cyrilzakka/clinical-trials huggingface dataset:
Ruboxistaurin in New York Heart Failure Classification III-IV Patients

This study evaluates the effect of ruboxistaurin for its safety, tolerability, and effectiveness in treating adult patients with heart failure. Patients will receive 1 dose of oral ruboxistaurin.

Ruboxistaurin is a drug initially developed for treatment of diabetic peripheral retinopathy. The proposed indication for ruboxistaurin in this study is the treatment of adult patients with New York Heart Failure Association (NYHA) Class III-IV heart failure. Ruboxistaurin is a protein kinase c-alpha (PKC-alpha) inhibitor and thus will produce an inotropic effect in the heart which holds the potential to improve cardiac function.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 30-75 years of age, inclusive
2. NYHA Class III-IV heart failure (HF) confirmed left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) \<40% as assessed by noninvasive imaging studies such as echocardiography or cardiac MRI within the last 6 months admitted with decompensated heart failure and almost ready for clinical discharge
3. Patient must have had adequate therapy for acute decompensated HF (heart failure) episode prior to enrollment

Exclusion Criteria:

1. Patients with acute coronary syndrome
2. Resynchronization therapy initiated less than 90 days prior to enrollment
3. (LVAD) left ventricular assist device or heart transplantation expected within the next 3 months
4. Patients on hemodialysis or end stage renal disease (ESRD)
5. Patients with serum albumin less than 3 g/dL or evidence of liver cirrhosis
6. Patients with uncontrolled arterial hypertension (systolic blood pressure \> 180 or diastolic blood pressure \>110)
7. Patients with severe valvular heart disease
8. Patients with acute myocarditis
9. Patients with serum creatinine \>3.0 mg/dl or BUN \>70 mg/dL
10. Patients with hemodynamic instability or significant active arrhythmias
11. Patients currently on intravenous inotropic therapy or those that have received inotropic therapy within the last 24 hours prior to study enrollment
12. Patients currently on CYP3A inhibitors, or patients that have taken CYP3A inhibitors within 3 months prior to enrollment
13. Patients with ongoing ischemia
14. Patients who have had a myocardial infarction within 30 days prior to study enrollment
15. Patients who are pregnant, nursing, or planning to become pregnant during the study period
Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients

The aim of this study is to compare the paramedian approach for spinal anesthesia using ultrasound assistance (USAS) versus conventional palpation in morbidly obese patients undergoing elective surgeries.

Performing spinal anesthesia using a conventional approach can be considerably challenging in obese patients. Multiple needle attempts may lead to a higher incidence of complications (e.g., postdural puncture headache, paresthesia, hematoma, and infection) and increase patient discomfort and dissatisfaction. Therefore, novel techniques are needed to improve the success rate of spinal anesthesia for such patients.

There are two puncture approaches for spinal anesthesia: median approach puncture and paramedian approach puncture. Early studies have noted that the success rate of paramedian approach puncture was higher than that of median approach puncture and that it is associated with fewer complications and postoperative complications.

A paramedian approach has been shown to improve the success rate of spinal anesthesia, especially in patients who are unable to sit up or those with a degenerative spine condition. The use of ultrasound has been suggested to increase the efficacy of spinal anesthesia.

Recently, ultrasound has emerged as a way to facilitate lumbar neuraxial blocks, namely, the ultrasound assistance (USAS) technique. The ultrasound assistance technique is beneficial for lumbar neuraxial anesthesia, improving technique performance by providing reliable anatomical information.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Both sexes
* Body mass index (BMI) ≥ 40 kg/m2
* Patients undergoing elective surgeries

Exclusion Criteria:

* Rejection of spinal anesthesia
* History of spinal deformity or spinal surgery
* Contraindications to spinal anesthesia (infection of the puncture site, coagulation dysfunction, allergy to local anesthesia, insufficient blood volume or abnormal spinal anatomy).
Computerized Cognitive Training for Patients With Epilepsy

This is a study on the effectiveness of computerized cognitive training for treatment of memory disorders in patients with epilepsy. Participants will be recruited from patients referred for neuropsychological assessment through the NYU Comprehensive Epilepsy Center's inpatient and outpatient services. Individuals meeting inclusion criteria will be screened for the presence of memory disturbance (defined by results of neuropsychological testing) and lack of exposure to any previous form of computerized cognitive training. All eligible subjects will be provided with an account for Lumosity with instructions to complete training modules 5 days per week for a total of 8 consecutive weeks. Outcomes will be evaluated through changes on the neuropsychological test battery.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of epilepsy based on medical records. The records will be reviewed by the PI and the approved study personnel to confirm that a diagnosis of epilepsy has been made.
* Presence of memory disturbance, as defined by an immediate or delayed memory index score \< 85 on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
* Availability of a home computer and internet for access to the computer training program.

Exclusion Criteria:

* Full Scale IQ \< 80, as assessed by an appropriate Wechsler scale (WAIS-IV or WASI-II).
* Epilepsy surgery within 8 weeks of the beginning of the trial.
* History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Alzheimer's disease, multiple sclerosis, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
* History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia or bipolar disorder). Patients with depression or anxiety (treated or untreated) without psychotic features are not excluded.
* Visual or auditory impairment, which precludes participation in part, or all of the testing or computer training.
* English as a first language will not be required, but participants must have either received some of their schooling in English or used English in their work for \>10 years.
* Previous exposure (\> one week) to Lumosity or a similar computerized training program.
Progesterone in Expectantly Managed Early-onset Preeclampsia

Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum

Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. Previous studies reported that patients with severe PE had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. Moreover, supplementation of placental ischemic rats with 17-OHPC decreased blood pressure, inflammatory cytokines, and ET-1 within 24 hours of treatment

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 20+0 and 33+6 weeks.
* Singleton pregnancy.
* Willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
* Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations).
* Platelet count \< 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
* Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
* Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
* Severe Oligohydramnios (AFI \< 5cm)
* Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
* Eclampsia;
* Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations);
* Intrauterine fetal death.
* Patient is unable or unwilling to give consent.
* Patients currently using progesterone for other indications.
Impact of Vouchers and Nutrition Education on the Consumption of Fruits and Vegetables Among Vulnerable Families (FLAM)

The purpose of this study is to assess whether fruit and vegetables vouchers combined with educational support may increase fruits and vegetables consumption of children aged 3 to 10 living in vulnerable families in Saint-Denis, France.


Eligibility Criteria:
Inclusion Criteria:

* At least one of the following criteria :

  * One or both parent(s) is/are beneficiary of resource allocation condition
  * One or both parent is/are unemployed
  * Household income below the poverty line
* Minimum of one child aged 3 to 10 at the time of the inclusion
* Stable housing

Exclusion Criteria:

* Parent is under 18
* Family having no permanent address or planned move within a year
* Consent form unsigned
* Opposition of a parent for their child's inclusion in the study
* Higher household income of 1700 euros per month for single-parent family or higher than 2 000 euros for other families
Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia

PRIME-Ataxia is a randomized controlled trial that aims to determine the feasibility and efficacy of an 8-week telehealth intervention of high intensity aerobic exercise prior to balance training compared to an 8-week telehealth intervention of low intensity exercise prior to balance training in people with spinocerebellar ataxias (SCAs). The investigators additionally aim to explore changes in motor skill learning on a novel motor skill task in a sub-group of participants pre and post intervention.

The PRIME-Ataxia randomized controlled trial involves 2 groups of participants (n=20). One group (high intensity exercise + balance) will receive high intensity aerobic exercise followed by balance training, and another group (low intensity exercise + balance) will receive low intensity exercise (stretching, warm up exercises) followed by balance training. Both groups will undergo four remote assessments (2 baseline assessments, a mid-intervention assessment, and a post-intervention assessment). A subset of individuals (n=12) from both groups will undergo an in-person assessment on a novel motor task, along with digital posturography assessment of standard functional assessments of mobility and balance at baseline 1 (week 0), and post-intervention (week 16).

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 to 85 years
2. Genetically confirmed diagnosis of SCA1, 2, 3, 6, and 7
3. Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease
4. Able to walk with/without assistive device
5. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) to confirm no medical contraindications to exercise
6. Care partner availability during assessments and/or intervention pending balance scores

Exclusion Criteria:

1. Severe non-ataxic motor symptoms such as dystonia, tremor, or Parkinsonism, measured by Inventory of Non-Ataxia Signs (INAS)
2. Peripheral sensory loss (as confirmed with monofilament or clinical proprioceptive testing)
3. Severe visual complications associated with ataxia (i.e., Spontaneous nystagmus, retinal or optic nerve involvement, especially in SCA7) defined as as have a score on the Snellen Visual Acuity test = 20/200 - 20/400, OR a visual field of 20 degrees of less.
4. Musculoskeletal injury that would prevent participation in an exercise program
5. Other concurrent disease of the cerebellum (e.g. stroke, multiple sclerosis)
6. Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
7. Currently engaged in \>3 week moderate-high intensity aerobic exercise and/or balance training
Two Consecutive Sunscreen Applications Optimize Sun Protection

The investigators aim to investigate how much two consecutive applications of sunscreen before sun exposure can increase the quantities of sunscreen applied and decrease the skin area left without sunscreen compared to a single application. Volunteers wearing swimwear applied sunscreen in a laboratory environment twice and had pictures taken in black light before and after. As sunscreens absorb black light the darkness of the skin increased with increasing amounts of sunscreen applied. The investigators conducted a standard curve establishing a link between picture darkness and applied sunscreen quantity. Participants were asked to apply sunscreen the way they would normally do but two consecutive times. No other advice was given. The level of protection was determined by picture analysis as measurements of darkness of selected skin sites as well as the percentages of skin area left without sunscreen in different body regions and in total.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasians between older than 18

Exclusion Criteria:

* Suffering from a skin disease, were allergic to the content in sunscreen, were pregnant or breastfeeding
Tai Chi Exercise in Older People

The effects of tai chi exercise and lower-extremity training on improving the primary outcome and secondary outcomes among older people will be compared.

Does not desire.

Eligibility Criteria:
Inclusion Criteria:

* Persons aged 60 years and older and who require medical attention in the emergency rooms due to sustaining a fall.

Exclusion Criteria:

* A major unstable cardiopulmonary disease
* Cognitive impairment
* Contraindications to physical exercise
* The inability to ambulate
* Frail elderly.
Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block

Regional block of ilioinguinal and iliohypogastric (IIIH) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. Magnesium sulfate (MgSo4) blocks N-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (LA) in different anesthetic approaches. Although the prolongation in postoperative duration resulting from the addition of MgSO4 to LA was significant in some literature studies, it was insignificant in others. This study was designed to investigate the adjunctive effect of MgSo4 when added to bupivacaine for IIIH blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (VRS) scores, analgesic consumption, and hemodynamics as secondary outcomes.

Regional block of ilioinguinal and iliohypogastric (IIIH) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. Magnesium sulfate (MgSo4) blocks N-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (LA) in different anesthetic approaches. Although the prolongation in postoperative duration resulting from the addition of MgSO4 to LA was significant in some literature studies, it was insignificant in others. This study was designed to investigate the adjunctive effect of MgSo4 when added to bupivacaine for IIIH blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (VRS) scores, analgesic consumption, and hemodynamics as secondary outcomes. Patients were divided into two groups of 45 patients each by means of coded envelopes according to the LA used for IIIH blockade. In the first group (control group), patients received 10 ml 0.5% isobaric bupivacaine plus 1 ml normal saline for IIIH blockade, whereas in the second group (MgSo4 group), 10 ml 0.5% isobaric bupivacaine and 1 ml of MgSo4 10% were prepared. All the patients received intrathecal 3 ml 0.5% hyperbaric bupivacaine, and then, IIIH blockade was performed under ultrasound guidance according to the group. Postoperatively, VRS scores,analgesic duration, and any complication were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult male
* American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

* Patients with body mass index greater than or equal to 35 kg/m2
* allergy to the study drugs
* on chronic analgesics or drug containing magnesium
Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder

Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. While effectiveness of TC-pTNS has been demonstrated in the literature, the success rate is heterogeneous, depending on the clinical picture. In an effort to ascertain clearly the efficacy of Tensi+ device, as well as its safety of use and assess comfort of use, the present study will evaluate the results of Tensi+ treatment in real life conditions in a prospective study. The main objective is to assess the efficacy (actual clinical benefit) of TC-pTNS with Tensi+ device for management of overactive bladder in an adult population at 3 months.

Included patients are prescribed a treatment with Tensi+ for 3 months. An evaluation visit is scheduled at 3 months. In treatment is continued, a follow-up visit is scheduled at 6 months.

Primary outcome measure

Success at 3 months defined as a composite parameter:

(i) Objective improvement, with at least 30% decrease of urgency episodes compared to baseline on 3-day bladder diary AND (ii) Subjective improvement, with patient Global Impression of Improvement score of 1 or 2 Time point(s) at which primary outcome measure is assessed : 3 months Secondary outcome measures (i) Evaluation of urinary symptoms based on bladder diary parameters (urinary frequency, incontinence episodes, maximum bladder capacity, nocturia episodes) and the Urinary Symptom Profile (USP) questionnaire (ii) Evaluation of adverse events (iii) Patient-reported Outcomes Measures (PROMs): Comfort of use (VAS in deciles), recommendation to another patient (binary), consumer grading regarding device usability details (iv) Quality of life measures (OABq questionnaire, VAS scale) (vii) Assessment of treatment persistence Time point(s) at which Secondary outcome measure is assessed\* : at 3 months and 6 months

Inclusion criteria : Age ≥ 18 years Overactive bladder symptoms

Number of subjects : 100


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients suffering from Overactive bladder symptoms

Exclusion Criteria:

* Pregnancy
* Patients with active implantable device or ankle orthopedic implant,
* Ankle articular diseases.
* Prior treatment with transcutaneous PTNS or percutaneous PTNS (any time),
* Sacral neuromodulation (anytime) or,
* Intradetrusor botulinum toxin injection within the past 6 months
* Antimuscarinic use within 1 month prior to the study
* 24hour diuresis \> 2800cc on bladder diary
* Known bladder disease
* Active urinary tract infection
* PVR\> 150 ml
* Pelvic organ prolapse stage \>2
* Predominant stress urinary incontinence
* Cognitive impairment
* Inability to use the device without a third party
* Inability to complete a bladder diary
* No health insurance coverage
Study the Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate

Study the effect of neurectomy of nasopalatine nerve on the sensation of anterior palate in patients undergoing rehabilitation of anterior maxillary ridge with dental implant

Replacement of missing teeth in the anterior maxilla could be challenging if enlargement of the nasopalatine canal which is located in the midline of the palate posterior to the maxillary central incisors or ridge atrophy occur after tooth extraction. This could place the neurovascular content of the nasopaltine canal in the path of the dental implant which may lead to complications such as nasopalatine canal cyst, sensory dysfunction or implant failure. Technique to overcome this problem have evolved including neurectomy of the nasopalatine canal content and obliteration of canal with bone graft.

Loss of sensation in anterior palate following this procedure could be an annoying complication for patients. In recent studies regaining of sensation following such procedure have been reported, Confirmation of such results is essential to rule out the side effect of loss of sensation in the anterior palatal region

Eligibility Criteria:
Inclusion Criteria:

* • Adult patients requiring dental implants placement in the anterior region of maxilla and has insufficient horizontal bone .

  * Patients should be free from any systemic conditions that may affect soft tissue healing.

Exclusion Criteria:

* • Patients with systematic disease that may complicate healing.

  * Uncontrolled diabetic patient.
  * Patients with advanced osteoporosis.
  * Patients under bisphosphonates treatment.
  * Patients with neurological disorders (neuralgias, Parkinson's disease).
  * Patients with horizontal ridge atrophy (if the horizontal dimension of the residual ridge \<3mm as determined with ridge callipers).
  * Heavy smoker patients.
Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study

This study is a follow-up extension study conducted in continuation of the prior MINT study (MMS-EEU-4), in which the long-term (i.e., 18, 24 months) clinical outcomes of Minimally Invasive Nasal Trabeculostomy (MINT) will be explored.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years to ≤ 85 years old
2. Subject who underwent MINT, and surgery was performed not earlier than 18 months from enrollment
Validation of CardioQ Versus PiCCO in Children

To compare the less invasive Oesophageal Doppler cardiac output Monitor (ODM) to the invasive (standard of care) Transpulmonary Thermodilution cardiac output monitor (TPTD) in children.

This is a validation study. The study period starts as soon as CMO approval is acquired and will end after inclusion of 17 patients. This study is designed to test the effectiveness of a non invasive ODM catheter compared to the invasive, gold standard, TPTD technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0 to 16 years with an indication for invasive CO monitoring (TPTD). Indication for invasive CO monitoring always implies intubation and sedation.
* Signed informed consent

Exclusion Criteria:

* Congenital or acquired cardiovascular diseases (intracardiac/extracardiac intrathoracic shunt
* Cardiac valve diseases
* Aortic arch anomalies
* Tissue necrosis of oesophagus
* Carcinoma of pharynx, larynx of oesophagus
* Severe bleeding diatheses
* Age \> 16 years
* Weight \< 3.5 kg or \> 50 kg.
Cannabinoids and Cerebellar-Motor Functioning

The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.

The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).

Eligibility Criteria:
Inclusion Criteria:

* Must have used cannabis at least once in their lifetime
* No cannabis use in the past month
* Men and women aged 21 to 35 years (extremes included) on the day of the first dosing

Exclusion Criteria:

* Hearing deficits
* Psychiatric or mental disorders
* Hearing Deficits