cyrilzakka/clinical-trials huggingface dataset:
Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer

Early single instillation of chemotherapy after TUR is recommended in the European Association of Urology Guidelines. Nevertheless, the procedure is suboptimal for patients with multiple tumors, sometimes is not tolerated and it can results in severe complications. In both laboratory and clinical studies, intravesical electromotive drug administration (EMDA) increases mitomycin-C (MMC) bladder uptake, resulting in an improved clinical efficacy in non-muscle invasive bladder cancer (NMIBC). The investigators will compare the effects of one immediate pre-TUR intravesical EMDA/MMC instillation with one immediate post-TUR intravesical passive diffusion MMC (PD/MMC) instillation and TUR alone in patients with NMIBC.

All eligible patients with primary NMIBC will be randomized into 3 groups who will undergo transurethral resection alone (TUR/alone); TUR plus single immediate postoperative instillation (immediately after TUR) of 40 mg PD/MMC with a dwell time of 60 minutes; or single immediate preoperative instillation (immediately before TUR) of 40 mg EMDA/MMC with 20 mA electric current for 30 minutes. Patients with intermediate and high risk NMIBC will undergo adjuvant intravesical therapy. The primary end points will be the recurrence rate and disease-free interval. All clinical analyses will be performed on an intent to treat basis.


Eligibility Criteria:
Inclusion Criteria:

* All patients with primary histologically proven stage pTa-pT1 transitional-cell carcinoma of the bladder

Exclusion Criteria:

* Previous treatments with bacillus Calmette-Guerin, mitomycin-C, or with any other intravesical cytostatic agent
* Concomitant urothelial tumours of the upper urinary tract
* Previous or concomitant muscle-invasive (ie, stage T2 or higher) transitional-cell carcinoma of the bladder
* Bladder capacity less than 200 ml
* Untreated urinary-tract infection
* Disease of upper urinary tract
* Previous radiotherapy to the pelvis
* Other concurrent chemotherapy
* Treatment with radiotherapy-response or biological-response modifiers
* Other malignant diseases within 5 years of trial registration (except for basal-cell carcinoma)
* Pregnancy or nursing
* And psychological, familial or sociological factors that would preclude study participation
Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma

This Phase III, multicenter, placebo-controlled clinical trial with sequential randomization is designed to evaluate the efficacy and safety of an experimental vaccine composed of hybrid dendritic cells (DCs) for the treatment of glioblastoma. Conducted at the Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP) and the Institute of Biomedical Sciences of the University of São Paulo (ICB/USP), the study is led by Professor José Alexandre Marzagão Barbuto. A multidisciplinary team of researchers specializing in neurosurgery, pathology, hematology, and other fields will contribute to a comprehensive approach.

The trial aims to determine whether the hybrid DC vaccine can increase overall survival in adult patients with glioblastoma who have completed standard treatment, including surgery, chemotherapy, and radiotherapy. Secondary objectives include evaluating progression-free survival, quality of life, immune response, and the safety of the intervention. The study will enroll 186 patients, who will be randomized into three groups: (1) a control group receiving placebo, (2) a group receiving the DC vaccine, and (3) a group receiving the DC vaccine combined with pembrolizumab.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a histological diagnosis of glioblastoma and confirmed IDH status.
* Currently undergoing standard-of-care treatment, which includes surgery, chemotherapy, and radiotherapy.
* Availability of pre-treatment magnetic resonance imaging (MRI).
* Ability to attend clinical follow-ups every 2 months.
* Functional performance score \> 50 at the time of study enrollment.
* Tumor cells capable of expansion in culture.

Exclusion Criteria:

* Patients with any concomitant neoplasm (except basal cell carcinoma).
* Pregnant or breastfeeding individuals.
* Patients with significant medical or surgical conditions as determined by the study team, psychiatric disorders, or those requiring medications or treatments that could interfere with study procedures or the evaluation of the vaccine's safety and efficacy.
* Patients who are HIV-positive, immunosuppressed, and/or have undergone organ transplantation.
* Refusal or inability to provide consent, such as patients with aphasia.
* Participation in any experimental treatment protocols within the 6 months prior to enrollment.
Assessment of the Influence of Cleft Repair on Microcirculation of the Palate

Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.


Eligibility Criteria:
Inclusion Criteria:

* patients with orofacial clefts, who undergo routine cleft repair

Exclusion Criteria:

* missing datasets
* no signed consent for research.
Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)

This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for patients with acute ischaemic stroke in 4.5 hours after stroke onset.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke with symptoms of neurological deficits.
2. Aged 18 to 80 years（including the critical value）.
3. NIH Stroke Scale（NIHSS）scores of 4 to 25（including the critical value）.
4. Treatment within 4.5 hours after stroke onset.
5. The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
6. CT showed negative or signs of early infarction.
7. Informed Consent Form signed by the patients or family (legal representatives) must be provided.

Exclusion Criteria:

1. Patients with premorbid modified Rankin Scale (mRS) score ≥2
2. CT showed multiple infarctions（low density\> 1/3 cerebral hemisphere）.
3. Transient ischemic attack.
4. Epileptic seizure after stroke.
5. Intracranial tumor, arteriovenous malformation and aneurysm.
6. Iatrogenic Stroke.
7. Planned for thrombectomy.
8. Cardioembolism and atrial fibrillation.
9. Myocardial infarction history within 3 months.
10. Severe cerebral trauma or stroke history within 3 months.
11. Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment.
12. Intracranial hemorrhage or subarachnoid hemorrhage on baseline.
13. Active visceral hemorrhage.
14. Patients with intracerebral hemorrhage history.
15. Patients with diabetic retinopathy history.
16. Puncture in 1 week which can not be oppressed.
17. Major surgery or severe trauma within 2 weeks.
18. Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
19. Heparin treatment within 48h and increased APTT is above ULN.
20. Using of oral anticoagulant drugs and PT \>15s or INR \>1.7.
21. High risk of acute hemorrhage include platelet count\<10\^9/L.
22. Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination.
23. Blood glucose \< 2.7 mmol/L or \> 22.2 mmol/L.
24. Pregnancy, lactating or menstrual women.
25. The investigator believes that the patient is not suitable for the study.
Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age at least 18 years at the time of signing informed consent.
* Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
* HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
* BMI: 25.0 - 40.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Simultaneous participation in any other clinical trial of an investigational medicinal product
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
* History of pancreatitis (acute or chronic)
* Screening calcitonin above or equal to 50 ng/L
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
* Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)
* Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
* Currently planned coronary, carotid or peripheral artery revascularisation
* Patients presently classified as being in New York Heart Association (NYHA) Class III or IV
Capsulotomy YAG Laser

Study of refractive changes after capsulotomy with YAG laser in facectomized patients.

A retrospective, quantitative study was carried out by analyzing the medical records of a reference ophthalmologic hospital in Goiás. Data from the pre and post YAG laser refractive index data were collected from 67 eyes of 66 patients analyzed in the period from May to November 2016.

We studied 67 eyes of 66 patients , both men and women , and 32 ( 47,7%) underwent myopia after the capsulotomy procedure with YAG laser and 25 ( 37.3%) hypermetropization and 10 (14.9%) maintained the refraction. The difference in refraction was found by the arithmetic mean of the spherical equivalent for the precapsulotomy procedure of -28.85D and post-capsulotomy of -31.75 D , giving a difference of -2.9 .

It was concluded with this study that the use of posterior capsulotomy with YAG laser post facectomy caused changes in the refraction of the patients studied, presenting myopia with greater frequency in the results. With these data, we observed the need for other future studies with a large number of eyes to prove what happened in this study.

Eligibility Criteria:
Inclusion Criteria: Complete data information about refraction and the date of the YAG laser -

Exclusion Criteria: Incomplete data

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Quantifying Physical and Biochemical Factors That Contribute to Primary Graft Dysfunction After Lung Transplantation

Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. Its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion Medical Systems) that also provides a physical estimate of pulmonary vascular permeability (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying physical and biochemical markers of PGD and assess their diagnosis and prognosis values.


Eligibility Criteria:
Inclusion Criteria:

* Lung transplant recipient
* Age \> 18 years
* Signed informed consent
* Social security affiliation

Exclusion Criteria:

* Age\<18
* Pregnancy or lactation
* Contraindication to femoral arterial catheterization
* Patient refusal
A Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Voluneteers

The purpose of this study is to determine the effects of NGX426 on intradermal capsaicin induced pain in hyperalgesia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, age 21-55

Exclusion Criteria:

* Allergy to study drug
Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy

The aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy.

The primary outcomes:

1. Ease of parenteral separation.
2. The compliance to anesthesia induction in pediatric patients.

The secondary outcomes:

1. Assessment of postoperative pain.
2. Time to first analgesic request.

Eligibility Criteria:
Inclusion Criteria:

1. ASA: class l
2. Sex: male and female
3. Age: from 3 to 10 years old
4. Children scheduled for adenotonsillectomy

Exclusion Criteria:

1. All children with a history of chronic illness, or developmental delay were excluded from the study
2. History of an autoimmune disease
3. Concurrent use of immunosuppressive treatment
4. Sleep disturbances, speech or communication problems
5. allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.
6. hydroxyzine is contraindicated in patients with acute porphyria

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The SPOT-HPV Study

The purpose of this research is to evaluate a new test for oral HPV DNA in saliva ('oral rinse test').

This cross-sectional study will characterize the prevalence of salivary TTMV-HPV DNA among participants with and without HPV-positive throat cancer

Oral HPV infection is common among healthy adult men, but most of these infections resolve spontaneously and only a very small percentage of oral HPV infections turn into HPV-positive throat cancer. This study is trying to understand whether this new oral rinse test detects HPV DNA from infection, cancer cells, or both. If this test is ONLY positive in people WITH cancer, it may be useful for diagnosing HPV-positive throat cancer in the future.

Along with the oral rinse test study participants will complete brief surveys and participants with a positive salivary TTMV-HPV DNA tests may have repeat saliva testing, blood tests and head/neck exam.

It is expected that about 360 people will take part in this research study.

An external laboratory called Naveris is supporting this research study by providing testing for HPV DNA.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years
* Able to provide informed consent
* Either one of the following:

  * Control cohort: Male individuals WITHOUT head and neck tumors that are, or may be, HPV-positive
  * Case cohort: Any individual WITH incident, untreated HPV-positive oropharynx squamous cell carcinoma

Exclusion Criteria:

* Unable to provide informed consent
* Head and neck tumors of non-oropharynx subsites that are or may be HPV-positive, including oral cavity, sinonasal, laryngeal, hypopharyngeal, or nasopharyngeal squamous cell carcinomas
A Study of LY3471851 in Participants With Psoriasis

The main purpose of this study is to learn more about the safety of LY3471851 when given by injection just under the skin to participants with psoriasis. The study will last up to 48 weeks and may include up to 23 visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of psoriasis for at least 6 months
* Have active psoriasis plaques according to study- specific criteria
* Be willing and able to undergo skin biopsies

Exclusion Criteria:

* Have received certain topical medications for psoriasis within 14 days prior to baseline
* Have received certain systemic medications for psoriasis within 4 weeks prior to baseline
* Have received LY3471851 previously
Coronary Atherosclerosis T1-Weighted Characterization (CATCH)

This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed Characterization (CATCH) that will improve the quality and reliability of coronary atherosclerosis evaluation, as well as simplify the scanning process and significantly shorten imaging time compared with conventional imaging methods.

Approximately 100 healthy male/female adult "normals" or "controls" and 40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease will be recruited. All subjects will be asked to undergo either a non-contrast MRI or a contrast-enhanced MRI of the coronary artery depending upon the focus of development at the time of their participation

It is anticipated that healthy volunteers will undergo non-contrast or contrast-enhanced MRI for evaluating the image quality associated with each acquisition module of the developed technique and motion artifact associated with motion compensation strategy. For subjects receiving contrast, a total dose of up to 0.2 mmol/kg of a gadolinium based contrast agent will be injected intravenously provided all the safety requirements are met.

Subjects undergoing a contrast-enhanced MRI will be screened using the standard clinical protocol to determine whether it is safe to administer contrast. If subjects do not qualify for contrast administration, they may be asked to have a research scan without contrast.

Research MRI results will be compared with clinical diagnostic CT and/or invasive imaging studies for patients who have been evaluated with these exams at Cedars-Sinai Medical Center..

Eligibility Criteria:
Inclusion:

* Healthy Volunteers: male or female ≥ 18 years of age with a BMI\<30, with no history of cardiovascular disease
* Patients: Medically stable, male or female ≥ 18 years of age who is have not suspected of having or has been diagnosed with coronary artery disease and undergone stenting or bypass surgery

Exclusion:

* Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.
* Inability to tolerate MR imaging secondary to an inability to hold breath for a short time or have claustrophobia.
* Non-compliant with visit instructions, including following procedure instructions
* Severe allergy to animal dander or animal-instigated asthma
* Specific to gadolinium-based contrast agents: Renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR \<45ml/min) or previous allergic reaction to gadolinium-based contrast agents.\*
* Volunteers who have had four or more prior previous gadolinium contrast scan
Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.

Double-blind, randomized, 6-period cross-over study in 16 healthy subjects. Each patient participates in 6 euglycemic glucose clamp experiments each.

The time interval between the study days is 2 to 28 days. At the clamp visits, subjects are connected to a Biostator (MTB Medizintechnik, Ulm, Germany) and receive an intravenous human insulin infusion (rate of 0.15 mU/kg/min) over the duration of each experiment to prevent a rise in endogenous insulin secretion. After a baseline period of 2 h the trial drug (6, 12, or 24 U of either Insulin Aspart or regular human insulin in random order) are administered s.c. with a syringe into the abdominal wall. Glucose infusion rates (GIR) necessary to keep blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered and recorded by the Biostator every minute for a period of 12 h post-dosing. Blood samples are drawn at regular intervals for the analysis of C-peptide and (depending on the trial drug administered) serum insulin or serum Insulin Aspart concentrations (measured with specific ELISAs).

Eligibility Criteria:
Inclusion criteria:

* Signed informed consent obtained before any trial-related activities
* Healthy subjects between 18 and 45 years inclusive
* Considered generally healthy upon completion of medical history and physical examination
* Body mass index (BMI) \< 27 kg/m2
* HbA1c \< 6,1 %
* Non-smoker for at least three months
* Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD), the oral contraceptive pill or barrier methods.

Exclusion Criteria:

* Participation in any other clinical trial and receipt of any investigational drug within four weeks prior to this trial
* Previous participation in this trial
* Clinically significant abnormal haematology or biochemistry screening test
* Any disease requiring use of non topical prescription medicines
* Any serious systemic infectious disease that occurred in the four weeks prior to the first dose of test drug
* Any intercurrent illness that may affect blood glucose
* Current addiction to alcohol or substances of abuse as determined by the investigator
* Known or suspected allergy against insulin or any component of the composition of the trial drug
* Blood donation \> 500 ml within the last nine weeks
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* If female, subject is pregnant or lactating