cyrilzakka/clinical-trials huggingface dataset:
Preoperative Imaging in DIEP Flap Breast Reconstruction

The purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast reconstruction.

This study will prospectively compare the clinical, economic and patient outcomes of preoperative imaging using either CTA or MRA with those of no preoperative imaging in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Subjects will randomly undergo either a CTA scan or an MRA scan, or no scan (control) preoperatively. An operative plan based on perforator size and course will be devised by an interventional radiologist and a plastic surgeon. The DIEP flap procedure will be planned for controls.

Subjects will not be told if the operative plan is changed intraoperatively. Flap dissection time and changes in operative plan will be recorded intraoperatively and surgeon stress will be evaluated following surgery. Pain and narcotic use will be evaluated preoperatively and on days 1-4 postoperatively. The Breast-Q will be completed preoperatively and at 3 weeks, 3 months and 12 months postoperatively. Groups will be compared in terms of all variables measured.

Eligibility Criteria:
Inclusion Criteria:

* candidate for DIEP flap breast reconstruction
* speak/read/write English
* have undergone or will undergo unilateral or bilateral mastectomy

Exclusion Criteria:

* previous abdominal surgery that may preclude a DIEP flap reconstruction
* active smoker
* BMI over 35
* severe claustrophobia
* sensitivity to intravenous CT contrast medium (Visipaque 320) or MR contrast medium (Gadovist 1.0)
* urgency of surgery that precludes study enrollment
GlucoClear ICU Study

The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.

Design: Non-randomized, non-treatment, prospective, open label Study.

The GlucoClear System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study subjects or the Study site clinical personnel. There will be no treatment of any subject based on the output of the System.

After providing written informed consent, subjects meeting inclusion/exclusion criteria will be monitored by the System for a maximum of 72 hours.

Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose measurements on blood glucose analyzers over the 72 hour period.

After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14 days later, and any subsequent adverse events will be documented.

Eligibility Criteria:
Inclusion Criteria:

* 18 years Surgical ICU or surgical ICU plus intermediate care unit stay ≥ 24 hours Signed consent

Exclusion Criteria:

Transplant patient End stage medical conditions or diseases Restricted venous access History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy test In another study
Is There a Worse Outcome When the Systolic Blood Pressure is Lower Than Heart Rate in Those Adult Trauma Patients With Isolated Head/Neck Injury

A systolic blood pressure (SBP) lower than the heart rate (HR) could indicate a poor condition in trauma patients. In such scenarios, the reversed shock index (RSI) is \<1, as calculated by the SBP divided by the HR. This study aimed to clarify whether RSI could be used to identify high-risk adult patients with isolated traumatic brain injury (TBI).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients having isolated TBI with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included

Exclusion Criteria:

* Patients with incomplete registered data were also excluded
Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads

Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.

Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.

Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria:

1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
2. LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)

Eligibility Criteria:
Inclusion Criteria:

* Indication for implantation of a CRT-D
* Age \>= 18 years
* Written informed consent

Exclusion Criteria:

* Already implanted LV or coronary sinus lead
* Previous unsuccessful LV lead implant attempt
* Patient is eligible for heart transplantation
* Comorbidities that results in life expectancy of less than 12 months
* Known pregnancy
* Inability to provide written patient informed consent
* Participation to another study with active treatment arm (i.e. randomized studies etc...)
* Patient is not willing or is not able to visit the study center for the study assessments within the first 3 months after implant
* Patient is not able to understand or answer the quality of life questionaire
LYNPARZA Breast Cancer in the Adjuvant Setting Japan Post-Marketing Surveillance (PMS)

To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual post-marketing use.

To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual post-marketing use.

This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.

Eligibility Criteria:
Inclusion Criteria:

* The patients who started treatment with LYNPARZA for the first time for the approved indication "Adjuvant treatment for patients with BRCA-mutated HER2 negative high recurrent risk breast cancer"

Exclusion Criteria:

* Patients who have no treatment history with LYNPARZA
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury

The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney injury (AKI) in critically ill patients.

Decreased circulating levels of active vitamin D metabolites, including 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D (1,25D), are common in critically ill patients, and lower levels are independently associated with a higher risk of acute kidney injury (AKI). Further, administration of 25D and 1,25D attenuates AKI in animal models. The purpose of this study is to assess if administration of 25D and 1,25D decreases the incidence and severity of AKI in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Admitted to the ICU within 48h prior to enrollment
* Likely to remain in the ICU (alive) for ≥72h
* Naso/orogastric tube or ability to swallow
* High risk of severe AKI

Exclusion Criteria:

* Serum total calcium \> 9.0 mg/dl or phosphate \> 6.0 mg/dL within previous 48h
* Currently receiving oral calcium supplementation
* Ingestion of vitamin D3 \>1,000 IU/day or any 25-hydroxyvitamin D or 1,25-dihydroxyvitamin D during the previous 7 days
* AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)
* History of transplantation or receiving chronic (\>7days) of immunosuppressive medications (not including glucocorticoid steroids at a dose less than or equivalent to prednisone 20 mg/day)
* Neutropenia in the previous 48h
* Active primary parathyroid disease, active granulomatous disease, or symptomatic nephrolithiasis in the previous 3 months
* Receiving cytochrome P450 inhibitors
* Chronic Kidney Disease stage V or End Stage Renal Disease
* Hemoglobin \< 7 g/dL
* GI malabsorption
* Prisoner
* Pregnancy or breast feeding
Dry Needling vs Dry Needling With ES in Patients With Neck/Shoulder Pain

First, we aim to determine if there is a difference in the rate of improvement, as measured by the Neck Disability Index (NDI) and Numerical Pain Rating Scale (NPRS), across a 6 week treatment period between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES) in subjects with upper trapezius active trigger points (aTrPs). Secondly, we want to determine if improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) alone or dry needling with intramuscular electrical stimulation (DN/IES) are maintained 6 weeks post treatment without further intervention.

Research Questions:

1. Is there a difference in the rate of improvement in NDI and NPRS across a 6 week treatment period in subjects with upper trapezius active trigger points (aTrPs) between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES)?
2. Are improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) maintained 6 weeks post treatment without further intervention? Tertiary exploration: If improvement is maintained, is there a difference in outcome maintenance between groups? Did improvement increase between 6 and 12 weeks?


Eligibility Criteria:
Inclusion Criteria:

18-59 years old have an active email account have at least one palpable active trigger point (TrP) (located in one or both upper trapezius) English speaking

Exclusion Criteria:

current or previous history of cancer active infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder smoke tobacco received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer
Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects

This study was planned to investigate the effect of premature babies receiving regular kangaroo care in the NICU on circadian rhythm, growth and physiological parameters, and breast milk cortisol levels

Kangaroo Care (KC) may have positive effects on biological phase markers of immature circadian rhythms in newborns. KC provides circadian rhythm development by reducing the stress of newborns. Skin-to- skin contact intervention, which is similar to kangaroo care, affects the ẞ-endorphin concentration, which reduces pain in premature babies, and is known to reduce cortisol levels. KC, which supports exclusive breastfeeding and breastfeeding, can affect the circadian rhythm in newborns by providing information about the time of day to newborns through the increase in breastfeeding rates and the hormones and immune elements contained in breast milk. Although there are a limited number of studies in the literature examining the circadian rhythm or sleep-wake cycle of babies in the neonatal intensive care unit, no study has been found examining the circadian rhythm of babies receiving regular kangaroo care using brain imaging methods. In this respect, the study has unique value. In addition, within the scope of the study, regular kangaroo care for three days had a positive effect on the growth and physiological parameters of babies any studies examining the effect of breast milk on cortisol levels No study was found.

Eligibility Criteria:
Inclusion Criteria:

* Being between 28+0-37 weeks of pregnancy,
* Birth weight \>1000 g,
* APGAR score \>7 at the 5th minute after birth,
* Ability to feed every 2-3 hours

Exclusion Criteria:

* Getting mechanical ventilation support
* Undergoing surgery
* Having diseases and disorders such as congenital brain malformations, meningitis, seizures, encephalopathy, congenital abnormalities, history of intraventricular bleeding, herpes, sepsis and heart or metabolic diseases.
* Taking medication that affects sleep patterns, such as theophylline, phenobarbital, midazolam, caffeine, fentalnil
* Having developed intraventricular hemorrhage
Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV

The proposed study is a substudy of ATN 106 and a cross sectional study intended to be conducted at each of the AMTUs newly participating in ATN III. The intent is to enroll all youth with behaviorally-acquired HIV who have enrolled in ATN 106. The study involves a review of the subjects' medical chart and a collection of an oral rinse sample.

ATN 114 is a cross-sectional substudy of ATN 106. In addition to sharing data collected in ATN 106, an oral rinse sample along with the subject's self reported history and medical chart abstraction of HPV vaccination status and medical chart abstraction of a history of oral condylomata, oral dysplasia and oral tumor viruses will be collected in ATN 114.

Recruitment is expected to last approximately one year, similar to the same timeframe for ATN 106. Enrollment may be terminated earlier at the discretion of the ATN Executive Committee and/or the ATN 114 protocol team should ATN 106 also terminate enrollment early. Individuals who have agreed to participate in ATN 106 may be simultaneously approached at any clinic visit, or, for community-based sites, contacted directly for participation in ATN 114. Site staff may also contact individuals via phone, e-mail, or any other agreed-upon methods of communication. Site staff should try as much as possible to incorporate the study visit into a regularly scheduled clinic visit.

Eligibility Criteria:
Inclusion Criteria

* Behaviorally acquired HIV-infection as indicated by medical chart abstraction or self-reported history of sexual risk and/or needle using behaviors; and
* Completion of the ATN 106 study visit (the same day or up to a maximum of 14 calendar days).

Exclusion Criteria

* Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to complete the study measures;
* Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or
* Intoxicated or under the influence of alcohol or other substances at the time of consent/assent for ATN 114.
Assessment of Respiratory Symptoms After Corticosteroid Treatment Period Using Impedance Pneumography

INTRODUCTION

Lung function assessment of preschool children is hindered by their limited co-operation in conventional tests such as peak expiratory flow (PEF) or spirometry and the methods available for younger children are, again, laborious and time consuming. However, impedance pneumography (IP) records indices of airway obstruction during normal sleep at home and has been shown accurate in wheezy preschool children (Seppä et al. J Appl Physiol 2013).

AIM OF THE STUDY

The general purpose of this study is to assess the clinical value of the information provided by overnight home recording of tidal breathing by means of IP technique in young children with asthmatic symptoms and inhaled corticosteroid (ICS) medication.

The main hypothesis is that IP measurement can distinguish between groups whose asthmatic symptoms recur or do not recur after ending the ICS drug treatment period.

METHODS

The study recruits 1-5 year old children (n=75) who have presented at the emergency room due to obstructive bronchitis and for whom an ICS drug treatment period has been prescribed based on the national guidelines.

The subjects will perform three overnight IP measurements at home at two weeks intervals close to and after ending of the treatment period.

SIGNIFICANCE OF THE STUDY

Being an affordable, simple and convenient ambulatory measurement method, IP may bring needed objectivity to asthma diagnostics and asthma drug response assessment in young children.

QUALITY CONTROL AND QUALITY ASSURANCE

Information of study personnel and training All personnel involved with the use of the IP measurement device will be instructed by Ville-Pekka Seppä.

Protocol amendments Essential amendments in the research protocol will be reviewed by the institutional review board and informed to National Supervisory Authority of Welfare and Health (Valvira).

DATA HANDLING AND RECORD KEEPING Electronic data collection Electronic data will consist of IP recorder device data files (.ipr). Upon complete protocol execution there will be three files for each patient. These files will be stored in a computer in TAYS Allergiakeskus.

Data management Access to all collected patient information and the patient information collected before the study in the primary care centers will be accessible to RN Tiina Mäki (0503439195), MD Marita Paassilta, and MD Jussi Karjalainen of Allergiakeskus.

Research group members from TUT will have access only to data that does not enable identifying individual patients and where individual patients are referred to by participant codes.

Study subject register The study subject register will be treated per the Finnish Personal Data Act article 10.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-5 yrs
* Recurrent obstructive bronchitis
* Inhaled corticosteroid treatment has been prescribed

Exclusion Criteria:

* Laryngeal disease
* Tracheobronchial malacia
* Parenchymal lung disease
* History of bronchopulmonary dysplasia
* Active implantable medical such as pacemakers
BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility

The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 23-33 years who underwent IVF due to unexplained infertility
* patients provided urine, blood, and follicle fluid (FF) samples on the oocyte retrieval day
* patients who did not smoke or use alcohol
* patients did not work in the plastic industry

Exclusion Criteria:

* patients who underwent IVF due to low ovarian reserve or tubal factor or male factor indications
* patients diagnosed with endometriosis
* patients with freeze-all cycles
* women with metabolic disease (such as hypertension or diabetes mellitus)
* patients with a known genetic problem (male or female)
Peer Delivery of HIV Self Test to Improve Linkage to HIV Prevention

Hypothesis: HIV-Self-Test (HIV-ST) will allow peers or peer-networks to effectively and efficiently link older adolescent girls and young women into HIV prevention and care services.

Design: A cluster randomized control trial comparing two models of peer delivery of HIV-ST, through incentivized respondent driven peer networks and direct distribution by peer navigators compared to standard of care (referral to HIV testing, prevention and care services by peer navigators) in improving the uptake of HIV prevention and care amongst young women (18-24) living in the rural uMkhanyakude district of KwaZulu-Natal, South Africa.

Objectives:

1. To increase the knowledge of HIV status among young women aged 18-24 years old through distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into HIV testing services.
2. To determine an increase in the rate of linkage among young women aged 18-24 to HIV prevention and treatment services facilitated by distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into services.
3. To conduct a process evaluation of the acceptability, feasibility, and reach (out of school, recently migrant and living in remote areas) in linking 18-24-year-old women to HIV prevention and treatment services of HIV-ST distribution through incentivized peer networks, or direct distribution by peer navigators or peer navigators referring into services.
4. To measure the cost per 18-24-year-old linked to prevention and care through peer-led incentivized HIV-ST delivery system or direct distribution of HIV-SS by peer navigators, compared to peer navigator referring into services.

Primary Outcomes:

The difference between the rate of linkage within three months of 18-24 years old women to HIV confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive. It will be between the two peer-delivery approaches to HIV-ST distribution (incentivized HIV-ST delivery through peer network and direct distribution of HIV-ST by peer navigators) compared to standard of care (peer navigator referral to HIV testing, treatment and prevention services). Rate is defined as the number of linkages per month of peer navigator outreach activity.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Aged 18-24 years
* Not currently on ART
* Provide written informed consent

Exclusion Criteria:

* Under 18 years or older than 24 years
* Participants not willing to consent or unable to provide informed consent
* Males
* Currently on ART