louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04764227: Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
Official title: Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Esophagus Cancer
Esophageal Squamous Cell Carcinoma
Chemoradiotherapy
Radiation Therapy
Postoperative
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form;
* Age 18-75;
* ECOG 0-2;
* Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
* The operative incision healed well;
* T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
* No radiotherapy, chemotherapy or other treatments pre (post) surgery;
* PS ECOG 0-2;
* Life expectancy of more than 3 months;
* Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L;
* Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\< 1.5 x ULN;
* Renal function: creatinine \< 1.5 x ULN
* No immuno-deficiency;
* Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

* Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
* Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
* Participation in other interventional clinical trials within 30 days;
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
* Drug addiction, Alcoholism or AIDS;
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
* Unsuitable to be enrolled in the trial in the opinion of the investigators.

Primary outcomes:
measure: Local control rate
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Kuaile Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03795727: Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact
Official title: Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact by Undergraduate Students and Postgraduate Dentists: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Contact
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of different matricing techniques either sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and contours during restoration of class II cavities with resin composite by undergraduate students or postgraduate dentists.


Eligibility criteria: Inclusion Criteria:

* Compound class II cavities
* Good oral hygiene
* No spacing or crowding
* Healthy peridontium

Exclusion Criteria:

* Complex class II cavities
* Poor oral hygiene
* Spacing or crowding
* Evidence of peridontal disease

Primary outcomes:
measure: Proximal contact
timeFrame: Up to 3 hours from randomization till contact is restored
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: El Manial
Study officials:
References:
Clinical trial NCT04348227: How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?
Official title: How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Hôpital Universitaire Fattouma Bourguiba
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in ICU in the period of the study, requiring mechanical ventilation for more than 24 hours

Brief summary: A previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our ICU. That has been related to lack of compliance to hand hygiene among health care providers in ou ICU.

Detailed description: A single-center cohort study performed in the department of Anesthesia and Intensive Care in our Hospital. All endotracheal isolates realised in the period of study are collected from the Department of Microbiology of our Hospital.

Eligibility criteria: Inclusion Criteria:

* Patients requiring mechanical ventilation for more than 24 hours

Exclusion Criteria:

-

Primary outcomes:
measure: MDR pathogens in endotracheal aspirates
timeFrame: 1 year
Secondary outcomes:
measure: Microorganisms in endotracheal aspirates
timeFrame: 1 year
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Department of anesthesia and intensive care, Fattouma Bourguiba Hospital
Study officials:
affiliation: Department of anesthesia and intensive care, Fattouma Bourguiba Hospital
name: Malek Khemili, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01598727: Near Infrared Fluorescent Imaging in Thyroid and Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics
Official title: A Phase I Feasibility Study of Intra-operative Near Infra-red Fluorescent Imaging in Thyroid/Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Hyperparathyroidism
Keywords: parathyroid surgery
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Fluoptics Ltd, Grenoble, France
First posted: 2012-05-15
Enrollment: 10
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: Hypothesis: Intraoperative use of near infrared fluorescent imaging technology and detection of Methylene Blue fluorescence will improve outcomes following thyroid and parathyroid surgery.

Aims: The aims of this phase of the study are to determine the feasibility of using near infrared fluorescent technology in the detection of parathyroid tissue and its differentiation from adjacent soft tissue during surgery on parathyroid glands.

Objectives of the phase I study:

1. To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device (Fluoptics).
2. To understand the patterns (onset, intensity and duration) of fluorescent staining of normal parathyroid glands, thyroid glands and other soft tissue structures encountered during parathyroidectomy.

Further research:

This will be followed by a phase II study during which fluorescent imaging will be used in conjunction with intraoperative incremental dose of IV methylene blue in both thyroid and parathyroid surgery. Phase II will enable us to develop a protocol for the use of a minimum possible dose of MB for the identification of parathyroid glands. This will then be tested in the pilot phase of a randomized clinical trial.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* all patients undergoing parathyroid surgery

Exclusion Criteria:

* patients undergoing re-do procedures
* patients unable to give adequate informed consent
* patients with a history of intolerance or sensitivity to MB
* patients with G6PD deficiency
* patients on serotonin reuptake inhibitors and patients undergoing thoracic exploration
* either alone or in combination with a neck exploration.

Primary outcomes:
measure: Determine patterns of fluorescence from soft tissue structures in the neck
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Department of General Surgery
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Saba P Balasubramanian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03078127: Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis
Official title: Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis (REACT-CF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Mucociliary Clearance Defect
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2017-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects will undergo baseline testing, followed by study procedures for three separate interventions, with subjects randomized into three arms in which a different sequence in which to complete the studies.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a pilot study investigating the effectiveness and clinical efficacy of airway clearance therapy (ACT) in cystic fibrosis (CF). Enrolled subjects will undergo measurements of mucociliary clearance (MCC) and exhaled biomarkers at baseline and after 3 different forms of ACT: high frequency chest wall oscillatory vest, oscillatory positive expiratory pressure device, and whole-body vibration.


Eligibility criteria: Inclusion Criteria:

* Adults with confirmed diagnosis of cystic fibrosis aged 18 years and older.

Exclusion Criteria:

* Pregnant or lactating women,
* Individuals with severe lung disease (FEV1 \<30%), or with exacerbations of lung disease requiring antibiotics or medication change within four weeks prior to enrolment.
* Individuals unable to use vest-based HFCWO, OPEP device, or who require oxygen supplementation at rest.
* Individuals with significant balance or gait impairment preventing them from tolerating being positioned on a vibrating platform.

Primary outcomes:
measure: Mucociliary Clearance-274
timeFrame: 274 minutes
Secondary outcomes:
measure: Mucociliary Clearance-90
timeFrame: 90 minutes
measure: Change in Rate of MCC
timeFrame: pre-ACT (0-16 mins) and during ACT (16-50 mins)
measure: Change in Fraction of Exhaled Nitric Oxide (FENO)
timeFrame: pre and immediately post intervention (50 mins post inhalation)
measure: Purine Analysis (AMP) in Exhaled Breath Condensate
timeFrame: pre and immediately post intervention (50 mins post inhalation)
measure: Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)
timeFrame: pre and immediately post intervention (50 mins post inhalation)
measure: Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate
timeFrame: pre and immediately post intervention (50 mins post inhalation)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Marsico Clinical Research Center
state: North Carolina
Study officials:
affiliation: Fellow
name: Aaron T Trimble, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Medicine
name: Scott Donaldson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01601327: Effects of Medications in Patients With Hypogonadism
Official title: Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Hypogonadotropic Hypogonadism
Keywords: hypogonadism
treatment
testis volume
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 119
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).


Eligibility criteria: Inclusion Criteria: hypogonadotropic hypogonadism

* decreased serum testosterone concentration below the normal range (serum T \< 300ng/dL),
* FSH and LH levels within or below the normal range,
* absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH,
* normal smell test and normal karyotypes

Exclusion Criteria:

* previous androgen treatment,
* history of smoking,
* presence of bilateral anorchia,
* intellectual deficiency,
* diabetes mellitus,
* arterial hypertension or dyslipoproteinemia,
* medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.

Participants with iron, vitamin B12 or folate deficiency were also excluded.

Primary outcomes:
measure: Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
timeFrame: 3 years
measure: Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
timeFrame: 3 years
measure: Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
timeFrame: 3 years
Secondary outcomes:
measure: Effect of testosterone enanthate on testis volumes
timeFrame: 3 years
measure: Effect of testosterone gel on testis volumes
timeFrame: 3 years
measure: Effect of human chorionic gonadotrophin on testis volumes
timeFrame: 3 years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Dep. of Endocrine and Metabolism
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Study officials:
affiliation: Gulhane School of Medicine, Department of Endocrinology and Metabolism
name: Aydogan Aydogdu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03218527: Influence of Circulating Endothelial Progenitor Cells and Modifiable Vascular Risk Factors on Carotid Plaque Vulnerability
Official title: Influence of Circulating Endothelial Progenitor Cells and Modifiable Vascular Risk Factors on Carotid Plaque Vulnerability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Stroke
Inflammation
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2017-07-14
Enrollment: 120
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: Adult patients diagnosed of ischemic stroke presenting at least on atherosclerotic plaque in the internal carotid artery ipsilateral to stroke

Brief summary: Ischemic stroke is a leading cause of death and disability worldwide. Atherosclerosis, responsible for the 20% of ischemic strokes, is characterized by lipid accumulation in the artery wall that leads to chronic inflammation, cell proliferation and ultimately to vessel stenosis. One of the main features related to plaque progression and vulnerability is inflammation. Positron emission tomography with 18-fluorodeoxyglucos (18-FDG PET) allows an accurate quantification of plaque inflammation and it has been proved its usefulness in predicting early stroke recurrences. The investigators aim to test how modifiable vascular risk factors influence plaque inflammation assessed by 18-FDG PET. In addition, investigators will assess the association of this inflammation and circulating endothelial progenitor cells


Eligibility criteria: Inclusion Criteria:

* Ischemic stroke within 7 days before inclusion
* At least one atherosclerotic plaque in the internal carotid artery
* \>18 years old

Exclusion Criteria:

* Cardioembolic strokes according to TOAST criteria
* Poor functional outcome (Rankin \>3) after stroke

Primary outcomes:
measure: Change in the Standardized Uptake Value (SUV) of the internal carotid artery
timeFrame: Baseline and at one year follow-up
measure: Change in the Target-to-Background Ratio (TBR) of the internal carotid artery
timeFrame: Baseline and at one year follow-up
measure: Change in the Endothelial Progenitor Cells Count
timeFrame: Baseline and at one year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT01145027: Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men
Official title: Relations Among Cephalic Phase of Insulin Secretion, Body Composition, Dietary Intake and Microvascular Reactivity in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microvascular Function
Keywords: Capillary recruitment
Cephalic Phase of Insulin Secretion
Dietary Intake
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-06-16
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Forty healthy volunteers will undergo two nailfold-videocapillaroscopy exams with a 10-minute interval between them, after an 10-h overnight fast in a temperature controlled room. The subjects will be randomized in two groups: one will receive a sensorial stimulus during the interval (stimulus group - SG) and the other will receive no stimulus (control group - CG). The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste.

Baseline microvascular parameters will be compared to the results after the interval. The investigators hypothesize that the SG will have greater capillary recruitment due to a possible effect of physiologically secreted insulin provoked by the sensorial stimulation (cephalic phase of insulin secretion).


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* Aged between 18 and 30 years
* BMI between 18.5 and 24.9 kg/m2

Exclusion Criteria:

* Diabetes mellitus, glucose intolerance or altered fasting glucose;
* Hypertension (Systolic pressure ≥ 130 mmHg and diastolic pressure ≥ 80 mmHg);
* HOMA-index ≥ 2.71
* Dyslipidemia
* Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
* Smoking
* Chronic use of any medication

Primary outcomes:
measure: functional capillary density (number of perfused capillaries on the studied skin area)
timeFrame: up to 30 minutes
Secondary outcomes:
measure: cephalic phase of insulin secretion (the occurence of increase in markers of this phase, such as insulin, C-peptide and pancreatic polypeptide)
timeFrame: Up to 30 minutes
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular
Study officials:
affiliation: Rio de Janeiro State University
name: Caroline Buss, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buss C, Kraemer-Aguiar LG, Maranhao PA, Marinho C, de Souza Md, Wiernsperger N, Bouskela E. Novel findings in the cephalic phase of digestion: a role for microcirculation? Physiol Behav. 2012 Feb 28;105(4):1082-7. doi: 10.1016/j.physbeh.2011.12.004. Epub 2011 Dec 14.
Clinical trial NCT05874427: Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form
Official title: Comparison of Patient Understanding and Anxiety Between the New Imaging Consent Form and the Existing Narrative Consent Form When Explaining the Procedure Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: lumbar radiculopathy
Multimedia informed consent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, double-blind clinical study to compare patient comprehension and anxiety by comparing a traditional paper consent form to a multimedia consent form for patients undergoing transforaminal epidural steroid injection.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients undergoing lumbar transforaminal block for the first time
* Patients who are able to understand the contents of the video consent form and written consent form.

Exclusion Criteria:

* Patients who have difficulty understanding or answering consent forms
* Patients who have previously experienced a transforaminal steroid injection

Primary outcomes:
measure: Patient comprehension assessed by Patient comprehension questionnaire
timeFrame: immediately before the procedure
Secondary outcomes:
measure: Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form
timeFrame: immediately before the procedure
measure: Assess patient satisfaction by Patient satisfaction ratings on a Likert scale
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul national university Bundang hospital
state: Kyoungki-do
Study officials:
References: