cyrilzakka/clinical-trials huggingface dataset:
Predictive Questionnaires for Risk of Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbations

COPD patients frequently suffer intermittent exacerbations of their disease characterised by acute deterioration of symptoms. Acute exacerbations of COPD (AECOPD) are associated with significant impairment of health status, use of health care resources, poor prognosis and increased mortality. The development of simple and practical predictive tools would help to identify COPD patients at greater risk of suffering exacerbations, which is important since those patients would need more intense and early treatment.

This one-year prospective cohort non-drug study will evaluate several COPD-specific questionnaires as predictive tools and the presence of cardiovascular comorbidities as risk factors, for the composite events in study cohorts. The trial duration consists of a screening period (4-6 weeks) and a follow-up period (12 months), 4 visits in total along the study.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 40 years
* Patients fulfilling criteria for COPD according to the Global initiative for chronic obstructive pulmonary disease (GOLD) stage I or higher
* Smokers or ex-smokers of at least 10 pack-years
* Patients suffering an AECOPD either:

  1. Admitted to hospital due to AECOPD (severe exacerbation) or
  2. Confirmed AECOPD at GP (general practitioner) setting (moderate exacerbation) Definition AECOPD: Increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both.

Exclusion Criteria:

* Patients who have never smoked
* Patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.)
* Exacerbation of COPD due to other causes such as pneumothorax and acute decompensated congestive heart failure
* Difficulties in communication (cognitive deterioration, sensorial disability, language barriers)
* Severe disease with poor vital prognosis (life length expectancy less than one year)
Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer

This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis.

Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis. Currently, there are no consensus panels being used; consequently, the leukemia \& lymphoma (L\&L) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise and training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed.

Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts .

The final diagnosis and the affected cell population will be determined by site standard of care .

Analysis of data will evaluate identification of 1) normal vs abnormal cell populations and 2) BCP-ALL, AML, and less certain diseases by the expert \& site analysts as compared to the final diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
2. Specimen with adequate volume (1 mL) to complete protocol tests.
3. Specimen is leftover PB and BM from routine flow cytometry laboratory testing for having or suspected of having acute leukemia disorders (i.e. AML, BCP-ALL, ALAL, etc.), myelodysplastic syndrome (MDS), other hematological, or non-hematological disorders.
4. Specimen from newly diagnosed or relapsed subject.
5. Only one specimen type (PB or BM) shall be enrolled per given subject.
6. Specimen is stored at room temperature, upon receipt by the site.
7. Specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
8. Age of specimen (BCP ALL T1: time of collection to start of first pre-wash; ALOT, AML T1-T4: time of collection to start of staining): ≤ 24 hours.
9. Specimens are from subjects irrespective of race, gender, and ethnicity

Exclusion Criteria:

1. Specimen is from healthy subject.
2. Specimen from subject \<3 years of age.
3. Specimen is from subject undergoing any treatment for any form of leukemia.
4. Specimen is from subject with minimal residual disease (MRD) as determined by the site.
5. Specimen is from subject suspected of plasma cell disorders.
6. Visibly clotted specimen.
7. Visibly hemolyzed specimen.
8. Frozen specimen.
9. Refrigerated specimen.
10. Fixed specimen.
Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol

Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent bolus of sedative frequently results in inappropriate sedation which comes with various side effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use target-controlled infusion(TCI) to provide proper sedation without serious side effects.

In this study, the investigators try to find the appropriate propofol target concentration with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol target concentration and side effects.


Eligibility Criteria:
Inclusion Criteria:

* patients who have lower extremity surgery under spinal anesthesia and who want to be sedated

Exclusion Criteria:

* patients who have deafness, neurologic deficit, Glasgow coma scale less than 15, history of drug allergy and who are on central nervous system-related drugs,
Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

This study is an open-label phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.

This study is an open-label phase Ⅳ clinical trial in healthy adult aged 18-59 years. The experimental vaccine was manufactured by Sinovac Research and Development Co.,Ltd.. A total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group A) who received two doses of primary immunization at an interval of 21 to 31 days. And the safety of booster immunization was evaluated in the extended safety group (group B), which included 1000 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-59;
* Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd at an interval of 21 to 31 days for group A.Have been vaccination two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd for group B;
* The subjects can understand and voluntarily sign the informed consent form;
* Proven legal identity.

Exclusion Criteria:

* History of SARS-CoV-2 infection;
* Any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated SARS-CoV-2 vaccine;
* Severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination);
* Autoimmune disease or immunodeficiency / immunosuppression;
* Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before primary immunization and before booster immunization;
* Already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results)
* Receipt of attenuated live vaccines within 14 days prior to booster vaccination;
* Receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination;
* Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
* Axillary temperature \>37.0°C prior to booster vaccination;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial
The Good Start Matters - Parenting Program

Early childhood is an important period where the family can support the development and maintenance of healthy eating and active behaviors to prevent or reduce childhood obesity. With this ultimate goal, we designed the Good Start Matters - Parenting program, which aims to engage families in positive parenting practices that support healthy child behaviors, and aim to evaluate the efficacy of this intervention with a Randomized Controlled Trial (RCT). The Good Start Matters - Parenting program is a 2-month mobile-Health (mHealth) parenting intervention which promote positive parenting (primary outcome) and support children's healthy nutrition, physical activity, and decrease screen-time (secondary outcomes).

Early childhood is an important learning period where dietary, physical activity and sedentary habits are forming, and developing unhealthy habits will set children up for obesity and other health risks later in life. Moreover, during early childhood the familial environment plays a key role in shaping children's behaviors through their parenting practices, which altogether illustrate the potential of the early years as a developmental period with opportunities for obesity prevention. This Randomized Controlled Trial (RCT) evaluates the efficacy of the Good Start Matters - Parenting intervention, a mobile-Health (mHealth) aimed at improving parenting and co-parenting practices and child health behaviors among British Columbian families of preschoolers. Participating families complete measurement tools at baseline and after 10 weeks. Families randomized into the intervention condition receive immediate access to the app, and control families receive access to the app after the completion of the second assessment. We expect that compared to control group families, intervention group families significantly improve their parenting and co-parenting practices and improve child health behaviors after 2 months of app use.

Eligibility Criteria:
Inclusion Criteria:

Children must be:

* Attending a childcare center invited to participate in the Good Start Matters study.
* Older than 2.5 and younger than 6 years

Parents must:

* Be the primary caregiver/legal guardian of an eligible child OR share childrearing responsibilities with an already enrolled primary caregiver/legal guardian of an eligible child
* Be fluent in English
* Have a cellphone number and smartphone device where they can receive text messages and download and access the app

Exclusion Criteria:

Parents and children:

- Currently participating in a pediatric weight management program or in a nutritional program are not eligible.

Children:

* With severe dietary restrictions that limit their ability to follow general nutritional guidelines for toddlers and preschoolers are not eligible.
* With severe physical limitations that limit their ability to follow general movement behavior guidelines for toddlers and preschoolers are not eligible.
Review of Multimodality Management of Anaplastic Thyroid Cancer

To describe the outcome of patients with anaplastic thyroid cancer treated with hyperfractionated radiotherapy and concomitant chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* anaplastic thyroid cancer treated with multimodality treatment

Exclusion Criteria:

* differentiated thyroid cancer
Bioequivalence of a Single Subcutaneous Dose of BEPO and REPO in Healthy Male Subjects

To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects

To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects

Eligibility Criteria:
Inclusion Criteria:

* Agree to all the purposes of the study by signing and dating the Informed Consent;
* Male, aged between 19 and 40 years, clinically healthy;
* BMI between 19 and 28;
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \< 85 mmHg

Exclusion Criteria:

* Hemoglobin \<13 g / dL
* Ferritin \<20 ng/mL or TIBC \> 360 ug/ dL
* Vitamin B12 \< 200 pg/mL or floate \< 4 ng/mL
* %reticulpcyte \> 3%
* platelet \< 100,000/ul or \> 400,000/ul
* GFR \< 60mL/min/1.73m2
* Going to or during treatment of the tumor
* Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation
* Clinical history of autoimmune or hereditary anemia
* A Positive reaction in the nicotine tests
* Principal Investigator of the study criteria.
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)

The primary objective of LUTEGA 2 is it to determine the long term effect (about 2 more years after LUTEGA 1, NCT00763659) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids in two different dosages on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy. The dosage groups are crossed after LUTEGA 1.

The LUTEGA 2 is a cross-over- study and the continue of LUTEGA 1. After one year of supplementation in randomized, placebo- controlled, double blind study (LUTEGA 1), the treatment arms are unblind to cross over the different dosage groups.

The measurement of optical density of macular pigment (MPOD) uses the 1- wavelength reflection method recording reflection images at 480 nm by a fundus camera. The patients are followed up over two years in eight more visits (every three months) In addition to the MPOD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample (every six months).

Eligibility Criteria:
Inclusion Criteria:

* All non- exudative forms of age related maculopathy

Exclusion Criteria:

* Exudative age related maculopathy
* decrease opacity of ocular media
IVF Clinical Trial of Two Different Treatment Protocols.

The purpose of this study is to compare two different in vitro fertilization (IVF) treatments: conventional IVF protocol and minimal stimulation IVF protocol, in terms of success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost of treatment.

A random population of 564 sub-fertile women or couples with a female between ages of 18 and 38 years and a desire to undergo their first IVF cycle will be included in this outpatient clinical trial. The participation in this study will be approximately six months with a total of 20 to 25 visits. After successful completion of the pre-screening tests participants are randomized into one of the two arms of the study: Arm A - mini IVF protocol, and Arm B - conventional IVF protocol.

Eligibility Criteria:
Inclusion criteria:

* Valid indication for IVF treatment
* First IVF attempt
* Female age between 18 and 38 years
* Male partner 18 years of age or older
* Both partners STD free
* Must be able to understand that they may NOT become pregnant

Exclusion criteria:

* Not willing or able to sign the consent form
* Pre-existing medical condition preventing/interfering with IVF treatment
* Abnormal IVF screening tests, which includes Complete Blood Count, Varicella titer, Rubella titer, PAP smear, Syphilis, HIV 1\&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea
* Abnormal pap smear
* Body Mass Index (BMI) falls below 18.5 or above 32.0
* Female participant with irregular menstrual cycles
Radiographic Assessment of the Healing Pattern Associated With Periradicular Endodontic Microsurgery

Endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in cases in which healing has not occurred after non-surgical treatment or if it is not feasible. Recent advances in techniques and materials have resulted in more predictable outcomes. Piezotome is a new and innovative device, but limited evidence is available regarding its use in endodontics. The aim of this study is to assess the healing pattern of conventional periradicular microsurgery and piezoelectric periradicular microsurgery in 2- Dimensional and 3-Dimensional imaging, and further to perform histological analysis for the presence, location, and arrangement of bacteria in the excised apical portion of the root canal system.

After meeting the inclusion criteria, a total of 44 Patients in need of endodontic microsurgery with persistent symptoms after acceptable primary root canal treatment or failed retreatment with persistent symptoms/periapical lesions will be included in this study. Participants will be randomly allocated to group one; conventional periradicular surgery or group two; piezoelectric periradicular microsurgery. A preoperative digital periapical and limited view cone beam computed tomography (CBCT) radiographs will be taken for each patient. At 12-18 months recall visit a second digital periapical radiograph and limited view CBCT will be taken. All images will be evaluated on high-definition LCD display with installed ImageJ software and CBCT software, and window settings will be fixed for all cases. Radiographs will be evaluated by two calibrated dentists. The excised root tip with their surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °C by immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic laboratory. Fixed specimens will be demineralized in 10% formic acid and processed. Serial sectioning with hematoxylin and eosin staining will be done to locate the areas with the most severe reactions. In addition, the Taylor modification of the Brown-Brenn staining will be used to detect the presence of bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Medically fit patients
* Age (18-65 )
* Teeth that are periodontally healthy
* Coronally sealed root canal treated teeth

Exclusion Criteria:

* Patients with an active systematic disease that may affect the short- and long-term outcomes or restrict surgical intervention
* Emotionally distressed patients
* Patients who had received analgesics or antibiotics prior to surgery will be postponed
* Cases where orthograde endodontic treatment is feasible, will be retreated at the post-graduate clinics and not included in this study
* Teeth with poor prognosis (e.g., non-restorable, vertical root fracture, short roots, non-strategic tooth, endo-perio lesion
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure

The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.

This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodynamics will allow accurate assessments of potential alterations of the pulmonary vasculature. This will be further investigated by the inclusion of two patient populations, one with a baseline pulmonary artery pressure \< 35 mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune parameter measurements will assess a potential link between systemic and pulmonary alterations and potential immune reactions following DEFINITY® administration.

The inclusion of patients in this study is not based on a required echocardiogram with DEFINITY® administration because patients would be exposed to an unjustifiable risk of invasive right heart catheterization and are unlikely to consent to such a procedure. Therefore, patients undergoing heart catheterization for clinical reasons, or patients who are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive DEFINITY® in this study.

Eligibility Criteria:
Inclusion Criteria:

* Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
* Be male or female above the age of 18
* Female patients who no longer have child-bearing potential
* Women of Child-Bearing Potential(WOCBP) who:

  1. are not pregnant and have been using an adequate and medically approved method of contraception
  2. have a negative urine pregnancy test
* Be able and willing to communicate effectively with study center personnel.

Exclusion Criteria:

* Women who are pregnant or lactating
* Known hypersensitivity or contraindication to or greater heart block
* Previous heart transplant
* Known right-to-left shunt (including atrial septal defect)
* Severe pulmonary artery hypertension (i.e., \> 75 mmHg
* Current uncontrolled ventricular tachycardia
* Second-degree or greater heart block
* Any contraindications for the use of a right heart catheter