cyrilzakka/clinical-trials huggingface dataset:
Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

Neuraxial analgesia is the gold standard to relieve labor pain. A recent "Practice guidelines for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation \< 5 cm) or on a individualized basis. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.

Neuraxial analgesia is the gold standard to relieve labor pain. It also helps to attenuate maternal anxiety and improve maternal satisfaction. A recent "Practice guidelines for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation \< 5 cm) or, for some special patients, be provided on a individualized basis. Studies showed that, when compared with late administration, early administration of labor analgesia resulted in equivocal findings for spontaneous, instrumented, and cesarean delivery. The investigators hypothesize that neuraxial labor analgesia provided on an individualized basis will further improve analgesia quality and maternal satisfaction. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Nulliparas (aged 18-36 years) with single cephalic term pregnancy;
2. Plan to deliver vaginally, and are considered suitable for a trial of vaginal delivery by obstetricians;
3. Admitted to the delivery room;
4. Agree to receive epidural analgesia during labor.

Exclusion Criteria:

1. History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists);
2. Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.
3. Other reasons that are considered unsuitable for study participation.
A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing


Eligibility Criteria:
Inclusion Criteria:

* Participants in general good health
* Participants seeking improvement of temple hollowing

Exclusion Criteria:

* Temple hollowing due to trauma, congenital malformations, or lipodystrophy
* Temporomandibular joint dysfunction or any other jaw issues
* Recurrent temporal headaches such as temporal tendinitis migraine
* Active autoimmune disease
* History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
* Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
* Fat injection or permanent facial implants anywhere in the face
* Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
* Temporary dermal filler injections above the subnasale within 24 months before enrollment
* Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment
* Botulinum toxin treatment above the subnasale within 6 months before enrollment
* Females who are pregnant, nursing, or planning a pregnancy
Validation, Implementation, and Cost-analysis of a Strategy for Personalized Diagnosis of Rare Kidney Diseases

Chronic kidney disease (CKD) affects about 10% of the world population, with high morbidity and mortality. Genetic kidney diseases are increasingly recognized across all age groups and represent over 20% of all the causes of CKD. Accurate diagnosis allows necessary and unnecessary diagnostic procedures to be defined, avoids unnecessary treatments, improves prognosis prediction, identifies other family members for genetic counseling, and defines risks for living donor kidney transplantation. The research group coordinated by the Principal Investigator has recently developed an algorithm for the genetic diagnosis in pediatric and adult patients with CKD. The application of this personalized diagnostic algorithm on a local study led to a global diagnostic yield of 70%, suggesting that this strategy has the potential to substantially improve the diagnostic approach to patients with rare kidney disorders. The aim of this study is to validate and implement these results by extending its application in a multicentric study involving nephrology units that are referral centers for rare kidney diseases at national level.


Eligibility Criteria:
Inclusion Criteria:

* proteinuria and/or hematuria in the absence of immune deposits on renal biopsy or immune-mediated glomerulopathy resistant to treatment (e.g., steroids, immunosuppressive drugs);
* family history of kidney diseases and/or consanguinity;
* extrarenal involvement;
* ultrasound evidence of at least two cysts in each kidney or hyperechogenic kidneys or nephrocalcinosis;
* persistent metabolic abnormalities (metabolic acidosis or alkalosis without kidney function impairment; calcium phosphate metabolism abnormalities) after exclusion of secondary causes;
* availability of clinical information.
* signed informed consent form

Exclusion Criteria:

* Refusal by the patient, parents, or legal guardian to provide informed consent.
Efficacy of Extended Infusion of β-lactam Antibiotics for the Treatment of Febrile Neutropenia in Hematologic Patients

This study evaluates the administration of beta-lactam antibiotics in extended infusion in hematological patients with febrile neutropenia after 5 days of treatment. The beta-lactam antibiotics analyzed are the following: piperacillin-tazobactam, cefepime and meropenem. Half of patients will receive the antibiotic in intermittent infusion, while the other half will receive it in extended infusion.

Febrile neutropenia (FN) is a very frequent complication in patients with hematological malignancies. It is associated with an important morbidity and mortality. Nowadays the use of betalactam antibiotics (BLA) in extended or continuous infusion (EI, CI) instead of intermittent infusion (II), has demonstrated a therapeutic success and lower mortality rate in critically ill intensive care patients. Neutropenic patients are a particular population since FN is assoicated with pathophysiological variations that compromise pharmacokinetic parameters of BLA, and may therefore, diminish their clinical efficacy. Information regarding the usefulness of BLA in EI in neutropenic hematologic patients is scarce.

The objective of this randomized clinical trial is to demonstrate the clinical superiority of the administration of BLA in EI compared to II in patients with FN.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age ≥18 years) of both sexes.
2. Patients admitted in Hematological wards.
3. With any of the following diagnoses:

   1. Acute leukemia receiving chemotherapy.
   2. Autologous or allogeneic hematopoietic stem cell transplant recipients.
4. With an episode of febrile neutropenia: ≥ 38.0ºC and \<500 neutrophils/mm3 or \<1000 with a predicted decrease within 24-48 hours.
5. Patient requiring treatment with a beta-lactam antibiotic: cefepime, piperacillin /tazobactam or meropenem, in monotherapy or in combination with another antibiotic.
6. Written informed consent has been obtained from the patient or their legal representative grants.

Exclusion Criteria:

1. Allergy to study drugs.
2. Patient receiving systemic antibiotic treatment (except for prophylaxis) at the time of onset of febrile neutropenia.
3. Absence of fever.
4. Patients with epilepsy.
5. Severe renal impairment (defined as creatinine clearance \<30 mL / min)
6. Previously enrolled patients in whom the time between the inclusion and the current episode is less than 5 weeks.
7. Previously enrolled patients without current resolution of the first episode.
Screening of OSA in Hospitalized Stroke Patients Using BSP

Obstructive sleep apnea (OSA) is prevalent in patients with stroke and has a negative effect on outcomes by predisposing them to recurrent stroke, increasing mortality, and so forth. Therefore, it is extremely important to identify OSA in patients with stroke.

Wearable devices can greatly reduce the manpower and material requirements of traditional laboratory-based polysomnography (PSG). With Photoplethysmography (PPG) technology and neural network algorithms, the Belun ring and the sleeping platform not only can detect blood oxygen, and heart rate but also can identify sleep stage and estimate the severity of sleep apnea.

In this study, inpatients with acute ischemic stroke in the hospital will proceed with three nights test for recording the parameters of the autonomic nervous system in the acute phase, evaluate whether sleep apnea and the feasibility of the Belun sleep platform.

It is important that early recognition of OSA and prompt treatment, which can potentially improve OSA-associated adverse outcomes, as well as understanding the degree of autonomic nervous function impairment for patients with acute ischemic stroke. After smoothing this process, it can help clinicians more accurately comprehend the condition, timing of admission, and discharge.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with confirmed acute ischemic stroke
* Age 18-80
* Able to consent

Exclusion Criteria:

* History of atrial fibrillation, LVEF \< 45%, pacemaker/defibrillator, left ventricular assist device (LVAD), or status post-cardiac transplantation, devastating strokes ( mRS \>= 4).
* Aphasia, severe bulbar palsy, unable to comprehend, consent, or answer questionnaires.
* Unstable cardiopulmonary status.
* Recent surgery including tracheotomy in 30 days.
* On narcotics.
* On O2, PAP device, ventilator, diaphragmatic pacing, or any form of nerve stimulator
* unable to understand instructions or to accurately use BRP during the instruction session.
* Patients with technically valid recording time under 4 hours will be excluded.
Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)

The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity in patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patient with office blood pressure ≥140/90 mmHg and 24-hour ambulatory blood pressure ≥130/80 mmHg at Baseline despite the stable use of at least two anti-hypertensive drugs at maximum tolerated doses of the patient for at least 4 weeks
* Patient with a fasting glucose ≥100 mg/dL (≥5.6 mmol/L) at Baseline or on drug treatment for elevated glucose
* Patient with a waist circumference ≥102 cm (≥40 inches) for male or ≥88 cm (≥35 inches) for female at Baseline
* Patient with any of the remaining two metabolic syndrome diagnostic criteria listed as follows at Baseline

  * Triglycerides ≥150 mg/dL (≥1.7 mmol/L) or on drug treatment for elevated triglycerides
  * High density lipid cholesterol (HDL-C) \<40 mg/dL (\<1.03 mmol/L) for male or \<50 mg/dL (\<1.30 mmol/L) for female or on drug treatment for reduced HDL-C
* Patient is ≥18 and ≤70 years old
* Patient must be able and willing to provide written informed consent to participate in this clinical investigation
* Patient must be able and willing to comply with the required follow-up schedule

Exclusion Criteria:

* Patient with secondary hypertension
* Patient with type I diabetes mellitus or type II diabetes mellitus requiring insulin therapy
* Patient with prior renal angioplasty, renal denervation, indwelling renal stents and/or aortic stent grafts
* Patient with renal arteries \<4.0 mm in diameter
* Patient with significant renovascular abnormalities (such as renal artery stenosis \>30%)
* Patient with an estimated glomerular filtration rate (eGFR) of \<45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula
* Patient with hemodynamically significant valvular heart disease, as determined by Study Investigator
* Patient has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days at Baseline or is expected to have cardiovascular intervention within the next 180 days
* Patient is in chronic atrial fibrillation/flutter or with severe conduction abnormalities or with an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for radiofrequency (RF) energy delivery
* Patient is currently being treated with drugs that cause salt retention (such as systemic corticosteroids or fludrocortisone), centrally acting sympatholytic antihypertensive drugs, direct vasodilators (such as alpha blockers) and continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea
* Patient with an active systemic infection or blood-clotting abnormalities or allergy to radiographic contrast
* Patient is pregnant or of childbearing potential and is not using adequate contraceptive methods or nursing
* Patient is participating in another clinical investigation
* Patient has a life expectancy less than 12 months, as determined by Study Investigator
HELP Therapy for Dry AMD

This is an open-label, single center clinical investigation to evaluate the efficacy and safety of Heparin-induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Therapy as a treatment for non-exudative (dry) Age-related Macular Degeneration (AMD). A total of 14 clinic visits are scheduled, one baseline visit, 8 visits for H.E.L.P. therapy treatments (to be performed over a period of 12 weeks for each patient) and 5 follow-up visits to be performed one week following the 4th H.E.L.P. therapy session and 12 weeks, 24 weeks, 36 weeks and 52 weeks after the final H.E.L.P. therapy session.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-exudative (dry) AMD
* Male or female, between 50 and 90 years
* Presence of soft, confluent drusen in study eye
* At least one large (\>125 μm) drusen
* Visual acuity (VA) between 20/32 and 20/100 Early treatment Diabetic Retinopathy Study (ETDRS) vision
* Fibrinogen level \>100mg/dL
* Willing to continue lipid-lowering medication throughout the treatment phase if such medication was taken already before the study
* Willing to continue regular supplemental intake of Age related Eye Disease Study (AREDS) vitamins or comparable supplements throughout the study course
* Written informed consent

Exclusion Criteria (related to the underlying disease):

* Any evidence of wet AMD in either eye
* History of treatment for wet AMD in either eye
* Geographic atrophy involving fovea in study eye
* Fellow eye \<20/400 VA
* Presence of cataract requiring treatment during study
* Presence of glaucoma requiring new treatment during study
* Presence of diabetic or other vascular retinopathy
* Previous retinal laser or surgical therapy
* Epiretinal membrane in study eye
* Any other ocular condition requiring therapy during the study

Exclusion Criteria (General):

* Participation in another clinical trial within 30 days
* Concurrent participation in another clinical trial
* Pregnancy or lactation
* Inability to give or understand informed consent
* Inability to maintain treatment and follow-up schedule
* Hypersensitivity to fluorescein
* Test positive for infectious status from HIV-, HBV- and HCV- infection

Exclusion Criteria (H.E.L.P. Apheresis):

* Heparin intolerance
* Heparin induced thrombocytopenia (HIT) II
* Hemorrhagic diathesis
* Ulcers in the gastrointestinal area
* Hemorrhage
* Coagulation disorder and neoplasm
* Liver diseases
* Severe heart failure and valvular defect
* Condition following apoplexia
* Dementia
* During pregnancy and lactation
* C1 esterase inhibitor deficiency or hereditary complement component 3 (C3) deficiency
Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Current therapies for Stage IV non-small cell lung cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV lung cancer

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV lung cancer.

Stage IV non-small cell lung cancers receive Antineoplaston A10 and AS2-1 capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV non-small cell lung cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV non-small cell lung cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IV non-small cell lung cancer that cannot be cured with existing therapeutic regimens
* Measurable disease by CT scan or MRI

  * Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* No hepatic insufficiency
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

* No renal insufficiency
* Creatinine no greater than 2.5 mg/dL

Cardiovascular:

* No chronic heart failure
* No uncontrolled hypertension

Pulmonary:

* No serious lung disease (e.g., severe chronic obstructive pulmonary disease)

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No other serious medical or psychiatric conditions
* No active infection
* No serious malabsorption syndromes

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy (less than 8 weeks if multiple tumors are involved) and recovered

Surgery:

* No prior extensive stomach or intestinal surgery
* Recovered from any prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No prior antineoplaston treatment
* No other concurrent treatment for metastatic lung cancer
A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]

This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.

Eligible participants will be categorized in to three groups as follows:

1. Participants with no prior chemotherapy for advanced disease;
2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
3. Participants who are 2L+ and previously treated for brain metastases.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC
* PDL1-positive status as determined by an immunohistochemistry assay performed by a central laboratory. A positive result in chemotherapy, chemoradiation of the tumor sample biopsy will satisfy the eligibility criterion
* Eastern Cooperative Oncology group Performance Status of 0 or 1
* Life expectancy greater than or equal to 12 weeks
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1
* Adequate hematologic and end organ function

Exclusion Criteria:

* Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day 1
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
* Known central nervous system disease, including treated brain metastases in the following participants:

  1. who will not receive prior chemotherapy for advanced disease
  2. who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (referred as 2L+ participants)
* Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases.
* Leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia
Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment

This study was to develop and evaluate the self-efficacy and resilience of the Breast Cancer Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy.

This study was to develop and evaluate the self-efficacy and resilience of the Breast Cancer Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy. In the first phase of this study, develop a prototype the Breast Cancer Self-Care App by conducting patients interviews. In the second phase, an experimental two-group pretest-posttest quantitative study design to evaluate the self-efficacy and resilience of the Breast Cancer Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy. The patients were randomized to the experimental and control groups. Patients in the control group received general routine care and patients in the experimental group received general routine care plus the Breast Cancer Self-Care App intervention. Both groups completed a basic demographics, self-efficacy and resilience questionnaires at the pre-test and after four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Consciousness clear, over 20 years old, can communicate in Mandarin and Taiwanese
* Diagnosed Breast Cancer I-III stage
* undergo first chemotherapy
* Have a smartphone
* Receiving treatment: EC/ EC+T/LC/LC+T E: (Epirubicin)、C: (Cyclophosphamide)、L: (Lipo-Dox)、T: (Taxotere)

Exclusion Criteria:

* DSM-V mentally ill
* IOS system smartphone
* over 65 years old