louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03318965: Scoring Systems in ICU and Malnutrition
Official title: Combination of APACHE Scoring Systems With Adductor Pollicis Muscle Thickness for the Prediction of Mortality in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Mortality
Anthropometry
Nutrition Assessment
Caliper
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 304
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 304 eligible critically ill patients

Brief summary: The objective of the present study was to compare the ability of acute physiology and chronic health evaluation (APACHE) scoring systems with the combination of an anthropometric variable score "adductor pollicis muscle (APM) thickness" to the APACHE systems in predicting mortality in the ICU. Three hundred and four patients enrolled in this prospective observational study. The APM thickness in dominant hand and APACHE II and III scores were measured for each patient upon admission. Given scores for the APM thickness, were added to APACHE score systems to make two composite scores of APACHE II- APM and APACHE III- APM. The accuracy of the two composite models and APACHE II and III systems in predicting mortality of patients was compared using area under the ROC curve.

Based on the study results, the area under the ROC curves improved in composite models. Therefore, it seemed that considering anthropometric variables may improve prediction of mortality in APACHE systems.

Detailed description: The baseline medical history, physical examination, Acute Physiology and Chronic Health Evaluation score II and III (APACHE) were recorded for all patients. All data were collected by a single physician. The APACHE II and III scores were gathered using the method presented by Knaus. The dominant hand APM thickness (as reported by the patient, or the relative) was assessed by Caliper (Vogel, Germany) in the emergency room or at the time of the ICU admission. To estimate weight for the APM thickness, multivariate logistic regression analysis was used to determine the relation between mortality and the APM thickness while controlling for other physiologic variables (12 physiologic variables for APACHE II and 18 physiologic variables for APACHE III).The area under the receiver-operating curves (ROC curve) to predict mortality was used to compare APACHE II, APACHE III, APACHE II- APM and APACHE III- APM systems.

Eligibility criteria: Inclusion Criteria:

* Older than 16 years of age

Exclusion Criteria:

* Splints, in the upper extremities
* Casts in the upper extremities
* Edema in the upper extremities
* Patients with readmission during the study period
* Those transferred from other ICUs

Primary outcomes:
measure: Prediction of Mortality
timeFrame: First day of ICU admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shahid Beheshti University
name: Zahra Vahdat Shariatpanahi, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01635465: Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer
Official title: A Randomised Controlled Phase II Trial of Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anthracycline-pretreated Metastatic Breast Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120

Brief summary: Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed description: A randomised controlled trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Eligibility criteria: Inclusion Criteria:

* female ≥ 18 years old ECOG 0-2

Exclusion Criteria:

* brain metastasis

Primary outcomes:
measure: RECIST 1.1
timeFrame: -7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
References:
citation: Li S, Meng W, Zhang J, Xie X, Hao C, Jia Y, Tong Z. A randomized controlled Phase II trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. J Cancer Res Ther. 2020 Sep;16(5):1069-1076. doi: 10.4103/jcrt.JCRT_792_19.
Clinical trial NCT00483665: Vasovist Endoleak Study
Official title: Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: endoleak
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2007-06-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after more than 1 year who have a stable or growing aneurysm according to diameters measured on CT angiography images and no evidence of endoleak on recent CT angiography

Brief summary: After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is needed to monitor the effectiveness of the treatment. One parameter in this follow-up is endoleak, which is leakage of blood into the aneurysm sac. The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.

Detailed description: After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm diameter and the presence of endoleaks is evaluated with computed tomographic (CT) angiography yearly after Endovascular Aneurysm Repair (EVAR).

The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.

The advantages of magnetic resonance imaging with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.

Eligibility criteria: Inclusion Criteria:

* Patient is more than one year after endovascular abdominal aortic aneurysm repair
* Patient has a stable or growing aneurysm according to diameters measured on CT angiography images
* No evidence of endoleak on recent CT angiography

Exclusion Criteria:

* contraindication for MRI examination

  * claustrophobia
  * pacemaker
  * other non-MRI compatible implants
* contraindication for use of contrast agent

  * known allergy to drugs or contrast media
  * MRI examination with the use of gadolinium within 24 hours of the blood-pool agent injection
  * severe renal impairment = creatine \> 2 mg/dl (=176 mmol/l)
  * patient clinically instable
  * Participation in drug research within 30 days before and 1 day after MRI-examination with use of Vasovist.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Mathias Prokop, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06262165: Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis
Official title: BILAN: Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood BIomarker ANaLysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Keywords: Biomarkers
Liver fibrosis
Liver steatosis
Anorexia nervosa
Enteral refeeding
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive inclusion of patients hospitalized in the endocrinology department for anorexia nervosa with malnutrition criteria.

Brief summary: The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis.

Detailed description: Study of the association between blood biomarkers and the presence of hepatic cytolysis, defined by AST and/or ALT above normal.

Eligibility criteria: Inclusion Criteria :

* Patient over 15 years old
* Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Admission to Nantes University Hospital.

Exclusion Criteria :

* Chronic active viral hepatitis
* Hemochromatosis
* Other genetic, autoimmune.
* Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months
* Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in women)
* Pregnant, parturient or breast-feeding women, persons deprived of liberty, adults under legal protection or unable to express their consent, persons not affiliated or not beneficiaries of a social security scheme, persons under guardianship or curators

Primary outcomes:
measure: Identification of new blood biomarkers and hepatic cytolysis
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References:
Clinical trial NCT01228565: Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Official title: Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Carcinoma
Keywords: Head and neck carcinoma treated by radiotherapy plus erbitux
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 76
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 aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.


Eligibility criteria: Inclusion Criteria:

* Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux

Exclusion Criteria:

* IMRT; Concomitant chemotherapy

Primary outcomes:
measure: Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Creteil
country: France
facility: CHI Creteil
city: Ferolles Attily
country: France
facility: Centre de Forcilles
city: Nantes
country: France
facility: CLCC Nantes
city: Paris
country: France
facility: CHU Pitie Salpetriere
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References:
Clinical trial NCT01615965: Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
Official title: Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
lymph node
micrometastasis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes of patients with prostate cancer by quantitative polymerase chain reaction and its impact on progression-free survival.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate cancer
* Locally operable tumor
* Negative bone scan (obligatory if Gleason Score \> 7 or PSA \> 20ng/ml
* Karnofsky ≥ 80%
* Age 18 - 75 years
* Informed consent in written form
* Sufficient hematologic, coagulatory and renal function
* Compliant patient and geographic precondition for adequate follow-up given

Exclusion Criteria:

* Manifest secondary tumor
* Organ metastases on CT-scan /MRI or in Histology
* Myocardial infarction or stroke within the last 6 months
* Severe cardiovascular (Grade III - IV according to NYHA), pulmonary (pO2 \< 60 mmHg), renal, hepatic oder hematopoetic impairment
* Severe active or chronic infection (z.B. pos. HIV-Antibody-Test, HBs-Ag-detected in Serum and/ or chronic Hepatitis)
* Severe psychiatric disease
* Previous chemotherapy
* Previous pelvine radiotherapy

Primary outcomes:
measure: Biochemical recurrence free survival
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of molecular detected lymph node micrometastases according to their topography
timeFrame: 2 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Urologic Department
Study officials:
References:
Clinical trial NCT03946865: Reiki Therapy - an Intervention in Hematology/Oncology Cancer Patients Hospitalized
Official title: Reiki Therapy - an Intervention in Hematology/Oncology Cancer Patients Hospitalized in an Inpatient Setting - a Pilot Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are trying to determine if offering and providing reiki therapy in hospitalized hematology/oncology cancer subjects has any effects on symptoms and feeling during the subjects hospital stay.

Detailed description: Primary Aim:

The primary aim of this study is to evaluate the feasibility of offering and providing Reiki Therapy in hospitalized hematology/oncology cancer patients. The intervention should not - interfere with the medical management of the participants. The investigators hypothesize that Reiki Sessions will be successfully integrated into conventional care of hospitalized cancer patients.

Secondary Aim:

The secondary aim is to evaluate the patient reported outcomes of their symptoms (pain, fatigue, anxiety) and feelings (happy, energetic, relaxed, and calm) before and after Reiki Therapy. The investigators' hypothesis is that there will be improvement of patients' symptoms/feelings score after the Reiki Therapy.

Eligibility criteria: Inclusion Criteria:

* Hospitalized hematology-oncology patients age 18 - 80
* Able to speak English and complete surveys
* Able to read, understand and sign inform consent.

Exclusion Criteria:

* Patient unwilling for reiki therapy.
* Unable to give written consent.
* Already having received or receiving other reiki treatment.
* Pregnant women. (As verbalized by participant)

Primary outcomes:
measure: Change in pain pain symptoms
timeFrame: Baseline, approximately 2 hours
measure: Change in fatigue symptoms
timeFrame: Baseline, approximately 2 hours
measure: Change in anxiety symptoms
timeFrame: Baseline, approximately 2 hours
measure: Change in feeling happy
timeFrame: Baseline, approximately 2 hours
measure: Change in feeling energized
timeFrame: Baseline, approximately 2 hours
measure: Change in feeling relaxed
timeFrame: Baseline, approximately 2 hours
measure: Change in feeling calm
timeFrame: Baseline, approximately 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02558465: Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)
Official title: Special Drug Use Investigation of Xarelto for VTE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Xarelto, rivaroxaban, VTE, PE, DVT, Japan, PMS, SDUI
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2015-09-24
Enrollment: 2540
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: Female and male patients who start rivaroxaban for VTE （pulmonary embolism, deep vein thrombosis) anticoagulation therapy

Brief summary: The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).


Eligibility criteria: Inclusion Criteria:

- Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.

Exclusion Criteria:

- Patients who are contraindicated based on the product label and have already received Xarelto treatment.

Primary outcomes:
measure: Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability
timeFrame: Up to 2 years
measure: Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Composite number of all-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack, or systemic embolism), clinically relevant non-major bleeding and all other adverse events/ADRs
timeFrame: Up to 2 years
measure: Number of participants with asymptomatic deterioration of thrombotic burden (change of D-dimer, imaging test such as CT or CCUS) by the end of standard observation period
timeFrame: at 1 year
measure: Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04617665: Effects of One-handed and Two-handed Mask Ventilation Techniques on Global and Regional Lung Ventilation
Official title: Department of Anesthesiology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two-handed mask ventilation has been shown to provide higher tidal volume than one-handed mask ventilation. The effects of the two techniques on respiratory mechanics during induction of general anesthesia, however, still need to be determined.

Detailed description: Mask positive pressure ventilation always causes the changes of respiratory mechanics such as ventral redistribution of regional ventilation, which impairs gas exchange. Two-handed mask ventilation has been shown to improve gas exchange by providing higher tidal volume than one-handed mask ventilation. We hypothesis that those higher tidal volume caused by two-handed mask ventilation would also improve the respiratory mechanics during induction of general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Scheduled for elective surgery with general anesthesia
* American Society of Anesthesiologist (ASA) physical class of I-II.

Exclusion Criteria:

* acute and chronic respiratory disorders, including chronic obstructive
* pulmonary disease (COPD) and asthma;
* a history of lung surgery;
* exist risk of reflux and aspiration;
* patients requiring an awake intubation;
* facial and thoracic deformities;
* implants exist in the body, such as cardiac pacemakers;
* pregnant women.

Primary outcomes:
measure: global inhomogeneity (GI)
timeFrame: 8 weeks
Secondary outcomes:
measure: centre of ventilation (CoV)
timeFrame: 8 weeks
measure: regional ventilation delay (RVD)
timeFrame: 8 weeks
measure: ventilation of regional lung ( %)
timeFrame: 8 weeks
measure: Expiratory tidal volume (TV)
timeFrame: 8 weeks
measure: PaO2/FiO2
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: