louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02982499: Biomechanics of Optic Neuropathy
Official title: Biomechanics of Optic Neuropathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Optic Neuropathy
Keywords: glaucoma
Leber optic neuropathy
anterior ischemic optic neuropathy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case group: Patients with optic neuropathy who are 18 years or older Control group: age-matched healthy subjects

Brief summary: The participant is being asked to be a subject in this research study because the participant may have a disorder that can cause optic nerve damage and impairment of his/her visual function which is called optic neuropathies (ON). Optic neuropathy refers to damage to the optic nerve (a "cable" connecting the eyes and the brain to transmit the visual signals) due to any cause.In this study, the investigator is using magnetic resonance imaging (MRI) and ophthalmic measures such as optic coherent tomography(OCT), which are non-invasive imaging tests to measure the changes in eye globe shape ,the flow of blood and brain fluid. It is hoped that this study will provide new knowledge that may allow the investigator to better understand the cause of symptoms associated with optic neuropathy and ways to better monitor what is happening.


Eligibility criteria: Inclusion Criteria :

* 18 years old and on
* Patients with optic neuropathy(10) and age controlled healthy subjects(10)

Exclusion Criteria :

* For patients: Subjects with history of neurological or ocular disease other than optic neuropathy and refractory error.
* For healthy control group: History of systemic disease except hypertension.
* Pregnant women and prisoners will be excluded.

Primary outcomes:
measure: Globe deformation
timeFrame: day 1
Secondary outcomes:
measure: intracranial pressure
timeFrame: Day 1
measure: Corneal thickness
timeFrame: Day 1
measure: Visual field defect
timeFrame: Day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Byron R Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06173999: A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma
Official title: A Phase Ib/II, Open-label, Multi-center Study of SHR2554 With CHOP/CHOEP in Treatment-naïve Patients With Peripheral T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Peripheral T-cell Lymphoma
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: SHR2554 with CHOP/CHOEP.
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Males or females aged 18-70 years (inclusive);
2. Histologically confirmed peripheral T-cell lymphoma;
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
4. Life expectancy ≥ 12 weeks;
5. Have measurable lesions ;
6. The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures.

Exclusion Criteria:

1. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
2. Known active HBV or HCV infection;
3. History of clinically significant cardiovascular disease;
4. History of other malignancies within 5 years;
5. Pregnant or lactating women;
6. Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination.

Primary outcomes:
measure: Safety endpoints: incidence and severity of adverse events (AEs)
timeFrame: through study completion, an average of about 6 months
measure: Overall response rate (ORR)
timeFrame: 90 days since the date of first dose
Secondary outcomes:
measure: Plasma concentration
timeFrame: Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle)
measure: Progression Free Survival (PFS)
timeFrame: through study completion, an average of about 6 months
measure: Overall Survival (OS)
timeFrame: 2 years since the date of first dose
measure: Duration of response (DOR)
timeFrame: through study completion, an average of about 6 months
measure: Incidence and severity of adverse events (AEs)
timeFrame: through study completion, an average of about 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01057199: Studying Biomarkers in Cell Samples From Patients With Acute Myeloid Leukemia
Official title: Critical Role of MicroRNA-34a and MicroRNA-194 in Acute Myeloid Leukemia With CEBPA Mutations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia
childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-01-27
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia with CEBPA mutations

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in cell samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To determine the significance of regulation of microRNA-34a and microRNA-194 by C/EBPα during granulopoiesis in patients with acute myeloid leukemia with CEBPA mutations.
* To determine whether overexpression of micro RNA-34a and microRNA-194 in myeloid progenitors with C/EBPα mutations leads to granulocytic differentiation.
* To examine how microRNA-34a and microRNA-194 downregulate E2F3 during granulopoiesis.
* To determine the role of microRNA-34a and microRNA-194 in myeloid cell proliferation.

OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including mutation analysis, gene expression analysis, RNA analysis, and fluorescence-activated cell sorting (FACS) analysis.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia with CEBPA mutations

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Significance of regulation of microRNA-34a and microRNA-194 by C/EBPα during granulopoiesis
measure: Relationship between overexpression of microRNA-34a and microRNA-194 in myeloid progenitors with C/EBPα mutations and granulocytic differentiation
measure: Downregulation of E2F3 by microRNA-34a and microRNA-194 during granulopoiesis
measure: Role of microRNA-34a and microRNA-194 in myeloid cell proliferation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Soheil Meshinchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02704299: The Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Official title: A Single-centered Clinical Trial of Surgery，Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Gastric Cancer.
Lead sponsor: Shanghai AbelZeta Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University Cancer Hospital & Institute
First posted: 2016-03-10
Enrollment: 36
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: TREATMENT

Brief summary: Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.

Detailed description: Safety:AE/SAE Efficacy:immunologic function;FPS

Eligibility criteria: Inclusion Criteria:

* Aged between 18 to 80 years, males and females.
* Subjects who understand and sign the consent form for this study.
* The pathologically confirmed advanced gastric cancer T3、T4 or T2 and Metastasis in lymph nodes.
* Subjects are surgical candidates.
* No distant metastasis (M0) and No distant lymph node metastasis.
* Expected survival time of at least 6 months.

Exclusion Criteria:

* Subjects who do not sign the consent form for this study.
* The subject has an allergic history of medicine or food.
* The subject has uncontrolled or hard-to-control diseases of cardiovascular,liver,kidney or lung,endocrine system.
* The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
* The subject has an history of other malignant tumour.
* The subject has history of alcoholism, drug abuse, or mental illness in the 12 years prior to this trial.
* The subject has participated in any other clinical trial in the 3 months prior to this trial.
* The subject is pregnant, lactating or planning to conceive within the next 24 months.
* The subject has any other unsuitable or adverse condition to be determined by the investigator.

Primary outcomes:
measure: Progression-Free-Survival(PFS)
timeFrame: 24months
Secondary outcomes:
measure: Incidences of adverse events or serious adverse events
timeFrame: 24months
Other outcomes:
Locations:
Study officials:
name: / / /, /
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02509299: Effect of Physiotherapy in Hospitalized COPD Patients
Official title: Effect of Different Physiotherapy Treatments in Hospitalized COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
NEMS
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) impacts negatively on the balance and strength of patients. Several studies have shown that acute exacerbations (AEs) decrease, pulmonary function and survival of COPD patients, and there are a lot of physiotherapy interventions to improve it during the hospital stay.

The objective of the present study is to examine the effects of a physical therapy program on balance and strength in COPD patients hospitalized due to acute exacerbation.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. It is a progressive disease, characterized by lung function impairment with airway obstruction.

Patients with COPD suffer exacerbations; the frequency of these exacerbations increases with the severity of the disease. It has been previously shown that the level of health-related quality of life of COPD subjects deteriorates considerably with increasing severity of disease and that the deterioration is linearly related to a decrease in FEV1 % predicted normal values.

Eligibility criteria: Inclusion Criteria:

* COPD diagnosis with exacerbation.
* No contraindication of physiotherapy.
* Signed written consent.
* Medical approval for inclusion.

Exclusion Criteria:

* Contraindications for physiotherapy
* Neurological, orthopedic or heart disease

Primary outcomes:
measure: Lower limb strength
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
measure: Balance
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Secondary outcomes:
measure: Respiratory function
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
measure: Anxiety and depression
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766999: Methemoglobinemia After Liposuction - Diagnostic by Pulse Oximetry and Blood Gas Analysis.
Official title: Methemoglobinemia After Liposuction Under Tumescent Local Anesthesia - Timecourse and Diagnostics by Pulse Oximetry and Blood Gas Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methemoglobinemia
Keywords: pulse oximetry
tumescent anesthesia
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 133
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - female patients scheduled for liposuction

Brief summary: Tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic surgical procedures such as liposuction. The subcutaneous adipose tissue is infiltrated with large volumes of a solution which also contain local anesthetics. However local anesthetics, can also lead to a marked production of methemoglobin. New generation pulse oximeters are able to measure SpMetHb non-invasivly.

The aim of this study is:

1. to investigate multi-wavelength pulse oximetry as a monitoring method for patients at increased risk for methemoglobinemia.
2. to illustrate MetHb concentrations over a course of 24 hours after a liposuction employing tumescent anesthesia has been carried out.


Eligibility criteria: Inclusion Criteria:

* planned liposuction in tumescent local anesthesia

Exclusion Criteria:

* hematologic disorders

Primary outcomes:
measure: Correlation between hemoximetric and pulseoximetric measured methemoglobin
timeFrame: 24 hours
Secondary outcomes:
measure: Time course of MetHb concentration following liposuction employing tumescent anesthesia.
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02656199: Change In Diaphragmatic Thickness Predicts Extubation Success
Official title: Can the Diaphragm Predict the Course of Mechanical Ventilation? A Prospective Study Evaluating Several M-Mode Ultrasound Measured Diaphragmatic Parameters and Their Effects on Weaning From Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mechanical Ventilation Complication
Keywords: Diaphragm
Ventilators, Mechanical
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 57
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 on mechanical ventilation in the intensive care unit

Brief summary: We will investigate whether measurement of the change in thickness of the diaphragm during the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We will also asses whether this is only possible on low levels of pressure support as has been shown previously, or if this technique retains its predictive power at higher levels of pressure support.


Eligibility criteria: Inclusion Criteria:

* age greater than 18, ventilated for \>24 hours

Exclusion Criteria:

* already chronically on mechanical ventilatory support, already has tracheostomy, has pathology that obscures visualization of the right hemidiaphragm, has acute stroke either hemorrhagic or ischemic, cannot identify appropriate decision maker to get informed consent.

Primary outcomes:
measure: Extubation Success
timeFrame: 48 hours
Secondary outcomes:
measure: Re-intubation
timeFrame: 48 hours from removal of ventilatory support
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Einstein Healthcare Network
name: Scott Blumhof, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02986399: Fast Track Hip Fracture - an Optimized Pathway for Hip Fracture Patients
Official title: Influence of a Fast Track Pathway for Hip Fracture Patients on Mortality and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Keywords: fast track
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2016-12-08
Enrollment: 2495
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult hip fracture patients operated at Akershus university hospital in 2012, 2013, 2014 and 2015.

Brief summary: The study examines if the introduction of a fast track pathway for hip fracture patients had an influence on mortality and quality of life by comparing these outcomes between all hip fracture patients operated at Akershus University Hospital two years before and two years after this change in standard care.

Detailed description: The Norwegian hip fracture register prospectively collects data on all hip fracture patients including, among others, time to surgery, type of fracture, type of surgery and American Society of Anesthesiologists (ASA) score. The register also collects quality of life data 4 and 12 months after surgery. Using the unique Norwegian personal identification number the data from the Norwegian hip fracture register will be connected with data from the electronic patient record at Akershus University hospital (AHUS). Fast track surgery for hip fracture patients was introduced at the end of 2013. Mortality and quality of life data will be compared for all hip fracture patients operated at AHUS two years before and two years after this change in standard care. The combined data from the register and the electronic patient records will be used for regression analysis.

Eligibility criteria: Inclusion Criteria:

* Operated at Akershus university hospital for a hip fracture (neck of femur, trochanteric, subtrochanteric) in 2012, 2013, 2014 or 2015
* 18 years or older

Exclusion Criteria:

* stress fracture

Primary outcomes:
measure: 30 day mortality rate
timeFrame: Within 30 days from surgery
Secondary outcomes:
measure: 1 year mortality rate
timeFrame: Within 1 year from surgery
measure: Quality of life
timeFrame: 4 and 12 months from surgery
measure: Readmissions
timeFrame: Within 30 days from discharge
measure: Postoperative infection
timeFrame: Within 1 year from surgery
measure: Re-operation
timeFrame: Within 1 year from surgery
Other outcomes:
Locations:
Study officials:
affiliation: Akershus University Hospital and Faculty of Medicine, University of Oslo
name: Asbjorn Aaroen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03874299: The TOGETHER Project - Kidney RNA-seq Validation
Official title: The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients-RNA-seq Signature Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Rejection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Renal transplant recipients.

Brief summary: The researchers are trying to develop a way to measure the risk of rejection through the validation of a blood test.


Eligibility criteria: Inclusion Criteria:

* Adult (\>/=18 years) renal transplant recipient.
* Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.

Exclusion Criteria:

-Adult (\<18 years) renal transplant recipient.

Primary outcomes:
measure: To validate the use of a RNA-seq based peripheral blood assay in renal transplant recipients.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: