cyrilzakka/clinical-trials huggingface dataset:
Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus

This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus will make three study visits. At each visit, the will consume an orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams). Endothelial function will be assessed before and two hours after beverage consumption. Endothelial function will be measured as the change in pulse amplitude in response to reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results will be used to plan a randomized, placebo-controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects
* Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose \>125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin.

Exclusion Criteria:

* Women with a positive urine pregnancy test
* Body mass index \>35 kg/m2
* Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion).
* Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate.
* Treatment with an investigational drug within the last twelve weeks
* History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* Treatment with vitamin E, vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded.
* Recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis).
* Ongoing illicit drug use or alcohol abuse.
* Sensitivity/intolerance to dietary polyols.
Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)

This study will examine resting dopamine function as well as dopamine response in the brain as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI) patients.


Eligibility Criteria:
Inclusion Criteria:

* Non-penetrating TBI
* Age between 18-50 years old
* Admitted to a North Texas TBI Model Systems-affiliated rehabilitation facility within 16 weeks of injury
* Rated at Rancho VI Los Amigos Levels of Cognitive Functioning Scale of less than or equal to Stage V at the time of enrollment
* Disability Rating Scale total score \>/= 7

Exclusion Criteria:

* Central Nervous System disorder resulting in functional disability predating TBI
* Documented diagnosis of disease processes impacted by the dopamine system (e.g., Parkinson's Disease, clinician diagnosed Attention Deficit Hyperactivity Disorder, substance abuse/dependence (excluding marijuana, alcohol, tobacco), or schizophrenia)
* Pre-injury use of dopaminergic pharmaceuticals (i.e., methylphenidate, amantadine, or dopamine receptor blockers such as olanzapine or quetiapine)
* Documented contraindication to use of methylphenidate including allergy
* Uncontrolled epilepsy
* Pregnant
* Medical condition not compatible with use of Methylphenidate
* Recent diagnosis or therapeutic study using radiopharmaceuticals
* Contraindications to the use of Ioflupane
* Allergic to Iodine
Post-Operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis

The goal of this clinical trial is to investigate post-operative pain (PEP) in teeth with symptomatic pulpitis following Vital Pulpotomy Treatments (VPT) with Calcium Silicate Cement (CSC). The main questions it aims to answer are:

* Is the post-operative pain one week after VPT significantly lower than pre-operative pain in permanent molars with symptomatic pulpitis?
* How does post-operative pain in these teeth correlate with patient-related factors, such as age, gender, and painkiller intake?

Participants will:

* Undergo Vital Pulpotomy Treatment with Calcium Silicate Cement (MTA)
* Provide pain level assessments before VPT, immediately post-treatment, and at 24, 72 hours, and 1 week after treatment.

If there is a comparison group:

Researchers will compare the post-operative pain levels in teeth with symptomatic pulpitis undergoing VPT to assess its effectiveness in reducing pain compared to a control group not undergoing the treatment.

Informed Consent:

Volunteers or parents will receive detailed information about protocols, risks, and benefits. Informed consent was obtained in writing after providing subject information, and participants could withdraw voluntarily at any time.

Sample Size Calculation:

Sample size calculation, utilizing G. Power-3.1.9.2, aimed at relationship analyses with a 95% confidence level, α=0.05, effect size of 0.30, and theoretical power of 0.80, resulting in a minimum sample size of 108.

Treatment Procedure:

Vital pulpotomy, administered by experienced professionals, involved local anesthesia, rubber dam isolation, caries removal, pulp amputation, hemostasis, application of ProRoot MTA and glass ionomer, and permanent restoration. Pain scores, assessed using the modified Wong-Baker scale, were recorded pre-treatment, at 24 and 72 hours post-procedure, along with inquiries about painkiller usage.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 7 and 70 years
* The teeth with diagnosis of irreversible symptomatic pulpitis
* Permanent first and second molars with vital pulp
* PAI ≤ 2 with vital pulp. (Ørstavik D, Kerekes K, \&amp; Eriksen HM (1986) The periapical index: A scoring system for radiographic assessment of apical periodontitis Dent Traumatol 2(1) 20-34, https://doi.org/10.1111/j.1600-9657.1986.tb00119.x.)

Exclusion Criteria:

* Clinical or radiographic signs of a necrotic pulp
* The presence of a sinus, buccal tenderness, pathological mobility or evidence of pathology on a periapical radiograph
* Teeth with horizontal or vertical root fractures
* Swelling, acute endodontic, or periodontal abscess
* Insufficient tooth tissue for a restoration, teeth requiring a post
* Unable to give informed consent
* Contraindicated systemic disease
* Allergies the local anesthesia
* Antibiotics, biphosphonates, and corticosteroid intake during the 7 days before treatment.
* Pregnancy or breastfeeding.
* Patients who needed endodontic treatment on several teeth to avoid a potentially confused pain referral.
Prolonged Nightly Fasting in Fibromyalgia

The present randomized-controlled pilot trial will test the feasibility, acceptability, and preliminary efficacy of an 8-week prolonged nightly fasting (PNF) intervention protocol in 20 adults with fibromyalgia.

Aim 1: Evaluate feasibility and acceptability of the PNF intervention among participants with fibromyalgia.

Aim 2: Evaluate preliminary efficacy of PNF on pain severity and sensitivity, mood, sleep and inflammation.

Fibromyalgia is characterized by chronic widespread pain, sleep disturbance, fatigue, negative mood, and cognitive dysfunction. It is estimated about 4 million individuals in the U.S. are affected by fibromyalgia, which results in high disability, lost productivity, and poor quality of life. Various medications have been tested, but findings suggest only small therapeutic effects with high side effects. First line evidence-based psychosocial interventions, such as cognitive behavioral therapy, also yield only small to moderate treatment effects and they require specialized personnel. Thus, there is a dire need to develop a novel approach to manage fibromyalgia symptoms with a high safety profile, are affordable, and are easily implemented by participants without extensive guidance and support from specialized personnel.

Prolonged nightly fasting (PNF) which is a type of time-restricted eating with no or minimal caloric intake for periods of time as few as 12 hours has been shown to promote various health benefits. PNF has also been demonstrated to be highly acceptable and adherable for adults with various clinical condition. Although some dietary patterns have been explored for their impact on pain, the effects of PNF on pain-related outcomes (e.g., pain severity, pain sensitivity), mood, sleep, and inflammation among individuals with fibromyalgia have not been examined. The present randomized-controlled pilot trial will test the feasibility, acceptability, and preliminary efficacy of an 8-week PNF intervention protocol in 20 adults with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65
* female
* able to speak, write, and read English
* classified as having fibromyalgia based upon criteria established by the most up-to-date 2016 American College of Rheumatology (ACR) Criteria for Fibromyalgia
* has a smartphone.

Exclusion Criteria:

* history of eating disorders assessed by MINI Neuropsychiatric Interview
* self-report of chronic malignant pain (e.g., cancer, HIV) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus)
* current use of melatonin or an immunosuppressant medication (e.g., steroids)
* currently pregnant, trying to get pregnant, or breastfeeding
* plans to relocate within the next 6 months
* has diabetes mellitus
* currently trying to lose weight
* currently routinely fasting more than 12 hours a night
* works night shifts
Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.

A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors:

* Body mass index \[kg/m2, Fractional polynomials FP2\].
* Smoking \[Years, linear relationship\].
* Employment status \[3 categories\].
* Maximum education degree \[4 categories\].
* Previous performance of physical exercise \[2 categories\].
* Baseline disability (measured with the Shoulder Pain and Disability Index) \[Fractional polynomials FP2\].
* Baseline pain intensity (measured with a numeric pain rating scale) \[Fractional polynomials FP2\].
* Pain duration \[Weeks, linear relationship\]
* Pain catastrophizing (measured with the Pain Catastrophizing Scale) \[Linear relationship\].
* Patient's expectations (measured with the Musculoskeletal Outcomes Data Evaluation and Management System) \[Linear relationship\].

Eligibility Criteria:
Inclusion Criteria:

* Full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging.
* Pain during resisted abduction and/or external rotation.
* Pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the Shoulder Pain and Disability Index.
* Pain lasting for at least 3 months.
* Adequate comprehension of written and spoken Spanish

Exclusion Criteria:

* Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side.
* Suspected neck-related shoulder pain.
* Suspected visceral-related shoulder pain.
* Sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year.
* Humerus and/or scapular fractures within the last year.
* Previous rotator cuff repair surgery within the last year.
* Presence of cancer, fibromyalgia, neurological and/or other systemic diseases.
* Cognitive impairment that makes it impossible to perform therapeutic exercise.
Sensory Processing Skills in Toddler With Joint Hypermobility

shows that children and adults with joint hypermobility may be identified with common clinical problems that are unrelated, such as chronic fatigue, anxiety, and a range of gastrointestinal functional disorders \[4-6\]. Considering the relationship of joint hypermobility with joint muscle tone and posture, sensory processing skills may also be affected in individuals with hypermobility. No study in the literature examines the relationship between joint hypermobility and sensory processing. This study was planned to detect joint hypermobility as early as 12-14 months and to examine its relationship with sensory processing skills.


Eligibility Criteria:
Inclusion Criteria:

12-14 month old healthy children

-

Exclusion Criteria:

* they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.
An Educational HIV Pre-Test Counseling Video Program for Off Hours Testing in the ED: A Randomized Control Trial

This study compared the educational effectiveness of a ten-minute pre-test counseling video with the usual practice of a session with an HIV counselor.

HIV is increasingly affecting urban populations, making the inner city ED a prime venue for C\&T because of their unique opportunity to identify HIV positive patients. These underserved communities often use the ED for their regular health care specifically because it provides services outside of the usual weekday working hours. However, there are significant barriers to HIV C\&T in the ED, such as the lack of resources to provide prevention oriented messages, cost issues, and the feasibility of providing the required manpower for testing. The objective of this study is to determine whether an educational video, with the required pre-test counseling elements, conveys the necessary information for inner city ED patients to consent to a standard Elisa HIV test.

In order to address the HIV testing needs of the patient population presenting to the ED, innovative methods must be developed to provide HIV C\&T, while simultaneously removing the barriers to testing. Video technology may provide an opportunity to make HIV counseling feasible when counselors are not available.

Eligibility Criteria:
Inclusion Criteria:

* All patients awaiting UC treatment were approached for the study.
* Patients 18 years of age and older were included
* Patients who spoke English and Spanish were included.

Exclusion Criteria:

* Clinically unstable,
* Diagnosed with HIV
* Unable to understand the consent process because such patients require unique arrangements for consenting processes.
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy

The purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing elective distal pancreatectomy for pancreatic cancer .
2. ASA statusⅠ-Ⅲ.
3. 18 years to 80 years （adults）.
4. Able to understand, communicate and sign an informed consent form.

Exclusion Criteria:

1. Laparoscopic surgery.
2. Preoperative chemotherapy or radiotherapy.
3. Pregnancy.
4. Allergic to any drugs used during the study.
5. Long-term receiving β-blockers.
6. Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.
7. Abnormal coagulation functions (platelet count prior to surgery \<100000/ μL , APTT value is more than the normal value, INR \> 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery).
8. Complicated with severe heart disease (NYHA classification \>3), severe renal insufficiency (serum creatinine \>1.8mg/dL or receiving renal replacement therapy), severe hepatic disease (Child-Pugh classification=C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute infectious diseases (WBC\>10000/μL) before surgery.
9. BMI \> 35.
10. All contraindications to epidural block.
11. Chronic opiate medication/drug abuse.
12. Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.
13. Refuse to sign an informed consent form.
Program of Exercise, Diet and Control of Psychological Stress in Cancer Survivors

A program of exercise, diet and psycho-emotional support could improve some outcomes in cancer survivors.

Cancer survivors will be randomised to one of the following groups: a) Supervised physical activity, b) Supervised physical activity + Diet counseling, c) Supervised physical activity + Diet counseling + psycho-emotional support

Eligibility Criteria:
Inclusion Criteria:

* cancer survivors attending their follow-up visits

Exclusion Criteria:

* Cardiac disease NYHA II
* non-controlled hypertension
* non-controlled metabolic disease
* chronic infectious disease
* non-controlled pain
* risk of bone fracture
* severe anemia, leucopenia or thrombopenia
A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.

This Phase 2 multi-centre study will be performed by 6 Canadian sites. It is an open-label, single-arm study in patients with Idiopathic Pulmonary Fibrosis (IPF) aged 40 years and older.

The duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is an adult aged 40 years or older
2. Patient has signed written informed consent.
3. Patient has been diagnosed of IPF according to the most recent guideline on IPF diagnosis and management released by American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT).
4. Female patients of childbearing potential must have a negative urine pregnancy test and agree to use adequate birth control from screening throughout the study and for 30 days after the last study drug administration.
5. If a male patient has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last study drug administration.

Exclusion Criteria:

1. Patient has a known diagnosis of a respiratory disorder other than IPF.
2. Substantial emphysema on high resolution computer tomography (HRCT) with degree of emphysema greater than fibrosis.
3. Patient is an active smoker.
4. Patient has evidence of active infection.
5. Patients currently has or has a history of cancer, except basal cell carcinoma or squamous cell carcinoma of the skin.
6. Patient has a concurrent medical or psychological condition that, in the investigator's opinion, may compromise the patient's ability to participate in the study or give informed consent, or may complicate the evaluations of the study drug.
7. Patient is receiving another investigational treatment for IPF at screening and/or plans to receive an investigational treatment for IPF during the current study.
8. Patient has chronic hepatitis or significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.
9. Female patient who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.
10. Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.
11. Patient has participated in an investigational clinical trial during the last 4 weeks.
Evaluation of Efficacy of the Prototype RPC (Rapid Pulse Confirmation) Device in Detecting Return of Pulsatile Flow in Patients Preparing to Separate From CPB (Cardiopulmonary Bypass)

Effective chest compressions are essential to survival in an arrest patient receiving CPR (cardiopulmonary resuscitation). A challenge in providing effective chest compressions is frequent interruption of compressions. A major cause of a recurrent interruption of chest compressions is pulse checks. Pulse checks are difficult to quickly and accurately perform in the AHA recommended time interval of under 10 seconds for reasons ranging from inexperience to body habitus. Unnecessarily long pulse checks often delay reinitiating chest compressions leading to a fall in perfusion pressure to the coronary arteries lowering the chances of return of spontaneous circulation (ROSC). To potentially solve the issues of evaluating the chest compression effectiveness and minimize the time interval of pulse checks, the authors have constructed a novel device that can be rapidly applied to an arresting patient and evaluate the current state of the circulatory system. The device is called the Rapid Pulse Confirmation (RPC) device. It is designed to applied over a major artery (radial, ulnar, brachial, carotid, and femoral) and detect Doppler shift of red blood cells to gauge red blood cell velocity and rate of pulsation. Feasibility testing on the device was carried out using patients requiring cardiopulmonary bypass. Arrest and return of spontaneous circulation during cardiopulmonary bypass is predictable and provided an ideal environment to test the initial performance of a device meant to detect return of spontaneous circulation. The primary working hypothesis was that there would be no significant difference in time of detection of ROSC between the arterial line catheter and the RPC device at the end of cardiopulmonary bypass. The secondary hypothesis was that there would be no difference in pulse rate reading between the arterial line catheter and the RPC device.


Eligibility Criteria:
Inclusion: 1.18 or older 2.EF \>40% on pre-operative echocardiogram 3.Patient with isolated cardiac valve disease to be repaired during scheduled surgery Exclusion: 1.Redo procedure 2.Emergency procedure 3.Peripheral vascular disease 4.Previous cannulation or harvesting of radial artery 5.Arterial stents in the radial, ulnar, brachial, femoral, or carotid arteries 6.History of peripheral arterial bypass 7.History of carotid artery stenosis 8.Thoracic outlet syndrome 9.Valvular heart disease NOT being repaired day of surgery 10.Heart rhythm other than sinus prior to procedure (occasional PVC's ok) 11.Patient refusal