louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07000032: The Swallowing Function of Oral Cancer Surgery
Official title: A Longitudinal Study on Dysphagia and Associated Nutritional Complications Following Oral Cancer Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: The Swallowing Changes
Keywords: oral cancer surgery
swallowing
nutrition
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 75
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 oral cancer surgery

Brief summary: This study enrolled patients who underwent oral cancer resection. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment.

Detailed description: Dysphagia is a common and debilitating symptom among patients who undergo oral cancer resection with reconstruction followed by adjuvant radiotherapy. During the course of the disease, approximately 20% to 98% of patients experience swallowing difficulties. This is primarily caused by tumor destruction, postoperative sequelae from surgical resection, and the adverse effects of radiotherapy and chemotherapy. The use of chemotherapy or radiotherapy-particularly when combined-increases the incidence of complications such as oropharyngeal mucositis, odynophagia, dysgeusia, xerostomia, nausea, vomiting, and fatigue. These complications may lead to dehydration and significant weight loss, which in turn negatively impact nutritional status, functional ability, and quality of life.

This study enrolled patients who underwent oral cancer surgery. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment.

Eligibility criteria: Inclusion Criteria:

* patients undergoing oral cancer

Exclusion Criteria:

* patients unable to unable to cooperate with the examination

Primary outcomes:
measure: bolus presence time
timeFrame: one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02760732: Drug Eluting Balloon for Treatment of Unstable Angina
Official title: Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angina, Unstable
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.

Detailed description: Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .

Eligibility criteria: Inclusion Criteria:

* Patients \> 18, \< 80 years old, with unstable angina
* Single-vessel or double-vessel disease
* Length of target lesion \< 25mm
* Diameter of target vessel \>2.5mm, \< 3.5mm

Exclusion Criteria:

* Left main disease
* Chronic total occlusion
* Severe Tortuosity
* Heavy calcification
* Severe liver failure, moderate or severe kidney failure
* Malignant disease
* Active infectious disease
* Pregnancy or breastfeeding

Primary outcomes:
measure: Changes in Target Lumen assessed by optical coherence tomography
timeFrame: 12 months
Secondary outcomes:
measure: Incidence rate of MACE
timeFrame: Incidence rate of MACE from baseline to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: The General Hospital of PLA
state: Beijing
Study officials:
affiliation: The General Hospital of PLA
name: CHEN YUN DAI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li B, Ding Y, Tian F, Chen W, Han T, Chen Y. Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial. Cardiology. 2017;136(4):252-257. doi: 10.1159/000452125. Epub 2016 Nov 16.
Clinical trial NCT03354832: In-utero Death and Birth Mortality in Reunion Island
Official title: Research Action on Infant Mortality in Reunion Island Evaluation of Factors Affecting In-utero Foetal Death and New-born Death in Reunion Island
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy Loss
Infant Death
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 45
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregant women or mother leaving in Reunion Island. Case and control women should have stay during all their pregancy and should have been admitted in an hospital in Reunion Island for delivery.

Brief summary: Infant mortality is still relevant despite the improvement and the accessibility of hospital care. Premature birth are two fold higher than in metropolitan France. Some factors has been suspected such as precariousness, alcoholism, congenital malformation, care accessibility, epidemic environment ... Nevertheless, the impact of these factors on foetal death or new-born death are not yet sufficiently quantified to provide appropriate care and prevention action in Reunion Island.

Detailed description: Through the analysis of interview of the mothers that have lost their infant during pregnancy or just after birth, the study aims to draw a picture of the pregnancy cares offer and pregnancy conditions in Reunion Island.

This study is an non interventional case-control study. Socio-economic conditions, pregnancy care and prevention are screened to identified the major cause of foetal or new-born death in Reunion Island. These data are still lacking and will be useful to identify which public health actions that should be organized.

Eligibility criteria: Inclusion Criteria:

* Case: foetal death (foetus weighing more than 500 g or more than 22-amenorrhea weeks old) or new-born death (premature: more than 23-amenorrhea weeks old or mature)
* Control: premature (more than 23-amenorrhea weeks old) or mature new-born, alive when the leave the hospital

Exclusion Criteria:

* medical abortion
* second pregnancy during the study period
* case under forensic expertise

Primary outcomes:
measure: Rate of suboptimal care
timeFrame: within 4 weeks after birth (control) or lost (case)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: Chu Reunion Island
Study officials:
affiliation: Centre Hpospitalier Universitaire de La REUNION
name: Jean-Bernard GOUYON, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812032: Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Official title: Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: NIDDM
Aspirin
platelet inhibition
Aspirin treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.


Eligibility criteria: Inclusion Criteria:

* Type 2 DM with micro- or macroangiopathy.
* HbA1c 6-9 % (Mono-S method).
* Need for, or already on-going aspirin treatment.
* Age 50-75 years
* Antecubital forearm veins allowing technically good sampling for platelet studies

Exclusion Criteria:

* Diet controlled DM.
* Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.
* Acute or chronic kidney disease (P-cystatin C within the reference interval)
* Acute or chronic liver disease (ALAT ≤2 times the upper reference value).
* A history of gastric or duodenal ulcer disease.
* Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.
* Thrombocytopenia (platelet count \<150 x 109/L)
* Anticipated need for alteration of concomitant drug therapy during the course of the study.
* Enrollment in another clinical study.
* Contraindication(s) to aspirin treatment.

Primary outcomes:
measure: An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA)
timeFrame: 12 or 24 hours after last dose of Aspirin
Secondary outcomes:
measure: Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion.
timeFrame: 12 or 24 hours after last dose of aspirin
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.
Study officials:
affiliation: Karolinska Institutet
name: Paul Hjemdahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02518932: The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man
Official title: The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Insulin Resistance
Lead sponsor: Elahi, Dariush, PhD
Sponsor class: INDIV
Collaborators: name: ICON plc
name: Massachusetts General Hospital
name: National Institute on Aging (NIA)
First posted: 2015-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.

Detailed description: The investigators have previously demonstrated that infusion of the pentapeptide during hyperglycemic clamps in dogs significantly increases the glucose infusion rate necessary to maintain stable hyperglycemia without any significant differences in insulin or glucagon secretion. The present study's aim is to examine whether this also occurs in humans. It may be necessary to examine a dose response curve. Specifically, in twenty healthy volunteers glucose infusion rate during the peptide infusion will be compared to the glucose infusion rate during saline administration during a 4 hour hyperglycemic clamp, in a cross over design(mg/kg/min).

Eligibility criteria: Inclusion Criteria:

* BMI 18.5-25;
* 33-38

Exclusion Criteria:

* T2D
* T1D
* Hypoglycemic agents

Primary outcomes:
measure: The effect of VTC-G15 on whole body glucose metabolism in man will be assessed by comparison of amont of glucose infusion during the peptide infusion compared to amount of infusion during placebo infusion (saline) mg/kg/min.
timeFrame: one year
Secondary outcomes:
measure: THe effect of VTC-G15(A pentapeptide cleavage product of GLP-1) on whole body glucose metabolism in man.
timeFrame: one year
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON PLC
state: Texas
Study officials:
affiliation: ICON plc, 8307 Gault Lane, San Antonio TX 78209
name: Dariush Elahi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01371032: Study: Study to Compare Video Miller Device to Direct Laryngoscopy
Official title: A Randomized, Prospective Study to Compare the Video Miller Device to Direct Laryngoscopy Using a Standard Pediatric Miller Blade for Tracheal Intubation of Children < 3 Years of Age Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgeries Undergoing General Anesthesia
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 28
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare:

the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure.

The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation.
2. Obtaining signed the informed consent by their parents or legal guardian.
3. American Society of Anaesthesiologists (ASA) physical status classification I - II or III

Exclusion Criteria:

1. Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation
2. Patients with facial abnormalities, and/or oral-pharyngeal malformation.
3. Emergency operation

Primary outcomes:
measure: Time to Obtain Glottic View
timeFrame: Times following initial insertion of laryngoscope blade to obtain glottic view
measure: Intubation Time
timeFrame: Times from insertion of laryngoscope blade to placement of tracheal tube
measure: Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform
timeFrame: Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform
Secondary outcomes:
measure: Glottis Visualization Using POGO Score
timeFrame: During intubation procedure, up to 3 minutes
measure: Glottis Visualization Using Cormack Lehane
timeFrame: During intubation procedure, up to 3 minutes
measure: Number of Participants Intubated With 1 and > 1 Intubation Attempts
timeFrame: During intubation procedure, up to 3 minutes
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Roya Yumul, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Ronald H Wender, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06721832: The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery
Official title: The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cervical Spine Surgery
Pain Management
Keywords: ESP
PAIN
Posterior cervical surgery
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Posterior cervical spine surgery, often performed on older individuals with significant comorbidities, is one of the most painful surgical operations. Anesthesiologists face a unique challenge in managing pain following these surgeries,Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016.Cervical erector spinae plane (ESP) block has been described to anesthetize the brachial plexus (BP), however, the mechanism of its clinical effect remains unknown. As the prevertebral fascia encloses the phrenic nerves, BP and erector spinae muscles to form a prevertebral compartment, a local anesthetic injected in the cervical ESP could potentially spread throughout the prevertebral compartment


Eligibility criteria: Inclusion Criteria:

* (ASA )classes I and II
* patients of either sex
* above the age of 18 who will undergo posterior cervical surgery

Exclusion Criteria:

* patient's refusal to participate
* any contraindications to peripheral nerve blocks
* history of ischemic heart disease
* patients on opioids for chronic pain
* patients with significant cognitive impairment

Primary outcomes:
measure: VAS
timeFrame: VAS scores at rest and on passive neck movement postoperatively at 0, 2, 4, 6, 8, 12, 24 and 48 hours
measure: Diaphragmatic excursion
timeFrame: 2- Diaphragmatic excursion assessed by ultrasound will be measured at baseline, in PACU 30 minutes after recovery, and 24h postoperative
Secondary outcomes:
measure: morphine intake
timeFrame: During 24 hrs postoperatively
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Benha university
state: ELkalyobia
Study officials:
References:
Clinical trial NCT01798732: PIO Laser Sclerectomy IOP SLT Sclerectomy
Official title: Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open-Angle Glaucoma
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 26
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 main objective of this study is to characterize the changes in IOP over 24 hours after selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP, type of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes in ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after selective laser trabeculoplasty.


Eligibility criteria: Inclusion Criteria:

* Primary Open-Angle Glaucoma
* IOP more than 21 mmHg
* Progression under maximal medical therapy
* aged more than 18 years

Exclusion Criteria:

* Pregnant woman

Primary outcomes:
measure: IOP change over 24 hours after selective trabeculoplasty SLT according to chronobiological data (decrease of IOP; type of 24h-IOP rhythm and 24h-PPm rhythm: MESOR, acrophase, bathyphase, amplitude and modeling)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Changes in the rate of ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after SLT.
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Paul ROMANET, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khayi H, Pepin JL, Geiser MH, Tonini M, Tamisier R, Renard E, Baguet JP, Levy P, Romanet JP, Chiquet C. Choroidal blood flow regulation after posture change or isometric exercise in men with obstructive sleep apnea syndrome. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9489-96. doi: 10.1167/iovs.11-7936.
Clinical trial NCT01807832: The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
Official title: The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Cough
Keywords: chronic cough
cough reflex hypersensitivity
capsaicin
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-03-08
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the capsaicin challenge can improve the diagnosis, treatment, monitoring and follow-up in patients with chronic cough.

Detailed description: Capsaicin is administrated in incremental concentrations with two inhalations of normal saline solution. Patients are instructed to exhale to functional residual capacity and than to inhale through the mouthpiece for 1 second (single breath inhalation). The number of coughs in the first 10 seconds after each inhalation is counted. C2; the concentration of which the patient responded by 2 coughs, C5;the concentration of which the patient responded by 5 coughs. The challenge ends at C5.

Eligibility criteria: Inclusion Criteria:

* Patients with persisting cough for more than 3 months, without known respiratory or lung diseases

Exclusion Criteria:

* Diagnosis of respiratory or lung diseases of any kind

Primary outcomes:
measure: cough reflex hypersensitivity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: