cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Imagery of Renal Nodules With Folate-fluorescein Conjugate(EC17)

According to the National Cancer Institute, an estimated 64,770 men and women will be diagnosed with kidney cancer in 2012. Of this number, an estimated 13,570 will die of this disease. Surgery remains one of the best options for patients presenting with operable Stage II or III cancers, however the five year survival rate for these candidates remains at a dismal 63.7% for Stage II and 11% for Stage III. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through imaging during surgery it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival.

Renal cell malignancies are the ideal disease to investigate intra-operative imaging. 70% of kidney malignancies express folate receptor alpha (FRA). It is important to note that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. Thus, the false positive detection rate is expected to be extremely low. A group well known to us in the Netherlands has completed a pilot study utilizing a folate-FITC conjugate in 12 patients with ovarian cancer. Another group of investigators in Mayo have subsequently performed this study on 20 more patients without any serious adverse events (personal communication). They report excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). All side effects reversed when the injection was halted. Patients with a history of allergic reactions to insect bites should not participate (fluorescein is derived from the firefly insect, folate is an essential vitamin).


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients 18 years of age or older
2. Patients presenting with a renal cell nodule or mass that are scheduled for open or laparoscopic resection based on clinical criteria
3. Good operative candidate
4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) test within 72 hours of surgery
2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
3. At-risk patient populations

   1. People who would be easily lost to follow-up (ex: People who are homeless or alcohol dependent)
   2. Children and neonates
   3. Patients unable to participate in the consent process
Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: Single Surgeon Study

Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical phase of their novel 3D virtual planning software, "IPS (Individual Patient Solutions) CaseDesigner (IPSCD)".

Objectives The authors aim to test pre-release versions of the IPSCD software under real-world working conditions by a single surgeon.In specific, the authors aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.

Study design closed beta-phase Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon will run all the virtual planning steps with both conventional software (Maxilim) and the novel software. Timing of the eight major steps will be measured with a digital chronometer.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages
* Patients of both genders
* Patients should present themselves at the division of Maxillofacial surgery
* Patients should receive standardized cone-beam computed tomography (CBCT) image acquisition, according to the IPSCD protocol
* Preoperative 3D virtual planning should be performed by the same surgeon

Exclusion Criteria:

* All patients that do not fit the abovementioned description
* Patients with posttraumatic deformity
* Patients with congenital deformity
* Patients with pre-prosthetic indication
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1

The purpose of this research study is to examine the effect of high-fat meals on the health of blood vessels. In addition, the study will examine how exercise/fitness/physical activity impacts blood vessels after consumption of a high-fat meal.

This is the first in a series of studies examining the impact of high-fat meals on blood vessels. During the preliminary visit of this study, eligible participants' resting metabolic rate, arm flow mediated dilation, and leg flow mediate dilation will be measured. They will complete handgrip and plantar flexion exercise tasks. Finally, they will be given a physical activity monitor to wear for 7 days. At their first visit, participants will eat a high-fat meal and blood will be drawn to measure blood vessel health. They will also repeat the arm flow mediated dilation, leg flow mediate dilation, handgrip, and plantar flexion exercise tests.

Eligibility Criteria:
Inclusion Criteria:

1. college-age: 18-30 years old
2. normal fasting triglyceride (\<150 mg/dL) (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition).
3. normal body composition: % body fat, males \<25%, females \<32% (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition)
4. self-reported engagement in moderate-vigorous intensity physical activity and/or an exercise training regimen OR self-reported low physical activity and no engagement in an exercise training regimen (International Physical Activity Questionnaire)
5. low cardiorespiratory fitness (VO2peak; male: =\<45 mL/kg/min; female: =\<35 mL/kg/min; categorized as =40th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47) OR high cardiorespiratory fitness (VO2peak; male: =55 mL/kg/min; female: 45 mL/kg/min; categorized as =70th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47)

f.) for female participants, presence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods.

.

Exclusion Criteria:

1. presence of diagnosed cardiovascular, metabolic, or renal disease or dysfunction
2. presence of signs and symptoms suggestive of cardiovascular, metabolic, or renal disease
3. presence of musculoskeletal injury
4. pregnancy
5. history of smoking
6. engagement in an abnormal eating behavior
7. unable to communicate effectively in English
8. moderate cardiorespiratory fitness (VO2peak; male: 46-54 mL/kg/min; female: 36-44 mL/kg/min)
9. elevated or high fasting triglycerides (\>150 mg/dL)
10. absence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods
Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

This is an unblinded pilot study of an environmental exposure to secondhand cannabis smoke in one group of healthy nonsmokers.

The goal is to gather accurate information on uptake of smoke toxicants from cannabis exposures in the real world. The investigators will be taking healthy nonsmokers to public places where people are consuming cannabis and measuring their uptake of cannabinoids.

Eligibility Criteria:
Inclusion Criteria:

-

Adult nonsmokers, aged 21-50, who:

* Are healthy on the basis of medical history
* Have systolic blood pressure \<150
* Have diastolic blood pressure \<100
* Have BMI between 18.1 and 34.9
* Able to perform moderate exercise,
* Are not exposed to tobacco or cannabis SHS in their daily lives. (Nonsmoking status and low SHS exposure are determined by self-report on the screening questionnaire, salivary cotinine \< 10 ng/ml and THC \< 50 ng/m and exhaled CO2 below 4 ppm)

Exclusion Criteria:

* Current use of cannabis products, including CBD and edible THC products
* Regular exposure to secondhand tobacco or cannabis smoke
* Positive SARS-CoV-2 antibody test
* Age 18 \< or \> 50
* Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma.
* Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications
* Systolic blood pressure \> 150
* Diastolic blood pressure \> 100
* Pregnancy or breastfeeding (by urine hCG and/or history)
* Alcohol or illicit drug dependence within the past 5 years
* BMI \> 35 and \< 18
* Current illicit drug use (by history or urine test)
* More than 1 pack year smoking history
* Ever a daily marijuana smoker
* Smoked anything within the last 2 months
* Occupational exposure to smoke, dusts OR fumes
* Concurrent participation in another clinical trial
* Unable to communicate in English
* No social security number
The Relative Effects of Olmesartan Medoxomil, Irbesartan and Valsartan on the Activity of the Blood Pressure Control System in Healthy Subjects

To assess the effects of 3 blood pressure drugs, called angiotensin receptor blockers, on the blood pressure control systems in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18 to 65
* In good health

Exclusion Criteria:

* Any serious health problems
* Positive test for HIV, Hepatitis B and C
* History of drug and alcohol abuse
From the Model to the Adaptation of a Therapeutic Education Program (TEP) in Cancer Research

The use of oral targeted therapies draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals \[1,2\]. These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" \[3\]. Nevertheless, in France, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research \[4\]. In May 2012, a therapeutic educational program for these patients has been developed in the oncology department of the Teaching Hospital of Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer patients treated by oral targeted therapies, becomes here an object of research: MODAP (action-research).

At the diagnosis, 25 to 30 % of renal cancer patients present a metastatic disease. The prognosis remains dark in spite of the advent of the targeted therapies from 2007. Actually, the use of oral targeted therapies, most of the time carried out on an outpatient basis (sunitinib in particular), draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals \[1,2\].

These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" \[3\]. Nevertheless, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research \[4\]: multiplicity of the pathology (a cancer, cancers), multiplicity of the patients' experiences, the difficulty of implementation? In May 2012, in front of the experience told by the patients and the professionals in the context of metastatic renal cancer, the members of the oncology department of the Teaching Hospital of Bordeaux, the therapeutic educational Federation, the Coordination Cancer Centre (3C), an anthropologist, an expert patient and a patient's association developed a therapeutic educational program for these patients \[current approval\].

This program, built on the model of the TE in France, becomes here an object of research: MODAP (action-research).

Eligibility Criteria:
Inclusion Criteria:

* Age = 18 years old
* Metastatic Renal cancer (carcinoma with clear cells and other subcategories)
* Indication of a first line of treatment of therapy targeted by Sutent ©
* General WHO 0-2 state
* Life expectancy = 12 weeks
* Agree to participate in MODAP (Therapeutic Education)

Exclusion Criteria:

* History of other cancer
* History of severe psychiatric affection
Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas

This study will compare the impact of a classical aerosol mask above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19.

Hospitalized patients with COVID-19 typically present with hypoxemia. In some patients, hypoxemia can be corrected with low flow nasal cannula. When placed above nasal cannula, some systems have demonstrated their interest in improving the performance of the patient's oxygen delivery. For example, two recent studies have shown that adding a Double-Trunk Mask (DTM) or Surgical Mask (SM) above nasal cannula has the potential to improve the PaO2 despite no change in oxygen output (1, 2) . However, no study has compared the effect on PaO2, of the addition of a classical aerosol mask above nasal canula.

Eligibility Criteria:
Inclusion Criteria:

Hypoxemia

Exclusion Criteria:

Hypercapnia

Confusion
The Compliance of DAPT and Statins on Clinical Outcomes in Percutaneous Coronary Intervention Patients

A nationwide retrospective cohort study. To investigate the real world medication compliance and the relation with clinical outcomes.

The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous coronary intervention. But, the discontinuation and compliance rate are unknown in the real world setting.

A nationwide retrospective cohort study. The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous coronary intervention. The discontinuation and uncompliance may increase a risk. But, the discontinuation and compliance rate are not well known in the real world patients undergoing bare metal stents(BMS) and drug eluting stents(DES) insertion.

To investigate the real world medication compliance and the relation with clinical outcomes, administrative claim data was extracted from the Korean National Healthcare Insurance(KNHI) database.

All Korean patient date undergoing PCI from January 1, 2011 to December 2011 is extracted. 5 year clinical outcomes are investigated.

Primary outcomes are the MACE including all-cause death, revascularization, critically ill status, and stroke) classified by the medication compliance. Medication complinace is measured by proportion of days covered(PDC)

Secondary outcomes are the patterns of medication persistence and its outcomes to understand critical points.

Eligibility Criteria:
Inclusion Criteria:

1. All claim of percutaneous coronary intervention using stent in the National Healthcare Insurance Service of Korea between January 1st 2011 and December 31st, 2011

Exclusion Criteria:

1. No use of stents
2. Stent not classified into DES or BMS
3. Use of DES and BMS together at the same initial day
Suprapostural Attention Focus and Postural Difficulty on H-reflex and Brain Activity: Aging and Parkinson's Disease

Inherent with intricate allocation of brain resource and attention shift, postural-suprapostural task is defined as postural control takes place while the other concurrent task is being performed. Recent studies have indicated that attentional focusing alters attention allocation in the brain as well as motor performance of a postural-suprapostural task. Also, most studies have demonstrated benefits of inducing an external focus relative to internal focus for motor performance. However, postural difficulty might be a critical factor for choosing an appropriate focusing strategy, and the strategy used in a particular difficulty level do not always generalize to other difficulty levels. Besides, despite a lot of studies have been done, current findings are confined to behavioral observations in young healthy adults for lacking direct neural evidence. With the uses of H-reflex, event-related potential and behavioral measures, the purpose of the 3-year research project is to investigate the differences in performance quality and intrinsic neural mechanisms of a postural-suprapostural task for older adults and patients with Parkinson's disease, by adopting external and internal strategies for suprapostural task under different posture difficulties. In the first year, the investigators will characterize suprapostural focusing effect on reciprocity of a postural-suprapostural task, with a special focus on modulation of motoneuron excitability in sitting and standing posture for healthy young and older adults using H-reflex technique. In the second year, the adaptive selection of suprapostural focusing strategy will be investigated for patients with Parkinson's disease by varying the standing surface (stable/unstable surface). In the third year, the investigators will investigate suprapostural focusing effect on brain resource allocation for patients with Parkinson's disease, in light of event-related potential and movement-related potential. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of concurrent postural and motor suprapostural tasks with internal/external focusing strategy under different posture difficulty, but to optimize treatment strategy for older adults and patients with Parkinson's disease with balance or multi-tasking disturbances.


Eligibility Criteria:
Inclusion criteria

* Independent standing balance on air pillow at least 20 sec
* No neurologic or orthopedic disorder

Exclusion criteria

* Had relative experience before
* Pregnant women
Prognosis of Cerebral Small Vessel Disease

Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation.

The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive deep perforator arteriolopathy (DPA), clinically symptomatic with either ICH, ischaemic stroke, cognitive impairment or severe radiological manifestation (Fazekas ≥II)
* Cerebral amyloid angiopathy (CAA according to modified Boston or Edinburgh criteria), clinically symptomatic with either ICH (including cSAH), amyloid spells, cognitive impairment or severe radiological manifestation (CMB≥2)
* Other SVD (i.e. CADASIL or other sporadic or genetic SVD)

Exclusion Criteria:

* Life expectancy of \<6 months due to not-SVD related causes (i.e. cancer)
* Patient is unlikely to attend follow-up visits
Hearing Loss and Osteoporosis

To compare the audiological profiles in postmenopausal women with and without osteoporosis and to examine the pattern of hearing loss in osteoporotic patients. postmenopausal women will be separated as normal, osteopenic and osteoporotic according to bone mineral densitometry results. The evaluation of hearing test will be done in these groups and the results will be compared between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Between 45-60 years
* postmenopausal women

Exclusion Criteria:

* Women over 60 years old,
* acute or chronic otitis media,
* ear surgery,
* use of ototoxic drugs,
* congenital hearing loss,
* previous long-term steroid use,
* malignant or benign neoplasm of the brain,
* Patients with a history of exposure to noise were excluded from the study.
Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression

This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.

This is a phase II open-label, single-ascending, fixed-order study to assess the feasibility and efficacy of inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.

Eligibility Criteria:
Inclusion Criteria:

* Patients in current treatment for depression with a partial response.

Exclusion Criteria:

* heart failure
* liver failure
* kidney failure
* uncontrolled high blood pressure
* history of heart rhythm disorders
* history of valvular heart disease
* history of chronic obstructive pulmonary disease (COPD)
* active or in treatment for bronchial asthma
* severe obesity
* coagulation disorders
* clinical evidence or history of increased intracranial
* clinical evidence or history of cerebrospinal pressure
* history or reports of epilepsy
* severe neurological disease
* pregnancy
* reported or clinically recognized thyroid disorders
* diagnosis or family suspicion of genetic monoamine deficiency oxidase
* previous adverse response to psychedelic substances
* symptoms or family members with a present or past psychotic disorder
* dissociative identity disorder
* bipolar affective disorder
* prodromal symptoms of schizophrenia
* problematic use or abuse of alcohol or other psychoactive substances (except tobacco)
* acute or subacute risk of suicide
* acute flu symptoms
* symptoms of airway infection
* contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days
Psilocybin With Intracranial Neural Sensing

This is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (DBS) devices. Outcomes include multi-site neural recording from previously placed ambulatory sensing-capable DBS devices, quantitative sensory and cognitive testing, and self-reports of pain. We hypothesize that psilocybin will change functional connectivity, decrease clinical and task-based pain reports, and improve cognitive functions.

This is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (DBS) devices. Outcomes include multi-site neural recording from previously placed ambulatory sensing-capable DBS devices, quantitative sensory and cognitive testing, and self-reports of pain. We hypothesize that psilocybin will change functional connectivity, decrease clinical and task-based pain reports, and improve cognitive functions.

Eligibility Criteria:
Inclusion Criteria:

* Currently implanted chronic brain sensing device (such as RC+S or Percept)
* Not currently enrolled in another trial
* Ability to speak and read English
* Able to attend all in-person and virtual visits
* No changes in medication or major surgical procedures anticipated for the trial
* Able to identify someone to accompany from the research unit at the end of drug administration day or agreement to have a study team member accompany them from the research unit

Exclusion Criteria:

* A health condition that makes this study unsafe or unfeasible, determined by study physicians
* Use of medication, vitamins, or supplements and unwilling or unable to discontinue medications that have problematic interactions with psilocybin
* Adulthood epilepsy or other seizure disorder
* Require supplemental oxygen
* Medical finding or diagnosis that would make participation in this trial unsafe