cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain

This study is being done to assess the safety of using the Angel Concentrated Platelet Rich Plasma System to process Platelet Rich Plasma (PRP) to treat arthritis of the low back (lumbar spondylosis).

This study is a pilot of the safety of using the FDA cleared Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set to process PRP to treat arthritis of the low back (lumbar spondylosis). Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. A final visit for evaluation and collection of lab samples will be conducted at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiographic (MRI, CT or lumbar x-ray) evidence of symptomatic facet arthropathy involving the bilateral bottom two facets (e.g., L4-5 or L5-6 and L5-S1 or L6-S1).
* Positive response, defined according to current clinical standards for the diagnosis of facet-mediated low back pain as greater than or equal to 75% pain improvement (as reported by patient) to diagnostic medial branch nerve blocks, one block with lidocaine and the other with bupivacaine.
* Low back pain VAS score of greater than or equal to 5 at the clinical visit just prior to the first medial branch nerve block.

Exclusion Criteria:

* Prior facet related procedure (intraarticular corticosteroid injection, radiofrequency ablation (RFA)) in last 6 months or prior fusion in the bottom two facets.
* Current opioid use of greater than 50mg oral morphine milligram equivalents per day.
* No advanced imaging (MRI, CT or lumbar x-ray) of the lumbar spine within the last 6 months.
* BMI \> 34.99 (WHO class I obesity).
* Active systemic or local infection as evidenced by fever \>100.4 degrees Fahrenheit, or any other clinical signs or symptoms of infection within 24 hours of the procedure.
* On anticoagulation drug and has been on hold for less than 7 days prior to the investigational procedure.
* Imaging evidence of high likelihood of failure for intra-articular injection in the opinion of the PI or delegate review of MRI, CT or lumbar x-ray imaging.
* History of chronic thrombocytopenia (or pre-operative platelet count less than 195,000 per μl).
* Undergoing chemotherapy at time of injection.
* Pregnant or breastfeeding.
* Use of illicit drugs within 30 days prior to study entry.
* NSAID use during the pre-procedural period (one week before Treatment Day 0).
* Preoperative hematocrit less than 36%.
* History of hemodynamic instability or inability to maintain stable oncotic pressure.
* History of prolonged clotting times.
* Prior history of lumbar procedure.
* Redness, swelling, rash or other concerning lesions at the injection site just prior to the procedure.
* Prior history of allergy to lidocaine or other local anesthetic agent.
High Dose Atorvastatin for Preventing Contrast-induced Nephropathy

The aim of this study is to determine the efficacy of atorvastatin in the prevention of contrast-induced nephropathy in patients undergoing computed tomography coronary angiography. Investigators assume that atorvastatin is effective in this regard. Investigators include patients referring for elective computed tomography coronary angiography and allocate them to atorvastatin or placebo from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* candidate of elective computed tomography angiogram
* willingness to participate

Exclusion Criteria:

* unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
* unstable serum creatinine
* unstable hemodynamic
* intravascular administration of contrast material in the past month
* using high dose atorvastatin in the past month,
* known hypersensitivity to atorvastatin
The Impact of a Caffeinated Sports Drink on Performance

Caffeine is known to enhance physical and mental performance, but few beverages combine caffeine with electrolytes and carbohydrates to enhance exercise performance. This study evaluates a caffeinated electrolyte-glucose drink's effect on endurance, strength, and cognition. Using a repeated-measures, cross-over design, 20 trained cyclists will complete one familiarization and four randomized 3-hour experimental trials (Liquid I.V.™ Energy Multiplier, Hydration Multiplier, Sugar-Free Hydration Multiplier, and water). Each trial includes 2 hours of cycling in a warm environment (32ºC), followed by strength and cognitive assessments. Cycling performance, capillary blood, urine, and expiratory gases will be collected.

Each subject will complete 5 trials (1 familiarization and 4 experimental) consisting of approximately 2 hours cycling in a warm environment (90ºF), followed by strength assessment and cognitive assessment via questionnaire. Each trial will be identical, with the only difference being the type of drink consumed during each trial. The first trial will be for familiarization without any blood sampling. The rest of the trials will be completed in a randomized order and the drink consumed

Cycling Endurance Exercise Performance

The exercise test will consist of a series of three consecutive cycling sets in a warm environment (90ºF), with each series consisting of:

1. a 30-min submaximal ride (50% maximal power as determined from the initial)
2. a 5-km time trial race-like performance effort. During each 30 min submaximal rides participants will drink a total 500 mL of fluid spread out during the 30 min. During the 5 km performance test the participants will drink 25 mL of fluid at the end of each kilometer.

At regular intervals throughout the exercise task, body weight, blood samples, respiratory gasses, and perceptual data will be collected. See study schematic provided below for specific measurement timepoints.

Upon completion of the cycling task subjects will moved to another room with cool temperature (70ºF), where strength and cognitive function will be assessed to determine the influence of each beverage on indices of exercise performance and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* Healthy and injury-free (muscle, skeletal) for greater than 2 months
* Active cyclists who train at least 3 times per week
* Body mass index (BMI) range of 18.5-30 kg/m2

Exclusion Criteria:

* • History of caffeine sensitivity

  * Cancer Diagnosis during the last 5 years
  * Pregnancy
  * History of renal disease, hypertension
  * History of a heat stroke
  * Use of testosterone therapy
  * Adults who are unable to consent (impaired decision-making capacity)
Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25

The intention of this study is to compare the performance of the single-use I-gel laryngeal mask with the classic laryngeal mask in 50 patients with a BMI\>25 during elective surgery. Primary outcome is the leak pressure. Secondary outcomes include ease and duration of insertion.

Inclusion criteria of this randomized cross-over study are: BMI \> 25, elective surgery in supine position, age\>18 years, ASA I-II; Exclusion criteria are: difficult airway, pregnancy, history of reflux or gastrointestinal disorders, abdominal or thoracic surgery; In this cross-over trial both airway devices are inserted in the same patient, the order of insertion is randomized. Patient receive monitoring with blood pressure, ECG and pulse oxymetry during operation. Anaesthesia is induced intravenously using fentanyl (0.001 mg/kg) and propofol (3-5 mg/kg). The I-gel laryngeal mask is inserted with a gastric tube. The classic laryngeal mask was cuffed after insertion with a cuff pressure of 60 cmH2O. The first device is removed 5 minutes after insertion and replaced by the second device. Ease of insertion is graded as very easy=1, easy=2, difficult=3 and very difficult=4. Leak pressure is measured by two tests: In the first test the spill valve is closed at a fresh gas flow of 6l/min and the minimum airway pressure at which gas leaked around the airway device is recorded by listening for an audible leak. In the second test leakage is measured during pressure controlled ventilation. Therefore we administer a fresh gas flow of 3l/min, FiO2 of 50%, inspiration to expiration ratio of 1:2 and a frequency of breathing of 12. Leakage can be measured by the respirator. We record inspiration pressure, mean pressure, plateau pressure, tidal volume and peep at which the first measurable leakage occurred.

For statistical analysis we will use t-tests with a power of 80% and a p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25, elective surgery in supine position,
* age \> 18 years,
* ASA I-II;

Exclusion Criteria:

* difficult airway, pregnancy,
* history of reflux or gastrointestinal disorders,
* abdominal or thoracic surgery;
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject.

The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects

Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV-1b infected patient
* HCV Ribonucleic acid (RNA) \> 100,000 IU/mL at screening
* Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort)
* Treatment naive subjects to Interferon (IFN) based therapy
* Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up

Exclusion Criteria:

* Patients who have;

  * Hepatocellular carcinoma
  * Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
  * Severe or uncontrollable complication
3-4 Year Outcomes Following Endovenous Steam Ablation for Venous Insufficiency

The aim of this study is to evaluate the long-term effects of endovenous steam ablation (EVSA). Postoperative data at 3-4 year follow-up will be collected from patients treated with EVSA.

Endovenous steam ablation (EVSA) of saphenous veins (saphenous vein reflux) is one of the endothermal methods in the modern treatment of venous insufficiency. Good results and long-term follow-up have been published for endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), while long-term effects of EVSA are less documented. Therefore, the aim of this study is to evaluate the effect of EVSA in 200 consecutive patients treated with EVSA and conduct prospective evaluations at 3-4 year follow-up. Standardized and validated measures will be compared to preoperative measures to evaluate change in patient-reported and clinical outcomes over time.

Eligibility Criteria:
Inclusion Criteria:

* Received steam ablation for treatment of saphenous vein reflux (clinical classes C2-C4) at Lovisenberg Diakonale Hospital 3-4 years (i.e, 36-48 months) prior to study enrollment.
* Ability to speak, understand, read, and write Norwegian in order to complete follow-up exams and questionnaires.

Exclusion Criteria:

* \<18 years of age
Investigation Into an Innovative, Clinical Slip Inducing Device in the Chronic Incomplete Spinal Cord Population

The objective of this project is to fully test a newly developed affordable cost variable slip inducer in the ambulatory, incomplete spinal cord population. It is a self-contained device using a moving serial plank mechanism with wheels on the underside of each plank that allow for structured slips while a person walks over the planks with a harness for safety.

All planks appear the same but can be adjusted on the underside allowing for it to be stable or can allow a slip in the forward and/or backward direction of up to 8 inches. This distance was determined from a review of slip bio-mechanics that noted that a slip is likely to occur when a slip distance exceeds 10 cm (3.9 inches) with the probability of recovery decreasing as the distance increases. The first goal of the project is to determine the optimal distance required for individuals with incomplete spinal cord injuries to have a 50% fall rate, as healthy individuals were found to have a fall rate of 50% at 11 inches. Investigators will then look at common clinical assessments and examine their ability to predict an individual's ability to recover from the individual's identified optimal slip distance. Investigators will also look at within session training effect on a person's balance control following a training session using the device.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a traumatic or non-traumatic incomplete spinal cord injury at least 6 months ago
* Between the ages of 18-85 years old.
* Ambulates as their primary means of mobility
* Able to walk without cane/crutch/walker for 30 feet.
* Weight less than 275 lbs.
* Medical clearance from physician

Exclusion Criteria:

* Uses a wheelchair as primary means of mobility
* Recent (\<6 months) lower extremity fracture
* Other neurological diagnoses that would impact balance such as peripheral neuropathy, stroke, brain injury, etc.
* Lower extremity amputation
* Currently pregnant
* Uses knee-ankle-foot-orthosis for mobility.
Impact of Various Sedation Regimens on the Incidence of Delirium

Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol, midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been reported to be used together with midazolam in ICU and the combination of propofol and midazolam is most commonly used, but things follow include a high incidence rate of delirium, But the combination of midazolam and dexmedetomidine may have complementary advantages and could have be a better choice for sedation. In this study, we attempted to observe the effects of two different drug regimens on delirium incidence rates in severe ARDS patients' : midazolam and propofol vs propofol and dexmedetomidine .


Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to give written informed consent.
* Mild, moderate or severe ARDS patients demanding invasive mechanical ventilation.
* Subjects whose expected time of mechanical ventilation is longer than 24 hours.
* Subjects aged between 18 and 70.

Exclusion Criteria:

* Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.
* Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.
* Subjects with heart rates less than 50 beats per minute.
* Subjects with second or third degree atrioventricular block.
* Subjects with serious cerebral injury, severe neurologic disorder (e.g acute stroke, uncontrolled epilepsy and severe dementia) or coma.
* Subjects with acute or severe liver disease (Child-Pugh class C), see attachment 2.
* ARDS patients caused by pulmonary fibrosis or COPD.
* Subjects on all types hemodialysis.
* Subjects with neuromuscular system disease, alcohol withdrawal syndrome or mental disease before entrance of ICU.
* Subjects suspected of narcotic analgesics abusing.
* Subjects needing neuromuscular blocking agents (except intubation).
* Subjects allergic to investigational products or with other contraindication.
* Subjects who are breastfeeding or pregnant
* Subjects participated in other study within 30 days before entrance of ICU
Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy

Objective: Explore the biomarkers related to proliferative diabetic retinopathy by analyzing the protein expression profile changes of plasma exosomes in patients with difference phases of diabetic retinopathy, and investigate potential molecular mechanisms and therapeutic targets. Methods: Enrich exosomes from plasma by column extraction method. NTA, WB and TEM were used to characterize the obtained exosomes, and exosome proteinomics was performed by chromatography⁃mass spectrometry. Corhorts: The study was divided into four groups: a healthy control group, a diabetic without diabetic retinopathy group, a non-proliferative diabetic retinopathy group, and a proliferative diabetic retinopathy group, with 6 cases in each group.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without diabetes/ Senile cataract patients without diabetes；
* Patients with diabetes who are diagnosed without DR, NPDR, and PDR by mydriatic fundus photography (or FFA)；

Exclusion Criteria:

* Patients with systemic diseases such as cancer, immune diseases, infectious diseases, and blood diseases；
* Patients with cerebral infarction, myocardial infarction and other cardiovascular and cerebrovascular diseases
Postoperative Course Following Wisdom Tooth Surgery

The purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth

A significant percentage of patients are subjected to surgical removal of 3. molars every year. The surgical mucosal and osseous procedure may lead to postoperative discomfort including pain, for the patient. Information with respect to how patients regard the impact of this surgical treatment on oral health including pain and swelling is of great interest. More precise information about the postoperative course following this surgery will be beneficial in improving clinical treatment procedures with respect to alleviating the patients' postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex of Caucasian origin, between the age of 18 and 45, who are candidates for surgical removal of one mandibular 3. molar

Exclusion Criteria:

* Chronic drug treatment (except birth control medication) with analgesics, anti-inflammatory treatment (both steroidal (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs)) apart from standard postoperative analgesic treatment administered by the operator.
* The necessity for anti-microbial drugs.
* Pregnant or lactating women.
* Patients with diabetes.
* Patients who due to age or communication skills are considered unable to complete patient forms.
* Professional evaluation suggests an alteration of the planned surgical area or treatment form.
* Surgery exceeding 45 minutes, from time of first incision to completed suturing.
* Known or assumed intolerance or hypersensibility to ibuprofen (standard postoperative analgesic treatment).
* Known or assumed intolerance or hypersensibility to the standard local anaesthetic Xylocain-adrenalin (lidocaine-adrenalin).
* Consumption of alcohol in the period from 2 days before or until the end of the primary observation period (postoperative days 0-7.
Pulmonary Echography and BNP Value Pre- and Post- Elective Cesarean Section in Spinal Anesthesia

Pregnancy is characterized by many biohumoral changes: circulation, respiratory mechanics, oncotic pressure, vascular permeability and many other systems are affected.

Vascular permeability is controlled by endothelial glycocalyx. Several factors such as sepsis, ischemia / reperfusion, inflammatory mediators, trauma, surgery including the Cesarean Section and fluid overload can increase vascular permeability due to a glycocalyx damage.

During Cesarean Section under subarachnoid anesthesia, hypotension may occur. It is a common side effect caused by reduced preload due to aortocaval compression by the uterus. Furthermore, subarachnoid anesthesia causes block of the sympathetic preganglionic fibers which is associated with vasodilation. These changes often require the use of vasopressors and fluids.

A fluid overload associated with the physiological and pathological factors discussed earlier might cause an increased risk of pulmonary edema and acute respiratory failure (IRA) in women undergoing cesarean section under arachnoid anesthesia.

IRA occurs in less than 0.2% of total pregnancies but it is one of the most common cause of admission to intensive care unit in pregnant women.

Among the causes that can lead to IRA in the last trimester of pregnancy we find pneumopathies such as asthma, pulmonary embolism due to amniotic fluid and pulmonary edema related to severe preeclampsia.

Diagnosis of pulmonary edema can be clinical or sub-clinical through laboratory tests such as BNP (b-type natriuretic peptide). It might also be necessary to execute instrumental examinations such as chest radiography (contraindicated in pregnancy) or trans-thoracic ultrasound.

Hypothesis: correlation between subarachnoid anesthesia, fluidic therapy and BNP values and ultrasound pattern


Eligibility Criteria:
Inclusion Criteria:

woman submit elective Cesarean Section:

* age \> 18 years
* American Society of Anesthesiologists (ASA) physical status classification system \> 2
* \> 37 gestational age
* arterial pressure \>/ = 140/90 mmHg and proteinuria \< 300 mmHg during anesthesia pre-examination
* no known cardiovascular/respiratory disease
* pre-partum pulmonary echography

Exclusion Criteria:

* age \< 18 years
* pulmonary echographic windows not satisfying
* blood loss during Cesarean Section more than 1000 mL and/or necessity to administer colloid
* postpartum hemorrhage within the first 24 hours following childbirth
* pre-eclamptic sign/symptoms within the first 5 days following childbirth
* twin pregnancy
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain

According to traditional Chinese medical theories, a variety of acupuncture formulas can treat diseases such as pain. For example, stimulating acupoints either local or distal to the pain site has been proposed under some conditions. We hypothesize that stimulating acupoints contralateral to the pain site can successfully treat chronic shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* Uni-lateral shoulder pain for 6 weeks to 2 years
* VAS score ≤ 50
* 25-65 years of age
* Positive Neer's or Hawkins' signs
* Accept the informed consent

Exclusion Criteria:

* Shoulder pain of neurological origins
* Shoulder pain of neck origins
* Systematic arthritis
* Wrist problems
* Previous shoulder, arm, neck or chest fractures or surgeries
* Mental diseases
* Pregnancy
* Inability to work for more than 3 months before treatment
* Diabetes
* Coagulative dysfunction
* Corticosterone or physicotherapy experience on the affected shoulder in the last 6 months
* Failure to accept the informed consent
Detection of Lung Cancer by Plasma Lipids

There are no reliable blood-based tests currently available for early-stage lung cancer diagnosis. We try to establish a highly accurate method for detecting early-stage lung cancer by combining machine learning with untargeted and targeted metabolomics .

All plasma lipids were first detected by untargeted metabolomics methods and 9 feature lipids of early-stage lung cancer were selected by support vector machine algorithm. Then, a targeted metabolomics method was developed to detect the 9 lipids quantitatively based on multiple reaction monitoring mode. Finally, a detection model was established based on the 9 lipids.

Eligibility Criteria:
Inclusion Criteria:

1. pulmonary nodules or opacity
2. plan to receive surgery

Exclusion Criteria:

1. history of other malignancies
2. received anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery