louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06457295: Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography
Official title: Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Retinopathy, DR
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients will be recruited from diabetics who will present for retinopathy screening examination at outpatient clinic of Sohag University Hospital.

Brief summary: the aim of this study is to assess the impact of duration of DM on OCTA parameters in diabetic patients without clinical Diabetic retinopathy.


Eligibility criteria: Inclusion Criteria:

1. Age : Above 40 years old
2. Type of DM: Type 2.
3. Fundus examination: no macular edema or other signs of clinical retinopathy

Exclusion Criteria:

1. Age : below 40 years old
2. Ocular history : any history of significant ocular injury or disease that could affect the retinal microvasculature such as retinal vascular occlusion, glaucoma, or vitreo-macular disease, as such conditions have also been noted to show sub-clinical OCTA changes \[13, 14\].
3. Fundus examination: macular edema or any other signs of clinical retinopathy

Primary outcomes:
measure: Density of vessels in superficial retinal layer by OCTA
timeFrame: baseline
measure: Density of vessels in deep retinal layer by OCTA
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rao HL, Pradhan ZS, Suh MH, Moghimi S, Mansouri K, Weinreb RN. Optical Coherence Tomography Angiography in Glaucoma. J Glaucoma. 2020 Apr;29(4):312-321. doi: 10.1097/IJG.0000000000001463.
Clinical trial NCT01215695: Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
Official title: Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Endotracheal Intubation
Keywords: Intubation, Endotracheal
Endotracheal Intubation, adverse events
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).


Eligibility criteria: Inclusion Criteria:

* BMI \> 35
* Thyromental distance \< 6 cm
* Sterno-mental distance \< 12 cm
* Mallampati grade 3 and 4
* Interincisor distance \< 38 mm
* Status of dentition: presence of buckteeth
* Neck movement \< 35°
* Neck circumference \>43 cm at the level of the thyroid cartilage
* Patients with immobilized cervical spine (C-collar in place).
* History of difficult laryngoscopy or intubation

Exclusion Criteria:

* Full stomach
* Hiatal hernia
* Severe GERD (Gastroesophageal reflux disease)
* Tumors of the upper airway

Primary outcomes:
measure: Intubation Time
timeFrame: 120 seconds
Secondary outcomes:
measure: The Number of Intubation Attempts
timeFrame: 30 minutes
measure: Neck Movement
timeFrame: 30 minutes
measure: Laryngeal View Grade of 1 or 2
timeFrame: 30 minutes
measure: Ease of Intubation
timeFrame: 2-4 hours after intubation
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Rainer Lenhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.
Clinical trial NCT04100395: Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients
Official title: Global Hemostasis Monitoring in Patients With Severe Trauma Using Sonoclot Signature Compared to Conventional Coagulation and Platelet Parameters
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Study of Hemostatic Profile in Traumatic Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study will be done on patients sample

Brief summary: 1. Analyzing the effects of severe trauma using sonoclot analyzer (which depicts the entire hemostatic pathway) ,subsequently describing the convenient therapy .
2. Assessing the correlations between sonoclot variables and conventional coagulation and platelet function tests

Detailed description: Coagulopathy is a physiological response to massive bleeding that frequently occurs after severe trauma and is an independent predictive factor for mortality\[2\]. . There are two of the major causes of coagulopathy in trauma patients

1. coagulopathy secondary to hemorrhagic shock due to massive bleeding and
2. coagulopathy secondary to severe head injury\[3\] which results in release of tissue factor from damaged brain tissue.

Therefore, it is very important to grasp the coagulation status of patients with severe trauma quickly and accurately with objective indicator in order to establish the therapeutic strategy .

The importance of viscoelastic devices in understanding the disease condition of patients with traumatic coagulopathy has been widely recognized in Europe. Viscoelastic hemostatic assays devices have practical advantages as point-of-care devices for monitoring major hemorrhage including speed of results and a set of parameters that assesses a global coagulation profile .

Also In the USA, Massive Transfusion in Trauma Guidelines proposed by the American College of Surgeons in 2013 presented the test results obtained by the viscoelastic devices, as the standard for transfusion or injection of blood plasma, cryoprecipitate, platelet concentrate, or anti-fibrinolytic agents in the treatment strategy for traumatic coagulopathy and hemorrhagic shock .

However, some studies have reported limitations of these viscoelastic devices

Eligibility criteria: Inclusion Criteria:

* -Patients \>18 years.
* Both sexes will be included.
* Recent trauma

Exclusion Criteria:

* -patients \<18 years.
* Patients with documented evidence of coagulopathy or bleeding diocese .
* Patients with liver disease.
* Pregnant women

Primary outcomes:
measure: global monitoring of coagulation profile
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01679795: Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flow-mediated Dilation Evaluation of the Brachial Artery
Keywords: hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.


Eligibility criteria: Inclusion Criteria:

* Women without menstrual cycles whithin the last 12 months and FSH\>30IU/L
* Healthy women
* Women that were not using drugs with potential vascular effect whithin the last 1 year
* Women that never used hormone replacement therapy

Exclusion Criteria:

* Smoking
* Blood Pressure \> 160/90 mm Hg.
* Breast and or endometrial cancer
* History of acute myocardial infarction
* Diabetes
* Vaginal bleeding of any origin
* Hepatic disease
* thrombophlebitis or thromboembolic disorders

Primary outcomes:
measure: Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: belo Horizonte
country: Brazil
facility: hospital das Clinicas - Universidade Federal de Minas Gerais
state: minas Gerais
Study officials:
References:
Clinical trial NCT02562495: Ultrasound to Evaluate the Quadriceps Muscle Wasting
Official title: Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Cerebral Pathology
Keywords: severe cerebral pathology
Ultrasound
thickness of the quadriceps
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of muscle loss. This is a serious pathology associated with high morbidity and mortality.

Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic Resonance Imaging (MRI) are considered as "gold standards" to quantify and monitor changes in muscle mass. But these tools are not adapted to ICU patients.

Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not expose the patient to additional radiation.

The objective of this study is to evaluate the correlation between US and CT scan to measure quadriceps muscle thickness of ICU patients.

Detailed description: As part of the monitoring of the neurological disease, brain CT scans are frequently performed. At the same time, an acquisition sequence centered on the quadriceps will follow the brain sequences. Up to three brain CT scans coupled with a quadriceps imaging will be performed between the day of admission and on the tenth day of hospitalization. An ultrasound of the quadriceps will be performed concomitantly. The thickness of the quadriceps is measured by an independent operator on CT and ultrasound images.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years admitted to intensive care for a severe brain injury (Glasgow \<8) and with a predictive duration of mechanical of at least 48hours

Exclusion Criteria:

* Pregnancy,
* Bilateral trauma of thighs,
* Coma induced by poisoning or by a metabolic disorder,
* Morbid obesity (BMI \> 35).

Primary outcomes:
measure: Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan
timeFrame: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )
Secondary outcomes:
measure: kinetic of the thickness of quadriceps
timeFrame: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jérôme MOREL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06021795: Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Official title: Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Third Wave Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-09-01
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: Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep

Detailed description: A single-center study in 25 subjects suffering from moderate to severe insomnia and assess the effectiveness of the intervention. Intervention consists of treatment using a customized audio track delivered via standard commercially-available bone conduction headsets daily for four (4) weeks. Effectiveness is defined by a statistically significant improvement in Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus the end of the study.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Meets DSM 5 criteria for insomnia disorder
* Insomnia Severity Index (ISI) of 15 - 28

Exclusion Criteria:

* Use of sleep medications, sedating or alerting medications or antidepressants in the last 3 months
* Diagnosis of any autoimmune disorder or any medical or sleep disorder that could affect sleep
* Pregnancy

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Otolaryngology Medical Group
state: California
Study officials:
affiliation: San Francisco Otolaryngology Medical Group
name: Elan Hekier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01232114: Safety Study of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia
Official title: Phase 2 Study of of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Dyspepsia(FD) Was Studied
Effect of Simotang on FD Was Studied
Lead sponsor: Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with functional dyspepsia primary care clinic were studied

Brief summary: Functional dyspepsia (FD) is a common functional gastrointestinal disorder and is steadily becoming a public health problem.Simotang is a classical formula that has been used to treat gastrointestinal disorders for hundreds of years \[9\] and was approved as an oral liquid drug by the Chinese National Food and Drug Administration in the 1980s.In this study,patients with functional dyspepsia were divided according to the inclusive criteria into treatment group and control group randomly, who were given Simo decoction or Domperidone tablets for 14 days。And then the gastric emptying, Symptoms in plasma were observed before and after treatment in mult-center.


Eligibility criteria: Inclusion Criteria:

* patients met the definition of the Rome III criteria for FD

Exclusion Criteria:

-

Primary outcomes:
measure: Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 14 days
Secondary outcomes:
measure: Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan university of TCM
state: Hunan
Study officials:
affiliation: Hunan university of TCM
name: Liu b yan, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06872814: Vaccine Hesitancy in Patients with Solid Tumors: a Cross-sectional Single-center Survey
Official title: Vaccine Hesitancy in Patients with Solid Tumors: a Cross-sectional Single-center Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Patients
Vaccine-Preventable Diseases
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of this cross-sectional survey will include out-patients of the Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo Pavia

Brief summary: Cancer patients have a well-known and higher risk of vaccine-preventable disease (VPD) than the general population. VPD can cause serious complications due to compromised immune system, malnutrition and the same oncology treatments and represent a severe financial burden with a delay in treating the underlying cancer The main purpose of this survey is to analyse the perception of cancer patients on the topic vaccines and vaccine-preventable diseases, the acceptability of vaccines and the evaluation of the determining factors associated with the choice of the patient to be vaccinated or not. This information will be used to improve the management of these issues.


Eligibility criteria: Inclusion Criteria:

1. \>18 years of age;
2. Oncology patient defined as a patient with solid tumors undergoing active systemic treatment or follow-up;
3. Written informed consent

Exclusion Criteria:

1. Patients with hematological tumors
2. Patients who are unable to understand informed consent document

Primary outcomes:
measure: assess the proportion of vaccinated subjects in our cohort of cancer patients undergoing active cancer treatment
timeFrame: 3 months
Secondary outcomes:
measure: assess the proportion of vaccinated subjects with the anti flu vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
timeFrame: 3 months
measure: assess the proportion of vaccinated subjects with anti SARS-CoV-2 vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
timeFrame: 3 months
measure: assess the proportion of vaccinated subjects with anti pneumococccal vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
timeFrame: 3 months
measure: assess the proportion of vaccinated subjects with anti HZ vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
timeFrame: 3 months
measure: assess which variables (sex, age, degree of education, marital state, commodities, type of tumor, type of oncological treatment) are associated with not willingness to receive vaccines
timeFrame: 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, SC Oncologia
Study officials:
References:
Clinical trial NCT05266014: This is a Dose-finding Study Followed by 2-year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Adolescent Subjects With Stargardt Disease
Official title: Phase 1/2, Open-Label, Dose-Finding Followed by 2-Year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Adolescent Subjects With Stargardt Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stargardt Disease
Lead sponsor: RBP4 Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Belite Bio, Inc
First posted: 2022-03-04
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stargardt disease 1 (STGD1) is the most prevalent form of juvenile macular degeneration. It is caused by a rare, inherited autosomal recessive trait, leading to severe and irreversible blindness by the first or second decade of life. Earlier onset of the disease is related to a rapid vision loss, while patients with a later onset tend to have a better prognosis.

This study will enrol subjects aged 12-18 years old with a confirmed clinical diagnosis of Stargardt disease type 1 (STGD1). This study will include 2 phases, the phase 1b portion is to determine the optimal dose for phase 2 based on the extent of retinol binding protein 4 (RBP4) reduction after 2 cycles of tinlarebant treatment. The phase 2 portion will evaluate the safety and efficacy of a single daily dose of tinlarebant over a 24-month treatment period.


Eligibility criteria: Major Inclusion Criteria:

Subject must have clinically diagnosed Stargardt disease with at least one mutation identified in the ABCA4 gene.

Major Exclusion Criteria:

Any ocular disease other than Stargardt disease at baseline that, in the opinion of the PI, would complicate assessment of a treatment effect.

Primary outcomes:
measure: To evaluate systemic and ocular safety and tolerability of tinlarebant.
timeFrame: From baseline to 24 months
measure: The optimal dose for Phase 2.
timeFrame: Up to 24 months
Secondary outcomes:
measure: Change in atrophic lesion size.
timeFrame: From baseline to 24 months.
measure: Maximum Plasma Concentration (Cmax) of tinlarebant in plasma.
timeFrame: Up to 24 months
measure: Time to Maximum Plasma Concentration (Tmax) of tinlarebant in plasma.
timeFrame: Up to 24 months
measure: Half-life (t1/2) of tinlarebant in plasma.
timeFrame: Up to 24 months
measure: Time to minimal plasma RBP4 level (Tmin)
timeFrame: Up to 24 months
measure: Minimum concentration of RBP4 (Cmin)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Sydney Children's Hospitals Network
state: New South Wales
city: Perth
country: Australia
facility: Lions Eye Institute
state: Western Australia
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: