cyrilzakka/clinical-trials huggingface dataset:
SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults

The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of ³400 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.

Exclusion Criteria:

* Use of any b-blocking agent, including eye-drops, Use of oral GCS as maintenance treatment, A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
Culinary Spices in Metabolic Syndrome.

This double blind, placebo controlled randomized controlled trial aims to evaluate the effect of three commonly used culinary spices - ginger (Zingiber officinale), cinnamon (Cinnamomum) and black seed (Nigella sativa) on the cardiometabolic parameters of individuals with risk factors of metabolic syndrome. Participants consume their assigned treatment for 12 weeks, and key cardiovascular and glucometabolic parameters are recorded at baseline, week 6, and week 12 of the study.


Eligibility Criteria:
Inclusion Criteria:

* age (18-50 years)
* 2 or more of MetS diagnostic criteria:
* high waist circumference (\>80 cm for female and \>94 cm for males),
* elevated blood pressure (equal to or greater than 130/85 mm Hg or use of medication for hypertension),
* high fasting blood glucose (equal to or greater than 100 mg/dL \[5.6 mmol/L\] or use of medication for hyperglycemia),
* lowered HDL cholesterol (less than 40 mg/dL \[1.03 mmol/L\] for men and less than 50 mg/dL \[1.29 mmol/L\] for women) and
* increased triglycerides (equal to or greater than 150 mg/dL \[1.7 mmol/L\]). Participants who had at least three risk factors out of five or had two risk factors and one borderline were included in the study.

Exclusion Criteria

* older than 50 years old or younger than 17 years old and
* did not meet the metabolic syndrome diagnostic criteria
* allergic to spices
* current smokers
* pregnant women
* lactating women or
* currently taking medication and if they
* refused to provide blood sample.
* acute illnesses
* chronic diseases such as kidney, liver, cardiovascular and gastrointestinal diseases were excluded from the study
AORIF Complex Ankle Fractures

The aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively.

Starting 05/01/13 patients with complex ankle fractures, older than 17 years, who sustained the injury less than 14 days before surgery and giving informed consent are consecutively enrolled. A complex fracture is defined as either an isolated malleolar fracture in combination with ligamentous instability, or a bi- or trimalleolar fracture. An unstable ligamentous injury is defined as either a disruption of the deltoid ligament leading to increased medial talar tilt, or an unstable syndesmotic injury assessed by the external rotation test both after osteosynthesis of all fractures. Exclusion criteria are isolated unimalleolar fractures, pilon fractures, open fractures, multiple injuries, mental illness, incompliance or pregnancy.

Data assessed are:

* Demographics
* Medical history
* Classification (AO, Haraguchi, ICRS, location and size defect)
* Surgery details
* Complications
* PROMs (FAAM, AOFAS, OMAS, FAOS, TAS, SF-12, EQ-5d, MoxFQ)

Eligibility Criteria:
Inclusion Criteria:

* Unimalleolar fracture + ligamentous injury
* Bi- or trimalleolar fracture ± ligamentous injury
* \> 17 years
* Date of injury less than 15 days
* Written informed consent

Exclusion Criteria:

* Isolated unimalleolar fracture
* Pilon fracture
* Open fracture
* Mental illness, incompliance, pregnancy
* Multiple injuries
The Biology of HIV Transmission

The purpose of this study is to look at the amount of HIV in the blood, genital fluid, and saliva of the partners of patients with early HIV infection. This study will also look at the strength of the immune systems of patients with early HIV infection.

Because HIV multiplies very quickly in the early stages of infection, patients with early HIV infection may be more likely to transmit HIV to their partners. The amount of HIV in blood, genital fluid, and saliva may determine the risk for transmission.

Persons with early HIV infection may represent high transmission risk to their partners. Early infection, characterized by rapid virologic replication, insufficient immunologic control of infection, and more rapid course of disease progression, may be associated with increased infectiousness. The viral determinants of transmission may in part be explained by viral burden in blood, genital fluids, and oral cavity fluids. All three fluids may be the source for transmitted virus.

Persons with suspected HIV infection are asked to identify their possible source partners. The importance of partner referral is emphasized and assisted recruitment or active tracing is offered if necessary. Source partners will not be approached uninvited. If a partner states that he/she does not want to be contacted, then he/she will not be contacted further for the purpose of this study or for any other study. All patients are offered HIV counseling and plasma testing for HIV-1 RNA and CD4+ cells. Blood specimens are collected for plasma determination, and cellular and plasma fractions are collected for CAF and neutralization antibodies. Neutralization assays are used to detect humoral immune response in patients with primary HIV infection. Genital fluids and saliva are analyzed for viral RNA. Patients are seen in the clinic on Day 1 for blood draw and return 2 weeks later for blood test results. A follow-up period of at least 4 weeks is planned. Compensation is provided to all patients.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Have sex with or share injection drugs with a person who is thought to have early HIV infection, or if they have recently become HIV-positive.
* Can provide written consent.
* Are available for a follow-up period of at least 4 weeks.
Hemodynamic Monitoring and Resuscitation in Hip Fractures

Background: Fracture of the hip is a potentially fatal event in an elderly, frail, highly comorbid patient group suffering from dehydration and hypovolemia, and it carries a risk that equals major trauma in young patients in regard of physiological insult and severity, yet no preoperative resuscitation and transfusion strategy is available. An important goal of hemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The peripheral perfusion index reflects changes in peripheral perfusion and blood volume and a decreased peripheral perfusion index predicts surgical complications and morbidity in acute surgical and septic shock patients. The research group hypothesize that elderly frail patients with a fracture of the hip suffer from hypovolemia and peripheral hypoperfusion of varying degrees and accordingly respond to controlled fluid resuscitation and that the non-invasive peripheral perfusion index will serve as an early predictor of a deteriorated circulation in reflection of stroke volume.

Methods: The main objective of this prospective observational study is to assess to what extend patients with fracture of the hip suffer from hypovolemia and respond to a fluid challenge. The secondary objectives are to evaluate correlation between the minimally-invasive measurements of stroke volume and blood volume and the non-invasive measurement of peripheral perfusion index and near-infrared spectroscopy, as well as prevalence of postoperative complications and mortality. Fifty consecutive patients over the age of 65 years, presenting with a hip fracture, treated in a multimodal fast-track regimen, will be included when written informed consent is available. All patients will receive epidural analgesia and preoperative stroke volume-guided hemodynamic optimization. Blood volume measurements are performed and all patients are monitored with peripheral perfusion index and near-infrared spectroscopy.

Discussion: This is likely the first study to address clinically applicable hemodynamic monitoring and resuscitation in patients with fracture of the hip where adequate resuscitation is easily missed. The study group aim to evaluate the feasibility of preoperative stroke volume-guided hemodynamic optimization in the context of minimally- and non-invasive monitoring of peripheral perfusion and blood volume measurements.


Eligibility Criteria:
Inclusion Criteria:

* Primary acute hip fracture
* Age grater than 65 years
* Written informed consent

Exclusion Criteria:

- Contraindications to epidural analgesia
Low Fresh Gas Flow in Prone Position

Low flow anesthesia in the prone position was safe in terms of systemic hemodynamics and did not reduce cerebral oxygenation compared to normal flow.

Patients were randomly allocated to either low fresh gas flow(LF, 0,5 L/min during maintenance) or normal flow (NF, 2 L/min)) general anesthesia. In both groups, participants were first administered with 100% oxygen at a 4 L/min flow rate. Propofol 2-2,5 mg/kg, rocuronium bromide 0,6 mg/kg, and fentanyl 1 mcg/kg IV were used for anesthesia induction.In the operating room, pulse rate, mean arterial pressure (MAP), peripheral hemoglobin oxygen saturation (spO2), and right and left side regional cerebral oxygen saturation (Masimo's O3 regional oximetry device) were measured before premedication and anesthesia induction, at 10 minutes after endotracheal intubation, at 10 minutes after prone positioning, at 1st, 2nd, 3rd, 4th and 5th hours of operation, before repositioning to supine, after the resumption of supine position and at 5 minutes after extubation. In conclusion, low flow anesthesia in patients undergoing surgery in the prone position did not cause a reduction in cerebral oxygenation compared to normal flow.

Eligibility Criteria:
Inclusion Criteria:

* undergoing surgery in the prone position
* having an American Society of Anesthesiologists (ASA) physical status I to III
* willingness to participate in the study

Exclusion Criteria:

* having a Glasgow coma scale (GSC) score ≤ 12
* previous history of cranial surgery
* advanced cardiovascular and/or pulmonary disease
* mental retardation
* neurological disease
Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents

This study is a multi-center and open design, phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in population aged 3\~17 years and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.

This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 3\~17 years . The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in 11 provinces from August 2021 to December 2022, including Liaoning, Heilongjiang, Anhui, Fujian, Jiangxi, Hubei, Guangxi, Chongqing, Guizhou, Yunnan and Gansu. Each province will serve as a research center, and each research center will select the corresponding research site.A total of 33000 subjects including patients with pre-existing will be enrolled with 3000 for each research center, including 600 subjects aged 3\~5years，1200 subjects aged 6\~11 years,1200 subjects aged 12\~17 years.

And subjects will receive two doses of vaccine on day 0 and day 28.

Eligibility Criteria:
Inclusion Criteria:

* Have not received any COVID-19 vaccine in the past or at least one dose of CoronaVac manufactured by Sinovac Research and Development Co.,Ltd;
* Population aged 3\~17 years ;
* The subjects can understand and voluntarily sign the informed consent form and participate in the follow-up;

Exclusion Criteria:

* History of severe allergy to the vaccine such as acute allergic reaction,angioedema and dyspnea ;
* Severe neurological disease such as Myelitis transverse,Guillain-Barre Syndrome and demyelinating disorders;
* Acute disease,acute onset of chronic disease and severe chronic diseases.
Effect of Energy Density on Liking and on Caloric Adjustment Conditioning

The main objective is to study, in 8-11 year old children, the influence of energy density conditioning on liking for new flavored beverages and on caloric adjustment after the beverage consumption. The stability of the energy conditioning was evaluated after a period without exposure and after an extinction period during which the energy density of the beverages was changed.


Eligibility Criteria:
Inclusion Criteria:

* regularly ate at the school canteen
* returned signed consent from parents

Exclusion Criteria:

* present health problems, food restrictions or food allergies
Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection in very low birth weight infants.


Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight infants \< 1500 gr

Exclusion Criteria:

* Genetic anomalies
* Not willing to participate
* Allergy to S. boulardii components
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)

This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.

Trial is based on:

* INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).
* CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC)
* INTENSIFICATION: Allo-BMT, ASCT
* MAINTENANCE: AraC

  a) Primary endpoints:
* Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
* RFS, DFS and OS.

  b) Secondary endpoints:
* Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
* Evaluation of prognostic clinical relevance of biological features at onset.
* Feasibility and outcome of consolidation with BMT.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years.
* WHO PS grade 0-2 (Appendix B) or Karnofsky \> 70.
* AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy
* All FAB subtypes except M3.
* CD33 positivity (\> 20%). It is mandatory to perform an immunotyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor.
* Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS).
* Adequate renal and liver function, i.e., creatinine \< 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.
* Written informed consent

Exclusion Criteria:

* Blast crisis of chronic myeloid leukemia.
* AML supervening after other myeloproliferative diseases.
* AML de novo or secondary previously pretreated.
* Concomitant malignant disease.
* Active central nervous system (CNS) leukemia.
* Active uncontrolled infection \[NB severe systemic infection should be excluded\].
* Concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease.
* Cardiac ejection fraction of 50% or less.
* Severe pulmonary dysfunction (CTC grade 3-4).
* Severe concomitant neurological or psychiatric disease.
* History of alcohol abuse.
* HIV positivity.
* Pregnancy.
* Man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy.
* Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer in the age between 19 and 55 years old.
* Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2
* Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

* Previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease.
* History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
* Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, ASTor ALT \>1.5 times of the Upper Normal Limit or total bilirubin \> 1.5 times of the Upper Normal Limit
* Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
* Participation in any clinical investigation within 3 months prior to study drug administration
* Subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing.
* SBP ≥ 140 mmHg or\< 115 mmHg, DBP ≥ 90 mmHg or \< 70 mmHg
* Caffeine \> 400mg/day
* Alcohol \> 30g/day
* Cigarette \> 10 cigarettes/day.
* Subjects who are judged unsuitable by investigators
The Efficacy of Ticagrelor on Abdominal Aortic Aneurysm (AAA) Expansion

Abdominal aortic aneurysm (AAA) is a major health problem and ruptured AAA is a common cause of death in Europe and North America. A key limitation of contemporary treatment strategies of AAA is the lack of therapy directed at reducing expansion. Although surgical repair is an effective treatment for large AAA, it is associated with significant mortality and morbidity as well as substantial cost. The rationale for this randomized controlled study is to investigate whether treatment with Ticagrelor inhibits growth of small abdominal aortic aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Male and female patients
* Age 50-85 years
* Documented infrarenal aortic aneurysm between 35-49 mm
* Acetylsalicylic acid (ASA)-naïve

Exclusion Criteria:

* Short expected survival.
* On anti-platelet therapy.
* On long-term oral or parenteral anticoagulant treatment.
* On strong inhibitors of CYP3A enzyme (Ketoconazole, Itraconazole, Voriconazole, Telithromycin, Clarithromycin, Ritonavir, Saquinavir, Nelfinavir, Indinavir, Atazanavir).
* On CYP3A (Cytochrome P450, family 3, subfamily A) substrates or inducers \>40mg daily doses (Simvastatin, Lovastatin, Rifampin/rifampicin, Phenytoin, Carbamazepine, Phenobarbital).
* Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta.
* Increased risk for bradycardia or ongoing treatment with any bradycardia inducing drug.
* Contraindication for Ticagrelor; hypersensitivity to Ticagrelor or any of the excipients, active pathological bleeding, history of intracranial hemorrhage, moderate or severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy), on haemodialysis.
* Known haemostatic or coagulation disorder, gastrointestinal bleeding within the past 6 months, or increased bleeding risk due to surgery or trauma within 30 days.
* MRI exclusion criteria, such as: severe claustrophobia, pacemaker, metallic implants in brain, cochlear implants.
* Metallic implants in aortic region.
* Enrolled in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to visit 1 of the current study.
* Any condition or laboratory finding which in the opinion of the Investigator makes the patient unsuitable for inclusion (eg, active malignancy other than squamous cell or basal cell skin cancer, long-term concomitant treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain

To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.


Eligibility Criteria:
Inclusion Criteria:

* Patients with posttraumatic pain which is able to be controlled with an oral NSAID
* Patients with "pain" that meets both of the following criteria within 48 hours after injury:

"Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 mm or more

* Patients with "inflammation" that meets the following criteria within 48 hours after injury.

"Inflammation" Categorical: "Mild", "Moderate" or "Severe"

Exclusion Criteria:

* Patients who have received analgesics and anaesthetics for injury
* Patients with a history/complication of aspirin-induced asthma
* Patients taking excluded medications
* Patients with a history/complication of ischaemic heart disease, serious cardiac arrhythmias, cardiac failure congestive and cerebrovascular disorder or with a history/plan of revascularization
Home Based Tele-exercise for People With Chronic Neurological Impairments

To assess the impact of a 12-week virtual seated physical intervention on cardiovascular health and wellness in people with chronic neurological impairments (CNI).

This study aims to examine how effective seated Zoom exercise classes are for a person with CNI for addressing cardiovascular health, physical wellness and quality of life. If these classes prove to be effective, online platforms could be a viable avenue for those with CNI to exercise and increase/maintain wellness without having to leave their homes. The investigators are also attempting to determine if a class with a live instructor vs a pre-recorded class has an effect on motivation, compliance, exertion and modifications/safety.

The entire process, including screening and consenting, will be done via Zoom and Redcap, potentially providing a blueprint for the future studies. This process can enable participants to participate in studies with minimal inconvenience, expense and effort of traveling for the consent process.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with chronic (\>6 months) neurological impairments
2. 18 to 75 years of age
3. Participants who can provide a medical clearance to participate in the program
4. Participants who can remain seated for at least one hour
5. Heart rate/BP considerations, per each participant's MD
6. Participants must be able to don/doff HR monitor without assistance, or have assistance if necessary
7. Participants must maintain their current exercise/physical activity routine during the course of the study
8. Clinically stable with no other neurological, medical or cognitive impairments
9. Reliable Internet connection and ability to use Zoom platform
10. Participants must speak and understand English
11. No contraindication/limitations to exercise
12. Currently exercising 2 days or less per week

Exclusion Criteria:

1. Participants with any cognitive impairment preventing safe and accurate participation in the program
2. Medical issues preventing safe participation
3. Other problems possibly contraindicating autonomous exercise at home if no supervision available.