louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03459352: Digital Symptom Tracking, Patient Engagement and Quality of Life in GI Oncology Clinic Patients
Official title: Feasibility Study of Digital Symptom Tracking, Patient Engagement and Quality of Life in Patients Seen in GI Oncology Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Patient Reported Outcomes
Symptom management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Noona Healthcare Inc
First posted: 2018-03-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A pilot study of an ePRO system in cancer patients receiving systemic therapies.

Detailed description: The primary purpose of this pilot study is to determine the feasibility of the Noona Healthcare Mobile PRO Application to describe oncology patient engagement using a web-based symptom self-monitoring instrument. Additionally, the studyy will dentify side effects as well as long term or chronic adverse events during and following cancer therapy based on the United States (US) National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), and identify patients to participate in future long-term Quality of Life studies following cancer therapy.

The study is not intended to compare outcomes between groups receiving different therapies.

Eligibility criteria: Inclusion Criteria:

1. Individuals (men and women) aged 18 years or older
2. History cancer with no limitation on prior lines of therapy in the metastatic setting
3. ECOG performance status of 0-2
4. Estimated life expectancy of at least 12 months
5. Access to smartphone, tablet or computer with capability to utilize symptom-tracking application
6. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
7. Willing and able to comply with all study procedures

Exclusion Criteria:

1. Concurrent disease or condition that interferes with participation or safety
2. Non-English speaking, as the application is developed in the English language
3. Children will not be included in the study. The pattern of disease and symptoms are different in children than in an adult population. The web-based tool was designed based on the symptom experience of adults with cancer.

Primary outcomes:
measure: Subject participation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: H. Kim Lyerly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04829552: Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units
Official title: Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units: A Multicenter Retrospective Cohort Study in the Beaumont Healthcare System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: anticoagulation
COVID19
thrombosis
heparin
coagulopathy
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 704
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 patients who were admitted to Beaumont Health System (Michigan, USA) ICU/SDU in the period of March 10th to April 15th, 2020.

Brief summary: This is a multi-center, retrospective, study to determine if therapeutic dose anticoagulation (High dose group) improves inpatient mortality in severely ill patients with COVID-19 compared to prophylactic dose anticoagulation (Low dose group). The study involved 704 individuals who were admitted to Beaumont Health System (BHS) from March 10th to April 15th, 2020.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* positive reverse transcription-polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens.
* Intensive care unit (ICU) patient or Step-down unit (SDU) patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula.
* peak d-dimer levels exceeding 1,000 mcg/mL at any time during admission.

Exclusion Criteria:

* Hospital length of stay less than 5 days.
* Hemorrhage before ICU/SDU admission.
* Treatment with an anticoagulant other than low molecular weight heparin or unfractionated heparin.
* Constant treatment with the same dose of anticoagulant for less than 5 days.

Primary outcomes:
measure: Inpatient all-cause mortality
timeFrame: During hospitalization, up to 6 months
Secondary outcomes:
measure: Rates of major bleeding events
timeFrame: During hospitalization, up to 6 months
measure: Rates of venous thromboses
timeFrame: During hospitalization, up to 6 months
measure: Intensive care unit/Step down unit length of stay
timeFrame: During hospitalization, up to 6 months
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Health System (BHS)
state: Michigan
Study officials:
References:
Clinical trial NCT00799552: Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
Official title: A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Keywords: Keratoconjunctivitis Sicca
Dry eye
Resolvin
Lead sponsor: Resolvyx Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 232
Sex: ALL
Minimum age (years): 18
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 compare the safety and efficacy of RX-10045 to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Have provided written informed consent;
* Have a history of dry eye for at least 6 months prior to enrollment;
* Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months;
* Demonstrate a response when exposed to the CAE.

Exclusion Criteria:

* Have an on-going ocular infection, or active ocular inflammation
* Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study;
* Have contact lens-induced dry eye;
* Have previously had laser in situ keratomileusis (LASIK) surgery;
* Be using or have anticipated use of temporary punctual plugs during the study;
* Have best corrected visual acuity \> +0.7 in both eyes;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Have a known allergy and/or sensitivity to the test article or its components;
* Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days

Primary outcomes:
measure: Corneal fluorescein staining and integrated subject diary data
timeFrame: 28 days
Secondary outcomes:
measure: Changes in dry eye signs and symptoms
timeFrame: 28 days
Other outcomes:
Locations:
city: Andover
country: United States
facility: ORA Clinical
state: Massachusetts
Study officials:
affiliation: Ophthalmic Research Associates, Andover, MA
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Maine Eye Care, Lewiston, ME
name: John Lonsdale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Eye Care Group, Waterbury, CT
name: Joel Geffin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05891652: Analgesic Effect of M-TAPA on LC
Official title: The Effects of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) on Postoperative Pain and Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: modified thoracoabdominal nerve block through perichondrial approach
postoperative pain
laparoscopic cholecystectomy
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: There were two randomized groups: Group M-TAPA (n=21) and Group Control (no block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for posteperative pain.
Primary purpose: TREATMENT

Brief summary: Objective: To investigate the postoperative analgesic efficacy of M-TAPA block and its effect on opioid consumption in patients undergoing laparoscopic cholecystectomy (LC) surgery.

Place and Duration of Study: Department of Anesthesiology and Reanimaton, Sivas Cumhuriyet University, Sivas, Turkey, from April 2023 to May 2023.

Methodology: There were two randomized groups: Group M-TAPA (n=21) and Group Control (no block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for posteperative pain. Numerical rating scale (NRS) and visual analogue scale (VAS) were used to assess postoperative pain. Total tramadol consumption was calculated.


Eligibility criteria: Inclusion Criteria:

* Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing open surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment

Primary outcomes:
measure: numerical rating scale scores
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: total tramadol consumption
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
References:
Clinical trial NCT02975752: EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA
Official title: Rapid and Highly Sensitive EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA Specimen of Lymph Node Metastases From Patients With Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Adenocarcinoma Metastatic
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with suspected lung cancer on the chest CT-scan images receiving EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration) for clinical pre-treatment workup of mediastinal and hilar lymph nodes

Brief summary: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

Detailed description: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.

Eligibility criteria: Inclusion Criteria:

* lung adenocarcinoma positive EBUS-TBNA specimen

Exclusion Criteria:

* other diagnosis

Primary outcomes:
measure: detection of mutations
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Interventional Pneumology
name: Filiz Özkan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00041652: Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
Official title: A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Breast Cancer
Breast Neoplasms
Keywords: Colorectal Cancer
Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Breast Cancer
Breast Neoplasms
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2002-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.


Eligibility criteria: Disease Characteristics:

* Histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
* Measurable lesion diagnosed by CT scan
* Recurrent/metastatic disease considered surgically unresectable.

Prior/Concurrent Therapy:

* Chemotherapy: Patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (Enrollment must occur at least 4 weeks beyond last treatment)
* Other: Prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study

Patient Characteristics/Inclusion Criteria:

* Performance Status: Patients with a Karnofsky performance status \> 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
* Hematopoietic: WBC \>/= 3000 mm3, neutrophils \>/= 1500 mm3, platelets \>/= 75,000, CEA \< 300 ng/mL
* Hepatic: Serum bilirubin \</= 2.0 mg/dL, ALT \< 2.5 x IULN
* Cardiovascular: Patients with LVEF \>/= 40% by required MUGA/2D-ECHO study.
* Pulmonary: Patients with FEV1 \>/= 60% by required Pulmonary Function Tests
* Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Cancer Center
state: California
Study officials:
affiliation: Gilead Sciences
name: Terence Rugg, MD
role: STUDY_DIRECTOR
affiliation: Gilead Sciences
name: Lauri Welles, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03027752: Pilot Study of Autoarterial Remodeling of Bifurcation of the Common Carotid Artery
Official title: The New Technique of Carotid Endarterectomy With Autoarterial Remodeling of Bifurcation of the Common Carotid Artery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis, Internal Carotid Artery
Keywords: carotid endaretectomy
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2017-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery


Eligibility criteria: Inclusion Criteria:

* stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ICA stenosis more than 70% symptomatic ICA stenosis more than 65%)
* the length of the atherosclerotic plaques in the ICA than 1 cm
* personally signed Informed consent for participation in the study

Exclusion Criteria:

* Chronic heart failure III-IV functional class NYHA classification
* Chronic decompensated "lung" heart
* Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l)
* Severe hepatic or renal insufficiency (bilirubin \>80 mmol/l, creatinine \>200 mmol/l)
* Polyvalent drug Allergy;
* Malignant tumor in the terminal stage with life expectancy of up to 6 months;
* Acute disruption of cerebral blood flow
* Extensive occlusion of the internal carotid artery.
* Exacerbation of systemic diseases.
* Pregnancy and lactation.
* The refusal of a patient to sign informed consent for participation in the study

Primary outcomes:
measure: Stroke or TIA
timeFrame: throughout 1 year
Secondary outcomes:
measure: Restenosis
timeFrame: 1 year
measure: Restenosis
timeFrame: 6 months
measure: paresis of the cranial nerve
timeFrame: up to 1 weeks
measure: The linear flow velocity in the region of the carotid artery bifurcation
timeFrame: 3rd day
measure: The linear flow velocity in the region of the carotid artery bifurcation
timeFrame: 6 months
measure: The linear flow velocity in the region of the carotid artery bifurcation
timeFrame: 1 year
measure: bleeding
timeFrame: 1 month
measure: Stenosis
timeFrame: 3rd day
measure: Oxygenation of the brain
timeFrame: during the surgical intervention
measure: Oxygenation of the brain
timeFrame: 6 months
measure: Oxygenation of the brain
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT01102452: A Study to Evaluate the Blood Glucose Regulation and Safety of PPB-R-203-02 Based Noodle Versus Commercially Available Wet Noodle in Patients With Diabetes
Official title: A Randomized, Two-Regimen, Crossover, Comparative Study to Evaluate the Blood Glucose Regulation and Safety of PPB-R-203-02 Based Noodle Versus Commercially Available Wet Noodle in 24 Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Pharma Power Biotec Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the result of PPB-R-203-02 based noodle and commercially available wet noodle on blood glucose control in 24 patients with diabetes for 2 days.

Detailed description: The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.

Eligibility criteria: Inclusion Criteria:

1. Diabetes mellitus patient.
2. Aged between 20 to 65 years old.
3. Informed consent form signed.

Exclusion Criteria:

1. A recent history of drug or alcohol abuse.
2. Sensitivity to analogous product.
3. Serious cardiovascular disorders.
4. Participation in another clinical investigation study.
5. Ongoing influenza, autoimmune disease and other metabolic diseases.
6. Pregnant or lactating women.
7. Individuals are judged by the investigators or co-investigator to be undesirable as subjects.

Primary outcomes:
measure: The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: PingTung Christian Hospital
Study officials:
References:
Clinical trial NCT00453752: Non-Invasive Diagnostic and Functional Evaluation of Cardiac Involvement in Patients With Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis
pulmonary hypertension
echocardiography
N-Terminal proBNP
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2007-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis patients and to establish whether it reflects the severity of RV overload.

Detailed description: Elevated serum brain natriuretic peptide (BNP) levels released from myocytes of ventricles upon stretch have been found in patients with isolated right ventricular (RV) pressure overload. However, limited data suggest that serum BNP may be elevated in patients with systemic sclerosis (SSc), especially with RV dysfunction. The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in SSc patients and to establish whether it reflects the severity of RV overload.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

* Cardiovascular disorders other than pulmonary hypertension
* Significant pulmonary function abnormalities
* Impaired renal function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Michał Ciurzyński
state: Lindleya 4
Study officials:
affiliation: Medical University of Warsaw
name: Michał Ciurzyński, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: