cyrilzakka/clinical-trials huggingface dataset:
Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

The goal of the study was to ascertain the influence of dental caries and teeth position as well as the type and amount of the applied dental materials (DMs) on the oxidative stress (OS) status in gingival crevicular fluid (GCF).

Six DMs were tested by investigators, each sealed in one session: amalgam (Amg), zinc phosphate cement (ZnPhC), zinc polycarboxylate cement (ZnPoC), glass ionomer cement (GIC) and composites, Tetric EvoCeram (TEC) and Beautifil (BF).

The study included 88 dental outpatients. Oxidative stress parameters, including malondialdehyde (MDA), glutathione (GSH) and total superoxide dismutase (tSOD) activity were measured in GCF, before (day 0) and after treatment (7th and 30th day).

Antagonistically positioned healthy teeth were used as a control.

Eligibility Criteria:
Inclusion Criteria:

Criteria related to the condition of teeth:

* Presence of proximal caries on anterior and posterior teeth
* Existence of the antagonistic tooth ("mirror"-positioned healthy tooth) to be used as control
* An absence of fresh post-extraction or traumatic wounds in the restoration area or in the area of restored surfaces
* An absence of infection in the area of restored surfaces

Other influencing criteria:

* Absence of bone-associated diseases or treatments
* Satisfactory oral hygiene
* Patients exhibiting good compliance

Exclusion Criteria:

Criteria related to the condition of teeth:

* Endodontic and/or periodontal infections in the area of the cervical filling
* Presence of periodontopathy
* Prominent periodontal pockets
* Subgingival carries
* Prominent fillings outside the cavity

Other influencing criteria:

* Patients on radiation or immunosuppressive therapy
* Presence of bone-associated diseases and malignant diseases
* Patients using drugs/alcohol/cigarettes (\> 20 cigarettes per day)
* Bad oral hygiene
* Patients exhibiting poor compliance
Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty

The study to determine the if the incidence of Fat Embolism is decreased using Computer Assisted technology when performing a Total Knee Arthroplasty.

Computer assisted total knee arthroplasty is at its inception currently. There are many unknowns about this specific technique, particularly when it comes down to fat embolism syndrome. There is a high incidence of fat embolism during total knee arthroplasty as seen both by echocariography as well as sampling of right atrial blood. During a jig-based, or traditional, total knee arthroplasty, a rod is placed inside the femur, and sometimes the tibia as well. Intrusumentations of the medullary canal is known to cause fat embolism. Fat embolism is a syndrome which can produce post-operative confusion, hypoxemia, all the way to post-op and intra-operative death.

Computer assisted total knee arthroplasty does not use intramedullary jigs. It is presumed that by not instrumenting the medullary canal, the rate of fat embolism will be significantly reduced.

Fifty patient s will be studied while they are having a computer assisted total knee arthoplasty. A PICC line will be placed in their arm by an interventional radiologist pre-operatively. This PICC line will be thread into the right atrium. Right atrial blood will be sent to pathology every 10 minutes during the 60 to 90 minute procedure and at intervals post-op. The right atrial blood will be stained for bone marrow elements.

This study is to presumed to show yet another benefit of computer assisted surgery.

Eligibility Criteria:
Inclusion Criteria:

* Must be a candidate for Computer Assisted Total Knee Arthroplasty

Exclusion Criteria:

* Mentally incompetent patients excluded
Effect of Roux-en-Y Gastric Bypass Versus Laparoscopic Adjustable Gastric Band Operations on Resistin, Apelin and Visfatin Peptides

This study aimed to measure, compare apelin, resistin, visfatin levels in patients underwent to RYGBP, LAGB and their relation with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of morbid obesity
* Being underwent LAGB or RYGBP

Exclusion Criteria:

* Having prior abdominal surgery history
Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery

a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.

Ciprofol is a better alternative to surgical sedatives. The clinical application basis of Ciprofol in pediatric anesthesia is still lacking. Therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. Our main hypothesis is that in pediatric surgery, using Ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic surgery under general anesthesia

Exclusion Criteria:

* Known allergies to propofol and ciprofol,
* Mental retardation, cognitive and affective disorders, psychiatric or neurological disorders;
* uncooperate with peripheral venipuncture and catheterization;
* History of acute upper respiratory tract infection in the past 2 weeks;
* With severe respiratory, circulation, liver and kidney insufficiency;
* Body mass index (BMI) of 30 kg/m² or 15 kg/m²;
* Known long-term use of sedative drugs;
* ASAⅢ grade or above;
* recent participation in other clinical studies.
Nitrous Oxide for Late-Life Depression - PROTO-BRAIN

Resistant Depression is a common condition in older adults and there is an urgent need for novel antidepressant in this population. Nitrous Oxide (N2O) has recently shown rapid antidepressant effect in midlife depression but no study has currently investigated the efficacy and safety of N2O in Late-Life Depression (LLD), while N2O may prove to be an ideal treatment for LLD because of glutamatergic antagonism and cerebrovascular effects and also a relatively good safety profile.

The goal of our study is to compare changes in depressive symptoms after 2 hours, 24 hours, 1 week and 2 week of a 1-hour exposure to EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) versus Medical Air.

Secondary Objectives include comparing differences in neuroimaging measures between 3 groups (responders and non-responders in the EMONO group, and patients in the control group).

Secondary objectives include:

* To compare changes in Brain Tissue Pulsatility (BTP) as measured with Ultrasound Tissue Pulsatility Imaging (TPI) between responders in the EMONO group (MADRS change of at least 50%), non-responders in the EMONO group (MADRS change of no more than 50%) and in the Air Medical group
* To compare baseline differences in structural (brain volumes, white matter hyperintensities) and functional (resting state connectivity in BOLD, Brain Pulsatility in BOLD, Brain Perfusion in ASL) among the 3 groups
* To compare changes in depressive and anxiety symptoms between the active and control group, as assess with Hamilton scale, CGI scale, QIDS-SR, VAS and the STAI scale
* To compare safety between the active and control group, as assessed with SSI, YMRS, CADSS, BPRS

Eligibility Criteria:
Inclusion Criteria:

* Aged 60-90 years-old
* Major Depressive Episode according to DSM-5 criteria, confirmed by the MINI - Mini International Neuropsychiatric Interview
* MADRS score greater than 20 (Montgomery Asberg Depression Rating Scale)
* Patient resistant to at least one well-conducted antidepressant treatment, as documented by the MGH-ATRQ scale
* Patient who can undergo N2O diffusion via a facial mask
* Patient who has signed an informed consent
* Person affiliated with a social security scheme

Exclusion Criteria:

* Bipolar disorder, schizophrenic disorder, neurodegenerative disease, documented by the MINI and the MMSE (non-inclusion if MMSE \< 24/30), addictive disorder
* Unstable somatic pathology (including unstable neurological or cardiological diseases at risk of interfering with N2O diffusion)
* Presence of active and significant psychotic symptoms, at investigator's discretion
* Contraindications to EMONO (50%N2O/ 50%O2) : pneumothorax, emphysema, bowel obstruction, intracranial hypertension, chronic deficiency in vitamin B12 or B9
* Contraindications to MRI, including claustrophobia
* Legal incapacity and/or other circumstances unabling the patient to understand the nature, purpose or consequences of the study
* A person participating in a drug clinical trial or during a period of exclusion from any clinical study
Exhaled Breath Particles in Lung Cancer

Lung cancer (CaP) is the leading cause of cancer related deaths on a global level. Early diagnosis is vital for survival and life quality of the affected patients, yet lung cancer is often diagnosed at advanced stages, causing poor five-year survival rates. Exhaled breath particles (EBP) and particle flow rate (PFR) collected by the particles in exhaled air (PExA) system is a safe and easily reproducible non-invasive method for gaining insight into the molecular environment of the distal airways. EBP and PFR have been found useful in detection of other airway diseases such as acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) and bronchiolitis obliterans syndrome (BOS). It has been shown that particles found in EBP reflect the general composition of respiratory tract lining fluid (RTLF) and that biomarkers found in EBP correlate to proteins that can be found in both bronchoalveolar lavage fluid (BALF) and plasma. Particle flow rate (PFR) has been found to differ between patients with lung cancer compared to control patients. In the present study the investigators aim to collect EBP samples and measure PFR from patients with primary lung cancer and from control patients. EBPs are collected for molecular analysis. The investigators aim to identify biomarkers for diagnosing, predicting prognosis of and evaluating surgical treatment of non small cell lung cancer.

EBP samples and measurements of PFR will be collected from patients with primary non-small cell lung cancer (NSCLC) at Skåne University Hospital (SUS) Lund. Measurements will be done at 2 time points, before and after surgical resection for NSCLC.

EBP samples will be collected at one time point from a matched (by age and smoking history) control cohort.

Blood samples will be collected from both cohorts, at the same time points as the EBP/PFR measurements.

Tumor tissue and healthy adjacent lung tissue will be collected from lung cancer patients with tumors greater than 3 cm in diameter on preoperative computed tomography.

The purpose of this clinical trial is to identify non-invasive means of diagnosing NSCLC at earlier stages. The PExA method is not associated with any risks and has potential minimize hospitalization associated with more invasive methods that are in clinical practice today, such as bronchoscopy and biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Primary lung cancer with clinical Tumor, Node, Metastasis (TNM) up to cT3N1M0 according to TNM 7th edition
* Able to take instructions and perform the standardized breathing maneuver

Exclusion Criteria:

* Dementia
* Severe neurological disease
* Drug abuse
* Heart failure New York Heart Association (NYHA) Classification, NYHA class III or IV
* Ejection fraction \< 50 %
* S-creatinine \> 140 µmol/L
* Poorly regulated diabetes mellitus
A Feasibility Study With a Novel, Dynamic and Disposable Over-the-counter Device for Stress Urinary Incontinence

This study was designed as an open label, feasibility, single-center, cross-over prospective study in women with stress urinary incontinence. Subjects served as their own control.

The primary objectives of this feasibility study were to evaluate the short-term efficacy of the Nolix device by measuring a reduction of SUI following a modified 1-hour PWG test and to measure the safety of the Nolix device based on adverse events that were reported by subjects during the study. The secondary objective was to assess usability and patient satisfaction using the Nolix device.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 21 and above
* Suffering from Stress Urinary Incontinence
* Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study

Exclusion Criteria:

* Age ≤ 21 years
* Pregnant or planning to become pregnant during the study.
* Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
* Severely atrophic vagina.
* A history of Toxic Shock Syndrome (TSS).
* Active urinary tract or vaginal infection.
* Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year).
* Has experienced unusual or unexpected vaginal bleeding within the last 6 months.
* Vaginal surgery within the last 3 months prior to entering the study.
* Has experienced difficulties with the use of intra-vaginal devices, including tampons.
* Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.
Women's INternational Transcatheter Aortic Valve Implantation Registry

The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.

WINTAVI is an international, multi-centre, prospective, observational registry. The purpose of this study is to collect 'real-world' data regarding the clinical utility of all commercially available Transcatheter Aortic Valve Implantation (TAVI) devices for percutaneous aortic valve implantation in female patients with severe Aortic Stenosis (AS) requiring treatment. Data collected in this study will provide additional information on the understanding of the safety and device performance in a 'real-world' setting and how to best treat patients with severe AS. This will include Quality of Life questionnaires (KCCQ).

Eligibility Criteria:
Inclusion Criteria:

1. Severe AS determined by echocardiogram and Doppler, defined as: mean gradient \>40 mmHg or peak jet velocity \>4.0 m/s and an aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2
2. Symptomatic AS demonstrated by angina, congestive heart failure, NYHA functional class ≥ II, or syncope
3. Logistic EuroSCORE suitable for TAVI
4. Patient must have other conditions (such as severe airways disease, porcelain aorta, previous thoracic radiotherapy, Childs Pugh class B and C liver disease) such that the multi-disciplinary team (interventional cardiologists, cardiothoracic surgeons and cardiac anaesthesiologists) agree that co-morbidities render SAVR of high or prohibitive risk.
5. Patient has been informed of the nature of the registry and has provided full written informed consent according to hospital practise

Exclusion Criteria:

1. Patient is not an eligible candidate for TAVI
2. Untreated clinically significant (\> 70% obstruction) coronary artery disease in the proximal segments of main branches suitable for revascularization
3. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
4. Hemodynamic instability (e.g. requiring inotropic support)
5. Active endocarditis or sepsis within 6-months prior to the study procedure
6. Use of investigational device without CE mark
Percutaneous Administration of Sirolimus in the Treatment of Superficial Complicated Vascular Anomalies

In this study, we investigate the safety and efficacy of topical sirolimus in the treatment of superficial complicated vascular anomolies.

Vascular anomaly is a kind of rare disease. According to histology, biological behavior and clinical manifestations, it can be divided into two categories: vascular tumor and vascular malformation.

mTOR inhibitors are proved with the properties of anti-proliferation and anti-angiogenesis. Therefore, they have been used in the treatment of vascular anomalies. Sirolimus, by its ability to prevent downstream protein synthesis and subsequent cell proliferation and angiogenesis, has become a novel and effective treatment. However, after the children reach complete response, there may still be skin manifestations that affect the appearance and cause psychological shadows. Therefore, intervention is required.

Studies have reported that topical sirolimus is effective in treating Kaposiform Hemangioendothelioma (KHE). It is absorbed through the skin, avoiding the first pass elimination effect of the liver. Fewer adverse reactions have been observed. In this study, we investigate the efficacy and safety of percutaneous administration of sirolimus in the treatment of superficial complicated vascular anomalies.

Eligibility Criteria:
Inclusion Criteria:

* Participant clinically or pathologically diagnosed with KHE, TA or complicated superficial vascular anomolies involving lymphatic components.

  1. The case is initial, with a relatively limited superficial lesion.
  2. The participant has residual surface lesions after oral medication.
* Participant with no use of other medication or surgical treatment
* Participant with detailed medical records of the disease at the time of screening
* Participant with signed and dated informed consent from the guardian(s)

Exclusion Criteria:

* Participants with Kasabach-Merritt Phenomenon, with platelets \<50×10 9 /L.
* Participants with general disease such as hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency.
* Participants with other hematological diseases or solid tumor.
* Participants allergic to sirolimus or dressing.
Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease

The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the prevention of Graft-versus-Host Disease (GvHD).

Approximately 30% of HLA-identical related bone marrow graft recipients and up to 90% of patients receiving bone marrow from unrelated donors develop significant acute GvHD despite the use of prophylactic therapies such as cyclosporine and methotrexate. About half of these patients respond to initial treatment with steroids and require no further treatment. The remainder of these patients are either unresponsive to initial therapy or become steroid-resistant over time. The prognosis in these cases is poor and mortality for patients with steroid-resistant GvHD may be as high as 50%.

ECP is a technique in which peripheral white blood cells are exposed to a photoactivatable compound (UVADEX) administered extracorporeally and ultraviolet A light. After cells are reinfused into the patient, their function is altered, thereby activating mechanisms that allow for further regulation of specific lymphocyte populations. ECP has shown activity in several inflammatory and autoimmune diseases, including scleroderma, rheumatoid arthritis, transplantation rejection, acute and chronic GvHD.

In a previous single-center, open label, single-arm study of 56 patients receiving ECP treatment on two consecutive days and reduced-intensity bone-marrow conditioning prior to bone marrow transplantation from matched or partially matched human donors, the incidence of grade II-IV acute GvHD was less than 10%. This is in contrast to an expected incidence of approximately 40%.

The purpose of this study is to determine the role of ECP, administered pre-transplant, in preventing GvHD when used in conjunction with a standard myeloablative conditioning regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of a malignancy of the blood (e.g. leukemia) for which allogeneic bone marrow or peripheral blood stem cell transplantation is a treatment option.
* Patients who are candidates for a standard allogenic bone marrow transplant or PBSC transplant.
* Patients must have adequate renal, hepatic, pulmonary and cardiac function to enable the patient to tolerate shifts in the volumes of body fluids associated with extracorporeal photopheresis, as determined by the physician's clinical judgement.
* Patients must weigh at least 40 kg (88 lbs)

Exclusion Criteria:

* Patients who have received a prior bone marrow transplant or peripheral blood stem cell transplant.
Retrospective Evaluation of Erector Spinae Plane Blocks

Retrospective Evaluation of Erector Spinae Plane Blocks

in our institue; we use erector spinae plane block as a part of multimodal analjesia. we want to evaluate block failures and complications related erector spinae plane block. In all patients performed regional anesthesia techniques, we use a regional anesthesia follow chart.

Eligibility Criteria:
Inclusion Criteria:

* patient performed erector spinae plane block

Exclusion Criteria:

-
Taste Function and Eating Habits in Polycystic Ovary Syndrome

This study evaluates taste function and eating habits in patients with PCOS compared to healthy women and before and after oral contraceptive use.

The objective of this study is to investigate the taste function and eating habits in patients with PCOS in comparison with healthy women at baseline and after routine use of an oral contraceptive (2mg ethinylestradiol and 0.03mg dienogest) along with general lifestyle advice for three months.

Patients with diagnosis of PCOS (Rotterdam criteria) will be recruited from Hacettepe University outpatient clinics. Along with clinical, hormonal and biochemical evaluation, taste function and eating habit tests will be performed at baseline both in patients and healthy volunteers. These tests will be repeated in women with PCOS after 3 months of oral contraceptive use.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with PCOS (Rotterdam criteria) who will receive oral contraceptive pill for long-term management

Exclusion Criteria:

* Any systemic illness
* Any other medication use
* Age\<18 or \>35 years
* Pregnant or nursing
* Untreated hypothyroidism or hyperthyroidism
* Known rhinoplasty or nasal surgery
* Known defect in smell or taste function
* Being active smoker.
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
2. Presence of FLT3-ITD and/or D835 mutation(s)
3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML
4. Age ≥ 18 years and ≤ 75 years
5. Adequate hepatic function
6. Adequate renal functions
7. ECOG performance status ≤ 3

Exclusion Criteria:

1. Known clinically active central nervous system(CNS) leukemia
2. Severe liver disease
3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed.
5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.