cyrilzakka/clinical-trials huggingface dataset:
BOAT: Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy (CRT)

Many heart failure patients are unable to reach target beta blocker doses. This study will address whether cardiac resynchronization therapy (CRT) will enable uptitration of beta-blockers to target doses and whether it will favorably affect remodeling by reducing left ventricular end systolic volume (LVESV), with measurable clinical benefit, beyond CRT alone (without changes in beta-blocker dose).

Beta blockers have been proven to have benefit in heart failure (HF) patients with regard to morbidity and mortality. However, initiation and uptitration remains a challenge in many patients. Worsening of heart failure, symptomatic hypotension and symptomatic bradycardia all limit up-titration to the target doses that have been shown to have mortality benefits (carvedilol \[Coreg\] 25 mg bid, metoprolol succinate \[Toprol-XL\] 200 mg qd) in the large clinical trials (COPERNICUS, MERIT-HF).

It is debated whether the benefit of beta-blockade is solely due to heart rate reduction or more broadly from the cardiac, central and peripheral effects of blocking sympathetic activity. Clearly, there is a remodeling effect on the dilated ventricle. Furthermore, patients with heart rates of 64 bpm or less are rarely begun on beta-blocker therapy. It is not known whether these patients should be given a pacemaker in order to then safely initiate beta-blocker therapy.

It is also clear that isolated right ventricular pacing can have deleterious effects on ventricular dyssynchrony and symptomatic heart failure despite medical therapy. Biventricular pacing (BIVPM), also known as cardiac resynchronization therapy (CRT), is the pacing mode of choice for patients with wide QRS complexes and symptomatic HF.

It is hypothesized that CRT therapy allows for increased Beta -blocker dose (or initiation of beta-blocker in patients previously intolerant) with improved NYHA, ejection fraction, and remodeling effects. The synergy between two established heart failure therapies requires further evaluation in a prospective randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* NYHA III-IV
* QRS \> 120 msec
* On medical therapy, but beta blocker dose not @ target (carvedilol 25 bid, metoprolol succinate 200 qd)

Exclusion Criteria:

* QRS \< 120 msec
* On target beta blocker dose
Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation

An open label, placebo and positive controlled, randomised, cross-over study in healthy male volunteers to determine the effect on penile skin sensation of a newly formulated tetracaine product PET500

This was an open label, placebo and positive controlled, randomised, dose-ranging, cross-over pilot study.

On each dosing day the subjects each received one dose of tetracaine (0.26 or 0.65 or 1.3mg), or placebo, or Stud100® (which served as a positive control) on the glans penis The doses of PET500 were applied in liquid spray form (260μl) at approximately the same time of the day as the previous application to locations on the glans penis in a randomised fashion.

Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

The first two volunteers included in the trial piloted the sensitivity assessments prior to the inclusion of all other subjects. Changes could be made to the assessment times on the basis of the pilot data to ensure subsequent timings were relevant. However any such changes were not to expose volunteers to more assessments than were specified in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

1. Male healthy subject aged 18 to 65 years, inclusive.
2. The subject is capable of understanding and complying with protocol requirements.
3. The subject is in good health as determined by medical history and physical examination at screening.
4. The subject signs a written, informed consent form prior to the initiation of any study procedures

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

1 History or hypersensitivity to tetracaine or ethanol.

2. History or signs of a sexually transmitted disease.

3. Any current penile abnormalities.

4. Known current drug abuser or alcoholic as determined by medical history.

5. Participation in a clinical trial within the last month prior to dosing on Day 1.

6. The use of concomitant systemic or topical medications or foods that may affect the study outcome and / or impair drug metabolising capacity.

7. A positive HIV 1 \& 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result.

8. Unfit to participate in the study in the opinion of the Principal Investigator.
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area

Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area.

The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).

A randomized, double-blind, parallel-group study 2 groups of patients: 10 patients with electrodes placed in STN and 10 patients with electrodes placed in Forel fields.

1 group of healthy paired-control (n=20).

Patients will be evaluated without and with treatment on two mornings (J0 and J0+1day).

In each condition of treatment, 3 conditions of stimulation were tested: without stimulation; frequency 25Hz, frequency 130 Hz.

Evaluations consist on :

* motor evaluation (UPDRS)
* gait evaluation (to walk on a gait mat)
* Stand-Walk-Sit Test

Eligibility Criteria:
Inclusion Criteria:

* Patients :
* Men or women aged between 45 -85 years
* Patients with an idiopathic Parkinson's disease according to UKPDSBB criteria
* Normal neurologic evaluation (except Parkinson's disease)
* Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
* Affiliated to National Health system
* Having given their informed consent

Healthy subject

* Men or women aged between 45 -85 years
* Normal neurologic evaluation
* Affiliated to National Health system
* Having given their informed consent

Exclusion Criteria:

* Patients :
* Patients suffering of an atypical Parkinson syndrome
* Patients with locomotive disorders which can interfere in gait evaluation
* Patients with dementia (MMS \<24)
* Under guardianship
* In excluding period for another study
* Person who participate to an other study

Healthy subject

* Subject with locomotive disorders which can interfere in gait evaluation
* Subject with dementia (MMS \<24)
* Under guardianship
* In excluding period for another study
Mindfulness Practice for Healthcare Professionals in Training

A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications, will be piloted to determine the feasibility, acceptability, accessibility, and preliminary effects within this population.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professional
* Healthcare professional in training

Exclusion Criteria:

* None
Accelerated Bilateral rTMS on Geriatric Depression

This study aims to evaluate the efficacy of accelerated bilateral repetitive transcranial magnetic stimulation (rTMS) on major depression, anxiety, cognitive function and physiological parameters in elderly depressive patients.

Repeated transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation treatment, showing good therapeutic effect to medicine treatment-refractory patients. Recent studies suggested bilateral DLPFC might be effective to geriatric depression. Accelerated treatment course was reported to have similar therapeutic effect and safety profile with traditional course. The investigators hypothesize accelerated bilateral rTMS is effective to geriatric depression and comorbid anxiety.

Cognitive impairment and decreased parasympathetic tone are common in patients with major depression. The investigators hypothesize cognitive function and physiological indicators improve after accelerated bilateral rTMS.

In this single-center, prospective double-blind, randomized, active-controlled trial, the investigators aim to recruit 100 patients older than 60 years, without neurocognitive disorders, and refractory to one or more antidepressants. The experimental group would receive an rTMS course with high-frequency stimulation at left DLPFC followed by low-frequency inhibition at right DLPFC, two sessions daily, five days a week, and two weeks in total. The standard treatment group would receive an rTMS course with high-frequency stimulation at left DLPFC as standard treatment parameters. Mood, cognition and physiological markers would be monitored every week. The primary outcome is response and remission rate of major depression measured by Hamilton Rating Scale for Depression.

Eligibility Criteria:
Inclusion Criteria:

* age between 60-85 years
* literate and received basic education for at least 2 years
* diagnosis of major depressive disorder, without psychotic features, according to DSM-5
* have a score of 20 or greater on the 17-item Hamilton Depression Rating Scale
* failed to achieve clinical response by at least 1 antidepressant trial of sufficient dosage for at least 4 weeks
* psychoactive agents were in stable doses before randomization

Exclusion Criteria:

* active suicide plans or attempts; or suicide attempts in the last 12 months
* diagnosis of schizophrenia or bipolar disorder according to DSM-5
* have DSM-5-confirmed substance use disorder (excluding tobacco) in the last 3 months
* have delirium, major neurocognitive disorder or MMSE \< 24
* current use of bupropion \>300 mg/day, tricyclic antidepressant, clozapine, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline or anti-epileptic agents excluding benzodiazepines
* history of severe head trauma, epilepsy, multiple sclerosis, stroke, brain tumors, intracranial aneurysm, active intracranial infection, increased intracranial pressure, metallic implants in the brain, major brain surgery or major neurological diseases
* with a cardiac pacemaker or defibrillator
* received rTMS treatment before
Retrospective Database Study: Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal

The aim of this study is to determine and compare the longevity of single-tooth cast restorations made of precious metal vs. non-precious metal (e.g. partial crowns, crowns) and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity.

Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) between 1997 and 2022 will be retrospectively analyzed. Patient-, tooth-, treatment-, and restoration-specific parameters will be obtained from digital and paper-based dental records.

Survival and success of the restorations will be assessed using Kaplan-Meier statistics. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis.

No patient treatment is associated with the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients insured in the statutory health insurance.
* Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022.

Exclusion Criteria:

* None.
Corneal Topographic Changes After Pterygium Surgery

The purpose of the study is to assess the corneal topographic changes after primary pterygium surgery

Prospective interventional comparative study . This study will be conducted on eyes with primary pterygium before and after successful excision in department of ophthalmology, Sohag university hospital to assess the corneal topographic changes using pentacam .

Postoperative evaluation will be scheduled for one month ,three and six months postoperative.

Eligibility Criteria:
Inclusion Criteria:

* patients with primary pterygium

Exclusion Criteria:

* patients with recurrent pterygium
* patients with primary pterygium with other ocular pathologies.
The Effect of Dexmedetomidine on Microcirculation in Severe Sepsis

Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to 44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Delayed diagnosis and treatment of microcirculatory dysfunction may cause tissue hypoperfusion and resulted in multiple organ dysfunction and death. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine also has anti-coagulation and anti-inflammatory effects, and it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators will conduct two animal studies and one clinical trial to investigate the effect of dexmedetomidine on microcirculatory dysfunction and organ injury in rat with endotoxemia and patients with severe sepsis and septic shock.

Sixty patients with severe sepsis and septic shock will be enrolled and randomized to control group or dexmedetomidine group. In the control group, the patients will be treated according to the clinical practice guideline. If sedation is required, non-dexmedetomidine sedative agents will be used. In the dexmedetomidine group, the patients will be treated according to the clinical practice guideline, and they will also receive continuous infusion of dexmedetomidine (infusion rate ranged from 0.1 to 0.7 mcg/kg/h) for 24 hours as needed. The sublingual microcirculation, serum level of Endocan, NGAL(Neutrophil Gelatinase-Associated Lipocalin), and BNP(B-type natriuretic peptide) will be examined at preset time points up to 24 hours. The vital signs, hemodynamic parameters, and survival of 28-day and 90-day will be recorded and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients who require sedation
* Patients who have diagnosis of severe sepsis / septic shock
* meet 2 or more of the 4 SIRS criteria
* with one organ dysfunction according the definition of Surviving Sepsis Campaign

Exclusion Criteria:

* less than 20 y/o
* refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment)
* 2nd and 3rd degree of AV-block
* the onset of severe sepsis/septic shock is more than 24h before enrollment
* APACHE II \> 30 at enrollment
* Severe liver cirrhosis (Child B or C)
* New onset of myocardial infarction within 30 days or heart failure (NYHA 4)
* attend other trial in ICU within one month
* patient who is pregnant
* receive organ transplantation within one year
* expected survival is less than 30 days by attending physician
* receive cardiopulmonary resuscitation within 4 weeks
* patients who have signed consent of refusal of cardiopulmonary resuscitation and invasive therapy
* have allergic history to dexmedetomidine
* receive renal replacement therapy within 24 hours before enrollment
* patient with HIV infection
* non-native speaker
* other factors not eligible for enrollment concerned by attending physician
Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI

Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI

Study setting:

Assisted Reproduction unit in Ain Shams University Maternity Hospital

Study population:

Patients underlying ICSI in Assisted Reproduction unit in Ain Shams University maternity hospital

Intervention:

After taking written informed consent, all patients recruited in the study will undergo, detailed medical history and complete clinical examination will be obtained along with necessary laboratory investigations and ultrasound findings The standard protocol of the Assisted Reproduction unit in Ain Shams University Maternity Hospital for induction of ovulation in ICSI patients which it is the long protocol will be given for all patients in the study. Endometrial and sub-endometrial blood flow for every patient in the 3 groups will be assessed by transvaginal ultrasound using Medison Sonoace R5 ultrasound machine, eight hours before giving the trigger, after they have completely emptied their bladders (2D power Doppler will be performed). This will be repeated one week after the day of embryo transfer. Endometrial blood flow will be detected by intra-endometrial or the adjacent sub-endometrial regions within 10 mm of the echogenic endometrial borders. Double thickness of the endometrium will be measured (maximum distance between each myometrial/endometrial interface through the longitudinal axis of the uterus). The pulsatility index (PI) and resistance index (RI) of the endometrial arteries will be calculated. Analysis will be used together with computer algorithms to form indices of blood flow within the endometrium. The parameters will be analyzed by software for: (i) resistance index (RI): the difference between maximal systolic blood flow and minimal diastolic flow divided by the peak systolic flow (S-D/S); (ii) pulsatility index (PI): the difference between maximal systolic blood flow and minimal diastolic flow divided by the mean flow throughout the cycle (S - D/mean); (iii) the ratio between peak systolic flow and lowest diastolic flow (S/D). These three parameters express the resistance to flow from the point of measurement downstream. The patients will be divided into three groups according to the condition of the endometrial blood flow: In Group 1, no endometrial blood flow is detected; Group 2 has sub-endometrial blood flow detected, and Group 3 has both endometrial and sub-endometrial blood flow detected.

Pregnancy will be assessed by serum B-HCG test after fourteen days of having embryo transfer, then two weeks later trans-vaginal ultrasound will be performed to insure the presence of gestational sac.

Eligibility Criteria:
Inclusion Criteria:

Age :20-35yrs.

1. Embryo transfer at 3rd or 5th day after ovum pick up.
2. The transferred embryos are in the four cell stage ,eight cell stage, sixteen cell stage or blastocyst stage.

Exclusion Criteria:

1. Age \<20 or \>35 yrs old.
2. Chronic medical disease.
3. Single embryo transfer.
4. Previous ICSI failure.
Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery

Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world\[1,2\]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. The development of ureteral access sheath (UAS) is a significant advance in flexible ureteroscopic management of urinary stones. The UAS has two major advantages: 1) facilitating multiple entries into the renal collecting system without causing recurrent trauma to the ureter and permit expeditious basketing of multiple stone fragments, 2) improving the irrigation with better fluid outflow, thereby reducing the renal pelvic pressure (RPP) and risk of infectious complications.

The tip bendable suction ureteral access sheath (S-UAS) is a novel UAS that has good flexibility and deformability at the tip, which can passively bend (bend \>90°) with the bending of f-URS and can connect to a vacuum suction device. Preliminary study showed that S-UAS can follow f-URS to cross the UPJ and into the renal pelvis and calices. S-UAS close to the stone can achieve complete stone-free status in RIRS. However, further clinical studies and comparisons with available techniques are required. This prospective, single-blinded, single-center, randomized control trial will evaluate the stone free rates, operative time, postoperative complications following RIRS with S-UAS. To the best of our knowledge, this is the first study to compare the clinical benefits of RIRS with S-UAS and traditional UAS.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years;
* American Society of Anesthesiology score 1-3;
* Upper urinary stone (kidney stone or upper ureteral stone) diameter of ≤ 3 cm confirmed by CT;
* Capable of giving written informed consent, which includes adherence with the requirements of the trial.

Exclusion Criteria:

* Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit);
* Patients with uncontrolled UTI;
* Patients with health or other factors that are absolute contraindications to RIRS;
* Patients unable to understand or complete trial documentation.
The Incidence of Postoperative Pulmonary Complications in Patients With a Positive and Negative AIR-Test During General Anesthesia

The overall objective of this study is to describe the incidence of postoperative pulmonary complications in patients with a positive and negative AIR-test result. Second, the investigators wish to describe the incidence of a positive AIR-test and its association with the development of PPC. In addition, the investigators aim to describe whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.

The 'AIR-test', a method wherein inspiratory oxygen concentration is reduced to 21% and pulse-oximetry hemoglobin saturation (SpO2) is monitored, can be used to demonstrate the presence of an atelectasis-induced alveolar shunt. It remains uncertain whether an intraoperative positive AIR-test is associated with clinical outcomes. It is hypothesized that in a general surgical population, the incidence of postoperative pulmonary complications (PPC) is higher in patients with a positive AIR-test than in patients with a negative AIR-test. The aim of this study is to describe the incidence of PPC in patients with a positive and in patients with a negative AIR-test. Second, the investigators want to describe the incidence of a positive AIR-test and its association with the development of PPC. The investigators also want to evaluate whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery under general anesthesia in the Amsterdam University Medical Centers, location Meibergdreef with an Endotracheal Tube;
* Patients \> 18 years;
* Preoperative SpO2 of ≥97%;
* AIR-test performed after induction of anesthesia, in a hemodynamic and respiratory steady state.

Exclusion Criteria:

* Age \< 18 years;
* No consent/objection;
* Patient participated in another conflicting interventional study on mechanical ventilation during general anesthesia