cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Right Ventricular Function Post Mitral Valve Operations

We aim to determine the function of Right ventricle post mitral valve surgeries in patients with pulmonary hypertension using transthoracic echocardiography3- and 6-months post-operatively to detect the effect of mitral valve surgeries over the RV function whether improving, deteriorating, or not changing at all.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent mitral valve surgeries who also had pulmonary hypertension in the period between March 2019 and March 2022 in Assiut university heart hospital

Exclusion Criteria:

* Patients who underwent mitral valve surgeries with normal pulmonary pressure. Patients who had other valve surgeries besides mitral as aortic and/or tricuspid valve surgeries. Patients had mitral valve surgeries with other heart conditions that needed another intervention in the same session as CABG for IHD.
Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke

Multicenter, randomized, double blind, parallel-group, placebo-controlled proof of concept study evaluating efficacy and safety of BP1.3656 in patients with fatigue following ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years old or more;
* Diagnosis of ischemic stroke at least one month and not more than six months prior to screening;
* Persistent fatigue since the stroke with a score ≥ 50 across all domains of the Multidimensional Fatigue Inventory (MFI-20);
* Modified Rankin Score (mRS) \< 3;
* Capability to participate in all study tests according to the investigator;
* Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to any study specific procedure;
* Females of child-bearing potential must have a negative pregnancy test performed at the screening and randomization visits and use a medically accepted effective method of birth control, agree to continue this method for the duration of the study up until three weeks after last treatment intake.

Exclusion Criteria:

* Any identified etiology for fatigue other than stroke (except post-stroke depression) according to the investigator;
* History of psychosis;
* Current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression, or organic brain syndrome preventing the patients from completing study assessments;
* Patients at risk of suicide according to the investigator;
* Major cognitive disorders, dementia according to the investigator;
* History of epilepsy or seizures disorder;
* History of alcohol or drugs (i.e. cannabis, cocaine, amphetamines or opioids) (ab)use/dependence within the 12 months prior to screening or with a positive drug test at screening;
* Glomerular filtration rate \<60 mL/min/1.73m² according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula;
* Clinically significant cardiovascular abnormalities (including clinically relevant ECG abnormalities) or, clinically significant hematological, neurological, endocrine abnormalities, severe hepatic impairment or Liver Function Tests (ASAT, ALAT) \> 3 ULN, or abnormal clinical laboratory results (in most cases \> 3ULN);
* Other active clinically significant illness, infection, acid-related gastric disorder, or neoplastic pathology within the last 3 years (patients with fully cured non-melanoma skin cancer or in-situ carcinoma of the cervix are eligible) which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise his/her study participation.
Feasibility of a Multi-Level School Intervention for LGBTQ Youth

The goal of this R21 grant is to test the feasibility of a theoretically informed, LGBTQ-affirming intervention (Proud \& Empowered; P\&E). Although LGBTQ adolescents experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce. For example, LGBTQ adolescents are 3 to 4 times more likely to meet criteria for an internalizing disorder and 2 to 5 times more likely to meet criteria for externalizing disorders than their heterosexual peers. Our intervention seeks to address disparate behavioral health problems such as depression, anxiety and trauma symptomology. Our goal will be achieved by completing two specific aims: 1) Assess the feasibility, including recruitment, enrollment, fidelity of service delivery, satisfaction, safety, and retention, of the intervention in a randomized control trial with four schools, 2) Obtain preliminary estimates of intervention effects on key behavioral health symptoms for LGBTQ youth and school climate (norms, attitudes, beliefs, behaviors) at the school level in preparation for a larger efficacy trial. This innovative R21 application brings together a team of nationally recognized minority stress and prevention science experts and responds to a nationally established public health need for research from the Institute of Medicine, the National Institutes of Health, and the National Gay and Lesbian Task Force.


Eligibility Criteria:
Inclusion Criteria:

* LGBTQ student in one of four high schools

Exclusion Criteria:

* Not meeting inclusion criteria
Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Respiratory Panel (RP) 2. The purpose of this study is to prospectively collect and test residual NPS specimens and generate performance data to support regulatory classification of the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.

The FilmArray Respiratory Panel 2 (RP2) is an automated sample-to-answer PCR-based diagnostic for the identification of common upper respiratory viral and bacterial pathogens in nasopharyngeal swab (NPS) specimens collected in viral transport media (VTM). The purpose of this study is to prospectively collect and test residual NPS specimens and generate performance data to support regulatory classification of the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.

Clinical performance evaluations will be initiated at sites in the US and/or EU during the 2016/2017 respiratory illness season, approximately September through December.Prior to performing the prospective clinical evaluation, each participating site will have the necessary Institutional Review Board (IRB) reviews (or equivalent for non-U.S. sites).

Specimens for inclusion in this study will be residual, de-identified NPS collected in VTM leftover from clinician-ordered respiratory pathogen testing.

Comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory.

This study is funded by BioFire Diagnostics, LLC. The FilmArray device conforms to the requirements of the European Union In Vitro Diagnostic Directive (IVDD). This study was designed such that every precaution has been taken to protect the health and safety of patients, users, and other persons.

Eligibility Criteria:
Inclusion Criteria:

* Specimen is residual NPS in VTM left over from standard of care testing under clinician order for respiratory pathogen analysis
* Specimen has been held at appropriate temperature
* Sufficient volume remaining after standard of care testing and available for use in the study

Exclusion criteria:

* Specimen other than NPS in VTM (e.g. nasopharyngeal aspirate, anterior or midturbinate swab, oropharyngeal swab, NPS collected in medium other than VTM)
* Specimen cannot be tested within the defined storage parameters
* Insufficient specimen volume for testing
Cardiovascular Risk Factors After Single Pancreas Transplantation

Patients accepted for the waiting list for single pancreas transplantation suffer from severe glucose instability with hyperglycemia due to diabetes type 1, but do not have significant diabetes-related complications. Pancreas transplantation restores normoglycemia in diabetes type 1 patients with unstable control of glycemia. Both hypo- and hyperglycemic events are abolished, and 70-80 % of the patients obtain satisfactory HbA1c levels (HbA1c 5.0-6.0 %) without the need of exogenous insulin. Endothelial dysfunction is considered as an early and potentially reversible stage in the atherosclerotic process. The endothelium is involved in homeostasis, leucocyte adhesion and vasomotor activity. Reduced endothelium-dependent vasodilation is associated with increments in cardiovascular risk factors, and endothelial dysfunction is a predictor for future cardiovascular disease. It has also been hypothesized that endothelial dysfunction may be involved in the impaired glycemic control by reducing the availability of glucose in peripheral muscles.Establishing normoglycemia by pancreas transplantation alone in previously diabetic type 1 patients has recently been shown to improve left ventricular ejection fraction, assessed by Doppler echocardiographic examination. In diabetic patients receiving a new pancreas it is possible to assess the effect of changing blood glucose excursions on cardiovascular risk factors, including endothelial function, without the use of antidiabetic drugs (exclude pleiotropic effects).

The primary objective of the present study is to assess if endothelial function (assessed by flow-mediated dilatation of arteria brachialis) is improved when hyperglycemia is reversed by single pancreas transplantation in patients with type 1 diabetes.

Secondary objectives are to investigate the changes in the following parameters by reversal of hyperglycemia by pancreas transplantation; Peripheral arterial tonometry, serum/plasma concentrations of endothelial dysfunction markers, blood pressure, lipid and lipoprotein concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes accepted for the waiting list for single pancreas transplantation
* Healthy volunteers (non-diabetic, non-transplanted)
* Over 18 years of age
* Signed informed consent

Exclusion Criteria:

* Non-functioning pancreas graft (defined as HbA1c ≥ 6.5 % with the need of insulin injections and fasting C-peptide concentration \< 300 pmol/L).
* Active infection
* Active autoimmune disease other than diabetes
* Severe liver disease
Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

The investigators aimed to understand better the efficacy in a randomized, double-blind, intraindividual design trial in 66 participants with AD treated with SNG100, and 2 different strengths of topical steroids hydrocortisone and the medium potent mometasone furoate cream.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females 6 years old or older with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist
2. Any child age 6 to 18 with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written informed consent must be given by parent/guardian.
3. Capable of complying with study requirements and study procedure.
4. Investigator Global Assessment (IGA) of 3.
5. The severity of atopic dermatitis will be defined as moderate by SCORAD range of 26-50 and EASI range of 7.1-21 points.
6. Child-bearing potential women must use a proper contraception method.

Exclusion Criteria:

1. As determined by the study doctor, a medical history that may interfere with study objectives.
2. Atopic dermatitis lesions that occur only on the face and scalp.
3. Presence of a secondary infection with bacteria, fungi, or virus.
4. Recent or current participation in another research study.
5. Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study.
6. Prior wound, tattoo, pigmentation or infection in the treated area.
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder

This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.

This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females (18 to 65 years old, inclusive) with agitation associated with schizophrenia or bipolar disorder. Subjects will be screened for eligibility within 15 days of first dose and no study procedures will occur unless subjects provide written informed consent. Subjects will receive single doses of 180 μg of Igalmi as needed for the treatment of agitation over a period of 7 days followed by a 3- day follow-up period during which time no Igalmi will be administered in an effort to characterize any potential withdrawal. Subjects will sublingually self-administer Igalmi for an agitation episode that reaches a pre-dose PEC total score of 14 or greater, as determined by a trained rater. Safety assessments will be conducted before and after each dose. If the subject's agitation is recurrent or persistent, repeat doses of 90 µg may be administered (no more than 2 repeat doses within a 24-hour period) in the absence of any safety concerns or adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects between the ages of 18 to 65 years, inclusive.
2. Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar I or II disorder.
3. Subjects who are currently moderate to severely agitated at least 3 days a week.
4. Subjects who read, understand, and provide written informed consent.
5. Subjects who are in good general health prior to study participation as determined by a detailed medical history and in the opinion of the Principal Investigator.
6. Subjects who agree to use a medically acceptable and effective birth control method
7. Subjects must be willing to remain in-clinic for the duration of the study.

Exclusion Criteria:

1. Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening.
2. Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment.
3. Subjects with congenital prolonged QT syndrome.
4. Prior treatment with Igalmi
Severity of Periodontal Recession and Associated Risk Factors in France.

The severity of periodontal recessions for each examined patient during dental consultation was evaluated. Moreover, the description of the number of periodontal recessions in patients with good health during dental consultation, the associated risk factors and evaluation of the number of recessions which need surgical therapy were realized.


Eligibility Criteria:
Inclusion Criteria:

Case:

* patients aged from 20 to 50 years
* patients with recession of more than 1mm
* patient with good health
* patients who aggreed to participate to the study

Controls:

* patients aged from 20 to 50 years
* patients with no recession or recession less than 1mm
* patient with good health
* patients who aggreed to participate to the study

Exclusion Criteria:

* patients with periodontitis
* patients with recession of Class III and IV of modified Miller classification
* patients with previous muco-gingival surgery
* patients pregnant, breatheeding
* patients refusing to participate to the study
Active Cycle Of Breathing Technique Verses Breathing Exercises In Post ICU COVID-19 Patients

The experiment was randomized and controlled. To create groups A and B,48 individuals were selected by sample selection criteria. Evaluation of oxygen saturation and pulmonary function tests were taken using a pulse oximeter and spirometer. Group A got chest physiotherapy with breathing exercises and ACBT whereas Group B got chest physiotherapy with breathing exercises. The treatment took 15-30 minutes and consisted of one session per day, treatment was given 6 days a week for up to 2 weeks and examined by using SPSS 22.

The experiment was randomized and controlled. To create groups A and B,48 individuals were selected by sample selection criteria. Evaluation of oxygen saturation and pulmonary function tests were taken using a pulse oximeter and spirometer. Group A got chest physiotherapy with breathing exercises and ACBT whereas Group B got chest physiotherapy with breathing exercises. The treatment took 15-30 minutes and consisted of one session per day, treatment was given 6 days a week for up to 2 weeks and examined by using SPSS 22.

Eligibility Criteria:
Inclusion Criteria:

* Adult population

  * Age limit 18 -50
  * All patients positive with confirmed COVID-19 by polymerase chain reaction (PCR) test and chest computed tomography scan (CT-scan)

Exclusion Criteria:

* The patient cannot take part in the trial if they have any kind of muscular-skeletal issue.

  * COVID-19-related intubation history
  * A clear clinical mental or cognitive disability of any kind.
  * Patient on ventilator
Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants

This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma
* Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma
* Stable renal function

Exclusion Criteria:

* Known sensitivity to bisphosphonates
* Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover
* Current active dental problems
* Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment

Other protocol-defined inclusion/exclusion criteria may apply.
Cytokine Hemadsorption in Covid 19 Patients With Bacterial Sepsis

In this retrospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients were the available data of laboratory diagnosis of COVID-19 (a positive throat swab nucleic acid test or positive serum COVID-19 specific antibody test),
* patients with COVID-19 induced sepsis was detection of bacterial agent in blood or tracheal culture

Exclusion Criteria:

* below 18 aged
* those who did not undergo hemoperfusion
CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients

The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.

As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.


Eligibility Criteria:
Inclusion Criteria:

* Adult hospitalized patients with a diagnosis of CAP (based on local medical practice) and decision taken by the investigator to treat with moxifloxacin and to start treatment with intravenous administration. The local moxifloxacin product information must be considered.

Exclusion Criteria:

* Contraindications stated in the local moxifloxacin product information; warnings and precautions must be considered.
The V-Tachogram:Decreasing Ventricular Arrythmias When Injecting Contrast in the Left Ventricle

The purpose of this study is to determine if increasing the linear rise rate of injection of x-ray contrast in the heart during left ventriculograms(part of a cardiac Catheterization procedure) will decrease the incidence of arrythmias and improve image quality?

The LV angiogram is performed frequently as part of the cardiac catheterization procedure. It is done by injecting a bolus of x-ray contrast into the ventricle through a pigtail catheter over a short period of time and observing the heart as it is pumped out. This provides information on regional wall motion abnormalities, ejection fraction, and mitral regurgitation. A common occurrence when performing a LV angio is frequent PVC's or V-tach during the injection, it has been suggested that ectopic's occurs about 54% of the time and that interpretability was limited 30% of the time(3) This is rarely serious and subsides at the end of the injection but the irregularity of the contractions does affect the diagnostic quality of the exam.

In an attempt to decrease the incidence of ventricular ectopic's during the LV angiogram Contrast injections with a greater linear rise increasing the injection duration to at least ½ the flow rate, greater than previous settings should decrease the tension and the contrast jets coming out of the catheter, decreasing the fling of the catheter at the initiation of the injection. Whether this affects the quality of the angiogram with a pig tail vs. a straight catheter will also need to be considered?

Eligibility Criteria:
Inclusion Criteria:

* Only ventriculograms that the operator deems necessary for the booked procedure will be considered. Only operators agreeing to the for mentioned settings will participate in the study. Patients will be randomized consecutively and should conclude in 3 to 4 weeks.

Exclusion Criteria:

* Patients with aortic valve disease, a-fib, and frequent benign ectopic beats and patients unable to follow instructions to stop breathing will be excluded.