cyrilzakka/clinical-trials huggingface dataset:
An Algorithm to Decide on Antibiotic Prescription in Lower Respiratory Tract Infection in Primary Care

The study is randomized clustered pragmatic trial whose objective is to decrease unnecessary antibiotic prescription in adult patients with lower respiratory tract infection managed at primary care level in Switzerland, using a simple algorithm based on 2 point of care test results

The study will have two distinct phases:

The first phase will test the feasibility of the intervention (UltraPro) along a pilot study. Following the setup of a lung ultrasound training curriculum for general practitioners, the practicality of the whole UltraPro algorithm will be evaluated at primary care level.

The second phase will be a pragmatic randomized three-arm intervention study using an algorithm based on the results of procalcitonin and lung ultrasound to manage patients with lower respiratory tract infections at primary care level. The procalcitonin-ultrasound algorithm will be compared to procalcitonin-guided management alone and usual care.

Eligibility Criteria:
All patients presenting to a participating GP's office for a consultation for an acute respiratory infection (ARI) will be screened for inclusion in the study

Inclusion Criteria:

* Informed Consent as documented by signature (Informed Consent Form)
* Patients aged 18 years or more
* No antibiotics prescribed for the current episode
* Acute cough of up to 21 days duration and at least one of the following symptom or sign:
* History of fever for more than 4 days
* dyspnoea
* tachypnoea (≥ 22 cycles per minutes)
* abnormal focal finding during auscultation

Exclusion Criteria:

* Previous prescription of antibiotics for the current episode
* Working diagnosis of acute sinusitis or a non-infective disorder
* Cystic fibrosis
* Previous episode of chronic obstructive pulmonary disease exacerbation treated with antibiotics during the last 6 months
* Known pregnancy
* Severe immunodeficiency (untreated HIV infection with CD4 count \< 200 cells/mm3, solid organ transplant receiver, neutropenia, treatment with corticosteroids with dose equivalent to 20 mg prednisone/day for \> 28
* Admission of the patient
* GP not available for performing study
* Patient unable to provide informed consent
ACY-6 Oral Administration of Acyline

In this study, we propose oral dosing of GIPET enhanced oral acyline (MER-104) to determine if this potentially useful compound is safe and effective at suppression of gonadotropins after oral dosing in man.

Hypothesis: A single dose of Acyline will suppress gonadotropins, and testosterone, estradiol and dihydrotestosterone (DHT) for 24 hours in man, and the magnitude and duration of the suppression will increase with increasing doses of Acyline.

The purpose of this study is to test how the body responds to a new oral form of acyline and to also look at the safety of oral acyline.

Acyline temporarily blocks the production of the hormone testosterone in normal men. It has been given to over 100 men in an injection form. This study will be testing acyline in a pill form. This is the first time the pill form has been tested in humans.

This study may help develop an oral form of a testosterone-blocker, which may be useful in the treatment of diseases such as prostate cancer, premature puberty and possibly in a male contraceptive.

This study requires three 12-hour blood draw periods for pharmacokinetics (PK) testing. PK testing looks to see how much study drug is in the blood. This gives information about how the body handles and gets rid of the study drug.

Eligibility Criteria:
Inclusion Criteria:

* Males between 18-50 years of Age in good health

Exclusion Criteria:

* Men in poor health, significant chronic or acute medical illness, known history of alcohol, illicit drug or anabolic steroid abuse
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection

The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:

* ≥ 6 years of age
* Subject has CF as diagnosed by one of the following:

  * Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test
  * Two well characterized genetic mutations in the CFTR gene
  * Abnormal nasal potential difference with accompanying symptoms characteristic of CF
* At high risk for disease progression as defined by one of the following subject populations:

  * First Cohort Criteria:

    * Those who are wait listed or eligible for lung transplant based on FEV1 criteria. Patients who have a level of lung function impairment consistent with lung transplantation criteria, but who are ineligible for transplantation for other reasons, can enroll in this program; or
    * Completed participation in CP-AI-006 (through Visit 20). Subjects who withdraw from CP-AI-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol.
  * Second Cohort Criteria:

    * Meets first cohort criteria
    * FEV1 ≤ 40% predicted at the time of consent
  * Third Cohort Criteria:

    * Meets first or second cohort criteria
    * FEV1 ≤ 50% predicted at the time of consent

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:

* Subjects with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance with the protocol or dosing requirements
* Subjects with hypersensitivity to any of the components of the drug product
* Currently enrolled in another clinical trial
* Pregnant or lactating females
Enhancing the Secondary Prevention of Coronary Artery Disease

People with coronary artery disease can reduce their chance of having a heart attack by making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). There are also many medications that have been proven to reduce the risk of heart attacks and may even help people live longer. This study will look at different ways of improving the use of these beneficial medications to enhance the quality of care for people with this condition.

BACKGROUND: Despite the abundant evidence base for secondary prevention, practice audits consistently demonstrate substantial "care gaps" between this evidence and clinical reality such that many patients with Coronary Artery Disease (CAD) are not offered all possible therapies for the prevention of myocardial infarction or death. For example, even after an acute myocardial infarction, almost one fifth of patients continue to smoke; over half with hypertension or hyperlipidemia have poorly controlled pressure or lipid levels; and proven therapies such as statins, ACE inhibitors, beta-blockers and antiplatelet agents are under-prescribed.

Multiple barriers are often responsible for the lack of implementation of proven efficacious therapies and traditional means of educating practitioners (journal articles, CME, conferences, etc) are usually ineffective in altering practice. Clearly novel interventions to improve the quality of prescribing are needed. Local opinion leaders are trusted by their peers to evaluate medical innovations and thus influence practice patterns within their community. Few controlled studies, however, have evaluated their effect on changing prescribing practices for common conditions such as CAD.

HYPOTHESIS: This trial will test 2 quality improvement interventions. The principle hypothesis is: does a one-page evidence summary endorsed by local opinion leaders increase the provision of secondary prevention therapies in patients with CAD compared to usual care? The secondary hypotheses are: does the same intervention but without local opinion leader endorsement improve the provision of secondary prevention strategies in patients with CAD compared to usual care? Does local opinion leader endorsement increase the effectiveness of the quality improvement intervention?

Eligibility Criteria:
Inclusion Criteria:

* Alberta residents who undergo a cardiac catheterization and are diagnosed with coronary artery disease (\> or equal to 50% stenosis in at least one vessel).

Exclusion Criteria:

* no fasting lipid panel within the previous 6 weeks
* on a statin at maximal dose
* on a statin/lipid lowering drug and LDL-C is 2.5 mmol/L or less (prior to Sept 2006) and LDL-C is 2.0 mmol/L or less (after Sept 2006)
* not on a statin and LDL-C is 1.8 mmol/L or less
* acute myocardial infarction or cardiogenic shock
* require emergency bypass surgery following catheterization
* contraindication to statins (e.g. cirrhosis, inflammatory muscle disease)
Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer.

OBJECTIVES: I. Determine whether aminocamptothecin colloidal dispersion (AC/CD) administered as a 120 hour weekly infusion is an effective treatment for advanced non-small cell lung cancer. II. Observe any toxicities associated with this treatment in this patient population.

OUTLINE: Patients receive a 120 hour continuous infusion of aminocamptothecin colloidal dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed measurable stage IIIB or IV non-small cell lung cancer No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3500/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Calcium and electrolytes normal Other: No other malignancy within past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix Not pregnant or nursing No active infections or other serious medical conditions

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy No prior radiotherapy to site(s) of measurable disease Surgery: At least 3 weeks since any prior surgery
House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance

In this project, PBMCs will be isolated from HDM allergic and non allergic patient and then stimulated with HDM crude extract. The expression of inflammasome and the correlation of inflammasome activation and steroid resistance will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* HDM allergic and non allergic subjects

Exclusion Criteria:

* Pregnant subject, cancer
Improvement of Patient Experience and Healthcare Providers' Productivity Using Virtual Reality in the Field of Radiation Therapy

The purpose of this study is to investigate the effect of providing information about radiotherapy using virtual reality and to see whether it would improve the productivity of medical staff, improve patient experience and satisfaction, and reduce patient's anxiety prior to radiotherapy.

All patients enrolled in this study will receive the same routine explanation all radiotherapy patients receive currently. However, prior to the routine explanation, additional detailed information regarding radiotherapy (from simulation to treatment) will be given in two different ways.

VR arm: The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality.

Printed document arm: The patients who are allocated to the Printed document arm will receive information about radiotherapy via printed document.

Patients will answer the questionnaire related to the anxiety scale related to radiotherapy and measure the vital signs such as blood pressure, pulse rate, and the respiratory rate. Also, patients will answer the questions about radiotherapy to assess the understanding of radiotherapy and questionnaire on hospital satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Breast cancer patients who received curative surgery and are planned to receive radiotherapy
2. Patients with cognitive abilities to receive virtual reality information
3. Patients who are 20 years old or older

Exclusion Criteria:

1. Patients who have vision or hearing problems to receive information
2. Patients who do not agree to this study
3. Pregnancy, Fetuses / Newborns, Minors, and Deficient Patients
4. 65 years old or older
5. Patients who have been treated for dizziness within the last 6 months
6. Patients who have experienced severe dizziness within the last 6 months when using electronic devices
Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale and Epilepsy

The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences.

In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.


Eligibility Criteria:
Inclusion Criteria:

* children aged 6 to 15 years and 11 months;
* male or female;
* with a diagnosis of ADHD : predominantly inattentive or combined hyperactive-impulsive and inattentive according to the DSM IV criteria;
* children who agreed to participate to the protocol and whose legal representatives have clearly expressed their non-opposition to participate.

Exclusion Criteria:

* Patients below 6 years old or patients older than 16 years;
* with a diagnosis of ADHD predominantly hyperactive-impulsive subtype ADHD according to the DSM IV criteria;
* mental retardation defined by a score \< 70 at the verbal comprehension index and the perceptual reasoning score of the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV)
* established diagnosis of any psychiatric co-morbidity other than ADHD according to the DSM IV criteria (pervasive developmental disorders including autism, bipolar disorder, psychotic disorder).
Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With Esophageal Varices After Ligation-A Clinical Research

This study is intended to include 20 patients with esophageal varices caused by liver cirrhosis who were admitted to the first affiliated hospital of nanjing medical university from May 2019, and randomly select 8 patients with gastric polyps as the control group.General clinical data, imaging data, endoscopic data and laboratory indicators were collected.Electrogastrogram (EGG) and Heart Rate Variability (HRV) were performed before and 24 hours after operation in patients with cirrhotic esophageal varices, and the dyspepsia scale was filled out.Electrogastrogram (EGG) and cardiac variability (HRV) were performed in patients with gastric polyps 24 hours before and after surgery, and the dyspepsia scale was filled.EGG uses the surface electrode to record gastric myoelectric activity, and evaluates the patient's gastric rhythm by normal slow wave ratio, overspeed ratio, overslow ratio, and rhythm disorder ratio.The HRV evaluates the balance state of the patient's autonomic nervous system with High Frequency (HF)/Low Frequency (LF).SPSS software was used for paired sample analysis of experimental results.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old with cirrhosis of esophageal varices who underwent endoscopic ligation
* Signed informed consent

Exclusion Criteria:

* Hemorrhage in the digestive tract, unstable vital signs
* Hepatic encephalopathy
* Unwilling to cooperate with the examiner
* Skin allergies
Study of the Aliviado DSD Caregiving Mastery Program

Delirium superimposed on dementia (DSD) is an acute and serious condition that is common in persons living with dementia (PLWD). Involvement of family caregivers may aid prevention, early detection, and management of DSD. The purpose of the proposed study is two-fold. First, the investigators will develop a family-centered, mHealth-enhanced DSD caregiving mastery program ("Aliviado DSD Caregiving Mastery Program") through a 5-week co-design workshop with 8 family caregivers (Aim 1). The investigators will adapt/refine the existing clinician-centered DSD contents and an mHealth app from the evidence-based "Aliviado Dementia Care" program for use by family caregivers to support their day-to-day implementation of DSD detection, prevention, and management tasks in the community. Second, the investigators will pilot test the full Aliviado DSD Caregiving Mastery Program with 30 family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).


Eligibility Criteria:
Inclusion Criteria:

To be eligible as a "dementia caregiver" in the co-design workshop, an individual must:

* be at least 18 years old,
* be English-speaking,
* provide at least 8 hours of unpaid care weekly or live with a community-dwelling PLWD,
* self-identify as unfamiliar with DSD,
* have the capacity to consent, and
* have Internet access

To be eligible as a "DSD caregiver" in the co-design workshop, an individual must:

* be at least 18 years old,
* be English-speaking,
* be a current or past dementia caregiver with experience caring for a relative or friend during his/her DSD episode within the past 12 months,
* have the capacity to consent, and
* have Internet access.

To be eligible to participate in the feasibility trial, an individual must meet all of the following criteria:

* Being 18 years old or older,
* English-speaking,
* Providing at least 8 hours of unpaid care per week to, or living with, a community dwelling PLWD whose Delirium Risk Assessment Score \>=5,
* Having the capacity to give informed consent, and
* Having a smartphone with Internet access.

Exclusion Criteria:

* Individuals who are blind or deaf will be excluded.
Flortaucipir 18F PET Imaging in BIOCARD Study

This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.


Eligibility Criteria:
Inclusion Criteria:

* Males or females that have provided consent and are currently enrolled in BIOCARD study
* Ability to tolerate PET scan procedures
* Ability to provide informed consent for study procedures

Exclusion Criteria:

* Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator
* Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.
* Has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.
* Has hypersensitivity to flortaucipir
* Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.
* Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to flortaucipir imaging visit.
* Is unsuitable for a study of this type in the opinion of the investigator.
Gallbladder Volvulus Diagnosed Intraoperatively: Case Report

85-year-old female patient presented with right upper quadrant pain of one day duration, diagnosed with acalculous cholecystitis, and intraoperatively diagnosed with gallbladder volvulus.

85-year-old female patient presented with right upper quadrant pain of one day duration that is associated with nausea and vomiting, but no fever or jaundice. She was tachycardiac and had severe abdominal right upper quadrant tenderness with positive Murphy's sign. Laboratory results showed only increase in inflammatory markers. Both ultrasound and computed tomography scan of the abdomen were done and acalculous cholecystitis was diagnosed. Open cholecystectomy was done but gallbladder volvulus was noted intraoperatively. Cholecystectomy was done and the patient had smooth postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

* any patient presenting with right upper quadrant pain

Exclusion Criteria:

* patients having non gallbladder related pathologies explaining right upper quadrant pain