cyrilzakka/clinical-trials huggingface dataset:
Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients

This non-interventional, biospecimen collection study is designed to help us better understand whether MS patients have impaired immune defenses to COVID-19 infection. The potential influence of immune modulating medications for MS will be considered through these exploratory studies. This study is also designed to provide context for interpretation of anti-SARS CoV2 serologies in MS patients during convalescence from COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria (Part A and B):

● Patient is outside of infectious period of COVID-19 defined as follows:

* Patient with mild to moderate illness who are not severely immunocompromised:

  * At least 10 days have passed since symptoms first appeared and
  * At least 24 hours have passed since last fever without the use of fever-reducing medications and
  * Symptoms (e.g. cough, shortness of breath) have improved
* Patient with severe to critical illness or who are severely immunocompromised:

  * At least 10 days and up to 20 days have passed since symptoms first appeared
  * At least 24 hours have passed since last fever without the use of fever-reducing medications and
  * Symptoms (e.g. cough, shortness of breath) have improved

    * Clinician-diagnosed MS treated or untreated with an approved DMT,
    * Ages 18 to 60,
    * EDSS 0 - 7,
    * Able to give informed consent,
    * Able to complete, or have someone help complete the patient questionnaire,
    * No high dose steroids, or IVIG, or PLEX use within 3 months of blood sample,
    * No convalescent plasma and/or polyclonal antibody treatments for COVID-19 within 3 months of blood sample collection.

Inclusion Criteria (Part B only)

* COVID-19 positive patients, who received OCR within 6 months of COVID 19 infection,
* EDSS 0 - 6.

Inclusion Critera (Redraws Only)

* Completed standard of care COVID-19 vaccination series
* On Ocrevus, glatiramer, interferon b, or not on any treatment disease-modifying treatment at the time of vaccination.

Exclusion Criteria (Part A and B):

* Concurrent immunosuppressive therapy, active systemic cancer, primary or acquired immunodeficiency (i.e., CVID, HIV infection),
* Active drug or alcohol abuse,
* Other anti-CD20 therapy apart from OCR,
* Uncontrolled diabetes mellitus,
* End-organ failure (cardiac, pulmonary, renal, hepatic),
* Systemic lupus erythematosus (SLE).

Exclusion Criteria (Part B only):

* EDSS \>6,
* Active infection (e.g., hepatitis).

Exclusion Criteria (Healthy Controls Sample)

* Concurrent immunosuppressive therapy, active systemic cancer, primary or acquired immunodeficiency (e.g. CVID, HIV infection),
* Active ongoing drug or alcohol abuse,
* Age \>60 or \<18,
* Uncontrolled diabetes mellitus,
* End-organ failure (cardiac, pulmonary, renal, hepatic),
* SLE
* No high dose steroids, or intravenous immunoglobulin (IVIG) or plasma exchange (PLEX) use within 3 months of blood sample collection,
* No convalescent plasma and/or polyclonal antibody treatments for COVID-19 within 3 months of blood sample collection.
Evaluation of Rebound Effect After Withdrawal of Proton Pump Inhibitor in Geriatric Population

Proton pump inhibitor are frequently used and are short term well tolerated ; but few studies show there are adverse event in long term prescription like fracture or pulmonary infection to Clostridum difficile. The fact is that multi medication in old patient increase the iatrogenic risk and decrease the medication compliance. The Proton pump inhibitor (PPI)are overused in this patient category.Several studies suggest the existence of a rebound effect when people were treated more than 8 weeks ; this effect seems to appear around 14 days after with hyperacidity symptoms.

But there are no studies about old patient. So in this context the aim of the study is to evaluate the prevalence of rebound effect occurence after the end of PPI 8 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in post acute and rehabilitation service
* more than 65 years old
* PPI prescription more than 8 weeks

Exclusion Criteria:

* PPI prescription under 8 weeks
* PPI prescription for digestive haemorragy
A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms

The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken once a day, in the treatment of troublesome post-menopausal symptoms.

This is a multi-centre, multi-country, double-blind, randomised, placebo-controlled Phase 2b study. The study will have a single-blind run-in period and will be adaptive with respect to the number of subjects recruited into each dose group. Four doses of BAY3427080 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups. Subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of 1 week, a 14 week treatment period, and then a final follow up visit 4 weeks after the end of the treatment period. There will be a total of 8 visits whilst participating in the study. Subjects will record their hot flashes in an electronic diary during the screening period to establish eligibility and throughout the study after randomisation.

Eligibility Criteria:
Key Inclusion Criteria:

* Postmenopausal
* Body mass index between 18 and 38 kg/m2, inclusive
* Subject experiences moderate or severe hot flashes

Key Exclusion Criteria:

* Inability to comply with the use of prohibited and allowed medications as described in the protocol.
* Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.
* Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
* Any clinically significant abnormal laboratory test result(s) measured at Screening.
* Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.
* Uncontrolled hypertension.
* A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.
Neurocognitive Risks in Children With Solid Tumors

The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Four factors seem to be associated with neurocognitive sequelae: treatment, the tumor itself, environmental factors like the socio-economic status of parents and biological factors.

Main purpose of the study is to establish a score to assess the risk of neurocognitive sequelae in these children based on these factors (treatment, tumor, and environmental factors)


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 6 to 16 years and 11 months during the study period
* Type of pathology: solid tumor
* Place of treatment and follow-up: Gustave Roussy
* Minimum time from the end of the initial treatment:
* For patients who have not received treatment with methotrexate: 6 months
* For patients being treated with methotrexate: none
* Obtaining the non-opposition of parents / legal representatives
* Affiliation to a social security scheme.

Exclusion Criteria:

* Patients with other pathologies associated with mental retardation (autism, genetic syndrome ...)
* Patients lost to follow-up
* Deceased patients
* Patients treated for a pathology whose prognosis is involved in the very short term (infiltrating glioma of the brainstem, recurrence of the pathology during treatment)
* Non-French speaking patients
Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging

In order to explain the value of adding CESM into the clinical pathway, and also to obtain the relevant clinical data to support future update of clinical guideline, we plan to evaluate the detection rate of CESM for additional findings on preoperative breast MRI and the relevant clinical safety in the study.

The goal of the prospective, multicenter, interventional Study is to prospectively evaluate the detection rate of preoperative contrast enhanced spectral mammography for additional suspicious findings of preoperative breast MRI in patients presenting with index breast lesions (BI-RADS ≥ 4).

The study plans to include 320 adult female patients with Index lesions of "BI-RADS≥4" in breast MRI.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult women aged 18-75 years old
* 2. First-time referral to the breast clinic or inpatient department of the study center for being diagnosed as presenting with suspicious breast lesions by previous procedures in 30 days
* 3. Presenting with Index lesions of "BI-RADS≥4" and additional findings in preoperative breast MRI
* 4. Sign the informed consent form for this study.
* 5. Commit to follow the research procedures and cooperate with the implementation of the whole process of the study.
* 6. In the case of women of childbearing age, have been taken contraception for at least one month prior to screening and have had a negative serum or urine pregnancy test and commit to use contraception throughout the study period

Exclusion Criteria:

* 1. Patients with contraindications of intravenous administration of iodine contrast agent, such as pregnant or lactating women, patients with a history of iodine contrast agent allergy, patients with obvious hyperthyroidism
* 2. It has been more than 14 days since the most recent preoperative breast MRI was performed for the relevant breast disease
* 3. For the relevant breast disease, the preoperative breast MRI images and reports received within 14 days before screening are not available or do not meet the requirements of clinical diagnosis
* 4. Patients who is receiving non-surgical interventional treatment such as neoadjuvant chemotherapy, hormone therapy or radiation therapy
* 5. Patients who have received any breast operation for the relevant disease, such as various biopsies, therapeutic breast surgery
* 6. Other patients assessed by the investigators as not suitable for the study, such as those who are difficult to cooperate with CESM examination due to unconsciousness, communication disorder or/and small breasts to meet the examination requirements
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

This is an international, multicenter, open-label, long-term safety study of ZX008 in patients with epileptic encephalopathy, including Dravet syndrome or Lennox-Gastaut syndrome. Subjects eligible for participation are those with Dravet syndrome who are currently enrolled in Study ZX008-1503, or those with Lennox-Gastaut syndrome who have successfully completed Study ZX008-1601-Part 2, and are candidates for continued treatment with ZX008 for an extended period of time, or those with Dravet syndrome, Lennox-Gastaut syndrome, or another epileptic encephalopathy who have completed participation in another Zogenix-sponsored study and have been invited to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant, nonlactating female
* Satisfactory completion of a core study
* Has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another Zogenix-sponsored clinical trials with ZX008
* Subject's caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability

Exclusion Criteria:

* Current cardiac valvulopathy or pulmonary hypertension that is clinically significant
* Moderate or severe hepatic impairment
* Receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008
Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses

Burnout appears to be highly prevalent among oncology nurses, which was a problem not only for the nurses themselves but for the patients for whom they provide care. How to mitigate and prevent burnout and improve nursing performance outcomes is an urgent problem for nursing manager.

In a sample of 99 oncology nurses, immunological characteristics were compared to burnout scores. In a randomized trial, 90 oncology nurses suffering burnout were randomized to receive psychological capital intervention or routine psychological care. Participants were assessed before and after treatment using measures of burnout, psychological capital and immunological characteristics.

Burnout appears to be highly prevalent among oncology nurses, which was a problem not only for the nurses themselves but for the patients for whom they provide care. And burnout-associated biomarkers remain controversial, and their potential roles in burnout are still unclear.

This study was a randomized controlled trial in which the independent variable was group psychological intervention, while the dependent variables were pre- and post-intervention scores on the Maslach burnout inventory and on the psychological capital scale, as well as values for various immunological indicators. In Stage 1 of the study, recruited subjects completed the psychological capital questionnaire and blood was sampled. In Stage 2, the research team administered a custom-designed psychological capital intervention (PCI) to part of the sample, while the other part received routine care . The PCI group received 1 h of counseling twice weekly for a total of 24 weeks in total. In Stage 3, the PCI and control groups completed the questionnaires again and provided blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were officially employed and licensed nurses who had been working in the cancer hospital for at least 2 years.

Exclusion Criteria:

* Subjects had recently suffered personal health problems or significant negative life events, such as the death or serious illness of a family member, or if they were on maternity leave or other types of leave from their nursing job.
Effectiveness Chronic Kidney Disease & Therapeutic Exercise

The purpose of this study is to assess the effectiveness and safety of the therapeutic exercise effects in patients with chronic kidney disease. An randomized clinical trial is carried out. A total sample of 70 patients with chronic kidney disease is recruited and divided into a therapeutic exercise group and a control group. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease

Exclusion Criteria:

* Cognitive impairment and non signed consent inform form
Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the best effect of airway clearance. The primary aim of this study is to assess the efficacy of a new ACT (Simeox) on pulmonary function in children with CF. 40 CF patients with stable respiratory function will be randomized 1:1 to Simeox or conventional chest physiotherapy (CCPT) therapy (control group) and treated at home during 1 month. After a short washout period, patients will be treated at home onto the alternative treatment for 1 month (crossover design). Lung function, quality of life, pulmonary exacerbation and safety will be evaluated at 1 month for each therapy period.


Eligibility Criteria:
Inclusion Criteria:

* Subject and his or her legally appointed and authorized representative will agree for treatment with Simeox technology
* willing and able to cooperate and learn new technic of drainage.
* age 8-18 years, on the date of admission to hospital.
* confirmed diagnosis of CF as determined by the investigator.
* able to perform pulmonary tests

Exclusion Criteria:

History of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. This includes, but is not limited to, the following:

* contraindications to bronchial chest physiotherapy
* hemoptysis
* pneumothorax
* heart disease
* recent chest surgery
* recent chest injury
* history of lung transplantation
A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.

As current study is conducted to provide additional information regarding safety and efficacy Bydureon, exenatide once weekly for injectable suspension, in the Korean population open label, non-comparative, multi-centre design is used.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 19-75 years of age
* diagnosed with type 2 diabetes mellitus
* Patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies;

  * Metformin
  * Sulphonylurea
  * Thiazolidinedione
  * Metformin and sulphonylurea
  * Metformin and thiazolidinedione

Exclusion Criteria:

* Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:

  1. Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
  2. Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
  3. DPP-4 inhibitors within 30 days of screening;
  4. Regular use (\> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;
  5. Regular use (\> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of screening;
  6. GLP-1 receptor agonist except exenatide within 3 months of screening;
* diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;
* type 2 diabetes by beta-cell dysfunction requiring insulin treatment
* Has ever used exenatide
* Pregnant or breast feeding patients
* Hepatic disease (defined by aspartate or alanine transaminase \>3.0 times the upper limit of normal
* End-stage renal disease or severe renal impairment (creatinine clearance \< 30 ml/min)
Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis

This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.

In this study, 40 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized into the tofacitinib treatment group and prednisolone treatment group. Patients will follow the same reduction steps for prednisolone and its placebo. The primary end point is the percentage of patients who are in complete response at week 24.

The efficacy will be evaluated at week 4, 12 and 24. Safety is also monitored during the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18-65 years old;
2. Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;
3. Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;
4. Patients who signed the informed consent form.

Exclusion Criteria:

1. Patients who failed or intolerant to either tofacitinib or its similar drugs;
2. Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
3. Not well controlled diabetes;
4. Moderate and severe hyperlipedimia;
5. Patients with history of thrombus;
6. Uncontrolled heart failure od renal dysfunction (eGFR \<30ml/min);
7. Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;
8. Upper GI bleeding happened in 3 months before enrollment;
9. Refractory hypertension;
10. Pregnant or intended to be pregnant recently;
11. Severe coronary artery involvement demonstrated by CTA;
12. Severe cranial or cervical or renal artery diseases that need surgery;
13. Patients that should not be included judged by the investigator.
Helmsley 3.0: Abbreviated MRE

The purpose of our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease.

This multi-center study will evaluate the effectiveness of an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) to document the presence and severity of small bowel inflammation, the presence and features of stricturing and penetrating disease in children and adults with Crohn's Disease.

The abbreviated MRI of the bowel or MRE will not involve IV contrast or an injection of glucagon and water will replace the oral contrast used in standard of care MREs. Scan time will be greatly reduced with the abbreviated MRE ( approximately 15 minutes) compared to a standard of care MRE (approximately 60 minutes).

Eligibility Criteria:
Inclusion Criteria:

* Established Crohn's disease diagnosis in patients 10 and older
* Undergoing clinical magnetic resonance enterography (MRE) examinations for any reason(s) below

  * Staging/ restaging/ follow- up of intestinal inflammation
  * Evaluation of known or suspected luminal narrowing/ stricturing disease
  * Evaluation of known or suspected internal penetrating disease

Exclusion Criteria:

* Undergoing initial imaging for suspected Crohn's disease where the diagnosis of Crohn's disease has yet to be definitively established
* New Crohn's disease diagnosis, undergoing baseline imaging
* Isolated colonic disease
* Known or suspected pregnancy
* Contraindication to magnetic resonance imaging (MRI)
* Ileostomy or prior ileal resection
* Less than 10 years of age
* Unable or unwilling to follow imaging procedures
* Non- English speaking
Combined Therapy in Age-Related Macular Degeneration (ARMD)

The purpose of this study is to investigate the efficacy of combined intravitreal therapy with or without prior photodynamic therapy in patients with wet age-related macular degeneration (AMD).

In patients with wet AMD, a significant improvement in vision was observed after combined intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the long-term sustainability of the therapeutic benefits.

This prospective study of a case series included eyes with predominantly classic lesions (Group 1; n = 52) and eyes with occult lesions (Group 2; n = 106). Patients with predominantly classic lesions received low fluorescence photodynamic therapy (42 J/cm2 for 72 sec), followed by, 24 hours later, a 1.5 mL core pars plana vitrectomy with intravitreal injection of dexamethasone (0.8 mg) and bevacizumab (1.25 mg). Patients with occult lesions received a 0.4 mL core pars plana vitrectomy with intravitreal injection of triamcinolone (8 mg) and bevacizumab (1.25 mg). At baseline and follow-up examinations, the best-corrected visual acuity (BCVA; logMar), central macular thickness (optical coherence tomography), intraocular pressure (IOP; Goldmann tonometry) were determined. In addition, the need for retreatment was assessed, and adverse events were monitored.

Eligibility Criteria:
Inclusion Criteria:

* Wet age related macular degeneration

Exclusion Criteria:

* Opacities in lens or cornea
* Ongoing intraocular inflammation
* Trauma