cyrilzakka/clinical-trials huggingface dataset:
High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease.

High-Flow Nasal Oxygen (HFNO) therapy has never been tested against Noninvasive ventilation, the reference standard therapy for acute exacerbation of chronic obstructive pulmonary disease (COPD), in randomized clinical trials.

The aim of the present study is to compare the effects of HFNO therapy on arterial blood gas variables over the first 24 hours of therapy, to those of Noninvasive ventilation, in patients experiencing a moderate (i.e. with arterial pH within 7.25-7.35) exacerbation of COPD.

As soon as admission to the intensive care unit, eligible patients who gave consent will be randomized to either HFNO or Noninvasive ventilation therapy for at least the first 24 hours.

In the usual care group , Noninvasive ventilation will be applied in alternance with standard nasal oxygen therapy.

In the intervention group, HFNO with be applied continuously over the first 24 hours.

In both groups, an oxygen saturation, as assessed by finger pulse oximetry, of 88-92% will be targeted.

The primary objective will be two-fold: to compare between groups 1) Efficacy, assessed by the arterial pH at 24 hours, and 2) Safety, assessed by the ratio of the arterial partial pressure in oxygen (PaO2) over the inspired oxygen fraction (FiO2) at 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Known Chronic Obstructive Pulmonary disease (COPD)
* respiratory rate or presence of accessory respiratory muscles activity on physical exam
* moderate exacerbation of COPD as defined by an arteria pH between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (PaCO2) equal or above 45 mm Hg

Exclusion Criteria:

* Age below 18
* Pregnancy
* Known sleep apnea syndrome
* Patent treated by noninvasive ventilation at home
* Not affiliated to French scial security
* Contraindication to aither Noninvasive ventilation or to High-Flow Nasal Oxygen therapy
* Previous inclusion in the study
Viral Load Changes in Lymphoma Patients With HCV Infection After Chemotherapy

In last few years, most researches about hepatic complication after chemotherapy focused on hepatitis B virus (HBV). With adequate prophylaxis and monitor, HBV-related hepatitis flares can be prevented. In contrast, cancer patients with hepatitis C virus (HCV) infection are traditionally considered as relative safe to receive chemotherapy. However, two large retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma patients with chronic HCV infection, including 3-4% hepatic failure. The risk factors to predict severe hepatitis are pre-treatment elevated ALT level and liver cirrhosis. Due to the lack of prospective studies, the dynamic changes of serum HCV RNA levels and the association of hepatitis are still unclear.

Some epidemiologic studies demonstrated an association between HCV infection and B-cell lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma and several reports showed higher prevalence of HCV infection among DLBCL patients than the controls. HCV infected DLBCL patients are reported to have distinct clinical characteristics, such as older, more with elevated LDH levels, and more with extra-nodal involvement. Regarding the impact of HCV infection on prognosis, the results are conflicting. Taiwan is an endemic area of HCV but there are limited reports addressing the clinical characteristics and prognosis in this unique population.

Therefore, the investigators initiate a prospective, multi-center observational study to clarify the dynamic association between serum HCV RNA levels and hepatitis in HCV-infected lymphoma patients treated with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed histologically proven malignant lymphoma
2. Eligible subjects must be positive for anti-HCV Ab
3. Age ≥ 20 years
4. Planned to receive chemotherapy
5. No recent chemotherapy and radiotherapy in the past one year. Pre-enrollment steroids for symptomatic relief are allowed but less than equivalent dose to prednisolone total 140 mg
6. Left expectancy ≥ 3 months
7. Signed informed consent
8. ECOG 0-2

Exclusion Criteria:

1. Patients not willing to receive chemotherapy
2. Chronic hepatitis B infection (positive for HBsAg), but those with resolved HBV infection (positive for anti-HBc and negative for HBsAg) are allowed
3. Other major systemic diseases, such as active infection, significant cardiac disease, neurologic deficit or psychiatric disorders, that the investigators consider to be at significant risk
4. Known human immunodeficiency virus (HIV) infection
5. Pregnant or breast-feeding woman
Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment

This trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers. Smartphone mobile applications may help current smokers quit smoking.

PRIMARY OBJECTIVES:

I. To test the acceptability and preliminary efficacy of a smartphone health application (app), Kick Ash, which will incorporate brief behavioral activation versus (vs.) a relaxation app, Breathe2Relax in a small randomized controlled trial of smokers with elevated depressive symptoms.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

GROUP II: Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* MD Anderson patient between the ages of 18 to 65
* Current smoker (i.e., at least 1 cigarette or e-cigarette per day)
* Smoking for at least one year
* Willing to set a quit date in the next 30 days
* Not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program
* Currently elevated depressive symptoms or a history of elevated depressive symptoms; (PHQ 2 = or \> 1); current or past
* English speaking and ability to read and comprehend English
* Currently own an iOS mobile phone or tablet (iPhone; iPad) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app

Exclusion Criteria:

* Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator
* Subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study
Can we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study

The purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.

For years it has been common to have patients fast before a cardiac catheterization. It is believed that fasting may lower the risks of upset stomach, vomiting, and aspiration (stomach contents going to the lungs). New findings show that fasting before the procedure may not be needed. This study will look at the safety and possible benefits of not fasting.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients

Exclusion Criteria:

* Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery
* Pregnant Women
* Prisoners
Archival of Human Biological Samples in CU-Med Biobank

CU-Med Biobank collaborates with different researchers for collecting and distributing human biospecimens and clinical data for assisting scientific research.

CU-Med Biobank will collect and store high-quality specimens from cancer-related or other diseases. All samples are linked to annotated clinical data from approved consented protocols. This system provides researchers with high- quality biological samples and comprehensive clinical, pathological including molecular/genetic information for their research. This standardized CU-Med Biobank is a pivotal bridge to improve the translation of basic research into clinical applications. These findings will contribute to improve prevention, enhance diagnosis, develop new treatment and eventual cure of diseases.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled subjects that have provided signed consent for the specimens and de-identified data to be collected, stored and distributed.

Exclusion Criteria:

* Subjects without signed informed consent for the specimens and de-identified data to be collected, stored and distributed.
A Comparison of OASIS Wound Matrix With Approved Dressings for Skin Graft Donor Sites

The investigators objective is to compare OASIS wound matrix with other commonly used dressings available for the donor site in split thickness skin grafting in order to determine which dressing provides the best outcome based on pain level, time to healing and aesthetic outcome.

Investigators seek to compare Oasis wound matrix with Tegaderm and Xeroform in order to determine whether advantages exist in one or more of the dressing types that are approved and currently used for split-thickness skin graft donor site dressings.

Patients will be randomly assigned to one of the three treatment groups and followed up post-operatively and treated as per current standard of care.

Data to be collected and analyzed includes: patient age, co-morbid illnesses, medication, skin-graft donor location, skin-graft donor area, STSG thickness, infection rate, complications involving the donor site, post-operative pain score every morning until hospital discharge, healing rate, photographs of the donor site immediately post-operatively and then at routine follow-up appointments.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo split thickness skin grafting
* patients able to consent without a proxy

Exclusion Criteria:

* confounding medical conditions
* previous skin grafting from site
* prior use of biological skin substitute on site
Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.


Eligibility Criteria:
Key Inclusion Criteria:

1. . Male and female subjects aged 18 to 75 years, inclusive.
2. . Diagnosis of UC for at least 3 months prior to screening.
3. . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
4. . Able to participate fully in all aspects of this clinical trial.
5. . Written informed consent must be obtained and documented.

Key Exclusion Criteria:

1. . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.
2. . Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse \> 90 bpm, temperature \> 37.8°C, hemoglobin \< 10.5 g/dl, or hs-CRP \> 30 mg/I).
3. . Disease activity limited to distal 15 cm (proctitis).
4. . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine \[6-MP\]) within 25 days prior to randomization.
5. . Unable to attend study visits or comply with procedures.
6. . Concurrent participation in any other interventional study.
7. . Prior enrollment in the current study and had received study treatment.
Personalized Depression Treatment Supported by Mobile Sensor Analytics

The current best practice guidelines for treating depression call for close monitoring of patients, and periodically adjusting treatment as needed. This present study seeks to develop and investigate an innovative digital system, DepWatch, that leverages mobile health technologies and machine learning tools to provide clinicians objective, accurate, and timely assessment of depression symptoms to assist with their clinical decision making process. Specifically, DepWatch collects sensory data passively from smartphones and wristbands, without any user interaction, and uses simple user-friendly interfaces to collect ecological momentary assessments (EMA), medication adherence and safety related data from patients. The collected data will be fed to machine learning models to be developed in the project to provide weekly assessment of patient symptom levels and predict the trajectory of treatment response over time. The assessment and prediction results are then presented using a graphic interface to clinicians to help them make critical treatment decisions. The main question the present clinical trial aims to answer are as follows:

1. Feasibility of the digital tool, DepWatch, to assist clinicians in depression treatment and inform their clinical decision process
2. Effectiveness of the digital tool, DepWatch, to improve depression treatment outcomes All study participants will carry the DepWatch app on their smartphones and wear a Fitbit provided by the study team during the study period. They will also complete brief questionnaires via the app at specific time intervals throughout the study period.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 year or older
* Moderate level of depression as defined by a score of ≥ 11 on the 16 item Quick Inventory of Depressive Symptomatology (QIDS) self-report questionnaire
* Initiating a pharmacological treatment for depression as monotherapy or adjunctive treatment or reporting a dose increase with their existing depression treatment.

Exclusion Criteria:

* Diagnosis of a primary psychotic disorder such as schizophrenia or schizoaffective disorder
* Currently active substance use disorder (within 1 month of enrollment) dominating clinical scenario
* Other clinically significant medical of psychiatric conditions that may adversely affect participants' study participation and/or affect their adherence to study protocol (as determined by study clinician) e.g., significant cognitive deficits
Prediction of Clinical Outcome in Thoracic ESPB

The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block. There have been no studies demonstrating predictive value of PI in thoracic ESPB for the relief of cervical radiulopathy

Eligibility Criteria:
Inclusion Criteria:

* Cervical foraminal stenosis
* Cervical central stenosis
* Cerivcal disc herniation
* Cervical spondylolisthesis

Exclusion Criteria:

* infection
* pregnancy
* allergy to local anesthetic agents
* previous cervical spine surgery
Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.


Eligibility Criteria:
Inclusion Criteria:

* English speaking adults (age \>17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.

Exclusion Criteria:

* Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (\< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.
18475 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response

The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.

The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. This study aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,
2. Patients in complete cytogenetic response for at least 1 year
3. Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)
4. ECOG ≤ 2,
5. Age ≥ 18 years
6. Signed informed consent,
7. Membership of a social security system

Exclusion Criteria:

1. Patients with CML-CP Philadelphia chromosome negative diagnosis.
2. Patients previously treated with Imatinib Mesylate at doses above 400 mg / day
3. Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg / d
4. Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment
5. Pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective
6. Known HIV positive
7. Patients previously treated with another tyrosine kinase inhibitor
8. Patient participating in another interventional clinical trial
9. History of non-compliance to Imatinib Mesylate
Induction of Cortical Plasticity

The study aims to induce plastic reorganization by a therapeutic protocol to increase the rate of gross total resection (GTR) and to optimize the oncological result.

Regarding the therapy of cerebral parenchyma tumors, the extent of resection (EOR) has a significant impact on the prognosis. However, total resection is not possible in up to 65% of cases because these tumors frequently infiltrate eloquent areas such as language or motor centers. Consequently, an optimal oncologic result from the surgical perspective cannot be achieved in a considerable large amount of patients. One possible solution is based on the tumor-induced shift of functional areas, which can move away from their original localization. Earlier studies already described the resection of glioma residuals during a second surgery after plastic reorganization has taken place. The authors complained that this reorganization is not detectable without surgery. Navigated transcranial magnetic stimulation (nTMS) was developed for the noninvasive localization of motor and language areas, which enables us to detect the spatial shift of cortical motor and language functions in tumor patients. Recent publications were already able to demonstrate that the individual and exact localization of the motor cortex leads to an increased EOR and prolongs the progression-free survival (PFS). Therefore, the current project intends to take advantage of this plastic reorganization for EOR optimization in cerebral parenchyma tumors. In this context, nTMS is supposed to also induce this plasticity within the frame of a repetitive stimulation protocol (rTMS). Besides other therapeutic applications, rTMS also showed a positive effect on the improvement of aphasia as well as motor recovery in patients after stroke, even in randomized multicenter studies, by inducing plastic reorganization. Moreover, rather than waiting for tumor-induced plastic reorganization, the investigators also aim to use the potential of rTMS for spatial plastic reorganization of functional areas adjacent to intracerebral parenchymal tumors to move functionally eloquent brain regions away from the planned resection cavity.

Eligibility Criteria:
Inclusion Criteria:

* Intracerebral tumor
* Cortical function is located within planned resection area as confirmed by preoperative navigated transcranial magnetic stimulation and/or intraoperative direct electrical stimulation mapping
* Informed consent for participation
* Age \>18 years

Exclusion Criteria:

* Prognosis less than 6 months
* Contraindications for MRI or nTMS (cardiac pacemaker, deep brain stimulator, cochlea implant
* Karnofsky-performance-index \<60%