cyrilzakka/clinical-trials huggingface dataset:
Reproducibility of Flow Measurements in the SMA Using Doppler Ultrasound

This will be a single center, methodological study in healthy male subjects to evaluate the intra-period, inter-period and inter-observer reproducibility of flow measurements in the superior mesenteric artery, using Doppler Ultrasound.

This will be a single center, methodological study in healthy male subjects, aged 18-50, to evaluate the intra-period, inter-period and inter-observer reproducibility of flow measurements in the superior mesenteric artery, using Doppler Ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a male ≥18 and ≤ 50 years of age.
* Subject is a non-smoker for at least 6 months prior to study start.
* Subject has a body mass index between 18-28 kg/m2.
* Subject is judged to be in good health on the basis of medical history and vital signs.
* Subject understands the procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria:

* Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study.
* Subject has burns, scars, flaps or grafts on the abdomen which, in the investigator's opinion, may interfere with the study assessments.
* Subject has an anatomical anomaly of the SMA as evaluated with DUS during screening which, in the investigator's opinion, may interfere with the study assessments.
* Subject currently uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study. Subject has taken 7 days prior to the start of the study any prescription or non-prescription drugs which, in the investigator's opinion, might confound the results of the study.
* Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit or has a history of drug (including alcohol) abuse.
* Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, ...) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study.
* Subject has any of the following vital sign measurements at screening: Heart Rate \<40 or \>100 beats/min, Diastolic Blood Pressure \<50 or \>90 mmHg, Systolic Blood Pressure \<90 or \>140 mmHg.
* Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks.
* Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study.
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia

Patients undergoing total knee arthroplasty with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents often cause hypotension or respiratory depression, especially in elderly patients. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes in elderly patients who often have multiple comorbidities. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in elderly patients undergoing knee surgery with spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
2. ASA class 1-3

Exclusion Criteria:

1. Patients with coagulation abnormalities
2. End organ diseases of liver, lung or kidney
3. Severe aortic stenosis
4. High degree AV block
5. Heart failure
6. Patients on MAO inhibitors
7. History of seizures or epilepsy
8. Glaucoma
18F-FDGal PET/CT and PET/MRI in Patients With Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the most common primary liver tumor and the fourth leading cause of cancer-related death worldwide. In Denmark, the incidence of HCC is 5.2 per 100.000 population per year with a dismal prognosis as the median survival time is just 7.7 months.

Extrahepatic spread of HCC is common at advanced stages with haematogenous spread to lungs, bones and adrenal glands or lymphatic spread to regional lymph nodes.

The majority of patients who develop HCC have cirrhosis of the liver and in these patients, diagnosis can be made non-invasively with characteristic contrast-enhancement pattern on computed tomography (CT) and/or magnetic resonance imaging (MRI). Although contrast-enhanced CT and MRI are considered equal in current guidelines, MRI may have a better sensitivity especially for small lesions.

Positron emission tomography (PET) is a molecular imaging technique based on the injection of a very small dose of a tracer substance labelled with a positron emitting radioisotope. PET with the glucose tracer 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) is an important tool in the staging of many cancer forms, but it is not included in the international guidelines for management of HCC because of suboptimal sensitivity of only up to 50-60 % for HCC situated in the liver.

In Aarhus, the liver specific tracer 18F-FDGal has been developed. It is a fluorine-18 labelled galactose analogue which in the human body is trapped in hepatocytes by phosphorylation by galactokinase. The first study of the diagnostic use of 18F-FDGal PET/CT in patients suspected of having HCC was published in 2011. The study showed good clinical potential for 18F-FDGal as a tracer for detection of intra- as well as extrahepatic HCC.

The aim of the present project is to establish the clinical impact and utilization of 18F-FDGal PET/CT and PET/MRI in patients suspected of having HCC or diagnosed with HCC, for staging and evaluation of treatment response including effect of treatment on liver function.

Hypotheses:

I. Adding 18F-FDGal PET/CT or PET/MRI to diagnostic work-up of patients suspected of or diagnosed with HCC will add to the establishment of a definitive diagnosis and improve staging and thus choice of treatment.

II. The uptake pattern of 18F-FDGal in HCC provides prognostic information and can be used to evaluate regional metabolic liver function before and after loco-regional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Newly-referred patients suspected of or diagnosed with HCC
* Age above 18 years

Exclusion Criteria:

* The patient does not want to take part in the study
* The responsible investigator determines that the patient is not qualified for a PET scan.
* Patients who are offered systemic chemotherapy or best supportive care will be excluded.
* Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 ml/min/1.73 m2 body surface area).
* Pregnant or nursing patients.
CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy

This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Cervical Dystonia
* Candidate for botulinum toxin type A therapy
* New to physician's practice, and/or new to botulinum toxin type A therapy, or has not been injected with botulinum toxin type A for at least 16 weeks as a participant in another clinical trial investigating botulinum toxin type A for cervical dystonia
* Able to follow study instructions and complete study activities

Exclusion Criteria:

* Patients undergoing elective surgery during the trial period
* Females who are pregnant, nursing, or planning a pregnancy
* History of poor cooperation or compliance with medical treatment or unreliability
* Any condition or situation in which, in the investigator's opinion, places the patient at significant risk, could confound the study data, or may interfere with the patient's participation in the study, including but not limited to unstable medical conditions
Ultrasound B Mode Imaging and Elastography

A Pilot Study on Ultrasound B mode Imaging and Elastography during administration of Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture.

Ultrasound analysis will be obtained on patient that receives Xiaflex as standard of care for Dupuytren's contracture

Eligibility Criteria:
Inclusion Criteria:

* Normal Hand or Hand Dupuytren's contracture

Exclusion Criteria:

* Previous treatment of Dupuytren's cord
Early Treatment Outcomes in Pierre-Robin-Like Phenotype

In a longitudinal cohort study, we want to assess the effect of the pre-epiglottic baton plate, the main treatment approach currently used in Germany for Pierre-Robin-Like phenotype, on upper airway obstruction and failure to thrive using objective criteria (mixed-obstructive apnea index assessed by polysomnography, standard deviation score for body weight) upon admission and 3 months after hospital discharge.

Pierre-Robin sequence consists of a small lower jaw, a retropositioned tongue (glossoptosis), and optionally cleft palate, leading to severe upper airway obstruction and failure to thrive; occasionally even to sudden infant death. Treatment approaches are heterogeneous, some are considerably invasive; few have been evaluated by objective tests.

In a longitudinal cohort study, we want to assess the effect of the pre-epiglottic baton plate on upper airway obstruction and failure to thrive using objective criteria (mixed-obstructive apnea index assessed by polysomnography, standard deviation score for body weight) upon admission and 3 months after hospital discharge. The pre-epiglottic baton plate is the main treatment approach currently used in Germany for this condition and practised standard care in the three participating study centers.

These data will help to compare the effect of the main treatment currently used in Germany with international data on more invasive treatments used in this rare condition.

Eligibility Criteria:
Inclusion Criteria:

* Infants \< 1 year at admission, Pierre-Robin-like phenotype

Exclusion Criteria:

* no parental consent; need for immediate tracheotomy
Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest

In this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours of whole body hypothermia (cooling) during recovery is better to help prevent brain injury and improve outcome. The investigators will also test the safety of cooling patients for 24 and 72 hours. The investigators hypothesize that 72 hours of cooling will be more beneficial than 24 hours without compromising safety.

Cooling has been shown to decrease the amount of brain injury that can occur after heart attacks in adults and in newborn babies with birth asphyxia (a lack of blood flow and oxygen to the fetus). It is unknown if cooling is effective in children after cardiac arrest. However, cooling is recommended by the American Heart Association as a "consideration" for use in children after cardiac arrest to prevent brain injury and has been used by doctors in our intensive care unit since 2002.

Children will be randomly assigned to receive either 24 or 72 hours of cooling and compare the results of 1) blood-and urine derived markers of brain injury, and 2) brain magnetic resonance imaging and spectroscopy (MRI and MRS), which measures the anatomy and chemical patterns in the brain without using ionizing radiation, between the two groups of patients with 24 or 72 hours of cooling. We will also evaluate if cooling has any effect on patient outcome and quality of life at 6 months and one year using telephone or mail questionnaires.

A child may take part in this research study if he or she had a cardiac arrest, received help with breathing and chest compressions to get a spontaneous heart rate by a health care worker, and remains unconscious in the intensive care unit (ICU). The attending physician in the ICU has already decided to cool your child to provide protection for his or her brain function.

Children invited to participate in this study also are between 1 week and 17 years of age, have access tubes already in place in an artery or vein for blood draws, a urine catheter, are able to undergo MRI and MRS brain scans, and, if female, cannot be pregnant.

Patients can not have had an acute brain injury from other causes (ex., meningitis, trauma), hemorrhage (excess bleeding from any site), congenital heart disease, do not resuscitate status, are undergoing a brain death examination, or have a known coagulation defect that makes them bleed more easily. The study will be performed on a total of 40 children strictly in this hospital.

Eligibility Criteria:
Inclusion Criteria:

* Chest compressions by a health care worker Age 1 wk - 17 yr ROSC attained PICU attending decides to cool Central venous or arterial catheter Glasgow Coma Score ≤ 8

Exclusion Criteria:

Other acute brain injury (TBI, meningitis) Do not resuscitate status Pregnancy Absolute contraindication to MRI Brain death evaluation Metabolic disorder Active hemorrhage Pre-existing coagulation defect
Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit

A randomized double-blind clinical trial will be performed in the neonatal intensive care unit of Makassed General Hospital in Beirut, Lebanon from December 2021 till August 2022. Randomized opaque envelopes to allocate the treatment will be used. The study will include neonates aged between 26 and 42 gestational weeks, who require phototherapy in the neonatal intensive care unit. Patients will be randomized into two groups.Both groups will receive standard conventional phototherapy, but the intervention group will receive 10 mg per day oral zinc sulfate until discharge.


Eligibility Criteria:
Inclusion Criteria:

* Infants (post-menstrual age ≥ 26 weeks) delivered by Cesarean section or vaginal delivery.
* Diagnosed to have hyperbilirubinemia:

Hyperbilirubinemia is defined as:

* for term and near-term neonates (neonates less than 35 weeks' gestation): Serum Total Bilirubin (STB) level that would qualify for phototherapy requirement as described in American Academy of Pediatrics 2004's guidelines or absolute STB level L 15 mg/dL;
* for preterm neonates (\< 35 weeks' gestation): STB level \> 1% of body weight

Exclusion Criteria:

* Infants less than 26 weeks postmenstrual age
* Allergy to zinc sulfate
* Any reaction seen after administration of first dose of zinc sulfate.
* Any contraindication to oral medication
* Infants with a history of taking phenobarbital by their mother
Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain

The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).

The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.


Eligibility Criteria:
Inclusion Criteria:

* Participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
* Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain
* Access to internet via computer or smartphone
* English-language proficiency (current version of the website is in English)

Exclusion Criteria:

* Underwent gynecologic surgery within 3 months of screening visit
* Plan to undergo gynecologic surgery within 6 months following screening visit
* Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study.
* Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
* Current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder),
* Current suicidal ideation or suicide attempt within 2 years of screening visit. The study will screen for severe depression and suicidality at each questionnaire time point and have developed a robust triage and referral plan.
Core Stability for Baseball Batting in Adolescents

Baseball batting is important to winning the games. Baseball batting is achieved by proximal-to-distal sequencing of body movements and controlled by the neuromuscular system. Poor lumbopelvic control could influence production and transfer of energy in the kinetic chain. This study aims to investigate the effects of functional movement training on hitting mechanics and bat swing velocity in high school baseball players.


Eligibility Criteria:
Inclusion Criteria:

* Sport specialization in baseball batting
* Active players on baseball teams

Exclusion Criteria:

* History of surgery in the lumbar area
* Severe musculoskeletal or neurological symptoms that interfere with participation in competition, training or tests
Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea

This is a validation study recruiting subjects with and without obstructive sleep apnea. All subjects will undergo a nocturnal standard polysomnography and UMindSleep assessment. Sleep parameters, such as sleep stages and apnea UMindSleep software. Correlation in each parameter between PSG and events in polysomnography (PSG) will be scored according to the AASM criteria while the sleep parameters will be automatically scored by the UMindSleep will be analyzed to determine the magnitude of agreement between UMindSleep and PSG.

Obstructive sleep apnea (OSA) is a common sleep disorder in the general population with a prevalence ranging from 4-30%. OSA has been shown to be a significant risk factor of many cardiovascular diseases and mental disorders. However, OSA is a neglected problem in the general population. In addition, there is a significant unmet need for the treatment of OSA. One of the major reason for the under-diagnosis and under-treatment of OSA in the general population is a lack of reliable screening tool in detecting OSA. In this regard, several devices, such as ApneaLink, have been developed for the screening of OSA. However, as this kind of device only employs time in bed rather than actual sleep time to calculate the apnea index or desaturation index, they tend to underestimate the severity of sleep apnea. In this regard, it is timely need to develop and validate new device that can integrate the actual sleep time and apnea or desaturation events for the precise calculation of sleep apnea index or desaturation index.

The UMindSleep is a handy and wearable device to acquire EEG, heart rate, saturation, snoring and temperature. The signal will be uploaded to a smartphone through Bluetooth. By integrating these signals, the system can automatically analyze several key parameters by the algorithms, such as sleep stages and desaturation events.

Eligibility Criteria:
Inclusion Criteria:

* complain of habitual snoring;
* AHI as measured by standard PSG \> 5/hour

Exclusion Criteria:

* Aged 17 years old or below
* patients with narcolepsy and REM sleep behavior disorder
Durability of Nevirapine-Based Antiretroviral Regimen

Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. In addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected individuals ≥15 years of age
* CD4 cell count \<350 cells/mm3
* Willing to participate and give consent form

Exclusion Criteria:

* previous antiretroviral therapy
* pregnancy
* receiving a medication that has drug-drug interactions with NVP or RFP
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>5 times of upper limit of normal range
Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy

The purpose of the study is to compare the effect between mirror therapy and task-oriented training on hand function in children with unilateral cerebral palsy.

Dysfunction in the upper limbs and hand function is one of the most common symptoms in children with cerebral palsy (CP), particularly children with unilateral CP which intern has the potential to limit the involvement of these children in life activities and cause distress and suffering for both children and their parents. Different rehabilitation intervention procedures addressing upper extremity dysfunction are essential to promote better use of disabled arms and hands in daily activities and achieving functional independence at home, in school and in the community. However, there is little evidence directed toward which intervention procedure is more effective on hand function therefore, there is need to compare between the functional outcome of mirror therapy versus task-oriented training on hand function in children with unilateral cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages will be ranged from 5 to 8 years old.
2. Wrist flexor spasticity ranged from grade 1 to 1+ according to Modified Aswarth scale.
3. Capacity to handle objects without continuous assistance (level I or II in accordance with the Manual Ability Classification System).
4. Ability to sit alone.
5. Sufficient cognition to follow simple verbal instructions.

Exclusion Criteria:

1. Fixed contracture or deformities in the upper limb.
2. Visual or auditory defects.
3. Botulinuim toxin injection in the last 6 months before the study.
4. Previous surgical intervention in the upper limb.
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries

This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery. The purpose of this research is to determine if any of these options are more (versus less) effective than the others to manage surgery related pain, after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Transgender persons 18 years and older
* Undergoing gender affirming surgeries performed by either Dr. Maurice Garcia (orchiectomy only, vaginoplasty with or without canal \& orchiectomy, colon-vaginoplasty, \& peritoneal vaginoplasty; Stage I phalloplasty, or stage II phalloplasty); Dr. Edward Ray (feminizing chest surgery, masculinizing chest surgery, stage I phalloplasty); Dr. Amit Gupta (orchiectomy and peritoneal vaginoplasty only); or Dr. Yosef Nasseri (colon vaginoplasty surgery)

Exclusion Criteria:

* Patients who do not meet the inclusion criteria above
* Any contraindications to the study drugs.
* Patients with neurologic deficits that preclude them from sensing pain.
* Patients with implanted pain neuromodulator devices (e.g., neurostimulator)
* Patients who do not speak English