cyrilzakka/clinical-trials huggingface dataset:
QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance

This is a local, prospective, non-interventional, regulatory post-marketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Qtern as indicated by the MFDS will be included. 600 patients are followed up 12 weeks and at least 60 patients of the 600 patients are followed up 24 weeks. Patients will be treated as part of routine practice at Korean healthcare centers by accredited physicians. In this study, patients will receive Qtern as indicated in the locally approved prescribing information.

As part of a post approval commitment, the MFDS has requested a post-marketing surveillance program to characterize safety in patients who are treated with Qtern for T2DM by physicians in the normal clinical practice setting. This study is designed to confirm assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Qtern under conditions of routine daily medical practice in Korea.

The primary objective of this study is :

Descriptive analysis of the proportion of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with Qtern for type 2 diabetes mellitus by physicians in the normal clinical practice setting over a period of 12 and 24 weeks.

The secondary objectives of this study are:

To follow the changes of the hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hr post-prandial glucose (PPG-2hr), blood pressure, abdominal circumference and body weight and self-reported data in this cohort of patients from baseline to completion of the study.

To evaluate the safety and tolerability of Qtern in patients with type 2 diabetes mellitus based on conducted laboratory test. (Laboratory tests are not mandatory because of the non-interventional nature of this study)

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 years and older
2. Patients with T2DM eligible for treatment with Qtern as indicated in the locally approved prescribing information
3. Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Patients treated with Qtern outside of the locally approved Prescription Information in Korea
2. Patients with contraindications for the use of Qtern (as described in the Korean Prescription Information)
Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study

Acute kidney injury (AKI) is a complex disorder with clinical manifestations ranging from mild dysfunction to complete anuric kidney failure. Its leads to sudden and rapid decline in renal excretory function within hours to days,accompanied by accumulation of nitrogenous waste products such creatinine,urea and other clinically un measured products

Acute kidney injury (AKI) is an under-recognized morbidity of neonates; the incidence remains unclear due to the absence of a unified definition of AKI in this population and because previous studies have varied greatly in screening for AKI with serum creatinine and urine output assessments. Premature infants may be born with less than half of the nephrons compared with term neonates, predisposing them to chronic kidney disease (CKD) early on in life and as they age. AKI can also lead to CKD, and premature infants with AKI may be at very high risk for long-term kidney problems. AKI in neonates is often multifactorial and may result from prenatal, perinatal, or postnatal insults as well as any combination thereof.

Eligibility Criteria:
Inclusion Criteria:

* All cases of acute kidney injury in neonates who will be admitted to NICU Assiut University Children Hospital during the duration of the study.

Exclusion Criteria:

* Cases with chronic renal affection Any case with congenital anomalies
Treatment of Tracheostomy Granulomas

This study plans to learn more about the different ways used to treat tracheostomy granulomas. Investigators want to see which standard of care method (steroid application, silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.

Upon joining the study patients will be assigned to one of the three treatment groups (steroid application, silver nitrate, and betadine). These three treatments are standard of care and patients would have been treated with one of them anyway. Patients will be followed for an observation period of six weeks with follow-up appointments, per standard of care, every two weeks (+/- 3 days) in order for a physician to evaluate if the treatment method is working. If during a follow-up visit, the physician determines the treatment method is not working, the follow-up period will end and participation in the study will be complete. In addition, if a patient is given a different form of treatment during the observation period, such as in the emergency department or through their primary care physician, the follow-up period will end and participation in the study will be complete.

Eligibility Criteria:
Inclusion Criteria:

* Children's Hospital Colorado inpatient or outpatient
* 31 days to 17 years (inclusive)
* Needs treatment for a tracheostomy granuloma

Exclusion Criteria:

* Tracheostomy granuloma has been treated in the last two weeks
Relationships Between OLST, GMFM and Pedobarographic Values in CP

The primary aim of this study was to investigate the relationship between the One Leg-Standing Test (OLST) and the Gross Motor Function Measurement (GMFM) and stance phase stability during gait in Unilateral Cerebral Palsy (UCP). The secondary aim was to explore a new well-defined pedobarographic parameter as a functional factor in the stability of stance in gait.

The investigator's hypotheses are (1) OLST has relationship between T2-T1 in children with UCP; (2) OLST has relationship between GMFM D and E.

Eighteen children with UCP and ten typically developing children (TDC) participated in the study. All participants and their legal guardians signed an informed consent form before participating. Firstly, to asses the stability in stance all participants were analyzed by using pedobarographic analysis and the OLST. After analysis, only the UCP group was evaluated with the GMFM. The TDC group was used for comparison of pedobarographic stance phase stability (T2-T1) and OLST values.


Eligibility Criteria:
Inclusion Criteria (for experimental group):

* diagnosed unilateral cerebral palsy
* be able to stand on the affected leg for 0 to 30 seconds

Exclusion Criteria:

* Children with UCP who had Botulinum Toxin-A injections to the lower limbs in the previous six months
* Lower limb surgeries
* Mental disorders
Run Daddy Run! A Lifestyle Intervention Focusing on Fathers and Their Children

The aim of this study is to develop and implement a multicomponent eHealth lifestyle intervention (focusing on (co-) physical activity and screen time) for fathers and their children, aiming to prevent childhood overweight and obesity.

The Run Daddy Run project aims to develop an effective lifestyle intervention for Belgian fathers and their primary school-aged children, to prevent overweight and obesity. There is focused on increasing (co-) physical activity and limiting individual and joint screen time. The project specifically targets fathers and their children because the literature shows that now often only mothers participate in lifestyle interventions, and fathers are underrepresented and difficult to involve. However, fathers play an important and unique role, independently of the mother, in shaping the child's behavior.

The Run Daddy Run intervention was developed based on the Intervention Mapping Protocol, a theoretical framework that is often used to develop interventions in a systematic way using empirical evidence and theoretical insights. A co-creation approach was also used for the intervention development, which is a bottom-up approach in which the target group (fathers in this case) is actively involved in the development of the intervention. The result of this approach is contextually appropriate intervention and intervention strategies.

Eligibility Criteria:
Inclusion Criteria:

* Fathers
* Primary school aged children

Exclusion Criteria:

- Unhealthy/disease
Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.


Eligibility Criteria:
Inclusion Criteria:

* Must use fluticasone and salmeterol for the first time
* Must use fluticasone and salmeterol for long-term

Exclusion Criteria:

* Patients with hypersensitivity to salmeterol and fluticasone
* Patients with infection which salmeterol and fluticasone is not effective
* Patients with deep mycosis
Developing a Whole-body MRI and Diffusion-weighted Imaging State-of-the-art Protocol: a Pilot Study

Whole-body magnetic resonance imaging (WB-MRI) is a non-ionizing imaging method that can provide WB coverage using essential imaging contrasts with the possibility to include sequences focusing in specific body-regions as needed per case. WB-MRI is increasingly being used for the management of cancer patients, especially metastatic ones. An integral part of WB-MRI is becoming whole-body diffusion-weighted MRI (WB-DWI) which is a non-invasive tool used for staging and response evaluation in oncologic practice. WB-DWI is an inherently noisy technique, resulting in it accounting for more than 50% of the acquisition time of conventional whole-body MRI studies with overall duration at least 1-hour. Reducing acquisition times, without compromising image or diagnostic quality would facilitate the wider adoption of clinical WBDWI, reducing costs, and improving the patient experience


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Patients with diagnosis of multiple myeloma, lymphoma, lung, prostate, breast, colorectal and gynecologic cancers;
* Patients with genetic syndromes responsible for an increased predisposition to neoplasms (e.g. Li Fraumeni syndrome);
* Signed written informed consent to personal data treatment for research purposes

Exclusion Criteria:

* Age \<18 years old;
* Refusal to sign the written informed consent to personal data treatment for research purposes.
Measurement of Age and Sex Related Changes in Nasal Tip Support Using Digital Newton Meter

Background:

It is predicted that the nasal tip support will decrease with aging due to weakening of cartilage and connective tissues. However, there is no consensus on the age at which this change began. It is quite difficult to evaluate the nasal tip support, while the ideal nasal tip support pressure is also not known. The aim of this study is to determine the nasal tip support pressure alterations in various age groups, by measuring nasal tip support with a Newton meter, according to age and gender.

Methods:

This prospective clinical study was conducted between January 2019 and April 2019 at a tertiary health facility. Nasal tip resistances in 4 different age groups, as 20-29, 30-39, 40-64 and 65 years and older, were measured with a digital Newton meter. A total number of 159 patients with a minimum of 36 patients in each age group were included in the study. Nasal tip resistance measurements were compared among nasal tip displacement distances of 2mm, 3mm and 4mm, according to age groups and gender.


Eligibility Criteria:
Inclusion Criteria:

* Four groups were formed as 20-29, 30-39, 40-64 and 65 years and older. A total of 159 patients with a minimum of 36 patients in each group were included in the study.

Exclusion Criteria:

* Patients with a history of nasal trauma, previous nasal surgery (septoplasty, rhinoplasty, tumor surgery), severe deviation of the caudal septum, visible external nasal deviation, and systemic disease affecting the connective tissue were excluded from the study.
Correlation Between Chronic Neck Pain and Shoulder Proprioception Among Patients With Cervical Radiculopathy

Is there correlation between cervical radiculopathy and shoulder proprioception or not?


Eligibility Criteria:
Inclusion Criteria:

* chronic neck pain with unilateral cervical radiculopathy.

Exclusion Criteria:

* has impingement syndrome ,history of instability and any systemic disease.
Effects of Crossover Point Exercise on Vascular Function of Women in Different Menopausal Years

Recruit postmenopausal women and randomly assign them to one of four groups: Early Postmenopausal Exercise Group (EE), Late Postmenopausal Exercise Group (LE), Early Postmenopausal Control Group (EC), and Late Postmenopausal Control Group (LC).

All participates will undergo a graded exercise test to determine their maximum oxygen uptake, and vascular function response will be measured immediately after the exercise test. The COP exercise intensity for postmenopausal women will be obtained through the exercise test, and subjects in the EE and LE groups will undergo exercise training at this intensity for a period of three months. Tests and analyses of relevant indicators will be conducted on subjects in all four groups before and after the intervention. The exercise load experiments will be performed on a cycle ergometer.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women without cardiovascular disease

Exclusion Criteria:

* Women with undetermined menopause
* BMI \<18.5 kg/m2 or BMI \>28 kg/m2
* fasting plasma triglyceride levels ≥500 mgdl
* diabetes mellitus or fasting glucose \>140 mgd
* blood creatinine \>2.0 mgdl
* uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>110 mmHg)
* untreated thyroid disease
* life-threatening illness with a prognosis of \<5 years;
* history of deep vein thrombosis,
* pulmonary embolism, or breast cancer;
* currently receiving estrogen therapy.
CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases

The aims of this study were

* to analyze CD160 expression in both normal and pathological eyes from human adults
* to evaluate association between CD160 presence on endothelial cells from blood vessels and retinal vascular disease

Anti-angiogenic agents stand first in the treatment of neovascular diseases of the retina. Intravitreal injections of anti-Vascular Endothelial Growth Factor (VEGF) agents have emerged over the past decade as the first line of treatment in some neovascular diseases of the retina. Nevertheless, anti-VEGF therapies suffer some limitations, among which a short time to recurrence (1 week to 3 months) of retinal neovascularization and an eroding biological effect after prolonged use and.

CD160 appeared in several experimental studies as a marker of activated endothelial cells, suggesting it could represent a promising target for novel anti-angiogenic.

Eligibility Criteria:
inclusion criteria :

* Patients with retinal surgery
* Patients who agree to participate to the study
* Major patient

exclusion criteria :

* Patient under law protection
* Minor patient
Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)

The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.


Eligibility Criteria:
Inclusion Criteria:

* Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an approved indication;
* The TKA occurred at least 12 weeks prior to enrollment

Exclusion Criteria:

* None
Chest Wall Muscle Stretching and Acute Effects in Chronic Obstructive Pulmonary Disease

The study hypothesis is chest wall muscle stretching increase distribution of volume variation of thoracoabdominal wall and reduce electromyographic activity of respiratory muscles in patients with Chronic Obstructive Pulmonary Disease.

Randomized controlled trial involving patients with Chronic Obstructive Pulmonary Disease evaluated before and immediately after a program of stretching muscles of the rib cage or after resting with time similar to the intervention, as volume variation of thoracoabdominal wall by optoelectronic plethysmography and on the electromyographic activity of accessory muscles of respiration.

Eligibility Criteria:
Inclusion Criteria:

* clinical and functional diagnosis of Chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2009),
* forced expiratory volume in one second (FEV1) less than 80% predicted post-bronchodilator;
* clinical stability during the study,
* both sexes,
* age above 40 years,
* body mass index (BMI) between 18.5 and 29.9 kg / m²;
* smoking history,
* symptoms of cough,
* dyspnea or hypersecretion,
* ex-smokers for at least three months.

Exclusion Criteria:

* Disease exacerbation for at least eight weeks,
* patients with other respiratory diseases,
* cardiovascular or osteoarticular and
* participants in pulmonary rehabilitation programs.
Evaluation of Educational Tools for Pregnant Women

Hypertensive disorders of pregnancy happen in 5% of pregnancies. Being aware of symptoms and complications may help women to present early and preserve their own and their baby's health.

The proposed research aims to evaluate the impact of educational tools in pregnant women from an ambulatory population. These tools include a detailed pamphlet (including a graphic-based summary), a magnet summarizing symptoms and appropriate action, and a video. Level of knowledge will be evaluated after one month with a validated questionnaire. We will also evaluate if getting more information about preeclampsia increases patient anxiety as well as satisfaction about the tools.

Background: Preeclampsia is a leading cause of maternal/fetal morbidity/mortality. Pregnant women are often poorly informed on preeclampsia and seeking care too late results in maternal/fetal complications. Many healthcare providers believe that delivering information for low-risk women only make them more anxious.

Preliminary data: We published that an information pamphlet on preeclampsia increases knowledge, without increasing anxiety, and generates high satisfaction in women hospitalized for preeclampsia.

Objectives: Demonstrate that (1) ambulatory low-risk pregnant women will benefit from the pamphlet/video with improved knowledge; (2) without any increase in anxiety, and with great satisfaction.

Design: Prospective randomized controlled pilot study. Inclusion criteria: consecutive pregnant women aged ≥18 y.o. between 200-326 weeks presenting at the clinic and who read/write French or English. Exclusion criteria: Anticipated delivery or termination within one month. Intervention: pamphlet, magnet and video. Control: no educational tool. At baseline, women in both groups will answer questionnaire #1 on demographics; one month later: self-administered questionnaire #2 on knowledge, anxiety, satisfaction.

Sample size: N=178 will provide 80% power to find a significant improvement of at least 20% in knowledge score and 96% power to find a difference of at least 1 on scale for anxiety (alpha of 5%). Assuming a drop-out rate of 10%, missing answers \<20%, and rate of answered questionnaire #2 of 50%, 400 subjects will be recruited.

Anticipated results: The tools will improve knowledge by about 20% in intervention group compared to control group. They will not increase anxiety over one point and will be highly appreciated by women.

Eligibility Criteria:
Inclusion Criteria:

* Women between 20+0 to 32+6 weeks pregnant
* Aged 18 years old or more
* Who present at the Blood Sampling in Pregnancy clinic
* With an adequate understanding of written and spoken French or English in order to read the pamphlet and fill out the self-administered questionnaire

Exclusion Criteria:

* Consideration of an interruption of pregnancy for maternal or fetal reasons
* Anticipated delivery within the next month.
Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

Study Design:

Eligibility Criteria:
Inclusion criteria:

1. Moderate to severe Primary Restless Legs Syndrome
2. Male or female patients aged at least 18 years

Exclusion criteria:

1. Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Mirapex
3. Pregnant and breastfeeding women
4. Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
5. Secondary RLS
Effect of Anesthesia Method on Neutrophil-Lymphocyte Ratio

The neutrophil/lymphocyte ratio (NLR) is a simple and inexpensive marker of the inflammatory response. NLR is affected not only by surgical trauma but also by the anesthetic method. The method of anesthesia can affect NLR, thereby modulating the inflammatory response and surgical outcomes. In this study, it was aimed to evaluate the relationship between blood NLR and anesthesia techniques in patients undergoing forearm surgery, and the secondary aim was to evaluate the relationship between Platelet/lymphocyte ratio (TLR), Mean Platelet Volume (MPV) and anesthesia techniques.


Eligibility Criteria:
Inclusion Criteria:

* Underwent forearm surgery
* Between aged 18-70
* Under general anesthesia or peripheral nerve block

Exclusion Criteria:

* acute infection
* morbid obesity
* chronic treatment with steroids or immunosuppressants
* recently received chemotherapy
* hepatic and renal dysfunction;
* chronic alcohol abusers
* Multiple trauma
* Patients with missing data in their files
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.

The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects who voluntarily sign the informed consent.
* Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

Exclusion Criteria:

* Subject is using or will use investigational medications, except as approved by Abbott.
* Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.
Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures.

Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures


Eligibility Criteria:
Inclusion Criteria:

* Malignant distal biliary stricture
* Need for Palliative and pre-operative biliary drainage
* Age \> 18
* Signature of the informed consent

Exclusion Criteria:

* Previous endoscopic/radiological biliary drainage
* Stricture close to the main hepatic confluence(\< 2 cm)
* Duodenal stenosis
* Post- surgical altered anatomy
* Benign disease