cyrilzakka/clinical-trials huggingface dataset:
Lactate Levels During Cardiopulmonary Bypass in Pediatric Patients

Many variables measured in critically ill patients have been used to estimate severity of disease, prognosticate morbidity and mortality, evaluate costs of treatment, and finally indicate specific treatment and monitor the adequacy of treatment and its timing. It is unlikely that one measurement can replace all of these, but in the remainder of this manuscript the investigators will show that lactate levels may come close. Although in our mind strongly linked to tissue hypoxia, lactate levels follow many more metabolic processes not related to tissue hypoxia and, therefore, subject to many disturbances found in various clinical situations

Forty consecutive pediatric patients who required cardiopulmonary bypass for repair or palliation of complex congenital heart disease will be enrolled in this study. Patients for the study were selected by convenience sampling, without randomization or control of surgical procedure, conduct of anesthesia, or CPB management.

Patients will be monitored intra-operatively using ECG, invasive and non-invasive blood pressure monitoring, pulse oximetry and capnography for determination of End Tidal Co2 ( ETCo2 ) and nasopharyngeal temperature. After induction of anesthesia and placement of an intra-arterial catheter 1 ml of arterial blood will collected into a heparinized 3 ml blood gas syringe and immediately analyzed on the arterial blood gas analyzer (GEM Premier 3000) for blood gas, hematocrit, electrolytes, calcium and glucose. Management strategy of cardio-pulmonary bypass (CPB) was standardized for all the patients. Lactate samples will drawn at specific time points within 5 time intervals: before CPB after induction, during cooling on CPB, during rewarming on CPB, immediately after CPB in the operating room, and after admission to the post-operative intensive care unit.

Differences in lactate levels related to diagnosis will examined. To examine the effect of patient diagnosis and surgical risk on serum lactate level and outcome, the investigators separated patients into surgical risk categories Risk adjustment for congenital heart surgery (RACHS-1). This classification does not include heart transplantation. Patient mortality and the prevalence of postoperative complications for each of the 3 surgical risk categories relative to the change in lactate will examined.

Eligibility Criteria:
Inclusion Criteria:

* age range (1-12 years)
* Usage of cardiopulmonary bypass

Exclusion Criteria:

* chest problems
* Renal problems
* Hepatic problems
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Males and females (ages 18-75 years)
* Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
* Must have been following a restrictive diet
* Diagnosis of combined dyslipidemia

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus
* Abnormal pancreatic, liver, or renal function
* Abnormal serum creatine kinase (CK) above the pre-specified level
* Significant heart disease
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in participants with Major Depressive Disorder (MDD) with a current depressive episode.

This is a phase 4, multicenter, open-label, flexible dose trial designed to assess the effects of brexpiprazole (flexible dose; 0.5 to 2 milligrams \[mg\], once daily \[QD\]) as adjunctive therapy to antidepressant therapy (ADT) on life engagement in participants with MDD. This trial is being conducted in line with the Canadian Product Monograph.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
* Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
* Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.

Exclusion Criteria:

* Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
* Participants with a concurrent DSM-5 diagnosis of the following will be excluded:

  * Schizophrenia or schizoaffective disorder
  * Bipolar I or bipolar II disorder
  * Post-traumatic stress disorder
  * Dementia
  * Eating disorder
  * Borderline personality disorder
  * Antisocial personality disorder
* Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.
Covert Saccade Triggers in Bilateral Vestibular Hypofunction

Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The triggering of these covert-saccade is still not known. They could be of visual origin but the short latency is unusual. The objective of this study is to evaluate the potential role of visual trigger in 12 patients with chronic bilateral areflexia, using different visuo-vestibular conditions. The latency of simple visually guided saccades will also be tested in the group of patients and a group of 12 healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* For all :

  * Age from 18 to 90
  * Understanding of the experimental instructions
  * Informed Consent
* For Patients :

Bilateral vestibular hypofunction with regards to the criteria of the of the Barany Society A. Chronic vestibular syndrome with at least three of the following symptoms

1. Postural imbalance
2. Unsteadiness of gait
3. Movement-induced blurred vision or oscillopsia during walking or quick head/body movements
4. Worsening of postural imbalance or unsteadiness of gait in darkness and/or on uneven ground B. No symptoms while sitting or lying down under static conditions C. Bilaterally reduced or absent angular VOR function documented by

   * bilaterally pathological horizontal angular VOR gain \< 0.6, measured by the video-HIT5or scleral-coil technique and/or
   * reduced caloric response (sum of bithermal max. peak SPV on each side \< 6°/sec7)and/or
   * reduced horizontal angular VOR gain \< 0.1 upon sinusoidal stimulation on a rotatorychair (0.1 Hz, Vmax = 50°/sec).

D. Not better accounted for by another disease

\* For Healthy control No ENT or neurological disorders

Exclusion Criteria:

* Corrected Visual Acuity lower than 5/10
* Other conditions leading to oscillopsia or ataxia
* Oculomotor palsy, ocular instability in primary position
* Treatment that may affect ocular motility (psychotropes)
* Cervical rachis pathology with instability
* Cochlear Implants
* Non-stabilized medical disease
* Pregnant women
* Patients under tutelage
* Patient without social security
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)

The purpose of this study is to estimate the prevalence of Vasomotor Symptoms (VMS) and prevalence of moderate to severe VMS in peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea and Taiwan) and the proportion of the following subpopulations: Hormone Replacement Therapy (HRT)-eligible and willing to take HRT; HRT-eligible and HRT-averse (i.e. not willing to take HRT); HRT-ineligible due to contra-indications/high-risk; and HRT-stoppers.

The study will also assess Health Related Quality of Life (HRQoL) and VMS related productivity loss among perimenopausal and post-menopausal women with moderate-to-severe MR-VMS and the respondents' attitudes toward prescription treatments.

The study will recruit women of 40-65 years old from an established consumer panel in China, South Korea, and Taiwan.

Women who meet the inclusion criteria for Part I will be recruited to sign the informed consent form (ICF) and participate in Part I of the survey.

Based on the information collected in Part I of the survey, peri- and post-menopausal women who meet the inclusion criteria for Part II will be directed to Part II of the survey. The survey will be terminated for women who do not meet the inclusion criteria for Part II.

Eligibility Criteria:
Inclusion Criteria (part I):

* Evidence of peri-menopause (changes in the regular period in terms of irregularity in the length of the period, the time between periods, and the level of flow), or
* Evidence of post-menopause (spontaneous amenorrhea over 12 months)

Inclusion Criteria (part II):

* Presence of moderate-to-severe menopause-related vasomotor symptoms (MR-VMS); Moderate: sensation of heat with sweating, able to continue activity; Severe: sensation of heat with sweating, causing cessation of activity)

Exclusion Criteria (part I):

* No evidence of peri-menopause or post-menopause, or
* Women who are currently participating or have participated in menopause-related vasomotor symptoms (MR-VMS) clinical trials

Exclusion Criteria (part II):

* Subjects who are treated with tamoxifen, aromatase inhibitors or Gonadotropin-releasing hormone (GnRH) agonists/antagonists for cancer or any other medical condition, or
* Subjects who have mild menopause-related vasomotor symptoms (MR-VMS) only
Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer

Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology
* CLDN18.2 expression confirmed by immunohistochemistry
* Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel
* At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry)
* Age ≥ 18 years
* ECOG performance status (PS) 0-1 or Karnofsky Index 70-100%
* Life expectancy \> 3 months
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dl
* INR \< 1.5
* Bilirubin normal
* AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Creatinine \< 1.5 x ULN

Exclusion Criteria:

* Pregnancy or breastfeeding
* Prior allergic reaction or intolerance to a monoclonal antibody
* Prior inclusion in the present study
* Less than 3 weeks since prior anti-tumor or radiation therapy
* Other investigational agents or devices concurrently or within 4 weeks prior to this study
* Other concurrent anticancer therapies
* History of positive test for human immunodeficiency virus (HIV) antibody
* Known Hepatitis.
* Uncontrolled or severe illness.
* Concurrent administration of anticoagulation agents with vitamin K antagonists
* Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)
Dysport in Vulvodynia Phase II Study

This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia.

The study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2). Both Stage 1 and Stage 2 will consist of a double-blind period (with treatment cycle 1; Dysport or placebo) followed by an open label treatment period. One or two optimally safe and effective doses of Dysport selected from Stage 1 will be further investigated in the Stage 2.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Have vulvodynia for at least 6 months and for no more than 15 years
* Have provoked pain at the vestibule on a Q tip test

Exclusion Criteria:

* Deep pain during intercourse
* Have genitourinary or gastrointestinal conditions which may interfere with the study
* Previous surgery that according to investigator's judgement may impact on study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting
Effect of Physical Activity Following Thoracic Mobilization on Heart Rate Variability and Pressure Pain Threshold.

Comparison of the effects of physical activity (treadmill running) plus thoracic mobilization, physical activity only or a placebo intervention (only manual contact thoracic mobilization), on heart rate variability and pressure pain threshold.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects
* Sedentary

Exclusion Criteria:

* Spinal pain
* Historic of trauma/surgery to the spine
* Diabetes
* Hypo/hyperthyroidism
* Alcoholic
* Smoker
* Hypertension
Brain-derived Neurotrophic Factor and the Antidepressant Efficacy of Brain Stimulation

This study evaluates an association between brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, intermittent theta-burst stimulation treatment or sham treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 21 to 70 years of age.
* Diagnosed with the recurrent Major depressive disorder (MDD) and currently having a Major Depressive Episode (MDE)
* Participants failed to respond to at least one adequate antidepressant treatment in their current episode
* Participants have a Clinical Global Impression - Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale (HDRS-17) at both screening and baseline visits ( Day -14 and Day 0)
* Participants must discontinue their antidepressant medications at least for one week ( at least two weeks if Fluoxetine) prior to the TMS intervention and keep antidepressant-free during the study duration.

Exclusion Criteria:

* a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria)
* Participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results.
* Participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers
* Women with breastfeeding or pregnancy
* Participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17)
The Value of Integrated Pulmonary Index Monitoring in Detecting Respiratory Events

Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation procedures and can provide early warning during cardiorespiratory derangements.The aim of the study is to determine whether the Integrated Pulmonary Index (IPI) detects changes in ventilation status early in patients undergoing gastrointestinal endoscopy under sedation, and to determine the risk factors affecting hypoxia and severe hypoxia.

A single-center and retrospective study was conducted in 154 patients who underwent upper and lower gastrointestinal system endoscopy in the endoscopy unit between October 2018 and December 2019. Patients who were monitored by capnograph in addition to routine monitoring (ECG, noninvasive blood pressure and pulse oximetry monitoring) during the procedure in the endoscopy unit were included in the study.

Patients were administered 2 mg midazolam as premedication for 5 minutes before the procedure and propofol 1-1.3 mg/kg bolus for sedation, followed by repeated doses (10-30 mg) according to the Ramsey sedation score. All patients were given 2 lt/min oxygen via nasal cannula during the procedure. In pulse oximetry, oxygen saturation longer than 15 seconds was defined as less than 92% hypoxia, and below 85% was defined as severe hypoxia.

IPI value was measured with Smart Capnography™, Microstream® Integrated Pulmonary Index device. According to the capnographic information obtained from the patients and preserved in the capnograph disc memory, the planned findings in the study are as follows:

1. Number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds)
2. Number of severe hypoxic events observed in patients (SaO2 value below 85%)
3. Apnea episodes observed in patients (observation of a straight line longer than 15 seconds on the capnograph, absence of respiratory activity)
4. Time from apnea to development of hypoxia and severe hypoxia in patients who develop hypoxia and severe hypoxia following apnea
5. Time between IPI=1, IPI\<7, EtCO2=0 and hypoxia and severe hypoxia.

Eligibility Criteria:
Inclusion Criteria:

* Patients monitored by capnograph
* ASA I-III
* Patients who underwent an elective endoscopic procedure

Exclusion Criteria:

* Patients who do not have capnograph monitoring or whose capnography records are missing
* Emergency endoscopic intervention (GIS bleeding, trauma, etc.)
* ASA IV-V
* Patients with pre-procedure SaO2 value below 90%, systolic blood pressure below 90 mmHg, heart rate below 50 beats/minute
LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease

The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when administered topically for up to 42 days, in subjects with severe dry eye disease.

This study is organized into 2 phases. Following a 2-week identification phase, eligible subjects with severe dry eye disease (DED) will be randomized into the treatment phase and will be dispensed study treatment for 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Must sign written informed consent.
* Physician diagnosis of DED of at least 6 months prior to Visit 1.
* Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis.
* Respond as "often" or "constantly" to the question "How often do your eyes feel uncomfortable?".
* Best Corrected Visual Acuity (BCVA) of 55 or greater in each eye as measured by ETDRS at Visit 1.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Presence of any acute infection or non-infectious ocular condition in either eye within 1 month of Visit 1.
* Contact lens wearers, defined as individuals who cannot be without their contact lenses for the entire duration of the study.
* Any chronic ocular degenerative condition that in the opinion of the Investigator could possibly advance during the time course of the study.
* Use of biologics treatments, such as systemic biologic anti-cytokines, including anti-TNFα drugs, or immunosuppressive therapy for the treatment of severe systemic autoimmune disorders.
* Diseases or conditions affecting the ocular surface that are associated with clinically significant scarring and or destruction of conjunctiva and/or cornea.
* Unwilling to abstain from topical ocular non-prescription medications during the course of the study, including concomitant use of artificial tears, gels, lubricants, re-wetting drops, allergy drops, etc. after Visit 2.
* Use of nasal, inhaled, systemic (including injections), or topical corticosteroids within 30 days of Visit 1.
* Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.
* Other protocol-specified exclusion criteria may apply.
Quantification of Metamorphopsia in Patients With Epiretinal Membranes

Aim of this study is to examine metamorphopsia before and 3 months after vitrectomy with membrane peeling among patients with idiopathic epiretinal membranes. Therefore, the correlation between the Alleye App and the M-chart test before and after ERM surgery and the associations of OCT biomarkers to postsurgical changes in metamorphopsia scores will be examined.

Epiretinal membranes are common disorders leading to visual loss and metamorphopsia in later stages. In most cases they are idiopathic with no identifiable cause (iERM). ERM can be visualized with optical coherence tomography (OCT) and can cause metamorphopsia, usually diagnosed with the Amsler grid or metamorphopsia chart (M-chart), which have influence on vision. ERM are surgically treated by vitrectomy and membrane peeling, however, postoperative visual acuity and quality of vision are difficult to predict. Quality of vision is highly dependent on metamorphopsia which can be an overlooked symptom. Thus, detailed examinations using M-charts prior to surgery can help to quantify the degree of metamorphopsia and might predict the potential benefit of the surgery. Recently, home monitoring tests for metamorphopsia using handheld mobile devices are becoming increasingly important. The Alleye App is one of two m-health applications with FDA approval, that is already in use for monitoring the progression of metamorphopsia in other retinal diseases such as age-related macular degeneration (AMD). It has yet to be evaluated for ERM. Aim of this study is to examine the correlation between the Alleye App and the M-chart test before and after ERM surgery and the associations of OCT biomarkers to postsurgical changes in metamorphopsia scores.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic ERM
* Sheduled surgery (vitrectomy with membrane peeling)
* Age 18 and older
* Written informed consent for participation in the study
* Metamorphopsia detected by the Amsler grid
* BCVA ≥ 0,1

Exclusion Criteria:

* Secondary ERM due to retinal tears, retinal detachment, retinal vascular diseases and uveitis
* Other macular disorders including AMD
* Previous intraocular surgery except for uncomplicated cataract surgery
* Pregnancy (pregnancy test will be performed in women of reproductive age)