cyrilzakka/clinical-trials huggingface dataset:
Hypersensitivity to Opening of BKCa Channels in Post-Traumatic Headache

The aim is to investigate whether opening of large conductance calcium-activated potassium (BKCa) channels induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years of age upon entry into screening
* History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
* ≥ 4 monthly headache days on average across the 3 months prior to screening Provision of informed consent prior to initiation of any study-specific activities/procedures.

Exclusion Criteria:

* \> 1 mild traumatic injury to the head
* History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
* History of moderate or severe injury to the head
* History of whiplash injury
* History of craniotomy
* History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
* Female subjects of childbearing potential with a positive pregnancy test during any study visit
* Cardiovascular disease of any kind, including cerebrovascular diseases
* Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
* Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
* Baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
* Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal

This is A non-blinded trial. Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily sign the informed consent form (ICF).
* Age 18-75 years old, either male or female.
* Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant,.
* Patients with a total or near-total thyroidectomy within 6 weeks prior to administered.
* Low iodine diet for 4 weeks prior to randomized.

Exclusion Criteria:

* Pregnant or breast feeding women.
* Patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)
* Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.
* Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
Electronic Memory and Management Aid

This study will evaluate the effectiveness of a personalized, web-based training intervention that was developed to teach use of an Electronic Memory and Management Aid (EMMA) application. The app-based system is designed to support everyday memory, daily activity management and positive health behavior engagement for older adults with subjective cognitive complaints or mild cognitive impairment. The investigators will also evaluate the degree to which a clinician is needed to oversee the uptake and utilization of the EMMA app during the web-based training intervention.

Participants will be randomly assigned to one of two groups, "Technical Support Only" group (T-only group) and "Technical + Clinician Support" group (T+C group). Participants will be enrolled in the study for 6 months.

Participants who pass initial phone screening criteria will participate in a 2-3 hour neurocognitive assessment over zoom to establish baseline cognition, prior to beginning the intervention. Participants will also complete questionnaires and a real-world measure assessing daily functioning. After the initial assessment is complete, participants will be given one-month to learn to use the EMMA app by completing the self-paced intervention via the adaptive, web-based training platform, which includes six lessons. EMMA device-use will be captured throughout the study by the app itself.

A component of the self-paced, web-based intervention involves setting goals related to using the EMMA app. A clinician will monitor the training data and goals the T+C group participants make and conduct brief problem-solving and goal-refining sessions during the intervention weeks. These sessions are expected to be 10-15 minutes. To keep training on track, the T-only group will receive brief phone check-ins to monitor progression through the web-based intervention. Following training, there will no longer be any differences in the treatment of both groups, which will be monitored for an additional three months. Immediately following training and at the end of the 3 month monitoring period, all participants will complete the battery of questionnaires and answer a semi-structured phone interview. In addition, at the end of the 3 month follow-up, all participants will again complete the neurocognitive assessment and real-world measure of daily functioning.

Eligibility Criteria:
Inclusion Criteria:

* Must be age 50 or older
* Self-reporting subjective cognitive complaints (screening questions)
* Must be able to read and speak English

Exclusion Criteria:

* Cannot provide own informed consent
* Have a known medical, neurological or psychiatric diagnosis that explains current cognitive complaints (e.g., stroke)
* Cannot complete remote study protocol due to severe vision or hearing difficulties
Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus

Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have or be suspected of having a ventilator-associated pneumonia (VAP) due to MRSA.
* Patient must be hospitalized for at least 5 days, must be ventilator-dependent ≥ 48 hours prior to screen/baseline, and anticipated to remain on the ventilator for 72 hours after enrollment so follow-up BAL can be performed.
* Clinical picture compatible with pneumonia (acquired during ventilation)
* Chest X Ray at baseline/screen or within 24 hours of initiation of therapy must be consistent with diagnosis of pneumonia

Exclusion Criteria:

* Hypersensitivity to linezolid, vancomycin, or one of the excipients in any of these drug formulations.
* Infections due to gram-positive organisms known to be resistant to either of the study drugs.
* Any antibiotic used in the treatment of MRSA, such as vancomycin, TMP/SMX, rifampin, or linezolid, for more than 48 hours prior to patient's enrollment into the study.
* Patients with neutropenia, AIDS, lymphoma or anticipated chemotherapy.
* Patients who have long-term tracheostomy (for more than 60 days). Acute tracheostomy patients are allowed.
A Study To Evaluate Methods To Evaluate Back Pain

The study is designed to assess methods used in clinical research.


Eligibility Criteria:
Inclusion Criteria:

* Lower back pain
* Male or female in generally good health, from 18 to 55 years of age (inclusive)

Exclusion Criteria:

* Pregnant or lactating
* Subject has evidence or history of radiculopathy, i.e. sciatica extending below the knee (numbness, tingling, or shooting pain), or other neurologic deficits (abnormal straight leg raise test, patellar reflexes, and/or bowel and bladder function);
* Subject has a history of previous back surgery;
* Subject has back pain resulting from traumatic injury involving physical evidence of bruising, swelling, or inflammation to the abdomen or low back area which occurred less than 48 hours prior to enrollment
* Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
* Is a member or relative of the study site staff, CRO or Sponsor organization directly involved with the study or had a household member or relative participate concurrently or previously in this study
* Has previously been enrolled in this study
Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure

Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use.

Several types of solutions are used in contact lens wear.

Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts.

The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to identify any potential consequences of contact lens wear and/or care solution used.

Eligibility Criteria:
Inclusion Criteria:

* Vision correctable to 20/30 or better in both eyes
* Successful soft contact lens wear for at least 2 weeks prior to enrollment

Exclusion Criteria:

* History of hypersensitivity to any of the components in any of the lens solutions
* One functional eye or a monofit lens
* Any abnormal slit-lamp finding at baseline
* Use of topical ocular meds
* Any systemic condition with significant ocular side effects or that interfere with contact lens wear
* Enrollment of the investigator's office staff, relatives or members of their respective households
* Enrollment of more than one member of the same household
Epidemiology of Sepsis in China

Sepsis is a common cause for morbidity and mortality in critically ill patients. In USA, the incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among different clinic trails. In addition, clinician empirical select antibiotic according to the epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In China, the MDRO is much higher than western country. There is no study about the epidemiology of sepsis in China. Therefore, it is necessary to conduct a study about it in China.

Sepsis,especially severe sepsis is a major cause of admission to the intensive care unit (ICU) and death. In USA, the incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among different clinic trails. Between 6 and 54% of patients admitted to ICUs have severe sepsis and the mortality rate for these patients varies from 20 to 60%. There is no exactly results of incidence of sepsis in China.

In addition, clinician empirical select antibiotic according to the epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In EPIC II study, the organisms of sepsis include Gram-positive microorganisms (69.8%),Gram-negative microorganisms(62.2%) and fungi (17%). In China, the MDRO is much higher than western country. In contrast to EPIC II study, one study in China showed that the organisms of sepsis include Gram-positive microorganisms (14.5%),Gram-negative microorganisms(62.5%) and fungi (2.2%). Therefore, it is necessary to conduct a study about epidemiology of sepsis in China.

Eligibility Criteria:
Inclusion Criteria:

sepsis patients who admitted into ICU during research period (include patients with sepsis at ICU admission and patients who has new sepsis during ICU period)

Exclusion Criteria:

The patients with second sepsis in ICU
The Effect of The STEADI Program on Falls and Falls Prevention in Neurosurgical Patients in Jordan

The goal of this interventional study will be to evaluate the effectiveness of the STEADI Program on falls and falling prevention compared with routine falling assessment in neurosurgical patients in Jordan. The researchers will compare the effectiveness of the STEADI intervention in the intervention group. Participants in the intervention group will be assessed for falls risk using well-established tools as recommended by the Centers for Disease Control and Prevention (CDC). The control group participants will receive regular falling assessment which involves using Morse Fall Scale.

The STEADI (Stopping Elderly Accidents, Deaths \& Injuries) program was developed by the Centers for Disease Control and Prevention (CDC) to help healthcare providers address falls among older adults. The STEADI program provides healthcare providers with tools and resources to screen their older patients for fall risk, assess risk factors, and develop and implement an individualized fall prevention plan. The STEADI program is an evidence-based approach to fall prevention and has been shown to reduce falls among older adults. However, evidence regarding the effectiveness and usefulness of the STEADI among neurosurgery patients is lacking. The investigators of the current research will conduct a 2-hour educational session to train healthcare providers in a neurosurgery unit on using the STEADI tools and algorithm. Then, the investigators will collect data to assess whether applying the STEADI decreases the risk for falls in neurosurgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Newly admitted patients to the neurosurgery unit as a case of neurosurgery, have ≥4 scores on the Stay Independent Brochure (SIB), 18 years old or older.

Exclusion Criteria:

* Bedridden and unconscious/comatose patients
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials

Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials


Eligibility Criteria:
Inclusion Criteria:

* Prior enrollment into selected oral cladribine clinical trials as of randomization to either study drug or placebo, once participation in the clinical trial has ended
* Written informed consent was given

Exclusion Criteria:

* Participants who cannot be reached by telephone
* Participants unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires
* Participants who - either during the lag interval or subsequently enter an interventional study
Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

OBJECTIVES:

I. Investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.

PROTOCOL OUTLINE: Patients receive colchicine orally twice daily for 24 months. After the first month, the dose of colchicine will increase and remain at that dose for the duration of study.

Patients are evaluated every 6 months during study.

Eligibility Criteria:
* Advanced hepatic fibrosis or cirrhosis in children
* Not pregnant
Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or female subject 40 years of age or older with a diagnosis of COPD.
* Subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.
* Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.

Exclusion Criteria:

* Subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug.
* Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics.
* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.
The Treatment of High Intensity Transcranial Current Stimulation for Alzheimer's Disease

Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment.

As the population is aging, there is an urgent need to develop new methods of treatment for AD. Noninvasive neuro-regulation is a new technique in treating neuropsychiatric diseases. It include transcranial magnetic stimulation, traditional transcranial direct current stimulation, traditional transcranial alternating current stimulation and etc. Previously, conventional transcranial direct current stimulation had shown inconsistent results in the treatment for AD. This may be related to the low current density of traditional electrical stimulation in deep brain areas, such as hippocampus and amygdala, and leading to poor stimulation effect. Compared with the traditional transcranial electrical stimulation technology, the high intensity tACS greatly improves the current intensity, so that the electric field intensity to the deep brain nucleus during stimulation is greatly increased, and it avoids side effects such as burning sensation. Therefore, it could be used for AD patients. However, there are few clinical studies on high intensity tACS on AD, so investigators designed a randomized double-blinded placebo-controlled trial to explore the effect of high-current tACS on AD. At the same time, multimodal functional brain imaging before and after treatment will be used to compare the changes of brain function activation and cerebral hemodynamics in AD.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of National Institute on Aging and Alzheimer's Association (NIA-AA) 2011 for Alzheimer's disease, Clinical Dementia Rating (CDR) score is greater than or equal to 0.5 and less than or equal to 1, and amyloid PET imaging is positive.
2. Have the ability to cooperate with neuropsychological testing, EEG measurement, and MRI examination;
3. Have willingness to undergo cognitive psychological evaluation;
4. Do not have cognitive impairment due to other degenerative diseases or viral and immune encephalitis;
5. The length of schooling is at least 3 years.

Exclusion Criteria:

1. Do not suffer from severe depression, anxiety and other mental illness;
2. Do not suffer from major diseases such as tumors, heart and lung diseases, nervous system diseases, etc.
3. Do not have been diagnosed with other dementia such as Parkinson's disease dementia (PDD), frontotemporal dementia (FTD), lewy body dementia (DLB), and normal cranial pressure hydrocephalus (NPH).
Usefulness of Video-Based Intervention in Helping Participants Encourage Their Families to Get Tested for BRCA Gene Mutations

This trial studies how well a video-based intervention works in helping participants encourage their families to get tested for BRCA gene mutations. Testing in families with BRCA gene mutations can allow for risk management and reduction with the overall goal of reducing cancer burden. Video-based intervention sent via text messages may help participants easily share information about BRCA gene mutations with family members.

PRIMARY OBJECTIVES:

I. To understand whether the use of a video-based message to encourage cascade testing, delivered via short message service (SMS) (text message) or shared on social media, is superior to a written message as a method of information-sharing among families that have BRCA gene mutations.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Participants receive a 2-minute information-graphic video via text message consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives that they can share with family via text message, email, or social media.

ARM B: Participants receive family letter via U.S. postal service mail consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who test positive for mutations in BRCA1 or BRCA2 are eligible for this study
* Family members who receive the video message/family letter will be invited to participate
Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.


Eligibility Criteria:
Inclusion criteria:

1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive on study day 1. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone \[FSH\] ≥ 38 mIU/mL) and must have a negative serum pregnancy test result before administration of test article.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg.
3. Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria:

1. Family history QT prolongation, syncope, seizure, or unexplained cardiac related death.
2. Presence or history of any disorder that may prevent the successful completion of the study.
3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.