cyrilzakka/clinical-trials huggingface dataset:
Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy

EILEEN was a non-interventional/observational, retrospective, multi-center, real life cohort study conducted in 14 private and academic oncology clinics in Turkey. Group I cohort of the study was based on secondary use of data of postmenopausal hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) patients treated with ribociclib in combination with letrozole (LET) or fulvestrant (FUL) after June 2020. Group II cohort of the study was a parallel, comprehensive chart review for detecting all postmenopausal HR+, HER2- MBC patients who were eligible for cyclin-dependent kinase inhibitors (CDKis) but received chemotherapy. The study used secondary data which was retrieved from electronic or paper medical records or clinical databases available at the sites. Regular follow up with close monitorization was used for the effective management of patients with breast cancer. Data sources included information about diagnosis, treatment and monitorization of patients at an individual level. The study used medical patient records at hospitals e.g. hospital discharge files, primary clinical records and electronic medical records.


Eligibility Criteria:
Inclusion Criteria:

Group I: Postmenopausal female patients who had histologically or cytologically confirmed HR-positive (10% or more ER+), HER2-negative, metastatic breast cancer and initiated ribociclib combinations per local label.

* Treated with ribociclib plus letrozole relapsed after 12 months completing adjuvant treatment or without any prior endocrine treatment for metastatic disease, 1 line or less chemotherapy was allowed.
* Treated with ribociclib plus fulvestrant, clinical and/or radiological disease progression after at least 6 months and at least 1 aromatase inhibitor treatment for metastatic disease or relapsed after 12 months adjuvant aromatase inhibitor treatment and/or relapsed within 12 months completing adjuvant aromatase inhibitor, 2 lines or less prior treatments and 1 line or less prior chemotherapy at metastatic setting were allowed.
* Had first treatment response rate assessment within 6 months after ribociclib initiation.
* Initiated ribociclib in combination with letrozole/fulvestrant after MBC diagnosis after local approval of ribociclib in June 2020.

Group II: Postmenopausal female patients who had histologically or cytologically confirmed HR-positive (10% or more ER+), HER2-negative, metastatic breast cancer eligible for cyclin-dependent kinase (CDK) inhibitors according to local label but started chemotherapy.

Exclusion Criteria:

* Pre- or perimenopausal women.
* Enrollment in an interventional clinical trial for MBC during the study observation period.
* Evidence of prior treatment with any CDK4/6 inhibitor in the adjuvant setting.
* Evidence of another primary cancer within 3 years prior to the initial line containing ribociclib.
Endoscopic Surveillance on a High-risk Population for Gastric Cancer in Latin America: The ECHOS Cohort Study.

The goal of this observational study is to evaluate the risk factors associated with incident HGD/GA in patients with CAG with or without IM who are enrolled in endoscopic surveillance, as well as to compare GA incidence according to the OLGA and OLGIM scales in patients 18 years or older.

. The main questions it aims to answer are:

* What risk factors are associated with incident HGD/GA in patients with CAG with or without IM?
* What is the comparative HGD/GA incidence according to the OLGA and OLGIM scales?

The Endoscopic Cohort and Histological OLGA staging (ECHOS) study is a retrospective longitudinal cohort developed in the Pontificia Universidad Católica de Chile health care system, an open health care system with 3 endoscopic units in Santiago, Chile. Patients 18 years or older were eligible for the study if they had at least one non-urgent outpatient EGD with gastric biopsies collected following the USSBP between June 2015 and June 2021. The baseline EGD was defined as the earliest examination conducted between this time frame that met inclusion criteria. Participants were included in the cohort if they underwent a subsequent "surveillance" EGD. In order for the subsequent EGD to qualify as surveillance, it needed to occur at least 6 months after the baseline EGD and include gastric biopsies collected according to the USSBP; one exception to the USSBP requirement was if HGD or GA was detected on the surveillance (i.e. non-baseline) EGD. Patients with prior history of HGD or any type of gastric malignancy, gastrectomy or non-gastric active malignancy were excluded. Also, patients with HGD or GA on the baseline EGD were excluded. Patients with indefinite (IND) or low-grade dysplasia (LGD) on the baseline EGD were considered for the cohort.

Eligibility Criteria:
Inclusion Criteria:

* At least one non-urgent outpatient esophagogastroduodenoscopy (EGD) with gastric biopsies collected following the Updated Sydney System Biopsy Protocol (USSBP) between June 2015 and June 2021.
* Underwent a subsequent "surveillance" EGD. For the subsequent EGD to qualify as surveillance, it needed to occur at least six months after the baseline EGD and include gastric biopsies collected according to the USSBP; one exception to the USSBP requirement was if HGD or GA was detected on the surveillance.

Exclusion Criteria:

* Prior history of HGD or any type of gastric malignancy, gastrectomy, or non-gastric active malignancy.
* HGD or GA on the baseline EGD was excluded.
The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis

Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
* Horizontal-rotatory spontaneous nystagmus.

Exclusion Criteria:

* History of vestibular disfunction before the acute onset of symptoms
* Simultaneous Hearing loss
* Neurologic disorder
* Pregnancy or lactation
* History of psychiatric disorders
* History of glaucoma
* Diabetes
* Hypertension
* Contraindication in receiving corticosteroids
Participant Satisfaction With Two Different Summative Assessment Methods - a Mixed Method Questionnaire Study

Participants of Immediate Life Support and Advanced Life Support Courses, where two different summative assessment methods were used are asked about their satisfaction with the assessment method using a questionnaire. Both quantitative questions using an 11-point-Likert scale as well as open-ended qualitative questions will be asked. The primary aim of this study is to find out which variant of summative assessment is perceived by course participants as testing their leadership competency best, immediately after the comparison as well as 1 year later to identify any long-term effects on the students.


Eligibility Criteria:
Inclusion Criteria:

* All 5th and 6th year medical students at the University of Bern, Switzerland, study year 2017/2018 and 2018/2019

Exclusion Criteria:

* Refusal to participate
Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary

Background Intra-abdominal abscess (IAA) is one of the most serious surgical infectious complications on pancreaticoduodenectomy (PD) patients. Preoperative biliary drainage (PBD) is considered as a risk of surgical infectious complications. However, the reason why PBD caused IAA was unknown. In this study, we hypothesize that bile contamination may increase the rate of IAA as bile from residual common bile duct (CBD) leaks and contaminates the abdominal cavity.

Methods We retrospectively collected PD patients with performance of bile culture between 2007 and 2019 in our institute. As to bile culture, we used a swab to do intraoperative bile cultures after transection of the CBD. IAA was defined as a postoperative fluid collection managed by CT-guided placement of drains with documental bacteriological culture.


Eligibility Criteria:
Inclusion Criteria:

* all pancreaticoduodenectomy patients

Exclusion Criteria:

* no bile cultures
Dose of Remi in Children

Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown.


Eligibility Criteria:
Inclusion Criteria:

* age from 3 to 12 years old
* patients scheduled for surgery under general anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists status \>=Ⅲ
* Body mass index\>=28kg/m2
* patients who cannot cooperate with intravenous anesthesia induction
* patients with risk of difficult airway
* patients who are allergic to benzodiazepines
* patients with delayed neurologic function
Effectiveness of a Telephone Intervention to Improve the Mental Health of Abused Women

The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.

Depression is one of the most common mental health sequelae of intimate partner violence (IPV). Although a range of interventions have been tried to improve the mental health of women survivors of IPV, the results are inconclusive. In this trial, a 12-week advocacy intervention consisting of empowerment and telephone social support is provided to abused Chinese women in a community setting. Usual community services provide the control condition.

Eligibility Criteria:
Inclusion Criteria:

* Chinese women 18 years of age or older
* Self-report of psychological, physical or sexual abuse by their current or former intimate partner in the previous 12 months
* Live or work in a community within the catchment area of a community centre designated for the proposed study

Exclusion Criteria:

* Perpetrator is not an intimate partner
Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.

Acute kidney injury is a common complication after cardiac surgery and is associated with decreased long-term survival.

Several experimental and animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of high dose erythropoietin. Clinical studies in human have also suggested that high dose erythropoietin has preconditioning effects against injury after ischemia and reperfusion on different organs in human, such as brain, heart, liver, and kidneys.

Administration of Epo in high doses in conjunction with cardiac surgery has shown to be safe with no direct side-effects.

The investigators therefore hypothesize that a preconditioning effect of erythropoietin before cardiac surgery can reduce the level of renal dysfunction after surgery in a group with preoperative renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* The patient is scheduled for non-emergent CABG surgery.
* CyC eGFR or MDRD eGFR \< 60 ml/min.
* The patient has given his/her written consent to participate

Exclusion Criteria:

* The patient has an uncontrolled hypertension.
* Hypersensitivity to the active drug.
* The patient is pregnant or is a fertile woman (\<50 years).
* The patient has been treated with Erythropoietin within 4 weeks prior to the surgery.
* Preoperative CyC eGFR or MDRD eGFR is \< 15, or the patient is treated with dialysis.
* The patient has a known malignancy.
* The patient is planned for Off-pump CABG surgery.
* The patient is included in other ongoing clinical trial. Yes / No
* Clinically judgment by the investigator that the patient should not participate in the study.
Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients

Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.

Use of Paricalcitol in stage Vd Chronic Kidney Disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. This study uses paricalcitol (vitamin D) versus atorvastatin versus paricalcitol plus atorvastatin treatments.

Eligibility Criteria:
Inclusion Criteria:

* Vd CKD patients using haemodialysis during 3 or more months.
* Tunnelized-bearer permanent catheters on haemodialysis at last 6 months previous at the beginning of the study. .
* Kt stable, over 45 litres on both sexs.
* Patients in treatment wiht atorvastatin
* Patients without infectious or inflammatory processes over 8 weeks.
* Two consecutive PTH \< than 400 pg/ml; Ca\<10.2 and P \<7.0 mg/dl.

Exclusion Criteria:

* Patients \> 18 years.
* Pregnant women.
* Patients hospitalized 4 weeks before the beginning of the treatment.
* Immunosuppressor intake.
Clinical Aspect of Erosive Pustular Dermatosis of the Leg

Erosive pustular dermatosis of the leg is a fairlyrecent clinical entity that was described the first time in 1987.

Diagnosis of erosive pustular dermatosis of the leg is made on clinical grounds. It presents as non-follicular pustules of variable size and numbers that rapidly give way to erosions and crusts on one or both legs, and which are found in particular on the anterior aspect of the middle third of the leg (. The lesions are of chronic progression, despite topical therapy. Erosive pustular dermatosis of the leg is seen in elderly patients, mainly female, and may be associated with chronic venous insufficiency or cutaneous atrophy. In the absence of specific criteria and because of the existence of misleading clinical forms, diagnosis is based upon exclusion.

The primary objective of this investigation was to describe the different clinical aspects of cases of Erosive pustular dermatosis of the leg.

Eligibility Criteria:
Inclusion Criteria:

- non-follicular pustules and multiple erosions on one or both legs showing no evidence of improvement after application of compression in the event of clinical signs of chronic venous insufficiency and showing no improvement following treatment with local and/or systemic antibacterial therapy, fungal samples from the pustules negative on direct examination, negative direct immunofluorescence results for biopsy samples (taken from around the lesion)

Exclusion Criteria:

- age \< 18 years old
Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors

This is a pilot study designed to explore the feasibility of non-invasively diagnosing the presence of cancer in the breast using non-invasive magnetic resonance imaging (MRI) methods and an analysis of vessel shape defined from these magnetic resonance images.


Eligibility Criteria:
Inclusion Criteria:

* adult women (age \>= 18),
* with Histologically documented newly diagnosed stage II-IV invasive breast cancer appropriate for neoadjuvant (preoperative) systemic therapy.
* ECOG performance status of 0, 1, or 2 at the initiation of the study.

Exclusion Criteria:

* pregnant women
* women with contralateral mastectomies
* known bilateral tumors
* subjects prone to claustrophobia
* contraindicated to have MRI
* mentally impaired
* not fluent in english
Comparative Effects of ACBT and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After CABG

To compare the effects of active cycle of breathing technique and diaphragmatic breathing on pulmonary functions and sputum diary after coronary artery bypass graf

It will be a randomized clinical trial. Age of selected subjects will be between 40 to 60 years and data will be collected from intensive care units (ICUs) and cardiac care units (CCUs) of selected hospitals. There will be 2 groups i.e. group A will receive active cycle of breathing technique (ACBT) and group B will receive diaphragmatic breathing technique. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. The trial will be completed in two days after patients admitted in the ICUs/CCUs and before and after each session, primary and secondary outcomes will be measured for both groups. After data collection, data will be analyzed using SPSS version 25

Eligibility Criteria:
Inclusion Criteria:

* Post-CABG patients
* Gender: males and females
* Have speaking, hearing and cognitive ability
* On mechanical ventilation for ≤ 24 h after CABG

Exclusion Criteria:

* Prior history of open heart surgery
* Prior severe pulmonary/hepatic or renal disease- Complications after CABG (cardiogenic shock, bleeding requiring transfusion, acute kidney injury, cardiac temponade and severe hypotension)
* Life-threatening arrhythmias (ventricular fibrillation, ventricular tachycardia, atrial fibrillation)
* On mechanical ventilator for more than 24 h after CABG
* Pulmonary complications (atelectasis, acute respiratory distress syndrome (ARDS), diaphragmatic injury)
Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures

This study evaluates estimate impact of introducers length during endovascular coronary procedures on rate of a radial artery occlusion. For half of participants will use short introducers, while for other will use long introducers during transradial coronary intervention.

The transradial approach for coronary angiography and interventions is increasingly utilized around the world. Radial artery occlusion is the most common significant complication after transradial catheterization, with incidence varying between 1% and 10%. Endothelial injury of the radial artery and decrease in blood flow after sheath and catheter insertion appear to contribute to thrombus formation and are predisposing factors for radial artery occlusion. Procedural factors can predict and influence radial artery occlusion incidence. Sheath size and its relation to radial artery diameter, as well as the utilization of specific pharmacological agents (such as anticoagulants and vasodilators) have been studied. But, impact of Introducer sheath length on the rate of a radial artery occlusion has not been studied. The investigators suggest that, longer introducer sheath sizes can prevented the vascular damage and a pro-thrombotic environment.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Applicability of transradial approach

Exclusion Criteria:

* Failure of the transradial approach
Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa

The primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.


Eligibility Criteria:
Inclusion Criteria:

* Study participants must produce sputum that is positive for Pseudomonas aeruginosa.
* Confirmed diagnosis of CF (positive sweat chloride \>60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype.
* Forced expiratory volume (FEV1) ≥40% predicted at Screening as calculated by the Knudsen reference equations.
* Clinically stable with no evidence of current pulmonary exacerbation.

Exclusion Criteria:

* History of lung transplantation.
* Use of intravenous antibiotics or oral quinolones within 14 days of Screening.
* Use of low dose oral antibiotics (e.g. tetracycline, sulfa) for acne or other conditions within 30 days of Screening.
* Use of systemic corticosteroids (≥20 milligrams \[mg\] of prednisone per day) within 30 days of Screening.
* Initiation of TOBI® (tobramycin), high dose ibuprofen, recombinant human DNase (rhDNase), or macrolide antibiotics within 60 days of Screening.
* History of sputum or throat swab culture yielding Burkholderia cepacia complex within 2 years of Screening or growth of Burkholderia cepacia complex from the sputum or throat swab culture obtained at Screening.
* History of biliary cirrhosis, portal hypertension, or splenomegaly or splenomegaly on physical exam at Screening or enrollment.
* History of daily continuous oxygen supplementation or requirement for more than 2 liter per minute (L/min) at night.

Note: Other inclusion/exclusion criteria may apply.
Efficacy of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome Post Mastectomy Lymphedema

Sixty eight female patients who had symptoms of carpal tunnel syndromesuch as wrist pain or numbness and paraesthesia and had lymphedema of an upper extremity.Their ages will be ranged from 40 to 60 years. The participants will be selected from Out Patient clinic of Faculty of Physical Therapy, Cairo University and randomly distributed into two equal groups.Duration of treatment for 4weeks.All subjects signed an informed consent form, and the rights of subjects were protected.

In this study the patients will be randomly assigned into two equal groups(34 patients for each group)Group A (experimental group):This group includes 34female patients who will receive extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide skin care and manual lymph drainage 2 sessions per week for 4 weeks. Group B (control group):

This group includes 34female patients who will receive shame extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide exercises, skin care and manual lymph drainage 2 sessions per week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

All participants could be considered and enrolled if they conformed to the diagnosis of CTS, with clinical symptoms for at least 3 months.

The clinical symptoms and signs for the diagnosis of CTS were as follows:

1. Paresthesias and painful swelling with weakness of the affected hand, exacerbated while sleeping or by repetitive use of the wrist, which would be relieved by shaking the hand with postural change.
2. Sensory loss with numbness in the regions of the hand innervated by the median nerve;
3. Impaired motor function with atrophy of the median nerve-innervated thenar muscles.
4. Positive Tinel's sign.

The subject selection will be according to the following criteria:

* Female patient their age range between 40-60 years.
* Symptoms of CTS as pain, tingling sensation for at least 3 months.
* Unilateral or bilateral Lymphedema following mastectomy
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* The potential participants will be excluded if they meet one of the following criteria:
* Local infections at the hand level.
* Patients with prior medical histories of cardiac arrhythmias.
* Patient with venous thrombosis.
* Areas of skin with lesions and impaired sensation
* Other diseases that cause significant swelling.
* During pregnancy and breastfeeding.