cyrilzakka/clinical-trials huggingface dataset:
Metabolic Abnormalities in HIV Infected and Uninfected Young Women

Though anti-HIV drugs can dramatically improve the health of people with HIV, some people taking these drugs develop serious long term effects in their metabolism. These effects include problems with bones, increased levels of blood sugar and lipids, and changes in body fat distribution. The purpose of this study is to see how many young women are experiencing these problems and how severe the problems are. This kind of study is the first step in determining how best to treat these problems.

Patients on highly active antiretroviral therapy (HAART) regimens develop potentially deleterious metabolic effects, including insulin resistance, dyslipidemia, osteopenia and osteoporosis, and hyperlactatemia. Changes in body fat distribution and bone metabolism are also documented. There is considerable evidence that protease inhibitors (PI) can induce insulin resistance and increase triglyceride and cholesterol levels. It is now also clear that both metabolic changes and fat distribution abnormalities occur in PI-naive patients treated with nucleoside analogue reverse transcriptase inhibitors (NRTIs). In addition to class specific effects, there is emerging evidence that there are differences within each class of drug in the nature and magnitude of metabolic effects. This study will examine the metabolic effects of HAART in young women.

Adolescent women aged 12 through 24 years will be recruited into each of 5 treatment strata: Stratum 1 - HIV uninfected; Stratum 2 - HIV infected but never had HAART; Stratum 3 - HIV infected on NNRTI regimen for 3 or more months and less than 2 weeks of PI therapy; Stratum 4 - HIV infected on PI regimen for 3 or more months and less than 2 weeks of NNRTI therapy; and Stratum 5 - HIV infected on NRTI-only regimen for 3 or more months and less than 2 weeks of PI or NNRTI therapy. Participants in the study will have one study visit conducted over 1 or 2 days. The study visit will include survey questionnaires, DEXA scanning, anthropometric measurements, and blood tests examining lactate, glucose, and lipid metabolism.

Eligibility Criteria:
Inclusion criteria

* Negative serum or urine pregnancy test if not sterilized
* Tanner Stage 4 or 5
* Accessible medical and medication history
* Willing to fast and complete clinical and laboratory evaluations
* Willingness and ability to give consent or assent with parental permission

Exclusion criteria

* Refusal to fast for 8 hours prior to specimen collection
* Unable to obtain history
* Pregnancy in last 12 months or currently pregnant
* History of anorexia or bulimia
* Type I Diabetes mellitus
* Type II Diabetes mellitus and cannot omit medication for the 48 hour period prior to laboratory specimen collection
A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort

Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).

A prospective NOD Cohort of 10,000 eligible, enrolled subjects will be assembled over the next 5 years, with each patient participating for up to 3 years from the date they meet biochemical (glycemic) criteria for diabetes. Sites electronic medical record databases or other avenues for recruitment, such as physician and self referral, will be utilized to identify subjects meeting criteria for NOD.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able and willing to provide informed consent and sign an informed consent form.
* Subject must sign an authorization for the release of their protected health information.
* Subject must be ≥50 and ≤85 years of age at the time of enrollment.
* Subject must have hyperglycemia and/or diabetes as one of the following within 90 days prior to enrollment:

  * All glycemic parameters must be measured in an outpatient setting

A. (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR

B. Any (2) PDMs present on consecutive or simultaneous testing:

* Fasting Blood Glucose (FBG) ≥126 mg/dl
* Hemoglobin A1c (HbA1c) ≥ 6.5%
* Random Blood Glucose (RBG) ≥200 mg/dl
* 2h Post Glucose (PG) ≥200mg (11.1 mmol/L) during OGTT (oral glucose tolerance test), OR

C. Any (1) PDM present followed by an anti-diabetes medication

* Subject must have \>1 glycemic parameter measured in the 18 months prior to the elevated index lab without meeting inclusion criteria A, B, or C.
* Subject must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24 months post-enrollment.
* Subject or authorized representative must be willing to complete a detailed questionnaire.

Exclusion Criteria:

* Subject must not have any past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C

  * Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.
* Subject must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

  * Ongoing work up for suspicion of pancreatic cancer is not an exclusion.
* Subject must not have any past history of pancreatic cancer.
* Subject must not be on anti-diabetes medications prior to the elevated index lab.
* Subject must not be on chronic or acute use of steroid medications within 90 days of the elevated index lab.

  * Allowed: Nasal, topical steroids, oral budesonide, ophthalmic
* Subject must not have had a recent (within 1 week of the elevated index lab) intra-articular steroid injection.
* In the physician's and/or investigator's judgement, subject does not have any co-morbidities that limit the subject's participation in the study.
Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis


Eligibility Criteria:
Inclusion Criteria:

* relapsing form of MS
* screening EDSS score 0 - 5.5, inclusive
* at least one clinical relapse in the 12 months before screening
* active disease, defined by set of MRI activity criteria
* failed prior treatment with beta-interferons or glatiramer acetate

Exclusion Criteria:

* signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis
* known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation
* pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames
Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

This research is being done to find out what types of gene mutations are present in people with cancer. This study is designed to help researchers and doctors understand more about cancer. With this information, doctors may have a better idea as to which cancer treatments are most appropriate for certain patients. The information will also help researchers find out the how to identify genes in cancers from biopsies and blood samples and how to use this information to help doctors and patients make treatment decisions.

This is a prospective cohort study with the goal of obtaining fresh tumor biopsies and one blood sample from patients with a confirmed histological or cytological diagnosis of cancer, who are potential candidates for a phase I or II clinical trial at their local institution. DNA from fresh tumor biopsies and from mononuclear blood cells will be subjected to targeted and genome-wide sequencing to enable molecular characterization of tumors. Application of genomic information by investigators will be captured. Archived tumor samples will be requested from all patients. For patients with malignant ascites or pleural effusions, fluid and tumor samples will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Histological or cytological proof of solid tumour cancer.
* At least one biopsiable lesion deemed medically accessible and safe to biopsy.
* Candidate for one or more phase I or II clinical trials in the local institution or in another Ontario institution, at the time of study enrollment or at a later time point.
* Fulfills local institution's laboratory parameters for tumor biopsy.
* Willingness and ability of patient to provide signed voluntary informed consent.

Exclusion Criteria:

* Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
* Any contraindication to undergoing a biopsy procedure.
Pneumatic Compression Vs Blood Flow Restriction for Muscle Recovery

Both BFR and intermittent pneumatic compression are purported to decrease symptoms associated with exercise induced muscle damage (EIMD) that cause delayed onset muscle soreness (DOMS). Blood flow restriction relies on applying pressurized cuffs to the most proximal portion of the limb. Another form of recovery often relied upon is pneumatic compression. The mechanism by which pneumatic compression works is similar to that of a massage, whereby the device progressively increases the pressure on a portion of the limb before releasing and moving further up the limb.The purpose of this study is determine whether BFR or pneumatic compression can be used to decreased DOMS which may indicate enhanced recovery.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* Recreationally active population
* Women should be on a form of hormonal contraception.
* No current musculoskeletal injuries or pathologies
* Must answer "yes" to all PAR-Q questions.

Exclusion Criteria:

* Individuals that routinely train trail running
* Discomfort when running
* Deep vein thrombosis
* Blood clots
* Cancerous lesions
* Sensory or mental impairment
* Unstable fractures
* Acute pulmonary edema
* Acute thrombophlebitis
* Acute congestive cardiac failure
* Acute infections
* Episodes of pulmonary embolism
* Wounds, lesions, infection, or tumors
* Bone fractures or dislocations
* Increased venous and lymphatic return
* Answers "no" to any of the PAR-Q screening questions
E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent

The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis.

This prospective multi-center study has been initiated:

* To document the acute and mid-term safety and overall clinical performance of the stent system in a "real world" patient population requiring stent implantation.
* To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Patient is \>18 years of age (or minimum age as required by local regulation)
* The patient has consented to participate by signing the "Patient Informed Consent Form" and/or has authorized the collection and release of his medical information by signing the "Patient Data Release Consent Form".
* The patient is suitable for implantation of one or more Endeavor(TM) ABT-578 Eluting Coronary Stent System in one or more native artery target lesions.
* Lesion length and vessel diameter of the target lesion(s) are according to the "Indications for Use" as mentioned in the "Instructions for Use" that comes with every Endeavor(TM) ABT-578 Eluting Coronary Stent System.
* The patient is willing and able to cooperate with registry procedures and required follow up visits.

Exclusion Criteria:

* Women with known pregnancy or who are lactating.
* Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
* Patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated.
* Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
* Current medical condition with a life expectancy of less than 12 months.
* The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this E-five registry once.
* Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
Twelve Step Based Self-help Groups for Substance Related Disorders

The Twelve Step groups are the most available and widespread self-help groups for patients with alcohol or drug related disorders. In a public health perspective, self-help groups (SHGs) may be considered as a supplement to professional treatment and provide aftercare soon as professional treatment has ended.

There is a need to investigate if U.S. findings and procedures concerning referrals from the health services to Twelve Step Groups (TSGs) can be replicated and accommodated to a cultural setting which is unfamiliar with these groups. There is also a particular need in the Norwegian treatment system to develop alternative treatment strategies for patients undergoing detoxification to improve their chances of long-term recovery, due to deficient formal follow-up alternatives.

We plan to carry out a RCT-study. One hundred and sixty patients entering a detoxification treatment center (Addiction Unit, Sørlandet Hospital, Kristiansand, Norway) will be assigned to two different groups: One given standard information about TSGs (brief advice) and one given intensive referral (motivational sessions and contact with TSG volunteers). A follow up assessment is planned at 6 months to determine whether intensive referral results in more TSG attendance, and if this mediates less substance use and better functioning outcomes.

This study introduces a new concept in the Norwegian health care system and relies on a systematic cooperation with user organizations (SHGs) and user volunteers. Thus the study focuses strongly on user resources.


Eligibility Criteria:
Inclusion Criteria:

* Patients with alcohol and substance use disorders treated on a detox ward

Exclusion Criteria:

* Severe psychiatric comorbidity
* Patients on opioid replacement therapy
* Those who have appointment with other inpatient treatment at intake (and will be transferred to such treatment)
The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values

This study is to investigate, in a larger cohort of consecutive men, the proportion of abnormal MRI prostate in different phi ranges, and the cancer detected in Chinese men with abnormal MRI. This study aims to evaluate whether MRI prostate can be omitted in men with lower suspicion of prostate cancer.

This is a prospective cohort study recruiting consecutive men with elevated blood test PSA 4-10 ng/mL, normal prostate on digital rectal examination, and result for blood Prostate Health Index (phi) known. A multi-parametric MRI prostate with contrast will be performed in all subjects. MRI prostate will be reported according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations\[10\] and scored from 1 to 5. A PI-RADS score of 3-5 is considered abnormal. The proportion of abnormal MRI in different phi ranges (primary outcome) will be compared.

The subjects will be offered a prostate biopsy according to usual clinical indications in our hospital: In men with phi \>35 (higher risk of significant prostate cancer), prostate biopsy (systematic biopsy, plus MRI-guided if abnormal MRI) will be offered. In men with phi \< 35 (lower risk of prostate cancer), prostate biopsy (systematic plus MRI-guided) will be offered only if MRI is abnormal.

Eligibility Criteria:
Inclusion Criteria:

* Ethnically Chinese Men ≥18 years of age
* Clinical suspicion of prostate cancer and indicated for prostate biopsy
* Serum Prostate-specific antigen (PSA) 4-10 ng/mL
* Serum Prostate health index (phi) result available
* Normal Digital rectal examination
* Able to provide written informed consent

Exclusion Criteria:

* Past or current history of prostate cancer
* On 5-alpha reductase inhibitor in the past 6 months (e.g. Finasteride, Dutasteride)
* MRI prostate performed in past 5 years
* Contraindicated to undergo MRI scan (e.g. pacemaker in-situ, claustrophobia, estimated glomerular filtration rate \< 50ml/min in serum renal function test within 3 months)
* Contraindicated for prostate biopsy (e.g. uncorrectable coagulopathy, active infection
Florida Cardiovascular Quality Network

Florida Cardiovascular Quality Network Application of Clinical Decision Support Software Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality Outcomes Registry

The Florida Cardiovascular Quality Network (FCQN) is a quality outcomes registry. In a diverse group of clinical sites in Florida, a large number of patients with known or possible stable ischemic cardiovascular disease (SIHD) referred for cardiovascular stress test will be enrolled in this quality demonstration registry. This registry is based on the hypothesis that evidence-based clinical guidelines and appropriate use criteria (AUC), when provided at the site and time of care (point of care), may improve physician clinical decisions and, thus, the overall quality and value of care for individual patients and populations. Specifically, this study registry will utilize multiple proven software tools at the point of care: (1) Seattle Angina Questionnaire (SAQ) as the method of measurement of patient angina symptoms; (2) FOCUS, American College of Cardiology (ACC) software to provide clinical decision support (CDS) as the primary method of determination of AUC in patients with a clinical indication for a cardiovascular stress test; (3) CATH/PCI, ACC / National Cardiovascular Data Registry (NCDR) to provide clinical decision support as the primary method of determination of AUC in the cardiac catheterization laboratory; (4) PINNACLE, ACC/NCDR clinical registry to provide an extensive database of clinical quality metrics; and (5) ACC CARDIOSMART software modules as the primary patient education tool for effective risk factor modification. The application of these clinically proven software tools, all applied at the point of patient care, may assist physician compliance with ACC guideline based AUC and may directly result in an increase in SIHD patients treated with guideline directed medical treatment as well as guideline directed interventional treatment. It is anticipated that this increased compliance with ACC guidelines and AUC may directly correlate with improved patient clinical outcomes.

Eligibility Criteria:
INCLUSION CRITERIA:

1. Patient presents for evaluation of SIHD and meets patient eligibility criteria as defined as SIHD Group A or SIHD Group B patient.
2. Patient is over 21 years of age
3. Patient is a stable clinic patient with the intention to continue in continuous medical care for the duration of the registry.

EXCLUSION CRITERIA:

1. Patient is diagnosed with acute coronary syndrome (unstable angina, myocardial infarction -either non-STEMI or STEMI)
2. Patient has a concomitant medical illness that may limit survival to less than 1 year
A Study to Investigate the Absorption, Metabolism and Excretion of Talampanel

The purpose of this study is to characterize the chemical breakdown and excretion of talampanel and its break down products in plasma, feces, and urine of healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Males, between 18 and 55 years of age, inclusive
* Body Mass Index range 18.0 to 30.0 kg/m2, inclusive
* Have NAT2 slow or rapid acetylator genotype
* In good health as determined by the investigator
* Negative test for selected drugs of abuse at screening
* Negative screens for Hepatitis B, Hepatitis C and HIV
* Sterile or agrees to use an approved method of contraception from Check-in until 45 days following Clinic Discharge
* Able to comprehend and willing to sign an Informed Consent Form
* Have 1 to 2 bowel movements per day

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, skin, liver, kidney, blood, heart or blood vessel, digestive system, brain or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection
* History or presence of an abnormal ECG,
* History of clinically significant alcohol or drug use within 1 year prior to Check-in
* Participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in
* Exposure to significant radiation within 12 months prior to Check-in -Use of any tobacco- or nicotine-containing within 6 months prior to Check- in
* Use of any drugs which may interact with the study drug within 30 days prior to Check-in
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in
* Use of any prescription medications/products within 14 days prior to Check in
* Use of any over-the-counter, non-prescription drugs within 7 days prior to Check-in
* Use of grapefruit or grapefruit-containing foods or beverages within 7 days prior to Check-in
* Use of alcohol- or caffeine-containing foods or beverages within 72 hours prior to Check-in
* Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion
* Receipt of blood products within 2 months prior to Check-in
* Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study
An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.

A traditional practice in many US hospitals includes use of 10-40 IU of Oxytocin mixed in various volumes of crystalloid administered at an unspecified and uncontrolled rate (quite often off the pump) in order to restore uterine tone and minimize routine blood loss in the third stage of labor. Many practitioners question high dose oxytocin regimens, timing and duration of Oxytocin administration for postpartum hemorrhage prophylaxis. Given the lack of a universally accepted, evidence based protocol, this study aims at comparing the efficacy of a traditional approach of administration of Oxytocin with an evidence-based designed algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Vaginal Delivery

Exclusion Criteria:

* Cesarean Delivery
* Allergy to Oxytocin
* Cardiac Arrhythmia
Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction

The purpose of this study is to determine whether using a pressure- vs. simple adhesive dressing affects the postoperative course and wound healing outcomes following Mohs surgery.

The investigators will randomize patients undergoing Mohs surgery to receive either a pressure or a simple adhesive dressing following their procedure. The hypothesis is that patients with the simple adhesive dressings will be more satisfied and comfortable with their wound care on follow-up. These patients are also expected to cite greater convenience managing the simple dressing at home. Finally, the investigators anticipate no difference in the number of postoperative complications between the two groups and expect that there will be a lower cost associated with the simple adhesive dressing as compared to the pressure dressing.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be considered for enrollment if they have been referred to a Mohs surgeon for consideration of Mohs surgery for non-melanoma skin cancer.

Exclusion Criteria:

* Lack of indication for Mohs
* Significant comorbidities
* Case of a high-risk location or tumor size which necessitates consultation with other specialties in advance.