cyrilzakka/clinical-trials huggingface dataset:
Anatomical Relationship Between Carotid Artery and Hyoid Bone in Stenotic and Non-stenotic Carotids

Ischaemic stroke is attributable to thromboembolism caused by carotid atherosclerotic disease in 18-25% of patients. Guidelines for prevention of stroke (especially carotid endarterectomy) in patients with carotid atherosclerotic plaque are based on the quantification of the degree of stenosis.

The hyoid bone, in proximity to the carotid artery, has been implicated in the pathophysiology of carotid artery dissection, atherosclerotic carotid disease, and compressive syndromes. In atherosclerotic carotid disease, pressure on the carotid artery induced by these bone structures has been proposed to play a possible role in plaque formation and rupture, leading to stenosis, occlusion, or artery-to-artery embolism. In a recent ultrasound study, dynamic displacement of the carotid artery with interference of the hyoid bone during swallowing, named as "flip-flop" phenomenon (FFP) has been associated with carotid artery stenosis and stenosis-related stroke. Another study based on CTA assessment observed no association between hyoid-carotid distance and plaque thickness, stenosis, or progression of thickness/stenosis. In that study, in almost two-third of the patients CTA was performed for stroke/transient ischemic attack work-up, including a vast majority of patients with absence of carotid stenosis (median degree of carotid stenosis was 7%), and plaque-related stroke was not assessed.

The objective of this study is to determine the anatomic hyoid-carotid interaction (ie, hyoid-carotid distance, carotid position relative to the hyoid bone, and hyoid morphology) based on CTA and its relation to the degree of carotid stenosis and stenosis-related stroke.


Eligibility Criteria:
* Patients followed at the University Hospital of Nîmes between November 2016 and March 2020
* Age \> 18 years
* Patients who underwent carotid endarterectomy for symptomatic or asymptomatic stenosis
The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

The purpose of this study is to verify that induction gemcitabine and cisplatin plus intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).

Patients with non-keratinizing NPC T1-4N2-3或T3-4N0-1M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy or CCRT alone. Patients in experimental group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before intensity-modulated radiotherapy (IMRT). Patients in control group receive IMRT concurrently with weekly cisplatin 40 mg/m² up to 7cycles.

IMRT is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.

Our primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma (including WHO II or III).
* Tumor staged as T1-4N2-3或T3-4N0-1M0 (according to the 7th AJCC edition).
* Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
* Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
* Adequate liver function: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤1.5×ULN.
* Adequate renal function: creatinine clearance ≥ 60 ml/min.
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Treatment with palliative intent.
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)

Interventional, prospective, single-centre study aimed to evaluate the impact of a video-assisted remote speech therapy consultation in relation to the complexity and specificity of the care of patients with ORL cancer. Three indications will be studied: phonation problems, swallowing problems and other problems.

The study will be conducted on a population of patients with T3, T4 ORL cancer requiring speech therapy.

Each patient included will have a video-assisted speech therapy consultation with a private speech therapist and an expert speech therapist. At the end of this video consultation, the patient and the private speech therapist will be asked to complete a satisfaction questionnaire.

At the follow-up visit following the video-assisted consultation, the patient will have completed participation in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at study entry.
2. Patient with carcinological pathology of the VADS, relevant to surgery and/or radiotherapy and/or chemotherapy.
3. Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).
4. Patient affiliated to a Social Security system in France.
5. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol.
3. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
Clinical Evaluation of Rapid Antibody Test for Covid-19

Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently results of the standard test for the virus take 2-3 days to be reported.

Watford General Hospital has imported rapid antibody tests manufactured by Zuhai Livzon Diagnostics Inc in China and our team would like to evaluate their accuracy and clinical usefulness. The test involves taking a drop of blood from the patient (either from a venous blood sample taken for other blood tests, or from a fingerprick). This is applied to a test strip (similar to a pregnancy test) and two drops of diluent are added. If the patient has antibodies to Covid-19, two lines appear on the test strip (like a positive pregnancy test) whereas if the patient has no antibodies, only one line appears (like a negative pregnancy test). There are two different types of antibody: IgM is produced early in the course of the illness (day 7-14) and then IgG is produced later and continues to be present, probably for months or years. There are two test strips, one for each of these types of antibody.

In this study we aim to evaluate the accuracy of this new test, in three groups of patients. Firstly those with proven Covid-19 and at least 7 days after the onset of their illness. We aim to recruit 200 patients in total: at least 138 patients with 10 or more days of symptoms, plus a subgroup of up to 62 patients with 7-9 days of symptoms (to explore the usefulness of the test earlier in the course of illness). The second group of 250 patients will be those hospital staff who report symptoms possibly caused by Covid-19 and are receiving a standard antibody test.

The third group of patients will be those followed up in a "virtual hospital" for clinically suspected Covid-19 who had never been tested with a standard PCR test.

As we are not sure of the accuracy of the new test, its results will not be used to make decisions about treatment for the patient.

This study will enable us to discover rapidly whether the new test is accurate, and if so we will conduct further studies to assess how it can help to improve management of patients with suspected Covid-19.


Eligibility Criteria:
Inclusion Criteria:

1. Inpatient or patient in the "virtual hospital" with confirmed Covid-19 infection on PCR OR with history of clinically suspected Covid-19 but no PCR test OR hospital staff with clinical suspicion of past Covid-19 infection.
2. Age 18 or over
3. At least 7 days since onset of symptoms
4. Willing and able to give written informed consent

Exclusion Criteria:

1. Symptom duration \<7 days.
2. Lack of written consent
3. Age under 18
Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.


Eligibility Criteria:
Main Inclusion Criteria:

* Patient meets DSM-IV criteria for schizophrenia.
* Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.
* Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.

Main Exclusion Criteria:

* Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
* Patient has Parkinson's disease.
* Patient has a history or complication of malignancy.
Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma

This is a multi-center prospective observational study that will capture detailed information about the treatment and long term outcomes of 250 patients with PNI resulting from upper extremity trauma. The study will focus on a young adult population to include individuals ages 18-65. Patients with PNI will be recruited during the hospitalization for initial treatment of the upper extremity injury. Additional patients may be identified during clinic visits for on-going treatment of upper extremity injuries as nerve injuries evolve or upon referral from outside physicians. However, all eligible nerve injuries must be treated within 6 months of the initial upper extremity trauma. Outcomes will be assessed at 3, 6, 12, 18 and 24 months following diagnosis of the nerve injury. All assessments will take place in the clinic and will include a patient interview and a brief exam to evaluate sensory and motor function.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-65
2. Sustained a peripheral nerve injury (including iatrogenic injuries and partial nerve injuries) resulting from upper extremity trauma meeting the following criteria:

   1. Involves injury or dysfunction to motor, or motor and sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized distal to the brachial plexus cord level and proximal to the distal flexion crease of the wrist
   2. Involves a "mixed" nerve segment (i.e. involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present) but does not include sensory only distal terminations of the same nerves.
3. Receiving surgical treatment (i.e. exploration, neurolysis, repair or reconstruction, nerve or tendon transfer) within 6 months of the initial injury.

Exclusion Criteria:

1. Injuries to the brachial plexus roots, trunks, divisions and cords
2. Injuries to the nerves distal to the distal flexion crease of the wrist
3. Injuries that involve a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral ante brachial cutaneous nerve, etc)
4. Previous motor or sensory deficit prior to injury (e.g. resulting from trauma, stroke, muscular, neurologic, neuromuscular disorder, etc.)
5. Documented psychiatric disorder that limits ability to consent and maintain follow-up
6. Unable to speak either English or Spanish
7. Severe problems with maintaining follow up (e.g patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).
A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy Volunteers

This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule formulation in healthy volunteers. Subjects will be randomized to one of four treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule formulation with or without a high fat meal, with a washout period of at least 14 days between treatments.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults, 18 to 55 years of age inclusive
* Body mass index (BMI) 18.0 - 30.0 kg/m2
* Healthy status defined as absence of clinically significant acute or chronic condition as determined by complete medical history and physical examination
* Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception as defined by protocol during treatment and for at least 3 months after the last dose of study drug
* Non-smokers or use of \< 10 cigarettes (or equivalent nicotine-containing product) per day
* Negative results on following screening laboratory test: urine drug screen, urine alcohol screen
* Willing and able to consume the study-specified meal on day of dosing

Exclusion Criteria:

* Pregnant or lactating women, or males with female partners who are pregnant or lactating
* History of current alcohol abuse and/or other drug addiction \</= 2 years prior to enrollment in the study
* Participation in other clinical studies within 60 days prior to study randomization
* Positive for hepatitis B, hepatitis C or HIV infection
Heart Rate Variability in Chronic Kidney Disease Patients

Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease patients

24hr Holter examination is a non-invasive tool in detecting and diagnosing cardiac arrhythmia. Moreover, Heart rate variability has been proven to been an important prognostic factor in many cardiovascular diseases. The traditional linear analysis of heart rate variability proved to predict clinical outcome in myocardial infarction patients. The more delicate non-linear analysis in heart rate variability is one of the hot topics in the world.

Despite some biochemical values like WBC counts, platelet counts, BUN, creatinine, lactate, clinical vital parameters like blood pressure, heart rate, and oxygenation have been used to predict clinical outcome in chronic renal disease(CKD) patients, the application is still limited. It is an international interest to find a more safe and simple technique to identify important prognostic factors in CKD patients. Our project aimed to recruit these CKD patients from our hospital and conduct a cross-sectional study. Cardiac ultrasonography and 24hrs Holter will be arranged. Linear and non-linear analysis of heart rate variability will be performed and serum marker that influence prognosis like WBC count, platelet count, lactate, BUN, creatinine, fibrosis marker and adiponectin will be checked. Short term and long term outcome was followed and identify important prognostic factors to improve and detect clinical prognosis.

Eligibility Criteria:
Inclusion Criteria:

* peritoneal dialysis more than 3 months

Exclusion Criteria:

* pregnancy 2. received CT in recent 3 months
Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions

The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT under non-fasting conditions in healthy, non-smoking, adult subjects.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* All subjects selected for this study will be non-smokers at least 18 years of age.
* Subjects will have a BMI (body mass index) of 30 or less.

Exclusion Criteria:

* Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
* Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
* Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
* All Female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident

The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the Social Condition and experience of the two groups.

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Social Condition and Experience of two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by video fluoroscopic Swallowing Study.
* Clear consciousness.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of androgenetic alopecia.

This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be randomized into the study. The study is designed as an 18-month study consisting of 2 phases. This study was a pilot study designed to determine feasibility of this procedure.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 18 years old and ≤55 years old
2. Subjects are in good health as judged by the investigator.
3. Diagnosed with by a dermatologist with moderate androgenetic alopecia.
4. Subject is seeking treatment for androgenetic alopecia.
5. Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
2. Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
3. Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
4. History of a clinically significant hematologic disorder as determined by the investigator.
5. Subjects currently receiving anticoagulant or anti-platelet therapy.
6. Subjects on daily Aspirin therapy for cardiovascular disease.
7. Subjects with chronic NSAID use, unable to wean off.
8. Subject is known to be HIV positive.
9. History of recurrent facial or labial herpes simplex infection
10. History of hypertrophic scars or keloids
11. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
12. Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
13. Pregnant or breast feeding
14. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
15. Subjects who are unable to understand the protocol or give informed consent.