cyrilzakka/clinical-trials huggingface dataset:
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension

The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

This study will have a main 24-week treatment period and a 28-week extension period of treatment. Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period.

Eligibility Criteria:
Inclusion Criteria:

* Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
* Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
* Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
* Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Exclusion Criteria:

* Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
* Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
* Has a history of chronic bronchitis
* Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
* Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 at Screening OR an eGFR ≥30 mL/min/1.73 m\^2 and \<50 mL/min/1.73 m\^2 at Screening with unstable renal function
* Has a history of malignancy \<=5 years
* Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
* Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
* Has a known allergy/sensitivity or contraindication to gefapixant
* Has donated or lost \>=1 unit of blood within 8 weeks prior to the first dose of gefapixant
* Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study
Measuring HIV Quality of Care

The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.

Background:

The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.

Objectives:

Our purpose in this project is to develop a method for assessing quality in two important areas of HIV care - antiretroviral medications and opportunistic infection screening and prophylaxis - and explore the determinants of high quality care in order to suggest quality improvement strategies.

Methods:

The analysis has four parts. First, it will describe the level of adherence to the indicators in VA HIV patients nationwide and compare VA HIV patients to national benchmarks. Second, it will analyze facility and patient level predictors of adherence to indicators of quality of care and compare them with the predictors in the non VA population using staged logistic regressions. Third, it will seek to validate certain indicators (e.g. HAART therapy) against clinical outcomes like hospitalization and immune status. We will also model the clinical "price" that the VA pays in suboptimal clinical outcomes as a result of current performance levels. Fourth, we will compare the performance of the facilities after one year of an intensive targeted indicator-specific feedback group versus those receiving aggregate data only.

Status:

Data analysis.

Eligibility Criteria:
Inclusion Criteria:

Facilities with HIV clinics

Exclusion Criteria:
Competency-based Intervention for Head Nurses

Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness.

Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness. This study aimed to evaluate the impact of the leadership competency intervention program on the leadership effectiveness of head nurses

Eligibility Criteria:
Inclusion Criteria:

* Head nurses

  * willing to participate in the study
  * work in general wards and toxicology, intensive and critical care units
  * Sign a consent

Exclusion Criteria:

* Head nurses

  * work in outpatient units
  * Did not sign a consent
  * Absent from training
Assessing Visual Processing in High Anxiety

High trait anxiety, a stable personality trait, is a risk factor for psychiatric disorders. Individuals with high trait anxiety have difficulty differentiating safety from threat, including visual information like emotional faces. This study aims to characterize visual system function in high trait anxiety. A portion of this study involves an intervention. For the intervention portion, a subset of participants will be asked to return for a lab visit upon completing the first portion of the study (multimodal magnetic resonance imaging (MRI) scan). During this follow up visit, participants will complete a computer task that involves looking at faces and identifying emotions. Participants will complete this task either six months or twelve months after their MRI scan visit. Results from this research have the potential to inform novel therapies that target the visual system in individuals at risk for the development of psychiatric disorders.

The purpose of this study is to understand how people with anxious personalities process emotional facial expressions. The intervention portion of this study is part of a larger study. The first portion of this study consists of a screening visit with questionnaires, and a second visit with a magnetic resonance imaging (MRI) scan and short computer tasks.

For the intervention portion of this study, a subset of participants will return to the lab for an in-person visit either six or twelve months after their MRI scan. This visit will last approximately two hours. Participants will be asked to complete a computer task where they will be asked to identify emotional face expressions and receive feedback on their performance. They will also complete questionnaires about their mood and emotions.

The primary purpose of this research is to gather scientific information about how people with anxiety process social and emotional information.

Eligibility Criteria:
Inclusion Criteria:

* Young adults varying continuously in trait anxiety as assessed by the Spielberger State Trait Anxiety Inventory (STAI).
* HTA participants with STAI trait scores of ≥44

Exclusion Criteria:

* contraindication to MRI
* history of head trauma or loss of consciousness
* major medical or neurological illness
* current psychiatric medication usage or use in the last three months
* alcohol/substance abuse or dependence and/or illicit substance use (excepting cannabis) in the last three months
Effect of Casodex on Tumour Hypoxia - Prostate Cancer

Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. One previous study has suggested that hormone therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to test that finding.


Eligibility Criteria:
Inclusion Criteria:

* Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project
* informed consent

Exclusion Criteria:

* Coagulopathy
Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Primary Objective:

To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death

Secondary Objective:

To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically proven pancreatic carcinoma
* Measurable locally advanced or metastatic disease
* Patient previously treated with 5-FU as a "radiation sensitizer" and all toxicities must have been resolved
* Patients must have received Gemcitabine-based chemotherapy (single agent or combination) as 1st line therapy for advanced or metastatic disease and all toxicities must have been resolved
* Patients received the last dose of gemcitabine at least 2 weeks prior to randomization
* Confirmed radiographic disease progression (Computed Tomogram (CT) scan or Magnetic Resonance Imaging (MRI) within 4 weeks prior to randomization
* Adequate liver and kidney function:

  * Total bilirubin inferior than 1.5 Upper Limit of Normal (ULN)
  * Creatinine clearance (ClCr) superior than 50 mL / min
  * Aspartate Transferase (AST) inferior than 3 ULN if no liver metastasis or AST inferior than 5 ULN if liver metastasis
  * Alanine Aminotransferase (ALT) inferior than 3 ULN if no liver metastasis or ALT inferior than 5 ULN if liver metastasis
* Adequate hematological function:

  * Neutrophils superior or egal to 1.5 x 109/L
  * Platelets superior or egal to 100 x 109/L

Exclusion criteria:

* Peripheral sensory or motor neuropathy \> grade 1
* Eastern Cooperative Oncology Group (ECOG) Performance status \> 2
* Serious cardiac arrhythmia, diabetes, or serious active infection or other active illness that would preclude study participation in the opinion of the investigator
* Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency
* Previous (greater than 5 years) or current malignancies of other origin within the past 5 years
* Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
* History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to LV or to any ingredients in the formulations or the containers
* Severe renal impairment (ClCr \< 50 mL/min)
* Pregnant women or breast-feeding
* Patients (male or female) with reproductive potential not implementing accepted and effective method of contraception (the definition of "effective method of contraception" will be based on the investigators' judgment)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Inherited Thromophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission

Inherited thombopllia and thrombotic risks in inflammatory bowel Disease during activity and remission

Inflammatory bowel diseases (IBD) are systemic conditions characterized by multiple intestinal and extra-intestinal manifestations related to the associated chronic inflammatory state. Among their diverse extra-intestinal complications, venous thromboembolism (VTE) remains one of the most under recognized causes of morbidity and mortality in these patients, highlighting the need for a better understanding of the underlying mechanism of hypercoagulability, in addition to the role of acquired and inherited risk factors that further increase the risk of thrombosis with its impact on patients' outcomes.\[1, 2\]

Eligibility Criteria:
Inclusion Criteria:

* Age (18yrs - 65yrs) both sex

Exclusion Criteria:

* Presence of acquired cause (pregnancy, recent surgery, history of drug, History of malignant Disease, History of blood or blood product transfusion in last 4 weeks)
Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers

The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.

This initial proof-of-concept study focuses on evaluating whether an NK1 antagonist, aprepitant, can block opiate reward in non-dependent opiate experienced volunteers in response to a standard opiate challenge. Sixty subjects will be included in a randomized controlled study. Following a training challenge session, they will receive 1 week treatment with aprepitant or matching placebo, followed by a challenge session during which subjective and physiological responses to the opiate partial agonist buprenorphine will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 50
* Current opiate use, without dependence

Exclusion Criteria:

* Clinical diagnosis of opiate dependence
* Positive urine screen for opiates on day of challenge sessions
* Meet diagnostic criteria for any other substance abuse disorder except nicotine within the last 12 months.
* Any ongoing prescription medication other than oral contraceptives or hormone replacement
* Any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.
Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study

This study will determine whether the ratio between 24h C-peptide urinary excretion rate and average 24h circulating glucose represent a good correlate of what is measured by the gold standard, i.e. M (glucose disposal rate) from a euglycemic-hyperinsulinemic clamp


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Age 18-65 y
* BMI between 20 kg/m2 and 35 kg/m2 (inclusive)
* Are willing to consume pre-prepared meals
* Have completed a high-dose (≥80 mIU/m2/min) euglycemic-hyperinsulinemic clamp during the last five years at Pennington Biomedical. The data from the previous PBRC clamp will be pulled and used in conjunction with data from this study.
* Willing to have blood and urine stored for future use

Exclusion Criteria:

* Major lifestyle changes since the euglycemic-hyperinsulinemic clamp was performed (i.e. gain/lost weight, stopped smoking, began/stop exercise).
* Unstable weight in the last 3 months \[gain or loss \>10 lb (or 4.5 kg)\]
* Diagnosed with diabetes
* Untreated hypertension and average screening blood pressure \>140/90 mmHg
* Previous bariatric surgery (or other surgeries) for obesity or weight loss
* Chronic use of medications affecting metabolism or sleep\*
* History of neurological disease
* History of cardiovascular disease, or other chronic diseases, that might affect pancreatic or glucose metabolism.
* Pregnant, planning to become pregnant, or breastfeeding
* Adherence to special restrained diets (e.g., low-CHO, low-fat, or vegetarian/vegan diets) over the last 3 months. \*Sporadic use of these medications is fine (however, enrollment will depend on a case-by-case basis). If taking sporadically, participants should not be taking the medication for 1-month prior to the first visit.
A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities

The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD dementia. The secondary objective of the study is to characterize ARIA, from both the imaging and the clinical perspective and to characterize the safety, tolerability, pharmacokinetics (PK), and immunogenicity of aducanumab.


Eligibility Criteria:
Inclusion/ Exclusion Criteria

Key Inclusion Criteria:

* Ability of the participant or his/her legally authorized representative to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
* Must have at least 6 years of education or work experience to exclude mental deficits other than MCI due to AD or mild AD dementia.
* Must have evidence of cerebral Aβ accumulation, based on a positive PET scan of the brain. Previously obtained positron emission tomography (PET) scan (within 12 months of screening) is permissible. Previous PET scan images must be submitted to the central imaging vendor to confirm that study inclusion criteria are met.
* Must consent to apolipoprotein E (ApoE) genotyping.
* Must meet all of the following clinical criteria for MCI due to AD or mild AD dementia according to NIA-AA criteria \[Albert 2011; McKhann 2011\], and must have the following: MCI due to AD (a CDR global score of 0.5, and an MMSE score between 24 and 30 (inclusive)), or Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score between 20 and 26 (inclusive)).

Key Exclusion Criteria:

* Any uncontrolled medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia, frontotemporal dementia, head trauma).
* Clinically significant unstable psychiatric illness (e.g., uncontrolled major depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder) within 6 months prior to Screening.
* Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening.
* Vaccinations within 10 days prior to randomization (Day 1).
* Female participants who are pregnant or currently breastfeeding.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Blood Flow Evaluation After Carotid Surgical Treatment

Approximately 20% of strokes originate from the rupture of an atherosclerotic plaque in the carotid artery. Surgical revascularization, i.e. carotid endarterectomy (CEA), is the treatment of choice for patients with a symptomatic carotid stenosis each year about 3,000 procedures are performed in the Netherlands. Currently, two surgical procedures are performed in clinical practice. Most frequently an endarterectomy is performed using a length incision over the artery, followed by a patch plasty (CEAP), in order to reduce the risk of restenosis. As an alternative the eversion technique (ET) was introduced, in which transversal arteriotomy is performed and the plaque is removed from within. After reconstruction with a patch a \>50% restenosis has been described in 6-36% of patients during long-term follow-up. When using the eversion technique this is seen in 1.7-2.5%, while also the risk on adverse events seem to be lower. One of the drivers for atherosclerosis in general is a disturbance of local blood flow. This may lead to turbulence, recirculation and stasis of blood. The subsequent low Wall Shear Stress may lead to the ne formation of plaque that in turn may become instable and cause recurrent ischemic events. Recently, a breakthrough was achieved in the imaging options of flow in the carotid arteries, using Vector Flow Imaging. Using a fully programmable ultrasound machine, over 10,000 frames per second can be captured, in comparison to about 50 in regular ultrasound. This enables the tracking of particles that, after processing will provide the needed flow information. A recent study, comparing flow before and after CEAP has shown that there is significant recirculation after reconstruction. This raises the question whether this would be more optimal after ET, which would support the potential lower incidence of recurrent stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Presence of carotid artery stenosis (≥50%) according to conventional clinically performed imaging (duplex/CT(A)/MR(A)) for which patient underwent uncomplicated CEA with either a patch plasty or the eversion technique
* ≥18 years old;
* Able to provide signed or oral informed consent
* Carotid artery \<25mm below skin

Exclusion Criteria:

* Carotid bifurcation with depth of center bulb lumen ≥2.5cm
* Restenosis after carotid revascularisation at side of interest
* Participating in another clinical study, interfering on outcomes
MANDARIN (S6371)

To evaluate the efficacy and safety of TheraSphereTM yttrium \[90Y\] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 and ≤80 age and provided study consent
* Patients diagnosed with HCC and clinically evaluated as inoperable (as per local practice) or who refuse operation (ablation, hepatectomy and liver transplantation)
* At least one well defined HCC tumor measurable by mRECIST in contrast-enhanced MRI
* China liver cancer staging (CNLC) stage Ib\~IIb
* Child-Pugh ≤ B7
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Tumor burden ≤50% of the total liver volume

Exclusion Criteria:

* Presence of extra-hepatic metastases or additional malignancies aside from HCC
* Patients with hepatic artery malformation and unable to intubate hepatic artery
* Patients who are allergic to contrast agents or have renal insufficiency (Serum creatinine\>2mg/ml or Creatinine clearance\<30mL/min) and are not suitable for injection of contrast agents
* Severe pulmonary insufficiency (FEV1/FVC\<50% or FEV1/predicting value\<50% or MVV\<50L/min)
* AST and ALT \>5 times upper limit of normal
* Clinical manifestations of decompensated cirrhosis (Grade2/3 of ascites, gastrointestinal bleeding, hepatic encephalopathy, etc. according to EASL Clinical Practice Guidelines)
* HCC invading biliary tract or causing biliary obstruction
* uncorrectable coagulation dysfunction and severe hemogram abnormality \[Prothrombin time (PT)\>6 seconds above control or PT-International normalized ratio (INR)\>2.5, WBC\<3.0x109/L, PLT\<50x109/L\]
* Infiltrative HCC tumor type
* Bilobar HCC disease
* Any presence of portal vein or hepatic veins or artery invasion
* Occlusion of portal vein completely with less collateral vessels
* Transjugular intrahepatic portosystemic shunt (TIPS) or Hepatic arterioportal fistula
* Patients during pregnancy or lactation
* Prior interventional therapy via hepatic artery or radiotherapy treatment for HCC
* Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques
* Radiation pneumonitis has been seen in patients receiving doses to the lungs greater than 30 Gy in a single treatment or greater than 50Gy in multiple treatment
* The absorbed dose of lung may exceed 30Gy in preoperative evaluation
* Receive any investigational therapy or anti-tumor therapy within 30 days prior to study enrollment
* Any other reason in which the investigator believes that the patient is unsuitable to participate in this trial