cyrilzakka/clinical-trials huggingface dataset:
Suvorexant in Insomnia Co-morbid With Fibromyalgia

This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.

It has now become clear that the relation of sleep and pain is bidirectional; acute and chronic pain is associated with disturbed sleep and disturbed sleep enhances pain. Experimental studies have shown that reduced and fragmented sleep in pain-free normals increases their pain sensitivity and daily self-report studies in chronic pain patients have shown a poor night of sleep is followed by enhanced next-day pain. In mediation analyses of large clinical data sets it is found that the sleep-pain side of the bidirectional relation, as opposed to the pain-sleep side, accounts for the greater variance. These data then would suggest that improving sleep in chronic pain disorders should attenuate daytime pain.

Most of the drugs used to treat chronic pain facilitate inhibitory central nervous system mechanisms as their primary mechanism of action. Suvorexant, recently approved by the FDA for the treatment of insomnia characterized by difficulties with sleep onset and sleep maintenance, has a unique mechanism of action. Suvorexant is a selective antagonist for orexin receptors (OX1R and OX2R). Orexins are considered to be involved in arousal and maintenance of the waking state.

As such, suvorexant may provide unique clinical benefit as a treatment in chronic pain conditions with co-morbid insomnia, and specifically for fibromyalgia with its putative central hyperarousal and hypersensitization. Thus, this project proposes to study objective and clinical measures of sleep, pain, and daytime sleepiness and fatigue in patients with fibromyalgia and co-morbid insomnia while treated short-term with suvorexant 20 mg versus placebo.

Those qualifying will receive suvorexant 20 mg and placebo for each of 9 nights in a cross over design with 7 nights of washout between treatments. Overnight sleep recordings (PSGs) will be collected on nights 7 and 8 of each crossover treatment arm to determine objective sleep measures. During the day following night 7 in each arm, a Multiple Sleep Latency Test (MSLT) at 1000, 1200, 1400, and 1600 hr will be conducted and nociceptive sensitivity \[finger withdrawal latency (FWL)\] testing to a radiant heat stimulus (1100 and 1500 hr) will be conducted on day 1 and day 8. Self-reported mood and pain indices will also be completed prior to each FWL test.

Primary outcomes to be measured include PSG sleep efficacy and FWL response on both conditions (suvorexant 20 mg versus placebo).

Eligibility Criteria:
Inclusion Criteria:

* meet Diagnostic and Statistical Manual 5th ed criteria for insomnia
* meet American College of Rheumatology criteria for fibromyalgia
* otherwise good psychiatric and stable physical health

Exclusion Criteria:

* other primary sleep disorders
* pain symptoms unrelated to fibromyalgia
* current pregnancy or breast-feeding
Psychological Impact of COVID19 Among Doctors in Assiut University Hospitals

study aimed to investigate the psychological impact of corona virus among doctor in Assiut University Hospitals, mainly stress and burn out will be assessed

Prolonged exposure to stressful working environments resulting in a state of physical and emotional depletion and burnout. Nowadays, while facing corona virus, health care workers are on the front line and directly assist in diagnosis, caring and treatment of patients with COVID, thus keeping them at higher risk developing psychological distress and other mental health symptoms.

According to previous studies, during the outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), frontline medical staff had reported high levels of stress that resulted in posttraumatic stress disorder (PTSD)

A lot of factors contribute to increase mental effect among healthcare workers as increasing the suspected cases and workload , depletion of personal protective equipment's , drug shortage and feeling inadequately supported .

In Toronto study(2008), four major risk factors for stress among medical staff during the SARS outbreak were identified; including the perception of the medical of their risk of infection, the impact of SARS on their work, feelings of depression, and working in high-risk medical units. moreover, there are other factors as social stigmatization and contact with infected patients, also has previously been shown to be associated with increased levels of stress and anxiety in medical staff .

Eligibility Criteria:
Inclusion Criteria:

* all doctors currently working in assiut University hospitals

Exclusion Criteria:

* no exclusion critiria
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy females 18-40 years of age inclusive.

Exclusion Criteria:

* Individuals who are pregnant or nursing.
* Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion.
* Individuals with a history of severe allergic reactions after previous vaccination
* Individuals with designated blood tests that are not within normal range
Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound

Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.

This is a research study to test a FDA-approved automated breast ultrasound (ABVS) machine in subjects recommended for an ultrasound of the breast. The main purpose of the study is to compare images obtained from the automated breast ultrasound exam with the standard physician performed handheld breast ultrasound exam for lesion detection equivalence.

Each subject will have a bilateral hand-held breast ultrasound and a bilateral automated breast ultrasound, both exams preferably done on the same day. The hand-held ultrasound will be performed by a breast imaging physician participating in the study and the automated ultrasound exam will be performed by a sonographer.

There is no radiation risk from ultrasound. The physician performing the handheld breast ultrasound is blinded to the study, will not know the subject's history, but only the reason for the breast ultrasound exam.

The automated scan requires gentle pressure on the breast during a scan. Three basic views will be acquired for each breast, each scan lasting approximately one minute. Once all necessary views are acquired, the images will be sent to a remote workstation, where a second radiologist, also blinded to the results of the handheld study, will interpret the automated ultrasound.

Once all images and patient information are gathered, the study radiologists will review the previous images, if available, to provide the final result that will determine clinical management. Therefore, it is possible that the hand-held or automated ultrasound scan will lead to further evaluation of the breast and possibly a biopsy.

Eligibility Criteria:
Inclusion Criteria:

* anyone who is referred for an ultrasound of the breast

Exclusion Criteria:

* Subjects whose breast thickness is greater than 6 cm.The maximum depth of image filed for the ABVS acquisition is 6 cm
Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia

The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital.

This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age) with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A switch to oral treatment may be allowed at the discretion of the Investigator. The total duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 65 years of age.
2. Presence of CABP warranting hospitalization.
3. Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection.
4. Radiographically confirmed pneumonia.

Exclusion Criteria:

1. History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent.
2. Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen.
3. More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment.
4. Life expectancy of \< 30 days or presence of an order of Do Not Resuscitate (DNR).
5. Evidence of significant hematologic, hepatic, or immunologic impairment.
OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)

1. To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan
2. Chronic brain infarction in Japan is better than EU/USA

Period:2005-2007

Observation Time:baseline, 8week, 24week

matters investigated:

1. QOL determination using SF-36 v2
2. Age, sex, brain infarction type, stroke severity (modified Rankin scale), side of stroke, complication, smoking, alcohol, dizziness-vertigo-presyncope-light headedness, combination medicine, subjective symptoms, psychic symptoms, rehabilitation, recurrence, evaluation of depression (Japan-Stroke Scale (JSS)-D)

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose last attack occurred more than 1 month ago
2. Outpatients (including hospitalization for rehabilitation)
3. Japanese nationality
4. Patients who consented to participate in this study
5. Group I: Patients with dizziness, vertigo, presyncope, and light-headedness which are likely due to secondary chronic cerebral circulation impairment associated with sequelae of brain infarction, and patients for whom KETAS (IBUDILAST) was prescribed Group II: Patients without dizziness, vertigo, presyncope, and light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction

Exclusion Criteria:

1. Patients who cannot read, understand and fill in the questionnaire by themselves
2. Patients who idle their time away
3. Patients who are hospitalized
4. Patients who are undergoing treatment for dizziness, vertigo, presyncope, light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction
5. Patients whose dizziness, vertigo, presyncope, and light-headedness is definitely or likely caused by Meniere disease, vestibular neuronitis, benign paroxysmal positional vertigo, otitis media, or epilepsy6. Patients whom the investigator judges are not suitable to participate in the study
Digital Assessment of Well-being in New Parents

The mental health of new parents around the time of the birth of their baby has been identified as a key priority in the NHS (National Health Service) Long Term plan. At present, there is no nationally implemented method for monitoring parents' mental health, although the use of the Edinburgh Postnatal Depression Scale (EPDS) has been recommended. This is a paper based questionnaire administered by health visitors in the postnatal period. For the purposes of this project, the investigators contacted health visitors in Manchester to find out how they use EPDS in practice. Currently, health visitors only use the questionnaire if they feel there is a need during visits, and the questionnaire is not kept (only the overall score). Since almost 20% of mums develop postnatal depression, more systematic and thorough screening is needed.

The investigators developed an app version of the EPDS which takes less than 2 minutes to complete on a smartphone. It is anticpated that this will be a more accessible and practical method of conducting this important assessment. This project is a feasibility study to find out whether an app would be a feasible, acceptable, valid and safe way to monitor perinatal mental health in women and their partners.

The investigators aim to recruit 20 women and their partners in late pregnancy (after 36 weeks gestation) and ask them to use the app. The app will prompt completion of the EPDS once per day until 6 weeks postnatally. Participants' responses on the app will be transferred to a secure server at the University of Manchester. Participants will be invited to complete a paper version of the EPDS at the beginning and end of the study to check validity. They will also be asked to complete a questionnaire measuring the acceptability of the app and to take part in a brief qualitative interview at the end of the study.


Eligibility Criteria:
The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital, Manchester. Their partners will be invited to participate where applicable.

Inclusion criteria for pregnant women:

* after 36 weeks gestation
* aged over 18 years
* fluent in English
* under the care of Manchester University NHS Foundation Trust

Exclusion criteria for pregnant women:

* current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study)
* fetal abnormality
* multiple pregnancy

Inclusion criteria for partners:

* male or female partners of a mum participating in the study
* aged over 18
* fluent in English.
Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies (IMMUNOSTROKE)

IMMUNOSTROKE study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of AIC management by reperfusion treatment and to monitor changes in these different parameters over time. Post-hoc analyses will make it possible to correlate the immuno-inflammatory and thrombo-inflammatory profiles and their evolution with the clinical outcome in terms of post-AIC functional and cognitive disability.


Eligibility Criteria:
Inclusion Criteria:

* Presenting an ISCHEMIC STROKE for which reperfusion treatment is indicated according to European and North American recommendations (intraveinous thrombolysis or mechanical thrombectomy or a combination of both)

Exclusion Criteria:

* Contraindication to performing a cerebral MRI (claustrophobia, pacemaker or other implantable device contraindicating the performance of MRI)
* Intracranial haemorrhage associated with AIC on initial imaging
* Immunosuppressive treatment or corticosteroid therapy on admission of the patient
* Pre-existing neurological disability limiting the neurological assessment to 3 months (mRS\>2 on admission)
* Dementia known and diagnosed pre-existing at ischemic stroke
* Absolute or relative contraindication to gadolinium injection (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance \<15mL/min, pregnant or breastfeeding woman).
Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

This is a single-center, prospective study to evaluate the efficacy and safety of sintilimab, bevacizumab plus SIRT (Sin-Bev-SIRT) in patient with unresectable HCC.

23 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive sintilimab (200mg I.V. Q3W) and bevacizumab (7.5mg/kg I.V. Q3W) at 3-7 days after SIRT. Sintilimab and bevacizumab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.

The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* Unresectable HCC (BCLC stage B/C or CNLC II/III) with diagnosis confirmed by histology/cytology or clinically
* At least one measurable untreated lesion
* Intrahepatic tumors can be treated with 1-2 sessions of SIRT
* Child-Pugh score 5-7
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Life expectancy of at least 3 months
* Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
* Patients with hepatitis C need to finish the anti-HCV treatment

Exclusion Criteria:

* tumor extent ≥70% liver occupation
* Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
* Vena cava invasion
* Central nervous system metastasis
* Metastatic disease that involves major airways or blood vessels
* Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy for HCC
* History of organ and cell transplantation
* Prior esophageal and/or gastric varices bleeding
* Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy
* Evidence of portal hypertension with high risk of bleeding
* Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment
* Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment
* Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy
* Peripheral blood white blood cell count \<3×10\^9/L and platelet count \<50×10\^9/L
* Prolonged prothrombin time \>4 seconds
* Severe organ (heart, lung, kidney) dysfunction
* History of other malignancies
* Co-infection with hepatitis B and C viruses
* Human immunodeficiency virus infection
* Pregnant or lactating patients
Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia

Myocardial protection is a fundamental element for the safety of patients when performing cardiac surgery. For this purpose, cardioplegia were rapidly established in clinical practice to protect the myocardium when performing aortic clamp.

Cardioplegia are procedures to stop the contraction of myocardium. It is usually achieved with the use of chemicals ( cardioplegic solutions) or cold temperature (such as chilled perfusate). The composition of the cardioplegic solutions and their method of administration continuously changed over the years.

At the present date, cold blood cardioplegias are performed in the investigator's center. The investigators regularly use two modes of administration: either by an antegrade path (injection in the coronary arteries), or a retrograde one (injection in the venous system). At present, there are no elements supporting the superiority or inferiority of one path compared to another. The difficulty lies within a clear estimation of the contractility state of the ventricular cardiac muscle.

Technological developments in recent years provided a solution to this problem. The analysis of the pressure/volume curves generated by a ventricle allows an accurate quantification of the myocardial contractility. This requires the use of conductance catheters to accurately measure the ventricular volume and the ventricular pressure. The absolute ventricular contractility is then deduced with the help of a software.

The investigators intend to use this pressure-volume loops, obtained with conductance catheters, to compare the contractility of the right heart ventricle after antegrade vs retrograde cardioplegia.


Eligibility Criteria:
Inclusion Criteria:

* Need for myocardial revascularisation
* Normal FEVG ( \> 50%)

Exclusion Criteria:

* Valvulopathy
* Associated procedures
Visual Rehabilitation After Occipital Stroke

This research aims to examine changes in plastic potential of the visual system with time from stroke affecting primary visual cortex. We will measure structural and mechanistic aspects of progressive degeneration along the early visual pathways, correlating them with changes in visual performance, and in responsiveness to visual restoration training. This project will advance both scientific knowledge, as well as technical capability and clinical practices for restoring vision and quality of life for people suffering from cortical blindness.


Eligibility Criteria:
Inclusion Criteria:

* Residents of US and Canada
* MRI and/or CT scans showing evidence of one-sided / unilateral stroke or stroke-like damage to the primary visual cortex or its immediate afferent white matter sustained less than 6-months prior to enrollment
* Reliable visual field defects in both eyes as measured by Humphrey, Macular Integrity Assessment (MAIA), Goldmann, and/or equivalent perimetry. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
* Ability to fixate on visual targets reliably for 1000ms (as demonstrated by visual fields, and verified in study participation)
* Willing and safely able to undergo magnetic resonance imaging (MRI) scanning
* Willing, able, and competent to provide informed consent
* Fluent in written and spoken English
* Cognitively able, responsible, and willing to complete daily visual training independently at home for several months.

Exclusion Criteria:

* Past or present ocular disease interfering with vision
* Best corrected visual acuity worse than 20/40 in either eye
* Presence of damage to the dorsal Lateral Geniculate Nucleus, as shown on MRI/CT scans
* Diffuse, whole brain degenerative processes
* Brain damage deemed by study staff to potentially interfere with training ability or outcome measures
* History of traumatic brain injury
* Documented history of drug/alcohol abuse
* Currently use of neuroactive medications which would impact training, as determined by PI
* Cognitive or seizure disorders
* One-sided attentional neglect
* Inability to perform the visual training exercises as directed