louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03613233: QoL Assessment in Traditional Glaucoma Surgery and MIGS.
Official title: Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: MIGS
canaloplasty
glaucoma
glaucoma surgery
glaucoma implant
deep sclerectomy
iridencleisis
QoL
quality of life
NEI VFQ 25
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).

Detailed description: Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.

Eligibility criteria: Inclusion Criteria:

patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:

* all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
* patients not tolerating antiglaucoma medications,
* patients with poor compliance
* progression in visual field

Exclusion Criteria:

* active inflammatory disease
* pregnancy
* mental disease or emotional instability
* general steroid therapy
* inability to fill in the questionnaire

Primary outcomes:
measure: NEI VFQ 25 quality of life score change
timeFrame: baseline (0-30 days; pre-operative) and three months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
Study officials:
References:
Clinical trial NCT02842333: Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
Official title: Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Leukemia
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.

The aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1 responses in patients in complete remission of CML two years after end of Tyrosine Kinase Inhibitor (TKi) treatments.


Eligibility criteria: Inclusion Criteria:

* For cohort A :

  * patient with chronic myelogenous leukemia in chronic phase in deep molecular response (MR4.0) persistent for 2 years or more after end of TKi treatments
  * patient with total cessation of TKi treatment
  * signed written informed consent
* For cohort B :

  * patient with chronic myelogenous leukemia in chronic phase, for whom a diagnosis of relapse was increased 1 year or less after stopping treatment with TKIs (inclusion of patient under TKi treatment after relapse is possible).
  * signed written informed consent

Exclusion Criteria (for all patients) :

* patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (corticoids ≤ 10 mg/day is allowed)
* active autoimmune diseases, HIV, hepatitis C or B virus
* patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
* patient under guardianship, curator or under the protection of justice.

Primary outcomes:
measure: UCP-specific Th1 responses measured by ELISPOT assay
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Dijon
country: France
facility: CHU de Dijon
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital Saint-Louis
Study officials:
References:
Clinical trial NCT03455933: Action Mechanisms of Shock Waves on Pain
Official title: Action Mechanisms Responsibles for the Effects of Shock Waves on the Pressure Pain Thresholds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asymptomatic Condition
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate whether the intensity of pain perceived during the application of extracorporeal shockwave therapy (ESWT) is determinant for producing changes in pressure pain threshold (PPT) in asymptomatic subjects. The investigators will perform a single controlled random trial to three groups. Two of them will receive ESWT whereas the third group will get a cold pressure test (CPT).


Eligibility criteria: Inclusion Criteria:

* Absence of pain or illness
* No changes in cognitive ability
* Good command of Spanish, both spoken and written

Exclusion Criteria:

* People with systemic diseases, tumors, infections, pacemakers, clotting disorders, skeletally immature, fibromyalgia, whiplash history, dizziness or in physiotherapeutic or pharmacological treatment
* Pregnant women

Primary outcomes:
measure: Pressure pain threshold
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
measure: Pain Catastrophizing
timeFrame: Baseline
measure: Kinesiophobia level
timeFrame: Baseline
measure: Pain intensity
timeFrame: During the intervention
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle Madrid
Study officials:
affiliation: Universidad La Salle, Mexico
name: Ibai Lopez de Uralde Villanueva
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Muntion A, Godefroy L, Robert H, Munoz-Garcia D, Calvo-Lobo C, Lopez-de-Uralde-Villanueva I. Study of the mechanisms of action of the hypoalgesic effect of pressure under shock waves application: A randomised controlled trial. Complement Ther Med. 2019 Feb;42:332-339. doi: 10.1016/j.ctim.2018.12.012. Epub 2018 Dec 18.
Clinical trial NCT00151333: Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)
Official title: A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics Trial of Multiple Ascending Fixed Doses of SRA-333 in Subjects With Mild to Moderate Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in subjects with mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
* Men and postmenopausal or surgically sterile women aged from 50 to 85 inclusive.
* Able to give informed consent. Patient's caregiver must consent to participate in the study.

Exclusion Criteria:

* Significant neurologic disease other than AD that may affect cognition.
* Current clinically significant systemic illness which is likely to deteriorate or affect the subject's safety during the study.

Other exclusions apply

Primary outcomes:
measure: To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease
Secondary outcomes:
measure: To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Ft. Lauderdale
country: United States
state: Florida
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06344533: Study of JMKX003142 Injection in Chinese Healthy Subjects
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Adult
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang Hangyu Pharmaceutical Co., Ltd.
First posted: 2024-04-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged 18-45 years (including boundary values).
2. Able to sign a written informed consent form.
3. Physical examination, clinical laboratory examination value, Virology examination, vital signs and ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
4. The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol

Exclusion Criteria:

1. Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
2. Participants in any other clinical study within 3 months prior to the first administration of this study
3. The investigators believe that the subject has other factors that are not suitable for participating in this experiment
4. Pregnant or lactating women

Primary outcomes:
measure: Number of the Adverse Events that are related to the single dose treatment
timeFrame: From Baseline to Day7
measure: Number of the Adverse Events that are related to the multiple dose treatment
timeFrame: From Baseline to Day12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02267733: Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients
Official title: Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Gammopathy
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status

Detailed description: In this study, we will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective of age. All patients will receive an initial vaccine followed by a booster vaccine 30 days (+/- 7 days) later and will then be followed for outcomes until the end of flu season.

Eligibility criteria: Inclusion Criteria:

* Understand and voluntarily sign an informed consent document
* Age \>= 18 years at the time of signing the informed consent form
* Diagnosis of any monoclonal gammopathy; Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic/ active multiple myeloma, asymptomatic / active Waldenstrom Macroglobulinemia (WM)

Exclusion Criteria:

* An serious egg allergy or prior serious adverse reaction to an influenza vaccine
* Use of any other influenza vaccine for the 2014 to 2015 flu season
* Women who are pregnant or plan to become pregnant in the study period

Primary outcomes:
measure: Rate of Disease Control
timeFrame: up to 10 months
Secondary outcomes:
measure: Influenza related morbidity rate
timeFrame: up to 10 months
measure: Serologic Protection Rate after initial vaccine
timeFrame: 30 days post vaccine
measure: Serologic Protection Rate after initial vaccine
timeFrame: 30 days post booster
measure: T cell response
timeFrame: 30 day post initial vaccine
measure: T cell response
timeFrame: 30 day post booster
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Andrew Branagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05590533: Turkish Version of F-2-MS
Official title: Validity and Reliability of the Turkish Version of F-2-MS Scale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cultural Adaptation
Reliability
Validity
Multiple Sclerosis
Fatigue
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with multiple sclerosis with an EDSS score of 5 or less

Brief summary: The aims of this study were to perform cultural adaptation of the F-2-MS and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking patients with Multiple Sclerosis.


Eligibility criteria: Inclusion Criteria:

* Individuals aged between 20-65 years, with an EDSS score of 0-5, who have not had an attack in the last 2 months, who have no cognitive problems (a score of 6 or more according to the Hodkinson Mental Test), who do not have additional neurological diseases other than MS, and who volunteer to participate in the study will be included.

Exclusion Criteria:

* Individuals with an EDSS score greater than 5, who are in the attack period, who have vestibulosupressant or drug or alcohol use habits that cause neuropathy, and who have communication problems will be excluded from the study.

Primary outcomes:
measure: F-2-MS Scale
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06685133: Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice
Official title: A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lung; Nodule
Lead sponsor: Noah Medical
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 50
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: Clinic patients

Brief summary: A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.

Detailed description: The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. Patients with indeterminate lung nodule
3. Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT
4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
5. Informed consent properly obtained per local regulations

Exclusion Criteria:

1. Known pregnancy or breastfeeding
2. Patients with pure ground-glass nodules on pre-procedural chest CT
3. Uncontrolled coagulopathy or bleeding disorders
4. Ongoing systemic infection
5. History of lobectomy or pneumonectomy
6. Patients with pacemakers or defibrillators
7. Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist
8. Patients with pleural effusion or diaphragmatic paralysis

Primary outcomes:
measure: Successful Navigation to the lesion
timeFrame: During the procedure
measure: Successful tool-in-lesion
timeFrame: During the procedure
measure: Serious Adverse Events
timeFrame: During the procedure and up to 7 days post procedure
Secondary outcomes:
measure: Diagnostic yield
timeFrame: End of procedure and up to 2-years post-procedure
measure: Center Strike
timeFrame: During the procedure
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: CHI Memorial Hospital
state: Tennessee
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
Study officials:
References:
Clinical trial NCT03279887: Lung Ultrasonography After Major Cardiac Surgery
Official title: Usefulness of Lung Ultrasonography for Diagnosis of Pneumonia After Major Cardiac Surgery: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Cardio/Pulm: Respiratory Failure
Cardiopulmonary Bypass
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute respiratory failure after cardiac surgery and hospitalized in the surgical Intensive Care Unit of ICU of Cardiology Institute, Pitié Salpêtrière University Hospital, Paris, France

Brief summary: Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia, but its usefulness and reliability was never evaluated after cardiac surgery. This study investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.


Eligibility criteria: Inclusion Criteria:

* Cardiac surgery with sternotomy and cardio-pulmonary bypass (CPB) less than 3 days before
* At least one component suggestive of ARF:

  * If mechanical ventilation, a PaO2 / FiO2 ratio \<200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation,
  * If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea\> 25/min, upper or intercostal swallowing, abdominal swing ...), SpO2 \< 90% or PaO2 \<60 mmHg despite oxygen therapy ≥ 3L/min.

Exclusion Criteria:

* Minor patients
* Pregnancy
* Sleep apnea syndrome
* Participation refusal

Primary outcomes:
measure: Final diagnosis of pneumonia
timeFrame: During the 72 hours following surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dureau P, Bougle A, Melac AT, Ait Hamou N, Arbelot C, Ben Hassen K, Charfeddine A, Deransy R, Arcile G, Rouby JJ, Granger B, Amour J. Colour Doppler ultrasound after major cardiac surgery improves diagnostic accuracy of the pulmonary infection score in acute respiratory failure: A prospective observational study. Eur J Anaesthesiol. 2019 Sep;36(9):676-682. doi: 10.1097/EJA.0000000000001022.
Clinical trial NCT00222287: The Effect of Feldenkrais Lessons on Walking and Balance
Official title: The Effect of Feldenkrais Lessons on Walking and Balance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Accidental Falls
Exercise
Keywords: Feldenkrais Method
movement class
balance
Four square step test
Activities Specific Balance Confidence Scale
systems theory
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of a series of Feldenkrais movement lessons on mobility and balance, particularly for older adults. The investigators hypothesise that mobility and balance will improve following the classes.

Detailed description: The Feldenkrais Method is an educational process which involves exploration of novel movement sequences that lead to expansion of the movement repertoire. This Method has been used with the aim of improving balance and mobility in several studies, and has been compared to the benefits of Tai Chi for improving balance in older adults. The current study investigates the effects of a 10 week series of Feldenkrais movement classes on gait parameters as measured on an instrumented gait mat, a balance test of stepping and turning (the Four Square Step Test) and a questionnaire about balance confidence (the Activites Specific Balance Confidence scale.

Eligibility criteria: Inclusion Criteria:

* community dwelling older adults (aged over 65)
* able to independently ambulate indoors and outdoors

Exclusion Criteria:

* currently undergoing physiotherapy treatment
* unable to comprehend written english
* unable to give informed consent
* walking with a walking frame indoors

Primary outcomes:
measure: Balance Confidence (as measured by ABC scale)
measure: Tempo-spatial parameters of gait
measure: Time to complete Four Square Step Test
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Mary Galea, PhD, B App Sc (PT)
role: STUDY_DIRECTOR
References: