cyrilzakka/clinical-trials huggingface dataset:
AIRVO Device Intervention for Moderate to Severe COPD

This is an open (non-blinded), single-arm, clinical trial to assess the efficacy of daily use of a high-flow nasal cannula (HFNC) device in patients with moderate to severe COPD, in addition to standard care, in reducing the amount of COPD exacerbations over a one-year period. Once enrolled in the study, all subjects will be asked to undergo a baseline walking test to measure pulmonary function (6MWT), verify their personal and medical history (demographics), as well as fill in some questionnaires regarding their COPD and its symptoms (SGRQ-C, CAT). All subjects will then receive their own AIRVO2 device, as well as training and instructions on how to use the device at home. Subjects will use the MyAIRVO2 device daily for the following 12 months. Follow-up visits will occur five times over the 12-month study period and will be similar to the baseline visit. Additional data will be collected by the study team for each subject from their electronic medical record during the 12-month study enrollment period. Only information regarding COPD-related medical and/or pharmacy costs, specifically to measure the amount of COPD exacerbations experienced by each subject, will be reviewed and recorded.


Eligibility Criteria:
Inclusion Criteria:

* • Moderate to severe COPD

  * ≥2 inpatient or outpatient claims (ER, or urgent care included) in the previous calendar year
  * ≥2 COPD exacerbations in previous year
  * Current established care within the Reno/Sparks area
  * Residing in Washoe County or Carson City County
  * Ability to travel to site
  * Willing to use myAirVo™2 for at least four hours per day but preferably ≥7 hours or overnight and be capable of handling the myAirVo™2 device after instruction
  * Prior PFT data available prior to admission into project
  * Understand and accept oral and written information in English
  * Life expectancy greater than 1 year

Exclusion Criteria:

* • End-stage renal disease (ESRD)

  * Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness, COVID-19)
  * Oxygen requirements greater than 6 L/min
  * Bipap or CPAP use in home
  * Receiving hospice care
  * PCP/PI determines the patient is not a good candidate for project inclusion
  * Lung CA
  * Active smoker status
Resistance Training on Growth Factors

The goal of this clinial trial study is to explore the effect of high or low intensity resistance training (LIRT) under similar training volume on change in serum levels of BDNF, IGF-1, VEGF, irisin, and plasma Hcy in young adults.The main questions it aims to answer are:

1. Whether high and low intensity will increase the serum levels of BDNF, IGF-1, VEGF, irisin, and reduce plasma Hcy.
2. whether a greater magnitude of change would be suffer in low intensity group when compared to high intensity group, as an effect of greater physiological adaptation produced by more repetitions required to complete.

Participants will performe two different intensity resistance training (HIRT, at 80%1RM with 12 repetitions and 4-5 sets and LIRT, at 40%1RM with 24 repetitions and 4-5 sets).

Researchers will compare the training effects of two different training on these growth factors.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 to 30 years
* no experiencing musculoskeletal disorders or sports injuries
* had not participated any regular aerobic endurance or resistance training with in the previous half years
* no smoking habit or intake alcohol and other medication (e.g., steroid hormone)
* good general body condition without any chronic diseases (e.g., osteoarthritis, metabolic syndrome or arthritis)

Exclusion Criteria:

* experiencing musculoskeletal disorders or sports injuries in recent 1 month
* had regular resistance training exercise
* intake any supplementary(drug and hormone)
The Effects of Kuvan on Functional Brain Connectivity in Individuals With Phenylketonuria (PKU)

The objective of the study is to determine whether Kuvan™ (sapropterin) improves the strength of the functional connectivity between brain regions in individuals with PKU.

The proposed study is designed to evaluate the hypothesis that functional connectivity may represent an early marker for neurocognitive improvements related to Kuvan treatment. As a first step in the study, 20 patients with PKU who are ≥ 6 years of age will receive baseline functional connectivity magnetic resonance imaging (fcMRI) evaluations before being treated with Kuvan™. Response to Kuvan™ will be monitored for 4 weeks. At the end of 4 weeks, response to Kuvan™ will be reviewed and all 20 patients will receive follow-up fcMRI evaluations. Fifteen patients with a reduction of ≥ 20% in blood phenylalanine will continue in the study and receive a third fcMRI evaluation at the end of 6 months of treatment with Kuvan™. For comparison purposes and to control for possible practice effects in repeated testing, a matched control group of 20 healthy individuals without PKU will used. All 20 of the control subjects will receive baseline and 4-week fcMRI evaluations; fifteen will receive a 6-month evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent or assent.
* Willing and able to comply with study procedures.
* Greater than or equal to 6 years of age.
* For phenylketonuria, intention of physician to prescribe sapropterin.
* For phenylketonuria, phenylalanine level greater than or equal to 300μmol/L.
* For phenylketonuria, negative pregnancy test if of childbearing potential.
* For phenylketonuria, willing to use contraception if sexually active.

Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant during study.
* Use of investigational product less than 30 days prior to or during study.
* Concurrent condition that could interfere with participation or safety.
* Any condition creating high risk of poor compliance with study.
* Perceived to be unreliable or unavailable for study.
* Use of L-Dopa, methotrexate, or other drugs that inhibit folate metabolism.
* For phenylketonuria, known hypersensitivity to sapropterin or excipients.
Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor block and duration until meeting discharge criteria in patients undergoing cervical cerclage. The hypothesis is that chloroprocaine will result in faster resolution of motor block.

Cervical cerclage is an ambulatory surgical procedure of short duration commonly performed under spinal anesthesia. Bupivaciane and chlororpocaine are both commonly used, but how their use impacts clinical care, in particular patient flow, is not well studied.

This is a prospective, randomized, double blind, controlled trial. Participants meeting inclusion criteria will be randomly allocated to receive spinal anesthesia with either chloroprocaine or bupivacaine.

Patients will then be assessed for motor block and sensory level until they are discharged from the recovery room.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification II or III females
* Age: 18-45 years old
* BMI ≤ 50 kg/m2
* Singleton pregnancy
* Simple prophylactic cervical cerclage
* Planning neuraxial anesthesia

Exclusion Criteria:

* Abdominal and complex cervical cerclage (e.g. bulging bag)
* Contraindication to neuraxial anesthesia
* Known hypersensitivity to chloroprocaine (a.k.a. Ester allergy), paraaminobenzoic acid (PABA) or bupivacaine (a.k.a. Amide allergy)
* Pseudocholinesterase deficiency
* Concomitant use with ergot-type oxytocic drugs
Longitudinal Evaluation of Hip Cartilage Degeneration: FAI

Femoroacetabular impingement (FAI) is one of the most common mechanisms leading to the development of early cartilage and labral damage in the non-dysplastic hip. Anatomic abnormalities of the proximal femur and/or acetabulum result in repetitive injury during dynamic hip motion, leading to abnormal regional loading of the femoral head-neck junction against the acetabular rim. The resulting damage to the cartilage, labrum, and surrounding capsular structures predispose the patient to developing hip pain and early osteoarthritic changes. Clinically, patients with FAI are a heterogeneous group, with a wide array of presentation from pain to instability that may or may not be related to activity. To date no studies have identified specific prognostic indicators associated with successful surgical treatment of FAI, leaving surgeons without adequate criteria to determine which patients are best suited for arthroscopy. The investigators propose to address this critical knowledge gap by identifying the patient characteristics and morphological features of the hip that are associated with the optimal clinical outcomes in patients undergoing hip arthroscopy or non-operative management for treatment of suspected FAI in order to establish a treatment algorithm for FAI patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients 35 years of age or younger enrolled in the HSS Hip Preservation Registry prior to September 30, 2016 with an MRI confirmed diagnosis of FAI will be eligible for inclusion in this study regardless of surgery status.
* Patients who agree to participate must complete a baseline questionnaire consisting of: 1) Modified Harris Hip Score (MHHS), an overall measure of hip condition; 2) the Hip Outcome Score (HOS), a measure developed specifically for younger active patients that measures quality of life and levels of sports and recreation; and 3) International Hip Outcome Tool (iHOT33), a newly developed hip specific outcome score, which measures a number of subscores relating to physical and social functioning with hip problems.

Exclusion Criteria:

* Patients over age 35 will be excluded as the focus of this study is early changes that may predispose to later degenerative changes.
* Patients undergoing revision hip arthroscopy as their first treatment in the Registry will not be eligible, as these are patients who have failed initial therapy.
* Patients with no complete questionnaires at any time point will be excluded.
68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies

As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.

Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. 68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a head-to-head comparison with 68Ga-FAPI-04 or 18F-FDG PET/CT scans in patients with various cancers.

Eligibility Criteria:
Inclusion Criteria:

* 18 years \< Age \< 75 years
* Various solid tumors with available histopathological findings, and have not been treated surgically.
* Signed informed consent.

Exclusion Criteria:

* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Comparison of Brachial Artery Dilatation, Uterine Artery Doppler, Umbilical Artery Doppler and 1st-trimester Visceral Adipose Tissue Measurement in Obese and Normal Pregnant Women

Brachial artery flow-mediated in obese and normal-weight pregnant women dilation of uterine artery doppler and umbilical artery doppler results comparison of

The systemic inflammatory effect caused by obesity and vascular disorder It has been reported that it creates studies. Healthy Vascular Endothelial structure increases vascular tone by regulating nitric oxide (NO) release. Reduced nitric oxide production, reducing flexibility It has a facilitating effect on hypertensive diseases and other obstetric diseases.

Endothelial function, which is a non-invasive, easily applicable, and reproducible method It can be detected by endothelium-dependent vasodilation. A good indicator of endothelial function in studies in which the brachial artery flow-mediated dilation (FMD) shown. Brachial artery blood pressure cuff at forearm level in normal healthy people with compression for 3-5 minutes 50 mmHg above systolic pressure, 60-120 seconds after loosening the cuff When measured later, individuals with healthy endovascular function and the brachial artery are also reactive hyperemia, and a 10% dilatation is expected. Many obstetric effects such as obesity preeclampsia, preterm labor, gestational diabetes, preterm labor Although it was found to be related to pathology, the relationship between them could not be determined exactly.

Our study aimed to increase brachial artery dilatation in obese and normal pregnant women.

By comparing, determine the level of nitric oxide and endovascular function. Also uterine Vascular structures of obesity by comparing vascular structures with artery and umbilical uterine dops examine the effect on

Pregnant women between the ages of 18-40 who apply to the Diseases and Obstetrics outpatient clinic will be taken. 24-28. Brachial artery dilatation, uterine, and umbilical artery doppler between 11-14, 37-40w weeks between gestational weeks, and visceral adipose tissue measurement at first trimester will be examined.

Eligibility Criteria:
Inclusion Criteria:

* obese and normal pregnant
* 11-14 weeks
* 24-28 weeks
* 37-40 weeks

Exclusion Criteria:

* smoking
* chronic vascular disease
* Diabetes mellitus
* Over 40 years old
A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Pregnant or nursing females.
Educational Programme Impact on Serum Phosphate Control

Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels \> 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric, clinical, demographic and laboratory parameters (serum phosphorus concentration will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention.

Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels \> 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric (weight, height, body mass index), clinical, demographic (sex, age, time on dialysis programme, literacy/schooling) and laboratory parameters (phosphate serum levels) will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention. Reduction of phosphate serum levels and positive/negative behavioral changes will be the evaluated outcomes. Statistical Analyses will be carried out in order to compare the effect of educational programme on phosphate serum levels and on the behaviour changes.

Eligibility Criteria:
Inclusion Criteria:

* patients who freely consent to participate in this study
* aged from 18 years or older
* both genders
* phosphate serum levels higher than 5.5 mg/dl (last 3 consecutive monthly measures)

Exclusion Criteria:

* patients who do not consent to participate in this study
* pregnant
* cognitive deficit
* mental diseases
* patients whose phosphate serum levels lower than 5.5 mg/dl or equal to 5.5 mg/dl
Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)

The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control.

The main question\[s\] it aims to answer are:

* To determine, whether abnormalities in brain glucose transport seen in individuals with uncontrolled diabetes, can be improved with better glucose control.
* Assess which factors, (duration of diabetes mellitus (DM) and glycemic control) contribute to changes in glucose transport

Participants will have:

* A screening visit
* placement of a continuous glucose monitor (CGM) 2 weeks before the first magnetic resonance spectroscopy (MRS) at week 0
* Additional visits/phone calls for intensification of diabetes management and nutrition visits
* Second magnetic resonance spectroscopy (MRS) at week 12


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18-60
* medical history for Type 2 diabetes
* HbA1c \> 7.5%, BMI ≥18 kg/m2
* Be willing to adhere to the intensification of their diabetes regimen

Exclusion Criteria:

* Creatinine \> 1.5 mg/dL
* Hgb \< 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants
* ALT \>3 x ULN
* untreated thyroid disease,
* uncontrolled hypertension
* known neurological disorders
* untreated psychiatric disorders
* malignancy
* bleeding disorders
* current or recent steroid use in last 3 months
* illicit drug use
* for women: pregnancy, actively seeking pregnancy, or breastfeeding
* inability to enter MRI/MRS (as per standard MRI safety guidelines).
Stenting for Symptomatic Intracranial Artery Stenosis Registry in China

Stenting for systematic Intracranial artery stenosis is challenged recently, especially for safety. This registry is aimed to explore the safety profile during peri-operation period in Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real world.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 year old
* medical failure patient with systematic Intracranial artery stenosis
* More than 3 weeks after most recent ischemic stroke
* Digital Subtraction Angiography(DSA) showed ≥70% stenosis in target intracranial artery
* Imaging test within 1 week showed bad collateral circulation in target vessel area
* Diseased vessel diameter≥2mm, length \<15mm, distal vessel is normal

Exclusion Criteria:

* Diffused intracranial stenosis
* Acute stroke or TIA within 3 weeks
* Pure penetrating branch stenosis showed by cerebral imaging
* Non-atherosclerosis pathology for the stenosis
* Intracranial hemorrhage in target vessel area within 6 weeks; or potential cardiac thrombus source
* Intracranial tumor, arterial aneurysm or intracranial arteriovenous malformation

  •\>50% stenosis in extracranial carotid artery or vertebral artery in operation side; Known contradiction to heparin, aspirin, clopidogrel, anesthesia or contrast; hemoglobin \<10g/dl，platelet count \<100000
* Modified Rankin score ≥3 related to target vessel;
* INR(International Normalized Ratio)\>1.5(irreversible），persist hemorrhage risk; life expectancy \< 1year
* Pregnant or beast-feeding
* Not suitable for endovascular stenting judged by Indication Judgement Committee
Optical Coherence Tomography (OCT) Intravascular Ultrasound (IVUS) Dual Imaging

Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly used and have been extensively studied separately to guide percutaneous coronary intervention and improve long-term outcomes. In this study, the investigators aim to directly compare high-definition IVUS images to OCT in the same patients to determine the differences between each modality as they relate to imaging coronary pathology, with the goal of determining which modality is most appropriate in particular clinical scenarios.

Intravascular ultrasound (IVUS) is an imaging modality that uses ultrasound waves to allow for detailed evaluation of coronary atherosclerotic plaques and the vascular response to coronary interventional devices to guide stent placement during percutaneous coronary intervention. Current conventional IVUS catheters emit ultrasound waves ranging from 20-40 megahertz (mHz), and more recently released high-definition IVUS catheters emit sound waves at 60 mHz, allowing for better image quality, quantitative accuracy, and precision in measurements.

Optical coherence tomography (OCT) is an alternative imaging modality used for similar purposes as IVUS, using a single optical fiber that emits infrared light to image the coronary artery. OCT uses light in the infrared spectrum with a central wavelength between 1,250 and 1,350 nm. Axial resolution with OCT is 10-20 microns, whereas it is typically 100-200 microns with IVUS. Thus, OCT allows for better image resolution, but this comes at the expense of tissue penetration.

Eligibility Criteria:
Inclusion criteria:

* Undergone diagnostic coronary angiography
* Evidence of coronary pathology that requires further imaging to guide treatment

Exclusion criteria:

Significant renal insufficiency
Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease

The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ESRD who currently require treatment for hyperphosphatemia

Exclusion Criteria:

* Female patient who is pregnant or lactating
* Patient has used any investigational product within 30 days of screening