cyrilzakka/clinical-trials huggingface dataset:
Adequate Definition of Delayed Graft Function in Living and Deceased Donor Kidney Transplantation

It is required to establish an adequate definition of delayed graft function in deceased donor kidney transplantation. We attempt to compare various definitions of delayed graft function and find the definition that can predict graft function survival best in deceased donor kidney transplantation.

Delayed graft function after kidney transplantation has been reported to be an important predictor for poor short and long-term survival. Delayed graft function increases post-transplantation morbidity, hospital stay, and incidence of premature graft failure. However, the definition of delayed graft function varies and more than ten definitions have been used in previous studies. Although the definition using dialysis requirements during seven days after transplantation has been used most frequently, dialysis may be required without any evidence of renal damage during one week after transplantation. Furthermore, the incidence of delayed graft function in living donor kidney transplantation using this definition has been reported to be relatively low (as low as 1.6%) compared with the incidence in deceased donor kidney transplantation (up to 50%). Therefore, it is required to establish a better definition of delayed graft function in deceased donor kidney transplantation. We attempt to compare various definitions of delayed graft function in deceased donor kidney transplantation and find the definition that can predict graft function survival best in deceased donor kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent living or deceased donor kidney transplantation between 2008 and 2013

Exclusion Criteria:

* incomplete data of postoperative creatinine during ten days after transplantation or postoperative urine output during three days after transplantation
* patients who underwent retransplantation
* patients who expired for reasons other than kidney transplantation
Open Suction vs. Closed Suction in ARDS

The alveoli tend to collapse in patients with ARDS. Endotracheal aspiration may increase alveolar collapse by decreasing the end-expiratory lung volume. The hypothesis is that closed endotracheal aspiration led to less end-expiratory volume loss when compared to open endotracheal aspiration.


Eligibility Criteria:
Inclusion Criteria:

Mechanically ventilated due to ARDS

Exclusion Criteria:

Hemodynamically unstable Air leaks syndrome (pneumothorax) Higher level of FiO2 (\>60%) Chronic obstructive pulmonary disease
Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.

This is a randomized, controlled pilot study to introduce eMedonline telemonitoring technology to CML patients taking Gleevec or Tasigna. eMedonline will be used to automatically collect time-dose specific medication data for individual patients, including dosing times, missed doses, adverse events and e-diary data. All data will be available to research staff for remote review via Web interface. Adverse events and non-adherence will prompt interventions including supportive care counseling.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older.
* Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate
* Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily
* ECOG Performance status 0, 1, or 2
* Adequate end organ function, defined as:

  * Total bilirubin \< 1.5 xULN
  * SGOT and SGPT \<2.5 x ULN
  * Creatinine \< 1.5 x ULN
  * ANC \> 1.5
  * Platelets \> 100,000
* Female patients of child bearing potential must have a negative urine or serum pregnancy test at screening.
* Patient is able to read and speak English
* Patient is willing and able to use a cell phone
* Written, voluntary informed consent

Exclusion Criteria:

* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
The Effect of Trunk Control on Sitting Balance and Upper Extremity Functions in Patients With Subacute Stroke

The study aims to examine whether trunk control affects sitting balance and upper extremity functions in patients with subacute stroke.

Patients who meet the inclusion and exclusion criteria will be informed about the study and the participants who agree to participate in the study will be given the "Mini-Mental Test" and "Brunnstrom Upper Extremity Staging" tests, respectively. Then, Trunk Impairment Scale, Trunk Control Test, Function in Sitting Test, and "Fugl Meyer Upper Extremity Test" will be applied respectively.

Thirty patients with stroke will included in the study. Trunk Impairment Scale and Trunk Control Test will used to assess trunk control assessment. Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. Function in Sitting Test will used to assess sitting balance. To evaluate between correlation trunk control and upper extremity and sitting balance will used to correlation analysis tests

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with stroke and being in the subacute period (stroke onset time is between 0-6 months),
* Over 18 years old,
* Mini-Mental Test score ≥ 24 points,
* Able to sit independently in a chair for 10 minutes
* To be able to understand and follow simple explanations.

Exclusion Criteria:

* Having been diagnosed with a brain stem or cerebellar stroke,
* Having neurological or orthopedic pathology,
* Having acute low back pain,
* Having undergone surgery in the last 6 months,
* Having neglect, aphasia and heminanopsis.
A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo

The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with vitiligo.

A secondary objective is to further evaluate the safety of TEV-53408.

The planned study period per participant is 84 weeks including a screening period (up to 4 weeks), a 24-week open-label treatment period, a 16-week washout period, and a 40-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a diagnosis of active or stable vitiligo for at least 3 months.
* The participant has a body mass index (BMI) within the range of 18.5 to 40.0 kg/m2
* A female participant is eligible if she is not pregnant or breastfeeding AND is a woman of nonchildbearing potential OR is a women of childbearing potential using a contraceptive method that is highly effective AND agrees not to donate eggs for the purpose of reproduction for the required period
* A male participant is eligible if he agrees to refrain from donating sperm PLUS remain abstinent from heterosexual intercourse OR use a male condom with a female partner for the required period
* The participant is capable of giving signed, informed consent
* The participant agrees to discontinue all agents and procedures used to treat vitiligo during the treatment period in the trial
* If receiving permitted concomitant medications for any reason other than vitiligo, the participant must be on a stable regimen,
* The participant must agree to avoid prolonged exposure to the sun, must use sunscreen, and must not use tanning booths, sun lamps, or other ultraviolet light sources

NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The participant suffers from vitiligo induced by exposure to chemicals or immunotherapy known to induce vitiligo
* The participant has other autoimmune diseases for which systemic immunotherapy is or may be warranted
* The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding fully-treated basal cell carcinoma
* Infectious disease
* The participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas
* The participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo. After 2 or more years since last melanocyte-keratinocyte transplantation procedure, the participants may be included in the trial.
* The participant has donated or received any blood or blood products (white blood cells, platelets, etc) within the 60 days prior to screening or has donated blood or blood products on 2 or more occasions within the 6 months prior to IMP administration, or has donated plasma within 7 days before the screening visit, or has planned donations during the trial
* The participant has current or history of alcohol or other substance abuse

NOTE- Additional criteria apply, please contact the investigator for more information
Monocyte Distribution Width (MDW): An Early Marker of Sepsis in Patients With Comorbidities

In patients with the aforementioned comorbidities, septic conditions are common and associated with high mortality rates. Early diagnosis, along with prompt and appropriate management, has become a major challenge for emergency departments. However, it is often difficult to determine whether sepsis is the primary factor behind clinical decompensation, especially in patients with complex comorbidities where symptoms may be nonspecific and overlap with other causes of deterioration. This diagnostic uncertainty complicates the timely initiation of targeted treatment, making the role of biomarkers even more crucial.

The measurement of sepsis biomarkers is widely used in clinical practice to enhance diagnostic accuracy, but there remains a need for a more reliable biomarker. A biomarker with higher sensitivity and negative predictive value (NPV) is essential for the early initiation of treatment. Several European and American studies have demonstrated the added value of MDW as an early predictor of sepsis in patients admitted to intensive care units, as well as its diagnostic performance when combined with the qSOFA score.

In the literature, the MDW threshold is established at 21.5, offering optimal diagnostic power with good sensitivity and specificity, supporting its clinical application and its approval by the United States Food and Drug Administration (FDA) and the European Conformity (CE).

In Tunisia, few studies have focused on the effectiveness of this non-invasive tool in septic patients in emergency settings and its reliability in this context, highlighting the relevance of our research.

We will test the effectiveness of MDW in the early diagnosis of sepsis as a factor of decompensation in patients with comorbidities: renal failure, heart failure, and COPD.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years admitted to the emergency department for decompensation of congestive heart failure or renal failure, or exacerbation of COPD.

Exclusion Criteria:

* Patients who received antibiotic treatment in the past 7 days, pregnant women, children, non-consenting patients, patients with a history of malignant hematologic disease, polytransfused patients or those who recently received a transfusion, and patients whose MDW was not reported due to ineffective monocyte counting.
Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects

This study is being done to learn more about normal thinking and behavior, mild thinking and behavior problems, Frontotemporal Dementia and other forms of dementia in families in which one or more relatives have a mutation associated with Frontotemporal Dementia.

This multicenter study will enroll 300 members of familial Frontotemporal Dementia (FTD) families across 8 experienced FTD research centers with a known mutation in MAPT, PGRN, or C9ORF72 (100 mutation carriers with mild dementia or minimally symptomatic yet non-demented, 100 asymptomatic mutation carriers, and 100 clinically normal relatives who are non-mutation carriers) to obtain annual assessments including T1-MRI, FLAIR, diffusion tensor imaging (DTI), ASL perfusion (ASLp), intrinsic connectivity functional MRI (icfMRI), MR spectroscopy (MRS), CSF, blood, and behavioral, neuropsychological and functional assessment, for a total of three assessments per participant.

A primary goal of this study is to identify the most robust and reliable methods to track disease progression in familial FTD so that disease-modifying therapeutic trials can be designed appropriately.

Eligibility Criteria:
Inclusion Criteria:

1. Must be a member of family with a known mutation in one of the three major FTLD related genes: MAPT, PGRN, or C9ORF72.
2. At least 18 years of age.
3. The predominant phenotype in the kindred must be cognitive/behavioral (ie, kindreds in whom parkinsonism or ALS is the predominant clinical phenotype among affected relatives may be excluded)
4. Have a reliable informant who personally speaks with or sees that subject at least weekly.
5. Subject is sufficiently fluent in English to complete all measures
6. Subject must be willing and able to consent to the protocol and undergo yearly evaluations over 3 years.
7. Subject must be willing and able to undergo neuropsychological testing (at least at baseline visit).
8. Subject must have no contraindication to MRI imaging.

Exclusion Criteria

1. Known presence of a structural brain lesion (e.g. tumor, cortical infarct).
2. Presence of another neurologic disorder which could impact findings (eg, multiple sclerosis).
3. Subject is unwilling to return for follow-up yearly, undergo neuropsychological testing and MR imaging.
4. Subject has no reliable informant.
A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed

The purpose of this study is to evaluate the steady state pharmacokinetics (PK) of rilpivirine (RPV) and determine the appropriate dose of RPV in combination with other antiretrovirals (ARVs) in participants aged greater than or equal to 2 to less than 12 years and to evaluate the safety and tolerability of RPV in combination with other ARVs in participants of same age group over a 48-week treatment period with primary endpoint at Week 24.

Participants infected with human immunodeficiency virus type 1 (HIV-1) are routinely treated with combinations of multiple drugs which reduces HIV-1 ribonucleic acid (RNA) to undetectable levels in a substantial proportion of participants and counteracts the risk of viral resistance development. RPV is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) with in vitro activity against wild type (WT) HIV-1 and against NNRTI-resistant HIV-1 mutants. A medical need still exists for the development of age/weight appropriate formulations in children less than (\<) 12 years of age. In this study, participants will switch to RPV plus other ARVs. The primary analysis will be performed at Week 24. A participant will be considered to have completed the study if he or she has completed assessments at Week 48 of the study intervention phase. The total study duration for each participant, including screening and study intervention phases, will be approximately 54 weeks. Key efficacy assessments include determination of plasma HIV-1 RNA viral load and measurement of CD4+ cell count. Key safety assessments will include the monitoring of (serious) adverse events (\[S\]AEs) and HIV-related events, clinical laboratory tests, cardiovascular safety monitoring (vital signs and 12 lead electrocardiogram \[ECGs\]), and physical examination (including growth).

Eligibility Criteria:
Inclusion Criteria:

* Weighing at least 10 kilogram (kg) at screening
* Have documented chronic Human Immunodeficiency Virus (HIV-1) infection
* On a stable antiretroviral (ARV) regimen for at least 6 months prior to screening and virologically suppressed with documented evidence of at least 2 plasma viral loads less than (\<) 50 HIV-1 ribonucleic acid (RNA) copies/milliliter (mL): one within 2-12 months prior to screening and one at screening
* Can switch from any ARV class
* Never been treated with a therapeutic HIV vaccine
* Historical HIV-1 genotyping result at screening for children aged \>=2 to \<6 years (and for children aged \>=6 to \<12 years if a historical HIV-1 genotyping result is available at screening) must demonstrate sensitivity to RPV and to the selected background ARVs

Exclusion Criteria:

* Have previously documented HIV-2 infection
* Have known or suspected acute (primary) HIV-1 infection
* Taken any disallowed concomitant therapies within 4 weeks before the planned first dose of study intervention
* Any current or history of adrenal disorder
* A history of virologic failure to ARVs with or without availability of an HIV-1 genotype result at the time of failure
Patient Perceptions of Physician Education and Quality by Race

Research has documented positive effects of doctor-patient race concordance, suggesting that increasing diversity among healthcare professionals may play an important role in addressing well-documented racial health disparities in the US. It also remains critical to improve the quality of interactions in race discordant doctor-patient relationships. However, as health systems consider policies to increase the number of minority healthcare professionals, especially among doctors, questions about the equilibrium effects of such initiatives naturally emerge. In this project, the investigators examine whether and how patients vary their perceptions of healthcare professionals by race.

Research has documented positive effects of doctor-patient race concordance. Given the low representation of minorities among doctors in the US, this evidence suggests that the path to addressing well-documented racial health disparities involves both increasing diversity among healthcare professionals and improving the quality of interactions in race-discordant doctor-patient relationships. Increased focus on improving minority representation among healthcare professionals, and especially among doctors, naturally raises questions about the equilibrium effects of such initiatives. In this study, the investigators aim to explore one potential avenue for equilibrium effects. A growing literature examines how doctors' behavior and beliefs change with patient race and potentially affect the quality of healthcare interactions. This project examines whether and how patients vary their perceptions of the quality of doctors based on race. Significant variation in the perceived quality of minority healthcare professionals could adversely affect the quality and effectiveness of healthcare interactions involving these professionals. Moreover, the range of potential negative patient attitudes that could be encountered in day-to-day clinical practice may also be considered an anticipatory tax and another barrier for prospective minority trainees.

This projects aim to test the following hypotheses: (1) whether subjects believe Black experts are less educated compared with White experts; (2) whether subject believe Black experts are lower quality compared with White experts; (3) whether there is any variation in these two outcomes based on respondent race. The investigators also explore a potential mechanism by examining the extent to which differences in patients' beliefs about the likely occupation of individuals explains differences in patients' beliefs about educational attainment and quality. In this case, the investigators hypothesize that the race of the individual in the photo may be affecting the weight that individuals put on the "expert attire" treatment.

Eligibility Criteria:
Inclusion Criteria:

- participant identifies as Black or White

Exclusion Criteria:

* participant doesn't identify as Black or White
* younger than 25 years old
European CURE-AF Study

A prospective, non-randomized, multi-center clinical trial. The patient population includes patients with permanent or persistent AF requiring valve replacements or repairs, ASD repairs, PFO closure or coronary artery bypass grafts (CABG) procedures. Patients are not allowed to have had previous atrial ablation, AV-nodal ablation, or surgical Maze procedure.

The Cardioblate Surgical Ablation System is cleared in Canada and Europe for ablation of cardiac tissue for the treatment of cardiac arrhythmias. In the United States, the Cardioblate bipolar is approved for soft tissue ablation, while the Cardioblate Pen is approved for cardiac tissue ablation. The purpose of the clinical study is to obtain a labeling claim for the US market that the Cardioblate Surgical Ablation System can be used for ablation of cardiac tissue in the treatment of cardiac arrhythmias such as atrial fibrillation among permanent and persistent AF patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following criteria to be enrolled in the study:

  1. Documented history of AF a For inclusion in permanent AF arm: Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines; Documentation of AF must include one or more chart references to AF and/or one or more ECG's with AF prior to the patient's surgery. Other supporting information could include references to cardioversion attempts using either drugs or electrical shock. b For inclusion in persistent AF arm: Patients must have a documented history of persistent AF as defined by the ACC/AHA/ESC Guidelines: characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days
  2. Concomitant indication (other than AF) for open-heart surgery for one or more of the following:

a Mitral valve repair or replacement, b Aortic valve repair or replacement, c Tricuspid valve repair or replacement, d ASD repair, e PFO closure, or f CABG procedures; 3 Able to take the anticoagulant warfarin or other ACC/AHA/ESC-recommended anticoagulant medication; 4 Greater than or equal to 18 years of age; 5 Able and willing to comply with study requirements by signing a Patient Informed Consent form.

Exclusion Criteria:

* Patients who meet any of the following criteria may not be enrolled in the study:

  1 Wolff-Parkinson-White syndrome, 2 NYHA functional class = IV, 3 Left ventricular ejection fraction ≤ 30%, 4 Left atrial diameter \> 7.0 cm, 5. Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery, 6 Preoperative need for an intra-aortic balloon pump or intravenous inotropes, 7 Previous atrial ablation, AV-nodal ablation, or surgical Maze procedure, 8 Contraindication for anticoagulation therapy, 9 Current diagnosis of active systemic infection, 10 Renal failure requiring dialysis or hepatic failure, 11 Documented myocardial infarction 6 weeks prior to study enrollment, 12 Life expectancy of less than one year, or 13 Pregnancy or desire to be pregnant within 12-months of the study treatment.