cyrilzakka/clinical-trials huggingface dataset:
Mepolizumab for Eosinophilic Fasciitis

This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.

This is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (Nucala) in the treatment of EF using mean change in the Rodnan Skin score (mRSS) before and after treatment. The study is powered at 90% to detect a 4 point change in the mRSS at a 5% significant level with a minimum target accrual of 6 patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years or older.
* History and physical examination consistent with EF
* Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF
* Documented peripheral eosinophilia (≥500 microliter)
* Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
* Patients who read and sign an approved informed consent for this study

Exclusion Criteria:

* Eosinophilic fascitis disease duration \> 5 years
* Known history of adverse reaction to mepolizumab (Nucala)
* Pregnant females
* Females actively trying to conceive
* Vulnerable study population
* Asthma requiring inhaled cortiosteroids
Determining Relationships Among Maternity Stress & Sleep

Psychosocial factors, including a previous history of depression, recent stressful life events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy have been shown to be associated with an increased risk for the development of postpartum depression (PPD). Biological mechanisms underlying the relationships among these psychosocial risk factors for PPD, and the development of PPD, remain unclear. However, evidence from non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine factors may play a role. The primary objectives of this study are: (1) to assess the feasibility of enrolling second trimester pregnant women, with or without depression histories, into a laboratory-based study protocol which includes a mild psychosocial stressor and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic hormone (ACTH) and cortisol; (2) to assess the feasibility of retaining participants, for a brief postpartum phone interview, after completion of the second trimester assessments; and (3) to establish proof of concept for measuring group differences, between women with or without depression histories, in second trimester prenatal measures of neuroendocrine stress reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* nulliparous women in their 2nd trimester of a singleton pregnancy
* women between 18-45 years of age
* women with a past history of depression
* women with no past history of depression

Exclusion Criteria:

* under 18 years of age
* over 45 years of age
* pregnancy gestation \> 22 weeks at study enrollment
* multiparity
* non-singleton pregnancy
* prior termination of pregnancy at \>12 weeks gestation
* prior loss of pregnancy \>2 times at \<12 weeks gestation
* prior history of stillbirth
* current substance use (alcohol and/or elicit drugs)
* current chronic steroid use
* current use of antidepressants, anti-anxiety medications, mood-stabilizers, psychotropic medications, progesterone treatment, or sleep medications
* current tobacco use
* diagnosed obstructive sleep apnea,
* diagnosed restless legs syndrome (RLS)
* certain cancers
* pre-gestational diabetes
* a body mass index (BMI) of \> 40kg/m2 just prior to pregnancy
* chronic hypertension (documented or taking medication for hypertension)
* gestational hypertension
* preeclampsia
* current anemia
* current or past history of psychosis, schizoaffective disorder,or bipolar disorder
* current depression
ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation

In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb. The device is wearable and light-in-weight for unilateral application during walking. It is hypothesized that with the intervention of the ENMS-BSF the gait pattern of persons after stroke can be improved with long-term rehabilitative effects.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months after the onset of stroke
* Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score \>21).
* Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance.
* Fugl-Meyer Assessment (FMA), total score on the lower limb \<20
* Functional Ambulatory Category (FAC) ≥4
* Berg Balance Scale (BBS) ≥40

Exclusion Criteria:

* The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) \>3.
* Receiving other lower limb rehabilitative interventions at the same time
A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer

This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to:

* Identify the recommended dose of AC682 that can be given safely to participants
* To evaluate the side effects of AC682
* To evaluate pharmacokinetics of AC682
* To evaluate the effectiveness of AC682

This is a Phase I, first in human, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent form (ICF)
* Patients must be ≥18 years-of-age at the time of signing of the ICF
* Female patients must be postmenopausal
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
* Patients with life expectancy ≥3 months
* Patients who have adequate organ functions at baseline
* At least 1 measurable lesion that meets the definition in Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 non-target lesion is required.

Exclusion Criteria:

* Treatment with any of the following: systemic anti-cancer chemotherapy, biologic, or hormonal agent from a previous treatment regimen or clinical study within 4 weeks prior to the first dose of AC682; systemic small molecules from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is longer) prior to the first dose of AC682 (at least 10 days must have elapsed between the last dose of such agent and the first dose of study drug)
* Radiation therapy such as wide-field radiotherapy administered ≤28 days of first dose of AC682
* Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
* Known symptomatic brain metastases requiring the use of steroids
* Any condition that impairs a patient's ability to swallow whole pills. Impairment of gastrointestinal function (GI) or GI disease or other condition at baseline that will interfere significantly with the absorption, distribution, or metabolism of AC682.
* Use of prophylactic growth factors and blood transfusions ≤14 days prior to the first dose of AC682 and during dose limiting toxicity observation period
Music Therapy and Humanization in ED Healthcare Professionals

Background: Healthcare professionals in emergency departments frequently experience stressful situations that could jeopardize their mental health, sense of purpose, and ability to empathize with patients, families, and colleagues.

Research question: What is the impact of a short music therapy program on the intra- and interpersonal factors of humanized care among emergency nursing staff at the University Hospital Fundación Santa Fe de Bogotá (FSFB)? Methodology: This research is a mixed-methods pilot and feasibility study. For the quantitative component, we will apply the HUMAS (Healthcare Professional Humanization Scale) and ProQOL (Professional Quality of Life) measure at the start and at the end of the music therapy program. For the qualitative component, focus group interviews will be conducted and analyzed via thematic analysis.

Discussion: This study seeks to support the nursing staff of the FSFB emergency department through an interactive, creative, and participatory music therapy self-care program focused on one of the most important pillars of the institution: the humanization of care.


Eligibility Criteria:
Inclusion Criteria:

* Be a member of the emergency department nursing staff at the FSFB for a minimum of 6 months.
* Be able to commit to participating in eight music therapy sessions over a four-week period.
* Have the minimum reading skills to understand the questionnaires

Exclusion Criteria:

- Staff with untreated mental health disorders.
Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis

This study evaluates the effect of sublimated mare milk supplement on patients with biliary cholangitis

Primary biliary cholangitis, formerly known as primary biliary cirrhosis, is a rare chronic disease that primarily affects women. Primary biliary cholangitis often progresses to the terminal stage of liver cirrhosis with its inherent complications. At this stage, the only way to save the patient's life is liver transplantation, and is accompanied by a number of painful symptoms (itching, mucous dryness, abdominal discomfort, fatigue), often restless legs syndrome, insomnia, depression and cognitive dysfunction.

The goal of the treatment is to prevent the terminal stage of cirrhosis of the liver and to alleviate the accompanying symptoms. Conventional drug therapy is aimed at slowing the progression of the disease and includes both approved for the use of these medications (ursodeoxycholic acid) and used outside the approved indications (derivatives of fibric acid, budesonide).

The role of this clinical trial is to increase the effectiveness of therapy for this disease. Against the background of the complexity of the treatment of primary biliary cholangitis, clinical medicine acquires a remedy in the form of a natural product - mare's milk, preventive, dietary, medicinal effects of which have been known for a long time. There are data from studies that have shown the efficacy and safety of using mare milk in patients with atopic dermatitis as well as with inflammatory bowel diseases. For the liver diseases, there are no reported studies.

In this trial, there will be two parallel groups: Interventional (supplement with standard treatment first for 3 months) and Standard treatment group. Differences in clinical, laboratory, liver encephalopathy and asthenia will be evaluated between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with morphologically verified diagnosis of primary biliary cholangitis
* Aged 18 to 75 years
* Willingness to consent to participate in the study
* Consent to adhere to treatment

Exclusion Criteria:

* Alcohol and/or drug dependence
* Presence of liver cirrhosis class C based on Child Pugh classification
* Allergic reaction to dairy products
* Presence of mental diseases, severe concomitant pathology
* Pregnancy and/or lactation
* Lactose intolerance
* Refusal to participate in the study
Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma

This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.


Eligibility Criteria:
Inclusion Criteria (condensed):

* Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
* Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, \>5% bone marrow plasma cells.
* Adequate vital organ function as indicated by ANC (\>1000/uL), platelet count (\>50,000/uL), hemoglobin (\>8 g/dL), serum ALT and AST (each \<3.0 x upper limit of normal), total bilirubin (\<2 mg/dL), creatinine clearance (\>30 mL/min), and cardiac ejection fraction (\>45%)

Exclusion Criteria (condensed):

NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary

* Active plasma cell leukemia
* Pregnant or lactating
* Active, uncontrolled infection
* Active and severe auto-immune disease
* Active arrhythmia, or obstructive or restrictive pulmonary disease
* Central nervous system disease
Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry

Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant.

Because of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the implementation of a BIA-ALCL case registry, in connection with a national Multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire nationale de recours- RCP).

This registry is opened in France and in Belgium


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with an anaplastic large cell lymphoma associated with breast implants

Exclusion Criteria:

-
NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal

This research is being done to find out if aerobic exercise is beneficial in reversing scarring. Physical activity has been shown to increase fitness in healthy individuals as well as in those with NASH. This research will allow for better understanding the effects of physical activity on fitness and endothelial function in patients with NASH with the goal of reversing scarring.

Approximately 12 people will take part in this research study at Penn State (PSU) Milton S. Hershey Medical Center (HMC), Penn State Physical Medicine \& Research (PM\&R) Laboratories housed at the Hershey Center for Applied Research (HCAR) and the Penn State University Fitness Center (UFC).

Preliminary studies show universally low cardiorespiratory fitness (CRF) in Nonalcoholic steatohepatitis (NASH) patients was dependent on body composition. The proposed work is based on the hypothesis that gains in cardiorespiratory fitness and improved endothelial function achieved through exercise can arrest or reverse progression of hepatic fibrosis, lessen cardiovascular disease risk (CVD), and improve all-cause mortality in patients with NASH. The aims of this research proposal are designed to characterize and better understand the effects of physical activity (PA) on CRF and endothelial function in patients with NASH. The goal is to arrest progression of fibrosis and reduce CVD risk. This proposal includes a cross-sectional study and a small pilot clinical trial in a high-risk subgroup of NASH most likely to benefit from PA.

Eligibility Criteria:
Inclusion Criteria

•Enrollment and completion of IRB study # 00011797

Exclusion Criteria

* Inability to provide informed consent
* Institutionalized/prisoner
* Non-English-speaking patients due to unavailability of translators for all visits/sessions
Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial

Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pain. it is shown that it increases health costs related to longer recovery times, longer hospital stay and related complications such as the increased risk of presenting chronic POP pain, which it has been estimated up to 20%, much higher if the surgery involves surgery in the gastrointestinal system.

The goal of analgesia in the postoperative setting is precisely to provide comfort to patients, minimize adverse effects and complications arising from the procedure.

The epidural analgesic technique (has been proposed as an analgesic management standard, since multiple studies have shown that it reduces opioid consumption, improves recovery and is a useful strategy for pain control. However, it is an invasive technique, with risk of complications such as hematomas and epidural abscesses, and it may be difficult to perform.

Currently it has been shown in multiple studies that the intravenous infusion of a local anesthetic, such as lidocaine, in this type of surgical scenarios can reduce the intensity of pain, opioid consumption, hospital stay and ileus with few adverse effects. In addition, these studies propose that, being a less invasive technique, it could be easier to implement and even be safer than the epidural technique.

The main hypothesis of this study is precisely that the infusion of lidocaine may be non-inferior to epidural analgesia in the analgesic management of patients undergoing major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years.
* Elective major open intra-abdominal surgery:

  * Cholecystectomy.
  * Total or subtotal gastrectomy.
  * Colectomy or Hemicolectomy.
  * Pancreatoduodenectomy.
  * Hepatectomy 1 or 2 segments.
  * Exploration and / or reconstruction of the bile duct.
  * Abdominal demolition.
  * Sigmoidectomy.
* Patient classified as ASA (American Association of Anesthesiology) 1, 2 or 3.

Exclusion Criteria:

* Pregnant woman
* Patient with contraindication for epidural analgesic techniques:

  1. Anticoagulated patient
  2. Active infection in the puncture site.
  3. Malformation in spinal cord.
  4. Sepsis without antibiotic treatment.
  5. Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
  6. Patient with known allergy to opioids and / or local anesthetics.
  7. Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
  8. Patient with liver failure or terminal renal failure.
  9. Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
  10. Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
  11. Patient who was technically impossible to place an epidural catheter in surgery.
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B

The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.


Eligibility Criteria:
Inclusion Criteria:

* The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B
* Aged 18 to 65 years old，male or female
* Patients with previously HBsAg-positive lasted for 6months at least：HBeAg-positive subjects, HBV-DNA\> 105copies/ml； HBeAg-negative subjects, HBV-DNA\> 104copies/ml.
* 2 times the upper normal limit (2 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
* Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
* Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
* WBC ≥ 3.5 × 109 / L, PLT ≥ 80 × 109 / L, serum albumin (ALB)≥ 35 g / L.
* Creatinine (Cr) ≤ 1× ULN，serum phosphate was normal.
* Patients signed an informed consent form and compliance was good.

Exclusion Criteria:

* Patients were infected with other viruses as HAV, HCV, HEV, HIV etc.
* Patients with cirrhosis or liver cancer.
* Pregnant woman, lactating women .
* Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
* Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
* Patients allergic for study drug.
Effect of Cancer Nurse Navigators on Patient Outcomes

There is widespread anecdotal evidence that Cancer Nurse Navigators (CNNs) are highly valued by cancer patients, but no studies have evaluated the effects of CNNs on important patient-reported outcomes or indicators of quality of care. This study has two aims:

1. To assess the feasibility of studying the impact of Aurora CNN Program.
2. To pilot test the effects of CNN services on patient-reported outcomes and indicators of quality of care.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (18 years of age or older)
2. Treated at Aurora St. Luke's or West Allis Medical Center
3. New or recurrent dx of lung, prostate, colorectal or breast cancer -

Exclusion Criteria:

1. Previously received CNN services at an Aurora treatment facility
2. Unable to read/write in English
3. Living in a nursing home/long term care facility
4. Not capable of completing study questionnaires -
Deep Learning-enhanced Personalized Monitoring of Aortic Stenosis - The DETECT-AS Prognostic Study

This study will evaluate the validity of a digital biomarker score for precision risk stratification among older adults with aortic sclerosis or mild aortic stenosis (AS) at three US health systems.


Eligibility Criteria:
Inclusion Criteria:

1. Age 65 years or older
2. Prior transthoracic echocardiogram within the past 2-3 years showing aortic sclerosis without stenosis or mild AS

Exclusion Criteria:

1. Opted out of research studies
2. Non-English speaking
3. Any echocardiogram within 24 months of medical record review.
4. Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
5. Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
6. Prior heart transplant
7. History of dementia
8. Unable to attend study visit at echocardiogram lab within four years of most recent echocardiogram.
9. Documented life expectancy of \<1 year or current participation in hospice services