cyrilzakka/clinical-trials huggingface dataset:
Simplified Conservative Measures in Managing Morbidly Adherent Placenta in Beni-Suef University

To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta.

According to the International Federation of Gynecology and Obstetrics (FIGO) guidelines, the principal surgical strategy to prevent excessive bleeding related to placenta accreta syndrome is to leave the placenta in situ and perform a primary peripartum hysterectomy at delivery. A hysterectomy may not be preferred by patients wishing to preserve fertility and is detrimental to multiple aspects of the pelvic floor, bowel, and physical functions.

Surgical principles in placenta accreta syndrome include avoiding disruption of the hypervascular placenta, stepwise devascularization, early and comprehensive blood product transfusion, and judicious use of interventional radiologic techniques such as vascular embolization.

Conservative management describes any approach whereby hysterectomy is avoided

Eligibility Criteria:
Inclusion Criteria:

* Gestational age more than 28 weeks as determined by LMP and ultrasound.
* Placenta previa as confirmed by ultrasound.
* Clinically stable with no or mild vaginal bleeding.
* No evidence of fetal compromise.
* Patient consent.

Exclusion Criteria:

* Vaginal bleeding
* Medical disorders
Neuroradiolological Analysis of COVID-19 Patients

To describe the radiological presentation of brain abnormalities in COVID-19 + patients


Eligibility Criteria:
Inclusion Criteria:

* Adults
* COVID-19 +
* Abnormal neurological examination
* who underwent a brain MRI

Exclusion Criteria:

* No participation agreement
* Non COVID-19 patients
* Patients COVID-19 + without neurological abnormality or without MRI examination
Safety and Effectivness of Quercetin & Dasatinib on Epigenetic Aging

Assessing the effects of Quercitin and Dasatinib over a 16 week period on participatns' epigenetic biological aging. The patients are being tested at baseline, halfway point, and after the trial period.

This is a prospective non-randomized clinical study of 20-25 patients to evaluate the effectiveness of Quercetin and Dasatinib supplements on the patient's epigenetic aging rate. The investigators predict that Quercetin and Dasatinib combined will slow cell proliferation and thus decelerate the rate of aging.

There is evidence that Quercetin and Dasatinib slows cell proliferation and decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of Quercetin and Dasatinib as an effective treatment option to improve clinical care of healthy individual's epigenetic aging rate thus prolonging longevity.

Despite considerable effort, successful treatment of reversing one's biological age has been shown to be a difficult therapeutic challenge. There is evidence that Dasatinib+Quercetin(Quercetin and Dasatinib) is a safe and effective treatment option to improve clinical care of healthy individual's biological age. Studies have shown that Dasatinib+Quercetin slows cell proliferation and decelerates aging and the risk of age-related diseases.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Ages 40 and older
* Patient must be able to comply with treatment plan and laboratory tests

Exclusion Criteria:

* Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
* No immune system issues or immunodeficiency disease
* No history of viral illness which could be reactivated by immune down regulation
* Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)
* Diagnosis of a transient ischemic attack in the 6 months prior to screening
* Patients infected with hepatitis, C or HIV
* Patients with Body Mass Index (BMI) \> 40 kg/m2
* Presence of active infection 9. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
* Unable or unwilling to provide required blood sample for testing
* As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.
* If the patient has previously used Quercetin and Dasatinib.
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene

The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 28 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.

Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Age between 18 and 80 years
* Inpatients with a DSM-IV diagnosis of Major Depression
* single episode or recurrent
* moderate to severe intensity
* without psychotic features
* Inpatients with a DSM-IV diagnosis of bipolar disorder I or II
* current episode with depressive symptoms
* moderate to severe intensity
* without psychotic features
* HAM-D score at the time of inclusion in the study ≥ 14
* Patient has already been adjusted to one of the following antidepressants in a dose which is still under the defined normal-dose:
* paroxetine \< 40 mg/d
* sertraline \< 100 mg/d
* citalopram \< 40 mg/d
* escitalopram \< 20 mg/d
* venlafaxine \< 225 mg/d
* amitriptyline \< 150 mg/d
* amitriptylinoxide \< 150 mg/d
* nortriptyline \< 150 mg/d
* trimipramine \< 150 mg/d

Exclusion Criteria:

* Acute suicidality (HAM-D Item 3 score \> 2)
* Acute alcohol-, hypnotics-, analgesics- or psychopharmacological intoxication or delirium
* Current alcohol dependence, or dependencies from other psychotropic substances
* Severe medical or neurological diseases: patients with severe hepatic (severe impairment of liver function, cirrhosis of the liver), renal (kidney malfunctions), cardiovascular (recent myocardial infarction, instable heart disease), neurological diseases (e.g. multiple sclerosis, Parkinson, dementia)
* Patients incapable of giving informed consent
* Pregnant or breast-feeding women
* Women of reproductive age without effective contraception
* Simultaneous participation in other clinical trials or participation in an other clinical trial within 6 weeks before the start of the study
* Hypersensitivity to the study medication or to one of the ingredients of the medication
* Simultaneous treatment with another antidepressant besides study medication (exception: trazodone up to 75 mg/d, mirtazapine up to 15 mg/d, trimipramine up to 50 mg/d)
* Simultaneous treatment with mood stabilizers or neuroleptic drugs (exception: quetiapine up to 50 mg/d, olanzapine up to 5 mg/d)
* Exclusion criteria of the study medication
Evaluation of Exercise Tolerance and Cardiac Output in Patients With Heart Failure After Intervention of Rehabilitation Program

Home-based rehabilitation programs have not been widely few been studied and the training effects are not unclear. This study evaluates the beneﬁcial effects of home-based cardiac rehabilitation on quality of medical care in patients with chronic heart failure.

cardiopulmonary rehabilitation programs are safe and effective for improving functional capacity, quality of life, as well as for reducing in the re-admission rate and all-cause mortality of patients with heart failure.clinical trials that have established the benefits of hospital-based cardiac rehabilitation for patients with chronic heart failure. Home-based cardiac rehabilitation could be more accessible and acceptable compared with hospital-based cardiac rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients with NYHA I, II, III, and LVEF\<50%.

Exclusion Criteria:

* Heart failure patients with NYHA I, II, III, and LVEF\<50%. But excluded pregnancy, disability.
Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).


Eligibility Criteria:
Inclusion Criteria:

* Newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
* Age ≥ 18 and ≤ 65 years old.
* Tumor staged as III/IVa (according to the 8th AJCC edition).
* No evidence of distant metastasis (M0).
* Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
* Adequate marrow: White blood cells (WBC) ≥ 4 × 10\^9/L, hemoglobin (HGB) ≥ 90 g/L, platelets (PLT) ≥ 100 × 10\^9/L (or within the normal range of the laboratory)
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN.
* Adequate renal function: creatinine clearance ≥ 60 ml/min.
* Written informed consent.

Exclusion Criteria:

* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Age \> 65 or \< 18.
* Treatment with palliative intent.
* Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
* Pregnancy or lactation.
* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any other serious diseases, which may bring greater risk or affect the compliance of the test, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Temporal Artery Thermometer in Patient Transport: Reliability and Validity.

Evaluate the reliability and validity of temperature measurements using an existing, Health Canada-approved, non-invasive temporal artery thermometer, and comparing results to an established, invasive gold standard (esophageal probe), in order to assess reliability of this non-invasive method to measure core body temperature in the setting of patients undergoing inter-facility patient transport by land, rotor-wing, and fixed-wing transport vehicles.

Interfacility patient transport can put the patient at risk a drop in body temperature. This drop can harmful to patients with particular illnesses (trauma, stroke, post cardiac arrest), and the very young or old. Measuring temperature and preventing temperature drops are challenging in the transport setting. The temporal artery thermometer (TAT) is widely available, easy to use, non-invasive way to measure body temperature. TAT is believed to be a good tool for paramedics to measure body temperature in the transport setting. However, the evidence on reliability and validity of TAT-derived temperature measurements is lacking because the TAT has not been evaluated in the transport setting. The goal of this study is to evaluate the reliability of the TAT device and compare measures of temperature with an established standard in a broad range of patients undergoing interfacility transport by land ambulance, and rotor- and fixed-wing aircraft.

Eligibility Criteria:
Inclusion Criteria:

The study will include patients who meet all of the following criteria:

* intubated
* mechanically ventilated
* transported for emergent or urgent indications
* transported between January 1 and December 31, 2019.

Exclusion Criteria:

The study will exclude patients with any one of the following:

* transports non-urgent conditions
* scheduled transports (for appointment, repatriations, or similar)
* patients who are not intubated and mechanically ventilated
* patients with contraindications to temperature probe insertion (esophageal stricture, varices or perforation; upper or lower gastrointestinal bleeding; congenital tracheo-esophageal abnormalities; post-operative patients with ear, nose, and throat or upper airway surgery; facial trauma or anatomic abnormalities; coagulopathy; anticoagulant use)
* scene responses
* patients transported posthumously
* patients in whom an invasive temperature monitoring probe was not inserted
Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in Reducing Catheter Related Bloodstream Infections

TegaCHG is a multicentric randomized study aimed at evaluating the possibility that the use of TegaDerm CHG dressing may reduce the incidence of catheter related blood stream infections (CRBSI). It implies the comparison between the incidence of CRBSI in patients with central venous catheter dressed with TegaDerm without chlorhexidine gluconate (CHG) and with CHG. The primary endpoint is the occurrence of CRBSI and the secondary endpoints are:

catheter colonization (growth of microbes from the culture of catheter tip, \> 15 CFU according to semi-quantitative method or \> 1000 CFU according to quantitative method); incidence of catheter exit site infection; occurrence of catheter related infections/sepsis or other severe infection-related complications; safety profile evaluation: occurrence of hypersensitivity to the dressing on the basis of local objectivity (erythema, edema, other) or on that of patient symptoms (itch, burning sensation); relating to the device performance: incidence of high/medium/low dressing edge lift, ability to visualize the catheter insertion site, easiness of removal, easiness of dressing application; incidence of unscheduled dressing change. The study hypothesis implies that the use of slow release device containing chlorhexidine may decrease the incidence of CRBSI. This has already been showed for chlorhexidine impregnated sponges. Scope of the study is to verify if this property is also true for TegaDerm CHG,which is a new chlorhexidine-releasing dressing in which the medication is directly released by an integrated transparent gel pad, so that the catheter exit site remains visible and easy to inspect without removing the dressing.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized patients, either in Intensive Care Unit or in non-Intensive Care ward settings
* Clinical indication for the insertion of a non-tunneled central venous catheter (excluding large bore catheters for dialysis or pheresis) or a PICC

Exclusion Criteria:

* Age \< 18 years
* Inability to obtain an informed consent
* Actual evidence - or recent history (\< 30 days) - of bloodstream infection
* Central lines inserted in the femoral vein
* Central lines inserted by surgical cutdown
* Use of so called 'treated' catheters, i.e. catheters whose internal and/or external surface is coated with antibacterial drugs as well as catheters whose polyurethane releases ions with potential antiseptic action, should be excluded by the present protocol
* Specific intolerance or known hypersensitivity to transparent dressings or to chlorhexidine
* Any form of dermatitis, burns, skin lesions or tattoos at the insertion site
* Burns over ≥ 15% of the body surface area
* Use of topical antibiotics within a 10cm of the catheter insertion site
* Enrollment in another investigational drug or device study at any time during this study or 30 days prior.
Heart Rate Variability in Duchenne Muscular Dystrophy During Computer Task

HRV is attained using a Polar RS800CX. Then, evaluated through linear, non-linear and chaotic global techniques (CGT). Forty-five male subjects were included in the DMD group and age-matched with forty-five in the healthy Typical Development (TD) control group. They were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer.

This is a cross-sectional study, where HR was recorded beat-to-beat (RR intervals) using the portable Polar RS800CX HR monitor (Polar Electro, Finland). HR was recorded before the onset and at the end of the five minutes of the computer maze paradigm task.

The subjects were seated in a standard chair (walkers, TD group and DMD) or in their own wheelchair (non-walkers, DMD group), the Polar watch was positioned on the wrist. The analysis of HRV was possible through the recording of RR interval in two periods: the period of twenty minutes at seated rest, and then during the computer task for five minutes.

The computer task used a maze paradigm with one correct pathway that could be negotiated and ultimately solved. All participants were positioned comfortably and an evaluator responsible for instruction and annotation of data.

Each individual was instructed to walk the correct path with the digital character pawn (pointed on the screen by the evaluator) to the exit of the maze identified by an "x" (pointed on the screen by the evaluator). It was provided for the subjects, who used the arrow buttons on the keyboard, identified by up, down, right and left, using the dominant hand, with the arrows moving through a 20 x 20 cm maze. Participants were requested to complete the maze as fast as possible.

HRV analysis followed the guidelines published by the Task Force of the European Society of Cardiology and North American Society of Pacing and Electrophysiology. The RR intervals were recorded, and then were downloaded to the Polar Precision Performance program (v.3.0). This software enabled the visualization of HR and the extraction of a cardiac period (RR intervals series; the variation of beat-to-beat interval in milliseconds) file in ".txt" format. For analysis of HRV data at rest, we analyzed 1000 consecutive RR intervals, and for HRV analysis for the computational task, the number of consecutive RR intervals obtained was exactly 256 RR intervals. Digital filtering complemented by manual filtering was performed to eliminate artifacts and only series with greater than 95% of sinus beats were included in the study. HRV analysis was undertaken through linear, non-linear and chaotic global techniques (CGT).

Eligibility Criteria:
Inclusion Criteria:

* DMD diagnoses was based on molecular methods and/or muscular protein expression.
* TD age-matched with DMD.

Exclusion Criteria:

* subjects with severely dilated myocardium.
* subjects with other associated diseases.
* individuals with inability to understand task instructions.
A4250, an IBAT Inhibitor in Pediatric Cholestasis

This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus

The primary aims of this Phase II exploratory study in patients treated with A4250 due to cholestasis induced pruritus are to:

* Assess the safety and tolerability of A4250, orally administered first as a single dose and then during a four week treatment period, as determined by the occurrence of treatment-emergent SAEs
* Explore changes in serum total bile acids after a four week treatment period

Secondary safety aims include assessment of the safety and tolerability of A4250, orally administered first as a single dose and then during a four week treatment period, as determined by the occurrence of treatment-emergent AEs and changes in safety parameters including laboratory tests and vital signs

Secondary efficacy aims are to:

* Demonstrate the efficacy of A4250, orally administered during a four week treatment period, on liver biochemistry variables and on pruritus parameters
* Evaluate the pharmacokinetic properties of A4250 orally administered first as a single dose and then after a four week treatment period
* Evaluate changes in VAS-itching score after a four week treatment period

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pruritus due to chronic cholestasis based on history and investigator judgment. This will include but will not be restricted to patients with Progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS), Biliary Atresia and Sclerosing Cholangitis

Exclusion Criteria:

* Any condition that in the opinion of the investigator constitutes a risk for the patient or a contraindication for participation and completion of the study, or could interfere with study objectives, conduct, or evaluations
* Clinical or biochemical signs of decompensated liver disease
* Liver transplantation
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Main Inclusion Criteria:

* FEV1/FVC ratio (post-bronchodilator) ≤70%
* FEV1 (post-bronchodilator) ≤50% of predicted
* Current smoker or ex-smoker
* Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
* Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline

Main Exclusion Criteria:

* COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
* Lower respiratory tract infection not resolved 4 weeks prior to baseline
* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Need for long-term oxygen therapy defined as ≥16 hours/day
Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes

To evaluate the impact of the DBLG1 hybrid closed-loop system on glycemic control and patient-reported outcomes in adults living with type 1 diabetes under real-life conditions.

This is a multicenter real-world observational study analyzing data on the use of the DBLG1 system in patients with T1D treated in the participating centers in Belgium. Data from patients with T1D who start(ed) with the DBLG1 between may-01 2022 up to and including August-01 2023 will be analyzed. Data will be collected during clinical routine follow-up from electronic medical records, questionnaires, standard of care laboratory tests and CGM-data. Baseline data from before start (up to -12 months) of the DBLG1 system and follow-up data at 4, 8, 12, 16, 20 and 24 months will be analyzed. There are no medical interventions, nor extra visits or laboratory tests planned outside normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 1 diabetes
* aged 18 years and older
* starting with the DBLG1 system in the participating centers
* who signed the informed consent

Exclusion Criteria:

* patients who do not have type 1 diabetes
* younger than 18 years
* who do not start with the DBLG1 system
* who are not able to sign the informed consent
* who do not want to sign the informed consent