cyrilzakka/clinical-trials huggingface dataset:
Sleep Apnea and Vascular Function

Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but given the association between OSA and obesity, adipose-derived hormones (adipokines) are likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown to be associated with deleterious effects on vascular function resulting in impaired endothelial function. This proposal is directed at investigating the molecular mechanisms of endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction associated with OSA is a result of molecular alterations within endothelial cells. As a part of these studies we will look at NO signaling pathways in adipose tissue and microvessels from normal and OSA subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non OSA, and newly diagnosed OSA subjects, naïve to CPAP treatment, aged 18-65 years, with BMI less than or equal to 55 kg/m2, who are free of all chronic diseases including diabetes, and cardiovascular diseases, will be recruited for our study. Subjects with dyslipidemia and hypertension will be allowed to participate in the study. Subjects taking anti-depressents, and anithypertensives will be allowed to participate in the study. Also, subjects taking beta blockers and beta agonists will be allowed to participate in the study.

If a subject is on aspirin or any other anti-inflammatory medication but free of known vascular disease and depending on the indication, the study doctor may ask the subject to suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in the study. In the event that the subjects does not stop the aspirin or other anti-inflammatory medication, they will not be able to participate in the study because of the risk of bleeding during the fat biopsy.

Exclusion Criteria:

* Body weight \>450 pounds (204.5kg)
* Pregnancy.
* Anemic (hemoglobin \<13.5 g/dL for men and \<12.0 g/dL for women.
* Postmenopausal
* Smoking
* Use of chronic Medications (aspirin, statins, anti-inflammatory drugs)
Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts

This is a randomized, blank-controlled study in adults with household contact exposure to individuals with SARS-CoV-2 infection. All subjects in the study will be household contacts with close exposure to the first household member known to be newly infected with SARS-CoV-2. Subjects in each cohort will be randomly assigned to the Chinese herbal medicine treatment group or blank control group in a 4:1 ratio, followed by 1 week of the treatment period and 2 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Household contact exposure to individuals with SARS-CoV-2 infection
2. Aged ≥18
3. General healthy or have a chronic, stable medical condition
4. Voluntarily signing a written informed consent form
5. Able to follow written and oral instructions in Chinese

Exclusion Criteria:

1. Moderate to severe symptomatic SARS-CoV-2 infection
2. An allergic history to Chinese herbal drugs or a known allergy to the ingredients of the study drug
3. Pregnancy, breastfeeding or plan to become pregnant within the study timeframe
4. Vulnerable adults (i.e., mentally or physically disabled to take care of himself/herself)
5. Any physical examination findings, and/or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study
Injection Site Tolerability of Multiple Dose Treatment With Long-acting Injectable Risperidone Administered Via Deltoid Muscle in Chronic Schizophrenia Patients.

The purpose of this study is to examine the discontinuation rate of schizophrenia patients receiving multiple sequential 2 mL injections of long acting injectable risperidone (an atypical antipsychotic medication) when administered into the deltoid muscle once every 2 weeks.

This is an open-label, multiple-dose, multicenter study in chronic schizophrenia patients, who are receiving long-acting injectable risperidone 25 or 37.5-mg injections into the gluteal muscle, and clinically require a higher dose. The study consists of a pretreatment screening phase, an 8-week, open label treatment phase during which patients will receive 4 sequential 2 mL injections with long-acting injectable risperidone (37.5 or 50 mg) administered every 2 weeks into the deltoid muscle in alternate arms (right versus left) for each visit; and a post treatment phase consisting of end of study evaluations upon completion of all the study procedures on Day 57 or at early withdrawal. The study hypothesis is that repeated injections of long-acting injectable risperidone into the deltoid muscle will be safe and well tolerated as assessed by the percent of patients who discontinue after at least 2 injections. Safety was assessed using adverse events (including occurrence of extrapyramidal symptoms as assessed by the Extrapyramidal Symptoms Rating Scale), clinical laboratory tests (hematology, serum chemistry, urinalysis, and pregnancy testing), vital signs, physical examinations, electrocardiograms, and injection site evaluation. The patients will receive 4 injections with long-acting injectable risperidone (37.5 or 50 mg) administered as 1 injection every 2 weeks into the deltoid muscle.

Eligibility Criteria:
Inclusion Criteria:

* Chronic schizophrenia of any subtype, according to DSM-IV criteria
* under current treatment with long-acting injectable risperidone 25 mg or 37.5 mg gluteal injections in an adequate study for at least 2 injections, and in need of a dose increase of long-acting injectable risperidone for clinical reason
* informed consent signed by the patient
* patient is otherwise healthy on the basis of a prestudy physical examination and medical history.

Exclusion Criteria:

* No DSM IV Axis I diagnosis other than schizophrenia
* no pregnant or breast feeding women
* no female subject of childbearing potential without adequate contraception
* no history of severe drug allergy or hypersensitivity
* no patients with inadequate mass in the deltoid regions to receive the intramuscular drug injections.
Tissue Sectioning by Electro-Dissociation

Currently there is no technique to produce thin (0.004-0.01 mm) serial sections of large fresh tissue specimens that are suitable for high-resolution in situ protein/gene expression studies without ice artifact or fixation-induced molecular damage. Traditional frozen sectioning preserves protein and nucleic acid structure, but the inherent ice artifact precludes reconstruction of protein and mRNA expression patterns in 3-dimensions. Since the limitations of the existing sectioning techniques result from the fact that they rely on mechanical cutting which in turn require the tissue to be stiff, we suggest a new approach to cut tissue via an electro erosion process that utilizes focus radio frequency (RF).


Eligibility Criteria:
Inclusion Criteria:

* Fresh Tissue
* Unfrozen Tissue
* Unfixed Tissue

Exclusion Criteria:

* Unfresh Tissue
* Frozen Tissue
* Fixed Tissue
Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens

The nail specimens from patients with suspect onychomycosis were analyzed. Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan. Comparing the array results with the regular methods by sensitivity, specificity, NPV and PPV.

The nail specimens from patients with suspect onychomycosis were analyzed.

Collection:

Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan.

Nail samples were collected as subungual scrapings, clippings, or curettings. Samples were immediately transported in sterile Eppendorf tubes at room temperature to the laboratory of Department of Dermatology, NCKUH, for KOH stain and routine fungal cultures.

Sample Prepare:

Each sample was cut into small pieces with a surgical blade and homogenization by 2-ml glass homogenizer. The suspension treated by lyticase at 37°C for 30 min and extracted DNA with Blood \& Tissue genomic DNA kit.PCR program and array hybirdization same with previous study.

Analysis:

If the results between array and culture method, discrepant analysis with re-sequencing, KOH mount and the patient's outcome of after antifungal treatment. The performance evaluation of the array and culture methods with Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) were calculated after discrepant analysis. Significant difference was estimated by Fisher's exact test.

Eligibility Criteria:
Inclusion Criteria:

* Atypically results by culture and microscopy
* Suspect tinea infection

Exclusion Criteria:

* Lost follow
* Not tinea unguium
Clinical Safety and Preliminary Efficacy of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients, such as malignant melanoma and lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Sex: male or female
* Age: from 18 to 80 years
* Patients must have histologically confirmed solid tumors that have failed standard therapies (surgery, chemotherapy, radiotherapy) and for which no curative options exist, including, but not limited to:

Non-Small Cell Lung Carcinoma Malignant melanoma Esophageal carcinoma Head and neck carcinoma

* HLA-A\*24:02
* MAGE-A4 positive in the test by RT-PCR on tumor tissue or immunohistochemistry of resected tissue of the patient.
* PS ECOG 0 or \<2
* Laboratory tests results 7 days before the start of treatment:

White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils: more than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum creatinine: less than 1.25 × ULN

* Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
* Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
* Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent

Exclusion Criteria:

* Patients with life-threatening condition or complication other than their basic disease
* Pregnant or lactation. Patients both males and female with reproductive potential (i.e. menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
* Active systemic infections
* History of neoplasms: other neoplasms
* Medical history: active CNS disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
* Metastasis: clinical symptoms of brain metastasis
* Other clinical trial: the subject received other clinical trial before this study
* Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
* Compliance: poor compliance
A Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Subjects and in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled AZD9164 following administration of multiple ascending doses in healthy male and female subjects and COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female, age 18-45, COPD patients \> 40 years
* Healthy subjects and COPD patients; Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy subjects; Females must have a negative pregnancy test, must not be lactating and must be of non-child-bearing potential, by the following criteria: - irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy
* COPD patients; Females must have a negative pregnancy test, must not be lactating and must be of non-child-bearing potential, by the following criteria: Post menopausal. Woman below 50 years old will be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments, and with LH and FSH levels in the post menopausal range. Women over 50 years of age will be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. - irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy
* Healthy subjects; Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
* COPD patients; Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Healthy subjects; Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study
* COPD patients; Any clinically significant disease or disorder (other than COPD) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study
* Healthy subject and COPD patients; Any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigator
* Healthy subject and COPD patients; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients

This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.

Fifteen prevalent and stable hemodialysis patients with secondary hyperparathyroidism eligible for treatment with calcium receptor sensitizers according to current KDIGO will be included.

Study phases will begin and end on the day of the first hemodialysis session of the week.

The run-in phase will last 4 weeks. No calcimimetics will be prescribed during the run-in phase.

The treatment phase starts with a dose of etelcalcetide is 2.5mg thrice weekly. Etelcalcetide dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly.

The wash-out Phase starts after completion of the 15mg thrice-weekly phase or in case a pre-specified safety endpoint is reached, etelcalcetide will be discontinued and patients will be followed for additional 8 weeks to study any potential reversibility of PTH lowering on T50 results.

For the individual patient, the study duration will be 9 months

Eligibility Criteria:
Inclusion Criteria:

* Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF)
* Secondary hyperparathyroidism defined as PTH levels \> 9x ULN according to current KDIGO guidelines if therapy-naïve, or patients already treated with calcium receptor sensitizers with PTH \> 2x ULN
* Albumin corrected calcium ≥ 2,08 mmol/l
* Calcium concentrations of dialysate stable for at least 2 weeks prior to screening

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study or participation in non-interventional studies
* Current treatment with etelcalcetide (Parsabiv©) or treatment with etelcalcetide within 3 months prior to study inclusion
* Patient has known sensitivity to any of the products or components of Parsabiv©
* Patient has received a parathyroidectomy
* Parathyroidectomy planned or expected during the study period
* Elective kidney transplant scheduled during the study period
* Therapy with bisphosphonates within the past 12 months
* Therapy with denosumab within the past 6 months
* Antacids containing aluminum, calcium, magnesium or bicarbonate
* Patient has a history of symptomatic ventricular arrhythmias or Torsades de Pointes
* Patient has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
* Pregnant or nursing (lactating) women
Ultrasound and Electrophysiology Study of Hand in Systemic Sclerosis Patients and Contributors of Hand Dysfunction

The goal of this research is to assess quality of life and hand function in systemic sclerosis patients via specific questionnaires, and to determine the main contributors to hand dysfunction via a thorough hand ultrasound study and electrophysiology study.

Systemic Sclerosis (SSc) is a rare multiorgan autoimmune disease characterized by vasculopathy and fibrosis. Its prevalence rates vary greatly by geographic area from 9.3 to 660 per million.

The disease is primarily observed in individuals aged 35 to 55 years, with females being four to six times more affected than males. Hand involvement is an early manifestation of systemic SSc. It's recognized as a major driver of disability and diminished quality of life .

Managing hand pain can be particularly challenging due to the coexistence of non-inflammatory arthralgia, inflammatory arthritis, acro-osteolysis, tenosynovitis, joint contractures, tendon friction rubs, nerve entrapment, Raynaud's phenomenon, digital ulcers, sclerodactyly, calcinosis and chronic pain. Due to the multifactorial etiology of hand functional disability in SSc, it is important to define the contribution of each factor or structure to this issue. This understanding is essential for developing a rehabilitation and medical treatment oriented approach to disease management. While physical examination and radiographs are the first line methods for evaluating hand pain, they are limited in scope and miss many underlying etiologies of hand impairment.

Musculoskeletal ultrasound (MSUS) is rapidly becoming a mainstay diagnostic tool in the assessment of rheumatic diseases due to its low cost, portability, and safety as a non-ionizing imaging modality. The Outcome Measures in Rheumatology (OMERACT) Ultrasound working group has provided definitions for pathologic lesions seen in rheumatic disorders, which offers a valuable framework for the assessment of hand impairment in SSc.

Eligibility Criteria:
Inclusion Criteria:

Adult SSc Patients ( \>18 yrs ) who are fulfilling the The EULAR/ACR 2013 classification criteria

Exclusion Criteria:

1. Individuals with other autoimmune diseases (systemic lupus, sjogren syndrome, rheumatoid arthritis dermatomyositis, mixed connective tissue disease).
2. Usage of drugs that can cause peripheral neuropathy and chronic alcohol abuse history.
3. Presence of diabetes mellitus, thyroid dysfunction and renal failure
Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

The primary purpose of this study is to collect preliminary and pilot data to begin to determine whether the use of body weight support treadmill therapy (BWSTT) with and without driven-gait-orthotics (DGO), results in improved motor recovery and ambulation MS patients with gait impairment

Gait impairment is a major cause of ongoing disability in patients with multiple sclerosis (MS). New treadmills that provide body weight support and even robotic assistance to the lower limbs have recently been developed and are now commercially available. These treadmills allow the subject to execute the integrated process of walking in a task-specific manner that is repetitively reinforced in a normal pattern. Data from studies using these body-weight supported treadmills (BWSTT) in spinal cord injury and stroke patients suggest that intensive task-specific gait rehabilitative training may help to restore a normative gait pattern, improve overground walking and enhance quality of life in multiple sclerosis patients with neurological gait impairment. In this study, we propose a series of prospective longitudinal clinical studies to collect pilot data on the use of task-specific BWSTT +/- Lokomat on improving ambulation, motor function and quality of life for MS patients with mild to moderate gait difficulty. Pilot data will also be collected for the effect conventional rehabilitation has on ambulation and motor outcomes as well as how these outcomes change during usual care. Our clinical research goals are to capture the initial pilot data (mean changes and variances in ambulation, motor, fatigue and quality of life outcomes) to facilitate the design of a larger clinical trial to test efficacy if these preliminary data are promising. The planned studies will study the effect of two forms of task specific training (BWSTT alone and BWSTT combined with Lokomat) compared to conventional gait rehabilitative methods and usual care

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MS by McDonald criteria. EDSS level between 4-6.5.

Exclusion Criteria:

* Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg, Uncontrolled diabetes (blood glucose 2X above the upper limit of normal or non-fasting blood drain).
* Symptomatic fall in blood pressure (\>30mm Hg), when upright in the body support apparatus, despite medical therapy.
* Circulatory problems, history of vascular claudication or pitting edema.
* Cognitive impairment MMSE \< 21.
* Body weight over 150 kg (structural limits of the Lokomat).
* Lower extremity injuries that limit range of motion or function.
* Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
* Unstable fractures.
* Pressure sores with any skin breakdown in areas in contact with the body harness or DGO apparatus.
* Chronic and ongoing alcohol or drug abuse.
* Pre-morbid, ongoing depression or psychosis.
Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

To examine nipple aspirate fluid for secretions that may be identified as a high risk indicator for development of breast cancer, and compare those to serum analysis.

To examine nipple aspirate fluid analysis in lactating women for local concentration of estrogen, prolactin, glucocorticoids, insulin, parity, prior lactation and age. NAF secretors have been reported to have modest increase in breast cancer risk compared to non-secretors . Estrogen levels have been found to be markedly higher in NAF samples than in the serum collected from the same women. Estradiol and estrone concentrations in premenopausal women are 10x and 20x greater in NAF samples than in serum and 50x and 35x greater in post-menopausal women not on HRT. It has been suggested that the disparity between serum and NAF levels may be due to local estrogen production via aromatase and sulfatase.

Eligibility Criteria:
Inclusion Criteria:

* women with high a high risk of breast cancer
* Older than 18

Exclusion Criteria:

* anticoagulants
* marked breast tenderness
* pregnant or within twelve months of breast feeding/childbirth