cyrilzakka/clinical-trials huggingface dataset:
Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

This two-phase project seeks to examine the cardiovascular response to consumption of cannabis variants of different cannabinoid composition through different methods (smoking vs. vaporizing), at rest and during aerobic exercise. Multiple measures that have been shown to predict risk factors for chronic-disease and negative health outcomes will be assessed following cannabis consumption at rest or in combination with exercise. These techniques will examine arterial stiffness, vascular function, and cardiac function. In phase I and II, subjects will visit the lab on 6 different occasions; with 1 visit acting as an introductory visit, 1 as an exercise control visit, 2 as resting cannabis visits, and 2 as cannabis + exercise visits. Cannabis used in phase I of this study will consist of approximately 10% THC. On all visits, pulse wave velocity, flow mediated dilation, and echocardiography measures will be performed following cannabis consumption by smoking or vaporizing, and cannabis consumption by smoking or vaporizing followed by 20 minutes of exercise on a cycle ergometer. Phase II of the study will implore a similar design. In favor of altering method of consumption, in all visits cannabis will be consumed by vaporization and will be either a high cannabidiol (CBD: (\~10%)) and low delta-9-tetrahydrocannabinol (THC: (\<1%)), or a high THC (\~10%) and low CBD (\<1%) variant.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 19-45yr
4. In good general health as evidenced by medical history and free of chronic disease
5. Must be experienced with cannabis use. This requires recreational cannabis use of a minimum of once per week in the past 30 days as confirmed by urine test
6. Experience consuming cannabis recreationally by vaping dried cannabis

Exclusion Criteria:

1. Deemed unfit to exercise by the PARQ+.
2. Current or past diagnoses of substance abuse disorder
3. Failure of recreational substance urine screening test
4. Current, past, or strong family history of psychosis, or has previously experienced a cannabis-related psychotic episode
5. Current or past diagnoses of cannabis use disorder
6. Current or past diagnoses of any mood or anxiety disorder
7. Identified ECG abnormalities
8. Systolic blood pressure exceeding 160mmHg
9. Diastolic blood pressure exceeding 90mmHg
10. Resting heart rate exceeding 100bpm, or lower than 40bpm
11. Diagnosed with respiratory disease
12. Diagnosed with cardiovascular disease
13. Diagnosed with liver disease
14. Diagnosed with kidney disease
15. Is Pregnant or planning to be pregnant
16. Currently taking prescription medication (excluding contraceptive medication)
17. Is a cigarette smoker
Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.

Propofol is administered as both low dose and as sole anesthetic in patients with history of PONV and/or motion sickness. But efficacy of one dose over the other is not studied. This study plans to clarify if propofol in low dose is as effective as its administration as sole anesthetic in patients with history of PONV and/or motion sickness

Eligibility Criteria:
Inclusion Criteria:

1. Undergoing general anesthesia for elective surgery
2. Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions
3. No documented allergy/adverse reaction to propofol
4. English speaking
5. At least 18 years of age

Exclusion Criteria:

1. Any anti-nausea medication taken within 24 hours prior to surgery
2. Unable to provide consent independently
3. Allergy or adverse reaction to propofol
4. Emergency surgery
Use of PET/MRI Tracer to Further Understanding of Prostate Cancer Development

The purpose of this study is to develop a novel technique for integrated PET/MRI tracer kinetic analysis for urologic malignancy.

Patients scheduled to undergo gadolinium-enhanced MRI for urologic malignancy will be recruited to undergo PET/MRI employing simultaneous dynamic acquisition of PET and gadolinium-chelate data sets. For initial technical development within this pilot study, analysis will be performed attempting to compute tracer delivery using inputs from an integrated MRI-perfusion analysis. Flow and permeability will be obtained from the MR perfusion analysis, which can be used to compute the inflow rate constant K1. K1, reflecting the transfer of contrast, will then be used to compute the metabolic uptake of FDG by the organ as well as of any visible tumors. A determination will be made whether this metabolic uptake is successfully computed for each case. If not, then acquisition and post-processing modifications will be made for subsequent cases.

Eligibility Criteria:
Inclusion Criteria:

The study population will consist of patients with known urologic cancer who are scheduled to undergo MRI with gadolinium for their routine care. Patients will be referred by the Urology or Medical Oncology Departments for participation in the study. Subjects will be selected on the basis of their willingness and ability to participate and on their likelihood of completing the study. Patients agreeing to participate will be presented with a flyer which will inform subject about the available research study and study contact information. participation is entirely voluntary, and a subject may withdraw from the study at any time. Normal volunteers will be recruited accessing the existing database of normal volunteers maintained in Radiology Research department.

Exclusion Criteria:

Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.

* Electrical implants such as cardiac pacemakers or perfusion pumps
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
* Ferromagnetic objects such as jewelry or metal clips in clothing
* Claustrophobia
* History of seizures
Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease

TITLE: Effects of a high-intensity progressive-cycle program on quality of life and motor symptomatology in Parkinson's disease population

BACKGROUND: The benefits of aerobic exercise in persons with Parkinson's disease (PD) have been widely studied; however, little research has been done on the effect of high-intensity aerobic exercise in this group.

HYPOTHESIS: The high-intensity aerobic training in pedaliers, combined with balance training, improves motor symptoms and quality of life in a population with Parkinson Disease, Hoehn \& Yahr 1-3.

OBJETIVES: To ascertain whether high-intensity aerobic training with exercise peddlers and balance training can improve motor symptoms and quality of life in a PD population of Hoehn \&Yahr (H\&Y) disability score 1-3.

METHODOLOGY Setting: Rehabilitation centers in secondary care. Design: A pilot randomized controlled trial. Participants: A total of 14 patients participated in the 8-week study. Interventions: They were comprised of a control group (n=7) that followed a balance protocol and an experimental group (n=7) that performed high intensity (70%) aerobic workout using an exercise peddler + a balance protocol once a week.

Main Outcome Measures: The primary outcome measures included the 8-Foot Up and Go, test, 6-minute walk test, test 2-minute step tets, Parkinson Disease Questionnaire-39 (PDQ39), Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Tinetti test.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson Disease, Hoehn \& Yahr score of 1-3.

Exclusion Criteria:

* History or evidence of dementia or other neurological impairment/cardiovascular diseases that may affect the high-intensity endurance workout
Lipase Levels and Coronavirus Disease 2019

Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.

In this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury and acute pancreatitis in the course of COVID 19 disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lipase levels measured during COVID-19

Exclusion Criteria:

Patients with age \<18 years Patients with pregnancy Patients whose lipase levels were not measured in the course of COVID-19 Patients with known solid organ malignacy Patients with known hematologic malignacy
The Relationship Among rSO2, MAP, et al by Near-Infrared Spectroscopy in Endovascular Neurosurgery

record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ disfunction and the outcome of patients after operation by Near-Infrared Spectroscopy in Endovascular Neurosurgery

record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ disfunction and the outcome of patients after operation using Near-Infrared Spectroscopy in Endovascular Neurosurgery meanwhile detect the Brain oxygen supply and function monitoring using noninvasive Near-Infrared Spectroscopy in Endovascular Neurosurgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) class I\~Ⅲ, ranging in age from 18 to 80 years

Exclusion Criteria:

* ASA\>Ⅳ
* Non-cooperators
* Morbid obesity (BMI\>35kg/m2)
* Preoperative hyperresponsiveness airway and gastro-esophageal reflux
* The existence of the state or a diagnosis of dementia, delirium, depression, cognitive dysfunction before surgery were also excluded
The Microbiome in (Non-) Obese Pregnancy and Pregnancy Outcomes

This research aims to elucidate an underlying mechanism of maternal obesity induced pregnancy and longterm health complications for mothers and their offspring.

With the increasing global prevalence of obesity, pregnancy problems related to maternal obesity are increasingly occurring. Microbial gut symbiosis plays an important role in health, with dysbiosis being associated with diseases such as obesity. Of interest are pregnancy, dietary patterns and pre- or probiotics that affect the composition of the gut microbiome. The microbiome itself can influence many physiological processes, such as immune responses (production of microbial products) and the nutrient-dependent one-carbon metabolism. It is hypothesized that gut dysbiosis, due to maternal obesity, during pregnancy can be considered an endogenous chronic stressor causing impaired immune response and carbon metabolism. Both processes result in excessive oxidative stress, detrimental to cell replication, differentiation and epigenetic programming of maternal and infant tissues. Together, these biological disturbances contribute to placental and vascular dysfunction, leading to an increased risk of preeclampsia or gestational diabetes mellitus. Vertical (during pregnancy) and horizontal (during delivery) transmission of gut dysbiosis from mother to newborn and epigenetic placental and foetal changes may ultimately lead to macrosomia and obesity in children. Therefore, the differences between the gut and vaginal microbiome, maternal and fetal immune responses and one-carbon metabolism in obese versus normal-weight pregnant women will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Participation in Predict study
* Preconceptional women who wish to become pregnant or pregnancy \<13 weeks of gestational age.
* BMI \> 30 kg/m2 or 18-25 kg/m2
* Understanding of Dutch in speaking and reading
* Willingness to give written informed consent

Exclusion Criteria:

* Age \< 18 years and \> 45 years.
* ≥13 weeks of gestational age
* Multiple pregnancy
* Smoking
* Gastro-intestinal diseases, heart diseases, liver, pancreas and kidney diseases.
* Use of antibiotics \< 2 weeks before sampling
* Pre-existent diabetes mellitus
Research on the Nature, Diagnosis, and Treatment of Obesity and Diabetes

The purpose of this study is to determine whether the level of FOXA2 expression in fat tissue is a biomarker of insulin resistance. To test this hypothesis, we will perform euglycemic-hyperinsulinemic clamps in normal and obese human subjects to calculate insulin sensitivity, and see if insulin sensitivity correlates with the FOXA2 expression in subcutaneous fat.

The investigators at Rockefeller University Hospital are engaged in research on the nature, diagnosis and treatment of obesity and diabetes. The investigators are trying to find out why insulin, a blood sugar lowering hormone that is released by the pancreas following a meal, does not work effectively in individuals with obesity or type 2 diabetes. The investigators have recently discovered a protein in fat cells of obese mice that helps fat cells to take up and break down sugar from the blood. This protein (called FOXA2) also prevents the generation of more fat cells. FOXA2 is only present in obese mice, but absent from fat stores of lean animals. Insulin can stimulate the production of FOXA2 in fat cells. Furthermore, the levels of FOXA2 protein correlate with the degree of blood insulin levels. In this study, we are would like to determine whether FOXA2 is also produced in fat cells of humans, and if its level correlates with the degree of obesity and insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy individuals
2. Age 21-45 years old
3. BMI: either \< 25, or 30-35, or \> 40
4. All patients must be willing and able to sign an informed consent form -

Exclusion Criteria:

1. Chronic illnesses other the than mild forms of illnesses related to obesity, such as hypertension, hyperlipidemia, and others, that do not require medical treatment
2. Diabetes mellitus previously diagnosed as per subject report or an abnormal 2 hour OGTT at screening
3. Chronic drug treatment for any medical condition
4. Active weight reduction of more than 7 pounds in the last 3 months
5. History of bleeding or blood clotting disorders
6. Subjects with hemoglobin \<8.5 gm/dl
7. Changes in smoking habits for the last 6 months
8. Current pregnancy or current breast-feeding in women
9. Allergic reaction to local anesthetics
10. History of anaphylaxis or anaphylactic-like reactions
11. Tendency to form scars (keloids) easily
12. Irregular menses
13. HIV and hepatitis B or C positive subjects -
Comparison of Postprandial Inflammation in Lean and Obese Subjects

The purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.


Eligibility Criteria:
Inclusion Criteria for lean subjects:

* age 25-50
* 20\<BMI\<25
* waist circumference \<94cm

Inclusion Criteria for obese subjects

* age-matched to healthy subjects
* 30\<BMI\<40
* waist circumference \>102cm

Exclusion Criteria for lean and obese subjects:

* Physiological or psychological diseases
* Allergies to food or intolerance to high-fat meal
* Vegetarians
* Chronic intake of drugs
* Smokers
* Diabetes mellitus Type I and II
* Debilitating kidney diseases
* Debilitating liver diseases
* Clinically established coronary heart diseases
* Ingestion of vitamins or dietary supplements during the course of the study
Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction

The aim of the study is to estimate the contribution of abdominal imaging by magnetic resonance Imaging (MRI) and abdominal scanner in the detection of subdiaphragmatic infarction associated to the atrial fibrillation in the cerebral infarction.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18
* Patient having a CHADS-VAsc Score ≥ 2;
* Patient hospitalized for a secondary established ischemic accident in an atrial fibrillation not anticoagulated (INR\<2 and/or receiving antiplatelet (aspirin, clopidogrel)) for less than 14 days;
* Patient affiliated to a national insurance scheme or beneficiary
* Patient having given a written consent

Exclusion Criteria:

* Patient presenting cognitive disorders incompatible with the planned examinations (MRI / SCANNER).
* Pacemaker or implantable defibrillator, or other contraindication in the MRI (metallic eye brightness, intra cerebral clip).
* Contraindication in injected scanner.
* Current pregnancy
Breast Cancer 2-PREVENT Translational Center of Excellence (TCE) - Metastatic Markers of Recurrent Tumor Phenotype for Breast Cancer

This is a cohort study of women with suspected or confirmed recurrent breast cancer, with accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent metastatic disease. Study participants will be ascertained from the population of all persons greater than eighteen years of age receiving care at the clinical practices of the Rowan Breast Center (RBC) at the University of Pennsylvania. The overarching goal of this study is to identify the genetic and molecular markers of molecular evolution identified in patients who have progressed from a primary diagnosis of breast cancer to recurrent, metastatic disease. As an observational study, this study seeks to gather data regarding the molecular and genetic changes that a primary cancer undergoes as a patient's cancer recurs and ultimately progresses. We anticipate enrolling 600 women with recurrent breast cancer who meet eligibility requirements for this study. Participation in this study will include the following: a biopsy and blood collection, completion of the study questionnaire, an optional bone marrow aspiration, and repeat collection of blood, offer of a research biopsy and a optional bone marrow aspirate collection at each progression time point. The study participants' medical information will be updated and changes in disease status will be captured on a regular basis.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed breast cancer - based upon pathology report of the primary or metastatic diagnosis
* Recurrent breast cancer (local, regional, or distant disease) - as determined by either clinical,radiological, or pathological evaluation
* Willing to undergo or provide tissue from a recent biopsy of recurrent tumor for both clinical and research testing
* Willing to undergo blood specimen collection
* Age 18 or over and are able to give informed consent

Exclusion Criteria:

* Non-metastatic breast cancer (stage I, II or III)
* Anticoagulation that cannot be interrupted for the purpose of study evaluation (patients must have normal INR and PTT at the time of study biopsy)
Perineural Steroids for Peripheral Nerve Blocks

This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.

The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. If this primary end point is met, this study will also serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of perineural dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* elective robotic medial MAKO partial knee arthroplasty
* agreed to a regional anesthesia technique

Exclusion Criteria:

* contraindications to regional anesthesia
* presence of a progressive neurological deficit
* a pre-existing coagulopathy, infection
* insulin and non-insulin dependent diabetes mellitus
* systemic use of corticosteroids within 30 days of surgery
* chronic use of an opioid analgesic (\>3 months or a combined total of more than 40 mg Oxycodone equivalents a day)
* pregnancy
* a prior history of an adverse event (for example: psychosis) or an allergy to dexamethasone
Pilot Study: Age Extension of NHS Breast Screening Programme

The purpose of this pilot study is to assess the feasibility and acceptability of randomising the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer sites in different areas of England.

Currently all women are invited for breast screening between the ages of 50 and 70. In 2007 the Cancer Reform Strategy announced that from 2012 the NHS Breast Screening Programme would be extended to cover women between the ages of 47 and 73. This means that all women will get two extra screening invitations in their lifetime. It also means that all women will get their first invitation before age 50. As capacity does not allow for full immediate roll out across the whole of England, the age extension will be phased-in with full coverage from 2012. Randomising this phasing-in would provide unbiased evidence on the extent to which it is beneficial to extend the age range for breast screening and whether an extra screen at younger or older ages is more worthwhile. To date there is no clear evidence on this as no trial has looked at the added value of one extra screen within an existing screening programme. This pilot study will assess the feasibility and acceptability of randomising the phasing-in of the age extension in six volunteer sites in different areas of England.

Eligibility Criteria:
Inclusion Criteria:

* female, and living in one of the 6 pilot areas, and
* aged 47-49 or 71-73 years, and
* in a screening invitation batch that includes their age group.
Immersive Physical Therapy in the Neonatal Intensive Care Unit (NICU)

To learn if and how the physical and occupational therapy program in the Newborn Critical Care Center helps parents with their stress levels and ability to meet the needs of their preterm infants.

Composed of one retrospective group and two prospective groups. Each group will be defined based on the stage of enrollment, which will coincide with the rollout of two different standard-of-care initiatives in the hospital. These initiatives are determined outside of the study protocol. The retrospective group will be composed of infants that are under the current initiative. The small baby unit will then be implemented within the hospital site, and infants and parents enrolled at that time will reflect the impact of the small baby unit. The small baby unit will then transition into an immersive physical therapy model, and any infants and parents enrolled at that time will reflect the impact of this second-tier initiative.

Eligibility Criteria:
Infant Inclusion Criteria:

* \<28 weeks gestation at birth
* born or transferred to UNC's Newborn Critical Care Center within the first 48 hours of life
* If in the SBU or Immersive PT groups: Must be cared for at certain UNC Hospital locations through at least 34 weeks postmenopausal age

Infant Exclusion Criteria:

* Has a high likelihood of transferring to an outside hospital
* Has a genetic abnormality, congenital neurological or musculoskeletal disorder

Maternal Inclusion Criteria:

* Is the biological parent
* Sex is female
* Understands English or Spanish Language
* Is at least 18 years of age

Maternal Exclusion Criteria:

* Is not the biological parent
* Sex is male
* Does not understand English or Spanish language
* Is under 18 years of age