cyrilzakka/clinical-trials huggingface dataset:
Engraftment Syndrome After Autologous Stem Cell Transplant: Retrospective Review in Patients With Multiple Myeloma

Engraftment Syndrome after Autologous Stem Cell Transplant: Retrospective Review in Patients with Multiple Myeloma

A retrospective chart review series will be performed fpr subjects enrolled from 1/1/2006.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Multiple Myeloma, developing engraftment syndrome

Exclusion Criteria:

* Patients with Multiple Myeloma, with no features of engraftment syndrome
Prenatal Molecular Characterisation by CGH+SNP-ARRAY of Supernumerary Marker Chromosomes and de Novo Apparently Balanced Reciprocal Translocations

In the prenatal period, les supernumerary marker chromosomes (SMC) and de novo apparently balanced reciprocal translocations are revealed by foetal karyotyping, which does not always make it possible to determine whether the anomaly is balanced or not and does not reveal uniparental disomy. The presence of these chromosomal rearrangements raises a difficult question for genetic counselling during pregnancy because of the risk of intellectual deficiency in the foetus. CGH+SNP-Array can provide information concerning 1) the balanced or not nature of these translocations 2) the presence or not of euchromatin in the SMC 3) the presence or not of uniparental disomy.


Eligibility Criteria:
Inclusion Criteria:

* Metaphase karyotyping with SMC or a de novo Apparently-balanced reciprocal translocation
* Parents covered by the National Health Insurance Agency,
* Consent of the parents

Exclusion Criteria:

* Persons not covered by the National Health Insurance Agency
* Normal foetal karyotyping or showing chromosomal anomalies not related to the present study (trisomy 18....) or inherited anomalies
* Absence of a sample from one of the parents
Novel Staging Schemes for Siewert Type II Esophagogastric Junction Adenocarcinoma: A Real-World Data Cohort Study From SEER Database

This study have two aims, the first is to explore the optimal cutoff of TLN for Siewert type II AEG using the Surveillance, Epidemiology, and End Results (SEER) database the second is to provide a more accurate staging for Siewert type II AEG patients.


Eligibility Criteria:
Inclusion Criteria:

Siewert type for adenocarcinoma of the esophagogastric junction; pathologically confirmed T1-4aN0-3M0 stage after surgery after a pathological examination of the LNs.
Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment

Sleep investigation in respirator treated ICU patients: the importance of intensive environment.

Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and increased mortality.

The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise, light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep quality in respirator treated ICU patients.

Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc. AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m. after randomization.


Eligibility Criteria:
Inclusion Criteria:

* awake and relevant respirator treated patients with expected 2 or more respirator dags

Exclusion Criteria:

* GCS \< 11
* cerebral hemorrhage or infarction during the current hospitalization
* delirium
* inotropes and/or vasopressors
Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome

The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.

Phase 3, Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects with Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months

Eligibility Criteria:
Inclusion Criteria:

* Confirmed genetic diagnosis of Prader-Willi Syndrome
* Age 12-65
* Obesity
* Age 12-17: BMI ≥ 95th percentile for age and gender
* Age 18-65: BMI ≥27 to ≤60 kg/m2

Exclusion Criteria:

* Subjects living in a group home ≥ 50% of the time
* Recent use (within 3 months) of weight loss agents including herbal medication
* Poorly controlled severe psychiatric disorders
Clinical Validation of a Predictive Test for Postpartum Depression

The goal of this observational study is to develop a blood test that may be predictive of postpartum depression. This Blood test is investigational and not yet FDA approved. Participants will not receive the results of this blood test.

Up to 500 pregnant women will be recruited for the study from 2 sites. Participants must be age 18 or above with a singleton pregnancy and able to provide written consent in English.

The Objective of this Clinical Trial is to prospectively validate the Enlighten Device test by prospectively determining false/true positive and negative rates. Building off of this, an exploratory objective of this study is to examine clinical factors associated with false positive/negative rates.

This project will address the following Aim:

Aim 1: Prospective collection of true/false positive and negative PPD outcomes through 6 months postpartum.

Primary Hypothesis H1a: 80% or greater of pregnant women who develop PPD by 3 months after delivery will be determined to be Biomarker Positive by the Enlighten Device in T3.

Primary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Device in T3 will develop PPD by 3 months after delivery.

Exploratory Aim 1: Investigation of clinical factors that may be associated with false positive and false negative rates, such as: medication use, stressful life events, and sociocultural context.

Participants will be screened during the second or third trimester and enrolled during the third trimester, before week 30 weeks of gestation. Participants may self- identify through study advertisements in participating clinics, social media outlets, and community outreach efforts. Enrolled participants will undergo blood collection during their 3rd trimester (\~27-30 weeks, a standard pregnancy-related blood collection timepoint) for completion of the Enlighten Device test, the blood-based epigenetic biomarker test. Participants will then be interviewed at 2 weeks, 6 weeks, 3 months, and 6 months postpartum for the development of depression symptoms. They'll also complete a multitude of other outcome measures at each of these visits.


Eligibility Criteria:
Inclusion Criteria:

* subject must be pregnant (singleton pregnancy)
* \<30 weeks' gestation, age 18 or above
* able to provide written consent in English

Exclusion Criteria:

* The study team and/or PI may exclude anyone deemed unsafe to participate in the protocol.
Effects of ART Simplification on Inflammatory Markers in CoRis (AIR)

The effects of the number of drugs included in antiretroviral therapy (ART) regimens of inflammatory markers remains undefined. We will evaluated in participants in the Spanish AIDS Research Network, whether triple ART, dual ART or monotherapy affect differentially the dynamics of inflammatory markers.

During treated HIV infection, higher levels of the inflammatory and coagulation markers interleukin-6 (IL-6), D-dimers, and high-sensitivity C-reactive protein (hs-CRP) are associated with an increased risk of cardio-vascular disease (CVD), cancer, and all-cause mortality. While ART decreases IL-6, D-dimer and hs-CRP levels, these biomarkers remain elevated relative to the general population even when the plasma HIV RNA is suppressed. Markers of inflammation and coagulation have been widely studied in the general population, and related to higher risk of CVD, cancer, kidney function decline and all-cause mortality. These data collectively suggest that chronic inflammation and/or hyper-coagulation contribute to the pathogenesis of these serious non-AIDS events during otherwise effective ART. Given the assumed, albeit unproven, role of these pathways in causing disease, both vascular and non-vascular, there is intense interest in studying interventions that reduce inflammation and/or coagulation.

Recent simplification strategies have demonstrated that once HIV RNA suppression is achieved, the extent of virological control does not appear to depend so much on the number of drugs, but on the time of HIV RNA suppression before the simplification. In fact, some simplification therapies, including dual regimens based in boosted-protease inhibitors (PI) have proved to be non-inferior to triple ART, provided that drug resistance has been excluded. More recently, dual therapies based in other combinations not based in boosted-PI have emerged as viable therapeutic strategies.

While these approaches of ART simplification seems to be non-inferior to standard triple therapy in terms of short-term plasma HIV RNA suppression and CD4+ T cell count dynamics, it is unknown whether ART simplification will prove safe in the long term. Mounting evidence support that the concentration of drugs, which may be related to the number of drugs, affects the extent of virological control in the tissues in which HIV persists and replicates, generating low-level viremia and contributing to chronic inflammation. It is likely that clinical trials powered to detect differences in clinical events will not be performed. Hence, the long-term clinical efficacy of ART simplification must be assessed in cohort studies and the long-term effects on inflammatory markers that independently predict mortality must be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects initiating ART in CoRIS from 2004 with triple therapy.
* HIV RNA suppression achieved in the first 48 weeks of ART.

Exclusion Criteria:

* ART initiation with regimens with less than three drugs
* Virologic failure in the first 48 weeks of ART
* AIDS conditions or serious non-AIDS events in the first 48 weeks of ART.
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.

AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis

Eligibility Criteria:
Inclusion Criteria:

* TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale
* History of sinusitis symptoms
* SNOT-22 ≥30
* No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings

Exclusion Criteria:

* Use of systemic corticosteroids within 6 weeks of screening
* Chronic use of antibiotic therapy within 3 months prior to Screening
* Nasal surgery (including polypectomy) within 6 months prior to Screening
* Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half-lives, whichever is longer
The Effect of Mobile Application Used by Patients

The aim of this study is to evaluate whether a patient-centered mobile application used during the perioperative period can improve anxiety, complications, comfort, and patient satisfaction compared to standard care.

Surgical intervention is a life-threatening condition. It is known that fear and anxiety experienced throughout the surgical process disrupt homeostatic balance, leading to biological, psychological, and social problems in individuals and prolonging the length of hospital stay.

In surgical cases that typically require a hospital stay of one day or less, when there is insufficient time for proper education and guidance, patients may experience anxiety and difficulties. This can lead to repeated hospital visits and increased costs. Effective and accurate communication between the patient and the nurse can ensure the best implementation of nursing care, help the patient feel safer, reduce anxiety, increase care satisfaction, and lower costs.

Complications frequently arise after hospital discharge. Due to a lack of information regarding recovery expectations, many patients may feel insecure, anxious, and alone.

The use of the internet for health information has significantly increased over the past decade. Mobile medical applications can be a useful tool for improving perioperative patient education and care. Most acute care hospitals provide discharge instructions in the form of a brochure, which is often difficult to follow. A mobile application could serve as an educational and instructional resource for patients throughout the perioperative period. It can provide real-time feedback on patients' adherence to perioperative ERAS elements and demonstrate their ability to aid recovery.

There are very few studies investigating the ability of mobile applications to assist in the recovery of surgical patients. Various studies have shown that complications, pain, anxiety, unexpected primary care visits, hospital readmissions, and rehospitalizations are primarily caused by a lack of information.

The aim of this study is to evaluate whether a patient-centered mobile application used during the perioperative period can improve anxiety, complications, comfort, and patient satisfaction compared to standard care.

Eligibility Criteria:
Inclusion Criteria:

Having a smartphone to install the mobile application No barriers to communication in Turkish Scheduled for surgery Willing to participate in the study Above 18 years of age Sufficient ability to use the mobile application

Exclusion Criteria:

Communication barriers Inability to use the mobile application Unwillingness to participate in the study
Effect of Surgical Smoke on Air Quality

This study; It was planned to (1) determine the effect of surgical smoke on indoor air quality and (2) examine its effect on physical symptoms and throat culture results in operating room employees and compare it with those working in internal units.

Background:This study is a experimental study. The aim of this study is; to determine the effect of surgical smoke containing toxic chemicals on indoor air quality and to examine the physical symptoms of employees in the operating room.

Method:It was carried out in general surgery operating room between June 2020 and July 2020 In the study, 45 air samples were taken from the with active sampling method before, during and after surgery. Physical complaints of 19 people working in the operating room were asked and throat cultures were taken before and after surgery. These results were compared with those working in internal units. Data were analyzed using a statistics program.

Eligibility Criteria:
Inclusion Criteria:

* Health workers in operating room

Exclusion Criteria:

* those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma
Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease

This research study is to determine the effectiveness of prednisolone and methotrexate for IGM patients over a period of one year, in terms of clinical and radiological response. Recruitment will be conducted in National University Hospital (NUH) for patients diagnosed with IGM.


Eligibility Criteria:
Inclusion Criteria:

* Women, aged between 21 and 60 years
* Positive diagnosis of idiopathic granulomatous mastitis based on histopathology results
* Willing and able to give informed consent

Exclusion Criteria (Patients who meet any of the following prerequisites will not be allowed to take part in this study):

* Women who are currently pregnant or breastfeeding
* Cognitive impairment which prevents the patient from giving voluntary consent
* History of any psychiatric conditions such as depression, psychosis, schizophrenia etc.
* History of cancer in the past 5 years
* History of abnormal renal or liver function
* History of diabetes mellitus
* History of pulmonary lung disease, pneumonitis, or related conditions
* Hepatitis B and/or Hepatitis C carrier
* Diagnosed with tuberculosis (Positive microbiological evaluation for Grocott Methenamine Silver stain and Ziehl- Neelsen stain)
* Any immunosuppressants or anti-inflammatory medications such as NSAIDS for the past 3 months
* Concomitant medication that may have contraindication with prednisolone and methotrexate use
* Hypersensitivity to components or drug products of prednisolone and methotrexate
* Vaccination with live virus vaccines prior to or during treatment
Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)

Acute kidney injury is associated with increased short-term and long-term morbidity and mortality. Long-term data is lacking in low to middle-income countries. Our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors.


Eligibility Criteria:
Inclusion Criteria:

* AKI stage 3
* At least 18 years old

Exclusion Criteria:

* ESRD patients (eGFR \< 15 mL/min/1.73 m2)
Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

Aim: The current study targets linking serum and salivary dipeptidyl peptidase-4 with oral squamous cell carcinoma and comparing it with potentially malignant lesions and control to validate dipeptidyl peptidase-4 as a diagnostic marker for early detection of oral cancer and to reveal its possible role in carcinogenesis.

Methodology: A total of 45 patients were recruited and subdivided into 2 groups: Group I: 15 patients having oral squamous cell carcinoma. Group II: 15 patients with potentially malignant lesions (leukoplakia and oral lichen planus) compared to 15 systemically healthy participants having no oral mucosal lesions acting as a control group (Group III). Serum and whole unstimulated salivary samples were collected from all participants to evaluate dipeptidyl peptidase level in different groups using enzyme linked immune-sorbent assay (ELISA) kit. ROC analysis was done to reveal area under the curve, sensitivity, specificity and diagnostic accuracy of DPP-4 among different groups.


Eligibility Criteria:
Inclusion Criteria:

* systemically healthy
* No current medication,
* both genders with age ranging from 30 to 65 years old.
* having oral leukoplakia, oral lichen planus or oral squamous cell carcinoma

Exclusion Criteria:

* systemic disease
* pregnancy
* lactation
* being diagnosed with any other oral mucosal lesion
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Eligibility Criteria:
Inclusion Criteria:

* Subjects \> or = 18 years of age and able to give informed consent
* Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
* Screening Visit laboratory Hgb indicative of anemia
* Screening Visit ferritin indicative of iron deficiency anemia

Exclusion Criteria:

* Known hypersensitivity to VIT-45
* Previously received VIT-45
* Parenteral iron in the 4 weeks prior to screening
* Chronic or serious active infection
* Malignancy history
* Aspartate aminotransferase (AST) or Alanine transaminase( ALT) greater than the upper limit of normal
* Anticipated need for surgery or initiation of dialysis during the study
* Pregnant or sexually active females who are not willing to use an effective form of birth control
Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)

The purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).

Primary Objective(s)

* Confirm performance of the ExoDx Prostate (IntelliScore) (EPI) utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated Prostate-specific antigen (2-10 ng/mL).
* Evaluate impact of the confirmed ExoDx Prostate (IntelliScore) on the decision to perform an initial prostate biopsy for men presenting with an elevated Prostate-specific antigen (2-10 ng/mL).

Secondary and Exploratory Objectives

* Assess physician satisfaction with the ExoIntelliScore Prostate report including test result presentation, graphics and interpretation.
* Assess patient satisfaction for ease of understanding test results and role on decision process to have a biopsy.
* Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate biopsy decision process.
* Correlation of the ExoIntelliScore Prostate score with the actual biopsy result.

Eligibility Criteria:
Inclusion Criteria:

* 50 years of age
* Clinical suspicion for prostate cancer
* Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL
* No clinical history of a prior negative biopsy

Exclusion Criteria:

* History of prior prostate biopsy.
* Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
* Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
* History of prostate cancer.
* History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
* No known hepatitis (all types) and/or HIV documented in patient's medical record.
* Patients with history of concurrent renal/bladder tumors.