cyrilzakka/clinical-trials huggingface dataset:
Retrospective Analysis of Skin/Soft Tissue Primary NK/T Cell Lymphoma

To study clinical features, prognostic factors and treatment outcome and to develop a possible prognostic index in skin/soft tissue primary NK/T cell lymphoma patients.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed extranodal NK/T cell lymphoma
* primary site is skin or soft tissue

Exclusion Criteria:

* involvement of upper aerodigestive tract
Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)

The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19.

As the COVID-19 pandemic is emerging as a global healthcare crisis, scientists worldwide are actively developing prophylactic and therapeutic interventions. Neutralizing antibody therapies are being developed for the treatment of COVID-19. The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. The LALA mutation was introduced to the Fc portion of CB6 (CB6-LALA) to lower the risk of Fc-mediated acute lung injury in animals. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19. The data from this study will inform decisions of the clinical use of JS016.

Eligibility Criteria:
Inclusion Criteria:

* Severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) infection
* Within 7 days from the onset of clinical symptoms or 4 days from the onset of severe symptoms
* Consistent with the National Health Committee New Coronavirus pneumonia diagnosis and treatment plan (Eighth Edition), general or heavy diagnostic criteria.

Exclusion Criteria:

* Sever Covid-19 Infection patients
* SARS-Cov-2 specific antibodies (including IgM and IgG) were positive before included
* Cardiac function grade III or IV, or left ventricular ejection fraction \< 30%
* History of known or suspected active pulmonary tuberculosis or extra-pulmonary tuberculosis
* Chronic renal failure needs maintenance dialysis
* History of solid malignant/tumor or hematological malignancy
* Pregnancy or lactation
The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring

The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent must be obtained
* 45-75 years of age
* Scheduled for bilateral knee replacement surgery

Exclusion Criteria:

* Employee or immediate family of either AkPharma or employee or immediate family of investigator or site personnel
* Pregnant or breast feeding Known allergy or hypersensitivity to calcium or phosphorus supplements
* Diagnosed with type I or type II diabetes mellitus
Analyzing Composition and Lubrication Properties of Synovial Fluid

To analyze the relationship between composition of synovial fluid and its lubrication properties

Patients suffering from serious arthritis may receive the artificial joint replacement surgery. Comparing to the articulation of articular cartilage, the artificial joint undergo a boundary lubrication in which a thin layer of synovial fluid molecules is formed between the artificial joint materials. Therefore a larger wear rate is observed in the artificial joint system. Researchers have devoted themselves to modifying the artificial joint materials in order to reduce the wear phenomena. We first propose that modification the lubrication by adding effective lubricating molecules may help to reduce the wear of artificial joint. However, there still lacks fundamentally understanding of the artificial joint lubrication mechanism under synovial fluid. Hence, we plan to investigate the boundary lubrication mechanism of synovial molecules, such as albumin, globulin, hyaluronic acid, and lipid in the first year. We would like to obtain the adsorption behaviors of the single molecules as well as multiple molecules on the surfaces of artificial joint materials by experiments. Molecular dynamics simulation will also be performed to gain the knowledge of adsorption energy and possible conformation change of the molecules. In the second year, the tribological heat and mechanical effects on the synovial molecules will be studied. The analysis platform will be established to perform the composition and properties measurement of the synovial molecules. In the third year, we will further discuss the effect of the synovial molecules transformation on the surrounding cells and tissues. Their influences on the tribological and biochemical behaviors will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to receive HA injection of one or two knees

Exclusion Criteria:

* Patients whose quantity of synovial fluid is not enough to be drawn
Message Testing for CKD

Members of CVS/Aetna will receive one of two text messages or receive no text message at all. In the available for members condition, participants will receive a text message that says, "Two common kidney tests have been made available for members. By taking them, you could stay ahead of any problems and keep enjoying life. Schedule a doctor visit today to ask about them." In the Checked Health condition, the message will say, "Have you checked your kidney health recently? By taking two common kidney tests, members can stay ahead of any problems and keep enjoying life. Schedule a doctor visit today to ask about them." There will also be a group of members that do not receive a text message at all.

The investigators will examine the proportion of participants that book an appointment, proportion of new diagnoses for CKD, creatinine tests and/or albuminuria tests, proportion of participants that looked for more information after receiving the text message. The investigators will examine these metrics 6 months after all of the text messages have gone out \~8,637. The investigators will examine difference in conditions between the metrics listed above in the DV section. The investigators will compare the two conditions to each other, as well as to the group who does not receive a text message. The investigators will conduct a series of chi square tests/logistic regressions to examine the differences.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be a health insurance customer with the company we are working with.
* All other eligibility criteria are determined by the company and not disclosed to us. They will pick a sample of customers for the study, with participants then being randomly assigned to treatments they qualify for.

Exclusion Criteria:

* NA
Pilot Study of Pentoxifylline for Hepatopulmonary Syndrome

The Hepatopulmonary syndrome (HPS) results from intrapulmonary microvascular dilatation that impairs arterial oxygenation in the setting of cirrhosis or portal hypertension. As many as 10-20% of cirrhotics being evaluated for orthotopic liver transplantation (OLT) have advanced HPS and mortality is greater in those with HPS than in those without HPS. Currently, OLT is the only effective treatment, although post-operative mortality in HPS is increased relative to cirrhotic patients without HPS, with a one-year survival of between 68-80 %. Therefore, an effective medical therapy for advanced HPS could improve both pre-operative and post-operative mortality.

Recent work in experimental models of HPS has revealed that both nitric oxide synthase-derived nitric oxide and heme oxygenase-derived carbon monoxide cause intrapulmonary vasodilatation. These alterations appear to be driven in part by TNF-α modulation of pulmonary blood flow and intravascular monocyte accumulation. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with inhibitory effects on TNF-α and has recently been shown to be beneficial in patients with severe alcoholic hepatitis where TNF-α overproduction contributes to liver injury. In experimental HPS, pentoxifylline administration also decreases the severity of oxygenation abnormalities. However, pentoxifylline therapy has been associated with dose limiting side effects in patients with liver disease and the tolerability of pentoxifylline in cirrhotic patients with advanced HPS is unknown. Therefore, this open label single arm clinical trial was designed to evaluate the efficacy and tolerability of 8 weeks of pentoxifylline in cirrhotic patients with advanced HPS being considered for OLT.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing liver transplantation evaluation for cirrhosis
* HPS (positive contrast echocardiography, hypoxemia, no other cause)
* PaO2 \< 65mmHg
* ability and willingness to give informed consent

Exclusion Criteria:

* Patients under the age of 19
* active bacterial infections
* known malignancy
* intrinsic cardiopulmonary disease
* known intolerance to pentoxifylline
tDCS and Metacognitive Strategy Training in Stroke

Specific Aim 1: Complete pilot testing of study protocol in individuals with chronic stroke for feasibility evaluation and protocol refinement. Specific Aim 2: Estimate the preliminary effect of CO-OP+tDCS on activity performance in individuals with chronic stroke.

A number of daily life activities are discontinued after stroke. These discontinued activities typically include basic self-care, instrumental activities of daily living, leisure, and work. These changes in participation contribute to decreased quality of life and life satisfaction. The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is a behavioral problem-solving intervention that focuses on teaching clients how to apply cognitive strategies to enhance learning and overcome activity performance barriers.

CO-OP uses meaningful, client-chosen activities to drive new skill learning and neural reorganization. Consistent with these principles of neuroplasticity, transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method of modulating cortical excitability through application of low currents to targeted regions on the scalp.

There are known positive effects of CO-OP to improve activity performance and for tDCS to improve impairment level outcomes post-stroke. The investigators hypothesize that the known effects of CO-OP may be amplified with use of tDCS to alter known neural hubs of executive networks that support problem-solving. In sum, (1) CO-OP is effective at improving activity performance, and (2) the effects of CO-OP may be amplified through novel methods that allow for placing the brain in an enhanced neuroplastic state, such as tDCS.

Eligibility Criteria:
Inclusion Criteria:

* \>6 months post-ischemic stroke
* not currently receiving therapy services
* a minimum of four self-identified functional goals

Exclusion Criteria:

* severe depressive symptoms (\>20 on Patient Health Questionnaire)
* dementia symptoms (\<24 on Montreal Cognitive Assessment)
* any additional neurological disorders
* moderate-severe aphasia (NIH Stroke Scale aphasia scale of greater than or equal to 2)
* any tDCS contraindication
The Safety and Efficacy of Alveolar Bone Defect Repair Induced by Gelatin Sponge-loaded Apoptotic Vesicle Complex

Distal bone loss of the second molar due to extraction of the third molar is one of the most common pathological conditions that results in tooth loss of second molar. However, regeneration of functional alveolar bone has proved difficult. Therefore, the investigators conduct a two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction.

This study is a single-center, prospective, two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. One socket for each participant in this study will receive gelatin sponge-loaded apoptotic vesicle complex after third molar extraction and socket debridement. The other side of socket for each participant in this study will receive commercial gelatin sponge after the same surgery. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-45 (including the boundary value)
2. Patients who need to extract the bilateral mandible third molars
3. Patients who voluntarily sign the informed consent form

Exclusion Criteria:

1. The adjacent second molars in the patient's oral cavity are affected by pulp injury or insufficient endodontic treatment, or show tooth fracture, or have a degree of motion of 3 degrees
2. The adjacent second molars have metal crowns or large amalgam restorations
3. There is an uncontrollable pathological process in the patient's oral cavity
4. Malnutrition (serum albumin concentration \<2 g/dl)
5. Other systemic, infectious diseases and hereditary diseases, or patients in the acute inflammatory phase and acute exacerbation phase of chronic diseases
6. Patients who are pregnant, lactating, or planning to become pregnant
Sevoflurane and Percutaneous Coronary Intervention by Stent

Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can represents a problem to the patients resulting in increase of morbidity and mortality.

Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty.

Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.

Several published clinical studies have shown the benefit of using inhaled anesthetic agents in patients undergoing coronary artery bypass graft(CABG). These benefits involve functional state of the heart and reduction damage to the organ. These events are related to intracellular phenomena that result in intracellular calcium homeostasis giving physical and functional benefits to the heart. Also disclosed is a modulation of the inflammatory response to endothelial level with resulting protective character to the coronary bed.

Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty. Even in smaller increases than 3 times baseline, a criterion that defines myocardial infarction, clinical impact can already be found. Increase in CK-MB more than 100% of baseline can represents a problem to the patients. This elevation of CK - MB is associated with various factors such as age, characteristic of the lesion, clinical status of the patient, inferring that endovascular procedures of coronary, simple or complex, have associated myocardial damage, which depending on the intensity of the damage, results in increased morbidity and mortality.

BACKGROUND AND OBJECTIVES:

Check for reduction in the percentage of patients that release CK -MB at levels above the 100% baseline in patients anesthetized with sevoflurane compared to the control group. Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Both gender.
2. Patients with coronary artery disease candidates for coronary angioplasty stent.
3. Cardiac catheterization on an urgent basis.
4. Coronary angioplasty in elective and urgency.
5. Age less than 80 years.

Exclusion Criteria:

1. Patients aged greater than or equal of 80 years.
2. Angioplasty balloon catheter statement.
3. Myocardial infarction with ST-segment elevation.
4. Angioplasty in saphenous vein grafts in patients after surgical revascularization.
5. Patient pregnant.
6. Dialytic insufficiency renal.
7. Patients submited a urgent cardiac catheterization but not progress with coronary angioplasty stent.
Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®

This study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in real life conditions according to the instructions for use.

The primary objective is to evaluate the safety of the total ankle prosthesis, EasyMove, up to five years of follow-up.

The secondary objectives are to evaluate both the safety and the performance of the total ankle prosthesis, EasyMove, up to five years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with the studied device according to the instructions for use, for primary surgery in patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis
* Adult patient (≥18 years old)
* Patient who received an information form and is willing to participate in the study

Exclusion Criteria:

* Contraindications listed in the instructions for use
* Patient who is not able to express his/her non opposition
Acute Effect of Whole Body Vibration on Reaction Speed and Proprioception

It will be determined whether the application of whole body vibration has an immediate effect on upper extremity reaction speed and proprioception.

Muscles and tendons are among the mechanisms affected by whole body vibration. In this way, it is thought that TVV indirectly affects the reaction speed of individuals. In the light of this information, this study was planned to investigate how whole body vibration application affects proprioception and reaction speed. The reaction rate and instantaneous effect of the virion given at 30 Hz and 2 mm amplitude in the push-up position on proprioception will be investigated. The aim of this study is to investigate the instantaneous effect of whole body vibration on reaction speed and proprioception in the upper extremity in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the ages of 18-25
* Those who do not have any orthopedic problems in the upper extremity
* Individuals without any neurological problems
* Those who volunteer to participate in the study

Exclusion Criteria:

* Those who have vertigo
Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up

The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.

The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.

Everolimus is a new proliferation signal inhibitor with immunosuppressive and antiproliferative activity.

The mechanism of action of Everolimus is distinct from that of calcineurin inhibitors.

Cardiac allograft vasculopathy is the major cause of late death in cardiac transplant patients.

The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.

The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year
* Signed informed consent
* 6 months to 15 year after heart transplantation
* Stable heart allograft function without rejection for at least 12 months
* Same immunusuppressive drugs for at least 3 months
* CNI based immunusuppression, with Cyclosporin levels C0 100-200 ng/ml FK levels of 5-10 ng/ml for preserved CNI levels.
* Poor renal function: creatinine \> 1.5 mg%.

Exclusion Criteria:

* Suspected non-compliance
* Intolerance to Everolimus
* Life expectancy \< 1year
* Proteinuria \> 1.5 g/24u/1.73m2
* Previous sirolimus treatment
* Patients who received any other investigational drug
* Patients with platelet count \<50,000/mm³ before baseline.
* Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L)
* Patients with an absolute neutrophil count of ≤ 1,500/mm3 or white blood cell count of ≤ 4000/mm³ at baseline
* Patients with a known hypersensitivity to similar drugs and to the components of the formulations
* Patients being treated with terfenadine, astemizole, or cisapride.
* Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.
* Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
* Patients with clinically significant systemic infection.
* Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer.
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
Partnership in Implementation Science for Geriatric Mental Health (PRISM)

The Partnership in Implementation Science for Geriatric Mental Health (PRISM) project proposes an evidence-based physical exercise intervention for older adults who exhibit behavioral and psychological symptoms of dementia (BPSD). The proposed evaluation study will conduct a randomized controlled trial with a Hybrid Type 3 design to compare the intervention arm that implements the culturally-adapted GTO model (GTO-ThAI) to deliver implementation support, with a control arm, which receives usual top-down administrative instruction for implementing a policy initiative.

The overall goal of this project is to establish a hub to integrate implementation research for scaling up sustainable, evidence-based mental health interventions with research capacity-building activities for East Asia. Specific scale-up study aims include: Aim 1: Assessing readiness for implementing the evidence-based physical exercise intervention for improving mental health of older adults in participating provinces of Thailand; Aim 2: Developing the GTO-ThAI implementation support model through a pre-implementation case study and formative evaluation; and Aim 3: Evaluation of implementation strategies and clinical outcomes through a hybrid Type 3 randomized trial to test an evidence-based implementation support strategy (i.e., the GTO-ThAI model) that emphasizes a systematic process to address implementation barriers to the delivery of the evidence-based physical exercise intervention (PEI), compared with the existing standard administrative procedures for delivering the same PEI.

Eligibility Criteria:
Inclusion Criteria:

* (a) adults who are aged 55 and older,
* (b) screen positive for dementia,
* (c) screen positive for BPSD, and
* (d) having a caregiver who is willing to participate in the study.

Exclusion Criteria:

* (a) caregivers who are cognitively not intact, and/or
* (b) not willing to participate in the intervention.