cyrilzakka/clinical-trials huggingface dataset:
Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis

This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University.

This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University. Men scheduled for biopsy will be approached by the study nurse who will explain the study and invite the men to participate. After the patients provide written consent, she/he will obtain the following information from the patient chart: age, race (self-report, white, black, other), height, weight (for determination of Body Mass Index, a variable reported to influence PSA). Blood draw for study analytes will be coordinated with routine blood draw for PSA testing to minimize the need for an additional needle stick. A copy of the informed consent is given to the patient and the original is placed in a file for the P.I.

The biopsy status of men at the time they are invited to participate is unknown. Men are "sorted" into cancer and non-cancer groups only after their biopsies are read. Serum samples are sent to the Department of Laboratory Medicine at Wake Forest. All assays are performed "in house". Based on consultation with our urologists, we anticipate that approximately 30% of the biopsies will be positive (i.e., prostate cancer). The majority (approximately 70%) will be negative (benign). Approximately 1-2% of the biopsies may be classified as "indeterminate". Because there will not be a sufficient number of "indeterminate" pathologies to be treated as a separate category, this group will not be analyzed further. However, men with "indeterminate" biopsies are eligible for the study if they are re-biopsied.

Eligibility Criteria:
Inclusion Criteria:

* Men age \> 40 years
* Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both.
* Ability and willingness to sign a written, IRB-approved informed consent document

Exclusion Criteria:

* Men using drugs known to interfere with serum PSA or with serum PTHrP and calcium. Drugs known to interfere with PSA include 5-alpha-reductase inhibitors (Proscar). Drugs known to interfere with calcium and/or PTH include lithium and thiazide diuretics.
* Patients with prior transurethral resection of the prostate (TURP) or equivalent procedure (laser incision). In these men the reduction in prostatic volume may give a biased estimate of the relationship between PSA, calcium and PTHrP.
* Patients on dialysis. These are excluded because dialysis increases the percentage of free PSA in serum.
The Role of Off-shift Robotic Telerounding Between Physicians and Nurses in the Surgical Intensive Care Unit

Hypothesis: The use of a mobile robotic telepresence system for off-hours rounding in the surgical intensive care unit has an impact on nurse-physician collaboration.

Study question: Does the addition of mobile video communication provided by RTP affect nurse-physician collaboration during off shift rounding in the surgical intensive care unit when compared to the more common clinical practice of off-shift rounding using the telephone?

This is a mixed-method study, involving both surveys and ethnographic fieldwork. The research team will utilize the Collaboration and Satisfaction About Care Decisions (CSACD) survey instrument at regular intervals to assess nurse-physician collaboration. The instrument is validated and reliable and has been extensively tested. Permission was obtained to use the instrument. The ethnographic investigation will run concurrently and be performed by a doctoral student from Massachusetts Institute of Technology (MIT). No part of the study will involve patient intervention. The study will be conducted in the surgical intensive care unit (SICU).

The survey-based portion of the study is a prospective, randomized, crossover-controlled trial; it will generate ordinal data regarding nurse-physician collaboration and satisfaction. The ethnographic portion of the study will involve observation and interviews. The MIT student will engage in unobtrusive observational shadowing of APs and nurses throughout the study, and will formally interview each observed AP and nurse twice during the entire length of the study: once at the onset of the study, and once as the study draws to conclusion. This observational shadowing will include visits to the SICU. All participants will be consented for the study. Consent for and implementation of these methods will be undertaken in a manner consistent with current best research practice; extensive measures will be taken to protect staff confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Full time registered nursing staff
* Resident physicians and critical care attending physicians

Exclusion Criteria:

* Non-registered nursing staff
A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

This study is being conducted to validate various biomarkers in patients with RA with varying levels of disease severity. Subjects with a diagnosis of rheumatoid arthritis (RA) will be included as controls. The sudy will measure the baseline levels and the intra- and inter-subject variability of exhaled nitric oxide (NO) in patients with inactive/mild and moderate/severe RA on stable therapy or during a course glucocorticoids. In addition exhaled NO levels will be correlated with intra-articular inflammation (power Doppler ultrasonography) as well as markers of systemic inflammation (CRP, ESR).


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of rheumatoid or osteo-arthritis.
* Weight greater than 45kg (females) or 50kg (males) but not overweight.
* Non-smokers.
* Taking stable anti-inflammatory medication for Rheumatoid Arthritis (RA) or Osteoarthritis (OA) for at least 8 weeks.

Exclusion criteria:

* Taking regular doses of glucocorticoid medication (greater than 5mg/day).
* Currently taking biological treatment for RA.
* Recent participation in another clinical trial.
Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although resection was recommend for early stage (BCLC A stage) patients according to the BCLC (Barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk for those with high-risk factors. However, the clinical value is still undertermined. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for BCLC A stage patients with high-risk factors is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years;
* BCLC A stage with high-recurrence risk factor;
* Patients with resectable primary hepatocellular carcinoma;
* Child-Pugh A or B (7 score) liver function;
* The volume of residual liver more than 30%

Exclusion Criteria:

* • With unresectable HCC

  * Pregnant woman or sucking period;
  * With other malignant cancer;
  * Received anti-HCC therapy before this study
Vitamin D Supplementation in Patients With Depression

Groups (intervention group receives 50000 IU vitamin D and control group receives placebo) through a random allocation. After 8 weeks, blood sample will be collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status and anthropometry indices) will be evaluated at beginning and end of interventional period.

In this double-blind randomized clinical trial, 60 patients aged 18-60y referred to Baharlou hospital with a history of mild to moderate depression diagnosed by a psychiatrist will be presented to the researcher. After receipt of a signed informed consent form, eligible patients will participate. A general demographic questionnaire will be completed by an interviewer. Individuals are randomly divided into intervention and control groups. A 10-ml venous blood sample will be collected from each participant. The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly. The control group receives placebo. The drug schedule of both groups (if any) will be unchanged according to the prescribing physician. After 8 weeks, blood sample will be collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status, anthropometry indices) will be evaluated at beginning and end of interventional period. Data will be analyzed by statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* age: 18 to 60 y
* Having mild to moderate depression

Exclusion Criteria:

* Having a history of heart infarction
* Having a history of angina
* Having a history of stroke
* Having a history of kidney stones
* Having a history of high blood pressure (systolic blood pressure higher than 174 or diastolic blood pressure higher than 104 mm Hg)
* Having a history of liver disease
* Having a history of hyperparathyroidism
* Pregnancy and/or lactation
* Reproductive-aged women (under 50 years old) who are not receiving adequate contraception
* Consuming nutritional supplement containing vitamin D from 2 months ago
* Not willing to continue the study
* Failure to follow the Supplemental Program
Outcome Comparison Between PFNA and InterTAN

The purpose of this study is to determine whether this two intramedullary fixations are effectively in the treatment of intertrochanteric fracture.

With the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. The best recommend treatment is surgical treatment of intramedullary fixation. However, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. Meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. This new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. It can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.

Eligibility Criteria:
Inclusion Criteria:

* Adult men or women aged 18 years and older (with no upper age limit).
* Fracture of the intertrochanteric fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
* Operative treatment of fractures within 14 days of presenting to the emergency room.
* Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
* Anticipated medical optimalization for operative fixation of the hip.
* Provision of informed consent by patient or legal guardian.
* No other major trauma.

Exclusion Criteria:

* Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
* Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
* Retained hardware around the affected hip.
* Infection around the hip (i.e., soft tissue or bone).
* Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
* Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
* Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
The ELFIE-HYPERTENSION

The ELFIE-HYPERTENSION randomized clinical trial is an academic-led, collaborative, pragmatic, randomized, open-label, parallel arm, multicenter, trial evaluating whether a digital health intervention based on the Elfie solution compared with usual care will reduce systolic blood pressure in individuals with hypertension.

The ELFIE-HYPERTENSION randomized clinical trial is an academic-led, collaborative, pragmatic, randomized, open-label, parallel arm, multicenter, trial evaluating whether a digital health intervention based on the Elfie solution compared with usual care will reduce systolic blood pressure in individuals with hypertension. The study will also evaluate whether this digital health intervention compared to usual care will improve diastolic blood pressure, adherence to anti-hypertensive medication, anti-hypertensive treatment intensification, body mass index, hypertension knowledge, self-care, quality of life, and the need for unscheduled cardiovascular-related medical assessment.

The hypothesis is that the Elfie solution will improve blood pressure control in individuals with hypertension

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 75 years
* Male and female patients
* Hypertension diagnosis based on the local guidelines criteria
* Uncontrolled blood pressure (systolic blood pressure ≥ 140 mmHg) on the screening visit
* Patients in whom medication adherence needs to be improved according to the healthcare provider clinical judgment
* Use of at least 1 anti-hypertensive medication
* Ownership of an active smartphone with operational system iOS (version 13.0 or later) or Android (version 8.0 or later) with access to the internet on 3G, 4G or 5G
* Ability to use a smartphone app

Exclusion Criteria:

* Refusal to provide written informed consent
* Current use of a health app with the aim to improve medication adherence and blood pressure control
* Illiteracy to read in the local language
* Known cognitive decline, dementia, or diagnosis of severe psychiatric conditions (depression, schizophrenia, bipolar disorder)
* Known use of illicit drugs or alcoholism
* Current participation in a cardiovascular randomized clinical trial
* Life expectancy \< 1 year
Norepinephrine and Phenylephrine, Which Better for Elderly?

this is a prospective, double-blinded and single-center study. this study is based on the Stroke volume variation fluid guided therapy, to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.


Eligibility Criteria:
Inclusion Criteria:

* radical resection of colorectal or gastric cancers,
* age over 65 years old,
* surgical time longer than 2hours,
* the American Society of Anesthesiologists(ASA) classification of II or III

Exclusion Criteria:

* history of severe cardiovascular diseases,
* history of severe liver and kidney diseases,
* evidence of arrhythmia on EKG,
* use of positive end-expiratory pressure (PEEP) during mechanical ventilation;
* conditions with relative contraindication for arterial catheterization
Lake Washington Vascular VenaSeal™ Post-Market Evaluation

New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System

New WAVES is an investigator initiated protocol that will assess clinical outcomes and patient satisfaction after treatment with VenaSeal(TM)/ Cyanoacrylate Adhesive Closure System 3 years post-treatment. All patients treated from a multi-provider practice, whom meet protocol inclusion criteria, will be invited to consider participation in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years; 2. Treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the Venaseal Closure System; 3. Treatment occurred at least 30 months prior to study; 4. Ability to understand the requirements of the study and to provide informed consent.

-

Exclusion Criteria:

1. Subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after Venaseal closure; 2. Patients in whom index procedure information is unavailable; 3. Patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb; 4. Limbs that were treated in the VeClose trial (patients who participated in VeClose and later had contralateral limb treatment will be included).

-
UVA1 Light for Scleroderma and Similar Conditions

The purpose of this investigation is to evaluate the effectiveness of high-dose UVA1 irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar from growth of fibrous tissue), scleroderma (deposits of fibrous tissue in the skin) and acne keloidalis nuchae (keloids on the back of the neck or hairline) old burn scars, granuloma annulare or other similar skin conditions. This UVA1 dosing schedule has been used successfully in Germany for various skin diseases, such as the above mentioned scleroderma.

Ultraviolet rays from the sun that reach the earth surface are divided into shorter wavelength, hence high energy, UVB (290-320nm) and longer wavelength, hence low energy UVA (320-400nm). The wavelengths of light that cause sunburn and are associated with skin cancer causation is the high energy UVB. UVA wavelengths can be further divided into relatively shorter wavelength, hence higher energy UVA2 (320-340nm) and longer wavelength, lower energy UVA1 (340-400nm). Phototherapy light boxes used in our clinic for the treatment of psoriasis, atopic dermatitis, and pruritus, as well as those used in tanning salons emit both UVB and UVA wavelengths of light. The advantages of using UVA1 light source in the treatment of skin conditions are 1) lack of skin cancer and sunburn causing rays (UVB) and 2) as a consequence, the ability to treat patients more safely and longer.

Keloid, scleroderma, acne keloidalis nuchae, and burn scars are all characterized by collagenous thickening of the skin resulting in superficial and deep cutaneous sclerosis. Treatments for these disabling conditions are inadequate at present. Recently, in non-controlled studies, UVA1 was shown to induce improvement in patients with scleroderma, granuloma annulare and urticaria pigmentosa (1-3). The mode of action of UVA1 treatment is not completely understood, however, local immuno-modulation appears to be important (4). UVA1 has also been shown to stimulate collagenase activity in a dose dependent manner in the dermis (5,6). We postulate, therefore, that UVA1 in appropriate doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen.

Based on the result of this pilot study, a formal controlled clinical investigation is planned.

Eligibility Criteria:
Inclusion Criteria:

* Age: 10-80 years
* Clinical diagnosis of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare, and other related conditions associated with altered dermal matrix.
* No disease states or physical conditions which would impair evaluation of the test site.
* Willing and able to receive UVA1 as directed in the protocol, make evaluation visits, and follow protocol restrictions.
* Signed, written, witnessed, informed consent form.
* Must live within driving distance of Ann Arbor, Michigan.

Exclusion Criteria:

* History of photosensitivity.
* Pregnant or nursing women.
* Systemic therapy for the fibrosing skin condition within 30 days prior to study enrollment.
* Involved in an investigational study within the previous 4 weeks.
Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with EF\>50% or without Transesophageal Echocardiography (TEE)

Exclusion Criteria:

* Patients with a history of heart failure or an EF\<= 35%.
CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

The primary objective of this pilot study is to develop a CGM-based model to predict the progression from prediabetes to diabetes in individuals with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* CF individuals aged 12-55 years.
* CF without diabetes or with prediabetes (as defined by OGTT and HbA1c).
* Willing to use a continuous glucose monitoring system with compatible smart phone for glucose data collection.

A person with CFRD and already using CGM, we will just collect their personal CGM data, and they are not required to have OGTT or HbA1c visit.

Exclusion Criteria:

* Pregnancy.
* History of transplant.
* Use of immunosuppressant drugs.
* Use of oral steroids or any medication known to interfere with glucose.
* Allergy to adhesives.
* Individuals with severe concurrent medical conditions that could confound glucose monitoring data (e.g., terminal illness, major organ failure).
* Conditions that may make unsafe for participants to do study or impair or confound the study at the discretion of the investigator
Leg Length and Quality of Life After Total Hip Arthroplasty

This study used 3D reconstructions from the EOS biplanar radiographic imaging system to perform leg length measurements before and after THA (Total hip arthroplasty) on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA and the relationships between the quality of life, estimated by the HOOS score (Hip disability and osteoarthritis outcome score), and the anatomy of the new hip in standing position.

The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.

This retrospective study used 3D reconstructions from the EOS biplanar radiographic imaging system (EOS imaging, Paris, France) to perform leg length measurements before and after THA on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA. Included patients either had hip osteoarthritis or femoral head osteonecrosis. Patients were excluded if they were undergoing revision surgery, or had a contralateral THA or total knee.

The performance of the surgeons was judged using the Cumulative Sum control chart (CUSUM) method.

Our objective was to study surgeon performance, measured by their ability to restore the initial preoperative length of the operated leg or to equalize the length of the two legs, and evaluate the relationships between the quality of life, estimated by the HOOS score, and the anatomy of the new hip in standing position using the EOS imaging system.

Eligibility Criteria:
Inclusion Criteria:

* unilateral total hip replacement for osteoarthritis or avascular necrosis healthy contralateral hip
* age over 18 years
* informed consent to participate in the study
* radiographs obtained after total hip replacement using the EOS imaging system, filled HOOS form
* clinical follow-up of 12 months at least

Exclusion Criteria:

* past history of contralateral hip replacement
* ipsi or contralateral knee replacement
* hip arthroplasty performed using a Kerboull cross
* post-operative complications such as infection