cyrilzakka/clinical-trials huggingface dataset:
Ventilator Mode and Respiratory Physiology

Modern intensive care units (ICUs) are increasingly adopting newer modes of mechanical ventilation such as adaptive pressure control (APC) modes but there are limited data available regarding risks and benefits of newer modes versus traditional ventilation modes. APC can inadvertently deliver high tidal volumes, which maybe harmful. High tidal volumes may be unrecognized by the provider, due to the complexities of ventilator algorithms and patient interactions. The objective of this aim is to identify risk factors for excess tidal volumes in patients on adaptive pressure control.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to ICU with acute respiratory failure
* On adaptive pressure control mode of ventilation
* Tidal volumes set between 5-8 cc/kg ideal body weight

Exclusion Criteria:

* Current use of neuromuscular blockade
* Inability to obtain consent from patient or surrogate decision maker
* Treating clinician refusal
National Cerebral and Cardiovascular Center (NCVC) Stroke Registry

A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.

This is a single-center registry of consecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center, a flagship stroke center in Japan.

Neurological emergencies other than stroke/TIA and subclinical cerebrobvascular inpatients are also enrolled.

Data are collected and analyzed to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.

The National Cerebral and Cardiovascular Center was founded in 1977 in Suita, Osaka, in order to provide the public with the most advanced treatment for cardiovascular and cerebrovascular diseases and to conduct the highest level of basic as well as applied research on the cardiovascular and cerebrovascular systems.

Eligibility Criteria:
Inclusion Criteria:

1. A patient with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center (NCVC)
2. Consent to participate in the registration by a patient or relatives obtained using an opt-out approach by the demonstrating contents of the registration on the hospital bulletin board

Exclusion Criteria:

1) Patients considered by the investigator to be unsuitable for participating in this registry
A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice

The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).

This is a non-interventional, retrospective and prospective study of participants with IBD. This study will collect data to provide accurate and comprehensive information related to treatment patterns associated with biologics use or non-biological therapy in participants with moderate to severe UC and CD in routine clinical practice.

The study will have retrospective data collection from past records of participants within the last 2 years before participant's enrollment. The prospective part of the study will include one year of observation and data collection after the participant's enrollment in the study.

The study will enroll approximately 2000 participants. Participants will be enrolled in one of the two groups:

* UC Participants
* CD Participants

This multi-center trial will be conducted in Russia, Belarus and Kazakhstan. The overall period of observation in this study will be approximately 12 months. Participants will make 2 visits within their routine practice to the clinic after the enrollment into the study including a final visit at Month 12.

Eligibility Criteria:
Inclusion Criteria:

1. Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study.
2. Has a moderate to severe IBD flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. IBD flare(s) must be confirmed in the source documentation.
3. Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy.

Exclusion Criteria:

1. Current or previous (within the last two years) indeterminate or not classified colitis.
2. Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years.
3. Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial.
4. Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
5. Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime.
Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Device for Medial Patellofemoral Ligament (MPFL) Reconstruction

This is a Post Market Clinical Follow Up Study in Orthopaedics. It will verify the long-term safety and performance of the device in the intended patient population, when indicated for the reconstruction of a ligament in the kneecap - the Medial Patellofemoral ligament (MPFL).

The Medical Device in this study, Poly-Tape, is a Class IIb CE-Marked device manufactured by Xiros Ltd. Poly-tapes are a single-use device, they are indicated for patients repair of soft tissue and/or reconstruction of ligaments, tendons, and other soft tissues. The device can be fixed to the bone using several different methods including screws.

This study is a prospective, multicentre, consecutively recruited non-randomised study. The total length of the study is expected to be 7 years. This includes a recruitment period of approximately 24 months and a 5-year follow-up. A total of 55 subjects will be enrolled into the study with follow up at 6 months, 1 year, 2 years and 5 years in clinic and by questionnaires. All subjects treated with the Poly-Tape for MPFL reconstruction, will be consecutively recruited into the study.


Eligibility Criteria:
Inclusion Criteria:

Patient must be 13 years old or above. Patients who require MPFL reconstruction. Patients willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC).

Exclusion Criteria:

These devices should not be used in procedures which bridge, disturb, or disrupt the growth plate in immature patients since they will not elongate as the patient grows.

Patients known to be hypersensitive to titanium alloy or polyester. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.

Patients with any infections or structural or pathological condition of the bone or soft tissue that would be expected to impair healing or secure fixation. Bone quality should be assessed prior to surgery.

Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.

Patients for whom the implantation is intended to be non-permanent, since they integrate well with the patient's tissue.
Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia

The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of patients with laryngeal dystonia (LD) - also called spasmodic dysphonia (SD).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.

Exclusion Criteria:

* Regular intake of benzodiazepines
* Cognitive impairment: score \< 27 on the Mini-mental State Examination (MMSE).
* Identify with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia other than LD, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis.
* Non-English speaker. We will not enroll people who cannot speak English, because the voice assessment procedures (Test sentences, CAPE_V clinical rating) have only been validated for English speakers at this point.
* Pregnant people. We will not enroll pregnant people as the device used in this study is investigational.
Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe

A cluster randomised trial to determine the impact of an integrated community-based package of HIV services incorporating HIV testing, linkage to care and ongoing adherence support, combined with sexual and reproductive health (SRH) services and general health counselling for 16 to 24 year olds on population level HIV viral load in a high HIV prevalence setting.

Young people fare disproportionately poorly across the HIV care continuum compared to other age-groups; the prevalence of undiagnosed HIV is substantially higher, and coverage of and adherence to antiretroviral therapy is lower, resulting overall in worse virological outcomes.

Aim: The aim is to determine the impact of an integrated community-based package of HIV services incorporating HIV testing, linkage to care and ongoing adherence support, combined with sexual and reproductive health services and general health counselling for 16 to 24 year olds on population level HIV viral load in a high HIV prevalence setting.

Design: This is a two-arm cluster-randomised trial in 24 clusters randomised 1:1 to standard of care or to the intervention package.

Intervention: Community-based package of services that includes: HIV testing and counselling, delivery of antiretroviral therapy, adherence support groups, mobile health, condoms, menstrual hygiene management, contraception and treatment of sexually transmitted infections, referral for voluntary medical male circumcision and cervical screening, risk reduction counselling and general health information and counselling. The intervention will be implemented over a two and half year period. The intervention will be implemented in 12 clusters, each with a population of approximately 2500-4000 16-24 year olds.

Study Outcomes: The study outcomes will be determined at a population level through a community cross-sectional survey among 18 to 24 year olds two years following the implementation of the intervention. The primary outcome is the proportion with HIV with a viral load \<1000 copies/ml. The secondary outcomes will reflect each step of the HIV care cascade: proportion with HIV who know their HIV status, proportion of those who know their HIV-positive status who are currently taking antiretroviral therapy, proportion of those taking antiretroviral therapy who are virally suppressed. Sexual and reproductive health knowledge, risks and behaviour will also be assessed.

Study population: The end-line survey will recruit 700 18-24 year olds per cluster (total 16 800).

Study sites: The study will be conducted in 3 provinces in Zimbabwe: Harare, Bulawayo and Mashonaland East.

Study Duration: The planned duration of the entire study will be 4 years

Eligibility Criteria:
Inclusion Criteria:

* Reside within cluster boundaries
* Aged 16 to 24 years

Exclusion Criteria:

* Reside outside the cluster boundaries
* Aged below 16 years
* Aged above 24 years
Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis

Adenomyosis affects approximately 21% of symptomatic women who present to gynecology clinics. The disease is characterized by heavy bleeding and pain during periods. Limited treatment options exist for the treatment of adenomyosis for women who desire future child-bearing or prefer to avoid surgery. Recently, ulipristal acetate has been studied as a treatment option for women who have fibroids and heavy bleeding. The majority of women treated with ulipristal stopped having periods altogether. Our study aims to determine whether ulipristal is an adequate treatment for women with adenomyosis.

Adenomyosis affects an estimated 20.9% of symptomatic women who present to gynecology clinics, with peak prevalence of 32% in 40-49 years old. Prior histologic studies in women undergoing hysterectomy show prevalence of with some variation due to differing histologic diagnostic criteria 10-37.1%. Heavy menstrual bleeding and dysmenorrhea are commonly manifested in women with adenomyosis. However, data on treatment of adenomyosis remains scarce. For women desiring definitive options, hysterectomy remains the treatment of choice. However, for women who desire future fertility, the currently accepted first-line therapy is progestogen therapy, particularly the levonorgestrel-IUD. Other limited studies have used danazol and GnRH agonists, but its use is limited by significant side effects.

Recently, the selective progesterone receptor modulators (SPRM) have emerged as successful medical treatment options for leiomyoma. The SPRM ulipristal acetate has been studied extensively in the treatment of leiomyoma and more recently endometriosis. Ulipristal acetate exerts both antagonist and agonist properties. Amenorrhea was achieved in 80% of women taking 5mg of ulipristal daily by treatment month 2 and up to 90% of women taking 10mg daily. Anovulation was achieved in 80% of women taking 5mg and 10mg dosing. Ulipristal acetate has not been studied as a treatment option for women with adenomyosis. We aim to study the effect of daily ulipristal on heavy menstrual bleeding in women with adenomyosis.

Eligibility Criteria:
Inclusion Criteria

* 18-51 years old
* PBAC score greater than 100
* Ultrasound or MRI findings of adenomyosis

Exclusion Criteria

* Inability to comprehend written and/or spoken English or Spanish
* Inability to provide informed consent
* Current uterine, breast, cervical or ovarian cancer
* Unwilling to use contraception
* Positive pregnancy test or planning pregnancy during the study period
* Submucosal uterine fibroids (or greater than a certain size)
* Current premalignancy or malignancy
* Endometrial ablation or uterine artery embolization
* Known hemoglobinopathy
* Known severe coagulation disorder
* Large uterine polyp (\>2cm)
* BMI \>40
* Previous or current treatment with SPRM or GnRH agonist
* Progestins, acetylsalicylic acid, mefenamic acid, anticoagulants, antifibrinolytic drugs, systemic glucocorticoids within 1 month of enrollment
Effect of BETY on Biopsychosocial States Associated With Chronic Pain in Rheumatic Individuals.

No study has been found in the literature investigating the effectiveness of an innovative exercise approach defined on a biopsychosocial basis and having its own original scale on individuals with rheumatism over the years. The aim of this retrospective study was to determine the effects of the Cognitive Exercise Therapy Approach on the biopsychosocial conditions related to chronic pain; functionality, mood and quality of life of individuals with rheumatism diagnosis and to examine the effectiveness of BETY as a routine exercise approach by presenting the results compared with the control group.

Cognitive Exercise Therapy Approach (BETY) is an innovative exercise approach developed through the participation of rheumatic individuals in exercise sessions for many years. The main purpose of BETY is to transfer the patient's negative cognitions about their disease to a positive cognition level through functional gains through exercise. Thus, cognitive restructuring will be achieved.

In order to correctly organize the optimum treatment, rheumatic patients need to be evaluated biopsychosocially. Individual-centered scales that evaluate the disease process are currently considered at least as much as objective tests in determining treatment effectiveness and are increasingly used in clinical practice. Due to the multidimensional structure of chronic diseases, there is a need for measurement tools that evaluate individuals in a biopsychosocial context. BETY-Biopsychosocial Scale (BETY-BQ) was developed for this purpose with the feedback of the recovery characteristics of rheumatic individuals who participated in BETY sessions over the years.

Eligibility Criteria:
Inclusion Criteria:

- Patients who were diagnosed as Ankylosing spondylitis (1984 modified New York criteria, RA (2010 ACR/EULAR criteria), PsA (2006 CASPAR criteria), SLE (2012 Systemic Lupus International Collaborating Clinics criteria), SSc (2013 ACR/EULAR criteria), pSS (American-European Consensus Group criteria), OA (1986 ACR criteria) and FMS (2016 ACR criteria)

Exclusion Criteria:

* Patients who had severe cognitive problems
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients

Background:

Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated

Aims:

To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2)

Methods:

Prospective, randomized, double blind, non-inferiority, controlled clinical trial

Expected Outcomes:

1. Primary outcomes:

   Biopsy proven acute rejection within first year following transplant
2. Secondary outcomes:

   1. Patient and graft survival at 1 year
   2. Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months
   3. Emergence of de novo donor specific antibodies (DSAs)


Eligibility Criteria:
Inclusion Criteria:

* • Male or female ≥ 18 years

  * Living donor
  * Low immunological risk (defined as):

    1. First (primary) transplant
    2. ≤ 4 antigen mismatches (HLA matching scheme)
    3. Negative HLA Ab screening

Exclusion Criteria:

* • High immunological risk

  * HLA identical or zero mismatched transplants
  * Receiving cyclosporin as primary maintenance immunosuppressant
  * Human immunodeficiency virus (HIV) co-infection
  * Pregnant or nursing female
  * Has received an investigational medication within the past 30 days
  * Has a known contraindication to the administration of Basiliximab
  * Suspected or known to have a serious infection
  * Multi-organ transplant
Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.

Recent evidence has shown that acute intermittent hypoxia can strengthen motor pathways after spinal cord injury, and enhance walking outcomes after walking rehabilitation compared to walking rehabilitation alone. A single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. Further evidence supports the hypothesis that acute intermittent hypoxia acts on all motor pathways, and thus can enhance the strength of most muscles in the body.

Spinal cord injury affects the muscles that control respiration. Decreased respiratory muscle function can lead to diseases of the respiratory system, which are the primary cause of death and significant cause of re-hospitalization after spinal cord injury. Deficits in postural muscle function affect one's ability to balance, safely maintain a seated position, or ambulate after spinal cord injury, severely impacting daily activities such as self-care and feeding skills.

This study will test the hypothesis that a single session of acute intermittent hypoxia will increase strength and activation of the muscles that control respiration and posture, leading to improved scores on functional assessments in individuals with chronic spinal cord injury. Our long term goal is to better understand the therapeutic potential of acute intermittent hypoxia combined with physical rehabilitation for individuals with chronic spinal cord injury.

Eligibility Criteria:
Inclusion criteria:

1. Male or female, ages 18-65
2. Greater than 6 months post-spinal cord injury
3. Spinal cord injury affecting segments between C4-T12
4. No other known neurological disorders
5. Able to provide informed consent
6. no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments.

Exclusion criteria:

1. Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia
2. Severe, untreated bladder or urinary tract infection
3. Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments
4. Women who report being pregnant or test positive on a pregnancy test
Hospice Quality Score Assessment Post Pharmacist Intervention

The study aims to investigate the impact of pharmacist delivered interventions on hospice patients quality metric scores.

The objective of this study is evaluate a program at a hospice involving activities designed to improve the site's National Quality Forum (NQF) and Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores. These scores are calculated by the hospice using existing patient satisfaction survey scores (HCAHPS). The institution quantifies their compliance with national quality metrics (NQF) and reports this existing data to the pharmacist providing counseling services to their patients. The pharmacist assesses for areas for improvement and provides additional counseling services to improve the continuity and quality of care. The pilot program is scheduled to launch April 2020 and the researchers will look to assess for changes in the NQF scores, HCAHPS scores, and time for their partnering pharmacy to refill the first set of prescriptions.

Eligibility Criteria:
Inclusion Criteria:

Adult patients who were referred to hospice by a healthcare provider

Exclusion Criteria:

Patients 89 years or older