cyrilzakka/clinical-trials huggingface dataset:
Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase

The purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 \[rHuPH20\]) injection at the time of infusion set insertion compared to sham injection.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.
2. Non-smoking participants with Type 1 diabetes mellitus (T1DM) treated with insulin for ≥12 months. Nonsmoking means abstinence from cigarettes and cigars for 3 months and negative cotinine screening tests at screening.
3. Body mass index (BMI) 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive.
4. Glycosylated hemoglobin A1c (HbA1c) ≤10% based on local laboratory results.
5. Fasting connecting peptide of insulin (C-peptide) \<0.6 nanograms per milliliter (ng/mL).
6. Current treatment with insulin \<90 units per day (U/d).
7. Current use of rapid acting insulin analog.
8. Routine use of CSII as the primary route of insulin administration for at least 3 months prior to screening
9. Participants should be in good general health based on medical history and physical examination without medical conditions that might prevent the completion of study drug infusions and assessments required in the study protocol.

Exclusion Criteria:

1. Known or suspected allergy to any component of any of the study drugs in this study.
2. Previous enrollment in this study.
3. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia. Participants taking maintenance doses of blood thinners (for example, coumadin or heparin) will be excluded.
4. Use of any long-acting insulin injection within 72 hours of Study Day 1; participants will continue to refrain from use throughout the duration of the study (Phases I and II).
5. Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator.
6. Current addiction to alcohol or substances of abuse as determined by the Investigator.
7. Blood donation or phlebotomy (\>500 milliliters \[mL\]) within the previous 8 weeks of the Screening Visit(s) in this study.
8. Pregnancy, breastfeeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device \[IUD\], oral or injectable contraceptives, or barrier methods).
9. Symptomatic gastroparesis.
10. Receipt of any investigational drug within 4 weeks of Study Day 1.
The Effects of Sensory Stimulative Activities on Sleep Performance in Elderly Adults: A Single-case Design

Older adults have a high prevalence of sleep disturbances, which negatively and severely impact their health and quality of life. Research indicated that 43% elderly outpatients in Taiwan have used benzodiazepine, which collectively led to great medical expenditure. Non-pharmacological treatments are highly recommended as first priority for sleep disturbance in practice. Music interventions have been reported to modulate the sympathetic nervous system and to improve the elderly's sleeping performance. Proprioceptive interventions can also activate the parasympathetic nervous system, providing calming effects and significantly reducing anxiety, hyperactivity and agitation in various populations. However, the effects of these intervention on the sleep disturbances in the elderly remain unclear. The research purpose is to investigate the effects of two sensory activities that are easily executed in everyday life - auditory (e.g. listening to the music before sleeping) and proprioceptive (e.g. joint compression exercises) interventions on improving the sleep performance of the elderly. Subjective sleeping quality assessment (Pittsburgh Sleep Quality Index \& Insomnia Severity Index) and objective physiological records measured by actigraphy are used as outcome measures.

In this single-case designs study, we will recruit six volunteering elderly with primary insomnia and use A-B-A-C-A-D design for 9 weeks including the three periods of baseline phases for 1 week(A), the music intervention phase for 2 weeks(B), the proprioceptive intervention phase for 2 weeks(C) and the combination phase for 2 weeks(D). The main outcome measures include the objective sleeping quality measured everyday by the actigraphy recording the sleeping performance and physiological data during sleep, and the subjective sleeping quality measured every week via the Pittsburgh Sleep Quality Index and the Insomnia Severity. The secondary outcome measures, including the Center for Epidemiologic Studies Depression Scale, Geriatric Anxiety Scale - Chinese Version and WHOQOL-BREF, will be assessed weekly. The above results will present in visually analyzing graphed data to compare the performance among different phases and to evaluate the impacts of different interventions. This study will aim to preliminary investigate the feasibility and effectiveness of the music intervention, the proprioception intervention and the combination of both approaches on improving the objective sleeping performance and the subjective sleeping quality of the elderly.

Eligibility Criteria:
Inclusion Criteria:

1. have experienced insomnia (PSQI\>5 at screening;) for at least one month.
2. Over 65 years of age or older.

Exclusion Criteria:

1. psychiatric or neurological problems
2. a history of alcohol / drug abuse
3. Hearing impaired.
An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors

This trial studies the use of a special type of computed (CT) scan called dual energy CT in detecting gastrointestinal carcinoid tumors. CT is an imaging technique that uses x-rays and a computer to create images of areas inside the body. Dual energy computed tomography is a technique used during routine CT scans to help obtain and process the image after the scan is complete. Doctors want to learn if dual energy computed tomography can help improve the detection of carcinoid tumors during routine CT scans.

PRIMARY OBJECTIVES:

I. Evaluate prospectively the sensitivity and specificity of dual energy computed tomography (CT) in detecting primary gastrointestinal (GI) carcinoid.

OUTLINE:

Patients undergo one dual energy CT scan during scheduled CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Patients with: clinical features of carcinoid syndrome (or) increased serum and urinary markers suggestive of carcinoid (or) endoscopic biopsy proven carcinoid (or) metastases which are biopsy proven as carcinoid.
* Patient is scheduled to have a clinically indicated staging CT exam.
* Patients who have signed their informed consent form to undergo the study.

Exclusion Criteria:

* Patients who have already had their primary GI carcinoid resected.
* Contraindication to intravenous contrast agents (e.g. allergy, renal failure, dialysis, pregnancy etc.).
* Pregnant patients.
Improving Our Understanding of Suicidal Ideation in Cancer Survivors

The goal of this project is to assess the feasibility of collecting physiological and psychological data that will allow for preliminary investigation of predictors of suicidal ideation in an ambulatory cancer population already seeking psychosocial support.

Exploratory analyses will be the first step to establishing possible predictive relationships. The long-term goal of this research is to identifying an integrated model of suicidal ideation in cancer, so that providers will be better able to identify appropriate screening methods to target patients at high risk for suicide. This information will ultimately inform the development of psychosocial interventions that specifically address the variables that increase suicide risk in patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be male or female, aged 18 or older.
4. Ambulatory oncology patients at the University of Colorado Cancer Center who are being provided psychosocial support services; specifically, having had at least one in-person meeting with a doctoral level clinical/counseling psychologist or masters level social worker.
5. Valid and private email account.

Exclusion Criteria:
Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)

On the basis of published data and the investigators' results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, the investigators propose a study to test whether or not an antioxidant supplementation has a therapeutic interest for patients with FSHD. Their results have important implications for the successful implementation of rational antioxidant therapy in FSHD in which cell loss could be linked to oxidative stress.

This study will compare the effect of the therapeutic interest of an antioxidant supplementation on the functional deficits and the molecular muscle abnormalities into two groups of patients affected by FSHD, one treated with the antioxidant supplementation during 17 weeks. The antioxidant by capsule consisted of:Vitamin E (400 mg /day), Selenium (200 µg/day in the form of selenomethionine), Vitamin C (500 mg/day), Zinc (25 mg/day in the form of gluconate). The second one treated with a placebo during 17 weeks. Patients will be assigned to intervention groups by chance, and neither physician, nor patient, will know which product is administrated (study in "double blind").

Eligibility Criteria:
Inclusion Criteria:

* FSHD patients will be recruited on the basis of:

  * The number of repeat units (4 to 9)
  * FSHD patients with a positive family history for FSHD
  * Not confined to a wheelchair
  * No smokers
  * No associated co-morbidity (cardiac or pulmonary disease, diabetes etc.)
  * No Medications or nutritional supplementation (vitamins and/or antioxidants) at the time of the study
  * No HIV positive

Exclusion Criteria:

* No consent form
Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome

The purpose of this study is to investigate the effects of vibration stimuli to contra lateral neck muscles on Contraversive Pusher Syndrome, function and neglect in stroke patients.

12 post-stroke subjects will be recruited from neurological rehabilitation department at Loewenstein rehabilitation hospital, Raanana, Israel. The patients will be randomly assigned to one of two groups: 1) Experimental group. 2) Control group. The 2 weeks intervention (10 sessions) in each group will include vibration stimuli (frequency of 1 Hz and amplitude of 20 mm) for 20 minutes and structured standard physiotherapy for 45 minutes. The vibration stimuli in the experimental group will be done to the contralesional neck muscles, whereas the vibration stimuli in the control group will be done in the contralesional hand. Different assessments will be done before the intervention, after the first day of intervention, after two weeks of intervention and one months post-intervention. The tests will include: Clinical Scale for Contraversive Pushing, Lateropulsion Scale, Subjective Straight Ahead, Postural Assesment Scale for Stroke Patients, Anterior and Lateral Functional Reach Test, Posturography, Behavioral Inattention Test, Mesulam Cancellation Test, Line Bisection Test, Dynamic Starry Night and sensation.

Differences between groups will be calculated using t-tests or Mann-Whitney, depending on distribution of normality with corrections for multiple comparisons. Smallest Real Difference (SRD) will be calculated for detecting the minimal detectable change.

Eligibility Criteria:
Inclusion Criteria:

* First stroke
* Age 25-75 years
* Able to understand research instructions
* Stable clinical/metabolic state.
* Having Contraversive Pushing Syndrome, based on Clinical Scale for Contraversive Pushing.

Exclusion Criteria:

* Having previous neurological and orthopedic disability.
* Having pacemakers.
Continous Assessment of Cerebral Autoregulation With Near-infrared Spectroscopy

Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the context of changes in cerebral perfusion pressure. In this study, investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.

Near-infrared spectroscopy (NIRS) is a noninvasive technology that real-time monitors cerebral tissue oxygenation index (TOI). Investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation of hypertensive participants and non-hypertensive participants.

Eligibility Criteria:
Inclusion Criteria:

* health people, or people with hypertension

Exclusion Criteria:

* diabetes, anemia, liver disease, kidney disease.
Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia of the Alzheimer's type
* Males, and females who are surgically sterile or one year postmenopausal
* A primary caregiver willing to accept responsibility for supervising the treatment

Exclusion Criteria:

* Any condition (other than Alzheimer's) that could explain patient's dementia
* An advanced, severe or unstable disease that may put the patient at special risk
* Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease
HELP Pain Training Program

The aim of this project is to develop and test the Helping Educators Learn Pediatric Pain Assessment \& Intervention Needs (HELP Pain) program. HELP Pain provides training for school providers (e.g., school nurses, mental health professionals) on strategies to assess and manage pain-related concerns in school children. Participants will learn cognitive behavioral therapy techniques to help school children manage pain, and report on their use of strategies, and child's progress throughout the school year. Follow-up data will be collected in year 2.

Chronic pain is common among school children, and impacts social, emotional and academic functioning. School providers are often tasked with addressing student pain, but may have limited training in evidence-based pain management strategies. Thus, the PI developed a training program, HELP Pain, to train school providers, such as school nurses and mental health professionals, in cognitive behavioral therapy strategies for addressing student pain. In this study, the feasibility and acceptability of the training program will be evaluated. Provider knowledge will be evaluated before and after receiving the HELP Pain training. Further, the use of HELP Pain strategies with students and their associated disability and pain outcomes will be evaluated. Results will help to tailor the HELP Pain training program for future use.

Eligibility Criteria:
Inclusion Criteria:

* engaged as a school provider in Michigan
Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)

A Multicenter, Randomized Controlled Study About the Safety and Efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for Chronic Aortic Dissection . (GALLANT Study)

This study is a multicenter, prospective, superiority, randomized controlled trial about the safety and efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System. It is expected to complete the implantation of 204 patients in 15 centers within 24 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years old, no gender limitation;
* The patient was diagnosed with chronic aortic dissection after the repair of the main artery dissection, with distal tears required seal;
* The maximum diameter of the descending thoracic aorta is 3.5-5cm；
* The number of thoracic descending aorta tears is ≤2, and the maximum diameter of the tears is 2-30 mm；
* With appropriate artery approaches, endovascular treatment can be performed；
* Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.

Exclusion Criteria:

* Rupture or threatened rupture of aortic dissection;
* Proximal type I internal leakage after aortic repair;
* New distal SINE;
* Abdominal aortic dissection aneurysm diameter ≥5 cm;
* The edge of the tear from the opening of celiac trunk is\<4 mm;
* The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.);
* Acute systemic infection;
* History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
* Cardiac function Grade IV (NYHA rating) or LVEF \&lt; 30%;
* Hematological abnormalities: leukopenia (WBC \&lt; 3×10\^9/L), anemia (Hb \&lt; 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count \&lt; 50×10\^9/L);
* Renal insufficiency: serum creatinine \&gt; 150 umol/L (or 3.0 mg/dL) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis;
* Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times;
* Allergic to contrast agents, anesthetics, patchs, and delivery materials;
* Pregnant or breastfeeding;
* Participated in clinical trials of other drugs or devices during the same period;
* Life expectancy is less than 12 months (such as advanced malignant tumors); Investigator judged that not suitable for interventional treatment.
The Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment inpatients with Hp eradication failure.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients with previous Helicobacter pylori eradication.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, bismuth and antibioticsin the previous 4 weeks.
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.
Evaluation of Cytidine Deaminase for Patient Suffering of a Myelodysplastic Syndrom or an AML Treated by Azacytidine

Myelodysplastic syndrome (MDS) is a group of medical conditions derived from progressive bone marrow failure that result in ineffective production of blood cells. Depending on the severity, MDS reduces the quality of life to the point of being life-threatening. There is a probability of death at all stages of the disease, due to complications and co-morbidities, with progression to acute myeloid leukemia (AML) being the worst evolution. Azacytidine is a nucleosidic analog with original epigenetic mechanism of action that is widely used for treating a variety of myelodysplasic syndromes. Although generally well tolerated, severe and sometimes life-threatening toxicities were unexpectedly observed in some patients. Genetic polymorphism affecting cytidine deaminase (CDA), the liver enzyme responsible for azacytidine detoxification step, could be responsible for poor clinical outcome due to on the one hand to severe toxicities in deficient patients, and on the other hand on treatment failure in ultrametabolizer patients.This clinical study aims at correlating the values in CDA levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patients have to be capable of submitting themselves at the rate of the visits, in the plan of treatmen, in the balance assessments of laboratory and other procedures of the study.
* Patient treated by azacytidine

Exclusion Criteria:

* Patients having an infection unchecked who could compromise the participation in the study
* Patients having other grave and/or unchecked concomitant diseases which could compromise the participation in the study
Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment

This study aim to investigate the effects of back care pillow, in adjective with standard physical therapy treatment for chronic non-specific low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Males or females
* Age 20 - 69 years old.
* Patients who have daily routine in so long bending of sitting or standing position at least 2 hours per day
* Patients with low back pain who have pain for more than 3 months
* Patients have pain at lower back without refer to leg
* Patients have moderate to severe pain of numerical rating scale (pain score ≥ 4)

Exclusion Criteria:

* Pregnant patients
* Underlying systematic or visceral disease, and specific condition such as neoplasm, ankylosing spondylitis, previous low back surgery
* Patients have Quada equine syndrome
* Patients with nerve root symptoms (neurological deficit)

  1. Patient have refer pain to leg area of same dermatome is problem.
  2. Abnormal reflex of lower extremity.
  3. Muscle weakness of area myotome is problem.
Supine Position for Colonoscopy Insertion

The purpose of this study is to determine whether the supine position is better than the left lateral horizontal body position to decrease cecal intubation time, patients' pain and the difficulty of colonoscopy insertion.

Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence has demonstrated its efficacy and advantages. Left lateral position for insertion, which results in air rising away from the left colon and producing acute bends in the sigmoid,might increase the risk of colonoscopy loop formation.When there is difficulty advancing the colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we perform a randomized controlled trial to compares supine position with left lateral position for the safety and efficacy of colonoscopy insertion.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 18-75 years
2. underwent screening, surveillance, and diagnostic colonoscopy

Exclusion Criteria:

1. \<18 or \>75 years old
2. major psychiatric disorders, colonic resection, pregnancy, presence of any contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)
3. Patients with severe cardiopulmonary and renal disease
4. Patients who are unwilling or unable to consent