cyrilzakka/clinical-trials huggingface dataset:
Gadobutrol Magnevist-controlled Body Study

The purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 20 years of age
* Is referred for a contrast-enhanced MRI of the body/extremities based on current clinical symptoms or results of a previous imaging procedure
* Is willing to undergo the routine contrast-enhanced MRI examinations
* Is willing and able to complete all study procedures specified in the protocol
* Subject is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test prior to the administration of gadobutrol or Magnevist

Exclusion Criteria:

* Is a female subject who is pregnant or nursing
* Has received any investigational product or has participated in any other clinical trial within 2 weeks prior to enrolling in this study
* Has been previously enrolled in this study or any other study using gadobutrol
* Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
* Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
* Has received any contrast agent within 24 hours prior to the study MRI
* Has a glomerular filtration rate value \<30 mL/min/1.73m2 derived from a serum creatinine result within 4 weeks prior to study enrollment
* Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure)
* Has severe cardiovascular disease (eg, acute myocardial infarction (\<14 days), unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\<48 hours)
* Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
* Has any contraindication to Magnevist according to the package insert
Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities

The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients

This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Men age 50-75 yrs.
* Women age 40-75 yrs
* One primary care visit in past 2 years.

Exclusion Criteria:

* High risk for colorectal or breast cancer.
EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment

This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* Age between 18 and 70 years
* Successful control of esophageal variceal bleeding within 6 weeks before enrollment

Exclusion Criteria:

* Gastric variceal bleeding
* Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min
* Portal vein thrombosis
* Prominent hepatic encephalopathy
* Coexisting untreated malignancy
* Severe cerebrovascular or cardiovascular disease, renal failure
* No previous history of endoscopic, radiologic, or surgical treatment for varices or ascites
* Contraindication to beta-blocker
* Pregnancy
* Refusal to give consent to participate in the trial
Release Versus Post Isometric Relaxation Among Futsal Players With Shin Splints

The aim of the study is to determine the effects of myofascial release versus post isometric relaxation among futsal players with shin splints

Previous literature did not compare the combined effects of both myofascial release and post isometric relaxation technique inn sgin splints patients so the purpose of this study is self-explanatory, with the basic goal of comparing these two techniques to determine their effects on patient Pain, and Functional disability thus improving overall performance of the futsal players.This study will be helpful in proposing proper treatment for shin splint, to make people aware of the condition rehabilitation and improving performance of the futsal players undergoing the condition. Thus it will be useful for the betterment of the players overall health and wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have leg pain with exertion of more than 1 or 2 hours
* Participants age 20-30 years
* Participants have MTSS for more than 2 weeks
* Subjects have No previous history of trauma to legs
* Subject having Local pain on lower anterior leg Gradual cessation of the offending activity

Exclusion Criteria:

* • Subjects have medical history of systemic disease

  * Subjects have Medical history of cardiovascular disease
  * Participants with History of metastatic diseases
  * Any trauma or pathology of lower limb Participants having Neuropathy of lower extremity
Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses

This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.

This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* An incidental liver mass amenable to US evaluation
* Undiagnosed liver mass
* Mass threshold size is 2.5 cm
* Source of subjects:

  * Liver mass found on conventional institutional US
  * Liver mass detected on CT and MRI that remain uncategorized
  * Referral of patient with a liver mass following detection in outside institution.
* Confirmatory CT or MRI performed within 60 days of initial scan according to the institutional protocols

Exclusion Criteria:

* Any known pre existing mass
* Pregnancy
* Severe or unstable cardiac disease, including angina, congestive heart failure, or arrhythmias
* Severe COPD
* Pulmonary hypertension
* Bidirectional shunts
* Transient right to left shunts
* Known hypersensitivity to Definity or any of its components
Artificial Intelligence for Automated Diagnosis of Breast Cancer

Mammography is a two-dimensional imaging technique which involves the tissues overlapping under the projective image; dense glandular tissue above or below the lesion can reduce the visibility of the lesion.

The trouble could be the interpretation of the image obtained which may lead to the inability to visualize a fist stage cancer and the probability that to a healthy person will be diagnosed a pathology that is not present (false positive). The introduction of an almost three-dimensional technique imaging called breast digital tomosynthesis (DBT) can overcome most limitations. In the last 5 years image analysis methods based on Artificial Intelligence (, AI) have also been massively introduced in breast cancer detection. The study is a prospective observational study based on Artificial intelligence whose the mail goal is to develop a method to identify a lesion.


Eligibility Criteria:
Inclusion Criteria:

* Patients who refer to the Regina Elena for diagnostic mammography tests
* Informed consent

Exclusion Criteria:

* presence of prostheses, artifacts, outcomes of a study in the breast intervention under the study
The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications. Furthermore, the soft tissue edema around the shoulder may extend to the thoracic cage, compress the chest and induce the respiratory distress immediately after surgery. The investigators attempt to determine the effect of shoulder arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial blood gases were measured and compared before and after the shoulder arthroscopic surgery.

Currently, most shoulder surgeries are performed with arthroscopy. The advantages of shoulder arthroscopic surgery are decreased blood loss due to minimal incision for scope, a reduced operation time, minimization of surgical stress, and rapid recovery time after surgery. During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications. Furthermore, the soft tissue edema around the shoulder may extend to the thoracic cage, compress the chest and induce the respiratory distress immediately after surgery. From these facts, the mechanism of respiratory discomfort after shoulder arthroscopic surgery may be because the upper airway obstruction or restrictive pathology due to direct compression of thoracic cage by the soft tissue edema. There have been no studies on the respiratory effect of shoulder arthroscopic surgery. We have observed frequent and severe respiratory discomfort after the shoulder arthroscopic surgery. Therefore, in this study we attempt to determine the effect of shoulder arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial blood gases were measured and compared before and after the shoulder arthroscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing arthroscopic shoulder rotator cuff repair surgery
* American society of anesthesiologist (ASA) class I or II
* Patients under 70 yrs.

Exclusion Criteria:

* Patients older than 70 yrs,
* Patients with anatomical derangement of upper airway,
* Patients with pulmonary or cardiac disease,
* Patients with a history of laryngeal or tracheal surgery or hemodynamic instability
NUsurface Implant Registry

The purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the NUsurface® meniscus implant in the real-world post-marketing setting

Patients eligible for the Registry includes any patient who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria (Evidence of a personally signed and dated informed consent document). The NUsurface Implant Regitstry is about data collection only and under routine standard of care by treating physician. Data collection points are pre-op (i.e. baseline), surgery and multiple times after surgery during the first 6 months to correspond to clinic standard of care schedules, 6 months, 1 year post-operatively and then yearly thereafter out to 10 years.Surveys used are KOOS; Knee injury and Osteoarthritis Outcome Score \& WOMET; Western Ontario Meniscal Evaluation Tool.

Eligibility Criteria:
Inclusion Criteria:

* New or current treatment with the NUsurface® meniscus implant
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry.

Exclusion Criteria:

* There are no protocol exclusion criteria; all subjects who meet the inclusion criteria are eligible for enrollment.
Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families

The goal of this project is to demonstrate digital training efficacy at scale and commercial readiness.

This pilot project will advance piloted digital training programs for CRAFT and maximize scalability. In this project, investigators will:

Aim 1: Optimize the digital CRAFT training product based on data and feedback from the pilot and commercialization advisors.

Aim 2: Conduct a fully powered randomized control trial of 3 levels of digital training (Level 1 - Digital tutorial only \[T\]; Level 2 - Tutorial \& digital training materials for self-study \[TM\]; Level 3 - Tutorial, digital materials, feedback and coaching \[TMC\]) to examine the effects of training on CRAFT knowledge, fidelity, and plus IP treatment entry/retention and counselor skill pre- and post-tutorial, at 12 weeks and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Be over 19
* Live in the US
* Work in a counselor-related profession
* Have counseling work that involves clients
* Work with CSOs impacted by OUD, or could work with this type of client
* Have not been certified in CRAFT
* Have not participated in the 2023 WTV counselor training pilot study
* Be able to provide at least 45-minute individual counselor sessions to at least one CSO (CSO)
* Be able and willing to complete intervention activities over the course of the 12-week study as determined by the random assignment including: participating in the tutorial and training and submitting the required session audiotapes
* Report having access to a computer and smartphone with internet access, email, and word processing capability
* Demonstrate complete understanding of the requirements for participation in the study by reading and signing the consent form and completing the online consent quiz or confirmation call
* Provide valid locator information to allow research and CRAFT training staff to contact them to schedule study-related appointments
* Complete the first assessment mock session with our standardized patient (SP) and pre-tutorial surveys

Exclusion Criteria:

* Does not agree to participate
* Does not complete the baseline assessment requirements
* Is not English-speaking
* Participated in the Qualitative Review aspect of the study
Effects of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People

Obesity and arterial hypertension (HTN) frequently coexist in the same patient. Moreover, the concept that obesity and HTN can be additive in terms of cardiovascular rist is widely accepted. Yet, clinical decision-making in obese patients is complicated by a surprising lack of evidence on the relative importance of obesity and HTN treatment and its efficacy and safety. Lifestyle interventions are the mainstay of obesity management programs and are also advocated in the prevention and treatment of HTN. Physical exercise and diet are recommended to prevent and control obesity and HTN. Aerobic exercise is firmly established as an effective measure for lowering blood pressure and reducing cardiovascular risk. However, there is no agreement about the optimal dose of frequency, intensity, duration and type of exercise. Therefore, the aims of the study are: 1) to assess the changes in selected parameters of blood pressure, cardiorespiratory fitness, body composition and biological markers brought about by a period of 16-week of different aerobic exercise programs with hypocaloric diet for overweight or obesity and primary hypertensive adults, and 2) to examine the effect of six months detraining subsequent to intervention. Secondary objectives are to examine the additional effect of the intervention on physical activity behavior and health-related quality of life.

METHODOLOGY: participants will perform a ramp incremental cardiopulmonary exercise bike test before, after 16-week of follow-up, and after 6-month detraining period (with no intervention only recommendations). After inclusion criteria they will be randomized to four parallel groups: 1) control group with only hypocaloric diet intervention and lifestyle recommendations; 2) Moderate (HR values between VT1 and VT2 or 50-75% of HR reserve) continuous exercise and high volume (from 20 to 45min) group and hypocaloric diet intervention; 3) high intensity (HR values up to VT2 to peak intensity or ≥76% to \<100 % of HR reserve) interval training and high-volume (from 20 to 45min) group alternating high and moderate intensities at different protocols and hypocaloric diet intervention; and 4) high-intensity interval training and low-volume (20min) group alternating high and moderate intensities at different protocolsand hypocaloric diet intervention.

Eligibility Criteria:
Inclusion Criteria:

* older than 18yr old and less than 70yr old
* overweight (BMI \>25)
* primary hypertension
* low-moderate cardiovascular risk
* not diet treatment
* sedentary behavior
* availability to exercise two days a week.

Exclusion Criteria:

* secondary hypertension
* pulmonary disorder
* neurological deficit
* physical incapacity to exercise
* to exercise frequently
* pregnancy or breastfeeding
* left ventricular hypertrophy
* more than three cardiovascular risk factors
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol

Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves and relates on the other hand on the dosage. Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.

This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma
* age 18 years and older
* minimum period of 6 month after renal transplantation
* stable renal function and a calculated creatinine clearance of at least 40 ml/min
* written informed consent
* proteinuria ≤ 800 mg/d at time of enrolment
* successfully treated solid tumor (no recurrence or metastasis in the last 2 years)

Exclusion Criteria:

* Current Sirolimus- or Everolimus- intake
* Instable graft function (creatinine clearance \< 40 ml/min)
* Graft rejection within the 3 previous months
* Proteinuria \> 800 mg/d
* Non-controlled hyperlipidemia (Cholesterol \>7,8 mmol/l (300 mg/dl), Triglycerides \> 4 mmol/l (350 mg/dl)
* Leucopenia \< 2500/nl
* Thrombocytopenia \< 90/nl
* Pregnancy or breastfeeding
* Women of childbearing age without highly effective contraception
* Known allergy to macrolides
* Current participation in other studies
* Refusal to sign informed consent form
* Neoplasm other than defined as inclusion criteria
* All contraindications to SRL (see package insert, appendix)
* Persons who are detained officially or legally to an official institute
* Acute infections (mycotic, viral or bacterial)
* Current intake of other substances with known nephrotoxicity
* Severe liver dysfunction
* Current intake of CY3A4-inhibitors (e.g. ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or CY3A4-inductors (rifampicin, rifabutin)
* sucrose-isomaltase deficiency, fructose intolerance, glucose-galactose intolerance
* azathioprine: known allergy to azathioprine or 6-mercaptopurine, severe bone marrow dysfunction, pancreatitis, vaccination with live vaccine
* tacrolimus: known allergy to tacrolimus
* mycophenolatmofetil: known allergy to mycophenolatmofetil, neutropenia, severe active gastrointestinal tract disease, Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome, current intake of azathioprine
* cyclosporine: known allergy to cyclosporine, increased intracranial pressure
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia

The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent
* Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation)
* Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent

Exclusion Criteria:

* Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent
* Subjects have heartburn in last 12 weeks before obtaining informed consent
* Subjects with irritable bowel disease (IBS)
* Subjects with diabetes mellitus requiring treatment
* Subjects with serious anxiety disorder
* Subjects with depression and/or sleep disorder
* Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)