI 30 and higher), Cardiovascular disease and Endocrine disorders.

Primary outcomes:
measure: prevention of post-operative pain
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
References:
Clinical trial NCT05326581: Optimization of Sequences to Improve the Quality and Comfort of the Magnetic Resonance Imaging Examination
Official title: Optimization of Sequences to Improve the Quality and Comfort of the Magnetic Resonance Imaging Examination
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Optimized MRI Sequences
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2022-04-13
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participation in the study will be offered to patients performing MRI imaging as part of the treatment as well as to healthy volunteers among the staff.

Brief summary: The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros.

Detailed description: The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros

Eligibility criteria: Inclusion Criteria:

* Subject over 18 years old
* Consent to participate in the study
* Member of or beneficiary of a social security scheme
* For patients: benefiting from an MRI examination as part of their care
* For volunteers: Consent to be informed if an unexpected anomaly is revealed by the imaging.

Exclusion Criteria:

* Subject benefiting from a measure of legal protection
* Pregnant or breastfeeding women
* For volunteers: Contraindication to MRI (detailed contraindications questionnaire, THI score \>28 questionnaire, hearing sensitivity questionnaire grade \>1)

Primary outcomes:
measure: Quality of imagery
timeFrame: Baseline
measure: Presence or absence of radiological image artifact
timeFrame: Baseline
measure: Confidence in diagnosis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
Study officials:
affiliation: Fondation A. de Rothschild
name: Julien Savatovksy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05611281: GS3-007a Oral Solution in Healthy Subjects
Official title: Phase I Randomized, Double-blind, Placebo-controlled, Single Multiple Dosing, Dose Escalation, and Food Effect Study of GS3-007A Oral Liquid in Chinese Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subject
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.

Detailed description: This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects aged 18-45 years (including boundary values), male and female;
* Body mass index: 19-26 kg/m2 (including boundary value), male weight ≥50 kg, female weight ≥45 kg;

Exclusion Criteria:

* Patients with a history of substance abuse and substance dependence;
* Family history of sudden death;

Primary outcomes:
measure: TEAEs
timeFrame: Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;
Secondary outcomes:
measure: PK characteristics
timeFrame: Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing;
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
state: Chengdu
Study officials:
References:
Clinical trial NCT00825695: Flavanol-Rich Cocoa and Cerebral Blood Flow
Official title: Flavanol-Rich Cocoa, Vascular Responses and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: MasterFoods
First posted: 2009-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to learn whether or not cocoa has a beneficial effect on blood flow to the brain in older subjects with diabetes mellitus or hypertension (high blood pressure). We hypothesize that cocoa, which contains flavanols (a type of polyphenol), may help to promote blood flow to the brain in older people with diabetes or hypertension.


Eligibility criteria: Inclusion Criteria:

* diabetes and/or hypertension

Exclusion Criteria:

* alzheimers disease, dementia, stroke, recent angina or heart attack

Primary outcomes:
measure: functional transcranial doppler measures
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Naomi D. Fisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06169995: A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy
Official title: A Multi-center, Open-label，Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in Upper Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation in the Upper Gastrointestinal Endoscopy
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy


Eligibility criteria: Inclusion Criteria:

1. patients or their guardians are able to provide a written informed consent
2. participants undergo upper gastrointestinal endoscopy
3. ≥18 years old, male or female
4. 18 kg/m2≤bmi≤30kg/m2

Exclusion Criteria:

1. Subjects to be intubated (including laryngeal mask placement);
2. Complex endoscopic diagnosis and treatment operations are required;
3. Severe cardiovascular disease within 6 months prior to signing the ICF;
4. Heart rate \< 50 beats/min during screening period;
5. Subjects with poor blood pressure control during screening;
6. Severe arrhythmias or heart disease; the circulatory system is unstable;
7. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
8. Subjects with a history of drug abuse;
9. Abnormal values of the laboratory examination;
10. Allergic to relevant drugs ingredient or component;
11. Pregnant or nursing women;
12. Subjects who has participated in clinical trials of other interventions recently;
13. Other conditions deemed unsuitable to be included.

Primary outcomes:
measure: Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy
timeFrame: on Day1
Secondary outcomes:
measure: Percentage of subjects receiving supplemental dose for sedation
timeFrame: on Day1
measure: The number of supplemental doses of the research drug
timeFrame: on Day1
measure: Wake-up time.
timeFrame: on Day1
measure: Incidence of sedation hypotension.
timeFrame: on Day1
measure: Incidence of respiratory depression
timeFrame: on Day1
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The Affiliated Hospital Of Guizhou Medical University
state: Guizhou
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT03749681: Neuroendocrine Tumors of Old Patients in the West of France
Official title: Neuroendocrine Tumors of Patients Aged of 75 y or Over in the West of France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroendocrine Tumors
Keywords: Neuroendocrine Tumors
75 y and over patients
Oncogeriatric follow-up
Oncologic care
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2018-11-21
Enrollment: 306
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with a neuroendocrine tumor whose medical file was analysed by RENATEN group between 2014 and 2017 in 4 western regions

Brief summary: Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A national network for the management of sporadic and hereditary malignant neuro-ENdocrine Tumor (RENATEN) is in charged of coordinating this specific care. This is part of the French National Cancer INstitute (INCa) Rare Cancer Plan.

The project is in the form of an analysis of elderly population (75 years or over) with a diagnosis of neuroendocrine cancer in the western part of the France (Brittany, Pays de Loire, Normandy, Center and a part of New Aquitaine areas) representing a population of more than 12 millions of inhabitants. Oncogeriatric evaluations, specialized meetings, ...would be analysed in order to improve the care of rare cancer patients.


Eligibility criteria: Inclusion Criteria:

* 75 years old or over at the time of diagnosis
* Patient with G1/G2/G3 neuroendocrine tumor diagnosed by pathological analysis
* Patient whose medical file was examined by RENATEN (National Network for the treatment of neuro-ENdocrine sporadic and hereditary disease Tumor) meetings or other multidisciplinary consultation meeting between 01/01/2014 and 31/12/2017
* Patient with care in private and public centers in the West of France

Exclusion Criteria:

* Patient with cancer other than a neuroendocrine tumor
* Patient with a G4 neuroendocrine tumor
* Patient who has objected to the study and collection of his medical data
* Refusal of participation

Primary outcomes:
measure: Tumor description : localization of the tumor (digestive or others) provided by scan or anatomopathologic report
timeFrame: 03/31/2020
measure: All anticancer treatment description in neuroendocrine tumors of 3 specific histological grade (G1, 2 or 3)
timeFrame: 03/31/2020
measure: Histology, differentiation status
timeFrame: 03/31/2020
measure: mitotic index and proliferation idex of the tumor
timeFrame: 03/31/2020
measure: Response rate
timeFrame: 03/31/2020
measure: progression free survival
timeFrame: 03/31/2020
measure: overall survival
timeFrame: 03/31/2020
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: