cyrilzakka/clinical-trials huggingface dataset:
Does Gender Play a Role in Bone-mineral Density Measurement Precision?

Bone mineral density (BMD) measurement using dual-energy x-ray absorptiometry (DXA) is the current gold standard for osteoporosis diagnosis and therapy monitoring. Like all quantitative tests, there is some variability in BMD results obtained when scanning a person more than once. As such, it is current clinical practice, based on the recommendation of the International Society for Clinical Densitometry, that each technologist perform a precision assessment. This approach consists of scanning 30 people twice; the data from which allow determination of what constitutes a real difference in BMD with 95% confidence. A precision assessment typically evaluates a specific clinic's population, using the age range and genders seen at that clinic. However men generally have larger, but often more arthritic, bones than women which may impact the precision results. Therefore, it is possible that gender-specific precision values should be used in clinical practice, however this issue has never been investigated.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Able and willing to sign informed consent

Exclusion Criteria:

* Inability to have DXA scans performed due to weight ≥ 450 pounds (exceeds densitometer table limit)
* Metallic hardware in, or overlaying, any of the measured skeletal sites
Metabolic Impact of Intermittent CPAP

Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid metabolism during sleep, which over time could lead to diabetes and cardiovascular disease. This study examines metabolic changes during sleep in patients with obstructive sleep apnea. Patients accustomed to continuous positive airway pressure (CPAP) therapy are enrolled to undergo sleep studies, either on CPAP therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained so that metabolic function can be compared between sleep apnea and CPAP nights.

Participants with a history of moderate severe sleep apnea (AHI\>20) will be enrolled if participants meet inclusion/exclusion criteria. Investigators will report to the sleep laboratory on two nights, (1) after continuing their CPAP or (2) after discontinuing CPAP for 3 nights. The order of observation will be randomized. A standard research dinner is provided before each study. IV's are placed so that blood can be sampled at frequent (30 min) intervals throughout the night. In the morning after each study, a glucose tolerance test and endothelial function study (endoPAT) are performed. Serum samples will be analyzed for glucose, insulin, free fatty acids, triglycerides, hormones, and other metabolic biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* History of moderate to severe Obstructive sleep apnea (OSA) (AHI or respiratory disturbance index (RDI)\> 10).
* They must also own a CPAP machine and report the ability to tolerate sleeping with or without CPAP during the night.

Exclusion Criteria:

* Uncontrolled hypertension with systolic blood pressure \>170 or diastolic blood pressure \> 110
* Congestive heart failure
* Use of clonidine or nicotinic acid medication
* Diabetes requiring the use of insulin
* Known pregnancy, by urine testing in women of child-bearing age
* History of falling asleep while driving, near miss
* High risk occupation (pilot, commercial driver)
* Hemoglobin \< 10 g/dL on point of care screening
ZNN Bactiguard Retrograde Femoral Nails PMCF Study

Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.

The objective of this prospective PMCF study is to collect data to confirm safety, performance and clinical benefits of the Zimmer Natural Nail (ZNN) Bactiguard Retrograde Femoral Nail (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.

The primary endpoint is the assessment of performance by analyzing fracture healing.

The secondary endpoints are the assessment of safety, clinical benefit and post-op fracture related infection (FRI). Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Clinical benefit will be assessed by recording patient-reported outcome measures (PROMs). FRIs will be classified according to the updated diagnostic algorithm defined by the FRI Consensus Group.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older.
* Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included.
* Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail.
* Patient must be able and willing to complete the protocol required follow-up.
* Patient must have a signed EC approved consent.
* Patients capable of understanding the surgeon's explanations and following his instructions.

Exclusion Criteria:

* Skeletally immature patients
* A medullary canal obliterated by a previous fracture or tumor
* Bone shaft having excessive bow or a deformity
* Lack of bone substance or bone quality, which makes stable seating of the implant impossible
* All concomitant diseases that can impair the operation, functioning or the success of the implant
* Insufficient blood circulation
* Infection
* Patient is unwilling or unable to give consent.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol/drug addiction, known to be pregnant or breast feeding).
* Patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).
* Not expected to survive the duration of the follow-up program
The Preoperative Health & Body Study

This study is designed to look at the changes that occur in women who take part in exercise and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators will look at changes in stress, anxiety, mood and quality of life, to see if these types of short programs can make women feel better during this time. The investigators are also interested in looking at whether a short exercise or Mind-Body program leads to any changes in markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development.

Since the investigators do not know if these blood or tumor tests have any relationship to cancer recurrence, the investigators do not plan to share the results of these tests with you or your physician.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, histologically confirmed stage I-III breast cancer
* Planning to undergo definitive surgical management with lumpectomy or mastectomy with in the next 8 weeks.
* Willing and able to participate in the intervention for at least 3 weeks prior to surgery.
* ECOG performance status of 0 or 1
* Approval by oncologist or surgeon
* Willingness to be randomized.
* English speaking and able to read English

Exclusion Criteria:

* Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in situ cervical cancer)
* Presence of metastatic disease
* Scheduled to receive any form of neoadjuvant cancer therapy
* Locally advanced breast cancer not amenable to primary surgery
* History of prior ipsilateral breast cancer
* Taking tamoxifen, raloxifene or an aromatase inhibitor at the time of breast cancer diagnosis
* Absolute contraindications to maximal exercise testing as recommended by the American Thoracic Society
* Any condition which in the investigator's opinion makes the subject unsuitable for study participation
* Participating in another clinical study with competing study outcomes
* Pregnant (i.e., positive beta-HCG) or breast feeding
* Unable to comply with protocol and/or not available for follow-up assessments
* Participation in more than 90 minutes a week of moderate-intensity recreational activity (not including activities such as gardening, bowling, golfing with a cart) as assessed by the Leisure Score Index of Godin Leisure- Time Exercise Questionnaire (LSI) (Appendix I) or recent participation (past 6 months) in two or more strength training sessions per week.
* Diabetes mellitus requiring insulin or oral agents; patients with diet-controlled diabetes will be allowed to participate
ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients

This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.

This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will meet all of the following:

  1. Have an indication for an ICD implantation or pulse generator change
  2. Have documented coronary artery disease. Documented coronary artery disease is defined as having at least one of the following present a) evidence of a prior MI on ECG and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or ST-T wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography.
  3. Willing and able to comply with protocol requirements, including keeping all required visits
  4. Willing to participate in the study and able to sign an IRB approved informed consent form
  5. Be at least 18 years of age when enrolled in the study

Exclusion Criteria:

* Patients will be excluded if they meet any of the following:

  1. Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time)
  2. Have NYHA Class IV Heart Failure
  3. Have persistent or permanent atrial fibrillation
  4. Have a known history of intermittent Bundle Branch Block
  5. Pregnant or planning a pregnancy during the study participation
  6. Have a life expectancy of \< 1 year due to any condition
  7. Are currently participating in a clinical investigation that includes an active treatment arm.
The Use of the VOMS Tool With Military Personnel to Track mTBI Recovery and RTD Status

The purpose of the proposed project is to determine if the VOMS is an effective screening tool to identify and track recovery of vestibular and ocular motor impairment and symptoms following mTBI, that corpsman-level medical personnel can successfully implement in combat and non-combat environments. A second purpose of the project is to determine if impairment and symptoms on the VOMS is more pronounced following blast compared to blunt mTBI.

Vestibular impairment and symptoms are prevalent following mild traumatic brain injury (mTBI) and may play a role in prolonged recovery. Researchers have indicated that ocular motor dysfunction and symptoms are common among personnel exposed to blast mTBI. In fact, researchers have suggested that vestibular and ocular motor outcomes such as VOR and vestibulo-spinal reflex (VSR) may be useful in identifying the effects of blast from blunt mTBI. There are currently no brief, clinical screening tools to identify vestibular/ocular motor impairment and symptoms in military personnel following mTBI. Our research team recently developed the Vestibular/Ocular Motor Screening (VOMS) tool to screen for vestibular/ocular motor impairment and symptoms following mTBI. Our preliminary research indicates that VOMS- a 5-min clinical screening tool that can be deployed by corpsman-level (i.e., Special Operation Combat Medics \[SOCM\], Special Forces Medical Sergeants \[18D\]) medical personnel with minimal training and materials- was nearly 90% accurate in identifying patients with mTBI from healthy controls. These preliminary findings suggest that VOMS may augment current clinical screening tools- such as the MACE- used by the U.S. Military. The proposed project addresses the "studies to develop standardized metrics for vestibular assessment and monitoring for return to duty" area in the Diagnostics subsection of the Hearing Loss/Dysfunction, Balance Disorder, and or Tinnitus section under the Clinical Trial Research Focus Area.

Eligibility Criteria:
Inclusion Criteria:

* All Participants:

  * Military personnel;
  * Age 18-40 years;
  * Normal or corrected normal vision
* mTBI Participants:

  * Diagnosed with mTBI (blast, blunt, or combo) within past 7 days
  * Clear mechanism of injury
  * Glasgow Coma Scale (GCS) = 13-15
  * Reported or observed signs (Loss of consciousness \[LOC\], amnesia, disorientation/confusion) at time of injury
  * Current reported symptoms and/or impairment (cognitive, balance, visual)

Exclusion Criteria:

* History of vestibular disorder;
* History of neurological disorder;
* History of previous moderate to severe TBI
Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy

The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.


Eligibility Criteria:
Inclusion Criteria:

* From 1 to 16 years old.
* Patients that signed the informed consent form.

Exclusion Criteria:

* Urgent colonoscopy
* History of intestinal resection
* Nephropathy, heart disease or metabolic syndrome.
Assessment of Human Exposure to Chemical Hazards

The aim of this study is to evaluate the occurrence of chemical hazards exposure in the Singapore population and assess their association with food consumption.

Human biomonitoring is an exposure assessment approach with the potential value-add supplementation to existing sources of information for regulatory risk assessments and for supporting food safety policies. The collaboration involving academic partners from the sciences and public health disciplines to quantify the in vivo chemical exposure of chemicals will take reference from the findings in the Singapore's total diet study on the prioritised chemical hazards of interest for a more precise assessment of the distribution of risk in the population. Direct measurement of chemicals and/or metabolites in biological specimens obtained from study subjects will be conducted to provide a more comprehensive understanding on the baseline dietary chemical exposure in the local population. Dietary assessment using food frequency questionnaire will be administered to the same group of study subjects to associate human exposure to chemical hazards with food consumption across the different population groups in Singapore.

Eligibility Criteria:
Inclusion Criteria:

* Must be English-literate and able to give informed consent in English
* 21 to 60 years of age (inclusive) at screening
* Healthy adults
* Race must be Chinese or Indian or Malay
* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Known or ongoing psychiatric disorders within 3 years
* Being diagnosed with cancer, heart disease, stroke, renal failure, serious mental or physical illnesses at the time of recruitment
* Have donated blood of more than 500 mL within 4 weeks of study enrolment
Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction

Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy

Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks (Q4W) in patients with hypercholesterolemia on stable diet and oral LDL-C-lowering drug therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years of age or older
2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
3. Body mass index (BMI) between 18 and 40 kg/m2

Exclusion Criteria:

1. Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
2. Homozygous familial hypercholesterolemia
3. LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
4. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
5. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
6. Newly diagnosed or poorly controlled (HbA1c \>9%) type 2 diabetes
7. Uncontrolled hypertension
8. Moderate to severe renal insufficiency
9. Elevated liver function test at screening
10. Uncontrolled cardiac arrhythmia or prolonged QT on EKG
11. A history of prescription drug abuse, illicit drug use, or alcohol abuse
Femoral Artery Crossover Rates in 1000 Consecutive Radial Cath Labs Procedures.

Comparison of Crossover rates of Radial Cardiac Catheterizations and/or PCIs into femoral vs published literature

A retrospective review of 1000 consecutive Radial or Ulnar Cardiac Catheterizations and/or Percutaneous Coronary Interventions performed in our Institute by one single operator could provide us with the cross over rates to femoral interventions. In this manner these rates could be compared to the published rates of other institutions benchmarking our techniques with the outcomes for such interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients coming to the emergency room requiring Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions

Exclusion Criteria:

* Cardiac Tamponade
* Cardiogenic Shock
Adherence to Gastro-protection in Non-steroidal Anti-inflammatory Drug (NSAID) Using Patients

Prospective multicentric study to evaluate the compliance of gastroprotective treatment in NSAID patients at risk of GI complications. Secondary objectives: To identify the factors associated to treatment compliance (both NSAID and PPI), to evaluate the relationship between compliance and NSAID-associated GI events


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients consulting to the specialized care clinics who have been prescribed NSAID and gastroprotection for at least 15 days following standard clinical practice.

Exclusion Criteria:

* Any gastroprotective treatment prescribed for other condition than NSAID-related gastrointestinal event prevention
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.

Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.


Eligibility Criteria:
Inclusion Criteria:

1. Patient was \> 18 years old at time of procedure
2. Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
3. Patient treated in routine clinical practice
4. Patient underwent his/her first follow-up visit within two months post-surgery

Exclusion Criteria:

No exclusion criteria have been defined for this data collection.
Functional ICUS in Uganda and Their Survival Outcomes

Aim of the study is to describe the functional characteristics of Icus in Uganda and their @8-day patient characteristics it is a prospective cohort study .All Icus in Uganda will be included and their admitted patients followed upto 28 days in the ICU for mortality

Intensive Care units are specialized units with expertise to provide organ support for the critically ill patients. There's a growing global burden of critical illness especially in the low-income coun-tries where critical care services are limited. Despite advances in critical care, the mortality in Uganda remains very high, with sepsis and trauma as the major contributors. There's paucity of literature regarding ICUs characteristics, disease burden and patient characteristics which could be contributing to the high mortality.

Objectives To describe the functional characteristics of the ICUs in Uganda. To determine the ICU mortality of critically ill patients in Uganda. To determine the risk factors of mortality of patients admitted in the ICU Methods A prospective cohort study will be carried out in all ICUs in Uganda. All new patients in the ICUs will be recruited into the study. Data will be collected onto two separate questionnaires, one for patient characteristics and the second for ICU functional characteristics. The patient's data will be collected within the first 24 hours and patients will be followed up for death\\discharge within 28 days in the ICU. The data will be collected from the patients' charts and entered into Epidata.

Eligibility Criteria:
Inclusion Criteria:

All new patients admitted to Uganda's Intensive Care Units ICUs in Uganda whose unit heads verbally consent to participate in the study.

Exclusion Criteria:

Patients transferred in from another unit will not be re recruited. ICUs that don't consent to the study.
Caloric Titration Method of Weight Loss and Maintenance

Study examined the effectiveness of daily self-weighing to prevent age related weight gain.

Were given scales to weigh themselves daily. Change in weight was measured at the beginning and end of the two year observation period.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* not pregnant
* not trying to gain or lose weight

Exclusion Criteria:

* diabetes
* history of an eating disorder
* Body Mass Index (BMI) greater than 27.0 kg/m2.