cyrilzakka/clinical-trials huggingface dataset:
Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial

The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours.

One of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight below 1250 gram
* Diagnosed patent ductus arteriosus by Echocardiographic examination

Exclusion Criteria:

* Accompanied other congenital cardiac anomalies
* Urine output of less than 1 ml/kg/h during the preceding 8 h,
* Serum creatinine level \>1.6 mg/dl,
* Platelet count \<60,000/mm3,
* Liver failure,
* Hyperbilirubinemia requiring exchange transfusion
* Severe intracranial bleeding (Grade III - IV)
* Intestinal abnormality and necrotising enterocolitis
Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer

Breast cancer is the most frequent cancer in women in western countries. The improvement of therapeutic management associated to the developement of supportive care allows patient to live longer in better conditions. But several studies have showed the deleterious impact of treatment such as chemotherapy on cognition. To limit these damages, non therapeutic approaches such as Adapted Physical Activity (APA) have been developped.

The goal of this study is to evaluate the benefit of APA program on cognitive functions in patients with locally advanced breast cancer.

Patient with cognitive complaint will be randomized in two groups :

* Experimental group : Immediate APA program (after randomization)
* Standard group : Delayed APA program (3 months after randomization)

APA program contains 10 sessions of APA within five weeks (twice a week). Each session is composed of 5 exercises (each made of 3 serial of 7 repetitions in slow speed).

A cognitive and quality of life assessments will occur in two groups at 3 and 6 months after randomization.

The primary objective of the study is to evaluate the impact of APA program on the improvement of cognitive functions in patients with breast cancer who have been treated by adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Women
* More than 18 years old
* Locally advanced breast cancer
* Patient who undergone surgery
* Cognitive complaint (FACT-COG inferior or equal to 8/16)
* No metastasis at the inclusion
* Patient who received adjuvant therapy by chemotherapy
* Patient with a social protection
* Barbizet scale Superior or equal to 3
* No neurological history
* No medical contraindication to APA
* Inform consent signed

Exclusion Criteria:

* Metastatic breast cancer
* History of other cancer (in 5 years before inclusion)
* Current chemotherapy or radiotherapy
* Chemotherapy or radiotherapy ended for more than 6 months
* Current APA program
* Blood transfusion for less than 6 mois
* Minimal mental score inferior to normal
* Patient no able to respond to the cognitive test
* Patient no able to realize APA program
* Drug use
* Alcohol abuse
* Patient Under guardianship or curatorship or deprived of liberty
Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.

OUTLINE:

Patients undergo diffusion-weighted MRI of the pelvis.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:

  * Gleason \>= 7
  * \> 50% biopsy cores +
  * Prostate-specific antigen (PSA) \>= 10
* Interested in undergoing a radical prostatectomy as definitive management for prostate cancer
* No clinical or radiographic evidence for distant metastatic disease

  * In subjects with PSA \< 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA \> 20, a bone scan must document lack of concern for bone involvement

Exclusion Criteria:

* Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor
* History of claustrophobia
* Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria
* Unable to give written informed consent
Ear Temperature as Predictor of Rectal Temperature Measured With Modern Devices in the Emergency Department.

Ear thermometers are often requested to be used rather than rectal thermometer (gold standard) for measuring the body temperature, as this method is faster and more user friendly. Former ear thermometers did not meet the required standards of accuracy for clinical use. However, a new generation of ear thermometers have been developed and widely used in the Emergency departments in Denmark. The devices have only been evaluated in two studies on adult populations, with conflicting results.

This cross-sectional study will examine patients by measuring both ear and rectal temperature in the same patient at the same time on admission to an emergency department, to evaluate if temperature measured in the ear can be used as the standard temperature measurement.


Eligibility Criteria:
Inclusion Criteria:

* admission to emergency department

Exclusion Criteria:

* no rectum
Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation

The purpose of this study is to show that amantadine might help to reduce the side effect of the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be developed in patients treated with the paliperidone ER or risperidone Consta.

High level of prolactin might stimulate breast development, might decrease sexual desire (libido). The goals of this study are to demonstrate that amantadine lowers prolactin levels, decreases side effects, and improves psychiatric symptoms.

Trial Description: A double-blind, placebo-controlled, prospective, randomized trial to evaluate the effects of two doses of amantadine or placebo in the management of antipsychotic-induced hyperprolactinemia and psychiatric status in patients with schizophrenia or schizoaffective disorder who are clinically stable on paliperidone ER or risperidone Consta. Placebo or amantadine 100 mg or 200 mg BID will be administered to participants for 4 consecutive weeks as an adjunctive therapy in 72 schizophrenia subjects treated with paliperidone or risperidone Consta to examine amantadine effects on fasting AM serum prolactin levels. Participants will be followed after suspension of amantadine or placebo for an additional 4 weeks for safety purposes. The goals of this study are to prospectively demonstrate that amantadine lowers prolactin levels, and evaluate the impact of amantadine on psychiatric symptoms, and on prolactin-related side effects in patients treated with paliperidone ER or risperidone Consta.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-65 years
* Diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
* Well established compliance with out-patient medications including paliperidone ER or risperidone Consta for 3 months

Exclusion Criteria:

* Current substance or alcohol abuse
* Significant medical illness
* Women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
* Subjects treated with more than one antipsychotic drug
The Computational and Neural Mechanisms Linking Decision-making and Memory in Humans

Learning to make good decisions in the present, and accurately recalling events and information from the past, are critical aspects of human cognition that are often impaired in many psychiatric disorders. This project aims to identify the how the choices individuals make influence what, and how, people remember by combining disparate techniques in computational modeling and direct brain recordings in human subjects. The researcher developed a dual-task paradigm, probing how decisions in one task affect immediate recognition memory. To examine the neural mechanisms underlying model-free RL's influence on memory, the researcher will record local field potential (LFP) and single neuron activity in various brain regions as epilepsy patients perform the proposed task. The results of this project will identify specific neurocomputational mechanisms unifying decision-making and memory processes.


Eligibility Criteria:
Inclusion Criteria:

* Has seizure activity which is deemed non-responsive to standard pharmacological intervention(s), as determined by treating Neurologist and established clinical practices
* Has elected to receive clinically indicated intracranial EEG (electrocorticography (ECoG), stereoelectroencephalography (SEEG)) and/or temporal responsive neurostimulation (RNS) for medication-refractory epilepsy outside of this research study, as determined by treating clinician(s) and per current clinical practice
* Capacity to provide written informed consent
* Language proficiency in English or Spanish
* Willing and able to comply with all study-related procedures

Exclusion Criteria:

* History of psychosis, such as in the context of depressive or manic episode.
* Active suicidal ideation with intent, suicide attempt within the last six months, or other serious suicide risk
* Inability to provide informed consent or reliably participate in study assessments, as per the Montreal Cognitive Assessment (MOCA; score \< 26) or in the opinion of the evaluating neuropsychologist.
* Individuals unwilling or unable to undergo electrode implantation procedures
* Medical contraindications to neurosurgery or for general anesthesia, neurosurgery, or an MRI scan (required for electrode implantation)
* Neurological disorder other than epilepsy or other significant brain pathology, if contraindicated in the opinion of implanting neurosurgeon.
* Women who are pregnant
Emergency Coronary Artery Bypass Graft in Acute Myocardial Infarction

A retrospective study investigating the early outcome of emergency CABG post MI in patients who were operated at Saud Al Babtain Cardiac Center.

A retrospective study of surgical patients who underwent Coronary Artery Bypass Graft for Acute Myocardial Infarction between December 2013 and February 2018 determining outcomes on morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with post cardiogenic shock who underwent CABG
* =/\> 17 years old

Exclusion Criteria:

* Patients other than post cardiogenic shock who underwent CABG or any cardiac surgeries
* \<17 years old
The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq

Objective. In this study, the investigators aimed to investigate the efficacy of combined a single platelet-rich plasma (PRP) and physical exercise (leg swing and quadriceps strengthening exercise) versus PRP and hyaluronic acid (HA) combination therapy. Methods. One hundred and six patients with grade Ⅱ-Ⅲ Knee osteoarthritis (KOA) according to the Kellgren-Lawrence classification were randomly divided into intra-articular injection of PRP combined with leg swing and quadriceps strengthening exercise (group A) and intra-articular combination injections of PRP and HA (group B). Patients in group A received twice intra-articular injection of PRP (2 ml, 2 weeks apart) and regular leg swing and quadriceps strengthening exercise for 3 months. Patients in group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks. The primary outcome measures were Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities (WOMAC) score. The second outcomes included single leg stance test (SLS) and functional activity by 2 minutes walking test (2MWT) and time up and go test (TUGT). All outcomes were evaluated at baseline and after 1,3,6, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 45 years old;
* KOA was diagnosed according to the American College of Rheumatology Classification Criteria;
* patients with the Kellgren-Lawrence grade (K-L grade) for KOA of Ⅰ-Ⅲ;
* a history of symptoms more than three month, and patients with independent mobility.

Exclusion Criteria:

* lower limb axial deviation large than 5° (valgus and varus knee);
* patients with diabetes mellitus, sever cardiovascular disease, immunosuppressive status, mental illness or other diseases than might affect the results;
* injections or other invasive treatments into the lower extremities were used in the past three months;
* patients willing to follow the doctor's recommendation for exercise training;
* patients with previous knee fracture or malignancy;
* patients with a previous history of hip or knee joint surgery;
* patients participating in hip or knee muscle strengthening in the past 3 months;
* patients did not complete the intervention strategies or regular follow-up.
An Expert System to Reduce Depression in Primary Care

The purpose of this study is to determine whether a home-based intervention matched to stage of change (readiness) for using effective methods to prevent or reduce depression can improve depression outcomes in primary care.

A variety of effective interventions exist for people who are willing to seek help for depression. However, there is a lack of interventions for individuals who are not willing to seek help or follow through with treatment recommendations. This is the first population-based intervention for depression that is appropriate for individuals in all stages of change-not merely the minority who are prepared to take action. Two primary care samples were included: 1) patients at risk for or experiencing depression but not involved in or planning treatment (Untreated Sample), and 2) patients newly prescribed antidepressant medication (Antidepressant Sample). Patients from both samples were randomly assigned to receive the intervention consisting of telephone assessments, a stage-based workbook, and three individualized, computer-generated reports mailed to the home (n=443), or usual care (n=459). Primary outcomes, assessed at 9 months, were change in depression severity, reliable and clinically significant change in depression severity, stage of change for using effective methods or prevent or reduce depression, onset of major depression if experiencing only subclinical symptoms at baseline, and medication adherence. The study design included an examination of whether the intervention effect was moderated by primary care sample, baseline use of effective methods to prevent or reduce depression, and level of depression.

Eligibility Criteria:
Inclusion Criteria:

* At risk for or experiencing depression (i.e., Beck Depression Inventory-II (BDI) score of 10 or higher; current major depression, minor depression, or dysthymia; or past major depression, minor depression, or dysthymia)

Exclusion Criteria:

* Younger than age 18
* Involved in counseling or planning counseling in the next 30 days
* Taking antidepressant medication or planning to take antidepressants in the next 30 days (exclusion criterion for Untreated Sample only)
* Suicidal ideation
* Severe depression (BDI \> 28) and deemed inappropriate for study by site clinician
* BDI \<10 and in the Maintenance stage for using effective methods to prevent or reduce depression
* History of bipolar disorder
Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma

Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed with upper tract urothelial carcinoma
* have no distant metastasis
* have an ECOG 0 to 2
* expected to receive radical nephroureterectomy

Exclusion Criteria:

* a prior history of bladder or synchronous bladder cancer
* administration of neoadjuvant chemotherapy
* the presence of severe complications
* deny to receive cytoscopy
* patients with advanced stage (T4)
* patients with contralateral UTUCs
Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia

This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects.

This cohort study will recruit chronic lymphocytic leukemia (CLL) patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group, and aims at observing the progression-free survival in CLL patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/) according to the World Health Organisation (WHO) classification 2008.
* Patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group.
* Previously untreated CLL patients requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of BR as first-line treatment.
* CLL patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of bendamustine and rituximab.
* Age ≥ 18 years old.
* Signed written informed consent according to ICH/EU/GCP and national local law.

Exclusion Criteria:

* Patients who have received 2 or more lines of prior therapy.
* Patients with:

Transformation of CLL into aggressive lymphomas (Richter's Syndrome). HIV infection. Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis

This study aims to explore the efficacy and safety of radiofrequency ablation combined with S-1 in pancreatic cancer patients with liver metastasis, as well as the correlation of serum microRNA and patients' prognosis. This protocol will be overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002).

Primary Outcome Measures:

To evaluate the overall survival (OS) in pancreatic cancer patients with liver metastasis treated with radiofrequency ablation combined with S-1.

Secondary Outcome Measures:

1. To explore the correlation of OS and serum microRNA of the patients.
2. To evaluate the progression free survival (PFS) and its correlation with serum microRNA.
3. To observe the objective response rate (ORR) and adverse effects of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky Performance Status ≥ 70
* Histologically/cytologically confirmed pancreatic adenocarcinoma.
* Patients must have underwent radical resection of the pancreatic lesion, or have their locally advanced pancreatic lesion controlled after first-line chemotherapy.
* At least one measurable liver metastasis by RECIST criteria must be present.
* Single liver metastasis smaller than 5cm, or multiple liver metastases less than 6 lesions and smaller than 3cm for each, without metastasis to other sites.
* Patients must have adequate organ functions reflected by the laboratory criteria below:

Granulocytes ≥ 2,000/uL, Hemoglobin ≥ 8.0 gm/dL, Platelets ≥ 100,000/uL, Serum creatinine \< 2.0 mg/dL, Bilirubin \< 1.5 mg/dL, SGPT \< 2.5 x normal, prothrombin time \<13.5s

* Prior therapy, e.g., chemotherapy, radiation, is allowed provided that at least 4 weeks washout time is given.
* Patients with jaundice must have a biliary drainage decompression operation before recruitment.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Prior treatment with S-1.
* Liver metastatic lesion is located at the surface of the liver, with more than 1/3 of the tumor protruding outside.
* Subject has Child-Pugh grade Class C hepatic impairment, massive ascites, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected, or other contraindication for radiofrequency ablation.
* Tumor invasion of Cavity organs.
* Known central nervous system involvement and leptomeningeal disease.
* Concurrent infection requiring intravenous antibiotics.
* Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
* Subject has previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
* Pregnant or lactating women.