cyrilzakka/clinical-trials huggingface dataset:
Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain

Prolonged, high intensity work in a hot environment results in significant strain on the body, known as heat strain. Heat strain in hot occupational settings such as agriculture, fire suppression, and military work can lead to \~20% of workers exceeding the glomerular filtration rate indicated thresholds for acute kidney injury (AKI). However, it is unclear whether these individuals truly experienced AKI or if these were normal, healthy physiologic responses. To better determine if AKI occurs in the staggering number of workers previously reported, AKI biomarkers are needed in addition to kidney function markers (e.g., glomerular filtration rate) to characterize this response. The product of urinary tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) is a promising Food and Drug Administration approved biomarker indicating risk of AKI and is currently used in hospitalized individuals. The usefulness of this biomarker in determining AKI in healthy individuals during heat strain is now beginning to be understood. Consecutive days of heat strain can result in repeated AKI, which is hypothesized to lead to chronic kidney disease. There is an epidemic of chronic kidney disease of non-traditional causes occurring in workers who undergo repeated days heat strain, including approximately 15% of outdoor workers in Central America. Of the few studies that investigated consecutive days of work in the heat, we demonstrated that participants exceed the glomerular filtration rate indicated threshold for AKI during consecutive days of heat strain. This project will determine whether \[TIMP-2 x IGFBP7\] increases during occupational relevant heat exposures in a healthy, active population. Additionally, this project will compare the impact of repeated exposures to a hot environment on risk of AKI.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals (18-39 years old)
* Regularly completes aerobic exercise at least 60 min per week

Exclusion Criteria:

* History of cardiovascular, metabolic, respiratory, neural, or renal disease
* Hypertensive or tachycardic during the screening visit (systolic blood pressure \> 139 mmHg, diastolic blood pressure \> 89 mmHg, heart rate \> 100 bpm)
* Current tobacco or nicotine use or previous regular use within the past 2 years
* Current or previous musculoskeletal injury limiting physical activity
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
* A positive pregnancy test at any point during the study or currently breastfeeding
* Study physician discretion based on any other medical condition or medication
SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty


Eligibility Criteria:
Inclusion Criteria:

1. Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent
2. Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
3. Male or female(≥ 40 years old and \< 80 years old)

Exclusion Criteria:

1. Unable to receive CT angiography of both lower limbs;
2. Malignant tumor within one year of the screening ;
3. History of venous thromboembolism;
4. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
5. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding
6. Any of the laboratory test indicators meets the following criteria:

   ①estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2 ;

   ②Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal value (ULN);

   ③total bilirubin was \> 2 times, etc
7. History of drug abuse;
8. Pregnant or lactating women
Protein for Premies

Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.

This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.


Eligibility Criteria:
Inclusion Criteria:

* very preterm infants \<32 weeks gestation and \<1500g birth weight
* \> 100ml/kg/d of enteral feeding

Exclusion Criteria:

* missing informed consent
* decision not to feed breast milk
* congenital malformations
* age \> 7 days at study entry
Effect of Chewing Gum on Abdominal Distension in Patients After Lumbar Spine Surgery

According to chewing gum can promote the recovery of gastrointestinal function, it is used as an intervention measure for patients after lumbar surgery to evaluate the effect of chewing gum on improving abdominal distension of patients after lumbar surgery, so as to provide basis for the application and promotion of chewing gum in lumbar postoperative nursing

In this study, the patients after lumbar surgery were given chewing gum after anesthesia. The exhaust time, defecation time and the incidence of abdominal distension of the two groups were compared, and the significance of chewing gum in improving abdominal distension after lumbar surgery was discussed

Eligibility Criteria:
Inclusion Criteria:

* The subjects aged 18 years or above were able to chew together;
* Good at listening, speaking, reading and writing;
* Lumbar degenerative disease was definitely diagnosed;
* General anesthesia was used;
* Methods: posterior lumbar decompression, bone graft fusion and internal fixation;
* No history of gum allergy;

Exclusion Criteria:

* None
Healthy Living After Knee Replacement

The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program.

Participants will be randomized to either a weight loss program or chronic disease self-management program. Both programs will be phone-based and include phone calls with a health coach weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12. Monthly calls with occur between months 13-18. Assessments examining outcomes will be completed at baseline, 6, 12, and 18 months.

Eligibility Criteria:
Inclusion Criteria:

Participants must:

* have a body mass index between 25-45 kg/m2
* have had a knee replacement (including primary, staged or independent bilateral, or revision) \<6 months prior to baseline assessment
* have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with Fitbit
* completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall)
* be English-speaking and able to read consent and study materials written in English
* be willing to attend 4 in-person assessments.

Exclusion Criteria:

* have any contraindications to diet or weight loss
* undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months
* have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke)
* are taking anti-obesity medications
* are enrolled in a formal weight loss program
* had or are planning to have bariatric/gastric/lap band surgery
* are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months.
Efficacy and Safety of SOM3355 in Huntington's Disease Chorea

Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age at time of consent.
* Diagnosis of HD definite by a movement disorders expert and confirmed by a number of HTT gene CAG repeats equal or greater than 36.
* Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control.
* Ability to walk independently or with minimal assistance.
* UHDRS TMC score equal or greater than 8.
* UHDRS TFC equal or greater than 4.
* Subject has provided written informed consent or through his/her legally authorized representative.

Exclusion Criteria:

* Onset of HD symptoms prior to age 18 (Juvenile forms of HD).
* Non-ambulatory patients.
* A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome.
* Pregnant or breastfeeding female patients, including those planning to conceive during the period of the trial.
* Patients with psychiatric symptoms, or other impairments, that would interfere with their full compliance with the Investigator instructions and testing, unless there is an identified caregiver to support the patient.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject's medical history and/or clinical laboratory test results at screening and baseline.
* Known allergy/sensitivity/intolerance to the study drugs or their excipients.
* Any significant laboratory results which, in the Investigator's opinion, would not be compatible with study participation or represent a risk for the subject while in the study.
* Prescribed anti-hypertensive medication, tetrabenazine, deutetrabenazine or valbenazine within 15 days prior starting the investigational treatment.
* Excluded concomitant medications: any anti-hypertensive medication, tetrabenazine, deutetrabenazine or valbenazine, all typical neuroleptics and all MAO inhibitors
* Subject has a history of alcohol or substance abuse in the previous 12 months.
* Patients with diabetic ketoacidosis or metabolic acidosis.
* Patients with cardiogenic shock, congestive heart failure, pulmonary hypertension due to right-sided heart failure, severe sinus bradycardia, atrioventricular block (grades II and III) or sinoatrial block.
* Subject has participated in an investigational drug or device trial within 30 days prior starting the investigational treatment.
Acute Intermittent Porphyria Related Abnormalities in Cardiovascular System

This study aims to assess the changes in the cardiovascular system in patients with acute intermittent porphyria (AIP).

Porphyrias are heterogeneous group of the disorders of heme biosynthesis. Acute intermittent porphyria (AIP) is the most common acute hepatic porphyria, caused by the mutations in the gene encoding hydroxymethylbilane synthase. Clinical symptoms i.e. abdominal pain, nausea, vomiting, paresis or paralysis, coma and/or mental abnormalities may be induced by many porphyrinogenic factors, such as drugs, alcohol, starvation or stress. The symptoms are often accompanied by tachycardia and elevated blood pressure. Due to the non-specific clinical picture, AIP is often diagnosed too late and causes a threat to the patients' lives.

There is a scarcity of data regarding the changes in cardiovascular system in patients with AIP. The aim of this study is to assess the structure and function of heart in patients with this disease. The prevalence of hypertension, cardiac arrhythmias and selected cardiovascular risk factors in patients with AIP will also be evaluated.

This is a case-control study with prospective observation of the subgroup of patients examined during the exacerbations of AIP.

Specific goals:

* assessment of the cardiac morphology and function,
* assessment of the concentrations of markers of myocardial injury (troponin T) and heart failure (NT-proBNP),
* assessment of the prevalence of cardiac arrhythmias and electrocardiographic abnormalities,
* assessment of the blood pressure profiles,
* assessment of selected cardiovascular risk factors,
* assessment of quality of life,
* assessment of clinical and biochemical factors associated with the pathological findings in patients with AIP.

Eligibility Criteria:
Inclusion Criteria:

* acute intermittent porphyria (AIP),
* age 18-65 years,
* at least one hospitalization due to exacerbation of AIP.

Exclusion Criteria:

* previous myocardial infarction,
* heart failure of established (other than porphyria) etiology,
* severe heart valve disease,
* congenital heart defects,
* history of myocarditis,
* pacemaker,
* hyperthyroidism / hypothyroidism (except for adequate thyroid hormone replacement therapy),
* chronic advanced lung diseases,
* lack of consent to participate in the study.
Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography

The main objective of the study is to assess whether the distal radial arterial approach (snuff box or back of the hand) is not inferior to the radial arterial approach at the wrist, in the management of coronary angiography for diagnostic purposes

Coronary angiography is the reference examination for anatomical exploration coronary arteries to determine the presence or absence of a predominantly obstructive coronary disease.

Historically, the femoral approach was the most common approach used in interventional cardiology. The radial approach to the forearm presents multiple advantages over the femoral route, and it became the gold standard approach to coronary angiography and intervention percutaneous coronary. Although uncommon, vascular complications related to the radial pathway exist.

This is why a more distal radial approach, above the long tendon extensor of the thumb (at the level of the anatomical snuff box) or downstream (at the back of the hand) was suggested more than 10 years ago. This pathway is now an advantageous alternative to the radial approach of first intention, both for the patient and for the practitioner.

The two procedures are common today but few studies have been developed to compare the two approaches. Therefore, the main objective of the study is to assess whether the distal radial arterial approach (snuff box or back of the hand) is not inferior to the radial arterial approach at the wrist, in the management of coronary angiography for diagnostic purposes

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged 18 and over
* Patient having a diagnostic coronary angiography programmed by radial route.
* Patient with a radial pulse at the anatomical snuff box and at the wrist noticeable

Exclusion Criteria:

* Patient requiring emergency coronary angiography or having an acute coronary syndrome
* Patient with severe arteriopathy of the supra-aortic trunks
* Patient with a history of coronary bypass surgery
* Tall patients (\>1.90m)
* Patient allergic to xylocaine
* Patient presenting a contraindication to the realization of a coronary angiography:

terminal IRC, pregnancy, severe sepsis....
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Males in good general health, 18 years of age or older.
* Have a previously documented testosterone deficiency.
* Willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

* Have a history of intolerance to Androderm or other testosterone products.
* Prostate specific antigen (PSA) level ≥ 4.0 ng/mL
* Prostate cancer or severe benign prostatic hypertrophy (BPH)
* Have significant abnormalities in the physical examination at screening.
* Have current dermatological disease, skin damage or blemishes.
* Have participated in an investigational drug study within 30 days prior to screening.
Nice Human Immunodeficiency Virus (HIV) Cohort

Historically, the database on the HIV was organized within the framework of the medico-economic file of the human immunodeficiency (DMI-2), introduced jointly by the Direction of Hospitals (Mission AIDS) and the INSERM at the end of the 80s. Today this database is fed via the computerized medical record NADIS. Most part of the research works on the theme of the HIV take support on this database (DAD, EuroAIDS, Neuradapt).


Eligibility Criteria:
Inclusion Criteria:

* Enrol consecutive patients with a scheduled visit in the outpatient clinic (regardless of CD4 cell count and ART status).

Exclusion Criteria:

-
Electronic Tools to Assist With Identification of and Counseling for Overweight Patients

The purpose of this study is to design and assess the impact of an electronic alert and tool set to assist with physician identification and counseling of overweight patients.

Overweight adults (Body Mass Index \[BMI\] 25-29.9) are at high risk for developing obesity, but rates of physician identification and counseling of overweight adults are low. Alerts and tools embedded in the electronic medical record have shown promise in enhancing quality improvement efforts.

Our aim is to design and assess the impact of an electronic alert and tool set to assist with identification and counseling of overweight patients with a BMI 27-29.9. Although the category of overweight patients spans BMI 25-29.9, we are including only patients with BMI 27-29.9 in order to focus resources on the most at-risk pre-obese population.

We will develop a tool set including the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians in the Northwestern Memorial Faculty Foundation General Internal Medicine (NMFF GIM) practice who consent to participate in the study will be randomized into two groups, with one group of physicians receiving access to these tools. The other group of physicians will continue to provide their usual care for overweight patients. Outcome measures will include the following: tool usage; documentation of overweight in the problem list, encounter diagnosis, or note text; counseling for overweight and documentation of specific behavioral goals. Measures will be obtained via retrospective chart review.

Eligibility Criteria:
Inclusion Criteria (physicians):

* Consenting physicians from the Northwestern Memorial General Internal Medicine (NMFF GIM) practice

Exclusion Criteria (physicians):

* Study investigators will be excluded from participation (Dr. David Baker, Dr. Joyce Tang)

Inclusion Criteria (patients):

* Adults ages 18-65 seen at the NMFF GIM who are patients of consenting physicians
* Have at least one appointment at the NMFF GIM clinic between 9/1/09-2/28/10
* Body mass index (BMI) 27-29.9 at one or more visits between 9/1/09-2/28/10

Exclusion Criteria (patients):

* Patients without at least one recorded height measurement from any prior visit or without weight information from a visit within the 6 month target window will be excluded due to inability to calculate BMI.
Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)

The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy lower blood glucose in patients with inadequate glycemic control This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy
* Non-pregnant females

Exclusion Criteria:

* Patients with Type 1 Diabetes or history of ketoacidosis
* Patients who have been treated with insulin or other antihyperglycemic agents
* Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease
A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* A woman of non-child bearing potential, i.e. being postmenopausal1 or permanently sterilised (e.g. hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or a woman of childbearing potential correctly and consistently using a highly effective method of non-hormonal birth control (i.e. IUD or bilateral tubal ligation) together with barrier methods at least 30 days prior to first administration of Microgynon® (Visit 2), during the trial and for 3 months after last intake of nintedanib.
* 2013 American College of Rheumatology (ACR) / European League against Rheumatism (EULAR) classification criteria for Systemic Sclerosis associated Interstitial Lung Disease (SSc) fulfilled
* SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography (HRCT); Extent of fibrotic disease in the lung \>= 10%
* Forced Vital Capacity (FVC) \>= 40% of predicted normal
* Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal
* Further inclusion criteria apply

Exclusion criteria:

* Aspartate Transaminase (AST), Alanine Transaminase (ALT) \>1.5 x Upper Level of Normal (ULN).
* Bilirubin \>1.5 x ULN
* Creatinine clearance \<30 mL/min
* Clinically relevant anaemia at investigators discretion
* Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) \<0.7)
* Other clinically significant pulmonary abnormalities
* Significant Pulmonary Hypertension (PH)
* Cardiovascular diseases
* More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers
* Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
* International normalised ratio (INR) \>2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \>1.5 x ULN)
* History of thrombo-embolic event within last year
* Previous or planned hematopoietic stem cell transplantation
* Clinical signs of malabsorption or needing parenteral nutrition
* Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
* Previous treatment with nintedanib or pirfenidone
* Further exclusion criteria apply