cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Benefits of Physiologic Insulin Delivery

In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users. In the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and compare it to subcutaneous injection. We will measure glucose, insulin and glucagon following these injections, to assess for benefits in counter-regulatory hormone production and insulin pharmacokinetics.

The eventual goal of this line of work is an implanted insulin pump that delivers insulin automatically into the peritoneum based on continuous glucose data. All prior intraperitoneal pharmacokinetic studies used only concentrated regular insulin, which may be too slow to provide full closed-loop insulin delivery without meal announcement. A description of intraperitoneal ultra-rapid insulin kinetics, as well as counter-regulatory hormonal factors that may counter hypoglycemia is needed. Upper versus lower peritoneal delivery may also affect insulin kinetics. A possible benefit of intraperitoneal insulin is restoration of glucagon response in longstanding diabetes and clearance of insulin by the liver, both of which could provide hypoglycemic rescue in automated insulin delivery systems.

Eligibility Criteria:
Inclusion Criteria:

1. 18-60 years of age
2. Clinical diagnosis of type 1 diabetes
3. On insulin pump therapy and continuous glucose monitor (CGM) for at least 3 months
4. Ability to safely receive intraperitoneal injection
5. For females, not currently known to be pregnant
6. Understanding and willingness to follow the protocol and sign informed consent
7. Ability to speak, read and write in the language of the investigators

Exclusion Criteria:

1. Diabetic ketoacidosis in the past 3 months
2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
3. Pregnant or lactating
4. Active infection
5. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
6. Known cardiovascular events in the last 6 months
7. Known seizure disorder
8. Inpatient psychiatric treatment in the past 6 months
9. Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
10. Suspected drug or alcohol abuse
11. Chronic kidney disease (GFR \< 60 mL/min/1.73m\^2)
Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones.

The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.


Eligibility Criteria:
Inclusion Criteria:

* healthy men and women
* age 18-60 years
* non-smoking
* not taking medication
* non-dieting (weight stable in prior 3 months)
* BMI 18-27
* English literacy
* ability to give blood

Exclusion Criteria:

* do not regularly consume breakfast
* food allergies to ingredients found in study products
* dislike for muffins, fiber bars, or hot cereal
* BMI \<18 or \>27
* diagnosed cardiovascular, renal, or hepatic disease
* diabetes mellitus (fasting blood sugar \>126 mg/dl)
* cancer in previous 5 years (except basal cell carcinoma of the skin)
* any gastrointestinal disease or condition
* recent bacterial infection (\< 3 months)
* recent or concurrent participation in an intervention research study
* history of drug or alcohol abuse in prior 6 months
* use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
* restrained eaters
* vegetarians
* people who eat more than approximately 15 grams of fiber per day
* women who are pregnant or lactating
* women with irregular menstrual cycles
Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM

This is a pilot study to investigate whether patients at advanced age are fluid responders via a reversible fluid challenge, the passive leg raise test. This will be measured with a non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .

The intervention is as simple as a passive leg raise with measurement of effect on Stroke volume.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥80 years of age, undergoing elective urologic surgical procedure

Exclusion Criteria:

* age \<80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to Lithium.
A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers

To compare the difference of a marker of cellular proliferation in all bronchial biopsy specimens of former smokers stratified by lung cancer risk, collected before and after treatment per patient between the enzastaurin and placebo groups.


Eligibility Criteria:
Inclusion Criteria:

* Sputum atypia participants with normal sputum cytology will be removed from the study)
* Metaplasia or dysplasia on at least one bronchoscopy specimen
* History of cigarette smoking ≥30 Pack Years
* Quit smoking ≥1 year prior to study entry
* Able to undergo bronchoscopy and helical computed tomography (CT) scanning of the chest
* Able to swallow tablets

Exclusion Criteria:

* Blood clotting abnormalities
* Current smoking within the past 1 year
* Unwillingness to abstain from smoking while enrolled in the clinical trial or unwillingness to avoid significant second hand smoke exposure
* Evidence for lung cancer or carcinoma in situ
* Active cardiovascular disease
* Current illicit drug or alcohol abuse
Pharmacokinetic Study of ASP1517 With Kremezin®

The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.


Eligibility Criteria:
Inclusion Criteria:

* Body weight (at screening): ≥50.0 kg and \<80.0 kg
* Body-mass index (BMI) (at screening): ≥17.6 and \<26.4 kg/m2
* Subject must agree to use contraception consisting of two established forms (1 of which must be a barrier method) starting at the time of informed consent and continuing throughout the treatment period and for 84days after ASP1517 administration in the last period:
* Subject must agree not to donate sperm starting at the time of informed consent and continuing throughout 84 days after the last administration of ASP1517 in the last period.

Exclusion Criteria:

* Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of the Period 1 (Day -1).
* Received or is scheduled to receive medications (including over-the-counter \[OTC\] drugs) within 7 days before the hospital admission day of the Period 1 (Day -1).
* Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1 (Day -1).
* Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) specified at screening or the hospital admission day of the Period 1 (Day -1).
* Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1 (Day -1). Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
* Concurrent or previous drug allergies.
* Development of (an) upper gastrointestinal symptoms within seven days before the hospital admission day of the Period 1 (Day -1).
* Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, gastrointestinal obstruction,oesophageal varices, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema.
* Concurrent chronic constipation or diarrhoea.
* A history of digestive tract excision.
* Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311 (FG-2216) or erythropoietin products.
* Excessive alcohol or smoking habit.
VeraFlo With Prontosan® and Wound and Fracture Healing.

To answer the question: "Do Prontosan instillations decrease time to wound and fracture healing and decrease bacterial load compared to wound vac treatment without Prontosan?," we will enroll up to 30 subjects (for an anticipated 20 complete data sets) into this trial. The subjects will be split equally into two different groups by randomization. One groups will have wound vac therapy with Prontosan, and one group will have wound vac therapy without Prontosan. Data related to wound and fracture healing and bacterial load will be assessed between the two groups to determine if wound vac therapy with Prontosan speeds up healing time and decreases bacterial load.

Surgical site infections (SSIs) are a devastating and relatively common surgical complication, occurring in 2% to 5% of patients undergoing surgery in the United States. SSIs can significantly increase patient morbidity, hospital stay duration, healthcare costs, and patient mortality (Anderson 2011).

Negative Pressure Wound Therapy (NPWT) with Vacuum-Assisted Closure (VAC) is an established adjunctive treatment option for open wounds that offers the ability to promote healing. However, there is limited evidence for its utility with active infections. Wounds that are acutely infected or that contain an adherent biofilm present a challenging problem (Kim et al 2015).

Wound VAC therapy involves cleaning the wound, applying a custom-fit foam to cover the wound, placing a transparent drape over the wound and adjacent skin, and attaching tubing to connect the foam to a VAC suction canister. NPWT is achieved with a pulling force supplied by the VAC suction canister. Typically, suction will remain at a constant pressure until the dressing is removed. Continuous VAC therapy was recently reported to be more effective than standard moist wound care in surgical site infection after ankle surgery (Zhou et al. 2015).

VAC therapy with instillations is a novel treatment option that provides the combination of negative pressure with intermittent instillation of a solution. Polihexanide (Prontosan®) is a modern antiseptic that combines a broad antimicrobial spectrum with low toxicity, high tissue compatibility, no reported adsorption and good applicability as solution, gel, ointment, foam and in wound dressing. Unlike other antiseptics, the antimicrobial efficacy of Prontosan® is not impaired in human wound fluid, human tissue or by high loads of blood or albumin. Furthermore, Prontosan® blocks the microbial attachment to surfaces and has been shown to effectively remove biofilms in vitro and in vivo (Hubner et al 2010).

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Patients who will be undergoing surgical management (including the use of NPWT therapy) of an infected lower extremity status-post open reduction and internal fixation (ORIF)

Exclusion Criteria:

* Pregnant females
* Incarcerated patients and those not able to give informed consent
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
* Failed compression therapy of at least 6 months' duration;
* Deep system venous reflux characterized by \>1 second reflux time;
* Presence of at least one target site within the target vessel.

Exclusion Criteria:

* Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
* Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
* Significant peripheral arterial disease with an ankle-brachial index of \<0.50 or with incompressible vessels;
* Acute deep venous thrombosis (DVT) within 3 months of consent;
* History of stroke within the last 6 months;
* Flow-limiting venous outflow obstruction central to the intended target sites;
* Insufficient inflow through the treatment vein upon manual augmentation;
* Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
* Chronic renal insufficiency with creatinine level of ≥2mg/dL;
* Hemoglobin level \<9.0 mg/dL;
* Platelet count \<50,000 or \>1,000,000 per mm3;
* Total white blood cell count \<3,000/mm3;
* Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
* Non-ambulatory patients;
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye

Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease.

Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 and Age \<=65.
2. complaint of DED symptoms for 6 months or longer at screening.
3. ocular surface disease index (OSDI) score of 25 or higher.
4. tear film breakup time (TFBUT) of 5 seconds or less.
5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
6. tCFS score of 4 or higher.

Exclusion Criteria:

1. History systemic autoimmune diseases and ocular/periocular malignancy.
2. Clinically relevant slitlamp findings or abnormal lid anatomy.
3. Active ocular allergies and active infection.
4. Pregnant or lactating women.
Effects of High Ventilation Breathwork With Retention (HVBR) on Health

The investigators are conducting a randomised-controlled trial comparing high ventilation breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min with brief retentions). The metric of 15b/min aligns with guidance from the British Journal of Nursing, Royal College of Physicians and Johns Hopkins Medicine which state that the average, healthy rate should range from: 12-20, 12-18 and 12-16b/min, respectively. The main questions the study attempts to address are: Does HVBR lead to improved state and trait mental health and wellbeing in a general population adult sample?

The study will be conducted entirely online through the research platform Prolific, so participant data will be anonymous. The investigators will collect self-reports of mental health and wellbeing before and after the three-week breathwork period, in addition to a follow-up three weeks later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Data on self-reported adherence to, and credibility/expectancy of, the breathwork will also be collected, along with participants' experiences to gauge the safety and tolerability of the breathwork protocol.


Eligibility Criteria:
Inclusion Criteria (self-assessed):

* Fluent in English and living in the UK
* Have access to headphones
* Comfortable with faster breathing and holding breath
* Willing to only practice breathwork in safe environment, lying down in soft area (i.e., bed, sofa, carpet/mat), and always away from water \& hard ground
* Willing to only practice the breathwork away from large meals (i.e., before or 1hour after) and bedtime (i.e., at least 1 hour before if practicing in evening)

Exclusion Criteria (self-assessed):

* Hypotension or hypertension (low or high blood pressure)
* History of respiratory or cardiovascular/heart problems or disease
* History of fainting or syncope
* Epilepsy or seizures
* History of panic disorder or panic attacks
* Cerebral aneurysm
* Have had problems with prior breathwork sessions (i.e., fainting)
* Pregnancy, think one might be pregnant, trying to get pregnant, or are breastfeeding
* Any problems which affect one's ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea)
* Any other physical/mental health conditions or current life events which impair or affect one's ability to engage in activities involving breath control
* Are taking any regular medication other than the contraceptive pill, including medications to reduce blood pressure (i.e., Ramipril or other ACE-inhibitors), beta blockers (i.e., Propranolol), antidepressants, anxiolytics or any other psychotropic medications
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder

The purpose of this clinical study is To verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Obsessive-Compulsive Disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis.
2. Severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale.
3. Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance).
4. Treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in 5.Sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic Lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response Prevention" of a minimum of 20 sessions with a documented lack of efficiency.

6.The ability to give written and informed consent.

Exclusion Criteria:

1. Co-morbid psychotic disorder according to DSM-IV criteria
2. Suicidal tendencies in the last 6 months
3. History of cerebral trauma
4. Clinically relevant internal or neurological disorder
5. Substance misuse or dependence in the last six months
6. Ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS
7. Participate in other clinical trial
8. The investigator and/or enrollment review committee, would preclude participation in the study
Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist

Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.

The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly.

The investigators conducted a prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia in consecutive elderly patients at a nursing home in Yubari during one year from 2009, with the results in a non-intervention group.

Eligibility Criteria:
Inclusion Criteria:

* The residents or an agent who understand the purpose of this study and give informed consent.

Exclusion Criteria:

* The residents contraindicated to vaccine
Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women.


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal
2. Subjects must qualify for one of the following categories (a or b):

   1. Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
   2. Equal or greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor

Exclusion Criteria:

1. One (1) or more osteoporotic vertebral fractures (T4 - L4)
2. BMD T-score at the lumbar spine or femoral neck less than -2.5
3. Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis