cyrilzakka/clinical-trials huggingface dataset:
To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet

The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg caffeine against 400 mg ibuprofen alone under fed conditions


Eligibility Criteria:
Inclusion criteria:

* Healthy males and females, 18 to 50 years (inclusive) at time of screening.
* Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).
* Body mass not less than 50 kg.
* Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the PI considers the deviation to be irrelevant for the purpose of the study.
* Non-smokers and mild or moderate smokers (\<= 10 cigarettes or pipes per day). Further inclusion criteria apply

Exclusion criteria:

* Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
* Current alcohol use \> 21 units of alcohol per week for males and \> 14 units of alcohol per week for females. One unit is equal to beer \[200 mL/10 ounces\], wine \[100 mL/4 ounces\], or distilled spirits \[25 mL/1 ounce\]) per day
* Regular exposure to substances of abuse (other than alcohol) within the past year.
* Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the PI. In this study the concomitant use of hormonal contraceptives is allowed.
* Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for anti-bodies or insulin), whichever is the longer) before administration of IMP in this study, at the discretion of the PI.
* Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
* History of hypersensitivity or allergy (angioedema or urticaria) to the IMP or its excipients or any related medication (Aspirin or any other NSAID).
* Diagnosis of hypotension made during the screening period.
* Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
* Resting pulse of \> 100 beats per minute or \< 40 beats per minute during the screening period, either supine or standing.
* Renal impairment.
* Positive urine screen for drugs of abuse. In case of a positive result the urine screen for drugs of abuse may be repeated once at the discretion of the PI.

Further exclusion criteria apply
ERG Protein Expression in Prostatic Adenocarcinoma and Its Clinicopathological Features

Evaluation the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.

Prostatic cancer is one of the most common malignancies in males and is the second leading cause of cancer-related deaths in males worldwide. The burden is expected to grow 1.7 million new cases and 499,000 new deaths by 2030. Although the diagnosis of prostatic carcinoma can usually be made on histological features, nowadays many immunohistochemical (IHC) markers are used to distinguish it from benign mimickers as well as in predicting prognosis and treatment. Out of these markers, Ets-related gene (ERG product) is a proto-oncogene which participates in chromosomal translocations and is frequently over expressed in prostatic carcinoma which harbors ERG-transmembrane protease, serine 2 fusion. ERG is a transcription factor belonging to the erythroblast transformation-specific (ETS) family. It is involved in many important cellular processes including differentiation, cell proliferation, angiogenesis, cell migration, hematopoiesis, and apoptosis. This proto-oncogene is expressed in the urogenital tract and hematopoietic cells. Gene fusions involving sequences of transmembrane protease serine 2 (promoter of TMPRSS2) and protein coding sequences of ERG result in over expression of ERG in prostatic tumors. This TMPRSS2-ERG fusion has been shown to occur in 50-70% cases of prostatic acinar adenocarcinoma in different studies. Genetic rearrangements were not identified in epithelial carcinomas until Tomlins et al. demonstrated ERG gene fusions in prostatic carcinoma.The presence of this fusion is now believed to be a critical event in the development of prostatic carcinoma.

TMPRSS2-ERG fusion results in constitutive expression of ERG oncoprotein resulting in enhanced proliferation and invasive potential of prostatic cancer cells. Moreover, TMPRSS2-ERG fusion gene product can be an important therapeutic target in prostatic cancer. Immunohistochemical (IHC) expression of ERG oncoprotein may serve as a surrogate biomarker of TMPRSS2-ERG fusion gene. Therefore in the present study we aimed to evaluate the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.

Eligibility Criteria:
Inclusion Criteria:

* All cases diagnosed as prostatic acinar adenocarcinoma

Exclusion Criteria:

* Other types of prostatic cancer.
Effects of Robotic Rehabilitation in Post-Stroke Patients

This study aims to evaluate the effect of robotic rehabilitation through training on a robot-assisted orthostatic board and neuromuscular electrical stimulation (NMES) on functionality in post-stroke patients. In this randomized controlled trial the patients will be allocated to a control group (which will receive conventional physiotherapy) or or to intervention group (which will receive conventional physiotherapy and robotic rehabilitation). Interventions will occur every day in the hospital phase and three times/week after discharge, totaling 18 sessions.The groups will be evaluated prior to any physiotherapy intervention, in the 10h session and at the end of six weeks of treatment (or 18 sessions).The following outcomes will be measured: functionality, peripheral muscle strength, muscle architecture and echogenicity, spasticity, cardiorespiratory repercussions, mobility, disability and dependence, quality of life and time of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of ischemic stroke, in the subacute phase (after 48 hours);
* To present hemiparesis or muscle weakness defined by the Medical Research Council (MRC) score;
* To understand simple commands and being able to report signs of discomfort.

Exclusion Criteria:

* Severe psychomotor agitation;
* Recent acute myocardial infarction (24 hours) and/or uncontrolled arrhythmias;
* Intracranial hypertension (PIC\> 20mmHg);
* Uncontrolled hypertension (PAS\> 230 mmHg and PAD\> 120 mmHg) or PAM \<60 mmHg;
* Decompensated heart failure;
* To present important hemodynamic changes during training;
* Peripheral vascular disease in the lower limb such as untreated deep vein thrombosis;
* Unconsolidated fractures or severe joint pain;
* Feverish state;
* Smokers;
* Epidermal lesions on the thighs that make it impossible to place self-adhesive electrodes for electrical stimulation;
* Pre-existing neuromuscular disease;
* Signs of rhabdomyolysis;
* Pregnancy.
Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias

The Apple Heart Study (AHS) is a research study conducted to evaluate whether the Apple Heart Study App can use data collected on the Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation. Up to 500,000 can participate in the study.


Eligibility Criteria:
Inclusion Criteria:

Possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:

* iPhone (5s or later) with iOS version 11.0 or later defined as iPhone model/iOS version used to complete screening eligibility.
* Apple Watch (Series 1 or later) with watchOS version 4.0 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility.
* Current resident of the United States at time of eligibility screening, defined by self-reported state of residence within the 50 states of the United States or District of Columbia.
* Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.
* Valid phone number associated with iPhone, ascertained from self-report.
* Valid email address, ascertained from self-report.

Exclusion Criteria:

* Self-reported diagnosis of Atrial Fibrillation.
* Self-reported diagnosis of Atrial Flutter.
* Currently on anti-coagulation therapy.
Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FG-3019, a therapeutic antibody designed to block the pro-fibrotic activity of connective tissue growth factor (CTGF). CTGF triggers the production of collagen and fibronectin, which cause scarring and thickening of the lungs. Participants will be assigned sequentially to one of the 3 dose group: Low, medium, and high FG-3019.


Eligibility Criteria:
Key Inclusion Criteria:

* have a diagnosis of idiopathic pulmonary fibrosis (IPF) by clinical features and surgical lung biopsy or according to the American Thoracic Society criteria

Key Exclusion Criteria:

* have a history of significant exposure to organic or inorganic dust or drugs known to cause pulmonary fibrosis
* have interstitial lung disease other than IPF
* have pulmonary fibrosis associated with connective tissue disease
* have other forms of idiopathic interstitial pneumonia, such as desquamative interstitial pneumonia, acute interstitial pneumonia, nonspecific interstitial pneumonia, or cryptogenic organizing pneumonia
* have end-stage IPF (total lung capacity of less than 45% of predicted value)
* are listed for lung transplantation at the time of study enrollment
* have significant heart problems
* are pregnant or lactating (if female)

Other inclusion and exclusion criteria may apply.
Correlation Between Plasma- and Endothelial DPP-4 Activity

The investigators want to estimate both the endothelial and the plasma activity of dipeptidyl peptidase 4 during different doses of sitagliptin in healthy subjects and patients with type 2 diabetes. Furthermore, the investigators want to investigate whether the current clinical dose of 100 mg of sitagliptin is sufficient to inhibit both the plasma and the endothelial activity of the enzyme dipeptidyl peptidase 4.

The two incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are secreted from the intestinal L- and K- cells, respectively in response to ingestion of nutrients. The two hormones are able to lower blood glucose levels during high glucose levels - by the so called incretin effect. GIP and GLP-1 are both rapidly inactivated by the enzyme dipeptidyl peptidase 4 (DPP-4). The remaining metabolites are without insulinotropic effects. The effect of DPP-4 inhibitors used in treatment of type 2 diabetes relies on their impact on DPP-4 activity.

DPP-4 exists in a soluble form in plasma ad as a membrane-bound form in blood vessels and other tissues. The impact of DPP-4 inhibitors on DPP-4 activity has only been evaluated in plasma. We aim to investigate plasma and endothelial DPP-4 activity (i.e. whole-body DPP-4 activity) in patients with type 2 diabetes during different doses of the DPP-4 inhibitor sitagliptin.

Both healthy control subjects and patients with type 2 diabetes are subjected to 4 experimental days (in a randomized order) with continuous infusion of GLP-1 and pre-treatment with 25 mg sitagliptin, 100 mg sitagliptin, 200 mg sitagliptin and placebo, respectively. Afterwards, we are going to measure the whole-body DPP-4 activity by comparing plasma levels of active (intact) GLP-1 and total GLP-1, and relate to plasma DPP-4 activity.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians with diet and/or metformin treated patients with type 2 diabetes (diagnosed according to the criterias of the World Health Organization)
* Normal Hemoglobin
* Prior Informed Consent

Exclusion Criteria:

* Nephropathy
* Liver disease
* Inflammatory bowel disease
* Pregnancy
Malignant Hyperthermia Registry and Genetic Testing

The purpose of this study is to to determine the penetrance of known and probable pathogenic variants in genes and the factors that contribute to penetrance in a population of children and adults in the United States exposed to Malignant Hyperthermia (MH) trigger agents.

The purpose of the study is to determine how genetic mutations and variants in combination with non-genetic factors influence risk for MH in children who had general anesthesia with triggering agents and develop reliable predictive MH risk algorithms. Rationale: Once the factors responsible for MH risk are determined, it will be possible to better predict risk and develop better individualization of anesthetics such as tailored selection of intravenous anesthetics, regional anesthesia and avoidance of all triggering agents. The long-term goal is to tailor and improve safety of anesthetic and clinical care and to reduce mortality, morbidity and cost of care due to MH with right anesthetics and muscle relaxants for endotracheal intubations for an individual child.

Eligibility Criteria:
Inclusion Criteria:

* Any English speaking person registered at NAHMR who has had a positive clinical manifestation of Malignant Hyperthermia
* Any person with a positive Caffeine Halothane Contracture probTest (CHCT) or a close relative of a person that had these.

Exclusion Criteria:

* Any person who has NOT had a positive clinical manifestation of Malignant Hyperthermia
* Any person with a positive Caffeine Halothane Contracture Test (CHCT) or NOT a close relative of a person that had these. Non-English speaking registrants will be excluded.
Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis

The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma.

The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

* clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to ARIA guidelines

Exclusion Criteria:

* diagnosis of bronchial asthma
* allergy to perennial allergens
* specific immunotherapy
* other chronic diseases
* tobacco smoking
* acute respiratory tract infection
* excluded drugs: inhaled and systemic glucocorticosteroids
Prospective, Observational Registry of Renaissance-guided Spine Surgeries

To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.

The key objective of this observational registry is to prospectively collect data to facilitate the quantification of potential short- and long-term benefits of Renaissance-guided spine surgery. It establishes a common framework for collaboration between surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or open surgical approaches.

The main endpoints that will be collected are surgical endpoints (e.g. complication rates), patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal alignment, mainly in reconstructive surgeries for spinal deformities) and technical parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing spinal surgery in a posterior approach where the surgeon used Renaissance surgical guidance system.

Patient capable of complying with study requirements. Signed informed consent by patient.

Exclusion Criteria:

Any significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study.

Patient cannot follow study protocol, for any reason. Patient cannot or will not sign informed consent.
Imaging With a New Agent That Finds a Cancer Protein Called HER2

The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or greater
* Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate.
* At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
* ECOG performance of 0-2

Exclusion Criteria:

* Life expectancy \< 3 months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy

This study evaluates 7 Tesla (T) magnetic resonance imaging (MRI) in observing changes in the brain (neuroimaging) in testicular cancer patients who have decreased testosterone (hypogonadism) and are on testosterone (androgen) replacement therapy. Symptoms of hypogonadism can include fatigue, weakness, loss of libido, depression, poor concentration and erectile dysfunction. Some patients experience mental changes after diagnosis and treatment. There is some evidence that hypogonadism produces structural changes in the brain. The 7T MRI uses radio waves and a very powerful magnet linked to a computer to create detailed pictures of areas inside the body. This study may help researchers learn if 7T MRI can produce better images to assess the changes in the brain structure of testicular patients with hypogonadism and on androgen replacement therapy (ART).

PRIMARY OBJECTIVE:

I. To assess longitudinal structural changes in brain architecture using MRI in hypogonadal men with testis cancer being treated with androgen replacement therapy.

OUTLINE: This is an observational study.

Patients undergo 7T MRI over 1-2 hours at baseline and at 12 months after baseline. Patients also undergo a proctored cognitive assessment over approximately 1 hour prior to each MRI. Additionally, patients undergo blood sample collection at screening and at 12 months after baseline MRI.

Eligibility Criteria:
Inclusion Criteria:

* Males age \>= 18 years
* Diagnosed with germ cell tumor of the testis (seminoma or non-seminoma) and treated with radical orchiectomy
* Diagnosed with hypogonadism and started androgen replacement therapy 6 months prior (+/- 2 weeks)
* Ability to understand and the willingness to sign a written informed consent
* Ability to undergo imaging procedure without any form of sedation

Exclusion Criteria:

* History of any neuropsychiatric disease
* History of narcotic use or psychiatric medications
* History of ART prior to current ART regimen
* Standard contraindications for MRI:

  * Prior work as a machinist or metal worker, or history of metal being removed from the eyes
  * Cardiac pacemaker or internal pacing wires
  * Non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or
  * Claustrophobia, or uncontrollable motion disorder
* Current active second malignancy
Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers

The present study was adopted to evaluate the pharmacokinetics and dose linearity of fexofenadine after oral administration.

The present study was adopted to evaluate the pharmacokinetics and dose linearity of fexofenadine after administration of single oral doses of 60 to 360 mg in an open-label, five-way crossover study.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and not more than 45 healthy male volunteers
* Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
* Who had passed all the screening parameters
* Free of any drug exposure known to interfere with the pharmacokinetics or assay of fexofenadine for at least 10 days prior to the study
* Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria:

* A clinically significant abnormal physical exam, medical history, or laboratory studies
* If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening
* A history of serious intolerance, allergy, or sensitivity to fexofenadine
* The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days
* A history of blood dyscrasias
* A history of alcohol or drug abuse within the past year
* Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
* Unable to tolerate vein puncture and multiple blood samplings
* Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
* Cannot follow instructions, in the opinion of the investigator.
Muscle Strengthening Exercises and Global Stretching in Elderly

Introduction: The life expectancy and the number of people hitting the old age have increased in recent years. The aging process is accompanied by morphological and functional changes that contribute to reduced functional capacity, increase the number of falls and the appearance of physical limitations. Exercise promotes maintenance of functional autonomy, improving the physical ability of the elderly making it more independent.

Objective: To evaluate the effect of a program of muscle strengthening exercises associated with global stretching on balance, fear of falling and functional capacity in elderly women.

Methods: This was a non-randomized controlled trial, in which 12 volunteers aged over 60 years were divided into two groups: intervention group (IG, n = 7) submitted to muscle strengthening exercises and stretching, 2 times per week for 12 weeks, and the control group (CG, n = 5), not submitted to the protocol but were educated about physical exercises. Before and after the protocol were evaluated scores of Berg Balance Scale, the Falls Efficacy Scale International (FES-I) and Evaluation of Functional Autonomy Development Group for Latin American Maturity (GDLAM). Data were statistically analyzed within and between groups with a significance level of p \<0.05.


Eligibility Criteria:
Inclusion Criteria:

* women aged over 60 years,
* independent in locomotion,
* with ability to understand verbal commands to perform the tests and participation in the treatment program

Exclusion Criteria:

* execution of other physical activities or doing other types of physical therapy,
* had any prior neurological deficit (stroke, traumatic brain injury, Parkinson's disease) or
* musculoskeletal diseases which compromising performance and mobility,
* use of orthosis for locomotion,
* inability to perform the evaluation tests and/or participation in the intervention session