cyrilzakka/clinical-trials huggingface dataset:
Middle-ear Reflex Testing Using Wideband Acoustic Immittance

This project will assess the middle-ear muscle reflex using wideband acoustic immittance which is a valuable method for evaluating infants, children, and adults. The developments will facilitate clinical applications that include hearing screening and diagnostic evaluation of persons of all ages with normal hearing and with hearing loss.

Measurement of middle-ear muscle reflexes (MEMR) constitutes an important component of the standard of care in auditory function assessment and diagnostic audiology. An important component of the middle-ear test battery involves characterizing neural function through the eighth nerve-brainstem pathway which is accomplished through measurement of the MEMR. The evaluation component of this project will involve testing of human subjects using wideband acoustic immittance in the evaluation of middle-ear muscle reflexes. Subjects in this project will be infants, children and adults with normal hearing as well as with conductive, sensory, and neural hearing loss. All subjects will receive wideband acoustic immittance (WAI) and middle-ear muscle reflex (MEMR) testing. Baseline testing includes pure tone audiometry and otoacoustic emissions.

Eligibility Criteria:
Inclusion Criteria:

* Normal hearing or hearing loss

Exclusion Criteria:

* None
Study on the Effect of a Beta Blocker on Increased Sensitivity to Pain in Humans Caused by Opioids

This research study explores whether a beta-blocker (propranolol) can prevent a person from becoming more sensitive to pain after administration of an opioid (remifentanil). Beta blockers inhibit the sympathetic (fight or flight) response and are often used to treat angina and high blood pressure. In a previous study in human volunteers, the investigators demonstrated an increased sensitivity to pain after a 60-minute infusion of the opioid remifentanil. The goal of this study is to identify a possible inhibitor of this phenomenon.

Recent evidence suggests that opioid therapy may cause a biphasic response, i.e. initial pain relief followed paradoxically by a longer lasting hypersensitivity to pain. Recent genetic analysis in mice suggests that beta adrenergic receptor antagonists reduce opiate-induced hyperalgesia (OIH). The purpose of this study is to determine the analgesic and antihyperalgesic properties of the beta-blocker propranolol on remifentanil-induced hypersensitivity in humans.

The investigators want to determine the analgesic and antihyperalgesic properties of the beta-blocker propranolol on remifentanil-induced hypersensitivity in humans. The investigators hope to learn whether the administration of beta-blocker propranolol will significantly diminish the hyperalgesic response after administration of an opioid.

The primary outcome measure for this study is change in size (area) of secondary hyperalgesia after cessation of remifentanil infusion, a measure of OIH.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men,
2. Age between 18 and 45 years
3. Normal weight (according to the table provided by Metropolitan Life Insurance).

Exclusion Criteria:

1. Hypersensitivity to opioids or naloxone,
2. History of addictive disease,
3. Significant cardiac, respiratory, gastrointestinal, neurological, dermatological, and psychiatric diseases,
4. Concurrent medication with an analgesic drug,
5. Student and employees affiliated with our laboratory
Hyperbaric Levobupivacaine for Spinal Anaesthesia

Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle.

There is no generic hyperbaric form of levobupivacaine currently available so we aimed in this study that to find the appropriate concentration of the levobupivacaine which achieves unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be suitable for outpatient anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Approval to participate in the study and spinal anesthesia
* American society of anesthesia (ASA) I,II physical status
* Scheduled for lower extremity surgery

Exclusion Criteria:

* Refuse to participate in the study
* American society of anesthesia (ASA)III, IV physical status
* Hypersensitivity to local anesthetics
* Emergency surgery
* Chronic pain treatment
* Peripheral neuropathy
* Severe systemic disease
Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease

This study evaluates nervous system hypersensitivity in individuals with inflammatory bowel disease (IBD) and experiences of ongoing musculoskeletal (MSK) pain. Previous results and current literature suggest that MSK pain in IBD may be influenced by hypersensitivity of the central nervous system, termed central sensitization. However, specific mechanisms contributing to pain experiences are unknown. Therefore, primary aims are to explore aspects of central sensitization through sensory testing in this population, and to investigate association of psychological and IBD features to sensory profiles. This study hypothesizes that IBD patients with MSK pain will demonstrate altered sensory function, and IBD/psychosocial features will be associated with altered sensory functioning and worse pain experiences.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or older)
* Clinical diagnosis of IBD or healthy control

Exclusion Criteria: Participants with IBD (with and without MSK pain) will be excluded if they report any of the following:

* pregnancy
* current history of drug or alcohol abuse
* any condition resulting in altered sensation such as: nerve injuries, neurological conditions (e.g. stroke, multiple sclerosis, and Parkinson's disease)
* surgery within the last 3 months
Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin

The drug-drug interaction study had been designed to investigate the effect of Leritrelvir on the pharmacokinetics of Midazolam, Omeprazole, Rosuvastatin and the effect of Verapamil and Rifampin on the pharmacokinetics of Leritrelvir


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight \>50 kg(male) or \>45kg(female) at screening (calculated as a function of measured height and weight according to the formula, BMI = kg/m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;
3. Normal physical examination,vital signs,12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

1. Participants with a history of hypersensitivity to study drug(Leritrelvir,Midazolam,Omeprazole,Rosuvastatin, Verapamil, and Rifampin) or any component of study medication;
2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
4. Participants who donated blood/bleeding profusely (\>400 mL) 3 months prior to randomization;
5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF\>450ms;
6. Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
7. Participants who test positive at screening and/or admission (Day -1) for alcohol abuse.
8. Females who are pregnant, lactating, or likely to become pregnant during the study.
9. History of dysphagia or any gastrointestinal disorder that affect absorption
Analysis of Orthopedic Patients Response to New Pain Modulating Substances and Drugs

Data of patient reported outcomes (PRO) are collected during treatment with various pain alleviation methods (drugs or substances)

The study aims at collecting BPI (brief pain inventory) and other PRO of patients in need of pain relief due to chronic orthopedic pain conditions

Eligibility Criteria:
Inclusion Criteria:

Chronic pain of orthopedic origin treated for at least one year unsuccessfully

Exclusion Criteria:

contra-indication for cannabis treatment
Paramedian CESI vs Selective Nerve Root PRF for Lower Cervical Radicular Pain

This study aims to compare the efficacy of ultrasound-guided selective cervical nerve root pulsed radiofrequency (PRF) versus fluoroscopy-guided paramedian cervical epidural steroid administration (CESI) for the treatment of lower cervical radicular pain refractory to conservative treatments. For this evaluation, a numerical rating (NRS), neck disability index (NDI), and Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS) scale will be used before and after both interventions.

Chronic cervical radicular pain is a common condition that affects the quality of life of many patients and is caused by compression or irritation of the cervical nerve roots. Treatment options for this condition include conservative methods such as medications and physical therapy, as well as interventions such as surgery or injections.

Two commonly used injections for chronic cervical radicular pain are ultrasound-guided selective nerve root PRF and fluoroscopy-guided paramedian CESI. PRF involves the application of pulsed radiofrequency energy (intermittent current, tissue temperature not exceeding 42 °C) to the cervical nerve root under ultrasound guidance. PRF is a non-destructive technique that modulates the activity of nerve fibers without causing thermal damage. CESI involves injecting local anesthetic and steroids into the epidural space between the laminae of the vertebrae under fluoroscopic guidance. The aim of both techniques is to reduce inflammation and pain transmission from the affected nerve root. The efficacy of both CESI and selective nerve root PRF has been demonstrated in clinical trials.

The primary aim of the investigators in this study is to compare the efficacy of these two treatments. A total of at least 60 patients, 30 patients in each group, will be enrolled for comparison. NRS, NDI, and LANSS scores before, 3 months, and 6 months after treatment will be compared both within and between groups. The secondary aim is to reveal the side effects and adverse events in these two treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

* Severe unilateral radicular pain due to cervical disc herniation (pain with a severity of 6 or more on a numeric rating scale of 0-10)
* Continued pain for more than 3 months
* Demonstration of herniated disc compression of the lower cervical spinal nerve roots on magnetic resonance imaging
* Failure in pain management with conservative methods such as analgesics and physical therapy

Exclusion Criteria:

* Pain radiating to both arms, hands or neck pain in the foreground
* Spinal stenosis or spondylolisthesis (only those with radicular pain due to disc herniation will be included)
* Cognitive impairment
* Hepatic or renal insufficiency
* Severe psychiatric illness
* Local or systemic infection
* Coagulopathy
VR to Evaluate Phantom Limb Pain

The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation.

We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.

The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity limb absence.

Phase 1: Complete in-lab or virtual iterative usability and functionality testing of hardware and software components of The Coapt Phantom Limb Pain Management System to ensure readiness for at-home use - COMPLETED

Phase 2: A clinical trial of The Coapt Phantom Limb Pain Management System during at-home use. We hypothesize that the system will improve PLP for individuals with upper or lower extremity absence, as measured through various questionnaires.

VR systems have been proposed as alternative technologies to treat PLP since they are relatively inexpensive and more readily available. Virtual reality environments allow for real-time control practice utilizing different tasks and games, and have been widely accepted as clinically viable options for administering therapy.

Effective PLP treatment methods are needed for individuals with limb absence that can be utilized on an as-needed basis in the home. VR therapy could potentially be an effective treatment for individuals with chronic upper or lower limb PLP.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 years old
* Amputation of the upper or lower limb, including amputation of multiple limbs
* English Speaking
* Chronic phantom limb pain (at least 6-months duration)
* Average phantom limb pain intensity of 4 or greater on a 0-10 numerical rating scale
* Average frequency of phantom limb pain episode of at least twice per month.
* Residual limb pain of less than 5 on the Numerical Pain Rating Scale
* Pain medication use stable for \> 1 month

Exclusion Criteria

* Unable to tolerate use of liner or cuff on their residual limb
* Skin irritation/wounds on residual limb that would prevent use of the electrode cuff
* Significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback.
* Non-English speaking
Hand and Engine-driven Techniques for Endodontic Retreatment

Numerous instrumentation techniques have been suggested for the nonsurgical retreatment of teeth with primary failure of endodontic therapy in laboratory studies. However, there is limited clinical evidence about those different techniques. The objective of this study is to compare the prevalence and intensity of postoperative pain, as well as the success rate after endodontic retreatment with hand or engine-driven reciprocating instrumentation. A randomized clinical trial will be performed, considering two comparison groups: hand preparation with stainless steel instruments or engine-driven reciprocating preparation with the Reciproc NiTi System (VDW, Munich, Germany), to verify which technique would lead to lower postoperative pain levels and higher endodontic success rates. Secondary outcomes related to technique efficiency will be also registered, evaluating the capacity of filling material removal and the time spent on the clinical procedures. Eighty individuals who need endodontic retreatment in single-rooted teeth will be selected (n=40/group). Endodontic reintervention will be carried out in two visits. Periapical radiographs taken after root filling removal protocols will be transferred to an image analysis software. Then, the percentage of remaining filling material in relation to the total area of the root canal will be evaluated. The clinical time spent with the removal procedure protocol will be registered, in minutes, by a digital stopwatch. After each visit, postoperative pain will be assessed using a numerical rating scale. The record of pain and analgesic drug intake will be performed in 12, 24, 48 hours and 7 days after the clinical procedures. Success rates will be evaluated after 3, 6, 12 and 24 months, through clinical and radiographic examination, considering the Periapical Index, a 5-point score system. Data of both groups (percentage of remaining debris, operating time, postoperative pain, clinical and radiographic success) will be analyzed for normality by the Shapiro-Wilk test. Assuming normal distribution, the data will be compared by t test. Pearson's correlation coefficient will be applied to detect possible correlations between the evaluated outcomes. Differences will be considered significant at P=0.05.


Eligibility Criteria:
Inclusion Criteria:

* Good systemic and oral health;
* Requiring root canal retreatment in single-rooted teeth (one root and one root canal);
* Asymptomatic persistent apical periodontitis.

Exclusion Criteria:

* Use of analgesics, anti-inflammatory drugs or other pain modulating drugs;
* Chronic systemic disease (eg: diabetes, hypertension, arthritis and renal dysfunction);
* Systemic disease that could interfere with bone quality;
* Pregnant or breastfeeding women;
* Teeth with untreated periodontal disease;
* Abnormal mobility and with excessively large or curved canals.
Use of Focalin for Fatigue in Sarcoidosis

Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis and its treatment can greatly affect your quality of life. Many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. These commonly reported symptoms often get in the way of everyday life.

This is to be a double blind, randomized trial with cross over of 12 patients with chronic sarcoidosis on stable systemic therapy. Patients will be screened for fatigue using a modified SNAP and Facit-F scores. Patients will be in the study for 20 weeks. Objective of study: To determine the effect of dexmethylphenidate hydrochloride, (d-MPH)(Focalin) on fatigue in Sarcoidosis. The is a common complaint in sarcoidosis, related to the chronic inflammatory nature of the disease. It may also related to therapy for the disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoidosis using standard criteria
* Disease for more than one year
* Complain of fatigue which has been present for more than six months.
* Over 18 years of age

Exclusion Criteria:

* Pregnancy
* Change in therapy for sarcoidosis in prior three months
* history of ventricular arrythmias
* Patients with a history of anxiety disorder, glaucoma, motor ties or a family history of Tourette's syndrome.
* Patients who are currently receiving or have received monoamine oxidase inhibitors within 14 days prior to study entry.
Phaco-UCP Versus Phaco Alone for OAG and Cataract

This study was carried out to evaluate the safety and efficacy of combined phacoemulsification and Ultrasound ciliary plasty (Phaco-UCP) as a first-line surgical treatment of coexisting cataract and op

/en angle glaucoma compared to phacoemulsification alone. To our knowledge, this is the first report of results of combined Phaco-UCP

the study involved 61 eyes of 61 patients with coexisting cataract and open angle glaucoma, 31 eyes were managed with Phaco-UCP and 30 eyes of age and sex matched patients were managed with phacoemulsification alone.

Patients were randomized for either combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) (the study group) or phacoemulsification alone (the control group). All surgeries were performed by one experienced surgeon (Y EZ).

Preoperative evaluation included manifest refraction, BCVA measurement, slit-lamp biomicroscopy, gonioscopy, indirect ophthalmoscopy, measurement of IOP with Goldmann applanation tonometry (average of 3 readings taken). Corneal diameter (White-to-white) and axial length measurement were done using IOL Master 500 (Carl Zeiss Meditec AG., Germany). Ultrasound pachymetry with Tomey SP-100 (Tomey Corp. Nagoya, Japan) and visual fields using Humphrey Field Analyzer (24-2, SITA, standard program Carl Zeiss Meditec AG., Germany) were also performed.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with POAG or pseudoexfoliation glaucoma with coexisting visually significant cataract that required phacoemulsification

Exclusion Criteria:

* patients with any other type of glaucoma, including narrow angle glaucoma, neovascular, uveitic or angle recession glaucoma, patients with advanced glaucoma characterized by advanced optic disc cupping or visual field damage, history of glaucoma or intraocular surgery and other ocular diseases that would affect safety or interfere with the procedure. We also excluded patients with incomplete follow-up or missing data
The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency

The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps.


Eligibility Criteria:
Inclusion Criteria:

* Subject is age 18 or older, able and willing to provide consent and agrees to comply with the study procedures
* Subject must have chronic venous insufficiency of stages C3, C4, or C5 according to the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification system
* Not compliant with their currently prescribed compression system

Exclusion Criteria:

* Active malignancy other than non-melanoma skin cancer
* Study ulcer suspicious for cancer
* Subjects who are pregnant and/or breastfeeding
* In the opinion of the PI the subject cannot comply with study procedures
Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects

The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males

Background: Glucagon like peptide-1 (GLP-1) promotes satiety and reduces food intake. GLP-1 is secreted from intestinal L-cells into the splanchnic circulation, it is (i) subject to rapid breakdown and (ii) submitted to a high liver extraction. Highest concentrations of GLP-1 are therefore found in the splanchnic blood rather than in the systemic circulation. An oral delivery system would mimick the physiological path of endogenous secretion. Objective: We aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males.

Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects
* no gastrointestinal or endocrine disorder

Exclusion Criteria:

* females
* alcohol or drug abuse
* active virus hepatitis
Paricalcitol in Fabry Disease

Proteinuria is the predominant risk factor for renal disease progression in Fabry disease (FD). When urine protein excretion is controlled to \<0.50 g/24 hr, the rate loss of glomerular filtration rate (GFR) is not significantly different from 0. However, enzyme replacement therapy (ERT) alone does not decrease proteinuria and it has been recommended that patients receiving ERT also receive anti Renin-Angiotensin-System (RAS) therapy. Emerging evidences show that paricalcitol (PCT) reduces proteinuria in presence of intensified inhibition of RAS; however, there is no evidence in FD. The aim of this study is to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria \>0.50 g/24 hr persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.


Eligibility Criteria:
Inclusion Criteria:

* genetically proven FD
* stable dose of ERT for at least 12 months
* stable dose of ACEi or ARB titrated to maximum tolerated dosage for at least 6 months
* persistent proteinuria \>0.50 g/24 h despite the use of ERT and ACEi/ARBs in 2 consecutive samples within 12 weeks

Exclusion Criteria:

* steroid/immunosuppressive treatment or glomerular filtration rate change \>30% in the past 3 months
* PTH levels \<20 pg/mL
* serum phosphorus \>5.0 mg/dL
* serum calcium (adjusted for albumin) \>10.0 mg/dL
* active malignancy.