cyrilzakka/clinical-trials huggingface dataset:
IMPaCT (Individualized Management Towards Patient-Centered Targets)

The investigators propose a pilot randomized controlled trial of a care transitions intervention in which trained Community Health Workers will act as supports for socioeconomically vulnerable patients who are being discharged from the Hospital of the University of Pennsylvania and Presbyterian Hospital. CHWs or IMPaCT Partners will help patients to overcome the challenges of transition, including arranging primary care provider (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based social services. As our primary outcome, the investigators will examine the effect of the IMPaCT intervention on rates of primary care follow-up. The investigators will also examine the effect of IMPaCT on secondary outcome variables including patients' satisfaction with the experience of transition, quality of discharge communication, medication adherence, self- rated health, and inpatient readmission within 30 days after discharge.


Eligibility Criteria:
Inclusion Criteria:

1. Participant admitted to the General Medicine services of the Hospital of the University of Pennsylvania (HUP), or Presbyterian Hospital during the enrollment period
2. Participant uninsured or insured by Medicaid at the time of discharge from the hospital
3. Participant is 18-65 years old
4. Participant is willing to participate and be contacted at 14 days post-discharge by telephone or through a home visit by research personnel (if no functioning telephone is present in the household)
5. Participant resides in one of the following zip codes: 19104, 19131, 19139, 19143, 19146. These zip codes have the highest frequency of readmissions to HUP and Presbyterian Hospital
6. Participant is English speaking

Exclusion Criteria:

1. Patients with insurance other than Medicaid will be excluded as they are outside of the population of interest for this intervention targeted specifically at socioeconomically vulnerable patients. Dual eligible patients (Medicaid and Medicare) will be excluded. Patients older than 65 are eligible for the Transitional Care Model Intervention, which is a separate intervention offered at Penn Medicine hospitals.
2. Non-English speaking participants will be excluded because in this pilot study, the study only has English-speaking PaCT personnel. In future studies, it will be important to study the effect of PaCT in non-English speaking populations.
3. Patients outside of the target zipcodes are being excluded for feasibility reasons during this pilot study: with only two PaCT Partners, we are choosing to focus our resources on a geographic area that has the highest rates of readmissions in order to facilitate home visits.
A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome

The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to:

* Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion of patients with CIS converting to CDMS
* Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS


Eligibility Criteria:
Inclusion Criteria:

* Subject must have experienced a first clinical episode suggestive of demyelinating disease
* Subject must present with an abnormal MRI displaying at least 3 T2 weighted hyperintense lesions typical of multiple sclerosis (MS)
* Subject must be greater than or equal to 18 years old
* Subject must have had onset of the clinical attack within the last 120 days
* Subject must give written informed consent
* Female subjects must be neither pregnant nor breast feeding, and must not be of child-bearing potential as defined by either:
* Being post-menopausal or surgically sterile
* Using hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study

Subjects electing treatment:

* Subject must be eligible for Interferon-beta 1-a therapy

Exclusion Criteria:

* Subject has evidence of other neurological diseases that could explain his/her symptomatology
* Subject is pregnant or in lactation
* Subject suffers from an intercurrent autoimmune disease
* Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the procedures required by this study
* Subject has received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, campath), within 12 months of study day 1

Subjects electing treatment:

* Subject has inadequate liver function, defined by total bilirubin, aspartate transaminase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \> 2.5 times the upper limit of normal values
* Subject has inadequate bone marrow reserve, defined as white blood cell count less than 0.5 times the lower limit of normal
* Subject has a known allergy to IFN or any of the excipients of the drug product
Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Neck Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study

This randomized, prospective study aims to evaluate the effectiveness and cost-efficiency of a Virtual Reality (VR)-assisted hypnotherapy program on quality of life in patients with chronic neck pain. The study compares a VR-assisted hypnotherapy group to a standard treatment group. Both groups will undergo a conventional physical therapy program supervised by physiotherapists for 3 weeks (15 sessions). The VR-assisted hypnotherapy group will receive additional sessions utilizing the HypnoVR software, which delivers relaxing virtual environments. Outcomes will be assessed immediately after treatment, at 1 month, and at 3 months post-treatment. Primary endpoints include pain reduction measured by the Visual Analog Scale (VAS). Secondary endpoints include functionality, quality of life, anxiety, depression, sleep quality, healthcare costs, and treatment adherence. Statistical analyses will determine the efficacy and economic impact of this innovative therapy for chronic neck pain management.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 80 years.
* Chronic neck pain lasting for more than 3 months.

Exclusion Criteria:

* History of spinal surgery.
* Beck Depression Inventory (BDI) score \>16.
* Presence of neurological deficits or concurrent neurological diseases.
* Medical conditions incompatible with the use of VR headsets (e.g., vision problems, epilepsy).
* Pregnancy.
* Recent changes in medication for chronic pain within the past 3 months (e.g.,- Pregabalin, Gabapentin, Duloxetine).
INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy
* Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
* Willing to provide fresh or archival tumor tissue for correlative studies.
* Eastern Cooperative Oncology Group performance status 0 to 1.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

* Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
* Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
* Laboratory values outside the protocol-defined range at screening.
* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
* Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
* Evidence of interstitial lung disease or active, noninfectious pneumonitis.
Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)

The goal of this study is to determine safety and tolerability and of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure and to study the preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.

In this study 9 patients with the diagnosis of premature ovarian failure will participate.

The patients will be divided randomly in 3 groups, each group contains 3 patients. First group will receive 5 millions of ADSCs, second group receive 10 millions cells and the third group receive 15millions of ADSCs.

Stem cell Transplantation method is intraovarian injection of ADSCs which will be performed under guidance of transvaginal sonography.

All the patients will be followed for 12 months after cell injection to evaluate any adverse events .

Eligibility Criteria:
Inclusion Criteria:

* female
* Age : 20-39
* FSH\>20

Exclusion Criteria:

* liposuction contraindication
* thyroid dysfunction
* immune system disease
* past history of cancer , chemotherapy , radiotherapy
* HIV+, hepatitis B, C
* Severe endometriosis
Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels

The serum procalcitonin levels are important during infections and sepsis. The investigators aimed to assess its predictive value in terms of post-cesarean wound infection.

The serum procalcitonin levels are important during infections and sepsis. Recent studies showed that serum procalcitonin levels are more sensitive than serum CRP levels.The investigators aimed to assess its predictive value in terms of post-cesarean wound infection. The serum procalcitonin levels are aimed to measure in participants who had cesarean section and developed surgical site infection. The investigators aimed to compare the serum procalcitonin levels between the patients who need secondary suture and the patients who did not need secondary suture.

Eligibility Criteria:
Inclusion Criteria:

* who developed surgical site infection after their cesarean sections.
* 18-40 years old

Exclusion Criteria:

* history of chorioamnionitis and premature rupture of membranes
* urinary tract infections
* any infectious condition other than surgical site infection
Impact of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen

The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.

Serum prostate-specific antigen (PSA) is widely used as a screening marker for prostate cancer. However, elevated serum PSA level could result from various conditions other than malignancy such as benign prostatic hyperplasia (BPH), urinary tract infection, or inflammation (prostatitis). Inflammation within the prostate is often sub-clinical, not readily visible on urinalysis, and can putatively and artificially elevate PSA. Non-steroidal anti-inflammatory drugs (NSAIDs) have shown benefits in reducing symptoms in patients with inflammatory conditions of the prostate. Ibuprofen (Advil, Motrin) is a widely available, cheap, and commonly used over the counter NSAID. NSAID's are routinely given to men with an elevated PSA for empiric treatment of inflammation; however, the impact of NSAIDs in men with elevated serum PSA is unknown.

Eligibility Criteria:
Inclusion Criteria:

* Male patients age between 18-80 years old with a screening PSA \> 3 ng/ml being considered for additional diagnostic testing (e.g., MRI, biopsy)
* Normal digital rectal examination.
* No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)

Exclusion Criteria:

* Active urinary tract infections or bacteriuria
* Known prostate cancer
* Urethral catheter within the last 6 weeks
* History of hypersensitivity or allergy to ibuprofen or NSAIDs.
* Known severe chronic kidney disease: eGFR \< 30 mL/min/1.73 m2
* Known history of severe liver disease (elevated AST or ALT greater than 3 times upper limit of normal)
* History of gastrointestinal bleeding or NSAIDs induced GI adverse events
* Concomitant dual-antiplatelet use or anticoagulants
* Concomitant anti-inflammatory or steroidal drugs
* Known bleeding disorder(s)
* Patients with a solitary kidney or history of a kidney transplant
* Any other medical contraindication to NSAIDs
Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability

Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.


Eligibility Criteria:
Inclusion Criteria for patients who have been in intensive care :

* Diagnosed with Covid-19
* Ventilated in ICU for at least 3 consecutive days
* ICU discharge between 4 and 8 weeks
* Approval received from a physician
* Command of the French language

Inclusion Criteria for patients who have NOT been in intensive care :

* Diagnosed with Covid-19 : positive serological test or positive PCR test following nasopharyngeal swabbing
* Approval received from a physician
* Command of the French language

Exclusion Criteria:

* Taking neuroactive substances that can alter corticospinal excitability
* Patients with co-morbidities leading to significant fatigue: e.g. cancerous pathologies, sleep apnea
* Patients with neurodegenerative or neuromuscular disease
* Contraindication to the application of a magnetic field
* Contraindication to the practice of Magnetic Resonance Imaging
* Participant is pregnant
* Patients with psychiatric disorders
* Paraplegic and hemiplegic patients
* Addictive disorders
The Effect of a Weight-Loss Diet in Women Doing Reformer Pilates: A 12-Week Evaluation

The purpose of this study is to determine the effect of a weight-loss diet on body composition in women who practice reformer pilates for 12 weeks. It compares dietary habits and macro and micronutrient intakes in subjects with and without a weight-loss diet at the start and end of the study.

The effect of a weight-loss diet on body composition in women reformer pilates for 12 weeks was compared in this study. It compares dietary habits and macro and micronutrient intakes in subjects with and without a weight-loss diet at the start and end of the study.

A total of 49 women (18 years old) were randomly assigned to one of two groups: control (CG: reformer pilates; n=23) or study (SG: reformer pilates + weight-loss diet; n=26). Subjects in both groups did pilates for 45 minutes three times a week for a total of 12 weeks. At the start and end of the study, their body weight (kg), waist circumference (cm), hip circumference (cm), neck circumference (cm), mid-upper arm circumference (cm), and body composition \[body fat (% ), body water (% ), body muscle (% )\] were all measured. Their waist/height ratio and body mass index (kg/m2) were also measured at the start and end of the study. All subjects' dietary habits were questioned, their 24-hour retrospective food consumption was recorded, and their physical activity levels were assessed using the International Physical Activity Questionnaire (Short Form).

Eligibility Criteria:
Inclusion Criteria:

* Agree to participate in the study
* Being in the age range of 18-65
* Female
* Not a regular Pilates practitioner, and physically independent to perform basic daily activities

Exclusion Criteria:

* Refuse to participate in the study
* Being younger than 18 or over 65
* Male
* A regular Pilates practitioner
* Not being suitable for physical activity
A Study of LY3202626 in Healthy Participants

The purposes of this study are to determine:

* If there are any differences in the way LY3202626 is handled by the body when taken in two different forms
* Whether a high fat meal affects the way the body handles LY3202626
* How well tolerated LY3202626 is

There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.

The study will last about 50 days, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Female participants must be of non-childbearing potential confirmed by medical history or menopause
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion Criteria:

* Are investigative site personnel directly affiliated with this study and their immediate families
* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Have a history of head trauma with loss of consciousness within the last 5 years
* Have known or ongoing psychiatric disorders
Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women

Iron deficiency and vitamin D deficiencies are common in menstruating women. The present assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron pyrophosphate) or with iron and vitamin D3 in iron deficient women on:

* Iron metabolism
* Biomarkers of bone remodelling
* Cardiovascular risk indexes


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker or smokers of ≤ 3 cigarettes/day
* Non-pregnant
* non-breast-feeding
* Serum ferritin \<30ng/mL
* Haemoglobin ≥11g/dL

Exclusion Criteria:

* Amenorrhea
* Menopause
* Any known health problems likely to influence iron status including iron-metabolism-related diseases (iron deficiency anaemia, thalassaemia, haemochromatosis)
* Chronic gastric diseases (inflammatory bowel disease, Crohn disease, gastric ulcers, celiac disease, hemorrhagic diseases)
* Renal disease or allergy to some of the components of the assay diary product.
* Blood donors
* Have regularly consumed iron or ascorbic acid supplements within the four months prior to participating in the intervention.
Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms

Thoracic aortic aneurysms (TAA) are considered "silent killers" because they scarcely display any symptomatology, but are correlated with significant mortality and morbidity. Current guidelines regard aortic aneurysm disease as a coronary artery disease equivalent and suggest aspirin and statin use to reduce the progression of atherosclerosis, as well as beta-blocker (BB) therapy. No therapy, however, is effective at limiting aneurysm expansion and preventing rupture, even in large trials. TAA has emerged as an inflammation-mediated disorder. Angiotensin-converting enzyme inhibitors (ACEIs) can reduce the wall shear stress and inflammation, both of which play vital roles in the expansion of the aneurysm.

The study will be a randomized, double-blind trial. Patients will be randomized into one of two parallel arms, receiving captopril or atenolol. The doses of captopril and atenolol will be 25 mg daily for the first 15 days, rising to 100 mg according to clinical tolerance and BP estimates. The sample size will be set at 424 subjects (212 per group). The primary end-point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months of therapy with captopril vs. atenolol.

BBs have not been precisely found to decrease aneurysm growth rates. ACEIs could lead to the prevention of aneurysm degeneration through their antihypertensive and anti-inflammatory properties.

The results of this trial will clarify that ACEIs are superior to BB therapy in reducing the growth rate of TAAs, the rate of change in aortic insufficiency, the time to aortic rupture or dissection, the need for aortic surgery or intervention, and death.


Eligibility Criteria:
Inclusion Criteria:

All adult men or women, aged at least 70 years, with TAA 3.0-5.5 cm in diameter measurements according to magnetic resonance imaging (MRI) of the aorta and with a systolic BP \< 150 mmHg will be eligible for inclusion in the study.

Exclusion Criteria:

Patients already receiving an ACEI or BB daily, patients with known renal artery stenosis (\> 50%), patients incapable of providing informed consent, history of aortic dissection, angioedema or any intolerance to ACEIs or BBs, asthma, pregnancy, frailty, respiratory failure, and renal failure.
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects

This is a prospective randomized study compared with active control arm.

This is a prospective randomized study compared with active control arm. The investigators compare the pupil size in subject when 30 minutes after administering IP (CTO0303 or active control).

Eligibility Criteria:
Inclusion Criteria:

* Pediatric or adolescent subjects those who get a written consent both whom and their parents (or legally acceptable representative)
* Pediatric or adolescent subjects aged 4 to 15 years old based on date of written consent

Exclusion Criteria:

* Subjects with a history of severe systemic reaction or increased sensitivity to atropine
* Subjects with anterior segment disease that interferes with ophthalmological examination (ex. corneal scar, corneal opacity and others)
* Subjects administered mydriatic medication within 14 days prior to administration of Investigational Product
* Subjects with contact lens