cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments

The investigators propose to make the first observations of LFMS treating a population of subjects with PTSD. A positive outcome for this study could translate directly into a new treatment modality for symptoms of PTSD in both acute and chronic situations. The investigator's goal is to demonstrate the safety and efficacy of LFMS as a possible aid in the treatment of PTSD.

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. LFMS electromagnetic fields are significantly weaker than those occurring in electroconvulsive therapy (ECT) and repeated transcranial magnetic stimulation (rTMS).

LFMS was discovered at McLean Hospital and has been studied as an experimental antidepressant treatment at McLean. Results from the investigator's single-visit protocol (2006-P-001655) are encouraging, and demonstrate an immediate mood improvement from LFMS in depressed subjects. This indicates that LFMS continues to show potential as a treatment for depression. The profile of clinical response to LFMS that was observed in that study included improvement in symptoms of anxiety. In this current proposal the investigator's will study the effects of LFMS on these symptoms of depression and anxiety that are present in a population with a primary diagnosis of PTSD. The proposed protocol involves three treatments on consecutive days with follow-up ratings one week after the first treatment and follow-up by phone ratings in weeks three and four after the first treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be men or women between the ages of 21-65.
2. Subjects will meet Diagnostics and Statistical Manual of Mental Disorders (DSM-IV) criteria for Post Traumatic Stress Disorder (PTSD), current.
3. Subject must have a PTSD Check List-5 (PCL-5) score greater than 38.
4. Subjects must be capable of providing informed consent.
5. Subjects must have an established residence and phone.
6. Subjects may be medicated or unmedicated.

Exclusion Criteria:

1. Dangerous or active suicidal ideation.
2. Pregnant or planning on becoming pregnant.
3. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
4. Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
5. Subjects must not have serious physical illnesses, neurological diseases or dementias.
6. Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
7. History of an Axis 2 disorder, schizophrenia or schizoaffective disorder.
8. Contraindications for magnetic resonance imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

This proof-of-concept case series will prospectively use magnetic resonance imaging (MRI) evidence of spared spinal cord neural fibers to guide the selection of 2 research participants to receive a surgically implanted epidural stimulator with the goal of restoring voluntary movement after spinal cord injury (SCI).

Because MRI evidence of spared spinal cord neural fibers demonstrated significant relationships with responsiveness to epidural stimulation in SCI in retrospective studies, the proposed study is a traditional feasibility study - a prospective investigation to be used to capture preliminary safety and effectiveness information to determine if MRI can/should be used in planning a future pivotal study.

This is an investigator-initiated proof of concept study performed at the University of Colorado Anschutz Medical Campus (CU Anschutz).

This 2-case proof-of-concept study will include 2 research participants with motor-complete SCI to evaluate the performance of the Medtronic epidural stimulator for restoring voluntary movement below the level of injury.

Participants will be enrolled at CU Anschutz. Screening data will be reviewed to determine participant eligibility. Two participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

The following treatment regimen will be used: epidural stimulation + 6 months of intensive outpatient physical therapy.

Total duration of study participation will be 8 months.

Eligibility Criteria:
Inclusion Criteria:

1. American Spinal Injury Association Impairment Scale B spinal cord injury diagnosis
2. Beyond 6 months of injury date
3. Spinal cord injury at a level range of cervical 7 to thoracic 8 (C7-T8) with signs of upper motor neuron injury
4. 18 years or older
5. Height 5'1" to 6'3"
6. Weight 250 lbs or less
7. Sufficient upper extremity strength to manage a stability aide
8. Magnetic resonance imaging evidence of spared spinal cord neural fibers

Exclusion Criteria:

1. Claustrophobia and/or other contraindications to magnetic resonance imaging
2. Unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators
3. Recent (within 3 months) history of fracture, contractures, pressure sore, deep vein thrombosis, urinary tract infection, or other infections that might interfere with interventions
4. Contraindications to epidural stimulator implantation surgery
5. Received botox injections into the lower extremities within the past 6 months
6. Pregnancy
7. Cauda Equina injury
8. Any other neurological disorder besides spinal cord injury
ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

The main objective of this study is to determine the safety of Ex Vivo Cross Linking (CXL) of donor corneal tissue in participants who have undergone high-risk penetrating keratoplasty.

This is a randomized, double-masked, multi site clinical trial to determine the safety of Ex Vivo CXL of donor corneal tissue in 96 participants who have undergone high-risk penetrating keratoplasty.

Participants will be randomized to receive either a corneal tissue that has been untreated vs. a corneal tissue that has been treated with Photrexa® Viscous \& Photrexa® and UV light. The tissue will be prepared by a Corneal Tissue Bank under Current-Good-Tissue-Practice (CGTP) and delivered to the respective institutions for transplantation. Participants will be monitored up to 24 months post-transplantation to assess for adverse events of the randomized tissue.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Willing and able to provide written informed consent
* Willing and able to comply with study assessments for the full duration of the study
* Patients undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft
* Superficial vessels are defined as those within the anterior one-third of the cornea and deep vessels within the posterior two-thirds of the cornea (i.e., deep stroma).

Superficial CNV involving ≤2 quadrants (equivalent to ≤6 clock hours) without deep CNV are classified as mild. CNV with \>2 quadrants of superficial vessels (\>6 clock hours) or 1 quadrant of deep vessels (\>3 clock hours) as severe (36).

Exclusion Criteria:

* History of Stevens-Johnson syndrome or ocular pemphigoid
* Ocular or periocular malignancy
* Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
* Uncontrolled glaucoma
* Change in topical corticosteroid regimen within 14 days of transplantation
* Use of systemic immunosuppressive for indication other than corneal graft rejection
* Participation in another simultaneous medical investigation or trial
* Pregnancy (positive pregnancy test) or lactating
* Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
* Ocular infection within 30 days prior to study entry.
* Presence of anterior chamber intraocular lens
* Active uveitis within 90 days prior to the study entry.
* No ocular surgery or procedure within 90 days prior to the study entry or concomitant to the study procedure.
Evaluation of Functional Magnetic Resonance Imaging (fMRI) in Patients Who Speak Two Languages Fluently

Functional magnetic resonance imaging (fMRI) is a non-invasive test used to detect changes in brain activity by taking picture of changes in blood flow. The imaging helps doctors better understand how the brain works. Task based fMRI (TB fMRI) prompts patients to perform different activities (e.g. word selection in a reading task), and is routinely performed on patients in preparation for a Neurological surgery (surgery that involves the nervous system, brain and/or spinal cord). The purpose is to locate areas of the brain that control speech and movement; these images will help make decisions about patient surgeries. However, there are however gaps in knowledge specific to the language areas of the brain, especially for non-English patients and bilingual patients (those who are fluent in more than one language). This study proposes to evaluate if resting state fMRI (RS fMRI) that does not require any tasks, along with a novel way to analyze these images using "graphy theory," may provide more information. Graph theory is a new mathematical method to analyze the fMRI data. The overall goal is to determine if graph theory analysis on RS fMRI may reduce differences in health care treatment and outcomes for non-English speaking and bilingual patients. We hope that the results of this study will allow doctors to perform pre-operative fMRI in patients who do not speak English.


Eligibility Criteria:
Inclusion Criteria:

All patients and volunteers will be recruited by listed consenting professionals. Volunteers do not need to be MSK employees.

* Patients/ healthy volunteers ≥ 18 years old
* Patients/ healthy volunteers must be able to perform the language paradigms on cue while inside the scanner
* Patients/ healthy volunteers who are monolingual English speakers, early bilinguals (English and Spanish) or late bilinguals (English and Spanish)
* Patients must be newly diagnosed with a glioma (from prior histology) or must be suspected to have a glioma on imaging (to be confirmed by post-operative histology)
* Patient's location of the tumor must involve the expected location of Broca's area (left pars opercularis and/or pars triangularis). This determination will be made on the basis of a pre-operative MRI by a fellowship-trained Neuroradiologist

Early bilingual will be defined as acquiring proficiency in the second language before 10 years of age.

Exclusion Criteria:

* Patients/ volunteers who are unable to comply or complete MRI exams as per the Department of Radiology's standard guidelines (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.)
* Patient/ volunteers who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.)
* Volunteers with a history of neurological disorders, psychiatric disorders or cancer
* Female patients/ volunteers who are pregnant or nursing
* Patients/ volunteers from the vulnerable population, as defined by 45 CFR 46
Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)

This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.

Migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. One group will receive active rTMS and another group will receive sham rTMS for treatment phase (5 sessions). Assessment will be made at baseline, month 1, month 2 and month 3 post-treatment.

Eligibility Criteria:
Inclusion criteria:

1. Males or females aged 18 to 60 years of age.
2. Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) for at least 1 year.
3. Frequency of migraine attacks 2-8 times per month with less than 15 headache days per month for at least 3 months prior to screening.
4. Demonstrated compliance with the headache diary during the run-in period by entry of headache data on a minimum of 24/30 days (80% compliance).
5. A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.

Exclusion criteria:

1. Patients with previous history of rTMS treatment.
2. Onset of headache at more than 50-year-old.
3. Headache with red flags symptoms that may suggest organic secondary headaches.
4. Pregnant or lactating women.
5. Patients with contraindications to TMS such as metallic implant and pacemaker based on the Screening 13-item Questionnaire for rTMS candidate.
6. Patients with medical conditions such severe hypertension, infections, malignancy, cardiovascular and cerebrovascular disease, epilepsy degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illness.
A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults

phase-1 study pneumococcal conjugate vaccine study in healthy adults

A Study to Evaluate the Safety and Immunogeneicity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy adults

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult older than 19 years old and younger than 50 years old
* A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form

Exclusion Criteria:

* A subject who participated in other clinical studies within 3 months before screening
* A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period
* A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients
* A subject who received immunoglobulin or blood-derived materials within 3 months before screening
* A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders
* A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction
* A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products
* A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae
* A subject who was vaccinated with any pneumococcal vaccine before screening
* A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine)
Idiopathic Toe-Walking Position Sensation

The aim of this study is to investigate the effect of plantar two-point discrimination on hip-knee-ankle position sense in children with toe walking.The main questions it aims to answer are:

* Are two-point discrimination and light pressure sensation in the plantar region affected in children with idiopathic toe gait?
* Does the two-point discrimination in the plantar in general and the heel in particular affect the position sense of the hip-knee and ankle?

Children who tend to walk on toes after they should have developed a heel-toe gait are diagnosed with idiopathic toe walking (ITW).Cerebral palsy, muscular dystrophy, and orthopaedic problems such congenital talipes equinus are some of the diseases that are frequently linked to a toe-walking gait. A diagnosis of ITW is made when there is no physical or medical cause for the absence of a heel strike. Five percent of healthy children are estimated to have ITW, and boys are more likely than girls to be affected. Reduced ankle range of motion is prevalent symptom in children with ITW. Since ITW often manifests as symmetrical tiptoe walking in children, reports showing a comparable bilateral reduction in ankle range of motion at both lower limbs indicate the symmetrical character of this gait type. Lower vibration perception thresholds, a tendency to be left-handed, and noticeable variations in sensory seeking and modulation scores are all characteristics of children with an ITW gait.

The small fibers that innervate the cutaneous receptors (such as Merkel's cell, Pacinian corpuscles, Meissner's corpuscles, and Ruffini endings in the skin) are more crucial for postural control than the large fibers that innervate the major muscle spindles and the Golgi tendon organs. Standing balance control is more dependent on Merkel's cells and Ruffini endings (slow adapting receptors), which are in charge of touch and pressure sensitivity, than it is on Meissner's and Pacinian corpuscles (rapid adapting receptors), which are in charge of vibrotactile sensitivity.Additionally, it has been demonstrated that tactile sensation in the foot sole affects the activity of the tibialis anterior muscle as well as the regulation of gait pattern at lower limb joints. These investigations support the notion that cutaneous feeling is crucial for preserving postural and gait stability.The literature states that plantar pressure and sensory changes have disruptive effects on postural control.The aim of this study is to investigate the effect of plantar two-point discrimination on hip-knee-ankle position sense in children with toe walking.

Eligibility Criteria:
Inclusion Criteria:

* Having idiopathic toe walking diagnosis

Exclusion Criteria:

* Having another known neuromuscular disease
Fluoride Retention in the Mouth of Older Adults

Individuals with dry mouth (a reduction in the production of saliva) suffer from high rates of oral diseases. Dry mouth is a common problem among older individuals, because many medications to control chronic conditions (such as blood pressure, bladder-control problems and depression) reduce the flow of saliva. For these individuals, fluoride is used to maintain a good oral health. Usually, higher fluoride concentration products, such as prescription toothpastes, are recommended. In this project, the ability to increase fluoride retention in the mouth by using calcium before a conventional fluoride rinse will be tested in older adults with a range of salivary flow rates. This approach was never tested in patients with dry mouth, for whom the treatment with calcium may also be beneficial. A crossover, clinical study with two experimental phases will be conducted, in which patients with a range of saliva flows (from normal to dry mouth) will rinse with a fluoride rinse only (used at over the counter concentration), or a fluoride rinse preceded by a calcium rinse. The concentration of fluoride and calcium in the saliva and dental plaque residues will be determined up to two hours after the rinse(s), to test the effect of the approach to optimize fluoride retention in the mouth of patients with dry mouth.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Good general health as evidenced by medical history
* Good oral health as evidenced by a clinical oral exam
* Having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth
* Having salivary flow rate ranging from normal to hyposalivation according to direct flow rate determination methods
* Agreement to adhere to the study protocol

Exclusion Criteria:

* Unable to understand and/or follow study instructions
* Active periodontitis
* Oral pain
* In need of urgent dental care
One-year Recurrence-free Survival of Melanoma Patients Eligible for a Sentinel Lymph Node Biopsy

Melanoma is one of the most aggressive solid cancers, although mortality can be reduced with early treatment. Immunotherapy has transformed the prognosis of this pathology.

The sentinel lymph node technique is used to classify the severity of melanoma. It is proposed for melanomas with a Breslow thickness of 0.8 mm to 1 mm, and recommended for melanomas greater than 1 mm or with ulceration, whatever the Breslow index.

This technique is particularly useful for assessing pathology by detecting the presence of lymph node metastases. Patients with lymph node involvement (micro or macro) are eligible for adjuvant treatment.

The new recommendations suggest adjuvant immunotherapy for stages IIB and IIC (without lymph node involvement assessed by the sentinel lymph node technique). This procedure is widely used at the CHRU de NANCY.

The aim of this study is to demonstrate the value of the sentinel lymph node in assessing the risk of melanoma recurrence at one year (or more).


Eligibility Criteria:
Inclusion Criteria:

Major patient with a melanoma with a Breslow index greater than 0.8mm or ulcerated melanoma, non-metastatic at diagnosis,

Exclusion Criteria:

* Metastatic patient
* Minor patient
* Melanoma with a Breslow index of less than 0.8mm and not ulcerated
* Patient objecting to data collection