cyrilzakka/clinical-trials huggingface dataset:
The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study

1. To explore the correlations among measures of PFM strength between using vaginal palpation quantified by modified Oxford Grading Scale and Levator ani testing and manometry in PHENIX instrument;
2. To determine the intra- and inter-rater reliability of PFM strength measured using manometry in PHENIX instrument.

This is a study using a randomized crossover blind method.All the volunteers are divided into 2 groups randomly. At the first time, a gynecological physician evaluates patient's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling patient her result, and record it on a unique paper other than in the Case Report Form.

At the same day, patient will be tested by inspector A or B randomly twice with the PHENIX instrument.A 5 minutes' interval is needed between two tests in order to reduce the possibility of fatigue of pelvic floor muscles. The outcome is secretive to the patient as well.

A second time evaluation is required in 3 days' later by a different inspector from the first time.(interrater and intrarater) All the data including strength of MOS and LAT, the outcomes by inspector A and B, cannot be collected together and told to the patient until she finished the whole process.

Pelvic floor muscle training is not permitted during the evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Having sex life and tolerable to vaginal examination
2. Planning to live locally for a long time

Volunteers are divided into three groups Group A: healthy women

1. healthy women for physical examination
2. except in the first year after delivery,duration of lactation or with a clear diagnosis as pelvic organ prolapse beyond the level of hymen or incontinence.

Group B:patients with pelvic floor disorders

1. patients diagnosed as incontinence by clinical presentation(patients with urinary incontinence are required to complete the questionnaire of ICIQ-SF)
2. patients with pelvic organ prolapse beyond the level of hymen
3. except in the first year after delivery,duration of lactation and patients with chronic pelvic pain

Group C: female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval)

Exclusion Criteria:

1. Patients who are undergoing pelvic floor muscle training
2. History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
3. History of pelvic radiotherapy
4. History of pelvic floor surgery
5. Duration of pregnancy
6. Latex allergy
7. Colpitis
8. Operation on pelvis within 6 months
A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR

To compare the time to response, response rates, remission rates, and side effects in Bipolar Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.

There are several studies demonstrating the efficacy of divalproex in the acute treatment of mania and mixed mania. In fact, the American Psychiatric Associations Practice Guidelines for Bipolar Disorder recommends divalproex as a first-line treatment for acute mania and acute mixed mania; divalproex is the treatment of choice in the treatment of acute mixed mania. The Food and Drug Administration (FDA) approved divalproex for the acute treatment of mania in the 1990's. A new formulation, divalproex, Depakote ER, was recently FDA approved for the treatment of epilepsy and prophylaxis of migraine headaches. In a pooled data analysis of nine open-labeled trials involving 321 epilepsy and bipolar disorder patients, Smith et al. that Depakote ER was associated with superior tolerability including less frequent tremors, weight gain, and gastrointestinal complaints (all p\<0.001) compared with Depakote DR. Depakote ER was preferred by subjects and it provided improved seizure control and a greater reduction in psychiatric symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages 19-65 (inclusive).
* DSM-IV diagnosis of acute mania or acute mixed mania .

Exclusion Criteria:

* DSM-IV diagnoses of bipolar disorder, depressed type, bipolar disorder rapid cycling type, major depressive disorder with psychotic features, schizoaffective disorder, schizophrenia, substance use disorder (active use within the last 3 months), or organic mood disorder.
* History of a seizure disorder or an unstable physical disorder judged to significantly affect central nervous system function.
* Female subjects who are pregnant or of childbearing potential who are not using medically accepted means of contraception and female patients who are breastfeeding.
* Subjects who require antipsychotic medications because of severe psychosis and /or agitation.
* Subjects on antidepressants or mood stabilizers including lithium, oxcarbazepine, carbamazepine, and lamotrigine.
* Subjects who have failed previous trials with Depakote DR or Depakote ER.
Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis

The aim of the study is to determine relevant morphologic parameters of the lung vasculature for the differentiation between different groups of patients with pulmonary hypertension (PH) by thoracic computer tomography (CT). In this pilot study patients undergoing right heart catheterization will be investigated by thoracic CT and special software to determine morphologic readouts.

The investigators expect that using this non-invasive method, parameters relevant for the differentiation of the patients with PH can be determined.

Pulmonary hypertension (PH) is defined as an elevated mean pressure in the pulmonary artery above 20mmHg determined at right-heart catheterization. Depending on the presentation and pathogenesis, patients are classified according to five main groups. A correct classification is crucial, since it is essential for the available therapy options.

A promising non-invasive method to provide important hemodynamic and clinical Information is the fully-automatic analysis of thoracic computed tomography images. This method can yield a number of quantitative morphologic readouts of the lung vasculature and the parenchyma.

This study aims to identify quantitative markers from the fully-automatic image analysis, which allow a discrimination between the various PH patient groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with right-heart catheterization
* Clinical indication for thoracic CT

Exclusion Criteria:

* Pregnancy
* Decreased kidney function
* Intolerance to contrast material
* Other standard CT contraindications
Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN) or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores during screening of 3 to 8 (inclusive).


Eligibility Criteria:
Key Eligibility Criteria:

* Must have had for at least 3 months painful diabetic neuropathy, or postherpetic neuralgia, or painful HIV-associated neuropathy, with moderate to severe pain on average.
* Must not have significant pain due to other causes (for example, arthritis).
* Must have intact skin at the treatment area.
* Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (12 weeks).
* Must not use topical pain medications on painful areas.
* Must be able to comply with study requirements such as completing daily pain diary and attending study visits and refrain from extensive travel during study participation.
* Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
* No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
* No history or current problem with substance abuse.
Comparison of Quality of Recovery (QoR)-15 Scores Between Propofol and Remimazolam Anesthesia

Remimazolam is a ultra-short-acting benzodiazepine that is rapidly metabolized in the body by tissue esterase and not accumulates in the body for long periods of infusion. In addition, similar to other benzodiazepines, it is possible to reverse the sedation and anesthetic effects through flumazenil. It has no injection pain and infusion syndrome compared with propofol. There is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. The purpose of this study is to determine whether there is any difference in the quality of postoperative recovery between propofol-based and remimazolam-based total intravenous anesthesia in female patients undergoing thyroidectomy. The QoR-15 questionnaire score, pain, nausea/vomiting, and the frequency of complications are evaluated and compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

•20≤Age≤65 female Open thyroidectomy ASA-PS I-III

Exclusion Criteria:

* Allergic history of any study drug
* Taking any sedative, opioid, or sleep aid drugs
* Psychiatric or neurological disorder
* BMI\>30 kg/m2
* Pregnancy
* Vulnerable patients
Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.


Eligibility Criteria:
Inclusion

* Diagnosed with primary glomerulonephritis
* Aged from 18 to 70 years，male or female
* Blood pressure can be controlled ≤140/90mmHg
* GFR≥45ml/min/1.73㎡
* 0.5g≤24 hours proteinuria≤3.0g
* Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
* Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

* secondary nephropathy
* Take the glucocorticoid,immunosuppressants and Tripterygium drug in the last 12 months
* Take other Chinese patent medicine and decoction which can reduce proteinuria in the last 2 weeks
* Take renin-angiotensin system blockers in last 4 weeks
* Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
* Pregnant or lactating women
* Allergic predisposition or known to be allergic to the drug composition
* Blood presser \<90/60mmHg
* With unilateral or bilateral renal artery stenosis
* With mental disorders and poor compliance
* Be suspected or confirmed with alcohol, drug abuse history
* Be participating in another clinical study at the same period
Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement

Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation. Little is known about the prevalence and timing of any conduction abnormalities that exist before (other than standard ECG) or after through long term cardiac monitoring.

Each subject who fulfills the inclusion/exclusion criteria will be provided with Zio patch for 2 weeks before TAVR. Immediately after the procedure, patients will be admitted per TAVR protocol and will be on telemetry. Data about their ECGs and any arrhythmias will be collected.

Upon discharge, patients will be provided with another Zio patch for 2 weeks. At the 2-3 months follow up, subjects will be provided with a third Zio patch for 2 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 and \<90 years old
2. Able to provide informed consent
3. Willing to follow up at Cleveland Clinic (per TAVR protocol)

Exclusion Criteria:

1. Prior CIED (Pacemaker or defibrillator)
2. Unable to provide consent
3. Unable to follow up at Cleveland Clinic per TAVR protocol
Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction

To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction.

The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).


Eligibility Criteria:
Inclusion Criteria:

* Optimal Heart Failure Therapy in accordance with European and National Guidelines
* LVEF ≤ 0.40
* eGFR \> 30 ml/min/1.73 m2
* BMI \< 45 kg/m2
* NYHA class I-III
* Age \> 18 years
* If T2D - optimal treatment in accordance with European and National Guidelines
* If T2D - stable doses of antiglycemic treatment for 30 days
* If T2D - HbA1C 6.5-10%

Exclusion Criteria:

* CRT-D/-P implanted \< 90 days
* Uncorrected severe valvular disease
* Non-compliance
* Use of metalozone
* NYHA IV
* Age \> 85 years
* Dementia
* Admission for HF \< 30 days
* Admission for hypoglycemia \< 12 month
* Known sustained VT
* Symptomatic hypotension and systolic BP \< 95 mmHg
* Unable to perform an exercise test
* Immobilization
* Pregnancy
* Participation in other medical trials
* Previous intolerance of Empagliflozin or excipients
Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients

The primary objective of this study is to show that cardiovascular risk factors associated with the chronic elevation of arterial resistance may be associated with "false" profiles of intracranial hypertension during transcranial doppler ultrasound of the middle cerebral arteries in intensive care unit patients. A "false" profile of intracranial hypertension is defined by a high pulsatility index without any intracranial pathology.


Eligibility Criteria:
Inclusion Criteria for entry in the study:

* Sedated patient under mechanical respiratory assistance

Inclusion criteria for entry in group 1: the patient meets at least one of the following criteria:

* The patient is a man over the age of 50 or a woman over the age of 60
* Hypercholesterolemia (LDL \> 1.6 g/L, HDL \< 0.4 g/L)
* Arterial hypertension for over 10 years (treated or systolic arterial pressure \> 140 mmHG)
* Type 2 diabetes for over 10 years
* Active or former smoker in the past 3 years
* History of cardiovascular event (peripheral artery disease, heart attack, stroke/transient ischemic attack over 3 months ago)
* Chronic renal insufficiency with MDRD \< 30 ml/min/1.73m\^2

Inclusion criteria for entry in group 2:

* The included patient is not in group 1

Exclusion Criteria:

* acute neurological disorder (brain trauma, infectious or immune meningitis, meningoencephalitis, ischemic or hemorrhagic stroke \<3 months)
* pregnant woman
* person under guardianship
* prisoners
* recent carotid surgery (\<1 month)
Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis

The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and analysis of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to complete disability (crippled) as defined by a score of 21% to 80% on the baseline evaluation of the Oswestry Back Pain Disability Questionnaire;
* Patients diagnosed with kyphosis and have a Cobb angle of at least 55 degrees;
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

* Patients under the age of 19;
* Pregnant patients or patients who are considering future pregnancies;
* Patients who were participating in any other investigational device or drug study or whose participation in a previous investigational study within 30 days of study entry may, in the opinion of the clinical investigator, impact analysis of this orthotic;
* Patients who, in the clinical judgment of the investigator, are not suitable for this study; Patients who, in the investigators opinion, are mentally or legally incapacitated preventing informed consent or unable to read or understand written material;
* Patients who are unable or unwilling to return to the study center for follow-up visits.
The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and the gut. There is evidence from experimental and clinical trials that the levels of PSP in the blood rise in the presence of inflammation or infection. What is not yet well known about PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in predicting appendicitis in patients that present at the emergency room with abdominal pain and a clinical suspicion of appendicitis.

Interim analysis will be performed once 123 patients are recruited. A power analysis will be performed and the sample size re-calculated based on the actual and precise data collected. At interim analysis, the external data monitoring committee will decide upon the continuation or discontinuation of the trial, as well the potential need to modify the sample size. If any changes are suggested by the external data monitoring committee, the principal investigators will decide on the feasibility of the potential changes and submit a formal addendum to the ethics committee. No changes will be made to the protocol or study design unless first approved by the ethics committee. Any changes to the protocol approved by the ethics committee will be updated at clinicaltrials.gov

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years of age (subject to the current ethics approval protocol, may change)
* Clinical suspicion of appendicitis as the primary or differential diagnoses
* Patients able to provide informed consent

Exclusion Criteria:

* Age \<18 years of age (subject to the current ethics approval protocol, may change)
* Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis
* Pregnancy
* Patients with impaired consciousness
* Patients not able to provide informed consent
* Patients that will receive an appendicectomy as part of another elective procedure
Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

Carotid Endarterectomy (CEA), surgical removal of the blockage in the neck artery, is the accepted management of choice for significant blockage of the carotid artery. Previous studies showed improved perioperative outcomes and prevention of recurrent blockage by the use of the patch to close the surgical incision in the artery. The ideal patch reduces bleeding and prevents recurrent blockage.This is looking at long-term results toward improvement with the use Accuseal patch than Bovine Patch.

This study will be a prospective, randomized, evaluation comparing the outcomes resulting from the use of two different patches (Accuseal vs Bovine Pericardial) used for CEA.Our proposed study will evaluate the perioperative (within 30 days of operation) and long-term (6 month, 1 year, 2 year, 3 year) complications associated with the Accuseal and Bovine Pericardial patches. This will include thrombosis of the carotid artery, and the degree of recurrent plaque formation of the patched artery as determined by duplex ultrasound evaluation in the perioperative and long-term periods.Patients will be blinded to the type of patch they received.Survival analysis (Kaplan-Meier) (used in this case for time to the event analysis) will be used for time to restenosis, time to stroke, and time to late death.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients with \>50% stenosis or Asymptomatic patients \>60% stenosis: i.e.: patients experiencing a neurological event(s) such as a trans-ischemic attack, cerebrovascular accident, amaurosis fugax, and/or a preoperative duplex ultrasound, magnetic resonance angiogram, or Angiogram indicative of severe \> 60% carotid artery stenosis.

Exclusion Criteria:

* will be enforced for those less than 18 years of age, patients who for religious reasons can not accept a Bovine Pericardial patch and those with a combined procedure ie: coronary artery bypass graft (CABG) and CEA.
Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart

Exclusion Criteria:

* Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial
* Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
* Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures
* Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies
* Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study
Oncology - Bolstering Oral Agent Reporting Related to Distress

Individuals on oral chemotherapy (OC) often face many challenges requiring adequate informational support, monitoring, and management. This pilot randomized control trial (RCT) aims to assess the feasibility, acceptability, and preliminary effects of a comprehensive OC intervention on medication adherence self-efficacy, medication adherence, and symptom distress.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of cancer, any stage
* Being followed by a care team at the affiliated hospital centre
* About to start or within the first cycle of oral anticancer treatment (traditional cytotoxic, targeted therapy, hormonal therapy as active ongoing treatment for cancer with the aim of killing cancer cells/shrinking tumor size)
* Has a computer/tablet/smartphone device with internet
* The ability to communicate, read, and write in English or French

Exclusion Criteria:

* Receiving IV chemotherapy, immunotherapy, and/or oral hormonal therapy as long-term maintenance treatment for prevention of cancer's return/growth of cancer cells after initial treatment
* Significant physical or cognitive limitations that would prevent ability to participate in study as reported by patient, primary healthcare provider, or research staff
* At imminent "end-of-life"
* Participating in an ongoing clinical trial