cyrilzakka/clinical-trials huggingface dataset:
Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness

With the appearance of the new SARS-COV2 virus, additional challenges are being imposed on the medical community after the resolution of acute COVID-19 illness, resulting in specific pathophysiologic mechanisms that while acutely damage the lung parenchyma might chronically impact the cardiopulmonary system.

This study aims to investigate changes after mild COVID-19 illness in echocardiographic indices at rest and stress.


Eligibility Criteria:
Inclusion Criteria:

* Having suffered mild COVID-19 illness
* PCR test negative after COVID-19 illness
* Men or women
* Age ≥18 years and \< 45.
* No history of other cardiovascular or lung disease.
* No cardiovascular risk factors, that is, arterial systemic hypertension, smoking, diabetes, dyslipidemia
* No ongoing or previous cardio or vasoactive treatment
* Able to use the semi-supine exercise bicycle
* Able to give informed consent

Exclusion Criteria:

* Poor acoustic window.
* Tricuspid regurgitation more than mild
* Professional sports activity
* Pregnancy
* Obesity (body mass index \[BMI\], ≥30 kg/m2).
* Inability to provide consent
Retinal Venous Pressure and ET-1 in Patients With Diabetes Mellitus

Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels.

Diabetic retinopathy and maculopathy are the main causes of visual loss. Hyperglycemia as the main risk factor of diabetic retinopathy induced damage to retinal capillaries. These in turn lead to hypoxia in the tissue and promote the release of VEGF (vascular endothelial growth factor) , which in turn increases the vascular pathology. Simultaneously, there is an increased expression of endothelin (ET-1). Endothelin increases vascular tone and regulates the micro-and macro-vascular remodeling.

In ocular blood flow perfusion pressure plays an important role. While in healthy eyes a spontaneous retinal venous pulsation is frequently observed, this is significantly less frequent in diseased eyes. An increased venous pressure lowers the ocular perfusion pressure, and increases the transmural pressure. A measurement of the retinal venous pressure and the hormone ET-1 in the blood will give us a better knowledge of the circulatory changes and their relationship to diabetes.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus type I or II
* no diabetic retinopathy

Exclusion Criteria:

* known diabetic retinopathy
* acute or chronic inflammation of the eyes
* narrow angle glaucoma
* minority
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma

The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female subjects (18-65 years of age)
* Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.
* Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
* Nonsmokers for at least 6 months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
* Written informed consent.

Exclusion Criteria:

* Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit.
* History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.
* History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
* History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma
* Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases
* Known intolerance or hypersensitivity or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).
Effects of rTMS and tDCS on Motor Function in Stroke

In this study the investigators aim to investigate the effects of two different types of non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This is a cross-over study where subjects will receive 5 sessions of stimulation (each separated by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham tDCS and rTMS.


Eligibility Criteria:
Inclusion criteria:

(1) All subjects must be between the ages of 18-90.

Exclusion criteria:

1. History of Major depression, as defined by Beck Depression scale 30;
2. Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing;
3. Contraindications to TMS

   * history of seizures
   * unexplained loss of consciousness
   * metal in the head
   * frequent or severe headaches or neck pain
   * implanted brain medical devices.
4. Contraindications to tDCS

   * metal in the head
   * implanted brain medical devices
5. Advanced liver, kidney, cardiac, or pulmonary disease;
6. A terminal medical diagnosis consistent with survival \< 1 year;
7. Coexistent major neurological or psychiatric disease (to decrease number of confounders);
8. A history of significant alcohol or drug abuse in the prior 6 months;
9. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials;
10. Subjects with global aphasia and deficits of comprehension
11. Pregnancy. Female subjects of child bearing potential will be asked to take a pregnancy test. If the pregnancy test is positive, the subject may not enroll in the study.
12. Use of neuropsychotropic medications \[healthy subjects only\]

Additional inclusion criteria for stroke subjects:

1. First-time clinical ischemic or hemorrhagic cerebrovascular events - evidenced by a radiological (or physician's) report
2. Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale
3. Stroke onset \>6 months prior to study enrollment .

Additional exclusion criteria for stroke subjects:

1. Subjects may not have already received TMS and/or tDCS stimulation for stroke;
2. History of epilepsy before stroke or episodes of seizures within the last six months;
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Vaginal laxity score, female sexual function index (FSFI), female sexual distress scale (FSDS), vaginal pressure, adverse events were examined. Follow up period is 3 months.


Eligibility Criteria:
Inclusion Criteria:

* vaginal laxity score \>= 3
* negative pregnancy test within 2 months

Exclusion Criteria:

* genital anomaly
* pelvic prolapse stage \>= stage 3
* active genital infection
* vulvar pain or deformity
* disease related to sexual behavior
* current, chronic NSAIDs intake
* fever
* any acute illness
* cognitive disorder
* pacemaker insertion
* metal implants
A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis

The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.


Eligibility Criteria:
Major Inclusion Criteria:

1. Participants diagnosed with ulcerative colitis.
2. Participants with moderate ulcerative colitis who satisfy all of the following criteria at Day of enrollment.

   1. Mayo Clinic scores of 6-10 .
   2. Endoscopic subscore greater than or equal to (\>=) 2.
   3. Rectal bleeding subscore \>=1.
3. Participants with inadequate response or intolerant to oral 5-ASA
4. Participants who are capable of providing written informed consent

Major Exclusion Criteria:

1. Participants with extensive detachment of mucosa or deep ulcer.
2. Participants with oral corticosteroid dependency.
3. Participants with a complication of marked reduction of immune function.
4. Participants who were clinically suspected to have a complication of infectious enteritis.
5. Participants with a history or complication of serious infection within 1 year prior to the day of enrollment.
6. Participants with central nervous system (CNS) neurological symptoms.
7. Participants with the following criteria:

   * Serious heart disease
   * Renal impairment
   * Hepatic impairment
8. Participants with a history of serious drug induced allergy with unknown cause.
9. Participants with malignant tumor or those whose treatments were completed in less than 5 years.
10. Participants with apparent psychological signs.
11. Pregnant women, nursing women, women with suspected pregnancy, women who wish to become pregnant during the period from informed consent through to the end of observation/examination at Week 8, and women who do not consent to the use of appropriate birth control methods.
12. Participants who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc.
13. Participants who are participants of another clinical study including follow-up observation at the time of informed consent.
14. Participants who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol.
15. Participants who received investigational drugs in the study of AJM300.
16. Participants determined to be ineligible for participation in this study by the investigator or sub-investigator.
Overtaking Intra and Inter Tumoral Heterogeneity In Von Hippel-Lindau Related Renal Cancer

The goal of this study is to comprehensively map intra and inter tumor heterogeneity of ccRCC in VHL patients through the use of imaging, molecular biology and genomics techniques.

It was hypothesized that the high intra- inter-tumor heterogeneity of sporadic ccRCC also defines VHL-ccRCCs, including different lesions within individual patients, and it was assumed that decoding VHL-ccRCC heterogeneity by coupling imaging, histology and molecular profiling of multiregional biopsies would help improve diagnostic tests and therapeutic choices for VHL patients.

In order to comprehensively map intra and inter tumor heterogeneity of ccRCC in VHL patients, the aims of the study are:

1. To integrate pre-surgery imaging using conventional multiparametric MRI with tumor histology of geographical predeterminated multi-region biopsies in each ccRCC of VHL patients.
2. To combine multiplex immunohistochemistry, bulk and single cell RNA sequencing and somatic mutations analysis with pan-tumor histological assessment.
3. To optimize a protocol to generate VHL-ccRCC-derived tumor organoids (patient-derived organoids, PDO) and test anti tumor agents like HIF2alpha inhibitor in organoid cultures representative of intra- and inter-tumor heterogeneity.

This study will develop standardized models for diagnosis and molecular characterization of ccRCC in VHL disease using a combination of imaging, intrasurgical biopsying and multi-omics analysis. It will benefit of a clinical and research program devoted to VHL disease established at OSR in 2021 that centralizes Italian VHL patients. Since the current study relies on tumor biopsy techniques that are already established in clinical practice, the translational findings will be directly available and immediately affecting patients' care.

Eligibility Criteria:
Inclusion Criteria:

* VHL syndrome
* Presence of at least 3 kidney tumors larger that 3cm to be surgically removed

Exclusion Criteria:

* Absence of VHL
* Quantity of kidney tumors \< 3
* Absence of surgery performance
Injection Regimen Trial of PEG-rhG-CSF During Breast Cancer Chemotherapy

The purpose of this study is to try to find a better injection regimen (including time and dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN in breast cancer patients who receive chemotherapy.


Eligibility Criteria:
Eligibility Criteria:

1. Female breast cancer aged 18-70 years old, the expected survival period is greater than 12 months.
2. No previous radiotherapy and chemotherapy.
3. No history of serious systemic disease.
4. KPS≥70.
5. White blood cell count\> 3.5 × 10 \^ 9 / L, neutrophil count\> 1.8 × 10 \^ 9 / L, platelet count\> 100 × 10 \^ 9 / L, hemoglobin\> 9 g / dl.
6. ALT (alanine transaminase) and AST (aspartate transaminase) \<1.5 times the upper limit of normal value, alkaline phosphatase \<2.5 times the upper limit of normal value, and total bilirubin \<1.5 times the upper limit of normal value.
7. Serum muscle plasma \<1.5 times the upper limit of normal value.
8. No abnormal blood coagulation.
9. Women of childbearing age had a negative serum or urine pregnancy test before the start of treatment and agreed to contraception during treatment.
10. Cardiac function: two-dimensional echocardiography examination LVEF (left ventricular ejection fraction) ≥ 55%.
11. Sign informed consent.

Exclusion Criteria:

1. Received systemic or local treatment for tumors, including chemotherapy, radiotherapy, and endocrine therapy.
2. A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
3. The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
4. Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue disease or bone marrow function suppression, and other diseases, can not tolerate chemotherapy-related treatments.
5. Two-dimensional echocardiography detection LVEF \<55%.
6. Severe cardiovascular and cerebrovascular diseases within the first 6 months of randomization (eg unstable angina, chronic heart failure, uncontrollable hypertension\> 150/90 mmHg, myocardial infarction, or cerebrovascular accident).
7. NCI peripheral neurotoxicity grade ≥2.
8. Those taking glucocorticoids.
9. Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab, or pertuzumab.
10. Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age.
11. Pregnant and lactating women.
12. After joining the test, a pregnancy test (+) before using the drug.
13. There are mental illness, cognitive impairment, unable to understand the test plan and side effects, unable to complete the test plan, and follow-up workers (systematic evaluation is required before the trial is enrolled).
14. No personal freedom and independent civil capacity.
15. The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).
Risk Factors for Complications After Carotid Endarterectomy

This study may determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Medical records will be accessed to find any information pertaining to postoperative complications. Additionally, it may determine the cognitive dysfunction of patients undergoing CEA, assessed by Mini Mental Status Examination (MMSE).

This is a multicenter prospective observational study; data will be collected from two sites: the lead site in Columbus, Ohio, USA and an international site in Girona, Spain for a total of 354 patients. The objective of this study is to determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Patients who undergo CEA are at increased risk of cardiovascular complications because of the high incidence of coexisting heart disease, high blood pressure, and diabetes. Common complications that occur after CEA are wound hematoma (collection of blood at the wound) and intracerebral hemorrhage (bleeding in the brain). Medical records will be accessed to find any information pertaining to postoperative complications. Another objective of this study is to determine the cognitive dysfunction of patients undergoing CEA. This will be measured by a Mini Mental Status Examination (MMSE) which will occur in person before the surgery and 30 days after the surgery over the phone. This study may provide data that will help identify how to optimize recovery for future CEA patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients males or females, 18 years of age and older
* Scheduled to undergo Carotid Endarterectomy

Exclusion Criteria:

1. Pregnant women
2. Incarcerated individuals
3. Patients not able to consent for themselves
4. Any disease or condition deemed by the investigator to disqualify the patient
5. Participating in any interventional clinical trial
Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy

This research is being done to study how the immune system in the small intestine improves after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the increase in the numbers of immune cells in the intestine to see if one type of HIV medication gives different results than other types of HIV medications.

While the world-wide AIDS epidemic continues to impact millions of individuals, effective anti-HIV medications have substantially reduced morbidity and mortality for those patients able to adhere to combination regimens. Despite improved survival, durable virologic suppression, and increases in peripheral CD4+T-cell counts in patients receiving potent antiretroviral therapy (ART), immune reconstitution remains incomplete as measured by a number of additional surrogate markers. Perhaps critically important among areas of apparent incomplete immune recovery is the gastrointestinal-associated lymphoid tissue (GALT), where CD4+T-cells repopulate very slowly, if at all. Raltegravir is a new ART agent from a novel class of HIV inhibitors, integrase inhibitors, that results in rapid suppression of HIV and recovery of peripheral CD4+T-cells. This project proposes to examine whether volunteers receiving raltegravir recover GALT immune cells more completely than those taking comparator ART.

Eligibility Criteria:
Inclusion Criteria:

* willing to sign consent form
* no known GI pathology
* no anticipated antiretroviral therapy adjustments or changes
* males \& females between the ages of 18 \& 50 years
* no active opportunistic infections (OI) or therapy for OI within 30 days of entry
* can be on secondary prophylaxis with a history of AIDS defining illness
* per standard of care requirements, all females of child-bearing potential must agree to use barrier methods to prevent pregnancy or be abstinent from activity while on study

Exclusion Criteria:

* abnormal coagulation parameters (PT \> or equal to 1.2 ULN)
* thrombocytopenia (platelet count \< 50,000 within 6 weeks)
* contra-indications to upper endoscopy or conscious sedation
* anemia (\> or equal to grade 1)
* aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy
Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

This study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with Histologic or cytologic confirmation.
* Wild type epidermal growth factor receptor status.
* Progressed after first-line chemotherapy.
* No previous systemic anticancer therapy.
* Measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated.
* Provision of written informed consent.

Exclusion Criteria:

* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
* Positive epidermal growth factor receptor mutation.
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.


Eligibility Criteria:
Inclusion Criteria:

* Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment
* Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent

Exclusion Criteria:

* History of IPD or other culture-positive pneumococcal disease
* Known or suspected impairment of immunological function
* Receipt of systemic corticosteroids or immunosuppressive therapy
* Received any pneumococcal vaccine \<12 months prior to enrollment
* Prior administration of PCV15 or PCV20
* Received any influenza vaccine \<6 months prior to enrollment