cyrilzakka/clinical-trials huggingface dataset:
Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data

This study intends to establish an automatic system for screening on children with congenital heart disease, the system include the auscultation of cardiac murmur and the test of oxygen saturation, the data was analyzed based on the cloud computing.

This study intends to establish a system for screening of children with congenital heart disease,with the combination of cardiac auscultation , the test of oxygen saturation, the use of cloud computing and data base. The investigators decide to do this project from three main points.1:How to establish a data-base system? 2:How to get heart sound signal? 3.How to analyze so many signals?

Eligibility Criteria:
Inclusion Criteria:

* Neonatal ward patients
* Patients with echocardiography reports

Exclusion Criteria:

* Severe pneumonia
A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Has been diagnosed with type 2 diabetes mellitus
* Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
* Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
* Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening
* Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:

  * Hormone replacement therapy (female subjects)
  * Oral contraceptives (female subjects)
  * Antihypertensive agents
  * Lipid-lowering agents
  * Thyroid replacement therapy
  * Antidepressant agents
  * Drugs known to affect body weight, including prescription medications (e.g. orlistat \[XENICAL®\], sibutramine \[MERIDIA®\], topiramate \[TOPAMAX®\]) and over the counter antiobesity agents

Exclusion Criteria:

* Has ever been exposed to exenatide (exenatide once weekly \[exenatide LAR\], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
* Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
* Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:

  * Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
  * Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
  * Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
  * Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
Psychosocial Factors and Cardiovascular Disease

To evaluate the role of psychosocial factors in the development of hypertension and cardiovascular disease.

To estimate the prevalence of masked hypertension and its potential role in the development of subclinical cardiovascular disease To compare the reliability of office blood pressure (BP), home BP and ambulatory BP, and their associations with subclinical cardiovascular disease

DESIGN NARRATIVE:

The studies had several interrelated themes. One was to explore the relationships between environmental stress and blood pressure over a range of time courses, with acute laboratory studies at one extreme, and long- term prospective studies at the other. The basic model of stress included three elements: the objective nature of the stressor, the individual's perception of it, and his or her physiological susceptibility. This model incorporated elements of the Karasek Job Strain model and the Frankenhaueser effort-distress model, with two components corresponding to demand and control. A third dimension was social support. These models were tested under both laboratory and field conditions. Blood pressure was the main dependent variable, together with structural changes in the heart and carotid arteries. Five projects were included. Project l evaluated the ability of ambulatory blood pressure, and blood pressure variability, to predict cardiovascular morbidity, and also included a cross-sectional study comparing the relationships between blood pressure and target organ damage in Black and white individuals. The hypothesis that white coat hypertension is a condition associated with lower risk than sustained hypertension was also tested. Project 2 (the Work Site Blood Pressure Study) prospectively evaluated the effects of job strain and social support on blood pressure and other outcome variables in a working population. Project 3 studied psychosocial and hormonal factors influencing diurnal variations of blood pressure in women, including the changes associated with menstruation and the menopause. Project 4 (the Masked Hypertension Study) assessed the prevalence of masked hypertension (normal BP in the clinic setting, but elevated BP in one's usual environment) and its association with subclinical cardiovascular disease (CVD); \~50% of the sample was re-evaluated an average of 6 years later. Project 5 (Improving the Detection of Hypertension) had repeat assessments of clinic BP, home BP and ambulatory BP in order to evaluate the test-retest reliability of each, and compare their associations with subclinical CVD.

The study was renewed in FY 1998, FY 2003 and in FY 2009 to continue follow-up and analysis.

Eligibility Criteria:
Employed screening blood pressure \<=160/105 mmHg not taking antihypertensive medication no evidence of secondary hypertension no history of cardiovascular disease (myocardial infarction, stroke, heart failure, peripheral vascular disease).
Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Male or female subjects 12 years of age or older
* Documented history of season allergic rhinitis to mountain cedar pollen
* General good health
* Other criteria apply

Exclusion Criteria:

* History of physical findings of nasal pathology (within 60 days prior to screening visit)
* Participation in any investigational drug study 30 days preceding screening visit
* History of respiratory infection/disorder with 14 days preceding screening visit
* Use of any prohibited concomitant medications
* Other criteria apply
Melanil in the Treatment of Melasma

The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group will receive treatment with Hydroquinone (2%). The estimated number of subjects to be recruited and randomized for the study is 150. The primary outcome measure: Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and 54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Melasma
* Fitzpatrick's skin types I to IV
* Signed informed consent
* Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc).

Exclusion Criteria:

* Fitzpatrick's skin types V and VI
* Treatment with steroids within the duration of the clinical trial.
* Oral contraception within the duration of the clinical trial
* Usage of other cosmetics within the duration of the clinical trial
* Treatment with Clofazimine within the duration of the clinical trial
Reducing Hypotensive Anesthesia Use with TXA During Orthognathic Surgery

This prospective study will analyze the need for deliberate hypotensive anesthesia (DHA) during orthognathic surgery when tranexamic acid (TXA) is administered. DHA has been proven to be effective although it comes with multiple risks related to organ hypoperfusion including kidney injury, stroke, and cardiac ischemia. Therefore, it may be potentially safer for patients to avoid deliberate hypotensive anesthesia if TXA alone adequately controls blood loss and provides adequate surgical site visualization.

Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. Patients will be evaluated for the following variables: sex, age, weight at time of surgery, preoperative hemoglobin, and preoperative hematocrit. Patients will be included if they are undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. All patients treated with orthognathic surgery already are provided 1g of TXA perioperatively and this will be continued through this study. All patients will be treated with 1g of TXA perioperatively and the anesthesia team will be instructed to limit deliberate hypotensive anesthesia unless otherwise directed by the surgeon. Perioperative and post-operative measurements will include: estimated blood loss, pre and post-operative hemoglobin, pre and post-operative hematocrit, average mean arterial pressure throughout the case (MAP), maximum MAP (excluding induction and emergence), minimum MAP (excluding induction and emergence), total MAP time under 65 mmHg, length of procedure, and surgeon evaluation of visual field throughout the procedure utilizing Fromme's ordinal scale. Based on these factors, it will help determine the need for deliberate hypotensive anesthesia during orthognathic surgery when tranexamic acid is administered.

Eligibility Criteria:
Inclusion Criteria:

* Bimaxillary orthognathic surgery completed at UAB Highlands Hospital

Exclusion Criteria:

* History of hypertension or previously diagnosed cardiac problems
* Bleeding diathesis
* TXA medically contraindicated
Use of "Smart Wheelchairs" to Provide Independent Mobility to Visual and Mobility Impairments

The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (but do not have a mobility impairment) with several single-case studio involving individuals who have a visual and mobility impairment. Our long-term objective is to provide independent mobility to veterans with mobility and sensory impairments.

There are currently very few mobility options for veterans who have a mobility impairment and visual impairment, and this population will grow as the number of older veteran's increases. The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (and may or may not have a mobility impairment) with several single-case studies involving individuals who have a visual and mobility impairment.

The key questions that will be addresses by the proposed research are:

Can smart wheelchair technology improve performance on realistic navigation tasks for individuals with visual and mobility impairments?

Will smart wheelchair technology increase the amount of independent travel by individuals with visual and mobility impairments?

Will using a smart wheelchair for an extended period of time diminish a person's ability to operate a "traditional" wheeled mobility aid?

Eligibility Criteria:
Inclusion Criteria:

* All participants will be completely blind
* Participants will be able to operate a power wheelchair with joystick control
* Participants will be able to push a manual wheelchair a minimum of 300 yards

Exclusion Criteria:

* Mobility impairment
Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails

To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation.

From August 2007 to January 2012, 32 patients undergoing surgery for medial humeral epicondyle fractures in our hospital were randomized into group A (traditional Kirschner wire) or group B (absorbable cartilage nail). The same surgical team performed the operations, and patients were followed for over a year. Group A had open reduction with K-wire fixation, and group B was fixed with absorbable cartilage nails. The Bede scoring system was used to evaluate elbow function at follow-up.

Eligibility Criteria:
Inclusion Criteria:

* fractures with more than 2 mm of displacement were treated with cast immobilization

Exclusion Criteria:

* fractures with less than 2 mm of displacement were treated with cast immobilization
A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)

This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as essential hypertension -

Exclusion Criteria:

* Patients with secondary hypertension or suspected of having secondary hypertension.
* Patients suspected of having malignant hypertension
* Patients with any serious diseases or symptoms
Early Stockholm Obesity Prevention Program

To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.

Early STOPP project wants to promote good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study.

Background Life is in constant change and affects our habits. In many ways this is positive but it also contributes to less favorable health factors. For example, take the car instead of cycling, take the lift instead of the stairs. This makes us less active in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children.

Good treatment methods for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is.

In Early STOPP project we study food, physical activity and sleep habits in the families with a little child. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured.

Eligibility Criteria:
Inclusion Criteria:

* one obese or two overweight parents, 1 year old child

Exclusion Criteria:

* weight effecting diseases
Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)

The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment.


Eligibility Criteria:
Inclusion Criteria:

* Received kidney transplant at least 3 months prior to study enrollment
* Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs
* Receiving MMF for at least 1 month prior to enrollment

Exclusion Criteria:

* Patients with any known hypersensitivity against mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also summary of product characteristics of EC-MPS)
* If applicable, GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea)
* Acute rejection \< 1 week prior to study enrollment

Other protocol-defined inclusion/exclusion criteria may apply.
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain

The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.

Hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small number of analgesics have been studied in children. The benefits to the subjects include contribution of knowledge that will provide for appropriate dosing regimen recommendations for future pediatric subjects.

Treatment consisted of both parenteral and oral hydromorphone. For up to 48 hours immediately following surgery, subjects were administered hydromorphone by IV PCA pump. Dosing with the oral hydromorphone HCl began when the subject was ready to take clear oral liquid. Subjects were administered oral hydromorphone HCl every 6 hours for up to 9 doses. The investigator determined the timing of the first dose based on each subject's clinical condition.

The duration of the treatment phase was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period).

Efficacy was based on the oral hydromorphone treatment. Adverse events were collected for both the oral and parenteral treatments.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects aged 28 days to 16 years,
* Prospective subjects anticipated to have postoperative pain requiring oral opioid analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours),
* Prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery.

Exclusion Criteria:

* Prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve,
* Prospective subjects who have received opioid analgesic therapy other than hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone,
* Prospective subjects who have received regional anesthetic blockade OR analgesic treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone.

Other protocol-specific inclusion/exclusion criteria may apply.
Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel

This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.

Magnetically controlled capsule endoscopy (MCE) has been widely used in clinical practice for upper gastrointestinal (UGI) tract and Small Bowel. However, the complete visualization of UGI tract still present challenges due to rapid transit through esophagus and duodenum, although technical improvements of MCE are helpful.

Detachable String MCE (DS-MCE) can control the movement of MCE through the string and MCE can start next examination after string detachment, which was proved to be an effective and safe method for complete viewing of the esophagus and stomach. In order to improve the duodenum visualization, endoscopist separate MCE from the string after finishing UGI examination so that can inspect the esophagus, stomach and duodenum under the string and magnetic field control.

This is a prospective, single-centered, self-controlled pilot study. Subjects with or without digestive symptoms receiving UGI endoscopy will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged 18 to 80
2. With or without gastrointestinal complaints
3. Scheduled to undergo a capsule endoscopy for both stomach and small bowel
4. Signed the informed consents before joining this study

Exclusion Criteria:

1. Pacemakers or electromedical devices implanted which are incompatible with magnetic field;
2. Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention;
3. Scheduled magnetic resonance imaging examination before excretion of capsule;
4. Pregnancy or suspected pregnancy;
5. Any contraindications about EGD.
6. Other circumstances that doctors consider inappropriate for the study.