cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Health in Children With Down Syndrome

The goal of the study is to learn more about tests that can assess lung health in children with Down syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 to 18 years, inclusive, at time of consent
* Diagnosis of Down syndrome/trisomy 21 or mosaicism
* Able to walk
* Had a swallow study (video fluoroscopic swallow study or fiberoptic endoscopic evaluation of swallowing) performed within 5 years of consent date

Exclusion Criteria:

* Pregnant or lactating
* Nonambulatory
* Have a tracheostomy or other known severe glottic or subglottic obstruction that would significantly affect the results of testing
* Have a significant acute respiratory illness, defined as treatment with steroids, antibiotics, or an increase in supplemental oxygen
* have a medical illness that would a)increase the risk the participate would incur by participating in the study, b) interfere with the outcomes of the study, or c) interfere with the performance of study participants
* Have a severe behavioral problem that would interfere with the performance of study procedures
EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC]

The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose vascular grafts have been treated with DuraGraft. All participating sites will be from countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.

Objectives:

(i) To evaluate the Safety and Performance of DuraGraft®

(ii) To characterize the use of DuraGraft and the outcomes of patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iii) To further characterize the incidence of MACCE outcomes associated with CABG in patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iv) To compare the use of DuraGraft among hospitals and practices

(v) To obtain patient reported quality of life information

(vi) To obtain important health economics outcomes

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts
* Patient is ≥18 years of age
* Patient (or a legally authorized representative) is willing and able to provide consent
* DuraGraft is being used for the CABG procedure

Exclusion Criteria:

* Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment
A School Program for Children Exposed to Violence

This study will develop a program to help school children deal with violence-related trauma.

The number of children who have been indirectly or directly exposed to violence has dramatically increased in the last decade. The emotional and behavioral consequences of violence exposure can be particularly devastating to children. Interventions are needed that can reduce symptoms related to traumas already experienced and enhance children's skills for handling extreme stress that might be experienced in the future. The Cognitive-Behavioral Intervention for Trauma in Schools (CBITS) program was developed between 1998 and 2001 to help children in the Los Angeles school district deal with traumatic events. Although promising, the program required a school-based mental health clinician for implementation. This study will evaluate the effectiveness of a program adapted for the Los Angeles CBITS program that can be used by school staff in a middle school setting. The adapted CBITS program will be compared to a wait list to determine which is more effective in reducing trauma-related stress and depression among sixth grade students.

Students who have experienced violence-related trauma will be randomly assigned to receive either 10 weekly sessions of group cognitive behavioral therapy or to wait 3 months. Self-report scales and interviews will be used to assess the emotional states of participants at study entry and study completion. No follow-up visits will be required.

Eligibility Criteria:
Inclusion Criteria:

* Students in 6th and 7th grade in two participating Los Angeles area schools
* Exposure to severe violence, as either a victim or witness, within 1 year prior to study entry
* Have symptoms of post-traumatic stress disorder at study entry
* Able to speak and understand English
* Parent or guardian willing to give informed consent

Exclusion Criteria:

* Post-traumatic stress disorder symptoms that are not related to a traumatic event
* Mental retardation
* Conduct disorder that would interfere with the participant's ability to engage in group therapy
Suture Contamination Rate in Adjustable Suture Strabismus Surgery

1. To establish the culture positivity rate in adjustable suture strabismus surgery
2. To identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material
3. To compare suture contamination rates with techniques to reduce the suture contamination rate

Patients will be randomized into 1 of 2 groups: those who received 1 drop of 5% povidone-iodine instilled directly over the sliding noose at surgery completion (group 1) and those who did not receive povidone-iodine at the end of the surgery (group 2).

Institutional standard surgical preparation will be performed in all patients with 5% povidone-iodine solution on the periocular skin and eyelid margins, followed by instillation of 1 drop of 5% povidone-iodine into the conjunctival cul-de-sac.

All operations will be performed using a sliding noose technique with a polyglactin 6-0 suture (Vicryl, Ethicon Inc). If a patient undergoes surgery on more than 1 muscle in the same eye, a 1-cm section of suture proximal to the knot will be collected from the nonadjustable suture as a control. The control suture will be placed in a tube with 2 mL of trypticase soy broth and agitated for 1 minute. At the end of surgery, patients in group 1 will receive a drop of povidone-iodine. A strip of neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic ointment will be then applied into the lower conjunctival fornix to patients in both groups.

Eligibility Criteria:
Inclusion Criteria:

* All strabismus patients age ≥ 18 years scheduled for strabismus surgery with adjustable sutures at the Bascom Palmer Eye Institute will be invited to participate.

Exclusion Criteria:

* Patient who has a history of allergy to povidone-iodine.
* Disorders affecting immune function.
* Patient who is unwilling to participate in the study
Iron Homoeostasis in Inflammation

The purpose of this study is to survey iron storage levels and their prognostic consequences in the context of acute inflammation. The impact of iron substitution in inflammatory states is controversial. We hypothesize that iron substitution may influence outcome in patients in inflammatory states.

* Background: Iron deficiency is frequently encountered in the elderly, after bleeding and in the context of neoplasia. Our 2013 pilot study showed that iron deficiency is a common problem in medical inpatients (13.7%) and that about 55% of these also showed signs of inflammation. The relevance of iron storage levels on clinical outcome in the presence of inflammation is conflicting. On the one hand, lack of iron prevents many viruses and bacteria, as well as other microorganisms, to reproduce and on the other hand the abundance of available iron stimulates hematopoiesis and reduces symptoms of iron deficiency.
* Methodology: We plan to enroll 1000-1500 patients with laboratory signs of inflammation during a period of six months and to analyze iron specific laboratory parameters twice during hospital stay. Additional laboratory analyses are planned for a smaller sample to portray the processes in iron homeostasis during inflammation.
* Significance: Contradicting evidence of forty and more years of scientific research backs current therapeutic practices in patients with inflammatory disease and iron deficiency. This study records prevalence of different iron storage states, mortality, morbidity and therapies in inflammatory states combined with iron deficiency and could very well be able to recommend a therapeutic regimen as well as limits for typically used laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18
* Hospitalized patient in internal medicine (≥ 24h)
* Evidence of an inflammatory state, determined as a C reactive protein (CRP) value \>5 mg/l
* Written informed consent

Exclusion Criteria:

* History of terminal renal insufficiency in terms of dialysis or use of erythropoiesis-stimulating agents
* Pregnancy
* History of allogeneic stem cell transplantation
Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
* Estimated glomerular filtration rate (eGFR) \> 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
* Acute diarrhea, or constipation within 3 weeks prior to randomization
* Any major surgery within 4 weeks of randomization

Other protocol defined inclusion/exclusion criteria could apply
Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors

In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of the noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to blood measurements from a laboratory analyzer.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
6. The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
7. The subject has any other serious systemic illness.
8. The subject is a current smoker.
9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject has a history of migraine headaches.
16. Th subject is currently taking antidepressants.
17. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
18. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Resistance Exercise Reduces the Expression of Inflammation and Fibrosis Associated Genes in Autoimmune Myositis Patients

The aim of this study was to investigate the effects of physical exercise on gene expression in muscle biopsies from patients with chronic polymyositis or dermatomyositis

Eight patients with polymyositis or dermatomyositis according to the Bohan and Peter criteria and who had all participated in a resistive exercise trial at Karolinska University Hospital, Stockholm, Sweden, were included in this study. Patients were included if they had a disease duration more than 12 months and they had to have a stable, low disease activity and medication for three months before enrollment in the study. Patients with inclusion body myositis were excluded as well as patients with co morbidities that contradicted vigorous exercise (severe osteoporosis with multiple fractures, malignant disease severe lung disease) or if they were physically active more than once a week. The median disease duration at time of study start was 4.5 years (range 2,7-29 year). All patients had been treated with glucocorticoids and other immunosuppressive therapies with some improvement of muscle function but with persisting muscle impairment. At time of study seven patients were still on immunosuppressive treatment, five were taking prednisone with a median dosage of 2.5 mg/day (range 0-6.25 mg/d). Six patients were treated with azathioprine, one in combination with cyclosporine A, one patient was treated with methotrexate and one with IVIG 2g/kg body weight every three months

Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they had a disease duration more than 12 months and they had to have a stable, low disease activity and medication for three months before enrollment in the study

Exclusion Criteria:

* Patients with inclusion body myositis were excluded as well as patients with co morbidities that contradicted vigorous exercise (severe osteoporosis with multiple fractures, malignant disease severe lung disease) or if they were physically active more than once a week.
Health Outcomes in Rheumatoid Arthritis

This research is being done to help us learn about how different factors related to treatment affect rheumatoid arthritis (RA). This is not a treatment study. We will follow the patient for one year as he or she receives usual treatment from his or her rheumatologist. Up to 360 adults with RA may join this study.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 19 or older
* Current active, adult-onset rheumatoid arthritis who meet American College of Rheumatology (ACR) criteria for RA and have: (ACR functional class I-III), defined as:
* 3 or more swollen or tender joints and
* Morning stiffness of 45min or longer
* OR judged by their rheumatologist to have active disease
* No evidence of other inflammatory diseases (e.g., Crohn's, IBS)
* Functional class I, II or III

Exclusion Criteria:

* Individuals with significant cardiovascular disease (CHF, stroke, MI)
* Unwilling to have medications monitored and/or comply with protocol
* Not fluent in English
* Planning to move from area within next year or change health insurance (which would preclude ongoing care by a Johns Hopkins rheumatologist)
* Enrolled in study evaluating efficacy of new or existing RA medications
Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation

The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Willing to provide voluntary consent and able to comprehend and sign the informed consent form;
* Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000;
* Clear intraocular media in study eye;
* Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye;
* No ocular or systemic condition which may affect visual acuity in study eye;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol;
* Previous refractive surgery in study eye;
* Previous IOL exchange in study eye;
* Other protocol-specified exclusion criteria may apply.
Antioxidant Supplementation in Patients With Kashin-Beck Disease

The purpose of this study is to determine whether antioxidant supplementation can have a positive health effect on patients suffering from Kashin-Beck disease.

Current research regarding Kashin-Beck disease, (KBD) have identified dramatic deficiencies of both selenium and iodine in patients with this disease. Initial supplementation of these trace minerals provided no measurable benefit to the affected population. Research conducted by Innovative Humanitarian Solutions, suggests that such deficiencies may not be causal, but markers of an underlying condition of extreme oxidative stress brought on by the improper functioning of the Glutathione Peroxidase enzyme in synthesizing H202 during periods of critical cellular development, primarily in mesenchymal cell development.

The purpose of this trial is to determine the efficacy of antioxidant supplementation in aiding the Glutathione Peroxidase enzyme in its proper function and thereby reducing oxidative stress and enabling the uptake of selenium and iodine which are necessary for proper bone growth and development.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed patients with Kashin-Beck disease

Exclusion Criteria:

* less than 24 hours from admission to ICU
* Patients who are moribund
* Lack of commitment to program
* Absolute contraindication to enteral nutrients
* Severe acquired brain injury
* Pregnant or lactating patients
* Previous randomization in this study
* Enrollment in a related interventional study
* Child's class C liver disease Metastatic cancer with life expectancy \< 6 months Seizure disorder requiring anticonvulsant medication
Study of the Carbon Dioxide Treatment for Fat Reduction

The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.


Eligibility Criteria:
Inclusion criteria:

* Male or female subject ages ≥ 18 years old
* Body mass index (BMI) between 18.5-24.99. (BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).

Subject in good health

* Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
* Subject agrees to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion criteria:

* Pregnant or lactating or intends to become pregnant in the next 9 months.
* Unable to understand the protocol or to give informed consent
* Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area
* Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months.
* History of asthma or chronic obstructive pulmonary diseases
* Active skin disease or skin infection in the treatment area
* Bleeding tendency or coagulopathy
* Subject who are allergic to lidocaine
* Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject
Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan

The broad, long-term objectives are to generate and test hypotheses leading to theories that guide improved care of patients with gestational diabetes. The purpose of this chart review study is to evaluate the Vanderbilt Gestational Diabetes Self-Management Education Program and Quality Improvement Plan in optimizing metabolic control and improving health outcomes during pregnancy with gestational diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Women with gestational diabetes who are referred to and followed in the Vanderbilt Eskind Diabetes Clinic and are participants in the gestational diabetes educational program.

Exclusion Criteria:

* Refusal of consent.
Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise

The purpose of this study is to investigate whether intradialytic exercise increases removal of waste products from blood, in comparison to the traditional prescription of increasing dialysis duration.

For patients with severe chronic kidney disease, regular dialysis to remove toxins and waste products from the blood is essential to maintain life. The adequacy of dialysis is quantified by the removal of these toxic solutes and is an important parameter in the assessment of the therapy.

Previous efforts to enhance urea clearance have centered around factors such as increasing dialysis dose by increasing dialysis time or carrying out more frequent dialysis sessions. However this concept is confronted with the barriers of patient compliance and cost implications. Many patients are resilient to increasing their dialysis time, presenting a major challenge for enhancing the efficacy of dialysis therapy. Therefore, alternative methods of improving dialysis adequacy, with interventions aimed at enhancing solute clearance, are highly warranted.

One such intervention could be exercising during haemodialysis (HD). 85% of the body is comprised of lean tissue, of which 73% is water. As many toxic solutes are water based, large amounts will be stored in the muscle. When sitting at rest during HD the blood flow to the muscles is four times less compared to the major organs. Additionally, the HD process causes blood vessels to constrict, further restricting blood flow to the muscle. Consequently there is insufficient blood flow to remove the toxins stored in the muscle. By exercising during dialysis, blood flow to the muscle is increased to sustain the demand for oxygen and energy, thereby allowing toxic solutes to be removed and cleared through the dialysis machine.

Therefore the aim of this study is to implement an efficient exercise intervention during dialysis and determine its effects on dialysis adequacy in comparison to the traditional prescription of increased dialysis time. In particular, the study aims to explore the acute effects of exercise during dialysis on the removal of several established uremic toxins.

Eligibility Criteria:
Inclusion Criteria:

* Stage 5 Chronic Kidney Disease
* Receiving maintenance haemodialysis for \> 3 months

Exclusion Criteria:

* Unable to give consent
* Present with contraindications to take part in exercise
* Haemoglobin \<11 g/dL
* Access recirculation
* Chronic persistent hypotension with pre dialysis systolic blood pressures \<100mgHg.
* Episodic treatment induced hypotension with frequent drops in intradialytic systolic blood pressure \>30mmgHg
* Unstable medical condition
* Currently taking medication affecting urea or creatinine generation