cyrilzakka/clinical-trials huggingface dataset:
Ozone Therapy in Ankylosing Spondylitis

The aim of this study was to investigate the effects of rectal ozone therapy added to medical treatment on pain severity, disease activity, spinal mobility, functional status, enthesitis, and quality of life (QoL) in patients with ankylosing spondylitis (AS).

Patients and methods: Patients who fulfilled the modified New York criteria for AS were included in this randomized controlled study. Thirty patients selected according to inclusion and exclusion criteria were randomized into two groups. Rectal ozone treatment along with medical treatment was administered to the patients in group 1, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks. The patients in group 2 continued only their current medical treatment. All patients received a comprehensive rheumatologic assessment including pain severity, disease-specific instruments for disease activity, functional status, spinal mobility, enthesitis score, and QoL.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as AS according to the Modified New York criteria

Exclusion Criteria:

* having other concomitant rheumatic diseases,
* receiving anti-TNF-α therapy within the last 3 months,
* being in clinical remission with standard medical treatment,
* being pregnant,
* having diseases such as favism, asthma, pancreatitis, and uncontrolled hyperthyroidism for which ozone therapy is contraindicated.
Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy

Abstract Background: A number of patients referring to the emergency departments (EDs) due to airway obstruction or decreased level of consciousness require the establishment of a definite airway using intubation. On the other hand, performing Nasogastric tube (NGT) insertion is very challenging in anesthetized and intubated patients. And, a conclusive method has not yet been presented in this regard. Hence, the current study aimed at comparing Digital Intubation (two-finger) and Video Laryngoscopy methods during NGT insertion.

Materials and Methods: The present clinical trial was performed on 76 intubated patients that were randomly divided into two groups. Groups A and B underwent Video Laryngoscopy and Digital Intubation (two-finger) methods, respectively. Then, the success rate, the number of attempts to insert NGT, duration of insertion, hemodynamic parameters, and patients' satisfaction level were recorded and examined in this study.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 year old patients that underwent rapid sequence intubation (RSI) and required NGT insertion

Exclusion Criteria:

* having skull base fracture symptoms
* coagulopathy and hemorrhagic disorders
* maxillofacial traumas leading to the deformity and disturbance in NGT insertion
* diseases and anomalies of the upper respiratory tract
* deviated nasal septum
* nostril stenosis
* esophageal disorders (esophageal stricture, esophageal varices)
* a history of head and neck radiotherapy, and
* patients intubated in and transferred from other centers
* patients with more than two unsuccessful attempts at NGT insertion were excluded from the study.
Vascular Effects of Attention Deficit Hyperactivity Disorder (ADHD) Medications in Youth

4.4 million children and adolescents in the United States have been diagnosed with attention deficit hyperactivity disorder (ADHD) and more than half are treated with medication. Most ADHD medications are stimulants, which activate the sympathetic nervous system (SNS). SNS activation is closely associated with vascular functional and mechanical abnormalities. Therefore, ADHD medications, via instigating SNS activation and altering the hemodynamic profile, may have untoward effects on the vasculature and increase risk of developing cardiovascular disease in children and adolescents who use them.

Our overall objective in this study is to determine whether ADHD medication use is associated SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents. We will address this objective by conducting a case-control study and obtain non-invasive measures of SNS activation, endothelial function, and arterial stiffness in children and adolescents (8-17 years old) with (using stimulant medication) and without ADHD.

SPECIFIC AIMS AND HYPOTHESES

Our overall objective in this study is to determine whether ADHD medication use is associated SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents.

Our hypothesis is:

Children and adolescents taking ADHD medications will have higher SNS activation, lower digital reactive hyperemia, and higher pulse wave velocity and aortic augmentation index compared to sibling controls without ADHD.

Study Design We will obtain non-invasive measures of SNS activation (heart rate variability), endothelial function (digital reactive hyperemia and brachial artery flow-mediated dilation), and arterial stiffness (carotid-radial pulse wave velocity; aortic augmentation index) in youth taking ADHD stimulant medication and in their healthy siblings without ADHD.

Study visits will be conducted at the Clinical and Translational Science Institute (CTSI) at the University of Minnesota. All vascular testing will occur in the Vascular Biology Laboratory within the CTSI.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-18 years old
* Current use of ADHD stimulant drug therapy limited to methylphenidates or amphetamines
* Sibling without ADHD between the ages of 6-18 years old

Exclusion Criteria:

• Known (diagnosed) cardiac disease
A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)

The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.


Eligibility Criteria:
Inclusion Criteria:

* Has histologically or cytologically-confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies
* Male participants refrain from donating sperm plus are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 95 days after carboplatin/paclitaxel
* Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or 30 days after paclitaxel or 6 months after carboplatin whichever occurs last, and agree not to donate or freeze eggs during this period
* Has adequate organ function

Exclusion Criteria:

* Has disease that is suitable for local therapy administered with curative intent
* Has a life expectancy of less than 3 months and/or has rapidly progressive disease
* Has a diagnosed and/or treated additional malignancy within 5 years prior to allocation with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer
* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has a history of or current non-infectious pneumonitis/interstitial lung disease that requires steroids
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B or Hepatitis C virus infection
* Has had an allogenic tissue/solid organ transplant
Evaluation of a New Imagingtechnologie for Thrombosis

Arterial and venous thrombi play an important role in various vascular diseases such as myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism. These thromboembolic disorders are the leading causes of morbidity and mortality worldwide. A non-invasive method for the quantitative and effective detection of thrombi in the whole body has not yet been established. In spite of the available techniques, 30% to 40% of ischemic strokes "cryptogenic" (undetermined cause, the source of thromboembolism is never identified). Possible causes of cryptogenic stroke atherosclerosis include in the aortic arch or intracranial arteries. A plaque in the arch or other large vessels could be an important source of cryptogenic strokes, however, are those difficult to detect by routine methods. The approach of thrombus targeted molecular imaging could identify potentially troublesome plaques early on before they become a dangerous rupture. The hypothesis is that the radiotracer 18F-arterial GP1 and venous thrombi using positron emission tomography (PET) can be made visible. The primary goal is the potential applicability of the substance as a PET tracer for diagnosing thrombi.

This is a first in man study with which we are testing the feasibility of the use of this radiopharmaceutical product to visualize a thrombus.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AAA (diameter \>3.5cm in duplex sonography) or acute DVT.
* Male and female patients 18 years and older,
* Signed Informed Consent after being informed

Exclusion Criteria:

* contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* women who are pregnant or breast feeding,
* women with the intention to become pregnant during the course of the study,
* other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease),
* renal clearance \< 30 mL/min
* known or suspected non-compliance, drug or alcohol abuse,
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,
* participation in another study with an investigational drug during the present study and 7 days thereafter.
* enrolment of the investigator, his family members, employees and other dependent persons
* last systemic treatment with GP IIb/IIIa antagonists should not have been applied within 48 h before performing study exam
Intraoperative Ultrasonographic Localization of Pulmonary Nodules in VATS

This study is conducted to explore the feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in video-assisted thoracoscopic surgery (VATS).

The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai Chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in VATS will be explored. The accuracy rate of localization will be evaluated using gray scale mode and elastography mode. Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are older than 18 year-old.
2. Chest CT shows pulmonary nodule suspected to be malignant that need to undergo VATS.
3. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

1. Patient with severe asthma and pulmonary fibrosis.
2. Refusal of participation.
3. Severe cardiopulmonary dysfunction and other indications that can't receive VATS.
FAST-FORWARD vs HAI5

Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions.

Previously, radiotherapy treatments for breast cancer usually consisted of 20-25 sessions to treat the entire breast, followed by an additional dose ("boost") to the tumor bed of 4-8 sessions. Today, 15-16 treatment sessions have become standard for whole breast irradiation, followed by a boost if indicated. The durability of further shortening the treatment to 5 sessions was proven in the FAST and FAST-FORWARD studies. After 10 and 5 years, the outcome was comparable with 25 and 15 radiation sessions, both in terms of toxicity and locoregional control.

There are currently 2 radiotherapy schedules in 5 sessions in use in Belgium (the FAST-FORWARD schedule and the HAI5 schedule), both of which have their advantages and disadvantages. In this project we want to investigate which schedule gives the fewest side effects and the best quality of life using questionnaires at different times (before, during and after radiation).

Patients participating in the study will be randomized 1:1 between the FAST-FORWARD schedule and the HAI5 schedule. The first group is treated according to the FAST-FORWARD schedule, consisting of 5 radiation sessions on 5 consecutive working days (e.g. Monday to Friday). In the schedule 2 rest days are allowed, so that the treatment lasts a maximum of 7 days. The second group is treated according to the HAI5 schedule, developed by the radiotherapy department of Ghent University Hospital. In this schedule, at least 1 day of rest is scheduled between each treatment session, so the treatment is administered over 10-14 days.

Eligibility Criteria:
Inclusion Criteria:

* histopathological diagnosis of breast cancer
* age 18 years or older
* male or female
* treated with breast conserving surgery or mastectomy with curative intent
* multidisciplinary decision of adjuvant radiotherapy after surgery

Exclusion Criteria:

* distant metastases
* decision of preoperative radiotherapy
* decision of partial breast irradiation
* positive resection margins ('ink on tumour')
* indication for boost on lymph node(s)
* history of thoracic or ipsilateral axillary radiotherapy (including radiotherapy of the contralateral breast or chest wall)
* need for bilateral irradiation
* breast reconstruction or expander
* patients unlikely to comply with the protocol (e.g. inability or unwillingness to complete the questionnaires at different time points).
Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation

T-PA release is impaired in obese subjects. In order to have a better mechanistic understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.


Eligibility Criteria:
Inclusion criteria:

1. Adults 18 years and greater
2. Healthy

Exclusion criteria:

1. PVC \< 30
2. Hypertensive subjects on ACE inhibitors
3. Pregnant or nursing mothers
4. Diabetic with HbA1C \> 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
5. Cholesterol \> 30 mg/dL above NCEP accepted level based on cardiac risk.
6. Triglycerides \> 200
7. Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure)
8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
9. History of cerebrovascular disease
10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
12. Angiotensin converting enzyme inhibitor use
13. Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control)
14. Other chronic medical illnesses at the discretion of the investigators
Web Based Renal Transplant Patient Medication Education

Information technology will be brought directly to renal transplant recipients to help them learn about the large number of medications they are required to take on a life long basis, in order to prevent errors and improve safety.

Transplant recipients are particularly vulnerable to medication errors because of the large number of chronic drugs needed to prevent rejection and treat comorbidities. Compliance failures directly compromise patient safety through acute immunologic events and premature graft loss. For society, the loss of invested fiscal and organic (organs) resources is catastrophic. As the unique constant in the chain of people who provide, modify and consume prescription medications, health information technology should be focused on empowering the patient to prevent medication errors. Our principal clinical hypothesis is that HIT can be proven to improve patient safety by minimizing medication errors. Specific aims address the creation of new knowledge and evidence ( in a renal transplant population) of benefits of widely applicable HIT tools. Web enabled education of two groups, new (\<6 months) and established (\> 6 months), kidney transplant recipients is proposed.

Eligibility Criteria:
Inclusion Criteria:age \> 18 or capable of managing own medications

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Exclusion Criteria:Education level below 10th grade

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IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients with Breast Cancer with Nodal Metastases

The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.


Eligibility Criteria:
Inclusion Criteria:

* Women age ≥ 45
* Clinical T1-2N0 ER+ invasive breast cancer
* US detected biopsy proven axillary nodal disease
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Palpable nodes on physical exam
* Her2+ or ER- invasive breast cancer
* Extranodal extension \> 3 mm on nodal biopsy
* More than 2 suspicious nodes on preoperative imaging
Letigen® and Cardiovascular Morbidity

Letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic and appetite-inhibiting properties. The drug was used as adjuvant treatment of obesity from 1990 and up to 2002 when it was withdrawn from the market by the manufacturer. The basis for this was a number of spontaneous reports about patients that died during treatment with Letigen®.

The causal relation has never been addressed. There are only sparse data from randomised studies and the above-mentioned reports are not conclusive.

We propose a controlled study based on data from Statistics Denmark that hold a complete copy of the Prescription Register of the Danish Medicines Agency and the Danish Hospital Discharge Register. The aim of the study would be to determine whether there is an excess frequency of deaths and serious cardiovascular events that can not be explained by particular characteristics of users of the drug. A well-known problem in such observational studies is a fundamental incomparability between users and non-users of drugs. In the present setting, it should be expected that use of Letigen® is associated with high BMI, smoking, alcohol abuse, type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy lifestyle. Thus, an uncritical comparison between users and non-users of Letigen® regarding serious cardiovascular events will probably show an excess frequency that can not necessarily be attributed to the drug. This problem can be addressed by a special epidemiological technique - the case-crossover design - which is particularly robust to such comparability problems. In brief, only cases should be included. Controls are the same persons at an earlier time, , where the case-defining disease has not yet developed. The exposure of cases will be compared with the exposure of the same persons' case history.

To account for the effect of chronic exposure, we also perform, as a secondary analysis, a conventional case-control study nested within the cohort of Letigen users, and employing a risk-set sampling technique.


Eligibility Criteria:
Inclusion Criteria:

* Use of letigen TM within the period Jan 1995 - Dec 2001
* The occurrence of a case-defining event

Exclusion Criteria:

* A cancer diagnosis other than non-melanoma skin cancer
* Age outside the range 18-70
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal Arteries

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the calf and foot arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Has known or suspected disease of the calf and/or pedal arteries
* Is scheduled for X-ray angiography

Exclusion Criteria:

* Has any contraindication to magnetic resonance imaging
* Is scheduled for any procedure before the X-ray angiography
* Had previously had stents placed bilaterally in the calf and/or foot arteries