cyrilzakka/clinical-trials huggingface dataset:
Improving Rehabilitation by Magnetic Brain Stimulation

We hope to understand the properties of the motor cortex in the brain of people with stroke using non-invasive magnetic stimulation.

This case series assesses the effects of five consecutive days of low-frequency (1 Hz) repetitive transcranial magnetic stimulation (rTMS) with and without a 6-Hz primer. Although this paper studies able-bodied individuals, similar rTMS protocols are used to facilitate motor recovery in patients with hemiplegia following stroke. However, the cortical mechanisms associated with repeated daily doses of rTMS are not completely understood.

Eligibility Criteria:
Inclusion Criteria:

* 3-24 months post stroke
* upper limb paresis
* CES-D below 16,

Exclusion Criteria:

* history of seizure
* metal in head
* score of less than 24 on the Folstein Mini-Mental Status Exam
* clinical judgement of excessive frailty or lack of stamina (e.g. cannot attend to instructions, stay awake, engage in functional activities)
* serious uncontrolled medical condition
* excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention as judged by the examining clinician
EARly Prevention of aTHeroma Progression

The purpose of this study is to compare standard therapy (risk factor control, life style modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on progression of coronary atherosclerosis in statin naive individuals who have mild CAD (nonobstructive coronary atherosclerotic plaques) and normal LDL (low-density lipoprotein) cholesterol levels(\<130mg/dl).


Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 35 years of age
* Mild CAD (nonobstructive coronary atherosclerotic plaques, lumen narrowing \<50%) and CAC score \<300 in at least one segment of proximal or mid-portion of major epicardial coronary arteries
* LDL cholesterol \<130mg/dl

Exclusion Criteria:

* History of stable angina, or acute coronary syndrome
* History of transient ischemic attack, or stroke
* Chronic kidney disease (eGFR\< 60ml/min)
* Diabetes mellitus with microvascular complications or insulin therapy
* Hypertriglyceridemia (triglyceride \>500mg/dl)
* Any statin therapy in the past 4 weeks
* Planned cardiac surgery or planned major non-cardiac surgery within 6 months.
* Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
* A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
* Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
* Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
* History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
* Unwillingness or inability to comply with the procedures described in this protocol.
* Positive pregnancy test (all female subjects of childbearing potential must have a urine ß-human chorionic gonadotropin(hCG) pregnancy test performed at Screening and/ or within 7 days prior to randomization) or is known to be pregnant or lactating.
* Hypersensitivity to Crestor
* Skeletal muscle disease
* Combination use with cyclosporine
* Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* Combination use of protease inhibitor
Cooling Vest in Men With Hot Flashes

This study is intended to determine the efficacy of the Cooling Vest in reducing the frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy treatment for prostate cancer.

The Cooling Vest is a vest manufactured by Nanohealth, Inc. It is a cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.

This study attempts to collect data on the effects of the Cooling Vest in men with hot flashes and night sweats due to the side effects of chemotherapy. Participants will use the vest for 4 weeks and questionnaires will be used to determine effect.

Eligibility Criteria:
Inclusion Criteria:

* Males, who are at least 18 years old.
* Self-reports having at least two (2) daily hot flashes associated with prostate cancer chemotherapy-induced hot flashes and night sweats.

Exclusion Criteria:

* Has another existing medical condition that would prevent study compliance.
"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis"

The purpose of this study is to determine whether instrumented lumbar fusion provides superior clinical outcomes in comparison to non-instrumented fusion in patients with "static" degenerative spondylolisthesis.

This study will determine whether instrumented lumbar fusion will provide superior clinical outcomes in comparison to non-instrumented fusion in patients with "STATIC" degenerative spondylolisthesis. At the time of scheduling surgery, patients who meet the inclusion/exclusion criteria will be asked to participate. Patients who agree, will be randomized to either non-instrumented or instrumented arthrodesis group. Intra-operative, peri-operative, and post-operative data will be collected and compared. The investigators predict to get very similar clinical outcomes between the two groups, with possibly less complications from the non-instrumented group and definitely a reduction in cost compared to the instrumented group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician.
2. Patients with concomitant spinal stenosis.
3. Laminectomy at any lumbar levels of stenosis.
4. Fusion only at L4-5 level.

Exclusion Criteria:

1. Prior lumbar spine surgery
2. Multi-level spondylolisthesis
3. Anterior interbody work/fusion
4. Tumor
5. Infection
6. Trauma
A Study of the Effects of LY3372689 on the Brain in Healthy Participants

This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females who cannot get pregnant
* Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins and arteries suitable for protocol required blood sampling

Exclusion Criteria:

* Have a history of head injury or contraindications to undergoing magnetic resonance imaging (MRI) examination
* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
* Have long exposure to sunlight routinely or use tanning beds regularly
* Participate in regular vigorous exercise
The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment

First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).


Eligibility Criteria:
Major Inclusion Criteria:

* Patients 18 years of age or older presenting with ST-elevation myocardial infarction in the left anterior descending artery (LAD) undergoing primary percutaneous coronary intervention.
* Competent mental condition to provide signed and dated ethics committee approved study consent prior to study related procedures
* Eligible for prasugrel, ticagrelor, cangrelor, tirofiban, UFH and GP IIb/IIIa inhibitors
* Referred for primary PCI within 5 hours of symptom onset with evidence of continuing ischemia and symptom to balloon time not exceeding 6 hours

Major Exclusion Criteria:

* Unconsciousness
* Previous bypass graft surgery
* Contraindication to CMRI
* Recent or current major bleeding within 30 days prior to intervention
* Recent major surgery within 30 days prior to intervention
* End-stage heart failure with inotrope support and/or consideration for LVAD or heart transplant
* Transient ischemic attack or stroke within 30 days prior to intervention
* Pregnant or females of childbearing potential
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.

The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 years old patients.


Eligibility Criteria:
Inclusion Criteria:

* The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study
* Male and female patients aged 7-12
* Patients with moderate course of influenza or other acute respiratory viral infections (AVRI)
* Patients with clinically diagnosed influenza or other ARVI based on the body temperature \> 37,5 ° C, not less than 1 of the following other symptoms of intoxication and not less than 1 of the following of catarrhal symptoms:
* Intoxication symptoms: headache, malaise, myalgia, pain in the eyeballs;
* Catarrhal symptoms: sore throat, rhinorrhea, cough, nasal congestion
* Uncomplicated course of influenza and other ARVI
* Interval between onset of symptoms and enrollment to the study of not more than 36 hours

Exclusion Criteria:

* Complicated course of influenza and other acute respiratory viral infections
* Treatment with antiviral drugs (antivirals, interferons and interferon inducers), drugs with immunomodulatory effects or antibiotics with systemic and local action within 7 days prior to the screening visit
* Severe influenza or other ARVI with symptoms of cardiovascular disease, and other symptoms of infectious-toxic shock, and meningoencephalitic syndromes
* Signs of primary viral pneumonia development (presence of two or more of the following symptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullness of percussion sound at symmetrical assessment of the upper and lower parts of the lungs
* Infectious diseases within the last week prior to enrollment
* "RRI children" (incidence of ARVI within the last 12 months is 6 times or more)
* Asthma history
* History of increased seizure activity
* Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis and also make it impossible to conduct a clinical study in the patient).
* Cancer, HIV infection, tuberculosis, including those in history
* Hypersensitivity to imidazolyl ethanamide pentandioic acid and/or excipients of Ingavirin product
* Diabetes, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, deficiency of sucrase/isomaltase, fructose intolerance, hereditary glucose malabsorption, deficiency of glucose-6-phosphate dehydrogenase
* Participation of the patient in any other clinical trial within the last 90 days prior to enrollment
Helping Veterans With SMI "StayQuit" From Smoking After Inpatient Hospitalization

Given the high prevalence and great cost of smoking for individuals with serious mental illness, an effective smoking cessation intervention for this group of smokers that begins in the hospital and continues following discharge is needed. The investigators will develop and pilot test StayQuit, a multifaceted smoking cessation intervention for smokers with serious mental illness that begins in the hospital and continues for three months after discharge. StayQuit will provide a personalized and tailored experience for smokers with serious mental illness at different levels of motivation to remain abstinent. In the hospital, StayQuit will include a brief motivational intervention that will help smokers relate sustained smoking cessation to their values and preferences, shore up motivation to stay quit, and gain experience using nicotine replacement therapy. This will be followed by cessation-focused discharge planning to engage Veterans in continued smoking cessation services with StayQuit staff. After discharge, StayQuit will offer 13 weeks (spread out over 3 months) of smoking cessation telephone counseling. The investigators will examine the feasibility of StayQuit by collecting both quantitative data on attendance and qualitative data on participants' experiences.


Eligibility Criteria:
Inclusion Criteria:

* Currently receiving inpatient care at the Baltimore VAMC inpatient psychiatric unit
* 18 years of age or older
* Self-reported smoking of 5+ cigarettes a day prior to hospitalization

Exclusion Criteria:

* Documented history of severe neurological disorder
* Intellectual developmental disorder indicated by chart review
Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus

Increased Femoral Anteversion is a transverse plan problem that affects lower body alignment, walking and standing characteristics and also pes planovalgus mostly accompanies with IFA. It is shown that children with IFA and PPV have back and leg pain, fatigue, muscle cramps and they are under the risk for chronic disorders such as osteoarthritis, scoliosis and muscle injuries.

Insoles, which reduce pronation of foot (flat foot), provide apparently a static correction by supporting proper alignment in children with IFA and PPV. However, the dynamic effects of insoles to lower extremity biomechanics while walking is not known.

The aims of this study are to determine the effects of the insoles on walking biomechanics in children with IFA and PPV by comparing with their healthy peers.


Eligibility Criteria:
Inclusion Criteria:

* Insole Group Between the ages 7-15, Trochanteric Prominens Angle Test \> 20⁰, Hip internal rotation angle \> 60⁰, Without insole Foot Posture Index score \> 5, With insole Foot Posture Index score \> 4, Using their insoles' at least one month.
* Control Group Between the ages 7-15, Trochanteric Prominens Angle Test \< 20⁰, Foot Posture Index score \< 5, Without any neurologic or orthopedic disease

Exclusion Criteria:

Neurological and / or musculoskeletal problems, Orthopedic problems to prevent walking.
Alzheimer's Disease Core Center

The main objective of this research project is to provide a comprehensive clinical database of patients with Alzheimer's disease (AD) and other forms of dementia, individuals with mild cognitive impairment (MCI), and age-matched normal controls. The study will also attempt to identify cognitively normal individuals at genetically defined risk for Alzheimer's disease through genetic screening.

All participants are seen annually. Autopsies to establish diagnoses in patients with dementia, patients with mild MCI, and cognitively normal elderly control subjects will also be conducted.

All participants are seen annually. In addition to a detailed neurological examination, participants will receive a standardized battery of neuropsychological tests and will undergo genetic testing. The investigators will provide standardized periodic longitudinal assessment of the research participants. Autopsies to establish neurohistopathological diagnoses in clinically well-characterized patients with dementia, patients with mild MCI, and cognitively normal elderly control subjects will also be conducted.

Eligibility Criteria:
Inclusion Criteria:

For patients with MCI, or dementia, the presence of cognitive deficits including memory, language, and executive function.

Exclusion Criteria:

Presence of non-neurological medical conditions interfering with cognition.
Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35

RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy.

PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery.

This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study

Pilot Study- Primary Objectives:

* Prospective evaluation of the technical feasibility of integrating PET-CT fusion in St Luke's Hospital
* Rate of PET-CT Scan based treatment delivery

Pilot Study- Secondary Objectives:

-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

Phase II Study- Primary Objective:

-The safety of PET-CT scan based radiotherapy, with regard to loco-regional disease control.

Phase II Study- Secondary Objectives:

-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell)
* TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion
* Measurable disease
* No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
* Patient suitable for radical 3-DCRT
* ECOG-Performance status ≤ 2 / KPS \> or equal to 60
* Weight loss \<10% within the 3 months prior to diagnosis
* No prior radiotherapy to the thorax
* Patient is suitable for lung-board immobilisation
* No chemotherapy received prior to planning PET-CT scan
* Age 18 and over
* Provision of written informed consent

Exclusion Criteria:

* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
* FEV1 \< 1
Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma

This study explores the human papillomavirus (HPV) self-collection experience among individuals with a history of sexual trauma. Cervical cancer is the fourth most common cancer in women worldwide and is the second leading cause of cancer-related death in women ages 29-39. Despite programs to improve accessibility of cervical cancer screening and overall high screening rates, disparities in routine surveillance have been demonstrated in certain populations, such as victims of intimate partner violence and sexual trauma. One barrier to participating in cervical cancer screening for this population is the office-based visit which necessitates the individual to undress, sit with their legs in stirrups, and undergo speculum examination for specimen collection. This type of visit may cause distress for participants who have experienced sexual violence. HPV self-collection has been studied with favorable outcomes in effectiveness and ease of use. This study evaluates the experience of HPV self-collection among individuals who have experienced sexual trauma.

PRIMARY OBJECTIVE:

I. To explore the HPV self-collection experience among individuals with a history of sexual trauma.

OUTLINE:

Participants complete a survey, use an HPV self-collection kit, and attend an interview over 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines
* Identify themselves as having a history of IPV, sexual abuse, or sexual trauma
* Participants will also need to have access to a smartphone, tablet, or computer with video capability
* English speaking
* Reside in the State of Oregon
* Patients who have participated in prior HPV self-collection study (reference Institutional Review Board \[IRB\] number- IRB# 23478) will also be eligible to participate in the interview if they meet the remaining eligibility requirements (i.e. history of IPV, sexual abuse, sexual trauma)

Exclusion Criteria:

* Individuals who are not English speaking
* Individuals \< 25 years old or no longer eligible/recommended to undergo cervical cancer screening
* Resides outside the state of Oregon
* Adults who are unable to consent or are decisionally impaired
* Individuals without a cervix (i.e. prior hysterectomy)
Effect of Food on the Pharmacokinetics of Oral Treprostinil

The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening.
* Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
* Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.

Exclusion Criteria:

* Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
* Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
* Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.