cyrilzakka/clinical-trials huggingface dataset:
Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome

The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome

The acute respiratory distress syndrome (ARDS) has a high mortality rate in children. Adverse long term sequelae, and in particular respiratory sequelae, have been described mainly in adults. Decrease in diffusing capacity, lung volume and exercise tolerance were observed. Lung function parameters improve during the follow-up until 6 month after discharge from the pediatric intensive care unit (PICU). After that, abnormalities in PFT are observed in a significant proportion of patients. Only two studies described long-term sequelae in children surviving to an ARDS and their results are conflicting. Two studies carried out in adults described the morphologic long-term sequelae by thoracic computed tomography. They showed reticular pattern with a striking anterior distribution in most patients evaluated more than 6 months after discharge from the PICU. There is, to our knowledge, no study describing morphologic pulmonary sequelae by thoracic computed tomography in children surviving to ARDS.

Respiratory assessment: respiratory sequelae in children surviving to the acute respiratory distress syndrome will be evaluated 1 year after discharge from the PICU. Assessment will include a clinical evaluation (respiratory history and physical examination), respiratory function tests and thoracic computed tomography

Eligibility Criteria:
Inclusion Criteria:

* children surviving to an acute respiratory distress syndrome and alive 1 year after discharge from the PICU

Exclusion Criteria:

* children suffering from neuromuscular disease
* children presenting symptoms of chronic respiratory disease before ARDS
Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters. The investigators hypothesize that the use of intra-operative CRRT in OLT recipients is associated with increased solute removal and improved acid-base statues when compared to controls who do not receive CRRT

as above

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older and able to sign consent (or surrogate)
* Receiving liver or combined liver-kidney transplant
* eGFR \< or equal to 40 ml/min immediately prior to transplant or currently on any form of renal replacement therapy for acute kidney injury or end-stage renal disease
* Pre-operative potassium of \< or equal to 5.5 mEq/L

Exclusion Criteria:

* Pre-operative hemoglobin \< or equal to 7 g/dL
* Pre-operative weight \> or equal to 125 kig
Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe

In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce mother-to-child HIV transmission. However, loss to HIV care after delivery has emerged as an important threat to the hoped-for impact of Option B+. Evidence suggests that one important contributor to postpartum loss to HIV care is perinatal depression (PND). In non-pregnant HIV-infected populations, depression has been linked to poor ART adherence, reduced engagement in care, and ultimately worse HIV clinical outcomes. Thus, interventions that integrate PND treatment with targeted support for HIV care retention are critical to the success of Option B+.

The Friendship Bench is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. It is proven to reduce depression in the general population in low-resource settings, but has not been adapted to address PND, or enhanced to support engagement in HIV care. The Friendship Bench offers an ideal framework for integrating retention support into a proven depression treatment model. Our long-term goal is to adapt, test, and scale up resource-appropriate interventions to reduce PND and improve engagement in HIV care. The objective of this proposal is to lay the groundwork for an effectiveness trial by adapting the Friendship Bench intervention to address PND and support engagement in care among perinatal HIV-infected women and assessing the feasibility, acceptability, and fidelity of the adapted intervention in Lilongwe, Malawi. In-depth perspectives on PND and its role in engagement in care will be gathered from HIV-infected women with PND, healthcare providers, clinic directors, and Ministry of Health officials using qualitative interviews and focus groups. This formative research will be used to develop an intervention protocol adapted to the unique needs of HIV-infected women during the perinatal period (Adapted Friendship Bench) and further enhanced to support engagement in HIV care (Enhanced Friendship Bench). The Adapted and Enhanced Friendship Bench interventions will be compared to enhanced standard care in a 3-arm pilot study. Feasibility, acceptability, and fidelity will be assessed at 6 months postpartum, along with the interventions' preliminary effectiveness across several mental health and engagement in HIV care measures.


Eligibility Criteria:
Women

Inclusion criteria:

* HIV-infected, pregnant women initiating or re-initiating ART during antenatal care (ANC)
* ≤30 weeks gestation to allow sufficient time for approximately 4 prenatal counseling sessions and approximately 2 postnatal counseling sessions.
* Screened positive for depression with a score \> 8 on the Self-Reporting Questionnaire 20-item (SRQ-20)
* At least 18 years of age

Exclusion criteria:

* Women already successfully established on ART will be excluded because they are at a lower risk for disengagement from HIV care.
National Education Programme for Patients With Chronic Adrenal Insufficiency

Even under established replacement therapy, patients with adrenal insufficiency still suffer from impaired quality of life and experience adrenal crises. Patient education is regarded as important preventive measure. In this study a german-wide standardized education Programme will be evaluated.

Design aspects:

In a prospective trial the efficiency of a german-wide education programme in patients with chronic adrenal insufficiency will be evaluated by using a questionnaire before and after training.

Patients:

Patients will be recruited out of the patient population of the participating nine medical centers. To achieve a anticipated number of 450 patients, each center will include al least 50 patients with chronic adrenal insufficiency under established replacement therapy .

Trial flow:

During sessions of 90 minutes duration, patients and relatives are educated in basic knowledge on adrenal insufficiency including the correct behaviour in emergency settings. Participants are provided with emergency cards and sets and are trained in self-injection of glucocorticoids. To evaluate the standardized education programme, patients complete three questionnaires (before, shortly after and 6-9 months after the training) at nine endocrine centres. All centres had been certified by the German Endocrine Society for the education programme. Questionnaires assess general knowledge on adrenal insufficiency and document the influence on patients' feeling of security.

Statistical Analysis:

Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. Data analysis is mainly descriptive.

Stopping rules:

Participation of patients is fully voluntarily. Patients are able to stop participation in the study at any point in time. In addition, patients might claim the elimination of all data material at any point in time.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* patient's written informed consent
* Ability to comply with the protocol procedures
* patients with primary or secondary adrenal insufficiency under established stable replacement therapy
Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.

RCC represents around 3% of all cancers, with the highest incidence occurring in Western countries . Within the several RCC risk factors identified, smoking, obesity, and hypertension are most strongly associated with RCC .

The EUA guidelines recommend PN for patients with T1 tumors, as PN preserved kidney function better after surgery, thereby potentially lowering the risk of development of cardiovascular disorders as well as improving overall survival(OS) for PN compared to RN, there is very limited evidence on the optimal surgical treatment for patients with larger renal masses (T2) .

Currently, the upper limit of PN indications remains undefined and is determined by an individual surgeon's expertise and preference. The degree of variability in the choice between PN and RN for a given tumor increases with tumor size. Surgeons committed to nephron-sparing are likely to expand the indications of PN, while those concerned with increased morbidity and doubtful of the clinical relevance of a moderate decrease in renal function are likely to perform RN, regardless of tumor size .


Eligibility Criteria:
Inclusion Criteria:

* Patients with localized RCC ≤ 10 cm in preoperative contrast enhanced imaging(T1 and T2a).

Exclusion Criteria:

* Patients who had other tumors
* benign tumors
* clinically unfit
* metastatic RCC
* patients with Clinical T2b or higher tumors,
* tumors with maximum diameter \> 10cm
Incidence of Obstetric Anal Sphincter Injuries After a Protection Training

This is a retrospective cohort study. This two cohort study seeks to compare the incidence of obstetric anal sphincter injuries (OASIS) in two time periods, before and after an educational workshop for improved perineal support.

Perineal trauma during vaginal delivery is a major health issue associated with significant morbidity. It has been associated with many long term sequelae, including urinary and fecal incontinence. Specifically, third and fourth degree lacerations are known risk factors for the development of fecal incontinence.

Due to their serious impact, third or fourth degree perineal tears are a commonly tracked adverse event in obstetric care (Agency for Healthcare Research and Quality and Joint Commission). As such, incidence data will soon be available to third-party payers and to the public on the Internet. Moreover, functional impairment after perineal lacerations continues to be a significant impetus for legal claims. Thus, reducing OASIS while preserving maternal and fetal outcomes is an important goal in clinical obstetrics.

At the two TriHealth tertiary care institutions, the overall rate of OASIS is 3.5%. This is comparable, but not superior, to published rates at other centers. In fact, the literature is quite variable, with reported incidences ranging from 0.25-6%. Indeed, TriHealth has recently set up a task force to reduce these injuries as part of recent endeavors for quality improvement. Prevention is the first step in improving these complications.

This study seeks to decrease the incidence of obstetric and anal sphincter injuries that may occur during the birthing process by bringing in a notable physician to review techniques with the obstetrics residents to help avoid these injuries then observe the deliveries of the women enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Obstetrics resident patients
* 18 years and older women who delivered vaginally between Oct. 2014 and Dec.2016

Exclusion Criteria:

* Women who delivered by cesarean section, preterm deliveries (less than 32 weeks), and multiple gestations
Atrial Fibrillation Burden and Long-term Risk of Thromboembolic Complications- the FinCV-4 Study

This study explores the association of symptomatic episodes of atrial fibrillation (AF) occurrence and long-term risk of thromboembolic complications in a retrospective setting.

The study population consists of the FinCV-dataset, which includes 7660 acute cardioversions for atrial fibrillation. The electronic patient records of FinCV-study patients are reviewed to collect data on anticoagulation, number of cardioversions as well as mortality and stroke data. We seek to explore the possible association between the frequency of AF paroxysms in low stroke risk patients and the occurrence of death, stroke and major bleed as well as the net clinical benefit of anticoagulation. Data collection is performed by reviewing electronic patient records.

Eligibility Criteria:
* primary diagnosis of atrial fibrillation (ICD-10 code I48)
* Cardioversion for acute (\<48 h) atrial fibrillation
* \>18 years of age
* living within the catchment area of the hospital
Plethysmographic Perfusion Index and Fluid Responsiveness

The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care.

In patients with acute circulatory failure, it is recommended to assess fluid responsiveness. Fluid responsiveness is defined by an increase in cardiac output of 10 to 15% after fluid loading. The assessment of fluid responsiveness usually needs cardiac output monitoring (or stroke volume). However, in limited resource settings or during the initial management of patients with acute circulatory failure, cardiac output measurement is usually unavailable. The perfusion index (PI) is derived from the plethysmographic signal of the pulse oximeter and represents the ratio between the ratio of pulsatile on non-pulsatile light absorbance of the plethysmography signal. The PI is influenced by vascular and stroke volume. The investigators hypothesized that the peripheral index could track the changes in cardiac output induced by fluid loading and therefore detect fluid responsiveness.

Adult patients with acute circulatory failure in whom physicians want to test the fluid responsiveness will be included. At baseline, the PI will be recorded. An initial echocardiography will be performed to measure the left ventricular outflow tract velocity time integral (a surrogate of stroke volume). A fluid loading with 500 ml of 0.9% Saline or Ringer Lactate will be performed. After fluid administration, the velocity time integral and the PI will be collected. Fluid-responsive patients are defined by a 15% increase in velocity time integral. The investigators will analyze the ability of the PI to detect fluid responsiveness.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 and older with acute circulatory failure (ACF).

Exclusion Criteria:

* Low echogenicity: the inability to perform echocardiographic measurements according to established recommendations.
* Absence of the plethysmographic signal.
Addressing Food Insecurity: Plant-Based Food Prescription Program

Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be all ages 0-99 (all arms)
* Families living under the federal poverty line AND who have food insecurity (all arms except Arm 2 which can include families with income above the federal poverty line who do not have food insecurity).
* Families cared for in either the Pediatric Mobile Clinic, Pediatric, Family Medicine, Internal Medicine or Med-Peds primary care clinics in the UHealth/Jackson Health System/Dade County Street Response.

Exclusion Criteria:

* Families who are not under the federal poverty line AND are not food insecure (all arms except Arm 2, which will include participants of all socioeconomic statuses and regardless of food security status, with no exclusion criteria in this category).
* Families who are not actively receiving outpatient primary care (all arms).
Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approac

The investigators designed a prospective randomized trial to evaluate whether an app based active muscle training program (GenuSport) can improve the postoperative strength by starting rehabilitation immediately after primary anterior cruciate ligament (ACL) reconstruction surgery as already shown for patients who underwent total knee arthroplasty. To the investigators knowledge this is the first study analyzing immediate postoperative serious gaming based training with the GenuSport device based on strength improvement.

The study is designed as a prospective randomized control trial. Participants awaiting primary ACL reconstruction surgery were recruited at a single tertiary healthcare center between April 2016 and February 2018. An ethical approval has been given by MHH ethic committee and an IRB was involved. Due to different postoperative treatment protocols and different surgical approaches we could include participants between 13 and 46 years. A computer based randomization was performed by generating a list of randomized numbers which have been provided in sealed envelopes by an independent examiner. The postoperative treatment protocol was apart from the use of the GenuSport knee trainer identically standardized. The pain management was the same for all patients, none of the participants received a continuous peripheral nerve block. The postoperative physiotherapy protocol included gait training, assisted walking with crutches, active and passive knee mobilization, strength exercises and stair climbing. In the training group each participant was additionally provided with a GenuSport knee trainer device (prototype plus tablet with software application) with the active knee extension training program for 6 weeks. Except of that fact the postoperative protocol was identical in both groups. Participant had to train five times daily with the knee trainer starting at the day of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients awaiting primary ACL reconstruction surgery
* Willingness to participate
* Ability to work with an app based training device

Exclusion Criteria:

* Additional meniscal suturing
* Additional collateral ligament repair
* Additional regenerative cartilage treatment
* Unwillingness to participate in the study
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant

Use of the EnSite NavX system to map the coronary vasculature during CRT implant

Objective(s):

To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.

Inclusion Criteria:

* Subject is between the age of 18 and 75 years
* Subject is willing and able to sign a study specific informed consent
* Subject is able to fulfill study requirements
* Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV
* Have persistent CHF symptoms despite contemporary CHF medical therapy
* Stable and optimal medical therapy (stability is no changes in past 3 months).
* Documented history of ischemic or non-ischemic cardiomyopathy.

Exclusion Criteria:

* Have any standard device exclusions including tricuspid valve prosthesis/ replacement.
* Have a positive urine or serum pregnancy test (if female and of childbearing potential)
* Be currently participating in an IDE or IND study.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for CRT implant including EF\<35%, QRS\>120ms, NYHA class III or IV
* Persistent CHF symptoms despite optimization
* Stable/optimal medical therapy
* History of ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

* Any standard device exclusion including TVR
* Positive pregnancy test
* Currently participating in IDE/IND study
24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations

The primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are insufficiently controlled with latanoprost monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive primary open-angle (POAG) and exfoliative glaucoma (XFG) patients will be recruited.
* Patients included will be older than 29 years
* Have early to moderate POAG, or XFG (less than 12 mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
* Will be on therapy with latanoprost for more than 3 months;
* Have at treated baseline IOP at 10:00 (two consecutive readings) greater than 21 mm Hg
* Have a reliable visual field (at least two visual fields with less than 30% fixation losses, false positives or negatives)
* Have a best corrected distance Snellen visual acuity \> 1/10
* Have corneal pachymetry within the 550 ± 55 μm range, understand the study instructions and are willing to attend all follow-up appointments
* Are willing to comply with study medication usage
* And have open, normal appearing angles

Exclusion Criteria:

* Patients will be excluded if they have: a risk for significant deterioration during the study
* Known previous history of lack of adequate response (\< 10% reduction) to any topical glaucoma medication
* Less than 20% daytime IOP reduction on latanoprost;
* Systemic contraindications to topical beta-blockers (asthma, bradycardia, severe congestive heart disease)
* Known contraindications to prostaglandins, history of ocular herpetic disease, or cystoid macular edema
* History of trauma, inflammation, surgery or past use of steroids (within two months)
* Severe dry eyes
* Use of contact lenses
* Signs of ocular infection, except blepharitis
* Corneal abnormality that may affect IOP measurements
* Unwillingness to accept the risk for hyperchromia of the iris or development of hypertrichosis
* And females of childbearing potential or lactating mothers