cyrilzakka/clinical-trials huggingface dataset:
Symbicort in Asthmatic Children - SEEDLING

The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years


Eligibility Criteria:
Inclusion Criteria:

* Baseline lung function tests results as determined by the protocol
* Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
* Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study
Reduction Dead Space Volume With Karydakis Modification

The purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates.

The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery, active infection, patients who did not accept the procedure and patients under age of 18. After excision of the sinüs volume was measured using a beaker. A flap extending across the cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was excised along the incision in the flap side. Skin was approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months were followed for wound drainage, seroma and hematoma formation, separation of skin and and recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* patients who accept the procedure
* chronic p.sinüs disease

Exclusion Criteria:

* previous sinüs surgery
* active infection
* patients who did not accept the procedure
* patients under age of 18.
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

Doctors leading this study hope to learn about a software that researchers at the University of Chicago have developed to help analyze radiographic images (different techniques for taking images that allow doctors to visualize the body's internal structures) of the prostate. Participation in this research will last about 12 months. There is a one-time MRI and 1-2 biopsies and then the investigator would like to follow the participant's progress.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known or suspected prostate cancer who have been referred for a diagnostic magnetic resonance imaging (MRI) exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
* Voluntary written informed consent before the MRI examination.

Exclusion Criteria:

* Subjects incapable of giving informed written consent.
* Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
* Subjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
* Prisoners.
* Minor children (under the age of 18 years old).
* Patients with previous treatments (surgery, radiation, focal ablation, hormone or other chemotherapy) for prostate cancer.
Stereotaxic Irradiation of Hepatocellular Carcinoma

Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.

Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy

Eligibility Criteria:
Inclusion Criteria:

* Primitive liver cancer (hepatocellular carcinoma), proved by histology or diagnostic according to BCLC criteria
* T1-3 N0 M0
* With only one intra hepatic lesion and dimensions between 1 cm and 6 cm (IRM or hepatic scanner)
* Stereotaxic radiotherapy treatment approved in multidisciplinary consultation, the patient being rejected for standard therapeutic
* Age \>= 18 ans
* Previous anti tumoral treatment allowed but suspended since at least 15 days before the inclusion
* OMS =\< 2
* Portal thrombosis allowed
* Portal high blood pressure allowed
* No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation
* In case of underlying cirrhosis, only the Child-Pugh A is allowed
* Life expectancy \>= 12 weeks
* Women must have an active contraception during all the study
* Patient affiliated to health insurance
* Patient must sign the consent

Exclusion Criteria:

* T4
* Cirrhosis Child B and C
* Hepatic lesion \< 1 cm or \> 6 cm
* 2 hepatic lesions or more
* Recurrent or metastatic disease
* Patient already included in another therapeutic trial with an experimental molecule
* Allergy to gold
* Pregnant women or susceptible to be pregnant or breastfeeding
* Unable for medical follow-up (geographic, social or mental reasons)
Effects of p38 MAPK Inhibitor POLB 001 on in Vivo LPS Challenge Responses

A single center trial to evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers aged 18 to 55 years, inclusive.
2. BMI in the range of 18 to 32 kg/m2 a minimum body weight of 50 kg.
3. Fitzpatrick skin type I-III.
4. Able to give written informed consent and willing to comply with all study-related procedures.
5. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion Criteria:

1. (A history of) any clinically significant medical condition or abnormalities, as judged by the investigator.
2. History of sepsis, cardiovascular disease or malignancy.
3. History of trauma with likely damage to the spleen or surgery to spleen.
4. History of alcohol or drug abuse.
5. Any clinically significant febrile illness 30 days preceding study Day 1.
6. History of serious bleeding.
7. Clinical evidence of significant or unstable medical illness including neurological, hematological, cardiovascular (including clinically significant arrhythmia), hepatic, pulmonary, metabolic, gastrointestinal, renal, psychiatric, endocrine, or infectious diseases or malignancies. Subjects who have had splenectomy.
8. Previous participation in a systemic (i.v./inhaled) LPS challenge trial within a year before the first study day.
9. Have any current and / or recurrent pathologically, clinically significant skin condition at the lower forearms (i.e., atopic dermatitis) including tattoos.
10. Antibiotic use, operation or intervention by surgeon/dentist within one month before the first study day.
11. Subjects who have used any prescribed or non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration, or less than 5 half-lives (whichever is longer), and during the study (except for vitamin/mineral supplements) unless, in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise safety.
12. Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless, in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise safety.
13. Any active inflammatory or infectious disease (e.g., periodontitis).
14. Known immunodeficiency.
15. Positive test results for Hepatitis B, Hepatitis C, HIV antibody.
16. Subjects who consume on average more than 3 units of alcohol per day (one alcohol unit =1 beer \[12 oz\] =1 wine \[5 oz\] =1 spirits \[1.5 oz\]) or are unable to abstain from using alcohol during the study
High Flow Nasal Cannula in the Emergency Department

The aim of this study was to describe the changes in respiratory rate, heart rate and dyspnea, before and after using HFNC in patients presenting to our emergency department with ARF.

A retrospective cohort study was performed. To all adults presenting to the emergency department who used high flow nasal cannula to treat clinical signs of acute respiratory failure based on the presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis despite conventional oxygen therapy ≥ 6 l/min. Demographic variables and clinical and gasometric parameters before and after two hours using HFNC were recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 18 years
* attended between July 1st, 2015 and January 31st , 2017 in the Emergency Department of the Hospital Italiano de Buenos Aires
* with clinical signs of acute respiratory failure

Exclusion Criteria:

- Pulse oximetry \> 90% breathing room air
Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease

The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.

Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive
* Pulmonary compromise requiring oxygen support of approximately 2-6 liters
* Able to self prone, or support in self-sitting position

Exclusion Criteria:

* Ventilator management
* Patients with autoimmune disorders or inflammatory conditions not related to COVID-19
* Pregnant women
Disseminated Endometrial Cancer Cells During Sonohysterography

The purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure and result in fluid dissemination and 2) evaluate functional viability of any disseminated tumor cells collected during SHG


Eligibility Criteria:
Inclusion Criteria:

* Stage I endometrial Cancer Disease
* State IIA endometrial Cancer Disease

Exclusion Criteria:

* Prior tubal ligation
* Prior bilateral salpingectomy
Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.

More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.

More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis: Confirmed translocation-positive Ewing sarcoma

Organ Function Requirements:

Serum creatinine \< 1.4 Adequate liver function

* Total bilitubin \<1.5x upper limit of normal for age
* SGPT (ALT) \< 5x upper limit of normal for age Adequate cardiac function \> 50% by echocardiogram Bone Marrow
* Absolute neutrophil count \> 750
* Platelet count \> 75

Exclusion Criteria:

* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained. Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy. Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy.
* Patients with known pre-existing diabetes mellitus will be excluded from study.
Evaluating Perceived Fitness to Drive While Intoxicated

The goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. The study team will enroll up to 30 adults aged \> 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. The protocol involves consuming three weight-based doses of alcohol with a target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. The control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired BACtrack smartphone application. The research team's previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood test.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-39 years old,
* Less than 4 drinking days and less than 12 drinks per week on average in the past 2 months,
* Have consumed at least 4 (women) or 5 (men) drinks on one occasion, in the past year without experiencing adverse effects
* Have a valid photo ID
* Willing and able to use a rideshare credit or septa token as transportation home from the study visit
* Drives at least 2 days per week on average.

Exclusion Criteria:

* Desire alcohol treatment now or received it in the past 6 months,
* Have Alcohol use disorder per DSM-V criteria
* Meet or have met criteria for a substance use disorder within the past 12 months per DSM V criteria
* Have a prior psychiatric condition requiring hospitalization
* Are non-English-speaking
* Individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol
* Are experiencing suicidal ideation
Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis

The purpose of this study is to evaluate the safety and efficacy of multiple intravenous doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on dialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females≥18 and≤70, Weight ≥ 45 kilograms (kg)
2. Participants with chronic renal failure on dialysis for ≥ 3 months prior to randomization.
3. On ESAs treatment for ≥8 weeks prior to randomization with stable doses and the average doses ≤ 10000 IU/week
4. Hemoglobin values of ≥ 10.0 and≤ 12.0 g/dL at Screening
5. Patients with a transferrin saturation≥ 20% and a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
6. Signed informed consent

Exclusion Criteria:

1. Pregnant or lactating females
2. Red blood cell transfusion within 3 months prior to randomization
3. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products
4. hemolytic syndromes or coagulation disorder
5. hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia),
6. Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
7. C Reactive Protein (CRP) greater than 30 mg/L within the 4 weeks prior to randomization
8. Uncontrolled or symptomatic secondary hyperparathyroidism(iPTH\>800pg/ml)
9. Poorly controlled hypertension within 4 weeks prior to randomization
10. Chronic congestive heart failure (New York Heart Association Class Ⅲ or IV)
11. significant symptom within 6 months prior to randomization (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including Active hepatitis B, Active hepatitis C, A positive test for HIV antibody or ALT\> 2 x upper limit of normal (ULN), AST\> 2 x upper limit of normal (ULN))
12. tumor malignancy
13. Expected survival less than 12 months
14. A scheduled kidney transplant
15. Major surgery (may Massive bleeding) during the study
16. expected conception within 4 Weeks after the end of the Study Treatment
17. The subject has participated in other clinical trial within the 12 weeks prior to randomization
18. Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures
HemoSonics-UVA Spinal Surgery

This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.

HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.

Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology

Eligibility Criteria:
Inclusion Criteria:

* • Subject is scheduled for major deformity correction spine surgery

  * Subject is older than 18 years
  * Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

* • Subject is unable to provide written informed consent

  * Subject is incarcerated at the time of the study
  * Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
  * Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
  * Subjects with history of active liver disease
  * Subjects affected by Factor V Leiden mutation
  * Subjects affected by von Willebrand disease
  * Subjects with an history of thrombotic disease (more than one DVT)
Partnership for Applied Research in Fracture Prevention Programs for the Elderly

During their lifetime, approximately 50% of Canadian women and 30% of Canadian men will experience at least one fracture due to bone fragility (FF). Evidence is growing regarding prevention programs' effectiveness to prevent falls, but prevention of fractures through fall prevention programs has enjoyed limited success. Falls prevention programs and post-fracture screening programs leading to pharmacological treatment are very different strategies, with a shared ultimate goal. Coordination between those who repair fractures and those who manage the patient to prevent the next fracture is critical. The overarching aim of this proposal is to generate evidence-based knowledge about the effectiveness and cost-effectiveness of an integrated FF prevention program, as well as a portrait of the barriers and facilitating factors for such programs. More specifically, the objectives are: 1) to combine existing fall prevention and post-fracture management programs in the province of Quebec into integrated FF prevention programs; 2) to compare the performance of these integrated programs to control sites, using a pragmatic study design; 3) to identify barriers as well as factors that improve effectiveness across different implementation milieu; and 4) to develop and engage in active knowledge transfer activities in Quebec regions where integrated FF prevention programs are neither adequately nor successfully implemented. Drawing upon the literature on integrated healthcare, fall and fracture prevention, we hypothesize that an integrated FF program can reduce the risk of a subsequent fracture by at least 30% in the population of interest. The proposed team is poised to develop new interdisciplinary collaborations among healthcare practitioners and decision makers involved in the prevention of FFs. The program is built upon existing healthcare and structures and programs and in turn, will truly measure the effectiveness of an integrated FF prevention program. The results will ultimately lead to improvements in the existing knowledge base, address policy-relevant and health systems problems, and assist in the design and implementation of FFs prevention programs.


Eligibility Criteria:
Inclusion Criteria:

* 50 years of age and over
* must have a primary care physician
* must be able to follow simple instructions
* must have sustained a fragility fracture within three months of the recruitment date.

Exclusion Criteria:

* severe kidney insufficiency (grade 4 or 5)
* advanced stage of cancer
* fracture to sites not commonly associated with osteoporosis such as toe, finger, hand, foot, ankle, patella, head, and cervical spine.