cyrilzakka/clinical-trials huggingface dataset:
Fathers' Breastfeeding Self-efficiency

The purpose of this study was planned to examine the effect of the education given through digital storytelling method on fathers' breastfeeding self-efficacy perception. The research is in a quasi-experimental design with no pretest-posttest control group.

In the study, intervention and control group data will be collected using the Personal Information Collection Form and the Father Breastfeeding Self-Efficacy Scale.

Personal Information Form: The Personal Information Form was developed by the researchers in line with literature information. There are questions about the socio-demographic characteristics of fathers, the role and responsibilities of fathers during breastfeeding.

Breastfeeding Self-Efficacy Scale for Fathers Short Form: The Breastfeeding Self-Efficacy Scale for Fathers was created by Dennis et al. to measure fathers' self-efficacy in supporting their spouses in breastfeeding, and its Cronbach's alpha value is 0.92.

Eligibility Criteria:
Inclusion Criteria:

* Not being between 0-6 weeks postpartum, not being married, not being literate

Exclusion Criteria:

-
Tart Cherry Juice and Markers of Inflammation, CVD, and Diabetes

In this study, the investigators recruited at-risk individuals (n=26) who were overweight (25.0-29.9 kg/m2) and obese (\> 30.0 kg/m2) and likely to exhibit one or more conditions associated with Metabolic Syndrome (MetS). In this 12-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or TCJ for 4 weeks, followed by a 4-week washout period, then consumption of the alternate beverage for 4 weeks. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of uricemia, lipidemia, glycemia, and inflammation.

In this study, the investigators recruited at-risk individuals (n=26) who were overweight (25.0-29.9 kg/m2) and obese (\> 30.0 kg/m2) and likely to exhibit one or more conditions associated with MetS. Participants were \>18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded. After enrollment, participants were randomly assigned to consume daily either 240 mL (8 ounces) of TCJ diluted (1:6 v/v) from concentrate (Coloma Frozen Foods, Coloma, MI ) or a placebo beverage for 4 weeks. The placebo was prepared by combining 48.3 g each of dextrose and fructose (Batory Foods, Des Plaines, IL), food-grade red and blue dyes (2.0 mL and 0.1 mL, respectively; McCormick \& Company, Inc., Sparks, MD), lemon powder drink mix (0.8 g; True Citrus, Baltimore, MD), powdered black cherry drink mix (4.0 g; Kraft Foods Group, Inc., Northfield, IL), and filtered, bottled water (local supermarket) to produce 1 liter of placebo beverage. After a 4-week washout period, participants consumed the alternate beverage for 4 weeks in this 12-week 2x2 crossover, placebo-controlled dietary intervention. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of uricemia (sUA), lipidemia (HDL, LDL, triglycerides, VLDL, total cholesterol), glycemia (fasting insulin and glucose, HOMA, QUICKI, McAuley indirect indices), and inflammation (hsCRP, TNF-alpha, and ESR).

Eligibility Criteria:
Inclusion Criteria:

* This study was a 12-week 2 x 2 crossover, randomized, placebo-controlled dietary intervention in overweight and obese participants (BMI\>25.0 kg/m2) who are more likely to exhibit \>1 of the 5 risk conditions associated with metabolic syndrome (MetS). BMI was the minimal criterion for recruitment.

Exclusion Criteria:

* Participants were \>18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded.
Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients

Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the patients, but the traditional approach still continues especially in thoracic surgery patients. For this purpose, we aimed to evaluate the effect of preoperative carbohydrate loading on postoperative morbidity in the patients.

The study was conducted on 94 patients. The patients in the control group were fasting after midnight. Experimental group patients consumed carbohydrate drink as liquid two hours before the operation. 47 patients were in the control group (A) and 47 patients were in the experimental group (B). The groups were compared in terms of length of hospital and intensive care unit stay, vomiting, gas-stool outlet, postoperative pain conditions (VAS), inflammation parameters, blood glucose, and mobilization time.

SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for statistical analyses. All means were presented with 95% confidence limits. In the empirical analysis, t-test and chi-square test were used. In addition, correlation analysis was used to determine the relationship between fasting time and surgical recovery time.

Eligibility Criteria:
Inclusion Criteria:

Stage I-Stage II all operable NSCLC patients -

Exclusion Criteria:

Patients with diabetes mellitus, a history of delayed gastric emptying, severe hepatic or renal failure, or any endocrine disorder that might influence the metabolic parameters were excluded, as were patients requiring urgent or emergent surgery.

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Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients

This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.

This protocol is a single arm pilot study of a novel breast cancer navigation app that is intended to assist patients with breast cancer understand their diagnosis and treatment options (both as part of standard of care practice and clinical trials) and manage their care, through treatment and symptom tracking. Patients will also be able to share information and get news via the app relevant to their cancer subtype. Results from this intervention will inform future clinical integration efforts, improve patient-centeredness of such an app-based health content and data platform, and inform the design of a larger, randomized study to demonstrate an improvement in patients' outcomes as well as enhanced Real-World Evidence (RWE) data collection.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, with histologically or cytologically confirmed invasive breast cancer stage I-IV
* Must be on, or planning to be on within 4 weeks of registration, active therapy, with the intent to receive some element of active therapy \> 28 days after registration
* Must be able to understand, read, and write in English and be able to sign informed consent
* Must have an Apple or Android smart phone that they are able to use and download the Outcomes4Me app on
* Must have the ability to access the internet at least once per week via their smart phone (having a computer is not required)

Exclusion Criteria:

* Participations seen for consultation opinion only and are not planning to receive some element of active treatment from an MGH medical or radiation oncology provider at MGH (Boston or Waltham sites) during the 12-week study period
Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma

* feasibility of physical activity
* increase of physical conversation
* Quality of Life (optional)
* vascular and metabolic effects

In this phase II pilot project the feasibility of a defined medical physical activity should be verified for increased physical conversation. The study is conducted multicentric (single group) with a study population of 30 patients. After completion of adjuvant chemotherapy the patients will participate a defined physical training, 3 times per week within a time period of 52 weeks. Planned study duration 2 years.

Eligibility Criteria:
Inclusion Criteria:

* complete resected, histologically confirmed adeno carcinoma of colon or rectal and condition after (neo-)adjuvant therapy either in (1) stage III or (2) stage II with risk factor
* 4-16 weeks after the end of an adjuvant chemotherapy
* ECOG 0,1
* Age \> 18 years
* adequate liver-, nephro- and hemogram parameters
* physical eligibility

Exclusion Criteria:

* significant comorbidities which exclude the participation
* evidence of local recurrence or distant metastases
* non-compliance of subject
* other malignancy within the last 5 years (except: skin basalioma, cervix carcinoma in situ)
* clinically significant cardiovascular diseases
* treatment with beta blocker without possibility of adjustment
* left bundle-branch block
* simultaneous chemotherapy or radiotherapy
* pregnancy
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension

This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for three months among patients with pulmonary arterial hypertension.

Idiopathic pulmonary arterial hypertension (PAH) is a life-threatening disorder of uncertain cause that leads to progressive right heart failure and death. Average survival has improved from about 2.8 years in the early 1990s to approximately 5-7 years with current treatments, but most patients will still die of their disease. Two classes of oral medications are approved for use in PAH: endothelin-1 antagonists, and phosphodiesterase-5 inhibitors. Both improve walk distance and symptoms in PAH, but most patients still have continued dyspnea, fatigue and significant elevations in pulmonary pressures. Those who remain severely impaired are generally started on a continuous intravenous prostacyclin. For those who are less ill but still symptomatic, few options are available.

Primary endpoint: the primary endpoint will be change in pulmonary vascular resistance (PVR) measured by right heart catheterization after three months of therapy.

Secondary endpoints

* Six minute walk distance
* QIDS-SR depression scale

Safety and tolerability endpoints will include a tabulation of adverse events to include but not limited to:

* Death
* Hospitalization
* Symptomatic hypotension
* Gastrointestinal side effects
* Depression

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure
2. PAH of the following subtypes: idiopathic PAH WHO functional class II-III
3. Catheterization within one week showing mPAP \>=25, wedge or LV end diastolic pressure ≤15, and PVR \> 4 wood units, and baseline fick cardiac output results available
4. Age 16-75
5. Able to complete a six minute walk distance
6. Women of childbearing potential\*: negative serum pre-treatment pregnancy test + consistently and correctly uses a reliable method of contraception\*\* Oral approved PAH therapy for \>3 months with no change in dose for \> 1 month

Exclusion Criteria:

1. PAH with connective tissue disease, congenital heart disease, portal hypertension, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathy, myeloproliferative disorders.
2. Moderate to severe obstructive or restrictive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 70% and FEV1 \< 60% of predicted value after bronchodilator administration. -or- total lung capacity (TLC) \< 60% of predicted.
3. Systemic systolic blood pressure \<100 mmHg Breastfeeding
4. Significant liver, renal or other medical disease preventing completion of the study procedures or with life expectancy \<12 months, or any other acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements
Psoas Compartment Block (PCB) Versus L.A Infiltration and Remifentanil Infusion During EVAR

Endovascular aneurysm repair (EVAR) was introduced in 1990 for the first time as a minimally invasive procedure instead of the conventional open surgical repair, with the aim to decrease morbidity and mortality . Nowadays EVAR has become an acceptable management for patients with infra-renal aortic aneurysms (AAA) . A lot of anesthetic techniques have been used successfully for EVAR. EVAR requires sedative analgesic medications to achieve an acceptable level of comfort to the patient and cardiorespiratory stability.

This is prospective randomized single blinded study of patients presenting with aorto-iliac aneurysm who will undergo EVAR. Patient's demographic data will be assessed, as well as clinical presentation, intraoperative complications.

30 patients undergoing elective EVAR will be included and will be divided equally into 2 groups.

First group is the psoas compartment block (PCB) (15 patients): 30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical landmark.

Second group is the LA and remifentanil group (LR) (15 patients): lidocaine 5 ml of 2% will be injected subcutaneous as local infiltration then remifentanil infusion with rate 0.03-0.1 μg kg-1 min-1. to achieve visual analog scale (VAS) 3 or less.

Vital date will be recorded as baseline then every 5 minutes till the end of the procedure. VAS will be recorded as baseline then every 5 minutes till the end of the procedure. Also stress response which will be measured subjectively as vital data and VAS and objectively as cortisol level in the blood which will be measured as base line and immediate after the end of the procedure.

Anatomical, imaging and clinical studies suggest that psoas compartment block (PCB) which was done at L2-L3 level has a high possibility to include L1-L2 roots, and thus can be suitable for inguinal surgery. In our study, the investigators introduce a modified PCB which will be performed in lateral decubitus by a 120 mm stimulated needle inserted at the junction between the lateral third and the medial two-thirds of a line drawn at L2-L3 interspace, between the interspinous line and a line passing through the posterior superior iliac spine (PSIS), parallel to the interspinous line . If twitching of the anterior thigh area is observed, the needle is moved slight cranially. When twitching of the inguinal field is observed, bupivacaine 0.5% 30 ml, will be injected

Eligibility Criteria:
Inclusion Criteria:

* All elective patients presenting with aortoiliac aneurysm who will undergo percutaneous EVAR.

Exclusion Criteria:

* Exclusion criteria included the presence of an aneurysm of the common femoral artery or severe atherosclerotic disease with total occlusion, emergency EVAR, uncooperative patient, patient on anticoagulation therapy, cerebrovascular disease, poorly controlled hypertension (systolic arterial pressure ≥160 mmHg), poorly controlled diabetes mellitus (random blood glucose ≥200 mg/dL) and renal insufficiency (creatinine \>1.5 mg/dL).
Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

This study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Half the participants will be evaluated for cervical pathology by portable colposcopy after VIA assessment, while the other half will be evaluated by conventional colposcopy. This study also will use collected lab specimens for human papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus (HIV)-positive women.

This research is a randomized, prospective trial designed to evaluate the value of magnification in making a diagnosis of high grade intraepithelial lesions of the cervix. The overall goal is to evaluate a cervical cancer screening protocol that provides the highest level of care possible for low-resource communities and hard-to-reach areas. Currently, a national cervical cancer screening and diagnosis program does not exist within Haiti.

All women meeting inclusion criteria will be randomized to portable (8x magnification with the Cerviscope) or conventional (25x magnification) colposcopy. After application of acetic acid to the cervix, the physician will record naked eye observations of the cervix by: 1) recording the location of all white lesions; 2) describing the vascular pattern; and 3) stating his/her clinical impression of a diagnosis. The physician will then follow-up with use of either the portable or the conventional colposcope to: 1) record the location of all white lesions; 2) describe the vascular pattern; and 3) state a clinical impression of diagnosis. Women will have biopsies in all four quadrants of the cervix even if no cervical lesions are seen to evaluate the accuracy of the visualization techniques against the gold standard of biopsy pathologic results. Treatment options will be dictated by biopsy results.

Biopsy material will also be evaluated for specific HPV genotype using lab-based measures. Results of these genotypes will be compared between women with high-grade disease vs. low-grade disease and in the subset of women with HIV compared to the HIV-negative population.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 25-60 years old
* Pre-tested as positive for human papillomavirus (HPV)

Exclusion Criteria:

* Pre-tested as negative for human papillomavirus (HPV)
* Pregnant at time of enrollment
* Prior hysterectomy
* \< 25 or \> 60 years old
* Male
The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension

The objective of this study is to investigate the effect of metformin on the correlation between hyperinsulinemia and hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 65 years of age, regardless of sex
* duration of hypertension was \<5 years
* overweight or obesity, mild to moderate hypertension, receive no euglycemic agent or antiobesity drug
Venous Thromboembolism in Primary Pancreatic Tumour Resection

This study will evaluate the development of venous thromboembolism (VTE) and possible determinants in patients with primary pancreatic cancer undergoing pancreatic cancer resection.

Cancer associated thrombosis (CAT) is the second cause of death, in oncologic patients after tumour progression itself. Patients suffering from malignancies are at increased risk for both venous (4-20%) and arterial (2-5%) thrombotic events. Moreover, cancer is one of the most important acquired risk factors for the development of venous thromboembolism (VTE).

Pancreatic cancer is the fourth most deadly cancer world-widely and has been recognised as the most prothrombotic malignancy, with a reported incidence of VTE (8-18%), followed by renal and ovarian cancer (VTE 5.6%). Although the exact pathophysiological mechanisms are still poorly understood it seems that pancreatic cancer induces a prothrombotic and hypercoagulable state.

Aims

* To evaluate the predictive value of preoperatively or early postoperatively obtained NLR, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
* To evaluate the predictive value of preoperatively or early postoperatively obtained coagulation biomarkers/parameters, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
* To evaluate the incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection
* To assess the perioperative coagulation status of patients with primary pancreatic cancer undergoing pancreatic cancer resection
* To evaluate any possible determinant or predictive factor for VTE among the coagulation parameters or patients' baseline characteristics

Eligibility Criteria:
Inclusion Criteria:

* Consecutive pancreatic cancer patients undergoing pancreatic cancer resection in University Hospital of Larissa, after informed consent will be included.

Exclusion Criteria:

* Refuse to participate
* Previous thromboembolic event \< 6 months prior to the operation
* History of inherited or acquired bleeding disorder
* ASA PS \> 3
* Concomitant presence of a second primary malignancy
* Unresectable pancreatic cancer
Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants

Parental smoking is associated with increased frequency of respiratory diseases including hospitalizations in infants.

Study hypothesis: Parental education regarding the association between parental smoking and respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the infant, provided shortly after the infant is born, will decrease infants' morbidity.

Mothers who are in Maternity ward following birth will fill a questionnaire regarding smoking habits. Parents will be divided into non-smokers and smokers. Half of the smoking mothers will receive guidance regarding the association between parents smoking and respiratory diseases in the infant. They will also get ideas on how to reduce smoke exposure by their infant. 3 months and 1 year later all parents will be contacted by phone and asked about their children's health.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at Asaf Harofeh Medical Center
* Infants born at \>35W gestational age

Exclusion Criteria:

* Infants requiring any supportive treatment (supplemental O2, fluids, glucose, antibiotics)
Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression

The purposes of this study are to determine:

* The safety of duloxetine and any side effects that might be associated with it.
* How duloxetine compares to escitalopram and placebo (an inactive ingredient)

duloxetine 60mg - 120mg, escitalopram 10mg - 20mg, and placebo, 8-month,

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 of age
* Must meet the criteria for major depressive disorder
* You must be able to visit the doctor's office about once a week for 2 to 3 months. After that, you will need to visit the doctor's office once a month for about 6 months
* You must be able to take the study drug as prescribed (6 capsules per day taken once-daily)

Exclusion Criteria:

* You are a woman and are pregnant or breastfeeding.
* You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
* You have a history of alcohol or drug dependence within the past 6 months
Peri-operative Risk Factors for Postoperative Pressure Ulcer in Surgical Patients

The aim of this retrospective study is to overall evaluate and validate preoperative and intra-operative risk factors for postoperative pressure ulcers in critically ill postoperative patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients in ICU with a greater than 48 hours
* Underwent a surgical procedures,
* Absence of pressure ulcer present at admission to the ICU and developed a stage II or higher pressure ulcer, deep tissue injury, or unstageable ulcer, as defined by the pressure ulcer staging guidelines of the National Pressure Ulcer Advisory Panel.

Exclusion Criteria:

* Patients will be excluded from the study if they had been diagnosed with pressure ulcer before the surgery
* Pediatric patients