cyrilzakka/clinical-trials huggingface dataset:
Impact of Ultrasound in Obstetric Anesthesia Central Blocks

This study aimed to evaluate the use of ultrasound in obstetric anesthesia, specifically for measuring epidural and intrathecal distances in pregnant women undergoing cesarean section. The relationship between skin-subdural distance (Ultrasound depth) and needle depth was assessed, and the accuracy of ultrasound in determining needle entry site, needle distance, trial attempts, and block success was examined. Additionally, complications such as paresthesia, lower back pain, and postoperative headache were queried and recorded.

Obstetric anesthesia generally posed low risks; however, the difficulty of the procedure and the potential complications increased due to the anatomical and physiological changes associated with pregnancy.

The aim of study was to measure epidural and intrathecal distances in pregnant women undergoing cesarean sections and to evaluate the relationship between the skin-subdural distance (Ultrasound depth) and needle depth. The investigator assessed the accuracy of Ultrasound in determining the needle entry site, needle distance (measured at the site where cerebrospinal fluid flow occurred or where there was a loss of resistance in the epidural space), trial numbers, and block success. Additionally, occurrences of paresthesia and lower back pain during the procedure, as well as postoperative headaches following dural puncture, were queried and recorded.

After obtaining approval from the Ege University Faculty of Medicine Ethical Committee, the study was prospectively conducted in the operating room of the Department of Obstetrics and Gynecology at Ege University Hospital. One hundred pregnant women classified as ASA I-II, between 37-42 gestational weeks, undergoing elective cesarean sections with neuraxial blocks (spinal and/or epidural), were included after obtaining their consent.

Eligibility Criteria:
Inclusion Criteria:

* Patients classified as ASA I-II
* Patients at 37-42 gestational weeks
* Patients scheduled for elective cesarean section under neuraxial block (spinal and/or epidural)

Exclusion Criteria:

* Patients who did not consent to spinal anesthesia
* Patients with contraindications for regional anesthesia (coagulopathy, local or systemic infection)
* Emergency patients
EMPagliflozin After Aortic Valve Replacement

The study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR). After AVR, patients will be randomized 1:1 to empagliflozin (SGLT2i) or placebo to investigate whether empagliflozin is superior to placebo in reducing left ventricular mass and improve symptoms to 6 months.

In this randomized, placebo-controlled, and double-blinded trial we investigate whether empagliflozin (SGLT2i) is superior to placebo in reducing left ventricular mass and improve symptoms.

All patients with AS who are referred to Rigshospitalet for AVR (both surgical and transcatheter approaches) will be screened for in- and exclusion criteria in the medical record based on the Danish Health Act §46 by the PI, co-PI, or a delegated study nurse. If the patient fulfills the inclusion criteria and none of the exclusions criteria, the patient is invited to participate in the study.

Included patients will be randomized 1:1 in blocks of 2, 4, and 6 patients to either Empagliflozin 10 mg daily or placebo. Point of randomization will be in the hospital when the patients has undergone AVR.

The total treatment period is 6 months with either 10 mg Empagliflozin or placebo. The trial participants will receive conventional treatment, which will be carried out irrespective of the inclusion in the trial in accordance with national guidelines. Routine clinical check-ups irrespective of the trial setup will be performed at 3 months after discharge, and study-outcomes will be assessed at discharge, 3 months, and 6 months (eg. echocardiography). Blood samples (including N-Terminal-proBNP, renal function and electrolytes, hemoglobin and HbA1c) will be part of such routine visits as well as a standardized symptom-scoring tool (KCCQ and NYHA classification). Compliance will be evaluated at 1-, 3- and 6-months. The assessment for 1-month will be per telephone and the assessment at 3- and 6-months will be at the routine clinical check-ups in the outpatient clinic.

The CT scan performed in the planning of the procedure will be used for the baseline assessment (before AVR). An identical exam (CT scan) will be performed at 6 months to assess change in LV mass.

Eligibility Criteria:
Inclusion Criteria:

Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days

Exclusion Criteria:

* Prior treatment with a SGLT2i
* Left ventricular ejection fraction \< 45%
* Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min
* Hypersensitivity to empagliflozin or placebo tablet
* Type I Diabetes
* Patients who do not understand Danish or English
* Women who are pregnant or are nursing or plan to become pregnant during trial
A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL

Research purpose： To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design： Single-arm, multicenter, prospective study


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 80 years
2. The histopathological diagnosis was diffuse large B-cell lymphoma, and immunohistochemistry was positive for CD20
3. Previously untreated disease
4. Ann Arbor stage I-IV disease
5. According to Lugano2014 criteria, there must be at least one matching evaluable or measurable lesion: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; For non-lymph node lesions, the measured extra-nodal lesions should be \> 1.0cm in length;
6. ECOG score 0-4(ECOG score 0-2 after pre-treatment and before R-mini-MCOP regimen)
7. Bone marrow function: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80g/L (neutrophil count ≥1.0×109/L, platelet count ≥50×109/L, hemoglobin ≥75 g/L in patients with bone marrow involvement);
8. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion;
9. Have the swallowing power
10. Life expectancy \> 3 months
11. Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF) -

Exclusion Criteria:

1. Previous systemic antitumor therapy (except pre-therapy used before the first cycle of R-CMOP);
2. Metastatic diffuse large B-cell lymphoma；
3. Known central nervous system lymphoma
4. Hypersensitivity to any investigational drug or its ingredients;
5. Uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
6. Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x103 copies /mL; More than 1x103 copies /mL of HCV RNA);
7. Human immunodeficiency virus (HIV) infection (HIV antibody positive);
8. Other serious comorbidities, intolerance to this protocol or inappropriate participation in this study (judged by the investigator)
9. Previous or current co-occurrence of other malignancies (other than non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years);
10. Inability to swallow the drug or any significant removal of the small intestine that may prevent full absorption of the drug;
11. Situations in which other investigators have determined that participation in this study is not appropriate.
Phase II Efficacy Study of AZD6244 in Colorectal Cancer

The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is.


Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer
* require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan
* have World Health Organisation (WHO) performance status 0-2 and life expectancy \> 12 weeks

Exclusion Criteria:

* previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine
* any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study
* nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)

This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed extensive-stage SCLC
* Disease control after the first line platinum/etoposide treatment
* ECOG performance status of 0 or 1
* Measurable disease according to RECIST Version 1.1 criteria
* Adequate bone marrow, liver, and renal function.
* Formalin Fixed Paraffin Embedded (FFPE) or frozen tumor tissue material must be available.
* Resolution of any toxic effects of prior therapy according to NCI CTCAE, v 4.0
* Full recovery from significant complications of the surgery
* If childbearing age, use of double-barrier contraceptive measures, oral or abstaining from sexual intercourse during the study and up to 90 days after the last dose of chemotherapy
* Negative pregnancy test within 72 hours prior to the initiation of study treatment, if of childbearing potential
* Signed informed consent prior to beginning protocol specific procedures
* Patients must be available for treatment and follow-up

Exclusion Criteria:

* Previous therapies with Tivantinib or other known c-MET inhibitor
* Radiotherapy for target lesions and major surgical procedure within 4 weeks, prior to the inclusion in the study
* Palliative radiotherapy within 2 weeks prior to the inclusion in the study
* History of malignancy in the past five years, excluding basal cell the cervix, prostate cancer with a value of prostate-specific antigen \<0.2 ng / mL
* History of cardiac disease
* Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections
* Pregnant or lactating women or childbearing/reproductive potential not using adequate contraception
* Need for breastfeeding during or within 12 weeks of completion of the study
* Gastrointestinal disorders that may interfere with the absorption of Tivantinib
* Inability or unwillingness to swallow the complete doses of Tivantinib
* Any known contraindication to treatment and other significant comorbid conditions which could jeopardize participation in the study
Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar

The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are:

- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture?

Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk.

Participants will:

* Receive fat grafting at time of scar revision.
* Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

Soft-tissue injuries from blasts, burns, or multiple traumas can cause severe damage, leading to loss of function, lower quality of life, long recovery times, and inability to work. When these injuries involve deep burns or full-thickness tissue loss in areas that move a lot, they are especially difficult to treat due to the risk of scarring, stiffness, and tissue sticking together. There is a need for a reliable, single-stage treatment that can provide soft, flexible tissue reconstruction with minimal risk, cost, and, complexity. To address this issue, the investigators propose a fat-based approach to reconstruction. Fat tissue is easily available from the patient's own body and carries many benefits in reconstructive surgery. Our team has shown that using a layer of fat immediately in treatment creates a soft, vascular layer that reduces scarring, improves tissue volume, and supports a one-stage, multi-layer reconstruction without the need for complex surgery or causing harm to the donor area. The purpose of this study is to compare this reconstructive approach under the following conditions:

• Demonstrate non-inferiority of autologous layered composite grafting to full-thickness skin grafting for delayed reconstruction of post-burn/trauma scar contracture.

Evaluators including dedicated observers will be blinded to treatment group/strategy.

Eligibility Criteria:
Inclusion Criteria:

* The proposed study will include adult patients 18 years of age or older,
* male or female,
* civilian, military, active duty or retired veterans
* presenting for scar contracture release and reconstruction at any level.
* Additional inclusion criteria includes willingness to be randomized to receive a fat graft.

Exclusion Criteria:

* Age \< 18 years of age,
* active infection,
* medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety,
* unwilling or unable to comply with study procedures,
* radiation to the site of interest,
* prisoners and/or vulnerable populations.
* In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.
EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Database

This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database.

This study includes all reports identified as exposure to an ICI and suspect of inducing adverse drug reaction.

The aim of the study is to characterize immune-related adverse reactions associated with immune-checkpoint inhibitors, particularly their time-to-onset, co-occurence, factors associate with their over-report and fatality.

Over the past ten years, immuno-oncology (IO) has gradually integrated the therapeutic arsenal of cancer treatment. CTLA-4, program-death 1 (PD1) and its ligand (PD-L1) and LAG3 were found to be major targets active in multiple tumor types. Immune checkpoint inhibitors (ICI) are antibodies blocking these targets and became a cornestone of cancer treatment.

This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database. VigiBase is managed by the Uppsala Monitoring Centre (UMC, Uppsala, Sweden) and contains about 30 million reports (as of Jan 2023) submitted by national pharmacovigilance centers since 1967.

The use of VigiBase® for pharmacovigilance analyses is not dependent on institutional review board approval. It is conditioned on institutional access provided and approved by the Uppsala Monitoring Centre. Since spontaneous reporting systems are based on anonymity and the process only requires patient non-opposition, no informed consent was requested to use VigiBase® in this study.

This study includes all reports associated with an ICI. The query is performed using the Medical Dictionary for Regulatory Activities (MedDRA), between January 1st 2008 (year of first report of ICI in VigiBase), and January 1st 2023. The analysis focused on reports suspected to be induced by an ICI (as opposed to concurrent use).

Eligibility Criteria:
Inclusion Criteria:

* Any report with an ICI "Suspect" or "Interacting" with the reported adverse drug reaction.

Exclusion Criteria:

* ICI not FDA approved
* No irAE identified in report
The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location

The primary aim of this study is to determine if a self-administered semi-quantitative urine pregnancy test and telephone pregnancy symptom questionnaire can reduce the percentage of women with a complete uterine evacuation who require a clinic or lab visit to confirm completion.

The investigators hypothesize that women with complete uterine evacuation will be less likely to require a follow-up clinic or lab visit by using a standardized pregnancy questionnaire and home SQ-UPT, than by using serum hCG as the objective measure of completion.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older with an undesired pregnancy \< 6 weeks gestation
* Women with a positive urine pregnancy test
* Proficiency in English
* Working phone and subject willing to be contacted by phone.
* Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction with assigned follow-up method

Exclusion Criteria:

* Women with presence of a yolk sac or crown rump length visualized on ultrasound
* Women with a gestational sac greater than 13mm \[11\]
* High Suspicion for ectopic pregnancy

  o Sign: Concerning adnexal mass seen on ultrasound in conjunction with pelvic pain and/or vaginal spotting
* Hemodynamic instability

  o Signs: heavy vaginal bleeding, hypotension, tachycardia
* Pelvic Infection

  o Signs: pain or fever
* Medical conditions that contraindicate uterine evacuation according to PPLM clinic policy

  o These include but are not limited to: a bleeding disorder or anticoagulation, significant cardiac disease, renal or liver failure, IUD in situ that cannot be removed
* Unwilling or unable to comply with study follow-up procedures
* Being in a situation where receiving phone calls or additional contact with research staff may endanger the privacy or safety of the subject (e.g. situations of domestic violence or abuse)
* Inability to give informed consent
* Previous participation in this study
Olfactory Training in Various Populations

To date, there is no validated pharmacotherapy for olfactory disorders. Interestingly, olfactory training - the intentional exposure to odorants for the purposes of retraining the sense of smell - has shown success with as many as 28% of subjects over the course of 12 weeks.

Study Objectives: The overall, primary goals of these studies are as follows:

1. To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature
2. To determine if using a larger panel of odorants (our 15 scents versus the 4 scents previously used in the literature) yields a significant difference in olfactory recovery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Quantifiable or subjective olfactory dysfunction
* ability to complete objective olfactory tests and comply with olfactory training protocol

Exclusion Criteria:

* Anyone lower than the age of 18, or greater than the age of 80
* Pregnant women, as sinonasal symptoms and changes in smell can occur in pregnancy and are multifactorial
* Patients with poor or questionable compliance, as participation requires daily compliance with study protocol
* Patient's that are unable to perform routine follow-up
* Patients who are participating in another study during this trial
* Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders, as these conditions are associated with baseline olfactory dysfunction.
* Patients with other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency, as their impact on olfaction is unknown
* Patients who are allergic to any of the smells or components of our olfactory testing and training
Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

There are in excess of 1 million operations performed annually to repair inguinal hernias, mostly in the male population. Unfortunately, some patients continue to suffer both groin or testicular pain for varying lengths of time postoperatively. This can lead to a severe degradation of the patient's lifestyle, work habits and sexual function. The origin of the pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also involves the spermatic cord and its structures, leading to orchidinia and possibly azospermia.

In this prospective randomized trial, male patients with a primary symptomatic unilateral inguinal hernia will be admitted to the trial. All patients must be over 21 years of age. In order to avoid inguinal nerve entrapment or damage by mesh fixation sutures Covidien Parietene ProGrip mesh will be employed. This mesh does not require fixation. Standard open inguinal hernia repair will take place with nerve preservation, as day surgery cases. In the randomized portion of the study, the mesh will be placed as usual along the posterior wall of the inguinal canal, however the inguinal ligament will be interposed between the mesh and the spermatic cord, thus isolating the cord from intimate contact with the mesh, and a reduction in postoperative inflammatory changes.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria:

* Medically unfit for surgical repair
Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient

This is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase III clinical study evaluating the efficacy and safety of ZL-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer (collectively referred to as relapsed ovarian cancer).The evaluation will be divided into two stages: Stage I will be conducted in all patients, and if the predetermined statistically significant difference is not reached, the trial will continue to extend to Stage II during which evaluation will be performed in gBRCA mutation-positive ovarian cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older female.
* High-grade serous or dominantly high-grade serous ovarian cancer
* The subject shall have received two lines of platinum-containing chemotherapy, complete response \[CR\] or partial response \[PR\] after first-line platinum-containing chemotherapy, and after received at least 4 cycles of platinum-containing (must be carboplatin or cisplatin or nedaplatin) in second-line platinum-containing chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Patients who have undergone ascites drainage with the last two cycles of the last chemotherapy regimen prior to enrollment.
* Symptomatic brain metastases or leptomeningeal metastases that have not been controlled.
* Patients who have been diagnosed previously or currently with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).