cyrilzakka/clinical-trials huggingface dataset:
Urodynamic Feasibility Study Utilizing the UroLift® System

UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Diagnosis of symptomatic BPH
* Age ≥ 45 years
* International Prostate Symptom Score (IPSS) ≥ 13
* Peak urine flow rate ≤ 12 ml/sec, voided volume ≥ 125 ml
* Prostate volume ≤ 80 cc per ultrasound

Exclusion Criteria:

* Current urinary retention
* Post void residual (PVR) urine \> 250 ml
* Have an obstructive or protruding median lobe of the prostate
* Active urinary tract infection at time of treatment
* Current gross hematuria
* Previous BPH surgical procedure
* Previous pelvic surgery or irradiation
* History of neurogenic or atonic bladder
* Stress urinary incontinence
* Biopsy of the prostate within the past 6 weeks
* Life expectancy estimated to be less than 1 year
* History of prostate or bladder cancer
* Elevated Prostate-Specific Antigen (PSA) without ruling out prostate cancer
* History of compromised renal function or upper tract disease
* Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
* Use of the following medications pre-screening (uroflow, questionnaires):

  * Within 4 months of baseline assessment: estrogen, any drug producing androgen suppression, or anabolic steroids
  * Within 3 months of baseline assessment: 5-alpha-reductase inhibitors
  * Within 2 weeks of baseline assessment: alpha-blockers, gonadotropin-releasing hormonal analogs, anticholinergics or cholinergic medication or phenylephrine, pseudoephedrine, or imipramine medications
  * Within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and antispasmodics
* Cystolithiasis within the prior 3 months
* History of co-morbidities that would affect having an elective urological procedure including: prostatitis, conditions that preclude the insertion of the UroLift System.
* Other co-morbidities that could impact the study results such as:
* Severe cardiac arrhythmias uncontrolled by medications or pacemaker
* Congestive heart failure New York Heart Assocation (NYHA) III or IV
* History of uncontrolled diabetes mellitus
* Significant respiratory disease in which hospitalization may be required
* Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
* A known allergy to nickel, titanium, or stainless steel
* Unable or unwilling to complete all required questionnaires and follow up assessments
* Unable or unwilling to sign informed consent form
* Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
CT Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma

Distinct vascular patterns (ECTC or Non-ECTC) of tumors plays an important role in tumor migration, metastasis and drug resistant in hepatocellular carcinoma (HCC). However, there is no non-invasive method to predict vascular pattern in clinical. In the present study, we prospectively assess CT perfusion parameters for evaluation of the vascular pattern in HCC.


Eligibility Criteria:
Inclusion Criteria:

1. age over than 18 years old
2. tumor size of less than 5 cm
3. Child-Pugh A class liver function
4. an Eastern Cooperative Oncology Group performance status of 0
5. no previous treatment for HCC
6. pathological diagnosis of hepatocellular carcinoma
7. adequate organ function (white blood cell count ≥3.0 × 109/L, absolute neutrophil count ≥1.5 × 109/L, platelet count ≥75 × 109/L, aspartate transaminase and alanine transaminase≤5 × upper limit of the normal, creatinine clearance rate of ≤1.5 × upper limit of the normal, and left ventricular ejection ≥45%)

Exclusion Criteria:

1. Patients who received antitumor therapy before recurrence, including radiotherapy, transarterial chemoembolization, tyrosine kinase inhibitor, and immune checkpoint inhibitor
2. a known medical history of HIV infection
3. pregnancy or breastfeeding
4. portal vein tumor thrombosis or hepatic vein thrombosis detected by any routine imaging modality, including ultrasonography, dynamic contrast CT and MRI
5. any evidence of tumor metastasis or prior recurrence
6. hepatic decompensation
the Effect of Mobile Medical Used for the Standardized Management of Gestational Diabetes

A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.

Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 45 years.
* With singleton pregnancy
* Diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
* Be able to use smart phone for chatting, read and write basic Chinese.
* Volunteer for research.

Exclusion Criteria:

* Pregnancies with diagnosed chronic disease
* Pregnancies with other pregnancy complications except GDM
* Pregnancies had recent trauma and treatment of glucocorticoids
Prehospital Recognition and Identification of Unspecific Symptoms

This study evaluates the predictive value of soluvent urokinase plasminogen activator receptor (suPAR) and lactate with respect to serious conditions among patients presenting to the EMS with unspecific symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Unspecific symptoms (not feeling well, decreased general health condition, unable to cope with usual daily activities, feeling weak)
* Normal vital signs
* Transported to ED
* Able to give informed consent/ Next of kin gives informed consent

Exclusion Criteria:

* Specific symptoms
* under 18 years of age
* Stays home / other caregiver than ED
* Referral from caregiver
* No personal numer (social security number)
Registry on Luma Vision's VERAFEYE System (ENLIgHT)

The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent
* Subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the VERAFEYE System as navigation and imaging system, per physician discretion;
* Subject is able to understand and willing to provide written informed consent
* Subject is able and willing to complete all study assessments at an approved clinical investigational center

Key Exclusion Criteria:

* Subjects who have undergone a previous cardiac ablation for the treatment of PAF/LAA Closure
* Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
* Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
* Unrecovered/unresolved Adverse Events from any previous invasive procedure
* Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)
Effect of a 4-week Post-exercise Sauna Bathing on Targeted Gut Microbiota

Body temperature fluctuations induced by acute exercise bouts may influence the intestinal barrier with related effects on epithelial permeability, immune responses, and release of metabolites produced by the gut microbiota.

Untrained males aged 22±1.5 years were randomly assigned to exercise training (ET) with or without post-exercise sauna treatments (S). Participants in the group ET+S (n=8) exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment. The control group (ET, n=7) engaged in the same exercise training program without the sauna treatments. Blood and stool samples were collected before and after the 4-week training program. Blood samples were analysed for the concentration of high-sensitivity C-reactive protein (hsCRP) and complete blood counts. Stool samples were analysed for pH, quantitative and qualitative measures of targeted bacteria and fungi, zonulin, and secretory immunoglobulin A. This study evaluated the effects of post-exercise sauna bathing in young men undergoing endurance training on gut bacteria inflammation and intestinal barrier function. Investigators hypothesized that sauna bathing applied immediately after a physical training session may impact homeostatic control of the gut microbiota and the function of the intestinal barrier.

Eligibility Criteria:
Inclusion Criteria:

* absence of medical contraindications such as epilepsy,addiction to medicines, alcohol and drugs, cancer, blood clotting disorders,
* no infections in the last 4 weeks prior to the study,
* no injuries in the last 4 weeks prior to the study.

Exclusion Criteria:

* the intake of antibiotics, steroids, oral antifungal agents (except for topical antifungals), antiparasitic agents, pre- and/or probiotics,
* history of travel to tropical countries during the last 4 weeks before the study,
* history of adverse responses to sauna bathing.
Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department

This is a single-arm pilot study to examine the impact of BXCL501 (sublingual film formulation of dexmedetomidine) administration on reducing the severity of undifferentiated acute agitation in patients presenting to the emergency department with underlying bipolar disorder or schizophrenia. This study is designed to evaluate BXCL501 for its FDA-approved indication -- treatment of agitation associated with bipolar disorder or schizophrenia -- applied in the emergency department setting.

This pilot study will enroll 30 male and female adults with primary psychiatric complaint and a documented diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder, presenting to the emergency department with clinical signs of acute agitation. Eligible subjects will receive an initial dose of BXCL501 (180mcg) and a repeat dose (90mcg) 2 hours after the first BXCL501 dose in the event of persistent or recurrent agitation (up to two repeat doses) while under medical supervision in the emergency department. Efficacy and safety assessments will be conducted periodically before and after dosing.

Eligibility Criteria:
Inclusion Criteria:

* English speaking adults age ≥18 years
* Patients with an established diagnosis of (1) bipolar I disorder, (2) bipolar II disorder, (3) schizophrenia, (4) schizoaffective disorder, or (5) schizophreniform disorder
* Judged to be clinically agitated at the time of Screening and Baseline with a AMSS ≥2
* Able to read, understand, and provide written informed consent
* Subject judged to be likely capable of self-administration of BXCL501 sublingually or buccally

Exclusion Criteria:

* Likely to be discharged, admitted, or transferred from the ED within 6 hours after study medication administration
* Administration of benzodiazepines or antipsychotic drugs in the 2 hours before study treatment
* Treatment with alpha-1 noradrenergic antagonists
* Female patients who are pregnant or are breastfeeding
* Hypotension (systolic blood pressure \<100 mmHg or diastolic blood pressure \<60 mmHg) and/or bradycardia (heart rate \<55 beats per minute) at the time of Screening or Baseline evaluation
* History of dysautonomia
* Patient with a known diagnosis of familial long QT syndrome, second degree or third degree atrioventricular block without pacemaker, or sick sinus syndrome
* Patients with serious or unstable medical illnesses determined by the study investigators or qualified designees
* Patients with history of allergic reactions to dexmedetomidine
* Patients previously enrolled and completed the current study
* Patients actively enrolled in other ED-based studies involving pharmacological or behavioral interventions
Central Executive Training (CET) for ADHD

The goal of the current project is to assess the efficacy of Central Executive Training (CET) for youth with ADHD. CET is a new, computerized training intervention that targets specific components of the working memory system. Two versions of CET were developed as part of our R34, each targeting a different combinations of executive functions. The final CET protocol reflects the contributions and feedback of a diverse group of caregivers, children with ADHD, and recognized experts in human cognition, ADHD treatment research, randomized control trial (RCT) intervention design methods, serious game theory and task design, cognitive training, and the role of executive dysfunction in ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 8-12 with principal ADHD diagnoses (via Kiddie Schedule for Affective Disorders semi-structured clinical interviewing (K-SADS)
* Parent AND teacher ratings in clinical/borderline range based on age and gender on ADHD-RS-5 or BASC-3 Attention Problems/Hyperactivity subscales
* Below average or lower working memory on at least one pre-treatment WM test. All ADHD presentations will be eligible.

Exclusion Criteria:

* gross neurological, sensory, or motor impairment
* history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (substance use, disruptive mood dysregulation, intermittent explosive, reactive attachment)
* intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form intelligence quotient (FSIQ) \< 78 (1.5 standard deviations (SD) below mean)
* conditions requiring acute intervention, e.g., active suicidality
* non-English speaking child or parent.
Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

In this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon.

Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age;
2. no intention of quitting in the next one month;
3. report ST as their primary tobacco of use;
4. have used ST daily for the past 12 months;
5. have been provided with, understand, and have signed the informed consent
6. are able to complete all study visits;
7. are in general good health as determined by medical history.

Exclusion Criteria:

1. currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program;
2. currently enrolled in another research study;
3. describe having a medical history of: (a) unstable angina; (b) myocardial infarction within the past 6 months; (c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia; or (d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
4. have phenylketonuria (PKU) \[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU\];
5. have another member of their household already participating in this study;
6. have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators;
7. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen;
8. are currently pregnant are trying to become pregnant;
9. are currently breast-feeding and unwilling to stop during this study.
Endotoxin and Intestinal Flora Before and After Gastric Bypass or Banding in Diabetics

This research project is designed to investigate endotoxin (a toxin present in the wall of certain kinds of bacteria) levels and the type of bacteria present in the intestine before and after Roux-en-Y gastric bypass or gastric banding surgery in patients that meet the classification for morbid obesity (body mass index \>40 kg/m2) and type 2 diabetes. It is known that the type of bacteria present in the intestines of normal weight and obese individuals are different, and it is also known that people with obesity and type 2 diabetes have higher levels of endotoxin. It has been shown that the bacteria change over the long run after Roux-en-Y gastric bypass surgery, but the short-term effects are not known and the endotoxin levels after this procedure have never been studied.

Evidence exists that (i) morbidly obese, T2D patients undergoing RYGB are highly likely to resolve T2D symptoms or dramatically reduce oral and/or insulin requirements, (ii) metabolic endotoxemia may incite the pathologic conditions of low-grade inflammation and subsequently insulin resistance, obesity and T2D, (iii) significant intestinal microbiologic flora differences exist between normal weight and obese/diabetic individuals, and (iv) RYGB alters long-term intestinal microbiologic flora. Therefore, it is logical to evaluate short- and long-term circulating endotoxin concentrations and intestinal microbiologic flora in context with weight loss and restoration of euglycemia to expand our knowledge of the mechanism of the benefits observed following RYGB.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age
* Morbid obesity (BMI \> 40 kg/m2)
* Confirmed T2D diagnosis/date of onset

Exclusion Criteria:

* Age \< 18 years of age
* BMI \< 40 kg/m2
* Type 1 diabetes
* Chronic use of non-steroidal anti-inflammatory agents (NSAIDs)
* Chronic use of systemic corticosteroids
* Anticipated inability to maintain current statin, angiotensin converting enzyme inhibitor (ACEI), or angiotensin receptor blocking agent (ARB) regimen
Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery

In 2011, 38.6 million hospital stays occurred in the United States at a cost of $387.2 billion. 47.9 percent involved hospitalizations during which surgical procedures were performed. Orthopedic procedures constituted the most frequently performed and most costly of operating room procedures. As the healthcare climate in the United States continues to change, there is a trend towards providing effective care in a fiscally conservative manner. Central to this strategy is the shift towards increasing ambulatory surgical procedures from surgeries requiring post-operative admission for patients. While savings to hospitals and third-party payers are implied, there may be an unrecognized increase in financial, physical, and psychosocial post-operative costs to patients undergoing ambulatory surgery and to their caregivers. Rawal et al., and McGarth and colleagues have found that patients undergoing orthopedic procedures had moderate to severe post-operative pain. We propose to present a survey to patients and their caregivers before surgery and at multiple timepoints post-operatively to acquire information on the impacts of ambulatory orthopedic surgery. In addition to assessing post-operative pain, this study serves to examine various other possible burdens to patients that have not been previously evaluated in this patient population.

REFERENCES

McGarth B, Elgendy H, Chung F, Kamming D, Curti B, King S. Thirty percent of patients have a moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. Can J Anesth. 2004; 51:886-891.

Rawal N, Hylander J, Nydahl P, Olofsson I, Gupta A. Survey of postoperative analgesia following ambulatory surgery. Acta Anesthesiol Scand. 1997; 41:1017-1022.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing outpatient arthroscopic knee debridement or meniscectomy surgery
* Age 18-85
* Primary caregiver available during preoperative period who is employed full-time or part-time
* English speaking
* Patients who are employed full-time or part-time

Exclusion Criteria:

* Patients on disability or worker's compensation
* Patients undergoing concurrent procedures
* Patients who are self-employed
* Caregivers who are self-employed
* Surgeons: Dr. Altchek, Dr. Warren, Dr. O'Brien
Food Orders on Blood Glucose and Fuel Use At Rest

Consuming a carbohydrate-rich food as the final food in a meal, as compared to the first food in a meal, has been shown to reduce blood glucose levels after eating in both diabetes patients and in healthy controls. However, gaps remain in the literature in this area of research, and currently little is known about how substrate (fuel) use is impacted by altering food order. In addition, most studies to date have used a mix of meat and plant foods, while little research has focused exclusively on vegetarian foods. This randomized experiment will examine how altering the order of foods eaten in a vegetarian meal impacts blood glucose and fuel utilization at rest.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Free from any allergy or condition that precluding consumption of edamame, butter, and rice
* Not currently pregnant
* Free of any medical conditions requiring the use of insulin
* Have no history of bariatric surgery
* Have no implanted electrical devices such as a pacemaker

Exclusion Criteria:

* Younger than 18 and older than 70 years old
* Having an allergy or condition that precludes consumption of edamame, butter, and rice
* Currently pregnant
* Any medical conditions requiring the use of insulin
* A history of bariatric surgery
* Having an implanted electrical device such as a pacemaker