cyrilzakka/clinical-trials huggingface dataset:
Coronary Bypass Grafting With Minimal Extracorporeal Circulation System Versus Off-pump Coronary Surgery

The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG).

This is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.


Eligibility Criteria:
Inclusion Criteria:

* Indication for coronary surgery established on the basis of current published guidelines

Exclusion Criteria:

* Documented preoperative systemic proinflammatory status and/or steroid administration within 6 months before surgery.
* Coexistence of a cardiomyopathy different than coronary artery disease that precise surgical treatment.
* Left ventricle ejection fraction of 40% or less.
* Treatment with erythropoietin (EPO) three months before the intervention
* Hematocrit less than 35% the day prior to the procedure
* Redo surgery
Use of Lumbar Motion Monitor to Predict Response to Radiofrequency Ablation After Medial Branch Diagnostic Blocks

The study is being performed to determine if adding an objective measurement of back function can assess the success of a commonly performed back injection procedure-lumbar medial branch blocks. Researchers also hope to compare whether those who have objective improvements after lumbar medial branch blocks will also have more successful lumbar medial branch radiofrequency ablation.

The current standard of care to determine the success of lumbar medical branch block(s) (MBB) is highly subjective, even if clinicians were to use validated questionairres. Currently, there are no studies that use a validated objective functional outcome measure to practically and efficiently assess lumbar MBB success prior to radiofrequency ablation (RFA). The addition of a validated objective measure of functional impairment to the current standard of care may help us improve in identifying the patients that will benefit from lumbar RFA. It has the potential to minimize procedures of limited benefit with a significant impact on containing healthcare spending. Additionally, it may further knowledge on how to appropriately select patients without relying on the stringent double block diagnostic technique put forth by the CMS that may exclude patients who could greatly benefit from a lumbar RFA.

As the objective measure the study will use a lumber motion monitor (LMM). The LMM weighs less than 5 pounds and fits on with a shoulder harness and belt. The LMM measures motion in all three directions (forward back, side to side, and twisting) just like the spine. The LMM testing may take up to 30 minutes depending on how many tasks can be performed by the participant and how many practice trials are required. The LMM testing includes bending forward and back to upright as fast as possible; comfortably while maintaining a twist position.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 20 years of age to 70 years of age
* Capable and willing to consent
* Participants literate in English language
* Patients with predominately bilateral axial pain and clinical suspicion of lumbar facet pain.
* Patients who have completed conservative care: physical therapy (PT)

Exclusion Criteria:

* History of drug abuse/ dependency
* History of prior lumbar medial branch block or medial branch radiofrequency ablation
* Changes to analgesic regimen in the last 30 days
* Allergy to lidocaine or bupivacaine local anesthetic
* Illiteracy (English)
* Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
* Predominately radicular pain.
* Patient reported limb pain greater than axial low back pain
* Previous lumbar spine surgery
* Any condition that the principle investigator may disqualify the patient
* Pregnancy
Contribution of "Praise Messages" to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia

This study evaluates the effects of praise message phone calls on antiretroviral therapy (ART) initiation, adherence, and prescription refills. The investigators will use randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs) in Ethiopia to a praise message phone call study arm or to a standard of care control study arm.

This study evaluates the effects of praise message phone calls on antiretroviral therapy (ART) initiation, adherence, and prescription refills. The investigators will use randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs) in Ethiopia to a praise message phone call study arm or to a standard of care control study arm.

Inadequate adherence to ART medication, missed clinics visits and loss-to-follow-up, and failure to refill prescriptions are major barriers to achieving viral suppression. Non-adherence is associated with a range of individual, social, community, and structural factors, including low health literacy, a lack of social support, low socioeconomic status, substance abuse, stigma and discrimination, and a lack of access to a reliable source of ART drugs. ART patients' perceptions about a lack of health provider respect and mutual trust are a possible further barrier to adherence.

Provision of HIV therapy within the MULU/MARPs drop-in-centers has attempted to mitigate some of the structural and social barriers to ART initiation and retention in care by bringing FSW friendly treatment services closer to clients and providing intensive counseling services, social and economic support services, and referrals to additional health services. Improving client perceptions of health care provider attitudes may further improve retention in care and adherence to treatment among FSW in Ethiopia. This study will measure the effects of praise message phone calls delivered the day after, and two weeks after, completing a ART appointment (i.e. initiation and/or prescription refill) on subsequent ART refills/HIV clinic visits.

This study will be conducted within PSI/Ethiopia's USAID-funded MULU/MARPs program, which provides HIV testing, treatment, and other services to female sex workers (FSW) through a network of drop-in-centers (DICs) across Ethiopia. Consenting FSWs who are living with HIV, who are ART naive, and who are referred for ART initiation to one of the 25 drop-in-centers (DICs) selected for "Test and Start" implementation will be enrolled in the study. Pre-study analysis indicates that each DIC enrolls between 3-4 FSWs living with HIV on ART each month (mean: 3.6). Over the course of our 9 month study, the investigators expect to enroll a total of 810 study participants.

Eligibility Criteria:
Inclusion Criteria:

* Written consent,
* ART naive,
* Female sex worker,
* Living with HIV,
* And, seeking care at a participating clinic

Exclusion Criteria:

* No consent,
* Previous ART,
* Has not exchanged sex for money in past 12 months,
* HIV negative,
* And/or, has not sought care at a participating clinic
Deep Learning in Retinoblastoma Detection and Monitoring.

Retinoblastoma is the most common eye cancer of childhood. Eye-preserving therapies require routine monitoring of retinoblastoma regression and recurrence to guide corresponding treatment. In the current study, we develop a deep learning algorism that can simultaneously identify retinoblastoma tumours on Retcam images and distinguish between active and inactive retinoblastoma tumours. This algorism will be validated through a prospectively collected dataset.

Retinoblastoma, the most common eye cancer of childhood, affects 1 in 15 000 to 1 in 18 000 live births. China has the second-largest number of patients with retinoblastoma in the world. Eye-preserving therapies have been used widely in China for approximately 15 years. Eye-preserving therapies require routine monitoring of retinoblastoma regression and recurrence to guide corresponding treatment. However, the major amount of qualified ophthalmologists are concentrated in several medical centres. Deep learning based on Retcam examination that can identify retinoblastoma will reduce screening accuracy of the local hospitals and reduce monitoring wordload. In the current study, a deep learning algorism was developed that can simultaneously identify retinoblastoma tumours on Retcam images and distinguish between active and inactive retinoblastoma tumours. This algorism will be validated through a prospectively collected dataset.

Eligibility Criteria:
Inclusion Criteria:

* Retinoblastoma patients undergo standard medical management.

Exclusion Criteria:

* The operators identified images non-assessable for a correct diagnosis, due to reasons such as blur and defocus, and excluded them from further analysis.
IVUS-Guided Treatment for Percutaneous Vascular Interventions

The main objective of the study is to survey and improve the IVUS image quality and X-ray system interoperability by collecting Procedural Data (e.g. raw, pre- processed ultrasound and X-ray data, endpoints such as fluoroscopy time, contrast load and radiation dose, workflow details) during routine intravascular procedures to assure adherence to the high standards of quality during care delivery and promote procedural standardization.

This is a prospective, multicenter, single-arm study to collect procedural data (e.g., raw, pre-processed IVUS, X-ray, and other procedural data) for image quality, workflow and interoperability assessments. Example of additional procedural endpoint data (e.g., time for fluoroscopy and IVUS, contrast load and radiation dose, workflow details, etc.) will be collected. The study will be conducted in a phased approach.

Since the collection of IVUS raw data with a second non-diagnostic pullback affects procedure time, the two aspects of this study - collection of raw IVUS data and procedural data, will be separated until IVUS raw data can be collected directly from the IVUS system with no additional procedural time.

Eligibility Criteria:
Inclusion Criteria:

1. The Patient is ≥18 years of age.
2. Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.

Exclusion Criteria:

1. Patients not meeting the instructions for use (IFU) of the respective IVUS catheters.
2. Patients with lesions or vessel segments deemed unsafe for multiple IVUS pullbacks.
3. Patients who are pregnant.
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)

The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age at time of screening.
* Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6) infection.
* Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or subject received a cadaveric or living donor kidney at least 3 months before screening.
* Subjects must be documented as non-cirrhotic.
* Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine.

Exclusion Criteria:

* Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
* Clinical history of fibrosing cholestatic hepatitis post-transplant.
* Re-transplantation of the liver or kidney.
* Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening.
* History of post-transplant complications related to hepatic or renal vasculature.
Investigating Variation in Hospital Acute Coronary Syndrome Outcomes

To investigate the causes of hospital variation in outcomes from acute coronary syndromes in England and develop recommendations for improving patient care.

Over the last few years the chance of dying from a heart attack in England and Wales has reduced dramatically. Even so, there remain huge differences in mortality between hospitals. For example, up to a third of patients with a heart attack who attend hospitals in England are more likely to die than would be expected. That is, the type of treatment and the risk of death depend upon where a patient lives and which hospital they attend. In part, the variation in death may be due to the services available at the hospital or to factors such as socioeconomic deprivation. It may also relate to other factors such as depression, cardiac rehabilitation, patient experience of hospital care and whether patients take their medication after discharge from hospital.

Notably, the challenges posed by poor drug adherence to secondary prevention medications are recognised by the World Health Organisation as the highest area of priority for improving individual health throughout the world. In addition, Patient Reported Outcome Measures (PROMs) are set to be the cornerstone of the evaluation of patient experiences of National Health Service quality of care.

Using statistical approaches that include measures of quality of life, we propose to examine data about heart attacks in England and investigate the 'postcode lottery of care'. Our aim, using regional data about heart attacks is to identify and measure the effects of hospital care. This research will identify hospital qualities that promote improved patient care. In doing so, best practice will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack.

Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years, both sexes, acute admission to the acute Trust with suspected acute coronary syndrome (ACS).

Exclusion Criteria:

Patients at a terminal stage of any illness, and those in whom follow up would be inappropriate or impractical.
The STAGE Study for Bipolar Disorder

When the investigators are caught up in emotions, it is by stepping back (or decentering) that the investigators are able to see the situation from another perspective. Individuals with emotional disorders, however, can have difficulties in being able to do this.

Research has shown that improving an individual's ability to step back from their emotions and take perspective is possible and can have beneficial effects on depressive symptomatology (Self Distancing and Perspective Broadening \[SDPB\] training). The SDPB training package involves two techniques: 1) stepping back from situations using mental imagery (building a mental picture of the situation and changing the distance to it) and, 2) reframing situations using perspective broadening reappraisals (giving new meanings to situations). The training package trains these SDPB techniques using an individual's memories and every day events. The fortnightly training comprises of two one to one sessions and daily homework for a week in between.The SDPB training package is aimed at improving an individual's ability to step back from, and put a new meaning to emotional events that take place in their lives.

The prospective pilot study aims to investigate whether the SDPB training package reduces symptomatology and improves these abilities in individuals who experience both depressive and manic episodes (Bipolar Disorder \[BD\]).

BD has a cumulative lifetime prevalence ranging from 1.52% across Europe and is treated with moderate success using Cognitive Behavioural therapy (CBT). However, 'moderate success' is considerably low compared to other mental health problems and CBT can be time time consuming, expensive, and cognitively demanding (requiring a high level of functioning of one or more cognitive functions). Accordingly, BD may be one of the emotional disorders in greatest need of novel and evidence based treatments.


Eligibility Criteria:
Inclusion criteria include:

- Individuals with a diagnosis of Bipolar Disorder whom are at the time of testing in a euthymic state (not in an episode of depression or mania).

Exclusion criteria include:

* Current substance dependence or abuse
* Current CBT treatment
* Individuals who are not fluent in English
* Organic brain injury
* Active psychotic and manic symptoms requiring hospitalisation
* Active suicidal risk.
Atypical Pneumonia

The goal of this observational study is to learn about causes of unresolved pneumonia in children who take appropriate antimicrobial therapy.

Recurrent pneumonia is defined as two episodes of pneumonia in 1 year or three episodes over any time frame. Non resolving pneumonias are characterized by the persistence of symptoms and roentgenographic abnormalities for more than 1 month. The key step in evaluating the patient referred for recurrent or persistent pneumonia is to review the clinical and radiographic features of the episodes to determine if there is adequate documentation to proceed with treatment. After deciding that a patient has had a persistent episode of pneumonia or the requisite number of recurrent episodes of pneumonia (accompanied by radiographic evidence of pulmonary infiltrates), it is essential to classify the episodes into those involving single or multiple lobes. On the basis of this classification.

Eligibility Criteria:
Inclusion Criteria:

* Patients with incomplete resolution by 4 weeks despite appropriate antimicrobial therapy.

  * From the age of one month to the age of 6 years old.

Exclusion Criteria:

* \*Age of the patient below one month and above 6 years old.

  * Patients with chronic lung diseases.
  * Patients with immunodeficiency.
  * Patient with aspiration pneumonia.
Extra Wide Field of View Lens Study

The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.

Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Screening for colorectal cancer at the age greater than or equal to 50 years, or evaluation of a positive stool test (i-FOBT) or polyp surveillance.
* Signed informed consent.

Exclusion Criteria:

* ASA classification ≥3.
* Age \<18 years.
* Known or suspicion of inflammatory bowel disease.
* Known polyp(s) for polypectomy.
* High risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease.
* Prior colorectal surgery.
* Vulnerable subjects or subjects unable to follow the procedures of the investigation, e.g., due to language problems.
* Unable or unwilling to undergo bowel cleansing for colonoscopy.
* Female patients who are pregnant or nursing.
* Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
Alternate Run Study

The proposed study will investigate the effect of alternating footwear model and workout-type on the occurrence of running-related pain. To achieve this goal participants will be randomly assigned into one of four different groups who will perform: 1) the same workout throughout a week in the same running shoe model, 2) alternating workout-types throughout the week in the same shoe model, 3) the same workout throughout a week in alternating shoe models, and 4) alternating workouts in alternating shoes. Participants will be characterized based on body alignment, strength, injury and training history. Pain and injury status will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Subjects in this study will include adults (men and women) between the ages of 19 and 60, have been running on a regular basis (minimum once per week) over the past 6 months, are able to run for 60 minutes continuously, could tolerate 20-40km per week in training, and have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months. Only neutral and pronated foot postures (Foot Posture Index between -2 and 8) will be recruited

Exclusion Criteria:

* have a history of surgery to their plantar fascia or Achilles tendon,
* have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity,
* take analgesic or anti-inflammatory medication 2 or more times per week over the past 4 weeks,
* take part in high impact activities 2 or more times per week during the study period
Bright Light Therapy on Post-stroke Insomniawith Post-stroke Insomnia

The objective of this study was to determine the effectiveness of bright light therapy as a treatment for early, mild-to-moderate stroke patients with post-stroke insomnia.


Eligibility Criteria:
Inclusion Criteria:

* first occurrence of stroke for the patient
* matched International Classification of Diseases (ICD)-10 codes (nontraumatic subarachnoid hemorrhage \[I60\], nontraumatic intracerebral hemorrhage \[I61\], other and unspecified nontraumatic intracranial hemorrhage \[I62\], or cerebral infarction \[I63\]) (World Health Organization, 1997)
* mild-to-moderate stroke (the National Institutes of Health Stroke Scale ≤14)
* age ≥18 years
* satisfactory cognitive function
* post-stroke insomnia.

Exclusion Criteria:

* Mini Mental State Examination (MMSE) score of ≤10
* recurrent stroke
* aphasia
* transient ischemic attack
* schizophrenia, bipolar disorder, mood disorder, previous insomnia disorder, or dementia before stroke
* taking sleeping pills or antidepressants for 5 or more days within a 6-month timespan before the onset of stroke
* post-stroke delirium
* a National Institutes of Health Stroke Scale score ≥ 14
* previous eye disease or post-stroke eye disease
* severe auditory impairment
* the use of psychotropic medications (hypnotics, benzodiazepine, benzodiazepine agonists, antidepressants \[mirtazapine or trazodone\] or antipsychotics)