cyrilzakka/clinical-trials huggingface dataset:
Effects of Different Concentrations of Pressurized-heparin Flushing Fluid on Coagulation and Platelet Function Monitored by the Sonoclot Analyzer

Heparin diluent or normal saline is generally used as the arterial tube flushing in clinical practice, but there is no consensus on the choice of flushing fluid. Heparin can affect the blood coagulation function, and even lead to heparin-related thrombocytopenia, increasing the risk of perioperative embolism. Sonoclot is a blood viscoelasticity test, which can provide comprehensive information on the coagulation's cascade and the entire process and be quicker and more effective than routine laboratory coagulation tests. In this research, the coagulation and platelet function analyzer called Sonoclot is used to evaluate the effect of different concentrations of pressurized heparin on the coagulation and platelet function of perioperative patients, which can provide a reference for the clinical choice of appropriate arterial flushing.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gastrointestinal cancer
* Ages ranged from 18 to 75
* ASA I\~III

Exclusion Criteria:

* Pregnancy
* modified Allen Test negative
* history of taking anti-platelet drugs such as aspirin one week before surgery, heparin allergy and thrombotherapy
* two failed catheterizations of the same artery
* significant diseases in liver and kidney function
* refusal of patients
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR

Performance evaluation of QIAstat-Dx cUTI Plus AMR Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment

The objective of the study is to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment.

The primary objective is to evaluate the performance of QIAstat-Dx cUTI Plus AMR Panel in comparison with the results obtained from the reference method.

The secondary objective of the study is to evaluate the safety ofQIAstat-Dx cUTI Plus AMR Panel with respect to users/operators.

The primary study endpoint will be the results for each analyte obtained from testing prospective specimens with QIAstat-Dx cUTI Plus AMR Panel and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined

Eligibility Criteria:
Inclusion Criteria:

* Specimens from subjects of all ages and demographic characteristics can be enrolled.

  * Specimen must come from patients with suspected cUTI by their healthcare provider:
  * Urine specimen with evidence of pyuria confirmed by positive urine analysis (Dipstick analysis positive for leukocyte esterase or at least 10 White Blood Cells percubic millimeter) And
  * A sign or symptom of a cUTI (for example: chills or rigors or warmth associated with fever, malaise, flank pain or pelvic pain and/or costo-vertebral angle pain or tenderness on physical examination, nausea or vomiting, dysuria, urinary frequency or urinary urgency)
  * Specimen must be residual leftover and de-identified
  * Specimen obtained preserved (containing boric acid, sodium formate or sodium borate) or unpreserved as midstream urine or fresh urine catheter
  * For Preserved Only: Fresh prospectively collected preserved specimens stored to up 48 hours at 15°C-25°C or 24 hours at 2°C-8°C.
  * For Unpreserved Only: Fresh prospectively collected unpreserved specimens stored up to 24 hours at 2°C-8°C.
  * Specimen must have a minimum of 3 ml of urine available.
  * Specimen date of collection and standard of Care testing results should be available.
  * Specimen must be unique (only one sample enrolled per patient).

Exclusion Criteria:

* Specimens enrolled in the study may be excluded for the following reasons:

  * Lack of clear subject identification or label on urine specimen.
  * Specimen has been centrifuged.
  * Obvious physical damage of residual specimen.
Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)

The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic Imunoglobulin A Nephropathy (IgAN) and high risk of progression.


Eligibility Criteria:
Inclusion Criteria

* Age \> 18 years
* Kidney biopsy showing crescentic IgA nephropathy within 6 months of enrolment (MEST-C-score =C1/C2).
* Quantified creatinine clearance \>20 ml/min/1.73m2
* Quantified Proteinuria \> 750 mg/24h based on a 24h urine collection while on maximum tolerated dose of RAS blockade
* Hematuria defined as \>10 RBC/hpf or hemoglobinuria \>1+
* Patients need to be in adequate supportive care (blood pressure \<125/85mmHg, lifestyle advice, and maximum doses tolerable of RAS blockade) at least 4 weeks prior to enrollment
* Patients would receive dietary and lifestyle counseling prior enrollment: low protein (0.8-1.0 g/kg/day) diet, low sodium (2 grams/day) intake, indication for smoke cessation, during the 4 weeks run-in period
* Has signed an informed consent form prior to any study-related procedures
* Patients with documented use of RAS blockade and adequate blood pressure control (\<125/85 mmHg) for ≥4 weeks, can be enrolled in the study and randomized without repeating a 4-week run-in period.

Exclusion Criteria

* Creatinine clearance \<20 ml/min/1.73 m2
* Liver function tests \> 2x upper limit of normal. (Serious cases of hepatotoxicity have been reported in patients with avacopan during first approval and ADVOCATE study (29) (30)
* Severe interstitial fibrosis and tubular atrophy (IFTA \> 70% on renal biopsy)
* Active cancer or acute non-controlled infection (including HIV, HBV, HCV)
* Women who are pregnant or breastfeeding
* Immunosuppression treatment:
* Rituximab less than 12 months prior to enrollment
* MMF, CYC, or immunomodulatory agents within 3 months prior to enrollment
* AZA within 3 months prior to enrollment.
* Glucocorticoids \>20 mg/day within 1 month prior to enrollment
* Secondary IgA nephropathy (associated with gastrointestinal diseases, infection, autoimmune, malignancy, respiratory tract, or skin)
* ANCA-associated vasculitis or other vasculitis diagnostic defined by ACR criteria/Chapel Hill Consensus conference
* Contraindication to use any of the protocol treatments (glucocorticoids, avacopan)
* Use of a strong/moderate CYP3A4 inducer
* Initiation of SGLT2 inhibitors is not allowed once patient has been enrolled in the study. Patients who have been on an SGLT2 inhibitor prior to enrollment on the study may continue on this therapy, at the same dose. No dose increase is allowed.
* Active, untreated and/or uncontrolled chronic liver disease (chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis, cirrhosis
* Unable to give written consent form
* As a safety measure patients who are pregnant or lactating will not be enrolled in the study.
Postmenopausal Pessary Users: Estrogen Versus Trimosan

The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy
* Is a new pessary user, or has not had a pessary for a year

Exclusion Criteria:

* Pregnancy
* Persistent Bacterial Vaginosis infection in the first two clinic encounters
* Currently on hormone replacement therapy
* Previously on hormone replacement therapy in the past 6 months
* Currently on antibiotics
* Patients with existing vaginal erosions/ulcerations
Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation

The patients are assigned by randomisation on one of the two laxatives. After cleansing they have to fill in an evaluation form to report their findings and difficulties. Also the surgeon will be asked to fill in a score-form to report all details concerning the bowel preparation.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Older than 18
* Informed consent signed
* Mode of surgery

Exclusion Criteria:

* Renal disease
* Heart failure
* Dehydration
* Abdominal obstruction
* Abdominal perforation
* Abdominal paralysis
* Toxic megacolon
Marginal Zone Lymphoma Cohort in Korea

Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study

Marginal zone lymphoma (MZL) is a distinct subgroup of non-Hodgkin's lymphoma (NHL), which is typically characterized by an indolent clinical course and long survival duration. MZL is responsible for approximately 7\~8% of all NHL. In Korea, MZL accounts for 21% of all B-cell lymphoma and is the second most frequent histologic subtype following diffuse large B-cell lymphoma. Annually, an estimated 500 patients are newly diagnosed with MZL. According to the previous large-scale analyses, MZL is usually a quiet indolent malignancy, which generally presents with limited stage of disease. Localized disease may be controlled with local treatment, and a high response rate can be achieved. Advanced MZL is associated with less favorable survival, and appears to be incurable with the currently available therapy. Transformation to large cell aggressive lymphoma may occur in the first recurrence or in subsequent relapses.

Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study especially related with Rituximab use (ex, Hepatitis B virus (HBV) reactivation)

Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed marginal zone lymphoma
* No history of chemotherapy
* enable to routine staging w/u and sampling including HBV serology
* informed consent

Exclusion Criteria:

* mixed with other type lymphoma
* refuse informed consent
* co-existing cancer needed treatment
* prior organ transplantation
* accompany with immunodeficiency
IFx-Hu2.0 Expanded Access Program

Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options.

To request access, use Responsible Party contact information provided in this record..


Eligibility Criteria:
Inclusion Criteria:

* To request more information use Responsible Party contact information provided in this record

Exclusion Criteria:

* To request more information use Responsible Party contact information provided in this record
Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

Purpose of this study:

To establish the superiority of myomectomy versus Uterine Artery Embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.

Background:

The use of uterine artery embolization (UAE) to treat symptomatic fibroids in women seeking future fertility remains a matter of debate, because of possible adverse effects on ovarian reserve and embryo implantation. In women with associated infertility factors, not eligible for myomectomy, poor fertility was obtained after UAE. On the other hand, fertility of women eligible for surgical myomectomy, deciding to have a UAE, compares favourably with the fertility obtained after myomectomy.

Study design:

Eligible women will be explored to pull out any other infertility factors such as:

* tubal factors (no hydrosalpinx at MRI, tubal permeability assessed by hysterosalpingography and/or negative serology of for Chlamydia)
* Endometriosis (clinical history and examination, MRI)
* Ovarian factors (normal AMH dosage, and Antral follicular count)
* Male factors (normal spermogram of the Partner if possible)

Women will be treated with fertility sparing ultra selective uterine artery embolization, or surgical removal of multiple myomas.

A six months convalescence/cicatrisation period will be respected, then women will be allowed to intend to conceive.

Several elements will be prospectively followed:

* Spontaneous pregnancy from 6 months to 18 months after treatment
* Pregnancy outcomes
* Symptoms and quality of live with UFS-QoL and WHQ questionnaires, at 3, 6, 12 and 18 months after treatment
* Uterine size with MRI, before and 3 months after treatment.
* Aspect of the uterine cavity with hysteroscopy before and 3 months after treatment.
* Ovarian reserve with AMH dosage, and Antral follicular count before and 3 months after treatment.
* Volume and molecular pattern of the endometrium at the implantation window before and 3 months after treatment (optional).
* Treatment's adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 and ≤ 43 years old
* At least one interstitial fibroid more than 3 cm on MRIat MRI)
* with symptoms: genital bleeding, chronic pelvic pain or heaviness, anemia, or infertility \> 1 year.
* With immediate desire to conceive
* without assisted reproductive indication: no tubal infertility, menstrual irregularities, hydrosalpinx, endometriosis, adenomyosis, or male infertility.
* Patient with health insurance, who can read and understand French and who has given written consent

Exclusion Criteria:

* Ongoing regnancy
* Emergency Situation
* Contraindication to surgery or uterine embolization: allergy to contrast medium , renal failure, immunodeficiency, contraindication to anesthesia, subserosal or submucosal pedunculated fibroids, fibroids with largest diameter inside of the uterine cavity
MEDECA - Markers in Early Detection of Cancer

Early diagnosis of cancer is key for improving patient outcomes, but cancers are difficult to diagnose if patients present with unspecific symptoms. The principal objective of the MEDECA (Markers in Early Detection of Cancer) study is to identify a multi-analyte blood test that can detect and map occult cancer within a mixed population of patients presenting with serious but unspecific symptoms. The study will include 1500 patients referred to the Diagnostic Center at Danderyd Hospital (DC DS), a multidisciplinary diagnostic center referral pathway for patients with radiological findings suggestive of metastasis without known primary tumor or suspicion of serious but unspecific symptoms. Blood samples are collected prior to a standardized and extensive cancer diagnostic work-up, including an expanded panel of biochemical analyses and extensive imaging such as computed tomography or magnetic resonance investigations. In collaboration with world-leading international scientists, the blood samples will be analyzed for a panel of novel and established blood biomarkers predictive of an underlying cancer, including markers of neutrophil extracellular traps, circulating tumor DNA, platelet mRNA profiling, affinity-based proteomics and nuclear magnetic resonance metabolomics. The diagnostic accuracy of the blood biomarkers with respect to cancer detection during the diagnostic work-up will be analyzed through machine learning.


Eligibility Criteria:
Inclusion Criteria:

- Age above 18 years

One or more of the following symptoms/clinical signs:

* General malaise
* Severe tiredness
* Unintentional weight loss
* Fever of unknown cause
* Uncharacteristic pain for \>4 weeks
* Abnormal laboratory tests (e.g., anemia, elevated alkaline phosphatase levels, erythrocyte sedimentation rate (ESR), calcium etc.)
* Diffuse pain without explanation
* Marked increase in drug usage
* Increasing health service seeking behavior
* Radiological findings suggestive of metastasis without known primary tumor or suspicion

Exclusion Criteria:

* Unwillingness to participate in the study
* Age below 18 years
Comparison of Postoperative Analgesic Efficacy of SPSIPB and Combination of IBPB and SCPB

Shoulder arthroscopy is one of the frequently performed surgical procedures today. After shoulder surgery, ensuring sufficent analgesia is necessary for both the patient's comfort and for the early and regular performance of the required postoperative rehabilitation exercises. Nerve blocks provide better pain control, opioid consumption in the postoperative period, and consequently have advantages such as fewer side effects and lower risks of pulmonary and cardiac complications. Multimodal analgesia approach is preferred for patients undergoing shoulder arthroscopy. Along with intravenous analgesic agents, peripheral nerve blocks (applied to every suitable and consenting patient) are performed based on patient preference. This study aims to compare the analgesic efficacy in the postoperative period of patients undergoing shoulder arthroscopy with a combination of interscalene brachial plexus block and superficial cervical plexus block with serratus posterior superior intercostal plane block.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* Body mass index 18 to 30 kg/m2
* Elective shoulder arthroscopy surgery

Exclusion Criteria:

* Under 18 and over 65
* ASA score IV and above
* Advanced co-morbidity
* History of bleeding diathesis
* BMI under 18 kg/m2 and over 30 kg/m2
* Patient refusing the procedure
* Patients who have previously undergone shoulder surgery
* Chronic opioid or analgesic use
* Patients who will operate under emergency conditions
* Patients who will not undergo shoulder surgery
Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer

A prospective, single-centre, proof-of-concept pilot study in patients with metastatic breast cancers (MBC) (whatever the immunohistochemical subtype) treated at the IUCT-O. Eligible patients will be selected and informed of this study during a medical consultation for cancer that has metastasised, has relapsed or is progressing metastatically, by medical oncologists at the Oncopole Claudius Regaud (OCR). Then, with the patient's agreement and before the start of anti-tumour treatment, a blood sample will be taken to detect DP-circulating cells. A breast cancer tumour sample (non-bone metastasis or, failing that, primary tumour) must be available (FFPE archived tumour block).

Each patient will participate in the study for one day.

60 patients will be included in this interventional study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic breast cancer eligible for 1st, 2nd or 3rd line treatment at stage IV, regardless of immunohistochemical subtype (triple-negative, RH+/HER2-negative or HER2-positive).
2. Patient with metastatic disease or metastatic relapse or progression who has not yet started 1st line treatment for metastatic disease or line 2 or line 3.
3. Tumour sample available (archived tumour block): non-bone metastasis preferred if available or, failing this, primary breast tumour.
4. Age ≥ 18 years and WHO ≤ 2.
5. Patient affiliated to a French Social Security scheme.
6. Patient having signed his/her informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria:

1. Associated pathology(ies) likely to prevent the study procedure from running smoothly.
2. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and/or procedures set out in the study protocol.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
4. Patient who has presented with another solid tumour (excluding carcinoma in situ of the breast or cervix) within 5 years.
5. Pregnant patient.
Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe

The study will be conducted to evaluate the effect of the vibration assisted syringe on pain perception and anxiety in children during intra oral injection of local anesthesia in comparison with conventional syringe.

As for granted the main concern in pediatric dentistry is to guarantee a positive response from child for any further appointments, that's why we aim to manage a successful dental procedure keeping a stress free situation. Conventional local anesthetic technique is the most commonly used technique for anesthetizing teeth but in turn it has shown the highest levels of discomfort in comparison with other techniques. VibraJect is vibration associated syringe device, it is simple and cost effective solution to alleviate injection discomfort. It works because the light pressure of a Vibraject injection is carried rapidly to the brain by thicker insulated nerve tissues. In contrast, the needle prick travels on thinner nerve tissues, arriving too late for the brain to register the sensation. Vibraject is good news for the patient, because the anesthetic itself causes virtually no discomfort and good news for the dentist, who can work easily knowing that patient, is comfortable.

Eligibility Criteria:
inclusion criteria

1. Cooperative patient. (rating 4 or 3 based on Frankl behavior scale).
2. Children aging from 4 to 6 years
3. Suffering from one or more deep carious lesions in their primary molars.
4. Restorable primary molars

Exclusion Criteria:

1. Medically compromised patients.
2. Uncooperative children (rating 1 or 2 on the Frankl behavior scale) needing special line of treatment through general anesthesia.
3. Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess.
4. Presence of any radiographic signs of abscess, bone loss, internal or external root resorption.
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application

The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application.

Patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (US and EU cohort) and followed-up over the period of 60 months.


Eligibility Criteria:
Key Inclusion Criteria - IP Cohort:

* De-Novo ventral/incisional hernia amenable to repair with GORE® SYNECOR IP Biomaterial
* Clean wound (CDC Wound Class I)
* mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group)

Key Exclusion Criteria - IP Cohort:

- Wound is either clean-contaminated, contaminated or dirty-infected

Key Inclusion Criteria - PRE Cohort:

* De-novo ventral/incisional hernia, with subject anatomy and surgical plan amenable to open surgical repair or minimally invasive surgery with the GORE® SYNECOR PRE Biomaterial placed in a sublay fashion within the preperitoneal space
* Clean wound (CDC Wound Class I)
* mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group)

Key Exclusion Criteria - PRE Cohort:

- Wound is either clean-contaminated, contaminated or dirty-infected