cyrilzakka/clinical-trials huggingface dataset:
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on samples collected by a healthcare professional versus self-collection; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.


Eligibility Criteria:
Inclusion Criteria:

Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.

Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:

* Currently experiencing symptoms of COVID-19.
* Be clinically diagnosed or suspected to have COVID-19.
* Recent past (3 weeks) exhibited symptoms of COVID-19.
* Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Interacted with a COVID-19 positive individual.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria may not be enrolled in this study:

* Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Have a deviated nasal septum.
* Cognitively impaired individuals resulting in the inability to provide informed consent
A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age

The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18 to 39 kilograms/square meter (inclusive) at the Screening Visit.
* Participants of nonchildbearing potential may be enrolled in the study.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy during the study intervention period, and agreement to continue adequate contraception or abstinence through 3 months following last study injection.

Exclusion Criteria:

* Have chronic illness related to Lyme disease or an active symptomatic Lyme disease infection as suspected or diagnosed by a physician.
* Received treatment for Lyme disease within the prior 3 months.
* Had previous vaccination against Lyme disease or participated in the past in any vaccine study for Lyme disease.
* Had a tick bite within 4 weeks prior to the study injection visit.
* Dermatologic conditions that could affect local solicited AR assessments (for example, tattoos; psoriasis patches affecting skin over the deltoid areas).
* Received systemic immunosuppressants for \>14 days in total within 180 days prior to the Screening Visit (for corticosteroids, ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.
* History of myocarditis, pericarditis, or myopericarditis regardless of the timing of past medical history.
* History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study injection.
* Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.

Note: Other inclusion and exclusion criteria may apply.
Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence

Fecal incontinence affects 18.4% adults in the community and greatly impacts quality of life. There's a problem like inconvenience, pain or allergic response in many therapeutic methods such as a surgical operation or material injection. ANT-SM is autologous adipose-derived stem cell, and so, expect of no immune responses. In this study, patients are given injection of ANT-AM in anal sphincter and followed for 4 weeks to test the safety.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Wexner's fecal incontinence score \> or egal 5
* patient who has fecal incontinence for more than 6 months
* Continuity of anal sphincter at endorectal ultrasound and abnormality of anal function at anorectal manometry
* negative for urine beta-HCG for woman of childbearing age
* agreement to participate, with signed informed-consent

Exclusion Criteria:

* Anorectal surgery within the last 6 months prior to the study
* patient who is allergy to bovine-derived materials and an anesthetic
* patients with a diagnosis of auto immune disease
* Diagnosis of HBV, HCV, HIV and other infectious disease
* Patients with a diagnosis of active Tuberculosis
* Patient is pregnant or breast-feeding
* Women within 6 months post partum
* Patient who is unwilling to use an "effective" method of contraception during the study
* Patients with a diagnosis of Inflammatory Bowel Disease
* Patient who has a clinically relevant history of abuse of alcohol or drugs
* Insufficient adipose tissue for manufacturing of ANT-SM
* Patient whom investigator consider is not suitable in this study
* Patients have history of surgery for malignant cancer in the past 5 years
* Patient who has to undergo ano-rectal surgery
* Patient who has a history of artificial anal sphincter surgery
* Patient who has taken cytotoxic drugs within the last 30 days
* Patient whom investigator consider is not suitable in this study reasons for severe ano-rectal disease, severe constipation, fistula, rectal prolapsed or neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis

This is a randomized, double-blind, placebo-controlled parallel group study on the efficacy and safety of intramuscular injections of autologous immunoglobulin in patients with moderate-to-severe atopic dermatitis.

Children and adult patients with moderate-to-severe atopic dermatitis (age ≥ 13 years) whose clinical conditions have not been effectively controlled by current standard medical therapies (topical moisturizers, topical corticosteroids, topical calcineurin inhibitors, and oral antihistamines) for more than 2 months will be include.

This is a randomized, double-blind, placebo-controlled parallel group study on the efficacy and safety of intramuscular injections of autologous immunoglobulin in patients with moderate-to-severe atopic dermatitis. After providing informed consent, patients will be assessed for study eligibility at the baseline visit. Patients will undergo screening within 28 days prior to randomization as "wash out period", and during the screening period, treatment with medications (including systemic corticosteroids and systemic immunomodulating agents) for atopic dermatitis will be wash-out for at least 28 days prior to baseline (exclude moisturizers).

At screening, plasma will be separated from patients' venous blood (400ml) aseptically and autologous immunoglobulin (total IgG) will be purified from the plasma by chromatography using Protein A during the screening period. Patients will be randomized in a 1:1 ratio to receive weekly treatment with autologous immunoglobulin or placebo (normal saline) will be administrated by intramuscular injection, once a week for 7 weeks (total 8 injections).

The investigators will evaluate the clinical efficacy and safety of intramuscular injections of autologous immunoglobulin in those patients with moderate-to-severe atopic dermatitis by measuring changes in the standardized clinical severity scoring system for atopic dermatitis (SCORAD) values, Eczema Area and Severity index (EASI) and quality of life together with laboratory parameters in blood samples before and after treatment. Systemic corticosteroids as a rescue treatment will be prescribed to control unacceptable symptoms of atopic dermatitis at the investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

1. Suitability of autologous blood donation criteria
2. Current standard medical therapies more than 2 months and moderate-to-severe atopic dermatitis
3. ≥10% lesion body surface area (BSA) of atopic dermatitis involvement in area

Exclusion Criteria:

1. Patients under the age of 13 year.
2. Patients who are unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes).
3. Patients with severe disease whose expected survival duration is less than 3 months.
4. Pregnancy or planned pregnancy within 1 year
5. Skin condition not appropriate for blood sampling and transfusion
6. The standardized clinical severity scoring system for atopic dermatitis (SCORAD) values \<25 (Mild atopic dermatitis)
A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.

This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients with active rheumatoid arthritis who have an inadequate response to current biologic or non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or in combination with their current non-biologic DMARD. Anticipated time on study treatment is 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis of \>/= 6 months duration
* DAS28 \>/= 3.2 at screening and baseline
* Inadequate response to biologic or non-biologic DMARDs
* Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug
* If continuing on a non-biologic DMARD, dose should be stable for at least 8 weeks
* Oral corticosteroids must have been at stable dose for at least 25 out of 28 days prior to baseline

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery
* Rheumatic autoimmune disease other then RA
* Functional class IV as defined by the American College of Rheumatology (ACR) classification
* Prior history of or current inflammatory joint disease other than RA
* Previous treatment with any cell-depleting therapies
* Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline
* Active infection or history of recurrent infection
* Positive for HIV or hepatitis B or C
* History of or current primary or secondary immunodeficiency
Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

Severe infections can be caused by various organisms, such as bacteria or viruses, and lead to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or even intensive care. For the treatment of bacterial infections to be successful, the correct antibiotics need to be given promptly. Early in the course of illness, clinicians often do not know exactly which bacteria are causing the infection. Furthermore, patients differ in terms of how their bodies process the antibiotics they are given; this means that some may get too much and others too little. This can in turn lead to some patients not being fully cured, and others coming to harm due to side effects of higher doses of these drugs.

For certain types of antibiotics, clinicians are able to measure their levels in the bloodstream, which can help guide dosing. This is called therapeutic drug monitoring, and is commonly used in clinical practice. One of the problems with therapeutic drug monitoring is that it is often not available outside of regular working hours, is costly, and most importantly, provides clinicians with useful information only after a few days of treatment have already been completed. This may be too late to treat these severely ill patients with life-threatening infections, where early and appropriate treatments matter.

The aim of our study, called TDM-TIME, is to look at how long it takes for blood samples to get from the patient to the laboratory to be measured, with the results then communicated back to clinicians. We are further looking to investigate whether steps can be taken to improve these timings, which would lead to shorter times until treatments can be improved. As our study is observational, we will not change anything about the treatment of our patients, but will only be measuring levels of antibiotics in their blood.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Admitted to intensive care;
* Treated for presumed or confirmed lower respiratory tract infection;
* Receiving OR about to receive the first dose of intravenous antimicrobials (either meropenem of piperacillin/tazobactam);
* Valid informed consent OR enrolment through deferred consent appropriate.

Exclusion Criteria:

* Severe anaemia (haemoglobin level \< 70 g/L);
* Unlikely to survive 24 hours as judged by the treating physician;
* Study antimicrobial course started more than 24 hours ago.
Biomarkers in Prostate Cancer Treated With SRP Following Failure of FAT

The ability of genomic biomarkers to Measuring tumour aggressiveness, and facilitate the selection of therapies in patients who had salvage radical prostatectomy after focal therapy and predict the risk of biochemical recurrence BCR after focal therapy or RP.

Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutual Montsouris). Primary radiotherapy, brachytherapy and whole-gland treatments were excluded, as to evaluate the true spectrum of morphologic changes caused by the focal emerging ablative modalities. Thirteen SRP after focal ablative therapies FAT (cryotherapy or high intensity focused ultrasound- HIFU or vascular-targeted photodynamic therapy- VTP) were identified from our prospective collected database. Genitourinary pathologists were provided clinical information related to prior therapies and immunohistochemical (IHC) markers were used in the diagnosis of limited primary PC on needle biopsy when necessary. Prostatectomy specimens were processed and the number of tumor foci, size of the dominant focus and pathological stage were recorded. Residual disease was graded according to the Gleason grading system. Treatment-related histologic changes were examined.

Eligibility Criteria:
Inclusion Criteria:

* Prostate Cancer treated with salvage radical prostatectomy following failure of focal ablative therapies

Exclusion Criteria:

* Primary radiotherapy, brachytherapy and whole-gland treatments
Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA

The purpose of this study is to compare two simple and safe emergency department discharge therapy for Type 2 Diabetes patients with severe hyperglycemia and with no indications for inpatient admission.

This study is an open label randomized controlled trial in adult DM2 patients seen in ED services at John H. Stroger Hospital of Cook County serving a largely uninsured/underserved population. Individuals more than 18 years of age with DM2, either with new onset DM2 or known diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting with fasting blood glucose (FBG) 300-500 mg/dl or random blood glucose (RBG) 400-700 mg/dl and who did not have any exclusion criteria listed in Table 1, were eligible for the study. Subjects were randomized to one of the two fixed dose treatment groups: 1) Glipizide XL 10 mg orally daily prior to breakfast (G group), 2) Glipizide XL 10 mg orally daily along with Insulin Glargine 10 units at bedtime, subcutaneously (G+G group).

Eligibility Criteria:
Inclusion Criteria:

* Individuals more than 18 years of age with DM2, either with new onset DM2 or known diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting with fasting blood glucose (FBG) 300-500 mg/dl or random blood glucose (RBG) 400-700 mg/dl and who did not have any exclusion criteria listed in Table 1, were eligible for the study.

Exclusion Criteria:

* Acute metabolic complications (diabetic ketoacidosis, hyperosmolar hyperglycemia associated with dehydration).
* Acute complications of chronic cardiovascular, neurological, renal, and other diabetic complications.
* Any subject with unstable vitals signs (temperature \> 101 degrees F, systolic blood pressure \< 90 or \> 180 mm hg, diastolic blood pressure \< 60 or \> 110 mm hg, heart rate \< 60 or \> 120 beats/minute).
* Electrolyte imbalances (serum bicarbonate level \< 20 mEq/L, serum sodium \< 125 \& \> 150 mEq/L, serum potassium \< 3.5 \& \> 5.5 mEq/L).
* Evidence of an impaired sensorium and/or dementia.
* Age \> 75 years
* Subjects with any acute medical illness.
* Type 1 diabetes or type 2 diabetics weighing less than 120 lbs
* Current addiction to illicit substances or alcohol abuse
* Pregnant or lactating subjects
Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain.

The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer
* 18 years or older

Exclusion Criteria:

* unable to give written consent
* unable to understand Danish
* Previous cosmetic surgery in the breast
* Previous surgery in ipsilateral breast
* Bilateral cancer
* Concomitant corrective surgery on contralateral side
* Pregnant
* Other disease or injury in the nervous system
* Psychiatric disease
* Alcohol or drug abuse
A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

The goal of this clinical trial is to learn about the safety and the pharmacodynamic (PD) effects of TPM502 in adults with celiac disease. The main questions it aims to answer are:

* if TPM502 is safe and well tolerated
* if TPM502 can induce modifications in parameters indicating that it may induce tolerance to gluten

Participants will:

* undergo 1-day gluten challenge during screening and after administration of TPM502 or placebo.
* receive 2 infusions of TPM502 or placebo, 2 weeks apart

This is a multi center, double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, and PD effects of two infusions of TPM502 in adult patients diagnosed with CeD.

The patient´s participation in the study comprises 3 phases: screening period, treatment period and follow-up period.

Patients fulfilling the eligibility criteria will be randomized to receive two infusions of TMP502 (or placebo) at the same dose level. Patients will undergo a second GC one week after the second infusion of TPM502.

The study includes 4 cohorts of patients, each cohort will receive escalating doses of TPM502 (or placebo). Upon completion of the 3rd cohort, a lower dose can be investigated, if deemed relevant.

Eligibility Criteria:
Inclusion Criteria:

* Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissue transglutaminase \>10x ULN and documented positive IgA anti-endomysial antibody (EMA) at time of CeD diagnosis (as per local guidelines)
* Serum anti-tissue transglutaminase 2 immunoglobin A antibodies within normal range (i.e., \<15 U/mL) at screening
* Serum IL-2 levels (AUC1-6h) above a pre-defined threshold following the GC at screening
* Patients must have been on GFD for ≥ 6 months
* Patients must have well-controlled CeD, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD, as per investigator's assessment
* HLA-DQ2.5 positive

Exclusion Criteria:

* Known or suspected refractory CeD (refractory CeD type I or II)
* Known intolerable symptoms following previous GCs, as per investigator's assessment
* HLA DQ8 positive
* Any active gastrointestinal disease such as gastroesophageal reflux disease, esophagitis or peptic ulcer, microscopic colitis, or irritable bowel syndrome, which in the opinion of the investigator might interfere with the assessment of the symptoms related to CeD
* Known history of or active Crohn's disease, ulcerative colitis, or ulcerative jejunitis
* Known wheat allergy
* Known hypersensitivity to i.v. iron preparations or any other excipients present in the reconstituted TPM502 or placebo
Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).

Papillomaviruses are responsible for almost all cervical cancers. In France, there are more than 3000 new cases of cervical cancer each year and nearly 1000 deaths. One of the ways to prevent this cancer is screening by PCR on cervical sample for which national coverage rate remains very insufficient (\<60%). The invasive and uncomfortable nature of cervical sampling has been identified as a major obstacle to screening. In this context, an alternative sample, such as the first-void urine, seems to be judicious. Nevertheless, some studies have shown a lack of sensitivity of the HPV PCR test on urine. As underlined by the French National Authority for Health (HAS), this is mainly due to a lack of standardization of urine collection. In this study, the investigators therefore propose to evaluate the performance of the HPV PCR test on first-void urine using a standardized protocol. Through a questionnaire, they will also evaluate the acceptability of the first void urine collection device.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age between 30 and 65
* Consulting in the Gynecology-Obstetrics department for primary cervical cancer screening
* Patient affiliated or entitled to a social security regimen
* Patient who has received information about the study and expressed non-opposition

Exclusion Criteria:

-
Screening for Excessive Gambling Behaviors on the Internet

The Internet medium is particularly vector for gambling problems. Since the opening of the online gambling sector in France, no screening for excessive gambling behaviours is provided for by the law, although it is known that preventive actions are more effective if they are implemented early in the gambler's career.

The investigators propose to develop a model for screening excessive gambling practices based on the gambling behaviours observed on French gambling websites, coupled to a clinical validation. The objective is to lead to early preventive measures directed towards the more vulnerable gamblers and adapted for each type of gambling.

This study will therefore contribute to setting up an innovative measure of prevention, to inform and protect gamblers as early as possible.


Eligibility Criteria:
Inclusion Criteria:

* users of French online gambling websites
* users with active accounts
* users that have placed at least one bet during the last 12 months

Exclusion Criteria:

* minor