cyrilzakka/clinical-trials huggingface dataset:
Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings

The present study proposes to test the effectiveness of the Building a Healthy Temple: Diabetes Self-Management Support Program (BHT DSMS), a rendition of the Stanford DSMP in a spiritual context for the Hispanic faith community members. Using a holistic approach through integrating spiritual and physical health, BHT translates the Stanford DSMP in a way that may result in lasting behavior changes and improved diabetes outcomes for Hispanics with type 2 diabetes (T2D).

The present study is proposing a 12-month translational study BHT DSMS to test the effectiveness of adapted Stanford DSMP in a spiritual context. A cluster randomized trial with repeated measures will be conducted to compare the effectiveness of DSMS intervention strategies among 360 adult diabetic congregants from 18 predominantly Hispanic churches in San Antonio, Texas (20 participants/church). Using cluster randomized trial design; nine churches will be randomly assigned to the Faith-Based (FB) intervention, and nine to the Faith-Placed (FP) intervention. The study will be implemented in two cohorts (8 churches for cohort 1 \& 10 churches for cohort 2). All intervention activities will be implemented over 14 consecutive weeks. Participants in the FB group will participate in BHT DSMS, which includes a Health Sermon, a 6-session Health Bible Study with cooking demonstrations, the Stanford DSMP and a Diabetes Resource Seminar delivered by two trained church lay leaders. Participants in the FP group will first attend a 7-session community health and safety curriculum as a partial attention control intervention, followed by the Stanford DSMP and Diabetes Resource Seminar facilitated by the local public health department. The primary outcome will be a change in HbA1c levels. Secondary outcomes include: changes in body mass index (BMI), waist circumference (WC), quality of life, diabetes self-care behaviors, eating behavior and physical activity level. Data will be collected at baseline, 6, 9, and 12-months during the study period. The aims of present study are 1) To test feasibility of the Stanford DSMP in FP and FB settings through observation and documentation of the implementation process, in-depth interviews with program staff and focus groups with participants to identify facilitators and barriers of the intervention. 2) To translate Stanford DSMP in a spiritual context for Hispanic faith community members and compare the effectiveness of a FB versus FP approach in improving diabetes outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Church eligibility: \[Churches must be predominantly Hispanics (60%) with at least 20 adult congregants with T2D willing to participate in the study. The rationale for 20 diabetic voluntary participants per church is based on the Stanford requirement of 12-16 participants allowed per support group and with an anticipated 25% attrition.\]
* Participants' eligibility: Participants will be adults age 21 and above that have been diagnosed with T2D.

Exclusion Criteria:

* Children, adults under 21 years of age, and pregnant women
A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema

The purpose of this study is to characterize the systemic and ocular safety and tolerability, pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of repeat administration of oral darapladib in diabetic macular edema patients with centre involvement.

This is a multi-national, multi-centre, randomised, double-masked, placebo-controlled, parallel-group study of repeat oral administration of 160 mg darapladib for 3 months in adult subjects with DME with centre involvement.

Eligible subjects will be randomised in a 2:1 ratio of active treatment to placebo, with the placebo group to allow a comparison of safety between treatment arms and to minimize the open label effect that can be observed with the visual acuity endpoint.

The primary aim of the study is to determine the effect of repeat doses of darapladib on the mean change from baseline of both best-corrected visual acuity (BCVA) and spectral domain OCT (SD-OCT) centre subfield. The study eye will be examined for changes over the life of the study. As this investigational treatment is systemic, the fellow eye may be examined in tandem to provide additional data.

Eligibility Criteria:
Inclusion Criteria:

* A female subject is eligible to participate if she is of: Non-childbearing potential or child-bearing potential and agrees to contraception for an appropriate period of time
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Confirmation of DME in the study eye by angiography
* Confirmation of retinal thickening in the study eye by study doctor
* Best corrected visual acuity score of 78-24 letters in the study eye

Exclusion Criteria:

* Additional eye disease in the study eye that could compromise study assessments
* Intraocular surgery, or laser photocoagulation in the study eye within 3 months of dosing
* Uncontrolled intraocular pressure in the study eye despite treatment with glaucoma medication
* Uncontrolled diabetes
* Certain types of liver disease
* Severe reduction in kidney function OR removal of a kidney OR kidney transplant
* Blood pressure higher than normal despite lifestyle changes and treatment with medications
* Certain medications that may interfere with the study medication or eye assessments (these will be identified by the study doctor)
* Current severe heart failure
* Severe asthma that is poorly controlled with medication
* Previous severe allergic reaction to food, medications, drink, insect stings, etc
* If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded
* Recent participation in a study of an investigational medication
* Any other reason the investigator deems the subject should not participate in the study
* Other protocol-defined inclusion/exclusion criteria may apply
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)

The study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bronchiectasis on HRCT
* Optimization of Therapy for at least 15 days before enrollment
* Autonomous patients with possibilities of practicing rehabilitations cycles

Exclusion Criteria:

* OSAS (ODI\>10/h)
* HOME NIV
* PH\<7,35 - paO2\< 60mmHg, paCo2\> 55 mmHg
* Lung cancer
* Contraindication to high-flow nasal cannula (hfnc)
Radical Fimbriectomy for Young BRCA Mutation Carriers

Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.

Most of ovarian carcinomas related to BRCA 1 or 2 mutations are of fallopian tube origin and especially from its distant part called the fimbria. These tubal, ovarian or primary peritoneal carcinomas are quite always of high grade serous type. They cannot be effectively screened due to the quickness of their evolution. In this context, a laparoscopic bilateral salpingo-oophorectomy (BSO) is the recommended prophylactic procedure.

Some BRCA-mutated women are reluctant to undergo this procedure considering the numerous adverse effects on body and quality of life, especially when hormonal replacement is forbidden. This refusal makes them at risk of developing a serous pelvic carcinoma.

The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion

Eligibility Criteria:
Inclusion Criteria:

* Woman aged over 35 years
* When project of childbearing is fulfilled
* With a BRCA 1 or 2 mutation, or a family history of breast/ovarian cancer
* Unprepared to undergo bilateral annexectomy
* With or without breast cancer
* Patient affiliated to health insurance
* Dated and signed informed consent

Exclusion Criteria:

* Menopausal woman defined as :

Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH\> 20 UI/l History of hysterectomy and FSH\> 20 UI/l

* Pregnant or breastfeeding woman
Cardiorespiratory Training and Ventilatory Muscle Strength

The cardiorespiratory training can increase muscle strength ventilatory.

Specifically for being an experiment parallel factorial intervention after met the eligibility criteria for the participants will be randomly allocated to three groups: control, respiratory training, cardiorespiratory training (indoor Bike).

Eligibility Criteria:
Inclusion Criteria:

- Have lower maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values normative reference proposed by the Brazilian Society of Thoracic.

Exclusion Criteria:

* Not be voluntary to the present study.
* Conditions that oblige participants are absent for more than two weeks of activities performed in the experiment.
Gravitational Arrhythmogenesis Can the Often-heard Symptom of Body Position Dependent Palpitations be Proven

This study aims to assess the relationship between body position and the occurrence of either atrial or ventricular premature beats and more complex arrhythmia

Rationale: Palpitations in a certain body position is an often-heard symptom, although there is currently no direct evidence that links body position with arrhythmia. The hypothesis is that arrhythmia is more prevalent in the specific body position that the patient reports to be arrhythmogenic.

Objective: The objective of this study is to assess the relationship between body position and the occurrence of either atrial or ventricular premature beats and more complex arrhythmia (AT, atrial fibrillation (AF), VT) in a population that have a self-reported preferential body position for symptoms.

Study design: Single cohort study. Subjects are recruited from the outpatient clinic. First, they will fill in a short questionnaire regarding their symptoms; second, they will be outfitted with a downgraded polygraphy device, that only monitors body position, and single and/or multi lead ECG for 24 hours. The acquired data will be analyzed at the Catharina Hospital and the Eindhoven University of Technology.

Study population: Outpatients with palpitations and a self-reported higher prevalence in a certain body position that have an indication to undergo Holter monitoring, independent of any previous diagnosis.

Main study parameters/endpoints: The frequency of ectopic beats or onset of complex arrhythmia (n per minute) in the body position that the patient has reported as arrhythmogenic, compared to arrhythmia rate in the other body positions, corrected for time spent per body position.

Eligibility Criteria:
Inclusion Criteria:

* Palpitations, spontaneously described to occur either predominantly or solely in a certain body position (upright, prone, supine, left or right lateral decubital position).
* Ability to provide informed consent

Exclusion Criteria:

* There are no exclusion criteria for this study.
Imidapril and Candesartan on Fibrinolysis and Insulin-Sensitivity in Patients With Mild to Moderate Hypertension

BACKGROUND The effects of ACE-inhibitors on fibrinolysis are well documented. Experimental and clinical studies have shown that ACE inhibitors induce a reduction in plasma PAI-1 levels in many cardiovascular diseases, like hypertension, coronary heart disease, and heart failure. Their effects on t-PA are more controversial, due to the fact that t-PA exists in several forms, including free and bound to PAI-1. Indeed an increase in t-PA activity has been observed in humans and it seems related to bradykinin increase which is known to stimulate endothelial t-PA synthesis. These favourable effects on fibrinolysis could be related not only to the Angiotensin II reduction and the bradykinin increase but also to the improvement in insulin sensitivity, as insulin has been suggested as one of the main regulators of fibrinolytic activity.

To date conflicting results have been reported about the effects of ARBs on fibrinolysis. Some studies have reported small improvements, others no significant effect. These conflicting results may be due to possible methodological bias but a possible pathophysiological explanation might be that receptor subtypes other than AT1 mediate the effect of Angiotensin-II on endothelial PAI-1 expression, i.e. the AT4 receptors, and during AT1 receptor blockade there is an important increase not only of Angiotensin-II, but also of all its catabolites including Angiotensin IV. The dissimilar effects on of ACE Is and ARBs may also depend on their different action on the RAS and their different effect on insulin sensitivity: ACE-Is improve insulin sensitivity, while the majority of ARBs have been reported to have a neutral effect. Moreover, unlike ACE-Is, ARBs do not affect the metabolism of bradykinin, which is known to stimulate t-PA synthesis and release.

AIM OF THE STUDY The aim of this study is to verify the effect of imidapril compared to candesartan on insulin sensitivity, evaluated through the euglycemic hyperinsulinemic clamp, and on fibrinolysis, evaluated through the plasma PAI-1 and t-PA activity, in mild to moderate hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* DBP ≥ 90 \< 110 mmHg and SBP ≥ 140 \< 180 mmHg
* Normal Body Mass Index (BMI) (≤ 25 Kg/m2)
* Normal kidney function (Creatinine Clearance \> 80 ml/min)
* Normocholesterolemia (TC \< 250 mg/dl)
* At least one of the following risk factor:

  * age (M \> 55 years)
  * smoking
  * family history of premature CV disease
  * echocardiographic LVH
  * carotid wall thickening (IMT \> 0.9 mm)
  * ankle/brachial BP \< 0.9

Exclusion Criteria:

* Secondary hypertension
* Overweight or obese state (BMI ≥ 25 Kg/m2)
* Suspected history of allergy to the ARBs, or ACEs
* Malignancy
* Renal, hepatic, endocrine, or gastrointestinal disease
* Women who are pregnant and lactating
* Women child-bearing potential
* Heart failure
* AMI and/or stroke in the previous 6 months
* CHD
* Diabetes mellitus
Incidence of Cystitis in Women Consuming a Mixture of Cranberry, Cinnamon, Probiotics

Cranberries are traditionally used for urinary comfort and prevention of urinary disorders of bacterial origin and despite an EFSA opinion invalidating the clinical efficacy of cranberries, its mechanism of action has been several times proposed by the scientific community: it would act by inhibiting the synthesis of P-fimbriae leading to a complete disappearance of these adhesins, and to bacterial-type deformation by lengthening of the cell body. Cinnamon and microbiotic strains could enhance this synergy.

This study aims to evaluate the effectiveness of a food supplement based on cranberry, cinnamon and microbiotic strains (Feminabiane CBU) on the symptoms of cystitis, urinary discomfort and the number of cystitis reported by women.

Women who use or not the cranberry, cinnamon, and microbiotic blend are encouraged to complete a 6-month diary in which they report any urinary tract disorders they encounter.

Eligibility Criteria:
Inclusion Criteria:

* Having at least 2 symptomatic episodes of cystitis during the last 6 months including at least 1 episode confirmed as being bacterial cystitis (by an urine bacterial analysis or validated by a doctor (date of appointment, list of prescribed treatments) ;
* Whose symptomatic episodes of cystitis over the past 6 months have had a significant impact on quality of life / urinary comfort (ACSS QoL\> 2);
* Having a smartphone compatible with the NURSTRIAL® data collection application;
* Not opposing the collection and processing of their personal data.

Exclusion Criteria:

* Presenting urinary discomfort with a severe impact on quality of life (ACSS QoL\> 7) during the last 24 hours prior to inclusion;
* Pregnant, breastfeeding or planning to become pregnant during the study;
* Under antibiotic treatment (or during the last month preceding inclusion);
* Under food supplementation with prebiotics or probiotics or having stopped it less than a month before inclusion;
* Having had recourse to a prophylactic treatment (cranberry juice) 15 days before inclusion;
* Having had local estrogen therapy during the 3 months preceding inclusion;
* Diabetic;
* Presenting an immunosuppressive disease;
* Presenting pelvic floor abnormalities (Cystocele surgery, etc.);
* Presenting or having a history of kidney disease (including kidney stones, urinary tract abnormalities, pyelonephritis, kidney failure, kidney transplantation);
* For women consuming supplementation: known allergy to plants of the cranberry family or to one of the components of the products.
The Impact of Omega-3 Supplementation on Gene Expression in Type 2 Diabetics

The aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics

Adipose tissue is recognized as an important endocrine organ in human. Not only it has function of storing unlimited energy but also its secretory roles is subject to intense research in recent years. Acylation stimulating protein(ASP), Retinol-binding protein 4 (RBP4) and lipocalin-2 (LCN2) are circulating adipokines elevated in diabetes. C5L2 is a G-protein-coupled receptor. activation of C5L2 by ASP, has been shown. Fatty acids may influence the expression of adipokines. Epidemiological studies showed that omega-3 reduce the development of insulin resistance and diabetes. Because fatty acids are the main component of adipose tissue, it is essential interest to clarify the biological effects of omega-3 on the expression of relevant adipokines.

Eligibility Criteria:
Inclusion Criteria:

* literate
* Willingness to participation
* Diabetic patients 30-65 years old
* Body mass index in the range 18.5-40
* Avoidance of dietary supplements
* vitamins and herbal products at least 2 weeks before and throughout the intervention

Exclusion Criteria:

* people who have used omega-3 supplements in last 3 months
* Having chronic renal disease
* hepatic disease
* gastrointestinal disease
* hematological disorders
* hypothyroidism or hyperthyroidism
* Treatment with Orlistat or sibutramine for weight loss
* Pregnancy and lactation
* Treatment with insulin or Thiazolidinediones
Effectiveness of the Z-Track Technique As a Pain-Reducing Strategy for Neonates During Intramuscular Injection: a Randomized Controlled Trial

A quantitative study, true experimental, posttest-only design has been used for the current study. one intervention (the Z-track technique) and one control group involved in the study. The primary outcome measure is the Neonatal/Infant Pain Scale to be used immediately after intramuscular injections to measure the pain level among neonates.


Eligibility Criteria:
Inclusion Criteria:

* Neonates delivered through cesarean section
* Apgar score of 8 or more
* Weight between 2500 - 3500 grams
* neonates receiving IM injections
* Males / females
* term neonates between 37th and 42nd week of gestation

Exclusion Criteria:

* Congenital anomalies
* neonates who received intramuscular injection such as the Hepatitis B vaccine
* Low birth weight
* Preterms
* Neural tube defects
* neonates who are of normal vaginal delivery
Effect of Preoperative Chest Physiotherapy on Lung Functions Among Open Heart Surgery Patients

Postoperative respiratory complications in patients who had chest-opening heart surgery are considered one of the serious factors threatening their life. However, these potential complications could be minimized using proper preoperative chest physiotherapy. This study was designed to assess the potential effects of using preoperative chest physiotherapy on oxygenation and lung functions among open heart surgery patients during postoperative period.

The research was lasted four months in outpatient clinic, cardiothoracic surgical department and intensive care unit at University of Pécs, Clinical Centre, Heart Institute, Hungary . A convenient sample of 100 patients were divided into two groups: group 1 and 2. Group 1 (G1) included patients undergoing planned surgery who performed chest physiotherapy at home in two weeks period before the surgical operation, and group 2 (G2) included patients who patients undergoing planned surgery but did not perform preoperative chest physiotherapy at home. Preoperative and postoperative chest physiotherapy was performed in G1, and only postoperative one made in G2. Potential effects of preoperative chest physiotherapy were studied in both groups with respect to oxygen saturation, pulmonary complications and length of hospital staying. O2 saturation,O2 supplementation, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) were all measured in a day before (zero day) surgery as well as the first seven days of postoperative period.

Results: Measures of oxygen level and lung functions were significantly (P\<0.05) changed in studied groups. The mean values of O2 saturation and supplementation measured in almost seven days of postoperative period were significantly (p\<0.05) higher among G1 compared to the values of G2. The same trend was also correct for the mean values of FVC and FEV1.

Conclusions: The results concluded that, the performance of preoperative chest physiotherapy before open heart surgery is recommended, as it might result in the decrease of complications of heart surgery, improvement of respiratory functions and length of staying at hospital.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.
taVNS in Mild to Moderate Parkinson's Disease

The purpose of this study is to find out whether a non-invasive form of nerve stimulation called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with Parkinson's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Age: 40-79 y
* Idiopathic Parkinson's Disease Diagnosis
* Disease Stage: Hoehn and Yahr stage 2-3
* Patient requires a minimum of 3 doses of levodopa daily
* Willingness to be videotaped

Exclusion criteria:

* Dementia or Montreal Cognitive Assessment score \<24
* Parkinson's Disease psychosis
* Ear trauma
* Facial pain
* Traumatic Brain Injury or clinical history of stroke
* Metal implants above the shoulders
* History of myocardial infarction or arrhythmia, bradycardia
* Active respiratory disorder
* Alcohol or substance use disorders
* History of Deep Brain Stimulation (DBS) or other brain surgery
* Epilepsy
* Pregnancy
* B-Blockers, dopamine blocking agent, antiarrhythmic medication, acetylcholine esterase inhibitor, midodrine, florinef, droxidopa, or anticholinergic drugs
Blood Pressure Monitor Clinical Test (Cuff Range: 22 Cm-36cm)

The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 22 cm-36 cm.


Eligibility Criteria:
Inclusion Criteria:

* cuff circumference: 22cm-36cm

Exclusion Criteria: