cyrilzakka/clinical-trials huggingface dataset:
Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation

The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC) extracorporeal circulation on neurocognitive function after elective coronary bypass grafting (CABG) as well as whether this can be attributed to improved cerebral perfusion intraoperatively.

Despite improvements in the biocompatibility of cardiopulmonary bypass (CPB) circuits, the activation of inflammatory systemic response can result in clinically relevant organ dysfunction. Regarding the central nervous system, prolonged hypoperfusion and microembolization during conventional CPB have been related to postoperative neurologic impairment with an incidence varying from 30% to 60%. This clinical scenario covers a spectrum from a transient subtle cognitive dysfunction to a permanent stroke. Postoperative cognitive decline (POCD) is characterized as impairment in attention, cognition, recognition, orientation, memory, and learning. It may result in prolonged hospitalization, increased morbidity and mortality, while it has an adverse impact on quality of life after surgery.

Near-infrared spectroscopy (NIRS) provides a continuous and noninvasive monitoring of regional cerebral oxygen saturation (rSO2). Recent studies have shown a significant relationship between intraoperative cerebral oxygen desaturation, indicative of cerebral ischemia, and early POCD in patients undergoing elective coronary bypass grafting (CABG) with conventional extracorporeal circulation (CECC). In an attempt to reduce CPB-inherent side effects, a minimal extracorporeal circulation (MECC) system was developed and it is evaluated in clinical practice. The aim of this pilot study was to define whether there is a difference in early postoperative neurocognitive functioning between patients being operated for CABG on MECC versus CECC systems as well as whether this can be attributed to improved cerebral perfusion intraoperatively.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for elective coronary artery bypass grafting

Exclusion Criteria:

* history of psychiatric disorder
* inability to undergo neuropsychological assessment
* history of transient ischemic attack or stroke
* carotid artery stenosis \> 60% assessed by duplex ultrasonography
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546

A 3-part Study to Assess Safety, Tolerability, PK and PD of Single (Part 1) and Multiple (Part 2) Ascending Doses of EXS21546, and to Evaluate the Relative Bioavailability of a Solid Dose Formulation Compared to a Powder for Oral Suspension (Part 3), in Healthy Male Subjects.

Part 1 is a randomised, double-blind, placebo-controlled, SAD study with a food effect assessment.

Part 2 is a randomised, double-blind, placebo controlled, MAD study over 14 days. In order to explore the potential CYP3A4 inducer effect, midazolam will also be administered in one cohort.

Part 3 is a 3-period, open label, randomised, sequential study. Each subject will receive solid dose formulation and powder for oral suspension in a randomised manner.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.0 to 30.0 kg/m2
* Weight ≥60 kg
* Must adhere to contraception requirements

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
* Subjects who have previously been administered IMP in this study.
* Evidence of current SARS-CoV-2 infection
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week
* A confirmed positive alcohol breath test at screening or admission
* Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* Subjects with pregnant or lactating partners
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
* Regimen L only: History of sleep apnea
* Subjects with a history of cholecystectomy or gall stones
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
* Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
A Study to Describe the Kidney Cancer Patient Population Treatment, and Results in the Hospital District of Southwest Finland.

The purpose of the study is to find out how patients with advanced kidney cancer have been treated in the hospital district of Southwest Finland over time.


Eligibility Criteria:
Inclusion Criteria:

For the characteristic group:

* Diagnosis of renal cell carcinoma (International Classification of Diseases 10th revision \[ICD\]-10:64) during 01 January 2010 and 31 December 2021

For the mRCC group:

* ICD-10 diagnosis code for metastasis (C77\*-C79\*), or
* American Joint Committee on Cancer (AJCC) stage 4, or AJCC stage data potentially not available for all patients
* Visit to oncologist (specialty code 65) with RCC as main diagnosis, or In Finland, the ICD-10 codes for metastatic disease are rarely used. In contrast, RCC patients visit oncologist, when and only when disease metastasises and therefore, the visit can be used as a proxy to a metastatic disease
* Initiation of treatment for mRCC

Exclusion Criteria:

For the characteristic group:

* Prevalent mRCC patients (i.e. diagnosis of metastatic RCC before 01 January 2010)
* Prevalent mRCC patients (i.e. diagnosis of RCC before 01 January 2010) if there is no records of metastatic disease during 2010-2021

For the mRCC group:

* Prevalent patients with mRCC (i.e. diagnosis of metastatic RCC before 01 January 2010)
* Patients without treatment for mRCC
ROsuvastatin LOading and Clinical Outcomes Trial

The aim of the present study was to evaluate the effect of pre-procedural single high loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite of death or myocardial infarction from cardiovascular (CV) causes, target vessel revascularization (TVR), or stroke.


Eligibility Criteria:
Inclusion Criteria:

* statin-naive patients
* stable ischemic heart disease
* de novo lesions appropriate for PCI

Exclusion Criteria:

* current statin use
* statin allergic patients
* acute coronary syndromes
* lesions not appropriate for PCI
* refusal for participation
* statin quitting during follow- up
Optimizing Anesthesia for Post Partum Tubal Ligations

In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.


Eligibility Criteria:
Inclusion Criteria:

* Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study

Exclusion Criteria:

* age less than 18 years old
* allergy to either local anesthetic class (amide or ester)
* contraindication to spinal anesthesia
The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy

To study the effect of Photosensitive hydrogel used for suture free anastomosis of lacrimal cyst and nasal mucoperiosteal flap in endoscopic nasal dacryocystostomy, and evaluate its adhesion to lacrimal cyst and nasal mucoperiosteal flap, promoting wound healing, forming a good anastomosis, preventing postoperative anastomosis and shortening operation time. Twenty patients with chronic dacryocystitis were randomly divided into photosensitive hydrogel group and suture group.Symptoms and nasal endoscopy were followed up 2, 6, and 12 weeks after surgery for both groups. And also adverse events were recorded at each follow-up.

After endoscopic dacryocystonasal anastomosis, granulation and/or cicatricial adhesion are the main reasons for surgical failure. How to achieve the ideal fit between the lacrimal sac flap and the nasal mucoperiosteal flap and avoid the proliferation of granulation and cicatricial adhesion is very important for the success of the operation. In this study, "photocoupling reaction" technology was used to achieve seamless integration and strong adhesion of photosensitive hydrogel materials to the wound, and the photohydrogel was applied to suture free adhesion and wound repair of the lacrimal cyst mucosal flap and nasal mucosal flap in endoscopic nasal Dacryocystostomy (En-DCR), and its feasibility, safety and effectiveness were evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in this clinical study and sign the informed consent;
2. Gender is not limited, age 18-75 years old;
3. The patient had symptoms and signs of chronic dacryocystitis, and the results of lacrimal passage irrigation suggested that the lower rush and return or upper rush and lower return, accompanied by mucous or purulent discharge reflux;
4. Lacrimal duct angiography suggests nasolacrimal duct obstruction without lacrimal canaliculi and/or duct obstruction.

Exclusion Criteria:

1. Age \< 18 or \> 75 years old;
2. Previous history of dacryocystonasal anastomosis;
3. Abnormal coagulation function;
4. Tumors of lacrimal passage, especially in patients with papilloma or malignant tumors;
5. in the acute dacryocystitis attack stage;
6. obvious scar constitution;
7. Complicated with serious nasal diseases, such as severe allergic rhinitis, chronic rhinosinusitis and nasal polyps, acute suppurative rhinosinusitis, severe atrophic rhinitis, and severe deviation of nasal septum;
8. Have serious heart, liver, kidney, lung and other basic diseases, can not tolerate general anesthesia;
9. Distance from the hospital, postoperative review is not convenient;
10. Participated in other clinical trials within the last 3 months;
11. Any medical history that the investigator determines may interfere with the test results or increase the patient's risk.
Assessing Medical Trial Experiences of Hairy Cell Leukemia Patients

The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.

This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for hairy cell leukemia.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of hairy cell leukemia studies.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Ability to understand and the willingness to sign a written informed consent document.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry

Prospective, observational cohort study for subjects with AA under the care of a dermatology provider. Approximately 5,000 subjects and 100 clinical sites in North America will be recruited to participate with no defined upper limit for either target.

The objective of the registry is to create a cohort of AA subjects to study long-term safety and effectiveness of AA treatments. Because the long-term understanding of safety and efficacy is still limited even after regulatory approval,enrollment and long-term follow-up of a large number of diverse real-world patients exposed to therapies of interest is important to understand safety and effectiveness. The observational structured data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AA to support ongoing risk benefit evaluation by drug manufacturers and regulators.Further, data collected will inform clinical decision making by subjects and treating providers. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of AA for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Eligibility Criteria:
Inclusion Criteria:

* A subject must meet all the following criteria to participate in the registry:

  1. Has been diagnosed with alopecia areata by a dermatologist or a qualified dermatology practitioner.
  2. Is at least 18 years of age or older.
  3. Is willing to provide Personal Information.
  4. Is prescribed or starting an Enrollment Eligible Medication at the time of enrollment.

Exclusion Criteria:

* Any of the following would exclude the subject from participating in the registry:

  1. Is participating or planning to participate in a double-blind randomized trial for an AA drug. Note:

Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021 (ImpactRA)

ImpactRA is an observational retrospective study. The management of the patient is not modified by this study. This study will be carried out based on the already existing data of the gynecological ward of CHU Clermont-Ferrand between 2016 and 2021. During this period of time, 17 patients have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, aided by augmented reality (AR). The investigators compared these 17 patients that underwent surgery with AR with 17 control patients that underwent the same surgery with the same indication but without AR.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 (included) and 84 (Included),
* Patient operated between 2017\* et 2021,
* Patient with one or more intrauterine myomas, with surgical treatment by laparoscopic myomectomy with or without AR,
* Patient with one or more intrauterine adenomyomas, with surgical treatment by laparoscopic adenomyomectomy with or without AR,
* Patient informed about the use of her data for research.

Exclusion Criteria:

* Patient who refused the use of medical data for research purposes,
* Patient operated prior to 2017\* and after 2021,
* Patient whose medical follow-up did not allow collection of the data required for the study.

(\*) An amendment validated by the ethics committee allows inclusion of patients operated during 2016
IR Beam Used Before Peripheral Intravenous Catheter Application on Vein Visibility

The study will be conducted in the Oncology and Cardiovascular Surgery (CVS) services of a university hospital. In the research, 30 patients will constitute the control group and 30 patients will constitute the experimental group. A nurse working in the clinics where the study will be conducted will perform the PIVK procedure, and we will randomly select the control and experimental groups and apply light to the area where the PIVK will be applied to the patients in the experimental groups with a flashlight that emits infrared rays for 10 minutes. The nurse will not be aware of whether the radiation application was made to the patient or not. The veins will be evaluated by the nurse performing PIVK. We will fill out the necessary forms in ANNEX 1 (control group) and APPENDIX 2 (experimental group) while the PIVK procedure is applied. After the procedure is completed, the patient's pain, anxiety and satisfaction level during the procedure will be marked. The data will be entered into the SPSS program and evaluated with statistical tests. According to the results, the effect of IR rays used before PIVK application on the patient's pain, anxiety and satisfaction and on the procedure time spent by the nurse for the application will be determined.

A nurse from the ward where the study will be conducted will be contacted and a meeting of approximately 20 minutes will be held about the study. The nurse will fill out the forms before and after inserting the catheter into the patient. Routine procedures such as tourniquet, hand opening and closing will be applied to the control group before catheter application. In the experimental group, catheter application will be made after the IR beam is applied.

Eligibility Criteria:
Inclusion Criteria:

Are between the ages of 18-70,

* PIVK will be inserted,
* Not receiving anticoagulant treatment,
* Does not have diabetes or peripheral neuropathy,
* No signs of infiltration or thrombophlebitis in the extremity where IR beam will be used,
* Dialysis patients without arteriovenous fistula,
* Does not have any communication problems and whose mental level does not cause any problems in participating in the research,
* Patients who volunteer to participate in the research will be recruited.

Exclusion Criteria:

* Sudden movements during PICK insertion,
* Missing patient data
COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS - A PROSPECTIVE RANDOMISED CONTROLLED STUDY.

Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management.

But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration .

This study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not.

There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone.

one study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS .

But there has been no prospective RCT to assess the utility of DPS to date

Inclusion Criteria: -

1. Symptomatic Walled-off pancreatic necrosis (WON)
2. Eligible for EUS guided BFMS placement
3. Signed informed consent .
4. Age \>18 Years

Exclusion Criteria: -

1. Types of pancreatic collections other than WON .
2. Drainage with stents other than BFMS
3. Previous attempts at drainage of WON
4. Coagulopathy (INR\>1.5) or thrombocytopenia(plc \<50000/cmm)- not correctable.
5. Pregnancy
6. Not willing to give informed consent

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic Walled-off pancreatic necrosis (WON)
2. Eligible for EUS guided BFMS placement
3. Signed informed consent .
4. Age \>18 Years

Exclusion Criteria:

1. Types of pancreatic collections other than WON .
2. Drainage with stents other than BFMS
3. Previous attempts at drainage of WON
4. Coagulopathy (INR\>1.5) or thrombocytopenia(plc \<50000/cmm)- not correctable.
5. Pregnancy
6. Not willing to give informed consent
Treatment Burden Screening Questionnaire Pilot Study

The main objective of this study is to develop and evaluate a clinic-based pilot intervention to optimize patient-centered diabetes care for low income patients at risk for low quality diabetes care and poor outcomes.

Single arm trial of a brief screening tool to identify areas of treatment burden in patients with diabetes, which will then be used as a tool in a primary care clinician visit discussion. We will assess (primary outcome) the acceptability and feasibility of 1. recruitment and retention processes; 2. screening tool usability; and (secondary outcomes) 3. outcome assessments. Data will include systematic tracking of recruitment and retention efforts, baseline and follow-up participant data, post-visit surveys of clinicians and participants, and patient participant qualitative interviews.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, a diagnosis of T2DM, receiving primary care in a participating clinic, and having an in-person clinic visit with a participating trained clinician.

Exclusion Criteria:

* Cognitive impairment, residing in a nursing home, and pregnancy (to avoid recruiting patients with gestational diabetes).