cyrilzakka/clinical-trials huggingface dataset:
Short- and Long-Term Hemodynamic Effects of Carotid Endarterectomy and Carotid Artery Stenting

Carotid artery stenting(CAS) and endarterectomy(CEA) are both important treatment strategy for patients with ICA (internal carotid artery) stenosis. Three dimensional pseudo-continuous arterial spin labeling (pCASL) is a noninvasive perfusion imaging modality to detect reperfusion for recanalization therapy. And it provides information about absolute CBF (ml 100 g-1 tissue min-1) at the brain tissue level. The aim of the present study was to evaluate the series hemodynamic changes in patients who had conducted CAS or CEA by using 3D pseudo-continuous arterial spin labeling (pCASL) to explore the potential pattern of CBF alternation and thus to improve the prevention strategy for hyperperfusion syndrome.

Patients:

Patients with unilateral severe internal carotid artery (ICA) stenosis of stroke eligible were enrolled who underwent CAS vs CEA.All patients underwent previous scan in 7 days before CAS and CEA and consecutive scan once per 24 hours after CAS and CEA.

Baseline characteristics of patients were recorded including age,gender, hypertension, hypercholesterolemia, diabetes melitus, smoking, obesity, qualifying stroke event.

Protocols:

MRI scan protocols T2 weighted image,T1 weighted image,diffusion weighted image(DWI),fluid-attenuated inversion recovery (FLAIR),arterial spin labeling(ASL) with Post labeling delay (PLD) of 2.0s,Territory ASL(TASL)(PLD=2.0s),3-dimensional Fast Spoiled Gradient Echo(3D-FSPGR).

Imaging evaluation：

1. Pseudo-continuous arterial spin labeling (pCASL) with post labeling delay (PLD) of 2.0s evaluation of cerebral blood flow in target downstream territory.
2. FLAIR hyperintensity vascular sign.
3. Collateral pattern assessment by Territorial ASL(TASL) (PLD=2.0s).

Treatment strategy:

Patients were randomly treated by CEA(carotid endarterectomy) or CAS(carotid artery stenting).

Follow up:

Patients were followed up every 24 hours after treatment procedure, and would have a repeat MRI scan after 3 months, 6 months and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* informed patient's consent for ICA stenting or endarterectomy
* lack of contraindications to MRI
* Symptomatic, unilateral ICA stenosis 70-99%;irrelevant stenosis \<50% of contralateral ICA
* TIA or stroke - within 360 days

Exclusion Criteria:

* Intracranial hemorrhage
* Informed consent not obtained
* Common exclusion for MRI such as patients with claustrophobia
* Patients with poor imaging quality（Poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional MRI and mistakes in the MRI process by accident factors which cannot to be applied to future analysis）
* Bilateral internal carotid artery occlusion
Individualizing Disease Prevention for Middle-Aged Adults

The primary objective of this study is to help patients compare the benefits of various preventive care services, based on their individual risk factors (such as smoking status, obesity, high blood pressure, high cholesterol, etc.). A tailored decision tool will be provided to each participant during primary care appointments to facilitate discussion between the participant and his/her provider regarding prioritizing preventive service recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an appointment with primary care provider during study period
* Two or more of the following risk factors:
* Tobacco use
* Overweight/obese
* Hypertension
* Hyperlipidemia
* Diabetes
* Alcohol Misuse
* Depression
* History of Sexually Transmitted Infection
* Being overdue for the following screenings: Colorectal, cervical, breast, lung

Exclusion Criteria:

- Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive pulmonary disease, end stage renal disease)
Like Father Like Son

This purpose of this study is to look at the best way to offer the Like Father Like Son + Spear \& Shield program.


Eligibility Criteria:
Inclusion Criteria:

* Men and women must be able to understand and sign the Informed Consent in English or local language.
* All participants must be adults able to provide consent
* Women participants may be pregnant
* Individuals not yet adults (infants, children, teenagers) are not eligible to participate
* Prisoners will not be eligible for recruitment

Exclusion Criteria:

- Participants not meeting any of the inclusion criteria.
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy

This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered as an early intervention in pediatric participants with spinal muscular atrophy (SMA) and 2 SMN2 copies who have previously received onasemnogene abeparvovec. Participants are children \< 2 years of age genetically diagnosed with SMA.


Eligibility Criteria:
Inclusion Criteria:

* \<2 years of age at the time of informed consent
* Confirmed diagnosis of 5q-autosomal recessive SMA
* Confirmed presence of two SMN2 gene copies
* Administration of onasemnogene abeparvovec pre-symptomatically or post-symptomatically
* Has received onasemnogene abeparvovec for SMA no less than 3 months, but not more than 7 months, prior to enrollment
* Has, in the opinion of the investigator, not experienced clinically significant decline in function from the time of onasemnogene abeparvovec administration

Exclusion Criteria:

* Treatment with investigational therapy prior to initiation of study treatment
* Any unresolved standard-of-care laboratory abnormalities per the onasemnogene abeparvovec prescribing information
* Concomitant or previous administration of a SMN2-targeting antisense oligonucleotide or SMN2 splicing modifier either in a clinical study or as part of medical care
* Requiring invasive ventilation or tracheostomy
* Requiring awake non-invasive ventilation or with awake hypoxemia (SaO2 \<95%) with or without ventilator support
* Presence of feeding tube and an OrSAT score of 0
* Hospitalization for pulmonary event within the last 2 months, or any planned hospitalization at the time of screening
* Any major illness requiring hospitalization within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to first dose administration.
Solutions for Hunger and Regulating Eating

The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.

The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare BWL, ROC with some aspects of BWL (ROC+) and an active comparator (AC). All treatment groups will be 1.5 hours (including weigh-ins) and will be provided in groups of 15-20 participants weekly for 4 months and twice a month for 2 months (total treatment duration = 6 months, 20 meetings). The investigators will recruit adults with overweight or obesity who are high in Food Responsiveness (FR) and will assess them at baseline, post-treatment (month 6), mid-follow-up (month 12) and follow-up (month 18).

Eligibility Criteria:
Inclusion Criteria:

* high Food Responsiveness
* BMI between 25kg/m\^2 and 45kg/m\^2
* able to read English at a 5th grade reading level
* willing and able to participate in assessment visits and treatment sessions, whether held in-person or via password protected Zoom meetings
* able to provide data through questionnaires
* has a smart phone through which they can complete Ecological Momentary Assessments

Exclusion Criteria:

* major medical conditions such as diabetes or recent history of coronary heart disease; symptoms of angina, stroke, osteoarthritis, osteoporosis, orthopedic problems that would limit activity during the following 18 months; or any other serious medical condition that would make physical activity unsafe
* bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, acute suicidal ideation, moderate or severe alcohol or substance use disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization in the past year)
* medical or psychological problems that could make adherence with the study protocol difficult or dangerous
* pregnant, lactating, or planning to become pregnant in the next 18 months
* participating in other weight control programs and/or taking medication for weight loss
* previous bariatric surgery
* moving out of the San Diego area for the duration of their study enrollment (18 months)
Efficacy of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain

this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain

Neck pain is one of the most commonly reported musculoskeletal disorders. The prevalence for neck pain varies between 16.7% and 75.1% in the general population. Up to 67% of world's population may present chronic non-specific neck pain at least once in their lives. The upper trapezius is probably the muscle most often beset by trigger points, it is indicated that the upper trapezius is the most sensitive of 8 different muscles (upper trapezius, pectoralis major, levator scapulae, teres major, supraspinatus, gluteus medius, infraspinatus, paraspinal) to the pressure of an algometer.Recently, the extracorporeal shock wave has been widely known to be an effective therapeutic modality in myofascial pain syndrome treatment and a systematic review provided promising insight into the effectiveness of ESWT in Myofascial pain syndrome treatment. sixty patients with non specific neck pain will be assigned randomly to two groups; first one will receive shock wave therapy and traditional therapy and the second one will receive traditional therapy only for six weeks.

Eligibility Criteria:
Inclusion Criteria:

* Sixty patients receiving a diagnosis of non-specific neck pain with upper trapezius myofascial trigger points by an orthopaedist physician.
* Body mass index of participants was normal less than (30 kg/m2)(Al-asadi, 2018).
* Age over 18 years.
* Presence of taught band.
* Presence of hyper irritable spot in a taught band, and reproduction of the typical referred pain pattern of the myofascial trigger point in response to compression

Exclusion Criteria:

* Having signs and symptoms of neurological disorders that cause nerve root compression.
* Headache as a consequence of specific headache diagnosis.
* Having a history of specific signs of malignancy, or infection.
* Having a history of trauma with or without proven structural disorders in the region of the neck, shoulder, and head (e.g. whiplash).
* Having signs and symptoms of cerebrovascular insufficiency.
* Having a severe chronic disease of the locomotor system (e.g. polyarthritis, muscular disease
* Any participant with contraindications to shock wave therapy
Using Indirect Calorimetry for Liver Transplants Patients

Although predicted REE calculated using the Penn state 1988 method agreed (ICC 0.61, p=0.00014) with the measured REE, all three predictive equations had a fixed bias and appeared to be inaccurate for predicting REE for liver transplant recipients.

Therefore, precise measurements using indirect calorimetry may be helpful when treating critically ill patients to avoid underestimating or overestimating their metabolic needs.

Rationale: The aim of this study was to compare predictive equations with indirect calorimetry and identify the appropriate energy expenditure requirement of liver transplant(LT) recipients in South Korea.

Methods: This prospective observational study was conducted in a surgical ICU in an academic tertiary hospital over three months. Thirty mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied. Resting energy expenditure(REE) was measured 48 hours after ICU admission using open-circuit indirect calorimetry. Theoretical REE was estimated using three predictive equations: Harris-Benedict methods, lreton-Jones ventilated, and Penn state 1988. The REEs derived from each predictive equation were compared with the measured REE using an intraclass correlation coefficient (ICC) and a Bland-Altman plot.

Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied.

Exclusion Criteria:

* Refusal
* patients who were extubated before 36 hrs
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)

This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep.


Eligibility Criteria:
Inclusion Criteria:

* Must be ≥18 yrs old on the day of signing informed consent
* Diagnosed with Primary Insomnia
* Good physical and mental health
* Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination
* A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception
* Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)
* Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1
* Regular bedtime is between 9 pm-1 am
* Willing to refrain from napping while in study
* Able to read, understand and complete questionnaires and all diaries
* Willing to limit alcohol, caffeine, and nicotine consumption while in the study
* For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory

Exclusion Criteria:

* Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study
* History or diagnosis of another sleep disorder
* Difficulty sleeping due to a medical condition
* History of a neurological disorder
* History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
* Ongoing depression
* History of substance abuse or dependence
* History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit
* Taking certain prohibited medications
* Consumption of the equivalent of \>15 cigarettes a day
* History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Participant is considered morbidly obese
* Previously randomized in another investigational study of suvorexant
Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism

The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.

Up to 50% of patients with a first episode of venous thromboembolism (VTE) have no identifiable cause (i.e. are unprovoked VTEs). The risk of recurrent VTE in this large group of patients with unprovoked VTE after 3-6 months of anticoagulant therapy is 5-10.8% in the year following discontinuation of oral anticoagulant therapy. One in six to one in twenty recurrences of a new VTE are fatal. Given the intermediate risks of recurrence in unselected unprovoked VTE patients, clinicians do not have clear guidance on whether to continue or discontinue anticoagulants in patients with unprovoked VTE. Recently attention has turned to the concept of risk stratification to identify subgroups of patients with unprovoked VTE who could safely discontinue oral anticoagulation therapy (OAT).

In the REVERSE I study, a clinical decision rule derivation study conducted from 2001 to 2006, we developed and internally validated the clinical decision rule "Men continue and HER DOO2" that identifies patients with a first unprovoked VTE who likely have a low risk of recurrent VTE and could safely discontinue OAT subsequent to 5-7 months of OAT. The present study will evaluate if the "Men continue and HER DOO2" rule (comprised of gender, elevated D-dimer levels, post-thrombotic signs, obesity, and older age) is safe, clinically useful, and reproducible when prospectively implemented in multiple centers and a variety of settings. If this clinical decision rule is validated, it will provide physicians with important information to allow them to more confidently identify unprovoked VTE patients at low risk of VTE recurrence who may not need to continue OAT.

Eligibility Criteria:
Inclusion Criteria:

* First episode of major unprovoked VTE
* VTE objectively proven
* VTE treated for 5-12 months with anticoagulant therapy authorized for the REVERSE II study (initial or ongoing therapy)
* Absence of recurrent VTE during the treatment period

Exclusion Criteria:

* Less than 18 years of age
* Patients who have already discontinued anticoagulant therapy
* Patients requiring ongoing anticoagulation for reasons other than VTE
* Being treated for a recurrent unprovoked VTE
* Patients with high risk thrombophilia
* patients who plan on using exogenous estrogen(OCP,HRT)if anticoagulant therapy is discontinued
* Patients with pregnancy associated VTE
* Geographically inaccessible for follow-up
* Patients unable or unwilling to provide informed consent
Effect of Vitamin D After Application With Valchlor

The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system.

An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown.

Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.

Primary Endpoint To determine the effect of a topical application of Valchlor on human subjects at the clinically approved dose.

Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin irritation 48 hours after topical application of Valchlor.

Eligibility Criteria:
Inclusion Criteria:

* Must be in general good health
* Fitzpatrick Skin Type I-VI
* Able to list all current medications and medical conditions
* Capable of giving informed consent

Exclusion Criteria:

* Women who are pregnant, nursing, or who may become pregnant in the next 3 months
* Participants taking illegal drugs
* Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
* Currently consuming 800IU or more of vitamin D a day
* Subjects whose BMI are \> 40
Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes

The purpose of this research study is to evaluate a transition preparation program designed for adolescents and young adults (AYAs) with type 1 diabetes (T1D). This transition program will support AYAs as they prepare to transition from pediatric to adult endocrinology medical care and will also include a caregiver. Results from this study will inform clinical recommendations regarding self-management best practices for AYAs with T1D prior to transitioning to adult medical care.

Investigators will recruit adolescents and young adults ages 16-22 years with T1D and a parent/guardian. Families will participate in one of two 6-month treatments: 1) SHIFT2, engaging in monthly sessions with transition coaches providing education on diabetes management and healthcare transition, or 2) Enhanced treatment (TAU+), engaging in routine medical care and receiving monthly education (no coaches).

Eligibility Criteria:
Inclusion Criteria:

AYA:

1. Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record)
2. 16-22 years old
3. English speaking
4. Children's Hospital of Richmond patient (Division of Pediatric Endocrinology)
5. must have a caregiver willing to participate

Caregiver:

1. Age greater than 18 years
2. Provides care to AYA and willing to participate

Exclusion Criteria:

AYA:

1. Non-English speaking
2. Significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability
3. Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder
4. Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes.
5. Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
6. Another member of the household (other than the participating parent) is a participant or staff member on this study.
7. Participation in another research study that may interfere with this study.
8. Previous participation in the SHIFT pilot study

Caregiver:

1. Non-English speaking
2. Significant psychiatric, cognitive, developmental conditions that would impair their ability to complete assessments and/or engage in supporting the AYA with diabetes self-care behaviors (e.g., psychosis, intellectual disability)
3. Another member of the home (not AYA) is a participant/staff member on current study
4. Participation in another research study that may interfere with current study
5. Previous participation in SHIFT pilot study