cyrilzakka/clinical-trials huggingface dataset:
Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction

The purpose of this study is to evaluate whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.

Distal radius fracture is one of the most common causes for visiting the emergency department. Nowadays, simple radiography is used as a control standard for evaluating reduction of distal radius fractures. The disadvantages include time wasting, frequent x-ray exposures and use of more sedation in determining adequate reduction, made scientists to evaluate alternative method such as ultrasonography which fast, easy and less dangerous were considered as advantages. The investigators goal was to identify whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.

Eligibility Criteria:
Inclusion Criteria:

* \> 21 years old and a diagnosing of a distal radius fracture based on simple radiography.

Exclusion Criteria:

* Open fractures
* more than 20 degree angulation
* joint internal involvement, communicated and along with Neurovascular compromised fractures
* patient's surgery due to other causes
* need to stay in the ICU and not being able to be treated at the same time for distal radius fracture
* patient's refusal to participate in the study
Timing of Preload Responsiveness in Sepsis

During acute circulatory failure, volume expansion does not always lead to a significant increase in cardiac output (fluid responsiveness). After initial resuscitation by rapid fluid administration, cardiac preload is no longer extremely low and only half of the patients respond to further volume expansion with the expected increase in cardiac output (fluid unresponsiveness). However, the time delay or the volume of fluid needed to be administered from the state of fluid responsiveness to fluid unresponsiveness is still not determined.

Objective To determine, in critically ill patients with acute circulatory failure,

1. : the time and/or the volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness during septic shock.
2. : determine the factors that influence this time and volume.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 ans
* Onset of septic shock

Exclusion Criteria:

* Planned to transfer the patient to another healthcare facility (inability to continue cardiac output measurements); urgent operation; Inability to measure the cardiac output.
Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura

The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged 16 to 18 years, inclusive
2. Written informed consent/assent signed from parent/guardian
3. Positive for T. trichiura by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
4. Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).

Exclusion Criteria:

1. Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
2. Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
3. Prior treatment with anthelmintics (eg, diethylcarbamazine \[DEC\], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.
4. Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
5. Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.
6. Pregnant (urine testing) or breastfeeding women
Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% / Ketorolac 0.3%

This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (OMIDRIA). Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgery/pars plana vitrectomy.

Cataract surgery can result in intra- and postoperative inflammation. Various strategies are employed to prevent and combat this inflammatory reaction, including preoperative topical NSAIDs, intraoperative NSAIDs or steroids, and postoperative topical NSAIDs and/or steroids. The only FDA-approved NSAID for intraoperative use is the ketorolac component of OMIDRIA® (Rayner Surgical, Bellevue, WA, USA).

Animal studies have assessed the concentration of ketorolac in the vitreous and demonstrated therapeutic levels out to 10 hours postoperatively. There is no human data for ketorolac levels in the vitreous following intracameral administration of OMIDRIA at the time of cataract surgery.

This study will enroll approximately 10-20 patients undergoing combined cataract surgery immediately followed by pars plana vitrectomy. Aqueous and vitreous samples will be taken intraoperatively and sent to an independent lab for analysis of ketorolac concentrations.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent
2. Undergoing cataract surgery immediately followed by pars plana vitrectomy
3. Diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters)
4. Willing and able to comply with all study procedures
5. Male or female, aged ≥ 18 years

Exclusion Criteria:

1. Age \< 18
2. Participating in another clinical trial
3. Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure)
4. Previous vitrectomy
5. Complications at the time of cataract surgery
6. A tear in the posterior capsule
Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD)

This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD.

The study hypothesis include:

* the study will achieve greater than 75% program completion and 75% study assessment completion
* patients with IBD will find VR-directed BGBT acceptable as an outpatient pain treatment
* outpatient VR-directed BGBT in IBD arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life
* will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the E-TAU arm


Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients (18 years and older) that carry a diagnosis of IBD and confirmed in the electronic health record (EHR) as receiving IBD-targeted treatment
* IBD-targeted treatment include 5-aminosalicylates, thiopurines, biologics, or small molecules such as Janus kinase inhibitor (JAK) inhibitors or sphingosine-1-receptor modulators.
* Self-report abdominal pain with an average severity ≥ 2 on a 0-10 pain scale over the last 24 hours,
* Participants are willing and able to pick-up and drop-off VR equipment at University of Michigan (UM)

Exclusion Criteria:

* Patients that do not report pain (i.e., score\<2) as they are less likely to benefit from VR-directed BGBT
* Patients with a history of conditions that could potentially be harmed by VR including seizures/epilepsy, loss of awareness, binocular vision loss, current pregnancy, or uncontrolled cardiac (e.g., arrhythmia, coronary artery disease) or neurological/cerebrovascular disease.
New Treatment Algorithm to Reduce Spherical Aberration After LASIK Correction for Myopia

The purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments.

Post-LASIK induction of spherical aberration is currently among the most prominent challenges for refractive surgery. The presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as "glare" and "halos," and "night myopia" or the induction of myopia under low lighting (larger pupil size). A modified Treatment Planning Software (TPS) "VSS-Rx1 OPM software" has been developed that uses a modified algorithm (software that designs the LASIK treatment profile) to limit the induction of postoperative spherical aberration. Commercially available software used to calculate the LASIK treatment profile was used in one eye (active comparator \[i.e., control\]) and VSS-Rx1 OPM software was used in the fellow eye (experimental). Subjects were masked to the use of either the commercially available or VSS-Rx1 OPM software.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age at the time of preoperative exam
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Demonstration of refractive stability
* Anticipated postoperative stromal bed thickness of at least 250 microns
* Willing and able to return for all study examinations

Exclusion Criteria:

* Pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair healing
* History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
* Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course
Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD

A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary endurance in patients with coronary heart disease of qi deficiency and blood stasis.


Eligibility Criteria:
Inclusion Criteria:

* Results of coronary angiography or spiral CT:Patients with coronary artery stenosis ≥ 50%, or with a clear history of myocardial infarction, or stable condition more than one month after ACS treatment (percutaneous coronary intervention therapy, PCI, coronary artery bypass graft, CABG)；
* LVEF≥40%；
* Angina grade Ⅰ-Ⅱ (CCS grade);
* The syndrome differentiation of traditional Chinese medicine is the syndrome of qi deficiency and blood stasis；
* 18 years old ≤ age ≤ 75 years old；
* In accordance with the risk stratification of cardiac rehabilitation in patients with coronary heart disease, the patients with moderate and low risk can carry out cardiopulmonary rehabilitation by exercise；
* Those who sign the informed consent form.

Exclusion Criteria:

* Patients with acute myocardial infarction or unstable angina pectoris, or within one month after PCI or CABG;
* Patients with absolute and relative contraindications in accordance with cardiopulmonary exercise test;
* Patients who took Zhenyuan capsule in the past 1 month or participated in other clinical trials in the past 1 month；
* Renal insufficiency, serum creatinine \> 2.5mg / dl in male and \> 2.0mg/dl in female；
* Patients with obvious liver disease or both ALT and AST were 3 times higher than the normal upper limit；
* New York heart function (NYHA) grade IV, or patients with recurrent malignant arrhythmias;
* Complicated with chronic obstructive pulmonary disease or even respiratory failure, or complicated with pulmonary infection;
* Diabetic patients with random blood glucose ≥ 13.7mmol/L or glycosylated hemoglobin ≥ 9.5%;
* Pregnant or preparing pregnant women, lactating women;
* Patients with acute cerebrovascular diseases; malignant tumors or patients with life expectancy of less than 1 year; patients with severe hematopoietic diseases; patients with severe mental illness;
* For those who are allergic to the known ingredients of the drug.
Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy

This is a study of patients with catamenial epilepsy. Catamenial epilepsies are defined as epileptic seizures during the menstrual cycle. Today, there are no recommendations and no care pathway for these patients. The aim of this study is to assess the number of patients reporting a link between the occurrence of their epileptic seizures and their menstrual cycle.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients (\>18 years)
* No menopausal
* Patients who have consulted in a Neurology department for refractory epilepsy
* Non opposition patient
* Affiliation to a social security scheme

Exclusion Criteria:

* Patients who understand French enough
Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct

Coronary Artery Disease (CAD) is the narrowing or blockage of the artery of the heart and is prevalent in end-stage liver disease. Consultation with cardiologist and stress tests are recommended to patients under consideration for liver transplant. The purpose of this study is to evaluate if Computed Tomography Angiogram (CTA) and CTA-derived Fractional Flow Reserve (FFRct) procedure influences decisions about further cardiac testing compared with Standard of Care (SOC) such as consultation by a cardiologist, Echocardiogram (ultrasound of the heart), Electrocardiogram (ECG) and stress tests.

The purpose of this study is to determine in end-stage liver disease patients whether non-invasive assessment of coronary artery disease prior to liver transplant using CTA (CTA) and CTA-derived Fractional Flow Reserved (FFRct) is superior to current standard of care (SOC) cardiovascular evaluation such as formal consultation by a cardiologist, electrocardiogram, echocardiogram, and pharmacological stress test such (e.g. Dobutamine stress echocardiogram and lexiscan myocardial perfusion imaging). The investigational portion of this study is the CTA and FFRct, which is a special x-ray scan that can identify blockages in the arteries and determine if blood flow is impaired. The CTA and FFRct will be done within 2 weeks after the standard of care evaluation.

All 100 patients will undergo standard of care stress test plus CTA/FFRct. The referring cardiologist will be blinded to the results of CTA/FFRct, and will make an "initial" recommendation based on the standard of care evaluation. After making the "initial" recommendation, the referring cardiologist will be unblinded to the CTA/FFRct results and make a "final" recommendation. The "initial" recommendation will consist of one of the following: further cardiac evaluation is not needed or cardiac catheterization is required. The "final" recommendation will consist of one of the following: further cardiac evaluation is not needed or cardiac catheterization is required. All patients will receive a 1 year phone follow up call.

The hypothesis is that in End Stage Liver Disease (ESLD) patients, non-invasive assessment for CAD using CTA/FFRct is superior to SOC cardiovascular evaluation (stress etst, echocardiogram, ECG). This study will look at the frequency of how often CTA/FFRct changed the clinical recommendation compared with the standard of care alone (Initial recommendation versus final recommendation).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with end-stage liver disease
2. Patients undergoing cardiovascular risk assessment prior to liver transplantation -

Exclusion Criteria:

1. Estimated Glomerular Filtration Rate (eGFR) \< 30 cc/min/1.73 m\^2 (unless patient is on dialysis or renal transplant is planned)
2. Heart rate \> 90 bpm despite beta blocker therapy
3. Body Mass Index (BMI) \> 40 plus chest obesity (i.e. truncal obesity and normal chest morphology is not an exclusion)
4. Pregnant Women
Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome

The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS.

Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 6-12% of reproductive-aged women within the general population. Currently, there is limited knowledge on the current lifestyles of women with PCOS and the psychosocial factors associated with PCOS.

The researchers plan to examine potential lifestyle differences and psychosocial factors between PCOS and healthy women. The Research Team is also interested in the relationships between biological markers and lifestyle endpoints in women with and without PCOS. Previous literature has shown there are biological marker differences between those with and without PCOS. By examining these relationships, researchers may further understand whether PCOS status is associated with lifestyle parameters.

To accomplish these objectives, 360 women (120 women with PCOS, 120 women without PCOS and with normal menstrual cycles, and 120 women without PCOS and with irregular menstrual cycles) will be included in this study. An equal number of lean and overweight/obese women will be recruited within each group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). Women will be included in the PCOS group if they have a confirmed PCOS diagnosis from their primary care provider. Participants will complete a food frequency questionnaire, a sleep questionnaire, and a physical activity questionnaire. A researcher may also provide participants with a waist-worn accelerometer to monitor physical activity and a wrist-worn accelerometer to monitor sleep for a week. Ultrasound scans of the ovaries will be assessed and the following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test; (2) dual X-ray absorptiometry (DXA) scan; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate; (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index); and (5) an (optional) subcutaneous fat biopsy. Women with and without PCOS will also be asked to complete a questionnaire that will assess the psychosocial factors (e.g., health beliefs). This can be conducted online, in person, or through phone.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 48 years
* BMI ≥ 18 kg/m2
* If ≥ 21 years old, must have completed a pelvic exam in the past 2 years
* In PCOS if: Confirmed PCOS diagnosis from their primary care provider

Exclusion Criteria:

* Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function
* Pregnant or breastfeeding
Prilosec Bioequivalence Study in Healthy Volunteers

This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venepuncture.
* Female could be of nonchildbearing potential (postmenopausal or irreversible surgical sterilization) and childbearing potential (negative pregnancy test at screening and use 2 effective methods of avoiding pregnancy).
* Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and a weight of at least 50 kg and no more than 100 kg, inclusive.

Exclusion Criteria:

* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
* Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.
* Moderate to heavy smokers (more than 10 cigarettes per day or equivalent in tobacco-containing products).
Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery

The investigators would like to compare the therapeutic and cost effectiveness of established therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck area an intervention known for analgesia but for which the antiemetic effects hasn't been entirely explored.

The rational is based on the knowledge of the anatomical innervation of the inner ear and the role of the parasympathetic nervous system in the emetic act. A lot of focus has been given on its counterpart the sympathetic nervous system and its role in painful conditions. The investigators believe that the nerve blockade of the parasympathetic innervation can have some beneficial effect in the post-surgical patient.

The researchers hypothesize another potential antiemetic mechanism by the blockade of the auricular branch of the vagus nerve at the ear canal (commonly described as nerve of Arnold) in conjunction with a block of the greater auricular nerve and lesser occipital nerve at the superficial cervical plexus level. The block would cover both the sensory innervation and of the ear canal and the inner ear. A regional anesthetic block prior to the surgical intervention on the inner ear at the superficial cervical plexus block is performed. This latter is a branch of the vagus nerve at the superficial cervical plexus (erb's point). The block would inhibit the vagal afferent to area postrema through inhibition of afferent vagal input to the medullary center.

The emetic act (vomiting) is a highly integrated physiologic reflex involving both the somatic and autonomic nervous system. Researchers do not know how much of a relation there is between the vagal nerve branches involvement and incidence of nausea and vomiting effects are from the inner ear injury and or the inflammatory response type of response triggering the area postrema. The usual prophylactic treatment of PONV (post operative nausea and vomiting) has been limited to anti-emetics such as dexamethasone along with aggressive fluid therapy and adequate analgesia.

Investigators are proposing to conduct a comparative study of the therapeutic and cost effectiveness of regional anesthesia and antiemetic therapy in the prevention and treatment of PONV in children undergoing inner ear surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patient Age 1-18 yo
* Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery
* Past history of PONV susceptibility

Exclusion Criteria:

* Patient/ Parents refusal
* Infection at the site of local anesthetic injection
* Known coagulopathy
* Existing VP shunt
* Severe mental disability
* Any known allergic to dexamethasone (Decadron) and/or ondansetron ( Zofran)