cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)

People receiving a head and neck cancer treatment often do not find an adequate therapeutic response for the side effects derived from this treatment. The objective of this study is to assess the effectiveness of a physical recovery program based on manual therapy over these problems.

Previous studies have shown the effectiveness of this type of programs on patients who have had cancer in other locations with clinically relevant results. There is a shortage of proposals for this subgroup of patients that require special attention. This project intends to carry out an experimental randomized controlled study with 84 patients treated of head and neck cancer who will be assigned randomly to the study groups: a) manual therapy program or, b) control group. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 months of patient follow-up.

Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 months after finishing the treatment.

Eligibility Criteria:
Inclusion Criteria:

* To have ended their treatment in the previous 6-24 months
* To have no metastasis or active cancer
* To have cervical and/or temporomandibular joint pain \>3 in a Visual Analogue Scale

Exclusion Criteria:

* Mental or physical illness preventing subjects from participating in the study
* Previous chronic pain conditions
* Previous cervical or temporomandibular joint pain
* Previous dysphagia disorders
Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis

The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.

Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (NCT00255164) and T-EE04-087 (this study, NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

* Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study
* Use of antacids (except for study supplied) throughout the study.
* Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
* Need for continuous anticoagulant therapy.
Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth

Salivary Bmp-2 Levels \& Radiographic Measurement Of Bone Density were evaluated At Extracted Tooth Socket in patients With \& Without topical Application Of Simvastatin

Objective: The objective of this study was to compare:

'The salivary BMP-2 levels in the experimental and the control groups with and without topical simvastatin application on wound of extracted tooth socket.

The bone density at extracted tooth socket by measuring mean gray value from Intra oral periapical (IOPA) radiographs in the experimental and the control groups.

Method: Twenty four patients either male or female without any systemic disease, aged between 18 years to 25 years were selected. The patients were equally divided by random computer generated numbers into experimental and control groups. In the experimental group, tooth extraction was followed by placement of simvastatin (containing 10 mg of drug). In the control group, only tooth extraction was done. Saliva sample was collected from patients on days 0, 3, 7 and 40 and levels of salivary biomarker BMP-2 were measured with the ELISA technique. IOPA radiographs were taken on days 0 and 40 to determine the bone density by measuring mean gray values with the help of ImageJ software. The data was entered in SPSS version 25 and analyzed. P-value of ≤ 0.05 was considered as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients with permanent dentition, age (18 years to 25 years) were considered.
* Patients undergoing extraction of maxillary or mandibular Pre molars for orthodontic procedure.
* Teeth which required only simple non surgical extraction only under local anesthesia.

Exclusion Criteria:

* Subjects taking antibiotics or non-steroidal anti inflammatory drugs (NSAIDS) within one week.
* Patients with oral mucosal lesions (leukoplakia, erythroplakia, lichen planus).
* Patients with oral carcinoma.
* Patients with xerostomia.
* Previous history of radiotherapy or chemotherapy
* Patient with known hypersensitivity to anti inflammatory drugs.
* Diabetic patients.
* Pregnant and lactating patients.
* Patients with social habits such as cigarette smoking and alcohol consumption.
* Teeth radiographically involved in any abscess/cyst/granuloma.
* Teeth requiring open surgical transalveolar extraction.
Assessment of Bronchial Asthma Among Patients Attending Sohag University Hospital

Asthma is a significant public health threat, affecting more than 300 million individuals globally. Asthma is classified as a non-communicable disease and leads to reduced quality of life, poor physical functioning and reduced emotional well-being. The impact of this disease can be widespread and extends beyond the person living with the disease, affecting the lives of their family members, carers, communities and the health care system (1).

Asthma is a variable chronic respiratory condition. It is characterized by symptoms of wheeze, cough, chest tightness, dyspnea and backed by variable airflow limitation, airway inflammation and airway hyper-responsiveness (AHR). The severity of asthma varies considerably, both between individuals and within individuals over time. Some people may have intermittent asthma and others may experience severe, potentially life-threatening disease (2, 3,4).


Eligibility Criteria:
Inclusion Criteria:

* bronchial asthma patients aged more than 18 years, both sexes are included

Exclusion Criteria:

* children ,patients who are unable to do spiromerty or contrindecated
18F-AV-1451 High Resolution Autopsy Study

The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.


Eligibility Criteria:
Inclusion Criteria:

* Projected life expectancy ≤ 6 months

Exclusion Criteria:

* Primary brain tumor, known metastases to the brain, central nervous system lymphoma
* Major, focal structural brain lesion
* Aggressively being treated with life sustaining measures
* Clinically significant infectious disease
* History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
* Have received or participated in a trial with investigational medications in the past 30 days
* Females of childbearing potential who are pregnant or not using adequate contraception
Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

To prospectively evaluate the long term metabolic and psychological effects of flexible intensive insulin therapy (FIT) courses in an unselected population of type 1 diabetic patients at the University of Basel Hospital. We hypothesize that both metabolic control and psychological parameters will improve.


Eligibility Criteria:
Inclusion Criteria:

* All patients participating in 5 consecutive FIT courses that began between April 2002 to April 2004

Exclusion Criteria:

* None
A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402

The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.

This study is designed as randomized, open-label, active-controlled and crossover assignment for evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects. The safety assessed through adverse events up to 17 days after administration. Additional variables (ECGs, laboratory test, vital signs, so on) will also be recorded and assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* No history of clinically significant medical disorder
* Capable of consent to participate in the study

Exclusion Criteria:

* History of hypersensitive reactions to study drug or other related drugs
* Any significant abnormality found during screening
* Any significant medical history
* History of alcohol abuse, smoking continuously
* History of drug abuse
* Clinically significant surgery within 4 weeks prior to administration of the study drug
* Participation in another clinical trial within 3 months prior to administration of the study drug
The Role of Gut Microbiota in Hypertension

Hypertension is the single most prevalent risk factor for heart diseases, heart failure, kidney failure and stroke. About 1 in 3 adults in the United States have hypertension. Approximately 28-30% of hypertensive patients suffer from resistant hypertension (RH). Inflammation has been implicated in the pathogenesis of the hypertension. Additional data suggests the involvement of gut microbiota in host normal cardiovascular functions and pathophysiology. Accumulating evidence demonstrates that antibiotic treatment benefits patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular events. Even though these studies did not address effects of antibiotic treatment on the gut microbiota, it is possible that gut microbiota could affect neurologic inflammation. Finally, intestinal microbiota has recently been proposed to modulate blood pressure (BP) through production of short-chain fatty acids. In order to investigate this, the investigators hypothesize that gut microbiota is involved in the neuroinflammation-mediated initiation and establishment of RH, and targeting gut microbiota by minocycline would produce beneficial outcomes in RH.

This is a prospective cohort design. This study will enroll 388 subjects: 81 patients without HTN as a reference group, 81 patients with controlled HTN, 55 patients with uncontrolled HTN, 55 with remodeled RH, and 81 patients with RH to characterize gut microbiota composition. Subjects will provide stool samples for analysis. Subjects will also provide a blood sample for inflammatory marker and stem cell analysis.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 and \<80
* is competent and willing to provide consent

Inclusion criteria for each subject group:

* Control subjects will have a systolic BP \<140mmHg with no cardiovascular disease
* Patients with controlled hypertension
* Patients with uncontrolled hypertension
* Resistant hypertension subjects will have systolic blood pressure (BP) ≥140 mmHg despite ≥3 anti-hypertensive medications of different classes one of which should be a diuretic
* Patients who are no longer RH subjects and have normal blood pressure
* Subjects participating in NCT 02133872 will be eligible to participate

Exclusion Criteria:

* currently pregnant or have been pregnant in the last 6 months;
* antibiotic treatment within 2 months of study enrollment;
* currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications);
* unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection);
* history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
Predicting Volume Response Study

The purpose of this study is to understand and document measurements in heart stroke volume (the volume or amount of blood pumped per heart beat) and cardiac output (the volume or amount of blood pumped by your heart per minute) during a passive leg raise maneuver (elevation of the legs), and to determine if these measurements can predict changes in the same as a result of fluid or blood product administration.

The administration of intravenous fluid and blood products for treatment of hypovolemia is common in the ICU setting. Static resuscitation endpoints such as heart rate, blood pressure, and CVP are frequently used to guide this therapy, despite compelling evidence they are unreliable in predicting patient response to therapeutic volume administration or as an endpoint for ongoing therapy. Dynamic parameters such as continuous stroke volume and cardiac output (index) monitoring, along with pulse pressure and stroke volume variance measures are more reliable in predicting and measuring response to fluid challenge and therapeutic volume administration. The purpose of this study is to observe changes in stroke volume (SV) and cardiac output (CO) during a passive leg raise maneuver (PLR) as a surrogate to volume challenge, and to determine if these changes can predict changes in the same parameters with fluid or blood product administration in surgical patients. The PLR maneuver involves positioning the patient to the supine position and elevating the legs to 45 degrees. The PLR moves blood from the capacitance vessels of the legs to the heart, potentially improving stroke volume (SV) and cardiac output (CO), without the administration of intravenous fluids. PLR may predict whether SV or CO would improve with administration of fluids, and guide decisions on whether fluid administration would be beneficial. Stroke volume and cardiac output (index) will be calculated by a commercial pulse power arterial pressure cardiac output system (LIDCORapid), using the patients' measured heart rate and blood pressure imported from the bedside monitor. By using the combination of a reversible volume challenge (PLR) and a minimally invasive monitoring system, it is hoped that a more reliable method will emerge to both predict a response and guide therapeutic volume administration, while reducing the risk associated with fluid volume overload.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older admitted to the Surgical Intensive Care Unit, anticipated to receive IV fluid boluses or blood products, with the presence of an arterial pressure line.

Exclusion Criteria:

* patients under 18 years of age,
* pregnancy,
* prisoners,
* inability to lay in the supine position,
* conditions of the lower extremities,
* pelvis or spine that preclude elevation of the legs
The Ohio State University Asthma Registry

The purpose of this study is to collect information in order to identify people who have asthma and who may be good candidates to participate in one of the future asthma studies to be conducted at The Ohio State University Asthma Clinical Research Center.

Patients from The Ohio State University Division of Pulmonary and Critical Care Medicine will be sent a letter explaining the registry and asking about their interest in participating in this registry. The registry and all procedures related to their inclusion will be explained, opportunity to ask questions will be given and a consent document signed prior to any registry activity. Information about the registry will be shared with the community by newspaper ads, Internet postings, word of mouth, flyers, and other pulmonologists in central Ohio. Those potential registrants may choose to make an appointment to complete lung function tests at the Asthma Clinical Research Center.

The registry and all procedures related to their inclusion will be explained, opportunity to ask questions will be given and a consent document signed prior to any registry activity.

Each participant will be asked to provide appropriate (general medical history, asthma history, current medications, past asthma medications, demographic information, weight height, smoking history, allergies, and prior surgeries. Participants will be asked to complete an Asthma Control Questionnaire, which will be scored to determine how well their asthma is controlled. All consented registrants will be given the opportunity to visit The Ohio State University Asthma Clinical Research Center where an extensive lung function test (spirometry) will be provided. At the Asthma Clinical Research Center each registrant will perform at least three lung function efforts, then given two puffs of albuterol (a fast acting medication that opens airways). After a standard waiting period that meets the standards of the American Thoracic Society, a second set of lung function test will be done. The results of the second set of tests will reflect any reversibility in lung function levels, and will serve as an indicator that treatment may improve lung function. All participants will be given copies of all lung function tests, and the results of the test will be explained to them. All study procedures are provided without cost to the registrant.

Eligibility Criteria:
Inclusion Criteria:

* asthma
* must be able to provide medical history

Exclusion Criteria:

* unable to give consent
Effects Of Atorvastatin On Macrophage Activity And Plaque Inflammation Using Magnetic Resonance Imaging

A new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits known as plaques has been developed. Heart attacks and strokes occur when plaques become inflamed, depending on the artery affected. Currently used clinical tests can only tell us how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is. This new method of scanning using magnetic resonance imaging (MRI) and a special agent called Sinerim can identify inflamed plaques. This study will evaluate patients with plaques in their arteries in their neck at risk of strokes to see whether treatment with a cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within the artery wall within the first three months of treatment. If this effect can be measured using MRI scanning with the use of Sinerim then the results of this study will provide additional clinical validation of the use of MRI scanning combined with agents such as Sinerem®.


Eligibility Criteria:
Inclusion criteria:

* Positive Sinerem®-enhanced MRI of carotid plaque confirmed by a consultant neuroradiologist
* Must either be statin naive or have been on a stable dose of a statin(Permitted statins and total daily dose are as follows: atorvastatin =10mg, simvastatin =40mg, pravastatin =40mg, fluvastatin =80mg, rosuvastatin =10mg for =4 weeks prior to screening, with no evidence of statin intolerability.)

Exclusion criteria:

* Require continued use of non-statin lipid modifying therapies or therapy with any other lipid regulating medications
* History of statin intolerance
* History of chronic viral hepatitis or other liver dysfunction
* Renal impairment with serum creatinine \>2.5 mg/dl (\>221 mol/L)
* History of myopathy or inflammatory muscle disease, or 3 times more than the upper limit of normal levels of total creatinine kinase in serum
* Doppler assessment of less than 40% stenosis during screening assessment
* Allergy to dextran and iron salts
* Contraindication to MRI scanning
* Planned carotid surgery or endovascular intervention earlier than 10 weeks within the study period
Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!)

Patients who have undergone curative treatment may be at risk of relapse. This study will collect, annotate, and sequence biospecimens (blood, stool, and tissue) from patients across different tumor types to detect molecular residual disease (MRD) before metastases become radiographically or clinically detectable. This will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types.

The development of anticancer drugs typically starts with patients with advanced cancers who have exhausted standard treatments. Yet even the most active new drugs produce only modest benefits in patients with advanced cancers because of the emergence of resistance, similar to the resistance that bacteria develop when they are repeatedly exposed to antibiotics. In order to achieve larger magnitude gains in survival and make greater impact in the field of cancer, promising drugs must be tested in patients with curable malignancies who have undergone definitive treatment but are at high risk of relapse. Interception is the active intervention of cancers at an early stage, offering an opportunity to eliminate molecular residual disease (MRD) before clinical relapse. MRD describes the situation in which cancer-derived biomarkers are detectable, typically using highly sensitive and specific molecular assays in blood or other body substances that are below the threshold of detection by conventional tests such as CT scans or radiological imaging. Using innovative technologies to monitor patients at high risk of relapse, and applying them to serial samples of their circulating tumor DNA, other body fluids, stool and radiological images, the goal is to develop AI-based models to identify those who are at the highest risk of relapse. This will allow interception studies to be conducted to target microscopic tumor cells in these patients to increase cancer cure rates.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histological confirmation of a solid tumor.
2. Patients must have early stage or locally advanced disease that is planned for or have undergone curative treatment.
3. Patient must be ≥ 18 years old.
4. All patients must have signed and dated an informed consent form.

Exclusion Criteria:

None