cyrilzakka/clinical-trials huggingface dataset:
Effects of Lidocaine Bolus and Infusion on Bispectral Index Values and Spectrum During Anesthesia Maintenance

Lidocaine has been shown to increase the hypnotic effects of Propofol, however no trials shows the effects on Bispectral Index Values (BIS) and spectral analysis during total intravenous anesthesia maintenance delivered with target controlled infusion (TCI) with stable Concnetration at the effector site of Propofol (CeP)

Lidocaine has been shown to increase the hypnotic effects of Propofol, however no trials shows the effects on Bispectral Index Values (BIS) and spectral analysis during total intravenous anesthesia maintenence delivered with target controlled infusion (TCI) with stable concentration at the effector site of Propofol (CeP).

Aim of this study is to analyze BIS values and power spectrum before and after a lidocaine bolus (1,5 mg/kg delivered in 10 minutes) and a subsequent continuous infusion (1,5 mg/kg/min for 30 minutes) delivered at anesthetist's discretion for postoperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Undergo general anesthesia with Target Controlled Infusion of Propofol (Schnider model) and Remifentanil (Minto model) and Lidocaine bolus and continuous infusion for a total of 40 minutes.

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity
Gallbladder Stenting in FC-SEMS

The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.

The main question it aims to answer is:

Does prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.

Participants will:

1. receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement
2. will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Signed informed consent
* Patients requiring covered metal stent placement for managing MBO
* High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:
* tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;
* presence of at least 2 of the following:

  1. gallbladder stones;
  2. CBD diameter ≤ 10 mm;
  3. intraprocedural gallbladder opacification;
  4. cystic duct orifice at risk of being covered by the fully-covered stent

Exclusion Criteria:

* History of cholecystectomy
* Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation
* Patients with previous gallbladder drainage
* Acute cholecystitis is already present based on the Tokyo guidelines
Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

The goal of this clinical trial is to evaluate the efficacy of a musical interventionand non-invasive brain stimulation in neurological patients. The main questions it aims to answer are:

* to evaluate the residual neuroplastic processes in DOC state related to music exposure
* to determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulation
* to evaluate the impact of this intervention on caregiver's burden and psychological distress.

Participants will be randomly assigned to one of three different music-listening intervention groups. Primary outcomes will be clinical, that is based on the neurologist's observations of clinical improvement, and neurophysiological, collected pre-intervention, post-intervention and post-placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Post-stroke aphasia
* Post-stroke neglect
* Patients with disorders of consciusness (DOC)

Exclusion Criteria:

* No auditory injury
* no hystory of neurological disease
* No hystory of psychiatric disease
* Previous stroke
* use of alcohol and drugs
* premorbid dementia
Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients

Deep brain stimulation of the NST is effective for cardinal motor signs in patients with idiopathic Parkinson's disease (IPD), its effects on gait disturbances, especially freezing of gait-FOG, and falls are variable from one patient to another, in part depending on the location of the NST-stimulating contact. The ability to change the shape of the current field, and thus the volume of activated tissue, with a directional stimulation electrode is a new treatment option for NSC SCP patients with Parkinson's disease. In this pilot research program, the main objective is to determine the impact of directional DBS on gait and balance issues for PD patients implanted in the STN, using previously described anatomical and functional data for gait disturbances to guide directional programming. Ten patients with Patients with severe form of Parkinson's disease eligible to deep brain stimulation of the subthalamic nucleus, will be included in two French sites.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years
2. Diagnosis of Parkinson's Disease; as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
3. Patients eligible for subthalamic bilateral deep brain stimulation (STN-DBS) according to local inclusion criteria;
4. Freezing of gait in the OFF-dopa condition with item 2.13 of the MDS-UPDRS \> 0 in usual life;
5. Patient having read and understood the information letter and signed the Informed Consent Form
6. Patient affiliated with, or beneficiary of a social security category
7. Stability of others medical disorders or that do not interfere with the research protocol.
8. Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestin or intra-uterine device or tubal ligation) since at least 3 months (negative urinary pregnancy test at inclusion)

Exclusion Criteria:

1. Actual and severe psychiatric pathology or other neurological disorder
2. Dementia (MMS \<24/30)
3. Contraindication to research MRI (without contrast product) such as claustrophobia, metallic splinters in the eyes, ferromagnetic foreign bodies close to nerve structures, cardiac, ORL and neurological devices not MRI compatible, wearing of osteosynthseis equipment prior to 1980, metal prostheses, bypass valves ventriculoperitoneal neurosurgery, tattoos containing iron particles...
4. Contraindication to surgery: hemostasis trouble, anticoagulants or antiagregants treatment, ongoing infection
5. Hypersensitivity to contrasts agents
6. Persons under guardianship, tutorship or any other administrative or judicial measure of deprivation of rights and liberty
7. Subject at the time of exclusion from other biomedical research or participating in any other biomedical research or therapeutic trial
8. Pregnant or parturient or lactating woman or lack of proven and effective contraception according to WHO definition (estrogen-progestin or intra-uterine device or tubal ligation) (for women of childbearing age)
Effectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children

this study conducted to evaluate the effectiveness of preoperative tour to simulation operating theater on reducing children's and parents' preoperative anxiety. half of the participant were taken in a tour to a simulation operating theater before the day of operation and the other half were given the standard of care.

the investigators examined the effectiveness of a preoperative tour to a simulation operating theater guided by an expert anesthesia technologist on reducing the Preoperative anxiety levels for children who were scheduled for elective day case procedures under general anesthesia, and their parents' anxiety levels through a 10-months randomized controlled trial at tertiary medical center in Riyadh-Saudi Arabia, and confirmed that children and parents who received the intervention had significantly lower preoperative anxiety levels than controlled children and parents.

Given that, the results showed critical levels of preoperative anxiety among school age children, and that preoperative tour to simulation operating theater as a child-friendly maneuver is directly applicable and could be considered for children scheduled for day-case procedures under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* children who were scheduled for elective day-case procedures under general anesthesia at KFMC.
* class 1 or 2 according to the American society of anesthesiology physical status.

Exclusion Criteria:

* diagnosed as having mental or psychological disorders.
Research on Quantification of VR(Virtual Reality) Related Stress and Relaxation

Current virtual reality device makes motion sickness and visual fatigue having limitation for recreation and other clinical approaches. Still there is no standardized quantification of motion sickness and visual fatigue measurement with objective approach. Current biofeedback accompanied with virtual reality would be promising tool for stress relief.

Current virtual reality device makes motion sickness and visual fatigue having limitation for recreation and other clinical approaches. Still there is no standardized quantification of motion sickness and visual fatigue measurement with objective approach. After quantification and improvement with these shortcomings, current biofeedback accompanied with virtual reality would be promising tool for stress relief. This research aims to measure objective motion sickness and visual fatigue with psychological stress in highly stressed group, and to compare between stress relief with existing biofeedback only approach and relief with mixed biofeedback and virtual reality relaxation.

Eligibility Criteria:
Inclusion Criteria:

* scored at least 20 on the PSS-10 (Perceived Stress Scale 10) to verify highly psychological stressed participants at the baseline visits.

Exclusion Criteria:

* the existence of a current Major depressive disorder or panic disorder, psychotic disorder (e.g., schizophrenia or delusional disorder), bipolar affective disorder,active alcohol or drug use disorder, neurological illness including significant cognitive impairment or Parkinson's disease, mental retardation, significant medical conditions, epilepsy, histories of alcohol or drug dependence, personality disorders, or brain damages during the screening and baseline visits, per the Mini-International Neuropsychiatric Interview (Sheehan et al., 1998) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* the existence of active disease in both orbital parts
Angiogenic Factors in the Placentas of Women With COVID-19

Aim: There have been few studies since the beginning of the pandemic researching the histopathologies and conducting molecular investigations of the placentas of SARS-CoV-2 positive pregnant women. The aim of this study was to analyze the changes in the expression of angiogenic growth factors in the placentas of pregnant women infected with SARS-CoV-2 (the COVID-19 group), and to make comparisons with the placentas of non-infected pregnant women (the control group).

Methods: Placentas taken at birth from 20 healthy women (control) and 20 women with a positive test for COVID-19 were prepared for histopathological examination. Immunohistochemical staining was applied in placental tissues with ACE2 (Angiotensin-conversion enzyme-2), VEGF (Vascular Endothelial Growth Factor), VEGFR-1 (Vascular Endothelial Growth Factor Receptor 1) and PDGF (Platelet-Derived Growth Factor).

Results: First, the presence of COVID-19 in the placental tissue was assessed by the ACE2 immunohistochemical method. It was seen that ACE2 was expressed weakly in the placental syncytiotrophoblast cells of non-infected women, but in the syncytiotrophoblasts of the placentas of women infected with COVID-19, ACE2 expression was much higher. VEGF in the endothelial and stromal cells of the villi of the control group was very strong, but in the villi of infected placentas it was significantly weaker. VEGFR-1 was positive in the endothelial membranes of the villi of the control group, but was significantly weaker in the villi of infected placentas. PDGF expression was strong in the syncytiotrophoblast and stromal cells of the control group, but was significantly noticeably weaker in COVID-19 positive placentas.


Eligibility Criteria:
Inclusion Criteria:

* Covid-19 patients while pregnancy
* Age range 18-50
* Being literate in Turkish
* Not having any additional disease
* Agreeing to participate in the study

Exclusion Criteria:

* High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
* Multiple pregnancy
* Pregnant women under the age of 18
* Smoking
* Medication use (excluding routinely used food supplements during pregnancy)
* Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
* Immunosuppressive use
* Presence of active or chronic infection
* Presence of active or chronic inflammatory disease
* Patients who gave birth at an external center or later chose to withdraw from the study
* Patients who did not have Covid-19 while pregnancy included in the control group
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.

Delivery of Interventions:

Prior to each visit, study subjects will be asked to:

* eat at least 150 gm carbohydrates per day
* refrain from strenuous exercise

On the day of the visit, study subjects will:

* eat a standardized meal prepared by the metabolic kitchen in the clinical research center
* be observed overnight to ensure a 12-hour fast
* have an IV placed, for a 16 hour kisspeptin or placebo infusion
* after the 12 hour fast, starting at 8 am in the morning will undergo a mixed meal tolerance test

Eligibility Criteria:
HISTORY

* no personal history of chronic disease, except well controlled thyroid disease
* no history of diabetes in a first degree relative, including gestational diabetes
* no family or personal history of hyperlipidemia
* normal timing of menarche (age 10-14)
* normal menstrual cycles (q25-35 days)
* no use of contraceptive pills, patches or vaginal rings within last 4 weeks
* nulliparous (no history of a pregnancy)
* no active illicit drug use
* no history of a medication reaction requiring emergency medical care
* no difficulty with blood draws
* stable weight for previous three months
* available for all parts of the study

PHYSICAL

* body mass index (18.5-25)
* systolic BP \< 120mm Hg, diastolic \< 80 mm Hg
* normal waist circumference (less than 32 inches)

LABORATORY STUDIES: (per Massachusetts General Hospital reference ranges)

* fasting LDL cholesterol less than 130 mg/dL
* fasting triglycerides less than 150 mg/dL
* normal hemoglobin
* hemoglobin A1C \< 5.7%
* blood urea nitrogen, creatinine not elevated
* AST, ALT not elevated
* negative serum pregnancy test
Vitamin D Deficiency and Low Bone Mineral Content in Children

The Vitamin D study is designed to investigate the effect of body fat mass on vitamin D levels in children. Earlier studies have shown that individuals with increased fat mass may have low vitamin D levels.

Our specific hypothesis states that children with increased fat mass will have lower blood levels of vitamin D when compared to non-obese children.Since vitamin D is the primary hormone for bone mineralization in humans, low levels of vitamin D could lead to decreased bone mineral content in these children.

Fifty prepubertal male and female children of ages between 3-12 years will participate in this study. Of these, 25 obese children will be enrolled in the study group, and 25 non-obese children will serve as controls.

All subjects will fill out a comprehensive mineral intake questionnaire as part of the study to ensure adequate calcium intake prior to the study.

All subjects will collect a first morning urine sample for calcium, creatinine, and NTX.

Fasting blood samples will be drawn for the following analytes: 25-hydroxyvitamin D, 1, 25-dihydroxyvitamin D, intact PTH, calcium, phosphorus, magnesium, osteocalcin, insulin, c-peptide, fasting blood glucose, leptin, and adiponectin.

Bone Mineral Content will be evaluated in 16 obese subjects with vitamin D level of \< 30 nmol/L.

Eligibility Criteria:
Inclusion Criteria:

* General: Prepubertal children (males, with testicular volume of ≤ 3 cc, and girls with Tanner 1 breast) of ages 7-11 years will be enrolled in the study.
* Study group: Subjects with a BMI of \> 95th percentile for age and sex.
* Control group: All control subjects will have a BMI of \< 85th percentile for age and sex.

Exclusion Criteria:

* known metabolic or genetic diseases resulting in obesity such as severe hypothyroidism, pseudohypoparathyroidism, or Cushing's disease
* diabetes mellitus
* subjects on lipid lowering medications
* subjects on medications known to impact body weight or calcium homeostasis
* subjects with a history of recent significant weight loss or gain
Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care.

The main objective of this work is to assess the intraoperator reproducibility in the calculation of the HEP score in a population of intensive care patients.

The "HEP score" (HIT Expert Probability) is also a clinical probability score, created thanks to the experience of clinicians (16). It is very recent and therefore still little studied and little used. In particular, it has not been the subject of a prospective validation study for ICU patients.

The use of this score is therefore not recommended in everyday practice.

However, the literature shows a higher diagnostic value of the HEP score especially for resuscitation-type patients, as well as when used by an operator with little experience. This could be due to greater detail given in consideration of other causes of thrombocytopenia (17).

The main objective of this work is to assess the intraoperator reproducibility in the calculation of the HEP score in a population of intensive care patients.

The secondary objectives will aim to:

* Evaluate inter-operator reproducibility
* Determine if the reproducibility of the HEP score is influenced by:

The patient's sex The type of heparin used (LMWH vs UFH) The severity of the patient (IGS2 score) A history of cardiac or orthopedic surgery

The expected consistent benefits allow validation of the HEP score in surgical intensive care (cf. EVHEP-TIH study).

This would allow a better assessment of the pre-test probabilities of TIH with the performance of biological tests.

Eligibility Criteria:
Inclusion Criteria:

* any adult patient (age ≥ 18 years), admitted to surgical intensive care, treated with heparin (UFH or LMWH), and suspected of TIH by a clinician in the department according to the criteria of the SFAR 2002.

Exclusion Criteria:

* Non-inclusion criteria: minor patients, pregnant women and adults incapable
A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004)

This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.

This open-label Phase 2 study will evaluate the efficacy and safety of belzutifan in participants with VHL disease who have at least 1 measurable RCC tumor. Belzutifan will be administered orally and treatment will be continuous. Participants will be evaluated radiologically approximately 12 weeks after initiation of treatment and every 12 weeks thereafter while continuing in the study for a minimum of 3 years and then every 24 weeks or more frequently if clinically indicated. Changes in VHL disease-associated non-RCC tumors will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration
* Has at least 1 measurable solid RCC tumor and no RCC tumor that requires immediate surgical intervention. The diagnosis of RCC can be radiologic (histologic diagnosis not required). Participants may have VHL disease-associated tumors in other organ systems

Exclusion Criteria:

* Has received prior treatment with belzutifan or another HIF-2α inhibitor
* Has had any systemic anti-cancer therapy (includes anti-vascular endothelial growth factor \[VEGF\] therapy or any systemic investigational anti-cancer agent)
* Has an immediate need for surgical intervention for tumor treatment
* Has evidence of metastatic disease on screening imaging
Rivastigmine Study in Adolescents With Down Syndrome

The purpose of this study is to determine if short term use of rivastigmine can improve functional abilities (for example, language, memory, and executive function) in adolescents with Down syndrome.

This 24 week, double-blind, placebo controlled trial will be completed at the Clinical Research Unit of Duke University Medical Center and at the Kennedy Krieger Institute (KKI). Sixteen evaluable subjects will be enrolled at Duke and 24 evaluable subjects will be enrolled at KKI. The study consists of four visits, a screening visit (-4 weeks), a baseline visit (week 0); a safety visit at week 10, and a final/termination visit at week 20.

The specific aims of this study are to: a) investigate efficacy of rivastigmine tartrate treatment; b) build upon our open-label treatment results of overall function and language improvement in adolescents with Down syndrome (DS) in a double-blind, placebo-controlled clinical trial; and c) investigate other specific cognitive domains that may selectively respond to rivastigmine tartrate treatment.

The original IRB-approved protocol included the Parent/Caregiver Rating Form of the Vineland Adaptive Behavior Scales- Second Edition (VABS-II) . The protocol was amended to replace the Parent/Caregiver Rating Form of the Vineland Adaptive Behavior Scales- Second Edition (VABS-II) with the Vineland Adaptive Behavior Scales, Second Edition, Survey Interview Form. The protocol was also amended to extend the trial from 12 weeks to 20 weeks. Due to the changes in the amended protocol the subject enrolled prior to the IRB amendment will not be included in the data analysis section.

Eligibility Criteria:
Inclusion Criteria:

1. Correct VERBAL responses for 7/9 of the Expressive One Word Picture Vocabulary Test items.
2. Subject able to put at least 2-3 words together in conversational speech.
3. Subject's speech is understandable to the examiner for the majority of the time.
4. Subjects are in good health and medically stable

Exclusion Criteria:

1. Subject uses sign language as a primary means of communication
2. Subject has a medical history that contraindicate the use of rivastigmine (For example, patients with active seizure disorders, asthma, celiac disease, heart disease or heart rhythm disorders).