cyrilzakka/clinical-trials huggingface dataset:
Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples

The main objective of this study is to develop protocols using FV urine that investigate in vitro whether infectious virions can be neutralized by HPV vaccination.

In total 50 women will be included in this trial whereof 25 fully vaccinated with a prophylactic HPV vaccine and 25 not vaccinated with a prophylactic HPV vaccine. These women will be asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc will be collected. HPV DNA positive women who gave their consent to be contacted with the results, will later be contacted again and asked to provide additional FV urine samples every day during 2 weeks. For this, urine collection devices (Colli-PeeTM, Novosanis) will be provided by postal mail. The collected urine samples (and blood sample as control for HPV antibodies) will be used for the development of protocols within this project.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-25 years of age
* Sexually active or has been sexually active in the past
* Cases (n=25): fully vaccinated women, i.e. receiving all necessary doses of the HPV vaccine (according to the KCE recommendations) able to prove their vaccination (brand and schedule) with an official document.
* Control group (n=25): women self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available.
* Willing to give informed consent to the CEV research team.
* Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF)

Exclusion Criteria:

* Women participating in another clinical study at the same time of this study.
* Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
Effect of Morning Snack on Cognitive Performance in Adults

To characterize the effects of three chocolate snacks on cognitive performance, subjective appetite, food intake control, and glycemic response in normal weight adults.

On 4 separate mornings, 7 days apart, 12 hours after an overnight fast, and 3 hours after a standardized breakfast of a cereal bar, orange juice and fruit cup, participants will consume isocaloric snacks of white chocolate, 2 types of dark chocolate or control (water), followed by an ad libitum pizza lunch 90 minutes later. Upon arrival, at baseline (0 minutes), participants will be asked to complete the motivation-to-eat, global vigor and subjective emotion visual analogue scales (VAS), a battery of cognitive performance tasks and have blood samples taken, as reported and validated in our previous studies. Over the 90 minute testing period, blood samples will be taken,the VAS questions will be completed and cognitive tasks will be completed. Cognitive performance assessments will include learning and memory, spatial memory, attention and processing speed, and executive functions. VAS measuring physical comfort is completed pre- and post-meal. Ad libitum food intake from a test meal will be measured.

Eligibility Criteria:
Inclusion Criteria:

* be between 18 and 35 years of age
* be healthy and have a have body mass index (BMI) between 18.5 and 24.9
* not be taking any medications, not smoking, and
* not have allergies to chocolate, dairy or gluten
* be tested during the early follicular phase of their menstrual cycle for women

Exclusion Criteria:

* anyone with food sensitivities or allergies to chocolate, dairy or gluten,
* smokers
* diabetic or overweight/obese individuals.
* Restrained eating habits, defined as scoring greater than 11 points on the eating habits questionnaire
Fetal Growth Restriction: Management Using Two Guidelines - Fetal Growth Antenatal Management Evaluation

The purpose of this study is to compare the composite neonatal adverse outcomes (CNAO) among pregnancies complicated by fetal growth restriction (FGR) managed using the Society of Maternal-Fetal Medicine (SMFM) versus International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) antepartum ultrasound guidelines, to measure the rate of the individual components of CNAO, to record the rate of cesarean delivery during labor, to tabulate the rate of deviation from the management protocol assigned at the time of evaluation, to record neonatal intensive care unit (NICU) admission rates and to measure the rate of the composite maternal adverse outcome (CMAO).


Eligibility Criteria:
Inclusion Criteria:

* FGR diagnosed during sonographic examinations
* estimated fetal weight less than or a fetal abdominal circumference less than the 10th percentile

Exclusion Criteria:

* Multiple gestations with FGR
Treatment of Urinary Stress Incontinence During or Following Correction of Pelvic Organ Prolapse

The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of women who underwent a surgical correction of POP may occur post-surgical urinary incontinence and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical intervention may be required. At this proposal, with the aim to reduce the incidence of postoperative urinary incontinence, the addition of a preventive continence procedure to a POP repair intervention has been widely proposed, but the potential benefits needs to be balanced against potential disadvantages.

Based on these considerations, the aim of this trial will be to compare two different surgical strategies for women with POP without urinary stress incontinence. Specifically, the efficacy to associate and to follow a preventive continence procedure to the correction of POP will be compared.

Women with POP not associated to urinary stress incontinence will be enrolled and randomized in two arms(groups A and B). Patients of group A will be treated with unique surgery (correction of POP plus preventive continence procedure), whereas in patients of group B POP will be surgically corrected and, in case of stress or mixed postoperative incontinence, a further intervention for urinary stress incontinence will be tailored.

All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Pelvic organ prolapse stage 2-3
* Absence of subjective urinary stress incontinence

Exclusion Criteria:

* pregnancy
* \<12 months postpartum
* systemic disease known to affect bladder function
* current chemotherapy or radiation therapy
* urethral diverticulum, augmentation cytoplasty, or artificial sphincter
* recent pelvic surgery
* patient age under 18 and over 80
* any previous pelvic surgery, diabetes mellitus and collagen disease
Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation

The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation, and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled iloprost has been researched in animal study, but not yet in human during one-lung ventilation. The investigators will enroll patients who diagnosed moderate to severe chronic obstructive pulmonary disease, preoperative pulse oximetry (SpO2) of below 95% at room air or PaO2 /FiO2 ratio\< 150 mmHg after initiating one-lung ventilation. The primary outcome is pulmonary oxygenation expressed by PaO2 /FiO2 ratio. And secondary outcome is assessment of cardiac function including Tei-index during nebulizing iloprost. The investigators hypothesized inhaled iloprost will improve oxygenation and decrease the FiO2 in chronic obstructive pulmonary disease during one-lung ventilation.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic obstructive pulmonary disease was defined as FEV1/FVC ratio \< 0.7 and an FEV 1 of 80% or less after inhalation bronchodilator : 1. Above 40 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status II, III.
3. Preoperative SpO2 95 % or less at room air (spontaneous ventilation) or 4. PaO2 /FiO2 ratio\< 150 mmHg after initiating one-lung ventilation

Exclusion Criteria:

1. Severe functional liver or kidney disease
2. Diagnosed HF (LV ejection fraction \<50% , or wall motion abnormality)
3. Arrhythmia or received treatment with antiarrythmic drug .
4. Severe bradycardia(HR \< 45 bpm) and AV block 6. pathologic esophageal lesion (esophageal stricture or varix ) 7. pregnancy 8. PaO2 /FiO2 ratio ≥ 150 mmHg after initiating one-lung ventilation
Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin

This study is designed to determine whether the combination treatment of Paclitaxel and Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than Paclitaxel alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age.
* Histologically documented diagnosis of epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, of any stage or grade at diagnosis. \*Patients must have received initial cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen.

  \*Eligible platinum resistant patients will have failed no more than two additional non platinum cytotoxic regimens for their persistent or recurrent disease.
* Measurable disease.
* Performance status 0, 1, 2 (Eastern Cooperative Oncology Group) .
* Adequate end organ function, defined as the following: total bilirubin \< 1.5 x upper limit of normal (ULN), SGOT and SGPT \< 2.5 x UNL, creatinine \< 1.5 x ULN, ANC \> 1.0 x 10E9/L, platelets \> 100 x 10E9/L.
* Written, voluntary informed consent.

Exclusion Criteria:

* Patient has received any other anticancer treatment within 21 days of first day of study drug dosing and shown recovery of any recent drug-induced neutropenia and thrombocytopenia.
* Patient has another primary malignancy that has required active intervention within 5 years, with the exception of basal cell skin cancer or a cervical carcinoma in situ.
* Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
* Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
* Patients on coumadin-derived anticoagulants.
* Patient with brain metastasis.
* Chronic liver disease, Hep B or C.
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
* Patient received chemotherapy within 3 weeks -unless the disease is rapidly progressing.
* Patient previously received radiotherapy to at least 25 % of the bone marrow.
* Patient had a major surgery within 2 weeks prior to study entry.
* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
* Patient is on any drug that may interfere with Gleevec (e.g., Dilantin, Coumadin,or others on the list on page 33-37 of the protocol).
The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease

The effectiveness of Bottle PEP in patients with Chronic Obstructive Pulmonary Disease


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD
* Stable Disease

Exclusion Criteria:

* Neuromuscular disease
* Recent pneumothorax
* Major surgery in the last 6 months
Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries

General anesthesia organizes the best option for controlled blood pressure during rhinoplasty surgery. The primary agent applied in controlling hypotension should have particular unique characteristics. The dexmedetomidine central and peripheral sympatholytic performance is usually indicated by low blood pressure and low heart rate. magnesium sulfate is among the best agents used.

This is a prospective comparative randomized study. 56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality. The amount of blood loss during the entire process was measured. The score of pain was evaluated using the NRS rating scale. Sedation score through Ramsey sedation score. The time required for the first requirement of analgesia was also recorded as well as intraoperative and postoperative problems.

Eligibility Criteria:
Inclusion Criteria:

1. 18-60 years old
2. ASA (American Society of Anesthesiologists) grading I and II
3. patients undergo rhinoplasty surgery under general anesthesia

Exclusion Criteria:

1. The pregnant ladies
2. patients suffering from hypertension ischemic heart diseases renal insufficiency, neuromuscular diseases, hepatic impairment
3. cerebrovascular inadequacy and diabetic neuropathy, coagulopathies,
4. patients taking antiplatelets
5. Refused study,
6. patients of age \< 18 or \> 60 were unauthorized from the study.
The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma

The clinical trial was designed to determine the efficacy (sensitivity and specificity) of the IUrisure test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of urothelial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with high suspicion/confirmed urothelial carcinoma by CT, CTU, MR and other imaging examinations and meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
2. Patients with highly suspected/confirmed recurrence of urothelial carcinoma who meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
3. The patient agrees to participate in this study and has signed the informed consent form.

Exclusion Criteria:

* (1) Patients with urothelial carcinoma combined with other malignant tumors; (2) Patients with a history of other non-urothelial carcinoma cancers; (3) Samples that are not urothelial carcinoma in surgical pathology; (4) Samples of Ta/low-grade urothelial carcinoma shown by surgical pathology.
The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus

The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance that is first identified during pregnancy, excluding diabetic patients diagnosed before pregnancy. The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus.

Eligibility Criteria:
Inclusion Criteria:

* women with gestational diabetes
* 18-45 years old
* 24-28 weeks gestation of pregnancy
* singleton pregnancy
* BMI≥18kg/m2

Exclusion Criteria:

* pregestational type 1 or 2 diabetes mellitus
* aged \<18 or \>45 years
* BMI\<18kg/m2
* multiple pregnancy
* Cushing's syndrome/ using exogenous steroids
* chronic infection ( HIV, Hepatitis B/C, Tuberculosis)
* any active chronic systemic disease ( except essential hypertension)
* Severe liver and kidney dysfunction
GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer

Prostate cancer is one of the most common malignancies affecting men all over the World. Metastatic prostate cancer responds to androgen deprivation for a variable period (20-25 months). Prostate cancer that grows despite castrate levels of testosterone and that no longer responds to any form of hormonal manipulation is defined as castrate resistant prostate cancer (CRPC).

Docetaxel combined with prednisolone has been shown to not only improve QOL and PSA response in CRPC, but also extend the overall survival1. However, the efficacy of the drug has not been universally effective, and nearly all patients have disease progression after docetaxel treatment.

After failure of a docetaxel regimen, With the exception of cabazitaxel or abiraterone, which are not widely and easily availabe in Korea, little treatment regimen can be applied to the patients with reasonable response and benefits.

Gemcitabine is a nucleoside analog with activity against a broad spectrum of solid tumors. When gemcitabine is used as first-line therapy for CRPC, disease control rate was 33% with median duration of 7.1 months. When it is combined with prednisone and zoledronic acid in pretreated patients with CRPC, the PSA response rate was 23% with a disease control rate of 57% in patients with measurable disease.

Oxaliplatin is newer platinum agent that has favorable toxicity profile and evidence of activity in cisplatin-resistant cell lines. Droz et al. performed a multicenter phase II study in 54 patients with metastatic CRPC who were randomized to receive oxaliplatin either alone or with 5-FU. More than 50% of the patients had received prior chemotherapy including cisplatin. Despite heavy pretreatment, PSA desclines were noted in 11% and 19% of patients in each arm.

Gemcitabine plus oxaliplatin combination was widely studied and has been reported to be safe and effective in various cancers.

This study is to assess the efficacy and safety of GEMOX in docetaxel-refractory CRPC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Clinical or radiologic evidence of metastatic disease
* Documented disease progression during hormone therapy (ADT plus antiandrogen) and no response to ADT withdrawal
* Docetaxel-refractory disease defined as disease progression documented either during treatment of within 60 days after the cessation of treatment with docetaxel
* Prior exposure to estramustine or mitoxantrone is allowed
* KPS ≥ 60
* No prior radioisotope therapy
* No prior radiotherapy 25% or more of the bone marrow
* No peripheral neuropathy grade 2 or worse
* Adequate organ and bone marrow function

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Presence or history of CNS metastasis
* Other serious illness or medical conditions
Pediatric Prospective Personalized Immune and Target Identification Trial

PPROSPERITIT is a prospective clinical study assessing the use of comprehensive molecular profiling to define the best matching targeted and immune treatment for relapsed, refractory or very high risk pediatric CNS tumors.

PPROSPERITIT will identify specific molecular changes by using genomic sequencing technologies in refractory/recurrent or very high-risk pediatric CNS tumors. The study will employ an analytically validated comparison of a selection of targeted agents/immune therapies on the basis of commercially available comprehensive genomic profiling FoundationOneHeme panel (F1Heme, comprising DNA and RNA analysis) vs selection of agents based on more complex DNA/RNA/Protein based analyses. This will be coupled to a computer algorithm that uses preexisting definitions and prioritization of target-agent pairs to assign patients by actionable mutation results to a targeted treatment. The selection of targeted agents will be performed by a multidisciplinary molecular tumor board, but the recommended treatment will not be a part of the PPROSPERTIT study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient Informed consent form must be appropriately obtained under the applicable local and regulatory requirements. Each patient must sign a consent form prior the enrollment to document their willingness to participate.
2. The subject is male or female, aged 1 - 19 years
3. The subject must have a histologically proven recurrent/ refractory or very high-risk CNS tumors
4. Patients must be in good overall physical condition, which allows tumor biopsy
5. Patients must have a life expectancy of at least 3 months.
6. Patients must have a tumor amenable to image-guided or direct vision biopsy and be willing and able to undergo a tumor biopsy and/or blood taking for molecular profiling.
7. Patients must be accessible for follow-up.

Exclusion Criteria:

1. Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
2. Pregnant and/or breastfeeding women, if applicable
3. No intention to treat the patient.
Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics

Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear.

This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life.

In China, the annual incidence of ischemic stroke is estimated to be between 2.5 to 3 million cases, making it the leading cause of death and disability among the population. Among these cases, cervical artery stenosis is a significant independent risk factor for ischemic stroke. Approximately 50% of patients with cervical artery stenosis are prone to develop vascular-related cognitive impairment due to cerebral hypoperfusion, severely affecting human health and quality of life.

There are currently two main surgical approaches for treating severe cervical artery stenosis: carotid endarterectomy (CEA) and carotid artery stenting (CAS). The effects of these two surgical methods on preoperative and postoperative intracranial and extracranial hemodynamic changes, the mechanisms underlying perioperative complications, the establishment of collateral circulation, and long-term prognosis remain unclear. Therefore, researching perioperative risk assessment and clinical efficacy of different surgical approaches is of great significance for patient outcomes.

This project aims to collect multimodal imaging data from patients with cervical artery stenosis, including brain CT perfusion imaging and CT angiography. Using artificial intelligence algorithms, three-dimensional models of cervical artery stenosis will be reconstructed, and computational fluid dynamics will be employed to automatically or semi-automatically analyze the hemodynamic characteristics of patients' carotid arteries. By monitoring cerebral blood flow velocity, local cerebral oxygen metabolism, and assessing postoperative stroke, ischemia-reperfusion injury, and collateral circulation both intracranially and extracranially, precise evaluations will be conducted.

Based on individual patient characteristics, the surgical approach can be optimized to prevent cerebral ischemia-reperfusion injury, improve clinical prognosis, and enhance the quality of life for patients.

Eligibility Criteria:
Inclusion Criteria:

1) Clinical diagnosis of carotid stenosis.

Exclusion Criteria:

1. Vascular stenosis with vascular malformations.
2. Aneurysm.
3. Severe heart, liver, or kidney disease.