louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05351515: Prevalence of Non-alcoholic Fatty Liver Disease Among Non-obese Obstructive Sleep Apnea by Using Transient Elastography
Official title: Prevalence of Non-alcoholic Fatty Liver Disease Among Non-obese Obstructive Sleep Apnea by Using Transient Elastography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea, Obstructive
Fatty Liver
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is proposed to recruit consecutive patients who have been referred to the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing. In order to invite subjects without symptoms of sleep apnea, collaboration with the Jockey Club School of Public Health and Primary Care, CUHK, to engage healthy volunteers.

Brief summary: Obstructive sleep apnea (OSA) and non-alcoholic fatty liver disease (NAFLD) are both common diseases related to metabolic diseases with potential cardiovascular consequences and liver complications respectively. Though studies show OSA may take part in the progression of hepatic steatosis, the independent contribution of OSA on liver fat accumulation is unknown. It is hypothesized that nocturnal intermittent hypoxia from OSA is the main driver of NAFLD in non-obese OSA patients. This study is to assess the effect of OSA on NAFLD in non-obese patients.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or more

Exclusion Criteria:

* underlying cause of liver disease
* history of excessive alcoholic consumption (more than 30 g/day for men and 20 g/day for women)
* secondary causes of hepatic steatosis (such as chronic use of systemic corticosteroids)
* positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or histological evidence of other concomitant chronic liver diseases.

Primary outcomes:
measure: Number of subjects found to have fatty liver disease among obese patients with obstructive sleep apnea
timeFrame: baseline
measure: Number of subjects found to have fatty liver disease among non-obese patients with obstructive sleep apnea
timeFrame: baseline
Secondary outcomes:
measure: Number of subjects found to have fatty liver disease among obese subjects without obstructive sleep apnea
timeFrame: baseline
measure: Number of subjects found to have fatty liver disease among non-obese subjects without obstructive sleep apnea
timeFrame: baseline
measure: mesenteric fat thickness by ultrasound scan of all subjects
timeFrame: baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: David Hui
role: STUDY_CHAIR
References:
Clinical trial NCT04202315: Use of Virtual Reality for Pelvic External Fixator Removal
Official title: Use of Virtual Reality for Pelvic External Fixator Removal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Fracture Pubic Rami Multiple - Unstable Closed
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 20
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: SUPPORTIVE_CARE

Brief summary: Assessing the role of virtual reality in decreasing pain and improving patient satisfaction in outpatient removal of pelvic external fixator constructs.


Eligibility criteria: Inclusion Criteria:

* Pelvis external fixator placed at study institution
* External fixator placed for pelvic instability

Exclusion Criteria:

* Infected pin or pins
* Loose pin or pins
* Psych history

Primary outcomes:
measure: Pain Score
timeFrame: During procedure
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington/Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Reza Firoozabadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05811715: Effects of Whole-body Stretching Exercise for Reducing Musculoskeletal Pain and Physical Exertion Among Healthcare Professionals
Official title: Effects of Whole-body Stretching Exercise During Lunch-break for Reducing Musculoskeletal Pain and Physical Exertion Among Healthcare Professionals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare Professionals
Lead sponsor: Najran University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of the study:To investigate effect of whole-body stretching (WBS) exercise during lunch-break for reducing musculoskeletal pain and physical exertion among healthcare professionals

Detailed description: This study involved a single-blinded 2-arm randomized controlled trial (RCT) to compare the effect of WBS exercise versus control group during lunch-break to reduce symptoms of WRMSDs in healthcare professionals. sixty healthcare professionals were recruited from Najran university hospital, Saudi Arabia. Study objectives and procedure were properly explained and written informed consent was obtained at the beginning of the study. All the participants were randomly assigned into two equal groups A and B.

Group A were received the 30 minutes of whole body stretching class while group B were received an education program which includes ergonomic principles, WRMSDs and their risk factors, as well as manual handling techniques were explained .

Eligibility criteria: Inclusion Criteria:

* Full time healthcare professionals with more than one year of experience were eligible to participate

Exclusion Criteria:

* Acute musculoskeletal symptoms (pain intensity on visual analogue scale (VAS) \> 7)

Primary outcomes:
measure: musculoskeletal pain
timeFrame: 6 Weeks
measure: physical exertion
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Najrān
country: Saudi Arabia
facility: Hashim Ahmed
state: Najran
Study officials:
References:
Clinical trial NCT02394015: Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC
Official title: Multicenter and Retrospective Observational Study to Analyze the Efficacy and Safety of the Combination With Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to Data Sheet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Epithelial Cancer Recurrent
Keywords: Platinum-sensitive Recurrent Ovarian Cancer
Lead sponsor: Grupo Español de Investigación en Cáncer de Ovario
Sponsor class: OTHER
Collaborators: name: PharmaMar
First posted: 2015-03-20
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received treatment with trabectedin - DLP for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.

Brief summary: Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC.


Eligibility criteria: Inclusion Criteria:

* Patients who have received at least one dose of trabectedin - doxorubicin pegylated for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.

Exclusion Criteria:

* Patients with records unavailable (lost, empty or not recoverable).

Primary outcomes:
measure: Efficacy progression-free survival (PFS)
timeFrame: Up to 12 months
measure: Overall survival (OS)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Response rate to previous and post-treatment (Percentage of responses (CR+PR)
timeFrame: Up to 12 months
measure: Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)
timeFrame: Up to 12 months
measure: Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)
timeFrame: Up to 12 months
measure: Impact of trabectedin - PLD combination in subsequent treatments
timeFrame: Up to 12 months
measure: Toxicity (adverse events)
timeFrame: Up to 12 months
measure: Comparison between PFS and PFS2
timeFrame: Up to 12 months
measure: Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: H. Clinic, Barcelona
name: Laura Vidal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Vall d'Hebron, Barcelona
name: Jose M Del Campo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05493215: Imatinib TDM in GIST
Official title: A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumors
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V)
* Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month
* Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease
* Age ≥18 years
* ECOG performance status of 0 or 1
* Normal organ function

Exclusion Criteria:

* Presence of PDGFRA D842V mutation
* Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug
* Concomitant anticoagulation with oral warfarin.
* Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6
* Uncontrolled intercurrent illness
* Concurrent malignancy

Primary outcomes:
measure: Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
timeFrame: 6 months
Secondary outcomes:
measure: Percent of patients achieving therapeutic levels of imatinib.
timeFrame: 6 months
measure: Quality of Life based on the EORTC QLQ-C30
timeFrame: 6 months
measure: Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years
timeFrame: 3 year
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Reema Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06650215: The 2-minute Walk Test in Hemodialysis Patients
Official title: Validity and Reliability of the 2-minute Walk Test in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients who are clinically stable, between 18 and 80 years of age, who are being followed up at the Hemodialysis Unit of Kırşehir Education and Research Hospital, who do not have any exclusion criteria, who can adapt to the evaluations to be made, who are willing to volunteer and who sign the informed consent form will be included in the study.

Brief summary: Walking tests are widely used to assess functional capacity in different populations because of their ease of administration, interpretability and representativeness of activities of daily living.The aim of our study was to investigate the validity and reliability of the 2-minute walk test in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Patients with end stage renal disease receiving hemodialysis
* Being clinically stable
* Being Aged between 18-80
* Volunteering to participate in this study

Exclusion Criteria:

* Having a musculoskeletal problem that may affect functional capacity measurement
* Having had a cardiac event in the past 3 months

Primary outcomes:
measure: Exercise capacity
timeFrame: 5 minutes
measure: Exercise capacity
timeFrame: 10 minutes
measure: Muscle functions
timeFrame: 1 minutes
Secondary outcomes:
measure: Physical activity
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Kırsehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
affiliation: Kirsehir Ahi Evran University
name: Merve Firat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01842815: Evaluation of the 755nm Alexandrite for Unwanted Tattoos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unwanted, Non Cosmetic, Tattoos
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.


Eligibility criteria: Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.

Primary outcomes:
measure: Tattoo Clearance
timeFrame: Post Treatment 1 (6 Weeks Post Baseline)
measure: Tattoo Clearance
timeFrame: Post Treatment 2 (12 Weeks Post Baseline)
measure: Tattoo Clearance
timeFrame: Post Treatment 3 (18 Weeks Post Baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern California
state: California
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT01013415: CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV Patients
Official title: A Phase I/II Study Of the Safety, Survival, and Trafficking of Autologous CD4-ZETA Gene-Modified T Cells With and Without Extension Interleukin-2 in HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1 Infections
Keywords: HIV-1
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2).

Detailed description: The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2). The treatments that the investigators are studying try to improve the immune system by changing some of your T cells so they can find and destroy HIV infected cells (HIV is usually able to hide from your T cells). In this study, the investigators are also trying to find out if giving you more IL-2 at the same time as gene changed T cells will help the T cells to live longer or fight HIV better.

Eligibility criteria: Inclusion Criteria:

* DOD beneficiary with HIV-1 infection
* Greater than or equal to 200 CD4 cells/mm3
* Undetectable viral load, for at least the previous 8 weeks
* Stable anti-retroviral regimen for greater than or equal to 8 weeks
* Venous access sufficient for apheresis
* Karnofsky performance \> 80%

Exclusion Criteria:

* Inadequate organ function
* Lifetime history of CD4 count less than 200 cells/mm3 on 2 consecutive measurements over at least an 8 week period
* Any previous history of gene therapy
* Recent IL-2 therapy or other treatment with an investigational agent
* Pregnancy
* some medications (hydroxyurea, corticosteroids and other immunosuppressants, chemotherapy, etc.)

Primary outcomes:
measure: Safety of CD4-zeta T cells with and without IL-2 in the setting of HAART
timeFrame: Through study completion, an average of 1 year
measure: Effect of IL-2 on the Persistence of CD4-zeta T cells
timeFrame: Through study completion, an average of 1 year
measure: To compare the viral load of subjects from baseline to the end of study.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: Naomi Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00029315: Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
Official title: Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Hemorrhage
Keywords: Intraventricular hemorrhage
Subarachnoid hemorrhage
Intracerebral hemorrhage
Pharmacokinetics
Recombinant Proteins
Anticoagulants
Tissue Plasminogen Activator
Pharmacology
Catheters, Indwelling
Cerebral Ventricles
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.

Detailed description: IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases. Evidence supports a strong contribution of IVH to morbidity and mortality after cerebral hemorrhage. External ventricular drainage (EVD) is required clinical management; however, EVD via intraventricular catheter alone fails to prevent much of the morbidity and mortality of IVH. This study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis, using rt-PA, as a method of removing this blood and altering morbidity and mortality. Patients will receive intraventricular injections of rt-PA or placebo every 12 hours. They will be followed prospectively with daily head CT scans during the acute-treatment phase and again between Days 28 and 32.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion criteria:

* Intraventricular hemorrhage (IVH) confirmed by CT scan
* More than 12 hours post bleed
* Hematoma size stable by CT scan
* Post-IVH catheter CT scan
* Able to begin study within 24 hours of bleed

Exclusion criteria:

* Infratentorial bleed
* Supratentorial bleed greater than 30 cc
* Unclipped aneurysm suspected
* Arteriovenous malformation suspected
* Any severe, complicating illness (e.g., AIDS or DNR)
* Cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis)
* Active internal bleeding
* Requirement for heparin doses greater than 10,000 U/day
* Concurrent coumadin
* Known allergy to rt-PA
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
References: