cyrilzakka/clinical-trials huggingface dataset:
The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction

Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance compared to healthy controls.

Insulin is a hormone produced by the body that lets sugar into the cells, where it is used for energy. Insulin resistance occurs when the body's cells have a decreased ability to react to insulin. This leads to an increase in insulin secretion. Over time, insulin resistance can lead to higher levels of sugar in the blood (diabetes), and can also contribute to obesity, high blood pressure, high cholesterol levels and heart disease. There are no simple tests to actually diagnose insulin resistance. Currently, the glucose tolerance test is used to diagnose IR, but it involves several blood draws over a 2-hour period. Another purpose of this study is to compare a blood test involving only one blood draw to the 2-hour glucose tolerance test, which involves several blood draws over a 2-hour period.

It is well known that diabetes often leads to erectile dysfunction. Because insulin resistance occurs before diabetes, it is possible that erectile dysfunction may occur in some individuals while they have insulin resistance, but before they develop diabetes. If this is true, it might be possible to use erectile dysfunction as a sign of insulin resistance, which may lead to more timely treatment of insulin resistance and may delay or prevent the development of diabetes, and the other problems mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age, male,

Exclusion Criteria:

* diabetes, peyronies
Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy

Given that the Emergency Department (ED) has become the entry way for large populations of patients into the health care system, a strategy of sampling MRSA isolates in ED populations and merging this information with patient-level data may present a window to hypothesize and investigate CA-MRSA transmission within the community and its impact on hospital-acquired infections.

Prospective cross-sectional study involving 500 patients enrolled over a one year period at the UFHealth Shands Hospital's Adult and Pediatric Emergency Department. The collected information will serve as pilot data for a future large comprehensive multi-site study.

Patients will have a wound culture and a nasal swab obtained as part of the study, which will be assessed for MRSA isolates using next-generation whole genome sequencing. The principal investigator or PI designee will also survey participants and review hospital records.

Eligibility Criteria:
Inclusion Criteria:

* Patient or Legally Authorized Representative (LAR) must have voluntarily signed an Institutional Review Board-approved informed consent form before initiation of any study procedures
* Patient presents with an acute abscess or a non-post-operative skin/soft tissue infection
* Patient presents through the UFHealth Shands Emergency Department

Exclusion Criteria:

* Patients who are employed by UFHealth and provide direct patient care
* Patients who have previously been enrolled in the study
* Patients who are not suitable for the study in the opinion of the investigator
Maladaptive Adipose Tissue Activity in Cancer

The purpose of this pilot research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer.

The purpose of this research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer. Many patients affected by cancer lose weight, despite normal or increased nutrition. It may progress to the condition called "cancer-associated cachexia." Cancer associated cachexia is defined by an ongoing loss of skeletal muscle mass with or without the loss of fat mass, and may negatively affect quality of life and the ability to undergo cancer treatments. Metabolism is the breakdown of food by the body into the energy that your body needs.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 40 years of age
* Have active cancer diagnosis.
* Have had a PET/CT scan within the past 12 months at time of enrollment.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Current use of beta-blockers
* Women who are pregnant or unsure of their pregnancy status
* Women who are breastfeeding
* Suffers from severe claustrophobia
* Diagnosed with a serious psychiatric condition which could impede the judgement of the investigators, and/or the successful conduct of the recording.
* In remission stage for cancer diagnosis
Repeatability and Concordance of VA Measured With ETDRS Numeric , Landolt C, and Letter Charts in Thai Individuals

This is a cross-sectional study to determine the repeatability and concordance of visual acuity level measured with the original ETDRS letter, ETDRS Landolt C, and ETDRS numeric chart in Thai individuals.

The ETDRS visual acuity chart has been used as a standard visual acuity measurement chart in ophthalmic clinical trials due to its proven high repeatability comparing to other visual acuity chart. However, the original ETDRS alphabet chart could not be used in every individual around the world, especially those who are non-english speakers. Landolt C chart has been a recommended chart to test visual acuity in those living in a country where English is not a common language, however, some difficulties including right-left confusion occurred when testing with the Landolt C chart, leading to the unreliable results of visual acuity measurement using the Landolt C chart. Recently, the ETDRS numeric chart was introduced by some medical equipment companies but there is limited information regarding the repeatability and concordance of the new ETDRS numeric chart comparing to the original ETDRS alphabet and Landolt C chart.

Therefore, this study aims to determine the repeatability and concordance of visual acuity level measured with the original ETDRS alphabet, the ETDRS Landolt C, and the ETDRS numeric chart. Results from this study would be able to suggest an appropriate ETDRS chart to be used in clinical studies in Thailand or other countries where English is not the native language.

Eligibility Criteria:
Inclusion Criteria:

* Thai nationality
* More than 18 years of age
* Educational level: at least high school
* Able to read English alphabet
Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

1. Evaluating the differences in the efficacy and safety of meropenem optimal dosing regimen predicted by the PPK/PD model combined with MAPB method for patients with malignant hematological myelopathy accompanied by fever, as compared with the current conventional treatment regimen;
2. The visualization software of meropenem individualized medication was developed with the help of JAVA development language, J2EE framework and SQL Server database.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, regardless of gender;
2. Patients with malignant hematological diseases with neutropenia and fever are judged as high-risk patients according to the Guidelines for Clinical Application of Antibiotics in Patients with Neutropenia and Fever in China (2020 Edition);
3. There is infection, and the results of drug sensitivity test show that pathogenic bacteria are sensitive to meropenem or meropenem is used according to experience;
4. The blood concentration of meropenem has reached a steady state;
5. Each patient's blood sample points ≥2, and cases with only one blood sample point can also be included in the database;
6. Sign the informed consent form.

Exclusion Criteria:

1. Patients with non-malignant hematological diseases;
2. Non-granular deficiency with fever;
3. Those who did not reach steady state when receiving meropenem;
4. There is a history of meropenem drug allergy;
5. The patient lacks treatment compliance based on the patient's history and the judgment of the researcher;
6. The patient has hemophagocytic syndrome;
7. Patients undergoing renal replacement therapy;
8. Patients with incomplete clinical evaluation data (such as lack of information on renal function and biochemical indicators, and inability to obtain blood samples);
9. The sample contains components that interfere with the determination of drug concentration (such as valproic acid and chloramphenicol);
10. Pregnant and lactating women;
11. Cases considered by the researcher as unsuitable for inclusion.
Challenges of Hip Fracture Care in Developing Countries. Experience at a Level 3 Center in Panama

An observational study using the information records at the Hospital Regional Rafael Hernandez, in Chiriqui, Panama, that will help to analyze the epidemiology and early treatments results of hip fracture patients treated in this institution.

Hip fractures are a major public health concern due to increasing ageing of the population, rising costs and associated morbidity and mortality. The problem is more serious in developing countries, because of limited economic and technical resources available. The aim of the following study is to analyze the epidemiology and early treatment results of hip fracture patients treated in our unit.

This study will be done at the Hospital Rafael Hernandez Regional Hospital, a third level facility located in the province of Chiriqui, Republic of Panama. It is a retrospective observational study.

For this the study will use the hospital records, including imaging studies were reviewed, including the Singh Index, and all relevant data will be analyzed with SPSS 21 software.

Eligibility Criteria:
Inclusion Criteria:

* All hip fractures

Exclusion Criteria:

* All other fractures and no recorded survey
Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)

The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to:

* A slower rate of decline in forced expiratory volume in one second (FEV1);
* A reduction in the frequency and severity of exacerbations;
* Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);
* Lower mortality;
* An improved quality of life as compared to a group of placebo treated patients.

Study Population: Patients with moderate to severe chronic obstructive lung disease.

Trial Phase: IV

Study Design: Prospective, randomised, double-blind, placebo- controlled clinical trial.

Study Medicine: Azithromycin.

Drug Administration: Oral.

Drug Dose: 500 mg once daily for 3 days every month.

Duration of Treatment: 3 years

Number of Evaluable Patients: 200 per treatment arm

Number of Included Patients: 400 per treatment arm, 800 patients in total.

Eligibility Criteria:
Inclusion Criteria:

* Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.
* Current or ex-smoker
* Postbronchodilator FEV1 \< 60% in stable condition (\> 4 weeks after hospitalisation)
* \< 300 ml bronchodilator reversibility in FEV1

Exclusion Criteria:

* Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).
* Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.
* Patients with pulmonary malignancy
* Patients with other pulmonary diseases than COLD.
* Patients with immunodeficiency. However, COLD patients treated with steroids can be included.
* Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.
* Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).
* Patients with known allergy or intolerance to azithromycin
* Pregnant or breastfeeding women
* Manifest heart, liver or renal insufficiency
* Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.
AMPLATZER Duct Occluder II Additional Sizes

The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.

To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States.

Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a PDA
* PDA ≤ 4mm in diameter
* PDA ≥ 3mm in length
* Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study

NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent

Exclusion Criteria:

* Weight \< 700 grams at time of the procedure
* Age \< 3 days at time of procedure
* Coarctation of the aorta
* Left pulmonary artery stenosis
* Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
* Intracardiac thrombus
* Active infection requiring treatment at the time of implant
* Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
* Other disease process likely to limit survival to less than six (6) months
* Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
Observation of ImageReady™ MR Conditional Pacing System in China

To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects

Key Inclusion Criteria:

1. Subject must have the Image Ready System as their initial (de novo) pacing system implant.
2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines.
3. Subject is able and willing to undergo an MR scan.•
4. Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at the intervals defined by this protocol.
5. Subject is age 18 or above.

Key Exclusion Criteria

1. Subject has or has had any pacing or ICD system implants.
2. Subject has any implants or devices that are not suitable for MR scan.
3. Subject is enrolled in any other concurrent study that might interfere with this study.
4. Subject has documented life expectancy of less than 12 months.
5. Women of childbearing potential who are or might be pregnant at the time of this study.

Primary Safety Endpoint:

MR Scan related Complication Free Rate Analyzed at MRI Visit +1 Month.

Primary efficacy Endpoint:

1. Pacing Threshold (at 0.5 ms pulse width) comparison pre and 1 Month post MR Scan: pacing threshold increase ≤ 0.5 V after scan.
2. Sensed Amplitude comparison pre- and 1 Month post-MR Scan: sensed amplitude: ≥ 1.0 mV after scan, and ≥ 50% of that before scan.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have the ImageReady System as their initial (de novo) pacing system implant
* Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines5
* Subject is able and willing to undergo an MR scan
* Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at the intervals defined by this protocol
* Subject is age 18 or above

Exclusion Criteria:

* Subject has or has had any pacing or ICD system implants
* Subject has any implants or devices that are not suitable for MR scan
* Subject is enrolled in any other concurrent study that might interfere with this study
* Subject has documented life expectancy of less than 12 months
* Women of childbearing potential who are or might be pregnant at the time of this study
Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).

Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.

Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire.

Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).

Eligibility Criteria:
Inclusion Criteria:

* A previous diagnosis of Barrett's Esophagus
* Patients must be over the age of 18
* Patient must be able to give informed consent

Exclusion Criteria:

* Subjects with any history of intestinal strictures
* OR subjects with a history of prior GI surgery
* OR subjects with a history of intestinal Crohn's disease.
Repeated Exposure to Umami Taste on Taste Perception, Hedonics, and Satiety

The purpose of this study is to determine how repeated dietary exposure to umami taste affects umami taste perception, hedonics, food preferences, and satiety. Healthy adult subjects will consume a low glutamate vegetable broth daily for one month, where the experimental group's broth is supplemented with the umami-rich stimuli of monosodium glutamate (MSG) and the control group's low glutamate broth is matched for sodium (NaCl).

The investigators hypothesize that repeated dietary exposure to umami taste will:

1. diminish umami suprathreshold intensity perception and hinder the ability to discriminate varying MSG concentrations
2. decrease liking of umami-rich foods and shift preferences upwards towards more intense umami stimuli
3. decrease satiation and decrease the satiating effect of a test meal


Eligibility Criteria:
Inclusion Criteria:

* Have normal sense of taste and smell (self-report)
* Likes soups or broths (self-report)
* Able to report to study site daily (self-report)

Exclusion Criteria:

* Restrained eater (score \> 12 on restrained eating subscale from Three Factor Eating Questionnaire)
* BMI \< 18 or \> 25 kg/m2 (self-report)
* Vegan (self-report)
* Hypertensive or on low-sodium diet (self-report)
* Allergic or sensitive to MSG (self-report)
A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs

The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 20mg and Metformin XR 1000mg with coadministration of the two separate drugs in healthy male volunteers.

1. Randomized, Open-label, Single-dosing, Two-treatment, Two-sequence, Two-period, crossover design
2. Wash-out period : 14days from the first dosing
3. Drug concentration analytical device : UPLC-MS/MS

Eligibility Criteria:
Inclusion Criteria:

* A healthy male adult at the age of 20 to 45 (both inclusive) at the time of screening test.
* Body weight equal to or greater than 55 kg and calculated ideal body weight (IBW) within ±20%
* An individual who has been given and fully understood detailed explanations about this study, decides to participate in the study of his own will, and provides written informed consent to comply with instructions.

Exclusion Criteria:

* History or presence of any clinically significant diseases in the hepatobiliary, renal, nervous(central or peripheral), respiratory, hemato-oncology, cardiovascular, urinary, musculoskeletal, immune, ear, nose and throat (ENT), mental, and, particularly, endocrine systems (e.g., diabetes mellitus, hyperlipidemia, etc.).
* History of any gastrointestinal disease that may affect absorption of the study drug (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgeries (except for simple appendectomy or hernia repair).
* Hypersensitivity to MP-513 or drugs containing metformin or other drugs in the same class as ingredients or to other drugs
* Vital signs in a sitting position corresponding to at least one of the following criteria: systolic blood pressure ≥ 140 mmHg or \< 90 mmHg, or diastolic blood pressure ≥ 95 mmHg or \< 60mmHg.
* Serum creatine \> upper limit of reference range
* Required to refrain from food intake for at least 24 hours during the study period due to surgery or religious reason.
* History or presence of drug abuse.
* Administration of drugs that either induce or inhibit drug metabolizing enzymes, such as barbitals, within 1 month prior to the first dosing.
* Intake of food or beverage containing grapefruit or cranberry within 1 week prior to the first dosing.
* Administration of any ethical drugs or traditional Korean herbal medicines within 2 weeks or any over-the-counter drugs or vitamin products within 1 week prior to the first dosing
* An individual who participated in another clinical trial and was administered any investigational product within 2 months prior to the first dosing.
* Whole blood donation within 2 months, apheresis donation within 1 month, or blood transfusion within 1 month prior to the first dosing.
* An individual who drinks excessive amounts of alcohol (more than 21 units/week, 1 unit =10 g of pure alcohol) or who cannot stop drinking alcohol from 24 hours prior to hospital admission through to hospital discharge.
* Having smoked 10 cigarettes/day or more on average over the past 3 months.