cyrilzakka/clinical-trials huggingface dataset:
Citalopram for Cocaine Dependence

This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 60 years of age
* meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine dependence
* be in acceptable health on the basis of interview, medical history and physical exam
* able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria:

* diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
* have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
* medical conditions contraindicating citalopram pharmacotherapy
* taking medications known to have significant drug interactions with the study medication
* pregnant or nursing for female patients
* having plans to leave the immediate geographical area within 3 months
Fibromyalgia in Rheumatiod and Psoriatic Patients

the study based on investigate for fibromyalgia among rheumatiod arthritis patient and psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices ....and its relation to serum Vitamin D level in those patients


Eligibility Criteria:
Inclusion Criteria:

- adult onset disease any patient diagnosed as rheumatiod arthritis and psoriatic arthritis above18years old

Exclusion Criteria:

* any other autoimmune diseases
Exploring the Relationship Between Varying CO2 Levels and the Regional BOLD Signal, by Using Breathing Exercises

The purpose of this study is to explore how arterial PaCO2 effect regional Blood Oxygen Level Dependent (BOLD) signal, and indirectly the brain regional O2 level .

Among many parameters effecting cerebral blood flow(CBF), partial pressure of CO2 (PaCO2) in arterial blood has a significant effect. A small increase in arterial PaCO2 level will cause a significant increase of CBF , followed by increase of O2 level . The main objective is to explore the effect of arterial PaCO2 level on regional CBF and brain O2 level, by using breathing exercises to modulate arterial PaCO2. The regional Blood Oxygen Level Dependent (BOLD) signal produced by MRI , will indicate the regional O2 level.

Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years old .

Exclusion Criteria:

* under 18 years old.
* Artificial pacemaker
* implantable cardioverter-defibrillator (ICD)
* Hearing aid, implantable or portable.
* artificial heart valve
* Surgical clips
* Metal fragments in eyes
* Electronic stimulators
* Implanted pumps
* Implantable Neurostimulation Device
* metal fragments of any sort
* Permanent makeup or tattoo
* transfusion pump
* pregnant or breast feeding women
* False teeth , retainer or dental crown
Sleep Disorders of Patients With Diseases of the Nervous System

The purpose of this study is to assist training doctors about different diseases of the nervous system affecting sleep.

Patients selected to participate in this study will have any of a variety of sleep disorders. They will undergo several tests including an overnight recording of brain activity, eye movement, leg movement, breathing, heart rate, and other measures.

Results of these tests will be used to better understand diseases causing sleep disorders and may be used to develop better treatments for them.

The objective of this protocol is to provide training in a broad range of neurological sleep disorders to clinical associates who are eligible for sitting in the Board examination of the Added Qualification of Clinical Neurophysiology administered by the American Board of Psychiatry and Neurology. This protocol is to supplement small accrual of research patients who are referred from within the NIH.

Eligibility Criteria:
* IINCLUSION CRITERIA:

Patients 5 years of age and older, with the following referring diagnoses:

Narcolepsy

Hypersomnia

REM behavior disorder

Frontal nocturnal dystonia

Restless legs syndrome

Insomnia

Parasomnia

Nocturnal epileptic seizure

Nocturnal movement disorder

Sleep-related diagnostic dilemma

Sleep apnea associated with neurological disorders

Patients who are ambulatory and who are able to comply with the study procedures.

Patients who are able to understand and sign the informed consent. (Parent or guardian for minors).

EXCLUSION CRITERIA:

Patients who have been diagnosed with acute and progressive neurological disorders.

Patients who are unable to comply with the study procedures and require other than standard care.
The Echodynamic Approach

The aim of this prospective observational study is to assess the accuracy of non-invasive hemodynamic parameter estimation via trans-thoracic echocardiography (TTE) compared to the invasive gold standard of right heart catheterization (RHC). This study will include patients who undergo both TTE and RHC on the same day, under the same hemodynamic conditions. The primary research question is: how does the echodynamic evaluation perform compared to right heart catheterization?

The non-invasive echocardiographic assessment will be used to esimate via mathematic formulas all the direct and indirect paramethers obtained from the right side catheterization. Each value obtained from the model using echocardiographic paramethers will be compared to the invasive finding.

Eligibility Criteria:
Inclusion Criteria:

* Clinical need for an invasive hemodynamic assessment and an echocardiographic evaluation on the same day

Exclusion Criteria:

* Incomplete hemodynamic assessment for any reason
Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

This study will be assessing the ability of PSMA-PET CT to determine the absence of clinically significant prostate cancer in patients on active surveillance (AS) with low risk and favorable intermediate-risk prostate cancer.

This is a prospective, multicenter, nonrandomized single-arm study assessing the diagnostic accuracy of PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) in determining the absence of clinically significant prostate cancer in patients on active surveillance (AS).The trial will enroll 200 subjects for low and favorable intermediate-risk prostate cancer patients per NCCN guidelines who have elected to pursue active surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Males aged ≥ 18.
* Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma).
* PSA \< 20 ng/ml.
* Ability to undergo yearly PSMA-PET CT.
* Ability to undergo yearly prostate mpMRI.
* Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
* Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
* Willingness to undergo yearly prostate biopsies.

Exclusion Criteria:

* History of prior treatment for prostate cancer.
* History of systemic therapy for prostate cancer.
* Inability to undergo transrectal ultrasound.
* Life expectancy less than 10 years.
* Not interested in pursuing active surveillance.
* Initial diagnosis of prostate cancer greater than 15 months.
EMG-Based Hand-Wrist Control: Study B Mirrored

Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects

System identification models relating forearm electromyogram (EMG) signals to phantom wrist radial-ulnar deviation force, pronation-supination moment and/or hand open-close force (EMG-force) are hampered by lack of supervised force/moment output signals in limb-absent subjects. In able-bodied and unilateral transradial limb-absent subjects, we studied three alternative supervised output sources in one degree of freedom (DoF) and 2-DoF target tracking tasks: (1) bilateral tracking with force feedback from the contralateral side (non-dominant for able-bodied/ sound for limb-absent subjects) with the contralateral force as the output, (2) bilateral tracking with force feedback from the contralateral side with the target as the output, and (3) dominant/limb-absent side unilateral target tracking without feedback and the target used as the output.

Eligibility Criteria:
Inclusion Criteria:

* Limb-absent subjects: unilateral trans-radial limb absence or amputation
* Be capable of completing the requested contractions on the affected dominant side

Exclusion Criteria:

* Past injuries to the upper limbs that would limit their ability to complete the requested contractions
* Scars that would impede the use of surface electrodes
PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon

The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.


Eligibility Criteria:
Inclusion Criteria:

• patients with confirmed pituitary disease

Exclusion Criteria:

• patients who do not have confirmed pituitary disease
Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment

The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of tonsil volume.

The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of tonsil volume. On basis of these finding and in view of the known safety profile (refer to Chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in tonsillar reduction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 70 years.
* Tonsillar Hypertrophy of grade 2 or higher on the BGST.

Exclusion Criteria:

* Age below 18 years.
* Patients with a pacemaker or similar electro stimulator.
* Patients for whom the anesthesia involves high risk.
* Epilepsy or other condition involving convulsions.
* Inability to give informed consent and to complete self-reported questionnaires.
* Patients with an inability to cooperate for treatment and follow-up.
* Severe heart disease.
* Pregnancy or breastfeeding.
* Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease).
* Bleeding diathesis.
* Patients suffering from obesity as indicated by a body mass index (BMI) \> 32kg/m2.
* Known or suspected complications for any general or local anesthetic agents and/or any antibiotic medications.
Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients

Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the usual treatment in young subjects, and although the optimal technique is still a matter of debate, conventional surgery with a direct approach is still the reference technique in young sportsmen and women. Studies investigating the evolution of ankle muscle strength following surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to determine the possibility of returning to the sport. This project thus proposes to study, in comparison with the healthy ankle:(1) the evolution of muscle strength in the flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12 months, following surgery for acute unilateral rupture of the Achilles tendon, operated on using the conventional technique in young sportsmen and women and in comparison with the healthy side.


Eligibility Criteria:
Inclusion Criteria:

* persons informed about the research
* sportsmen and women (competition or leisure, practiced \> 3h/week)
* Between 18 and 45 years old
* First episode of acute traumatic unilateral rupture of the Achilles tendon
* Open surgery in the Orthopaedic and Traumatology Department of Dijon University Hospital
* Identical post-operative immobilisation programme for 6 weeks
* Absence of major post-operative complications delaying the rehabilitation

Exclusion Criteria:

* persons without national health insurance cover
* concomitant joint disease that could be aggravated by the tests
* heart disease/contra-indication to effort required during the isokinetic test
* management other than open surgery (orthopaedic, functional, percutaneous surgery, ...)
* Rupture of the contralateral tendon
* Contra-indication for the use of the Biodex S4 pro
Glycocalyx During Normothermic Machine Perfusion

An organ intended for transplantation is normally stored on ice (cold storage, CS) after explantation from the donor. During this storage process, damage to the endothelial glycocalyx occurs. It is known from numerous studies that the integrity of the endothelial glycocalyx is necessary for organ function. Normothermic machine perfusion is an alternative storage method for explanted livers, where the graft is perfused with warm blood. This study aims to clarify the influence of normothermic machine perfusion on endothelial glycocalyx damage of the graft.


Eligibility Criteria:
Inclusion Criteria:

* First deceased donor liver transplantation receiving a graft after normothermic machine perfusion
* Recipient age \>18 years
* Written informed consent

Exclusion Criteria:

* Age \< 18 years
Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health

The purpose of this study is to explore physiological interventions and biomarkers for Apnea of Prematurity in newborn infants.

Apnea of prematurity is defined as cessation of breathing that lasts for more than 20 seconds and/or is accompanied by oxygen desaturation or a decrease in heart rate (bradycardia). Because apnea presents itself within a variety of diseases in newborns, its diagnosis is based largely on the exclusion of other findings. The difficulty in relating the manifestation of apnea to its cause can lead to issues regarding appropriate medical management and delays in treatment.

Our exploration of physiological interventions for Apnea of Prematurity begins with stochastic resonance. Stochastic resonance is the introduction of noise to a system, to alter the system's behavior. This technology has been examined in previous medical applications. The hypothesis for this work is that stochastic resonance stimulation, in the form of gentle vibrations, will stabilize immature breathing patterns in infants.

In this research study, we will use an apnea mattress developed by engineers at the Wyss Institute, Harvard University, which provides gentle vibrations to the infant. We will closely follow the research protocol from UMass Medical School. Whilst the infant is on the mattress, clinical care data will be collected to determine effect on breathing patterns. We also hope to collect enough baseline and intervention data signals to be able to identify candidate biomarkers for apnea. This will assist in development of predictive algorithms for apnea in infants.

Eligibility Criteria:
Inclusion Criteria:

Eligible subjects are infants currently inpatient in the NICU at Beth Israel Deaconess Medical Center and:

* Born premature, at a gestational age \< 36 weeks
* Demonstrate irregular breathing by having had at least one documented clinical apnea (\> 20 seconds), bradycardia (\< 100 bpm) and/or desaturation (\< 90%)

Exclusion Criteria:

Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:

* Is at a Post Conceptual Age of \> 45 weeks at time of study (Calculated as: weeks of age at birth + weeks of age since birth)
* Has demonstrable pulmonary disease at time of study, i.e. Chronic Lung Disease, Infant Respiratory Distress Syndrome
* Has Hypoxic-Ischemic Encephalopathy including a cord pH of ≤ 7
* Has a congenital abnormality
* Has a genetic syndrome
* Has an anatomic brain anomaly
* Has hydrocephalus or intraventricular hemorrhage \> Grade 3 or 4
* Is anemic (hemoglobin \< 8g/dL)
* Has an infection at time of study
* Is undergoing therapeutic hypothermia
Aphasia Therapy: Factors of Efficacy

Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has remained unclear, however, whether intensity of therapy or constraint is the relevant factor. This study will give an answer to this question to improve speech and language therapy.

Although there is clear evidence that aphasia therapy is effective, questions remain as to the intensity of administered therapy, the preferred therapeutic approach and its initiation with regard to stroke onset. CIAT is a a high intense group therapy administered over 2 weeks. Additionally, patients have to communicate solely in spoken words or sentences (constraint). This study compares CIAT with an approach of the same intensity without constraints and a less intense house-typical therapeutic approach.

Eligibility Criteria:
Inclusion Criteria:

* first ever stroke
* suffering from aphasia

Exclusion Criteria:

* severe cognitive or attentional impairments
* severe depression
* left-handedness
* severe dysarthria
* apraxia of speech
* severe deafness
* additional neurological diseases affecting speech (e.g. Parkinson's disease)
Neuroinflammation and Postoperative Delirium in Cardiac Surgery

Up to 50% of patients over 60 years old develop postoperative delirium following cardiac surgery. Delirium increases morbidity and mortality, and may lead to long-term cognitive impairment similar to patients with a diagnosis of Alzheimer's disease. The underlying mechanisms behind delirium are not understood, and therefore the current prevention and treatment strategies are inadequate. Several hypotheses exist for the pathophysiology of delirium, one of which is the role of neuroinflammation. The stress associated with high-risk procedures such as cardiac surgery may lead to systemic inflammation causing endothelial dysfunction and disruption of the blood brain barrier (BBB). When this occurs, the brain is susceptible to neuronal injury via neuroinflammation after which a state of delirium may ensue. To characterize the mechanisms of neuroinflammation in delirium, the investigators will explore the biomarkers most closely linked to each step of the proposed pathway.

Aim 1a. Test the hypothesis that endothelial injury is associated with delirium. The investigators hypothesize that endothelial dysfunction is associated with an increased incidence of delirium after cardiac surgery. To test this hypothesis, the investigators will measure biomarkers from subjects undergoing cardiac surgery. Blood samples from three time points \[baseline, upon arrival to the intensive care unit (ICU), and postoperative day 1 (POD1)\] will be analyzed and compared between patients that did and did not develop postoperative delirium.

Aim 1b. Test the hypothesis that BBB disruption is associated with delirium. The investigators hypothesize that disruption in the BBB is associated with an increased incidence of delirium after cardiac surgery. To test this hypothesis, the investigators will measure levels of biomarkers at baseline, upon arrival to the ICU, and on POD1.

Aim 1c. Test the hypothesis that neuronal injury is associated with delirium. The investigators hypothesize that neuronal injury is associated with an increased incidence of delirium after cardiac surgery. To test this hypothesis, the investigators will measure levels of biomarkers at baseline, upon arrival to the ICU, and on POD1.

Eligibility Criteria:
Inclusion Criteria:

* open heart surgery

Exclusion Criteria:

* acute coronary syndrome with troponin leak or unrelenting angina
* liver dysfunction (transaminases 2x normal)
* history of myopathy or liver dysfunction on prior statin therapy
* use of potent CYP3A4 inhibitors such as antifungal azoles, macrolide antibiotics, HIV protease inhibitors, and nefazodone.
* pregnancy or breast feeding
* cyclosporine use
* dialysis
* history of kidney transplant
* fibrate users who cannot stop fibrate use
Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy

It is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can impair sexual functioning and cause a decreased sexual health quality of life.

At the present time, there are no Food and Drug Administration (FDA) approved medications for the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment options is concerning because the number of women diagnosed with breast cancer continues to increase; their longevity, also, continues to increase with the use of newer adjuvant chemotherapies. Local health care practitioners have observed that the benefits of vaginal testosterone for sexual health in breast cancer survivors are similar to the benefits of vaginal estrogen in women without breast cancer.

The purpose of this study is to evaluate the impact of using a daily compounded vaginal testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and sexual functioning.


Eligibility Criteria:
Inclusion Criteria:

* Women with breast cancer
* Currently taking an aromatase inhibitor (AI)
* Age \> 50 years of age
* Postmenopausal, or two years since last menstrual cycle
* Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse
* Changes in sexual health quality of life/sexual functioning since starting AI therapy

Exclusion Criteria:

* The use of other treatments for breast cancer such as chemotherapy or radiation within the past 12 months
* A known sensitivity to medications containing testosterone
* The use of exogenous hormone replacement therapy (HRT) in the past three months, including systemic and local estrogen or testosterone therapy