cyrilzakka/clinical-trials huggingface dataset:
Long-term Immunogenicity of a Live Herpes Zoster Vaccine in Systemic Lupus Erythematosus (SLE) Patients

A recent randomized controlled trial (RCT) from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated herpes zoster (HZ) vaccine (Zostavax) in stable systemic lupus erythematosus (SLE) patients with a previous history of HZ or varicella infection. An important research question is whether the immunogenicity of the HZ vaccine in SLE patients is long-lasting. There is no information in the literature regarding the long-term immunogenicity and safety of Zostavax in SLE patients. This prompts the current extension study which is planned to evaluate the long-term immunogenicity and efficacy of Zostavax in our original patient cohort.

A recent RCT from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated Zostavax in stable SLE patients with a previous history of HZ or varicella infection. An important research question is whether the immunogenicity of the HZ vaccine in SLE patients is long-lasting. There is no information in the literature regarding the long-term immunogenicity and safety of the HZ vaccine, Zostavax, in SLE patients.

Patients who had completed the original RCT and had been followed for 5 years since HZ vaccination or placebo injection were invited to participate in this extension study. Blood samples will be taken for a repeat assessment of the humoral and cell-mediated response to VZV at 5 years.

Outcomes of interest Primary outcome Difference between the two groups in the proportion of patients who have a persistent and 50% increase in IgG to VZV (humoral response to Zostavax) at 5 years compared to baseline Secondary outcomes

1. Difference between the two groups in the cell-mediated response to Zostavax at 4 years as compared to baseline
2. Vaccine efficacy - difference in the rate of clinical HZ reactivation between two groups of patients at 5 years
3. Vaccine safety - difference between the two groups in terms of SLE flares and new autoimmune phenomena at 5 years

Eligibility Criteria:
Inclusion Criteria:

1. SLE patients who fulfill ≥4 of the 1997 ACR or the 2012 SLICC/ACR criteria for SLE or healthy controls who had participated in the original RCT
2. Age ≥18 years
3. Having completed the original RCT of HZ vaccine vs placebo
4. Having been followed for 5 years since HZ vaccination or placebo injection
5. Willing to comply with all study procedures

Exclusion Criteria:

1. Patients who refuse to participate in this long-term extension study
2. Patients in the placebo group who have subsequently received HZ vaccination
3. Patients who cannot give a written consent (mentally incapable or illiterate)
Investigating the Use of TaVNS to Treat Insomnia in Individuals with Breast Cancer (taVNS-insomnia-BC)

In the present study, the investigators aim to investigate feasibility of utilizing noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to address insomnia in patients with stage I-IV breast cancer.

The study will evaluate the feasibility, safety, and tolerability of nightly, at-home self-administered taVNS treatments. Study staff will monitor for adverse reactions, unanticipated adverse device events and severe adverse events as described to evaluate safety, tolerability, and biocompatibility. Additionally, investigators will estimate effect size by collecting outcome assessment data as described below. An additional objective is to use information gained through this study to inform product development activities. Specific information about the comfort, ease of use, and other user subject feedback will be used to inform future product development efforts for optimizing device designs.

Specific Aim 1: To evaluate the feasibility of using taVNS for patients with breast cancer to treat insomnia. HYPOTHESIS: Investigators expect that 40 patients with stage I-III breast cancer and insomnia will be enrolled and undergo taVNS to address insomnia, quantified by various sleep related outcome measures, with an estimated recruitment rate of 70%, eligibility rate of 70%, completion rate of 80%, and follow up rate of 80%.

Specific Aim 2: To evaluate the efficacy of repeated, nightly taVNS on sleep quality, anxiety, and cancer related fatigue. HYPOTHESIS: Investigators hypothesize that patients will report improved sleep, anxiety, depression, and cancer related fatigue after one week of taVNS.

Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age
2. diagnosed stage I-IV breast cancer
3. self-reported difficulty falling asleep, staying asleep, or waking up too early, for at least three nights per week for a duration of at least three months
4. beginning or worsening of sleep disturbance since cancer diagnosis (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
5. English-speaking

Exclusion Criteria:

1. Are using a daily sleep aid except melatonin (use of a sleep aid as needed will be permitted, and use will be noted).
2. have a history of severe mental illness
3. have an implanted medical device of any type
4. have a history of seizures
5. have peripheral neuropathy including temporal mandibular disorders and Bells Palsy
6. have vasovagal syncope
7. have moderate to severe cognitive impairment
8. have \<6 months to live as determined by the physician
The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis：A Multicenter RCT

The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.

The treatment of cirrhotic patients with PVT (portal vein thrombosis) is clearly recommended in guideline now. Several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with PVT.The present studies are most observation studies with small sample size and low quality. The investigators need more high-quality research such as randomized controlled trials. This is a Zelen-designed multicenter randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator will make sure wether their are fond of the group and make decision by themselves. The recanalization rate and complications will be analyzed

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years old;
* A clinical, radiological or histologic diagnosis of Liver cirrhosis and portal hypertension;
* Diagnosed of Portal vein thrombosis;
* Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
* Have undergone endoscopy to prevent variceal rebleeding.

Exclusion Criteria:

* Age \<18 or \>70 years;
* Portal vein thrombosis diagnosed before 6 months;
* Patients with signs of acute PVT such as fever，abdominal pain or intestinal obstruction，who should be treated immediately;
* Pregnant or nursing;
* Hepatocellular carcinoma or other cancer;
* Severe cardiopulmonary diseases or concomitant renal insufficiency;
* cavernous transformation of the portal vein;
* Contradictions to endoscopy;
* Contradictions to anticoagulation,such as:allergy to LMWH or warfarin, severe uncontrolled hypertension, history of hemorrhagic cerebral vascular accident, recent peptic ulcer disease, bacterial endocarditis, ulcerative colitis，sustained platelet count \< 50 x10\^9/L);
* Taking immunosuppressive agent;
* Coagulation disorders other than the liver disease related;
* Variceal bleeding failed to control.
Evaluation of the Safety and Efficacy of Single-use Precision Filtered Infusion Sets for Intravenous Infusion

This study is a pre-market clinical trial of a single-use precision filter infusion set for pumps, to evaluate the safety and effectiveness of a single-use precision filter infusion set for pumps after being used in humans, and to provide clinical evidence for the official application of the product in China

This experiment compares the single-use precision filter infusion set produced by Shandong Xinhua Ande Medical Products Co., Ltd. for the same intended use that has been approved to market, and compares the performance of the two products in clinical use, the overall pass rate, and the occurrence of phlebitis Rates and adverse events are used to evaluate the safety and effectiveness of single-use precision filtration infusion sets for pumps.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 years or older, gender not limited;
2. intravenous infusion requiring drug filtration, flow regulation, dosing and extension of infusion line;
3. not participating in other clinical trials within one month;
4. able to understand the purpose of the trial, voluntarily participate and sign the informed consent;
5. willing to follow up and evaluate according to the requirements of the trial protocol.

Exclusion Criteria:

1. Patients with positive pregnancy test in women of childbearing age or lactating women;
2. Patients with uncontrollable cardiomyopathy, heart failure and unable to tolerate infusion;
3. Patients with uncontrollable decompensated renal function, especially in the anuric phase of acute renal failure and unable to tolerate infusion;
4. Patients with uncontrollable extensive inflammation of the lung parenchyma, pulmonary congestion, pulmonary edema and unable to tolerate infusion;
5. 0.2um size Test devices combined with any of the following drugs or preparations: fatty milk type, blood products type (blood cells, globulin, etc.), drugs that will produce insoluble precipitates with each other, etc.; 6, patients who are clinically infused with very small amounts of drugs (due to residual test line may reduce the amount of drugs delivered to patients); 7, puncture sites with inflammation, tumors, trauma, scars, etc.; 8, those who may be allergic to product materials; 9 Patients with AIDS;

10. Patients with mental disorders; 11. Other patients who are considered by the investigator to be unsuitable for participation in this study
Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer

CONSORTIUM-IO was the first-in-human multicenter, open-label study; the main objectives were to evaluate:

* Safety and tolerability of VE800 in combination with nivolumab
* Efficacy as measured by objective response rate

The study planned to enroll approximately 111 patients with melanoma, gastric/gastroesophageal junction (GEJ) adenocarcinoma, or microsatellite-stable (MSS) colorectal cancer (CRC).

Nivolumab is already approved by the U.S. Food and Drug Administration (FDA), however, it is not approved for the study cancer indications. VE800 was the investigational product, which was designed to enhance the immune response to the tumor.

Eligibility Criteria:
Partial Inclusion Criteria:

* Patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease.
* Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1
* Tumor lesions amenable for biopsy, if deemed safe by the investigator
* Toxicity from prior cancer therapy should have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual was allowed)

Partial Exclusion Criteria:

* Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion did not apply to patients with melanoma)
* Receipt of any conventional or investigational systemic anti-cancer therapy within 21 days prior to the first dose of vancomycin
* Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab were acceptable as prophylaxis for bone metastasis.
* Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment
* Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment were permitted to enroll.
* Patients with known active hepatitis (e.g., hepatitis B or C) NOTE: Patients with previously treated hepatitis B or C were permitted to enroll if there was evidence of documented resolution of infection.
* Received a fecal transplant, spore or other preparation of fecal material, isolated bacterial products, genetically modified bacteria, or VE800
Prevalence of Sleep Apnea and Atrial Fibrillation

The investigators will screen consecutive patients presenting to the atrial fibrillation clinic for sleep apnea using a FDA-approved home sleep testing device, WatchPAT to determine prevalence of sleep apnea in a clinic-based sample.

The investigators will determine the prevalence of sleep apnea among consecutive patients with atrial fibrillation (AF) regardless of symptoms and determine the predictive value of screening tools for sleep apnea in this population. The primary outcome will be the prevalence of sleep apnea among all-comers with AF. Three secondary outcomes will be evaluated in the study. Investigators will determine the efficiency and time-to-diagnosis of sleep apnea using a FDA approved home sleep testing device (i.e. WatchPAT). These analyses will be compared to published studies performed using a traditional home sleep study test (which historically takes approximately 8-10 weeks). There will be no collection of data from a non-intervention group in our study. Second, investigtaors will calculate the predictive value of traditional clinical screening tools in an AF population using the STOP-BANG questionnaire and Epworth Sleepiness Scale. Third, investigators will identify potential risk factors for AF in patients with sleep apnea using a logistic regression model.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AF confirmed on any electrocardiographic recording
* Age greater than or equal to 18
* Ability to read and understand consent form, complete questionnaires, and provide informed consent

Exclusion Criteria:

* Prior diagnosis of sleep disordered breathing or negative testing within the past 2 years without significant change in weight or clinical symptoms of sleep apnea
* History of Raynaud
Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes

The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* T2DM
* 30≤ age≤70 years old
* BMI 18.0-28.0 Kg/m2
* HbA1c ≥8.5%
* Negtive GAD、ICA、IAA
* Patients do not use antihyperglycemia drugs
* Patients use antihyperglycemia drugs for ≥8 weeks(exclusion of DPP-4 inhibitors and GLP-1 receptor agonist)

Exclusion Criteria:

* T1DM,GDM
* Congestive heart failure (New York Heart Association Functional Classification III-IV)
* ALT or AST\> 2 times above normal,GFR \<50ml/min
* Severe infection in the previous 3 months
* Severely acute or chronic diabetic complications
* Patients who were taking medications,known to affect glycaemic control, such as glucocorticoids(aside from antidiabetic medications)
* History of pancreatitis
* Trauma or patients operating at a scheduled time
* Any mental health condition
Studying Umbilical Cord Blood From African-American Donors

RATIONALE: Studying umbilical cord blood in the laboratory and gathering information about current and previous pregnancies from African-American umbilical cord blood donors may help doctors learn more about the umbilical cord blood of these donors.

PURPOSE: This clinical trial is looking at umbilical cord blood from African-American donors.

OBJECTIVES:

* To correlate the total nucleated cell yield of cord blood units from African-American cord blood donors with gestational history, maternal history, and delivery information.

OUTLINE: This is a multicenter study.

Donors complete questionnaires about their demographics, maternal history, gestational history, and delivery. Cord blood units (CBU) are collected in utero and transported to the Stem Cell Processing Laboratory where they are evaluated for CBU volume and cell count (i.e., total nucleated cell yield) and cryopreserved. The study results will then be used to devise future interventional strategies to improve the yield of nucleated cells of CBU.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* African-American participant in the National Marrow Donor Program cord blood collection protocol C-2844
* Recruited from the Labor and Delivery Suites of the Detroit Medical Center or its affiliated sites

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12

The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and tolerability following IV administration of CINRYZE in this study population.

Each subject received CINRYZE for treatment of a single acute angioedema attack.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for this protocol, subjects must:

1. Be at least 10 kg of body weight.
2. Have a confirmed diagnosis of HAE.
3. Have an acute HAE attack and be able to initiate treatment within 8 hours after onset of symptoms.

Exclusion Criteria:

To be eligible for this protocol, subjects must not:

1. Have any active infectious illness.
2. Have had a prior HAE attack and/or received any C1 INH product within 7 days prior to dosing with study drug.
3. Have received therapy with antifibrinolytics (e.g., tranexamic acid), androgens (e.g., danazol, oxandrolone, stanozolol, or testosterone), ecallantide (Kalbitor®), or icatibant (Firazyr®) within 7 days prior to dosing with study drug.
4. Have a history of allergic reaction to C1 INH products, including CINRYZE (or any of the components of CINRYZE), or other blood products.
5. Have participated in any other investigational drug evaluation within 30 days prior to dosing with study drug, or have previously received treatment with CINRYZE in this study at any time.
P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW).

Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose.

This was a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with known or highly suspected focal areas of disruption of the Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.

Two subsets of subjects were included in the study:

* The subset 1 included the first randomized subject of each study center. Subjects were randomly assigned in a 1:1 ratio to receive 0.05 or 0.1 mmol/kg BW of P03277 and 0.1 mmol/kg BW of gadobenate dimeglumine.
* Subset 2 was composed of all subjects (except the first one of each study center) selected by the study center. Subjects were randomly assigned in a 1:1:1:1 ratio to receive 0.025, 0.05, 0.1 or 0.2 mmol/kg BW of P03277 and 0.1 mmol/kg BW of gadobenate dimeglumine.

During the course of the study, two MRIs were obtained from each subject: one unenhanced and P03277-enhanced MRI; and one unenhanced and gadobenate dimeglumine-enhanced MRI. MRI images were evaluated off-site by 3 independent blinded readers for the primary endpoint (CNR).

Eligibility Criteria:
Inclusion Criteria:

* Female or male adult subjects, with known or highly suspected focal areas of disrupted Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm (long axis). This lesion had been detected on a previous imaging procedure (computerized Tomography \[CT\] or MRI).
* Subject scheduled for a routine contrast-enhanced MRI examination of Central Nervous System for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the study.

Exclusion Criteria:

* Subject presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m² based on one eGFR assessment performed the day of the MRI prior to the first contrast agent injection.
The Effect of Progressive Muscle Relaxation on Psychological Symptoms and Mental Well-Being in Patients With Schizophrenia

Schizophrenia is a mental illness that progresses with delusions or hallucinations, causes changes in interpersonal communication, thoughts and behaviors, continues with recovery and repetitions, and in which the interpretation of reality is impaired. Drug treatment alone is not sufficient in schizophrenia, and it is known that negative symptoms continue even in patients with a good response to drug treatment. For this reason, complementary therapies, psychosocial approaches and rehabilitation in addition to drug therapy increase the effectiveness of the treatment.

Schizophrenia is a mental illness that progresses with delusions or hallucinations, causes changes in interpersonal communication, thoughts and behaviors, continues with recovery and repetitions, and in which the interpretation of reality is impaired. Drug treatment alone is not sufficient in schizophrenia, and it is known that negative symptoms continue even in patients with a good response to drug treatment. For this reason, complementary therapies, psychosocial approaches and rehabilitation in addition to drug therapy increase the effectiveness of the treatment.It is seen that the tension, the effects of stress, the state of anxiety, blood pressure, heart rate, lactic acid production, sensitivity to pain are reduced by performing relaxation exercises in a suitable environment, regularly and in accordance with the technique. Helps you think positively Studies involving patients with schizophrenia have also proven the beneficial effect of progressive relaxation, with positive changes observed through relieving anxiety, reducing psychological stress, and increasing psychological well-being.

Eligibility Criteria:
Inclusion Criteria:• Being 18 years or older,

* Having a confirmed diagnosis of schizophrenia for at least 6 months
* Having the ability to communicate and read,
* Volunteering to participate in the research.

Exclusion Criteria:• Being closed to communication,

* Not complying with the principle of voluntarism
* Patients in acute exacerbation period