cyrilzakka/clinical-trials huggingface dataset:
Construction of Microfluidic Exosome Chip for Diagnosis of Lung Metastasis of Osteosarcoma

Use exosome microfluidic chips to establish a combination of exosome subgroup level (exosome barcode) markers for the early diagnosis of osteosarcoma lung recurrence, and establish the basis of microfluidic chip based exosome biomarker for monitoring the early therapeutic response of the second-line therapy for recurrent osteosarcoma.

Osteosarcoma is the most common primary malignant bone tumor in adolescents, and lung metastasis is the main cause of its poor prognosis. Our previous data on the basis of second-line chemotherapy combined with VEGFRi targeted therapy for patients with lung metastases from osteosarcoma showed that some patients with early diagnosis of lung metastases may achieved long-term tumor-free survival upon prompt treatment. However, plasma biomarker for the early detection of recurrent osteosarcoma is still lacking to date. Our preliminary studies indicate that exosome is a potential source of liquid biomarker for the early diagnosis of osteosarcoma lung metastasis. We, therefore, have developed a microfluidic biochip based on nano-zinc oxide microcolumns. This chip can quickly and efficiently screen and capture exosomes and achieve quantitative and qualitative detection of exosome and its subgroups. This technology may be able to achieve early sensitive exosome quantification for lung metastasis of osteosarcoma. But the clinical efficacy and utility of the microfluidic chip based exosome detection for the early diagnosis osteosarcoma recurrence remains to be validated.

This research plan uses our newly developed microfluidic chip technology to capture and efficiently capture exosomes for quantitative and qualitative and marker screening, and establish a combination of exosome subgroups level as a biomarker for the early diagnosis of osteosarcoma lung metastasis.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy pathologically diagnosed as primary high-grade osteosarcoma (including ordinary osteosarcoma, vasodilatory osteosarcoma, small cell osteosarcoma, high-grade surface osteosarcoma);
2. Age no less than 12 years old and no older than 60 years old;
3. New-onset patients who have not received chemotherapy, radiotherapy, surgery, Chinese medicine and other treatments.
4. The primary site is the limbs and pelvis.

Exclusion Criteria:

1. Pathological diagnosis of surgical gross specimens except primary high-grade osteosarcoma;
2. Failure to collect circulating exosomes as planned;
3. Suffering from chronic diseases, which may lead to an increase in non-tumor-related circulating exosomes, such as autoimmune diseases , Chronic infections, etc.;
4. The use of targeted drugs may lead to a decrease in tumor-related circulating exosomes;
5. Withdrawal from the trial for any reason.
Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

Robotic right hemicolectomy with intra-corporeal anastomosis may have better short-term recovery outcomes and decreased incidence of incisional hernia when compared to the laparoscopic actual standard of care, for similar safety outcomes.

During laparoscopic right hemicolectomy (lapRHC) for cancer or polyp, intra-corporeal anastomosis (ICA) offers better short-term recovery and decreased incidence of incisional hernia (IH) when compared to extra-corporeal anastomosis (ECA). However, because of the technical limitations of laparoscopy, ICA has not gained in wide acceptance and ECA has remained the standard of care. On the contrary, robotics offers improved suturing capacities and facilitates the realization of ICA. Therefore, robotic right hemicolectomy (robRHC) with ICA may have better short-term recovery outcomes and decreased incidence of IH when compared to the laparoscopic actual standard of care. In a randomized controlled trial, we will compare robRHC with ICA with lapRHC with ECA, in terms of recovery of bowel function (time to first passage of faeces). Secondary outcomes will notably include length of stay, incidence of IH, patient-reported esthetical outcomes and safety outcomes (morbidity, mortality, proximal and distal margins, harvested lymph nodes).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients requiring elective minimally invasive RHC for cT1-T3 Nx M0 cancer of the right colon (including cancer of the appendix, caecum, ascending colon and hepatic flexure).

Exclusion Criteria:

* Not scheduled for minimally invasive RHC (refuses surgery and/or planned open approach)
* Emergency surgery
* Hereditary colorectal cancer
* Inflammatory bowel disease
* Synchronous resection of (an)other organ(s)
* Synchronous surgical procedure (including more extended resection of the lower gastrointestinal tract)
* cT4
* cM+
* History of laparotomy
* Pregnancy
* No anastomosis planned
* Unable to provide informed consent
* No informed consent
Six Minutes Walk Test in Children on Regular Hemodialysis

To evaluate exercise tolerance and the reproducibility of the six minute walk test in children and adolescents with ESRD on regular hemodialysis and to compare their functional exercise capacities with reference values for healthy children. To investigate predictors of poor 6MWT performance in children on regular HD

The six-minute walk test (6MWT) is a submaximal test that assesses the functional exercise capacities of healthy subjects or those with a chronic disease, as well as the effects of interventions, such as pulmonary rehabilitation or drug therapies. It can predict prognosis, mortality and morbidity in adults and children with lung and/or heart diseases . A study with of children with stage V chronic kidney disease (CKD) has used the 6MWT to demonstrate decreased exercise tolerance , which appears to be caused by several factors, such as anemia, metabolic acidosis, electrolyte imbalance, osteopenia, growth deficiency, malnutrition, inactivity, uremic muscle dysfunction and associated comorbidities . The findings of this study suggest that the 6MWT could be used as a clinical tool to monitor functional exercise capacity in children with kidney disease. The 6MWT is a sub-maximum effort test that is more representative of daily life activities than other effort tests and has low cost and easy applicability . The distance walked in the 6MWT shows an association with VO2 peak, making it a viable and safe alternative for patients who cannot tolerate the ergometric test .

Eligibility Criteria:
Inclusion Criteria:

* Children with ESRD who on regular hemodialysis at Assiut University Children Hospital .

Exclusion Criteria:

* Any subject with underlying primary cardio-pulmonary disease or condition that interfere with the walk test as hemiplegia and cerebral palsy.
The German Version of the Awareness of Social Inference Test

Goal of the current project is the development of a German-language test battery for a realistic investigation of core areas of social issues Cognition (emotion, perspective taking). This test battery should be used in the investigation of patients with neuropsychological disorders. Investigators plan to establish a German-version of the TASIT that is more sensitive and shorter in administration than the original TASIT.


Eligibility Criteria:
Inclusion Criteria:

* from the age of 35,
* at least 7 years of education
* understand German or Swiss German
* Subjective statement of good health
* Signed consent

Exclusion Criteria:

* Montreal Cognitive Assessment (MoCA) value below the fifth percentile of subjectively cognitive healthy persons
* signs of depressive mood (Geriatric Depression Scale (GDS) score ≥ 5 points or Beck Depression Inventory (BDI) ≥ 10 points)
* Severe sensory deficits with potentially negative influence test results
* Severe motor deficits with potentially negative influence test results
* Systemic diseases or brain diseases with potentially negative Influence on test results
* St. n. Traumatic brain injury (with unconsciousness of at least 30 minutes)
* Severe pain with potentially negative influence on the test results
* Psychiatric problems like alcohol dependence syndrome or Schizophrenia according to Diagnostic and Statistical Manual (DSM)®-5
* Regular use of drugs with potentially negative Influence on the test results with the exception of taking Benzodiazepines at night
* general anesthesia less than 3 months ago
Oral Health Related Quality of Life in Cad Metallic and Poly Ether Ether Ketone (Peek) Partial Denture Frameworks in Mandibular Kennedy Class I Cases

The aim of this study was to compare CAD Poly ether ether ketone (PEEK) RPD to CAD metallic RPD in treating partial edentulism in terms of Oral health related quality of life


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral free end saddles in the mandible (Kennedy class I) with the last standing abutment second premolar
* Opposing dentition is fully intact or restored to be intact
* Adequate inter-arch space of at least 7mm
* Angle's class I maxilla-mandibular relationship
* Patients with no periodontal disease and good oral hygiene
* Cooperative patients showing motivation to follow-up

Exclusion Criteria:

* Periodontal affection of the abutment teeth
* Skeletal mal-relationship
* Unmotivated patients to maintain adequate oral hygiene and to follow up---- ---- Patients with neuro-mascular disorders
* Systemic disease affecting periodontal health like uncontrolled diabetes
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).

The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.

The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.


Eligibility Criteria:
Inclusion Criteria:

Age:

1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).

   Disease Characteristics:
2. The participant has had signs and symptoms consistent with PsA for at least 3 months.
3. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
4. The participant has active arthritis as shown by a minimum of \>=3 tender joints in TJC68 and \>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
5. The participant has at least 1 active lesion of plaque PsO \>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.

   Medications for PsA:
6. The participant has had at least one of the following:

   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR
   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR
   3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.

Exclusion Criteria:

PsA and PsO:

1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).
Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia"

The aim of this study is observation, in an Italian real-world setting, of metabolic effects in patients with schizophrenia who will switch from any mono-therapy or poly-therapy antipsychotic regimen to monotherapy with lurasidone or to one of the other four most used atypical antipsychotics.

The aim of this study is the observation, in psychiatric Italian real-world settings, of metabolic effects, effectiveness, side effects and therapeutic adherence in patients with schizophrenia who switched, for any reason (efficacy, safety, metabolic problems, therapeutic adherence or patient's request), from any mono-therapy or poly-therapy antipsychotic regimen to monotherapy with lurasidone or with one of the four most used atypical antipsychotics in Italy (aripiprazole, olanzapine, quetiapine, risperidone). Patient's past medical and psychiatric history of the last 12 months will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of schizophrenia according to DSM-5.
* Patients who gave their written consent for participation in the study and for personal data processing and willing to comply with all study procedures.
* Male and female patients ≥ of 18 years old at baseline.
* Patients treated or in treatment with any typical or atypical antipsychotic monotherapy or polytherapy.
* Patients switched from the pre-existing therapy to lurasidone, aripiprazole, olanzapine, quetiapine or risperidone in monotherapy within the preceding 2 weeks. The date of the switch is considered as baseline.

Exclusion Criteria:

* Female patients who are pregnant or lactating
* Patients fulfilling DSM-5 criteria for diagnosis of bipolar disorder and/or dementia.
* Amphetamines and/or Opiates abuse or dependence , as defined by DSM-5 criteria.
* Patients with no history of antipsychotics use.
* Patients recruited in another study as follows:
* currently enrolled in any pharmacological or non-pharmacological, interventional or observational study:
* who participated in the last 30 days to any observational or no-profit interventional study;
* who participated in the last 12 months to any interventional commercially sponsored study.
Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study

Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. One brain imaging study showed an increase in opioid activity in athletes after endurance training. However , a decrease in opioid tone related to receptor desensitization in the brain has been raised in the sport and it is possible to feel like , the subject must perform physical exercise more frequently . Consequently, in order to deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be assessed pre- training compared to a group of sedentary control subjects .

Preliminary results of a previous study the investigators are conducting on anorexia nervosa (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and the regulation of gonadal function. However, the relation of cause and effect between these anomalies and undernutrition remains to be determined . Given the addictive component in the endurance sport and the variability of the nutritional status of its practitioners , evaluation of brain activity in these subjects could provide additional answers.


Eligibility Criteria:
Inclusion Criteria:

For High-level sportswomen :

* 18-35-year-old
* High-level sportswomen
* BMI\>19kg/m2
* Absence of eating disorders
* In pre-competition period
* Signature of written consent

For controls :

* 18-35-year-old
* Sedentary normal weight women
* BMI\>19kg/m2
* Normal nutritional markers
* Absence of eating disorders or other psychiatric or organic diseases

Exclusion Criteria:

* Oral contraception
* Heart failure
* Neuroleptics, antiparkinson drugs, alpha-methyl-dopa, beta blockers, inhibitors of monoamine oxidase-A or MOA-B, tricyclic antidepressants, selective serotonin reuptake inhibitor, thyme-regulators (lithium), anticonvulsant drugs, codeine, morphine, drugs containing tramadol, dopaminergic drugs
Assessment of a Weight Management Program for Weight Gain in Patients With Schizophrenia

The purpose of this study is to develop the weight management program, which is combined with healthy diet, proper physical exercise, and behavior modification, related to patient's quality of life. The patients groups are in routine practice with 5-20 mg olanzapine. The study results may be utilized for patients who have gained weight on olanzapine and also other antipsychotic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18 and 65 years (inclusive)
* Subjects must meet the DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Subjects must have been treated with olanzapine (5 to 20 mg/day) for at least 12 weeks prior to study entry and who experienced a weight gain of greater than or equal to 7% of body weight during olanzapine treatment

Exclusion Criteria:

* Treatment with an injectable depot neuroleptic 14 days before visit 1
* Subjects with an PANSS score greater than 70
* One or more seizures without a clear and unresolved etiology
* Known diagnosis of DSM-IV substance dependence (except nicotine and caffeine) within the past 2 months, which in the opinion of the investigator is affecting the diet and/or weight of the subject
* As a result of liver function test, ALT/AST ranges are shown twice the upper limit of the normal reference range
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).


Eligibility Criteria:
Inclusion Criteria:

* All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).

Exclusion Criteria:

* History or presence of other concomitant liver diseases
* Clinical complications of PBC
* History or presence of hepatic decompensating events
* Current or history of gallbladder disease
* If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Development of Intravitreal Ranibizumab by Determining the Pathogenesis of Macular Edema With Retinal Vein Occlusion

The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. In particular, we focus on the correlation between the treatment effectiveness of ranibizumab and the role of the cytokines involved in the cause of macular edema.

Methodology:

Aqueous humor samples (0.1ml) were obtained during intravitreous injection of ranibizumab to measure the levels of cytokines. Targeted cytokines are follows; IL-1, IL-2, IL-6, IL-8, IL-9, IL-10, IL-12, IL-13, IP-10, MCP-1, MMP-1, MIP-1β, PDGF, VEGF, PlGF, ICAM-1, TNF-α, RANTES, VEGFR-1, VEGFR-2, which has been reported that the expression level is increased in macular edema associated with RVO. Cytokines are measured by multiple ELISA (Luminex). Aqueous humor samples are obtained in the same manner from patients recurred after the first injection or continuous monthly injections. Statistical analysis is conducted to examine the difference of cytokine levels between early or late/incomplete responders of ranibizumab, and predict the number of injections to stabilize cytokine levels.

Number of centers \& patients: Single center, 100 patients

Sample size justification: Sample size calculation was not done, since this study is a single-arm, observational study.

Population: Inclusion criteria: patients with RVO and macular edema

Eligibility Criteria:
Inclusion Criteria:

* Foveal thickness \> 300 μm
* Best corrected visual acuity \< 20/30

Exclusion Criteria:

* History of retinal diseases other than BRVO, glaucoma, uveitis, diabetes mellitus, rubeosis iridis, ocular infections, laser photocoagulation, and intraocular surgery
Cardiac Rehabilitation in Coronary Artery Diseases

Cardiac rehabilitation is approaches that focus on accelerating the recovery process of patients after a cardiac event, improving their physical, psychological and social conditions, and controlling risk factors. Cardiac rehabilitation is known to be an effective and cost-effective approach in the secondary prevention of cardiovascular diseases, most of which are caused by preventable risks. Ischemic heart diseases, one of the cardiovascular diseases, are responsible for 16% of total deaths in the world and have increased significantly since 2000, causing 8.9 million deaths in 2019.

When coronary artery diseases cannot be prevented, the basic approach should be to ensure the individual's compliance with treatment and healthy lifestyle behaviors, and to increase the quality of life and life span.

For this reason, the aim of the study is to examine the effects of technology-based education structured according to the health promotion model in cardiac rehabilitation on healthy lifestyle behaviors, health fatalism and risk knowledge level.

Question 1. Does technology-based education structured according to the health promotion model affect the healthy lifestyle behaviors score? Question 2. Does technology-based education structured according to the health promotion model affect the health fatalism score? Question 3. Does technology-based education structured according to the health promotion model affect the cardiovascular disease risk factors knowledge level score?


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of coronary artery disease (acute coronary syndrome, coronary revascularization, atherosclerotic heart disease, etc.),
* Being stable in health (the patient's health status does not change suddenly and is under control),
* If an interventional procedure has been performed, at least three months have passed after discharge,
* Being between the ages of 18-65,
* Being literate,
* Using smart phone and internet,
* Living in the city center

Exclusion Criteria:

* Having a disability (vision, hearing, neurological, cognitive, etc.) that may interfere with education,
* Cardiac rehabilitation is contraindicated
* To have participated in a cardiac rehabilitation program given by another institution before or during the study,
Noninvasive Cochlear Stimulation System

The purpose of this research is to develop a portable wearable hardware headset using a computer-based software that can establish the optimal stimulation parameters appropriate for medical and consumer environments for individuals with hearing impaired and normal hearing individuals.


Eligibility Criteria:
Inclusion Criteria:

- Employee of Mayo Clinic.

Exclusion Criteria:

* Pregnant.
* Cochlear implants.
* History of fluctuating sensorineural hearing loss.
* Skin diseases of the head.
* History of acute paroxysmal tachycardia.
* History of trigeminal neuralgia.
* Recent of paralysis of the facial nerve.
* Recent cerebrovascular stroke.