louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05617469: DLCS for Predicting Neoadjuvant Chemotherapy Response
Official title: Deep Learning Radio-clinical Signatures for Predicting Neoadjuvant Chemotherapy Response and Prognosis From Pretreatment CT Images of LAGC Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
CT Images
Deep Learning
Neoadjuvant Chemotherapy
Tumor Regression Grade
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with histologically confirmed GC/esophagogastric junction cancer (EGJC) who received NCT prior to surgical resection

Brief summary: The early noninvasive screening of patients suitable for neoadjuvant chemotherapy (NCT) is essential for personalized treatment in locally advanced gastric cancer (LAGC). The aim of this study was to develop and visualized a radio-clinical biomarker from pretreatment oversampled CT images to predict the response and prognosis to NCT in LAGC patients.


Eligibility criteria: Inclusion Criteria:

1) patients with GC/EGJC confirmed by pathological examination; 2) patients who underwent D2 lymphadenectomy; 3) patients who received at least two cycles of preoperative chemotherapy; 4) patients with negative resection margins; and 5) patients with complete CT image data and clinical data.

Exclusion Criteria:

1) patients unable to undergo D2 radical gastrectomy after neoadjuvant therapy; and 2) patients with incomplete CT images and clinical data.

Primary outcomes:
measure: Tumor regression grade
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
state: Zhejiang
Study officials:
References:
Clinical trial NCT06614569: Long-Term Follow-Up of Subjects Treated With AXO-AAV-GM2 for Tay-Sachs or Sandhoff Disease
Official title: Long-Term Follow-Up of A Two-Stage Dose-Escalation Study to Evaluate the Safety and Efficacy of Bilateral Intraparenchymal Thalamic and Intracisternal/Intrathecal Admin of AXO-AAV-GM2 in Tay-Sachs or Sandhoff Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: GM2 Gangliosidosis
Tay Sachs Disease
Sandhoff Disease
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Tay-Sachs or Sandhoff Disease who were previously treated with AXO-AAV-GM2

Brief summary: This study is to continue Long-Term Follow-Up of Patients who were previously treated with AXO-AAV-GM2 Gene Therapy as treatment for Tay-Sachs or Sandhoff Disease to follow the subjects through 5 years after their initial gene therapy treatment.

Detailed description: Subjects will be contacted bi-annually for a total of five years following the administration of AXO-AAV-GM2 for the collection of clinical information, especially pertaining to de novo cancer, neurologic, rheumatologic, and hematologic/immunologic disorders. This will be done to comply with FDA Recommendations and NIH Guidelines for long-term follow-up for research involving gene therapy with AAV Vectors.

Eligibility criteria: Inclusion Criteria:

* Subjects who were previously enrolled in the study "A Two-Stage Dose-Escalation Study to Evaluate the Safety and Efficacy of Bilateral Intraparenchymal thalamic and intracisternal/Intrathecal Admin of AXO-AAV-GM2 in Tay-Sachs or Sandhoff Disease."

Exclusion Criteria:

* Subjects who were not previously enrolled under the initial protocol.

Primary outcomes:
measure: Long term Safety of AXO-AAV-GM2
timeFrame: Every 6 months, up to five years
Secondary outcomes:
measure: Long term Impact of AXO-AAV-GM2
timeFrame: Every 6 months, up to five years
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Terence Flotte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060369: BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock
Official title: BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Keywords: Tissue Perfusion
Noninvasive Monitoring
Near-infrared spectroscopy
CareGuide
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Reflectance Medical, Inc.
First posted: 2017-02-23
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: Our study population is made up of adults admitted to an ICU with established or emerging shock.

Brief summary: This pilot study aims to examine the relationship between continuously measured CareGuide™ muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring techniques during the care of subjects with suspected established (Cohort A) or emerging (Cohort B) shock in the intensive care unit (ICU).

Detailed description: Approximately 50 subjects meeting recruitment criteria will be enrolled with a minimum of 20 subjects meeting entry criteria for established shock (Cohort A).

Noninvasive near-infrared spectroscopy CareGuide™ measurements of SmO2, tissue pH and hematocrit will be collected from enrollment through device removal. These data will be compared to specific hemodynamic and laboratory parameters obtained as a part of routine care during the CareGuide™ monitoring period.

Eligibility criteria: Inclusion Criteria:

Subjects who are:

1. To be admitted to the intensive care unit
2. At least 18 years of age
3. Men or Women
4. Informed consent from subject or surrogate
5. Clinical diagnosis of established (Cohort A) or emerging (Cohort B) shock, as described above.

Exclusion Criteria:

Subjects with:

1. Body mass index \>37
2. Trauma (primary diagnosis)
3. Pregnancy
4. Non-global conditions leading to regional increased lactate production (e.g. isolated thrombotic or embolic phenomena, limb, compartment syndrome)
5. Known untreated hypothyroidism
6. Known hypersensitivity to medical adhesives
7. Suspected carbon monoxide poisoning or methemoglobinemia
8. Goals of care restricting vital sign acquisition
9. Family member of investigators or study staff

Primary outcomes:
measure: Peak systemic lactate
timeFrame: Duration of monitoring (< 1 week)
Secondary outcomes:
measure: Peak systemic lactate
timeFrame: Duration of monitoring (< 1 week)
measure: Temporal assessment of SmO2 and lactate
timeFrame: Duration of monitoring (< 1 week)
measure: Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive)
timeFrame: Duration of monitoring (< 1 week)
measure: Systemic pH
timeFrame: Duration of monitoring (< 1 week)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05984069: Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported
Official title: Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Intensive Care Syndrome
Keywords: Intensive Care Unit
frailty
fatigue
ICU acquired-weakness
FACIT-F
physical activity
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to intensive care, all etiologies combined, excluding immediate post-operative scheduled surgery, with mechanical ventilation for more than 5 days or length of stay in ICU over 10 days.

Brief summary: After a prolonged stay in Intensive Care Unit (ICU), fatigue is the most common symptom reported by patients in the Post Intensive Care Syndrome (PICS). Other complications have been described, including ICU-acquired weakness, leading to increased morbidity and mortality after discharge. Actually, risk factors associated with post-ICU fatigue self-reported are not really known.

Detailed description: Frailty, defined as a decrease in physiological reserves leading to an alteration in the mechanisms of adaptation to stress, increases the incidence of PICS and could therefore be a cause of post-ICU fatigue self-reported.

The aim of this study is to identify a relationship between markers of frailty, ICU-AW, ICU story and the post-ICU fatigue self-reported 6 months discharge in patients with prolonged ICU stays.

Eligibility criteria: Inclusion Criteria:

* Patients with a length of stay in intensive care \> or equal to 7 days, or mechanical ventilation \> or equal to 5 days

Exclusion Criteria:

* Scheduled surgery with admission in ICU
* Pregnancy
* Guardianship

Primary outcomes:
measure: Frailty
timeFrame: 1 year
Secondary outcomes:
measure: Fatigue
timeFrame: 1 year
measure: ICU-acquired weakness and fatigue
timeFrame: 1 year
measure: Fatigue, quality of life, anxiety and depressive disorder
timeFrame: 1 year
measure: Kinetic of muscle mass loss and post-ICU fatigue self-reported
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
city: Saint-Étienne
country: France
facility: Hôpital Privé de la Loire
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jérôme MOREL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06319469: The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention
Official title: The Additive Value of Pyridostigmine to Silodosin in the Management of Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Hyperplasia
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 140
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute urine retention, AUR, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (BPH). AUR is defined as the sudden and painful inability to void freely. This study aims to evaluate whether pyridostigmine bromide added to silodosin is beneficial in treating acute urine retention caused by BPH.

Detailed description: AUR, or acute urine retention, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (BPH). AUR is defined as the sudden and painful inability to void freely. (Hartung, 2001).

Between 0.4 and 25% of males seen in routine urological care are reported to have AUR each year (Schulman, 2001). According to a significant US cohort study, if a 60-year-old man survived for another 20 years, his probability of experiencing an AUR episode would be 23% (Jacobsen et al., 1997).

The current standard of care for AUR typically involves immediate bladder catheterization, followed by subsequent removal of the catheter to test whether normal voiding returns, that is, a trial without a catheter (TWOC) (Gwon et al., 2023).

Eligibility criteria: Inclusion Criteria:

* Patients with a retention volume of less than 1000 milliliters who were over 50 years old and going through their first episode of acute urine retention (AUR) due to benign prostatic hyperplasia (BPH) were included in this study

Exclusion Criteria:

* The individuals who do not meet the eligibility requirements are those who have been diagnosed with an infection of the urinary tract, have repeatedly retained urine, have had unsuccessful trial voiding procedures in the past, have a retention volume of more than one liter, have had a history of prostatic or bladder neck surgery, have been diagnosed with prostate carcinoma, have experienced urethral stricture, have a neurogenic bladder, have been diagnosed with renal failure, or have been diagnosed with liver disease.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 3 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Seuf University Hospital
Study officials:
affiliation: BENISEUF UNIVERSITY
name: ALSHAIMAA Ibrahim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462769: Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Cardiac Surgery
Official title: Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Minimally Invasive Cardiac Surgery
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

Brief summary: A single-center prospective study. Patients undergoing minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA; Teleflex/Essential Medical, Malvern, PA). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.


Eligibility criteria: Inclusion Criteria:

* Operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Any vascular groin-related complication
timeFrame: During the first 8 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT00238069: Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea
Official title: Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Sleep Apnea
Keywords: Asthma
Sleep Apnea
Obesity
CPAP
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2005-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. This study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. This study involves 2 bronchoscopies.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18yrs at the time of recruitment)
* Body mass index (BMI) ≥ 30
* Symptoms suggestive of sleep apnea
* Epworth Sleepiness Score (ESS) within range
* Positive sleep study for sleep apnea

Exclusion Criteria:

* Tobacco use within the last 3 months.
* Presence of other significant comorbid heart or lung disease
* Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
* Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
* Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
* Presence of severe or uncontrolled sinusitis, such that CPAP therapy will be difficult or uncomfortable.
* History of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of CPAP therapy.
* Night shift workers, or other subjects with significantly altered sleep-wake cycles.
* Baseline post-bronchodilator FEV1 \< 70% predicted.
* Severe gastroesophageal reflux disease.

Primary outcomes:
measure: Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
measure: Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
measure: BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.
measure: Endobronchial biopsies to analyze extent and type of inflammatory cell.
Secondary outcomes:
measure: Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
measure: Spirometry measured at three time points: before, during, and after CPAP therapy.
measure: Post-CPAP methacholine for bronchial hyperreactivity
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
Study officials:
affiliation: National Jewish Medical and Research Center faculty
name: Richard Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05233969: Pain-Related Self-Efficacy in Individuals With Chronic Neck Pain
Official title: An Investigation of Factors Affecting Pain-Related Self-Efficacy in Individuals With Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neck Pain
Keywords: Neck Pain
Self Efficacy
Physical Activity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 69
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with chronic neck pain

Brief summary: The factors affecting pain-related self-efficacy in individuals with chronic neck pain were investigated. A total of 69 subjects participated in the study. After the demographic data of the subjects were taken, pain-self-efficacy questionnaire, Timed Up and Go Test, Berg Balance Scale and International Physical Activity Questionnaire were administered, respectively.


Eligibility criteria: Inclusion Criteria;

1. Adults aged 30 to 65 years,
2. Adults with neck pain for at least 3 months,
3. Having a score of 3 or more on the visual analog scale for pain ,
4. To be willing to participate in the study.

Exclusion Criteria;

1. Diagnosed with neurological, vestibular, rheumatic, or endocrine disorders,
2. Had previous spinal surgery, neck trauma associated with post-traumatic amnesia or concurrent head injury, or cervical fracture or dislocation,
3. currently receiving treatment for neck pathology.

Primary outcomes:
measure: Pain-Self-Efficacy Questionnaire(PSEQ)
timeFrame: five minutes
Secondary outcomes:
measure: Time Up and Go(TUG)
timeFrame: five minutes
measure: Berg Balance Scale(BBS)
timeFrame: ten minutes
measure: International Physical Activity Questionnaire(IPAQ)
timeFrame: ten minutes
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Merve Karapinar
Study officials:
References:
Clinical trial NCT05852769: A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
Official title: A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BMS-986196
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-05-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
* Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m\^2), inclusive, and body weight ≥50.0 kg.

Exclusion Criteria:

* History of rhabdomyolysis.
* History of peptic ulcer disease or significant GI bleeding.
* History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 26 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 26 days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 26 days
Secondary outcomes:
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Up to 26 days
measure: Apparent terminal phase half-life (T-Half)
timeFrame: Up to 26 days
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to 26 days
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 52 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 28 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 21 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 28 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 28 days
measure: Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Millcreek
country: United States
facility: ICON plc
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: