cyrilzakka/clinical-trials huggingface dataset:
Mixed-Methods Study of Multidimensional Adversity in Inner-City African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus

The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing multidimensional adversity (MDA) and living in the inner-city.

Multidimensional adversity (MDA), defined as having three or more social adversities such as loss of employment, housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD such as self-monitoring and behavior modification. This study utilizes a convergent parallel mixed methods study design to understand facilitators and barriers to care and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing MDA and living in the inner-city.

Aim 1 (Qualitative): Identify facilitators and barriers to care in African American adults with DKD experiencing MDA and living in the inner-city using in-depth patient and stakeholder interviews.

Aim 2 (Quantitative): Examine the effect of increasing burden of MDA on clinical outcomes (hemoglobin A1c, blood pressure, lipids), quality of life, and self-care behaviors (diet, exercise, and medication adherence) in a sample of 300 African American adults with DKD experiencing MDA and living in the inner-city.

Aim 3 (Integrative): Integrate findings from Aims 1 and 2 and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing MDA and living in the inner-city.

Eligibility Criteria:
Inclusion Criteria:

1. self- report as AA/Black
2. age ≥18
3. screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool
4. diagnosed type 2 diabetes (T2DM) with HbA1c≥8 and chronic kidney disease (CKD) including ESRD
5. able to communicate in English.

Exclusion Criteria:

1. cognitive impairment at screening visit
2. active psychosis
3. active alcohol or drug abuse/dependency
Prosthetic Device in Children With Upper Congenital Limb Deficiency

This is a study being performed to evaluate the safety and effectiveness of 3D printed myoelectric prosthetic devices in children with a congenital upper limb deficiency.

The purpose of this study is to learn more about whether myoelectric prosthetic devices would be beneficial and useful for children. The study protocol specifies 4 study visits over the course of a year at the following intervals: baseline, 3 month, 6 month, 12 months. In following the protocol, each study visit will use the Assessment of Capacity for Myoelectric Control (ACMC) functional testing. The study participants will also complete several parent-child reported health related quality of life and musculoskeletal questionnaires. Specifically, the Pediatric Outcomes Data Collection Instrument (PODCI), the Pediatric Quality of Life Inventory (PedsQL), and the Children's Hand-Use Experience Questionnaire (CHEQ) will be used to measure efficacy of the myoelectric devices..

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 6 to 17 with congenital/infant upper limb deficiency identified by Limbitless Solutions will be referred to OHSU for evaluation and selection.
* All approved and consented subjects will receive a Limbitless 3D printed myoelectric device as delivered by established protocol.
* Preference will be given to children with long term previous experience with Limbitless Solutions' bionic systems.

Exclusion Criteria:

* Non English-speaking children and families. Due to the entirely volunteer nature of this project, the investigators are unable to hire appropriate translation services or create translated forms and surveys in other languages currently.
* Shoulder or wrist disarticulation will be excluded.
Study of Bronchiectasis and Associated Cardiovascular Comorbidities

Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis

The study will include patients with bronchiectasis, and in an attempt to correlate the effect and burden of cardiovascular comorbidities in those patients, we will study the quality of life in those patients in comparison to the control group ( patients with bronchiectasis and without any other comorbidities) using SF-36 quality of life questionnaire. We will also study the inflammatory markers in both groups using D-dimer, BNP, and CRP and correlate them with the frequency of hospital admission, the severity of symptoms, and the general health state.

Eligibility Criteria:
Inclusion Criteria:

• Any Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.

Exclusion Criteria:

* Any Patients who refuse to participate in the study.
* Any other comorbidity or end-organ failure may affect the study's result.
Augmented CBGT for Perinatal Anxiety During a Global Pandemic (COVID-19)

This study will evaluate the effectiveness of an augmented version of our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and impact content.


Eligibility Criteria:
Inclusion Criteria:

* Females, aged 18-45 years
* Pregnant or up to six months postpartum
* Primary diagnosis of an anxiety disorder, as per the MINI for DSM-5, with or without comorbid depression
* No concurrent psychological treatment
* Not taking psychoactive medication or medication is stable in dose and type for at least 8 weeks prior to the study (as per Canadian Psychiatric Guidelines) and throughout study duration (participants will not be excluded from treatment if medication/dose changes during the study duration, however, they must notify the study team immediately)
* Fluent in English in order to understand the consent and group material

Exclusion Criteria:

* Severe depression/suicidality
* Primary diagnosis other than an anxiety disorder
* Psychotic or current substance/alcohol use disorder
A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections

The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections


Eligibility Criteria:
Inclusion Criteria:

* Systemic or invasive fungal infection
* Infection caused by organism for which there is no current treatment or infection with evidence of failure and/or intolerance to treatment with approved antifungal agents

Exclusion Criteria:

* Liver function test abnormalities
* Renal disease
* Fungal infections not considered to be invasive or systemic
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage

The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.

Intracerebral hemorrhage is a devastating disease with a high rate of severe disability and death, while no specific treatment has been proven to improve functional outcome. As a result, new approaches need to be developed to treat intracerebral hemorrhage. Animal and human trials showed treatment with remote ischemic conditioning was safe for intracerebral hemorrhage. And repetitive remote ischemic conditioning has been shown to improve sensorimotor and neuropathological outcomes following experimental hemorrhagic stroke. Therefore, we hypothesize that repetitive remote ischemic conditioning could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled double-blind trial to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan
3. Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
4. NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
5. Able to commence RIC treatment within 12 hours of stroke onset
6. Signed and dated informed consent is obtained.

Exclusion Criteria:

1. Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
2. A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
3. Already booked for surgical treatment
4. Life expectancy of less than 90 days due to comorbid conditions
5. Severe hematologic disease
6. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
7. Concurrent use of glibenclamide or nicorandil
8. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC
9. Severe hepatic and renal dysfunction
10. Platelet count \<100×10\^9/L
11. Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range
12. Known pregnancy, or positive pregnancy test, or breastfeeding
13. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
14. A high likelihood that the patient will not adhere to the study treatment and follow up regimen
15. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Risk Factors for Advanced Fibrosis Among FLD Patients

The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.

To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. Within the data lake of Helsinki University Hospital, they identified a large number of individuals with or without FLD. The investigators will now randomly invite 1000-1500 individuals with FLD to a follow-up study including investigation of metabolism and progression of liver disease (elastography, blood tests) as well as gathering life-style information. Register data on previous diagnoses and medication will be used to evaluate cardiovascular disease.

The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.

To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. This allows them to study also individuals who have had abdominal imaging for any reason (usually not for suspected liver disease). Within the data lake of Helsinki University Hospital, the investigators identified 61,271 individuals with FLD and 155,521 without. The investigators have obtained national register data on their diagnosed diseases and medication.

The investigators will now invite a random sample of 1000-1500 individuals with FLD (aged 20-60 years at the time of the previous imaging) to a follow-up study. Progression of liver disease will be studied by elastography, measurement of fat content and a blood sample for fibrosis markes (ELF score). The participants' metabolism will be evaluated with several laboraroty tests and an i.v. glucagon tolerance test and amino acid response. Questionnaires will be used to obtain life-style information.

Eligibility Criteria:
Inclusion Criteria:

* Liver imaging results in the Helsinki University Hospital datalake 2010-2018 and a finding of fatty liver disease (without liver cirrhosis)
* Age 25-70 years(20-60 yrs at the time of the index imaging (2010-2018)
* Biobank consent with the Helsinki Biobank to be contacted for possible studies

Exclusion Criteria:

Liver cirrhosis at index imaging date; pregnancy; active treatment for cancer
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

The primary objectives of this study are:

* To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH
* To evaluate changes in liver fibrosis, without worsening of NASH


Eligibility Criteria:
Key Inclusion Criteria:

* Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader
* In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 at Screening
* Screening laboratory parameters, as determined by the central laboratory:

  * Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
  * Hemoglobin A1c (HbA1c) ≤ 9.5%
  * Alanine aminotransferase (ALT) \< 5 x Upper Limits of Normal (ULN)
  * Platelet count ≥ 125,000/μL

Key Exclusion Criteria:

* Prior history of decompensated liver disease including ascites, hepatic encephalopathy, or variceal bleeding
* Child-Pugh (CP) score \> 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
* Model for End-Stage Liver Disease (MELD) score \> 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
* Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
* History of liver transplantation
* Current or prior history of hepatocellular carcinoma

Note: Other protocol defined Inclusion/ Exclusion criteria may apply
Community-Based Environmental Health Intervention

This community-based project, called the Together for Agricultural Safety project, was developed to help farmworkers reduce their exposure to dangerous agricultural chemicals (such as pesticides) through education and social marketing. The project is a partnership of university researchers and the Farmworkers Association of Florida. After collecting extensive data from farmworkers, health providers and farm owners about primary means of pesticide exposure we are collaboratively developing an intervention that will reduce pesticide exposure by educating workers and owners about: the need to have adequate washing facilities; to wash hands frequently; to obey reentry intervals; to change work clothes after work to prevent child exposure and more.


Eligibility Criteria:
Must be an agricultural worker in the fernery or nursery industries in Central Florida.
ParentCorps: Promoting Healthy Development in Children From Low Income Communities

The purpose of this study was to determine whether ParentCorps promotes academic achievement and prevents mental health problems in children living in disadvantaged urban communities


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in Pre-K
* At least one English-Speaking caregiver

Exclusion Criteria:
A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.

Study SSGJ-608-PsO-II-01 is a phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple-dose escalation and dose finding study to identify the doses of treatments ，and to further evaluate the effect of different dose regimens of recombinant anti-IL-17A humanized monoclonal antibody versus placebo in Chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. Phase Ib One of three dose levels of copanlisib is assigned at registration according to the dose escalation scheme. Phase II The copanlisib dose for the Phase II part of the trial will be based on the MTD established in the Phase Ib part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 Years to 65 Years, both male and female.
* BMI ≥18 kg/m\^2 and ≤32 kg/m\^2 ，and male weight ≥50 kg, female weight ≥45 kg during the screening.
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomizationas as determined by the investigator..
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
* According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).
* Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.

Exclusion Criteria:

* History of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline.
* History of drug-induced psoriasis.
* Ongoing use of prohibited treatments.
* Have previously received any drug that directly targets IL-17.
* Have concurrent or recent use of any biologic agent within washout periods or \<5 half-lives prior to randomization.
* Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), syphilis and/ or active tuberculosis.
* Pregnant or lactating women.
Safety and Efficacy of Lorbrena

To investigate the following matters under post-marketing use of Lorbrena in patients who received this drug

1. Factors affecting the onset of central nervous system disorder
2. Effect of Lorbrena in combination with CYP3A inducers on the onset of hepatic dysfunction


Eligibility Criteria:
Inclusion Criteria:

* All administered patients

Exclusion Criteria:

* Nothing
Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage

Terlipressin and somatostatin/octreotide are the first-line choices for the treatment of acute variceal bleeding in liver cirrhosis. Acute kidney injury can develop in patients presenting with acute variceal bleeding. On the other hand, evidence suggests that terlipressin can reverse hepatorenal syndrome. It has been hypothesized that terlipressin can protect the renal function in cirrhotic patients with acute variceal bleeding, except for control of bleeding.


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhotic patients who were admitted between January 2010 and December 2018.
2. A diagnosis of acute gastrointestinal bleeding.
3. Patients who received terlipressin or somatostatin/octreotide.
4. Age or sex was not limited.
5. Use of endoscopy was not limited.
6. Comorbidity was not limited.
7. Malignancy was not limited.

Exclusion Criteria:

1. Renal parenchymal diseases.
2. Absence of baseline serum creatinine.
3. Absence of serum creatinine 3-5 days after terlipressin or somatostatin/octreotide.
4. Duration of terlipressin or somatostatin/octreotide was less 3 days.
5. Patients who underwent transjugular intrahepatic portosystemic shunt.
6. Patients who underwent surgical shunt, splenectomy with or without devascularization, or liver transplantation.
Closed Loop Glucose Control in Intensive Care Unit

The purpose of this study is to assess the efficacy, safety and feasibility of a computer-based control algorithm to control glucose levels in adults in intensive care unit, in comparison to standard care.

This will be a single centre, open-label, randomised, parallel design, feasibility study conducted at Neurosciences Critical Care Unit (NCCU), Addenbrooke's hospital, Cambridge, UK. Study will aim for 24 adult subjects (12 participants in each arm of the trial) and study will last for up to 49 hours in each subject. Subjects will have a commercially available Conformité Européenne(CE) marked subcutaneous glucose sensor inserted at the start of the study. Glucose data from the sensor will be transmitted to a small bedside tablet computer, containing the algorithm which will determine insulin infusion rates aimed at maintaining glucose level between 6.0 - 8.0 mmol/L. The advice from the algorithm will be sent to the infusion pump via USB cable and insulin will be delivered intravenously. The system will also deliver intravenous glucose via a second infusion pump at times of low glucose levels. Samples for reference glucose values will be obtained either from an arterial line or central venous cannula and will be analysed using standard blood gas analyser in real time. Subjects randomised to standard care will receive intravenous insulin based on current treatment guidelines at the Neurosciences critical care unit (NCCU), Addenbrooke's Hospital, Cambridge, UK.

The primary outcome is time spent in target glucose range between 6.0 to 8.0 mmol/L as recorded by reference glucose. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by reference glucose, and sensor accuracy. Safety includes evaluation of significant hypoglycaemia and hyperglycaemia and other adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Admitted to Neurosciences critical care unit; (all patients are eligible regardless of admitting diagnosis except where specified under exclusion criteria)
* Stay in intensive care unit expected to be at least 48 hours
* At least one of the following conditions applies:
* Not on insulin infusion and single confirmed reference blood glucose level \> 10.0 mmol/l
* Already on insulin infusion including those subjects with pre-existing diabetes.

Exclusion Criteria:

* Patients with diabetic ketoacidosis or hyperosmolar hyperglycaemic non-ketotic coma (HONK)
* Patients who are receiving therapeutic hypothermia
* Known or suspected allergy to insulin
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e. liver failure, other fatal organ failures)
* Patients with significant abnormalities of blood clotting.
* Moribund patients likely to die within 48 hours
* Pregnancy