cyrilzakka/clinical-trials huggingface dataset:
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.

The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020

Exclusion Criteria:

* previous device implantation
* valve-in-valve procedure
* patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)
Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children

The purpose of this study is to learn more about antimicrobials, especially drug levels in the CSF that would normally be used in young children as part of standard care. These drugs are approved by the Food and Drug Administration (FDA) for treating infections. They are used extensively in children in the United States, but they have not been extensively studied in children or babies. The investigators do not have very much information on how children and babies handle these drugs; that is, how long it takes for the drugs to be removed from the blood circulation and to pass out of the body and how much goes into the central nervous system. The investigators also do not have good information to guide how often the investigators should give the drugs to children and babies to get the maximum effect on infections with the minimum amount of drug. Thus, the investigators will collect more information about how these drugs should be used in children and babies by doing this drug levels research study.


Eligibility Criteria:
Inclusion Criteria:

* Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care

Exclusion Criteria:

* Lack of consent
Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis

This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis.

The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.

The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take place at the end of the 12th month of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age.
* Hepatic biopsy consistent with non-alcoholic steatohepatitis: presence of \>20% steatosis associated with hepatocyte swelling and/or intralobular necrosis within the last 18 months.
* Serum levels of ALAT and/or ASAT \> 50 UI/L at the time of screening (with at least 3 elevated transaminase values within the last 12 months).

Exclusion Criteria:

* Hepatic biopsy not performed within the last 18 months.
* A single normal transaminase value within the last 12 months.
* Treatment with ursodesoxycholic acid within the last 12 months.
* Loss of more than 15% body weight between the time of the liver biopsy and the time of screening.
* Alcohol consumption of \>20 g/day for women and \> 30 g/day for men
* Hepatitis from other causes: chronic viral hepatitis B or C, elevated ferritin levels associated with C282Y homozygosity, primary biliary cirrhosis, primary sclerosing cholangitis, well documented auto-immune hepatitis (specific autoantibodies, hypergammaglobulinemia, consistent histologic changes), alpha1 antitrypsin deficiency, Wilson's disease, HIV infection.
* NASH from secondary causes: long term amiodarone administration, corticosteroid therapy, anti-obesity surgery within the last 2 years, tamoxifen.
* Child's type B or C cirrhosis.
* Presence of hepatocellular carcinoma.
* Treatment with rosiglitazone or pioglitazone currently or during the 3 preceding years, treatment with Vitamin E within the 6 months prior to screening.
* Women who are pregnant or nursing.
* Unavailability of hepatic biopsy slides for centralized interpretation.
Optimizing Plyometric Training for Functional Recovery Post-ACL Reconstruction

While surgical anterior cruciate ligament reconstruction (ACLR) of the knee restores passive stability, studies are showing consistently poor long-term outcomes. Unusually high risks of early-onset osteoarthritis and re-injury, and low rate of return to sport following ACLR all seem to be related to a chronic tendency to land stiff-legged from a jump or hop, which itself may be due to fear of re-injury. Decreased knee bending for force absorption simultaneously decreases performance level and increases risk for injury and arthritic changes.

The purpose of the proposed study is to compare a current best-practice plyometric training program to one utilizing body weight support to increase repetition and improve performance in the initial phases. The investigators hypothesize that we will see larger improvements in absorptive capacity of the knee and better confidence in activity immediately following body weight support training, as well as improved retention of training effects after a two-month period.


Eligibility Criteria:
Inclusion Criteria:

* speak and understand English
* age between 12-35 years
* unilateral anterior cruciate ligament reconstruction between 6-48 months prior
* activity level greater than or equal to level 5 on the Tegner Activity Scale

Exclusion Criteria:

* Weight in excess of 300 pounds (136 kg)
* contralateral/bilateral ACL reconstruction or an unreconstructed ACL injury
* history of a posterior cruciate ligament injury
* lower extremity of back injury or other condition (e.g. cerebral palsy) that has limited their normal activities of daily living within the last 6 months
Omphaloceles and Associated Malformations

Major birth defects like omphalocele are diagnosed in 3-8% of all newborns in Germany each year. Prevention and treatment quality of congenital malformations are key concerns for child health. Poor long-term outcome is more likely in the presence of associated structural or chromosomal abnormalities that occur in approximately 50-77% of these infants. Furthermore, many newborns have respiratory failure and supposedly pulmonary hypertension - another reason for increased mortality.

As part of the Surveillance Unit for Rare Pediatric Conditions in Germany (Erhebungseinheit für seltene pädiatrische Erkrankungen in Deutschland), all neonatological departments receive over two years monthly reporting cards to notify the study centre of cases, which will be analysed based on anonymised questionnaires.

An observational study using anonymized questionnaires, enrolled over two years (01/07/2019 - 30/06/2021) via the Surveillance Unit for Rare Pediatric Conditions in Germany (ESPED - Erhebungseinheit für seltene pädiatrische Erkrankungen in Deutschland). The nationwide epidemiological data collection contents information about the incidence of omphalocele, associated malformations and risk factors for the occurrence of omphalocele, especially for pulmonary hypertension and its treatment.

We use the following inclusion criteria: preterm and term babies' ≤ 28 days of life.

The aim of our study is a reliable, population-related data acquisition about prevalence of omphalocele, associated malformations and possible risk factors and characteristic early warning symptoms regarding concomitant diseases. Thereby, in the future it will be possible to develop prevention strategies für early detection and treatment of omphalocele and the associated malformations/ diseases to improve outcome for these babies. A further aim is to follow-up the thriving and the psychomotor development of these babies in the age of two years.

Eligibility Criteria:
Inclusion Criteria:

* preterm and term newborns ≤ 28 days
* present omphalocele

Exclusion Criteria:

* none
Impact of Two Different Types of Sedation on ICEB

The QT interval is a measure of the combination of cardiac depolarization and repolarization as it encompasses both the QRS complex and the J-T interval. QT, QTc, QTd prolongation or shortening has been associated with ventricular arrhythmias . In order to define non-torsogenic drug-induced arrhythmias, the index of cardio-electrophysiological balance (iCEB), which is a new marker calculated with the QT/QRS formula, has been defined. In our study, we planned to evaluate the effects of dexmedetomidine and propofol on cardiac electrophysiology with all these parameters, especially the newly defined iCEB.

Seventy patients who underwent operation under regional anesthesia and received intraoperative sedation will be included in the study. The patients will be divided into two groups, Group D (dexmedetomidine) and Group P (propofol). Sedative agent infusion will be started immediately after spinal anesthesia is administered. Preoperative ASA (American Society of Anesthesiologists) scores, demographic data, comorbidities and medications used will be recorded. Vitals and ECG prior to spinal anesthesia will be recorded. After that, spinal anesthesia will be applied and vitals and ECG will be recorded at 1, 5, 10, 15, 45 and 75 minutes. The sedation levels of the patients will be measured noninvasively by bispectral index (BIS) monitoring. Patients will be kept within the limits of light sedation. The maximum dose of 1.4 micrograms/kg/hour in the dexmedetomidine group (group D, n=35) and 4.5 milligrams/kg/hour in the propofol group (group P, n=35) will not be exceeded. The following parameters were set as the safety endpoint during sedation:

* Respiratory rate ≤8
* SpO2; 95
* Heart rate; 40
* Systolic blood pressure;80 At these endpoints, the patient's sedation dose will be reduced regardless of the BIS value.

During sedation, patients will be given 3 liters of nasal oxygen per minute, which can be increased according to need. Just before and 1st, 5th, 10th, 15th, 45th, 75th minutes after spinal anesthesia systolic arterial pressure, diastolic arterial pressure, mean arterial pressure,peak heart rate, oxygen saturation, bispectral index, QT time, QTc, QT distribution, Tpe, iCEB will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA Ⅰ-Ⅱ ,
* 18-80 years old, who will be operated under spinal anesthesia

Exclusion Criteria:

* Hypersensitivity to the propofol,dexmedotimidine
* preoperative QTc prolongation
* preoperative heart disease
* use of drugs that affect the QT interval
* severe sinus bradycardia
* preoperative electrolyte abnormalities
* liver and kidney function abnormalities
* non-sinus rhythm
Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians

Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Patients, aged \> 18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathological findings.

Exclusion Criteria:

* Those with systemic disease associated cutaneous amyloidosis
* Pregnancy or lactating woman
* Those who are allergic to urea, olive oil
* Those who are photosensitive to ultraviolet radiation
* Those who had been previously treated with any of which -medications, radiation, laser within 3 months and 1 month for topical therapy
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
* BCVA must be between ≥ 24 and ≤ 83 letters;
* Visual loss should be mainly due to the presence of any eligible types of ME.

Exclusion Criteria:

* Women of child-bearing potential,
* Active malignancies;
* History of stroke less than 6 months prior to screening;
* Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
* Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
* Any type of advanced, severe or unstable ocular disease or its reatment;
* ME with a high likelihood of spontaneous resolution.

Other protocol-defined inclusion/exclusion criteria may apply.
The Impact of Internationalize Medical Services to localPeople Seeking Medical Care

Recently The Department of Health of Taiwan has launched the "Internationalize Medical Services Flagship Program", expecting to promote Taiwan's high-quality of medical services to the international market, and anticipating "customers stroll in, medical services walked out".

In order to avoid expansion of this program might alienate the rights and best interests of local people seeking medical services, therefore, this research project is a join effort of experts to form an advisory counsel; by collecting most current international medical services data; then using both qualitative and quantitative questionnaires to investigate whether by implementation of internationalize medical services will cause great impact on local people.

To study the various of insurance income of health care organization after they promote international medical services; and to understand the impact of assess to medical care and quality of medical services to local people due to internationalize medical services.

The last through advisory counsel, to make specific recommendations on mechanism of management and to set evaluation of indicators to monitor international health care, to avoid edge out local people the right of seeking medical care to ever happened, and to aid future planning of policy and implementation.

The main objectives of this study are:

1. To understand the impact from internationalize medical services to local People seeking medical care, and the impact to management of health care organization, make specific recommendations for assessment, management mechanisms and measurable indicators, and aid future planning of policy and implementation.
2. To avoid expanding the flagship program of internationalization of medical services might jeopardize local people's right to seek medical care, assess the impact to local people after the program implemented.

Eligibility Criteria:
Inclusion Criteria:

* Administrative staff in Hospital
* Hospital provide the internationalize medical services

Exclusion Criteria:

-
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking

Use lay language.

Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of Parkinson's disease. Depending on methodological approach of the study, its prevalence is estimated to be between 16 and 51%.

Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which seems to play a central role in the control of mood and motivation. The subcortical components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and the constituents of the limbic system (particularly the hippocampus and amygdala), all of which are located deep inside the brain (18). The hypothesis is that depletion of striatal dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical circuits results in hypofunction of these circuits and the loss of frontal cortical activity, particularly within in the frontal orbital cortex, the anterior cingulate cortex and the prefrontal cortex

The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods

3 groups :

* 20 apathetic patients with Parkinson's disease
* 20 non apathetic paired patients)
* 20 healthy paired control

Description of the protocol for patients :

J0 : Inclusion visit (duration : 4h):

* motor assessment (UPDRS)
* neuropsychological and psychiatric assessment : Cognitive assessments : Mini Mental State MMS, MATTIS Apathy assessment: Apathy Inventory from Robert et al (2002); Lille apathy rating scale (LARS) ; Starkstein scale.

Depression assessment : Montgomery et Alsberg depression rating scale (MADRS)

J0+1 day : MRI (magnetic resonance imaging) acquisition (30 minutes) Multimodal MRI examinations will be performed (Diffusion-weighted data and high-resolution 3-dimensional (3D) T1- weighted as well as T2-weighted images) on each subject on a GE 3-T.

Eligibility Criteria:
Inclusion Criteria:

-

Patients :

* Men or women aged between 18 -85 years
* Patients with an idiopathic Parkinson's disease according to UKPDSBB criterias
* Non dement (MMS ≥ 26 ; MATTIS ≥ 130)
* Affiliated to National Health system
* Having given their informed consent

Healthy controls

* Men or women aged between 18 -85 years
* Affiliated to National Health system
* Having given their informed consent

Exclusion Criteria:

* Patients :
* Patients suffering of an atypical Parkinson syndrome
* Psychiatric pathology
* Severe tremor form of PD
* Depression (MADRS \>16)., dementia (MMS \< 26, MATTIS \< 130).
* Pregnant
* Under guardianship
* In excluding period for another study
* Any contra-indication to MRI

Healthy subject

* Subject with neurological, psychiatric diseases
* Depression, dementia, apathy
* Pregnant
* Under guardianship
* In excluding period for another study
* Any contra-indication to MRI
Emotional Intelligence In Pregnancy and the Puerperium and Baby Blues Symptoms: A Randomized Clinical Trial

Background: Emotional intelligence pertains to the capacity for making decisions and adjusting to life's fluctuations, an attribute influenced by emotional conditions. Several scenarios impact nearly 80% of females, influencing their nurturing abilities. This study aimed to analyze the effectiveness of the "Happy in My Maternity" project in reducing baby blues symptoms in postnatal women. Methods: Employing a randomized clinical trial, hybrid interventions based on mobile application and i-person were conducted as part of an educational and emotional regulation curriculum. Enrollment encompassed the well-being of women. The program retained thirty-five participants, with thirty-four constituting the control cluster. The Trait-Meta Mood Scale (TMMS-24) questionnaire evaluation was administered to gauge emotional intelligence.


Eligibility Criteria:
Inclusion Criteria:

i) to have between 28 and 38 weeks of pregnancy, ii) pregnant women with follow-up and control at the participant hospital iii) women who signed their consent to participate in the study

Exclusion Criteria:

i) Women with high-risk pregnancies ii) Women suffering from psychiatric disorders before pregnancy such as anxiety, affective or disruptive behavior disorders
Assessing Vein Graft Properties Between Conventional & No-Touch Harvesting Technique - (PATENT SVG)

The purpose of this study is to compare saphenous veins harvested using the atraumatic pedicled ("no-touch") technique to saphenous veins harvested using the conventional open technique in patients undergoing isolated coronary artery bypass surgery. Investigators will compare the biological structure of the saphenous veins harvested using these two techniques. There is some evidence that saphenous veins harvested using the "no-touch" technique may allow for better patency up to 8 years following bypass surgery. We may be able to detect early differences in vascular structure, observed at the time of conduit harvest.

Atherosclerosis is a complex, multifactorial inflammatory disease, which is initiated largely in areas of endothelial injury, secondary to biomechanical disturbances, or systemic factors such as lipoprotein disturbances, hypertension, diabetes, and smoking (the response to injury hypothesis). Accumulating data indicate that structural and/or functional alterations in endothelial integrity play a primordial role in the development of atherosclerosis via promoting aberrant interactions between modified lipoproteins, monocyte-derived macrophages, T cells and normal cellular elements of the arterial wall inciting early plaque formation. As such, strategies, either pharmacological or mechanical in nature which reduce and/or restore endothelial homeostasis remain an important cornerstone to limit atherosclerosis.

Investigators hypothesize that saphenous veins harvested using the atraumatic pedicled ("no-touch") technique from patients undergoing isolated coronary artery bypass surgery will exhibit superior indices of vasomotor structure compared to veins harvested using the conventional open technique. We anticipate that leg healing will not be significantly altered using the "no-touch" technique.

Eligible patients will have two SVG segments harvested, one from each lower leg. One leg will have the SVG harvested in the conventional fashion and the contralateral leg will have the SVG harvested using the "no touch" technique. This will be determined by block randomization revealed at the time of skin incision. For patients with very small lower leg saphenous veins, the surgical protocol would be to then use the thigh segment instead. Patients will have Duplex scans to evaluate saphenous veins pre-operatively.

Eligibility Criteria:
Inclusion Criteria:

1. Age\> 18 years and able to provide informed consent
2. Requiring isolated, primary coronary artery bypass graft surgery
3. Elective or urgent cases
4. With or without the use or cardiopulmonary bypass
5. Left ventricular ejection fraction \> 20%
6. Patient require at least 2 SVG's

Exclusion Criteria:

1. Unable to give consent
2. Unable to use bilateral lower greater saphenous veins ( severe peripheral vascular disease,varicose veins, previous vein stripping, previous amputation, inadequate ultrasound appearance )
3. Pregnant women, women of child bearing age
4. Preoperative persistent atrial fibrillation
AZD5423 Single Ascending Dose Study

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
* Use of any prescribed or non-prescribed medication