louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00990496: A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
Official title: A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma multiforme
GBM
Cytomegalovirus
CMV
Cytotoxic T lymphocyte
CTL
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-10-06
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.

Detailed description: Tumor specimens of consenting patients will be tested by immunohistochemistry (IHC) for the presence of IE-1 and/or pp65. Subjects whose tumors test positive for either or both CMV antigens will be consented for the treatment phase which will include a regimen of fludarabine and cyclophosphamide daily for two days, cyclophosphamide only for a third day, followed by one day of rest prior to the day of CTL infusion.

This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before termination.

Eligibility criteria: Inclusion Criteria:

FOR SCREENING

* Patients must have a histopathologic diagnosis of GBM.
* Patients from 5 to 65 years of age with GBM.

FOR TREATMENT

* GBM has progressed following primary therapy.
* Tumor is CMV pp65 or IE1 positive by immunohistochemistry (IHC).
* Subjects must have pulse oximetry \> or = 94 % on no supplemental oxygen.
* Creatinine clearance must be \> 50 cc/min as estimated by patient's serum creatinine, weight, and age.
* Bilirubin must be \< 2.0 mg/dl and SGOT/SGPT \< 2.5 X normal.
* ECOG performance status must be \< or = 2, and for patients \<16 years of age, Lansky performance status must be \> or = 70%.

Exclusion Criteria:

* Pregnant females
* Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the T cell infusion

Primary outcomes:
measure: To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.
timeFrame: 2 years
measure: To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.
timeFrame: 2 years
measure: To determine safety of allogeneic CTL infusions in this patient population.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Kenneth Lucas G. Lucas, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03413696: Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Official title: Effects of Health Literacy and Hepatitis C Knowledge on Hepatitis C Treatment Willingness in HIV-coinfected Patients, According to Hepatitis C Treatment Referral Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Hepatitis C, Chronic
HIV/AIDS
Keywords: HIV
Health literacy
Hepatitis C
Hepatitis C knowledge
HIV knowledge
Hepatitis C treatment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients living with HIV, coinfected with HCV, who are receiving care at the UCSD Owen Clinic at the time of data collection

Brief summary: A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment referral status: not-referred, referred-attended, referred and no-show.

Detailed description: The main purpose of this research study is to investigate the prevalence of inadequate health literacy and hepatitis C knowledge and their determinants among people living with HIV/AIDS co-infected with hepatitis C. The observation will determine if health literacy and/or hepatitis C knowledge are predictors of patient willingness and intention to be treated for HCV in the overall cohort and stratified according to study groups as noted above.

Eligibility criteria: Inclusion Criteria:

* Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic
* Regardless of ethnic background
* English or Spanish speaking
* With active HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody

Exclusion Criteria:

* Neurocognitive impairment precluding participation
* Physical illness precluding participation

Primary outcomes:
measure: Inadequate health literacy (s-TOFHLA inventory)
timeFrame: Baseline before HCV treatment consideration
Secondary outcomes:
measure: Hepatitis C knowledge (using the modified Treolar's scale)
timeFrame: Baseline before HCV treatment consideration
Other outcomes:
measure: Determinants of inadequate health literacy and HCV knowledge
timeFrame: Baseline before HCV treatment consideration
measure: Predictors of patient willingness to HCV treatment
timeFrame: Baseline before HCV treatment consideration
Locations:
city: San Diego
country: United States
facility: Owen Clinic - University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Edward Cachay, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04139096: Genetic Susceptibility to Radiation Induced Thyroid Cancer
Official title: Genetic Susceptibility to Radiation Induced Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Neoplasms
Genetic Susceptibility
Radiation Exposure
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2019-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort of subjects treated for a skin hemangioma at Gustave Roussy Institute from 1947 to 1973, mostly by radiotherapy.

Brief summary: Case control on thyroid cancer occuring in a cohort of 7300 subjects treated during their childhood, mostly by radiotherapy, for a skin Angioma at Gustave Roussy, Villejuif France between 1947 and 1973.

This case control study, which is included in a larger european project, aims to investigate the DNA variant interacting with the risk of radiation induced thyroid cancer after irradiation.

The sutdy is planed to include about 30 cases and 30 controls. Matching criteria are date of birth, gender, and age at irradiation.


Eligibility criteria: Inclusion Criteria:

Diganosis of thyroid cancer during the followup or selected as a control matched on gender, date of birth and age at skin hemangioma diagnosis.

Exclusion Criteria:

No available adress Refusal

Primary outcomes:
measure: Number of Differentiated thyroid carcinoma
timeFrame: From hemangioma diagnosis to the end of the followup, in average 45 years after hemangioma diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustae Roussy
state: Val de Marne
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Florent de Vathaire, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825396: An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension
Official title: A Pilot, Open-Label, Controlled Clinical Trial of C-KAD Ophthalmic Solution in Reducing Intraocular Pressure in Patients With Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Hypertension
Lead sponsor: Chakshu Research, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-21
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of topical C-KAD Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Both eyes having intraocular pressure in the range of 22-30 mmHg at baseline
* Both eyes having best corrected visual acuity better than 20/50

Exclusion Criteria:

* Advanced glaucoma
* Closed or barely open anterior chamber or history of angle closure

Primary outcomes:
measure: Mean change in intraocular pressure from baseline
timeFrame: 150 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Associates
state: North Carolina
Study officials:
affiliation: Chakshu Research, Inc.
name: Ira Wong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01766596: Study the Signs of Ocular Degeneration in a Population Cohort (Dijon 3C Montrachet Cohort)
Official title: Study the Signs of Ocular Degeneration in a Population Cohort (Dijon 3C Montrachet Cohort): Seek Correlations Between Signs of Neurological and Vascular Degeneration and Signs of Ocular Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AMD
Glaucoma
Keywords: Ophthalmology
Age-related ocular pathologies
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 1153
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study proposed in Dijon is above all to focus on the possible relationship between age-related ocular pathologies (AMD and glaucoma) and et les degenerative neurological and cardiac pathologies.

The principal objective is to seek in subjects who have undergone cerebral MRI and echocardiography, associations between the thickness of postganglionic fibers measured by Optical Coherence Tomography at the 7th year (n=1500) and signs of cerebral impairment (psycho-cognitive tests, circulation time, MRI signs). This association will be studied after taking into account the principal environmental (particularly dietary) and genetic risk factors.


Eligibility criteria: Inclusion Criteria:

* Persons who have given their written consent
* Persons who are taking part in the Dijon 3C study

Exclusion Criteria:

* Persons who are not registered with social security agency
* Persons who are unable to sit upright during a consultation

Primary outcomes:
measure: Measure the mean thickness of postganglionic fibers
timeFrame: T=7 years of the 3C cohort
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
Study officials:
References:
Clinical trial NCT01505296: Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
Official title: Randomized Comparison of Catheter Ablation Versus Anti-arrhythmic Drug Therapy in Patients With Recently Diagnosed Paroxysmal Atrial Fibrillation as Assessed by a Continuous Implantable Monitor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Catheter ablation
Lead sponsor: Valley Health System
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2012-01-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.

Detailed description: Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.

Eligibility criteria: Inclusion Criteria:

* Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy

Exclusion Criteria:

* Previous treatment with Class IC or class III AAD
* Previous AF ablation procedure
* Congestive heart failure (NYHA III-IV functional class)
* Left Ventricle ejection fraction less than 35%
* Left atrial diameter \> 55mm
* Unwillingness to participate

Primary outcomes:
measure: Percentage of AF burden
timeFrame: 4 months
Secondary outcomes:
measure: All-death death
timeFrame: 4 months
Other outcomes:
Locations:
city: Ridgewood
country: United States
facility: Valley Health System
state: New Jersey
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: Valley Health System
name: Jonathan Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia
name: Evegny Pokushalou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05654896: Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma
Official title: Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma: an Open-label, Randomised, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Antibiotic Prophylaxis
Keywords: Antibiotic
TACE
HCC
Lead sponsor: Pakistan Kidney and Liver Institute and Research Center
Sponsor class: OTHER
Collaborators: name: Ahmad Zia
name: Muhammad Junaid Tahir
First posted: 2022-12-16
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.

There would be two comparison groups. Current standard of care treatment at PKLI\&RC (as per local guidelines) would be given to all patients receiving TACE for the intervention group or 'antibiotic group' (i.e., Inj. Ceftriaxone 1g, intravenous × stat). While no antibiotic would be given to the 'no antibiotic group'.

Detailed description: Liver cancer especially hepatocellular carcinoma (HCC) is among the top five most common carcinomas in the world. According to the latest Cardiovascular and Interventional Radiological Society of Europe (CIRSE) standards of practice guidelines (2021), routine antibiotic prophylaxis is not recommended. However, prophylactic antibiotics are recommended in cases where there is a high risk of developing a liver abscess. These include biliary obstruction or the presence of a bilioenteric anastomosis. This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of primary liver cancer or hepatocellular carcinoma.
2. Patients receiving TACE in PKLI \& RC.
3. Patients giving informed consent.

Exclusion Criteria:

1. Receiving two or more TACE during the same hospitalization
2. Use of any antibiotics other than the prophylactic antibiotic in 48hours prior to TACE
3. Known hypersensitivity to specified antibiotic used in the study
4. Incomplete or missing laboratory investigations and data
5. Taking Sorafenib before TACE
6. TACE combined with ablation or immunetherapy
7. Tumor size \>10 cm
8. Portal vein thrombosis
9. Dilated biliary channels on CT scan / Billiary invasion by tumor

Primary outcomes:
measure: Leukocytosis
timeFrame: 2 days
measure: Liver abscess
timeFrame: 30 days
measure: Liver abscess and intervention
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Kidney and Liver Institute
state: Punjab
Study officials:
affiliation: PKLI & RC, Lahore
name: Ahmad Zia Ud Din
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03078296: Burnout Among Members of AAGL
Official title: Burnout and Associated Factors Among Members of the American Association of Gynecologic Laparoscopists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout, Professional
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: members of the AAGL

Brief summary: This study seeks to determine the burnout rate among minimally invasive gynecologic surgeons (MIGS) as well as to evaluate other personal, professional, and psychosocial factors associated with this condition.

An anonymous electronic survey will be sent to the American Association of Gynecologic Laparoscopists (AAGL) members. The survey will contain items that will inquire about socioeconomic background, professional characteristic, and about physical and psychologic well-being.


Eligibility criteria: Inclusion Criteria:

* members of the AAGL

Exclusion Criteria:

* not a member of the AAGL

Primary outcomes:
measure: Burnout as assessed by questionnaire
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
Study officials:
References:
Clinical trial NCT05350696: Comparative Study Between ESPB Versus IV Morphine as Postoperative Analgesia After Spine Surgeries .
Official title: Comparative Study Between Erector Spinae Plane Block Versus Intravenous Morphine as Postoperative Analgesia After Spine Surgeries .
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Discectomy
Vertebral Fractures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative pain is often severe in patients undergoing lumbar surgery. Due to postoperative pain, patients are unwilling to get out of bed at an early stage, which affects their recovery.

Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet demonstrated. The specific mechanism is still controversial.

The erector spinae block is achieved by injecting the local anesthetic solution (with possible adjuvants) between the erector spinae muscles (iliocostalis, longissimus, spinalis/ from lateral to medial) and the transverse process .

The technique is performed under ultrasound guidance.


Eligibility criteria: Inclusion Criteria:

* Lumbar Disc Prolapse.
* Fracture Lumbar Vertebrae

Exclusion Criteria:

1. Patient refusal.
2. Drug abuse.
3. Patient with significant neurological, psychiatric or neuromuscular disease.
4. Chronic pain on medicine.
5. known allergy to the study medications.
6. Infection at the site of infiltration.
7. Patients with bleeding tendency.

Primary outcomes:
measure: Postoperative analgesia .
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Avoid side effects of using systemic morphine.
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27.
citation: Tseng V, Xu JL. Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: Is There a Better Option? J Neurosurg Anesthesiol. 2021 Jan;33(1):92. doi: 10.1097/ANA.0000000000000631. No abstract available.
Clinical trial NCT02637596: Quality of Life After Radiofrequency Ablation of Pancreatic Cancer
Official title: Quality of Life After Intraoperative Radiofrequency Ablation of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients treated with intraoperative radiofrequency ablation (RFA).


Eligibility criteria: Inclusion Criteria:

* histologically proved locally advanced or metastatic pancreatic cancer. Patients with histologically proved resectable pancreatic cancer with low Karnofsky index.

informed consent

Exclusion Criteria:

* cystic tumor

age under 18

Primary outcomes:
measure: Quality of life after RFA of pancreatic cancer
timeFrame: 3 years
Secondary outcomes:
measure: 3- months perioperative morbidity and mortality
timeFrame: 3 years
Other outcomes:
measure: Overall Survival
timeFrame: 3 years
Locations:
city: Brno
country: Czech Republic
facility: Department of surgery Masaryk University Hostpital Brno
state: Bohunice
Study officials:
affiliation: Department of surgery Masaryk University Hospital Brno
name: Jan Hlavsa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: