cyrilzakka/clinical-trials huggingface dataset:
In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?

Investigators aimed to evaluate the performance of The European Organization for Research and Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological Treatment(CUETO) risk tables on all non-muscle invasive bladder cancer patients(NMIBC), and those not treated with BCG and treated with BCG separately.

Risk tables can be used for the prediction of recurrence and especially progression of nonmuscle invasive bladder cancer .The European Organization for Research and Treatment of Cancer(EORTC) developed a risk table,which provides a scoring system for recurrence and progression risk.The EORTC risk table includes these factors: number of tumors,tumor size,prior recurrence rate,T stage,presence of carcinoma in situ(CIS),and grade for NMIBC patients not treated by maintenance bacillus Calmette-Guerin(BCG) instillation therapy.The Spanish Urology Association for Oncological Treatment(CUETO)later proposed a modified model to be used for patients only treated with BCG instillation.This risk table includes these factors:age,gender,recurrent tumor,number of tumors,T stage,CIS,and grade.

There is no risk table that can be used for NMIBC patients treated or not treated with BCG.Should we use the EORTC risk table for patients not treated with BCG and the CUETO table only for those treated with BCG or is one of them sufficient to predict recurrence and progression in all patients?The main aim of this study was to compare the utility of the EORTC and CUETO risk tables in all patients, and separately in patients not treated with BCG and treated with BCG.

Eligibility Criteria:
Inclusion Criteria:

* primary or recurrent bladder cancer
* non-muscle invasive bladder cancer
* at least 60 months follow-up period if progression was not determined.

Exclusion Criteria:

* primary CIS,
* muscle-invasive disease after second look TUR-BT
* non-urothelial carcinoma of the bladder,
* concomitant upper urinary tract tumor,
* not able to contacted for whatever reason
Effect of Position During Spinal Anesthesia on Hemodynamic Change in Cesarean Section

Hypotension is the most common complications after spinal anesthesia especially in pregnant patients who undergoing cesarean section. Position during spinal anesthesia may be altering the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena cava that may decrease venous return and cardiac output. This leads to hypotension.The hypothesis is the right lateral position during spinal anesthesia in pregnant women will be had hemodynamic changing more than the left lateral position. This objective is to compare hemodynamic change between left and right lateral position during spinal anesthesia in pregnant women undergoing cesarean section.

Study design: A randomized controlled trial

Study setting:

The study will be conducted in the operating rooms at Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand

Study period:

The total duration of participation in the randomized study is up to the operative day.

Study population:

Pregnant patients undergoing cesarean section receiving spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml.

Study sample:

Inclusion criteria

1. Signed informed consent
2. Pregnancy
3. Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml
4. Elective and emergency surgery

Exclusion criteria

1. Contraindication for spinal anesthesia
2. Complicated pregnancy such as maternal heart disease, eclampsia, severe fetal distress, abruption placenta, twin pregnancy, and placenta previa totalis
3. Maternal height \< 150 cm.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Term pregnancy
* Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml

Exclusion Criteria:

* Contraindication for spinal anesthesia
* Height \< 150 cm.
* Complicated pregnancy e.g. heart disease, preclampsia, eclampsia, diabetes millitus, twin, abrupt placenta, placenta pre via, and fetal distress
* Failed spinal anesthesia
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination

Our objective is to determine the effectiveness of varied outreach methods (e.g. automated reminder calls/text messages with or without personalized calls/texts) to children age 12-14 months or 4 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the MMR vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Age: 12-14 months old OR 4 years old
* Has not yet received first MMR (for 12-14 month olds) OR second MMR (for 4 year olds)
* Has not had a well child check in past 365 days (for 4 year olds)
* No appointment scheduled in the next 45 days
* Parent preferred language = English or Spanish

Exclusion Criteria:

* Phone number not available in electronic medical record
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator.
* Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization.
* Minimum body weight of 37 lbs.

Exclusion Criteria:

* Six-month history of drug or alcohol abuse.
* Status epilepticus within 6 months prior to screening.
* Abnormal platelet or ALT/AST levels.
Phenotyping Asthma for Bronchial Thermoplasty

This study will evaluate a new imaging technology, called optical coherence tomography (OCT) to examine the asthmatic airways before and after bronchial thermoplasty, which is a new treatment option for severe asthmatic patients. The aim of this study is to learn more about how airways respond to this new treatment. In the future the investigators hope OCT will aid clinicians in the initial assessment, management and long-term follow up of patients receiving bronchial thermoplasty.

Asthma currently affects over 300 million individuals worldwide and the number of the affected patient is continuously increasing. Approximately 10% of asthmatics have poorly controlled, severe symptoms.

The exact mechanisms behind the development of asthma are unknown. However, the excessive contraction of airway smooth muscle leading to airway constriction is thought to be responsible for the majority of the symptoms of asthma. A new treatment option, termed bronchial thermoplasty, can offer relief for individuals with severe asthma. Bronchial thermoplasty works by reducing smooth muscle with thermal energy.

This new imaging technology, called optical coherence tomography (OCT) is the first imaging modality that is capable to visualize airway smooth muscle in humans. In this study the investigators will examine the asthmatic airways before and after bronchial thermoplasty to learn about how airways respond to this treatment. The long term goal of this study is to use OCT to look at the airways with the hope of helping clinicians monitor and predict the response to bronchial thermoplasty.

During the scheduled bronchial thermoplasty procedure, OCT imaging will be performed. The study imaging will add less than 10 minutes to the time required for the standard procedure.Twelve months following the completion of bronchial thermoplasty, the investigators will ask the participants to return to the hospital to undergo follow-up tests including a CT scan and a bronchoscopy procedure with repeat OCT imaging. The investigators expect these test to be accomplished in 2 additional visits.

Eligibility Criteria:
Inclusion Criteria:

1. Patient undergoing elective bronchial thermoplasty
2. Patient is between the ages of 18 and 60
3. Patient is able to give informed consent
4. Negative pregnancy test for all female of childbearing potential who are sexually active and not using contraception, are seeking to become pregnant, or who are nursing.
5. Nonsmoking (\<5 pack year tobacco exposure)
6. No history of co-existing lung disease
7. Meet American Thoracic Society criteria for diagnosis of asthma with either/or

   1. Bronchodilator response to albuterol (≥12% change in FEV1)
   2. Positive methacholine bronchoprovocation (PC20 \< 25 mg/ml)

Exclusion Criteria:

1. Patients who are pregnant.
2. Patient does not meet the requirements to undergo clinical bronchial thermoplasty, as determined by the treating physician
Effectiveness of Lyophilized Growth Factors for Subacromial Impingement

The aim of this study is to evaluate the efficacy of ultrasound-guided injection of platelet-derived lyophilized growth factors in treatment of subacromial impingement.

A new patented product named lyophilized Growth Factors has been developed. It is a novel advanced and refined form of conventional platelet-rich plasma. Effectiveness of intra-articular lyophilized Growth Factors injection has been studied in thirty patients with symptomatic primary knee osteoarthritis and has shown encouraging results regarding improvement of pain, stiffness and function in addition to decreasing knee effusion.

The lack of good quality evidence to support the efficacy of injecting platelet-derived lyophilized growth factors in treatment of subacromial impingement highlights the need for thorough evaluation of the outcome of this novel therapeutic option in patients with subacromial impingement.

Eligibility Criteria:
Inclusion Criteria:

* Clinically:

  1. Anterolateral shoulder and/or lateral upper arm pain.
  2. Painful arc of motion between 70° and 120°.
  3. Positive impingement sign (Neer's test or Hawkins-Kennedy test).
* Ultrasonographically:

The elicitation of a transient arc of pain during shoulder abduction which coincides with passage of the supraspinatus insertion beneath the coraco-acromial arch.

Exclusion Criteria:

* History of shoulder surgery, fracture, dislocation or subluxation.
* Patients with full-thickness rotator cuff tear, weakness on arm elevation, or positive "drop arm sign".
* Patients who have been diagnosed with a frozen shoulder or degenerative arthropathy of the glenohumeral joint.
* Patients with disorders of the cervical spine or upper extremity that have a significant impact on the shoulder
* Patients with diabetes mellitus, rheumatoid arthritis, hypothyroidism or other painful or function limiting disorders of the shoulder.
* Significant cardiovascular, renal or hepatic disease.
* Active infection in the area to be treated.
Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients

This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older with diagnosis of Advanced Renal Cell Carcinoma (aRCC) with predominantly clear-cell histology
2. Received any of the following therapies in the first-line setting:

   1. Nivolumab + Ipilimumab between 8/1/2021 and 6 months prior to data collection
   2. Pembrolizumab + Lenvatinib between 8/1/2021and 6 months prior to data collection
3. Participant had at least 6 months of follow-up from initiation of index treatment (patients who deceased prior to 6 months since index treatment initiation would still be eligible)

Exclusion Criteria:

1. Receipt of any immunotherapy or tyrosine kinase inhibitor (TKI) therapy as part of a Randomized Controlled Trial (RCT)
2. Participant received any systemic therapy for Advanced Renal Cell Carcinoma (aRCC) prior to index therapy, including neoadjuvant or adjuvant therapy
3. Any active malignancy in the 3 years prior to initiation of 1L therapy for aRCC, except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, or breast cancer, or localized prostate cancer with a Gleason score ≤3+4 that has been treated more than 12 months prior to full study screening and considered to have a very low risk of recurrence.
Risk Management in Nursing Homes

The Réseau QualiSanté (risk management network) hardly works on risk management in nursing homes. A model to help nursing homes managers to structure and analyze adverse events has been constructed by a working group of health professionals in the Réseau QualiSanté. Several questions appeared: is the model able to increase patient safety culture of professionals working in nursing homes? How to characterize adverse events in nursing homes? How frequent are they? The main objective of this research project EHPAGE is to measure the impact of the model to structure and analyze adverse events in nursing homes on the patient safety culture of professionals. The project combines quantitative data (questionnaire) and qualitative data (interviews).

The main objective of this research project EHPAGE is to measure the impact of the model to structure and analyze adverse events in nursing homes on the patient safety culture of professionals. The coaching model is composed of a 20 hours methodological help for each nursing home and of an implementation kit.

To answer to the main objective, quantitative and qualitative data will be collected twice during the project: before the implementation of the coaching model and 12 months after.

Secondary objectives are:

1. To encourage the place of patient safety culture in strategic issues of nursing homes
2. To develop patient safety culture of professionals working in nursing homes
3. To develop a way to structure and make the reporting of adverse events in nursing homes more sustainable
4. To describe epidemiologic characteristic of adverse events in nursing homes
5. To propose a French validated questionnaire to evaluate patient safety culture reported by professionals in nursing homes An ancillary study is perform to describe epidemiologic characteristic of adverse events in nursing homes

Eligibility Criteria:
Inclusion Criteria:

* Nursing homes members of the Réseau QualiSanté (risk management network)
* Public or private legal status
* Agreeing to participate in the project

Exclusion Criteria:

* None
Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft

In this work, the manifestations of ocular irritation associated with vicryl 8/0 sutures fixed conjunctival auto-graft in pterygium patients were evaluated. The severity of post-operative foreign body sensation, pain, and watering was subjectively evaluated. The localized nasal quadrant conjunctival hyperemia was also evaluated. It was found that sutures fixed conjunctival auto-graft can be used safely with short-term minimal to moderate tolerable manifestations of ocular irritation with no significant complications.

All the patients were subjected to pterygium excision surgery with conjunctival auto-graft under local anesthesia. The graft was fixed by vicryl 8-0 sutures.Ocular irritation symptoms including pain, foreign body sensation and watering were subjectively evaluated. Pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep. Foreign body sensation and watering of the eye were evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome. The score of patients' subjective symptoms evaluation were collected in a total score which ranged from zero to a maximum of 10. A total score of 3 or less was considered as minimal irritation (grade I), 4-6 was considered as mild-moderate tolerable irritation (grade II), and 7 or more was considered as severe annoying irritation (grade III).

The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated 2 weeks, 1,2 and 3 months post-operative using the Cornea and Contact Lens Research Unit (CCLRU) photographic grading scale. In this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe. Decimal fraction of 0.5 was added to describe the intermediate cases.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pterygium

Exclusion Criteria:

* Previous ocular surgeries
* Ocular surface disorders
Multifidus & Gastrocnemius Muscle Thickness & Postural Stability in Spinal Cord Injury Patients: A Correlational Study

This study aims to investigate the relationship between multifidus and gastrocnemius muscle thickness with postural stability in patients with spinal cord injury.

Ultrasound imaging will be used to measure multifidus and gastrocnemius muscle thickness in patients with spinal cord injury. Postural stability will be assessed using the Berg Balance Scale, a clinical balance test consisting of 14 items that evaluate an individual's ability to maintain balance during various functional tasks such as standing unsupported, reaching forward, turning, and standing on one leg. The Berg Balance Scale is a reliable and valid clinical balance test that is commonly used in spinal cord injury patients. Statistical methods, including correlation and regression analysis, will be used to analyze the data and investigate the relationship between the multifidus and gastrocnemius muscle thickness and postural stability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of spinal cord injury at least 6 months prior to study enrollment.
* Patients who are able to follow instructions and comply with study procedures.

Exclusion Criteria:

* Patients with severe cognitive impairment or inability to follow instructions.
* Patients with other medical conditions that may affect muscle thickness or postural stability, such as Parkinson's disease, multiple sclerosis, or severe osteoarthritis.
* Patients with contraindications for ultrasound imaging, such as pregnancy or implanted devices that may be affected by the imaging.
* Patients with severe motor deficits that may limit their ability to perform the study procedures.
* Patients who are unable to tolerate the testing procedures, such as the Berg Balance Scale or ultrasound imaging.
Idarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML)

The goal of this clinical trial is to compare the clinical efficacy and safety of IAC regimen and IA regimen as induction chemotherapy for initial diagnosed acute myeloid leukemia (AML) patients. The main question it aims to answer is:

•Does IAC regimen higher the complete remission rate in initial diagnosed AML patients? Researchers will compare IAC regimen to IA regimen to see if IAC works to treat AML.

Participants will:

* Receive IAC or IA as induction regimen
* Receive a second cycle of re-induction if partial remission
* Visit the clinic once every 3 to 6 months for assessment


Eligibility Criteria:
Inclusion Criteria:

* Initially diagnosed as AML (except APL)
* Aged between 18 and 60 year old
* Eastern Cooperative Oncology Group (ECOG) score no more than 3
* Informed consent file (ICF) signed

Exclusion Criteria:

* AML secondary to chronic leukemia and myeloproliferative neoplasms (MPNs)
* With other underlying malignancies
* Severe and uncontrolled infection
* Intolerant to the chemotherapy
A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response

Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4 cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary treatment or with disease refractory to any therapy in 1st or 2nd line (including Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of alemtuzumab s.c.

After the first phase (completed treatment of 7 patients) an interim analysis of safety and efficacy will be performed. In case of a sufficient risk benefit assessment followed by the enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be based on all patients enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with CD23+, CD5+, CD19+, light chain monoclonal B CLL
* 1st or 2nd relapse after fludarabine or any other primary treatment regimen or refractory to primary or secondary treatment (including fludarabine) and simultaneously indication for treatment according to the NCI Workshop Criteria 1996
* Age 19-75
* WHO performance score 0-2
* Informed consent given by the patient

Exclusion Criteria:

* HIV positive or positive for Hepatitis B or C
* active uncontrolled infection
* child bearing age without adequate control of fertility, pregnant or lactating women
* intolerance towards any ingredient of either oral fludarabine or alemtuzumab
* allergy against foreign proteins
* previous treatment with alemtuzumab
* treatment with an experimental drug within the previous 2 months
* second malignant disease (non CLL)
* CLL in transformation (Richter syndrome)
* decreased kidney-function with creatinine-clearance \< 30ml/min
* severe concomitant diseases or major organ dysfunctions
* patients who are unable to comply with the requirements of the protocol