cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on Chest X-ray

This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities

In the study, the standalone performance of Lunit INSIGHT CXR was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax.

Eligibility Criteria:
Inclusion Criteria:

* Chest radiographs of aged 14 years or older
* Conventional PA or AP chest radiographs
* Chest radiographs with confirmed radiology reports

Exclusion Criteria:

* Chest radiographs taken in postures other than PA and AP
* Chest radiographs from dual-energy radiography
* Invert-grayscale chest radiographs
Online Education and Breastfeeding Motivation

Introduction: Breastfeeding is not just a physiological event. Psychological and emotional factors affect breastfeeding. Motivation is also among these factors. For this reason, it should be considered that there will be problems with breastfeeding in the postpartum period. Since breastfeeding education can be a solution to these problems, it can increase the motivation of mothers for breastfeeding.

Purpose: To examine the effect of online breastfeeding education on breastfeeding motivation.

Methods: The type of the study was planned as a prospective, randomized controlled experimental study with pretest-posttest control group. The sample group of the research will be reached at Pamukkale University Obstetrics and Gynecology clinic and online via social media. The sample reached will be trained in the online environment. The research will be carried out between February 2022 and December 2022. A total of 50 people, 25 in the experimental group and 25 in the control group, will be included. Evaluation will be made with the Breastfeeding motivation scale (for primiparous mothers). Motivation scores will be compared before and after the training.

Breastfeeding protects children against diseases such as gastrointestinal, asthma, diabetes, otitis media, sudden infant death syndrome and obesity. At the same time, it supports the increase of children's IQ level and brain development. Among the benefits for women's health are its contribution to the involution process in the postpartum period, protection against postpartum depression, ovarian and breast cancer. The social impact of breastfeeding is that it provides economic benefits.Despite all the benefits of breastfeeding, breastfeeding rates are not sufficient. Globally, the rate of exclusive breastfeeding of children for the first six months is 41%, and the rate of breastfeeding with complementary foods for two years is 45%.

There are many factors that affect breastfeeding. These; social, environmental, cultural and personal factors. These factors can affect the motivation of women internally and externally.For this reason, internal and external motivations of women will be supported with breastfeeding education.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18-49 years old,
* Having given birth for the first time,
* Being in the postpartum period between the 4th and 8th weeks and breastfeeding,
* Volunteering to participate in the research,
* Speak and understand Turkish.

Exclusion Criteria:

* not be between the ages of 18-49,
* Having more than one birth,
* not breastfeeding,
* Not being able to speak or understand Turkish.
Comparison of Chen's U-suture Technique with Duct-to-Mucosa Anastomosis and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy

Data of patients treated with pancreaticoduodenectomy in 21 hospitals from January 2014 to December 2019 were retrospectively collected and classified to Chen's group, duct-to-mucosa group and invagination group according to different pancreaticojejunostomy. Propensity score matching analysis was performed to balance the baseline differences among three groups. The surgical outcomes were compared. Independent risk factors for postoperative pancreatic fistula were confirmed by logistic regression analysis, and subgroup analysis was also conducted.


Eligibility Criteria:
Inclusion Criteria:

* open pancreaticoduodenectomy
* Chen's U-suture technique or invagination or duct-to-mucosa anastomosis

Exclusion Criteria:

* missing data
Diabetes Group Prenatal Care

The investigators primary objective is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities in women with diabetes.

Long term, the investigators aim to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve glycemic control and, ultimately, maternal and neonatal outcomes in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities, which have been associated with improved glycemic control, in women with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* English (WUMC) or Spanish speaking (DH)
* Type 2 White's Class B diabetes OR gestational diabetes diagnosed by 2-step method \< 32 weeks
* Ability to attend group prenatal visit at specified days and times
* Willingness to be randomized
* Randomization at 22 weeks 0 days-32 weeks 0 days
* Ability to give informed consent

Exclusion Criteria:

* Multiple gestation
* Major fetal anomaly
* Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider
* Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider
Auto-antibody Dosage from Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease

Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 2-13 years
* Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls)
* Obtained informed consent

Exclusion Criteria:

* none
The Relationship Between Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria

This study was designed to determine the association between preoperative and postoperative hypoalbuminemia and AKI in older age hip fracture surgeons, to determine which period of hypoalbuminemia contributes more to AKI development, the incidence of AKI according to anesthesia type, the presence of other factors affecting AKI development, the duration of hospitalization and cost- to be investigated.


Eligibility Criteria:
Inclusion Criteria:

* patients with femur fracture surgery
* 65 years and over
* Patients with ASA I - IV physical condition
* patients with spinal anesthesia or peripheral nerve block

Exclusion Criteria:

* Patients undergoing emergency surgery
* patients with preoperative serum creatinine (sCr) level\> 1.5 mg / dl
* patients with low serum albumin levels in both preoperative and postoperative periods
* patients receiving preoperative ventilator care
* patients with spinal anesthesia or peripheral nerve block contraindications (coagulopathies, local infection at the puncture site, spot infection) or nonsteroidal antiinflammatory drug (NSAID)
Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes

The study team will examine the effect of a ketogenic diet alone and ketogenic diet supplemented with oral ketones on how the body of individuals with type 2 diabetes respond to insulin, regulates insulin secretion, food intake and energetic pathways and influences body fat distribution.

Subjects will be randomized into three groups (1) standard, weight maintaining diet containing approximately 25-35% protein, 45-55% carbohydrate, 20-30% fat; (2) weight maintaining isocaloric ketogenic diet containing approximately 15-25% protein, 5-10% carbohydrate, 70-80% fat; (3) weight maintaining isocaloric diet containing approximately 15-25% protein, 5-10% carbohydrate, 70-80% fat supplemented with the ketone ester of beta-hydroxy butyrate, 8 grams every 8 hours to further increase the plasma ketone concentration by \~3 mM. Subjects will be further randomized on the basis of:

(i) HbA1c 7.0-8.5% and 8.5-10.5% to ensure similar baseline levels of glucose control and (ii) drug naïve versus drug-treated. At the time of screening, after a 10-12 hour overnight fast, indirect calorimetry will be performed with a ventilated hood system for 60 minutes to measure baseline energy expenditure. An initial weight maintenance energy requirement estimate as 1.5 times resting energy expenditure (obtained by indirect calorimetry) will be started. Diets will consist of a 10-day rotating menu using NutriAdmin for meal planning and Nutrition Maker for analysis of recipes Food will be prepared in the Cafeteria and or the Metabolic Kitchen at the Texas Diabetes Institute and certified by a dietician. Subjects will report to the diet kitchen at 8 AM on Monday through Saturday where they will eat their breakfast and pick up food for their lunch and dinner. On Saturday, participants also will be given food for their Sunday meals. Subjects will maintain a daily dietary log with all food consumed. On each visit subjects will be weighed; dietary log will be reviewed and the caloric content of the diet will be adjusted to maintain the body weight constant. Blood pressure will be measured in the reclining position x 2 separate days. Antidiabetic medications will not be changed during the study unless hypoglycemia (fasting plasma glucose \<70 mg/dl or symptoms) occurs. The study duration will be 10 days which should be sufficient to observe the effect of hyperketonemia on glucose/lipid metabolism and energy expenditure. If participant cannot come on the last days of his/her diet treatment, than we will extend this period up to 13 days and participant will be given diet for additional days till completion of the study visits.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18-70 years
2. BMI = 27.5-42 kg.m2
3. HbA1c = 7.0-10.5
4. Weight stable (±4-5lb) in the preceding 3 months
5. Good general health

Exclusion Criteria:

1. Use of medications that affect glucose tolerance other than metformin/sulfonylurea/DPP4 Inhibitor
2. Major organ disease
3. Estimated Glomerular filtration rate (eGFR) \<60 ml/min
4. Type 1 diabetes
5. Hematocrit \< 34 (if HbA1c is in the 8.5 to 10% range)
Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses

This study aims to evaluate the functional outcomes of patients with distal femur tumor prostheses in comparison to a matched control group.

The aim of this case-control study will be to compare functional outcomes-including results from the TUG and 6MWT, knee flexor and extensor muscle strength, sagittal knee range of motion-and health-related quality of life between patients with distal femoral megaprostheses and healthy controls. By employing both traditional assessments and IMU technology, the investigators will provide a comprehensive evaluation of functional recovery in this population, thereby informing clinical practice and rehabilitation strategies.

Two functional tests that will be conducted are the Time Up and Go Test and the 6-Minute Walk Test. These tests will be administered using a non-invasive Inertial Measurement Unit (IMU), specifically the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), positioned at the S1 level to collect spatiotemporal gait data. These data will then be analyzed in comparison to values obtained from healthy participants.

The assessment will include anamnesis and a complete clinical examination of tumor patients with distal femur megaprostheses undergoing surgery at Hospital la Fe in Valencia, focusing on knee joint mobility and muscle group strength. Subjective function will be evaluated using questionnaires such as the SF-36 for both cases and controls and the MSTS (Musculoskeletal Tumor Society Score) for cases.

Eligibility Criteria:
Inclusion Criteria (cases group):

* Megaprosthesis of unilateral distal femur
* Tumor cause
* Ambulation capacity

Exclusion Criteria (cases group):

* Neurological alterations prior to the inervention than affect the lower limbs or general movement
* Patient incapable of ambulation due to progression of his/her pathology
* Patient with palliative treatment for advanced tumor diseas
* More than one ipsilateral or contralateral prosthesis
* Infection, traumatic or sequel to revision surgery cause
Kegel Exercises Prior to Strength Training to Improvestress Urinary Incontinence

This comparative pre-post intervention study investigates the feasibility and benefits of Kegel exercises amongst incontinent women, prior to commencing resistance training, to reduce the risk of stress urinary incontinence compared to a group of women without prior Kegel exercises.

The aim of the study is to determine whether a program of Kegel exercises prior to a resistance training program will result in reduction of stress urinary incontinence and whether this should be prescribed to incontinent women prior to performing resistance training. It is hypothesized that performing kegel exercises prior to resistance training would improve pelvic floor muscle strength and reduces the odds of experiencing SUI during resistance training.

Eligibility Criteria:
Inclusion Criteria:

* being female
* over eighteen years of age
* suffer from stress urinary incontinence
* did not perform Kegel exercises
* had no experience in regular resistance/strength training
* completed a physical activity readiness questionnaire (PAR-Q) form.

Exclusion Criteria:

* pregnancy, breastfeeding
Simulation Training and Teamwork Concerning Intubation on the Icu

To assess effects of the simulation education on the group intubating patients in the iCU, in this prospective study investigators will video-record real-life intubations and simulations. From videos will be assessed correlation of technical and non-technical skills before and after the education and performance in real-life vs simulation intubation.

The aim of this trial is to study the effects of simulation education on the action of the group managing patient's airway in the intensive care unit (ICU). Before simulations investigators will video-record 20 real-world intubations. Consequently will be run simulations to whole staff of the ICU. After the education further 20 real-world intubations will be recorded. Also simulations are recorded. From the videos investigators assess technical and non-technical skills of the group before and after simulation education, correlations between groups and influence of the education on action of the group. On the first part of the study, hypothesis is that group's good non-technical skills improve also technical skills. On the second part of the study hypothesis is that performing well in simulation correlates with performing well in real-world situation and teams with less experience the correlation is stronger.

Eligibility Criteria:
Inclusion Criteria:

-intubations in the icu operated by staff who have given informed consent to this study

Exclusion Criteria:

* intubations in the icu operated by anybody who have rejected video-recording
* intubations in the icu, when patient or patient being unable, close relative has denied permission to use video in this study
* intubated patient is a child, a prisoner, under military service, under forensic psychiatric evaluation, or patient can't give informed consent for example because of the cognitive impairment
* patient is isolated
AmB Dose for Cryptococcal Meningitis

Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients.

Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV infection
* Naive to antiretroviral therapy
* Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
* Agree to participate the study

Exclusion Criteria:

* Having receiving antifungal treatment for ≥3 days
* ALT or AST \> 5\* upper limit of detection (ULD), or neutrophil\< 0.5\*10E9 cells/L, or hemoglobin \< 90g/L or platelet \<50\*10E9/L or serum creatinine \> ULD
* Pregnancy or breastfeeding
* Concomitant medications that are contraindicated with any research drug
* Any other contraindications for using amphotericin B or 5FC
* Inability to follow-up as accessed by the investigator
The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes

Determine if the daily docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA) supplement will reduce serum levels of biomarkers of sub-concussion injuries over a course of American football season among collegiate football athletes.

American football is one of the most popular sports in the U.S. Yet this sport is associated with increased risk of concussion (also known as mild traumatic brain injury, or mTBI) and sub-concussive injury from repeated head impacts (RHI) due to the aggressive and high-speed nature of the game. Current protective equipment used by players are not sufficient to reduce concussion incidence and severity, nor are there any therapeutics available to prevent concussion. This study is a randomized, double-blind, placebo controlled trial to determine if an omega-3 polyunsaturated fatty acid (PUFA) fish oil supplement containing 3.0 grams of docosahexaenoic acid (DHA; 22:6n-3) and eicosapentaenoic acid (EPA; 20:5n-3) can reduce blood biomarkers of sub-concussion injuries compared to placebo (high-oleic safflower oil) over a course of the American football season among collegiate football athletes.

The dosage of DHA/EPA used in this study is generally safe, and procedures involved, monthly blood draws, surveys, and Magnetic Resonance Imaging (MRI), pose minimal risks to participants. While this study provides no direct benefit to participants, successful outcomes of this study can benefit the society by shedding light on development of potential preventative therapeutics for sports-induced mTBI and brain injury from RHI. The risk-benefit profile is appropriate for conducting this study. Based on preclinical studies and previous clinical study results, the investigators expect that in comparison to placebo treatment, DHA and EPA treatment throughout the course of one American football season can maintain lower levels of sub-concussion associated biomarkers, inflammatory cytokines, and cardiovascular risk markers. The investigators also expect participants treated with DHA and EPA to have lower brain MRI imaging markers of sub concussion injury.

Eligibility Criteria:
Inclusion Criteria:

1) University of Arizona National Collegiate Athletic Association (NCAA) Division I American football athletes cleared to participate in university athletics as determined by the team physician.

Exclusion Criteria:

1. Chronic daily anti-inflammatory drugs (\>20 d).
2. Medications for blood lipids.
3. Active fish oil or omega-3 fatty acid supplementation.
4. Consumption of more than two servings of fish per week.
5. Injured and unable to participate in regularly schedule conditioning or competitions.
6. Acute concussion experienced within 30 days of starting the study.
7. Fish allergies.
Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.

PRIMARY OBJECTIVES:

I. Compare the efficacy of medroxyprogesterone, in terms of induction of histologic response, in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus.

II. Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.

III. Examine the mechanisms surrounding the dynamic changes in endometrial tumor cells by determining possible correlations among histologic response, steroid receptor status, immunohistochemical measures of growth and apoptosis, and gene expression profiles in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.

A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus

  * All histologic grades and stages eligible
  * Diagnosis by endometrial curettage or biopsy within the past 8 weeks

    * Must have the initial tissue block or 16 unstained sections of 5 micron thickness available
* Performance status - GOG 0-3
* No history of thrombophlebitis or thromboembolic disorders
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis
* No concurrent aminoglutethimide
* No prior cancer treatment that would preclude study therapy
* No concurrent bosentan
* No concurrent rifampin