cyrilzakka/clinical-trials huggingface dataset:
Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)

Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). The RACE7 ACWAS showed that a wait-and-see approach (WAS) in patients with recent-onset AF (rate control for symptom relief followed by delayed cardioversion if needed \<48h) allows spontaneous conversion to sinus rhythm in 69% of patients, obviating active cardioversion. Recurrences within one month were seen in 30% of patients in both groups, i.e. the initially chosen strategy did not affect the recurrence pattern. Considering the latter, it remains unclear whether cardioversion is needed at all, especially since cardioversion strategy does not seem to affect behaviour of the arrhythmia over time. Instead of cardioversion a watchful-waiting rate control strategy may be appropriate as initial strategy. This allows observing the electrical and clinical behavior of arrhythmia, providing a solid basis for comprehensive and effective early rhythm control. This study is a multi-center clinical randomized controlled trial to show non-inferiority of watchful-waiting with rate control versus routine care in terms of prevalence of sinus rhythm at 4 weeks follow-up, using a novel telemonitoring infrastructure to guide rate control during follow-up.

Until recently standard of care for patients with recent-onset atrial fibrillation (AF) was early cardioversion. This has just been expanded with a delayed cardioversion approach. However, considering the recurrent and transient nature of AF, cardioversion might not be needed at all and rate control medication might be sufficient to accomplish spontaneous conversion to sinus rhythm. The aim of this trial is to evaluate effectiveness (presence of sinus rhythm) of a watchful-waiting approach, i.e. symptom reduction through rate-control medication and monitoring until spontaneous conversion is achieved compared to routine care, consisting of either early or delayed cardioversion. The trial is a multicentre prospective, randomized, open label, non-inferiority trial comparing the interventional watchful-waiting approach to routine care (control).The primary endpoint (presence of sinus rhythm), will be assessed after 4 weeks. The total follow-up time is 1 year.

Eligibility Criteria:
Inclusion Criteria:

* ECG with atrial fibrillation
* Duration of the current AF episode \<36 hours
* Symptoms due to atrial fibrillation
* Age \> 18 years
* Able and willing to sign informed consent
* Able and willing to use telemetric rhythm recorder

Exclusion Criteria:

* History of persistent AF (episode of AF lasting more than 48 hours and terminated by cardioversion)
* Deemed unsuitable for participation by attending physician
* Hemodynamic instability (heart rate \>170 bpm, systolic blood pressure \<100 mmHg)
* Acute heart failure
* Signs of myocardial infarction
* History of syncope of unexplained origin
* History of untreated Sick Sinus Syndrome
* History of untreated Wolff-Parkinson-White syndrome
* Currently enrolled in another clinical trial
Effect of an Inhibitor of Cholesterol Absorption on Vitamin D Levels

Double-blind randomized controlled trial to evaluate the serum levels of 25(OH)D after a single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.

Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo.

Objectives: To evaluate the serum levels of 25(OH)D after a single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.

Experimental design: Double-blind randomized controlled trial. Research location: Porto Alegre Clinical Hospital (HCPA), RS, Brazil. Participants: Medical residents of the HCPA. Intervention: The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection \[25(OH)D, PTH, calcium, albumin\]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.

Statistical Analysis: Paired samples t-test or Wilcoxon signed rank-test will be used for comparing variables in two distinct moments (before cholecalciferol and 14 days after). The correlation between the numerical variables will be evaluated by the Spearman's correlation coefficient. A p value of less than 0.05 was considered statistically significant.

Expected results: Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo.

Cost/benefit of the project: This is a low budget and minimal risks study that will contribute to a better understanding of the absorptive process of vitamin D and the effect of ezetimibe on its absorption.

Eligibility Criteria:
Inclusion Criteria:

* Medical students of the HCPA

Exclusion Criteria:

* Body mass index \>+ 25 or \< 18.5 kg/m2
* Known liver, kidney or endocrine disease
* Known malabsorption
* Use of supplements of calcium and/or vitamin Danticonvulsants, barbiturates, or glucocorticoids
* Travel outside the Brazilian south region during the previous 120 days
Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery

Refractive surgeries can be divided into two distinct categories: 1) corneal surgeries (superficial and deep procedures) carried on the surface of the eye and 2) lens surgeries (phakic IOL, refractive lens exchange) - an intraocular intervention, performed in the anterior or posterior chamber or on the lens. In the proposed protocol focus is on the corneal refractive surgeries impact on monochromatic higher-order aberrations on the one hand and chromatic aberrations on the other. During the surgery in order to get the patient emmetropic, refractive surgery corrects optical defects by decreasing aberrations of lower orders ) simultaneously increases high-order aberrations (that is perceived by the patient as halo, glare or starburst). Informations about prevalence and causes of higher order aberrations after refractive surgery are numerous but there is no information about chromatic aberrations.


Eligibility Criteria:
Inclusion Criteria:

* patient after corneal refractive surgery at least for 4 months
* post surgical refraction within +/- 0.75 diopter of spherical and +/- 1.0 diopter of cylindrical error
* willing and able to understand and sign an informed consent form.

Exclusion Criteria:

* patient unable to participate in the study
* any corneal diseases, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
* corneal macula and obvious pannus; current enrolment in another clinical trial/research project
Chronic Remote Ischemic Preconditioning as a Complement to Conventional Prenatal Care for Preeclampsia

Pre-eclampsia is a disease specific to pregnancy that affects 3-5% of women. It is defined by the appearance of high blood pressure after 20 weeks of amenorrhea associated with the presence of proteins in the urine, dysfunction of organs such as the liver, kidneys, lungs or brain, or dysfunction of the placenta. The cause of this disease is still unclear but it would most likely be a placental origin. Pre-eclampsia is a progressive disease that can lead to important complications. To date, there is no treatment for pre-eclampsia other than childbirth and more particularly placental delivery. Nevertheless, it is possible in some cases to stabilize arterial hypertension and thus to hope for a prolongation of the pregnancy.

Our research project aims to study the effect of preconditioning on blood pressure.

Preconditioning consists of using a blood pressure cuff and inflating it on the upper limb -like during a standard blood pressure measurement- for several minutes followed by a rest period in order to create "ischemia-reperfusion" periods. This technique would allow the release of beneficial substances into the bloodstream that would lower blood pressure. This method has been used for several years in different specialties and has produced good results on the heart, kidneys, lungs and brain.

With this technique we hope to stabilize or even reduce blood pressure in cases of pre-eclampsia and thus prolong the pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age between 24 0/7 and 36 6/7 weeks' gestation
* Hospitalization for non-severe pre-eclampsia (non-severe hypertension = Systolic blood pressure between 140 and 160mmHg, diastolic blood pressure between 90 and 110mmHg associated with one of these: proteinuria \>=300mg/24h/thrombocytopenia 100-150G/L/central symptoms such as headache responding to standard analgesics/hyperreflexia without clonus/decreased fibrinogen/haptoglobin \<0.1/utero-placental dysfunction with IUGR and/or umbilical Doppler Class II)
* Maternal age \>18 years
* Good comprehension of French allowing easy understanding of the information protocol and the consent form

Exclusion Criteria:

* Chronic hypertension
* Renal disease
* Pre-pregnancy diabetes
* Autoimmune disease (SAPL, SLE, Sjögren)
* Severe PE (Systolic blood pressure \>160mmHg, diastolic blood pressure \>140mmHg, hepatic cytolysis at twice the norm, right hypochondrium or epigastric pain, central symptoms such as clonus or headache resistant to usual treatment or disturbed consciousness, thrombocytopenia \<100G/L, acute pulmonary edema, renal failure defined by doubling of baseline creatinine value or creatinine \>97 micromol/L)
* Suspected fetal anomaly or malformation
* HELLP syndrome
* Eclampsia attack
* Pathological fetal monitoring
* Known maternal upper limb vascular anomaly
* Severe maternal cardiac pathology
* Maternal history of deep vein thrombosis of the upper limb
Assessing Perceptions of ML Explanations by Medical Oncologists

The objective of this proposal is to conduct a vignette-based survey among practicing oncology clinicians who treat non-small cell lung cancer to assess the trustworthiness of explainable predictions from a neurosymbolic AI vs. State-of-the-art post-hoc explanatory algorithms, using simulated patient data.


Eligibility Criteria:
Inclusion Criteria "Medical oncologist" or "Hematologist/Oncologist" designation at Penn Treats lung cancer

Exclusion Criteria:

Non-medical oncologists No email address or physical address listed Does not treat lung cancer
A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants with locally recurrent or metastatic breast cancer. The study consists of three parts. Part 1 (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab), Part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or bevacizumab or trastuzumab) and Part 3 (pictilisib will be administered in combination with letrozole). Part 1 and Part 2 consists of two stages; a dose escalation stage and a cohort-expansion stage.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
* Adequate organ and bone marrow function as assessed by laboratory tests
* Evaluable disease or disease measurable per RECIST
* Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
* Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, radiotherapy, or hormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study treatment
* Uncontrolled current illness
* Active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis)
* Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
* Known HIV infection
* New York Heart Association (NYHA) Class II or greater congestive heart failure
* Active ventricular arrhythmia requiring medication
* Pregnancy, lactation, or breastfeeding
* Known significant hypersensitivity to study drugs or excipients
* History of arterial thromboembolic disease within 6 months of first study treatment
* No more than two prior chemotherapy regimens for metastatic disease
Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

The purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).

A total of 41 patients awaiting transurethral resection of the prostate (TURP) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until TURP. In both groups, the extent, intensity and intracellular location of hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF)will be evaluated. Microvessel density will be also compared in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* 50 years old or older
* International Prostate Symptom Score (IPSS) \>8
* Maximum flow rate (Qmax) \<15 ml/s
* transurethral resection of the prostate (TURP)

Exclusion Criteria:

* urethral catheter
* urinary tract infection (UTI)
* liver disease
* renal disease
* unexplained hematuria
* prostate specific antigen (PSA) \> 4ng/ml (included if prostate biopsy was negative)
* interstitial cystitis
* bladder cancer or prostate cancer
* pelvic surgery or irradiation
Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.

To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms.

I.Test drug

1. Name: Silodosin 8mg/capsule
2. Dosage form: capsule (Silodosin)
3. Dose(s): 8mg
4. Dosing schedule: Oral, once daily
5. Mechanism of action: Silodosin blocks the α1A-adrenergic receptors in the prostate gland and urethra, causing smooth muscle relaxation. Since the intraurethral pressure of the urethra is reduced, urine can pass more easily and the urinary symptoms are relieved.
6. Pharmacological category: α1A-adrenergic receptor blocker

II.The process of the experiment (brief describe) Eligible subjects will be randomized to a study medication according to the randomization schedule (a 1:1 randomization ratio). There are 2 groups in this study, with group A (treatment group, silodosin 8mg, once daily, 8-week duration) and group B (control group).

III. The primary endpoint is the rate of Foley removal. The secondary endpoints are the rate of urinary tract infection, residual urine amount and the rate of re-on Foley.

Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 20 years of age
* Newly diagnosed of acute brain injury with Foley insertion with 5 days

Exclusion Criteria:

* Subjects with already in use of α1A-adrenergic receptor blocker used
* Subjects with urethral trauma
* Subjects with a history of prostate, penile, testicular, bladder, or urethral cancer or has received pelvic radiation, systemic chemotherapy, or intravesical chemotherapy
* Expected survival days for brain injury less than 28 days
* Subjects with a history of renal dysfunction (elevated creatinine (\>2.0 mg/dL))
* Subjects with severe liver impairment (Child-Pugh score≧10)
* Subjects with CYP3A4 inhibitors (ketoconazole、clarithromycin、itraconazole、ritonavir) used
* Subjects with pregnancy
* Subject who has been in an investigational drug study in the past 3 months
* Subjects who is considered as ineligible for participation in this clinical study by the principle investigator or the co-investigator's judgement.
Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects

The study purpose is to examine polymorphism of genes associated to post-operative persistent pain and to verify the possible association between genotype phenotype and ADRB2 polymorphism in orthopaedic surgery. The primary aim is to evaluate the expression of ADBR2 in VAS\>4 patients and to compare it to those with VAS\<4.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* ASA I to III

Exclusion Criteria:

* Contraindications to regional anesthesia procedures
* Not stabilized neurological diseases
* Diabetes
HRQoL in Patients with Solid Tumors Treated with Hadrontherapy

The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results.

Since 2011, CNAO has been treating patients suffering from solid tumors with particle therapy (both protons and carbon ions). Hadrontherapy improves outcome of radioresistant tumors which normally do not benefit from conventional radiotherapy. The treated population is highly heterogenous in term of tumor site, histotype, treatment fields and doses however its common anatomical origin justifies a unified approach in evaluating a QoL in this setting. QoL of patients suffering from these tumors have been poorly investigated and there are still few studies on patient reported outcomes (PROs) and QoL following hadrontherapy. In this context, therefore, there is a need to generate data by designing distinct cohort studies, conceived within a single protocol, that will gather quality of life data by means of standardized questionnaires of patients along their oncological history. Thanks to this protocol design, the investigator will be facilitated, in the future, in adding new cohorts pending a study protocol amendment and ethical approval.

Eligibility Criteria:
Cohort A ("survivors"):

Inclusion Criteria

* Patients with at least a follow up of 5 years with head and neck, skull base and brain tumors and no evidence of progressive disease.
* The patient is able to give consent

Exclusion Criteria:

* Re-irradiation.
* Second tumor.
* Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life.

Cohort B:

Inclusion Criteria:

* Histological and/or radiological diagnosis of head and neck tumors
* Patients candidate for curative intent hadrontherapy
* Patients ≥ 18 years of age
* The patient is able to give consent

Exclusion criteria:

* Re-irradiation.
* Second tumor
* Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life
* Presence of diffused metastasis
Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia

The pathophysiology of functional dyspepsia is still unclear but several peptides have been indicated in the etiological factors in FD. Ghrelin and leptin are involved in regulation of appetite and gut motility and serotonin is a typical neurotransmitter related with sensory and motor functions of gut. On the other hand, transient receptor potential vanilloid receptor 1 (TRPV1) has been proposed to be involved with functional gastrointestinal disorder, and expression of this receptor could be regulated by nerve growth factor (NGF) or glial cell-line derived neurotrophic factor (GDNF). The investigators aimed to determine whether expressions of ghrelin,leptin, serotonin,TRPV1,GDNF and NGF in blood or gastric mucosa of FD patients are different from those in healthy controls, and whether some changes of their expression correlate with certain dyspeptic symptoms. The investigators also investigated the effect of H. pylori infection by comparing their expressions before and one year after H. pylori eradication.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed upper GI endoscopy and questionnaire about gastrointestinal symptoms

Exclusion Criteria:

* Daily user of NSAID or anticoagulants
* with concomitant systemic diseases such as diabetes mellitus or any malignancy
* Participants with major depression, psychosis, eating disorder
* Participants with typical reflux symptom
* Patients with Benign gastric ulcer or duodenal ulcer
* Patients with past gastrointestinal surgery
Endoscopic Submucosal Dissection Using a Thulium Laser

We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia.

Instead of endoscopic knives, a thin, flexible fiber is inserted through the working channel of the endoscope. Acetic acid (1.5%) and indigo carmine dye are sprayed onto the lesion to clarify the margin. Markings are made 10 mm outside the tumor margin using a laser fiber with a power setting at 30 W. After marking, a mixture of sodium hyaluronate with indigo carmine and epinephrine (1:25000) is injected into the submucosa outside the marking dots. A circumferential mucosal incision and submucosal dissection are performed by a thulium laser fiber with a power setting at 30 to 40 W. Activation of the laser beam is controlled by stepping on a foot pedal. Hemostasis during procedure is also attempted using the thulium laser. When hemostasis is not achieved properly, additional use of hemostatic forceps or a hemoclip will be considered.

Eligibility Criteria:
Inclusion Criteria:

* biopsy-proven gastric epithelial neoplasia

Exclusion Criteria:

* a.differentiated adenocarcinoma, ulcer(+), more than 3cm b.differentiated adenocarcinoma, submucosal invasion(+), more than 3cm c.undifferentiated adenocarcinoma, more than 2cm
Airtraq Versus Fiberoptic for Awake Tracheal Intubation

The airway management is a vital act in anesthesia. The gold standard technique for planned very difficult intubation is nasotracheal fiberoptic intubation. The success rate with this procedure is 98.8%. However, learning this technique is difficult and it's considered uncomfortable by patients and practitioners.

The Airtraq® videolaryngoscope is commonly used for difficult orotracheal intubation. Cases of awake intubation by Airtraq® have been described.

Furthermore, the French Society of Anesthesia-Resuscitation, in its last formalized expert recommendations (2017) on difficult intubation, proposes the use of video laryngoscopes as an alternative to the fiberoptic bronchoscope.

We propose a non-inferiority study evaluating the use of Airtraq® for the realization of a awake intubation compared to the gold standard (fiberoptic bronchoscope). This prospective randomized study should include 78 patients in two groups. The purpose of this study is to improve the comfort of patient and practitioner during an awake tracheal intubation, to facilitate the learning of the technique.


Eligibility Criteria:
Inclusion Criteria:

* Formal indication of awake intubation or patient with two criteria of difficult intubation and ventilation
* Major patient
* Patient able to understand oral and written information

Exclusion Criteria:

* Mouth opening (inter-incisor distance) \<16 mm does not allow insertion of the Airtraq® videolaryngoscope
* Surgery requires nasotracheal intubation
* Loco-regional anesthesia of larynx impossible