louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02150161: Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy
Official title: Fentanyl vs. Lidocaine/Ketamine Infusion for Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Opioid Free Anaesthesia
Postoperative Analgesia
Lead sponsor: Clinica Santa Maria
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 53
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: TREATMENT

Brief summary: The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* ASA I-II
* Undergoing elective hip arthroscopy

Exclusion Criteria:

* Known allergies to study drugs
* Opioid use 1 month prior to surgery
* BMI \>30
* Unable to comprehend visual analog scale

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting in the recovery room
timeFrame: first 3 postoperative hours
measure: morphine consumption in the recovery room
timeFrame: first 3 postopeartive hours
Secondary outcomes:
measure: Incidence of postoperative nausea and vomiting on day 1
timeFrame: 1st postoperative day
measure: Anesthestic gas consumption
timeFrame: intraoperative
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Santa Maria
Study officials:
affiliation: Clinica Santa Maria
name: David Torres, MD; MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01921361: The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Official title: The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perioperative/Postoperative Complications
Keywords: Shivering
Dexmedetomidine
Spinal anesthesia
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 120
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: The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.

Detailed description: The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride.

Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received.

Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.

Eligibility criteria: Inclusion Criteria:

* 18-65 y/o patients
* American Society of Anesthesiologists' physical status class I-II
* Scheduled for the spinal anesthesia

Exclusion Criteria:

* Patients who have the body temperature over 37.3 celsius degree
* Pregnants
* Known allergies to the study drugs
* Contraindication to spinal anesthesia

Primary outcomes:
measure: shivering score
timeFrame: 1 day (From start of anaesthesia till discharge from the recovery room )
Secondary outcomes:
measure: blood pressure
timeFrame: 1 day (From start of anaesthesia till discharge from the recovery room )
measure: heart rate
timeFrame: 1 day (From start of anaesthesia till discharge from the recovery room )
measure: core temperature
timeFrame: 1 day (From start of anaesthesia till discharge from the recovery room )
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Resul Altuntas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04137861: Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)
Official title: Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iatrogenic Perforation of Primary Molars
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 76
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars


Eligibility criteria: Inclusion Criteria:

* Apparently healthy children aged from 4 to 7 years
* No history of spontaneous pain or swelling
* No signs or symptoms of irreversible pulpits or loss of vitality
* Absence of radicular or priapical lesions.
* Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars.

Exclusion Criteria:

* Children with systemic disease
* Presence of priapical lesions

Primary outcomes:
measure: clinical success
timeFrame: 9 months
measure: radiographic success
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
citation: Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.
Clinical trial NCT06926361: Effects of Mindfulness-based Interventions on Improving Teacher Wellbeing and Teaching Outcomes: A Multi-site, Mixed-methods Randomized Controlled Study
Official title: Effects of Mindfulness-based Interventions on Improving Teacher Wellbeing and Teaching Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Teaching Skills
Keywords: Mindfulness
Teachers
School
Professional development
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: University of Macau
First posted: 2025-04-13
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of MBCT-L among Chinese teachers on their mental well-being and teaching outcomes and explore the mechanisms of how mindfulness practice brings these benefits. The study is a multi-site, mixed-methods randomized controlled trial including 160 teachers.


Eligibility criteria: Inclusion Criteria:

1. Teachers aged 21-65 years;
2. Teachers currently working in a school; and
3. Teachers willing to commit time for the 8-week course.

Exclusion Criteria:

1. Teachers previously joined a related group mindfulness-based intervention, such as mindfulness-based cognitive therapy (MBCT), mindfulness-based stress reduction (MBSR), Mindfulness - Finding Peace in a Frantic World (FPFW); or
2. Teachers who are mentally unstable or having active suicidal risk.

Primary outcomes:
measure: Teaching efficacy
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
measure: Teaching practices
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
measure: Classroom climate
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
Secondary outcomes:
measure: Stress
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
measure: Anxiety
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
measure: Depression
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
measure: Burnout
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
Other outcomes:
measure: Trait mindfulness
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
measure: Emotion regulation
timeFrame: Baseline, 9 weeks, and 3 months post-intervention
Locations:
Study officials:
References:
Clinical trial NCT00002061: A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Official title: A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphatic Disease
HIV Infections
Keywords: T-Lymphocytes
Immune Tolerance
Inosine Pranobex
Killer Cells
T-Lymphocytes, Helper-Inducer
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunologic parameters:

* Increase in natural killer (NK) cell activity.
* Increase in total T-cells (OKT-11).
* Increases in absolute number and percentages of T-helper cells (OKT-4).


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
* Lymphoid malignancy.
* Infectious mononucleosis caused by cytomegalovirus (CMV) or Epstein-Barr virus (EBV).
* Heart disease (especially if receiving cardiac glycosides).
* Hemophilia.

Patients with the following are excluded:

* Kaposi's sarcoma or overt opportunistic infections.
* Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophile test (EBV) or cell culture (CMV).
* A history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
* Critical illness.
* Condition requiring hospitalization.
* Women of childbearing age are excluded.

Prior Medication:

Excluded:

* Steroids, cytotoxic immunosuppressive agents.
* Antiviral medicine.
* Excluded within 1 month of study entry:
* Immunomodulators (including Isoprinosine).

Prior Treatment:

Excluded:

* Radiotherapy.

Patients who have unexplained immunodepression and are at risk of developing AIDS.

* Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).

IV drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Newport Pharmaceuticals International Inc
state: California
Study officials:
References:
Clinical trial NCT03357861: Cancer Patients Treated With Immunotherapy in Intensive Care Unit
Official title: Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted in Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Critical Illness
Immunotherapy
Keywords: cancer
intensive care unit
checkpoint inhibitors
adverse event
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Jules Bordet Institute
First posted: 2017-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients treated with anti-CTLA4 and/or anti-PD-1 / anti-PD-L1 or up to 6 months after stopping admitted in ICU

Brief summary: This work aims to describe the characteristics and methods of management of patients suffering from a solid tumor treated with immunotherapy admitted to intensive care.

Detailed description: The place of checkpoint inhibitors (anti-PD-1 and PD-L-1) is currently validated in the management of melanoma and metastatic non-small cell lung cancer. The toxicity profile is specific with adverse effects related to immunity. Some side effects (myocarditis, colitis, interstitial lung disease, etc.) can be severe and patient could be hospitalized in intensive care unit.

The question of immunotherapy's imputability in the acute disease is becoming more frequent.

Eligibility criteria: Inclusion Criteria:

* \> or = 18 years old;
* with a solid tumor;
* Treatment with anti-CTLA4 and / or anti-PD-1 / PDL-1 still in progress or up to 6 months after stopping;
* Admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason.

Exclusion Criteria:

* Minors;
* Pregnant or lactating woman;
* Admission after surgery of a scheduled surgery or for the security of procedure;
* Anti-CTLA4 and / or anti-PD-1 / PDL-1 treatment stopped for more than 6 months;
* Subject under guardianship or deprivation of liberty;
* Refusal of consent;
* No affiliation to a health insurance scheme.

Primary outcomes:
measure: To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy.
timeFrame: At ICU discharge (maximum 30 days)
Secondary outcomes:
measure: Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care.
timeFrame: At ICU discharge (maximum 30 days)
measure: Description of ICU survival
timeFrame: At ICU discharge (maximum 60 days)
measure: Description of hospital survival
timeFrame: At hospital discharge (maximum 60 days)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Grenoble
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: UniversityHospital Grenoble
name: Anne-Claire TOFFART, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00003261: Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
Official title: Treatment of HIV-Related Primary Central Nervous System Lymphoma (HIV-PCNSL): A Phase II Trial With Neoadjuvant Chemotherapy (High-Dose Methotrexate (MTX) Plus High-Dose Zidovudine) and Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: AIDS-related primary CNS lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma.

Detailed description: OBJECTIVES:

* Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients.
* Evaluate the toxicity and overall survival of these patients.

OUTLINE: Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks. Patients receive 3 courses of therapy. Following chemotherapy, patients receive radiation therapy to the lesion site daily.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: This study will accrue 14 patients.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS
* No systemic lymphoma

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-3

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3000/mm\^3
* Platelet count at least 80,000/mm\^3

Hepatic:

* No serious impairment of liver function

Renal:

* No serious impairment of renal function
* Creatinine clearance at least 40 mL/min

Cardiovascular:

* No serious impairment of cardiac function

Neurologic:

* Neurological functional status 0-3

Other:

* No prior or active CNS-opportunistic infections
* No AIDS dementia complex
* No active systemic infections

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy

Primary outcomes:
measure: Efficacy
measure: Toxicity
measure: Overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
Study officials:
affiliation: Centro di Riferimento Oncologico - Aviano
name: Umberto Tirelli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02770261: Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy
Official title: A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Cholesterolemia
Keywords: DP-R208
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2016-05-12
Enrollment: 219
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Both man and woman who is over 19years old.
* Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL

Exclusion Criteria:

* Therapeutic lifestylechange is not enought during the study period
* SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit

Primary outcomes:
measure: Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol
timeFrame: 8weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Changkyu Park
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho KI, Kim BH, Park YH, Ahn JC, Kim SH, Chung WJ, Kim W, Sohn IS, Shin JH, Kim YJ, Chang K, Yu CW, Ahn SH, Kim SY, Ryu JK, Lee JY, Hong BK, Hong TJ, Gyu Park C. Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study. Clin Ther. 2019 Aug;41(8):1508-1521. doi: 10.1016/j.clinthera.2019.05.007. Epub 2019 Jul 12.
Clinical trial NCT01216761: A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions
Official title: Blood Culture Contamination: A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteremia
Keywords: Bacteremia
Blood culture
Contamination
Antiseptic agents
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2010-10-07
Enrollment: 3879
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Background: Contaminated blood cultures result in unnecessary antibiotic use, increased length of stay, and additional laboratory tests, all of which increase healthcare costs. While the optimal skin antisepsis agent for reducing blood culture contamination is not known, the cost of various agents differs substantially.

Objective: To determine the relative rates of blood culture contamination for 3 skin antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT) and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical patients.

Detailed description: A group-randomized crossover trial was conducted to test the null hypothesis of no difference in blood culture contamination rates among 3 antiseptic skin preparations. The sequence of 3 different antiseptic treatments was randomly assigned to 3 separate hospital floors, therefore in this trial cross-over occurred at the hospital floor level (not the individual patient level).

Also, it is possible for subjects to have multiple blood culture sets obtained during the study. Thus, the number of blood culture sets will not equal the number of unique subjects in the study.

Eligibility criteria: Inclusion Criteria:

* Patient on general medical, surgical, and cardiology floors
* Receipt of a peripheral blood draw for blood culture collection
* Blood draw performed by phlebotomy team

Exclusion Criteria:

* None

Primary outcomes:
measure: Blood Culture Contamination
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Laraine L. Washer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Washer LL, Chenoweth C, Kim HW, Rogers MA, Malani AN, Riddell J 4th, Kuhn L, Noeyack B Jr, Neusius H, Newton DW, Saint S, Flanders SA. Blood culture contamination: a randomized trial evaluating the comparative effectiveness of 3 skin antiseptic interventions. Infect Control Hosp Epidemiol. 2013 Jan;34(1):15-21. doi: 10.1086/668777. Epub 2012 Nov 26.