cyrilzakka/clinical-trials huggingface dataset:
Pretreatment With Mifepristone Prior to Mirena Insertion

Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use.

The levonorgestrel releasing intrauterine system (IUS), Mirena, represents a highly effective contraceptive method that is cost-effective and requires limited patient effort. Furthermore Mirena offers numerous noncontraceptive benefits and addresses different medical needs for women in reproductive and non reproductive age. Side effects such as menstrual abnormalities are important reasons for early discontinuation of a contraceptive method. Irregular bleeding pattern and spotting represents a well known adverse effect during the first months of use with Mirena and corresponds to the most important factor that negatively influences the acceptability of the IUS. Up to today no standard treatment has been suggested to resolve this issue.

By inducing amenorrhea within a short period of treatment with an anti-progesterone, mifepristone, prior to insertion of Mirena, the bleeding irregularities during the first months of use might be reduced and could therefore represent an important strategy for increasing acceptability of this contraceptive system.

The purpose of the present study is to evaluate the bleeding pattern during the first months of use of Mirena in patients treated with mifepristone compared to placebo in women using Mirena for contraception. The study will also address the effect of mifepristone on endometrial morphology and breast tissue.

Eligibility Criteria:
Inclusion criteria:

* Pre-menopausal women, \>/= 18 years of age.
* Desire of Mirena for contraception
* Good general health (as judged by; general physical examination
* Willing and able to participate after giving informed consent

Exclusion criteria:

* Any hormonal treatment or IUD use within 2 months prior to study start
* History of malignant disorder of the breast
* Any contraindication to mifepristone
* Pregnancy or breast feeding within 2 months prior to study start
MDCT of the Coronary Arteries in Heart Transplanted Patients

Heart transplanted patients often develop coronary artery disease and therefore have their coronary arteries examined with coronary angiography once a year.The purpose of the study is to validate computer tomography of the coronary arteries against coronary angiography and intravascular ultrasound in heart transplanted patients. Additionally the association between different inflammatory markers and the development of CAD specific to heart transplanted patients will be studied.

Heart transplanted patients (HTx) often develop coronary artery disease (CAD) which is a major cause of graft failure and death in this group of patients. Therefore, heart transplanted patients have their coronary arteries examined annually. At present this is being done with coronary angiography. Recent development of the computed tomography (CT) technology has made it possible to examine the coronary arteries with CT angiography (CTA), which is a non-invasive method. The goal of the study is to validate CTA against coronary angiography.

Coronary artery disease lesions in heart transplanted patients differ from CAD lesions in native hearts. HTx patients develop diffuse intimal thickening affecting the whole length of the vessel starting in the periphery. These lesions specific to HTx patients are not depicted on coronary angiography. The second aim of this study is to compare the accuracy of CTA depicting such lesions with the gold-standard, intravascular ultrasound.

The third aim of this study is to study the association between different inflammatory markers and the development of CAD specific to heart transplanted patients.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplanted patient
* Age 18 or above.

Exclusion Criteria:

* Heart transplantation less than a year ago.
* Renal insufficiency with estimated creatinine clearance \< 50 ml/min.
* History of contrast induced nephropathy.
* Known allergic reaction to CT contrast.
* Pregnancy
* Atrial Fibrillation
* Severe heart failure NYHA class IV.
* Hypotension (systolic blood pressure (BP) \< 100 mmHg and/or diastolic BP\<50 mmHg) or hemodynamic unstable patients.
* Severe pulmonary disease making the patient unable to hold his/her breath in more than 10 seconds.
Early Versus Late Use of Hi-VNI in Covid-19

This study evaluate early administration of high-velocity nasal insufflation in COVID-19 patients presented with acute respiratory failure after failure of conventional low flow nasal cannula bypassing the escalating step of Non re-breathing mask where early use of High velocity nasal insufflations achieved better improvement of respiratory distress, lower oxygen requirements and shorter ICU stay.

The study included 30 COVID-19 patients admitted to intensive care of COVID-19 zone, chest Department, quarantine section, Assiut University hospital. All patients were positive for COVID-19 infection by nasopharyngeal swab for detection of viral RNA by real time PCR for SAR-COV-2 RNA assay on 7500 Applied Bio-system. All patients received treatment based on the protocol of Egyptian Ministry of Health, Patients enrolled in the study were categorized into 2 groups, the 1st group included patients whom were shifted to Hi-VNI after failure of high flow nasal cannula, while the 2nd group included patients shifted to Hi-VNI after failure of non-rebreathing mask, using a Precision flow vapotherm (vapotherm, Inc, 100 Domain device Exeter, NH 03833, T: 603-658-0011, USA), that provide high velocity humidified flow through narrow bore nasl prongs

Eligibility Criteria:
Inclusion Criteria:

* 1-severe COVID Patients with hypoxemic respiratory failure. 2- Patients with no comorbidities

Exclusion Criteria:

1. Non severe COVID Patients
2. Patients with comorbidities (e.g chronic chest dis, DM, renal failure and hepatic failure
3. Patients indicated for mechanical ventilation
4. Patients with marked hypercapnia in need for non-invasive ventilation
Risk Factors for Postoperative Nausea/Vomiting

General anesthetic technique plays a key role in most surgical procedures. This technique has some complications especially postoperative nausea/vomiting (PONV). This complication can lead to serious problems. Department of Anesthesiology has developed and implemented a PONV prophylaxis guideline for high risk PONV patients but PONV still remains.

Objective: To identify risk factors for PONV after implementation of PONV prophylaxis guideline.

Methods: This will be a retrospective analytic study. Relevant clinical data from medical records of adult patients undergoing general anesthesia in Srinagarind Hospital from November 2014 to February 2015 will be used to identify relevant risk factors.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I-III

Exclusion Criteria:

* Incomplete or illegible medical records
* Patients who underwent cardio-thoracic surgery
* Patient who had chronic treatment with antiemetic drugs
Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children

Needle-related procedures are among the most common sources of pain and distress for children in the health care setting. More than 50% of children reported pain during these procedures. The necessity for pain management during these procedures is well established. Topical anesthesia has been shown to be effective in managing needle-related pain. Eutectic mixture of local anaesthetic (EMLA) cream is the topical anesthetic most used. The application of this mixture of lidocaine and prilocaine reduce pain during needle procedures in children. To be effective EMLA cream must be applied for at least 60 minutes before needle procedure. This is the major limitation for its use in emergency settings.

Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and tetracaine) through the skin. There is evidence of pain relief after 30 minutes from its application. Only one randomized controlled trial compared the two topical anaesthetics in children during venipuncture and showed that Ralydan patch led to superior analgesia than EMLA cream, even if in this study the two anaesthetics were applied only for 35 minutes before needle procedure. No differences were found in success rate of the procedure and vein visibility. In adult patients, Ralydan and EMLA were equally effective in pain relief after 60 minutes from application.

To the best of the investigators' knowledge there is no published study that compared needle procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect.

The aim of this study is to compare Ralydan patch and EMLA cream at time of their maximum analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the first attempt and pain relief in children.


Eligibility Criteria:
Inclusion Criteria:

* Age 3 to 10 years
* Need for peripheral IV line or venipuncture
* Informed consent signed by parents or legal guardians

Exclusion Criteria:

* Need for emergency care
* Known allergy or sensitivity to local anesthetics
Role of Gum Chewing in Post-operative Gut Motility After Cesarean Section

Many women deliver by caesarean section nowadays. The proportion of women who deliver by caesarean section ranges from 15% to over 50%, in some countries. After a caesarean section it is common for the bowel to stop working for several hours or days. Although this usually resolves by itself in a few days, it may be very uncomfortable. The retained gases and stools can cause the mother's belly to become swollen and painful with cramps and she may feel nauseated and vomit so she is not able to eat. She may need additional medications to ease these symptoms and her hospital discharge may be delayed. The use of medications that relieve pain during labour and painkillers following the surgery can also delay bowel function. Small intestine activity after abdominal operations returns to normal function within a few hours, gastric activity returns to normal within 24-48 hours, and colon activity returns to normal within 48-72 hours. Due to the delayed motility of the gastrointestinal system in the postoperative period, gas and secretions accumulate in the stomach and small and large intestines, which causes abdominal distension, nausea, vomiting, and pain, all of which negatively affect the comfort level of the patients. Chewing sugar-free gum after cesarean section can promote the early recovery of gastrointestinal function, but the side effects of chewing gum are still unclear, which needs more clinical, large sample and high-quality studies to further verify.


Eligibility Criteria:
Inclusion Criteria:

* Females of age 18-40 years
* Parity \<5
* Presenting at gestational age ≥ 37 weeks,
* Undergoing cesarean section (as per operational definition) under spinal anesthesia

Exclusion Criteria:

* Females with history of chronic constipation (medical record)
* Females with obstructed labour, hypothyroidism (TSH\>5IU)
* Females with intra operative complications such as bowel injury, history of gastrointestinal surgery, and water and electrolyte disturbances (on medical record), abnormal placenta (accrete, increta, previa, abruption)
The Effects of Lateral 45° Downward Position on the Optic Nerve Sheath Diameter

Trendelenburg position and carbon dioxide (CO2) pneumoperitoneum are in association with increased intracranial pressure (ICP) reflected by the optic nerve sheath diameter (ONSD). Measurement of ONSD by ultrasound (US) guidance can be used in the diagnosis of ICP. The investigators interrogated the effects of lateral 45° downward position and CO2 insufflation on ONSD in patients undergoing laparoscopic transperitoneal nephrectomy.

Transperitoneal laparoscopic nephrectomy is a popular and increasingly used alternative to the laparoscopic retroperitoneal approach because of benefits such as minimal invasion, the transperitoneal path provides a larger working space and familiar anatomic landmarks. This technique requires a steep (35° to 45°) lateral downward (SLD) position and a CO2 pneumoperitoneum. SLD may lead to pathophysiological changes such as pulmonary dysfunction with the formation of atelectasis and increasing airway pressure as well as ocular complications. These are firstly reported 2 patients with bilateral ischaemic optic neuropathy (ION) after a da Vinci robotic-assisted procedure. SLD has raised concerns that prolonged elevation of venous pressure in the head may increase the risk of developing ION. However, a few investigations have yet been made into intraoperative changes in intraocular pressure (IOP) and optic nerve sheath diameter (ONSD) - correlating with intracranial pressure (ICP) - and their adverse ocular effects. The operative conditions get better the steeper the positioning, providing an excellent intraabdominal view and probably less bleeding. The hypothesis of the study is that patients placed in SLD for several hours have a high risk for ocular changes and peri- and postoperative complications. The aim of this study was to investigate the influence of capnoperitoneum and permanent 45° SLD on IOP and ONSD in patients undergoing laparoscopic transperitoneal nephrectomy. The investigators also analyzed the hemodynamic and respiratory parameters, duration of surgery during laparoscopic nephrectomy. Perioperative and postoperative complications were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years who have undergone laparoscopic transperitoneal nephrectomy.

Exclusion Criteria:

* Those who have neurological and cerebrovascular disease.
Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy

STEPUP is a 12-week randomized clinical trial among 126 postpartum women with pregnancies complicated by hypertensive disorders. Participants will be randomized to a control arm and receive a Fitbit or an intervention arm. The intervention arm will receive a Fitbit and set a step count goal, receive daily feedback via text about whether they reached their goal, and will be placed in virtual teams with other participants where they can win points for their team if they meet their daily goals. The main study outcomes will be increase in mean step count and change in psychosocial survey measures.

Women with hypertensive disorders of pregnancy, such as preeclampsia and gestational hypertension, are at elevated risk of developing hypertension, diabetes, heart failure, and premature atherosclerotic cardiovascular disease. Current guidelines recommend intensive lifestyle modification for women with a history of hypertensive disorders in pregnancy in order to reduce the risk of developing cardiometabolic risk factors or overt CV disease. However, limited research exists to guide how to implement lifestyle modification for this population. The postpartum period poses unique challenges to adopting a healthy lifestyle. Remote interventions using mobile technology may be particularly effective. Social incentives designed using insights from behavioral economics have been demonstrated to motivate health behavior change, such as increasing physical activity. The objective of this study is to use a randomized clinical trial to test the effectiveness of a 12-week team-based, mobile health interventions using wearable devices and social incentives to increase physical activity in the postpartum period.

Eligibility Criteria:
Inclusion Criteria:

* Delivered a live baby at HUP or PAH within 4.0-12.6 weeks prior to study enrollment;
* Diagnosis of chronic hypertension, gestational hypertension, or preeclampsia during most recent pregnancy;
* Participating in Heart Safe Motherhood (HSM) program;
* Ability to read and provide informed consent to participate in the study;
* Has smartphone and email address

Exclusion Criteria:

* Does not speak English
* Answers yes to any of the following questions:
* Are you currently participating in any other physical activity studies?
* Do you have any medical conditions or other reasons why you could not participate in a 12-week physical activity program?
* Participants will be excluded after completing the baseline period if their baseline step count is too high (greater than or equal to 10,000 steps per day).
Antibiotic Use & Open Fracture of the Lower Extremity

It is important to recognize the potential for renal injury and be cognizant of this during the management of complex trauma patients. The primary aim of this study is to investigate the necessity of aminoglycoside usage for patients with open lower extremity fractures. Hypothesis: adding aminoglycoside on top of cephalosporin in treating lower extremity fracture will make no significant difference in term of clinical outcomes when compared to cephalosporin alone.

The trauma patient is particularly susceptible to renal injury due to factors such as renal hypoperfusion in the acute setting, the concomitant administration of necessary intravenous contrast agents for diagnostic, and sometimes additionally therapeutic imaging (3). This is additionally complicated by the presentation of trauma patients with pre-existing renal disease.

This study will assess whether prophylactic antibiotics \<72hrs have similar outcomes as ≥ 72 hrs of antibiotics, whether type of antibiotics impacts outcomes in patients in either group, help determine the incidence of infection in Gustilo Type III lower extremity fracture when treated either with a single agent (cephalosporin) or dual agent (cephalosporin + aminoglycoside) and the complication profile of patients with Gustilo Type III lower extremity fracture when treated either with a single agent (cephalosporin 1st generation) or dual agent (cephalosporin 1st generation + aminoglycoside).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years of age
* All patients with open grade II or grade III lower extremity open fractures according to the Gustilo Classification of open fracture.

Exclusion Criteria:

* Any significant injuries in addition to the lower extremity fracture as determined by the PI that may confound the data.
* Inability to give informed consent or comply with data acquisition (Part 3).
* Pregnant or breast feeding patients due to the potential risks to the mother and/or fetus.
* Prisoners
* Previous bone malignancy
* Bowel or enteric injury at index admission
* TBI of AIS ≥ 5
University of Pittsburgh Brain Health Initiative

This project will define the prevalence of brain health (i.e., normal cognitive, neuromotor, behavioral function) in living professional football retirees and group-matched controls through a comprehensive assessment of clinical, neuroimaging, and biomarker measures.


Eligibility Criteria:
Inclusion criteria:

Former professional football player/exposed group:

1. Professional football retiree aged 29-59
2. Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season
3. Fluent in English (translations are not available/validated for most neuropsychological tests)

Control/unexposed group:

1. Age 29-59 male
2. High school education or beyond
3. Fluent in English (translations are not available/validated for most neuropsychological tests)

Exclusion criteria:

Control/unexposed group:

1. Played organized football beyond high school
2. History of severe TBI
3. Current unstable cardiovascular disorder

For both groups:

1. Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.
2. Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia
Circadian Rhythmicity in Cold-induced Thermogenesis

This study aims to investigate whether maximum cold-induced non-shivering thermogenesis (e.g. thermogenesis as a consequence of BAT activity) differs between morning and evening.

Brown adipose tissue (BAT) recently emerged as a novel player in energy expenditure (EE) in humans as it combusts fatty acids and glucose towards heat. Human BAT can be activated by sympathetic stimulation resulting from cold exposure or treatment with sympathomimetic drugs. Short-term acclimation to mild cold was shown to reduce fat mass in obese subjects and decrease peripheral insulin resistance of patients with T2DM. Recently, in preclinical studies the investigators showed that BAT has a circadian rhythm. It is currently unknown whether this is also the case in humans. The investigators postulate that BAT activity should display a circadian rhythm that adapts to changes in circadian behavior, and may determine glucose/lipid levels throughout the day.

Eligibility Criteria:
Inclusion Criteria:

* Dutch white Caucasian males or females
* Age: 18-35 years
* Lean group: BMI ≥ 18 and ≤ 25 kg/m2
* Obese glucose tolerant group: BMI ≥ 30 and ≤ 42 kg/m2 and fasted plasma glucose levels \< 5.5 and/or 2 h after OGTT ≤ 7.8 mM
* Obese impaired glucose tolerant group: BMI ≥ 30 and ≤ 42 kg/m2 and fasted plasma glucose levels ≥ 5.5 and/or 2 h after OGTT between 7.8 and 11.1 mM

Exclusion Criteria:

* Diabetes mellitus (determined on basis of fasting or OGTT defined by ADA criteria (30)
* Any other active endocrine disease (thyroid disease, any signs of Cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia)
* Any chronic renal or hepatic disease
* Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta blockers, antidepressants)
* Smoking
* Abuse of alcohol or other substances
* Pregnancy
* Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
* Current participation in another research projects that may influence the current research project
* Clinically relevant abnormalities in clinical chemistry at screening (to be judged by the study physician)