cyrilzakka/clinical-trials huggingface dataset:
Performance Evaluation of the Nanomix eLab® CRP, PCT, and LAC Assays With the Nanomix eLab System

The performance of the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays will be demonstrated during a method comparison study in which venous whole blood and plasma samples are used. eLab results will be compared to an FDA cleared predicate device. Demographic information will be collected for the subject. Venous blood will be collected in 2 Li-heparinized tubes (2-4ml per tube). One tube will be used for testing at the site and the second tube will be processed to plasma for storage and subsequent shipment to a designated testing site. Whole blood samples will be tested on the eLab C-Reactive Protein, Procalcitonin, and Lactate test as soon as possible after collection; testing on whole blood must be completed within 30 minutes of collection. A predicate Lactate test will also be run as soon as possible after collection; testing of WB on the predicate must be completed within 30 minutes of collection. Plasma will be separated from the whole blood via centrifugation within 30 minutes of collection and tested on the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays and started on predicate CRP and PCT devices (If available at the site) within 30 minutes of the eLab whole blood test. The remainder of the plasma specimen and plasma from the second collection tube will be frozen within one hour of collection, then stored at approximately -20 degrees C or colder.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Must have provided written informed consent
* Admitted to ICU, Emergency Department or other medical wards for acute illness and observation of infection and meeting SIRS criteria (such as elevated heart rate, tachypnea, hypotension, fever, hypothermia, or elevated respiratory rate)

Exclusion Criteria:

* Pregnant or nursing
* Admitted to ICU after trauma
* Admitted to ICU after surgery
* Cardiogenic shock
Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe (CMPASS-EU)

The study aims to collect information on the current treatment patterns for Hepatitis C in participating countries. There is also a focus on patients receiving a daclatasvir-containing treatment regimen who will be followed prospectively for 12 months after treatment initiation to collect real-world data on effectiveness and safety of the treatment. Additional analysis will differentiate between selected subpopulations.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Adult (≥18 years at inclusion)
* Diagnosed with a chronic hepatitis C infection
* Whose physician has already decided to initiate a new HCV treatment or a new daclatasvir-containing regimen
* Informed consent to participate in the study

Exclusion Criteria:

* Participation in a clinical trial or an early access program for HCV therapies
Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)

The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)

Post traumatic stress disorder (PTSD) is a disabling mental health disorder that impacts the lives of individuals. This study aims to understand nitrous oxide's effects in PTSD.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80
* Veterans of the United States Uniformed Services
* primary diagnosis of PTSD
* sufficient severity of PTSD symptoms
* fluency in English
* capacity to provide informed consent

Exclusion Criteria:

* psychiatric or medical conditions that make participation unsafe
* pregnant or nursing females
* allergy to nitrous oxide
Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combin

Unintentional weight loss (UWL) is commonly associated with a wide variety of diseases and there is still no valid diagnostic pathway for evaluating UWL. When detecting UWL coupled with GRAIL Galleri testing, (an investigational pan-cancer early detection test), it is thought that there is a greater positive predictive value in detecting malignancies. This study aims to test the potential synergistic effects of UWL detection and GRAIL usage to detect malignancy at an even earlier rate. UWL will be measured using weekly weight tracking.

Enrolled participants will be provided with a Fitbit Aria Smart Scale and will be asked to weigh themselves each week at a similar time of day wearing a similar amount of clothing for a total of three years. These weight data will be automatically pushed to the Fitbit cell phone application and patients who lost ≥5% from their baseline will be identified, and the intentionality of this weight loss (intentional or unintentional) will be assessed. All patients with UWL will be asked to have a GRAIL Galleri test, a health history and physical examination, a blood draw, imaging, routine cancer screenings done if not already completed, and referral to a specialist if a new cancer is detected.

Eligibility Criteria:
Inclusion Criteria:

* Age range: from 40 to 80 years
* Access to a device (cellphone, computer, tablet) that is compatible with the Fitbit Aria Air smart scale utilized in this study
* Willing to comply with all study procedures and be available for the duration of the study
* Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document
* Subjects must speak English to maximize chance of understanding the trial rational and study procedures

Exclusion Criteria:

* Active cancer diagnosis - current diagnosis, currently undergoing cancer treatment, or concluded cancer treatments within 3 years
* Actively trying to lose weight with medications or bariatric surgery
* Pregnant
IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)

Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and B-mode imaging). This medical device has CE-marking and is approved for use in Europe and other nations.

This is a post-market, non-randomized multi-center surveillance study.

This is a post-market surveillance study that is prospective, controlled, multi-center, to evaluate if Imagio OA can downgrade BI-RADS ( Breast Imaging-Reporting and Data System) classification following CDU (Conventional Diagnostic Ultrasound) for the visualization and characterization of suspicious masses prior to core needle biopsy (CNB) or excision. Investigators will perform CDU to reach a diagnosis and decision to biopsy. Imagio OA will not be used as the reason to perform or to defer a CNB (Core Needle Biopsy) or excision.

Eligibility Criteria:
Inclusion Criteria

* Female
* 18 years of age or older
* Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan

Exclusion Criteria:

* Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos)
* Pregnant or lactating
* Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU
A Study of JR-141 in Patients With Mucopolysaccharidosis Type II

The purpose of this study in patients with mucopolysaccharidosis type II (MPS II) is below,

* to collect the safety information of JR-141
* to evaluate the plasma pharmacokinetics of JR-141
* to explore the efficacy of JR-141 on MPS II-related central nervous system symptoms and general symptoms


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6 years or older at the time of informed consent.
* Patients diagnosed with MPS II.
* Patients who have received idursulfase (0.5 mg/kg/week) continuously for at least 12 weeks until the initial dose of JR-141.

Exclusion Criteria:

* Patients with a history of hematopoietic stem cell transplantation, excluding those who need enzyme replacement therapy even after hematopoietic stem cell transplantation.
* Patients in whom lumbar puncture cannot be performed.
* Patients who have developed serious drug allergy or hypersensitivity that is inappropriate for participation in the study.
* Patients who have received other investigational products within 4 months before enrollment in the study.
Enhanced Respiratory Polygraphy in Suspected OSA

Obstructive Sleep Apnea (OSA) remains underdiagnosed in 2022, as a result of the unawareness of its serious health-related consequences and the lack of diagnosis accessibility. Respiratory polygraphy (PV) is widely used as a screening tool and sometimes a diagnosis test, although polysomnography (PSG) remains the gold standard investigation as it provides complete information about sleep architecture and arousals. Thus, it has been shown that the Apnea Hypopnea Index (AHI) and Respiratory Disorder Index (RDI) are underestimated by PV vs PSG. Approaches to substitute PSG by simpler but equally efficient diagnosis tests have included devices aiming to record complementary signals and to analyze them with Artificial Intelligence. In this context, ASEEGA algorithm has demonstrated its performance for automatic sleep scoring in healthy individuals and patients with various sleep disorders, based on a single channel EEG analysis.

This study aims at comparing the real-life performance and feasibility of added single channel EEG automatic sleep scoring using ASEEGA to PV versus standard PV and PSG in adults referred to a regional sleep reference center for suspected OSA.

We hypothesize that this approach (1) is as accurate as PSG and more accurate that PV for AHI analysis, and (2) is less time-consuming than PSG.


Eligibility Criteria:
Inclusion Criteria:

- Hospitalized at the Center for Sleep Medicine and Respiratory Diseases, Hôpital de la Croix-Rousse, Lyon Academic Hospital, Lyon between 09/2022 and 11/2022 for PSG following suspected OSA .

Exclusion Criteria:

* Unreliable sleep scoring due to artefacts (\> 10% of the recording) or to epileptic abnormalities on the electroencephalography recordings
* Presence of other suspected sleep disorder: central hypersomnia, rapid-eye-movement (REM) or non-REM sleep parasomnia, sleep-related motor disorders...
* Ongoing psychotropic medication
* Opposition of the patient to the use of their data.
Fat and Transcapillary Insulin Transport

There is a current debate whether impaired insulin-mediated microvascular perfusion limits the delivery of hormones and nutrients to muscle and whether short term FFA elevation affects transcapillary transport of insulin and glucose thereby representing a rate-controlling step for insulin-stimulated muscular glucose disposal in humans.

To address these questions, the investigators determined the changes of interstitial glucose and insulin in skeletal muscle of healthy volunteers during intravenous administration of triglycerides or glycerol under physiologic and supraphysiologic hyperinsulinemic conditions.

Increased lipid availability reduces insulin-stimulated glucose disposal in skeletal muscle, which is generally explained by lipid induced inhibition of myocellular insulin signalling, It remains unclear whether lipids also impair transcapillary transport of insulin and glucose which could thereby become rate-controlling for glucose disposal Increased accumulation and availability of lipids cause impaired skeletal muscle insulin sensitivity. It is yet unclear if transcapillary transport of insulin and glucose is impaired by acute elevation of free fatty acids and represents a rate-limiting step during the development of short-term lipid-induced insulin resistance. We determined the changes of interstitial glucose and insulin in skeletal muscle of healthy volunteers during intravenous administration of triglycerides and heparin or glycerol under physiologic and supraphysiologic hyperinsulinemic conditions.

Eligibility Criteria:
Inclusion Criteria:

* The volunteers have to be older than 19 years,
* nonobese (body mass index, BMI less than 27 kg/m2),
* normolipidemic (fasting serum concentration of triglycerides \< 140 mg/dL and
* total cholesterol \< 200 mg/dL) and
* non-smokers.

Exclusion Criteria:

* The following exclusion criteria will be applied:

  * any medication within two weeks prior to the start of study,
  * regular alcohol consumption \> 40 g/d,
  * acute inflammatory disease defined by serum C-reactive protein \> 1 mg/dL,
  * abnormalities in the screening visit or in laboratory tests considered as clinically relevant,
  * family history of diabetes mellitus or dyslipidemia,
  * glucose intolerance,
  * allergy or hypersensitivity against study medication,
  * blood clotting disorders.
Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System

During laparoscopy, trocars are essential: they allow the passage of instruments through the wall. In gynecology, with exception, trocars 5mm (used for the passage of endo-scissors and forceps) and 10 to 12mm are used (especially for optics).

Trocars are responsible for complications, such as vascular wounds, digestive wounds, pain, infections or postoperative hernias, or aesthetic sequelae, and should be chosen with caution: most complications of laparoscopy are essentially due to their placement, and the complications at the introduction of the first trocar are the most frequent.

The MiniLap® system developed by Teleflex does not require trocars in the case of a single forceps, or a single 5mm trocar with the necessary forceps change (this is the Percuvance® system). The aim of the latter is to make minimally invasive surgery even less invasive, thanks to a reduction in the number of trocars used (in many cases, elimination of two trocars), smaller incisions (percutaneous use of instruments, with a diameter of 2,4mm) thus reducing the complications


Eligibility Criteria:
Inclusion Criteria:

* BMI \<35kg / m2
* No history of multiple abdominopelvic surgery
* Without absolute contraindication to laparoscopy
* In the context of ambulatory surgery
* With precise laparoscopy of indication:

  * Exploratory or diagnostic
  * Exploration of infertility
  * Performing a tubal permeability test
  * Performing a salpingectomy
  * Realization of a tubal sterilization
  * Realization of a tubal plasty
  * Performing an ovariectomy
  * Performing a simple ovarian cystectomy
* Patient have been informed during her preoperative consultation and have signed the consent in a free and informed manner upon admission to hospital

Exclusion Criteria:

* Performing an emergency surgery
* Carcinological surgery
* Performing a benign but complex surgery such as:

  * Hysterectomy
  * Prolapse cure
  * promontofixation
  * Complex surgery of endometriosis
  * Removal of large cyst from the ovary.
* Person unable to receive informed information and / or give consent. Person deprived of liberty.
* Pregnant or nursing woman.
Aspiration for Pain Relief Following Ankle Fracture

This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.


Eligibility Criteria:
Inclusion criteria:

* AO/OTA fracture classification 44
* Closed fracture
* Injury within 24 hours of presentation
* Skeletally mature
* Able to provide consent to participate in study

Exclusion Criteria:

* Any concomitant injuries affecting Numerical Rating Scale
* Soft tissue wounds at aspiration sites that compromise ability to aspirate
* Patient not able to complete pain medication log
* Patient not able to participate in follow up
Anti-PD-1 Antibody Plus Regorafenib in Refractory Microsatellite Stable Metastatic Colorectal Cancer

Managements for refractory proficient mismatch repair (pMMR) or microsatellite stable (MSS) metastatic colorectal cancer (mCRC) were still challenging and controversial. Our study sought to investigate the efficacy and safety of anti-PD-1 antibodies plus regorafenib in refractory pMMR/MSS mCRC between July 2019 and June 2021 at the Hunan Cancer Hospital.

We retrospectively analyzed the efficacy and safety of 103 pMMR/MSS mCRC patients treated with at least one dose of anti-PD-1 antibodies plus regorafenib (80 mg once daily for 21 days on/7 days off 28 days as a cycle) between July 2019 and June 2021 at the Hunan Cancer Hospital. All patients had previously received at least second-line treatment. The patients were evaluated by computed tomography every 2 or 3 treatment cycles until progression or being lost to follow-up. The primary end point was overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* 1.Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).

  2. Have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for RAS wild-type).

  3.Has measurable or non-measurable disease as defined by RECIST version 1.1 4.Is able to swallow oral tablets. 5.Estimated life expectancy ≥12 weeks. 6.Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 7. Has adequate organ function.

Exclusion Criteria:

* 1.Pregnancy, lactating female or possibility of becoming pregnant during the study.

  2.Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).

  3.Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.

  4.Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction

The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to traditional pain management techniques which rely almost exclusively on opioid analgesics and sedatives like diazepam (valium). This expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will produce muscle relaxation, the combination of which will target different sites of pain generation, thus producing better analgesia. We also hypothesize that additional benefits may accrue from this regimen including decreased nausea and vomiting, sedation and constipation as a result of diminished opioid use1.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing immediate unilateral or bilateral tissue expander breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy requiring postoperative expansions
* Women undergoing immediate bilateral tissue expanders breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy requiring postoperative tissue expansions.

Exclusion Criteria:

* Subjects who are unable to read or speak English;
* Breast reconstruction using the latissimus dorsi flap combined with a tissue expander;
* Documented diagnosis of chronic pain, chronic migraine, upper limb spasticity, cervical dystonia, axillary hyperhidrosis, strabismus or blepharospasm;
* Hypersensitivity to any botulinum toxin (BT) preparation or to any of the components in the formulation;
* Infection at the proposed site of injection;
* Pre-existing neuromuscular disorders (including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis);
* Aminoglycosides intake at the time of surgery (these antibiotics can potentiate the effect of BT);
* Women who are pregnant or breast feeding.
Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel

The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.

This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of BACMUNE (MV130) in the prevention of disease due to SARS-VoC-2 infection in healthcare personnel

Eligibility Criteria:
Inclusion Criteria:

* Health personnel who are or have been in contact with patients with disease due to SARS-COV-2 infection within the last 14 days before randomization.
* Negative result for test against COVID-19.
* Subjects who have given informed consent.
* Men or women aged between 18 and 65 years, both included.
* Subjects who have a smartphone where they can load an APP for monitoring the symptoms.

Exclusion Criteria:

* Subjects who are participating in another clinical trial.
* Subjects who are unable to offer cooperation and/or have serious psychiatric disorders.
* Subjects who are allergic to any of the compounds included into MV130.
* Subjects who present contraindications to any of the components of BACMUNE (MV130).
* Subjects who are not able to comply with the dosage regimen.
* Subjects with immunodeficiencies.
* Subjects with malignancy involving the bone marrow or lymphoid systems.
* Pregnant or suspected pregnant women and breastfeeding women.
* Subjects in medical treatment that affects the response of the immune system. It includes corticosteroids (equal to or more than 20 mg for more than 2 weeks), immunosuppressants, biological agents (such as anti TNF-alpha monoclonal antibodies, etc.).
* Subjects with HIV.
* Subjects under treatment with metformin.
* Subjects treated with Sertraline.
* Subjects treated with statins.
Therapeutic Effects of Customized Insoles on Children With Flat Foot

Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch-support shoe insoles to children with flat foot.

A total of 52 children with flat foot will be collected. The participants will be randomized into two groups, including study group (insoles group) and control group (without insole group).

All participants in the insoles group will be evaluated at baseline, that is before the customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, balance, physical activity, functional performance, and quality of life will be re-evaluated up to 12 weeks after shoe insoles wearing in the insoles group.

The control group will be evaluated at the baseline and up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* flat foot

Exclusion Criteria:

* age less than 3 years old or older than 10 years old
* pathological flat foot
Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study

Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies.

During the past two decade, the introduction of protocols for prophylactic antibiotics for women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for 1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the morbidity and mortality at Sheba medical center in the last 12 years in children with positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is less then expected. If proven right, we would then check the reasons for that outcome considering the type and length of treatment and the different virulence of the streptococcus.

This is a retrospective case control study. We will review from archive the charts of all the neonates with positive blood culture for GBS, reviewing the course and severity of their illness.

Eligibility Criteria:
Inclusion Criteria:

* GBS positive blood culture neonate and preterm babies

Exclusion Criteria:

* Congenital malformations