cyrilzakka/clinical-trials huggingface dataset:
Screening for BCRL in Targeted Therapy for Breast Cancer

This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.

A Perometer and Sozo devise will be used to measure volume changes

This study will compare patients' relative arm volume changes and symptoms data from before drug therapy throughout drug treatment and for up to six months after treatment has finished.

A Perometer and Sozo device will be used to measure volume changes

All participants will be accrued at Massachusetts General Hospital for a target accrual of 166 participants.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.
* Subjects that will be eligible for the study include:
* Females between 18 and 80 years of age
* With a history of breast cancer
* 4 weeks or more post-surgery
* With or without edema
* Undergoing treatment with targeted therapy for early or metastatic disease.

Exclusion Criteria:

- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).
HIV Database (DBHIV)-Establishment of a Database of HIV Patients

In Italy, there are over 90,000 patients with HIV-1 infection on antiretroviral therapy (ART). The availability of different classes of antiretroviral drugs (nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease, and the number of HIV-infected patients over 50 years of age has increased significantly and the number of elderly subjects is progressively increasing. Furthermore, HIV infection seems to accelerate the aging process, causing immune system dysfunction, excess oxidative stress and increased inflammatory processes (inflammaging).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients with chronic HIV infection (certified by a positive test for the detection of anti-HIV antibodies)
* Ability to sign the informed consent or signature of the declaration in lieu of consent in the case of deceased patients

Exclusion Criteria:

* lack of willingness to provide free and informed consent.
The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns

This is a randomized clinical trial study to identify the role of AMT (amniotic membrane transplantation) in treating epithelial defect, symblepharon prevention preventing corneal vascularization and opacity decreasing pain and improving visual acuity, and patients with acute chemical burns.

The study is on patients with grade II-IV acute ocular chemical burns (Roper - Hall classification) in the first 2 weeks of injury.

After topical anesthesia, all patients initially will receive first aid therapy; which included irrigation with normal saline to normalize ocular surface PH and removal of early particulate maeuil and debris. After complete examination and obtaining informed consent, the patients will be randomized using a treatment assignment list to either AMT with conventional medical therapy (group A) or medical treatment only (group B). In the patients with bilateral injuries the eyes will be randomized separately. AMT will be performed within 24h of presentation. amniotic membrane will remain in place for 7-14 days. The patients will be examined at days 1, 3, 7, 10, 14, 21, 28 and then biweekly until 3 months and monthly until (1 year in every visit, visual acuity (by sneillen charts), reduction of pain (subjectively) size of corneal epithelial defect (by fluorseein satiny extent of corneal vascularization and opacity, and symblepharon formation will be assessed. Digital photographs at each visit will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chemical eye burn grade 2-4
* Burning has been occurred in 2 weeks

Exclusion Criteria:

* Grade I burnings
* More than 2 weeks have passed of burning
* Follow up of the patients has been disconnected in 6 month
Primary Dependence to Analgesic Drugs

Abuse of analgesics represents an important part of prescription drug abuse. The consequences in terms of morbidity and mortality at the population level could reach worryingly high levels, as illustrated by the US context. This issue should not focus only on opioid analgesics, but must also account for some antiepileptics or antidepressants with abuse potential (for example, pregabalin or gabapentin). In France, reports related to tramadol abuse are increasing, in particular since dextropropoxyphene withdrawal. Trends of growing abuse are also reported for other analgesics. Patients with no history of primary dependence constituted a significant proportion of those developing a tramadol abuse. There is therefore a need for early identification of these patients and to raise awareness of health professionals on this issue, in particular in primary care. Given the extensive use of analgesic drugs in France, the problem of primary dependence should not be neglected. Since it will affect people who have no history of drug abuse, strategies for identification and prevention are differing from a population already using psychotropic products for example.

To date, prescription drug abuse has been considered in terms of the secondary or tertiary prevention, and primary prevention remains poorly explored. By reconstructing the entire trajectories of patients having developed primary drug dependence, from the genesis of first drug exposures, investigators will identify patients' profiles and early changes in drug use that could accurately predict future complications. Pharmacoepidemiological methods are particularly relevant in the field of abuse and drug dependence. By definition, specialized care seeking can only be achieved after emergence and identification of the problem. Outpatients data obtained through medico-administrative database are then the only source of evidence that could enable to ascertain accurately history of past drug consumption

Eligibility Criteria:
Inclusion Criteria:

* Subjects included in the SNIIRAM (French National inter-scheme health insurance information system) database
* Age \>18 at index date (date of first analgesic dispensing)
* At least three dispensing of analgesic drugs
* At least two years of available follow-up at the date of first analgesic dispensing in the SNIIRAM database
* No dispensing for any of the analgesics of interest in the past 12 months (selection of new users only)

Exclusion Criteria:

* none
Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease

The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.


Eligibility Criteria:
Inclusion Criteria:

* Lactating women with Chagas disease, not treated before
* Use of contraception

Exclusion Criteria:

* History of allergy to benznidazole or its excipients
* Pregnancy
* Significant heart involvement (due to Chagas disease)
* Significant systemic diseases that could affect the interpretation of the results in the opinion of the principal investigator
Bone Metabolism After Bariatric Surgery

The purpose and objective of this study is to determine the changes in bone metabolism after bariatric surgery in postmenopausal women.

This is a prospective cohort study that will enroll up to 40 postmenopausal female subjects with class II and III obesity from the Duke Center for Metabolic and Weight Loss Surgery. The study team will enroll subjects that are already being scheduled for either sleeve gastrectomy or Roux-en-Y gastric bypass. The osteoclast activity, the osteoblast activity, and the bone mineral density will be measured in all subjects preoperatively and 12 months postoperatively through research specific blood tests and Dual energy x-ray Absorptiometry (DEXA) scans.

The primary endpoints are change in osteoclast activity as measured by C-terminal telopeptide of type I collagen and change in bone density as measured by DEXA scan. These are continuous variable and given the small sample size the investigators will use a nonparametric Wilcoxon rank-sum test to compare the difference in one year change in these variables. There is a slight risk of loss of confidentiality. Every effort will be made to protect all PHI. There is also the risk of increased exposure to radiation from the DEXA scans performed twice with each subjects participating in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women as determined by having a history of no menstrual bleed for greater than one year.
2. Body Mass Index ≥35 kg/m² and stable weight for the previous 3 months.
3. Able to speak and read English.
4. Being scheduled for either Roux-en-Y gastric bypass or sleeve gastrectomy.

Exclusion Criteria:

1. A documented history of osteoporosis or currently receiving medical treatment for osteoporosis with bisphosphonates, teriparatide, raloxifene, or denosumab.
2. Weight greater than 295 pounds as this is the weight limit for our Dual-energy X-ray absorptiometry machine.
3. Current or past (less than 1 year from enrollment) usage of estrogen hormone replacement therapy.
4. Current smoker
5. Any history of glucocorticoid use greater than one year in duration or current use of glucocorticoids.
Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores

This will be a pilot study to investigate the use of belatacept (BMS) therapy in kidney transplant patients who have a MAPI score of greater than or equal to 8. The MAPI (Maryland Aggregate Pathology Index) score is a preimplantation donor scoring system which has five histopathological parameters that impact long-term kidney outcomes. Many kidney transplant recipients use calcineurin inhibitors (CNIs) as one of their anti-rejection medi cations. Kidney function may be affected by anti-rejection medications known as calcineurin inhibitors (CNIs). Sometimes CNIs can lead to toxicities and eventually loss of the kidney or episodes of chronic allograft nephropathy (CAN). Avoiding CNI immunosuppression and using belatacept therapy (BMS) instead, may be associated with improved kidney transplant outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation.
* Recipients of deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death) with MAPI score ≥ 8.
* Cold ischemic time less than 40 hours at time of reperfusion.
* Negative serum pregnancy test for female patients.
* Patients who can understand the purposes and risks of the study, provide informed consent, and can comply with the treatment and follow-up requirements.

Exclusion Criteria:

* Cold ischemic time (CIT) \> 40 hours
* Patients who are sensitized with current PRA\>40%, ABO incompatible transplants, or T, or B cell crossmatch positive transplant.
* Patients without antibody to EBV
* Patients receiving multiple organ transplants.
* Patients unable to take oral medication at time of randomization
* Patient with a history of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of carcinoma in situ
* Patients who tested positive for HIV, Hepatitis C or Hepatitis B surface antigen.
* Recipients of organs from donors who test positive for HIV, Hepatitis C or Hepatitis B surface antigen
* Patients with a clinically significant systemic infection within 30 days prior to transplant
* Patients who have cardiac failure at time of screening or any other severe cardiac disease as determined by the investigator
* Patients with abnormal laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study.
* Females, pregnant or lactating, or are of childbearing potential unwilling to use an effective means of contraception or are planning to become pregnant.
* Patient with active tuberculosis infection
Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.

Eligibility Criteria:
Inclusion Criteria:

* The subject is female and at least 18 years of age.
* The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
* The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics.
* The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for \> 6 months.

Exclusion Criteria:

* The subject has an active urogenital infection or active skin infection in region of surgery.
* The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.
* The subject is having a concomitant pelvic floor procedure.
* The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
* The subject had a prior surgical stress urinary incontinence (SUI) treatment.
* The subject has undergone radiation or brachy therapy to treat pelvic cancer.
* The subject has urge predominant incontinence by MESA assessment.
* The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.
* The subject is pregnant and/or is planning to get pregnant in the future.
* The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU).
* The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.
Anticoagulation With Enhanced Gastrointestinal Safety

This study is a pragmatic cluster randomized controlled trial to evaluate the effectiveness of a clinician-facing implementation strategy on the use of medication optimization (defined as either discontinuation of all antiplatelet therapy or initiation of and adherence to a proton pump inhibitor (PPI)) to reduce upper GI bleeding risk in patients prescribed anticoagulant-antiplatelet therapy (AAT) relative to usual care.

This is a pragmatic, single-center cluster randomized controlled trial to evaluate a clinician-facing implementation strategy to increase the use of evidence-based practices (EBPs) to reduce bleeding in patients who are using AAT and who are managed by the Michigan Medicine anticoagulation monitoring service. The active intervention is clinician notification with nurse facilitation (CNNF), which consists of an anticoagulation clinic nurse sending an electronic health record message that identifies the patient as high risk for upper GI bleeding and recommends either discontinuing the antiplatelet agent or initiating a PPI; the nurse also pends medication orders for PPIs and provides patient education upon request. Clinicians will be cluster randomized, such that up to 4 patients cared for by each clinician will receive the same clinician-level notification.

This study will use a "wait-listed design," in which patients will be randomized to either have their clinicians receive CNNF or be included in a wait-list control group. At the completion of the study, the patients who were randomized to the wait-list control group will receive the intervention.

Eligibility Criteria:
Inclusion Criteria for Patients:

* Enrollment with the Michigan Medicine anticoagulation monitoring service
* Currently prescribed warfarin with anticipated use for ≥90 days on day 1 of trial enrollment, according to the electronic health record documentation.
* Currently prescribed an antiplatelet medication (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic health record medication list

Inclusion Criteria for Clinicians:

* Cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria
* Michigan Medicine primary care providers for patients who meet eligibility criteria
* Clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria

Exclusion Criteria for Patients:

* Age less than 18
* Currently prescribed a PPI
* Documented intolerance or allergy to PPI use
* Left ventricular assist device
* Heart transplant
* Participation in a previous pilot study of these implementation strategies

Exclusion Criteria for Clinicians:

* Cardiologists specializing in electrophysiology or who saw the patient for a clinic visit related to a TAVI procedure unless they are the clinician of record for a patient followed by the anticoagulation service who does not have a Michigan Medicine PCP.
* Participation in a previous pilot study of these QI strategies
Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases

The aim of this study is to assess the impact of individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback, to improve the general functional state, selected motor activities, stimulation and strength of specific muscle syndromes as well as postural parameters in children, adolescents and adults with neuromuscular diseases.


Eligibility Criteria:
Inclusion Criteria:

* confirmed genetic Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), limb-girdle dystrophy, spinal muscular atrophy (SMA), myopathy or neuropathy
* continued/uninterrupted rehabilitation process for 3 months
* patient's condition allowing full understanding of commands

Exclusion Criteria:

* patients using a respirator
* painful complaints
* after injuries and fractures in the last 6 months
* significant weakening of muscle strength, preventing movements and activation of selected muscle groups, visible in the EMG examination
* cognitive impairment-lack of or poor cooperation between the patient and the therapist,
Inhaled Fentanyl Citrate & Dyspnea

"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve the perception of dyspnea during strenuous exercise in healthy, young men in the presence of an external thoracic restriction. To this end, the investigators plan compare the effects of inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing with and without external thoracic restriction in healthy, men aged 20-40 years.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 20-40 years
* FEV1 ≥80% predicted
* FEV1/FVC \>70%

Exclusion Criteria:

* Current or ex-smoker
* Body Mass Index \<18.5 or \>30 kg/m2
* History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
* Taking doctor prescribed medications
* History of using pain-relieving (opioid) and/or anti-depressant medications in the previous 6 weeks
* Allergy to latex
* Allergy to lidocaine or its "caine" derivatives
Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects

Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Minimum of two psoriatic plaques (i.e., one clinical target lesion and one biopsy target lesion).
* Each of the two target lesions must have a psoriatic lesion severity sum (PLSS) of ≥6
* Body mass index (BMI) of 18 to 38 kg/m2 (inclusive)

Exclusion Criteria:

* Prior exposure to \>2 systemic biologic agents and/or small molecules including investigational therapies for the treatment of psoriasis or have not discontinued systemic biologic agents and/or small molecules anti-psoriasis therapy including investigational therapies due to lack of efficacy;
* Subjects with significant health problems, other than having plaque psoriasis (as determined by medical history, physical examination, chest X-ray, vital signs and 12-lead ECG) that could either interfere with study evaluations or place subject at undue risk;
* Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis at Visit 1;
* Conditions (e.g., clinically-significant eczema or severe acne in the target lesion area) that would interfere with study evaluations;
* Positive quantiFERON®-TB Gold test, negative chest X-ray findings for tubercle bacillus (TB) or lack any other evidence of active or latent TB;
* History of a clinically-significant infection (e.g., required oral antimicrobial therapy) within 4 weeks prior to Visit 2;
* Subjects who do not have clinical laboratory test results within the normal reference ranges (i.e., are deemed not to be clinically significant) or clinically not acceptable to the Investigator;