cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax (V212-003)

A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat treated VZV vaccine V212 or with Zostavax™.

The enrollment of participants into this study was conducted in 2 parts, Part A and Part B. The first 42 eligible participants were enrolled into Part A of the study. In Part A, the reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners performing the reading at each timepoint; all subsequent skin test readings in Part A were performed at 48 hours post administration. After all skin test reactions were obtained at baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the frequency of baseline negative skin tests in order to confirm that the planned sample size (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours (post administration) in order to determine the preferred time for evaluation of the skin test reaction.

The interim analysis from Part A confirmed the study sample size, an additional 78 subjects were enrolled into Part B to achieve the planned sample size (N=120). The study procedures for Part B of the study were identical to those in Part A with the following exceptions: (1) baseline skin test readings were performed only once, at either 48 or 72 hours (post administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was needed for the skin test reading at baseline.

All eligible participants, regardless of treatment group, were administered three injections of the varicella antigen (VZV Skin Test reagent), once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination. Reactions to the skin test were assessed by the same examiner for each participant to the greatest extent possible.

Eligibility Criteria:
Inclusion Criteria:

* Participant has prior history of Varicella
* Female participants are of non-childbearing potential

Exclusion Criteria:

* Participant has had a hypersensitivity reaction to any vaccine component
* Participant has a prior history of Herpes Zoster
* Participant has received any Varicella or Zoster vaccine including Zostavax
* Participant has a history of immunosuppression caused by disease, corticosteroids, cancer therapy or organ transplant
* Participant has an active cancer
* Participant has received or will receive a live virus vaccine or an inactivated virus vaccine 4 weeks prior to participating in study (with the exception of influenza vaccine)
* Participant is not bed-ridden or homebound
Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

By collecting blood, urine and stool samples before and after oral Enterobacteriaceae capsule (FMT) from CKD subjects, we investigated the role and related mechanisms of gut microecology in the development of CKD using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry.

Patients involved in the trial received 16 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects: Patients with chronic kidney disease (CKD)
2. GFR ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/L
3. Negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception
4. Age: 18-70 years
5. Signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (FMT)

Exclusion Criteria:

1. Had taken antibiotics for nearly 14 days
2. Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV, HCV
3. White blood cell count \< 3.0x109/l; Platelet count \< 80x109 / L, or had other hematologic diseases
4. Presence of malignancy and other diseases with expected survival time \< 3 months
5. Presence of IBD, CDI, or gastrointestinal tumors
6. Presence of active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation
7. Were or had undergone FMT
8. Psychosis and cognitive impairment
9. History of alcohol or drug abuse
10. Pregnant or lactating women
11. Difficult to follow-up
12. Difficult or unwilling to cooperate
Trial of Supported Employment Versus USES Supported Employment

The purpose of this study is to test the effectiveness of USES, a strengths-based enhancement to supported employment (SE), as compared to supported employment alone.

The objective of this study is to test the effectiveness of supported employment plus Using Strengths in Employment Services (USES), an enhancement to supported employment that seeks to identify and increase the use of personal strengths, as compared to supported employment alone, for veterans with severe mental illness and/or substance abuse disorders. We hypothesize that rates of competitive employment will be greater in the experimental group than the control group. We also expect that individuals in the USES group will have greater job tenure, and will show greater improvements in recovery measures such as empowerment, self-efficacy and self-esteem.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* Unemployed
* Referred by clinician to SE services
* Able to provide informed consent
An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis

This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.

A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 Feb 2010.

The efficacy data for Months 0-6 in this study report is from the core study NCT00537082.

Eligibility Criteria:
Inclusion Criteria:

* Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
* Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

* Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Dynamic Stabilization Versus Fusion

The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.

Two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. Up to now it is not clear whether fusion (Gold-standard) or the non-fusion technique is superior. Nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-OP rate compared with fusion as the standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis
* Indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with Modic changes
* Failure of adequate conservative measures for more than 3 months
* Correctly signed informed consent form

Exclusion Criteria:

* Olisthesis more than grade I, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance)
* Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness)
* Previous fusion or stabilization surgery
Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

The goal of this clinical trial is to learn about the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs. The main questions it aims to answer are:

1. How effective IVIG is in preventing donor-derived infections
2. Does IVIG has potential immunomodulatory effect on transplanted organs

Donor-derived infections are defined as any infection present in the donor that is transmitted to one or more recipient. Donor-derived infections can be categorized into two groups: "expected" and "unexpected" infections. Expected transmissions occur when the donor is known to have an infection, as demonstrated by positive serology or nucleic acid test (NAT) result for cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis B and C, or positive cultures in the donor at the time of donation. Unexpected transmissions may occur despite current screening strategies and are not expected in the donor at the time of organ placement.

Intravenous immunoglobulins (IVIG) are produced by pooling together of serum immunoglobulins from multiple donors, and are known to have powerful immunomodulatory and anti-inflammatory functions in vitro and in vivo. The goal of this study is to figure out the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs.

Eligibility Criteria:
Inclusion Criteria:

* Any person approved as a transplant donor with recipient who has never undergone a previous transplantation
* Transplant donor must be 6 years old or older
* They must have provided signed informed consent
* The donors must be willing to contribute samples of blood

Exclusion Criteria:

* Any potential transplant donor who is receiving or have received anti-herpes medication in the past week
* Any potential transplant donor to a recipient who has received a previous solid organ transplant
* Any potential transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications
* Any potential transplant donor who is on corticosteroids
The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease

Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC.

Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis.

In this study, LINFU® will be evaluated in patients who exhibit symptoms suggestive of PDAC (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) or have evidence of imaging studies suggestive of PDAC. In addition, patients with PDAC identified only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and to determine whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Both males and females will be enrolled and must be at least 18 years of age and under age of 90
* Patients, who in the opinion of the Investigator, require biopsy to rule out PDAC because they display at least one of the following or both: a) clinical symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc. b) one or more imaging studies suggestive of PDAC
* All patients must undergo contemporaneous imaging, either within 90 days before the LINFU® procedure or within 30 days after the procedure, with one or more of the following: EUS± FNA, MRI/MRCP, ERCP, CT or CEUS.
* Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Exclusion Criteria:

* Patient under the age of 18 and over the age 90
* Contraindications to LINFU®/EUS/ERCP as determined by study investigators: Patient with uncorrectable coagulopathy; Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist; Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
* Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
* Patients who are already known to have PDAC by cytologic or histologic evidence
* Patients with intraductal papillary mucinous neoplasm of the pancreas (IPMN) identified either before the study or during the study through imaging evaluation will be excluded
* Pregnant females will be excluded
* Patient that is unable to provide informed consent
* Patient with known allergy to the microbubble contrast agent or secretin
Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI

There are already recently published data on the tolerability and efficacy of the combination of ketamine and/or esketamine with MAOIs. However, these reports are few and far between, and to our knowledge, there are no data involving intranasal esketamine.

Given the numerous interactions between MAOIs and other antidepressants, and the impossibility of combination, this pharmacological class is neglected. This is despite the fact that MAOIs are the only truly tri-aminergic drugs, that they have unparalleled efficacy in certain forms of resistant apathetic depression, and that new, more dietary permissive forms have appeared on the market. The arrival of antidepressants that can be combined with MAOIs, such as ketamine and esketamine, changes the situation and could offer a new treatment opportunity to many patients in a therapeutic impasse. For these opportunities to become a reality, sharing the clinical experience gained by specialized centers is essential.


Eligibility Criteria:
Inclusion criteria:

* Major subject.
* Having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022.
* Not objecting to the reuse of their data for scientific research purposes.

Exclusion Criteria:

- Subject who has expressed opposition to the reuse of their data for scientific research purposes.
Tumor-specific T Cells in Lung Cancer

Non-small cell lung cancer is characterized by aggressive growth and treatment resistance. New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear. The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group)
* Healthy donors (control group)
* written informed consent

Exclusion Criteria:

* Autoimmune disease
* Patients receiving immunomodulatory drugs, e.g. tacrolimus
* Prior malignancy
* Pregnancy
Patient Education Following a Stroke

The rapid diagnosis and treatment of acute ischemic stroke are critical in the reduction of morbidity, disability and stroke associated mortality Under-education about stroke may prevent people from recognizing symptoms early enough to seek immediate care.

The studies reported on stroke patients managed in stroke center have shown that 39-42% of patients could not name any symptoms of stroke and 36% to 43% no risk factor of stroke.

The stroke patients are therefore a population at high risk for neurological events and cardiac vascular recurrence. However, no studies have evaluated the interest of the development of therapeutic workshops in stroke unit to educate patients about symptoms suggestive of stroke, risk factors and what to do in cases of stroke.

Investigators assume that the setting up of a therapeutic education workshop in the stroke unit may allow a better understanding of the symptoms, risk factors and what to do following stroke. So there is a direct benefit to the patient represented by a better knowledge of stroke (warning signs, risk factors, what to do), improved treatment compliance and reduced risk of recurrence.

More generally, there is a real benefit to promote these messages to the public through the patient and his relatives


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Diagnosis of ischemic stroke;
* Patients with back home or shorter rehabilitation;
* Patients affiliated to a social security scheme;
* Patients who consented to participate in writing.

Exclusion Criteria:

* Patients with cognitive disorders, vigilance, aphasia.
* Patients institutionalized.
A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis

This study is the first to be performed in Amyotrophic Lateral Sclerosis (ALS) patients with the novel compound TCH346. Its purpose is to evaluate the safety and clinical effects of 3 dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of laboratory-supported probable, probable or definite ALS. The study will require patients to visit the study center a total of at least 7 times over the course of up to 14 weeks. The study consists of 2 phases: A screening phase (up to 2 weeks) when patients will be evaluated for eligibility to participate in the study, and a double-blind treatment phase (12 weeks) when patients will receive daily doses of either TCH346 or placebo and will be evaluated for clinical effects. In addition, patients eligible to participate in this study will be required to have 3 magnetic resonance spectroscopic (MRS) scans. The MRS is a non-invasive, painless, "brain scan". The MRS will require traveling to a designated center in Montreal, Canada, which is very experienced in performing such MRS scans in ALS patients.


Eligibility Criteria:
* clinical diagnosis of laboratory-supported probable, probable, or definite ALS;
* have sporadic or familial ALS;
* have shown ALS symptom onset for no more than 3 yrs., inclusive, prior to randomization;
* FVC of \>60%;
* ability to tolerate MRS evaluation
Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials

This registry will be used to identify patients who have etiology diagnosed or suspected to be Alzheimer's disease and positive amyloid scans, and have indicated their interest in being contacted for an Eli Lilly and Company (Lilly) Alzheimer's Disease drug research trial.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 50 years of age at the time of consent;
* Patients who have objectively verified cognitive impairment and etiology diagnosed or suspected to be Alzheimer's disease;
* Patients who are willing to make available to Avid a positive amyloid scan, or if an amyloid scan is not available, are willing to undergo amyloid scanning via the Florbetapir F 18 PET Scan Addendum;
* Patients who are willing to be contacted for possible participation in Lilly drug research trials targeting Alzheimer's disease;
* Patients who give informed consent or have a legally authorized representative (LAR) to consent for enrollment; and
* Patients who have a partner (informant) who is willing to participate as a source of information and has at least weekly contact with the patient (contact can be inperson, via telephone or electronic communication). The informant must have sufficient contact such that the referring physician feels the informant can provide meaningful information about the patient.

Exclusion Criteria:

* Patients who have a Mini Mental State Examination (MMSE) score of \< 16;
* Patients who have an amyloid-negative PET scan (either a historical scan or scan via the Florbetapir F 18 PET Scan Addendum);
* Patients who have serious or unstable medical conditions that would exclude completion of all procedures and data collection for the registry, or would be likely to preclude participation in a drug research trial;
* Patients who are currently participating in a clinical trial with an investigational agent; or
* Patients who, in the opinion of the physician, are otherwise unsuitable for this registry.
Fibromyalgia During the COVID-19 Pandemic

On 12 January 2020, the World Health Organization (WHO) confirmed that a novel coronavirus was the cause of a respiratory illness in a cluster of people in Wuhan City, Hubei Province, China, which was reported to the WHO on 31 December 2019.

There is evidence of a high prevalence of psychiatric comorbidities in Fibromyalgia (FM )(especially depression, anxiety, post-traumatic stress disorder), which are associated with a worse clinical profile.

In these challenging times of COVID-19, anxiety increased among the general population. Fibromyalgia patients are more at risk of developing anxiety in these difficult times. This might result in more frequent visits to the rheumatology clinics with an exacerbation of their chronic pain syndrome.

The first confirmed case relating to the COVID-19 pandemic in the United Arab Emirates was announced on 29 January 2020.

On March 11, the World Health Organization (WHO) declared the global outbreak a pandemic. Many measures have been taken by the UAE government since the COVID-19 outbreak started hitting the region. From Mid March, the UAE had advised all citizens to restrict themselves to essential travel only and had implemented a curfew between 8 pm and 6 am every day starting from the end of March. On April 5th, UAE imposed a two-week lockdown to contain the COVID-19 pandemic and announced there will be disinfection drives.

Many awareness campaigns were initiated by rheumatologists through different media channels advising patients with rheumatic diseases to avoid clinics and hospitals unless they have an emergency. Some healthcare facilities started telemedicine services including rheumatology outpatient clinics. However, most of the clinics and hospitals have maintained open rheumatology clinics aiming to manage emergency cases.

Fibromyalgia (FM) is a chronic disorder characterized by widespread and chronic musculoskeletal pain and other frequent syndromes such as chronic fatigue sleep disturbance, cognitive impairment, irritable bowel disease, depression, and anxiety.

There is evidence of a high prevalence of psychiatric comorbidities in FM (especially depression, anxiety, post-traumatic stress disorder), which are associated with a worse clinical profile.

In these challenging times of COVID-19, anxiety increased among the general population. Fibromyalgia patients are more at risk of developing anxiety in these difficult times. This might result in more frequent visits to the rheumatology clinics with an exacerbation of their chronic pain syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 year
* Diagnosis of primary fibromyalgia
* Newly diagnosed and follow up patients are included
* Patients who have physically attended the rheumatology clinic during the study period.

Exclusion Criteria:

* Patients aged \< 18-year-old
* Patients with inflammatory arthritis and associated FM (Secondary FM)
* Patients who didn't physically attend the rheumatology clinics (Those who used Phone calls and other telemedicine platforms).