cyrilzakka/clinical-trials huggingface dataset:
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Eligible pediatric patients with acute flares of ileocecal Crohn's disease will be randomized to receive either PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, or an identical-appearing placebo preparation.

Patients will be required to maintain a daily diary and to return at 2 weeks for blood and stool tests. At the four week mark, patients will return for clinical evaluation, global assessment of disease activity and change in disease activity, as well as additional laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Age less than 18 years
* Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
* Harvey Bradshaw Index of at least 7
* The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
* Written informed consent

Exclusion Criteria:

* Concomitant corticosteroids, budesonide
* Corticosteroids within 2 months
* Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
* Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
* If the severity of the flare has started to decrease spontaneously
* Coexisting diagnosis of primary sclerosing cholangitis
* Infectious diarrhea
* Signs of intestinal obstruction or perforation
* New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare
* Hypersensitivity to 4-ASA or any components of PASER®
* Pregnancy or breast-feeding
* Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active
* Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC \< 3,000 during the preceding three months
Utilizing the HITSystem for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya

Overall, there are an estimated 98,000 children living with HIV in Kenya. Children who are initiated on ART in Kenya and other low resource settings face several challenges with ongoing care due to current limitations of paediatric HIV treatment services. High quality paediatric HIV care requires routine monitoring of clinical and virologic status, support for ART adherence, and patient outreach to optimize retention in care.

The HIV Infant Tracking System (HITSystem) is a web-based, system-level intervention that has dramatically improved EID HIV-related outcomes in Kenya, Tanzania, and Malawi.

The objective of this study is to implement and evaluate the impact of HITSystem 3.0 on paediatric clinical outcomes, adherence, retention and viral suppression over 12 months among children in HIV care. Outcome measurements will be evaluated separately in children aged ≤2 years and in those aged 3-16 years.

Primary Outcomes

1. The proportion of HIV infected children in each arm who are retained in HIV care at 12 months. Retention will be defined as regular engagement with HIV care, as measured by having attended the last three scheduled monthly appointments on time (see section 3.3 for further description).
2. The proportion of HIV infected children who are virally suppressed (VL \<50) at the end of the 12-month follow-up period.

The proposed trial design is an unblinded CRT with two arms: the HITSystem 3.0 Intervention vs. Standard of Care (SOC) as the control. The CRT will be implemented in 20 health facilities (10 intervention and 10 control) in Western Nyanza province in Kenya and will collect data from HIV-infected children aged ≤16 years. Outcomes will focus on ART retention, adherence and viral suppression.

Outcomes will be assessed among all HIV positive children aged ≤16 years attending the trial facilities for HIV care at the start of the trial, or who are diagnosed as HIV positive during the first 12 months of the trial. Follow-up data will be collected on each child for 12 months. Therefore, the total duration of the trial will be for 24 months.

All HIV-positive children and their caregivers attending health facilities randomised to the intervention arm will be monitored by the HITSystem 3.0.

The study will be conducted in Western Nyanza province, Kenya, which comprises six counties.


Eligibility Criteria:
Inclusion Criteria:

Health facilities must meet the following criteria to be eligible for the trial:

1. Level 3-5 and located in the Western Nyanza Province.
2. Currently provide PMTCT, EID and paediatric ART programmes.
3. Either government or private not-for-profit
4. Agreement to participate, which will be granted by both Kisumu County minister of health, as well as the facility Director of Medical Operations (DMO).

Exclusion Criteria:

1. Facilities that are classified as Level 1-2.
2. Facilities that are participating in other research involving paediatric ART programmes.
3. Private commercial facilities
Strategy of Turning Performance in Individuals With Stroke

This is a single-blind randomized controlled trial study. Thirty individuals with chronic stroke will be recruited and randomly assigned to the experimental and control groups. Subjects in the experimental group will receive exergame-based balance training, while subjects in the control group will receive upper limb and trunk training. Both groups will undergo a four-week intervention consisting of three sessions per week, each lasting 60 minutes.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years
* single incident of stroke
* stroke duration of at least 6 months
* lower limb Brunnstrom motor recovery stage between level three and five
* Functional Ambulation Categories scale ≥3

Exclusion Criteria:

* Individuals with cognitive impairmen (the Mini-Mental State Examination with a score below 24)
* visual or auditory impairments
* communication disorders
* other neurological diseases affecting motor performance, or any orthopedic conditions that could influence walking ability
* contraindications to physical activity, such as angina or uncontrolled hypertension
Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (SECOX) regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic hepatocellular carcinoma (HCC) not suitable for surgery or various loco-regional therapies.
* Diagnosis of HCC confirmed either by cyto-histological confirmation or by non-invasive criteria according to the European Association for Study of Liver disease (EASL) criteria.
* Child-Pugh A or B7 cirrhosis.
* Eastern Co-Operative Group (ECOG) performance status ≤ 2.
* Life expectancy of ≥ 12 weeks.
* Adequate organ function (blood transfusion or use of biologic response modifiers is not permitted).
* Measurable disease with at least one lesion, which is at least 1 cm in one dimension on computed tomography (CT) or magnetic resonance imaging (MRI).
* Able and willing to meet all protocol-required treatments, investigations and visits.
* Signed written informed consent form.

Exclusion Criteria:

* Prior systemic therapy for advanced HCC.
* Central nervous system (CNS) metastasis.
* History of liver transplantation.
* Peripheral sensory neuropathy with functional impairment before the first cycle of treatment.
* History of cardiac disease.
* Uncontrolled hypertension.
* Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)

The specific aim of this pre-post trial is to compare data regarding oral feeding, length of stay, and growth outcomes of 100 NICU infants to these same outcomes following the implementation of a developmentally supportive, infant driven feeding program with the NICU staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding program on a second sample of 100 NICU infants at Children's Memorial Hospital.

The specific research questions considered in this study are:

1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term?
2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term?
3. What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU?
4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU staff evaluations and communications related to managing oral feedings with medically fragile infants?


Eligibility Criteria:
Inclusion Criteria:

* Infants of all gestations and diagnostic groups in this tertiary level NICU will be included in the sample

Exclusion Criteria:

* Infants with medical diagnoses known to impact sucking and swallowing
* Infants unable to manage their oral secretions
* Infants who remain hospitalized beyond 3 months adjusted age

  * Infants who expire or are transferred to another inpatient unit or hospital/facility prior to discharge from the NICU
Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmed rectal cancer
* Clinical stage T3-4 or T any N1
* No metastasis
* Distance of tumor is no more than 10cm from anal verge
* No previous radiotherapy
* Age ranged from 18 to 70
* Eastern Cooperative Oncology Group score system 0-1

Exclusion Criteria:

* Clinical stage T1-2 N0
* Distance metastasis
* Multiple primary tumor
* Cachexy
The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve

The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.

The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients with non endometriosis ovarian cysts
* Age between 15-40 years
* Regulars menses
* Signed informed consent

Exclusion Criteria:

* Patients with Previous surgery,
* Patients with infertility,
* Patients with endometriosis or
* Patients with suspicious of malignance
Prevalence of Ocular Disorders in Multiple Myeloma (MM-OO-16)

Overall survival of multiple myeloma (MM) patients has increased significantly due to the availability of the new drugs. Moreover, since MM is an incurable disease, patients are exposed to repeated lines of therapy with different agents. It is therefore increasingly important to monitor the long-term side-effects of treatments. In the present study we focused on ocular disorders. This is an observational study aiming to assess the prevalence of ocular disorders in 100 patients on treatment or follow-up for MM.

This is an observational study aiming to assess the prevalence of ocular disorders in patients on treatment or follow-up for MM.

Study population Patients diagnosed with multiple myeloma on treatment and/or on follow-up after treatment for multiple myeloma. The study aims to enroll 100 patients.

Endpoints Primary endpoint: To determinate prevalence and main characteristics of ocular disorders in patients on treatment / or previously treated for Multiple Myeloma.

Secondary endpoints:

1. To evaluate the relation between the kind of treatment for multiple myeloma and the development of ocular disorders
2. To evaluate the relation between patient's characteristics and comorbidities (such as sex, age, smoking, hypertension, diabetes, autoimmune diseases) and the presence of ocular disorders in this population of patients.

Study design Patients will be enrolled in the study at any time starting for the 3rd month of treatment, regardless if they are still on treatment or not.

Patients will undergo an ocular evaluation including visual acuity analysis, evaluation of the anterior ocular segment, fundus oculi analysis, ocular pressure measurement, Schirmer's Test.

If clinically required by the ophthalmologist, the patient will also undergo:

* Optical computerized tomography
* Fundus autofluorescence
* Fluorescein angiography
* Computerized visual field

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of Multiple Myeloma
* Patients have started an active treatment for Multiple Myeloma since at least two months
* Patients on active treatment for relapsed/refractory multiple myeloma
* Patients on follow-up after previous active treatment for multiple myeloma

Exclusion Criteria:

* Bilateral blindness preceding the diagnosis of multiple myeloma
* No signature of the informed consent
* Patients have started an active treatment for Multiple Myeloma since less than two months
Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.

Primary objectives

1. To identify the factors associated with the development of hyponatremia in patients receiving high-dose cyclophosphamide (2.5 grams or more).
2. Generate and validate a predictive score of developing hyponatremia high-dose cyclophosphamide.
3. To estimate the incidence of hyponatremia in patients undergoing high-dose cyclophosphamide.

Study design. Observational prospective cohort study of Patients after infusion of high-dose cyclophosphamide. Follow up period will be from cyclophosphamide infusion until one month after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over 18 years) who were admitted to the Hematology / Oncology and Medical Clinic Hospital Italiano de Buenos Aires infusion of high-dose cyclophosphamide for conducting MSCH prior BMT, GATLA and HyperCVAD in the period 2015-2017.

Exclusion Criteria:

* Refusal to participate or to the process of informed consent.
Comparison Erect Spine in Cardiac Surgery

Open cardiac surgeries are characterized by the increased use of opioids and longer extubation times, being post-sternotomy pain one of the causes of greater patient discomfort, plexus blockages have been used more frequently given the good results of anatomical studies and case series that are just beginning to be published. however, there is not enough data to convince the scientific community of its advantages, continuing to carry out its performance due to lack of evidence. Dexamethasone also shows an excellent result blocking the inflammatory chain and it was evidenced that it prolongs the time of blockages when used perineurally in the plexus blockages. This study wants to show the improvement of pain in patients who undergo this type of surgery and also show the advantages of a longer blockage, which can reduce use of analgesic and opioids, as well as decrease the time of hospitalization This is a double-blinded, randomized, clinical trial designed to determine the efficacy of spine erector whit dexamethasone gives more duration of the blockage and less pain after cardiac surgery.

Evaluation of acute pain pos cardiac surgery in patients that who were subjected at myocardial revascularization. We offer Espine erector block (ESP) with linear array Transducer and needle 100mm bilateral as a technique that offer results more hopeful and less invasive in patients with open cardiac surgery. Favoring the implementation of Fastrack anesthesia techniques in cardiac surgery and minimizing complications in this group of patients

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery bypass graft with cardiopulmonary bypass
* Left ventricular ejection fraction ≥ 45%

Exclusion Criteria:

* Reoperation
* Low cardiac output syndrome
* Preoperative coagulopathy
* Presence of ventricular assist device other than intraaortic ballon pump
* Emergency procedures
* Bacterial or fungal infection in the preceding 30 days
* Active neoplasia
* Allergy or intolerance to steroids
* Allergy to ropivacaine
* Patient refusal
* Participation in other study
A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression

The purpose of this study is to evaluate the efficacy and safety of escitalopram treatment in participants with severe major depressive disorder (MDD \[marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation\]).

This is a single-arm (clinical study in only one group of participants), open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), and prospective (study following participants forward in time) study. The study consists of 2 parts: Screening (that is, 5 days before study commences on Day 1) and Treatment (that is, Week 1-8). All the eligible participants will be receiving flexible doses of escitalopram orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Efficacy will primarily be evaluated by remission rate at the end of the study. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
* Scores of greater than or equal to 30 on the Montgomery-Asberg Depression Rating Scale (MADRS) Exclusion Criteria:
* Pregnant or lactating female participants
* Participants who are previously or currently diagnosed with the following mental disorders by DSM-IV: organic mental disorder, schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizoaffective disorder, delusional disorder, undifferentiated mental disorders and bipolar affective disorder, participants with history of drug abuse, including alcohol and drug abuse in the past 12 months
* Participants who have significant risk of suicide on clinical assessment (has a score of greater than or equal to 5 on item 5 of MADRS) or have made a serious suicide attempt within the past 6 months and have any contraindication to escitalopram
* Participants who have known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease currently taking other psychotropic drugs and anticonvulsant agents or continuously taking benzodiazepines or sleeping pills for over five days in the past one week
* Participants who have history of seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative diseases, parkinson disease and any movement disorders) and have multiple drug adverse reactions
A Team-based Approach to Improve Knowledge and Judgment Performance in Electronic Fetal Monitoring

The primary objective of this study is to compare performance of nurses, midwives, and physicians working as individuals versus working as teams in electronic fetal monitoring (as assessed by differences in knowledge and judgment scores).

Electronic fetal monitoring (EFM) has been used as a tool to evaluate fetal wellbeing in obstetrics for decades, with limited results with regard to improve fetal outcomes. There remains wide variation in the interpretation of fetal heart rate (FHR) tracings between different practitioners, which may explain the limited impact of this ubiquitous tool. The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam was established to improve patient safety in obstetrical care by optimizing and standardizing the credentialing process for EFM.

The Fetal Monitoring Credentialing (FMC) test is a validated tool to assess the knowledge and judgment of test-takers based on script concordance theory, an approach to testing that allows assessment on real-life situations by comparing to the clinical reasoning of a panel of reference experts.

It is known that in clinical practice patients are cared for by teams of individuals (RN's, CNM, resident physicians and attendings). These individuals are all trained to approach a laboring patient from their own unique training. Even amongst experts in the field there is only moderate agreement on the interpretation of tracings with poor agreement on what constitutes a category III tracing. The absence of complete agreement in clinical practice creates differences in opinions of interpretation and agreement regarding next step in management for obstetric patients.

It is hypothesized that a team-based participation in the Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam will improve knowledge and judgment scores.

Eligibility Criteria:
Inclusion Criteria:

* Must be a registered nurse, certified midwife, physician (resident, attending, MFM and General OB/Gyn) and have full obstetric privileges to provide patient care at participating hospitals.

Exclusion Criteria:

* Any individual who does not meet inclusion criteria or is unable to participate in all exams at the designated time points.