louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02965157: Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lymphoma, B-Cell
Lead sponsor: Beijing Biohealthcare Biotechnology Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.


Eligibility criteria: Inclusion Criteria:

1. Relapsed or refractory CD20+ B-cell lymphoma.
2. Measurable disease.
3. Performance status ECOG 0-2.
4. Age:18-65.
5. Fertile females/males must consent to use contraceptives during participation of the trial.
6. Signed informed consent

Exclusion Criteria:

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
2. Patients with primary CNS lymphoma.
3. Known human immunodeficiency virus (HIV) infection.
4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
7. Patients that do not consent to that tissue and blood samples are stored in a biobank.
8. Pregnancy.

   -

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Tumor Hospital
Study officials:
References:
Clinical trial NCT02168426: Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Official title: Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patient Under Going Colorectal and Stomach Cancer Surgery
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days postoperatively.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of GI cancer
* Operable

Exclusion Criteria:

* Withdrew consent
* Pregnant
* Ascites
* Distant metastasis
* Liver dysfunction (serum total bilirubin \>2.0 mg/dL)
* Renal failure (serum creatinine \>1.5 mg/dL)
* A past history of small bowel obstruction.

Primary outcomes:
measure: ileus rate
timeFrame: within 60 days
Secondary outcomes:
measure: adverse effect rate
timeFrame: within 60 days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Won-Suk Lee
Study officials:
References:
Clinical trial NCT04621526: Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol For Chronic Subdural Hematoma
Official title: Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol Combination During Burr-Hole Surgery For Chronic Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Conscious Sedation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-11-09
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inadequate sedation and analgesia indicated by intraoperative movements are markers of inadequate MAC during burr-hole surgery for chronic subdural hematoma evacuation especially when general anesthesia poses high risk for the patients.

Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to provide monitored anesthesia care with variable success if used as solitary agents as each drug has its limited use.

Detailed description: * Null hypothesis (H0): There are no differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
* Alternative hypothesis (H1): There are differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.

Eligibility criteria: Inclusion Criteria:

* Patient acceptance.
* Both sex.
* Age (50-80) years old.
* Patient with Body Mass Index (BMI) (25-30kg/m²).
* American Society of Anesthesiologist (ASA) II / III
* patient scheduled to burr-hole surgery for chronic subdural hematoma evacuation under MAC.

Exclusion Criteria:

* Patient with difficult airway (mallapati III,IV).
* Altered mental status (psychiatric and anexity disorder).
* Post-traumatic stress disorders.
* History of allergy to study drugs.
* Patient on sedative or hypnotic medication.
* Patients with on painkiller.
* Patients with any degree of heart block.
* Sever liver, respiratory or renal impairment.

Primary outcomes:
measure: The onset time of sedation
timeFrame: with in 30 minutes before start of surgery
Secondary outcomes:
measure: The extent of airway obstruction
timeFrame: intraopertive
measure: rescue analgesic (fentanyl)
timeFrame: intraoperative
measure: number of participant with complications
timeFrame: intraoperative
measure: Recovery time
timeFrame: with in one hour postoperative
measure: The Neurological status of participants
timeFrame: at baseline then within one hour postoperative
measure: surgeon satisfaction
timeFrame: with in 24 hours after surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitsals
Study officials:
affiliation: Zagazig University
name: Alshaimaa Kamel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092326: A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)
Official title: A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: dental surgery
molar removal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 269
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Detailed description: The duration of treatment is 24 hours.

Eligibility criteria: Inclusion Criteria:

* Impaction of a molar tooth requiring removal

Exclusion Criteria:

* Any known allergy to the study drugs

Primary outcomes:
measure: Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.
Secondary outcomes:
measure: Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Desjardins PJ, Black PM, Daniels SE, Bird SR, Petruschke RA, Chang DJ, Smugar SS, Tershakovec AM. A double-blind randomized controlled trial of rofecoxib and multidose oxycodone/acetaminophen in dental impaction pain. J Oral Maxillofac Surg. 2007 Aug;65(8):1624-32. doi: 10.1016/j.joms.2006.06.268. No abstract available.
Clinical trial NCT00006326: Safety and Effectiveness of 3 Anti-HIV Treatments in Patients Who Have Failed Previous Treatments Containing Nelfinavir
Official title: A Randomized, Open-Label Study to Evaluate 3 Salvage Regimens in HIV-Infected Subjects Experiencing Virologic Failure on an Initial HAART Regimen Containing Nelfinavir
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Indinavir
Delavirdine
Reverse Transcriptase Inhibitors
Salvage Therapy
Anti-HIV Agents
Viral Load
Nelfinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if 3 anti-HIV drug combinations are safe and effective in patients who have failed previous anti-HIV treatments using nelfinavir (NFV).

Detailed description: Patients receive 1 of 3 salvage regimens. Treatments A and B include delavirdine, 1 of 2 doses of indinavir, and 2 nucleoside reverse transcriptase inhibitors (NRTIs) to which the patient has not been exposed. Treatment C includes ritonavir, indinavir, and 2 NRTIs to which the patient has not been exposed. When virologic failure is first observed, the patient must return in 2 weeks for confirmation of failure and start the salvage regimen within 1 month of the first assay in which failure was observed. Patients who have less than 400 copies/ml HIV RNA after 16 weeks of therapy are considered responders and continue on the study. Those who have more than 400 copies/ml after 16 weeks of therapy are considered nonresponders and should be discontinued from the study. In addition, patients who respond and subsequently rebound with a viral load 0.5 log above the nadir and greater than 400 copies/ml on 2 consecutive assays at least 2 weeks apart are considered treatment failures and should be discontinued from the study. Patients have regular physical exams, as well as virologic, immunologic, and pharmacokinetic assessments.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Had a viral load of less than 400 copies/ml, followed by an increase in viral load while taking an anti-HIV drug combination including NFV (treatment failure).
* Can start the study treatment within 1 month of treatment failure.
* Have a viral load of less than 30,000 copies/ml when they enter the study.
* Have not taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) other than NFV.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Susan Conner
state: California
Study officials:
References:
Clinical trial NCT00270426: Benazepril for Advanced Chronic Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Failure
Keywords: Advanced Chronic Renal Insufficiency
Benazepril
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2005-12-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to further determine whether benazepril, could safely slow the progression of renal dysfunction in non-diabetic patients with advanced renal insufficiency.


Eligibility criteria: Inclusion Criteria:

1. serum creatinine concentration 1.5-5.0 mg/dL (133-442 µmol/L)
2. creatinine clearance 20 to70 mL/min/1.73 m2, with variations of less than 30 percent in the three months before the screening evaluation
3. non-diabetic renal disease
4. persistent proteinuria (defined as urinary protein excretion greater than 0.3 g/day for three or more months without evidence of urinary-tract infection or overt heart failure \[New York Heart Association class III-IV\]).

Exclusion Criteria:

* immediate need for dialysis; treatment with corticosteroids, non-steroidal anti-inflammatory drugs or immunosuppressive drugs; renovascular disease; myocardial infarction or cerebrovascular accident in the year preceding the trial; connective-tissue disease; obstructive uropathy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southern Medical University
name: Fan Fan Hou, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hou FF, Zhang X, Zhang GH, Xie D, Chen PY, Zhang WR, Jiang JP, Liang M, Wang GB, Liu ZR, Geng RW. Efficacy and safety of benazepril for advanced chronic renal insufficiency. N Engl J Med. 2006 Jan 12;354(2):131-40. doi: 10.1056/NEJMoa053107.
Clinical trial NCT03294226: Comparison of AuraGain With I-gel for Pediatric Patients
Official title: A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.


Eligibility criteria: Inclusion Criteria:

* ASA physical status: 1-3
* age: from 6 months to 6 year
* body weight: 5-20kg
* patients undergoing upper/lower extremity surgery at supine position

Exclusion Criteria:

* patients who do not want to participate in this study
* patients with known difficult airway including congenital facial anomaly or history of difficult airway management
* patients with aspiration risk (gastrointestinal stenosis or stricture)
* patients with symptom of upper respiratory infection on the day of surgery
* patients scheduled for day surgery
* patients judged as not eligible by researchers for other reasons

Primary outcomes:
measure: requirement of additional airway maneuver
timeFrame: during placement/maintenance of the device
Secondary outcomes:
measure: insertion time
timeFrame: during placement of the device
measure: success rate
timeFrame: during placement of the device
measure: ease of gastric tube insertion
timeFrame: within 10 minutes after device insertion
measure: adverse effect at operating room
timeFrame: during anesthesia
measure: postoperative adverse effect
timeFrame: within postoperative 24 hours
measure: fiberoptic view of glottis
timeFrame: within 10 minutes after device insertion
measure: oropharyngeal leak pressure
timeFrame: at 1 minute after device insertion, at 10 minutes after device insertion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: University of Ulsan, College of Medicine, Asan Medical Center
name: Won Uk Koh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04960826: Study of an Environmental Risk Factor in Crohn's Disease
Official title: dEoxyniValenol as Risk Factor for Inflammatory Bowel Diseases: Human detoxifiCaTion and Impact On intestiNal Microbiota and Homeostasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2021-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Group 1: patients with ileocolic Crohn's disease requiring surgery
* Group 2: Patients requiring ileal and / or colonic surgery for a reason other than Crohn's disease or ulcerative colitis (for example, cancer, polyp or diverticulum).

Brief summary: Inflammatory bowel disease (IBD) are lifelong chronic diseases affecting the gastrointestinal tract. The precise etiology and the different actors participating to the pathophysiological process leading to the disease development are still not well understood. A complex interaction between genetics, gut microbiota and environmental factors is thought to trigger the inappropriate mucosal immune response observed in IBD patients. We hypothesize that DON might be an environmental risk factor for IBD.The focus on the human relevance of the gut effects of DON by studying its exposure, metabolism and adverse effects in health and disease focusing on IBD patients


Eligibility criteria: Inclusion Criteria:

* Group 1: patients with ileocolic Crohn's disease requiring surgery
* Group 2: Patients requiring ileal and / or colonic surgery for a reason other than Crohn's disease or ulcerative colitis (for example, cancer, polyp or diverticulum).

Exclusion Criteria:

* Vegetarian or vegan patients, celiac disease, gluten sensitivity, eating disorders, people with a particular diet or eating behavior or suffering from obesity or anorexia
* Surgical history: patient having undergone intestinal resection
* Current treatments: patient receiving antibiotic or probiotic treatment within 6 weeks prior to inclusion / patient having taken topical treatment (suppositories or enema of 5ASA or corticosteroids) within 6 weeks prior to inclusion

Primary outcomes:
measure: Quantification of Deoxynivalenol and its conjugated metabolites by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS).
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
Study officials:
affiliation: University Hospital, Lille
name: Philippe ZERBIB, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188526: Computed Tomography (CT) Guided Lung Biopsy: Core or Fine Needle Aspiration
Official title: CT Guided Lung Biopsy: Core or Fine Needle Aspiration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a comparison of core needle biopsy with fine needle aspiration biopsy in the evaluation of lung nodules.


Eligibility criteria: Inclusion Criteria:

* All patients having a lung biopsy

Exclusion Criteria:

* Lymphoma

Primary outcomes:
measure: Diagnostic accuracy
Secondary outcomes:
measure: Complication rate
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, FRCP C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109757: Evaluation of Hearing Protection Fit Testing Program
Official title: Evaluation of Hearing Protection Fit Testing Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing conservation
Personal attenuation rating
earplug
Lead sponsor: United States Air Force
Sponsor class: FED
First posted: 2014-04-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The specific aim of this research is to evaluate the performance, effectiveness, and long-term training benefits of a formal hearing protection fit testing program. This study may provide preliminary evidence on the benefits of direct education/training combined with a formal hearing protection device (HPD) fit testing on HPD fittings on United States Air Force (USAF) employees. Currently, Public Health provides informal, subjective training to employees; this practice may be altered by the results of this study.


Eligibility criteria: Inclusion Criteria:

* Subjects must be enrolled in the hearing conservation program, and can be civilian or active duty/uniformed. Subjects must be currently using some form of in-the-ear hearing protection device on a regular basis and have ear canals free of cerumen, infection, or any other obstruction.

Exclusion Criteria:

* Not enrolled in the hearing conservation program. Not using in-the-ear hearing protection device on a regular basis. Ear canals containing cerumen, infection, or other obstructions.

Primary outcomes:
measure: Degree of earplug fit for participants in the Air Force Hearing Conservation Program as a measure of education and personnal attenuation rating.
timeFrame: 6 mos after intial subject visit
Secondary outcomes:
Other outcomes:
Locations:
city: Elemendorf Air Force Base
country: United States
facility: Elmendorf Air Force Base
state: Alaska
city: Dayton
country: United States
facility: Wright-Patterson Air Force Base
state: Ohio
Study officials:
affiliation: United States Air Force School of Aerospace Medicine
name: Quintin A Hecht, Au.D.
role: PRINCIPAL_INVESTIGATOR
References: