louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02824419: Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
Official title: Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pulmonary Sarcoidosis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of the current study is to evaluate the potential of the selected PET tracers to detect sarcoidotic lesions in lungs. The tracers are already in clinical use for the detection of certain inflammatory processes or malignant tumors, and their targets present similarities with molecular mechanisms of sarcoidosis.

Detailed description: The diagnosis of sarcoidosis is difficult since there is no specific noninvasive method available to diagnose sarcoidosis. FDG-PET imaging is in use, however, FDG is not a specific tracer for sarcoidosis and other inflammatory diseases may interfere with the imaging findings. The aim of the current protocol is to evaluate the potential of other inflammatory PET-tracers in the detection of sarcoidotic lesions.

The patients with active sarcoidotic lesions in lungs will be recruited. First, the patient undergoes PET-FDG scan and then the patient undergoes the PET scan either with C11-methionine or 68Ga-DOTANOC. The results with the latter tracers will be compared to the imaging results with FDG.

Eligibility criteria: Inclusion Criteria:

* Patient with sarcoidosis

Exclusion Criteria:

* any malignant disease
* any significant other inflammatory or infectious disease affecting lungs
* pregnancy

Primary outcomes:
measure: The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
Study officials:
affiliation: Turku PET Centre, Turku University Hospital, Turku, Finland
name: Juhani Knuuti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05029219: Virtual Reality Intervention Procedure Simulator
Official title: A Prospective Randomized Controlled Study for the Efficacy of Virtual Reality Intervention Procedure Simulator on the Training of Pain Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Novice Doctor
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to prove the effectiveness of the virtual reality program in educating lumbar transforaminal epidural blocks to novice doctors.


Eligibility criteria: Inclusion Criteria:

* Residents in department of anesthesiology and pain medicine unfamiliar with fluoroscopy guided epidural block

Exclusion Criteria:

* Residents in department of anesthesiology and pain medicine familiar with fluoroscopy guided epidural block

Primary outcomes:
measure: Checklist score
timeFrame: 60 min of education programs
Secondary outcomes:
measure: Global rating score
timeFrame: 60 min of education programs
measure: Time taken to perform lumbar transforaminal epidural injection
timeFrame: Procedure duration
measure: Number of fluroscopy shots when performing lumbar transforaminal epidural injection under a fluoroscopy guide
timeFrame: Procedure duration
measure: Participants' satisfaction with the curriculum
timeFrame: 60 min of education programs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT02604719: Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH
Official title: Tranexamic Acid and Ethamsylate For Preventing Post Partum Hemorrhage in Patient Undergoing LSCS at High Risk For Post PartumHemorrhage : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postpartum Hemorrhage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage

Detailed description: Research Question:

Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?

Eligibility criteria: Inclusion Criteria:

1. Women undergoing elective caesarean section
2. Patient having one or more risk factor for PPH

   * Multiple pregnancy
   * Polyhydramnios (AFI \>25cm)
   * Macrocosmic baby (\>4.5 Kg)
   * Prolonged , augmented and obstructed labour
   * Obese patients(BMI \>30)
   * Premature rapture of membranes
   * Previous history of PPH
3. Age ≥18 years
4. Gestational Age ≥ 35 Weeks
5. Informed Oral Consent From The Patient

Exclusion Criteria:

1. History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke)
2. History of epilepsy or seizure
3. Any Known Cardiovascular , renal or liver Disease
4. Autoimmune Diseases
5. Sickle Cell Disease
6. Severe hemorrhagic Disease
7. Placenta Previa.
8. Morbidly adherent Placenta
9. Abruptio placenta
10. Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome
11. Administration Of low molecular weight heparin or Anti platelets the week before delivery .

Primary outcomes:
measure: PPH defined as blood loss ≥500 cc
timeFrame: the first 24hours
Secondary outcomes:
measure: severe PPH (>1000 cc), .
timeFrame: first 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02451319: Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS
Official title: Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nephrolithiasis
Keywords: RIRS, holmium, 1-2 cm,stones,kidney
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).


Eligibility criteria: Inclusion Criteria:

* Patients who are between 18-90 years old
* Patients undergoing RIRS for treatment of 1-2 cm diameter kidney stones

Exclusion Criteria:

* Patients who have congenital urogenital abnormalities
* Patients who have previous stone surgery history

Primary outcomes:
measure: Safety - complications according to clavien system
timeFrame: postoperative 24 hours
measure: safety - visual analog score
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: efficiency - stone free rate
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Tuekey Ministry of HealthDıskapı Yıldırım Beyazıt Training and Research Hospital
Study officials:
affiliation: Dıskapı TRH
name: Nihat Karakoyunlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redondo C, Ramon de Fata F, Gimbernat H, Meilan E, Andres G, Angulo JC. Retrograde intrarenal surgery with holmium-YAG laser lithotripsy in the primary treatment of renal lithiasis. Actas Urol Esp. 2015 Jun;39(5):320-6. doi: 10.1016/j.acuro.2014.06.004. Epub 2014 Oct 25. English, Spanish.
Clinical trial NCT01580319: Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
Official title: Outpatient Strategy of Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Hypercholesterolemia
High Blood Pressure
Sedentary Lifestyle
Keywords: obesity
cholesterol
cholesterol, LDL
cholesterol, HDL
blood glucose
Triglyceride
C-Reactive Protein - hs
blood pressure
physical activity
Sedentary Lifestyle
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2012-04-19
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research project is about a physical activity intervention in pediatric outpatients to try control and prevent heart diseases such as hypertension, obesity, high cholesterol.

Detailed description: Control Group: receive information about health lifestyle Interventional Group: receive a structured plan with exercises to do 3 times per week within 50 minutes.

It is a randomized clinical trial and population are children and adolescents.

Eligibility criteria: Inclusion Criteria:

* 6 to 17 years
* obesity
* high cholesterol

Exclusion Criteria:

* congenital heart diseases
* less than 6 or more than 17 years old

Primary outcomes:
measure: Reduction on risk factors for a cardiovascular diseases (reduction on BMI, cholesterol, LDL, glucose, high-sensitivity C-reactive protein, blood pressure and/or increase on HDL)
timeFrame: These measurement were taken at end of followup (27th week)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia / Fundação Universitária de Cardiologia
state: Rio Grande do Sul
Study officials:
affiliation: Instituto de Cardiologia
name: Claudia C Cesa, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00715819: Use of Otoscope as a Non-invasive Tool for Diagnosis of Pilomatricoma
Official title: Use of Otoscope as a Non-invasive Tool for Diagnosis of Pilomatricoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilomatrixoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-07-15
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Stanford University Dermatology Clinics and Lucile Packard Children's Hospital are evaluating the use of the otoscope for the diagnosis of skin lesions. We are particularly looking for children and/or adults with nodules, cysts, tumors, or pilomatricomas. The study will take 15-30 minutes and we will use light to examine and take a picture of your skin lesion. There is no monetary compensation for participating in the study.

Detailed description: Pilomatricoma is a benign tumor that presents as a 3-30mm firm, solitary, deep dermal or subcutaneous tumor on the head, neck, or upper extremities. The clinical diagnosis is often made by the firm, sometimes rock hard texture of the skin. The diagnosis can be confirmed by a skin biopsy and/or excision of the lesion. We have recently noted that pilomatricomas appear as a black mass in the skin when the lesion is transilluminated by placing the light of a fiberoptic otoscope adjacent to the skin lesion. We would like to confirm our impression by a prospective study using transillumination to examine subcutaneous tumors in the skin. Pilomatricoma is also known as a benign calcifying or calcified epithelioma, pilomatrixoma, or a calcifying epithelioma of Malherbe.

Eligibility criteria: Inclusion Criteria:- Potential participants will be any patient that is seen at Stanford Dermatology or LPCH that has a cyst, nodule, vesicle, tumor, or possible pilomatricoma Exclusion Criteria:- Inability of subject or subject's guardian to understand informed consent form.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Odmara Liz Barreto-Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05302219: Plethysmography Curve Variability Depending on the Breath Cycle
Official title: Plethysmography Curve Variability Depending on the Breath Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea
Circulatory; Change
Respiration
Keywords: pulse oximetry
photoplethysmography curve
breath cycle
apnea
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants go through all assigned interventions in one study arm.
Primary purpose: OTHER

Brief summary: The aim of the study is to analyze the variability of plethysmography curve depending on the breath cycle (respiratory rate and tidal volume).

Detailed description: The plethysmography curve measured by finger sensors using pulse oximetry shows the changes in blood volume at the measured site. The presence of respiratory information within the pulse oximeter signal is a well-documented phenomenon. However, previous studies have mainly focused on extracting the respiratory rate from the plethysmography curve. The aim of this study is to analyze the variability of plethysmography curve as a function of both respiratory rate and tidal volume. Furthermore, the aim is to analyze the possibilities of apneic pause detection from the plethysmography curve.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers/students from the Czech Technical University in Prague

Exclusion Criteria:

* any acute illness
* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* diabetes
* hypotension or hypertension

Primary outcomes:
measure: Variability of plethysmography curve depending on the respiratory rate
timeFrame: 1 hour
measure: Variability of plethysmography curve depending on the tidal volume
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Faculty of Biomedical Engineering, Czech Technical University in Prague
Study officials:
affiliation: Czech Technical University in Prague
name: Veronika Rafl Huttova, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Jakub Rafl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson LM. Respiration signals from photoplethysmography. Anesth Analg. 2013 Oct;117(4):859-865. doi: 10.1213/ANE.0b013e31828098b2. Epub 2013 Feb 28.
Clinical trial NCT03137719: Infections in Hospitalized Cirrhotic Patients
Official title: Infections and Other Complications of Cirrhosis: A Prospective Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized cirrhotic patients

Brief summary: Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This study aims to determine the current practice and outcomes in these following areas:

1. Community-acquired infections
2. Nosocomial infections
3. Development of second infections
4. Factors predicting ICU care, organ failure, death, and disability
5. Patterns and adequacy of albumin use in infected and non-infected patients
6. Per and post-liver transplant outcomes
7. Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
8. Regional variations in outcomes and therapeutic strategies


Eligibility criteria: Inclusion Criteria:

* Male and Female over 18 years of age
* Cirrhosis as diagnosed by either liver histology or a combination of clinical biochemical (low platelets, elevated bilirubin, and/or INR, low albumin) radiologic (nodular liver on ultrasound) and endoscopic (esophageal varices) criteria
* Subject must be able to understand and provide informed consent
* Evaluated in the ER or admitted to the hospital for non-elective reasons

Exclusion Criteria:

* admitted for elective purpose

Primary outcomes:
measure: Frequency, Cause and Outcome of Community-acquired infections
timeFrame: From admission to 1 year post-discharge from the hospital
measure: Frequency, Cause, and Outcome of Nosocomial infections
timeFrame: From admission to 1 year post-discharge from the hospital
measure: Development of second infections
timeFrame: From admission to 1 year post-discharge from the hospital
measure: Factors predicting ICU care, organ failure, death, and disability
timeFrame: From admission to 1 year post-discharge from the hospital
measure: Patterns and adequacy of albumin use in infected and non-infected patients
timeFrame: From admission to 1 year post-discharge from the hospital
measure: Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
timeFrame: From admission to 1 year post-discharge from the hospital
measure: Peri and post-liver transplant outcomes based on physiological parameters
timeFrame: From admission to 1 year post-discharge from the hospital
measure: Regional variations in outcomes and therapeutic strategies
timeFrame: From admission to 1 year post-discharge from the hospital
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04510519: Scaling Mental Healthcare in COVID-19 With Voice Biomarkers
Official title: Scaling Mental Healthcare in COVID-19 With Voice Biomarkers: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Generalized Anxiety
Lead sponsor: Kintsugi Mindful Wellness, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes men and women over the age of 18 years

Brief summary: This study aims to advance research on group sessions for mental health. The first-of-its-kind study measuring various features in a group setting, combining rich metadata in creating state-of-the-art machine learning models, and developing workflows for mental health that are both scalable and personalized.

Detailed description: The anticipated impact of this study is defining voice biomarker features and reward functions for a deep reinforcement learning based system from group interactions that improve depression and anxiety outcomes. The investigators' ability to quantify the real-time impact of human-intervention in scaled group video sessions can be very meaningful for creating best practices in the area where measurement is infrequent.

The investigators' priority is to scale the optimal mix of individuals for group therapy sessions based on reward functions that maximize improvements in depression and anxiety scores. Current group therapy appointments may track little save few who use various group feedback questionnaires (e.g. OQ, GCQ, or GQ). Voice biomarkers can play a key role in the real-time measurement of mental health.

The proposed work is to conduct a feasibility study on creating reward functions that most effectively enable engagement for group sessions as measured by voice biomarkers before, during, and after group video meetings.

Eligibility criteria: Inclusion Criteria:

* Ownership of a personal iPhone (version iOS 12.0 or later) and willingness to install and maintain the Kintsugi app for remote participation throughout the study duration
* Able to understand and comply with instructions in English

Exclusion Criteria:

* Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
* Has a visual or physical motor impairment that could interfere with study tasks
* Is site personnel directly affiliated with this study

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: March 30, 2021
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: June 20, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Kintsugi Mindful Wellness, Inc.
state: California
Study officials:
References: