cyrilzakka/clinical-trials huggingface dataset:
Clinical Genetics and Screening for Idiopathic Pulmonary Fibrosis

Background:

Idiopathic pulmonary fibrosis (IPF) is the most common and severe form of interstitial lung disease. Between 2% and 20% of patients with IPF have a family history of the disease, which is considered the strongest risk factor. Therefore, genetic testing has been increasingly considered as a potential tool to identify patients at risk of developing IPF.

According to some studies, genetic testing (particularly of MUC5B and TERT mutations) could be useful to rapidly identify unidentified and/or asymptomatic individuals (in families as well as in the general population) who have interstitial lung anomalies (ILA) that may indicate a initial stage of pulmonary fibrosis. Finding efficient screening methods and associated targeted treatments for IPF may be essential to improving the prognosis and quality of life of those suffering from this disease.

Objectives of the study:

The study involves two populations of study subjects:

* patients with FPF and sporadic IPF
* first-degree relatives of patients with FPF and sporadic IPF (biological relatives, not spouses)

The primary objective is to determine the prevalence rates of interstitial lung abnormalities in at-risk relatives of patient with IPF and FPF.

Study design:

Multicenter, cross-sectional study without drug and without device conducted in two major Italian tertiary referral hospitals.

The entire project is expected to last 24 months.


Eligibility Criteria:
Criteria for PATIENTS:

Inclusion Criteria:

1. patients aged ≥18 years when signing the informed consent
2. diagnosis of IPF based on 2022 ATS/ERS/JRS/ALAT Guidelines as confirmed by the investigator based on chest HRCT scan and if available surgical lung biopsy
3. diagnosis of FPF defined as the presence of fibrotic ILD in at least two members of the same biological family
4. at least one 1st degree relative \>40 years of age.

Exclusion Criteria:

1. patients with Interstitial Lung Diseases other than Idiopathic Pulmonary Fibrosis, including but not limited to patients with granulomatous lung disease, autoimmune/collagen vascular disease associated interstitial lung disease, and drug induced interstitial lung disease
2. unwilling or unable to sign informed consent

Criteria for FIRST DEGREE BIOLOGICAL RELATIVES:

Inclusion Criteria:

a. subjects aged ≥40 years

Exclusion Criteria:

1. previous diagnosis of IPF
2. a history of severe or poorly controlled anxiety, severe or poorly controlled depression according to the opinion of the investigators, suicidal ideation, or other psychiatric illness requiring hospitalization
3. unwilling or unable to sign informed consent 400 first-degree relatives of participating patients will be recruited
Effects of LGI Steam Bread on Glycemia Control in T2DM in China

This was a single-center, randomized, open, prospective, parallel-controlled, head-to-head comparison trial. To investigate the effects of low glycemic index（LGI）related steam bread on glycemic control，islet function in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18yrs；
* Diagnosed as Type 2 Diabetes;
* Had been on a stable hypoglycemic regimen for at least 30 days prior to screening；
* HbA1c between 7.5% and 11.0% (both upper and lower limits included) in the 90 days prior to screening;
* Fasting C-peptide ≥1.0ng/ml in the 90 days prior to screening;
* Be willing to accept and adhere to LGI steamed bread as a staple food for at least 14 days

Exclusion Criteria:

* Diagnosed with type 1 diabetes, or secondary diabetes;
* Have clinically significant liver disease, moderate/severe kidney injury, or end-stage renal disease;
* Has unstable CV disorders, including heart failure (NYHA) class III or IV), intractable angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥105mmHg);
* An Acute Coronary Syndrome event (ACS) occurred within the 6 months prior to randomization
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.

A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States


Eligibility Criteria:
Inclusion Criteria:

* De novo metastatic (stage IV) disease at initial breast cancer diagnosis during 2015-2019
* HR+/HER2- molecular subtype at diagnosis
* Initiated 1L systemic therapy with palbociclib + AI or AI alone

Exclusion Criteria:

* Patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.
Step Down Colon Cancer Risk

Hypothesis 1: Exercise will decrease serum markers in a dose response manner.

Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.

Primary Aim: To conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. The major outcomes are changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2.

Secondary Aim. To compare changes in the secondary outcome of physical activity over three months.

Eligibility Criteria:
Inclusion Criteria:

* aged 50 to 80
* no personal cancer history
* found to have an adenomatous polyp upon colonoscopy at BJH/WUSM in the previous six months
* no contraindications to beginning an exercise program
* no previous diagnosis of familial polyposis syndromes
* no previous diagnosis of ulcerative colitis or Crohn's disease;

Exclusion Criteria:

* Participants who are regular NSAID users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. Regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other NSAID 5 or more days of the week.
Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy

This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol, aldosterone, corticosterone, and others) that are important in keeping you alive. The drug used in this study has been approved by the Food and Drug Administration (FDA) for routine clinical use in the treatment of patients with proteinuria and patients with idiopathic nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been adequately assessed. This is the reason for conducting this research study.


Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic MN with diagnostic biopsy performed less than 36 months from the time of dose randomization.
2. Age \> 18 years.
3. Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to ACTH treatment and have adequately controlled blood pressure
4. Proteinuria of \>4.0 on a 24-hour urine collection.
5. Estimated GFR \>40 ml/min/1.73m2 while taking ACEI/ARB therapy.

Exclusion Criteria:

1. Age \<18 years.
2. Estimated GFR \<40 ml/min/1.73m2, or serum creatinine \>2.0 mg/dl.
3. Renal biopsy showing more than 30% glomerulosclerosis and/or tubular atrophy.
4. Patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin A, tacrolimus) or mycophenolic mofetil for \>1 month, and alkylating agents or rituximab for \>6 months.
5. Resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus steroids.
6. Patients with active infections or secondary causes of MN.
7. Type 1 or 2 diabetes mellitus.
8. Pregnancy or nursing.
9. Acute renal vein thrombosis documented prior to entry by renal US or CT scan and requiring anticoagulation therapy.
Tissue Flossing in Tennis Elbow Patients

The aim of the present intervention is to determine the effectiveness of the application of tissue flossing in patients with tennis elbow

The application of tissue flossing has been deemed to provide beneficial results in patients with ankle range of motion limitation. Although, tissue flossing is widely extended among athletes due to its effectiveness in pain, function and range of motion, the evidence is limited.

The aim of the present protocol is to determine the effectiveness of tissue flossing in patients with tennis elbow.

Eligibility Criteria:
Inclusion Criteria:

* Elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of lateral epicondylalgia.
* Diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by gripping activities.
* Reduced grip strength and increased sensitivity to manual palpation over the lateral epicondyle.
* Pain with stretching or contraction of the wrist extensor muscles.

Exclusion Criteria:

* Upper limb fractures, surgery or concomitant disease.
* Red flags presence.
* Mental disorders.
Collagen Markers in Heart Failure and Preserved Ejection Fraction

Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics

Heart failure (HF) is a growing public health problem. While HF with deteriorated ejection fraction has faced numbers of (non) pharmacological advances, HF with preserved ejection fraction, which represents half of admission has today no efficient treatment.

Fibrosis is found in heart of patients with HF and preserved ejection fraction, is reponsible for stiff heart and has link to the transition to compensated/decompaseted HF and death.

The purpose of this work is to characterise myocardial fibrosis by any means to change the prognosis of patients with HF and preserved ejection fraction

Main purpose:

Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics

* Patients selection

  1. - Inclusion Criteria: Male or female \> 18 and \< 85 years of age. Recent HF decompensation (framingham criteria, ejection fraction \> 50% with 72 hours after admission and BNP \> 100 ng/L or NT-proBNP \> 300 ng/L), signed inform consent.
  2. - exclusion criteria: hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, significant respiratory disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No health insurance.
* Control group

  1. - inclusion criteria: Male or female \> 18 and \< 85 years of age. signed inform consent. Health insurance.
  2. - exclusion criteria: significant ischemic heart disease, significant valvular heart disease, pericarditis, pulmonary hypertension, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, significant respiratory disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No health insurance.

Eligibility Criteria:
- inclusion Signs of heart failure Elevated BNP EF \> 50% within 72 hours after admission
NMR Scanning on Patients

This protocol is designed to investigate the use of novel techniques in MRI that may not yet be commercially available. Specifically, the protocol enables patients to take advantage of new pulse sequence software, coil design or post processing capabilities not otherwise available. The informed consent explains MRI in lay terms, describes the use of contrast agents and lists contraindications to MRI.

NMR imaging promises to provide useful and unique diagnostic information in a variety of diseases. In an attempt to evaluate its role, we plan to study a wide range of diseases during the initial year of imaging. Exposure to magnetic fields and radiofrequency energies of this magnitude have demonstrated no deleterious effects clinically or in the laboratory. The only restrictions will be those imposed by ferromagnetic objects within the patient which would increase the risk of placing them in a strong magnetic field.

Eligibility Criteria:
Any patient undergoing MRI for research or clinical purposes who is participating in a currently active NIH protocol.

No patients with pacemakers, cochlear implants, implanted pumps, shrapnel, metal in the globe of the eye, cerebral aneurysm clips or other contraindication to MRI.
Fluorescent Cholangiography During Acute Cholecystitis

This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis


Eligibility Criteria:
Inclusion criteria

* Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window)

Exclusion criteria

* Laparoscopic operation converted to open operation prior to completed fluorescent and X-ray cholangiography
* Allergy towards iodine, Iohexol or indocyanine green
* Legally incompetent (any reason)
* Cholangitis (as defined above)15
* Withdrawal of inclusion consent at any time
MMP-9 Monitoring Particulate Cerebral Embolisation

1. In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration cross CEA will be identified.
2. And the part of patients suffered particulate cerebral embolic injury, their MMP9 level will increase in the early stage after CEA.


Eligibility Criteria:
Inclusion Criteria:

-All patients enrolled had at least ≥70% unilateral or bilateral stenosis of Internal -Carotid Artery， or those who had a \<70% stenosis but obvious cerebral ischema symptoms had been existed.

Exclusion Criteria:

* Exclusion criteria included poor temporal window
* Refused to cooperate with us
* Nonatheromatous such as takayasu arteritis and fibromuscular dysplasia.
Pharmacy Education During Covid-19 Outbreak

Coronavirus disease 2019 (COVID-19) outbreak is considered one of the most important public health crisis all over the world. General recommendations and rules around the world have been legislated to avoid or delay transmission of covid-19. Education process and learning plan are changed to focus on online Learning instead of traditional educational model. Pharmacy is one of the important practical medical science which affected by Covid-19 outbreak.

Detailed Description:

The survey will enroll as many individuals of the Egyptian pharmacy students as possible in the survey portion of the study - The number of participates have no limitations, at least 100 participants.

The survey will be enrolled in online google form, face to face interview(this will be reduced to encourage social isolation) \& semi-structured telephone interviews if possible.

The research procedures:

An online survey link will include questions regarding the effect of COVID 19 pandemic on the educational process in Egypt,and how the online learning process are affecting pharmacy students it will measure the impact on the psychological health of the students as well as their level of understanding of information.and their overall satisfaction from the e learning method of education used during the COVID 19 pandemic Face to face and semi-structured interviews if possible: For those Egyptian citizens who state that they would like to participate in an interview, a random sample will be contacted.

Inclusion Criteria:

pharmacy students

Exclusion Criteria:

non pharmacy students

Eligibility Criteria:
Inclusion Criteria:

* pharmacy students

Exclusion Criteria:

* non pharmacy students
Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (\> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors.

The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an established diagnosis of EE defined as \> 20 eosinophils/HPF in the setting of dysphagia or food impaction.
* Males and females age \> 18 years of age.
* Ability to undergo ambulatory pH monitoring.
* DEERS (Defense Enrollment Eligibility Reporting System) eligible.
* Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
* Willingness to participate and have additional biopsies taken during endoscopy and answer a questionnaire.

Exclusion Criteria:

* Patients \< 18 years of age.
* Inability to give consent.
* Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
* Contraindications to proton pump inhibitors or steroids.
* Inability to accurately fill out a short questionnaire.
* Pregnant females. A urine beta human chorionic gonadotropin (BHCG) prior to endoscopy will be offered to all female patients of child bearing potential (exceptions include post-menopausal, hysterectomy or bilateral tubal ligation). Positive BHCG results will prevent enrollment.
* Known coagulation abnormalities, thrombocytopenia and patients on coumadin.
Efficacy of Epidural Etanercept in the Treatment of Sciatica

Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. In animal studies, the application of TNF-alpha to nerve roots results in pain behavior indicative of radiculopathy. The use of TNF-alpha inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior. Open-label studies in humans have shown both etanercept and infliximab provide excellent, long-term relief in patients with acute radiculopathy from herniated disc. However, a recent placebo-controlled study failed to demonstrate any significant difference from placebo. The investigators have already established the safety of neuraxial etanercept in a trial that has just been completed (not yet published). The objective of this study is to determine whether small doses of epidural etanercept, an anti-TNF-a medication, is an effective treatment for LBP caused by nerve root irritation (i.e., radiculopathy).

As per the wishes of the Dept. of the Army and Walter Reed Army Medical Center Dept. of Clinical Investigation, patients will be randomized in a 3:1 ratio to receive 2 transforaminal epidural etanercept or saline injections at 2-week intervals. Both patients and physicians will be blinded as to the injectate and treatment group. There will be 3 study groups. Group I will receive either 2 mg of etanercept or saline per injection. Group II will receive either 4 mg of etanercept or saline per injection. Group III will receive either 6 mg of etanercept or saline per injection. In each group there will be 8 patients: 6 who receive etanercept and 2 who receive saline. As per a previous study we just completed, etanercept doses will not be escalated until all 6 patients have completed their 1-month follow-up visits without any evidence of toxicity or complications.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic low back pain of radicular origin of \> 2 months but \< 1 year duration.
2. Failure of conservative therapy to include physical and pharmacotherapy.
3. MRI evidence of a herniated disc corresponding to the patient's radicular symptoms.
4. Normal white blood cell count (drawn in 1 blood vial).

Exclusion Criteria:

1. Uncontrolled coagulopathy.
2. Pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists.
3. Allergy to contrast dye.
4. Unstable medical condition (e.g., unstable angina or congestive heart failure).
5. Rheumatoid arthritis, Crohn's disease or spondylarthropathy.
6. Unstable neurological condition (e.g., multiple sclerosis)
7. Systemic infection
8. Age \< 18 or \> 70 years.
Community-Based Peer Facilitator Intervention (Zimbabwe)

The goal of this community randomized operations research study was to evaluate the effect of a peer-facilitated community support group intervention on uptake of maternal and neonatal child health (MNCH) and PMTCT services and on adherence outcomes in Zimbabwe.

To increase uptake of, and retention within maternal and child health/prevention of maternal-to-child HIV transmission (MCH/PMTCT) services, the investigators conducted a community-based peer facilitator intervention study in Hurungwe District of Zimbabwe. Using a paired community randomized design, 16 health facility-linked communities were randomly allocated to the intervention or control condition, with a total of approximately 1,600 pregnant and lactating women, (100 women in each community), recruited into the study. In the intervention communities, 24 trained peer facilitators (3 in each community) using participatory educational approaches were encouraging women to form antenatal and post-natal groups, and to utilize and adhere to MCH/PMTCT services and recommendations.

Peer facilitators, by the definition of this project, were women from the community who were peers to pregnant and lactating women; who had recently been through the process themselves and could speak to their experience. A key activity of the community-based peer facilitators was the encouragement of the formation of women into groups, and the participation of these women into antenatal care (ANC), prevention of maternal to child transmission (PMTCT), and postnatal care (PNC) programs. The group process was enable solidarity and support among the women at the vulnerable times of pregnancy and lactation.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and breastfeeding women who were 18 years of age and above, regardless of HIV status, were eligible to participate in support groups.

Exclusion Criteria:

* Women less than 18 years and those who were mentally ill were excluded as they could not give informed consent.