louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03458520: Pediatric PET/MR Image Registry
Official title: Pediatric PET/MR Image Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Soft Tissue
Lymphoma
Osteosarcoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-03-08
Enrollment: 100
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and young adult (\<40 years) male or female subjects with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor

Brief summary: The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.


Eligibility criteria: Inclusion Criteria:

* Patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor.
* We might also include some patients with leukemia if there is concern for a focal lesion in any of their organs.
* Participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry.

Exclusion Criteria:

* Patient has contraindications for MRI or PET/MR. This includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level \> 200 mg/dl.
* Lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age).
* Patient has a CNS primary tumor.
* Pregnant women and fetuses

Primary outcomes:
measure: Number of tumors
timeFrame: up to 12 months
Secondary outcomes:
measure: Metabolic activity of tumors
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Heike Daldrup-Link, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04633720: Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance Volume Profile in Children
Official title: Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance-volume Profile in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Compliance
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In children under 6 years of age undergoing regular surgery during general anesthesia, the intratidal compliance profile is evaluated when different tidal volumes are applied at different positive end expiratory pressures.

Then determine the most appropriate combination of positive end-tidal pressure and tidal volume.


Eligibility criteria: Inclusion Criteria:

* Children undergoing surgery \> 1 hour under general anesthesia
* Children ≤ 6 years
* American society of anesthesiology physical status I, II

Exclusion Criteria:

* Previous lung surgery
* Bronchopulmonary dysplasia, respiratory distress syndrome
* Other interstitial lung disease
* Laparoscopic surgery
* Thoracic surgery, abdominal surgery

Primary outcomes:
measure: Intratidal compliance profiles in each ventilator settings
timeFrame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Secondary outcomes:
measure: Respiratory compliance
timeFrame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
measure: Driving pressure
timeFrame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
measure: Blood pressure
timeFrame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Lee JH, Kang P, Song IS, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Determining optimal positive end-expiratory pressure and tidal volume in children by intratidal compliance: a prospective observational study. Br J Anaesth. 2022 Jan;128(1):214-221. doi: 10.1016/j.bja.2021.09.024. Epub 2021 Oct 20.
Clinical trial NCT05545020: Trivalent Chromium Treatment for Rheumatoid Arthritis
Official title: Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trivalent chromium has shown good results in abolishing inflammation and had a successful result in treating animal model of rheumatoid arthritis. In addition to that, trivalent chromium lacks many side effects which are related to the already known medications of the disease.

So this study aims to evaluate the efficacy of trivalent chromium supplementation in rheumatoid arthritis treatment and measuring the outcomes of that in rheumatoid arthritis patients.

Detailed description: Rheumatoid arthritis is a debilitating autoimmune disease which is treated by medications that have many side effects. Trivalent chromium, a naturally occurring element with regulatory effects on blood sugar, has shown anti-inflammatory properties in many studies and has shown a good response at alleviation of rheumatoid arthritis in the disease animal model. For these reasons trivalent chromium should be tried in rheumatoid arthritis patients.

Eligibility criteria: Inclusion Criteria:

* rheumatoid arthritis

Exclusion Criteria:

* other autoimmune diseases

Primary outcomes:
measure: Arthritis scored by DAS28 score
timeFrame: three months
measure: ESR in mm/hr
timeFrame: three months
measure: CRP mg/dL
timeFrame: three months
measure: Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)
timeFrame: three months
Secondary outcomes:
measure: Serum urea
timeFrame: three months
measure: serum creatinine
timeFrame: three months
measure: SGOT
timeFrame: three months
measure: SGPT
timeFrame: three months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University, Egypt
Study officials:
References:
citation: Hassouna SS, Sheta E, Zaki I, Harby SA, Allam EA. Trivalent chromium supplementation ameliorates adjuvant induced rheumatoid arthritis through up-regulation of FOXP3 and decrease in synovial Cathepsin G expression. Inflammopharmacology. 2022 Dec;30(6):2181-2195. doi: 10.1007/s10787-022-01025-8. Epub 2022 Jul 13.
Clinical trial NCT00785720: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.


Eligibility criteria: Inclusion criteria:

* Phototype Skin II and III;
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History of photodermatosis active;
* Family or personal antecedent of cutaneous photoinduced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT03026920: Pelvic and Acetabular Fracture in Old People
Official title: Different Surgical Methods for Pelvic or Acetabular Fracture of Old Man
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Dislocation
Keywords: Fracture
outcome
pelvic
acetabular
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It was reported that satisfactory postoperative outcome was difficult to obtain for the pelvic or acetabular fracture in old people. The less invasive surgical method was conducted in this study. Then, the clinical results were compared with the patients treated using traditional methods to assess the less invasive method.

Detailed description: Pelvic or acetabular fractures were caused by high energy trauma, which may lead to poor prognosis for the old. The patients over 60 years were included in this study. The surgical procedure was conducted in two weeks. The less invasive methods involved Stoppa approach and novel plate. The data including surgical time, blood loss and results of follow-up were recorded. The clinical results were compared with the patients treated using traditional methods. Thus, the clinical outcome of Pelvic or acetabular fractures in old man was assessed.

Eligibility criteria: Inclusion Criteria:

Over 60 years old Fracture involving pelvis or acetabulum Operation was conducted within 14 days Sign the consent form

Exclusion Criteria:

Presented with a pathologic acetabular fracture Refused to participate Follow-up insufficient 12 months

Primary outcomes:
measure: fracture union time
timeFrame: 4 months
Secondary outcomes:
measure: complication
timeFrame: 12 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
Study officials:
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
name: Ruipeng Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086774: Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Dry eye
Tear Film Stability
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the optical effects of Systane Ultra


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or more.
2. Subjects must have Tear Break Up Time (TBUT) \< 5 seconds
3. Subjects must have a maximum blink interval (MBI) \< 10 seconds
4. Subjects must be willing to comply with all study requirements.
5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
3. Subjects with known sensitivity to planned study concomitant medications
4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Primary outcomes:
measure: Improvement in maximum blink interval (MBI)
timeFrame: 1 day
Secondary outcomes:
measure: Tear film stability and contrast sensitivity
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01201174: Hemolysis in Patients With Hereditary Spherocytosis (HS)
Official title: Oxidative Stress Contributes to Hemolysis in Patients With Hereditary Spherocytosis (HS) and Can be Ameliorated by Fermented Papaya Preparation (FPP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hereditary
Hemolysis
Keywords: Hemolysis in Patients with Hereditary Spherocytosis
with documented family history of HS.
spherocyte morphology,
splenomegaly and non-immune mediated hemolysis.
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-09-14
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In the present study the investigators are going to explore the oxidative status of HS-RBC and its contribution to hemolysis

Detailed description: The oxidative status of cells, which is determined by the balance between pro-oxidants, such as the reactive oxygen species (ROS), and antioxidants, is a major regulator of cellular functions. Impaired balance between pro- and antioxidants causes oxidative stress which may result in oxidation of proteins, lipids and DNA with the final outcome of premature cell aging and apoptosis \[1,2\]. Oxidatively stressed red blood cell (RBC) have been observed in various congenital and acquired hemolytic anemias, including thalassemia, sickle cell anemia, congenital dyserythropoietic anemia, G6PD deficiency and paroxysmal nocturnal hemoglobinuria (PNH) as well as in myelodysplastic syndrome (MDS). Although the primary etiology is different in these anemias, oxidative stress mediates several of their pathologies, mainly hemolysis \[3\].

Hereditary Spherocytosis (HS) is a genetic disorder of the RBC skeleton with primary deficiency in spectrin, ankyrin-1, band 3 or protein 4.2 associated with chronic hemolytic anemia \[4\]. Secondary protein deficiencies resulting from oxidative stress are often observed and may be involved in the clinical manifestations of the disease \[5\].

Eligibility criteria: Inclusion Criteria:

* patients \> 5 years
* with documented family history of HS
* patients should have clinical and laboratory findings, consistent with mild to severe HS, diagnosed on the basis of spherocyte morphology, elevated MCHC (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis.

Exclusion Criteria:

* non

Primary outcomes:
measure: ROS, reduced glutathione (GSH) and lipid peroxides will be measured in RBC
timeFrame: year
Secondary outcomes:
measure: Hemolysis
timeFrame: year
Other outcomes:
Locations:
city: Holon,
country: Israel
facility: Wolfsson Medical Center
state: Israel,
Study officials:
affiliation: HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER
name: GHOTI HOSSAM, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741220: Resilience and Mentoring in German-speaking Intensive Care Providers and Anesthesiologists
Official title: Resilience and Mentoring in German-speaking Intensive Care Providers and Anesthesiologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Work Engagement
Well-being
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: Graz University of Technology
First posted: 2012-12-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: German-speaking intensive-care providers and anesthetists

Brief summary: The aim of this study is to identify factors influencing work engagement and wellbeing in German-speaking intensive-care providers and anesthesiologists.


Eligibility criteria: Inclusion Criteria:

* resident or staff anesthetist
* since more than 6 months working for the same institution

Exclusion Criteria:

* no informed-consent

Primary outcomes:
measure: Utrecht Work Engagement Scale
timeFrame: 4 weeks
measure: Positive and negative affective scale
timeFrame: 4 weeks
measure: Psychological Well-Being questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Acceptance and Action Questionnaire
timeFrame: 4 weeks
measure: Experience Questionnaire
timeFrame: 4 weeks
measure: Dutch Workaholism Scale
timeFrame: 4 weeks
measure: Multidimensional Perfectionism Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical Univeristy Graz
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
Study officials:
affiliation: Medical University Innsbruck
name: Horst Mitmansgruber, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz
name: Helmar Bornemann-Cimenti, MD, DMedSci
role: STUDY_DIRECTOR
affiliation: Medical University of Graz
name: Andreas Sandner-Kiesling, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05673174: Avicena LVDP Validation Study in Healthy Volunteers
Official title: Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: left ventricular diastolic pressure
Lead sponsor: Avicena LLC
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers, no history of Heart Disease.

Brief summary: The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Adult subjects \>21 years of age.
2. No known significant health problems.
3. Willing and able to participate in all study evaluations.
4. Ability to understand and sign informed consent.

Exclusion Criteria:

1. Open skin lesions at the site of Vivio application / examination.
2. Inability to obtain brachial artery blood pressure.

Primary outcomes:
measure: To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Avicena
state: California
Study officials:
References:
Clinical trial NCT02008474: SHARE Study 4: Financial Incentives for Weight Loss
Official title: Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 examine different types of monetary incentive paradigms for weight loss.


Eligibility criteria: Inclusion Criteria:

* BMI \>=25kg/m2
* English speaking
* Age 18-70

Exclusion Criteria:

* Health problems that make weight loss or unsupervised exercise unsafe
* Current pregnancy or plan to become pregnant int he next 12 months
* Planned relocation
* Current participation in weight loss research study

Primary outcomes:
measure: weight change from initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram
timeFrame: 0 to 3 months
Secondary outcomes:
measure: weight change from the initial assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
timeFrame: 0 to 12 months
measure: Weight change from the 3 month assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
timeFrame: 3 to 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena Wing, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Tricia M Leahey, PhD
role: PRINCIPAL_INVESTIGATOR
References: