cyrilzakka/clinical-trials huggingface dataset:
Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing

The purpose of this study is two-fold. In the first phase, the goal is to characterize the stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and stool (raw stool and rectal swab) specimens collected using various standard, medically established procedures with and without transport media and tested at various time points and under different temperature conditions, and also to look at variation between repeat sampling events. The intention is for these data to support decisions made by BioFire regarding the appropriate specimen type and handling guidelines for future tests. In the second phase of the study, collection and transport conditions identified in Phase 1 will be used to collect specimens for pilot performance evaluations of a new molecular diagnostic test.

This evaluation will be initiated at several sites in the US. In the first phase of the study, multiple specimens will be collected from each subject and tested using various pre-analytical techniques. Current BioFire FilmArray test panels will be used to assay each specimen and evaluate the multiple variables: repeat sampling, native specimen stability, or other post-collection variables. In the second phase of the study only two specimens will be collected from each subject: one for testing with the new test (using handling procedures identified in Phase 1) and another for testing with the reference method. Up to 2,000 subjects will be enrolled across all sites in each phase (up to 4,000 subjects total). Enrollment is expected to last approximately 18 months to cover both phases of the study. All specimens and subject data will be de-identified and coded. Prior to study initiation, each participating site will have the necessary Institutional Review Board (IRB) reviews. Specimens in both phases will be tested at the study site using various BioFire test platforms and cartridges.

Eligibility Criteria:
Inclusion Criteria:

* Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue. OR Subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days
* If age 18 or over, subject provides written informed consent
* If under the age of 18, parental permission and assent (as appropriate) is obtained
* Subject is willing and able to provide at least two (up to three) specimens: any combination of NS, NPS, or TS OR rectal swab or stool

Exclusion Criteria:

* Subject is unable to provide consent or parental permission and assent (as appropriate) cannot be obtained
* Subject is unable or unwilling to provide two specimens
* Subject's health care provider determines that specimen collection represents an unacceptable risk
RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency

FOVELASS is a multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating SSV insufficiency, conducted by the French Society of Phlebology.

Saphenous vein insufficiency is a common finding in varicose veins cases. International guidelines currently recommend endovenous thermal ablation using laser (EVLA) or radiofrequency as first line treatment for truncal Great Saphenous Vein (GSV) incompetence in preference to Ultrasound Guided Foam Sclerotherapy (UGFS) (1,2). This GSV-based recommendation has tended to be used for treating Small Saphenous Vein (SSV) incompetence.

To date, no RCTs have directly compared UGFS and EVLA for SSV treatment. The French Society of Phlebology (SFP) decided to compare these two most utilised endovenous treatments in France in a controlled study called the FOam VErsus LAser in the SSv (FOVELASS) study, involving 13 investigators in 11 vascular medical centres.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic varicose veins (CEAP C2s-C6)
* underlying isolated SSV incompetence (SSV reflux time\>0.5sec on duplex ultrasound (DUS))
* reflux involving at least 15 cm of proximal SSV
* minimal SSV diameter of 4 mm at mid-calf (luminal diameter in standing position)

Exclusion Criteria:

* SSV treatment in the preceding 3 months
* post-thrombotic disease
* deep or superficial vein thrombosis of less than 3 months duration
* coexistent ipsilateral GSV insufficiency
* morbid obesity (BMI\>40)
* presence of significant arterial disease (ABPI\<0.5)
Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

Transurethral resection of the prostate (TURP) is the current standard procedure for men with prostate volume 30-80 gm. In case with large prostate adenoma (\>80 g), the resection time required by TURP is associated with increased risk of TUR syndrome, blood loss and other complications.

Many types of minimally invasive surgery exist along with new equipment and techniques. Many types of laser devices such as greenlight laser, thulium laser and holmium laser, are used to enucleate the prostate. Increasing evidence has proven their safety and efficacy However, the use of laser devices is difficult and associated with steep learning curve and high medical expenses.

PKEP is a safe and effective procedure for the treatment of bladder obstruction secondary to BPH. This procedure not only improves maximum flow rate at 3 and 12 months after surgery, but it also improves all other recorded parameters (IPSS, QOL, IEFF-5, PVR, PSA).

A button electrode can be effectively used to enucleate the prostate because of its powerful vaporisation and strong coagulation (B-TUEP technique) ,such as that with a holmium laser, thulium laser and greenlight laser. However its associated with short term complication as early irritative symptoms, Bulai reported that 16.7% of the patients suffering from early irritative symptoms while Geavlete reported that 11.4% of patient suffering from early irritative symptoms.

Aim: compare safety and efficacy and adverse events of endoscopic enucleation of large prostate using hot knife electrode (needloscopic enucleation) versus the standard vaporization electrode ( vapoenucleation) patients \& methods: Patients will randomly be divided into two equal groups: Group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).

Group B: Patient will be subjected to endoscopic enucleation of the prostate by bipolar hot kife electrode (needloscopic enucleation) Inclusion criteria: patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)\>7 due to BPH.

exclusion criteria: prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.

Operative Technique: Endoscopic enucleation of the prostate in saline utilizing either bipolar vaporization electrode or bipolar hot knife (collin's) electrode.

follow up: operative time, resected tissue weight, cath time, hospital stay and change of; IPSS,QOL, Qmax, PVR, PSA, IIEF-5 \& MSHQ-EjD besides; perioperative adverse events are recorded \& followed-up.

Eligibility Criteria:
Inclusion Criteria:

* patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)\>7 due to BPH.

Exclusion Criteria:

* prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.
Accuracy of Automatic Contusion Volume Scanning for Predicting the Incidence of Pneumonia in Patients With Thoracic Trauma

The goal of this retrospective observational study is to evaluate the diagnostic accuracy of pulmonary contusion volume in predicting early pneumonia in patients with thoracic trauma.

The primary question we aim to answer is: What is the diagnostic accuracy of pulmonary contusion volume in predicting pneumonia within 7 days post-trauma?

Moreover, we aim to explore which is the overlap between the contused segments and those developing pneumonia.

Finally, we aim to explore relevant differences in radiomic features between contused segments that developed pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the ED for trauma as primary diagnosis
* Whole-body contrast CT scan performed within 6 hours from admission

Exclusion Criteria:

* Age \<18 years
Collection of RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients With Suspicion of Covid-19

Constitution of a collection of SARS-CoV-2 RNA extracts from nasopharyngeal and saliva / sputum samples, from the same patients (paired samples), taken during the same consultation in an indication of detection of SARS-CoV-2 in with a view to developing tests / diagnostic tools for SARS-CoV-2.

In order to preserve their anonymity, the participant will be identified in a dedicated form by a unique identification number. An identification list of participants will be kept in the investigator's file. The investigator will ensure that the anonymity of each person participating in the research is guaranteed.

The source documents are the original documents, data and files from which the data concerning the participant is reported in the Data set_COLL001.xls form provided to the investigator which will serve as an observation notebook.

The investigator must agree to allow direct access to research source data during monitoring, audit or inspection visits. The source data is for the most part computerized and accessible after authorization.

The data will be transcribed into an Excel form Data set_COLL001.xls pseudonymized form which will serve as an observation book. The data will be recorded and then transmitted to ID SOLUTIONS via the Data set_COLL001.xls form provided to the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Male, female adult
* Patient with an indication for SARS-CoV-2 screening.
* Patient having been informed and having given his non-objection to participate in the study
* Patient affiliated with a French social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Pregnant or breastfeeding women
* Vulnerable people Adults placed under tutorship or curatorship or under judicial protection, Patient unable to personally give consent, or adult protected by law, Opposition expressed to inclusion in the study.
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement

This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.

About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.

Eligibility Criteria:
Inclusion Criteria:

* Primary cancers undergoing curative surgery (R0)
* Life expectancy \> 2 yrs
* Neoadjuvant radiotherapy with or without chemotherapy

Exclusion Criteria:

* Pelvic extenteration or extended resections
* Previously irradiated patients (i.e. radiation therapy for a previous cancer)
* Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder
* sensitivity to porcine derived products or polysorbate
Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.

Although shoulder surgeries can effectively relieve pain intensity and restore shoulder function, some patients reported persistent post-operative pain at the 6-month post-surgery follow-up visit. This randomized study aims to determine the effectiveness of three different types of bio-psychosocial support to pre-operative shoulder surgery patients. This study will examine the differential effects of brief mindfulness-based breathing, heart rate variability biofeedback (HRV-BF), and cognitive behavioral pain psychoeducation for pre-operative patients.


Eligibility Criteria:
Inclusion Criteria:

shoulder pain patients with

* (1) pain ≥3months and ≥3 days per week
* (2) pain intensity ≥ 40 (VAS scale from 0 no pain to 100 very painful)
* (3) the surgical indication would be based on orthopedics opinions

Exclusion Criteria:

* history of shoulder surgery in the prior 3 years
* osteoporotic vertebral fractures or rheumatologic diseases
* chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
* neurological disease (i.e., stroke, parkinson's disease, etc..)
* psychiatric disease (i.e., dementia, depression, schizophrenia, etc)
* cancer
* patients who practiced yoga, meditation, chi-qong, mindfulness, or deep breathing exercises more than three times per week
Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions

The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to anastrozole or any comparable or similar product.
Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic (MOVE)

Complex practical basic life support (BLS) training have been stopped all over the world due to coronavirus disease (COVID-19) pandemic in 2020. While launching the new Simulation Centre at Medical Faculty of Masaryk University in Brno, Czech Republic, teachers and students have been dealing with the risk of COVID-19 transmission during the simulation training. One of the highest risks for the transfer of COVID-19 between the medical students is during the mouth-to-mouth ventilation training in BLS. It has been assumed that rescuers during BLS simulation training with use of breathable nanofiber respirator with layers with accelerated copper can provide efficient mouth-to-mouth rescue breaths to the mannequin in compliance with safety rules.

The main aim of this study is to assess the efficiency of mouth-to-mouth ventilation through breathable self-sterilizing nanofiber respirators with accelerated copper in COVID-19 pandemic time. 100 volunteers (medical students trained as BLS trainers an medical students trained in BLS) will provide 2 minutes cycle of BLS according to European Resuscitation Council (ERC) guidelines 2021 wearing the breathable self-sterilizing nanofiber respirators with accelerated copper in three different mannequins: Professional Adult Medium Skin CPR-AED Training Manikin (trademark) with CPR Monitor (Prestan = trademark), Resusci Anne QCPR AED (Laerdal = trademark), Resusci Baby QCPR (Laerdal = trademark). The mannequin will be utilised in a randomised order. The efficiency of mouth-to-mouth rescue breaths as "visible breath " and "not visible breath" will be recorded. In first BLS mannequin, the visibility of chest rising by the observer will be recorded. In two other mannequins, the ventilation metrics and each rescue breath evaluation in QCPR Skill Reporter (software trademark) will be recorded. Overall, 3 levels of visible breath according to the relation to set optimal breath volume (400 to 600 mL in adult, 30 to 50 mL in infant): low volume breath (below 400ml in adults and below 30ml in infant), optimal volume breath (between 400-600ml in adult and between 30-50 ml in infant), high volume breath (over 600ml in adult and over 50ml in infant) will be evaluated. For the primary analysis of efficiency of mouth-to-mouth ventilation, data from all three mannequins using outcome No breath / Visible breath will be evaluated. Secondary analysis will utilize data from two mannequins where detailed stratification No Breath / low / optimal / high Visible breath is possible. The mean volume of rescue breaths in the 2-minute cycle, average pause, longest pause, success in achieving the optimal breath volume, adverse events will be recorded. Regarding the technique of provided mouth-to-mouth ventilation, head tilt in adult or neutral position in infant and pinching of the nose will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* medical students trained in BLS as BLS trainers
* medical students trained in BLS

Exclusion Criteria:

* refusing to participate
* non-medical students
Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)

The investigators plan to perform an exploratory study to investigate the effects of electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic syndrome (PTS), as well as quality of life of patients with PTS. The investigators theorize that electro-stimulation will provide both a mechanical benefit via muscular contraction and increased venous outflow from the affected extremity, as well as an anesthetic effect, which the investigators anticipate will translate into improved symptomatic outcomes, quality of life (QOL) benefits.

The purpose of this study is to determine the optimal electrical stimulation intensity level at which subjects using the portable electrical muscle stimulator (VeinoPlus) have the largest benefit for relief of post thrombotic symptoms. To determine if the subjects reported benefit from the device and willingness to continue using the device.

Subjects will be pre-screened on the phone for eligibility, and an initial appointment will be set. The subject will be given a device and complete a quality of life survey. The subject will also be assessed on the Villalta scale. After two months, the subjects will return for the final visit where the Villalta scale and quality of life survey will be reassessed, and the device taken back.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Presence of previously objectively documented unilateral, lower extremity deep venous thrombosis
* Presence of PTS (typical pain and swelling - worse after standing and vertical activity and relieved by rest and the horizontal position), severe enough that the patient is interested to explore a treatment option that might improve these symptoms. Symptoms had to have been stable for ≥ 3 months. Unstable symptoms are defined as: worsening, improving or variable symptoms over preceding months.
* Subjects must be willing and able to give written informed consent.

Exclusion Criteria:

* Inability or refusal to provide informed consent
* Pregnancy
* Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
* Geographic inaccessibility to prevent scheduled return evaluations
* Incapable of responding to questionnaires
* Expected lifespan \<6 months
* Presence of cardiac pacemaker
* History of cardiac arrhythmia
* Presence of infected, or inflamed areas or skin eruptions; phlebitis, thrombophlebitis, active venous ulceration
* History of seizures
The Relationship Between the Surgery-related Anxiety and HRV: Prediction for Aggressive Emergence Behavior

Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system. Anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low HRV. This study is to investigate the relationship between the surgery-related anxiety and the HRV which is known to reflect the balance of autonomic nervous system. Furthermore, this study also focuses on HRV's role as a predictor for aggressive emergence behavior, which might also be considered as partially related to imbalance of autonomic nervous system.


Eligibility Criteria:
Inclusion Criteria:

1. 20-60 years old male, ASA 1-2
2. scheduled for elective closed reduction for nasal bone fracture

Exclusion Criteria:

1. Patients having hearing difficulties, Foreigner, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale \< 15
2. patients with severe cardiopulmonary dysfunction
3. patients taking any neurologic medication (anti-depressant, anti-convulsant, etc)
4. patients taking any cardiovascular medication
5. patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc)
6. patients refusal
Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria

* Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
* Received at least 3 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and at least 3 prior lines of therapy (LOT).
* Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
* Participants must have measurable disease during screening.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

* Active or history of central nervous system involvement with MM.
* Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis.
* Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)

The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* A diagnosis of PASC as indicated by past COVID-19 infection, and persistent symptoms, including 'brain fog', confusion, short-term memory deficits, trouble concentrating, delirium, difficulties in multitasking.

Exclusion Criteria:

* History of epilepsy
* Metallic implants in the head and neck,
* Brain stimulators
* Pacemakers
* Pregnancy
* Active substance dependence (except for tobacco)
* Premorbid major neurological illness
* Severe mental illness (e.g., bipolar disorder, schizophrenia)
* Attention Deficit Hyperactivity Disorder