cyrilzakka/clinical-trials huggingface dataset:
Cost-Effectiveness of Web-Based Follow Ups

Complications following total joint arthroplasty are rare, and the majority of follow-up visits are routine. The technology now exists to conduct annual follow-up assessments without having to physically see the patient.

This study will investigate the cost-effectiveness of web-based follow-up assessments compared to standard in-clinic follow-ups. We will also assess patient satisfaction, preference, and the validity of the web-based follow up assessments. Patients coming up to their 1 year follow-up or greater will be randomized to either the web-based group or the usual care group.

Web-based patients will complete all questionnaires using an online database system, and have their x-ray taken at their local radiology facility. The surgeon will review radiographs online. If there are any concerns with the x-ray or responses to questionnaires, arrangements will be made for the patient to be seen at the clinic. Patients in the Usual Care group will come into the clinic for their follow-up assessment and have their x-ray taken at University Hospital as usual.

Online assessment could significantly decrease wait times in orthopaedic clinics, as well as increase availability for OR time and new consultations. This approach could also potentially reduce patient burden by decreasing travel distances, financial burden and time requirements.


Eligibility Criteria:
Inclusion Criteria:

* patients who have had a primary total hip or total knee arthroplasty

Exclusion Criteria:

* patients with osteolysis, or previous complications from their joint replacement
Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

The goal of this prospective cohort study is to evaluate the neurologic changes in patients that received transapical beating-heart septal myectomy. The main questions are: whether this novel operation way would cause neurologic impairment; whether this novel operation way have similar neurologic lesions, compared to other cardiac surgery ways. Participants will undergo detailed neurologic and cognitive assessment at baseline, after procedure, and at 30 days. Researchers will compare the clinically relevant manifestations and brain lesions measured by cognitive evaluation forms of the nervous system (i.e. Montreal cognitive assessment) and diffusion-weighted magnetic resonance imaging (DW-MRI) to assess the safety of transapical beating-heart septal myectomy on nervous system.

Nervous system complication is one of the common complications caused by cardiac surgery, including ischemic stroke, encephalopathy, neurocognitive dysfunction, which can increase the mortality of patients, hospitalization cost and lead to long-term quality of life impairment. At present, embolism is considered to be the main mechanism of postoperative nervous system complication. Imaging studies have confirmed that 30% to 50% of perioperative strokes are caused by brain embolism larger than 200 μm. For example, a study using diffusion-weighted magnetic resonance imaging (DW-MRI) found that 66% of patients who received aortic valve replacement had a new cerebral infarction with a brain injury volume of about 126 mm3. Recently, our team have invented a novel surgical method called transapical beating-heart septal myectomy (TA-BSM) to cure hypertrophic obstructive cardiomyopathy (HOCM). To date, this novel therapy displayed ideal effectiveness on these patients, however, whether this novel operation way would cause neurologic impairment is unclear. In this study, researchers will compare TA-BSM with cardiac surgery involving left heart operation, and analyze the clinically relevant manifestations and brain lesions measured by cognitive evaluation forms of the nervous system (i.e., Montreal cognitive assessment) and diffusion-weighted magnetic resonance imaging (DW-MRI) in these patients received above therapies. This study is to assess the safety of TA-BSM on nervous system and contributes the further improvement of this novel cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

meets indications for transapical beating-heart septal myectomy procedure or these cardiac surgery involving left heart operation, such as hypertrophic obstructive cardiomyopathy, mitral valve prolapse, and ventricular septal defect; willing to comply with protocol-specified follow-up evaluations.

Exclusion Criteria:

severe brain infarction, such stroke and cerebral hemorrhage recently; the implantation of metal materials, including Pacemaker; not able to undergo MRI examination; peptic ulcer or recent gastrointestinal bleeding (\<6 months); the history of myocardial infarction; cognitive impairment in the past; not able to finish nervous system evaluation scale.
EBV-TCR-T Cells for EB Virus Infection After HSCT

This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of EBV-TCR-T cells in patients with EB virus infection after HSCT.

EBV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic EBV-TCR-T cell therapy in subjects with EBV infection, patients with EBV emias or EBV positive PTLD will be enrolled, and donor derived EBV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).

Eligibility Criteria:
Inclusion Criteria:

1. Age 1-70 years, including boundary values, gender unlimited;
2. The EBV DNA copies number of allogenic HSCT patients with EBV infection (EBV emia and EBV positive PTLD) still did not decrease，after treated with lower dosage of Immunosuppressants，or antiviral therapy or Rituximab（Rituxan）；
3. Allogenic HSCT patients could not tolerate the antiviral therapy and / or Rituximab（Rituxan）；
4. The EBV-positive diagnosis criteria: EBV DNA copy number\>1000 copies/ ml, or the tissue EBV-EBER pathological result is positive, the diagnosis of PTLD was based on the diagnostic criteria of WHO 2016；
5. Estimated life expectancy ≥ 3 months；
6. ECOG 3 ；
7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.

Exclusion Criteria:

1. Patients with active aGVHD III-IV and / or mild and severe cGVHD;
2. Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollment；
3. Pregnant or lactating women;
4. Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;
5. patients with organ failure:

   * Heart: NYHA heart function grade IV;
   * Liver: Grade C that achieves Child-Turcotte liver function grading;
   * Kidney: kidney failure and uremia;
   * Lung: symptoms of respiratory failure;
   * Brain: a person with a disability;
6. The researchers found that it was unsuitable for the recipients to be enrolled.
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm

The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.

Intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a primate model of subarachnoid hemorrhage (SAH). This was a Phase IIA dose escalation study of sodium nitrite to determine its safety in patients with aneurysmal SAH and to establish its pharmacokinetics during a 14 day infusion.

Sodium nitrite was delivered intravenously for 14 days in 18 patients with SAH from a ruptured cerebral aneurysm using a dose escalation scheme in three cohorts of 6 patients each (3 nitrite, 3 saline), with a maximum dose of 64 nmol/min/kg. Sodium nitrite blood levels were frequently sampled and measured using mass spectroscopy and blood methemoglobin levels were continuously monitored using a pulse oximeter.

Eligibility Criteria:
Inclusion Criteria:

* Ruptured cerebral aneurysm

Exclusion Criteria:

* Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Observational Study on Skeletal Ewing's Sarcoma

Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by skeletal Ewing Sarcoma

The Ewing sarcoma treatment is based on chemotherapy, surgery and radiotherapy. Chemotherapy, performed with a combination of several drugs, is given as primary treatment before surgery.

Surgical intervention must be performed in all cases in which it is possible to obtain an excision with free margins and with acceptable functional deficits. However, when, after surgery in case of incomplete resection, post-operative radiotherapy is used, in order to reduce the risk of local recurrence as much as possible.

Subsequently in the local treatment, a phase of maintenance chemotherapy is foreseen, the intensity of which is modulated according to the response to induction therapy.

The treatments are carried out with different programs for patients with localized disease or metastatic disease and derive from clinical trials carried out in the last 30 years.

These results are the result of national and international prospective trials which, precisely due to the rarity of the disease, took many years to execute, and it is significant to know that randomized studies were in very limited numbers, as almost all the studies were represented by studies of uncontrolled phase II Improving treatments requires the expansion of knowledge on the biological behavior of this tumor and the acquisition of as much information as possible deriving from clinical experience.

For this reason, pending the definition of a new prospective randomized trial, which will take time (approximately two years) to be made operational, it is considered useful from a scientific point of view to prospectively collect data relating to new cases of Ewing's sarcoma 'bone.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Ewing's sarcoma of the bone
2. Diagnosis of Ewing-like sarcoma (round cell sarcoma with fusion of the EWSR1 gene with others not of the ETS family, sarcoma with CIC rearrangement or sarcoma with BCOR rearrangement)
3. Diagnosis of extraosseous Ewing's sarcoma for patients
4. Age at diagnosis \<50 years
5. Assessment of the extent of the disease at onset in accordance with the European Society of Medical Oncology guidelines
6. Patients or parents oe guardians of minors who have given their written informed consent to participate in the study

Exclusion Criteria:

1. Presence of comorbid factors who can compromise the compliance of the treatment plan or the evaluation of the outcomes, including but not limited to organ pathologies that contraindicate the use of chemotherapy and psychological or social conditions that do not allow for adequate compliance treatment or adequate follow-up
Head Out Water Immersion for Hemodynamic Stability During Dialysis

Immersion to the neck before and during hemodialysis session may increase intravascular volume, potentiate the ability to ultrafiltrate excess water, with less symptoms of shock, muscle crumps etc.

The aim of the present study is to compare blood volume, hemodynamic and endocrine parameters of chronic ESRD patients undergoing forth dialysis session in water immersion vs. control regular session.

10 chronic hemodialysis patients, treated in the hemodialysis unit of Asaf-Harofeh Medical Center will be enrolled in the study.

Hemoglobin and albumin will be detected at baseline, and a recent (less than one year) echo will be used for the detection of ejection fraction.

The study will be a cross over study. Each set of studies will consist of two dialysis sessions, an immersion session, and a dry, non-immersion session. The study sessions will be short, 3 hours sessions with 250-350 ml/min blood flow (depends on the patients access) dialysate flow was 500 ml/min and dialysate sodium was 137meq/l. The temperature of the dialysate will be adjusted to 37°C and its composition as follows: Na+ = 137 mEq/L, K+ = 2.0 mEq/L, Ca2+ = 3.0 mEq/L, Mg2+ = 1.0 mEq/L, HCO3-= 30 mEq/L, glucose =100 mg/dL, CH3COO-= 8 mEq/L. The sodium concentration will be constant during treatment.

Ultrafiltration will be determined as the mean of UF during the ten previous sessions±10% according to the patients weight on admission. The immersed and dry session will be done in the midweek sessions, in random order, at least one week apart from each other.

Head-Out Water Immersion

A bath will be used for immersion. The bath will be filled with purified water before each of the session, and will be heated to 34-35°C. Patients will enter the bath and sat upright for few minutes and then connected to dialysis. The water will circulate through a thermostats and heating device in order to maintain a constant temperature.

Patients with arterio-venous fistula or graft in their arm will be immersed in water up to their axilla, with their arm lining on a floating pad. For patients with perm-cath immersion will only be done up to 5 cm below the catheter insertion.

Study procedure

Subjects will enter the bath and sit for few minutes, after which blood samples will be drown for baseline measurement. During the session blood pressure and heart rate will be measured every 15 minutes by conventional sphygmomanometry. and blood volume will be estimated by using blood volume monitor (Crit-Line).

Blood samples will be drown at baseline and after one hour, and before caseation of the session for plasma renin activity, aldosterone, atrial natriuretic peptide. Baseline and end of session urea will also measured for URR.

Eligibility Criteria:
Inclusion Criteria:

* chronic hemodialysis patients

Exclusion Criteria:

* anemia (HB\<10) active infectious disease cognitive impairment dialysis access installed in the leg inability to cooperate with the study procedure Clinically evident overhydrated patients(edema, pulmonary congestion, pulmonary effusion)
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines

A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines


Eligibility Criteria:
Inclusion Criteria:

* Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria:

* Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
* From screening, Subject who get a plastic Surgery within 48 Weeks
* Subject who has skin disorder including infection and scar on injection site
* Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
* Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
* Any condition that, in the view of the investigator, would interfere with study participation
Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

* Men and women at the age of 12 or older at the Screening visit.
* Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

* Those with more than two nodular acne lesions or any cysts.
* Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
* Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment.
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes

The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 35 to 70
* Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :

  * presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random glucose \>200 mg/dL) or
  * fasting plasma glucose elevation on more than 1 occasion \> 125 mg/dL or
  * patient currently undergoing pharmacological and/or non-pharmacological treatment for diabetes mellitus
* CSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c \> 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)
* HbA1c ≥ 7,5% and ≤ 10 %
* BMI ≥ 25 and ≤ 45
* Stable body weight (≤10% variation) during the 3 last months

Exclusion Criteria:

* Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies
* Monogenic diabetes (MODY, mitochondrial diabetes...)
* Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)
* Current treatment specifically addressed for weight lost (orlistat, sibutramine, rimonabant may be interrupted at least 3 months prior to inclusion in the study)
* Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study period
* Clinically significant hepatic disease
* Documented gastroparesis, or current use of drugs that directly affect gastrointestinal motility, or any significant abdominal disease that may increase the risk of adverse gastrointestinal effects induced by exenatide
* Kidney failure (MDRD less than 50 ml/min)
* Pregnancy/breastfeeding
* Any social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the study
* Concurrent enrolment in another clinical trial
* Geographically inaccessible for follow-up visits required by protocol
Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old

The goal of this study is to learn if a patient decision tool for HPV vaccination works for decision-making among adults ages 27-45. Researchers will compare a web-based patient decision tool to an information sheet to see if the tool works for decision-making. Participants will take a baseline survey, view the intervention or control condition, and then take a follow-up survey.


Eligibility Criteria:
Inclusion Criteria:

* Unvaccinated for HPV
* 27-45 years
* Resides in the United States
* Reads English
* Consents to participate

Exclusion Criteria:

* none
Using Yogic Breathing to Reduce Stress in Anesthesia Personnel As Measured by Hair Cortisol

Mind body exercises have long been used as a way for individuals to reduce stress and improve well-being. Recent studies indicate that yogic breathing (YB, also known as pranayama) could potentially impact both the mind and body by engaging both the physiological and neural elements and can thus be a specific tool that can be utilized by healthcare workers to combat burnout and decrease perceived levels of stress. Our aim is to understand and measure both subjectively and objectively the effects of long-term yogic breathing on stress levels in anesthesia personnel. This will be a single arm longitudinal trial designed to evaluate the feasibility and estimate the efficacy of implementing a yogic breathing program for stress reduction among anesthesiology practitioners at one academic medical center. The primary aim of the trial is to estimate the correlation between participant stress with average duration of yogic breathing over time. Secondarily the feasibility of implementing yogic breathing practices among anesthesiology practitioners will be evaluated. Feasibility measures will include recruitment rates, retention at 1year follow-up, and adherence to the yogic breathing program at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* All clinical members of the MUSC anesthesia department (Attending physicians, resident physicians, and CRNAs)

Exclusion Criteria:

* Pregnancy (or anticipated pregnancy)
* chronic steroid use
* inadequate hair length for testing (less than 3cm at the back of the head)
* residents with anticipated graduation within the next one year.
Intestinal Microbiota and Vitamin K Levels in PXE Patients (IMPROVE Study)

This study aims to demonstrate a potential association between gut microbiota composition, plasma levels of various forms of vitamin K, and severity of clinical manifestations of Pseudoxanthoma Elasticum (PXE).

Vitamin K deficiency contributes to pathological calcification which underlies the clinical picture of pseudoxanthoma elasticum (PXE), an inherited autosomal recessive disease. A substantial proportion of vitamin K, namely the K2 form (menaquinones), is produced by gut microbiota. In healthy volunteers fecal levels of the major menaquinone producers, Escherichia coli and Bacteroides species, are approximately 5 and 9 log10 CFU/g dry weight respectively. There is however a lack of data on gut microbiota in PXE patients. The objective of our project is to demonstrate a potential association between gut microbiota composition, plasma levels of various forms of vitamin K and severity of clinical manifestations in PXE patients.

This study will be performed as Research surrounding bio collection "Clinical and biological exploration of PXE patients" kept at the Center of Biological Resources of Angers University Hospital (bio collection n° DC 20116-14-67, authorization to transfer n° 2016-27-99). Fecal samples, plasma samples and clinical data will be collected from patients diagnosed with PXE who will be monitored at the Angers University Hospital Referral Center (France) in 2019-2020. Clinical severity of PXE will be assessed using modified Phenodex score. Gut microbiota will be analyzed using metagenomic sequencing. Plasma Vitamin K species and fecal excretion of menaquinones will be assessed using HPLC. Plasma dp-ucMGP (circulating biomarker of vitamin K status) and serum PIVKA-II (protein induced by vitamin K absence-II) will be assessed using immunoassay. Results will be compared to healthy age- and gender-matched controls from the pre-existing Biofortis database.

Eligibility Criteria:
Inclusion Criteria:

* Patients with phenotypically and genetically (ABCC6) proven PXE
* Aged over 18 years
* Written consent obtained for Angers University Hospital (France) PXE bio-collection

Exclusion Criteria:

* Patients under the age of 18
* Patients unwilling to participate in the study, or unable to sign the bio-collection consent form