cyrilzakka/clinical-trials huggingface dataset:
Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study

The purpose of this 2-group, randomized, controlled trial is to evaluate the refined SystemCHANGE™ against attention control patient education in CKD patients taking RAAS medications.

In this study, the investigators will test a refined SystemCHANGE™ in patients taking RAAS inhibiting medications. Participants will be recruited from two sources: 1) the largest and most comprehensive health care system in the state and 2) one of the largest essential health care systems in the country. Data are collected at baseline, 8 weeks (immediately post-intervention), and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* prescribed at least 1 daily RAAS inhibiting medication
* CKD diagnosis estimated glomerular filtration rate (eGFR) category G1 to G4
* RAAS inhibiting medication adherence of \<.85 documented during the screening phase
* proteinuria defined as a urine Protein-to-Creatinine ratio \> 150 mg/g or urine Albumin-to-Creatinine ratio \>30mg/g
* able to speak, hear, and understand English determined by the ability to participate and comprehend conversation about potential inclusion in the study
* self-reported ability to open a pill cap
* able to self-administer RAAS inhibiting medications
* willing to use a study phone
* has no cognitive impairment as determined by a score of 4 or greater on the 6-item Telephone Mental Status Screen Derived from the Mini-Mental Status Exam (cognitive screener)
* has no other diagnoses that may shorten life span, such as metastatic cancer
* is not currently hospitalized
* receives care through two approved health care systems

Exclusion Criteria:

* Participants with kidney failure defined by GFR \<15 mL/min/1.73
* Participants will be excluded if they are receiving dialysis or have dialysis access placed (e.g. graft or arteriovenous fistula) in anticipation of starting dialysis.
* Kidney and kidney-pancreas transplant recipients will be excluded.
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas

The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.

The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition and characteristics and to investigate the effect of both high 2-palmitic vegetable oil and oligofructose in infant formula on stool softness and bacteria. Because some studies demonstrate the benefit of high concentrations of a non-digestible carbohydrate in the formula, we will study 2 concentrations of added oligofructose.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, term (no less than 37 weeks, 0 days and no greater than 42 weeks, 0 days) singleton infants, between 7 days and 14 day post natal age
2. Weight for age ≥5th percentile according to Filipino growth tables/charts.
3. HM infants were exclusively consuming and tolerating HM
4. Mother must have made the decision to continue to exclusively breastfeed.
5. Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula
6. Parent/guardian must have previously made the decision to continue to exclusively formula feed

Exclusion Criteria:

1. Infants who are receiving any amount of supplemental HM with infant formula feeding or visa versa
2. Infants who are receiving any infant formula containing pro- or prebiotics
3. Family history of siblings with documented cow's milk protein intolerance/allergy
4. Conditions requiring infant feedings other than those specified in the protocol
5. Major congenital malformations (e.g. cleft palate, hemangiomas, extremity malformation)
6. Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus, cytomegalovirus)
7. Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases
8. Infants who have received any experimental treatment, participated in any other clinical trial, or received any other investigational intervention unrelated to this trial, prior to enrollment
9. Infants of any ancillary personnel connected with the study or the infants of first and second-degree relatives (parents, brothers, sisters, children, or grandchildren) of ancillary personnel
10. Presently receiving or have received any medication(s) which are known or suspected to affect fat digestion, absorption and/or metabolism (e.g., pancreatic enzymes), any vitamin and/or mineral supplements which contain calcium, all antibiotics and antifungal medications (except topical), suppositories, bismuth-containing medications, herbal supplements, or medications which may neutralize or suppress gastric acid secretion
11. HM-fed infants whose mothers are presently receiving or have received any antibiotics or antifungal medications (except topical), post partum
Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia.

The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia (stating the date of birth) and second if desflurane is non-inferior in the occurrence of airway complications compared to sevoflurane or total intravenous anesthesia with propofol in the setting of laryngeal mask airway.

Eligibility Criteria:
Inclusion Criteria:

* Planned anesthesia with use of LMA (laryngeal mask airway)
* Planned duration of anesthesia between 0.5 and 2 hours
* Age between 18-75 years
* Both gender
* Body mass index (BMI) \<35
* ASA 1-3
* Written informed consent prior to study participation

Exclusion Criteria:

* Planned additional regional and local anesthesia
* Contra-indication for the use of a laryngeal mask airway
* Asthma
* COPD IV
* Known allergy or hypersensitivity to any drugs administered during this study
* Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
* Participation in a drug or device trial within the previous 30 days.
* Patients legally unable to give written informed consent.
* Patients with severe psychiatric disorders
* Recent (\<6 months) history of alcohol or drug abuse
* Patients with severe neuropsychiatric disorders
* Non-fluency in German language
A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls. In addition, secondary and exploratory objectives were to assess medication adherence, healthcare utilization and costs, and patient-reported outcomes.

This was a phase 4, open-label, prospective, pragmatic clinical trial to assess the difference between all-cause hospitalizations in participants using Abilify MyCite (for Months 1-3, then prohibited for Months 4-6) versus virtual matched controls from baseline to Day 180. Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which was oral aripiprazole or any other product). Eligible participants entered a screening period of up to 13 days. For participants enrolling into the study, those not on aripiprazole at screening used the screening period for conversion to aripiprazole from other antipsychotics. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.

After the visit at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) could have been initiated per the joint decision of the participants with their study physician; participants in this second, optional interventional period were to have a visit at Day 360. During this second, optional interventional period, participants may have started and stopped Abilify MyCite as clinically indicated.

A parallel exploratory study that would utilize a different set of physicians and participants from the main study was planned; however, that study was never initiated.

Eligibility Criteria:
Inclusion Criteria:

* Participants are actively enrolled in an Anthem-affiliated commercial, Medicaid, or Medicare health plan with medical and pharmacy benefits.
* Participants must have a smartphone with data plan.
* Participants currently prescribed aripiprazole, or appropriate for aripiprazole treatment.
* Participants must have a current diagnosis of SCH, BP1, or MDD.

Exclusion Criteria:

* Any participant who participated in another clinical trial within 30 days of enrollment into the current study.
* Females who are breast-feeding and/or who are pregnant at the time of study enrollment, or who plan to become pregnant during the study.
* Participants who are currently being treated with a long-acting injectable antipsychotic.
Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.


Eligibility Criteria:
Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18-65
4. In good general health as evidenced by medical history or diagnosed with \<specify condition/disease\> or exhibiting \<specify clinical signs or symptoms or physical/oral examination findings\>
5. Fasting glucose \>5.6 and\<7.0 mmol/L and/or HbA1C \>5.6 and \<6.5 %
6. Ability to take oral medication and be willing to adhere to the \<study intervention\> regimen
7. Females currently on hormone replacement therapy (HRT) can participate in the study if they have been on HRT for at least 6 months and will continue to be on HRT during the study.
8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
9. Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria

1. Treated or untreated diabetes
2. 19\>BMI\<40.0 kg/m2
3. Blood pressure (BP) ≤ 150mmHg systolic and ≤ 95 mmHg diastolic
4. Current use of medications or antioxidant vitamins or supplements that would impact dependent variables, including glucose metabolism.
5. Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, hematological-oncological disease and free of recent infection (prior 2 weeks)
6. Pregnancy or lactation
7. Treatment with another investigational drug or other intervention within 1 year.
8. Current smoker or tobacco use within the past year.
9. Disqualifying findings on physical examination include cardiac murmurs, diminished pulses or the presence of bruits in the lower extremities, lower extremity thrombophlebitis, evidence of peripheral neuropathy, paresis or edema.
Assessment of the Prevalence of Lysosomal Acid Lipase Deficiency in Patients Waiting for a Liver Transplant.

Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked to decrease enzymatic activity of LAL, responsible for intracellular accumulation of cholesterol esters and triglycerides.

The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty liver, hepatic fibrosis that can evolve up to cirrhosis.

LAL deficiency is responsible for significant morbidity and early mortality in children, adolescents and adults in connection with a multi visceral disease reaching the liver, gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for the synthesis of the LAL.

The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto blotting paper .

Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.

Inclusion period of 12 to 18 months (100 patients).


Eligibility Criteria:
Inclusion Criteria:

* patients registered on the liver transplant waiting list.
* patients with cryptogenic cirrhosis, NASH

Exclusion Criteria:

* Patients without metabolic syndrome clinical, biological or radiological.
A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.


Eligibility Criteria:
Inclusion Criteria:

* Children of 6 month to \<36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.

Exclusion Criteria:

* History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.
Clinical Decision Support for Women With a History of Gestational Diabetes

The investigators hypothesize that computer-assisted decision support will increase the percentage of women with a history of gestational diabetes who receive appropriate follow-up screening.

Specific Aim 1: Develop an algorithm to identify cases of gestational diabetes among patients in the Partners Health Care system using administrative and laboratory data.

Specific Aim 2: Assess primary care provider knowledge, attitudes, beliefs, and barriers to compliance regarding screening guidelines for women with a history of gestational diabetes.

Specific Aim 3: Test whether a computer-assisted decision support tool to identify patients with a GDM history and prompt screening will increase compliance with guidelines. The investigators hypothesize that decision support will significantly increase in the percentage of women screened.

Approximately 5 percent of women are diagnosed with gestational diabetes (GDM) during pregnancy. These women face an increased risk of progression to type 2 diabetes1 and may benefit from lifestyle interventions and screening to detect early disease. However, studies have shown that less than half of women are screened appropriately in the postpartum period. This performance gap may reflect both lack of communication between obstetric and primary care providers and lack of knowledge of appropriate screening guidelines. The investigators plan to assess a quality improvement initiative, using administrative and clinical data, to identify women with a history of GDM and implement decision support to enhance quality of care.

Eligibility Criteria:
Inclusion:

* Primary care clinic (gynecology, internal medicine, community health center)
* Use longitudinal medical record (LMR) program for documentation
* Previously participated in rct of decision support intervention

Exclusion:

* None
Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive People With Obesity

Whole Body Vibration Therapy (WBVT) has been identified as a useful tool to increase peripheral blood flow. The present study aimed at how dynamic exercises with WBVT immediate effect on hemodynamic response and fatigue parameters in patients with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between age 18-65 with Body Mass Index (BMI) of \>29.9 kg/m2

Exclusion Criteria:

* Unstable hypertensive patients
* History of cardiovascular, neurologic, or orthopedic diseases,
* Presence of knee prosthesis, hip replacement
* Chronic inflammatory disease,
* Anti-inflammatory treatment
* Cognitive impairments
* Pregnancy.
The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study

The goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity. Ultimately such a newly derived test would allow treating physicians to start pre-emptive therapy early, with the goal of achieving remission quickly and with a shorter duration of treatment; identify individuals who will have less severe flares and will thus require less aggressive treatments; or intensify and lengthen treatment for those individuals who will need such therapy.

The design of this study is to follow individuals with a known diagnosis of SLE for changes in disease activity during the course of one year of observation. Clinical data and blood and urine samples will be collected at scheduled monthly visits. The clinical data and blood samples will be used for identifying gene expression profile(s) that are associated with increases in SLE disease activity (lupus "flares").

This study is currently enrolling individuals who have an established diagnosis of SLE to participate. There is no cost to volunteers who participate and the study pays for the visits to the clinics for monthly collection of clinical information and blood and urine samples. Women who are or become pregnant may participate in the study with the recommendation of their health care providers and the study doctors.

Eligibility Criteria:
Inclusion Criteria:

* Individual has met the diagnostic criteria for SLE (at least 4 out of the 11) American College of Rheumatology (ACR) criteria and:
* Has experienced specific manifestations of lupus disease activity within the last 12 months including the following:

  * Lupus nephritis (kidney disease); vasculitis and or central nervous system involvement and/or:
  * Required treatment with at least 20 mg per day of prednisone (or equivalent) and/or:
  * Required hospitalization directly due to SLE disease

Exclusion Criteria:

* Subjects unable or unlikely to cooperate with the procedures of the protocol
* Substance abuse / dependence that in the opinion of the investigator could compromise the subject's ability to complete the study
* Subject with a more dominant autoimmune disease, e.g. Rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, scleroderma
* History of malignancy within the last five years with the exception of basal cell carcinoma
* Active infection: Known HIV positive status, currently active tuberculosis , active infection receiving antibiotics
* Had tissue or organ transplantation (including bone marrow)
* On chronic hemo- or peritoneal dialysis
The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony

Patient-ventilator asynchrony is known to frequently occur during lung protective ventilation in patients with ARDS. Previous clinical studies showed that patient-ventilator asynchrony was associated with worse outcome in ICU. Therefore, strategies to reduce patient-ventilator asynchrony need to be established promptly. Several asynchronies, e.g., breath stacking are caused by vigorous spontaneous breathing effort. Recently, the investigators' group found that higher positive end expiratory pressure (PEEP) reduced the intensity of spontaneous breathing effort of in severe ARDS model (rabbits, pigs) and patients with ARDS. Thus, the investigators conjectured that higher PEEP may reduce the intensity of spontaneous breathing effort and thereby reduce patient-ventilator asynchrony during protective ventilation strategy, compared with lower PEEP in patients with ARDS.

The cross-over study will enroll 10 participants fulfilled with the criteria of Berlin definition of moderate-to-severe ARDS and under mechanical ventilation in intensive care unit (ICU) at Osaka University Hospital. Informed consent will be obtained by legal representatives. After obtaining informed consent, participants will be randomly assigned to one of two groups: "higher PEEP - lower PEEP" or "lower PEEP - higher PEEP". PEEP, either higher or lower, will be set according to higher or lower PEEP/FIO2 table. The depth of sedation will be monitored quantitively and maintained to be the same throughout the protocol. The intensity of spontaneous breathing activity will be assessed with esophageal balloon manometry and electrical activity of diaphragm. At each PEEP setting, asynchrony index will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≧ 18 years old
2. Patients with moderate to severe ARDS under mechanical ventilation＊ ＊ Definition of moderate to severe ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 200 mmHg with PEEP ≧ 5 cmH2O)

Exclusion Criteria:

1. Lack of informed consent
2. Continuous neuromuscular blockade at enrollment
3. DNR (do-not-resuscitate)
4. Moribund patient not expected to survive 24 hours
5. Massive hemoptysis
6. Increased intracranial pressure (\> 18 mmHg)
7. Existence or high risk of pneumothorax
8. Known pregnancy
9. Actual body weight exceeding 1 kg/cm
10. Patient judged to be inappropriate for the trial by intensivist
Efficacy of Postural Reeducation in Elite Gymnasts With Back Pain

Introduction: Low back pain is a musculoskeletal disorder that is associated with symptoms such as pain, limitation of joint range and postural problems in athletes. Methods: The study design is a randomized controlled clinical trial with a minimum of 35 elite gymnasts with back pain. Two postural treatments will be implemented, Mezieres Method and Isostretching to verify if there is improvement of back pain in gymnasts and to compare both procedures. Discussion: This trial could generate a greater understanding of the importance of posture related to low back pain and its possible treatments.

A randomized controlled clinical trial with two groups (intervention and placebo) will be implemented. The intervention group will have the Mezieres technique as postural treatment while the placebo group will follow a total of 6 isostretching positions.

In total, the two treatments with 30 minutes and duration or with a frequency of 2 weekly sessions will be implemented for a period of 12 weeks. All treatments will be performed by the same certified therapist and with a minimum of 5 years of experience in postural treatments. The measurements will be made immediately after the first session, in 2 weeks, 6 weeks and in the last week of intervention by a blind researcher who did not participate in the treatments, but with experience in this field.

Eligibility Criteria:
Inclusion Criteria:

* Elite gymnastic athletes with low back pain
* Active participation in the national competition
* Practice at least three times a week for 60 minutes
* Minimum training time of 7 hours a week

Exclusion Criteria:

* Gymnast whom suffer from chronic disease or acute musculoskeletal injury
* Herniated disc
* Spondylolisthesis