cyrilzakka/clinical-trials huggingface dataset:
Imaging Biomarkers in Preclinical and Symptomatic AD

The purpose of this research study is to evaluate adult children of parents with and without Alzheimer's disease which represent an ideal population for investigating the biological changes that precede the clinical onset of AD. The investigators will be imaging the brain to detect the presence of amyloid deposits (plaques in the brain). Amyloid is a protein that may be related to dementia of Alzheimer's disease (DAT).

This study will use a radioactive tracer called \[11C\]-Pittsburgh Compound B (11C\]PIB), which is a tracer that binds to beta amyloid protein in the brain. This compound is considered investigational, which means that it has not been approved by the United States Food and Drug Administration (FDA).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, any race;
* Age ≥ 18 years;
* Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.

Exclusion Criteria:

* Hypersensitivity to \[11C\] PIB or any of its excipients;
* Contraindications to PET, CT or MRI (e.g. electronic medical devices, inability to lie still for extended periods) that make it unsafe for the individual to participate;
* Severe claustrophobia;
* Women who are pregnant or breast-feeding will be excluded from PIB PET participation;
* Has any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the subject, limit the subject's ability to tolerate the research procedures, or interfere with collection of the data;
* Currently participating in any clinical trial which involves an active study medication or placebo within the past 30 days before scanning and up to 2-weeks past the imaging visit.
* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1
The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients

The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
* All genders，range from 18～60 years old
* Karnofsky performance status(KPS) ≥ 80
* Clinical stage III\~IVb(UICC 8th)
* Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
* Without significant cardiac，respiratory，kidney or liver disease
* Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
* white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
* alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 1.5×upper limit of normal(ULN), bilirubin \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
* Inform consent form

Exclusion Criteria:

* Distance metastases
* Second malignancy within 5 years
* Drug or alcohol addition
* Do not have full capacity for civil acts
* Active systemic infections
* Chronic consumptions
* Mental disorder
* Pregnancy or lactation
* Concurrent immunotherapy or hormone therapy for other diseases
* Severe complication, eg, uncontrolled hypertension
Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response

The aim of the present trial is to study the effect of the combination of plant extracts (BSL_EP024) in the activation of the immune response.

More than 90% of the diseases are related, directly or indirectly, with immune alterations. Traditionally, protection against infections and improvement of the immune response has been addressed by natural means through the use of plant extracts. This activity has been attributed to phenolic compounds.

The aim of the present study is to evaluate the effect of the combination of plant extracts (BSL_EP024) on immunological response parameters.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult between 18 and 55 years.
* Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

* Be under pharmacological treatments that may affect the immune response (anti-inflammatory drugs of chronic or frequent use, antiallergic treatments).
* Have allergy to some plant extracts
* Suffer from gastric problems or ulcers.
* Receive treatment with anticoagulant activity.
* Have a low expectation of adherence to the study protocol.
Shared Decision Making With Anal Cancer Patients on Radiation Dose

The purpose of this study is to maximize patient involvement in the treatment of anal cancer. Specifically, the investigators will investigate whether patients wish to take part in the decision making on radiation dose and whether they want a high or low radiation dose.

The study will also provide new knowledge on the effect and side effects of irradiation of anal cancer, and detailed data from the dose planning will be instrumental in optimizing future decision aids.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma of the anal duct or perianal (non-hairy skin, max 5 cm from the anal verge)
* T2-T4 N0-3
* Age ≥ 18 years
* Performance status 0-2
* Sufficient organ and bone marrow function defined as:

  * Neutrophils ≥ 1.5 x 10\^9/L
  * Thrombocytes ≥ 100 x 10\^9/L
* Curative intent radiation treatment deemed possible
* Patients chooses 1 of 3 options:

  * I do not wish to decide on details of my treatment, but I would like to receive the standard treatment
  * I want to receive the high radiation dose
  * I want to receive the low radiation dose
* Written and orally informed consent

Exclusion Criteria:

* Non-resectable metastases
* Tumor \> 10 cm or the total tumor volume (incl. lymph node metastases) is too large to be included in an appropriate radiation field (after possible neoadjuvant chemotherapy)
* Pregnant or breastfeeding women
* Fertile women not willing to use effective contraception
* Serious co-morbidity that would hinder interfere with radiation treatment or hinder patient compliance (e.g. incapacity to understand or complete questionnaires)
Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation.

The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day.

The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Participants in the colorectal cancer screening program that give consent

Exclusion Criteria:

* Contraindication for colonoscopy
Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour

With the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of physical illness in depression, the serotonin hypothesis seems to fail in approaching the etiology of depression. Based upon the evidence from epidemiological data, case-control studies of PUFAs compositions, and antidepressant effects in clinical trials, phospholipid polyunsaturated fatty acids (PUFAs) is enlightening a promising path to discover the unsolved of depression.

There are several important questions to answer regarding phospholipid polyunsaturated fatty acids (PUFAs) hypothesis of depression. Firstly, although case-control studies revealed that depressive patients had lower levels of omega-3 PUFAs, the abnormal findings in individual PUFA of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) or arachidonic acid (AA) are not consistent. Secondly, the deficits in n-3 PUFAs are related to their metabolic enzymes. However, the association study of polymorphisms of PUFA-metabolism related genes in depression is limited. Thirdly, the active component of antidepressant effect in n-3 PUFAs is still in debate. Fourthly, the molecular mechanisms of n-3 PUFAs' antidepressant effects have yet to be elucidated in human brain functional neuroimaging or in cellular models.

This 3-year proposal is divided into 2 clinical studies. In study 1, the investigators aim to test the clinical and biological effects of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) for depressive symptoms in a 12-week, double-blind, placebo-controlled trial of patients with drug-free MDD. In study 2, the investigators will measure the biological and neuroimaging markers to investigate the biological mechanisms of EPA (3.5 g/d) versus DHA (1.75 g/d) in 12-week, double-blind, randomized-controlled trial with patients with drug-free major depression disorder (MDD).

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder
* Age being age 18-65.
* Capacity and willingness to give written informed consent.
* Free from antidepressants, mood stabilizers, and antipsychotics for more than 4 weeks.

Exclusion Criteria:

* Any major medical illnesses.
* A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.
SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.

Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years who are able to give their informed consent
* Patients undergoing lung resection surgery for either malignant or benign conditions including:

  * Lobar and sublobar resections
  * Open, video-assisted thoracoscopic or robotic surgeries
  * Diagnostic or therapeutic procedures

Exclusion Criteria:

* Traumatic pulmonary contusion or laceration
* Lung reduction surgery
* Planned removal of more than 10 lung lesions
* Pneumonectomy
* Known hypersensitivity to bovine protein
* Known hypersensitivity to Brilliant Blue FCF (E133)
* Presence of active infection
Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound

Construct a breast cancer risk prediction model based on traditional Chinese medicine four diagnostic instruments and B-ultrasound images. Ensure that the key evaluation indicators of the model reach a high level through clinical verification, so as to contribute to accurate clinical diagnosis and treatment decision-making.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged between 30 and 75.
2. Patients who have a mass detected by US examination, need to undergo surgery or needle biopsy, and obtain a definite pathological result.
3. Patients who have obtained complete identification results of tongue, pulse, face, and constitution through the traditional Chinese medicine four diagnostic instruments.

Exclusion Criteria:

- 1. Patients with severe heart, liver, or kidney insufficiency, or other serious systemic diseases.

2. Patients with a history of other malignant tumors. 3. Cases with poor - quality B - ultrasound images. 4. Cases with an unclear pathological diagnosis. 5. Patients with obvious lesions on the face, in the oral cavity, or on the tongue that may affect the measurement results.
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A

The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained from participant or legally authorized representative
* 15-60 years old
* Factor VIII level \< 1% as documented by previously measured factor VIII and genotyping
* Previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as documented by the study site investigator) prior to study entry
* Observed decrease of efficacy by subject and/or treating physician after being switched from Recombinate rAHF to Advate rAHF-PFM

Exclusion Criteria:

* The participant has a detectable factor VIII inhibitor at screening, with a titer \>= 0.4 Bethesda Unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the local and the central laboratory
* The participant has a known hypersensitivity to mouse or hamster proteins
* The participant is participating in another investigational drug study within 30 days prior to screening
* The participant is identified by the investigator as being unable or unwilling to cooperate with study procedures
Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation

The aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation.

Primary Objective:

* To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices.

Participants will be enrolled after receipt of one dose of Menactra® during a routine health care visit. They will be monitored for safety throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 2 through 55 years on the day of enrollment "2 through 55 years" means from the day of the 2nd birthday to the day before the 56th birthday
* For adults (18-55 years old) Informed consent form has been signed and dated by the participant.
* For minors: Informed consent form has been signed and dated by the parent. In addition, in accordance with the Institution Ethics Committee/Institution Review Board requirements and as appropriate for the age of the participant:
* participants aged 14 to 17 years are required to sign and date the informed consent form,
* participants aged 10 to 13 years are required to sign and date the assent form,
* for participants under 10 years, consent may be asked orally according to participant's age and ability for understanding
* Receipt of one dose of Menactra® on the day of inclusion and prior to enrollment into the study, in routine practice according to the approved local product insert.

Exclusion Criteria:

* Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure.
FCM Analysis GR in Steroid-Treatment Patients

Monitoring the GR with a GR-MoAb and FITC-Dex probes by FCM would be useful and convenient in determination GR before the steroid treatment in clinical, especially in steroid resistant states, in order to design more efficient clinical treatment protocols.

In order to assess the efficacy of this method, 100 patients with nephrotic syndrome and systemic lupus erythematosus receiving sufficient prednisolone thereafter and 50 age- and sex-matched normal controls will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SLE and NS

Exclusion Criteria:

* Receiving hormone replacement therapy or had received hormone replacement therapy in three months before start of the study
* Received drugs or drinks containing alcohol within one month
* Having symptom such as infection
* Supersensitivity and endocrine disturbance.
Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease

The indication of Pu Yang Wan Wu Tang is stroke sequelae, such as half body paralysis, aphasia and muscle weakness.

Pu Yang Wan Wu Tang is proved to have the effect of protecting nerve and blood vessel, anti-inflammation, anti-coagulation, dilating peripheral vessel, promot-ing micro circulation, improving hemodynamics, and activating central nerve system. Huangqi could attenuate podocyte injury by regulating the expression and distribu-tion of nephrin and podocin. Huangqi and Danggui are associated with fewer infiltra-tion of macrophages and limitation of renal intrinsic cell activation, which may lead to earlier and persistent reduction of proteinuria.

This research will use the compound Chinese medicine, Pu Yang Wan Wu Tang. Those treatments combined Western medicine to assess the efficacy and drug safety on the CKD cases. Series of blood and urine were collected regularly during study to prove the role of Chinese medicine in the treatment of CKD, and to assess their drug safety.

The final goal of the plan is to establish the new indication of Pu Yang Wan Wu Tang and enhance the interaction and cooperation between Chinese and Western medicine.


Eligibility Criteria:
Inclusion Criteria:

* Participants' age is between 20 to 80 years.
* Participants CKD stage are from 2 to 4(eGFR from 89 to 15)
* Participants under regular western medicine therapy.
* Participants who agree to follow the trial protocol.
* Participants who can complete the study treatment and assessments.

Exclusion Criteria:

* Participants who are already under hemodialysis, Peritoneal Dialysis or kidney transplant.
* Participants who are participating in other clinical trials.
* Participants with hematopoietic system diseases, severe psychiatric or psychological disorder, or cancer.
* Women who are pregnant.
The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children

Systemic lidocaine administration may improve postoperative pain and recovery after laparoscopic inguinal hernia repair in pediatric patients


Eligibility Criteria:
Inclusion Criteria:

* Age between 1 and 6 year-old
* ASA class 1 and 2
* Pediatric Inguinal hernia patients who are scheduled for elective laparoscopic inguinal hernia repair

Exclusion Criteria:

* Allergy to local anesthetics or contraindication to use of lidocaine
* Current active upper respiratory infection or history of upper respiratory infection within 2 weeks
* Severe cardiovascular disease
* Renal failure
* Liver failure
* Neurologic and psychologic disease
* Chronic treatment with analgesics
* Previous history of laparoscopic operation
* Parents' refusal
Quantitation of Cardiac Output Change by Impedance Cardiography in Subjects Undergoing Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI

The aim of this study is to test for an early post-stress cardiac output (CO) change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (CZT) SPECT camera.

Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is a well-established noninvasive procedure for the evaluation and risk stratification of patients with coronary artery disease (CAD) (1). However, it has been recognized that in certain patients SPECT MPI is unable to detect the presence of or underestimates the extent of CAD. The fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease (2) has stimulated studies to improve the diagnostic accuracy of SPECT MPI. Such studies have analyzed post-stress parameters such as left ventricular (LV) ejection fraction (EF) (3, 4), wall motion abnormalities (5) and transient LV dilation (6) with images acquired on conventional Anger cameras as long as 60 minutes after the stress tracer injection. Such delayed assessment may miss early ischemic stunning as a result of its transient nature. However, detection of an early post-stress decrease in cardiac output (CO) may serve as a potential marker for the presence of significant or extensive ischemia. The aim of this study is to test for an early post-stress CO change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (CZT) SPECT camera.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the Nuclear Cardiology Center for a clinically indicated exercise stress MPI study

Exclusion Criteria:

* known standard contraindications for ergometry
* anemia
* hyperthyroidism
* intra- and extra-cardiac shunts
* significant arrhythmia
* hemodialysis
Treatment of Alcohol Withdrawal in Hospital Patients

The purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.

Studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence units without other illness. On general medical hospital wards, withdrawal may be affected by comorbid medical illness. A clinical trial was undertaken to determine whether there is a difference between symptom-triggered (ST) and fixed-schedule (FS) dosing of lorazepam in patients hospitalized on general medical wards at a University medical center. Subjects were assessed by their nurses with the Revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale. Subjects in the ST arm received lorazepam doses based on CIWA-Ar score. Subjects in the FS arm received scheduled lorazepam with tapering over 4 days.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol dependence (based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
* Daily alcohol use for at least seven consecutive days with the last use no more than 72 hours prior to enrollment
* Patients on the General Internal Medicine service

Exclusion Criteria:

* Unable to give informed consent
* Chronically maintained on prescription sedative-hypnotics