cyrilzakka/clinical-trials huggingface dataset:
Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

The purpose of this study is:

* To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
* To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.

Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven idiopathic membranous nephropathy
* Nephrotic syndrome with proteinuria ( \> 4 g/day) and serum albumin \< 30 g/dl
* Age 18-60 years with informed consent

Exclusion Criteria:

* Patient with abnormal liver function tests
* Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
* Active/serious infection
* Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
* Patient who is diabetic
* Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center

The aim of this study is to establish an innovative Cardiac Tele-Rehabilitation (CTR) model. It could expands assistance resources through coordination with public administrations, developing a physical exercise program (PEP) assistance model in phase II that resolves the current situation of lack of adherence in the PEP due in part to the long waiting time to start it. To sum up this study could improve adherence in Cardiac Rehabilitation Phase III. It represents an opportunity to validate an innovative model for the realization of the PEP for phase II that could be expanded to other centres.

Cardiac Rehabilitation (CR) programs show benefits in cardiovascular morbidity and mortality, exercise capacity, risk factors and quality of life. The use of new information and communication technologies (ICT) allows remote monitoring of activity and rhythm, defining a new model of cardiac tele-rehabilitation (CTR) and proving to be safe.

The investigators intend to evaluate a new model of CR in Phase II in acute coronary syndrome (ACS), based on the implementation of the physical exercise program (PEP) in a public sports centre (PSC) with tele-monitoring by means of a wearable electronic device, S-PATCH3-Cardio, to compare the adherence of a PEP based on a CTR-PSC model with the traditional in-hospital program (PEP-H) maintaining the efficacy and safety of the CR program.

Patients with recent stratified ACS of low and / or moderate risk will be included who will be randomly assigned to the PEP-H group who will perform 18 PEP sessions with strength training and cardiorespiratory resistance in a hospital, or a CTR-PSC group that performs the 18 sessions of the PEP with strength training and cardiorespiratory resistance in the PSC.

All patients will perform the rest of the CR program at the hospital that it includes: functional tests, consultations with nurse, cardiologist, rehabilitation doctor, and the educational program, with 10 Workshops in a Cardio-healthy Classroom.

Eligibility Criteria:
Inclusion Criteria:

* Recent ACS (1-12 months) of low / moderate risk for the realization of a PEP and without physical impediments for it
* Availability of a mobile phone with Android operating system where you can install the S-PATCH3-Cardio application
* Patients who recognize that they are trained to operate the S-PATCH3-Cardio device after being instructed in its operation and perform a 24-hour simulation.
* Signature of informed consent

Exclusion Criteria:

* Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient\> 1.1)
* Mental disability
* Associated comorbidity that prevents performing PEP
Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

We expect that in laparoscopic gastro-intestinal surgery, a single shot spinal with bupicavaine/morphine will result in a better analgesia in hte first 48 hours. Herby the patients will require less systemic opioids, which will decrease the side-effects. Furthermore, we expect the patients to recover quicker and show an earlier mobilisation and a shorter hospital stay.

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic Gastro-intestinal surgery

Exclusion Criteria:

* Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery
Opioid-Free Anesthetic for Tonsillectomy

Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic

Objectives:

Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy.

Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy.

Study Design: Prospective, randomized, multi-center trial study

Study Interventions and Measures:

Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group

The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 2 to 18 years.
2. American Society of Anesthesiologists {ASA) ≤ 3 physical classification system
3. Girls after menarche must have a negative pregnancy test.
4. Scheduled tonsillectomy or tonsillectomy combined with adenoidectomy and/or ear tube placement at the Children's Hospital of Philadelphia (CHOP) main or ambulatory surgical centers.
5. Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

1. Current (Within the last 30 days) opioid use for pain control
2. High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis
3. Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement
4. History of drug abuse, chronic pain, bleeding disorder
5. Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated
6. Significant congenital disorders, medication allergies or comorbidities, specifically a pre-disposition to bradycardia or conduction abnormalities, cyanotic cardiac disease and use of medications that would increase risk of bleeding or bradycardia.
7. History of hepatic dysfunction, renal dysfunction, thrombocytopenia, or anemia (including pre-surgery laboratory abnormalities)
8. History of hypersensitivity to NSAIDs
9. Patients with asthma, including patients who have experienced aspirin- or NSAID-sensitive asthma or a history of exacerbation when aspirin or NSAIDs are administered (e.g. bronchospasm, urticaria, etc.)
10. Subjects receiving medications that could impact metabolism of either study drug should also be excluded
11. Trisomy 21 diagnosis
12. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
13. Patients on a Ketogenic diet
14. Parents or subjects who do not speak English
Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

The aim of this study is to retrospectively investigate the effect of combined modality treatment of pediatric hepatoblastoma and the factors affecting the prognosis in accordance with the experience at the pediatric oncology department at South Egypt Cancer Institute.

Background:

Hepatoblastoma (HB) is the most common malignant liver tumor in children, with an incidence of 0.7 to 1 per million children \<15 years of age. Till 1970s, surgery was the primary modality of treatment of HB. Unfortunately, up to 60% of the patients present in an unresectable stage. Later, the chemo- responsiveness of the tumor was demonstrated which led to the incorporation of adjuvant chemotherapy with cisplatinum and doxorubicin in the treatment of HB. International Society of Pediatric Oncology (SIOP) pioneered the concept of neoadjuvant chemotherapy in the management of HB.

Patients \& Methods:

In the period from 2002 January till 2016 January, retrieval \& analysis of the medical records of pediatric patients with hepatoblastoma will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. After pathologic confirmation of the diagnosis, these data will be categorized according to patients' demographics, presenting features, laboratory studies, including tumor markers \& histologic subtype, radiographic evaluation, disease staging, treatment course given, and subsequent treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age less than 19 years.
* Patients diagnosed with hepatoblastoma.

Exclusion Criteria:

* Patients whose age more than 18 years.
A Study for Type 2 Diabetic Patients

The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
* Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
* Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
* Able to perform self monitoring of blood glucose

Exclusion Criteria:

* Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
* Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
* Have a body mass index greater than 35 kg/m2
* History or presence of kidney disease
* Have cardiac disease (Class III or IV)
A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients

this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment


Eligibility Criteria:
Inclusion criteria

1. Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC patients who have received or been intolerant to at least one prior line of standard treatment.
2. No EGFR mutation or ALK rearrangement.
3. ECOG PS score 0 or 1.
4. BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
5. Body weight ≥ 60.0kg and ≤ 75.0kg.
6. Adequate organ function per protocol-defined criteria.

Exclusion criteria

1. Exposure to any anti-PD-1, PD-L1, PD-L2 antibodies.
2. Allergic to any component of sintilimab.
3. Active autoimmune diseases.
4. Clinically unstable central nervous system metastasis.
Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Mixed Hyperlipidemia and Two or More Risk Factors

To measure the percentage of patients who achieve all the treatment lipid goals being treated with ezetimibe/simvastatin 10/20 with or without MK0524A (1-2 g/day).

Patients will receive placebo for 4 weeks, then Vytorin 10/20 mg for 6 weeks, if efficacy of treatment is achieved, they will continue with Vytorin 10/20 mg + placebo for 12 more weeks, if not achieved, will receive Vytorin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with Vytorin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive Vytorin 10/20 mg + MK0524A 2 gr for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient Without Ischemic Cardiovascular Disease Who During The Treatment With Statin Have LDL-C \<130 Mg/Dl at Visit 1 Or Within The 6 Month Period Before Visit 1

Exclusion criteria:

* The use of any other lipid lowering agent
* Life expectancy lower than a year.
* Any condition that may interfere with the adherence to the study protocol
A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis

The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years or older who have given written Informed Consent
* Patients with proven ulcerative colitis
* Active disease course for the last 6 weeks or longer with bloody diarrhea
* Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine.

Exclusion Criteria:

* Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
* Crohn's disease,
* Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis,
* Treatment with other investigational medicinal product within 3 months prior to study entry
Cannabis and Parkinson's Disease Tremor: A Natural History Study

This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor.

Ten individuals with Parkinson's disease (PD) and tremor who use Cannabis were observed for two weeks. Individuals were asked to keep a journal of Cannabis use (form, delivery method, amount) and wear an accelerometer on the wrist with the dominant tremor. Analyses will be performed to describe whether Cannabis use affects PD tremor following use.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's Disease
* Presence of PD-related tremor
* Currently using Cannabis for management of tremor
* Obtaining Cannabis in accordance with Washington State law
* Willing to log activities and experiences
* Willing to wear a motion sensor
* Able to attend 2 on-site visits

Exclusion Criteria:

* Presence of active infection within 5 days prior to enrollment
* Presence of unusual stressor within 5 days prior to enrollment
* Pregnancy
Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)

This is a retrospective external field study of a novel in vitro diagnostic (IVD) assay (ImmunoXpert™).

The study will involve reviewing the medical charts of about 4500 pediatric patients that were tested using ImmunoXpert™ as part of the routine workup for acute febrile illness.

ImmunoXpert™ uses a computer algorithm to combine immunoassay measurements of three host immune proteins (TRAIL, IP-10, and CRP) present in human blood. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection.

Statistical analysis will be performed to compare the diagnostic accuracy of ImmunoXpert™ with that of current practice lab testing e.g., WBC, CRP, and PCT (whichever were taken as part of routine care) and clinical suspicion at time of requisition.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 3 month to 18 years that were admitted due to acute febrile illness, and ImmunoDx test was taken as part of their workup.

The febrile illness should also fulfill the following criteria:

* The patient had a peak temperature ≥38°C (AND)
* Symptoms initiated ≤ 7 days before sampling (AND)
* A retrospective diagnosis of bacterial or viral or mixed infection was anonymously determined by a panel of three independent senior pediatricians.

The non-infectious disease control group will include:

* A retrospective diagnosis of a non-infectious disease was anonymously determined by a panel of three independent senior pediatricians physicians.
* Patients with a non-infectious disease ( and ImmunoDx test was wrongly taken)

Exclusion Criteria:

* Samples from patients who had one or more of the following criteria will be excluded from the study:
* Another infection episode during the last 3 weeks before sampling
* Congenital immune deficiency (CID)
* A proven or suspected HIV-1, HBV, HCV infection
* Active hematological malignancy
* Current treatment with immune-suppressive or immune-modulating therapies including without limitations:
* Use of high dose steroids \>1 mg/kg/day prednisone or equivalent in the last two weeks
* Monoclonal antibody administration
* Intravenous immunoglobulin (IVIG)
* Other illnesses that affect life expectancy and/or quality of life
* Suspicion of gastrointestinal infection
Field Triage of Older Adults Who Experience Traumatic Brain Injury

Our overall goal in this proposed study is to describe the current prehospital trauma triage process for older adult (age≥55) patients with suspected Traumatic Brain Injury (TBI), to identify the effect of certain medications (anticoagulants and platelet inhibitors) on TBI-related need for trauma center services, and to identify novel TBI screening strategies that are feasible for use in the prehospital setting.

Traumatic brain injury (TBI) is major source of disability and death for older adults. Of particular concern is that older adults most frequently sustain TBIs after low-mechanism injuries, such as falls from standing height, and frequently use anticoagulants and platelet inhibitors, which place them at risk for worse clinical outcomes. With the growth of the older adult population and the expanding use of anticoagulants and platelet inhibitors, TBI among older adults will continue to be a major source of morbidity and mortality unless methods are identified to improve outcomes in this unique population.

Building upon our long-standing and highly successful EMS research laboratory that has specifically focused on the triage of injured patients and the prehospital care of older patients and employing a combination of qualitative and quantitative methods, we will collect data from a large, multi-county catchment area that includes multiple EMS agencies, urban and rural environments, as well as trauma centers and non-trauma centers. In this study, we will: 1) identify candidate neurologic scales to maximize detection of high-risk older adult TBI patients; 2) characterize the current trauma triage process used by EMS providers to identify older patients with suspected TBI and patients taking anticoagulants and/or platelet inhibitors; 3) assess the public health burden of TBI among older adult EMS patients taking anticoagulants and/or platelet inhibitors; 4) assess the predictive ability of novel prehospital-based neurologic screening strategies to identify high-risk older adult TBI patients in the prehospital setting who require TBI-related trauma center care. Findings from this study have the potential to shift clinical practice in the prehospital setting by informing future recommendations for the identification of TBI among older adults taking anticoagulants or platelet inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* EMS Provider arriving with a patient who is injured \>=55 years old

Exclusion Criteria:

* No systematic exclusions
Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk

Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients who underwent elective coronary percutaneous intervention with a zotarolimus eluting stent versus a sirolimus eluting stent and short Dual Antiplatelet Therapy (DAPT).


Eligibility Criteria:
Inclusion Criteria:

Patients 18 years old or older with an ischemic de-novo lesion(s) in coronary artery or coronary bypass graft suitable for percutaneous coronary intervention, in context of acute coronary syndrome or chronic coronary syndrome with evidence of ischemia by non-invasive study or pressure guidewire that can be treated by DES, and has at least 1 major or 2 minor Academic Research Consortium High Bleeding Risk criteria:

Major criteria:

* 1. Anticipated use of long-term oral anticoagulation
* 2. Severe or end-stage Chronic Kidney Disease (CKD) (eGFR \<30 mL/min)
* 3. Hemoglobin \< 11 g/dL
* 4. Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent.
* 5. Moderate or severe baseline thrombocytopenia (\<100,000/uL)
* 6. Chronic bleeding diathesis
* 7. Liver cirrhosis with portal hypertension
* 8. Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
* 9. Previous spontaneous intracranial hemorrhage
* 10. Previous traumatic intracranial hemorrhage within the past 12 months
* 11. Presence of Brain Arteriovenous malformation (AVM)
* 12. Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months
* 13. Non-deferrable major surgery on DAPT
* 14. Recent major surgery or major trauma within 30 days before PCI

Minor Criteria:

* 1. Age 75 years old and older
* 2. Moderate CKD (eGFR 30-59 mL/min)
* 3. Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women
* 4. Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion
* 5. Long term use of NSAIDs or steroids
* 6. Any ischemic stroke at any time not meeting major criterion

Exclusion Criteria:

* STEMI undergoing primary PCI
* Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI
* Unprotected left main lesion
* Reference diameter larger or shorter than available stents
* Life expectancy \< 12 months
* In-stent restenosis o thrombosis of previous stent
* Inability to give written consent