cyrilzakka/clinical-trials huggingface dataset:
Feasibility and the Effects of Mindfulness-Based Stress Reduction (MBSR) on College Students

The goal of this retrospective control study is to learn about the effects of Mindfulness Based Stress Reduction (MBSR) intervention in military medical students' resilience, post-traumatic stress disorder symptoms (PTSD) and posttruamatic growth (PTG) etc. The main questions are aims to answer:

1. Would MBSR intervention improve psychological resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth in military medical students？
2. Would MBSR intervention reduce anxiety, depression, and PTSD symptoms in military medical students？
3. Would the effects of MBSR intervention persist for at least one month in military medical students？ Participants in the intervention group will complete 8-week of MBSR training while those in the control group will not. Researchers will compare resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth, etc. between the two groups.

Recruitment for the study was done via broadcast email and posted notices online. 372 students filled out screening questionnaires and indicated their intention to participate the Mindfulness Based Stress Reduction (MBSR) course. We selected 120 students according to the participant criteria. Of the 120 participants, 60 were randomly assigned to the MBSR or control groups. However, 8 participants were absent more than two courses in the MBSR group, and 24 participants did not complete the post-test. Eventually, we enrolled 52 participants in the intervention group and 36 participants in the control group.

We designed a questionnaire survey on the internet to collect data. Two trained psychology teachers organized the survey at three time points: baseline (T0), the immediate postintervention (T1), and 1 month postintervention (T2).

Independent samples t-test and c2 analyses were used to test for possible group differences in demographic variables at baseline (T1).

Next, 2 (group) × 3 (time) mixed-model repeated-measure analysis of variance ( ANOVA) was conducted to determine the effect of MBSR. Effect sizes were reported as partial η² (ηp²) coefficients. To further interpret any time-by-group interactions, a series of t tests examined possible differences among baseline, post intervention and 1 month later after intervention.

Eligibility Criteria:
Inclusion Criteria:

* No regular meditation and yoga practice within the past 6 months;
* No current psychiatric symptoms and physical contraindications to exercise;
* the resilience scale scores were in the last 27% of the total 372 students.

Exclusion Criteria:

* Unwillingness to participant the mindfulness class;
* Absence from 2 or more classes;
* Do not complete the pre-, post-test and follow-up psychological assessment.
C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the available C-arm Cone-Beam Computed Tomography (CBCT) data acquisition systems currently widely available worldwide in interventional angiography suites to enable acute ischemic stroke patients to be imaged, triaged, treated, and assessed using a single modality in one room.

This is an evaluation to determine the efficacy of the use of C-arm CBCT with SMART RECON novel software for the rapid assessment of time-resolved CTA and CT perfusion in the setting of ischemic cerebrovascular events. As a leading center for the treatment of cerebrovascular disease in the Midwest as well as being one of the first Comprehensive Stroke Centers in the United States we have a large potential patient group to assess.

The pilot plan is to compare conventional CT/CTA/CTP acquired during the clinical work up with C-arm CBCT/CTA/CTP acquired in the angiography suite at initiation of therapy. The C-arm CBCT acquisition provides whole brain coverage (compared to only 8 cm brain coverage with conventional CT) with less radiation and higher resolution; the CT perfusion maps obtained using C-arm CBCT and new reconstruction algorithms provides better perfusion maps.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute ischemic stroke presenting within 8 hours of onset
2. Patients that present with a large artery occlusion
3. Adults 18 years of age or older.
4. Women of childbearing potential must not be pregnant.
5. National Institutes of Health Stroke Scale (NIHSS) of \>5
6. No severe co-morbidities

Exclusion Criteria:

1. Women that are pregnant
2. History of severe renal disease (e.g. stage 4-5)
3. History of renal transplant
Thoracoscopic Sympathectomy for Blushing

To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy.

To determine the outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing. In addition, following randomization investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery

Eligibility Criteria:
Inclusion Criteria:

* Isolated disabling facial blushing
* Over 18 years of age
* Willing to be randomized

Exclusion Criteria:

* Primary hyperhidrosis in palms or axillae
* Previous lung surgery
* Bradycardia
* Arrythmias
* Pregnancy
Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases

The purpose of this trial is to study health related quality of life (HQoL)after resection of colorectal liver metastases combined with perioperative chemotherapy. The investigators want to study if an aggressive, life prolonging and multimodal treatment can be defended from a quality of life perspective.

Background: Hepatic resection is the only treatment with potential curative intent for patients having colorectal liver metastases. Combined with chemotherapy, the overall 5-year survival is 40-50%. The disease free 5-year survival is about 20%, and about 70% of resected patients experience recurrence from their disease. Even if surgery is superior all other treatments, most patients will finally die from their cancer. However; surgery contributes by adding years of life, and for a minority, a disease free life. There has been much effort to study predictors for outcome after surgery, but little has been focused on quality of life following this treatment.

Method: EORTC Validated questionnaire (European Organisation Research of Treatment of Cancer) version QLQ-C30 (3.0) and QLQ LMC21. The patients fill out the questionnaire before surgery as a baseline, and then after 3,6 and 12 months after surgery. The investigators also register important clinicopathological data about each patient prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Liver metastasis from colorectal cancer
* Resectability, with intension of R0 resection
* No macroscopic tumor left after surgery
* Patients with combined resectable extrahepatic tumors are also included.
* Patients must complete the questionnaire before the operation.

Exclusion Criteria:

* Drop out of questionnaire after surgery
* Patients found to be irresectable during the operation or where macroscopic tumor tissue are left behind.
WAVE Study- Walking and Aging in VErona Study

Monocentric unblinded two parallel-group randomized controlled trial to evaluate the effect of diet with or without Nordic Walking on weight loss, physical performance and cardiovascular risk factors in overweight and obese population

To examine the impact of a 48-week of diet +/- Nordic Walking program on physical performance, muscle function, cardiovascular risk factors and arterial stiffness in community-dwelling overweight and obese elderly men and women.

Eligibility Criteria:
Inclusion Criteria:

* 60-90 years

  * Males and females

    . BMI \> 27 kg/m2
  * living in Verona (Italy)
  * stable weight in the 3 months
  * not involved in physical exercise programs
  * informed consent sign

Exclusion Criteria:

* cardiovascular disease (unstable angina, recent myocardial infarction, cardiac arrhythmias, heart failure, valvular heart disease, aortic aneurysm, recent intracerebral or subdural hemorrhage, not controlled hypertension)
* musculoskeletal disease (symptomatic discal hernia, symptomatic arthrosis, acute articular, tendon or ligament lesions, hip prothesis).
Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

Phase I/II study with intravitreal triamcinolone acetonide microspheres(RETAAC)for treatment of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is that single intravitreal injection of RETAAC is safe and efficient compared to conventional treatment. Fifty patients will participate in this study and will be randomized into treatment and observation groups. Efficacy will be evaluated by best corrected visual acuity and macular thickness measured by optic coherence tomography (OCT) after 12 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus (type 1 or 2)
* Diabetic macular edema in study eye associated to diabetic retinopathy
* Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography.
* Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
* Macular thickness greater than 300 mcm on OCT.

Exclusion Criteria:

* Uncontrolled systemic disease
* Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
* HbA1c levels greater than 10%
* Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
* Presence of epiretinal membrane
* Presence of vitreomacular traction in the study eye.
* Aphakic or anterior chamber intraocular lens in the study eye.
* Neovascularization of disc or elsewhere in the study eye.
* History or presence of choroidal neovascularization in the study eye.
* Presence of rubeosis irides in the study eye.
* Eye opacity that interfere with clinical documentation and photography.
* Intra-ocular surgery 90 days before initial visit.
* Previous vitrectomy in study eye.
* Previous history of intravitreal or periocular corticoid or any other intravitreal drug in study eye.
* Scheduled surgery for study eye.
* Patients with known allergies to fluorescein, iodo-povidone or any component of study drug.
Dysregulated Urea-synthesis at Terminal Uremia

This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"


Eligibility Criteria:
Inclusion Criteria:

* Age \> or equal to 18 years
* Chronic hemodialysis during 3 months
* Patients with functioning arteriovenous-fistula assigned to "Center-Hemodialysis" at "Nyresygdomme, AUH Skejby"

Exclusion Criteria:

* Active infection
* Conditions with vomiting or diarrhea
* Diabetes
* Active disease being treated with chemotherapy, radiationtherapy, biologic- or similar treatments. Disease under observation can be included.
* Liver disease
* Vessels on the upper extremities not suited for cannulation
* Prednisolone treatment during the last 8 weeks
* Pregnancy
* BMI \> or equal to 30 or \< or equal to 18
* Physically or mentally condition that does not allow the project to be completed
* Language-difficulties that does not allow the project to be completed
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:

• How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.

Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Have been diagnosed with stage IV non-squamous NSCLC
* Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
* Agree to use adequate methods of contraception

Exclusion Criteria:

* Unable or unwilling to take folic acid and vitamin B12 supplementation
* Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff

Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation
* Patients scheduled for surgery which duration is expected to less than 3 hr

Exclusion Criteria:

* Difficult airway
* Rapid sequence induction
* Recent sore throat
* Recent upper respiratory infection
* Asthma
* Chronic obstructive pulmonary disease
* Chronic cough
* Pregnancy
* Allergy to lidocaine
* Friable teeth
* History of head and neck surgery
* Multiple intubation attempts
* Regional anesthetic agents
* Gastric tube
* Dexamethasone
Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy

This study aims at evaluating efficacy and safety of probiotics combined with triple therapy (Clostridium butyricum capsule and Bacillus coagulans tablets, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that probiotics combined with triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.

Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18\~75,both gender.
2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
3. Patients are willing to receive eradication treatment.
4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
2. contraindications or allergies to research drugs.
3. Substantial organ impairment(eg liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease.
4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
5. Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma.
6. Pregnant or lactating women.
7. Underwent upper gastrointestinal Surgery.
8. highly atypical hyperplasia, have symptom of dysphagia.
9. Evidence of bleeding or iron eficiency anemia.
10. A history of malignancy.
11. Drug or alcohol abuse history in the past 1 year.
12. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
13. a person with a mental disorder
14. Enrolled in other clinical trials in the past 3 months.
15. Refusal to sign informed consent.
Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.


Eligibility Criteria:
Inclusion Criteria:

* 23 years of age or older.
* Clinical history of confirmed type 2 diabetes.
* Evidence of DKD Stages 1-3:
* Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
* Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
* All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
* The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

* Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria.
* Patients with ESRD or on renal recovery treatments at time of enrollment.
* Patients who are pregnant at the time of enrollment.
* Patients who are currently hospitalized.
* Patients who are currently on Enbrel.
Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).


Eligibility Criteria:
Inclusion Criteria:

* Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (\>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
* Females of child-bearing potential must have a negative pregnancy test at enrollment
* Persons who are currently taking aspirin between 75 and 150 mg once daily

Exclusion Criteria:

* Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
* Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
* Persons with known bleeding disorders
* Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
* Persons with a history of ischemic stroke
* Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
* Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
* Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
* Persons with known severe liver disease
* Persons with kidney failure requiring dialysis
* Persons with life expectancy \< 1 year
Evaluating Improvement Strategies in Addiction Treatment

Addiction treatment is often characterized by long delays between first contact and treatment as well as high no-show and drop out rates leading to unused capacity in apparently full agencies. Patients do not get needed care and agency financial stability is threatened. The Network for Improvement of Addiction Treatment (NIATx) began as a high-intensity improvement collaborative of 39 addiction treatment agencies distributed across 25 states. NIATx substantially improved time to treatment and continuation in treatment by making improvements to organizational processes (such as first contact, intake and assessment, engagement, level of care transitions, paperwork, social support, outreach, and scheduling) in preliminary studies. While the results are very encouraging, they have, by intent, been obtained from a select group of agencies using a high-cost combination of services. A more practical diffusion model is needed to spread process improvements across the spectrum of treatment agencies. This study is a cluster-randomized trial to test the effectiveness and cost of less expensive combinations of the services that make up the NIATx collaborative (interest circles, coach calls, coach visits and learning sessions).

This cluster-RCT randomly assign 201 treatment agencies in 5 states to four experimental arms. The agencies were randomized to an intervention for 18 months with a 9 month sustainability period. The study aimed to: 1) Determine whether a state-based strategy can (with NIATx support) can lead mainstream treatment agencies to implement and sustain process changes that improve the study's primary outcomes: time to treatment, annual clinic admissions, and continuation in treatment; and 2) Evaluate the effectiveness and cost of the services making up NIATx. This study aims to create a practical model for improving efficiency and effectiveness of addiction treatment.

Eligibility Criteria:
Inclusion Criteria:

* at least 60 admissions/year
* provide outpatient and intensive outpatient levels of care (as defined by ASAM)
* provide or use detox services provided by others
* have tax-exempt or government status or rely on public funding (e.g., block grants, Medicare, Medicaid, local government, private philanthropy) for at least 50% of their budget
* have adopted no more than two of the planned interventions

Exclusion Criteria:

* are current NIATx members
Cone Beam CT (CBCT) Arthrogram of the Ankle in Assessement of Osteochondral or Cartilage Lesions

This study aims to compare weight-bearing Cone Beam CT arthrogram and conventional CT arthrogram in assessement of patients with ankle osteo-chondral or cartilage lesions.

Weight-bearing Cone Beam CT (CBCT) arthrogram, a technique with less radiation dose than conventional CT, is hypothesized non-inferior to conventional CT arthrogram to diagnose osteo-chondral (OCL) or cartilage lesions of the ankle.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years;
* Patients require CT arthrogram of the ankle;
* Affiliated to a social security schema;
* Informed consent signed by patients.

Exclusion Criteria:

* Pregnant women;
* Impossibility of injection of intra-articular contrast product;
* Hypersensitivity reactions to iodinated contrast agent;
* Patient refusal;
* Patient under french AME scheme;
* Patient under guardianship by tutor or curator.