louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03803475: Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
Official title: Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 485
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Detailed description: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues

Primary Objective:

Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Eligibility criteria: Inclusion Criteria:

1. Male, age \>= 18.
2. Histopathologically proven prostate adenocarcinoma.
3. Concern for metastatic disease in one of the following settings:

   1. Initial staging with intermediate to high risk prostate cancer.
   2. Biochemical recurrence after initial therapy.
4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Primary outcomes:
measure: Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
timeFrame: 1 day
measure: Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group
timeFrame: 1 day
measure: Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group
timeFrame: 1 day
measure: Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group
timeFrame: 1 day
measure: Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Hope, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800475: Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets
Official title: A Relative Bioequivalence Study of 600 mg Gemfibrozil Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Keywords: bioavailability
Gemfibrozil
Lead sponsor: Blu Caribe
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.


Eligibility criteria: Inclusion Criteria:

* healthy men or women 18 years of age or older
* weight within +/- 20% for height and body frame
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to gemfibrozil
* use of tobacco products
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 28 days prior to study dosing

Primary outcomes:
measure: Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05223075: Articaine Versus Lidocaine Buccal Infiltration
Official title: Articaine Versus Lidocaine in Only Buccal Infiltration Anesthesia for the Extraction of Mandibular Anterior Teeth.Asplit Mouth Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain
Keywords: buccal infiltration
lidocaine
articaine
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: assess the effect of articaine versus lidocaine in only buccal infiltration of local anethesia in lower anterior teeth


Eligibility criteria: Inclusion Criteria:

* medically stable
* 18years or older
* patient with bilateral lower anterior teeth requiring non surgical removal

Exclusion Criteria:

* grade 3 mobility
* neurological disease
* allergy to anethesia

Primary outcomes:
measure: pain during extraction
timeFrame: during extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT04511975: A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS
Official title: A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: MDS
Keywords: MDS
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an open-label, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of IBI188 in combination with Azacitidine in newly diagnosed higher risk MDS patients.


Eligibility criteria: Main Inclusion Criteria:

1. Newly diagnosed MDS subjects with higher risk.
2. Age ≥ 18 years old.
3. Eastern Cooperative Oncology Group score of 0-2.
4. Adequate organ function.
5. Subjects should take effective contraceptive measures.
6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Main Exclusion Criteria:

1. Subject who has transformed from MDS to AML.
2. MDS subjects with lower risk.
3. Subjects who have received chemotherapy.
4. History of chronic hemolytic anemia
5. Prior exposure to any anti-CD47 or anti-SIRPα agents.
6. Subjects participating in another interventional clinical study.

Primary outcomes:
measure: Adverse Events
timeFrame: 28 days
measure: Efficacy of IBI188 in combination with AZA
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Brick
country: United States
facility: New Jersey Center for Cancer Research
state: New Jersey
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
Study officials:
affiliation: Innovent Biologics
name: Yi Luo
role: STUDY_DIRECTOR
References:
Clinical trial NCT02199275: Effect of General Anesthesia on Enterocyte Damage
Official title: Impact of General Anesthesia on Enterocyte Damage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-urgent Surgery
General Anesthesia
Keywords: Non-urgent surgery
General anesthesia
Enterocyte damage
Intestinal fatty acid-binding protein
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults requiring non-urgent surgery, in whom a protocol of general anesthesia using propofol and remifentanyl with monitoring of bispectral index is expected.

Brief summary: During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.

Detailed description: Inclusion criteria

* Indication of non-urgent surgery
* General anesthesia protocol using propofol and remifentanyl
* One half of the patients have a history of ischemic arteriopathy
* One half of the patients have no history of ischemic arteriopathy

Exclusion criteria

* Age \< 18 years old
* Pregnant

Primary objective

Is there a significant elevation of I-FABP between the pre-anesthesic period and 11 minutes after induction of general anesthesia ?

Secondary objectives

1. Is I-FABP elevation higher among patients with history of patent arteriopathy ?
2. Is I-FABP elevation higher among patients presenting with hypotension during anesthesia ?

Eligibility criteria: Inclusion criteria

* Indication of non-urgent surgery
* General anesthesia protocol using propofol and remifentanyl
* One half of the patients have a history of ischemic arteriopathy
* One half of the patients have no history of ischemic arteriopathy

Exclusion criteria

* Age \< 18 years old
* Pregnant

Primary outcomes:
measure: I-FABP elevation after induction of general anesthesia
timeFrame: 11 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU de Besançon
Study officials:
References:
Clinical trial NCT05397275: The Effect of Progressive Relaxation and Breathing Exercise on Sleep Quality and Exercise Self-Efficacy in Patients With COPD
Official title: The Effect of Progressive Relaxation and Breathing Exercise on Sleep Quality and Exercise Self-Efficacy in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Asthma
Keywords: Exercise Self-Regulatory Efficacy,
sleep quality
PGE with breathing exercises
pulmonary rehabilitation
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Aim: This study was conducted to determine the effect of progressive muscle relaxation and breathing exercise on sleep quality and exercise self-efficacy in chronic obstructive pulmonary patients.

Methods: This study was conducted as a randomized controlled experimental study. The study was conducted with 64 chronic obstructive pulmonary patients, where 36 of them were in the intervention group and 34 in the control group. Data of the study were collected using the descriptive information form, the Pittsburgh Sleep Quality Index, and the Exercise Self-Regulatory Efficacy Scale (Ex-SRES) for patients with COPD.

Results: When the total scores pertaining to the sleep quality index and exercise self-efficacy of the individuals in the intervention and control groups were compared, it was found that there were statistically significant differences in the intervention group compared to the control group (p \< 0.05).

Keywords: Exercise Self-Regulatory Efficacy, sleep quality in patients with COPD, PGE along with breathing exercises, pulmonary rehabilitation


Eligibility criteria: Inclusion Criteria:

* were to be 18 years of age or older
* not using sleeping pills
* verbally stating that they have moderate and severe sleep disorders.

Exclusion Criteria:

* having any lung disease other than COPD
* having cardiological problems (heart failure, uncontrollable hypertension, history of angina and myocardial infarction, heart valve problems), psychotic disorder,
* inability to communicate verbally and having hearing problems.

Primary outcomes:
measure: progressive muscle relaxation exercises changes sleep quality and exercise self-efficacy.
timeFrame: 1 mounth
Secondary outcomes:
measure: progressive muscle relaxation exercises with breathing exercise changes sleep quality and exercise self-efficacy.
timeFrame: 1 mounth
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University
Study officials:
References:
Clinical trial NCT03673475: Internal Jugular Vein Distensibility and Pleth Variability Index(PVI) for Evaluating Fluid Responsiveness
Official title: Internal Jugular Vein Distensibility and Pleth Variability Index for Evaluating Fluid Responsiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intravascular Volume
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing major abdominal surgery

Brief summary: Assessment of intravascular volume status is crucial in order to predict the efficacy of volume status in major abdominal surgery. The aim of the study is to verify the feasibility and usefulness of the internal jugular vein distensibility index as an adjunct to the pleth variebility index(PVI) to predict fluid responsiveness in major abdominal surgery.

Detailed description: Forty patients above age 18 and ASA status I-III who are undergoing major abdominal surgery will be enrolled in the study. patients with right heart failure, arrythmia, severe valve stenosis or regurgitation will be excluded. After induction of general anesthesia, when the patients are hemodynamically stabilised, PVI and jugular vein distensibility will be calculated and recorded. after volume load with 500 ml gel infusion(in 15 min), measurements will be repeated within 10 minutes and recorded. Patients will be allocated to 2 groups according to the change in mean arterial pressure(MAP) after volume expansion: Responders will be defined as an increase in MAP by \>%10; while nonresponders will be defined as an increase in MAP \<%10 or decrease in MAP.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists(ASA) physical status I-III patients
* patients undergoing major abdominal surgery

Exclusion Criteria:

* arrythmia
* severe right ventricle failure

Primary outcomes:
measure: number of patients with significant change in VJI distensibility and pleth variebility index
timeFrame: during surgery at day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Tepecik Training and Research Hospital
Study officials:
affiliation: Tepecik TRH
name: Yucel Karaman, ass. prof
role: STUDY_CHAIR
References:
Clinical trial NCT01815775: Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
Official title: Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Normal Pressure Hydrocephalus
Keywords: Normal pressure hydrocephalus
flow MRI
dementia
cerebrospinal fluid
shunt
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of predictive value of surgery response.

In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.


Eligibility criteria: Inclusion Criteria:

* age: over 20 years
* diagnostic of normal pressure hydrocephalus
* ventricular dilation visible on radiological examination
* patients gave their written informed consent

Exclusion Criteria:

* age: less than 20 years
* MRI contra-indication
* pregnancy
* lumbar puncture within 48 hours before MRI
* cardiac arrhythmia
* cerebral/lacunar stroke

Primary outcomes:
measure: CSF stroke volume
timeFrame: Day 1
Secondary outcomes:
measure: Hakim's triad evaluation
timeFrame: Day 1
measure: Hakim's triad evaluation
timeFrame: Day 90
measure: Hakim's triad evaluation
timeFrame: Day 365
measure: Neuropsychological test
timeFrame: Day 1
measure: Neuropsychological test
timeFrame: Day 90
measure: Neuropsychological test
timeFrame: Day 365
measure: CSF stroke volume
timeFrame: Day 60
measure: CSF stroke volume
timeFrame: Day 365
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
state: Picardie
Study officials:
References:
Clinical trial NCT04894175: Association Between Treatment Adherence and Treatment Adherence in Sleep Apnea (SEMSAS)
Official title: Association Between Treatment Perception and Treatment Adherence in Obstructive Sleep Apnea Patients Treated by Continuous Positive Airway Pressure (SEMSAS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Auxilair
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 302
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: Population will be screened by clinicians (pulmonologists) in ambulatory medicine

Brief summary: The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.


Eligibility criteria: Inclusion Criteria:

* Obstructive Sleep apnea diagnosed, whatever the initial severity and treated with CPAP
* Voluntary patient
* patient in the national healthcare insurance system

Exclusion Criteria:

* Patient with central sleep apnea
* Treatment other than CPAP
* Person with liberty privation or under legal protection

Primary outcomes:
measure: Continuous positive airway pressure adherence
timeFrame: 3-month
measure: Continuous positive airway pressure adherence
timeFrame: 1-year
Secondary outcomes:
measure: To compute an overall score to predict CPAP adherence
timeFrame: 3-month and 1-year
measure: To study the impact of health litteracy on CPAP adherence
timeFrame: 3-month and 1-year
measure: To study the impact of precariousness on CPAP adherence
timeFrame: 3-month and 1-year
measure: To study the impact of patient quality of life on CPAP adherence
timeFrame: 3-month and 1-year
measure: To construct an overall predictive model of CPAP adherence
timeFrame: 3-month and 1-year
measure: To assess the interactions between CPAP adherence trajectories and patients parameters
timeFrame: 3-month and 1-year
measure: to assess the improvement of quality of life according to health litteracy and precariousness
timeFrame: 1-year
measure: Define patient phenotype according all collected variables
timeFrame: At inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: Gentina
Study officials:
affiliation: Hopital La Louvière
name: Thibaut Gentina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05343975: Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures
Official title: Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Disease
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred to the ICO of Angers for management of a breast pathology, or during screening, requiring the performance of one (or more) breast micro or macrobiopsy.

Brief summary: A prospective, non-randomized, single-center cohort study to evaluate the value of audio-guided meditation during breast biopsy procedures.

The main criterion of judgment is based on the evaluation of tolerance, which includes anxiety and pain felt. This is assessed with questionnaires (STAI-ETAT and EN) before and after the procedure.

Secondary endpoints include tolerance of additional physical pain, reduction in the number of per-procedure complications, overall satisfaction of the practitioner with the biopsy procedure, and comparison of the tolerance of the procedure in patients who practice meditation at home before the procedure

Detailed description: audio-guided meditation during breast biopsy procedures questionnaires (STAI-ETAT and EN) before and after the procedure.

Eligibility criteria: Inclusion Criteria:

* Breast pathology requiring the performance of one (or more) breast and/or axillary micro or macrobiopsy,
* Informed patient, with collection of the non opposition

Exclusion Criteria:

* Excluded forms of the disease: biopsy concerning organs other than the breast and/or axilla
* Persons deprived of their liberty, under court protection, under curatorship or under the authority of a guardian,
* Impossibility to submit to the medical follow-up of the trial for geographical, social or psychic reasons (invalidating psychiatric disorder diagnosed of psychotic type).

Primary outcomes:
measure: To describe the level of pain according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure
timeFrame: immediately after procedure
measure: To describe anxiety according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure
timeFrame: immediately after procedure
Secondary outcomes:
measure: per-biopsy complications
timeFrame: immediately after procedure (same day of the biopsy)
measure: satisfaction of the radiologist with regard to the procedure
timeFrame: immediately after procedure
measure: efficacy of the procedure
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Angers 02
country: France
facility: Institut de Cancerologie de L'Ouest (Ico)
Study officials:
affiliation: INSTITUT DE CANCEROLOGIE DE L'OUEST
name: Pierre BERGE, MD
role: PRINCIPAL_INVESTIGATOR
References: