louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02581735: Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia
Official title: Effectiveness of the uPatient Platform in the Fulfillment of the Prophylactic Treatment in Patients With Hemophilia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemophilia
Keywords: Haemophilia
Adherence
Prophylaxis treatment
Quality of Life
Illness Behavior
Veritas-Pro questionnaire
uPatient
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
Collaborators: name: Universidad de Murcia
name: Medtep Inc.
First posted: 2015-10-21
Enrollment: 40
Sex: MALE
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia

Brief summary: Research project whose main objective is to evaluate the use of a technology platform (uPatient) to register the prophylactic treatment of patients with hemophilia treated in different Hematology and Hemotherapy services of several hospitals in Spain.

Detailed description: The data obtained in this project will identify the level of compliance to the pharmacological treatment of patients with hemophilia prophylaxis. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for patients with hemophilia. Clinical data were also obtained regarding the joint of patients participating in the study state.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A or B
* Patients over 13 years old
* Patients on prophylactic treatment.

Exclusion Criteria:

* Patients who do not sign the informed consent document
* Patients who do not make domiciliary self-treatment
* Patients who do not have good adhesion to prophylactic treatment

Primary outcomes:
measure: Registration of the uPatient platform
timeFrame: Screening visit
measure: Change from baseline the quality of life at 6 months and at the end of the study
timeFrame: Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year
measure: Change from baseline the perception of disease at 6 months and at the end of the study
timeFrame: Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year
measure: Change from baseline the compliance to the prophylactic treatment at 6 months and at the end of the study
timeFrame: Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year
measure: Change from baseline the joint status at the end of the study
timeFrame: Screening visit and through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Real Fundación Victoria Eugenia
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04643535: In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery
Official title: Glycocalyx as Predictor of Complications After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endothelial Dysfunction
Cardiovascular Diseases
Surgery
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 600
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: All patients benefiting from cardiac surgery

Brief summary: Cardiac surgery has been described as altering endothelium structure and function, notably because of the use of cardiac-pulmonary bypass (CPB). Among the endothelial structure, glycocalyx, the thin layer recovering the endothelial surface, may be altered by the inflammatory process and probably the modification of flow during CPB. Endothelial and glycocalyx integrity are essential for vascular function and glycocalyx destruction is associated with organ failure and mortality. On the other hand, a chronic alteration of glycocalyx is observed in many diseases such as diabetes, hypertension or chronic kidney failure, all pathologies frequently observed in patients benefiting grom cardiac surgery.

Thus the preoperative alteration of glycocalyx may be associated with postoperative organ failure.


Eligibility criteria: Inclusion Criteria:

* all patients benefiting from a cardiac surgery with cardio-pulmonary bypass

Exclusion Criteria:

* impossibility to carry out the measurement by glycocheck device
* refusal to participate

Primary outcomes:
measure: association between preoperative sublingual glycocalyx thickness (glycocheck device) and major postoperative complications
timeFrame: 48 hours
Secondary outcomes:
measure: association between preoperative sublingual glycocalyx thickness (glycocheck device) and death
timeFrame: 28 days
measure: association between preoperative sublingual glycocalyx thickness (glycocheck device) and cardiac arrythmia
timeFrame: 28 days
measure: association between preoperative sublingual glycocalyx thickness (glycocheck device) and Cerebral stroke
timeFrame: 28 days
measure: association between preoperative sublingual glycocalyx thickness (glycocheck device) and cognitive dysfunction
timeFrame: 28 days
measure: association between preoperative sublingual glycocalyx thickness (glycocheck device) and myocardial ischemia
timeFrame: 28 days
measure: association between preoperative sublingual glycocalyx thickness (glycocheck device) and acute respiratory failure
timeFrame: 28 days
measure: association between preoperative sublingual glycocalyx thickness (glycocheck device) and sepsis
timeFrame: 28 days
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
Clinical trial NCT01467635: EBUS-TBNA Versus EBUS-TBNB
Official title: Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mediastinal Lymphadenopathy
Hilar Lymphadenopathy
Carcinoma
Lymphoma
Sarcoidosis
Mycobacterial Disease
Keywords: Endobronchial ultrasound
Transbronchial needle aspiration
Transbronchial biopsy forceps
Mediastinal lymphadenopathy
Hilar lymphadenopathy
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Chelsea and Westminster NHS Foundation Trust
name: Heidelberg University
First posted: 2011-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).

The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.


Eligibility criteria: Inclusion Criteria:

* Scheduled for EBUS-TBNA as part of clinical care
* Lymph nodes larger than 10mm in diameter
* Age \> 18 years
* Able to provide written informed consent

Exclusion Criteria:

* Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
* Inability to obtain informed consent

Primary outcomes:
measure: The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
timeFrame: 18 months
Secondary outcomes:
measure: The difference in the complication rate between the two study arms
timeFrame: 24 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik, University of Heidelberg
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: The Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust
name: Zaid Zoumot, MBBS, MRCP, MSc
role: STUDY_DIRECTOR
affiliation: Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust
name: Pallav L Shah, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724035: Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery
Official title: Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Extremity
Orthopedic Surgery
Trauma
Forearm Injuries
Nerve Block
Keywords: Anesthesia
Upper extremity
Nerve block
Ultrasound
Brachial plexus
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques.

Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery.

The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.

Detailed description: Real-time ultrasound guidance has substantially reduced the risk of pneumothorax and/or vascular puncture during infraclavicular brachial plexus blocks. The role of this technique has thus been expanded to overlap those procedures for which an axillary nerve block would be commonly considered as first choice.

A reference block for upper limb surgery thanks to its safety profile and clinical efficacy, the axillary approach may be more painful or unpleasant for some patients.

The investigators aim to determine possible differences in onset time and patient acceptance between the two techniques.

Eligibility criteria: Inclusion Criteria:

* ASA Physical Status Class \<4
* Scheduled upper extremity orthopedic surgery

Exclusion Criteria:

* Psychiatric or cognitive disorder
* Allergy to study drugs
* Contraindication to nerve block at the assigned site

Primary outcomes:
measure: Onset time of brachial plexus sensory block
timeFrame: q5min up to 30 min after the block
Secondary outcomes:
measure: Onset of brachial plexus motor block
timeFrame: q5min up to 30 min after the block
measure: Patient satisfaction (3-point scale)
timeFrame: End of surgery
measure: Anesthesia-related procedural pain (0-10 numerical rating scale)
timeFrame: End of block placement
measure: Rescue analgesic requirements during surgery
timeFrame: During surgery
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University Hospital / Azienda Ospedaliero-Universitaria
state: PR
Study officials:
affiliation: Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of Parma
name: Guido Fanelli, MD
role: STUDY_CHAIR
affiliation: UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma
name: Giorgio Danelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05445635: Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses
Official title: Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Nodule, Solitary
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Since the beginning of lung screening program in the different countries around the world by chest CT scan, numerous lung nodules and masses of unknown etiology are diagnosed.

Usually, the pathological diagnosis is obtained by bronchoscopy. However, peripheral bronchi cannot be seen after the fifth bronchial division as the diameter of the broncoscope is greated than the diameter of the bronchi. Therefore, the Iriscope was developed. It consists in a thin catheter with a mini-camera at its distal extremity.

The aime of this study is to evaluate the diagnostic yield of bronchoscopy guided by Iriscope in the setting of peripheral lung nodules and masses supect of malignancy, to compare the Iriscope to endobronchial radial ultrasonography (which is a validated technique to guide bronchoscopy in the setting of peripheral lung nodules and masses) and to evaluate the added value on the diagnostic yield by combining these 2 techniques.


Eligibility criteria: Inclusion Criteria:

* Lung nodules or masses suspect of malignancy with a diameter between 2 and 5 centimeters

Exclusion Criteria:

* Any contraindication to general anesthesia
* Coagulopathy

Primary outcomes:
measure: Diagnostic yield of bronchoscopy
timeFrame: Pathological diagnosis just after the bronchoscopy. In case of unspecified diagnosis after bronchoscopy, a follow up may be performed by chest ct scan up to 6 months.
Secondary outcomes:
measure: Complications of bronchoscopy
timeFrame: Just after the bronchoscopy to 1 month after the procedure
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium
name: Olivier Taton, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00521235: Effect of Different Working Conditions on Risk Factors in Dentists Versus Trainers
Official title: Effects of Different Working Condition on Risk Factors in Dentists Versus Trainers. A Combined Crosssectional and Longitudinal Trial With Student and Senior Employees.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: risk factors
metabolic syndrome
dentists
trainers
Healthy subjects
students
seniors
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: University of Erlangen-Nürnberg
First posted: 2007-08-27
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female students of dentistry male and female students of sports male dentists male teachers of physical education

Brief summary: The aim of the study is to validate the sanitary consequences of dental studies respectively the longtime executed profession. In comparison to this cohort we will also check a collective of subjects with an optimum of physical activity.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Age 19-30 years(longitudinal)
* 55-60 years (crosssectional)
* Dentists
* Trainers

Exclusion Criteria:

* Pregnant
* CVD
* Medication; and
* Diseases affecting body composition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Zahn-, Mund- und Kieferklinik, University of Erlangen-Nurnberg
state: Bavaria
Study officials:
affiliation: Zahn-, Mund- und Kieferklinik, University of Erlangen-Nurnberg
name: Julia S Bauer, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zahn-, Mund- und Kieferklinik, University of Erlangen
name: Stefan Eitner, DMD, PhD
role: STUDY_DIRECTOR
affiliation: University of Erlangen-Nürnberg Medical School
name: Wolfgang K Kemmler, PhD
role: STUDY_CHAIR
affiliation: University of Erlangen-Nürnberg Medical School
name: Simon O von Stengel, PhD
role: STUDY_CHAIR
affiliation: University of Erlangen-Nürnberg Medical School
name: Jürgen Weineck, PhD, MD
role: STUDY_CHAIR
affiliation: Zahn-, Mund- und Kieferklinik, University of Erlangen
name: Manfred Wichmann, DMD, PhD
role: STUDY_CHAIR
References:
citation: Kemmler W, von Stengel S, Kohl M, Bauer J. Impact of exercise changes on body composition during the college years--a five year randomized controlled study. BMC Public Health. 2016 Jan 19;16:50. doi: 10.1186/s12889-016-2692-y.
Clinical trial NCT01584635: The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia
Official title: Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achalasia
Keywords: Less invasive treatment for Achalasia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.

The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry.

Exclusion Criteria:

* Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol.
* Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met:
* The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation)
* The patient is at least one year postmenopausal (no menses for 12 months).
* The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration.
* Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
* Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods.
* Vulnerable populations, such as those with diminished mental acuity, will be excluded.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 5 years post surgery
Secondary outcomes:
measure: Eckardt symptom score
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Katzka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04162535: Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery
Official title: Contributions to the Elucidation of the Mechanisms and Effects by Which Certain Perianesthetic Interventions Modify Long-term Evolution of Patients With Digestive Cancers Subjected to Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Colorectal Cancer
Keywords: Anesthesia
Propofol
Sevoflurane
Lidocaine
Cell Culture
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
name: Prof. Dr. I. Chiricuta Institute of Oncology
First posted: 2019-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old patients admitted for elective colorectal surgery

Exclusion Criteria:

* Pre-existing chronic pain
* Chronic medication that may interfere with pain: antiepileptics, NSAIDs, corticosteroids
* Contraindications to any of the medications in the study
* Significant psychiatric disorders (Axis I disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.)
* Hepatic (ALT and / or AST\> 2 normal wave) or renal (serum creatinine\> 2 mg / dl)
* Convulsive conditions that require medication in the last 2 years
* Planned regional analgesia and / or anesthesia (spinal or epidural)
* Corticosteroid-dependent asthma
* Autoimmune disorders
* Antiarrhythmic drugs (verapamil, propafenone, amiodarone) that may interfere with the antiarrhythmic action of lidocaine

Primary outcomes:
measure: Evaluation of the antiproliferative and apoptotic effects of anesthetic agents
timeFrame: up to 4 years
measure: Evaluation of patients serum on cell culture
timeFrame: up to 1 week
Secondary outcomes:
measure: Lidocaine concentration
timeFrame: up to 4 years
measure: Survival Comparison
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor
state: Cluj
Study officials:
affiliation: UMF Iuliu Hatieganu Cluj-Napoca
name: Ionescu Daniela, MD PHD DEEA
role: STUDY_DIRECTOR
References: