cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Pneumoconiosis High Risk Early Warning Models

Precaution of pneumoconiosis is more important than treatment. However, the current process can't early warn the high-risk dust exposed workers until they are diagnosed with pneumoconiosis. With the feature of efficiency, impersonality and quantification, artificial intelligence is just appropriate for solving this problems. Therefore, we are aiming at adapting deep learning to develop models of pneumoconiosis intelligent detection, grade diagnosis and high risk early warning. The annotated images will be used for convolutional neural networks (CNNs) algorithm training, aiming at pneumoconiosis screening and grade diagnosis. Moreover, risk score calculated by density heat map will be used for early warning of dust-exposed workers. Then follow up of cohort will be implied to verify the validity of the risk score. By this way, the high-risk dust-exposed workers will get early intervention and better prognosis, which can obviously reduce medical burden.

Pneumoconiosis, the predominant occupational disease in China and all over the world. Chest radiography is the most accessible and affordable radiological test available for the physical examination of dust-exposed workers and mass screening for pneumoconiosis. But the diagnosis process has some disadvantages, such as strong subjectivity, inefficiency, and disability of judgement of borderline lesion, etc. Besides, precaution of pneumoconiosis is more important than treatment. However, the current process can't early warn the high-risk dust exposed workers until they are diagnosed with pneumoconiosis. With the feature of efficiency, impersonality and quantification, artificial intelligence is just appropriate for solving the aforesaid problems. Up to now, there has been rare research about adapting deep learning for pneumoconiosis grade diagnosis and high risk early warning. In our previous studies, we set up a chest radiograph database, which contains more than 100,000 digital pneumoconiosis radiography images. The result of detection-system evaluation demonstrated that the accuracy in the identification of pneumoconiosis could reach 90%, with an AUC(Area Under The Curve) of 0.965 and a sensitivity of 99%. More works need to be continued. Therefore, we are aiming at adapting deep learning to develop models of pneumoconiosis intelligent detection, grade diagnosis and high risk early warning. The annotated images will be used for convolutional neural networks (CNNs) algorithm training, aiming at pneumoconiosis screening and grade diagnosis. Moreover, risk score calculated by density heat map will be used for early warning of dust-exposed workers. Then follow up of cohort will be implied to verify the validity of the risk score. By this way, the high-risk dust-exposed workers will get early intervention and better prognosis, which can obviously reduce medical burden.

Eligibility Criteria:
Inclusion Criteria:

1. workers exposed to dust;
2. have digital chest radiography

Exclusion Criteria:

1. basal pulmonary disease;
2. dimission from dust-exposed work
Antibiotic Prophylaxis in Total Knee Prosthesis

Knee prosthesis infection is a severe complication. The use of a tourniquet during surgery impairs the efficacy of the antibiotic prophylaxis. We hypothesize that the antibiotic administration before tourniquet release decrease the infection rate. Methods: patients who undergo a total knee arthroplasty will be randomized to receive one of the following regimens of antibiotic prophylaxis:Standard: cefuroxime 1.5 g i.v. 10 min before tourniquet + placebo 10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.Experimental: cefuroxime 1.5 g i.v. 10 min before tourniquet + cefuroxime 1.5 g i.v. 10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.

Objective: when surgery is performed under ischemia, the ideal timing for the administration of antibiotic prophylaxis has not been well defined. Currently, antibiotics are given 10 minutes before ischemia and the infection rate is about 3-5%. In 2005 we performed a study where the efficacy of the standard prophylaxis was compared with a new regimen that consisted in administering the antibiotic 10 min. before tourniquet release. The results were positive although the difference was not statistically significant. In the present study we are proposing a new protocol where the antibiotic is given 10 min. before the inflation of tourniquet and 10 min. before its release. Methodology: all patients who undergo a total knee arthroplasty will be randomized to receive one of the following regimens of antibiotic prophylaxis:Standard: cefuroxime 1.5 g i.v. 10 min before tourniquet + placebo 10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.Experimental: cefuroxime 1.5 g i.v. 10 min before tourniquet + cefuroxime 1.5 g i.v. 10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.The infection rate with standard regimen is 3.4%. We believe that the new regimen will decrease the rate of infection to 1%. To demonstrate differences between both arms, it will be necessary to include 666 patients per arm.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing knee arthroplasty

Exclusion Criteria:

* patients allergic to penicillin
iBAILA - Investigating Brains & Activity to Improve Latino Aging

Examine the impact of the BAILAMOS (TM) dance program on lifestyle physical activity

Examine the impact of the BAILAMOS (TM) dance program on lifestyle physical activity (PA). Hypothesis 1: Intervention group will demonstrate greater improvement in Lifestyle PA than controls. 2) Test the impact of BAILAMOS (TM) on cognitive function and quality of life. Hypothesis 2: Intervention group will demonstrate greater improvement in cognitive function and quality of life than controls. 3) Test the impact of BAILAMOS (TM) on brain network functional connectivity. Hypothesis 3: Intervention group will demonstrate enhanced Default Mode Network (DMN), Executive Network (EN), and sensorimotor network connectivity vis a vis controls.

Eligibility Criteria:
Inclusion Criteria:

* age \> 60 years;
* Latino/Hispanic;
* ability to speak Spanish;
* participation in \<150 minutes/week of aerobic exercise;
* adequate cognitive status as assessed by the Mini Mental State Examination (\>14/21);
* danced \< 2 times/month over the past 12 months;
* willingness to be randomly assigned to treatment or control group;
* no plans to leave the U.S. \> two weeks during the study.

Exclusion Criteria:

* uncontrolled cardiovascular disease or diabetes mellitus;
* pacemaker or metallic implants (infusion pumps, metal prostheses, metallic-backed transdermal patches or metallic shrapnel); - claustrophobia that precludes MRI;
* stroke within the past year;
* healing or unhealed fracture(s);
* hip or knee replacement within the past 6 months;
* heart failure;
* recurrent falls within the past year;
* regular use of a walker or wheelchair;
* weigh more than 300 pounds, as unable to fit into MRI. The EASY (Resnick et al., 2008) will be used to learn if physician consent is needed for program enrollment.
Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia

Hepatitis C is a public health problem and the high cost of the Direct-Acting Antivirals (DAA) is one of the main limitations for treatment worldwide.

In Colombia, the Ministry of Health and Social Protection (MoHSP) has made progress in addressing Hepatitis C problem in order to control the infection and resolve barriers to access to medicines. One of the strategies implemented was the purchase of DAA, in association with the PAHO, and the instauration of the Clinical Pathway for the treatment of chronic hepatitis C.

The implementation of the Clinical Pathway has required the integration of health care processes and the respective report in the health information systems, allowing a high level of control in the monitoring of the Hepatitis C and the subsequent generation of indicators. However, there is limited information on the effects of the strategic purchase and the instauration of the Clinical Pathway on the costs of care, clinical outcomes and the quality of health care for patients with Hepatitis C in Colombia.

The aim of this study is to establish the effect of strategic purchasing and the Clinical Pathway for the treatment of chronic Hepatitis C, in the clinical results, in the general costs and quality of health care of Hepatitis C patients in Colombia.

A quasi-experimental design with a non-equivalent control group will be performed, where there will be an intervention group and a control group formed naturally before the investigation. In order to reduce the possible selection bias due to the lack of randomization, the propensity score method will be used. 62 patients will be included in each arm.

An estimation and comparison of the direct costs of the care of patients with Hepatitis C, before and after the implementation of the strategic purchase and the Clinical Pathway will be made, using a "top to bottom" method.

A questionnaire will be applied to the patients of the intervention group in order to identify barriers and facilitators to Hepatitis C health care and patient satisfaction with health care process under the Clinical Pathway.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Chronic Hepatitis C confirmed by quantitative HCV RNA test
* Patient affiliated to the contributory system of one Health Promoting Enterprise from Colombia.
* Patients with prescription of pharmacological treatment for Hepatitis C.

Exclusion Criteria:

* Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug.
Sodium Tungstate in Obesity

The purpose of this study is to compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade I and II).


Eligibility Criteria:
Inclusion Criteria:

* BMI: 30-39.9 Kg/m2
* In case of male gender, 18 to 65 years old
* In case of female gender, diagnosis of menopause
* Body weight changes \< 3 kg in the last 3 months
* In case of arterial hypertension or dyslipemia, no changes in dose in the last 2 months

Exclusion criteria:

* In case of female gender, absence of menopause
* Evidence of secondary causes of obesity
* Diabetes, type II
* Concomitant treatment with drugs affecting body weight
* Previous surgical intervention of obesity
The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes

The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole use results in reduced embryo implantation due to luteal phase insufficiency. The combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to overcome the luteal phase insufficiency effecting endometrial receptivity.

In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in normoresponders will increase oocyte maturity, embryo quality and embryo implantation and reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose) alone trigger.


Eligibility Criteria:
Inclusion Criteria:

* Age; \< 40 years
* Cycle number; cycles 1 or 2
* Antral follicle count; \>10 and \<25
* BMI; \>18 and \<30
* Normogonadotrophic cycle length; 24 to 25 days
* Male; ejaculated semen only

Exclusion Criteria:

* Presence of endocrine disorders; (diabetes mellitus, hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome)
* Previous major uterine surgery (that would affect endometrial receptivity)

Secondary exclusion criteria

* \<5 follicles at the time of trigger
* \<2 full formed blastocyst on day 5 of embryo culture
Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis

This is a study of multiple doses of inhaled QBW276 in patients with cystic fibrosis on top of standard of care. The study was divided into 3 Cohorts. Cohorts 1 and 2 are designed to be a randomized, double-blind, placebo-controlled, parallel arm, multiple dose study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of inhaled QBW276 over 1 week (cohort 1) or 2 weeks (cohort 2) in patients with cystic fibrosis regardless of their genotype.

The study was terminated after Cohort 2 due to the resource issues.


Eligibility Criteria:
Inclusion Criteria:

* Cohorts 1 and 2 = any genotype on any standard of care treatment
* Cohort 3 = F508del homozygotes on standard of care at that time
* FEV₁between 40 and 100%
* LCI2.5 ≥ 8 if FEV₁is more than 80%

Exclusion Criteria:

* Adrenal or electrolyte abnormalities
* Lung transplant
* Autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.)
Hypertension Management Using Remote Patient Monitoring: Study 2

The investigators will conduct a pragmatic pilot test of a remote patient monitoring system (RPM) for blood pressure measurement for Medicare patients with hypertension with and without the support of a care management program. The primary objective is to better understand how patients' remote monitoring of blood pressure and the direct transmission of this data to a healthcare system's EHR can be used by the patient and the care team to support optimal hypertension care and whether the addition of active care management increases the use of RPM and improvements in blood pressure.

This pilot study will be conducted in four Northwestern Medical Group (NMG) primary care practices. Two practices will have RPM available for primary care physicians to order for their eligible Medicare patients and two practices will also receive the support of a care management program to assist with patient enrollment, blood pressure monitoring and taking action in the setting of uncontrolled blood pressure.

The investigators will conduct a pragmatic non-blinded, non-randomized pilot study with contemporaneous controls among NMG outpatient clinics that provide adult primary care. They will make comparisons of data obtained through the course of routine care delivery from pilot and non-pilot practices.


Eligibility Criteria:
Inclusion Criteria:We will use these criteria to determine which patients will be included or excluded in the study analytic data set.

General inclusion criteria:

* Adults aged 65 to 85 years at the time of the study start date
* Receive their primary care from an eligible Northwestern Medicine clinic site
* One or more office or telehealth visits in the year preceding the study start date

Inclusion criteria primary population:

* Last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic
* Diagnosis of hypertension in the year preceding the study start date (problem list or encounter diagnosis)

Inclusion criteria for secondary population

* Meet criteria for primary population OR
* Diagnosed hypertension but did not have the last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic OR
* No diagnosis of hypertension in the past year but did have the last office blood pressure ≥140 mm Hg systolic or ≥90 mmHg diastolic

Exclusion Criteria:

* Persistent atrial fibrillation as indicated in the electronic health record (EHR)
* Stage IV or more severe kidney disease, defined as estimated glomerular filtration rate \<30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)
* Diagnosis of dementia as indicated in the electronic health record
Health System Dynamic & Resource Requirement in a South African COVID-19 Field Hospital

The aim of this study is to describe the patient clinical profile, resource requirements, and health system dynamics in a field hospital during the second wave of the Coronavirus (COVID-19) pandemic, leading to the outbreak of viral severe acute respiratory syndrome (SARS-CoV-2 virus), in South Africa. By describing the field hospital in this unique setting, the investigators hope to provide an efficient guide to similar settings across low- and middle-income countries.

This was a retrospective, single-center study. A total of 596 patients with confirmed COVID-19 were admitted to Mitchells Plain Hospital of Hope (MPHOH), Cape Town, South Africa, between January 1st and February 28th, 2021. Patient clinical characteristics, outcome, and resource allocation was collected. Daily hospital dynamics, including admissions, discharges, deaths and oxygen use was analyzed and compared to the local and national COVID-19 incidence rates.

The aim of the study is to amplify what is known about field hospitals in resource-constrained setting, so as to guide meaningfully the future COVID-19 public health response. Understanding not only the patient profile, but clinical resource requirements, and health system dynamic in a South African field hospital during the second wave of the COVID-19 pandemic can help in preparation for a future infection surge. This will shed light on the extent and timing of excess demand for intermediate care facilities for COVID-19 during peak infection periods in this region. Furthermore, lessons learnt here can guide efforts in similar settings across low-and middle-income countries.

Data was collected on all patients admitted to MPHOH between January 1st and February 28th 2021 using notes from patient folders' and an electronic hospital records systems. Patient demographics, clinical profile, resource utilization; as well as the hospital dynamics were collected. COVID-19 incidence rates were collected from the National Institute for Infectious Diseases, South Africa

A descriptive data analysis was performed to report the number, mean, median, and range of all relevant values. Hospital level data were summarized into weekly intervals, described and compared to COVID-19 incidence rates. Statistical data analysis was performed using R Statistical Computing program and Microsoft Excel.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the Mitchells Plain Hospital of Hope COVID-19 field hospital between 1st January 2021 and 29th February 2021. Patients admitted to the hospital must have been: over 18years of age, diagnosed with COVID-19 via polymerase chain reaction (PCR) test, transferred from a referring facility.

Exclusion Criteria:

* No patients were excluded.
Usability of a Novel Cueing Device for Patients With Parkinson's Disease

Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. The investigators developed a smart, small and lightweight, easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse generators and a battery-driven power supply. The device is programmed via a Graphical User Interface (GUI).


Eligibility Criteria:
Inclusion Criteria:

* Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian gait like hypokinetic movements and/or FOG have to be present.
* Parkinsonian gait is measured by the following items of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10 and item 3.11. The Hoehn and Yahr (HY) stage during ON is 1-4/5.
* MoCA ≥ 22/30.
* Participant has signed the informed consent.

Exclusion Criteria:

* Inability of the participant to understand the IC or to follow the procedures of the study (as judged by the Qualified Physician).
* Significantly, impaired cognitive skills render the participant unable to use the TCD.
* Presence of severe motor fluctuations and severely impaired walking ability as defined by HY stage V during ON.
* Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).
A Study to Determine the Correct Dose of Amikacin Which is Delivered Directly to the Lungs of Ventilated Patients as an Aerosol Via an Investigational Device Called the Pulmonary Delivery Device System (PDDS)

This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years of age or older with a clinical diagnosis of VAP, HAP or HCAP who are expected to be on mechanical ventilation for at least 3 days

Exclusion Criteria:

* Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP\>15cm H2O, creatinine\>2 mg/dL, or who are pregnant
Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept

The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept (Enbrel®).

Study participants need to have been self-administering etanercept for greater than or equal to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a 4-week screening period and a 5-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Subject has diagnosis of RA or PsA and indicated for treatment with etanercept per the current label, based on history.
* Subject is willing to self-inject per investigator judgement at screening.
* Subject has no known history of tuberculosis.

Exclusion Criteria:

* Latex allergy.
* Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first study dose of etanercept.
* Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.
* Other criteria may apply.