cyrilzakka/clinical-trials huggingface dataset:
Protocol for Evaluation of eLearning of Quality Improvement Methods

This study evaluates the use of eLearning of quality improvement methods. Participants who use eLearning only, facilitated learning only and a combination of eLearning and facilitated learning will complete questionnaires and be interviewed to establish the effect of eLearning of quality improvement methods to improve knowledge, change in behaviour and impact on healthcare services for better patient care.

Quality improvement (QI) is an increasingly important element of delivering health care. Learning and feeling confident in using QI methods is an essential part of healthcare practice. eLearning is a cost effective way of capacity building to a large cohort of health care professionals and service users. National Institute of Health Research Collaboration for Leadership in Health Research and Care Northwest London has developed a suite of eLearning modules (QI4U) to support an introductory understanding of technical aspects of QI. This protocol describes a trial to evaluate the experience of learning, knowledge gained, change in behaviour, and impact of eLearning of QI methods.

Participants will belong to one of three Groups of learners over the course of 12 months: learners using only QI4U (group 1); people using only facilitated learning (Group 2); and learners using a combination of QI4U and facilitated learning (Group 3). The Kirkpatrick model will be used to evaluate the learning. The primary outcome of interest will be transfer of knowledge gained from learning into clinical practice for service improvement by individuals (level 3). Secondary outcomes will include reaction or experience of QI4U, knowledge gained, and the results or impact of learning through QI4U on service improvement (levels 1, 2 and 4).

Transfer of knowledge into clinical practice will be assessed by interviews with individual learners. Experience of eLearning and knowledge gained will be assessed using feedback forms, questionnaires, time spent doing QI4U and reflective logs. Impact will be assessed by interviews with organisational leads with a high prevalence of QI4U learners.

This study will provide evidence on the effectiveness of using eLearning as a means for learning QI. It will serve to evaluate learners' experience of using eLearning and the impact of various training methods within the context of learning QI.

Eligibility Criteria:
Inclusion Criteria:

* clinicians, managers, commissioners, service users and carers, and researchers who have an interest in learning QI methods.

Exclusion Criteria:

* No exclusion criteria
Peripheral Stimulation Neural Response

Few patients recover full hand dexterity after an acquired brain injury such as stroke. Repetitive somatosensory electrical stimulation (SES) is a promising method to promote recovery of hand function. However, studies using SES have largely focused on gross motor function; it remains unclear if it can modulate distal hand functions such as finger individuation. The specific goal of this study was to monitor the effects of SES on individuation as well as on cortical oscillations measured using EEG, with the additional goal of identifying neurophysiological biomarkers.

Participants with a history of acquired brain injury and distal upper limb motor impairments will receive a single two-hour session of SES using transcutaneous electrical nerve stimulation. Pre- and post-intervention assessments consist of the Action Research Arm Test (ARAT), finger fractionation, pinch force, and the modified Ashworth scale (MAS), along with resting-state EEG monitoring. We will assess for any association between SES and changes in motor outcome as measured using the ARAT, MAS and finger fractionation. In addition, EEG power analyses will be performed to determine if there are any differences between SES responders vs. non-responders.

Eligibility Criteria:
Inclusion Criteria:

* between 18-80 years old, with a history of an acquired brain injury resulting in residual hemiparesis or other motor deficits of the arm/hand equal to or more than 6 months prior to enrollment; and capacity to adhere with the schedule of interventions and evaluations determined in the protocol.

Exclusion Criteria:

* Subjects are excluded if they met any of the following criteria: currently pregnant; uncontrolled medical conditions; significant cognitive impairment on the Montreal Cognitive Assessment (MoCA ≤ 23); ≤ 10 degrees of active index finger range of motion; significant hand joint deformity; severe active alcohol or drug abuse; significant depression (PHQ-9 ≥15); baseline spasticity score (MAS) \>3 for any joint tested (wrist and metacarpophalangeal joint flexion and extension); apraxia screen of Tulia (AST) \<5; absent light touch, proprioception, pinprick and vibration sensation on the modified Nottingham Sensory Assessment; no upper limb strength against gravity; severe aphasia; or had an implanted pacemaker.
Retrospective Evaluation of ASIPP Guidelines Implementation

To demonstrate clinically significant improvements in the patients treated following ASIPP guidelines compared to the patients who were treated prior to the establishment of ASIPP guidelines.

We have performed one study in the past showing that the implementation of guidelines improved outcomes by reducing the number of procedures and also the cost. However,, no large scale study has been performed thus far.

Eligibility Criteria:
Inclusion Criteria:

Evaluate all patients undergoing the following interventional techniques during 1999 and 2000 compared to patients undergoing interventional techniques during 2004 and 2005

* Cervical facet joint nerve blocks
* Thoracic facet joint nerve blocks
* Lumbar facet joint nerve blocks
* Lumbar interlaminar epidural steroid injections
* Cervical interlaminar epidural steroid injections

Exclusion Criteria:

Non-availability of appropriate data
Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors

The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.

The objective of this study is to determine whether SONDA is non-inferior in predicting visual field limitations compared to the SAP in patients with a (supra)sellar tumor. The study population will be made up of patients with a (supra)sellar tumor complicated by compression of the optic chiasm as well as healthy controls. The patients will be asked to join the study when the patients are referred to the UMCG for further diagnostics and treatment. In case the patients show signs of visual field loss the patients will be asked to participate in the study. The researchers will reuse data from healthy controls collected in previous studies where possible and, if necessary for age matching, recruit new participants. Participants will be asked to perform the SONDA test before and after surgery. The first time the participants will perform the test twice and will also perform routine eye test and be asked to fill in a questionnaire to evaluate the experience.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a (supra)sellar tumor
* Visual field loss based on the most recent SAP; False positive rate \<15%; fixation losses \<20%
* Informed written consent

Exclusion Criteria:

* Neurological disorders
* Eye disease not related to a (supra)sellar tumor
Aspiration Treatment of Perianal Abscess

The purpose of this study is to compare aspiration and oral antibiotics with surgical incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula formation. Included patients will be randomised to either aspiration or incision.

Anorectal abscess is a common condition, caused by cryptoglandular polymicrobial infection, where the traditional treatment is surgical drainage. Anorectal abscess is associated with recurrence rates between 6-44 % after surgical drainage and persistent subsequent fistula up to 37 %. Inadequate incision, missed abscess components or fistulas can be the cause of recurrence . Surgical drainage is associated with discomfort from prolonged wound healing, affecting the daily activities as well as the potential risk of complicated scaring and fecal incontinence. Less invasive method with pus aspiration under antibiotic cover has been shown to be safe in terms of recurrence rate and subsequent fistula formation and well tolerated by the patients with less morbidity and wound complications and a potential lower risk of fecal incontinence. However, this has been shown only in few studies with small population and no randomized controlled study comparing the two approaches has been conducted or published to our knowledge. The risk factors of recurrence and subsequent fistula formation are not that clear but age below 40 years, absence of diabetes mellitus and recent smoking are shown to be risk factors for developing recurrent abscess and fistula. Applying aspiration and antibiotics method for the treatment of perianal abscess can be an advantage for the society due to a shorter recovering period, quicker return to daily activity and work and avoiding wound healing problems and sphincter damage; thus lower expenses. The results of this study have the potentials to reveal the risk factors of developing fistula after perianal abscess.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 yrs old
2. Perianal abscess (without spontaneous rupture)
3. Abscess larger than 2 cm in diameter
4. Signed informed consent

Exclusion Criteria:

1. Malignancy within 5 yrs
2. Previous radiotherapy of the abdomen and pelvis
3. Recurrent abscess within 6 months
4. Immune suppressed patients
5. Pregnant and lactating women
6. Abscess with horseshoe formation
7. Allergy to Clindamycin
Community Health Workers and Precision Medicine

The purpose of this randomized controlled trial is to evaluate whether a trained community health worker (CHW) who engages with newly diagnosed patients after a diagnosis of cancer can effectively improve knowledge and receipt of evidence-based precision medicine cancer care services among low-income and minority patients.

The goal of this study is to reduce cancer disparities by improving the knowledge and delivery of evidence-based precision medicine for cancer care. We plan to randomize newly diagnosed patients and those currently under cancer care to either a control arm (usual cancer care alone) versus an intervention arm (layered on top of usual cancer care alone) where patients are assigned to a community health worker who will assist patients in ensuring the following discussions with their care team: 1) precision cancer care 2) cancer diagnosis and treatment plan 2) adherence to treatments and 3) goals of care and symptom burden. A total of 55 participants per study group (total 110) will be recruited in Monterey County from Pacific Cancer Care.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with a cancer diagnosis.
* Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by a physician.
* The patients must be 18 years or older.
* Patients must have the capacity to verbally consent in English or Spanish.
* Patients must be racial/ethnic minorities OR low-income status OR public insurance (Medi-Cal or other) OR have health insurance provided by an agricultural company OR be uninsured

Exclusion Criteria:

* Patients under 18 years of age.
* Inability to consent to the study due to lack of capacity as documented by the referring physician.
* Patients without a newly diagnosed malignancy or patients without relapse of disease.
The Effect of Video-based Testimonials About Psychotherapy on Treatment Expectations and a Short Online Intervention

Research has shown that treatment expectations play a major role in the course of mental disorders and that positive expectations have a beneficial impact on treatment outcomes. Expectations can develop in different ways and an emerging body of research shows that social learning plays a significant role in this process. To date, most studies have investigated the impact of social learning on treatment expectations in the context of pain relief. Little is known about the impact of social learning in the psychotherapeutic treatment of depression. Therefore, this study investigates whether treatment expectations about depression therapy and treatment effects of a short online intervention can be modulated via social learning, i.e., showing positive treatment testimonials.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* be able understand German (at least B1 level)
* have access to a computer device with internet access

Exclusion Criteria:

* age below 18 years old
* non correctable hearing or visual impairment
* diagnosis of borderline-personality disorder
* diagnosis of post-traumatic-stress-disorder
* self-reported suicidality
MPFL Reconstruction With or Without Tibial Tubercle Transfer

This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL) reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.

70 patients with recurrent patellar instability were randomly assigned to undergo MPFL reconstruction with or without tibial tubercle transfer. Follow-ups were performed at 12 and 24 months postoperatively, and computed tomography (CT) was performed immediately after the operation and at follow-up. The knee function was evaluated preoperatively and at 2 years postoperatively using Lysholm,Tegner and Kujala scales. Redislocation or multiple episodes of patellar instability were considered failures.

Eligibility Criteria:
Inclusion Criteria:

* recurrent patellar dislocation or instability,patients with TT-TG value equal to or greater than 20 mm,patients with closed epiphyseal plate

TT-TG：Two lines drawn perpendicular to posterior bicondylar line, one line through middle of the trochlear groove(TG) and the second through tibial tuberosity (TT). Distance between the lines is measured.

Exclusion Criteria:

* bilateral patellar dislocation, a previous surgery in the involved leg,patients with open epiphyseal plate,patients with severe trochlear dysplasia
CAVA: Electrode Pad Appraisal Trial

This trial requires healthy volunteers to wear a selection of CE marked electrodes for up to 30 days. The results from this trial will determine which electrodes should be used with the CAVA device, which is a medical device for monitoring dizziness.

Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on our health service. There are multiple causes of dizziness, and these originate from pathologies affecting a large variety of different organ systems. Dizziness is usually episodic and short-lived, so when a patient presents to their health care provider, examination is often normal. As such, diagnosis is challenging and patients often experience significant delay in receiving a diagnosis. We have developed a device for monitoring dizziness and in 2018 we evaluated the device by undertaking a clinical trial involving healthy volunteers. Following the promising results from the first trial, we will conduct a second trial in 2019 on patients suffering from dizziness.

During the healthy volunteer trial, a minor issue was encountered relating to long-term daily wear of the device's electrode pads. Specifically, nine participants reported varying degrees of skin redness and inflammation beneath their electrode pads, mostly occurring after around two weeks of wear. The issue was self-limiting and resolved after a few days of non-wear. The team worked closely with a consultant dermatologist in order to monitor and manage this adverse event.

Since the issue was identified, the team has consulted with a number of people with relevant expertise in order to determine the causes of the issue and to find the most viable solution. Based on these discussions, we propose that the causes of this issue were due to a combination of wear duration, and/or repeated removal, and/or the specific type of electrode pad used. To confidently identify the cause of this issue and to evaluate a number of possible solutions, we intend to undertake a trial to evaluate the tolerability of alternative electrode pads and different patterns of wear.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over.
* Able to commit to 30 days of continuous wear of the electrode pads as per the study plan.
* Own a telephone.

Exclusion Criteria:

* Potential participants who have a history of dermatological disease, damage around the forehead, or fragile skin.
* Potential participants who have an allergy to plasters and/or medical adhesives.
* Potential participants who have taken part in a previous CAVA trial.
* Potential participants who are currently taking part in another trial.
* Unable to follow the testing protocol.
Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

This clinical trial evaluates the use of a tool kit, Stress, Affect, Language and Speech Analysis (SALSA), for early identification of cognitive side effects of immunotherapy compared to the standard of care assessment.

PRIMARY OBJECTIVES:

I. To investigate the use of a toolkit for automated administration and scoring of cognitive tests (Stress, Language and Speech Analysis, or SALSA) in adult cancer patients who are treated with commercial chimeric antigen receptor T cell therapy (CAR-T) products at University of Minnesota and are at risk of developing immune effector cell-associated neurotoxicity syndrome (ICANS).

OUTLINE: This is an observational study.

Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* \* ≥ 18 years of age at initiation of therapy

  * Planning to undergo inpatient CAR-T therapy for primary malignancy
  * Fluent in English (written or spoken)

Exclusion Criteria:

* \* Subjects with speech or hearing impediment that would make them unable to be assessed with SALSA

  * Subjects with diagnosed cognitive impairment prior to CAR-T therapy
  * Unwilling or unable to sign voluntary written consent
The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases

Polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. Some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or Sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. Recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. However, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood.

The investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. Moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients \> 18 years old
* patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma.

Exclusion Criteria:

* Age \< 18 years;
* chronic viral hepatitis;
* HIV infection, syphilis,
* tuberculosis
Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children \< 5.

Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.


Eligibility Criteria:
Inclusion Criteria:

* children \< 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to participate

Exclusion Criteria:

* children with facial malformations making NP sampling unacceptable
* children in foster care
Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette syndrome (TS). Unfortunately, medications are often ineffective and frequently have significant side-effects. This is a pilot therapeutic study using a dietary approach, the modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability, and efficacy of dietary therapy in patients with TS ("proof of concept") and to determine whether this intervention is worthy of evaluation in large-scale clinical trials. The modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under investigation for neurological conditions other than epilepsy, including Alzheimer disease, headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and depression.


Eligibility Criteria:
Inclusion Criteria:

* Ages 12-65 years
* Tourette syndrome (vocal and motor tics for over a year)
* \> 20 score on the Yale Global Tic Severity Scale
* Ability to follow instructions and comply with the dietary changes

Exclusion Criteria:

* Secondary tics
* Underweight (BMI \< 5%)
* Prior use of the Atkins diet for over 2 days
* High cholesterol or triglycerides
* Major depression or anxiety disorder
* Pregnancy
* Substance abuse