cyrilzakka/clinical-trials huggingface dataset:
Development of Standard References of Maximal Inspiratory Pressure and Maximal Expiratory Pressure in Healthy Adults

(1) Maximum respiratory pressure (MRP)1) Maximum inspiratory pressure (maximum intake pressure) and maximum expiratory pressure (MEP) Digital spirometer (Pony FX, COSMED Inc., Italy) are used to measure the micro-paste in a seated position. MIP is based on the pressure maintained for at least 1 second, inhaling or exhaling with maximum effort in the maximum exhalation state (=residual volume) and the maximum exhalation state (=total lung capacity). The maximum positive pressure value of the MEP and the minimum sound pressure value of the MIP are selected among the three or more attempts. 2) Using the MVV (maximum volitional ventilation) Digital spirometer (Pony FX, COSMED Inc., Italy) machine, repeat breathing deeply and quickly for 12 seconds while wearing a nose plug, and multiply it by 5 to obtain the L/min value. (2) Measure the values of the Pneumatic ventilation. · FVC (forced vital capacity): Total expiratory volume of one of the maximum effort gases · FEV1 (forced expiratory volume 1, effort expiratory volume): Ejected expiratory volume of the first second of the maximum effort expiratory volume (FEV1/FVC): FVC ratio, percentage of FVCs, and extraction of the FVC (excessive flow). PEF): Highest speed of effort opportunity


Eligibility Criteria:
Inclusion Criteria:

1. 19 to 65 years old.
2. a patient under general anesthesia
3. Patients in ASA class I to II
4. a patient with no history of thoracic anatomy or surgery
5. Patients with normal chest X-ray findings for preoperative evaluation.

Exclusion Criteria:

1. Patients with no natural history of thoracic abnormalities or surgery
2. Patients with asthma, pneumonia, tuberculosis, pneumothorax, chronic obstructive pulmonary disease and epileptic pulmonary disease
3. Patients who have difficulty communicating with the examiner.
A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)

This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject has at least 3 years of car driving experience
* Subject signs the trial Informed Consent Form
* Subject is in a healthy condition as judged by the investigator
* Subject has a regular sleep pattern

Exclusion Criteria:

* Subject has insomnia or any other sleep disorder
* Medication or drug use of any kind prior to the study
* Relevant history or presence of a significant medical illness
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)

The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.

Subjects with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before receiving 4 weeks of treatment using a pneumatic compression device. Subjects will be seen in clinic weekly for an evaluation, complete symptom and quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 18 years of age or legal age at the time of enrollment.
* Chronic venous insufficiency confirmed by ultrasound within previous 12 months.
* Active ulceration (CEAP classification of C6)
* Ulcer duration: ≥ 2 month but not greater than 24 months - non healing VLU with conservative treatment.
* Ulcer size ≥ 2cm2 ≤ 50cm2
* Leg circumferences within the following range:Ankle - 12 to 44cm;Calf - 22 to 60cm; Below knee - 22 to 68cm

Exclusion Criteria:

* Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
* Greater than 3 separate full thickness ulcers on the study limb
* Target ulcer is of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
* Treatment of the target ulcer with living cellular therapy within 30 days of the time of enrollment.
* History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 3 months.
* Either the dorsalis pedis (DP) or posterior tibial (PT) systolic pressure \< 80mmHg for diabetic patients or \< 60mmHg for non-diabetic patients on study limb or transcutaneous partial pressure oxygen (Tcp02) ≤ 30mmHg or great toe systolic pressure ≤ 40mmHg.
* Acute thrombophlebitis.
* History of pulmonary edema or decompensated congestive heart failure.
* Currently has an active infection of the skin such as cellulitis requiring antibiotics.
* History of cancer within the last 5 years with the exception of treated non-melanoma skin cancer or cervical carcinoma in situ.
* Poorly controlled diabetes with a Hemoglobin A1c (HbA1c) value of \>12%.
* Changes to medications that affect edema within the last 30 days
* Need for current and ongoing therapy with corticosteroids (exception for continued low dose usage) or cytotoxic drugs or the current use of Daflon 500.
* Currently pregnant or trying to become pregnant.
* Inability or unwillingness to participate in all aspects of study protocol.
* Currently participating in another clinical trial.
Nurse-led Educational Intervention on Patients With Glaucoma With Low Health Literacy

Introduction: Chronic diseases are a major cause of ill health, disability and death worldwide and are potentially preventable and treatable. Glaucoma is among the main causes of morbidity and blindness; its early detection can reduce the risk of poor patient outcomes. The existence of health illiteracy among these patients and the absence of self-management of these diseases are a barrier to their effective management worldwide.

Aim: The investigation of effect of a nurse-led patient education on both the incidence of negative outcomes and the activation levels of glaucoma patients with low health literacy status. Secondary objectives of the present study are the assessment of patient activation and health literacy prior to (baseline) and after (follow-up period)patient education at predefined times, as well as the association of patient socio-demographic and clinical parameters with the patient activation and health literacy levels.

Methodology: A quasi experimental study will be conducted with follow-up in a population of patients with diagnosed glaucoma, who will attend the outpatient ophthalmological clinic of the Heraklion University General Hospital. The research tools that will be used for the assessment of health literacy will be the Greek version of the European Health Literacy Survey Questionnaire 16 (HLS-EU-16) and for the assessment of the patients' activation level the Patient Activation Measure - 13 (PAM-13) questionnaire will be used, which will be translated . The data will be analyzed using the Statistical Package for Social Sciences (SPSS) (IBM Statistics) software program, version 24.0, and ethical and moral rules will be followed.

Expected results: The proposed study is expected to underline both the level of health literacy of glaucoma patients in Greece and the importance of self-management of chronic diseases carried by patients. Additionally, the present study is expected to highlight the significance of the nurse-led education process of patients with low health literacy status on reducing the poor patient outcomes incidence and the improvement of their activation levels, leading to the optimal self-management and self-care.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Informed written consent to participate in the study
* Adequate knowledge of the Greek language (writing and reading)
* Diagnosis of the condition for at least six months

Exclusion Criteria:

* Patients with incomplete health records
* Patients who provided incomplete information
* Patients who wished to stop participating were excluded
How Does Magnesium Status Influence Calcium Homeostasis?

The investigators aim to recruit 60 women who have agreed to participate in an existing randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency, HSC 2009-0055). In this trial, the investigators propose to evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis. The investigators will stratify 60 subjects in the sub-study, ensuring that approximately 20 subjects are randomized into each treatment arm (placebo, low-dose and high-dose vitamin D). The investigators already assess calcium homeostasis throughout the study by measuring bone mineral density, fractional calcium absorption, serum and urine calcium levels, among other tests. In the sub-study of 60 women, the investigators will evaluate whether habitually higher magnesium intake increases or decreases fractional calcium absorption. The investigators will evaluate the interplay between magnesium stores, vitamin D levels and serum parathyroid hormone levels. The investigators will directly assess magnesium stores using serum magnesium and 24-hour urine magnesium levels, and will measure magnesium absorption using the dual stable isotope approach.

Use of serum magnesium isotopes to measure fractional magnesium absorption Four day food diaries to assess magnesium intake Standard urine and serum chemistries for remaining labs as noted above

Eligibility Criteria:
Inclusion Criteria:

* participants eligible for the study "Treatment of vitamin D insufficiency" are eligible for participation in the current sub-study

Exclusion Criteria:

* identical to those covered in HSC #2009-0055
Effect of Low-Volume HIT vs. MIC Exercise in Individuals With Increased BMI

To compare the effect of low volume high intensity training and moderate intensity continuous exercise on Rate Pressure Product (RPP) and functional capacity. Limited literature available on effectiveness of Low-volume HIIT in comparison of other Aerobic interventions in obese individuals. In our community, people are sedentary and not involved in routine exercise because of increased weight, so Low volume HIIT would be safe and convenient for such individuals to perform. There is also limited studies available on female gender so both genders are included in this study.

Some recent studies suggest that the rising interest for the potential of high- intensity interval training (HIIT) to enhance the metabolic health in overweight adults. HIIT has also been found to induce comparatively fast enhancements in overall-body aerobic capacity and muscle mitochondrial markers in individuals with overweight.

The main advantage of HIIT is that low-volume HIIT protocols can involve a shorter time as compared with MICT, and time limitations have been recognized as a generally reported hurdle to daily exercise involvement.

Latest studies propose that's when compared to moderate intensity continuous training (MICT), HIIT has been shown to produce similar and sometimes better improvements in results such as cardiorespiratory fitness in spite of often demanding a smaller amount of time commitment and lesser energy expenditure. On the other hand, low volume HIIT is still undecided whether this form of physical training is superior, equivalent or inferior to more outdated forms of exercise training such as MICT for the management cardio metabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 23-29.9 kg/m 2 (Overweight-Type I Obese)
* Able to do exercise (PAR-Q)

Exclusion Criteria:

* History of chronic diseases and medication use
* Considerable mental or physical disability, neurological or musculoskeletal problems
* Severe personality disorders or drug addiction.
* Pregnant females
Effect of Tamoxifen or an Aromatase Inhibitor on Estrogen Metabolism in Women Treated for Newly Diagnosed Breast Cancer

RATIONALE: Studying samples of urine in the laboratory from women with breast cancer may help doctors learn whether tamoxifen and aromatase inhibitors alter the metabolism of estrogens.

PURPOSE: This clinical trial is studying the effect of tamoxifen or an aromatase inhibitor on estrogen metabolism in women undergoing treatment for newly diagnosed breast cancer.

OBJECTIVES:

* Learn the effects of selected chemotherapy agents on the profile of estrogen metabolites, glutathione conjugates, and depurinating DNA adducts in urine from women with breast cancer.
* Determine whether tamoxifen citrate or aromatase inhibitor alters the metabolism of estrogens.

OUTLINE: Patients are stratified according to planned therapy (tamoxifen citrate vs aromatase inhibitor).

Patients receive tamoxifen citrate or an aromatase inhibitor as planned. Urine samples (and nipple aspirate fluid, if possible) are collected before beginning treatment and after 2-6 months of treatment. Samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultraperformance liquid chromatography with tandem mass spectrometric detection.

Patients' information, including race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy, and disease type, is collected through medical record review.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ductal carcinoma in situ or invasive breast cancer
* Scheduled to receive tamoxifen citrate or an aromatase inhibitor
* Estrogen receptor or progesterone receptor positive
* ECOG performance status 0, 1, or 2

Exclusion Criteria:

* Not pregnant or nursing
* No prior antiestrogen drug such as tamoxifen citrate or raloxifene
* No concurrent estrogens
Sitagliptin (DPP-4 Inhibitor) and NPH Insulin in Patients With T2D

To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin , with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus biguanide: effects on beta cell function and on metabolic profile.

Glucose control is fundamental in the treatment of type 2 diabetes (DM2). Studies suggest that drugs that boost levels of glucagon-like peptide (GLP-1) improve glycemic control and have long-term beneficial effect on the function of pancreatic beta cells. Objective: To compare the short and long term effects of sitagliptin (which inhibits the DPP-IV enzyme, increasing the levels of GLP-1) with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus biguanide. Effects on beta cell function and on metabolic profile were analyzed. Methods: 40 patients with DM2, HbA1c between 6.6 to 10%, in use of metformin and glibenclamide will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group). Measurements of HbA1c, metabolic and hormonal profile at fasting and post-meal (every 30 minutes for 4 hours) will be evaluated before and after 6 months (short term) and 12 months (long term) of adding sitagliptin or NPH insulin.

Eligibility Criteria:
Inclusion Criteria

* outpatients with T2D inadequately controlled with metformin plus glyburide
* HbA1c levels between 6.6 and 10%
* body mass index \< 35 kg/m2

Exclusion Criteria

* heart failure
* respiratory failure
* uncontrolled hypertension
* impaired hepatic function
* impaired reanl function
* endocrine disorder
* gastrointestinal disorder
* malignancy
* alcohol abuse
* previous use of insulin
* previou use of based incretin therapy
* type 1 diabetes.
Absorption Kinetics of Polyphenols in Angel's Plant (Angelica Keiskei)

The absorption kinetics of polyphenols in angel's plant (Angelica keiskei), which is a dark green leafy vegetable rich in antioxidant nutrients, will be determined in older adults in this pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (\>60 yr, n=5)
* subjects with metabolic syndrome (\>60 yr, n=5)
* Subjects who has

  * high fasting plasma glucose (\>5.6 mmol/L),
  * central obesity (waist-hip ratio, \>0.9 for men, \>0.85 for women)
  * either high blood pressure (\>130/85 mmHg) or high triacylglycerol (\>1.7 mmol/L) will be selected to have metabolic syndrome.
* normal hematological parameters, normal serum albumin, normal liver function, and normal kidney function
* no history of smoking or alcoholism.

Exclusion Criteria:

* consume \>7 alcoholic drinks/wk
* taking cholesterol medication or hormone replacement
Blocking of the Gut Hormone Receptor for Glucagon-like Peptide 2 (GLP-2) by the GLP-2 Receptor Antagonist GLP-2(3-33)

This project will describe the role of physiological levels of GLP-2 in regulating the blood flow to the intestines and the effect of the antagonist GLP-2(3-33) in blocking these effects of GLP-2.

Ten healthy participants will meet fasting and attend four randomized experimental days of MRI-scans of the abdomen. Each day will include subcutaneous injections of GLP-2 or saline and intravenous infusion of either the GLP-2 (3-33) antagonist or saline. The infusion start at timepoint -20, while the subcutaneous injection is given to timepoint 0 and the participant will lay in the scanner in one hour after injection. Eight MR-scans are done repeatedly to measure the blood flow in larger abdominal vessels and four blood samples are taken during the experimental day for analysis of GLP-2(1-33), GLP-2(3-33) and bone markers.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* BMI 19-28 kg/m2

Exclusion Criteria:

* Chronic illness that affects the cardiovascular system or gastrointestinal tract
* Treatment with medicine or supplements that cannot be paused for 12 hours
* Intake of above 14 alcoholic drinks per week or substance abuse
* Liver enzymes (ALAT) above 2 times normal values
* Decreased kidney function (eGFR below 90 or creatinine levels over reference value)
* Low blood percentage (hemoglobin below reference value)
* Any condition or disease that the persons responsible for the study find would interfere with the participation of the study.
Safety Surveillance After Immunization With IXIARO

This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military, to detect adverse events that occur more frequently after IXIARO and to electronically follow up pregnancies during or shortly before which IXIARO was administered.

There will be no intervention and no individuals contacted.


Eligibility Criteria:
Inclusion Criteria:

* Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO (IXIARO exposed group) or at least one dose of JE-VAX (comparison group).

Exclusion Criteria:

* Individuals who have an ICD-9-CM code suggestive of one of the predefined adverse events screened for in IC51-401 prior to vaccination with IXIARO cannot with certainty be classified as being "disease free" at study entry and will be excluded for that adverse event.
Weekly and Every 3 Week Administration of Paclitaxel Liposome Injection in Metastatic Breast Cancer

This is a open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen.


Eligibility Criteria:
Inclusion Criteria:

* Female or Male \>18 years of age and \< 70years of age, If female of childbearing potential, pregnancy test is negative before first dose of study drug and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
* Stage IV disease
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Suitable for the treatment with paclitaxel as single agent regimen (first line or prior first line chemotherapy including adriamycin is allowed, If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen and if Her2+ patient, Herceptin therapy will be allowed.
* Patient has the following values at Baseline: Absolute neutrophil count ≥ 1.5 x 10\^9cells/L; platelets ≥ 100 x 10\^9 cells/L; hemoglobin ≥ 10 g/dL. Aspartate transaminase (AST or SGOT), alanine aminotransferase (ALT or SGPT) ≤ 2.5x upper limit of normal range (ULN); total bilirubin ≤ 1.5ULN; creatinine ≤ 1.5 mg/dL.
* Informed consent has been obtained.

Exclusion Criteria:

* Parenchymal brain metastases.
* History of other malignancy within the last 3 years
* New York Heart Association (NYHA) Grade 2 or greater congestive heart failure,history of myocardial infarction or unstable angina or new occured angina within 6 months prior to study enrollment.
* Concurrent other anticancer therapy.
* History of serious organic disorders (including active infection or Cardiovascular disease), serious hepatic disease, serious blood coagulation diseases, cachexia
* Sensory neuropathy of \> Grade 1 at baseline.
* Patients with prior hypersensitivity to paclitaxel
* Pregnant or nursing women
* enrolled in a different clinical study
* No psychiatric illness and other situations that would limit compliance of study
High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients

The aim of this prospective, randomized, double-blinded study is to investigate the additional benefits of high-intensity laser therapy (HILT) over conventional physiotherapy, related to pain and function, in patients with knee osteoarthritis (KOA).

The study was performed in Baskent University Physical Therapy and Rehabilitation Unit. 43 patients of both sexes, who were diagnosed clinical and radiographic knee osteoarthritis, with Kellgren Lawrence Grade 2 and 3, were randomly assigned in two groups. Group 1 (n = 21) received TENS, HP, exercises (EX), and High-Intensity Laser Therapy (HILT; Nd:yag laser, 10W). Group 2 (n = 22) received the same interventions but placebo HILT. All interventions were applied for 10 sessions. The Visual Analog Scale (VAS), Western Ontario \& McMaster Universities Osteoarthritis Questionnaire (WOMAC), and Lequesne Algofunctional Index (LAI) were performed before, after, and at 12-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* both sexes and age between 40 and 65;
* pain at least 3 months on single or both knees
* diagnosed as KOA with Kellgren Lawrence (KL) Grade 2 or 3 KOA on weight-bearing anteroposterior X-ray images
* normal serum acute phase reactants and uric acid levels
* had no major effusion in the joint.

Exclusion Criteria:

* therapeutic joint injection in the last 6 months
* physical therapy and/or HILT in the last 3 months
* any surgical invention for the knee joint
* malignancy in the last 5 years.