cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress

The purpose of this pilot study is to develop and assess a multimodal mindfulness activity program for physical and occupational therapy students intended to teach management of stressors impacting educational performance. This study will use a two group, randomized controlled design in which approximately 25 students will be randomized to an intervention group and 25 to a control group. Intervention will be implemented in an 8-week period with pre- and post-study measures administered at 1-week prior to and 1-week following intervention.

College students have reported increasing stress levels in the last 5 years with 1 in 6 students experiencing anxiety levels that adversely impact school function. This study's intervention uses a variety of media and both online and in-person delivery strategies. For example, students will have the opportunity to participate in yoga, Tai Chi, guided imagery meditation, creative arts, journaling, and pet therapy. Students will additionally have the opportunity to participate in activities delivered through online media and accessible at all times throughout the study. Approximately 50 occupational and physical therapy students will be recruited to participate in this study. Half will be selected by chance to participate in the 8-week program; the remaining half will be selected by chance to participate in a non-intervention group in which they do not receive the program but are still assessed at pre- and post-program to measure perceived stress levels. It is anticipated that study results will provide information to educational institutions to help students better manage stress levels.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be student volunteers in the Columbia University Physical and Occupational Therapy Programs.
* Students must be in their first or second year, second semester in order to compare GPA pre- and post-intervention.

Exclusion Criteria:

* Students who are practiced meditators or who have prior experience with mindfulness training will be excluded from study participation, as such previous experience could bias intervention results.
FastThread Interference Screws

Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction.

The objective of the study is to evaluate the continued safety and effectiveness of the PEEK and Biocomposite FastThread Interference Screws used for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) repair or reconstruction (PCL at US sites only, Biocomposite screw PCL only).

To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate effectiveness, patient reported outcomes will be collected at 3 months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS) for measuring pain in the affected knee and the Knee Injury and Osteoarthritis Outcome Score (KOOS) as well as Range of Motion (ROM, optional) for measuring knee functionality.

Eligibility Criteria:
Inclusion Criteria:

* Subject requires surgery using the Arthrex PEEK Interference Screw for ACL or PCL (PCL at US sites only) repair or reconstruction or the Arthrex Biocomposite Interference Screw for PCL (PCL at US sites only) repair or reconstruction.
* Subject is 18 years of age or over.
* Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
* Subject signed informed consent and is willing and able to comply with all study requirements.

Exclusion Criteria:

* Current bilateral injury of the ACL or PCL.
* Injury of the ACL and PCL in the same knee.
* Insufficient quantity or quality of bone.
* Blood supply limitations and previous infections which may retard healing.
* Foreign-body sensitivity.
* Any active infection or blood supply limitations.
* Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
* Subjects that are skeletally immature.
Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer

This is a randomized, double blind placebo controlled study to evaluate safety and efficacy of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy (WBRT) as primary treatment for brain metastases secondary to non-small cell lung cancer.

Eligible patients for this trial will be randomized to lucanthone or placebo in a ratio of 1:1. The treatment will consist of WBRT given in a dose of 30 Gy in ten fractions. Lucanthone/placebo will be given as an adjunct to the WBRT on days that WBRT is administered. Tumor assessments will be done with a brain MRI. Radiological assessments on the tumor will be made periodically throughout the study and will be discontinued at the time of tumor progression. Safety will be evaluated for one year during the study period and survival data will be collected thereafter.

Eligibility Criteria:
Inclusion Criteria:

* The patient has given informed consent.
* The patient is willing and able to abide by the protocol.
* The patient is between age 18 and 70 (between 19 and 70 in Alabama).
* The patient has histologically proven NSCLC with radiologically documented brain metastases.
* Newly diagnosed or stable systemic disease, on or off systemic therapy.
* If receiving systemic therapy for NSCLC, at least two weeks since patient received systemic therapy.
* Able to withhold systemic therapy for duration of WBRT therapy.
* If the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception.
* The patient's Karnofsky Score is greater than or equal to 70%.

Exclusion Criteria:

* Patient has a diagnosis of recurrent brain metastases.
* The patient has an absolute neutrophil count less than or equal to 1.5 X 10 9/L.
* The patient has a screening platelet count less than 100,000/uL.
* The patient has a screening bilirubin greater than 1.6 mg/dL.
* The patient has a screening creatinine greater than 2.25 mg/dL in men and 1.8 mg/dL in women.
* The patient has a screening ALT/AST greater than 2.5 times the upper limit of the laboratory reference range.
* The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
* The patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
* The patient has received prior chemotherapy or radiation therapy within two weeks of beginning WBRT on protocol.
* The patient is allergic to gadolinium contrast.
* More than 21 days has or will elapse between the brain MRI documenting the brain metastases and the initiation of WBRT.
Lung Bacteriobiota and Influenza Mortality

Influenza is a potentially lethal disease still responsible for thousands excess deaths both in Europe and the United States. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. Lung microbiota has been shown to be involved in the immunity against influenza and is correlated with lung inflammation in numerous chronic respiratory diseases. We therefore aim to analyse the correlation between lung bacteriobiota and influenza ICU mortality

Influenza is a viral disease which is still responsible for thousands of excess deaths par year both in Europe and in the US. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. As lung microbiota is correlated with lung inflammation in numerous chronic respiratory diseases, we hypothesize that lung microbiota would be correlated with influenza outcomes. In a pilot study, we found that lung bacteriobiota but not mycobiota is associated with influenza ICU mortality. We therefore aim to confirm this correlation between lung bacteriobiota and influenza mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patient above 18 year-old admitted to intensive care unit
* Influenza diagnosis by PCR or rapid diagnostic test

Exclusion Criteria:

* Guardianship or curatorship
* Prisoners
* No health insurance
* No legal representative
Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax

Patients with chest trauma undergo ultrasound to detect a collapsed lung. Two techniques have been described. A single view for each hemi-thorax, and multiple views for each hemithorax. The investigators are comparing these two techniques in a randomized prospective trial.

This is a randomized, prospective blinded study on trauma patients arriving to an emergency department.

Study Setting and Population This study will be conducted on the University Campus of the University of Massachusetts Medical Center, which is an urban academic emergency department that sees 80,000 patients annually and has a dedicated Level I trauma service that is staffed by trauma surgery and emergency medicine. Adult patients with acute traumatic injury who are undergoing a CT scan of the chest are eligible for enrollment.

Study Protocol Trauma patients are enrolled as they arrived to the emergency department. The investigators will include any trauma patient aged 18 and over. The investigtors will exclude any patient who was too unstable and required clinical care that prevented performing a chest wall ultrasound, patients with a chest tube in place prior to arrival, pregnant women, and prisoners. Imaging decisions on trauma patients will be made early on in their evaluation. The patient will be assigned using a pre-determined randomization scheme to a single view or four views of each hemi-thorax prior to any imaging being done. Ultrasounds will be performed and interpreted by credentialed physicians using a 7.5Mhz linear array transducer on a portable ultrasound machine (Zonare z.one ultra) with digital clips recorded for later review. When the investigators obtain a single view of each hemi-thorax, the probe will be placed in a longitudinal orientation on the midclavicular line in the third intercostal space. When the investigators obtain four views of each hemi-thorax, the first image location will be the same as in the single view and then the probe will be moved inferiorly and laterally to obtain the additional three images. Immediately following the ultrasound examination, the patient will be transported to the CT scanner for further imaging.

The goal of this study is to determine if a single view of each hemi-thorax can identify a pneumothorax or if additional images should be included. The primary study endpoint is the presence of a pneumothorax on ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had trauma and are receiving a chest CT.

Exclusion Criteria:

* Clinically Unstable
* Clinical care prevented ultrasound
* Patient with a chest tube in place
* Pregnant Women
* Prisoners
USG Block of Cutaneous Nerves of the Arm

For superficial surgery of anteromedial and posteromedial surfaces of the upper arm, the medial brachial cutaneous nerve (MBCN) and the intercostobrachial nerve (ICBN) must be selectively blocked, in addition to an axillary brachial plexus block. We compared efficacy of ultrasound-guided (USG) versus conventional block of the MBCN and the ICBN.

The primary objective of our study was to compare the effectiveness of conventional and USG blocks of the MBCN and the ICBN in the axillary fossa. Our hypothesis was that the proportion of patients with complete anesthesia in the entire posteromedial and anteromedial surface of the arm would be greater if a USG technique were used, compared with a conventional technique. The secondary objectives were onset time of complete anesthesia, volume of local anesthetic used for the procedure, tourniquet tolerance during surgery, and ultrasound visibility of MBCN and ICBN.

Eligibility Criteria:
Inclusion Criteria:

* Surgery of the distal upper limb : hand, forearm, lower third of the arm ,including the elbow
* Urgent or planned surgery
* Locoregional anesthesia : axillary brachial plexus block, completed by a medial brachial cutaneous nerve block and an intercostobrachial nerve block

Exclusion Criteria:

* Refused to sign informed consent
* Pregnant women
* Allergic to the local anesthetic
Food Supplementation With Eufortyn Colesterolo Plus for LDL Modulation in Subjects With Polygenic Hypercholesterolemia

This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.

The objective of this study is to evaluate the effect of dietary supplementation of a combined supplement containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara cardunculus) and Cynara scolimus, associated with high coenzyme Q10 bioavailability (Q10 phytosome® Ubiqsome) and zinc, on the glycometabolic structure of subjects with suboptimal levels of LDL cholesterolemia compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects agree to participate in the study and having dated and signed the informed consent form.
* Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
* Male or female aged ≥ 18 years and ≤ 70 years old.
* LDL-Cholesterol plasma levels \>115 mg/dL and \< 190 mg/dL.
* TG\<400 mg/dL.
* Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to ESC/EAS guidelines 2019, the intervention strategy does not require a pharmacological lipid lowering intervention.

Exclusion Criteria:

* Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 5%;
* Obesity (BMI\>30 kg/m2) or diabetes mellitus;
* Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
* Antihypertensive treatment not stabilized since at least 3 months;
* Anticoagulants therapy
* Uncontrolled hypertension (systolic blood pressure\> 190 mmHg or diastolic arterial pressure\> 100 mmHg);
* Known current thyroid, gastrointestinal or hepatobiliary diseases;
* Any medical or surgical condition that would limit the patient adhesion to the study protocol;
* Abuse of alcohol or drugs (current or previous);
* History of malignant neoplasia in the 5 years prior to enrolment in the study;
* History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
* History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
* Known previous intolerance to one component of the tested nutraceuticals
* Women in fertile age not using consolidated contraceptive methods
* Pregnancy and Breastfeeding.
Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation (Study P05876)

The investigation will be conducted to define safety and efficacy under the conditions of post-marketing use of this drug in subjects with allergic rhinitis.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated with Nasonex for perennial or seasonal allergic rhinitis.

Exclusion Criteria:

* Patients with an infection for which there is no effective antimicrobial drug or systemic fungal infection \[symptoms may exacerbate\]
* Patients with a history of hypersensitivity to any ingredient of this drug
Using Digital Data to Predict CHD

This project seeks to identify and characterize features derived from digital data (e.g. social media, online search, mobile media) which are associated with coronary heart disease (CHD) and related risk factors, and develop models that use digital data and conventional predictive models to predict CHD risk and health care utilization.

Cardiovascular disease is the leading cause of death in the US. While secondary prevention approaches have improved longevity of patients, risk factors and adverse health behaviors (e.g., physical inactivity, smoking) are highly prevalent, and in most contemporary series, less than 1% of adults meet all factors of ideal CV health. The logistics and practicalities of meeting the goal of ideal CV health have not been clearly elucidated. Practice guidelines recommend using the Framingham risk score (FRS) or other risk prediction tools to classify patients' risk of CV disease. These models however are imprecise and there is increasing focus on identifying markers that provide better measures of risk. As digital platforms are increasingly used to document lifestyle and health behaviors, data from digital sources may provide a window into manifestations of novel risk factors and potentially a better characterization of existing risk factors. While it seems like a cliche to mention the profound impact of digital data on everyday lives, there is indeed great substance in the opportunities these new media provide for understanding behavioral, social, and environmental determinants of health. This project seeks to identify and characterize features derived from digital data (e.g. social media, online search, mobile media) which are associated with coronary heart disease (CHD) and related risk factors, and develop models that use digital data and conventional predictive models to predict CHD risk and health care utilization.

Eligibility Criteria:
Inclusion Criteria:

* 30 - 74 years of age
* Willing to sign informed consent
* Primarily English speaking (for language analysis)
* Has an account on any of the following digital data platforms (Facebook, Instagram, Twitter Reddit, Google (gmail), or smartphone or wearable device such as Apple Health, Fitbit, Samsung Health, MapMyFitness or Garmin) and willing to share data
* If has social media account, Instagram or Facebook, willing to share historical and prospective data (60 days) If has Google (gmail) account, willing to download and share google takeout zip file
* If has smartphone or wearable device, willing to share step data
* Willing to share access to medical health records
* Willing to share healthcare insurance information

Exclusion Criteria:

* Patient does not meet age inclusion criteria above
* Does not use and post on digital data sources we are studying or unwilling to donate data
* Patient is in severe distress, e.g. respiratory, physical, or emotional distress
* Patient is intoxicated, unconscious, or unable to appropriately respond to questions
Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain

Aim of the study It could be stated that chronification of low back pain in some respects depends on the emotional reactions to the acute pain state. This approach enables advancing novel therapeutics for preventing pain chronification by altering the pain-related affective states. At present, no publication evaluating the efficacy of IET in altering brain responses related to sub-acute low back pain seems available. Neither have we found any studies specifically addressing the efficacy of mindfulness training on the functional connection between PFC and NAc.

The aim of this study project is three-fold:

1. A systematic literature review of behavioural methods in the prevention of low back pain chronicity Orenius T, Silén E, Nuortimo A, Ristolainen L. Psychological interventions in preventing chronicity of sub-acute back pain: a systematic review. Scand J Pain. 2022 Jan 24;22(2):211-217. doi: 10.1515/sjpain-2021-0063. PROSPERO: CRD42019053580
2. A pilot study (n=7+7) to address the efficacy and feasibility of IET in preventing chronicity of sub-acute pain
3. A full scale study (n=20+20) addressing the efficacy and feasibility of IET in the prevention of chronicity of sub-acute low back pain

To assess the efficacy of IET on the chronification of LBP, participants who are found to have a higher risk of pain chronification due to the presence of a biomarker (positive mPFC-Nac connectivity) will be randomized to the intervention group (IET) or control group A (treatment as usual). To assess how well this biomarker predicts the chronification of LBP, participants who are not found to have the biomarker will be assigned to control group B (treatment as usual).

Eligibility Criteria:
Inclusion Criteria:

The selection of subjects will meet same criteria as in the study by Baliki et al. (2010).

* Low back pain diagnosed by a clinician
* Low back pain intensity \> 40/100 on NRS
* Low back pain duration 4-12 weeks

Exclusion Criteria:

* Other chronic painful condition
* Systemic disease
* History of head injury
* Diagnosed psychiatric disorders
* Depression exceeding mild depression (score \> 19), as defined by Beck's Depression Inventory (BDI)
Oncoliq: Test for Early Breast Cancer Detection.

Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test will allow improving the accuracy of cancer detection which will impact on health, reducing the patient mortality and health costs.

To develop this test, it has been finished the preclinical PHASE I: in laboratory animals; PHASE II: exploratory clinical phase for the discovery of candidate biomarkers in breast cancer patients and PHASE III: clinical validation of biomarkers showing that Oncoliq has 91% of sensitivity.

Currently it is been setting up a "pilot test" for breast cancer to enrol 500 woman volunteers without previous cancer diagnosis that go to the annual medical control. The results of the pilot test will give the accuracy for early breast cancer detection.


Eligibility Criteria:
Inclusion Criteria:

* Women patients performing gynecological control
* Between 50-70 years old
* Without personal history of oncological disease
* Informed consent signed

Exclusion Criteria:

* Patients who don´t meet the inclusion criteria.
* Active infection with SARS-CoV-2 (COVID-19).
Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

Acupuncture has been used for centuries in China in the treatment of diarrhea. Our hypothesis is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients with diarrhea-predominant IBS

Patients will complete a diary to determine if they qualify for the study. Patients will be randomized to receive either acupuncture or sham acupuncture (needle insertion 1 cm away from acupuncture site). Patients will be blinded to whether they are receiving acupuncture or sham acupuncture. The acupuncturist is blinded as to the patient response. The patients will undergo venupuncture to draw blood to determine sertotonin and beta-endorphin levels. They will receive treatment in 12 sessions over 4 weeks. They will maintain a diary during this time period to document level of pain and frequency of bowel movements. Blood will be drawn at week 2 and 4 and, 6 weeks after cessation of treatment, subjects will again record abdominal symptoms and frequency of bowel movements for 2 weeks. Blood will be drawn for hormone levels at 8 weeks after completion of study.

Eligibility Criteria:
Inclusion Criteria:

* frequence of bowel movement of at least 3/day
* global disease severity of at least 3

Exclusion Criteria:

* taking medications which will influence frequency of bowel movement
* patient taking anticoagulants or suffering from coagulopathy
* pregancy