cyrilzakka/clinical-trials huggingface dataset:
Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital stay, mortality, nutritional status at two years of chronological age and predisposing factors to the development of parenteral nutrition associated cholestasis (PNAC) between the two groups, and to evaluate the adverse effects of the method of cycling used.

This was a single-center, prospective randomized not blinded study was conducted in a level 3 neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians were excluded.


Eligibility Criteria:
Inclusion Criteria:

* Newborns who needed long-term PN for more than ten days and were diagnosed with a pathology that makes likely the need to extend it.

Exclusion Criteria:

* Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians
Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

We hypothesize that there is a statistically significant difference in miRNA profiling and expression of subjects with asthma upon its exacerbation compared to patient's baseline level or following effective treatment of an exacerbation of asthma. Therefore, plasma miRNA profiling may provide noninvasive, highly specific and sensitive biomarkers for asthma exacerbation's detection and treatment follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Literacy: The subject must be able to read and comprehend English. Consent: The subject must have the ability to give informed consent. Type of subject: The subject must be seen in the outpatient setting at one of the clinics staffed by faculty members of the Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine.
* Asthma: The subject must have a history of physician diagnosed asthma for at least 1 year and must have a current exacerbation of asthma requiring oral glucocorticosteroids. Asthma exacerbation is defined below.

Asthma exacerbation (relapse or de novo) is defined as either:

1. An increase of asthma symptoms (cough, wheeze, chest tightness, and /or shortness of breath) that does not resolve within 2 hours after the use of rescue albuterol or corticosteroids and requires a medical visit or
2. During a scheduled visit, the subject has acute worsening of asthma symptoms and a reduction of \>20% in peak flow, which in the opinion of the investigator requires treatment with oral glucocorticosteroids.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Any other coexistent lung disease (COPD, interstitial lung disease, allergic bronchopulmonary aspergillosis, TB, sarcoidosis).
* Any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbates during the study. The list of conditions/diseases that will result in exclusion if determined to be clinically significant includes, but is not limited to: uncontrolled hypertension; hematological, hepatic, neurological, thyroid, peptic ulcer, or renal disease; immunologic compromise; current malignancy.
* Past or current use of tobacco (\<10 pack year smoking history and no smoking within the last 5 years).
The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain

The study aims to investigate the influence of 5 dry cupping treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the quality of life (SF36). To investigate neurophysiological effects of cupping we also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) at pain related and control areas. The treatment group then receives 5 cupping treatments over a period of two weeks. After the cupping series resp. a waiting period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.

see above

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75
* permanent neck pain for at least three months in a row
* a minimum of 40mm of neck pain on a 100mm visual analogue scale (VAS)
* having been in treatment to an orthopaedic or to a neurologist

Exclusion Criteria:

* neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling.
* invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment.
* serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment.
* non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.
Acceptability of Telehealth Triage Using Robotic Systems in COVID-19

The overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in order to prevent disease transmission to healthcare workers and minimize the use of personal protective equipment (PPE) have renewed interest in telemedical solutions as a method to triage and manage individuals with COVID-19. This investigation deploys a legged robotic platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the emergency department. The primary objective is to measure the patient response to interacting with these systems.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to the emergency department for evaluation
* \> 18 years old

Exclusion Criteria:

* Brought to emergency department via ambulance
* \<18 years old
* non-english speaking
* in extremis, or unable to participate due to underlying acute medical condition
ctDNA as a Biomarker for Treatment Response in HNSCC

Tumours continually shed DNA into the circulation, where it can be accessed. This circulating tumour DNA (ctDNA) directly reflects tumour burden and has great potential to be a sensitive biomarker for treatment recurrence. These "liquid biopsies" could give a more real-time picture of the genomic status and evolution of a tumour and can be easily assessed for measurement of different biomarkers. However, in head and neck squamous cell carcinoma (HNSCC) patients treated with primary curative radiotherapy, data regarding ctDNA kinetics and its correlation with outcome are scarce. A new or additional tool for response evaluation next to or instead of conventional imaging after treatment would be beneficial to detect recurrences in an earlier stage, thereby increasing the chances of success of salvage therapy. More importantly, an early response parameter during treatment could help to identify patients that have a good treatment response and might benefit from treatment adaptation. With this study, we aim to reveal ctDNA as an effective tool for future dose (de)-escalation trials in HNSCC.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Stage II-IV carcinoma of the larynx, hypopharynx, oral cavity or HPV negative oropharynx or stage II-III HPV positive oropharyngeal carcinoma, histologically confirmed according to the American Joint Committee on Cancer (AJCC) staging manual 8th edition
* Indication for primary curative radiotherapy with or without concurrent radio sensitizer
* WHO performance status 0-2
* Signed written IC

Exclusion Criteria:

* Metastatic disease
* Radiotherapy with palliative intent
* Diagnosis of any other malignancy within 5 years prior to start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g. surgery, radiation or castration).
Caracteristics of the Patients Hospitalized With Unvonluntary Commitment Procedure, in the Context COVID-19

The actual worldwide context (disease outbreak, confinements instaured in many countries) is a stressful factor for many people. It can have consequences on mental health : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. Patients with mental disorders are especially vulnerable.

On march 17th, the french government ordonned a national confinement to slow the progression of the COVID-19 outbreak, for 15 days at first then renewed several times. This situation has led to a reorganization of care as requested on March 22nd, 2020 in the recommendations applicable to the organization of care in psychiatric services : priority to telephone contacts and teleconsultation by multiplying contacts and assessments.

By the time the reorganization of care became operational, the most vulnerable patients may have experienced a decompensation of their disease.

It is important to know if the COVID-19 outbreak combined with the confinement increased the number of unvoluntary commitment the month after the announce of the confinement.

This could help us understand which patients are more vulnerable is this context, and improve our organization (ambulatory and hospitalization care) if this situation occurs again.

The main objective is to notice if we can observe a increase in the number of unvonluntary commitment the month after the announce of the confinement in the psychiatric hospital La Colombière, CHU Montpellier, France.

Secondary objectives :

* Describe the causes of unvonluntary commitment, and the principal psychiatric diagnostic of the patients
* Assess the lengh of the hospitalization
* Assess the number of patients hospitalized without psychiatric antecedent
* Assess the number of treatment interruptions in the recent history before hospitalization
* Asses the number of patients living alone
* Asses the number of patients using drugs

It is expected to highlight :

* An increase of the number of unvontuntary commitment
* If one or several mental disorders were more at risk of requiring an unvonluntary commitment
* An increased lengh of hospitalization
* An increased number of unvonluntary commitment of patients without psychiatric antecedent
* An increased number of treatment interruptions
* A link between hospitalization and living alone
* A link between hospitalization and using drugs

The medical file of all the patients unvonlutary commited from march 12th to April 09th 2020 are screened, and compared to the patients unvonlutary commited during the same period in 2019.

The caracteristics of interest are their age and sex, if the patient lives alone, the matter of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the moment of the hospitalization and if this psychiatric decompensation happens in a context of treatment interruption.

Eligibility Criteria:
Inclusion criteria:

- Unvonluntary commitment in psychiatric hospital La Colombière, CHU Montpellier, from march 12th to april 19th (2019 and 2020).

Exclusion criteria:

- refusal to participate
SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Primary Objective:

* To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.

Secondary Objective:

* To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,
* To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,
* To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of the International Index of Erectile Function),
* To assess the onset of action of XATRAL 10mg OD,
* To assess the peak flow rate improvement (Qmax),
* To assess the safety and the tolerability of XATRAL 10mg OD.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
* Patients with an I-PSS total score ≥ 8,
* Patients sexually active

Exclusion Criteria:

* Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life condition.
* Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period.
* Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer.
* Patients having received 5α-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or α1-blockers within 30 days prior to inclusion. Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion.
* History of postural hypotension or syncope.
* Known hypersensitivity to alfuzosin.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility

The study targets to evaluate the role of estimation of plasma expression levels of gene of microRNAs 203 and 210 in helping to diagnose and grade endometriosis. The study included women with unexplained infertility and clinical picture suggestive of presence of endometriosis were divided randomly into two groups: Control and study groups. All patients underwent exploratory laparotomy for diagnosis and grading of endometriosis if present. Patients of study group gave blood samples for estimation of plasma expression levels of microRNA 203 and 210 using qRT-PCR procedure.


Eligibility Criteria:
Inclusion Criteria:

* 30-45 years old
* Unexplained infertility

Exclusion Criteria:

* Presence of other causes of infertility,
* age out of the predetermined range,
* the presence of immune disorders,
* maintenance on immunosuppressive drugs
Effectiveness of a Standardized Bereavement Intervention in Primary Care

The purpose of this study is to evaluate the efficacy of "Primary Bereavement Care" (PBC) -a standardized bereavement intervention- delivered by family physicians (FP), in widows.

Nowadays there is little evidence about what is the best bereavement intervention in primary care and each family physician (FP) assists bereaved people in a different way. The death of a loved one is the most stressful life event that can face a person; in fact, bereavement is associated with an increased risk of depression, generalized anxiety and panic disorder, alcohol abuse and use of medications, sudden cardiac events, suicide, and an increased demand for health resources. The FP is the only specialist who -through his position in the health system and in the community- can give emotional support to the bereaved and simultaneously deal with the health problems associated with the process. In response to this, our work group has designed a guide specifically for FP: Primary Bereavement Care (PBC), and is currently testing its efficacy in a randomized controlled study.

Comparison (s): Recently widows attended by FP trained in PBC through seven PBC sessions, compared to recently widows attended by FP not trained in PBC through seven "ordinary" sessions.

Eligibility Criteria:
Inclusion Criteria:

* Partner death during the last 3 months.

Exclusion Criteria:

* Partner death through suicide or AIDS.
* Son or daughter death during the last 3 years.
* Parent or sibling death the year before.
* Alcohol or drug abuse.
* Psychotic disorder or dementia.
* To be confined to bed
* Illiteracy.
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 50 and over.
* Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
* Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
* Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
* Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.

Exclusion Criteria:

* Subjects who have previously had corneal surgery.
* Subjects who have potential visual acuity which is \< 6/12 due to other ocular pathology
* Subjects with corneal pathology.
* Subjects with astigmatism of greater than 1D.
* Subjects diagnosed with glaucoma.
* Subjects diagnosed with diabetes.
* Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
* Subjects with a know history of poor compliance
* Subjects with planned adjunctive surgery
Methylenetetrahydrofolate Reductase Deficiency in Ischemic Stroke

Adult onset epileptic seizures is rare and often associated with metabolic disorders, drugs and intracranial pathologies such as ischemia, hemorrhage or space-occupying lesions. Methylenetetrahydrofolate reductase (MTHFR) deficiency is one of the reasons that cause epileptic seizures in adults and can be ignored. MTHFR deficiency is an autosomal recessive disorder that results in hyperhomocysteinemia and causes a predisposition to venous and arterial thrombosis. The incidence of the polymorphism is around 40% in some countries. The aim of the retrospective study is to investigate the incidence of MTHFR deficiency in patients with adult-onset epileptic seizures.

Epileptic seizures that begin in adulthood seriously affect patients, their relatives and the society in which they live financially and psychologically. The etiology of epileptic seizures starting at adult age includes head trauma, central nervous system infections, intracranial lesions, cerebrovascular events, metabolic diseases and drugs. While the causes of childhood epileptic seizures are generally considered idiopathic, adult-onset epileptic seizures are almost always due to a pathological process. Epileptic seizures in adults may be a symptom of ischemic stroke. MTHFR deficiency is associated with raised homocysteine concentration in the body and increased risk of stroke (1). Studies have demonstrated that hyperhomocysteinemia is an independent risk factor for stroke (2).

MTHFR is the key enzyme in remethylation of homocysteine to methionine. MTHFR deficiency is an autosomal-recessive disease characterized by high homocysteine and low or normal methionine. MTHFR deficiency can cause vascular thrombosis in adults at early age; increased osteoporosis in elderly people; deep vein thrombosis, abortus during pregnancy; and infertility in adult males. In children, it is associated with intrauterine growth retardation, congenital heart diseases, neural tube defects, chromosome anomalies and hematologic tumors. In any age group, it might cause convulsions, increased thrombosis risk with some anticonvulsants and with the use of nitrogen protoxide in surgeries, and neuromotor retardation (3).

The aim of this retrospective study is to investigate the incidence of MTHFR deficiency in patients presenting with adult-onset epileptic seizures and diagnosed as ischemic cerebrovascular disease as a result of diagnostic tests.

Eligibility Criteria:
Inclusion Criteria:

* The patients with adult-onset epileptic seizures and diagnosed ischemic stroke in 3 years period.

Exclusion Criteria:

* Pediatric patients with epileptic seizures
Chinese Exercise Modalities in Parkinson's Disease

This study will compare the effects of two Chinese and one Western exercise modalities on the signs and symptoms of Parkinson's disease.

The long-term goal of this project is to study the effects of different exercise modalities on Parkinson's disease (PD). PD is a disorder whose primary disability stems from motor dysfunction including balance. Recent studies have shown that the risk of falling in the elderly can be reduced through the practice of the Chinese complementary and alternative medicine (CAM) such as T'ai Chi Chuan (TCC). This finding may be highly significant to PD. Although a recent report from Emory suggests PD patients can do well with aerobic (walk-run) exercise training (AET), it is still unclear whether the potential anti-Parkinsonian effect of such modalities is secondary to improved physical fitness (CRF), motor control or both. CAM interventions such as TCC may offer a unique opportunity to examine these fundamental questions.

In PD we hypothesize that exercise training will reduce primary and secondary disability and that some of these changes represent adaptive reprogramming of central motor pathways. We will conduct a controlled double-blind, 16-week dose-response study of exercise based on caloric expenditure and thus on the cardiorespiratory fitness effects of exercise (CRF). The treatments will be Qi Gong (minimal caloric expenditure), TCC (low expenditure), and walk-cycle AET (moderate expenditure).

We will examine exercise-induced change in motor control using quantitative measures of motor disability, including dynamic gait stability measures. We will also examine exercise effects on central and peripheral indices of Parkinsonian motor disability.

A caloric "dose-response" effect of exercise would suggest CRF is a major determinant of the anti-Parkinsonian effects of exercise. If the Chinese modalities are as effective or superior to AET however, this would suggest that other mechanisms such as change in central motor programming may be playing a role (e.g. relaxation effects, reinforcement of central motor programs?). A better understanding of exercise-induced neural plasticity and motor control would offer a significant, and heretofore unexploited rehabilitative potential in PD.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients with Parkinson's Disease, defined as a clinical state in which at least two of these four cardinal features are present- 1) slowness of movement, 2) tremor at rest, 3) muscular rigidity, 4) gait disturbance or posture imbalance.
* Ambulatory patients with Parkinson's Disease not exercising regularly more than 2x per week. Willing to be randomly assigned to 1 of the 3 exercise modalities: Tai Chi, Qi Gong and Aerobic exercise.

NOTE THAT PARTICIPATION IN THE STUDY REQUIRES BI-WEEKLY PARTICIPATION IN A 16-WEEK SUPERVISED EXERCISE PROGRAM PLUS RELATED EVALUATIONS AT EMORY. ACCORDINGLY, RECRUITMENT IS LIMITED TO LOCAL PATIENTS.