cyrilzakka/clinical-trials huggingface dataset:
Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou

The purpose of this study is to elucidate the local epidemic problem and epidemiological characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and clinical treatment system of severe cases to reduce the morbidity and mortality of dengue fever.

To study the epidemiological and pathogenic of dengue virus in Guangzhou, which help to reveal the regular prevalent pattern and the natural epidemic focus of dengue fever. To establish dengue virus sequence database of Guangzhou region, research the biological characteristics and molecular characteristics of dengue fever epidemic strains especially in 2014 in Guangzhou region, to determine the source and variation of this epidemic strains , which finally help to reveal the cause of the pandemic.

To investigate the serum epidemiology of 7800 large groups of people in 12 county-level cities in Guangzhou by stratified random sampling method. It will enrich the research database of the dengue fever serological antibody level survey of people in Guangzhou. After that the investigators could provide a scientific reference for setting up a risk evaluation and implementation of targeted control measures, and also provide reference for analysis of the epidemic situation in other areas.

To study on molecular markers predictive of severe dengue fever and protective immunity after dengue virus infection. The investigators will obtain both serotype-specific and cross-reactive antibodies, which is highly protective neutralizing antibodies. Then the investigators will explore the potential for clinical application about these neutralizing antibodies. The dengue virus were sequenced which caused dengue fever or severe dengue fever in 2014, and do bioinformatics analysis to find the genetic loci which may be responsible for virulence of dengue virus.

To sum up the clinical and laboratory data of dengue fever in 2014, to carry out the research on the diagnosis and treatment of dengue fever, to explore the effectiveness, safety and mechanism of Integrated Chinese and Western medicine treatment for dengue fever patients，to establish of a more perfect system for the diagnosis and treatment of dengue fever in China.

Eligibility Criteria:
Inclusion Criteria:

* Dengue patients confirmed by dengue virus NS1 or RNA

Exclusion Criteria:

* Pregnant women
* Fever diseases caused by other viruses
* Combined bacterial infection
* Without complications such as diabetes and tumor.
A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Posterior Cavities

The aim of this study is to evaluate and compare the clinical performance of 2 ion-releasing bulk-fill restorative materials in comparison with a bulk-fill resin composite restoration in posterior cavities.


Eligibility Criteria:
Inclusion Criteria:

* Criteria for patient's inclusion in the study will be the presence of at least 3 occlusal or proximal carious lesion in posterior teeth, favourable and stable occlusion between the remaining teeth, the patients must be older than 18 years old with permanent dentition, moderate oral hygiene, asymptomatic vital teeth with no sensitivity to percussion, and the presence of contact with adjacent teeth

Exclusion Criteria:

* Exclusion criteria will be, sever bruxism, patients with known unavailability to attend recall visits, patients with known allergy to any component of the study materials, pulp exposure during caries excavation, patients with unstable medical conditions and pregnant or lactating individuals.
Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV)
* A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV).
* A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce SAR through a standard skin prick test.
* Other criteria apply

Exclusion Criteria:

* History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit \[SV\])
* History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza,) within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
* Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable
* Have any conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial
* Other criteria apply
Is COPD a Risk Factor for Cardiovascular Disease?

Patients with chronic obstructive pulmonary disease suffer from significant cardiovascular morbidity and mortality. This study wants to determine whether chronic obstructive pulmonary disease might be a risk factor for coronary atherosclerosis and other cardiac markers independent of conventional cardiovascular risk factors. The study is designed as a retrospective matched case-control study with follow-up via telephone interview.

Patients with chronic obstructive pulmonary disease (COPD) suffer from significant cardiovascular morbidity and mortality. Coronary artery disease has often been linked causally to COPD, but the exact pathophysiological mechanisms underpinning this association remain speculative. A retrospective case-control study matching COPD patients and controls one to one for smoking history and conventional cardiovascular risk factors will be performed to study the association between COPD and cardiovascular outcomes. Filling in this knowledge gap may contribute to the understanding of the interplay between COPD and cardiovascular disease.

The objective of this retrospective case-control study is to determine whether COPD might be a risk factor for coronary atherosclerosis, impaired left ventricular ejection fraction, and major adverse cardiovascular events independent of conventional cardiovascular risk factors.

Eligibility Criteria:
Inclusion Criteria:

* SPECT-CT imaging due to preoperative assessment between 01.01.2007 and 31.07.2013.
* Coronary artery calcium score and left ventricular ejection fraction data available.
* History of smoking (smoker or ex-smoker).
* COPD group: Documented chronic obstructive pulmonary disease (post-bronchodilator FEV1/FVC \< 0.7).
* Control group: Exclusion of chronic obstructive pulmonary disease (post-bronchodilator FEV1/FVC \> 0.7).

Exclusion Criteria:

* Known coronary artery disease or coronary symptoms (angina pectoris) at the time of the SPECT-CT investigation.
* Known congenital or structural heart disease.
* Previous heart transplantation.
Psychosocial Effects of Coloring in Preeclamptic Pregnant Women

Preeclampsia is one of the major causes of maternal and neonatal mortality and morbidity, affecting approximately 3-5% of pregnancies. A diagnosis of preeclampsia may lead to psychological problems such as psychosocial distress, depression, and anxiety due to prolonged hospitalization, concerns about the future health of the baby, separation from family, and adapting to a foreign environment. Health professionals play a crucial role in the diagnosis, treatment, and care of high-risk pregnancies and also implement non-pharmacological supportive methods such as yoga, progressive muscle relaxation, and mindfulness. One of these non-pharmacological methods is mandala. According to the literature, integrating mandala coloring into perinatal care is believed to have beneficial effects.

Therefore, the primary aim of this study is to investigate the effects of mother-baby themed coloring on anxiety. The secondary aim is to determine its effects on psychosocial health and cortisol levels.

H1a: Is there a difference between anxiety scores in preeclamptic pregnant women who were and were not exposed to dyeing activity?

H1b: Is there a difference between psychosocial health scores in preeclamptic pregnant women who were and were not exposed to dyeing activity?

H1c: Is there a difference between cortisol levels in preeclamptic pregnant women who were and were not exposed to dyeing activity?


Eligibility Criteria:
Inclusion Criteria:

* Having a single and healthy fetus
* Gestational age ≥ 20 weeks
* Diagnosed with preeclampsia by a physician
* Not having a history of treated pregnancy

Exclusion Criteria:

* Using psychiatric medication (self-report)
* Receiving psychological counseling during the intervention
* Diagnosed with severe preeclampsia
Kinetics of Surfactant Proteins, Phosphatidylcholine and Body Water in Intensive Care Unit (ICU)

Analysis of kinetics of phosphatidylcholine and specific surfactant proteins, total body water and water turnover in patients with acute respiratory distress syndrome (ARDS) and in intensive care unit (ICU) patients by using non radioactive isotopes as deuterium and Carbon-13.

Patients with adult respiratory distress syndrome (ARDS) have low concentrations of disaturated-phosphatidylcholine and surfactant protein-B and C in bronchoalveolar lavage fluid and altered fluid metabolism.

Injection of stable isotopes such as 13 Carbon Leucine and deuterated water allows the analysis of disaturated-phosphatidylcholine and surfactant protein-B and C kinetics, total body water and water turnover in patients with ARDS and in human adults with normal lungs (controls).

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were:

* adult patients older than 18 years
* expected intensive care unit (ICU) length of stay greater than 120 hours from the onset of acute respiratory failure, defined according to the acute respiratory syndrome (ARDS) Berlin criteria or patients admitted for acute neurological failure defined as Glasgow coma scale \< 8.
* All patients with ARDS also had sepsis syndrome or septic shock according to the surviving sepsis campaign criteria at the admission to the ICU, while no patients with acute neurological failure was septic.

At the start of the study, patients with ARDS/sepsis fulfilled also the following criteria:

* start of the study within 72 hours from the onset of the respiratory failure;
* stable hemodynamic conditions, defined as no need of fluid boluses for at least 6 hours before the start of the study;
* serum urea and creatinine within the normal ranges.

Patients with acute neurological failure fulfilled the following inclusion criteria:

* normal chest radiograph;
* arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2/FiO2) \>300;
* no evidence of sepsis, according to body temperature, C reactive protein, white cell count and differential count within normal ranges;
* intubation and mechanical ventilation started within 72 h before the beginning of the study.

Exclusion Criteria:

Exclusion criteria for all study subjects were:

* presence of liver failure or renal failure (transaminases \> 3 and creatinine \> 2 times the normal values),
* burns \> 30% of body surface bone marrow or lung transplantation,
* need of fluid boluses to maintain hemodynamic conditions during the study or extracorporeal circulatory support.
An Open-Label Maintenance Study of the Enzyme Replacement Therapy Replagal in Patients With Fabry Disease

This study will continue to evaluate the safety of using intravenous doses of Replagal for two patients with Fabry disease. Fabry disease is a genetic disorder inherited as an X-linked recessive trait. It causes a deficiency in the enzyme alpha galactosidase, which normally breaks down a lipid, or fatty substance called ceramidetrihexoside, a building block in all cells of the body. The deficiency in breaking down the lipid eventually causes that lipid to accumulate and injure cells. Vascular, renal, and neurological problems are the results. It is not known exactly how lipid accumulation brings about such problems, studies of another lipid storage disorder.

Two patients 7 to 17 years of age who have Fabry disease and have been receiving intravenous infusions of Replagal at a dose of 0.2 mg/kg of body weight every 2 weeks may be eligible for this study.

Participants will undergo the following tests and procedures:

* Physical examination.
* Neurological examination.
* Medical and medication history.
* Vital signs.
* Assessment of height and weight.
* Blood tests to determine complete blood count and chemistries.
* Electrocardiogram.
* Doppler blood flow study.

Participants will go through a baseline evaluation, over a period of about 1 day. They will receive an intravenous infusion of Replagal every other week, at the dose of 0.2 mg/kg of body weight. Vital signs will be measured before the infusion and immediately and after and 1 hour afterward. There will be careful monitoring for allergic reactions and side effects. The infusion time takes approximately 40 minutes.

This study will last at least 1 year, or until the sponsor doing the investigating or the drug manufacturer decides to withdraw support of the study.

Objectives: This goal of this study is to continue treating two patients with Fabry disease using enzyme replacement therapy (ERT) using Replagal (agalsidase alfa) at a dose of 0.2 mg/kg of body weight administered every 2 weeks. Study Population: Two patients with Fabry disease who are currently on clinical research protocols 00-N-0185/TKT011 or 02-N-0220/TKT015 and who are stable on ERT. Design: This is an open label study. Outcome Measures: Mainly safety parameters will be obtained. Study duration is estimated to be 2 years.

Eligibility Criteria:
* Patients are under direct care of PI and have previously been treated with Replagal under TKT, Inc. sponsored study numbers 02-N-0220/TKT/010/015.
Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

The purpose of this study is to evaluate the usefulness of adding Milrinone to the current standard treatment for cerebral vasospasm.

The goal of this study is to assess the efficacy of milrinone as an agent to treat cerebral vasospasm by adding it to standard therapy. This will take the form of a randomized, controlled trial in which patients will receive either standard hyperdynamic therapy or hyperdynamic therapy + milrinone. The hypothesis of this study is that good outcomes will be 25% more common in the experimental (milrinone) group than the control (standard therapy) group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age
* Aneurysmal subarachnoid hemorrhage, proven on CT angiogram or digital subtraction angiography
* Aneurysm treated, either by endovascular embolization or surgical clip ligation
* Evidence of increased velocities on transcranial dopplers (TCDs) and/or radiographic evidence of vasospasm as seen on angiogram
* Cerebral vasospasm as demonstrated by patient's clinical exam (new focal deficit or change in mental status not attributable to any other cause)

Exclusion Criteria:

* Recurrent subarachnoid hemorrhage
* Untreated ruptured aneurysm, for any reason
* Patients who die prior to treatment for aneurysm
* Patients who are not able to complete at least 6 months of follow-up
* Patients who are admitted already in vasospasm (i.e. a delayed admission)
* Creatinine clearance less than 20 ml/min
* Women with a positive pregnancy test or who are lactating
* Other comorbidity which may adversely affect patient outcome, at the discretion of the principal investigator
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with carboplatin and/or Paclitaxel chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with a histologically or cytologically diagnosed malignant solid tumour
* Adequate bone marrow, hepatic and renal function
* Performance status of no more than 2 ( ECOG scale).

Exclusion Criteria:

* Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
* Major surgery with 4 weeks of entering the study and must have recovered from effects of the major surgery
* More than two previous courses of platinum-containing chemotherapy
* Heavily pre-treated patients(\> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency

This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.

Criteria for evaluation:

1. Adverse events
2. Nutritional endpoints

   * BMI (height \[only prior to the start of Lipacreon treatment\] and weight)
   * Serum total protein
   * Albumin
   * Total cholesterol
   * Triglycerides
   * Haemoglobin
3. Symptoms related to exocrine pancreatic insufficiency

   * Steatorrhoea
   * Frequency of bowel movements
   * Diarrhoea
   * Foul stool odour
   * Decreased appetite
   * Abdominal distension
4. Patient's quality of life (QOL)
5. Degree of general improvement

Eligibility Criteria:
Inclusion Criteria

* Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency

Exclusion Criteria

* Patients with a history of hypersensitivity to the ingredient of LipaCreon.
* Patients with a history of hypersensitivity to porcine protein.
Oral Biopsies: Evaluation of the Post-surgical Discomfort

Aim of this study is to evaluate the post-operative course in patients undergoing diagnostic or therapeutic oral mucosal biopsies.

To evaluate the wound healing, all variables connected with the surgery (including post-operative complications) were recorded. To evaluate the psychological and behavioral impact of the post-operative discomfort, two survey tools were administered: OHIP-14 and visual number scale of pain (VNS) were administered at 6h, 7 days and 21 days after biopsy.


Eligibility Criteria:
Inclusion Criteria:

* no systemic or local contraindications for surgical treatment
* need for an oral biopsy (both excisional and incisional).

Exclusion Criteria:

Since no absolute contraindications to oral biopsies are reported, no exclusion criteria were selected for this study, but if any relative contraindication was present (i.e. bleeding disorders) biopsy was performed after the resolution of the problem
Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes

The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in the cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant impact on the millions of Americans who have T2DM. This project is designed to 1) determine the mechanisms underlying EPC dysfunction in older, sedentary adults with T2DM compared those with normal glucose metabolism and impaired glucose metabolism, and 2) determine if aerobic exercise training is an efficacious therapy for EPC dysfunction in T2DM, and whether improvement in EPC number and function translates to improved endothelial function, increased capillarization, and improved glucose metabolism in T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-80
* Non-smoker
* If woman, postmenopausal \>1 year

Exclusion Criteria:

* History of heart disease or stroke
* Cancer
* Poorly controlled hypertension or dyslipidemia
* Kidney or Liver diseases
Improved Adherence to C. Difficile Isolation Protocols Through Improved Education Methods

This clinical trial studies how well inter-disciplinary educational methods work in improving adherence to isolation protocols in patients with Clostridium (C.) difficile infections. An inter-disciplinary educational method may help to prevent the spread of infection.

PRIMARY OBJECTIVES:

I. To lower rates of C. difficile transmission through improved adherence to recommended isolation protocols.

SECONDARY OBJECTIVES:

I. Improve resident knowledge of infection control procedures and engagement in quality improvement initiatives.

OUTLINE:

Residents and nurses are given a short presentation on isolation protocols for diarrhea and enteric pathogens approved by Infection Control and covering their recommendations.

After completion of study, residents and nurses complete post-tests to determine the effectiveness of the training every 6 months.

Eligibility Criteria:
Patient Criteria

Inclusion Criteria:

* Patient on the gynecologic oncology service
* Admitted to Seidman 6th floor of the Seidman Cancer Center
* Diarrhea or clinical concern for C. difficile infection

Exclusion Criteria:

* None

Medical Staff Criteria:

Inclusion Criteria:

* Any resident or nurse treating a patient meeting the above criteria

Exclusion Criteria:

* None
Analysis of the Quality and Quantity of Antibiotic Prescriptions for Bacterial Respiratory Tract Superinfection in Patients Hospitalized in COVID-19 Wards

In this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made.

Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.

Patients hospitalized on a COVID-19 ward for more than 24 hours will be included. Those with one or more antimicrobial prescription(s) for a presumed respiratory tract (super)infection will be identified and every antibiotic dose will be scored as appropriate, inappropriate, suboptimal or unnecessary by at least two infectious disease (ID) specialists, on an independent manner. If the scoring of the two ID specialists will defer, a third ID specialist will come to a conclusion after discussion with the two other ID specialists.

A quantification of the total amount of antibiotics, prescribed for presumed respiratory tract (super)infection will be made for patients with a COVID-19 diagnosis, but also a quantification for every category of appropriateness will be made.

Possible drivers like the degree of hypoxemia, laboratory parameters, qSOFA score, duration of symptoms, age, comorbidities, symptoms,... associated with the prescription of antimicrobials for a presumed respiratory tract (sur)infection will be identified.

Eligibility Criteria:
Inclusion Criteria:

* Men and women hospitalized in one of the COVID wards (no data will be collected during a stay on the ICU department) of UZ Brussel for more than 24 hours and willing to sign the informed consent form (or signed by one of their legal representative(s) if unable).

Exclusion Criteria:

* patients younger than 18 years old
* patients not willing to sign the informed consent form
* patients hospitalized for a shorter duration than 24 hours on a COVID-19 ward