louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01538823: Urine Proteome of Surgical Patients and Healthy Volunteers
Official title: Urine Proteome of Surgical Patients and Healthy Volunteers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Cancer
Keywords: Surgery, Renal Cell Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to have full or partial kidney removal surgery (possibly because of kidney cancer).

Patients scheduled to have a procedure because you may have bladder or prostate cancer.

Patients scheduled to have some other type of surgery (non-urological). Healthy volunteers

Brief summary: The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective, screening techniques.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Planned procedure with presumptive diagnosis of RCC, bladder or prostate cancer OR control patient undergoing non-urological surgery OR normal healthy volunteer OR post surgical patient with a diagnosis of RCC and under surveillance for reoccurrence of RCC or treatment of metastatic RCC
* Signed, informed consent

Exclusion Criteria:

* Patients on dialysis

Primary outcomes:
measure: evaluation of novel bio markers
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jerry Morrissey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu R, Gupta R, Wang Z, Wang C, Sun H, Singamaneni S, Kharasch ED, Morrissey JJ. Bioplasmonic paper-based assay for perilipin-2 non-invasively detects renal cancer. Kidney Int. 2019 Dec;96(6):1417-1421. doi: 10.1016/j.kint.2019.08.020. Epub 2019 Sep 3.
Clinical trial NCT03461523: Observational, Prospective, Single-center Study: Should Body Mass Index (BMI) be Added to the Scoring Criteria of Hepatic Critically Ill Patients in Intensive Care Unit??
Official title: Observational, Prospective, Single-center Study: Should Body Mass Index (BMI) be Added to the Scoring Criteria of Hepatic Critically Ill Patients in Intensive Care Unit??
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICU Stay & Mortality
Lead sponsor: National Hepatology & Tropical Medicine Research Institute
Sponsor class: OTHER_GOV
First posted: 2018-03-12
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that will be admitted to ICU will be categorized into; BMI \< 18.5Kg/m2 =underweight, BMI between 18.5-24.9Kg/m2 = normal weight, while BMI between 25-29.9Kg/m2 = overweight \& obese = BMI ≥ 30Kg/m2

Brief summary: The purpose of the study is to evaluate the hypothesis of poor clinical outcomes in critically ill patients that are having abnormal BMI.

Detailed description: All demographic data will be obtained including the patients' age, sex, body mass index (BMI) \& categorized into; BMI \< 18.5Kg/m2 = underweight, BMI between 18.5-24.9Kg/m2 = normal weight, while BMI between 25-29.9Kg/m2 = overweight \& obese = BMI ≥ 30Kg/m2, associated co-morbidities (diabetes mellitus, hypertension, chronic renal failure, cancer\& chronic liver disease), the cause of admission to ICU, Sequential Organ Failure Assessment (SOFA), nutritional risk screening (NRS) on admission \& discharge, prior cardiac arrest, previous ICU admission within 6months, nosocomial infection, organ failure e.g. cardiovascular, respiratory, renal \& organic support requirement e.g. hemodynamic support, mechanical ventilation, renal replacement therapy (RRT).

Eligibility criteria: Inclusion Criteria:

* Patients who are admitted to the intensive care unit of National Hepatology \& Tropical Medicine Research Institute (NHTMRI) for medical \& surgical indications during the period from February 2018 to December 2020.

Exclusion Criteria:

* Patients will be excluded if they have stayed in ICU ≤24 hours and underweight (BMI\<18.5).

Primary outcomes:
measure: ICU stay
timeFrame: average 2 - 4 weeks
measure: Mortality
timeFrame: average 2-4 weeks
Secondary outcomes:
measure: the need for mechanical ventilation
timeFrame: during ICU stay 2-4 weeks
measure: Duration of mechanical ventilation
timeFrame: 1-4 weeks
measure: the need for pharmacological support
timeFrame: 1-4 weeks
measure: occurrence of nosocomial infection
timeFrame: 2-28 days
measure: Hospital stay
timeFrame: average 2-28days
measure: Hospital mortality
timeFrame: average 28 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NHTMRI
Study officials:
References:
Clinical trial NCT02711423: A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
Official title: A Single-Center, Randomized, Investigator/Subject-Blind Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Gantenerumab Following SC Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.


Eligibility criteria: Inclusion Criteria:

* Healthy males 18 to 45 years of age, inclusive
* Body mass index (BMI) 20.0 to 32.0 kilograms per meter-squared (kg/m\^2), inclusive

Exclusion Criteria:

* History of cancer or any clinically significant disease affecting one of the major organ systems
* Prior administration of gantenerumab
* Clinically significant laboratory test results
* Clinically relevant history of hypersensitivity or allergic reaction following exposure to a drug, food, or environmental agent
* Known hypersensitivity to gantenerumab or excipients of study drug formulation
* Abnormal skin condition or potentially obscuring tattoo, pigmentation, or lesion in the area intended for SC injection
* Familial history of early-onset Alzheimer's disease

Primary outcomes:
measure: Percentage of participants with adverse events (AEs)
timeFrame: Up to 12 weeks (from Baseline to Day 85 +/- 5 days)
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of gantenerumab
timeFrame: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
measure: Area under the plasma concentration-time curve (AUC) of gantenerumab
timeFrame: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06467123: A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder Pain
Official title: A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain.


Eligibility criteria: Inclusion Criteria:

* Shoulder pain intensity rated as 3/10 or higher in the past 24 hours

Exclusion Criteria:

* Non-English speaking
* Systemic medical conditions that affect sensation, such as uncontrolled diabetes
* History of shoulder surgery or fracture within the past 6 months
* blood clotting disorder, such as hemophilia
* contraindication to the application of ice ((blood pressure \> 140/90 mmHg, cold urticaria, cryogobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* Unable to exercise without a medical clearance (assessed on the PAR-Q+ on the first visit)
* Exceed pressure and sensory safety thresholds (assessed on the first visit)
* Categorized as low irritability (assessed on the first visit)
* currently pregnant
* currently receiving physical therapy to treat shoulder pain

Primary outcomes:
measure: Report rate of adherence and adverse effects
timeFrame: through study completion, 4 weeks
measure: Report preliminary outcomes of treatment effects
timeFrame: through study completion, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Abigail Anderson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01791023: Stress Reactivity of Physical Stressor on Depression
Official title: The Effect of Acute Exercise on Reactivity and Recovery of Cortisol and DHEAS Levels in Depressive and Healthy Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Physical exercise
Stress
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Depressive elderly individuals have showed higher basal level of cortisol and lower level of dehydroepiandrosterone (DHEA). Moreover, changes on these hormone levels have also observed in reactivity of an acute stress, such as physical exercise. On the other hand, physical training can modulate the release of these hormones. Therefore, depressive elderly individuals physically actives might show attenuated reactivity of an acute physical stressor compared to sedentary elderly individuals. The aim of these study is to compare the effect of an acute physical stressor on cortisol levels in depressive and healthy individuals, physically actives and sedentaries. Additionally, the sulfated form of DHEA (DHEAS) serves as a reservoir for DHEA, because of that it is expected that DHEAS levels might reduce after the acute physical exercise.

Detailed description: Depressive and healthy individuals were submitted to one session of 30 minutes of physical exercise of moderate intensity. Before and soon after the exercise it was collected saliva - to analyse cortisol and DHEAS hormones - and some psychological and physical aspects were also collected, such as anamneses, scales of anxiety, temperaments, mood, stress and quality of life. Moreover, during exercise heart rate and mood scale were assessed. To evaluate the reactivity and recovery of physical stressor (physical exercise) saliva tubes and psychological scales were collected 30 minutes and 45 minutes after the end of exercise.

Eligibility criteria: Inclusion Criteria:

* Age above of 60 years old
* Clinical diagnostic of depression

Exclusion Criteria:

* Hormonal replacement
* Physical disease
* Fasting

Primary outcomes:
measure: Changes from baseline in cortisol and DHEAS levels to after an acute session of exercise
timeFrame: From before and to after one session of 30 minutes of exercise.
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Deolindo Couto Neurology Institute
state: RJ
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Helena S Moraes, Ms
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00541723: Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles
Official title: A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lateral Periorbital Wrinkles
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).

Detailed description: Conducted in Europe

Eligibility criteria: Main Inclusion Criteria:

- Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale at maximum smile

Main Exclusion Criteria:

- Significant facial asymmetry

Primary outcomes:
measure: Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
timeFrame: Week 4
Secondary outcomes:
measure: Response assessed by the investigator at maximum smile for either eye area compared to baseline.
timeFrame: Weeks 2, 4, 12, and 20
measure: Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.
timeFrame: Weeks 2, 4, 12, and 20
Other outcomes:
Locations:
city: Cannes
country: France
city: Nice
country: France
city: Paris
country: France
city: Duesseldorf
country: Germany
city: Karlsruhe
country: Germany
city: Munich
country: Germany
city: Starnberg
country: Germany
city: Roma
country: Italy
city: Bexley. Kent
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Sutton Coldfield
country: United Kingdom
Study officials:
affiliation: MediZen, Sutton Coldfield, United Kingdom
name: David Eccleston, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03304223: IL2 Imaging in Renal Transplantation
Official title: A Proof of Concept Study for [18F]FB-IL2 PET Imaging of Infiltrating T Cells After Renal Transplantation; a Diagnostic Tool for Acute Rejection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplant Rejection
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 20
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: DIAGNOSTIC

Brief summary: After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection. However, this is an intervention associated with complications like bleeding, patient discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false negative results. So, the introduction of a new non-invasive diagnostic tool for allograft rejection could have major implications for the care of renal transplant recipients. For the purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET), the tracer 18-Fluor-Interleukin-2 (\[18F\]FB-IL2) has been developed. The investigators hypothesized that a high correlation exists between \[18F\]FB-IL2 uptake and the extend of T cell infiltration into renal transplants with signs of rejection


Eligibility criteria: Inclusion Criteria:

* Female or male aged between 18 and 80 years.
* Renal Transplant recipients
* The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.
* All patients will have a clinical indication for renal biopsy.

Exclusion Criteria:

* Patients with multiple-organ transplants.
* Female patients who are pregnant or unwilling to use adequate contraception during the study.
* Claustrophobia
* Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
* A clinical reason for an immediate start of a therapeutic intervention with immunosuppressive medication.

Primary outcomes:
measure: The ability of the [18F]FB-IL2 PET to detect renal transplant rejection
timeFrame: At study day 2, when PET procedure is performed.
Secondary outcomes:
measure: Uptake of [18F]FB-IL2 and correlation with renal function
timeFrame: At study day 2, when PET procedure is performed.
measure: Uptake of [18F]FB-IL2 and correlation with T-cell subpopulations
timeFrame: At study day 2, when PET procedure is performed.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Jan-Stephan F Sanders, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04349423: Daily Assessment of Mood and Social Media Behaviors Study
Official title: Daily Assessment of Mood and Social Media Behaviors Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Depression
Cortisol
Keywords: Social Media
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to social media usage groups to assess if reduction social media will improve mood and in turn lower depressive and anxiety symptoms. The groups include 0 minutes, 30 minutes, 1 hours of use a day.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn more about social media usage and its relation to emotions, biology, and mental health. Participants will complete daily assessments (5 times a day) over the course of 11 days in which they will report on their social media use, behaviors, and mood. During the first 4 days participants will be asked to continue using social media as typical. In the second half (7 days) participants will be randomized to social media usage groups (0 minutes, 30 minutes, 1 hour, 2 hour, 3 hours). There will be mental health and well-being measures provided at the beginning and end of the study. Lastly, to better understand how social media usage effects underlying mechanisms of stress, participants will be asked to provide saliva samples for 3 nights (pre, mid, and post) to assess for basal cortisol levels.


Eligibility criteria: Inclusion Criteria:

* Having a smartphone

Exclusion Criteria:

* Below age of 18

Primary outcomes:
measure: Changes in "Positive and Negative Affect Schedule" (PANAS)
timeFrame: Pre and post. Daily 5 times a day for 11 days
measure: Changes in "Depression Anxiety and Stress Scale" (DASS)
timeFrame: Pre and Post. Daily for 11 days
measure: Changes in "Behavioral Activation for Depression Scale"
timeFrame: Pre-Post- Daily for 11 days
measure: Changes in "Social Media Use"
timeFrame: Daily for 11 days
measure: Changes in "A clinically useful depression outcome scale" (CUDOS)
timeFrame: Pre-Post- Daily for 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
References:
Clinical trial NCT06555250: Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis
Official title: Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis in the Context of Preoperative Assessment of Rhizarthrosi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhizarthrosis
Prosthesis Failure
Keywords: rhizarthrosis
bone scintigraphy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient who beneficiate of a bone scintigraphy before arthroplasty for rhizarthrosis with failure medical treatment, without osteoarthritis of the STT joint on planar radiography

Brief summary: Rhizarthosis can be treated by prothesis of the carpo-metacarpal (CM) joint of the thumb. But, if the scaphotrapeziotrapezoid (STT) joint is also affected by arthrosis, treating the CM joint exclusively may result in partial pain relief. Thus, bone scintigraphy could identify early arthrosis of the STT joint when its appearance seems to be normal on planar radiography, suggesting another surgical procedure.


Eligibility criteria: Inclusion Criteria:

* failure of medical treatment of rhizarthrosis
* eligibility for prothesis
* no osteoarthritis of the STT joint on planar radiography
* no opposition from the patient

Exclusion Criteria:

* Refusal by a patient

Primary outcomes:
measure: Search for a statistically significant association between scintigraphic STT hyperfixation and residual pain after TM prosthesis for patients with no radiographically obvious STT involvement.
timeFrame: before surgery and 4 month after surgery
Secondary outcomes:
measure: Search for an association between scintigraphic STT hyperfixation in quantitative analysis and residual pain after TM prosthesis for patients without advanced STT involvement on radiography.
timeFrame: before surgery
measure: Assessing the involvement of other carpal joint compartments
timeFrame: before surgery
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References: