cyrilzakka/clinical-trials huggingface dataset:
The Effect of Colchicine on Inflammation in ACS Patients

This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients

This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameters as well as to examine the drug safety and tolerability in these patients.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* \>18 yrs
* STEMI patients who were successfully treated with PCI.

Exclusion Criteria:

* Pregnant or breast-feeding women or women of childbearing potential.
* Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents.
* Known hypersensitivity to colchicine or current chronic treatment with colchicine.
* Severe renal failure (estimated creatinine clearance \<30ml/min) or hepatic failure (Child Pugh score B or C )
* Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction.
* Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir, clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gp inhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine, verapamil, ketoconazole, itraconazole) and grape fruit juice
Pneumonia in the Intensive Care Unit (ICU) Setting

The purpose of this observational study is to collect prospective data on the occurrence of bacterial and viral pneumonia in the ICU setting. Current classification systems for pneumonia promote over treatment with antibiotics as they do not specifically recognize the presence of culture-negative and viral pneumonia. The investigators will collect data to determine if a novel pneumonia classification system can be developed that more accurately links the etiology of pneumonia (antibiotic-susceptible bacterial pneumonia, antibiotic-resistant bacterial pneumonia, culture-negative pneumonia, viral pneumonia) to clinical outcomes. Additionally, the investigators will collect data on the practice of antimicrobial stewardship in the ICU setting to determine if further improvements in antibiotic practices can be accomplished in the future.

The investigators will be prospectively collecting data on patients admitted to the 8300 and 8400 medical intensive care units at Barnes-Jewish Hospital requiring invasive mechanical ventilation for support in respiratory failure from pneumonia. Data will be collected on patients admitted from 1/2016-12/2016. The investigators will be collecting initial patient characteristic data as well as reviewing microbial specimen results (tracheal aspirate, bronchial alveolar lavage, viral multiplex, blood cultures) and antibiotic usage in real time. The investigators will identify any changes in antibiotic usage demonstrated with the advising of the ICU antibiotic stewardship team.

Eligibility Criteria:
Inclusion Criteria:

* age 18+, admitted for 8300 or 8400 medical ICU between 1/2016 and 12/2016 for respiratory failure from pneumonia, requirement of \> 24 hours of invasive mechanical ventilatory support for pneumonia

Exclusion Criteria:

* Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids \> 20mg/day Prednisone equivalent, other home immunosuppressants, solid organ or bone marrow transplant patients, cystic fibrosis, bronchiectasis, active malignancy, receiving chemotherapy or radiation therapy within the past 3 months, hematologic malignancy
* Chronic ventilator dependence
Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients

The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction

Delivering hybrid expander supported by 2 miniscrews in palate to perform Alt-RAMEC protocol for 9 weeks then intervention group will start protraction using class iii elastics on modified lingual arch with hooks in canine area and 2 miniscrews labially between lower lateral and canine while control group use face mask for protraction of maxilla

Eligibility Criteria:
Inclusion Criteria:

* Male or Female Growing Patient ( CVM2-CVM3 )
* Skeletal class III (ANB ≤ 0 , A-NV≤ -2 and wits appraisal \< -0.3mm)
* Erupted upper and lower first permanent molars and permanent incisors
* Reverse overjet up to -4 mm

Exclusion Criteria:

* History of previous orthodontic treatment
* Cleft lip/palate patients
* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
* Patients with syndromes
Assessment of Nutritional Status in Systemic Sclerosis

The main theme of the cohort of systemic sclerosis (SSc) patients is the determination of nutritional status, its evolution and the evaluation of its management in patients with scleroderma.

The main objectives are :

* To determine the incidence of malnutrition and its main determinants (disease characteristics, severity, eating habits, physical activity) in patients with scleroderma.
* For patients with undernutrition at inclusion or at 18 months follow-up:

evaluate the impact of a standardized nutritional intervention (dietary advice, oral supplements, artificial, enteral or parenteral nutrition) on nutritional and disease parameters.

Follow-up visits will take place every 6 months for 2 years. (M6, M12, M18 et M24).

During each visit: a clinical examination, with anthropometric measurements, a 3-day dietary survey and a blood sample (10 ml), completion a multiple-choice of quality of life and physical activity evaluation.

Paraclinical evaluation : echocardiography, lung function tests, screening for osteoporosis (M6 and M18).

If undernutrition is detected during a follow-up visit, the subject will be referred to a specialized service.


Eligibility Criteria:
Inclusion Criteria:

* All SSc patients aged 18 or more
* Patient followed at the Montpellier University Hospital
* Patients must fulfil the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria for SSc.
* Health insurance (affiliation to social security)
* Collection of non-opposition to participate in the study

Exclusion Criteria:

* Patient under the protection of justice curatorship / guardianship;
* Patients who have already planned to move out of the region in the next two years, making the follow-up impossible.
Blood Based Eyedrops From Different Sources in the Treatment of Severe Keratopathy

Topical preparations (eye drops) derived from the blood have become a relatively common treatment for more advanced forms of keratopathy. The purpose of this study is to evaluate the effect of two blood components from donors (serum cord blood and serum from adult subject donor peripheral blood) in the treatment of severe keratopathies.

The rationale for the use of eye drops prepared from the blood as a source is mainly based on their content in growth factors (Growth factors, GF), which play an important role in regulation of many processes involved in normal healing of damaged corneal epithelium . The most used product so far is the eye drop prepared from serum (Autologous Serum, AS) or from platelet-rich plasma (Plasma Rich Platelet, PRP) of peripheral blood taken from the patients themselves. More recently, treatments were introduced by homologous sources that undoubtedly offer advantages as compared to autologous sources. In particular the homologous sources show:

* not invasiveness to the patient, who could in time not like the repeated withdrawals
* applicability even in patients with underlying systemic conditions. They may contain in their blood, among others, higher levels of pro-inflammatory factors, with the consequence of poor and inappropriate final product to be prepared and delivered to the eye

  * reliability, since the homologous products can be prepared, controlled, also validated under the microbiological profile and standardized advance, then kept frozen until the dispensation
  * conceptually unlimited availability of the product to be dispensed
  * versatility of therapeutic indications, based on different GF levels which are estimated in advance

The purpose of this study is to evaluate the effect of two products derived from two different blood sources (cord blood collected at birth from placenta umbilical veins and adult subject donor peripheral blood) in the treatment of severe keratopathies.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of severe dry eye , scored as level severity 3 according to the Dry Eye WorkShop grade (DEWS, Ocular Surf 2007)
* corneal epithelial damage, stained with fluorescein as vital dye, NEI (national Eye Institute) score\> 6 (estimated with imageJ software) damage coverage\> 25% of total corneal area
* good general health condition
* ability to adhere to treatment and to the procedures provided by the study

Exclusion Criteria:

* concurrent treatment with hypotensive drugs
* ocular surgery in the 12 months preceding enrollment .
Effects of Routine Physical Therapy With and Without Neurodevelopmental Technique on GMF, Spasticity and HRQOL in Diplegic CP

The aim of this study is to investigate the effects of routine physical therapy with and without neurodevelopmental technique on gross motor function, spasticity and health related quality of life in diplegic cerebral palsy.

The neurological illness known as cerebral palsy is caused by damage to the growing brain and therefore is indicated by anomalies of muscle strength, mobility, and motor functions. Cerebral palsy affects posture, muscle tone, and movement development. Neurodevelopmental technique and routine physical therapy are considered to be effective in treatment of cerebral palsy. This study will investigate the combined effects of neurodevelopmental technique and routine physical therapy versus routine physical therapy on gross motor function, spasticity, and health related quality of life in diplegic cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an age of 8 to 18 years of both genderswith confirm diagnosis of diplegic cerebral palsy
* Patients could ambulate functionally
* Patients having limited or no prior exposure to NDT
* Individuals with mild to moderate diplegic cerebral palsy, based on established classification scales (GMFM grade I-III)

Exclusion Criteria:

* Patients with other motor or sensory dysfunctions and unable to understand and obey commands
* Patient undergone any orthopedic surgery that was ought to treatspasticity
* Patients with spasticity level 4-5 according to Modified Ashworth Scale
* Patients with Botulinum toxins type A injection within last 6 months
Cohort Study on the Treatment of Severe Pneumonia with Traditional Chinese Medicine

This is a multicenter, prospective cohort study, with syndrome differentiation and treatment of traditional Chinese medicine as the exposure factor. Patients using syndrome differentiation of traditional Chinese medicine combined with conventional treatment of Western medicine are classified as the treatment cohort of Integrated Chinese and Western medicine, and patients using conventional treatment of Western medicine only are classified as the treatment cohort of Western medicine

Severe pneumonia is a severe respiratory disease with high mortality, many complications and poor prognosis. Traditional Chinese medicine has certain curative effect in the adjuvant treatment of severe pneumonia, but there is a lack of systematic TCM syndrome differentiation scheme and its curative effect evaluation in the real medical environment. The cohort study on the efficacy of TCM syndrome differentiation scheme in the adjuvant treatment of severe pneumonia is conducive to providing new evidence for the optimization and evidence-based evaluation of TCM treatment scheme for severe pneumonia. Therefore, this study took severe pneumonia as the research object, standardized use of traditional Chinese medicine diagnosis and treatment scheme as the exposure factor, carried out a multi center prospective cohort study, used the 90 day mortality, 28 day mortality, treatment failure rate, etc., to evaluate the clinical efficacy and safety of integrated traditional Chinese and Western medicine in the treatment of severe pneumonia, and provided evidence for the application and promotion of traditional Chinese medicine in severe pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* It met the diagnostic criteria of severe pneumonia;
* Age ≥ 18 years old, regardless of gender.
* Voluntary treatment.
* Sign the informed consent form.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients with mental illness who are unable to cooperate or unwilling to cooperate with follow-up;
* Those who are participating in clinical trials of other drugs;
* Known allergic to therapeutic drugs.
A Study of Iron Oligosaccharide in CHF Patients

The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with congestive heart failure with a need for parenteral iron.

Iron dextrans have been marketed for more than 50 years and the compiled preclinical and clinical experience with iron dextrans in general is well established. Pharmacosmos A/S already markets the iron dextran CosmoFer® worldwide, except in the US where the product is named INFeD®. A new iron oligosaccharide has been manufactured by Pharmacosmos A/S and it is a further development of CosmoFer® where ferric hydroxide has been combined with low molecular weight oligosaccharides in a relatively strong complex. This iron carbohydrate complex builds on the well established efficacy and safety profile of existing iron dextran but with a significantly reduced anaphylactic potential.

In order to ensure that iron oligosaccharide will not lead to unexpected adverse events the existing clinical information on iron dextrans in general needs to be supplied with clinical safety data from a limited number of relevant patients exposed to iron oligosaccharide in open label non-comparator studies.

The primary objective of the present study is to obtain safety reassurance with the use of iron oligosaccharide given either as repeated IV boluses or as total dose infusion for the correction of anaemia in patients with congestive heart failure in order to ensure that iron oligosaccharide will not lead to unexpected adverse events in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Congestive heart failure
* ≥ 18 years of age at screening
* Haemoglobin \< 110 g/L (or 6.8 mmol/L)
* Serum ferritin \< 800 µgram/L
* Life expectancy beyond 12 months
* Willingness to participate after written informed consent

Exclusion Criteria:

* Non iron deficiency anaemia
* Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis)
* Drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes)
* Patients with a history of multiple allergies
* Decompensated liver cirrhosis and hepatitis (alanine aminotransferase \> 3 times normal) Acute or chronic infections Rheumatoid arthritis with symptoms or signs of active inflammation. Pregnancy and nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception Active bleeding Planned elective surgery during the study where significant blood loss is expected Participation in any other clinical trial within 3 months prior to screening
Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase

LOVED stands for the Living Organ Video Educated Donors (LOVED) program. It is a culturally tailored program for African Americans to reduce the disparity of low rates of living kidney donation. It is a mobile health delivered platform that does not require transplant center visits, thus increasing the reach of the program compared to center-based program to enhance living kidney donation. The purpose of LOVED is to give education and encouragement to those who need a kidney transplant and teach about the process of living donation to be better educated when approaching others about donating a kidney. The ultimate goal of the program is to increase the number of living kidney donor transplants, especially among African Americans in South Carolina. The program was created to educate those in need of a kidney about the donor process, to dispel myths about living donation, discuss who can be asked to donate and develop and practice skills to start asking others for a living kidney donation. The program is designed to be completed using a tablet computer and is made up of weekly video education clips, resources, short quizzes to reinforce the learning points and weekly video chat sessions with others who need a kidney led by a "navigator" who was once a living donor kidney recipient. The video clips are made up of stories and brief educational messages from transplant center staff, physicians, former donors and recipients. The video chat sessions were designed to solve and address individual issues for those enrolled in the program and to give a sense of community as they continue on their journey to find a kidney. This randomized control trial uses groups of 6-9 participants in each LOVED group that lasts 8-weeks each. A total of 60 participants will be recruited with 30 assigned to LOVED and 30 assigned to a standard care groups. This program is funded by a grant from the National Institute of Health and was developed at the Medical University of South Carolina.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* African American
* Legally competent
* Able to read and speak in English
* Able to use tablet computers (after instruction)
* Able to use cell phone
* 5 years or less on the kidney waitlist with active status including pre-emptive and ESRD patients on dialysis
* 10 years or less on dialysis

Exclusion Criteria:

* Patients who have currently identified PDs moving through the evaluation stage
Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Eligibility Criteria:
Inclusion Criteria:

* A history of birch pollen allergy
* Positive skin prick test to birch
* Positive conjunctival test to birch
* Positive specific Immunoglobulin E (IgE) to birch

Exclusion Criteria:

* Forced expiratory volume in 1 second (FEV1)\<70% of predicted value
* History of seasonal allergy interfering with study
* History of symptomatic perennial allergy
* History of emergency visit or admission for asthma in the previous 12 month
A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Kidney Transplant Recipients

The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppression medication adherence among adult kidney transplant recipients. The investigators aim to test this by randomly assigning transplant recipients to the intervention (use of an mHealth app to manage and track their immunosuppression regimen) or control arm (standard of care) upon discharge from their initial transplant hospitalization, and tracking medication adherence over time. The study population will be approximately 50 adult kidney transplant recipients at the Johns Hopkins Hospital.

In adult kidney transplant recipients, the leading predictor of rejection, kidney loss, and death is immunosuppressive medication nonadherence. An estimated one-third of kidney transplant recipients reportedly experience medication nonadherence, and even minor deviations from the required protocol have been shown to have negative effects. However, due to the lack of systematic measurements of adherence, the direct relationship between the level of immunosuppressive medication adherence and poor outcomes is not well understood. Therefore, the investigators believe that mHealth technologies could be a feasible way to allow clinicians and researchers to better understand baseline adherence measurements, and increase immunosuppression adherence among kidney transplant recipients.

We will use a mobile health platform that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take their medication as prescribed and gives providers the assurance that their patients are supported and successful in treatment. DOT is the practice of watching a patient take every dose of medicine in-person, and has typically only been done in extreme cases because it can be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and without added burden; emocha's technology allows this through enabling patients to use their mobile application to view their regimen, record themselves taking every dose of their medication, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to conduct a randomized control trial to compare medication adherence between patients who use the mHealth system against controls who do not.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥22 years)
* Receive a kidney transplant at the Johns Hopkins Hospital

Exclusion Criteria:

* Non-English speaking participants