louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04935632: Perioperative Collection of Temperatures and Hypothermia
Official title: Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Hypothermia; Anesthesia
Hypothermia, Accidental
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients operated on at the Léon Bérard Centre, whether for scheduled, emergency or outpatient surgery

Brief summary: Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.

Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.

This study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.


Eligibility criteria: Inclusion Criteria:

* \>= 18 years old
* surgeries performed at the Centre Léon Bérard

Exclusion Criteria:

* Digestive endoscopy, interventional radiology, brachytherapy (operating rooms outside the central operating room)
* Patient who decline to participate in the study
* Active systemic infection
* Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Intrathoracic Chemotherapy (HITeC)
* Deprivation of liberty
* operation performed under local anesthesia only

Primary outcomes:
measure: Incidence of intraoperative hypothermia
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Incidence of hypothermia in the post-anesthesia care unit (PACU)
timeFrame: Up to 24 hours
measure: Tympanic temperature in the post-anaesthesia care unit (PACU)
timeFrame: Up to 24 hours
measure: Intraoperative tympanic temperature
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
state: Rhone
Study officials:
References:
citation: Sari S, Aksoy SM, But A. The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors. Int J Clin Pract. 2021 Jun;75(6):e14103. doi: 10.1111/ijcp.14103. Epub 2021 Feb 28.
Clinical trial NCT03313232: Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study
Official title: Low Dose Exposure to Oxidized R-limonene - A Double Blinded Vehicle Controlled Repeated Open Application Test (ROAT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Contact Dermatitis Due to Cosmetics
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Sahlgrenska University Hospital
name: Göteborg University
First posted: 2017-10-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1) Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a previous doubtful patch test to oxidized R-limonene and 3) healthy controls with no contact allergy to oxidized R-limonene


Eligibility criteria: Inclusion Criteria:

* Positive patch test (at least one reading) or doubtful patch test (at least two readings) to oxidized R-limonene 3% pet. (with 0.33% hydroperoxides content) according to international guidelines, within the last five years.
* Aged 18 years or older
* Received written and verbal information on the study.
* Signed written consent form.

Exclusion Criteria:

* Active eczema in test areas.
* Pregnancy or breast feeding.
* Treatment with topical corticosteroids or other immune-suppressants on/near test areas within two weeks prior to study start.
* Systemic immune-suppressant treatment within seven days prior to study start.
* UV exposure of test areas within three weeks prior to study start.
* Unable to cooperate or communicate with the investigators.

Primary outcomes:
measure: Positive ROAT (minimum score of 5)
timeFrame: Day (D) 21
Secondary outcomes:
measure: Minimal eliciting concentration (MEC)
timeFrame: Day (D) 7
Other outcomes:
measure: Epidermal inflammatory markers
timeFrame: Positive ROAT or Day (D) 21
Locations:
city: Hellerup
country: Denmark
facility: Department of Dermatology and Allergy, Gentofte University Hospital
state: DK
city: Göteborg
country: Sweden
facility: Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital
state: SE
Study officials:
References:
Clinical trial NCT02396732: Aspirin and Enoxaparin for VTE in Trauma
Official title: The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Venous Thromboembolism
Thromboprophylaxis
Trauma
Keywords: Aspirin
Enoxaparin
Thromboprophylaxis
Trauma
Venous thromboembolism
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Blunt or penetrating trauma
* Requires VTE thromboprophylaxis
* High-risk for VTE

Exclusion Criteria:

* Presence of VTE upon admission
* Pregnant or nursing
* Inability to give informed consent by patient or healthcare proxy
* Contraindication to enoxaparin
* Contraindication to aspirin
* Epidural or subdural hematoma
* Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures

Primary outcomes:
measure: Incidence of Venous Thromboembolism
timeFrame: Up to 2 months of hospitalization
Secondary outcomes:
measure: Change in Hypercoagulability
timeFrame: Baseline, up to 2 months hospitalization
measure: Mortality
timeFrame: Up to 2 months of hospitalization
Other outcomes:
Locations:
city: Miami
country: United States
facility: Ryder Trauma Center
state: Florida
Study officials:
affiliation: University of Miami
name: Kenneth Proctor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06043232: MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Official title: The Role and Mechanism of MMR/MSI Phenotypes in Evaluating Vaccine Benefit in Glioblastoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Keywords: Glioblastoma multiforme
DC vaccine
Mismatch repair
Microsatellite instability
Biomarker
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing glioma surgery at Huashan Hospital

Brief summary: Glioblastoma (GBM) is the most malignant primary intracranial tumor with a median survival of about 18 months, and new therapies are urgently needed. Tumor vaccines has been shown to improve survival of GBM, but not all patients can benefit from vaccine treatment and biomarkers are urgently needed. Deletion of mismatch repair (MMR) protein and microsatellite instability (MSI) state are important features in the biological evolution of GBM, and may be used as markers for tumor vaccine. Therefore, this project will collect samples from GBM patients before and after vaccine treatment respectively, and evaluate the role of MMR/MSI gene phenotype in predicting vaccine efficacy and the potential molecular mechanism. Moreover, MMR/MSI phenotypes will be assessed by deep-learning and radiomics using images to establish noninvasive markers for vaccine.


Eligibility criteria: Inclusion Criteria:

The patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled

1. They were 18-80 years old, male and female;
2. The pathological results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);
3. Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
4. Sign informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria will not be included in this study:

1. Participants in other clinical trials;
2. Pregnant women.

Primary outcomes:
measure: Transcriptomics
timeFrame: 36 months
measure: Immunomics
timeFrame: 36 months
measure: Proteomics
timeFrame: 36 months
measure: Radiomics
timeFrame: 36 months
measure: IHC analysis
timeFrame: 36 months
measure: Genomics
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital，Fudan University
Study officials:
References:
Clinical trial NCT01111032: Comparison of Two-treadmill Test Protocols to Evaluate Endurance in People With Cancer
Official title: Comparison of Two-treadmill Test Protocols to Evaluate Endurance in People With Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Treadmill
Exercise
Cancer
Validity
Reliability
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2010-04-27
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult well cancer survivors

Brief summary: During this study the investigators will compare the use of two treadmill tests in people diagnosed with cancer. The STEEP treadmill protocol is often used to evaluate the endurance of people diagnosed with cancer, however, since it is based on step increases in speed or ramp, it may not related to normal function. The new test, which is based on the body response to increased activity has not been used with people with cancer but may provide a better approximation of endurance demands during daily function. Our question is whether the new treadmill test can be used to evaluate aerobic function with people with cancer better than the STEEP treadmill test.


Eligibility criteria: Inclusion Criteria:

* Participants are required to be adults (age 16 or over),
* Diagnosed with cancer, at any stage of treatment (during or after treatment),
* Able to follow instructions in English, and provide informed consent.
* Participants need to be considered "well" to participate. A "well participant" has been defined as a cancer survivor who is living at home, able to ambulate independently without a gait aid (single point cane is acceptable), has no acute medical conditions, and passes pre-exercise safety screening.

Exclusion Criteria:

* Cancer survivors with metastatic disease.
* Cancer survivors who are defined as unwell.

Primary outcomes:
measure: STEEP treadmill test
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, Henderson Campus
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Oren Cheifetz, M.Sc. PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01959932: Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.
Official title: A Randomized, Controlled, Open-label, 3-arm Parallel Group, Single-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smoking, Healthy Subjects Switching to the Tobacco Heating System 2.2 (THS 2.2) or Smoking Abstinence, Compared to Continuing to Use Conventional Cigarettes, for 5 Days in Confinement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Candidate Modified Risk Tobacco Product
Conventional cigarettes
Reduced exposure
Confinement
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 169
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: OTHER

Brief summary: The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).


Eligibility criteria: Inclusion Criteria:

* Subject is Caucasian.
* Current healthy smoker as judged by the Principal Investigator.
* Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Primary outcomes:
measure: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
timeFrame: 5 days
measure: Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
timeFrame: 5 days
measure: Concentration of S-phenylmercapturic Acid (S-PMA)
timeFrame: 5 days
measure: Levels of Carboxyhemoglobin (COHb)
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kajetany
country: Poland
facility: BioVirtus Research Site Sp. z o.o.
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: BioVirtus Research Site
name: Katarzyna Jarus-Dziedzic, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01993732: Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function
Official title: Ovarian Tissue Cryopreservation As A Means Of Preserving Ovarian Function in Females Undergoing Therapeutic Procedures That Will Potentially Lead To The Irreversible Loss of Ovarian Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Effects of Chemotherapy
Unspecified Complication of Bone Marrow Transplant
Auto Immune Disease
Keywords: Cancer
Cryopreservation
Ovarian Function
In Vitro
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 15
Sex: FEMALE
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to retrieve and cryopreserve ovarian tissue from females undergoing a treatment that may lead to irreversible loss of ovarian function.

Detailed description: The aim of this preliminary study is to retrieve and properly cryopreserve ovarian tissue for autotransplantation in any premenopausal female whose ovarian function is threatened in a physiological, pathological or iatrogenic manner in an effort to observe the return of ovarian endocrine function and development of egg(s) appropriate for use in in vitro fertilization.

Eligibility criteria: Inclusion Criteria:

* Patient must be female.
* Patient must have a disease process where the disease or its treatment adversely affects ovarian function.
* Patient must be recommended for this study by their oncologist or specialist.
* Patient (or legally authorized representative) must sign an informed consent.

Exclusion Criteria:

* Patients cannot be male.
* Patients must not be HIV positive.
* Patient cannot have a poor diagnosis such that she is not expected to survive to adulthood.
* Patient cannot have any medical condition that would contraindicate surgery.
* Patient cannot have any medical condition that would contraindicate general anesthesia.
* Patient cannot have any medical condition that would contraindicate pregnancy.

Primary outcomes:
measure: Return of hormones produced by the ovarian tissue
timeFrame: 3 months after re-implantation
Secondary outcomes:
measure: Development of egg(s) appropriate for use in in vitro fertilization
timeFrame: Participants will be followed through their reproductive years (until the patient reaches 45 years of age)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert and The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Estil Strawn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00402532: Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation
Official title: Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Transplantation
Keywords: Lung Transplantation
Immunosuppression
Mortality
Graft rejection
Bronchiolitis obliterans
Opportunistic infections
Nephrotoxicity
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2006-11-22
Enrollment: 190
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 Everolimus is effective in the treatment and prevention of chronic graft dysfunction and chronic graft rejection after lung transplantation.


Eligibility criteria: Inclusion Criteria:

* Recipient of Single or Bilateral Lung Transplantation
* Informed consent
* Recipients who are able to receive Everolimus at week 3 after Lung Transplantation
* women of childbearing potential must have a negative pregnancy test within 48 hours of enrolment
* women of childbearing potential must use appropriate contraceptive method at enrolment, during the study and up to 8 weeks after the end of the study
* donor must not have relevant pulmonary diseases
* donor must have oxygen partial pressure higher than 300 mmHg at FiO 1.0 and positive end-expiratory pressure of 5 cm H2O.

Exclusion Criteria:

* systemic infection of the donor
* donor: signs or symptoms of aspiration
* donor: severe pulmonary injury or contusion
* donor: malignant neoplasm of the lung
* donor: HIV positive
* recipients who receive immunosuppressive agents not used in this protocol
* recipients who participated within 30 days before study start or are currently participating in another investigational drug trial
* HIV positive recipient
* systemic infection of the recipient
* recipients of combined/ multiple transplantations
* pregnancy of the recipient
* recipients with signs/ Symptoms of impaired wound healing of the pulmonary anastomoses
* recipients who are still on artificial respiration or who are not able to swallow tablets at week 3 after transplantation

Primary outcomes:
measure: Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation
timeFrame: 2 years
Secondary outcomes:
measure: Incidence and severity of Nephrotoxicity within 2 years of transplantation
timeFrame: 2 years
measure: Incidence and severity of opportunistic infections within 2 years of transplantation
timeFrame: 2 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Division of Thoracic and Cardiovascular Surgery
Study officials:
affiliation: Hannover Medical School
name: Martin Strueber, Dr.
role: PRINCIPAL_INVESTIGATOR
References: