cyrilzakka/clinical-trials huggingface dataset:
tACS for Neuropathic Pain Management After SCI

The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for neuropathic pain management in people after spinal cord injury.


Eligibility Criteria:
Inclusion/exclusion criteria for SCI subjects

Inclusion criteria: A patient who

1. has neuropathic pain after traumatic spinal cord injury or amputation or brain injury;
2. has chronic pain, \>3 months;
3. is between 18 to 75 years of age;
4. is stable on oral pain medications at least two weeks. Patients are allowed to continue their pain medications, i.e., no change in pain medications.

NOTE: we plan to begin the study with the spinal cord injury (SCI) subject population as a cohort first, then expand to other subject populations

Exclusion criteria: Patients will be excluded if they

1. are currently adjusting oral pain medications for their neuropathic pain;
2. have pain, but not neuropathic, e.g., from inflammation at the incision wound of the residual limb or neuroma;
3. have a pacemaker metal implants or supplemental oxygen;
4. have amputation in their arm(s);
5. fail to have a motor contraction in the arm muscles with TMS;
6. are not able to follow commands, or to give consent;
7. have asthma or other pulmonary disease;
8. are not medically stable;
9. have preexisting psychiatric disorders;
10. alcohol or drug abuse.
Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

Glucocorticoids are known to cause an increase in insulin resistance, leading to hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and outpatient setting, steroids are used for their anti-inflammatory property to treat a variety of conditions. There is a paucity of information regarding the best way to treat steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin, an intermediate-acting insulin, given at the time of steroid administration to the patient's standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen which will consist primarily increasing the prandial doses at lunch and supper in order to determine which regimen is superior for glycemic control.

Inpatients who will receive single daily doses of prednisone or methylprednisolone for treatment of their underlying condition and who become hyperglycemic will be eligible. Subjects will be randomized in a 1:1 fashion to one of two arms: (1) to their standard basal bolus insulin the addition of NPH insulin given at the time of the steroid adminstration, adjusting the dose based on the dose of steroid; (2) an increase in the basal and prandial bolus insulin doses based on the dose of steroid. Glycemic control and the incidence of hypoglycemia will be assessed over the first 3 days after initiating these insulin regimens.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving once daily dosing of methylprednisolone or prednisone in a dose of 10 mg/day or greater
* Hyperglycemic (Glucose level \> 126 mg/dL)
* Diabetic and nondiabetic patients
* Expected duration of hospital stay and time on steroids \>= 3 days
* Patient of appropriate caregiver able to give Informed Consent

Exclusion Criteria:

* Patients with 2 or more doses of methylprednisolone/prednisone per day
* Steroids other than methylprednisolone or prednisone
* Pregnancy
* estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2
COVID-19 Testing Sample Acquisition Throughput and Efficiency

This QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.

Beginning in March 2020, the MGH began outpatient testing for COVID-19 (SARS-CoV-2) utilizing a provider-administered nasal swab samples. This was administered with infection control protocols utilizing full PPE protection for health providers who would don and doff gowns and gloves with each sample acquisition. With an aim to decrease PPE usage and increase efficiency, personal protective booths with HEPA-filtered air called "Hexapods" were employed, after infection control approval, within the MGH system beginning on April 16, 2020.

Ambulatory Care Management at MGH systematically monitors testing completed and PPE usage on a weekly basis. Managers in charge of personnel changes shared necessary team structures and median salaries for different personnel involved with sample acquisition. MGH Materials management were able to report on costs related to consumable supplies used during testing.

In this investigation, this routinely collected data and averaged timed sample collection observations were used to compare before and after the Hexapod utilization.

Eligibility Criteria:
Inclusion Criteria:

* All testing performed at designated outpatient SARS-CoV-2 at Massachusetts General Hospital (MGH) testing sites beginning March 2019.

Exclusion Criteria:

* SARS-CoV-2 tests performed not performed within designated outpatient testing sites at MGH.
* Testing performed within the hospital for Emergency Department or Inpatient visits.
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson's disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic PD
* have undergone neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)
* Existing 7T brain imagery

Exclusion Criteria:

* history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
* other significant neurological disorder
* history of dementia or cognitive impairment as found with UBACC (or MacCAT-CR)
* post-operative complications or adverse effects
Left Ventricular DYsfunction in DiAbetes

The purpose of this study is to evaluate the prevalence, during the enrolment, of Left Ventricular Dysfunction diastolic and/or systolic in patients with diabetes mellitus type 2 without known or documented heart disease history and recognize its predictive clinical, biohumoral and with non-invasive techniques parameters.


Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus type 2
* absence of heart disease previously reported
* age \>45 years
* Informed Consent

Exclusion Criteria:

* presence of heart disease previously reported
* diabetes type 1
* serious systemic disease, with an expected lifetime lower than 2 years
* no willingness to participate to the screening
* inadequate compliance to study procedure
* participation to other study
WashU DIEP Flap Video and Patient Understanding Improvement

Patients will complete a survey before and after watching the WashU DIEP Flap Video at their pre-operative standard of care visit, and a third survey at their post-operative standard of care visit. These surveys will use questions from SILS, APAIS, PEMAT, and AIM/IAM to assess the patient's health literacy, demographics questions, and questions concerning patient understanding and anxiety surrounding the procedure. The purpose of the post-op survey will be to assess how well the video set expectations of the procedure and recovery process and will repeat questions asked pre-operatively. Survey responses will be analyzed to determine if there are beneficial trends and improvement in patient understanding and anxiety due to adjunct video usage.

Primary Objective: The primary aim of the study is to determine if our animated video affects understanding and anxiety survey scores in patients undergoing DIEP breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to have DIEP-flap breast reconstruction at Barnes Jewish Hospital
* Speak English
* ≥ 18 years of age

Exclusion Criteria:

* Non-English speaking are excluded as the consent, questionnaires, and video are only available in English.
Pediatric Telephone Center Board 15

This study evaluates the follow-up of advices given in a Urgent Medical Aid Service (SAMU 29) for every pediatric's emergency call under 15yo and try to evaluate the adhesion's factors.

Many of pediatric's medical emergency are followed by a medical advice in a Urgent Medical aid Service (SAMU).

This advices could be medications advices, to see a general praticionner the same day or later, or to consult in an emergency department.

But the rate of advices really followed by callers is unknown. This study evaluate by who, when and why this advices are followed or not.

Eligibility Criteria:
Inclusion Criteria:

* all emergency calls at SAMU 29 for under 15yo childs
* medical advices were given by the physician (medication at home OR consult in an emergency department OR consult the general praticionner the same day or later.

Exclusion Criteria:

* all emergency calls at SAMU 29 for upper 15yo childs
* participation opposition.
* need for an ambulance or an emergency medical team at home
A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors

To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available
* Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion
* Adequate bone marrow, renal and liver function

Exclusion Criteria:

* Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of starting study treatment
* Patients with known symptomatic brain metastases requiring steroids
* Prior treatment with a compound of the same mechanism
Imaging Outcomes of Cognitive Behavioral Therapy (CBT) for Battered Women With Posttraumatic Stress Disorder

Identifying neural mechanisms of posttraumatic stress disorder (PTSD) treatment could help elucidate reasons for variable treatment response and identify novel treatment targets. Exposure-based therapies have been associated with decreased amygdala and increased cingulate cortex response during emotional processing. The current study examined whether cognitive therapy for PTSD in women reduces activation in insula and amygdala and enhances activation in prefrontal regions during emotional anticipation and pre-treatment prefrontal activation predicts treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* Intimate partner violence (IPV) trauma defined as physical and/or sexual abuse committed by a romantic partner, occurring within five years of, but having ended at least one month prior to, enrollment in the study.
* Seeking treatment for posttraumatic stress disorder (PTSD) symptoms and meeting full or partial Diagnostic and Statistical Manual, 4th edition (DSM-IV) criteria for PTSD prior to treatment, verified through the Clinician-Administered PTSD Scale (CAPS).

Exclusion Criteria:

* Substance abuse in the past year
* History of \>2 years of alcohol abuse
* Use of psychotropic medications within 4 weeks prior to the study, bipolar disorder or schizophrenia, irremovable ferromagnetic bodily material, pregnancy, or claustrophobia.
Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.

This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).

Eligibility Criteria:
Inclusion Criteria:

* Subject should have normal eyes and use no ocular medications
* Subject with -1.00 to -10.00 D myopia, less than -1.25 D astigmatism
* VA correctable to 20/25 or better.
* Willing to comply with all study procedures and be available for the duration of the study.
* Provide signed and dated informed consent form.

Exclusion Criteria:

* Subjects have history of allergies that would contraindicate solution use and/or "normal" contact lens wear.
* Cornea sensitivity low, high myopes, Keratoconus, dry eye with Schirmer Test \< 5mm/5min or other physical condition that would contraindicate contact lens wear.
* Subjects have other active ocular or systemic disease that would contraindicate contact lens wear.
* Subjects have medications that would contraindicate contact lens wear.
* Females who are pregnant, breastfeeding, birth control pill taken or who intended to become pregnant over the course of the study.
* Current drug or alcohol use or dependence that would interfere with adherence to study requirements.
* Individuals participating in other clinical studies.
Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease

The investigators propose to study the transfer of nifurtimox into breastmilk of lactating women who receive the drug for the treatment of Chagas disease.

Breastmilk and blood samples will be obtained from these patients at pre-specified times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by these women to nifurtimox. This study will help clarify safety of continuing breastfeeding while receiving treatment with nifurtimox for Chagas disease.


Eligibility Criteria:
Inclusion Criteria:

* Lactating women with Chagas disease, not treated before
* Use of contraception

Exclusion Criteria:

* History of allergy to nifurtimox or its excipients
* Pregnancy
* Significant heart involvement (due to Chagas disease)
* Significant systemic diseases that could affect the interpretation of the results in the opinion of the principal investigator
EEG Monitoring for PERFormance Anticipation

Identify, characterize and then validate electrophysiological markers linking electrophysiological cerebral activity and performance in cognitive and physical fatigability in humans. To do this, noninvasive explorations of electroencephalography (EEG) and magnetoencephalography (MEG) will be carried out under two conditions of different experiments, the first one that induces a cognitive fatigability and the second one that induces physical fatigability.


Eligibility Criteria:
Inclusion Criteria MGPFco group:

* Adult subjects, male or female, right-handed or left-handed, from 18 years up to 70 years;
* Having duly completed the entire confidential medical questionnaire;
* Written consent of free, informed and express participation;
* No hearing problems;
* Having normal or corrected vision;
* Affiliation to a Social Security scheme.

Inclusion Criteria MGPFph group:

* Adult subjects, male or female, right-handed or left-handed, from 18 years up to 35 years;
* Practicing at least five hours of sports per week;
* Presenting a certificate of no contraindication to an exercise test, intense sports practice or an energy sport in competition of the current year;
* Having duly completed the entire confidential medical questionnaire;
* Without cardiovascular or motor disability;
* Without tumoral, inflammatory, cardiac, pulmonary, renal, digestive (malabsorption syndrome) or liver disease;
* Written consent of free, informed and express participation;
* Affiliation to a Social Security scheme.

Exclusion Criteria:

* Pregnant women, nursing mothers or those of childbearing age without contraception
* Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of liberty or of liberty
* Persons protected by the law
* Persons who have performed a maximum stress test within 15 days of the date of inclusion,
* In the course of drug treatments against indicated for the protocol (treatment for neurological diseases, psychiatric ...).
* Metal implants incompatible with MRI (for the subjects concerned, see appendices)
* Metallic implants incompatible with the MEG (for the subjects concerned, see appendices)
Treatment of Moderate to Severe Facial Acne Vulgaris

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Must be between 12 and 45 years of age.
* Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face

Exclusion Criteria:

* Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
* Has a history of pseudomembranous colitis or antibiotic-associated colitis.
* Has a history of hepatitis or liver damage or renal impairment.
Magnetic Resonance Imaging (MRI) Using Liverspecific Oral Contrast Agent in Metastatic Colorectal Cancer Patients

The purpose of this study is to determine whether MRI with manganese containing contrast agent detects more livermetastasis compared to CT scan


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved liver metastasis

Exclusion Criteria:

* pacemaker, metal in the body, claustrophobia, pregnancy, age below 18 years, psychiatry patients
Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging

The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years
* Free and informed consent signed
* Histologically confirmed adenocarcinoma of the breast, metastatic or non-metastatic
* LVEF\> 50% angioscintigraphy before the start of treatment with Herceptin ®,
* Overexpression of HER2 in the invasive component of the primary tumor (3 + 2 + according to ICH or with confirmation of positivity by FISH or CISH)
* Patient receiving treatment with Herceptin ®,
* Inclusion in the control group: patients treated with Herceptin ® episode without LV dysfunction,
* For the inclusion in the Group LV dysfunction: the appearance of a decrease in LVEF during treatment with Herceptin ®, angioscintigraphy identified.

Exclusion Criteria:

* Heart disease or serious medical conditions do not allow to administer Herceptin ® (documented history of heart failure, angina requiring treatment, severe dyspnoea at rest or oxygen dependency),
* History of ischemic heart disease or myocarditis
* Known allergy to trastuzumab, murine proteins or any of the excipients
* Patients with an indication against the MRI (claustrophobia, ferromagnetic foreign body, pacemaker or implantable defibrillator, known allergy to gadolinium salts)
* Renal impairment (creatinine clearance \<60 ml / min according to the MDRD formula)
* Arrhythmia atrial fibrillation,
* Contraindications to the administration of Dotarem ®,
* Patient unable to give informed consent,
* Adult Trust,
* Pregnant or lactating
* Patient unable to undergo a medical for geographical, social or psychological.
Polish Translation and Validation of NBSS, Qualiveen and SF-Qualiveen

The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires.

The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires in patients with spinal cord injury and multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury patients
* Multiple sclerosis patients
* Age \> 18

Exclusion Criteria:

* Spinal shock patients
* Urinary tract operation in the last month
* Quality of life changes in the last month
* Urinary tract infections in the last month
* Bladder management changes or drug changes in the last month
Complications Related to Arthroscopic Surgery of the Hip - a Prospective Cohort Study

Arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to perform the surgical procedure. A retrospective study has described neuropraxia, ankle joint pain and a skin burn after surgery (1). Moreover, it has been described that surgeons performing the procedure have a learning curve related to the number of complications described postoperatively. At the investigators' institution, hip arthroscopies have been performed since 2010 and the 3 surgeons have 4-12 years of experience. During the past years, changes have been made to secure the best possible comfort for the patient during the arthroscopic procedure. Hence, there is a rationale for investigating complications after hip arthroscopy in a setting that is less affected by the surgeon's learning curve and with the patient comfort in focus.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark, during one year.

Exclusion Criteria:

* Non