cyrilzakka/clinical-trials huggingface dataset:
Training and Coaching to Promote High Performance in Veteran Affairs (VA) Nursing Home Care

This study aimed to explore the feasibility of an educational intervention to strengthen workplace learning systems in four VA Community Living Centers (CLCs).

Background:

The study explored the feasibility of an educational intervention to strengthen workplace-learning systems in four VA Community Living Centers (CLCs).

Objectives:

Specific aims were to 1) conduct a feasibility study to assess whether the educational intervention is practical to implement as designed and 2) conduct a pilot study to validate the methodology proposed for assessing outcomes of this educational intervention.

Methods:

A multi-level intervention targeting the translation of workplace learning into practice was implemented. The Direct Care Worker (DCW) intervention targeted both clinical knowledge and effective communication. The Coaching Supervision training addressed management and supervision practices for nurses, combined with effective communication. Four CLCs received both interventions, administered by the Paraprofessional Health Institute (PHI), using a train-the-trainer approach over the course of four 3-day sessions. Quantitative and qualitative data were collected to assess factors influencing effectiveness of implementation and to understand the impact of the trainings on participants.

Status:

The study has been completed with educational interventions implemented and qualitative and quantitative data collected.

Eligibility Criteria:
Inclusion Criteria:

* VA Employees: psychologists, nurse-managers and front-line nursing care staff assigned to CLCs will be included

Exclusion Criteria:

* Those not working in the CLC,
* Those working in the CLC but not involved in the training intervention that is the focus of the study (e.g. Environment Management Service personnel, dietary personnel)
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants must be ≥ 18 years old
* Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and \< 170 mmHg at Screening
* Fulfil at least 1 of the following 2 criteria:

  1. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
  2. rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
* Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
* Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening
* Randomisation Criterion:
* Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit

Exclusion Criteria:

* Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
* Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
* Serum sodium level \< 135 mmol/L at Screening
* Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation
* New York Heart Association functional heart failure class IV at Screening
* Persistent atrial fibrillation
Safety and Dose-escalation Study of AAV2-hCHM in Participants With CHM (Choroideremia) Gene Mutations

This clinical study evaluates the safety and tolerability of AAV2-hCHM in participants with Choroideremia gene mutations.

The primary objective is to evaluate the safety and tolerability of subretinal administration of AAV2-hCHM, in an inter-subject group dose escalation in individuals with choroideremia, based on a comprehensive clinical monitoring plan. The secondary objectives are to define the dose of AAV2-hCHM required to achieve stable, or improved, visual function/functional vision and to assess development of immune responses to adeno-associated virus vector, serotype 2 (AAV2) and Rab escort protein 1 (REP-1).

Eligibility Criteria:
Inclusion Criteria:

* Male at least 18 years of age diagnosed with CHM gene mutation
* Central visual field (VF) \<30° in any of the 24 meridians (using Goldmann perimetry III4e isopter) in the eye to be injected
* Any evidence of functioning outer retinal cells within the central 10°

Exclusion Criteria:

* Previous history of ocular inflammatory disease (uveitis)
* Prior intraocular surgery within six months
* Participation in a previous gene therapy research trial within one year of enrollment or participation in any other ocular gene therapy trial
* Participation in a clinical study with an investigational drug in the past six months
* Grossly asymmetrical disease, or other eye morbidity, which may render the contralateral eye ineffective as a control
* Visual acuity \<20/200 on standard Early Treatment of Diabetic Retinopathy Study (ETDRS) testing in the eye to be injected
* Presence of disease which may preclude the participant from participation in this trial
* Use of medications known to be neuroprotective or retino-toxic that could potentially interfere with the disease process and/or cause ocular adverse events; individuals who discontinue use of these compounds for 6 months may become eligible
* Identification by the investigator as being unable or unwilling to perform/be compliant with study procedures.
The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients

The goal of this observational study is to learn about the association between cardiac valve calcification and the 1-year mortality after lower-extremity amputation in diabetic patients. Diabetic patients requiring lower-extremity amputation were retrospectively studied. Preoperative detailed anamnesis was taken. Cardiac valve calcification was assessed using echocardiography at baseline. One-year follow-up was conducted and included clinical visits, hospital record assessment, and telephone reviews to obtain the survival status of patients. Researchers compare the survival group to the mortality group to study the relationship between the cardiac valve calcification and mortality.

This study aimed to investigate the association between cardiac valve calcification and 1-year mortality in diabetic patients after lower-extremity amputation. The investigator recruited consecutive patients who were admitted to the Sun Yat-sen Memorial Hospital for diabetic foot ulcers that needed amputation surgery. Clinical characteristics of each patient and the laboratory examination were collected before surgery. Cardiac valve calcification was assessed at baseline. This study obtained the survival status of patients within one year through outpatient follow-up and telephone follow-up. Researchers compared the survival group to the mortality group to see if the mortality group had a higher prevalence of heart valve calcification.

Eligibility Criteria:
Inclusion Criteria:

* Had echocardiography at baseline
* With diabetic foot ulcers that required amputation after orthopedist's assessment

Exclusion Criteria:

* Fractures due to traumatic reasons that required extremity amputation
* Amputation level below the ankle
* Severe sepsis that required vasoactive agent treatment
* Rheumatic heart disease
* Heart valve surgery history
Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers

An Open-label, Randomized, Single-dose, Crossover Study

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.

Exclusion Criteria:

* History or evidence of clinically significant disease
* History of drug/alcohol abuse
* Participated in other studies and received investigational products within 6 months prior to the first study dose.
* AST(GOT) or ALT(GPT) \> 2 X upper limit of normal at screening
* Not able to use a medically acceptable contraceptive method throughout the study.
The Influence of an E-learning Program on Recognition of Actinic Keratosis

The evaluation on the diagnostic accuracy of actinic keratosis recognition by general practitioners before and after participation on an e-learning program.

Actinic keratosis is defined as the most frequent common intra-epithelial neoplasm in the Caucasian population, with an increasing prevalence. If left untreated, actinic keratosis has the potency to develop into a cutaneous squamous-cell carcinoma. Treatment of actinic keratosis is aimed at both lesion reduction and to prevent malignant transformation. To achieve treatment adherence for patients, it is necessary to raise physician awareness about actinic keratosis.

This study primarily aimed to investigate whether the sensitivity of establishing a correct actinic keratosis diagnosis by general practitioners (in training) would increase after participating in an e-learning program about the recognition of actinic keratosis. This was achieved by comparing the results of a pre- and post-test completed by general practitioners which was incorporated in the e-learning program.

Eligibility Criteria:
Inclusion Criteria:

* general practitioner in the Netherlands
* access to e-learning module via phone/computer/tablet
* knowledge of the Dutch language

Exclusion Criteria:

* no knowledge of the Dutch language
* different specialists than general practitioner
Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis

Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and possibly with an increased cardiovascular morbidity and mortality. Statins lower serum cholesterol levels and may thus improve the cardiovascular risk in PBC patients. The aim of our study therefore was to prospectively examine the efficacy of low-dose atorvastatin on indicators of cardiovascular risk such as dyslipidemia and vascular function as well as safety in patients with PBC.

Primary biliary cirrhosis (PBC) is often associated with abnormalities in serum lipids. Hypercholesterolemia is an established risk factor for cardiovascular morbidity and mortality. Since many PBC patients have a very slow progression of their underlying liver disease cardiovascular risk factors may become more relevant as prognostic facors. Whether statins lower serum cholesterol levels and reduce the cardiovascular risk in PBC patients remains to be determined. Statins are generally well tolerated and are not associated with an increased risk of hepatotoxicity in patients with nonalcoholic fatty liver disease (NAFLD). However only limited data on safety on statins in chronic cholestatic liver diseases are available. In a recent pilot study at the Medical University of Graz atorvastatin did not statistically increase liver enzymes in PBC patients. However, data on long-term treatment with atorvastatin in these patients are not yet available. Moreover, long-term treatment with statins may have potential beneficial immunomodulatory effects on the disease course of PBC in analogy to other immune-mediated disorders such as rheumatoid arthritis and multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* LDL-cholesterol \> 130 mg/dl
* Primary biliary cirrhosis (AMA positive or biopsy proven)
* Male or female gender
* Age 18-70 years
* Normal kidney function

Exclusion Criteria:

* Primary biliary cirrhosis Stage III-IV (Ludwig Score)
* Liver cirrhosis
* Decompensated liver disease ( \> Child-Pugh class B, ascites, esophageal varices)
* ALT or AST \> 2x ULN
* Pregnancy or breastfeeding
* Premenopausal women without certain contraception
* Known hypersensitivity to HMG-CoA reductase inhibitors
* Current treatment with lipid-lowering agents other than atorvastatin; immunosuppressants, macrolides
Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years smoking history and current non smoker. A pack year = number of packs of cigarettes smoked per day x years smoked.
* Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A and B only)
* ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
* Tumor sample available and adequate for analysis.
* At least one measurable target lesion.
* Adequate cardiac, kidney, and liver function
* Adequate blood counts

Exclusion Criteria:

* More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
* Significant cardiac disease or dysfunction.
* Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2.
* Active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
* Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only).
* Major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day 1.
* Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
* Inability or unwillingness to swallow HKI-272 capsules.
* Pregnant or breastfeeding women.
Impact of Timing of Premedication on Mucosal Visibility During Endoscopy-A Randomized Controlled Trial

UGI endoscopy(esophagogastroduodenoscopy) is the main diagnostic modality for direct visualization ,real time assessment and interpretation of findings encountered. The evaluation of esophagogastroduodenoscopy (EGD) quality measures encompasses several categories, such as structure, procedure, result, and adverse events. The peri-EGD period procedures fall under the procedural area, which is primarily concerned with preventing and minimising missed diagnoses.

. More aid in the identification and characterisation of gastrointestinal mucosal lesions is provided by endoscopes equipped with improved imaging technologies, such as multiband or narrow-band imaging (NBI). Despite these advancements of technological aspects, the unclean mucosal surface of the stomach can make these high-end pieces of equipment virtually useless To visualize properly and diagnose accurately there should be clear visibility of mucus apart from operator experience. Since the stage at diagnosis of upper gastrointestinal cancer is a major factor in survival, early detection is essential in improving the prognosis of patients the main factors responsible for hinderance of mucosal visibility are mucus foam and bubbles, which requires additional care for the clearance to enhance the vision and also decrease endoscopy duration by alleviating the need of repeated flushing and suctioning during endoscopy. The froth and bubbles are made of mucous secretions mixed with gastric juice and bile. Simethicone (polydimethylsiloxane and silicon dioxide) has been proven to be a promising defoaming agent as an endoscopic premedication in removing bubbles . Simethicone works by reducing the surface tension of air bubbles, and releases the trapped air by causing small bubbles to coalesce and collapse . N-acetylcysteine (nac), a mucolytic agent, has also been used as premedication acts by removing the mucous overlying the gastrointestinal mucosa 4-point scale described by Basford et al

1. No adherent mucus and clear views of the mucosa.
2. A thin coating of mucus that did not obscure views of the mucosa.
3. Some mucus/bubbles partially obscuring views of the mucosa (i. E. A small mucosal lesion might be missed without flushing
4. Heavy mucus/bubbles obscuring views of the mucosa (i. E. Extensive flushing is needed to avoid missing small mucosal lesions)

Procedure

• Premixed medication (150mg simethicone and 600mg nac with 100ml of water) was given at specified timing Primary objective - comparison of mucosal visibility between 4 groups Secondary objectives - adverse events adequate gastric mucosal visibility lesion detection rate

Eligibility Criteria:
Inclusion Criteria:

Age \>18years

Exclusion Criteria:

* History of upper gastrointestinal surgery
* Neurological disorders with impaired swallowing
* Active gastrointestinal bleeding,
* Caustic ingestion
* Pregnancy.
* Known history of multiple allergies
* Gastric outlet obstruction
* Esophageal motility disorders
* Contraindication for upper GI endoscopy
A Comparison of a Currently Marketed Hearing Aid Programmed With Two Different Fitting Methods

This study is designed to investigate the benefits of the hearing aid in the laboratory and in daily life when fitted with two different methods. Subjective and objective evaluations will be made. The aim is to show the benefits of the hearing aids with both fitting methods with the help of data obtained, and to improve the available fitting methods in order to further increase the benefit for people with hearing disorders in situations where the standard method and those trained to perform it are not available.

Benefits of amplification and accessories used with it outweigh anticipated risks in mild to profound hearing impaired subjects. The basic benefit of amplification should be present with any method that the trained professional fitting the instruments uses. The goal of this study is to compare two fitting methods and determine whether the end user perceives more benefit from one fitting method over the other. The objective benefit is expected to be the same; however, the subjective benefit may be different due to a possible psychological effect from more effort or time spent by the trained professional.

Bernafon will conduct this clinical investigation to test current hearing instruments fitted with the standard procedure and a self-directed procedure. Safety and performance validation of the new self-directed fitting software is needed before release to the market.

The reason for this study is to evaluate a currently marketed, CE certified, hearing aid and determine whether different fitting methods provide the same perceived benefit. Additionally, this study will validate the safety of the fitting procedure as well as collect post market safety information about the devices themselves. The goal is to evaluate the audiological performance objectively as well as the subjective benefit. Furthermore, it is important to identify unexpected, unwanted behavior from the fitting software and the devices.

Eligibility Criteria:
Inclusion Criteria:

* All types of hearing loss (sensorineural, conductive, mixed)
* If the hearing loss is conductive or mixed it must first be approved for amplification by a physician
* All shapes of hearing loss (flat, sloping, reverse slope, notch)
* Severity ranging from mild to severe
* First time hearing aid users (never worn hearing aids before)
* German speaking
* Both genders
* Ages 18 and older
* Ability and willingness to sign the consent form

Exclusion Criteria:

* Current hearing aids users
* Contraindications for amplification
* Active ear disease
* Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant
* A reduced mobility unable to attend weekly study appointments
* A reduced ability to describe auditory impressions and the usage of the hearing aids
* Uncooperative so that it is not possible to record a valid pure tone audiogram
* A strongly reduced dexterity
* With psychological problems
* Central hearing disorders
* Bernafon employees
* Family members of Bernafon employees
The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain

This study is comparing the effectiveness of a mechanical manual therapy device to a specific exercise to no treatment in individuals experiencing neck pain. We are interested in the effects of the interventions on neck pain, disability related to neck pain, and pain sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* currently experiencing neck pain which does not extend below the elbow
* pain at least 4/10 over the past 24 hours
* appropriate for conservative management of neck pain
* english speaking

Exclusion Criteria:

* surgery to the neck within the past 6 months
* systemic problem know to affect sensation
* other chronic pain condition other than neck pain
* neck pain as the result of trauma such as whiplash
* neck pain as the result of a fracture
A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)

The goal of this clinical trial is to evaluate the efficacy and safety, of JYP0061 in acute NMOSD patients. The main questions it aims to answer are: efficacy and safety of JYP0061 in acute NMOSD patients. Participants will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids or high-dose JYP0061. Efficacy and safety evaluations will be conducted according to the protocol.

This study will be an open-label, multicenter phase 2 clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids. The efficacy and safety measures will be conducted according to the protocol. If JYP0061 is effective and safe for acute NMOSD patients, then subjects will be treated with high-dose JYP0061 or standard dose glucocorticoid. The efficacy and safety measures will be conducted according to the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Neuromyelitis spectrum disease (NMOSD) patients according to 2015 International consensus diagnostic criteria.
* Positive Aquaporin 4 immunoglobulin G (AQP4-IgG)
* Patients with acute NMOSD
* Female serum pregnancy test results were negative at the time of screening, subject (including partner) had no child-rearing plan and voluntarily adopted double contraceptive (non-oral contraceptives) within 6 months from screening to the last study drug administration, and had no sperm/egg donation plan;
* Have fully understood this study, voluntarily participate in the experiment, and voluntarily sign the written informed consent.

Exclusion Criteria:

* Pregnant or lactating women;
* Suspected or clear allergy to similar ingredients or any ingredient in the study drug, or allergic constitution;
* Symptoms improved in the acute phase before the study drug was used;
* Unable to complete MRI or gadolinium enhanced examination;