cyrilzakka/clinical-trials huggingface dataset:
Immunosuppressive Treatment in Chronic Virus-Negative Inflammatory Cardiomyopathy

Evaluating Immunosuppressive treatment (Mycophenolate mofetil and prednisolon compared to placebo) for 6 months in patients with chronic virus- Negative Inflammatory cardiomyopathy - a multicenter, randomized, double-blind, placebo-controlled trial.

Inflammatory cardiomyopathy constitutes a relevant part of the cohort of non-dilated left ventricular cardiomyopathy / dilated cardiomyopathy (DCM) and is associated with adverse outcome. Urgent medical needs remain with respect to the therapeutic options for inflammatory cardiomyopathy. So far, no specific therapy for patients with inflammatory cardiomyopathy is available. Existing data on immunosuppression for inflammatory cardiomyopathy is preliminary and needs further validation by larger randomized, controlled, multicenter trials.

Patients with biopsy-proven virus-negative inflammatory dilated or non-dilated left ventricular cardiomyopathy and moderate to severe deterioration of cardiac function despite optimal medical treatment (OMT) for heart failure (HF) will be randomized (1:1) in a double-blinded way to Mycophenolate mofetil (MMF) 1g bid and prednisolone at initially 1mg/kg in a step-down regime for 6 months or placebo. The clinical benefit will be measured with respect to absolute increase in LVEF (metric and binary co-primary endpoints assessed by MRI core lab) of immunosuppressive treatment with MMF and prednisolone compared to placebo at 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Medical therapy for HF for ≥3 months and \<10 years according to current guideline recommendations
3. Persistent reduction of LVEF \<50% on a routine echocardiographic evaluation (Simpson's biplane) not older than 1 month at time of inclusion
4. EMB with immunohistochemical evidence of lymphocytic myocarditis defined as ≥14 leukocytes/mm2 including up to 4 monocytes/mm2 with the presence of CD3 positive T-lymphocytes ≥7 cells/mm2 and increased MHC-II expression as approved by the histopathology core lab
5. Absence of established cardiotropic virus infection in EMBs (i.e. enteroviruses, HHV-6, EBV, CMV, adenoviruses, parvovirus B19 \>500 copies) as approved by the histopathology core lab
6. Negative pregnancy test and the use of a highly effective contraceptive measure in women with child-bearing potential (according to CTFG recommendations)
7. Written informed consent.

Exclusion Criteria:

1. Histopathological (as approved by the histopathology core lab) and/ or clinical evidence of acute lymphocytic myocarditis, sarcoidosis, GCM or eosinophilic myocarditis,
2. Known systemic inflammatory disease,
3. Recent major surgery within \<6 weeks, recent ICD implantation within \<6 weeks or recent CRT implantation within \<3 months prior to,
4. Known coronary artery disease responsible for cardiac dysfunction (i.e., prior myocardial infarction, persistent stenosis ≥ 70%),
5. Pregnancy or lactation,
6. Contraindications to immunosuppressive treatment with MMF + corticosteroids,
7. Inability to provide informed consent.
TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland

All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have been treated in the Region Västra Götaland. During the study period, ESD was introduced as a treatment modality, and it will investigated how this may have influenced treatment strategies for complex adenomas. Clinical outcome measures will include recurrence rates and re-intervention rates for the respective treatments. Possible areas of improvement will be identified and determine if evidence based and best practice guidelines are met with the current treatment strategies in Region Västra Götaland.


Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer resected by local resection

Exclusion Criteria:

* All other types of resection or treatment for rectal cancer
COHERE - COntextualized Care in cHcs' Electronic Health REcords

This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. This study will test the hypothesis that providing care team members with CDS about patients' known social risks will result in improved outcomes. This study's primary outcomes are hypertension and diabetes control, but the results will have implications for a wide range of morbidities.

The investigators will use a randomized quasi-experimental design to assess impact of the CDS tools designed to support social risk-informed care. After conducting a 12-month pilot study with 3 CHCs to test and further refine the CDS tools, 6 CHCs will be recruited to participate in the main trial. All OCHIN clinics with \>200 SDH screenings (excluding the pilot clinics) will be identified and randomized to a potential intervention group or a control group. Clinics from the potential intervention group will be recruited in a random order until 6 agree to participate. This recruitment method ensures randomization between intervention and control clinics, without recruiting CHCs to a study in which they might not receive an intervention. Intervention sites will be trained in how to use the tools shortly before the tools are activated and will be followed for 12 months to assess tool adoption and impact on the CQMs of interest. Use of the CDS tools will occur as part of the regular care patients receive and will not require special clinic visits. Patients will interact with providers as they normally would, augmented by the intervention when clinicians choose to utilize the CDS tools. For all study clinics, quantitative data will be collected (via EHR data extraction) on social risk data collection and action by care team members. Limited clinical data will be collected on patients who are seen at a study CHC during the study period. Qualitative data will also be collected which includes semi-structured interviews with clinic staff from all study CHCs enrolled in the main trial.

NOTE: Individual patients will not be assigned to an intervention. Instead, randomization and intervention will occur at the clinic level. While CHCs will be recruited that have previously screened patients for social risks, it is unlikely that these CHCs will have screened all patients in their clinics. Thus, the CDS tools will not apply to all patients in participating clinics, and it cannot be guaranteed that individual patients will receive an intervention.

Eligibility Criteria:
Inclusion Criteria:

* Clinic has conducted \>200 social risk screenings in the last 12 months at the time of randomization.
* Clinic provides primary care
* Joined OCHIN by 07/01/2021

Exclusion Criteria:

* Clinic participated in pilot
* Clinic is a school-based health center
* Clinic provides care to prison population
Safety and Efficacy of Two-step Radical Prostatectomy

The goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as prostate cancer pathologically by prostate biopsy
2. Evaluated as localized prostate cancer by imaging studies
3. Prostate volume\>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging
4. Gleason score≤ 4+3=7
5. Preoperative PSA\<20ng/mL
6. Estimated survival\> 10 years；
7. Informed consent is obtained from the patient

Exclusion Criteria:

1. The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
2. Any contraindication of surgery or anaesthesia
Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis

The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Conjunctivitis allergic conjunctivitis

Exclusion Criteria:

* Severe ocular allergy
* Vernal keratoconjunctivitis
Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease

A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind was performed in 30 male patients (50-60 years old) with Intermittent Claudication (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6 months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2 weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks and 125 mg twice daily/eight weeks) or control group.


Eligibility Criteria:
Inclusion Criteria:

* Arterial hypertension and hypercholesterolemia
* ABI \<0,9
* Positive claudiometry with a claudication distance between 50 and 500

Exclusion Criteria:

* surgical patient
* Previous revascularization procedure in the Member studied
* Smoker
* Uncontrolled hypertension
* Cardiac Stress Test unfinished
* Prior DVT
* Concomitant severe disease
* Obesity
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin

The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.


Eligibility Criteria:
Inclusion Criteria:

* male or female, hospitalized patients 2 years of age or older
* Adult patients or guardian for pediatric patients to provide written informed consent

Exclusion Criteria:

* patient with a history of hypersensitivity to hydantoins
* patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree A-V block, or Adams-Stokes syndrome
* pregnant or nursing female patients
Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability

The main objective is the evaluation of the prognostic value of ctDNA (circulating tumor DNA) as a marker of surgical futility in patients with operable PDAC.

In the era of personalized medicine and treatments guided by tumor biology, no specific tumor marker has real prognostic value. This is the reason why the search for a specific marker through a noninvasive blood test that can give indications on the usefulness of the resectability of pancreatic adenocarcinoma would be very valuable. Our project proposes the evaluation of ctDNA during various treatment courses of patients with PDAC in order to evaluate its efficacy as a prognostic and predictive marker of response to treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with PDAC with indication to surgical resection, including those undergoing upfront surgery or surgery following induction treatment. Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded
2. Non-metastatic status confirmed by an abdomen CT-scan (as our routine clinical practice).
3. Patients able to give a specific informed consent.
4. Age ≥ 18 years.

Exclusion Criteria:

1. Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded (drop-out)
2. Non-controlled congestive heart failure.
3. Non-treated angina.
4. Recent myocardial infarction (in the previous year).
5. Non-controlled AHT (SBP \>160 mm or DBP \> 100 mm, despite optimal drug treatment).
6. Long QT.
7. Major non-controlled infection.
8. Severe liver failure.
9. Age \< 18 years.
10. Informed consent not signed.
11. Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.
Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point

This study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years.

The objectives of tis study are to rigorously evaluate the effect of Tribal Turning Point (TTP) on diabetes risk factors in Native youth. The investigators will enroll up to 360 youth who are aged 7-10 years, overweight/obese (BMI \>85th percentile), self-identify as American Indian, and have \>1 parent/primary caregiver willing to actively participate in the program. Within each community, youth will be randomized to the TTP program or a general health and safety control program. The multi-component TTP intervention is a youth-centered adaptation of the Diabetes Prevention Program designed to reduce diabetes risk factors by improving activity and dietary behaviors. Informed by the pediatric weight management literature, the 12-month intervention includes 12 active learning group classes, 7 individual youth/parent motivational interviewing counseling sessions, and community-specific resource toolboxes. In this trial, the investigators will assess the effect of TTP on anthropometric, metabolic, and behavioral risk factors for type 2 diabetes at the end of the intervention (12mo) and after 1 year of follow-up (24mo).

Eligibility Criteria:
Inclusion Criteria:

* self-identify as American Indian
* BMI \>=85th percentile for age and sex
* have at least one parent/primary caregiver (parent) willing to actively participate

Exclusion Criteria:

* diabetes
* any serious youth/parent health concerns that would interfere with participation
* plans to move out of the area during the study period
Testing Protocol to Efficiently Induce Itch

This subproject aims to evaluate a new nerve excitability protocol to induce itch in healthy controls by electrical stimulation. Itch has many similarities with pain, and the nerve fibers that mediate the two sensations probably have the same morphological and excitability properties. The method used in this project will be the same as our research group uses for studying nociceptor fibers (PTT technique), but the focus is on the itch sensation. Since the itch fibers also terminate in the epidermis, our PTT technique should also be able to activate itch fibers, similar to pain fibers. If itch could be effectively induced by electrical stimulation, this would generate a valuable tool for studying itch in healthy controls. The sub-project takes place in 2 sessions (2 hours each).


Eligibility Criteria:
Inclusion Criteria:

Healthy men and women in the age 18-80 years who speak and understand

Exclusion Criteria:

* Pregnancy or breast feeding
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
* Skin diseases
* Past history of conditions possibly leading to neuropathy
* Inability to cooperate
* Current use of medications that may affect the study, e.g., analgesics
* Previous traumatic experience of an electrical accident
* Consumption of alcohol or painkillers within the last 24 hours
* Participation in other pain studies throughout the study period
* Patients with cardiac diseases (e.g., pacemaker).
Diagnostic Evaluation of Sarcopenia in Elderly Patients

Sarcopenia is a generalized progressive skeletal muscle disorder that represents a related physiological vulnerability that is associated with or increases the likelihood of adverse outcomes, including falls, fractures, physical disability and death. The parameters used to assess sarcopenia in clinical practice have limited use due to their custody.

In this perspective, this study proposes or develops a tool for the diagnosis of having sarcopenia with a specific boa and a sensitive boa.

low cost and useful.

Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas, Faculty of Medicine, University of São Paulo will be selected

This study was of clinical importance, due to sarcopenia and a relevant factor, and could lead to consequences and poor prognosis in patients with gold, and it was not a method of clinical practice to properly endorse body composition in this population.

Sarcopenia is a progressive and generalized skeletal muscle disorder that represents an age-related physiological vulnerability that is associated with an increased likelihood of adverse outcomes, including falls, fractures, physical disability and mortality. The parameters used to assess sarcopenia in clinical practice have limited use due to its cost.

In this perspective, this study proposes the development of a tool for the diagnosis of having sarcopenia with good specificity and good sensitivity and of low cost and useful.

Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas, Faculty of Medicine, University of São Paulo will be selected. After signing the informed consent, sarcopenia will be assessed using the reference method (DXA) and anthropometry. The data obtained by the methods are treated statistically to obtain correlation and thus a new tool for the evaluation of sarcopenia patients in the elderly can be developed.

This study is of clinical importance, as sarcopenia is a relevant factor and can lead to consequences and poor prognosis in elderly patients, and there is no low-cost method in clinical practice to properly assess body composition in this population.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Sign free and informed consent;
* Demonstrate interest, conditions and availability to participate in all procedures included in the study protocol;

Exclusion Criteria:

* Refusal to participate;
* Patients who have not undergone cognitive testing;
* Physical amputation;
* Patients undergoing interventional treatment for sarcopenia;
Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy. The hypothesis of the study was that the percentage of subjects with at least 40% improvement in visual analog scale score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared Photoenergy (MIRE) treatment than for sham treatment.

Pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. This study is designed to evaluate the effectiveness of monochromatic near infrared photoenergy therapy (MIRE) in the treatment of pain in axonal peripheral neuropathy. This will be compared with a placebo (sham) device.

The MIRE is a FDA approved, drug-free, non-invasive, medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy (MIRE) through contact with the skin. The effect of MIRE is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation. MIRE is also thought to increase local levels of nitric oxide (NO) which may decrease pain levels.

Study subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks. Response will be measured during and after the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-85; able to give informed consent
* Documented painful, distal peripheral neuropathy of idiopathic cause, or related to impaired glucose tolerance or diabetes mellitus.
* Neuropathy documented by one of the following studies: nerve conduction studies and needle electromyography (EMG); quantitative sensory testing of the foot with Computer Aided Sensory Evaluator (CASE IV); quantitative sudomotor axon reflex test (Quantitative Sweat MeasurementSystem \[Q-Sweat\]); neurology specialty examination; and neuropathy impairment score (NIS) of less than 25.
* Stable pharmacotherapy for neuropathic pain for at least two weeks.
* Optimal pharmacotherapy has been achieved.
* Subjects cannot be on Cyclooxygenase-2 (COX 2) inhibitors
* Pain Visual Analog Scale (VAS) of greater than or equal to 4/10
* Subject has provided written informed consent
* Not currently using transcutaneous electrical nerve stimulation (TENS)
* Not currently receiving acupuncture

Exclusion Criteria:

* Pregnant or likely to become pregnant
* Current diagnosis of cancer
* Neuropathy impairment score (NIS) of greater than 25.
* Diagnosis of severe neuropathy of known etiology for which specific treatment is available (i.e., acute and chronic inflammatory polyradiculoneuropathies, vasculitis, B 12 deficiency).
* Unstable diabetes mellitus defined as a hemoglobin A1c (HbA1c) greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.
Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents

The aim of this prospective, randomized study is to compare the efficacy and safety of biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based everolimus eluting stents (PPDES).

Restenosis affects 20-40% of de novo coronary lesions treated with bare-metal stents. Although it is often considered a benign process, recent data indicate that in-stent restenosis has a negative impact on long-term survival of patients treated with coronary stents. Drug eluting stents have emerged as the most effective strategy for the prevention of restenosis. A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare-metal stents. Available evidence shows that all 3 limus drugs - rapamycin, everolimus and biolimus - are very effective in suppressing neointima formation after coronary stenting. Drugs are fully released within a few weeks from the majority of current DES. However, most of the DES use permanent polymers, which continue to remain in the vessel wall even after accomplishing their drug-release mission. Their permanent presence may be associated with persistent inflammatory reaction and delayed neointimal proliferation and vessel thrombosis. Clinical trial evidence with biodegradable polymer DES is still limited, but there are great expectations that this DES technology might be the dominant one in the years to come.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
* In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

* Target lesion located in the left main trunk.
* In-stent restenosis of DES.
* Cardiogenic shock.
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome.
* Inability to take dual antiplatelet therapy for at least 6 months.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.