cyrilzakka/clinical-trials huggingface dataset:
Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in children with moderate and severe bronchopulmonary dysplasia.

Bronchopulmonary dysplasia (BPD) is one of the most common chronic lung diseases with poor prognosis, especially in preterm infants with moderate and severe BPD. However, there is lack of effective therapies for this disease.

hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So,the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants with moderate and severe bronchopulmonary dysplasia.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy
2. The legal representative or the participant had signed consent.

Exclusion Criteria:

* 1. Severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, III-IV grade pulmonary hypertension, Lung transplantation, current indications of acute surgery after lung transplantation) 2. Participants whose age is more than 1 year old.
Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy.

The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection Thi study is a prospective, open label, single arm, self control, single center study.

This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Primary Carotid Endarterectomy under local anesthesia in symptomatic or asymptomatic patients.

Exclusion Criteria:

* General anesthesia
* Selective carotid artery shunting.
* Previous major hemispheric stroke.
* Any known major hemispheric lesion.
* Significant movement disorder.
* Local skull or skin affliction which prevents electrodes application.
* Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Pathological Subtrochanteric Fractures in 194 Patients

In this study, the investigators analyze a consecutive series of patients operated for pathological subtrochanteric femur fracture to describe survival and reoperation rates after surgery and to identify risk factors for death. Moreover, the investigators include a cohort of patients with non-pathological subtrochanteric fractures for comparison.

The Scandinavian Sarcoma Group (SSG) has initiated a Skeletal Metastasis Register in 1999. The Register is a quality-control database which prospectively collects individual-based information on patients operated for skeletal metastases in the long bones and pelvis. Data on patient identity, age, sex, primary tumor, location of metastases, type of pathological fracture, and perioperative treatment were gathered. Information concerning surgical procedures such as method of fixation, type of implant, and postoperative complications are registered. Moreover, some clinical data such as pain levels (no, light, moderate, strong, or severe pain), pain medication use, mobility, and the Karnofsky performance score are recorded.

We will identify all patients surgically treated for pathological subtrochanteric femur fractures during 1999-2009.

The Stockholm Hip Fracture Group provides data on the reference group. During 2003, a consecutive series of patients with acute non-pathological subtrochanteric femur fractures treated in Stockholm were included in a prospective cohort study. The regional ethical review board located at the Karolinska Institutet approved the study (DNR 206/02).

The aim of this study is to analyze survival and reoperation rates of patients operated for pathological subtrochanteric femur fracture. We want compare those findings with a cohort of patients with non-pathological subtrochanteric fractures.

Eligibility Criteria:
Inclusion Criteria:

* All patients with pathological subtrochanteric femur fractures register in the Scandinavian Sarcoma Group Register
Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.

Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with gynecologic cancers.


Eligibility Criteria:
Inclusion Criteria:

* patients with gynecological cancer ASA score 1 or 2 via laparascopy or laparatomy

Exclusion Criteria:

* ASA score \>2 orthopedic problems ileostomy or colostomy \>24 hours stay in intensive care unit early postoperative complications (relaparotomy, massive blood transfusion)
Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS.

To evaluate the influence of vasoactive medication on the spinal vasculature, we have chosen patients scheduled for arterial dilation of the lower limb as our study population. In these patients the spinal cord perfusion is not compromised. However, most patients will suffer from hypotension during surgery, due to the non-invasive type of surgery and the vasodilating effects of the anesthetics. Therefore, bolus administration of vasoactive medication (ephedrine, phenylephrine) is routinely required in order to increase the blood pressure.

The aim of the study is to observe the influence of a bolus administration of ephedrine and phenylephrine on the spinal vasculature, measured by NIRS.

During the preoperative visit, baseline MAP (mean arterial blood pressure) will be defined.

All patients receive standard anesthesia care during the surgical procedure. Before induction of anesthesia, 6 additional sensors (stickers) are applied to the back of the patient (at three levels: 2 at the upper thoracic level, 2 at the lower thoracic level and 2 at the lumbar region). 2 sensors are routinely applied to the forehead to measure the cerebral oxygenation and a BIS sensor is applied to measure the depth of anesthesia. Through an intravenous line anesthetics will be administered. Vasopressor agents will be administered through a second intravenous line. After induction of anesthesia, an endotracheal tube is placed. According to the estimated duration of surgery a bladder catheter is placed.

If - after induction of anesthesia- MAP has decreased more than 20%, a vasopressor agent will be administered in order to increase the blood pressure to normal (preoperative) values. According to the MAP, several bolus administrations and incremental bolus dosages might be needed to reach the target blood pressure range (MAP decrease less than 20%). According to the group to which the patient has been randomized, a bolus of ephedrine and/or phenylephrine will be administered.

The study will be completed when MAP decreases more than 20% from baseline for the 4th time.

A total amount of Ephedrine and Phenylephrine resp. of 140 mg and 1500 μg will not be exceeded.

If the administration of the vasopressor study medication does not achieve the desired result, the patient will receive an appropriate treatment.

The endovascular surgical procedure can start without delay and the duration of surgery will not be prolonged because of the measurements and blood pressure management.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18y
* scheduled for dilation of arterial blood vessels of the lower limb

Exclusion Criteria:

* Age \< 18y
* BMI \> 30
* severe valvular disease
* previous aortic surgery
* paraplegia/ paraparesis
* renal replacement therapy
A Study of ABT-751 in Patients With Renal Cell Cancer

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with renal cell cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.


Eligibility Criteria:
Inclusion Criteria

* Renal Cell Carcinoma.
* Recurrent tumor.
* At least 6 weeks post-nephrectomy.
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney, and liver function.

Exclusion Criteria

* Pregnant or breast feeding.
* Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
* CNS metastasis.
A Real-world, Prospective Observational Study of Rimegepant ODT for the Acute Treatment of Migraine Attacks in Adults.

This study aims at characterizing the effectiveness of rimegepant as an acute migraine treatment in a real world setting on two aspects:

* Consistency of response to rimegepant across multiple attacks
* Effectiveness of rimegepant in users taking concomitant migraine preventive medications, namely monoclonal antibodies targeting CGRP and onabotulinumtoxinA

This study will be conducted in a real-world setting in the US using a bespoke interface contained in the Migraine Buddy mobile application. Participants who report using rimegepant for the acute treatment of migraine will be recruited and will be asked to complete a series of questionnaires during the screening and study period. Patient reported outcome measures will be collected at study enrollment, daily during the 28-day observation period, and at the end of the study period.

Research Questions:

1. In adult patients currently receiving a prescription for rimegepant for the acute treatment of migraine, what is the population-level consistency of rimegepant response for pain reduction, meaningful pain relief, performance in daily activities, and return to normal function across multiple attacks in a real-world setting, regardless of prophylactic background?
2. What is the satisfaction level of patients receiving rimegepant on background migraine prophylaxis (specifically, anti-CGRP mAbs or onabotulinumtoxinA (Botox)?
3. What is the efficacy, safety, and tolerability of rimegepant for the acute treatment of migraine, when taken in combination with preventive medications that act on the same pathway?

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients with migraine ≥18 years old
* Having received a prescription for rimegepant for acute treatment
* Experienced between 3 and 14 Headache days in the last 30 days
* Planning to use rimegepant for attacks happening during the next 30 days

Exclusion Criteria:

* Report currently using rimegepant as preventive
* Report currently using concomitantly onabotulinumtoxin and any of the mAbs
* Currently participating in a Migraine-related clinical trial
* Reports a diagnosis from a doctor or other health professional of cluster headache, post-traumatic headache, new daily persistent headache, or hemicrania continua
Skeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions

The aim of the study will investigate whether impairment in the action of insulin to promote the use of glucose in skeletal muscle (insulin resistance) as a result of oral ingestion of a liquid meal rich in saturated fat is linked to reduced ability of muscles to synthesise new protein in response to dietary protein intake, which ultimately may compromise maintenance of muscle size and quality of life and whether partially replacing saturated fat in the liquid meal with omega 3 polyunsaturated FA (n3PUFA) will ameliorate these negative effects.


Eligibility Criteria:
Inclusion Criteria:

* Male, healthy, overweight (BMI\>27 kg/m2 and fat mass \>30%) non-diabetic individuals.

Exclusion Criteria:

* Diabetes, smoking, cardiovascular disease
Fast Titration Of Quetiapine Versus Currently Approved Titration

The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days.

Exclusion Criteria:

* Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.
Does Anxiety in Children on the Day of Surgery Impact Compliance in the Ophthalmology Clinic?

The hypothesis is that pediatric patients with increased levels of anxiety on the day of surgery, in particular at point of anesthetic induction, will demonstrate decreased compliance with assessment in ophthalmology clinic postoperatively.

There are many studies demonstrating pediatric anxiety from a surgical experience leading to postoperative maladaptive behaviors such as nightmares, separation anxiety, eating problems, and increased fear of doctors. There is a significant amount of research looking at day of surgery anxiety and pain in children and possible modifiers. Very little work has explored the effect of maladaptive behaviors with follow up physician visits. Strabismus surgery is particularly important as children require early and regular follow up assessments after surgery for optimal outcome. These assessments are meticulous and require good patient cooperation in order to obtain useful information for the pediatric ophthalmologist.

The study hypothesis is that pediatric patients with increased levels of anxiety on the day of surgery, in particular at point of anesthetic induction, will demonstrate decreased compliance with assessment in ophthalmology clinic postoperatively. The investigators expect this decrease in compliance will be evident based on changes seen on the ophthalmology clinic compliance scores generated pre and postoperatively.

The proposed study will be a prospective cross sectional study. Investigators will be measuring compliance in the ophthalmology clinic pre and postoperative and relating any changes in compliance with anxiety levels on the day of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 - 10 years old
* ASA I - III
* Primary strabismus surgery one or both eyes

Exclusion Criteria:

* Preexisting anxiety disorder
* Preexisting chronic pain or chronic analgesia use
* Neurobehavioural pathology limiting our ability to assess the patient eg: Cerebral Palsy, Autism or Developmental Delay.
* Inability to adhere to study protocol
* Consult in Anesthesiology clinic prior to surgery
Improving Right Ventricular Function in Young Adults Born Preterm

The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.

The purpose of this study is to evaluate the short-term therapeutic effects of sildenafil and metoprolol on right ventricular function in young adults born premature using novel 4-Dimensional flow Cardiac Magnetic Resonance Imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male or female aged 18-35
3. History of preterm birth (either a or b):

   1. Participant in the Newborn Lung Project (birth year 1988-1991, birth weight \<1500 g)
   2. Non-NLP participant, with birth weight \<1500 g and gestational age 32 weeks or less, verified by medical records

Exclusion Criteria:

1. Pregnant or lactating
2. Use of prescribed medications that would interfere with study medications

   1. Sildenafil: Use of phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil), nitrates, soluble guanylate cyclase inhibitor (riociguat) within 48 hours of study visit
   2. Metoprolol: Use of nodal blocking agents including beta blockers, non-dihydropyridine calcium channel blockers (i.e. diltiazem), and anti-arrhythmics (i.e. amiodarone)
3. Presence of known comorbidities for which these therapeutic interventions would be contraindicated:

   1. Moderate to severe heart failure
   2. Severe bradycardia (heart rate \<45), or second or third-degree heart block
   3. Systolic blood pressure \<90 mmHg or \>190 mmHg
   4. Angina
   5. Severe peripheral arterial circulatory disorders
   6. History of severe bronchospasm
4. Presence of any implanted device incompatible with CMR imaging
5. Known allergic or hypersensitivity reaction to components of the study medications
6. Any other reason for which the investigator deems a subject unsafe or inappropriate for study participation.
Predictive and Advanced Analytics in Emergency Medicine - Neurological Deficits

Future predictive modeling in emergency medicine will likely combine the use of a wide range of data points such as continuous documentation, monitoring using wearables, imaging, biomarkers, and real-time administrative data from all health care providers involved. Subsequent extensive data sets could feed advanced deep learning and neural network algorithms to accurately predict the risk of specific health conditions. Moreover, predictive analytics steers towards the development of clinical pathways that are adaptive and continuously updated, and in which healthcare decision-making is supported by sophisticated algorithms to provide the best course of action effectively and safely. The potential for predictive analytics to revolutionize many aspects of healthcare seems clear in the horizon. Information on the use in emergency medicine is scarce.

Aim of the study is to evaluate the performance of using routine-data to predict resource usage in emergency medicine using the commonly encountered symptom of acute neurologic deficit. As an outlook, this might serve as a prototype for other, similar projects using routine medical data for predictive analytics in emergency medicine.


Eligibility Criteria:
Inclusion Criteria:

* Female and Male subjects
* Age ≥ 18 years

Exclusion Criteria:

- none
Sex Differences in Sympathetic Activity and Vascular Reactivity During Acute and Chronic Hypoxia.

This study aims to investigate sex differences in blood pressure control associated with exposure to acute hypoxia (low oxygen), and short term acclimatization to hypoxia at high altitude.

About 200 million people worldwide live at high altitudes. Millions of others travel to high altitude every year for work or travel. The low oxygen (or hypoxia) experienced at high altitudes causes considerable physiological stress, and the body adapts in order to maintain adequate oxygen delivery to its tissues. One of these adaptations is an increase in the activity of the sympathetic nervous system. This system is responsible for the "fight or flight" response. Sympathetic activity regulates the size of the blood vessels, which will affect blood pressure. Previous studies suggest that males and females regulate their blood pressure in different ways. Females tend to have lower resting sympathetic activity, and less vasoconstriction in response to stressors than males. Blood pressure changes are also influenced by levels of sex hormones; for example, estrogen may cause opposing vasodilation. Therefore, it is important to understand the differences in how males and females respond to low oxygen.

The main purpose of this study is to examine the differences between males and females in control of blood vessels during exposure to low oxygen. To study this question, we will test vasoreactivity to set physiological stressors in both males and females. Participants will be recruited at the Canadian sites, and we will test them while they breathe low oxygen for a short amount of time at low altitude. We will also perform assessments on the same participants during a two week stay at high altitude at White Mountain, CA, which is at an altitude of 3,800m. These data will have implications in the basic understanding of differences between male and female physiology. Specifically, to males and females living or travelling to high altitude.

Eligibility Criteria:
Inclusion Criteria:

* Between ages of 18-50
* No medical history of cardiovascular, respiratory, nervous system, or metabolic disease
* Females must be pre-menopausal

Exclusion Criteria:

* Any known cardiovascular, respiratory, nervous system, or metabolic disease (however, participants with controlled arterial hypertension will not be excluded)
* Having travelled above 2,000m within 1 month of testing at low and high altitude
* Females who are pregnant, confirmed by a pregnancy test
* Females who are post-menopausal
* Participants that are classified as obese (body mass index \> 30kg⋅m²)
* Have a history of smoking regularly in the last 6 months (but nicotine substitutes (patch, gum) not an exclusion criteria)
* Those with a known allergy to sulfites
* Participants taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants
Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?

In this study the investigators would like to show that when patients undergo upper limb surgery under supraclavicular brachial plexus block, additional blocking of the Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet pain.

The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm. Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet pain is complex and the study team hypothesize that blocking the ICBN has no impact on tourniquet pain. Patients will receive a supraclavicular block and be divided into two groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will receive a supraclavicular block as their primary anesthetic and then be divided into two groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics, conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will be the primary measures of this study.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) 1-3
* Distal upper extremity surgery with anticipated use of tourniquet
* Outpatient surgery
* Patients who desire regional anesthesia as primary anesthetic

Exclusion Criteria:

* ASA 4 or greater
* Allergies to local anesthetic
* Refusal of regional anesthesia
* History of chronic pain syndromes
* Patients who do not desire regional anesthesia as primary anesthetic