cyrilzakka/clinical-trials huggingface dataset:
Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds

This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.

160 people from the Denver area will participate. Duration is up to 5 years with 10-12 visits in that period. Subjects are randomized into one of 4 arms to receive either Zostavax or HZ/su. In this single blind study all subjects receive 2 injections: one at the first visit (Day 0) and the second at Day 60. HZ/su subjects will receive vaccine at both visits; Zostavax subjects will receive vaccine at the first visit and a placebo at the Day 60 visit. Blood is collected from all subjects at most visits. Some subjects spit into a tube for saliva collection. A urine sample is collected prior to vaccination if subject is a woman of childbearing potential. Subjects are asked to complete a diary to record any reactions in the 30 days after each injection. The Day 90 visit is the last one until the annual visits for blood draws begin at Day 365. Some subjects are also seen at Year 2 and Year 4; all subjects are seen at Year 5 for blood draw.

Eligibility Criteria:
Inclusion Criteria:

* History of varicella or residence int he US for 30 years
* For Arms C and D - prior live zoster vaccine at least 5 years previously
* For Arms A and B - Age 50-59 or 70-85
* For Arms C and D - Age 70-85
* For women of childbearing potential, a negative pregnancy test and agreement to use adequate contraception from 30 days before until 3 months after the last dose of any study vaccine

Exclusion Criteria:

* History of herpes zoster
* For Arms A and B - prior live zoster vaccine
* Immune compromising illness or therapies or chronic illness
* Allergy to previous herpes zoster vaccine
* Other investigational drugs or vaccines within the past 6 months before the study and until last visit
* Blood products for 3 months prior to or planned during the study
* Concomitant non-topical antiviral therapy within 3 days prior to and 7 days after vaccination.
* Vaccines within 2 weeks (inactive vaccine) or 4 weeks (live vaccine) prior to the study until 30 days after any dose of either vaccine.
* Pregnancy or breast-feeding
* Current drug addiction or alcoholism.
Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery

The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.

In the last years, the life expectancy of ACLD patients has increased due to the improvement of the therapeutic strategies of the complications of cirrhosis. .Although surgical procedures have become less invasive the mortality rate in ACLD patients undergoing extrahepatic surgery remains high. For these reasons, an accurate prediction of operative risk for patient-tailored surgical planning becomes crucial.

Purpose of the study: To evaluate the prognostic role of portal hypertension by non- invasive methods in predicting post-operative complications in ACLD patients undergoing elective extrahepatic surgery.

Study type: An international multicenter, prospective, uncontrolled observational study

Study design: In cirrhotic patients undergoing extrahepatic surgery, within one month, a complete baseline evaluation is provided. Baseline evaluation (T0) includes: signature of informed consent, clinical history of liver disease, comorbidities and risk factors for hepato-biliary complications; complete laboratory tests; liver and spleen elastography (with Transient Elastography, ARFI or 2D-SWE).

After surgery, each patient is evaluated at T1 (+90 days) with Elastography, laboratory tests, clinical examination and T2 (+ 365 days) by a clinical examination.

Each center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner.

Study duration: The study period will last approx. 730 days, with a planned follow-up of 365 days after surgical intervention

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs;
* Advanced chronic liver disease (LSM\>10 kPa)
* Any etiology (viral, metabolic, alcoholic, cholestatic and autoimmune);
* Elective extrahepatic surgery planned within three months and requiring regional or general anaesthesia;
* Patients are willing and able to give informed consent

Exclusion Criteria:

* Presence of hepatic decompensation at the time of informed consent or previous events of hepatic decompensation during the last three months before enrollment.
* Presence of portal vein thrombosis
* Previous placement of TIPS,
* Prior liver transplantation,
* Surgical resection or shunt.
* Presence of active HCC that needed treatment at the time of informed consent
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB

Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).


Eligibility Criteria:
Inclusion Criteria:

1. Patient between 18 and 80 years of age
2. Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs.

   * Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically.
   * Longstanding AF: Persistent AF of 12 months (or longer) duration.
   * Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted.
3. Patient is willing and able to provide written informed consent.
4. Patient has a life expectancy of at least 2 years.
5. Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria:

1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months.
2. Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications
3. Myocardial infarction within 8 weeks.
4. Prior cardiac surgery.
5. Patient requires cardiac surgery for treatment other than for AF.
6. Class IV NYHA heart failure symptoms, unless due to uncontrolled AF
7. Cerebrovascular accident within previous 6 months
8. Known carotid artery stenosis greater than 80%
9. Evidence of significant active infection
10. Patient unable to undergo TEE
11. Pregnant woman
12. Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
13. Presence of thrombus in the left atrium
14. Co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
15. Patient is enrolled in another cardiac clinical trial
16. Left ventricular ejection fraction \< 30%
17. Left atrial transverse diameter \>6.0
18. Patient has undergone previous thoracic targeted radiation
A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.

This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas. Dose Escalation Phase: Approximately 40-50 subjects with a maximum number of 62; 1-20 subjects for enhanced PDx cohort. Dose Expansion Phase: Estimated between 2 and 5 cohorts, each of approximately 40-50 patients to be expanded.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
2. Aged 18 to 75 years as of the date of consent.
3. Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies.
4. Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.1.
5. Estimated life expectancy of a minimum of 12 weeks.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.

Exclusion Criteria:

1. Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase.
2. Prior treatment with a 4-1BB agonist.
3. Subjects with primary liver cancer.
4. Known history of human immunodeficiency virus infection.
5. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
6. Pregnant or nursing females.
New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies

This study aims to discover novel biomarkers and therapeutic targets for osteoporosis through the use of advanced omics technologies, including proteomics and metabolomics. By analyzing bone and plasma samples from patients with osteoporosis, the research seeks to understand the underlying mechanisms of the disease and identify potential diagnostic and therapeutic biomarkers.

Study Objectives:

1. To investigate the proteomic profile of bone and plasma in clinical osteoporosis compared to patients with osteoarthritis.
2. To study the metabolomic profile of serum in clinical osteoporosis compared to patients with osteoarthriti.
3. To identify and validate potential biomarkers for osteoporosis diagnosis and treatment.
4. To elucidate the pathophysiological mechanisms involved in osteoporosis.

Methodology:

Clinical Osteoporosis:

Patient Recruitment: 60 postmenopausal women will be divided into two groups: those with osteoporotic hip fractures and a control group with osteoarthritis undergoing total hip replacement.

Sample Collection:

Bone Samples: Collected from the femoral neck during surgery, cleaned, and divided into four parts. One part will be used for bone density analysis (pQCT or DXA), and the other parts will be stored for proteomic analysis.

Blood Samples: Fasting morning blood samples will be collected for general biochemical tests, bone turnover markers, and stored for metabolomic and proteomic analyses.

Technologies and Analysis:

Proteomics: Utilizes mass spectrometry to identify and quantify proteins in bone and plasma. Key pathways and protein networks involved in osteoporosis will be identified using bioinformatics tools.

Metabolomics: Analyzes small molecules in serum to uncover metabolic changes associated with osteoporosis. Both targeted and non-targeted approaches will be used to identify significant biomarkers.

Expected Outcomes:

1. Identification of specific proteins and metabolites as biomarkers for osteoporosis.
2. Enhanced understanding of the molecular mechanisms driving bone loss.
3. Validation of therapeutic targets for potential treatment strategies.

Significance:

This integrative approach combining proteomics and metabolomics aims to provide a comprehensive understanding of osteoporosis, facilitating the development of more accurate diagnostic tools and effective treatments for this widespread bone disease.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal Female Patients with osteoporotic subcapital femoral neck fracture (Arm 1)
* Postmenopausal Female Patients with hip osteoarthritis that will undergo Total Hip Replacement (Arm 2)

Exclusion Criteria:

* Patients that have undergone before osteoporotic fractures
* Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y002#

An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
2. Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
3. Measurable disease as defined by the protocol
4. ECOG score is 0 or 1.
5. Expected survival time ≥12 weeks.

Exclusion Criteria:

1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
2. Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
3. No unmobilized mononuclear cells can be collected for CAR T cell production.
4. Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses \< 10mg/ day).
5. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).
Validity of 6 Minutes Stepper Test in Hypertension

The six minutes stepper test (6MST) was used assess exercise capacity of individuals having different chronic conditions. In the literature, there are some validation studies analyzing validity of 6MST. In this study, the main aim was to analyse validation of 6MST in hypertensive individuals.

6MST is a space-safe, feasible and sensitive test to assess exercise capacity. In the literature, there are lots of field tests assessing exercise capacity of individuals with chronic status. But common field tests eg 6MWT requires long spaces and it could become an important barrier in clinical settings. Hypertension is a common chronic disease and hypertensive individuals are important candidates of cardiac rehabilitation. As an important outcome assesing exercise capacity are very important before and after cardiac rehabilitation. In this study, the main aim was to investigate reliability and validity of 6MST in systemic hypertension.

Eligibility Criteria:
Inclusion Criterias:

* Being 18 to 65 years,
* Diagnosed with hypertension and willing to participate the study.

Exclusion Criterias:

* having a neurological, cognitive and/or orthopedic disease that affect the measurements,
* severe respiratory disease (FEV1 \< 35%; FVC \< 50%),
* presence of acute infection,
* any malignancy,
* dementia,
* any cardiovascular event in the last 6 months,
* uncontrolled hypertension and diabetes
* body mass index (BMI) higher than 40 kg/m2
Mechanisms of Neural Mobilization in the Treatment of Chronic Pain

The purpose of this study was to determine the effect of a manual therapy technique (neural mobilization) on measures of clinical pain and function, experimental pain sensitivity, and on the function of the median nerve in individuals with carpal tunnel syndrome. The investigators hypothesized that individuals receiving a neural mobilization technique known to directly stress the median nerve would demonstrate greater improvements in clinical pain and function, experimental pain sensitivity, and median nerve function than those receiving a sham technique.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age
* signs and symptoms of carpal tunnel syndrome for greater than 12 weeks

Exclusion Criteria:

* non english speaking
* prior surgery for carpal tunnel syndrome
* systemic condition known to affect sensation
* chronic pain condition other than carpal tunnel syndrome
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)

The investigators recently conducted a double-blind, randomized controlled trial (n=60) of limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine, as determined by reduction in meth-positive urines. Sexual risk behaviors also declined significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily doses were taken. All participants received weekly substance use counseling and monthly, brief clinician-delivered adherence counseling. The investigators propose expanding upon these results by lengthening the treatment period to 24 weeks, with adherence reminders added to the counseling, and determining if efficacy is sustained up to 12 weeks after drug discontinuation. The sample size for this 9-month study is 120.


Eligibility Criteria:
Inclusion Criteria:

1. born male, or born female and does not identify as female;
2. reports anal sex with men in the prior three months while under the influence of meth;
3. diagnosed with meth dependence by SCID;
4. interested in stopping or reducing meth use;
5. at least one meth-positive urine during screening and run-in period;
6. no current acute illness requiring prolonged medical care;
7. no serious chronic illnesses that are likely to progress clinically during trial participation;
8. able and willing to provide informed consent and adhere to visit schedule;
9. age 18-69 years;
10. baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by clinician in conjunction with symptoms, physical exam, and medical history
11. current CD4 count ≥ 200 cells/mm3; or CD4 count of 100 - 199 cells/mm3 and HIV viral load \< 200 copies/mL
12. text-capable cell phone or access to email

Exclusion Criteria:

1. Evidence of current major depression by SCID;
2. history of bipolar disorder or psychotic disorder, as determined by SCID;
3. known allergy or previous adverse reaction to mirtazapine;
4. taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamineoxidase inhibitor;
5. moderate or severe liver disease (AST, ALT, and total bilirubin \>= 5 times upper limit of normal);
6. impaired renal function (estimated GFR \<40 ml/min);
7. currently participating in another research study;
8. pending legal proceedings with high risk for incarceration during the time of planned study participation;
9. any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.
Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up

This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®. This study aims at collecting clinical data, to confirm the General Safety and Performance Requirements of Vectorio® which is a Lipiodol Resistant Mixing \& Injection System for cTACE.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male adult patient older than 18 years
2. Patient with confirmed diagnosis of HCC and eligible for cTACE procedure
3. Patient affiliated to national health insurance according to local regulatory requirements
4. Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent form

Exclusion Criteria:

1. Patient with contraindications to cTACE procedure
2. Patient with known contra-indication(s) to the use or with known sensitivity to Lipiodol or chemotherapeutic agent
3. Pregnant or breast-feeding female patient.
4. Patient unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study
Effect of Probiotics on Cardiometabolic Health

Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms. This trial aims to examine its protective effect in humans.

Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.

However, whether administration of probiotics also has a protective effect in subjects with metabolic syndrome (MetS), who are at high risk for developing atherosclerosis, remain unknown.

Eligibility Criteria:
Inclusion Criteria:

* Local residents aged between 30-60 years old;
* Stable weight (\<5% weight change over last 3 months);
* Central obesity defined as waist circumference ≥90 cm in males or ≥80 cm in females, Plus any two of the following four conditions i) Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L); ii) Reduced HDL cholesterol: serum HDL-c \<40 mg/dL (1.03 mmol/L) in males or \<50 mg/dL (1.29 mmol/L) in females; iii) Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; iv) Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)
* Absence of any systemic, cardiovascular diseases, as well as infections within the previous month;
* Absence of any diet or medication that might interfere with metabolic homoeostasis and gut microbiota, especially antibiotics and probiotics 4 weeks before recruitment.

Exclusion Criteria:

* Acute illness or current evidence of acute or chronic inflammatory of infective diseases;
* Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment;
* Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
Study of Women Who Have AIDS

To study the effect of pregnancy, age, drug use, and coinfections on HIV progression rate. To document the prevalence, incidence, characteristics, and course of HIV infection and anogenital intraepithelial neoplasia among HIV-positive and HIV-negative women. To study the effect of HIV disease on gynecologic health including infections and reproductive function.


Eligibility Criteria:
Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France

Evaluation of the following prognostic factors in France, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,Upfront surgery.


Eligibility Criteria:
Inclusion criteria:

* - Diagnosic of Ovarian or Tubal Cancer C56 et C570
* +/-
* Carcinose péritonéale C786
* Tumueur maligne secondaire de la plèvre C782,
* Tumueur maligne secondaire des ganglions C770 à C779,
* Tumueur maligne secondaire du foie C787,
* Tumueur maligne secondaire du péritoine C786

Exclusion criteria:

* autres causes de :
* Carcinose péritonéale C786
* Tumueur maligne secondaire de la plèvre C782,
* Tumueur maligne secondaire des ganglions C770 à C779,
* Tumueur maligne secondaire du foie C787,
* Tumueur maligne secondaire du péritoine C786