cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography

This is a blind evaluation, self-control, multicenter clinical trial designed to determine the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA), as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically significant coronary stenosis, using invasive fractional flow reserve (FFR) as the reference standard.


Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 years old;
* Subjects with clinical need and consent for coronary angiography;
* Can provide the results of coronary CT angiography within 60 days prior to ICA or agree to undergo coronary CT angiography;
* The subjects knew about the experiment and signed the informed consent voluntarily.

Exclusion Criteria:

* Patients who have had percutaneous coronary intervention (PCI);
* Patients who had CABG;
* Acute coronary syndrome, such as acute ST segment elevation;
* Severe tachycardia or arrhythmia;
* Patients with severe hepatorenal insufficiency;
* Patients with congenital heart disease, implanted pacemaker or defibrillator, artificial heart valve;
* Failure to perform invasive FFR examination or obtain FFR value due to various reasons;
* Allergic to β - blockers, nitrates and adenosine, sick sinus syndrome, long QT syndrome, severe hypotension, severe asthma, severe COPD or COPD;
* Persistent or significant clinical instability, including acute chest pain (sudden onset), cardiogenic shock, blood pressure instability (systolic blood pressure \< 90mmHg) and severe congestive heart failure (according to the heart classification of the New York Heart Association, grade III or IV of cardiac function) or acute pulmonary edema;
* The CTA images of coronary artery showed that the stenosis rate was less than 30% or greater than 90%, or the diameter of diseased segment was less than 2.0mm;
* CT-FFR can not be calculated because of the quality of CTA image;
* Known pregnant and lactating women;
* Having participated in other clinical trials within 3 months;
* Other situations that the researchers judged were not suitable for inclusion.
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis
* Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion Criteria:

* Pregnant or lactating women
* Active infection
* Positive for hepatitis B, hepatitis C or HIV infection
* Concomitant anti-TNF drugs
* Contraindications to treatment with RoActemra/Actemra
Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis

This is a Phase 2, multi center, randomized, placebo controlled parallel group study to evaluate the clinical efficacy and safety of LC51 0255 in subjects with moderately to severely active ulcerative colitis


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 80 years
* Active UC confirmed by endoscopy
* Moderately to severely active UC defined as a 3-component Mayo Clinic score

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
* Treatment with cyclosporine, tacrolimus, sirolimus, methotrexate, or mycophenolate mofetil within 16 weeks of screening
* Treatment with a biologic agent (ie, anti TNFs, anti integrins, and anti interleukin 23) within 8 weeks prior to screening endoscopy
* Any prior exposure to S1P receptor modulators, natalizumab, lymphocyte-depleting therapies (ie, alemtuzumab, anti CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
Sacral Neuromodulation & Urodynamics

In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR).

Long-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy


Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder
* Non-obstructive urinary retention

Exclusion Criteria:

* Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)
Exploring the Nature, Assessment and Treatment of Stuttering

The purposes of this study are to 1) investigate potential speech, language, and psychosocial contributions to the experience of stuttering in monolingual and multilingual speakers, and to 2) evaluate interdisciplinary, telehealth, and speech-language pathology treatment methods and clinical training specific to fluency disorders.

Stuttering is a neurophysiological communication disorder characterized by a disruption in the forward flow of speech. Stuttering is multifactorial in nature, meaning there are several factors that likely to contribute to the development of stuttering in children and persistence of stuttering into adulthood. About 1% of the worldwide population stutters. In the United States, over 3 million people stutter. Research suggests people who stutter present with negative cognitive and affective components of the disorder, and that the general population holds negative perceptions of stuttering. Historically, people who stutter spend thousands of dollars on treatment that is not effective in mitigating the negative impact of stuttering on their overall communication and quality of life.

Speech-language pathologists evaluate and treat persons who stutter across the lifespan. Research suggests speech-language pathologists report fluency disorders (stuttering and cluttering) as the communication disorders with which they feel least competent and comfortable.

Thus, the purposes of this study are to 1) investigate potential speech, language, psychosocial, and motor contributions to stuttered speech production in monolingual and multilingual speakers and to 2) evaluate interdisciplinary, telehealth, and speech-language pathology treatment methods and clinical training tools specific to fluency disorders.

Eligibility Criteria:
Inclusion Criteria:

A participant will be considered a child who stutters (ages 2-17 years) if

* their parent/caregiver reports concern that their child is a person who stutters,
* they exhibit three of more stuttering-like disfluencies (e.g., sound/syllable repetitions, (in)audible sound prolongations, whole-word repetitions) per 300-word speech sample, or
* they present with an overall score of 11 or higher on the Stuttering Severity Instrument - 4th Edition (SSI-4).

A participant will be considered an adult who stutters (18+ years) if

* they report they are a person who stutters,
* they have received a formal diagnosis of stuttering from a certified speech-language pathologist,
* they exhibit three of more stuttering-like disfluencies (e.g., sound/syllable repetitions, (in)audible sound prolongations, whole-word repetitions) per 300-word speech sample, or
* they present with an overall score of 11 or higher on the Stuttering Severity Instrument - 4th Edition (SSI-4).

Exclusion Criteria:

• There are no exclusion criteria for persons who stutter.
Tanezumab In Osteoarthritis Of The Hip Or Knee

The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

* pregnancy or intent to become pregnant
* BMI greater than 39
* other severe pain, significant cardiac, neurological or psychiatric disease
Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia

This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia
* BMI\>25
* American Society of Anesthesiologists (ASA) classification I, II, III

Exclusion Criteria:

* Patient refusal
* Contraindication for spinal anesthesia
* Contraindication for remimazolam infusion
* History of hypersensitivity to remimazolam
* History of chronic use of benzodiazepine or opioid
* Baseline MOAA/S score of 4 or lower
* Pregnancy
Investigating Auto Adjusting Dynamic AFO

Offloading Ankle Foot Orthoses (AFOs) are devices designed for people following lower-limb reconstruction to restore mobility by reducing mechanical loading through the injury site and redistributing it proximally. While they perform well for some users, their current form limits full functional potential and may put joints proximal to the injury at risk of long-term damage. This study is directed toward designing and testing a lightweight, variable stiffness, dynamic brace that can adjust in response to user activity.


Eligibility Criteria:
Inclusion Criteria (Healthy Volunteers):

-able to run continuously for 1 minute

Inclusion Criteria (All Other Volunteers)

* prescribed an offloading Ankle-Foot Orthosis (AFO) for walking/running
* Use prescribed offloading AFO at least 20 hours per week
* Prescribed AFO strut length of at least 200 mm
* Able to run continuously for 1 minute

Exclusion Criteria (Healthy Volunteers):

* limited sensation in the lower limbs
* use an assistive device

Exclusion Criteria (All Other Volunteers):

* Unable to ambulate (walk/run) continuously with AFO for at least 1 minute
* Unable to sit, stand, or negotiate a step onto lab treadmill
A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers

An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the effect on ECG of escitalopram after oral administration in elderly volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy subject aged 65 or older at screening
* A body weight in the range of 50 kg (inclusive) to 90 kg (inclusive) with BMI range of 19.0 to 28.0
* subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator
Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy

The objectives of this study were to assess the tolerability and safety of E2007 in patients with refractory partial or generalised seizures and to assess the pharmacokinetics of E2007 in epileptic patients receiving at least one concomitant anti-epileptic drug.


Eligibility Criteria:
Inclusion Criteria

A patient who met the following inclusion criteria was eligible to participate in the study:

1. Males or females with simple or complex partial seizures with or without secondary generalization, or primary generalized tonic-clonic seizures according to the International League against Epilepsy classification. Patient records were to document the frequency of seizure.
2. Age: 18 to 65 years.
3. Race: any.
4. Patients receiving up to two additional anti-epileptic medications at doses that were stable for at least the four weeks immediately preceding baseline.
5. Patients willing and able to co-operate with the study procedures including completion of patient diaries.
6. Patients living at home with a partner or carer able to monitor compliance.
7. Patients giving informed consent to participate in the study.

Exclusion Criteria

A patient who met the following exclusion criteria was not eligible to participate in the study:

1. Pregnant or lactating women.
2. Women of childbearing potential unless (1) surgically sterile or (2) practicing effective contraception (eg, abstinence, IUD or barrier method plus hormonal method) and having a negative serum beta-HCG result at screening and being willing to remain on the current form of contraception for the duration of the study. Postmenopausal women could be included but were to have been amenorrhoeic for at least 12 months to be considered as not being of child-bearing potential.
3. Fertile men not willing to use reliable contraception or with partners not willing to use reliable contraception.
4. Patients with status epilepticus within the past 24 months.
5. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, abdominal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
6. Patients with significantly elevated liver enzymes (abnormal bilirubin level, or serum transaminase levels more than 1.5 times the upper limit of normal).
7. Patients taking drugs other than anti-epileptic agents which induce the enzyme cytochrome P450 3A4 (since these might reduce the plasma concentration of E2007), including dexamethasone, rifabutin, rifampacin, St John's Wort.
8. Patients with past or present drug or alcohol abuse.
9. Patients with unstable psychiatric illness.
10. Patients who had received an investigational drug within the three months before baseline.
11. Patients without a reliable partner or carer.
12. Patients with any condition which would make the patient, in the opinion of the investigator, unsuitable for the study.
Evaluation by Ultrasound Imaging of Local Anesthetic Spread to the Popliteal Fossa During an Adductor Canal Block

Adductor canal block is an effective analgesic technique for major knee surgery. However, the saphenous nerve block is not sufficient to explain this block's efficiency. It has been shown that adductor canal block can spread to the tibial and fibular nerves through the adductor hiatus. However this diffusion's frequency has never been measured. The main objective of this study is to assess the frequency of the spread of the adductor canal block to the fibular and tibial nerves assessed by ultrasound observation at the popliteal fossa.

Adductor canal block is an effective analgesic technique for major knee surgery. The PROSPECT group recommends this block in first intention for locoregional anesthesia in total knee arthroplasty. It has been shown to not be inferior to femoral nerve block in this indication.

The adductor canal block targets the saphenous nerve and, through its spread in the adductor canal, the posterior branch of obturator nerve and the vastus medialis nerve. However these nerves can't fully explain this block's efficiency.

It has been shown that local anesthetic can spread in the adductor canal to the tibial and fibular nerves through the adductor hiatus. However, this spread is inconstant, and no study has evaluated the frequency of this spread yet.

The main objective of this study is to assess the diffusion's frequency of adductor canal block to fibular and tibial nerves through ultrasound observation at the popliteal fossa.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective knee surgery under general anesthesia
* in center of Ambroise Paré hospital
* receiving an adductor canal block

Exclusion Criteria:

* patients cognitively impaired
* patients suffering from peripheral neuropathy at the lower limb
* patients receiving an IPACK block or surgical knee infiltration to complete the adductor canal block analgesia
* patients who refused to take part in this study
* pregnant or breastfeeding patients
* patients under guardianship
* imprisoned patients
* patients without any medical insurance
Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy

The study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with HR+/HER2- A/MBC who received palbociclib combination therapy with AI as first-line treatment in the US community oncology setting.


Eligibility Criteria:
Inclusion Criteria:

* Female or male sex.
* Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis.
* Age ≥18 years at A/MBC diagnosis.
* Initiated palbociclib in combination with an AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019. Note that the date of the start of the inclusion period reflects the month of palbociclib US FDA approval.
* Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
* Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).

Exclusion Criteria:

* Enrollment in an interventional clinical trial for A/MBC during the study observation period.
* Evidence of prior treatment with any CDK4/6 inhibitor in the adjuvant setting.
* Evidence of another primary cancer within 3 years prior to the initial line containing palbociclib.
Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone

Antithyroid drugs are widely used in treatment of Graves' disease (GD), but after therapy withdrawal, relapse rate is very high. The aim this trail is to evaluate the effects of intrathyroid injection of dexamethasone combined with antithyroid drugs on patients with newly diagnosed GD.

The morbility of GD is nearly 0.5% and the underlying cause of 50 to 80% of cases of hyperthyroidism.Recently,anti-thyroid drugs are still the main therapy for Graves'hyperthyroidism in a lot of districts, but the relapse rate is very high (51\~68%) after withdrawal of anti-thyroid treatment.In order to reduce the relapse rate, some studies tried to prescribe replacement thyroxine, either with the anti-thyroid drug treatment, or after this was completed, but there is no clear evidence in favour of giving thyroid hormone supplementation following the initial treatment of Graves' thyrotoxicosis with anti-thyroid medication. Therefore, the optimal medical therapy for Graves' hyperthyroidism remains a subject of debate.

It is well known that glucocorticoids have anti-inflammatory, immunomodulation and immunosuppression effects and they has long been used to treat GO, and is one of the most effective medicine ,it can decrease some cytokines and reduce inflammatory status ,and improve some thyroid specific antibody, like as thyrotropin receptor antibodies (TRAb), antithyroperoxidase antibodies (TPOAb) and antithyroglobulin antibodies (TGAb).These studies suggested that glucocorticoids might affect autoimmune process and have some benefit effects on GD. Moreover glucocorticoids have been used to treat GD in several early reports, in which serum free triiodothyronine (FT3) and thyroxine (FT4) or total T3(TT3) and TT4 levels decreased after 8 days or three weeks treatment with glucocorticoids . But in those studies, the number of selected patients is small, and the duration of the therapy is relatively short, so that might not confirm the effects of glucocorticoids on GD.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed of Graves' Disease

Exclusion Criteria:

* Pregnancy
* Allergy to ATD, Alanine aminotransferase (ALT) or asparate aminotransferase (AST) above 2 times of upper normal range
* Non-compliance because of psychiatric or other serious diseases, or unwillingness to participate in the study.
Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

Post operative sore throat after general anesthesia with endotracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. The investigators want to study the effect of tramadol on postoperative sore throat in general anesthesia with endotracheal intubation.

Design: A prospective, randomized, controlled study. Setting: Single-center university hospital. Participants: The study included 168 patients undergoing thyroid surgery under general anesthesia with endotracheal intubation.

Interventions: The patients were allocated randomly into the following 3 groups: the control group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and another 5ml of normal saline was injected intravenously when the incision was washed and sutured；the pre-tramadol group: patients will be injected intravenously 5ml of tramadol (1mg / kg) 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured. the post-tramadol group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and 5ml of tramadol (1mg / kg) was injected intravenously when the incision was washed and sutured. Postoperatively, all patients will receive standard treatment.

Eligibility Criteria:
Inclusion Criteria:

- Female with American Society of Anesthesiologists (ASA) physical status I-II; Elective thyroidectomy(non-endoscopic) with endotracheal intubation; The patient signed the consent form.

Exclusion Criteria:

- History of thyroid surgery A history of preoperative sore throat; Pregnancy; Retrosternal goiter; Thyroid tumor invading trachea need trachea reconstruction; Potentially difficult airway; Clinical diagnosis of chronic sore throat; Clinical diagnosis of psychosis; Tracheotomy after operation； Transfer to intensive care unit after operation； Contraindications to tramadol； Body mass index (BMI) \> 30kg/m\^2.
Comparing 4L Golytely to 2L Golytely With 15mg Bisacodyl Regimens for Inpatient Colonic Preparation

The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients undergoing colonoscopy
* Age 19 or over

Exclusion Criteria:

* Unable to provide informed consent
* Patients with constipation
* Patients with suspected bowel obstruction or severe inflammatory bowel disease
* Same-day colonoscopy
* Intensive/critical care patient
* History of colorectal resection