louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02488746: Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)
Official title: Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastric Neoplasms
Gastrointestinal Stromal Tumors
Lead sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in which a subepithelial gastric tumor has been detected (in our hospital, other hospitals or by transferring doctor).

Brief summary: Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.


Eligibility criteria: Inclusion Criteria:

* presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
* age 18 years or older
* participant has given informed consent

Exclusion Criteria:

* tumor size \> 40 mm (endosonographic measurement) or large extramural tumor mass
* signs of systemic dissemination of tumor
* current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
* former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
* moribund patient
* limited possibility to give informed consent (e.g. language barrier, psychiatric disease)
* pregnancy and lactation period

Primary outcomes:
measure: Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved
timeFrame: intraoperative
Secondary outcomes:
measure: Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved
timeFrame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
measure: Rate of complications (bleeding, perforation)
timeFrame: 6 months after resection
measure: Duration of hospitalization
timeFrame: within one week after resection
measure: Number of participants with local or systemic recidive of tumor
timeFrame: 6 months after resection
measure: Number of participants with needs of surgical therapy or endoscopic re-resection
timeFrame: 6 months after resection
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
state: Baden-Württemberg
Study officials:
affiliation: Klinikum Ludwigsburg
name: Karel Caca, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT01191346: Radiation Planning Study for High Grade Brain Tumors
Official title: 3T Versus 1.5T MR Approaches in Target Definition for Malignant Gliomas: Is There a Significant Difference in Tumor Extent and Radiation Treatment Volume?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Grade Glioma
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high grade glioma planning to receive radiation therapy

Brief summary: The purpose of this research study is to see if a higher strength MRI procedure provides better images to use in planning radiation treatments for patients with brain tumors in the future.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, newly diagnosed Grade III-IV glioma
* Planning to undergo radiation therapy

Exclusion Criteria:

* Grade I or II glioma
* Patients unable to undergo MRI imaging

Primary outcomes:
measure: Treatment volume
timeFrame: 1 year average
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Jessica Guarnaschelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854412: The Effect of Weight Loss on Serum Mannose-Binding Lectin(MBL) Levels
Official title: The Effect of Weight Loss on Serum Mannose-Binding Lectin (MBL) Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Obesity
Weight loss
Very low-calorie diet
Mannose-binding lectin
Insulin resistance
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2009-03-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: High levels of mannose-binding lectin (MBL), an activator of a part of the immune system called the complement system, have been associated with increased mortality and risk of early signs of kidney damage in patients with type 2 diabetes. The effect of weight loss and changes in insulin resistance on MBL levels have been poorly elucidated.

This study includes 36 nondiabetic obese subjects, who will receive a very low- calorie diet (VLCD) of 800 kcal/day for 8 weeks.

Fasting blood samples will be obtained at baseline and after 8 weeks of VLCD and concentrations of MBL, glucose and insulin will be measured. Insulin resistance is assessed using the HOMA-IR method.


Eligibility criteria: Inclusion Criteria:

* Obese

Exclusion Criteria:

* Diabetes
* Other severe disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04745312: Effect of Lighting Supplementation on Daytime Cognition
Official title: The Effect of Lighting Supplementation on Cognitive Task Performance During the Day
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-visual Effects of Light
Keywords: Light
Cognition
Alertness
Learning
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to examine the efficacy of supplementing sub-optimal ambient room lighting with a task lamp on working memory and procedural learning.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-30 years;
* Healthy (no medical, psychiatric or sleep disorders;
* Non-smoking for at least 6 months;
* Body Mass Index of \>18 or \<30 kg/m2;
* Able to maintain 7-hour consistent sleep schedule during the study
* Able to refrain from caffeine, alcohol, medication and supplements during the study

Exclusion Criteria:

* History of alcohol or substance abuse;
* positive result on drugs of abuse urine toxicology;
* Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, narcolepsy, insomnia, or any significant sleep complaint
* Psychiatric disorder, or first degree relative with a psychiatric disorder
* Recent acute or chronic medical disorder
* Use of drugs or medication (birth control OK) likely to affect sleep, alertness or light sensitivity, as determined by the investigators
* Visual disorder, including but not limited to color blindness, or family history of glaucoma
* Pregnancy or lactation
* Shift work (\> 2 nights / week in the last 3 months and not during the study)
* Transmeridian travel (2 or more time zones) in the past 3 months
* Any other reason as determine by the Principal Investigator

Primary outcomes:
measure: Working memory
timeFrame: 8 hour light exposure
Secondary outcomes:
measure: Procedural learning
timeFrame: 8 hour light exposure
Other outcomes:
measure: Vigilance
timeFrame: 8 hour light exposure
measure: Subjective sleepiness
timeFrame: 8 hour light exposure
measure: Memory recall
timeFrame: 8 hour light exposure
measure: Psychological distress
timeFrame: 8 hour light exposure
measure: Affect
timeFrame: 8 hour light exposure
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shadab A Rahman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04299412: Diagnostic Accuracy of the DPP II Assay
Official title: Diagnostic Accuracy of the DPP Fever Panel II Asia and the DPP Micro Reader
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Febrile Illness
Melioidosis
Diagnoses Disease
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 104
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: Sera samples were collected between December 2014 and June 2018 for the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study that was conducted by the Menzies School of Health Research in Darwin, Australia. Patients recruited during that study presented to the Royal Darwin Hospital (RDH) with suspicion of melioidosis and consented to provide blood samples and to allow their use in diagnostic studies. Their samples are stored at -80°C in the Tropical and Emerging Infectious Diseases laboratory at the Menzies School of Health Research.

Brief summary: Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Although this is considered the gold standard, bacterial isolation has low diagnostic sensitivity, requires specific infrastructures (biosafety level 3 laboratories) and skilled staff that are not always available in LMICs. This may lead to inappropriate patient management and care.

Chembio, in partnership with FIND, has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect antigens from common causes of febrile illnesses, included Burkholderia. FIND will conduct a laboratory study in Menzies Health School of Research to estimate the diagnostic accuracy of the DPP II Assay using retrospective samples that are positive for B. pseudomallei. Results will help in estimating the diagnostic accuracy of the assay for this pathogen.


Eligibility criteria: Inclusion Criteria:

- Samples that can be included in the trial must have been collected exclusively during the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study (HREC 04/09) conducted by the Menzies School of Health Research. They must be well-characterized with confirmation of presence or absence of B. pseudomallei by bacterial culture.

Exclusion Criteria:

* Samples with volume \<120 µL
* Samples collected during projects other than the HREC 04/09 project

Primary outcomes:
measure: Point estimates of sensitivity and specificity, with 95% confidence intervals, for the detection of B. pseudomallei by the DPP assay in comparison to a reference standard.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Darwin
country: Australia
facility: Menzies School of Health Research
Study officials:
References:
Clinical trial NCT03555812: Pelvic Inclination Measurement by Navigated Ultrasound
Official title: Pelvic Inclination Measurement by Navigated Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Hip, Arthroplasty, pelvic inclination, ultrasound
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: measurements of pelvic inclination
Primary purpose: OTHER

Brief summary: Prospective, multicenter, non-randomized study.

Primary endpoint : to confirm the proper functioning of the device in vivo by analyzing intra and interobserver reproducibility of repeated measurements on healthy controls.

Secondary endpoint : to describe the values of pelvic inclination while standing, sitting and lying in patients with severe hip osteoarthritis before and after total hip arthroplasty

After signing the inform consent form:

For the first endpoint (, 3 healthy volunteers of different morphotypes will have one consultation comprising :

* a medical examination
* 10 measurements of pelvic inclination in sitting position, 10 measurements of pelvic inclination in supine position and 10 measurements of pelvic inclination in standing position, each realized per three different operators. These measurements will be carried out with navigated ultrasound.

For the secondary endpoint, 30 patients awaiting for a hip replacement surgical intervention will realized one consultation the day before the intervention, and one consultation at 2 months after surgery, each comprising :

* a medical examination
* 3 measurements of pelvic inclination (1 standing, 1 sitting and 1 supine). These measurements will be carried out with navigated ultrasound.


Eligibility criteria: Inclusion Criteria:

For primary endpoint

* No medical or surgical history
* Major healthy voluntary topic with

  * Body Mass Index (BMI) \<20 for a subject
  * 24 \<BMI \<26 for a subject
  * BMI\> 30 for a subject
* Subject having signed an informed consent

For the secondary endpoint

* Adult patient requiring total hip arthroplasty for severe hip osteoarthritis
* Patient having signed an informed consent

Exclusion Criteria:

* Minor subject
* Resumption of total hip prosthesis
* Subject who can not express their consent to research
* Presence of medical or surgical history for healthy volunteers

Primary outcomes:
measure: Pelvic inclination measurement
timeFrame: Day 0
Secondary outcomes:
measure: Variation of pelvic inclination before and after hip replacement
timeFrame: Month 2
Other outcomes:
Locations:
city: Brest
country: France
facility: Clinique de Keraudren
city: Brest
country: France
facility: Brest University Hospital
Study officials:
References:
Clinical trial NCT04749212: Perioperative Troponin I and NT Pro-BNP in Lung Resection
Official title: Incidence and Clinical Relevance of Perioperative Elevation of Troponin I and N- Terminal Pro-Brain Natriuretic Peptide in Patients Undergoing Lung Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Ischemia
Thoracic Cancer
Complication,Postoperative
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 475
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adulty patients undergoing elective thoracic and lung resection surgery: neumonectomy, lobectomy, bilobectomy or segmentectomy

Brief summary: After lung resection, troponin elevation may be regulated by mechanisms other than myocardial ischemia. Perioperative natriuretic peptides measurement may help identify changes in ventricular function during thoracic surgery. Integrating both cardiac biomarkers may improve the predictive value for cardiovascular complications after lung resection.

Detailed description: Objectives: To evaluate the incidence and magnitude of perioperative N-terminal pro brain natriuretic peptide (NT-proBNP) and high-sensitivity troponin I (Tn I) elevation in patients undergoing pulmonary resection and its predictive value for cardiovascular complications. Methodology: Prospective, multicenter, observational cohort study in patients \>45 years undergoing elective thoracic surgery for lung resection. Cardiac biomarkers Tn I and NT-proBNP will be measured preoperatively and at postoperative days 1 and 2. Risk score for major cardiovascular postoperative complications will be calculated depending of both biomarkers perioperative changes.

Eligibility criteria: Inclusion Criteria:

* Age ≥45 years old
* Patients undergoing elective surgery for lung resection

Exclusion Criteria:

* Patients undergoing urgent, emergent, or nonthoracic surgery
* Patients or family did not consent to participate
* Presence of symptoms related with infection or sepsis
* Patients with a documented history of severe heart failure and/or ejection fraction lower than 30%

Primary outcomes:
measure: NT-proBNP perioperative changes
timeFrame: Change from baseline NT-proBNP at two-days after surgery
measure: TnI perioperative changes
timeFrame: Change from baseline TnI at two-days after surgery
measure: Major cardiovascular complications
timeFrame: 30-days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
References:
Clinical trial NCT04268212: An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients
Official title: Effects of Bitter Melon Intake and Moderate-Intensity Physical Activity on Postprandial Glucose Responses in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study compared the effect of bitter melon intake and moderate exercise on postprandial glucose levels as measured by incremental area under the curve (iAUC) in eight patients with type 2 diabetes.

Detailed description: Background: This study compared the effects of bitter melon intake and moderate-intensity physical activity on postprandial glucose responses in type 2 diabetic patients.

Methods: A total of 8 patients with type 2 diabetes were randomly assigned to two sequences (AB, BA) with two treatments (A or B) using a 2 x 2 randomized cross-over design: A) 100 ml of bitter melon juice administered 15 minutes prior to the 75-g oral glucose load; B) 30 minutes walking at moderate-intensity performed 15 minutes after the oral glucose load.

Eligibility criteria: Inclusion Criteria:

* An age of 20 to 79 years
* Physician-diagnosed type 2 diabetes
* Medical clearance for physical activity from their healthcare provider

Exclusion Criteria:

* Pregnant or were receiving insulin treatment
* An allergy to bitter melon
* Medical conditions that impacted the normal the functioning of the gastrointestinal tract
* Contraindications to physical activity

Primary outcomes:
measure: mean glucose
timeFrame: 2-hour postprandial period
measure: incremental area under the curve
timeFrame: 2-hour postprandial period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Arizona State University
name: Chong Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02190812: An Intelligent Evaluation of Wrist Strength for the Elderly People and Its Clinical Application
Official title: An Intelligent Evaluation of Wrist Strength for the Elderly People and Its Clinical Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluation of Wrist Muscle Strength
Keywords: wrist muscle strength
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Use the system to evaluate of wrist muscle strength.

Detailed description: The muscle strength of involved wrist muscles may be gradually reduced as aging, and impair their operating skills and even life quality of the elderly. This study has proposed an evaluation system of wrist muscle strength to grip or twist. This system consists of a torque meter (FUTEK TDF400) and three plugs/sockets for simulation of common grip or twist in daily living. This study has completed to evaluate the wrist muscle strength of men and women. In addition to the effects of age and gender, this study analyzes the influence of applied force and its plug/socket diameter on the wrist muscle strength. Simultaneously, this study measured the effect of proper forearm supporter to alleviate pain and improve the wrist and grip strength in the subjects with tennis elbow. And quantitative surface EMG was used to analyze the relationship between different forearm muscles involved. In order to achieve the user-friendly effect, this system intergraded with Cloud service and Bluetooth technology, and developed a portable and intelligent evaluation system of wrist muscle strength. It can help medical personnel to assess and analysis of real-time data. The traditional training of wrist muscle is using grip or grasp a soft tennis ball. In this study a portable grip ball training system is developed. It consists of a pressure sensor and LabVIEW program. It's expected to reduce the risk of injury of the elderly in their daily lives.

Eligibility criteria: Inclusion Criteria:

* Between 20 and 75 years old.
* No significant upper extremity joint pain or nerve palsy.(patients with tennis elbow typical of lateral elbow pain)
* Never received surgical treatment of upper limb joints
* No significant history of cardiovascular disease

Exclusion Criteria:

* Significant disturbance of consciousness
* Unable to communicate with hearing and speech mode
* Lack of mental ability
* Emotional instability
* Significant systemic disease
* With upper limb joints or muscles, tendons obvious lesions

Primary outcomes:
measure: wrist muscle strength
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: