cyrilzakka/clinical-trials huggingface dataset:
18F-MFBG Cardiac Imaging for Heart Failure Administration

The clinical feasibility of 18F-FMBG cardiac PET imaging will be observed in sympathetic nervous system activity in patients with heart failure, predicted cardiac events, guided ICD implantation, and evaluated therapy efficiency.

This is a prospective, single-center clinical study, using18F-meta-fluorobenzylguanidine (18F-MFBG) cardiac PET imaging to present the sympathetic nerve status in heart failure, including ICD implantation. Through follow-up, we analyze the correlation between the distribution of the tracer in the heart and the functions and progression of the patients, including the occurrence of ventricular arrhythmias and sudden cardiac death, And further investigate the guiding value of 18F-MFBG cardiac sympathetic nerve imaging in the screening of ICD implantation patients, including primary and secondary prevention, reducing the cost of ICD implantation and related complications. Furthermore, to evaluate the therapy efficacy for these patients with heart failure using 18F-MFBG cardiac imaging has been considered.

Eligibility Criteria:
Inclusion Criteria:

* 1. Clinically confirmed patient with chronic heart failure, LVEF ≤ 40%, cardiac function NYHA 2-3 grade, survival period greater than 1 year, evaluated by the Heart Failure Center of Sichuan Provincial People's Hospital.
* 2. Chronic heart failure patients were evaluated by the Cardiology Department of Sichuan Provincial People's Hospital 5-10 days before ICD implantation.
* 3. All patients above have signed an informed consent form.

Exclusion Criteria:

* 1. Heart failure, heart function NYHA levels ⅠOR Ⅳ.
* 2. The patient has already implanted ICD or CRT.
* 3. Heart transplant patients.
* 4. Patients with malignant tumors.
* 5. Heart valve disease.
* 6. Myocardial infarction occurred within the past three months.
* 7. The patient has contraindications for ICD implantation surgery.
* 8. The patient does not cooperate or is unwilling to conduct the study.
Whole Body Electromyostimulation and Nutritional Therapy for Patients With Chronic Liver Disease

The purpose of this study is to explore the influence of an innovative combined therapy involving optimized protein-rich nutritional therapy and highly effective muscle training by personalized whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass, strength and functionality, physical capacity, fatigue and quality of life of patients with chronic liver disease.

In the course of chronic liver disease a systemic inflammatory reaction promotes mediators leading to a loss of appetite, as well as to metabolic and hormonal changes. Consequences hereof are a decreased food uptake, a deteriorated nutrient utilization and a loss of muscles, with or without fat loss leading to cachexia. Especially muscle loss has a relevant influence on morbidity and mortality of chronic liver patients. The loss of muscle is probably due to a deteriorated protein synthesis with concurrent anabolic resistance. These pathologic processes increase the protein requirements of chronic liver patients dramatically.

The purpose of this study is to establish an innovative combined therapy involving optimized nutritional therapy and highly effective muscle training by personalized whole-body electromyostimulation (WB-EMS) exercise to improve the quality of life (QLQ) of patients with serious chronic disease. An improvement of QLQ results from an increase in muscle mass and strength, thereby increasing physical activity, physical capability as well as tolerance to and applicability of therapy. In the course of a 3-months intervention study the efficacy of a combined German-guidelines-recommended protein-rich nutritional therapy with an innovative exercise therapy will be documented for patients with chronic liver disease. An effective stopping of the progress of muscle wasting or even increase of muscle mass, strength and function in the patients of the trial would benefit each patient and his family individually, since it could mean a considerable improvement in his QLQ and tolerability of therapeutical treatment.

Eligibility Criteria:
Inclusion Criteria:

• Patients with chronic liver disease in curative or palliative treatment

Exclusion Criteria:

* Healthy persons or patients under age
* Pregnancy, Lactation,
* Psychological disorders, epilepsy, sever neurological disorders
* Participation in other exercise- or nutrition studies within the last 6 months
* acute cardiovascular disease
* Rheuma
* Intake of anabolic drugs,
* Skin injuries in the area of electrode placements
* Electronic implants (defibrillator, pacemaker)
* Persons in mental hospitals by order of authorities or jurisdiction
Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.

Proximal humerus fractures are more common in older people. They can be caused by a minor trauma on an osteoporotic bone.

Non- or little-displaced proximal humerus fractures are treated orthopedically. When the displacement is more important, the choice of the treatment is crucial and the algorithm of treatment is in permanent evolution. The technology and design of the implants and the operative techniques of osteosynthesis and arthroplasty have evolved. Patients live longer, they lead a more active life and their expectations have changed. The goals of the treatment should be an increase in shoulder function and a decrease in treatment failure.

This study analyzes the results of the treatment by intramedullary osteosynthesis using a Multiloc nail from Synthes between 2012 and June 2017. The study will compare the functional results obtained after fixation by a Multiloc nail, a Philos plate or arthroplasty.The functionality of the shoulder and the quality of life will be evaluated according to the type of treatment.


Eligibility Criteria:
Inclusion Criteria:

All patients being treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.

Exclusion Criteria:

None
Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane

To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Elective laparoscopic colorectal surgery
* ASA I-III

Exclusion Criteria:

* Contraindication to Na Channel Blocker
* Chronic Opioid use
* Liver dysfunction
* Renal insufficiency
* Epilepsy
* Psychomotor retardation
* BMI \>40
* Sleep Apnea
* Cardiac Rhythm Disorders
* Planned open or concomitant procedure
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium. Both of these medicines are FDA-approved to treat mania in adults and lithium is also FDA approved in children; quetiapine is commonly used in children with mania, but is not FDA approved for this indication in this age group.


Eligibility Criteria:
Inclusion Criteria - First-episode manic bipolar patients (N=100; 15-20 patients/year):

1. Patients meet DSM-IV criteria for type I bipolar disorder, manic or mixed.
2. Patients have an index Young Mania Rating Scale (YMRS)70 total score \>20.
3. Patients have \<3 months of lifetime anti-manic or anti-depressant medication exposure, including no active psychotropic medication in the one weeks prior to the index admission. Importantly, patients will NOT be taken off medications for this study; this criterion is to exclude subjects receiving active treatment at the time of admission to support the 'first-episode' criterion.
4. Patients have no more than two prior episodes of major depression.
5. Patients are between 12 and 35 years old; subjects \< 18 yrs old have a Tanner greater than or equal to 4

Exclusion criteria: All subjects will be excluded from participation for the following reasons.

1. Any chemical use disorder within 3 months.
2. Any medical or neurological disorder that could influence fMRI and MRS results.
3. A history of mental retardation or an estimated IQ total score \<85.
4. An MRI scan is contraindicated in the subject.
5. The patient cannot attend follow-up visits.
6. A positive urine pregnancy test (in women).
Endocrine Dysfunction and Quality of Life After Subarachnoid Hemorrhage

Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and reduced quality of life.


Eligibility Criteria:
Inclusion Criteria:

* acute aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

* unable to give informed consent
Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks

The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver Elastography ratio) during normal pregnancy


Eligibility Criteria:
Inclusion Criteria:

* major pregnant women
* singleton pregnancy

Exclusion Criteria:

foetus:

* fetal pulmonary disease
* fetal liver disease
* chromosome fetal abnormalities
* fetal growth restriction

mother:

* BMI\>30 in beginning of pregnancy
* premature ruptured membranes
* high blood pressure
* pre-eclampsia
* gestational diabetes
Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with melanoma and colorectal, gastric, ovarian, breast, lung and kidney epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals. This protocol is expected to prolong survival of metastatic cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* One of the following metastatic cancers: Melanoma, breast, ovary, colorectal, gastric, lung or kidney
* Above 18 years of age
* Failure of at least one chemotherapy protocol
* Clinical performance status of ECOG 0,1
* Absolute neutrophil count greater than 1000/mm3
* Serum ALT/AST less than three times the upper limit of normal
* Serum creatinine less than or equal to 1.6 mg/dl.
* Must be able to understand and sign the Informed Consent document

Exclusion Criteria:

* Below 18 years of age
* Women who are pregnant
* Life expectancy of less than three months
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.

The investigators will conduct a comparative effectiveness study among Medicare Parts A, B, and D beneficiaries with inflammatory bowel disease. The investigators will compare the incidence of severe infection, bowel resection surgery, and death among new users of anti-tumor necrosis factor therapies and corticosteroids. The investigators will compute propensity scores to describe the propensity for treatment with anti-tumor necrosis factor drugs compared to corticosteroids, and will match corticosteroids and anti-tumor necrosis factor drug treated patients on the propensity score. Cox regression will be employed to assess the hazard ratio for each of the outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will be required to have at least two diagnosis of inflammatory bowel disease within the 6 months prior to initiating anti-TNF therapy or corticosteroids. To assure full coverage, patients will be required to have Parts A, B, and D Medicare coverage.

Exclusion Criteria:

1. Diagnosis of rheumatoid arthritis, psoriasis, ankylosing spondylitis, or psoriatic arthritis in the 6 months period prior to initiation of the therapy.
2. Less than 6 months of follow-up time within the data source prior to initiation of the therapy.
3. Diagnosis of cancer in the 6 months prior to initiation of the study medication.
4. Initiation of anti-TNF therapies within the first 6 months following surgery.
5. Patients who are in managed care plans (Medicare Part C).
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer

This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.
* Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists.
* Stage IA with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; Stage IB with or without high-risk factors. The pathological stage is based on the 8th edition of AJCC lung cancer staging.
* EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al.
* ECOG performance status 0-1.
* Sufficient organ function in liver, renal, kidney and hematology.
* With written signed informed consent form, ability to report adverse events, and good adherence to clinical study.

Exclusion Criteria:

* Lung cancer with small cell or neuroendocrine cancer cell.
* EGFR exon 20 insertion positive.
* Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.
* Women who are pregnant or breastfeeding.
* Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional Chinese medicine within 14 days before enrollment.
* Concurrent with other malignancies excluding carcinoma in situ.
* With uncontrolled systematic diseases such as active bleeding, unstable angina, heart infarction within 1 year, chronic heart failure and uncontrolled hypertension and diabetes mellitus; with active infection of HBV, HCV or HIV, or other infections requiring injection of antibiotics.
* Gastrointestinal disorders which may affect drug taking or absorption.
* With history of QT prolongation or relative risk factors including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome et al.
* With history of interstitial lung disease or relative risk.
* Allergic to any component of furmonertinib tablet.
* Mental illness or drug abuse.
* Live vaccination within 30 days before enrollment.
* Other situation judged by investigator such as failure to follow the rules of study.
* Attending another study of investigational drug, or received other study drugs or medical devices with 4 weeks before enrollment.
Vitamin D Binding Protein (Gc) Allele Variation Effects Response to Vitamin D Treatment

We have just completed a randomized, clinical trial of 100,000 IU Vitamin D3 given as a single dose at the beginning of winter. We found a wide range of responses to the dose. This study proposes that genetic differences account for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

We suspect that the wide range of response is effected by other factors such as variation in Vitamin D binding protein (the major transporter of Vitamin D metabolites).

Gc, also known as Vitamin D binding protein (DBP), group specific component, or Gc globulin, is a 52-58 kDa multifunctional plasma protein, synthesized in the liver. The gene encoding for Gc is located on chromosome 4, and three common co-dominant alleles give rise to three phenotypes (Gc1s, Gc1f, and Gc2). Gc binds actin, recruits neutrophil leukocytes and converts into a macrophage- and osteoclast- activating factor. It also is the major transporter of Vitamin D and its' metabolites. Lauridsen et al. showed that Gc phenotype correlates with 25(OH)D levels in a group of postmenopausal women.

This study proposes that Gc phenotype accounts for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* Must be willing to participate with an additional blood draw.
* Must have been in the previous study.

Exclusion Criteria:

* Will not be eligible if not a part of the previous study
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2

DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed meal-stimulated C-peptide.

Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other standard of care treatments.

The following visits are required:

* Screening Visits: 2 to 3 appointments will be conducted to determine eligibility. At 2 of these visits participants will drink a liquid meal and have blood tests done over the post-meal period. Participants will also be required to wear a continuous glucose monitor for a short period of time.
* Dosing Visits: 8 outpatient visits on consecutive days, each lasting about 2-4 hours.
* Follow-up Visits: weekly for the first month, then every 2 weeks for 3 months, followed by monthly visits through 1 year. There will be 3 visits in the second year.
* The total duration of the study is 2 years.
* Glucose test strips and glucose monitors will be provided to participants for the duration of the study. Frequent glycemic monitoring will occur through lab testing and blood glucose self-monitoring to help facilitate tight glycemic control in all subjects. Subjects will be asked to intermittently record their insulin doses using a telephone or web based system and continuous glucose monitoring will be performed every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Ages 12-17
* Diagnosis of diabetes mellitus, consistent with ADA criteria
* No more than 90 days between diagnosis and administration of study compounds
* Requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration of study compounds. In Canada, has to be using insulin at the time of dosing.
* Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50 nmol/L
* Positive for one or more of the autoantibodies typically associated with T1DM: antibody to glutamic acid decarboxylase (anti-GAD); antibody to protein tyrosine phosphatase-like protein (anti-IA-2); zinc transporter autoantibodies (ZNT8); insulin autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and negative for the other autoantibodies will only be eligible if the subject has used insulin for less than 7 days total.

Exclusion Criteria:

•Other, significant medical conditions based on the study doctor's evaluation
Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.

To determine the pharmacokinetics of ethionamide (Eto) and ethionamide-sulfoxide (Eto-SO) in participants with tuberculosis (TB) when Eto is dosed under programmatic conditions.

A single-centre, open-label, exploratory pharmacokinetic study. This study is designed to collect blood samples from participants established on a TB treatment regimen which includes Eto. These samples will be analysed for concentrations of Eto and its metabolite Eto-SO.

The medication will not be provided by the study, participants will receive their standard of care medication from their local clinic. Participants will continue to take their total daily dose of Eto on study as prescribed by their primary caregiver, this will not change for their participation on study.

Eligibility Criteria:
Inclusion Criteria:

* Provide written, informed consent prior to all trial-related procedures.
* Male or female, aged between 18 and 65 years, inclusive.
* Receiving Eto as a component of a treatment regimen for tuberculosis for at least one month at the time of enrolment.
* Ability and willingness of participant or legally authorized representative to provide informed consent.

Exclusion Criteria:

* Evidence of clinically significant conditions or findings, other than TB, that might compromise safety of the participant or the interpretation of trial endpoints, per discretion of the Investigator.
* Receiving prohibited concomitant medications (see Prior and Concomitant Medications)
* Evidence of illicit substance use (cannabis, methamphetamines, opiates)
* Pregnant or breastfeeding or planning to become pregnant during the study period.
* Laboratory values: participants with the following laboratory values at screening
* creatinine \>1.5 times upper limit of normal \[ULN\];
* haemoglobin \<8.5 g/dL;
* Alanine aminotransferase (ALT) ≥2.0 x ULN;
Self-Managed Intervention for Anxiety in Parkinson's Disease

A mixed methods randomized controlled feasibility and acceptability study will be conducted to determine the effects of a self-managed, focused breathing intervention on anxiety in persons who have been diagnosed with Parkinson's disease.

This study is being conducted to determine the feasibility and acceptability of using focused breathing as a self managed, non-pharmacologic intervention for anxiety experienced by those with Parkinson's disease. Participants meeting eligibility criteria will be randomized to either an intervention or control group. Those in the intervention group will be taught how to perform focused breathing and asked to practice it twice daily for six weeks for a minimum of four minutes each time. Anxiety, depressive symptoms, sleep, self-efficacy and quality of life with be measured in participants in both the intervention group before beginning to practice focused breathing as well as in the control group. After six weeks of practice the same measurements will be collected from the intervention group. Additionally, intervention participants will participate in a brief interview at the end of their six weeks of practice. Control group participants will be taught how to perform focused breathing six weeks at the end of a six week wait-period, following collection of data using the aforementioned measures..

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease
* Hoehn \& Yahr I, II, \& III
* Self report or clinical diagnosis of anxiety
* Ability to speak and read English

Exclusion Criteria:

* Montreal Cognitive Assessment scores less than 26, indicating cognitive impairment
* Persons under the age of 18 are excluded from this study