cyrilzakka/clinical-trials huggingface dataset:
Primary Prevention of CHD Risk Factors Occurring in US

To evaluate the effectiveness of primary prevention of coronary heart disease risk factors by examining data from the National Health Examination Survey (NHES) and the National Health and Nutrition Examination Surveys (NHANES) to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts.

BACKGROUND:

The coronary heart disease risk factor profile of Americans has been improving, with decreasing blood pressure and cholesterol levels. However, it is not apparent whether this improvement is due to primary prevention of risk factors through lifestyle choices or to secondary prevention (management) of established risk factors. Since secondary prevention only targets people with high blood pressure or cholesterol levels, the effect should be demonstrated by temporal declines in the upper percentiles (75th, 90th) of the blood pressure and cholesterol distributions. Primary prevention should shift the entire risk factor distribution, including the percentiles in the middle (50th) and lower (10th, 25th) portions of the distribution. Thus, the effectiveness of primary prevention programs can be evaluated by examining temporal changes in the middle and lower percentiles, and the effectiveness of secondary prevention can be evaluated by examining temporal changes in the higher percentiles.

DESIGN NARRATIVE:

Data from the National Health Examination Survey and the National Health and Nutrition Examination Surveys were examined to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts. The results of these analyses provided information that may help guide further research and application of population prevention strategies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension

The purpose of this study is to evaluate the strategy of initiating double oral combination therapy with bosentan and sildenafil at the time of diagnosis of pulmonary arterial hypertension (PAH) in a preliminary way.

Current treatment paradigms for PAH suggest adopting goals of therapy with relatively objective parameters such as 6 minute walk distance to determine when to add a second oral agent (1). This often entails observing deterioration in the patient on a single agent before instituting the second one. This strategy could be problematic, as patients may never recover the function lost due to progressive PAH (2). In addition, given the malignant nature of the clinical course of PAH in many cases and the nature of the underlying proliferative vasculopathy, some have argued that altering this paradigm to resemble that used in cancer chemotherapy may be more appropriate (3). That is, "induction" therapy at diagnosis with multiple agents followed by a maintenance phase of treatment might offer significant benefits to the patient.

This open-label pilot study is the first to investigate the potential efficacy and safety of a first-line combination strategy in consecutive patients with PAH in contrast to the "add-on" strategy for combination therapy. It will serve as the basis on which to consider larger, multicenter investigations of this strategy.

1. Hoeper M, et al. Eur Respir J. 2005 Nov;26(5):858-63.
2. Halpern SD, et al. Proc Am Thorac Soc. 2008 Jul 15;5(5):631-5.
3. Provencher S, et al. Chest. 2005 Dec;128(6 Suppl):622S-628S.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic Functional Class III PAH in the following categories: Idiopathic (IPAH), Familial (FPAH), Associated with connective tissue disease, Associated with drugs or toxins
* PAH diagnosed by right heart catheterization, defined as: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, PVR \> 3 mmHg/l/min (Wood units) or \> 240 dyn sec cm-5, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
* Baseline 6 MWT distance \> 150 and \< 450 m

Exclusion Criteria:

* Treatment with ERAs other than bosentan;
* Treatment with PDE5 inhibitors other than sildenafil;
* Treatment with any prostanoid;
* PAH associated with thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy; valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization
* Restrictive lung disease: total lung capacity (TLC) \< 60% of normal predicted value;
* Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) \< 50%
Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation

Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit problems with pulmonary vascular resistance as well. In some studies, an increase in pulmonary vascular resistance has been used as an indicator for increased 3-day and 3-month mortality after heart transplantation2. In this study, the investigators would like to look at pulmonary vascular resistance in patients with a surgical history of the Fontan procedure followed by heart transplantation.

Children born with certain congenital heart diseases such as tricuspid atresia or single ventricle physiology normally undergo the Fontan procedure during their course of treatment. The Fontan procedure however is palliative and some of these children will eventually require heart transplantation. It has been shown in pre-clinical animal models that pulmonary vascular resistance actually increases after having the Fontan procedure however this has not been quantitated in the human population.1

This is a retrospective chart review with the primary objective of examining Fontan patients with pulmonary vascular resistance and who have undergone heart transplantation. We will review 50 charts at Children's Healthcare of Atlanta, Egleston Hospital. Three other United States' sites are participating. All de-identified data will be forwarded to the Great Ormond Street Hospital in London, England for study analysis. In order to ascertain this objective, the following data will be collected.

1. Diagnosis
2. Surgical History
3. Information from Pre-transplant evaluation
4. Post-transplant hemodynamics
5. Post-transplant catheterization results

Eligibility Criteria:
Inclusion Criteria:

* patients who have undergone the Fontan procedure
* patients cared for at Children's Healthcare of Atlanta
* Patients who have undergone a heart transplantation at Children's Healthcare of Atlanta

Exclusion Criteria:

* Those patients who do meet inclusion criteria
Host Dysregulation-Driven Sepsis Prediction Model

The aim of this study is to identify risk factors associated with sepsis and to construct a predictive model for sepsis. This will provide an objective theoretical and empirical foundation for the diagnosis, assessment, and management of sepsis in our country.The primary questions addressed are:

What are the risk factors for the development of sepsis? How do we improve the prognosis of sepsis?


Eligibility Criteria:
Inclusion Criteria:

* Patients with Infection or Suspected Infection

Exclusion Criteria:

* Patients with Autoimmune Diseases
* Pregnant Women
* Patients with Advanced-Stage Cancer and Systemic Metastasis
Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage

Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.

Hypothesis:

Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.

Research question:

Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Aim of the Work

Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.

Hypothesis:

Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.

Research question:

Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Primary outcome:

Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.

Secondary outcome:

• Curettage (surgical evacuation of the products of conception)

* Incomplete abortion (retained products of conception).
* Considerable bleeding that necessitates immediate evacuation.

Eligibility Criteria:
Inclusion Criteria:

* Woman age more than 18 years old (age of legal consent).
* BMI ranges between 25 kg/m2 and 35 kg/m2.
* Gestational age of 63 days' gestation (or less).
* Missed abortion.
* Hemoglobin leve

Exclusion criteria:

* Woman age less than 18 years old.
* BMI less than 25 kg/m2 or more than 35 kg/m2.
* Gestational age more than 63 days' gestation.
* Molar pregnancy.
* Hemoglobin level less than 10 gm/dL.
* Fibroid uterus.
* Uterus with congenital anomalies.
* Previous attempts for induction of abortion in the current pregnancy.
* Coagulation defect i.e. coagulopathy.
* Contraindication for induction of abortion e.g. heart failure.
* Allergy to misoprostol or letrozole.
High Dose Vitamin D Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation

The purpose of this study is to test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

Vitamin D deficiency is common in childhood and has been associated with increased incidence of graft versus host disease (GVHD) and decreased survival in patients undergoing hematopoietic stem cell transplantation (HSCT). Recently, quality improvement efforts to correct serum vitamin D levels among inpatients at CCHMC who have already received HSCT and who were vitamin D deficient suggest that current recommended doses of vitamin D are inadequate to treat vitamin D deficiency. Possible hindrances to vitamin D treatment in the HSCT population include malabsorption related to gut GVHD, mucositis, increased requirement for calcium and/or vitamin D, kidney disease, liver disease, and infection. Single, high dose vitamin D treatment (stoss-therapy) has been utilized effectively to treat rickets and other chronic illnesses such as cystic fibrosis in children. The investigators hypothesize that stoss-therapy provided orally prior to transplantation will result in rapid and sustained correction of vitamin D deficiency in children who require HSCT. The investigators propose to test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Step 1: Patients who are preparing for HSCT, 25OHD level (\<50 ng/mL), and no prior history of HSCT.
* Step 2: Patients who are preparing for HSCT 25OHD level (\<50 ng/mL).

Exclusion Criteria (both Step 1 and Step 2):

* Patients with history of pathologic fractures,
* uncorrected hypocalcemia or hypophosphatemia,
* known history of nephrocalcinosis or nephrolithiasis,
* current granulomatous disease,
* those currently in ICU.
A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO)

Post-surgery complications in women with vulvar neoplasms (vulvar intraepithelial neoplasia and vulvar cancer) are still high and an instrument assessing patients self-reported post-vulval surgery symptom experiences is missing. The study aims to develop and validate a postoperative instrument to assess symptom experiences in women with vulvar neoplasms. In this mixed-method project 20 patients were interviewed, a WOMAN-PRO instrument was developed and content validity was tested by 6 experts and 10 patients. The instrument's psychometric properties and the prevalence of symptoms will be examined in a cross-sectional study in the University Hospitals Munich, Freiburg, Berlin, Düsseldorf, Zurich, Basel, Berne, and the Cantonal Hospital St. Gallen (N=150). The goal of this project is that symptom assessment becomes a standard component of clinical practice (to promote the early detection and treatment of symptoms) and research.


Eligibility Criteria:
Inclusion Criteria:

* above 18 years old
* able to read and write German
* diagnosed with vulvar neoplasms
* treated with vulval surgery during the prior six month

Exclusion Criteria:

* cognitive impaired
* concurrently under psychiatric treatment or terminally ill
Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.

A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 18 to 55 years
* Capable of understanding and complying with the Clinical Study Protocol
* Body mass index (BMI) of 19 to 30 kg/m2 and weight of 50 to 100 kg

Exclusion Criteria:

* Previous enrollment in the present study
* Receipt of another investigational product within 4 weeks before this study or plans to participate in another study at the same time as this study
* Female subjects with a positive urine pregnancy test
Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:

The aim of this study is to evaluate the differences between men and women undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at 30 and 90 days, 1, 5, and 10 years.

Observational, multicentre, retrospective data collection from the mandatory Quality Assurance database (the Netherlands Heart Registry, (NHR), supplemented with data from the electronic patient files (EPIC). The retrospective data is already available.

In addition, we will continue the retrospective study into a prospective registry of data after the analysis of the retrospective data. Patients will be approached one, five and ten years after the operation and a questionnaire will be sent to document quality of life. No research-related interventions other than questionnaires will be performed

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* All patients who underwent cardiac surgery from 1 January 2016 to the start of the study, in either of the centres (AMC or VUmc) (retrospective)
* All patients undergoing cardiac surgery from the start of the study (\~March 2022) until approximately 2032

Exclusion Criteria:

• Patients who object to the re-use of their care data or do not give consent
The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease

The effects of Application intervention on the physiological indicators and low protein diet cognition among the patients with chronic kidney disease

The low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or above and agree to participate in the research
* Conscious, literate and able to communicate in Mandarin and Taiwanese
* Have the ability to use vehicles
* Kidney disease stage is 3b as calculated by the MDRD formula From stage 5 to stage 5, he has not yet received alternative therapy and is diagnosed as a patient with chronic kidney disease by a nephrologist.

Exclusion Criteria:

* Blindness
* Cognitive abnormalities diagnosed by a doctor as dementia or mental disorder
* People who have no ability to act independently and are assisted by others in daily life
* Patients with nephrotic syndrome are excluded.
Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction

Early reperfusion strategies in tandem with remarkable advances in drugs and devices for treating myocardial infarction (MI) have contributed to a reduction in early mortality, but cardiovascular disease remains the leading cause of death worldwide. Current management strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart failure. In this respect, stem-cell therapy has shown potential benefits for repairing the damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive therapeutic candidates because of their high capacity for replication: paracrine effect: ability to preserve potency: and because they do not cause adverse reactions to allogeneic versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but only one clinical trial using MSCs via the intracoronary route in the setting of acute myocardial infarction (AMI) has been carried out. The investigators therefore assessed the safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in patients with AMI.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years
* ischemic chest pain for \>30 min
* admitted to hospital \<24 h after the onset of chest pain
* electrocardiography showed ST segment elevation \>1 mm in two consecutive leads in the limb leads or \>2 mm in the precordial leads
* they could be enrolled in the study \<72 h after successful revascularization

Exclusion Criteria:

* cardiogenic shock (defined as systolic blood pressure \<90 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation)
* life-threatening arrhythmia
* impossible conditions for cardiac catheterization
* advanced renal or hepatic dysfunction
* history of previous coronary artery bypass graft
* history of hematologic disease
* history of malignancy
* major bleeding requiring blood transfusion
* stroke or transient ischemic attack in the previous 6 months
* structural abnormalities of the central nervous system (brain tumor, aneurysm, history of surgery)
* traumatic injury after myocardial infarction
* use of corticosteroids or antibiotics during the previous month
* major surgical procedure in the previous 3 months
* cardiopulmonary resuscitation for \>10 min within the previous 2 weeks
* positive skin test for penicillin
* positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test)
* pregnancy, possible candidate for pregnancy or breastfeeding females
* drug abusers
* inappropriate patients to participate in the study according to the chief investigator
The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of COPD
* FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC \< 70%

Exclusion Criteria:

* Any clinically relevant abnormal findings at screening examinations
* Any clinically significant disease or disorder
The Effect of Care Protocol on the Outcomes of Patients With Lung Surgery

This randomized controlled trial evaluates the effect of the care protocol, which consists of independent nursing interventions, which play an important role in accelerating the recovery process of the patient, such as the patient's position, mobilization, use of spirometry, and providing shoulder exercises after thoracotomy. The hypothesis of this research is; the care protocol applied to the patients after thoracotomy has an effect on the patients' pulmonary function tests (FVC, FEV1, FEV1/FVC) and on the mobilization of the patients, the development of complications, the time of chest tube removal and the discharge

Methods: In the study, 80 patients were randomly assigned to the study and control groups. Nursing interventions will be applied to the patients included in the study group (n=40), starting from the 0th day (the first day spent in the intensive care unit) after the thoracotomy in line with the prepared care protocol application steps until discharge. maintenance protocol; It will consist of position of the patient, mobilization, use of spirometer and shoulder exercises. The primary outcome of the research is the effect of the maintenance protocol used in the improvement of respiratory function on respiratory function tests. The secondary outcome of the research is to determine the effect of the care protocol on mobilization, complication development status, chest tube removal and discharge time in patients. The results are obtained by recording PFT values on the 1st, 5th and discharge days before and after thoracotomy. Postoperative (0.,1.,2.,3.,4.,5.) days and discharge day; mobilization, complication development status, chest tube removal time and discharge date will be recorded on the Patient Results Form.

Eligibility Criteria:
Inclusion Criteria:

* Accepting to participate in the research,
* 18 years and older,
* Conscious, oriented and cooperative,
* Able to speak and understand Turkish,
* Does not have any psychiatric disease,
* Elective thoracotomy performed,
* Chest tube inserted,
* Patients who were followed up in the intensive care unit on the first day after surgery and admitted to the clinic the next day
* Patients without a history of metastatic disease

Exclusion Criteria:

* Those who do not accepted to participate in the research,
* Under 18 years of age,
* Unconscious, without orientation and cooperation,
* Who cannot speak or understand Turkish,
* Having a psychiatric problem,
* Non thoracotomy
* Non chest tube,
* Metastatic disease,
* Emergency thoracotomy applied,
* Patients staying in the intensive care unit for more than one day.