cyrilzakka/clinical-trials huggingface dataset:
Effect of Radiofrequency Ablation in Patients With Ventricular Arrhythmia Undergoing CABG

Patients with myocardial infarction related potential malignant ventricular arrhythmia have high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG) Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular arrhythmia at the same time. The observation indexes include the morbidity of potential malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term after CABG surgery.


Eligibility Criteria:
Inclusion Criteria:

* The patients have been receiving coronary artery bypass grafts from 2015.1-2017.12
* The patients had old myocardial infarction related potential malignant ventricular arrhythmia
* Anti-arrhythmic drug treatment is invalid
* All enrolled patients must being signed the informed consent

Exclusion Criteria:

* Severe heart failure( ejection fraction under 35%)
* Patients with acute myocardial infarction
* Patients with ICD implanted
Retrospective Study: Long-term Health of Living Kidney Donors

Kidney transplantation, is the preferred treatment option of end stage renal disease. Compared to dialysis, patients who receive kidneys have a 70% reduction in death, a dramatically improved quality of life and cost the health care system considerably less. As a result, there are over 3000 Canadians on the waiting list for a kidney. In order to meet the shortage of cadaveric kidneys, the rates of living kidney donation have nearly doubled over the last 10 years. Yet despite its advantages for the recipient, living kidney donation remains a complex ethical, moral, and medical issue. The premise for accepting living donors is that the "minimal" risk of short and long-term medical harm realized by the donor is outweighed by the definite advantages to the recipient and potential psychosocial benefits of the altruistic gift to the donor. The only benefit for the living donor is psychological - donors experience increased self-esteem, feelings of well-being, and improved health related quality of life with their altruistic act of assuming medical risk to help another. The short-term consequences of living donation are well established. On the other hand the long-term consequences of living kidney donation are far less certain. The main medical concerns of living kidney donation include an increased risk of hypertension, proteinuria, and low glomerular filtration rate (GFR- a measure of the filtering capacity of the kidney). Estimates of these outcomes are variable, inconsistent, and uncertain in the literature. This study is designed to quantify the long-term medical and psychosocial implications of living kidney donation.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years old
* Living kidney transplant occurred between 1970 and 2006
* no history of hypertension, kidney disease or proteinuria prior to donation

Exclusion Criteria:

* a medical condition (such as cardiovascular disease, pulmonary disease, or active cancer) which makes one ineligible to be a donor. Blood group and immunological incompatibility (such as positive cross-match, poor HLA matches) are not reasons for exclusion.
* The eligible non-donor subsequently went on to donate a kidney
* Either the donor or the eligible non-donor are unable to give informed consent
* The living donor or eligible non-donor is currently pregnant
Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP

Nursing study, prospective, randomized, two-center open-label.

Patients will be randomized into two groups during their first laying Qutenza®:

* Patients receiving the laying of Qutenza® without refrigerated cushion
* Patients receiving the laying of Qutenza® associated with a refrigerated cushion

The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Major
* Do not opposing the participation in the study
* Monitoring in the case of localized neuropathic pain
* Diagnostic with neuropathic pain score ≥ 4
* Neuropathic pain conventional treatment failure of first-line
* Front advantage of laying a first patch Qutenza®
* With ability to understand the proposed study

Exclusion Criteria:

* Patch Installation on the feet, face, mucous membranes
* Eutectic mixture of local anesthetics (EMLA) Pose premedication
* Having Already received prior to the installation of a patch of Qutenza®
* Allergy to components Qutenza®
* Known and poorly stabilized hypertension
* Known cryoglobulinaemia
* Pregnant or lactating women
* Patient enjoying a measure of legal protection (guardianship, guardianship ...)
* Private Patient freedom
* No affiliation to a social security scheme.
* Refusal to participate in the study
Bone Marrow Angiogenesis in Acute Myeloid Leukemia - Evaluated by Dynamic Contrast Enhanced Magnetic Resonance (MR) Image

In malignant or neoplastic disease, angiogenesis is defined as the generation of new capillaries from preexisting blood vessels, e.g. by sprouting or by intusseption. Through the pioneering work of Folkman, it was recognized that angiogenesis plays an important role in tumor development, progression, and metastasis. It is also conceivable that there are forms or developmental stages of leukemia, multiple myeloma, or lymphomas that will progress independently of angiogenesis. Synthesis of angiogenesis activators, such as vascular endothelial growth factor (VEGF) and other angiogenic factors, such as basic fibroblast growth factor (bFGF), has been demonstrated for leukemia cells, non-Hodgkin's lymphoma, and myeloma cells. Microvessel density is also significantly elevated over normal controls with progressive increases according to the stages of myelodysplastic syndrome. Increased microvessel density (MVD) in the bone marrow was found in patients with multiple myeloma in comparison to normal controls and increased MVD is an adverse prognostic marker in multiple myeloma. However, the functional status of the blood vessel (e.g. permeability) cannot be determined by the above mentioned methods.

In malignant or neoplastic disease, angiogenesis is defined as the generation of new capillaries from preexisting blood vessels, e.g. by sprouting or by intusseption. Through the pioneering work of Folkman, it was recognized that angiogenesis plays an important role in tumor development, progression, and metastasis. It is also conceivable that there are forms or developmental stages of leukemia, multiple myeloma, or lymphomas that will progress independently of angiogenesis. Synthesis of angiogenesis activators, such as vascular endothelial growth factor (VEGF) and other angiogenic factors, such as basic fibroblast growth factor (bFGF), has been demonstrated for leukemia cells, non-Hodgkin's lymphoma, and myeloma cells. Microvessel density is also significantly elevated over normal controls with progressive increases according to the stages of myelodysplastic syndrome. Increased microvessel density (MVD) in the bone marrow was found in patients with multiple myeloma in comparison to normal controls and increased MVD is an adverse prognostic marker in multiple myeloma. However, the functional status of the blood vessel (e.g. permeability) cannot be determined by the above mentioned methods.

Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia (AML) patients with intention to receive induction chemotherapy
* Dynamic contrast-enhanced magnetic resonance imaging (dMRI) performed before, during and after complete course of induction chemotherapy
* Age and sex matched normal volunteers

Exclusion Criteria:

* AML patients with palliative chemotherapy only
Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block

This prospective double blinded study will be conducted over 60 pediatric patients ASA (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who will be scheduled for unilateral groin surgery. Patients will be randomly allocated into 3 study groups: Control group that only received local anesthetics ( bupivacaine) Group II bupivacaine with the dexmetedomidine ( 0,5mcg/kg ) and group III bupivacaine with the dexmedetomidine (1mcg/kg).Patients in all groups will receive quadratus lumborum block.

Bradycardia, hypotension, atropine, and bolus fluid infusion requirements will be recorded. When there was up to a 30% decrease in basal mean blood pressure, a crystalloid infusion bolus will be given at 10 ml/kg. When bradycardia occurred , atropine will be given at a dose of 0.02 mg/kg. Patients will be followed up in the postoperative recovery unit for the first 2 hours, and then in the ward. The RAMSEY sedation scale and WATCHA agitation scale were evaluated at 5, 15, 30, and 60 minutes in the postoperative recovery unit. Nausea, vomiting, and other side effects were recorded if present.

Time to first analgesic requirement ( primary outcome) , FLACC Scale scores will be recorded within 24h postoperatively, total dose of analgesic consumption, incidence of postoperative complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression will be recorded.


Eligibility Criteria:
Inclusion Criteria:

The study included children aged 1-7 years with ASA (American Society of Anesthesiologists) I-II, who underwent elective, unilateral, groin surgery (inguinal hernia, orchiopexy, hydrocele) with the consent of their families

Exclusion Criteria:

* Children who were aged outside the range of 1-7 years, with ASA III or higher, allergic to local anesthetics, had an infection in the injection area, had contraindications for regional anesthesia such as coagulopathy, whose families did not give consent, were undergoing laparoscopic orchidopexy, undergoing bilateral surgery, had a body mass index of \>30 kg/m2, and were expected to be admitted to the intensive care unit during the postoperative period were excluded from the study
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients with Diffuse Peritonitis

Does the administration of the probiotic Lactobacillus plantarum sp. have an impact on reducing leukocyte levels, segmented neutrophil counts, postoperative pain, and length of hospitalization in patients with diffuse peritonitis caused by perforated acute appendicitis who underwent laparotomy appendectomy at Dr. Hasan Sadikin Hospital?

To determine whether the administration of the probiotic Lactobacillus plantarum sp. to patients with diffuse peritonitis caused by appendiceal perforation undergoing laparotomy appendectomy at Hasan Sadikin Hospital Bandung and Siloam Karawaci Hospital has a significant effect on leukocyte levels, segmented neutrophil counts, postoperative pain levels, and length of hospitalization compared to the placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with diffuse peritonitis caused by appendicitis
* Patients undergoing laparotomic appendectomy.
* Patients aged 18 years or older.

Exclusion Criteria:

* Patients with a history of previous laparotomy.
* Patients who underwent laparotomy combined with surgery on other parts of the body.
* Patients with a history of cancer.
* Patients with pre-existing comorbidities (uncontrolled diabetes mellitus, congestive heart failure, end-stage renal disease \[ESRD\], human immunodeficiency virus \[HIV\], and systemic lupus erythematosus \[SLE\]).
* Patients with multiple organ dysfunction syndrome (MODS).
* Patients with prior consumption of probiotics.
The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men

To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists.

No studies have examined the influence of factors such as exercise and dehydration on the pharmacokinetic profile of asthmatic drugs (beta2-agonists). Exercise may modify the metabolism and excretion of drugs, and sweat loss during exercise can result in dehydration, both affecting the urine concentration of the drug.

Eligibility Criteria:
Inclusion Criteria:

* men
* aerobic capacity more than 50ml / min / kg
* more than 5h training pr week

Exclusion Criteria:

* smokers
* allergy for the medicine
* chronic diseases
A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in aSTS in a Real World Setting in Greece

This non-interventional study aims primarily at assessing the clinical effectiveness and the impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it represents an attempt towards gaining experience on the routine use of trabectedin in daily clinical practice in a representative sample of Greek subjects with aSTS.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

* Adult outpatients (18 years and older) of either gender;
* Patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs;
* Patients for whom the decision to prescribe therapy with trabectedin (Yondelis®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study;
* Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
* Patients must have signed an informed consent document;
* Patients must be able to read, understand and complete the study specific questionnaires.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation in this study:

* Patients who have received more than one cycle of trabectedin at the time of enrolment into the study;
* Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
* Patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with trabectedin.
A Common Polymorphism of the SRD5A2 Gene is Not Associated With Male-to-Female and Female-to-Male Transsexualism

Genetic variations, i.e. polymorphisms, may be associated with gender dysphoria, e.g. transsexualism. This study aims to identify such variations.

Context: Early developmental exposure of the brain to sex steroids may play a role in the etiology of transsexualism.

Objective: To assess the association between transsexualism and allele and genotype frequencies of the steroid 5-alpha reductase (SRD5A2) Val89Leu polymorphism.

Design and Patients: We performed a case-control study of 100 male-to-female (MtF) transsexuals, 47 female-to-male (FtM) transsexuals, 755 male controls, and 915 female controls. DNA was extracted from buccal swabs and genotypes were determined by polymerase chain reaction.

Results: SRD5A2 Val89Leu allele frequencies (SRD5A2 V: 137/200 \[69%\] and SRD5A2 L: 63/200 \[31%\] vs. SRD5A2 V: 1065/1510 \[71%\] and SRD5A2 L: 445/1510 \[29%\], respectively; p=0.6; Odds Ratio \[OR\] 1.10; 95% Confidence Interval \[CI\] 0.76-1.58) and genotype distributions (SRD5A2 V/V+V/L: 92/100 \[92%\] and L/L 8/100 \[8%\] vs. SRD5A2 V/V+V/L: 683/755 \[91%\] and L/L 72/755 \[9%\], respectively, p=0.7; OR 0.82; 95% CI 0.24-2.84) were not significantly different between MtF transsexuals and male controls. SRD5A2 Val89Leu allele frequencies (SRD5A2 V: 70/94 \[74%\] and SRD5A2 L: 24/94 \[26%\] vs. SRD5A2 V: 1253/1830 \[69%\] and SRD5A2 L: 573/1830 \[31%\], respectively; p=0.3; OR 0.75; 95% CI 0.45-1.26) and genotype distributions (SRD5A2 V/V+V/L: 44/47 \[93%\] and L/L 3/47 \[7%\] vs. SRD5A2 V/V+V/L: 823/915 \[90%\] and L/L 92/915 \[10%\], respectively, p=0.6; OR 0.61; 95% CI 0.11-3.32) were also not significantly different between FtM transsexuals and female controls. Of note, there was no gender-specific genotype distribution among controls.

Conclusions: The SRD5A2 Val89Leu polymorphism is not associated with transsexualism and is no candidate gene of this condition.

Eligibility Criteria:
Inclusion Criteria:

* transsexual individuals as defined by DSM IV criteria

Exclusion Criteria:

* unwillingness to participate
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer

Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide.

Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed extensive disease of Small cell lung cancer
* no prior chemotherapy or radiotherapy for lung
* measurable lesion for RECIST
* over 18 years
* ECOG 0\~2
* expected life span more than 3 months

Exclusion Criteria:

* acute or active infection
* uncontrolled cerebral nerve symptoms or metastasis
* significant myocardial infarction or cardiac disease within 12 months
Cross-sectional Follow-up on Digestive and Social Functions of SPN

An observational cross-sectional follow-up study on the quality of life (two aspects, digestive physiological and social psychological functions) of solid pseudopapillary neoplasm of the pancreas (SPN) patients recruited in PUMCH from 2001 to 2026. The quality of life is evaluated by a questionnaire made up of eight validated scales.

Solid pseudopapillary neoplasm of the pancreas (SPN) is a rare tumor with uncertain malignant potential. It is a rare entity of pancreatic tumor with low potential malignancy, constituting 1% to 3% of pancreatic tumors and 10%-15% of pancreatic cystic neoplasm. Although the reported cases of SPN have been increasing rapidly all over the world during the last two decades, its long-term follow-up studies in large cohorts remain missing.

From this, this observational cross-sectional follow-up study on the digestive physiological and social psychological functions of SPN patients aims to achieve a comprehensive understanding on how SPN and surgery affects the quality of life. Patients are recruited in PUMCH from 2001-2026 with a definite pathological diagnosis.

The quality of life after surgery is evaluated by a questionnaire made up of six validated scales (digestive physiological functions via: 8 symptoms scale of the EORTC core quality of life questionnaire (EORTC QLQ-C30); gastrointestinal symptom rating scale questionnaire (GSRS); social psychological functions via: sense of coherence-9 questionnaire (SOC-9); patient health questionnaire-9 questionnaire (PHQ-9), general anxiety disorder-7 questionnaire (GAD-7) ; post-traumatic embitterment disorder 21 questionnaire (PTED-21); work ability index questionnaire (WAI); body image scale questionnaire (BIS)). To our knowledge, this is the largest SPN cohort worldwide and the first study to concentrate on the quality of life of SPN after operations.

Eligibility Criteria:
Inclusion Criteria:

* SPN patients with pathological diagnosis after surgery
* Approval to participate
* patients with valid and complete questionnaires results inspected by two experienced surgeons

Exclusion Criteria:

* Refusal to participate
* patients with invalid or incomplete questionnaires results
TES for the Treatment of RP

Retinitis pigmentosa (RP) is a progressive degenerative disease of the retina, which often leads to blindness. 1 in 4000 people in the UK are affected by RP yet there is no established therapy for treating or delaying its progression.

Transcorneal electrical stimulation (TES) has garnered attention as a possible therapeutic option for RP. Research has shown that TES improves retinal cell viability and visual function. An initial pilot study of TES on 24 participants with RP demonstrated that it was safe and improved vision.

This study aims to confirm the safety of the new CE-approved Okustim device and to further characterise the benefits of TES on a larger scale. 12 participants will be enrolled for 1 year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye Hospital.

Recruited participants will undergo weekly TES of 1 eye for 30 minutes for a period of 6 months. This will be followed by a further 6 months of observation without stimulation giving a total participation time of 1 year. Participants will be assessed at 3, 6, 9 and 12 months after their initial baseline visit by clinical examination, investigations and questionnaires.

Participants should have a diagnosis of RP and be capable of giving consent. Participants, or a carer, should have sufficient motor skills to attach the device themselves. As this study seeks to ascertain the impact of TES on RP, participants with other eye diseases (e.g. diabetic retinopathy) cannot be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male or Female, 18 or more years of age
* Diagnosis of retinitis pigmentosa (rod-cone dystrophy) made by an ophthalmologist
* Participants should have a visual acuity of ≥ 0.02 (Snellen Chart)
* Able (in the investigators opinion) and willing to comply with all study requirements
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
* Participants, or a designated other, should have sufficient motor skills (assessed by the investigator) to apply the device independently

Exclusion Criteria:

* Female participants who are pregnant, lactating or planning pregnancy during the course of the study
* Diabetic Retinopathy
* Previous arterial or venous occlusion of the retina
* Previous retinal detachment
* Previous silicone oil tamponade
* Dry or exudative age-related macular degeneration
* Macular oedema
* All forms of glaucoma
* Any form of corneal degeneration that reduces visual acuity
* Neovascularisation of any origin
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
* Forms of mental illness related to bipolar affective and schizoid-affective disorders, and all forms of dementia
* Simultaneous participation in another interventional study or history of interventions where effects may still persist