cyrilzakka/clinical-trials huggingface dataset:
RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC

Renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC) undergoing laparoscopic partial nephrectomy with precise segmental renal artery clamping than those with complete renal arterial clamping.

Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).We hypothesized that renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC) undergoing laparoscopic partial(LPN) nephrectomy with precise segmental renal artery clamping than those with complete renal arterial clamping.

Eligibility Criteria:
Inclusion Criteria:

* 1.Age ≥18 2.Estimated GFR \>30 mL/min/1.73m2 3.Anticipated intraoperative warm ischemic time ≤30 min 4.Subjects who signed informed consent forms

Exclusion Criteria:

1. Allergy to iothalamate, shellfish or iodine
2. Use of metformin or amiodarone
3. intraoperative warm ischemic time \>30 min
4. Inability to maintain a stable regimen of medications which affect GFR for \> one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
5. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
6. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
7. Inadequate intravenous access
8. Severe anemia (Hct \<21%)
9. Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
10. History of contrast-induced nephropathy
11. Hyperthyroidism
12. Pheochromocytoma
13. Sickle cell disease
14. Urinary retention or incontinence
15. Status post organ transplant
16. Pregnancy or active breast feeding
17. Cognitive impairment with inability to give consent
18. Institutionalized status
Water Exchange Versus Carbon Dioxide for Colonoscopy

Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.

Single blinded randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for screening or polyp surveillance colonoscopy
* Patients accepting sedation on demand

Exclusion Criteria:

* Demand for sedation/analgesia before the start of the procedure
* Previous partial or total colonic resection
* Pregnancy
* Unwilling/unable to provide informed consent
Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study

The present study aims at obtaining more in-depth information on how patients with chronic lymphocytic leukemia treated with idelalisib and rituximab react to treatment.

This cohort study will recruit patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab between 01/07/2014 and 31/05/2017 at European centres adhering to the GIMEMA group and the ERIC group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/SLL) according to the World Health Organisation (WHO) classification 2008.
* Treatment with idelalisib and rituximab started between the date of Country marketing authorization approval of idelalisib (EMA approval 18/09/2014) and 31/05/2017 given at European centres adhering to the GIMEMA group and the ERIC group.
* One of the two following conditions must be satisfied:

  * Previously untreated CLL requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)\] with deletion 17p13 and/or TP53 mutation.
  * Relapsed refractory CLL., i.e. patients who received at least one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, or high dose steroids requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)
* Age ≥ 18 years.
* Signed written informed consent, if applicable, according to ICH/EU/GCP and national local law.

Exclusion Criteria:

* Patients with CLL treated with idelalisib within interventional clinical trials or outside the approved indication.
* Patients with:

  * Transformation of CLL to aggressive lymphomas (Richter's Syndrome).
  * HIV infection.
  * Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
Tau PET Imaging in Atypical Dementias

The goal of this study is to demonstrate the feasibility of mapping tau pathology in subjects with Primary Progressive Aphasia, using PET protocol with F-AV-1451 (trade name AV-1451) and to systematically document the extent and location of tau pathology in PPA patients in vivo using the same techniques.


Eligibility Criteria:
Inclusion Criteria:

* Must have primary progressive aphasia

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Receiving radiation clinically
INTRAGO-Intraoperative Radiotherapy for Glioblastoma - a Phase I/II Study

Glioblastoma multiforme (GBM) is a disease with an extremely poor prognosis. Despite surgery and radiochemotherapy, the tumors are likely to grow back very quickly.

Intraoperative radiotherapy (IORT) may improve local control rates while sparing healthy tissue (Giordano et al. 2014). IORT takes place before cranioplasty directly after gross (or subtotal) tumor resection. Several past studies on IORT for GBM conducted in Japan and Spain have yielded encouraging results (Sakai et al. 1989; Matsutani et al. 1994; Fujiwara et al. 1995; Ortiz de Urbina et al. 1995).

However, the full potential of the procedure is to date largely unexplored as most previous studies used forward-scattering (electron-based) irradiation techniques, which frequently led to inadequately covered target volumes. With the advent of the spherically irradiation devices such as the Intrabeam® system (Carl Zeiss Meditec AG, Oberkochen, Germany), even complex cavities can be adequately covered with irradiation during IORT. However, there is no data on the maximum tolerated dose of IORT with low-energy X-rays as generated by this system.

The INTRAGO I/II study aims to find out which dose of a single shot of radiation, delivered intraoperatively direct after surgery, is tolerable for patients with GBM. A secondary goal of the study is to find out whether the procedure may improve survival rates.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed glioblastoma multiforme in frozen sections
* Age ≥50 years
* Karnofsky Performance Index ≥ 50%
* Informed consent
* Adequate birth control (e.g., oral contraceptives)

Exclusion Criteria:

* Astrocytoma ≤ WHO grade III
* Gliomatosis cerebri
* Multifocal lesions
* Infratentorial localization
* Previous cranial radiation therapy (any location)
* Uncontrolled intercurrent illnesses including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
* Contraindications for general anaesthesia
* Bleeding or clotting disorders
* Contraindications for MRI or CT scans
* Pregnant or breastfeeding women
Clinical Efficacy and Safety of Dendritic Cytotoxic Lymphocyte(DC-CTL) Cell Infusion in NSCLC Patients

Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy.

60 patients with stage III-IV NSCLC will be randomly divided into group A (receive DC-CTL treatment with chemotherapy) or group B (Just receive chemotherapy), and the randomize ratio will be 1:1, patients in group A will receive 3 cycles of DC-CTL treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks). Patients in group B will receive only 4 cycles chemotherapy(every 2 weeks).

Eligibility Criteria:
Inclusion Criteria:

* The patient who have signed the informed consent;
* Histologically confirmed with NSCLC at stage III-IV
* Expected survival time is more than 2 month;
* Eastern Cooperative Oncology Group(ECOG) performance status was 0-2

Exclusion Criteria:

* Hemoglobin \<8.0 g/dL, White blood cell \<3 x 10\^9/L; Platelet count \<75 x 10\^9/L; alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN) and Creatinine(CR) more than normal limits on 3.0 times;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* Patients who had used long time or are using immunosuppressant;
* Patients who had active infection;
* Patients who are suffering from serious organ dysfunction;
* Patients who are suffering from other cancer;
* Other situations that the researchers considered unsuitable for this study.
Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer

The primary outcome of the study is to determine if a difference in terms of pregnancy rate exists between direct and afterload embryo transfer (ET) techniques.

The secondary end points include the evaluation of the difficult transfer rates.

The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.

Any blastocysts that underwent preimplantation genetic testing will be excluded from the analysis, as well as embryos derived from gamete donation or those imported from other centers.

Data are gathered using a specific internal web-based database, which allows to organize, store and readily retrieve information about patients and IVF cycle.

Eligibility Criteria:
Inclusion Criteria:

* IVF procedure
* Fresh and frozen single blastocyst transfer

Exclusion Criteria:

* Any blastocysts that underwent PGS testing
* Embryos derived from gamete donation
* Embryos imported from other centers
Delivery Room Intervention and Evaluation Network

The American Academy of Pediatrics (AAP) convened the multi-center Delivery Room Intervention and Evaluation (DRIVE) Network to establish essential infrastructure to collect, coordinate, and analyze core demographic, resuscitative, and outcome data for an inclusive and diverse population of infants who receive delivery room resuscitation at participating centers. The DRIVE Network consists of delivery hospitals across the United States, covering a range of geographic, urban/rural, racial/ethnic diversity across the country. Together, DRIVE seeks to compare practice-level delivery system characteristics, identify best practices, evaluate outcomes from various interventions, and promote professional development through dissemination via the wide reach of the Neonatal Resuscitation Program.

Basic neonatal resuscitation, which includes drying, warmth, stimulation, suctioning of the baby's nose/mouth as needed, and PPV, comprise the essential skills to which 95% of babies will respond and breathe, yet more data are collected about advanced resuscitative measures that occur in only 3-5% of deliveries. Existing neonatal networks and registries focus on high-risk and premature infants and are not all-inclusive of newborn babies and the basic neonatal resuscitation interventions which save the most lives, but about which little data have been collected in a standardized way. Studying quality of care at birth is also important as it is well known that there is variation between centers, as well as long-standing disparities in infant mortality in the United States.

The objective of this project is to establish essential infrastructure to collect and coordinate core demographic, resuscitative, and outcome variables in an inclusive and diverse population of infants at participating centers. The overarching goal is to relay data back to individual centers, benchmarking their own results against the entire network. Individual centers can employ quality improvement techniques to target professional development activities and improve resuscitation practices. AAP would also use these data to continually improve the educational framework around NRP. Additionally, external investigators could also submit proposals to query the network database on important research questions involving neonatal resuscitation.

Eligibility Criteria:
Inclusion Criteria:

Inborn infant in receipt of a significant resuscitation intervention (CPAP, PPV, intubation, or CPR) at birth

Exclusion Criteria:

Not live born
Evaluation of Accuracy of One-Step Nucleic Acid Amplification (OSNA) in Diagnosis of Lymph Node Metastases of Papillary Thyroid Carcinoma

The incidence of node metastases in papillary thyroid carcinoma (PTC) is high, ranging from 20% to 90%. Prophylactic central lymph node compartment dissection (CLND), suggested from the latest guidelines for high-risk tumors, meets resistance due to the high incidence of postoperative complications. Recently, new molecular biologic techniques, such as One Step Nucleic Acid Amplification (OSNA), have spread widely, allowing to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19. The aim of this study is to evaluate the application of OSNA to intraoperative diagnosis of node metastases of PTC.

Papillary thyroid carcinoma (PTC) is the most common malignant thyroid neoplasm; it originates from follicular cells of thyroid gland, and represents over 80% of thyroid tumors. The incidence of PTC has progressively been increasing in the last decades, doubling since the 1970s, due to the diffusion of screening ultrasound. Although PTCs are considered slow-growing tumors, the incidence of node metastases is high, ranging from 20% to 90%. The real impact of node metastases on prognosis is still a matter of debate: reports in literature demonstrate a reduction of disease-free survival but are divergent on overall survival. Diagnostic tools have poor accuracy for central lymph node compartment, which is the most frequent site of metastases.

The last guidelines suggest a prophylactic central lymph node compartment dissection (CLND) in patients with high-risk PTC; nevertheless, this indication meets resistance due to the higher incidence of postoperative complications, especially hypoparathyroidism and recurrent laryngeal nerve (RLN) palsy.

Recently, new molecular biologic techniques have spread widely, mainly in diagnosis of node metastases in breast carcinoma; these assays allow to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19 (CK-19). One Step Nucleic Acid Amplification (OSNA) is routinely used in diagnosis of node metastasis in sentinel lymph node (SNL) of patients affected from breast cancer. The aim of this study is to evaluate if application of OSNA to intraoperative diagnosis of node metastases of PTC is possible.

Eligibility Criteria:
Inclusion Criteria:

Preoperative diagnosis of thyroid carcinoma

Exclusion Criteria:

-
Frequency Response of the Foot-Yangming Stomach Channel: Zu-San-Li and Xian-Gu

The main purpose of this study is to detect the frequency response in the electric wave transmission through the channels inside human body. With the electric signals in different frequencies, analyzed by the digital signal processing technique, the adaptability of the channel for different frequencies may be revealed. With this study there will be a feasible connection between the physiological signals and the channel theory in Chinese medicine, and the basis of the physiological signals can be drew out for the description of the internal organs, the strong or weak, the truth or falsity.

The Zu-San-Li is the open acupoint on foot-Yangming channel, the stomach channel. Qi, the main concept in TCM, will flow from the open acupoint to go into deep internal organs. Xian-Gu is another Yu acupoint on foot-Yangming channel. The inborn original Qi flows from the Yu acupoint infuse into blood vessels. So in this study the investigators will take these two acupoints for the acupuncture. Since the direction of the channel is from Zu-San-Li to Xian-Gu, the investigators pick Zu-San-Li as the input and Xian-Gu the output for the electrical signals.

For this experiment, the investigators planned enrolling 30 male sub-healthy volunteers, aged in 20-35 years old, to finish the whole experiment procedures.

After the acupuncture, the electric signals of different modes will be input from the subject's open acupoint (Zu-San-Li), and measure the frequency respond voltage from the output acupoint (Xian-Gu).

Each subject must complete the acupuncture of Zu-San-Li and Xian-Gu, and be input 5 sets of the electric signals of different modes two times on the trial. The variety conditions of the wave form and electric voltage will be recorded and measured respectively.

The investigators plan to obtain the data in six months, and complete the data analysis and sorting in two months.


Eligibility Criteria:
Inclusion Criteria:

* have never got myocardial infarction, heart failure, or any other heavy diseases
* in normal mental state, can match with the researcher
* would like to obey the experiment 24-hour related rules
* sign the written agreement

Exclusion Criteria:

* The one who has arrhythmia, or is equipped with the heart stanza machine.
* Get myocardial infarction, heart failure, and the other heavy diseases
* The mental state is unsteady.
* Female.
* Does not sign the written agreement.
ECV - Epihunter Clinical Validation

The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.


Eligibility Criteria:
Inclusion Criteria:

* Subjects should have an indication of having absence seizures
* Subjects should be admitted for video EEG monitoring as part of their clinical practice
* Age \> 4 years

Exclusion Criteria:

* Head circumference should be compatible for wearable EEG device (40-70cm)
* The subject should be able to understand instructions and refrain from removing the device from its head
SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)

The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical data) with 80% power. Primary and secondary outcome variables are international accepted parameters in stent-trials, which sufficiently describe the efficacy and safety of the investigated device and allow clinical conclusions. Additional attention will be paid to those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT).

The aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4 mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion is longer than 34 mm, more than one stent needs to be used.

Eligibility Criteria:
Inclusion Criteria:

* All common significant coronary lesions
* Target lesion length \>34mm need to be covered with at least 2 devices
* Patients eligible for this study must be at least 18 years of age
* The patient must fulfil the standard recommendations for percutaneous coronary intervention (PCI), based on the last ESC recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment

Exclusion Criteria:

* Intolerance to sirolimus
* Allergy to components of the coating
* Pregnancy and lactation
* Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
* Cardiogenic shock
* Risk of an intraluminal thrombus
* Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
* Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
* Severe allergy to contrast media
* Lesions which are untreatable with PCI or other interventional techniques
* Patients with an ejection fraction of \< 30 %
* Vascular reference diameter \< 2.00 mm
* Treatment of the left stem (first section of the left coronary artery)
* Indication for a bypass surgery
* Contraindication for whichever accompanying medication is necessary
CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

The aim of this prospective study is to reveal the natural history of symptomatic hemorrhage in adult patients with cerebral cavernous malformation with the goal of informing the treatment plan.

Cerebral cavernous malformation Patients with newly diagnosed, cerebral cavernous malformation who will visit one of the study centers during the period from June 2016 to December 2017. Patients would be eligible for enrollment if they were 18 years of age or older and had at least 1 cerebral cavernous malformation. If the patient had multiple cavernous malformations, index cavernous malformation would be enrolled. Index lesion will be determined according to the criteria.

* Index lesion decision criteria I. Symptomatic II. Asymptomatic (priorities are as follows)

  1. Previous bleed
  2. Brain stem location
  3. Deep nuclei (thalamus, caudate, basal ggl, hypothalamus)
  4. Periventricular
  5. Largest

All patients who would visit a study center during the enrollment period and meet these criteria will be asked to join the study. The cohort will consists of patients who agree to participate. Target population of this study is 228 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed cerebral cavernous malformation who agreed to participate.
* 18 years old or more

Exclusion Criteria:

* Patients who underwent treatment(surgery or radiosurgery) for cavernous malformation
* Patients who are accompanied by other serious medical problems