cyrilzakka/clinical-trials huggingface dataset:
Infranodal Conduction Time During TAVR as Predictor of HAVB

Consecutive patients with high grade aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve (Medtronic CoreValve Evolut R® or Edwards Sapien S3®) without pre-existing pacemaker devices are eligible for inclusion. During the TAVR procedure, an electrophysiologic study including measurements of infranodal conduction times (HV-interval before and after valve implantation) will be performed. Electrocardiograms before TAVR, before discharge, after 30 days and after 12 months will be analyzed regarding new onset LBB and the occurrence of high-degree AV block (HAVB) .


Eligibility Criteria:
Inclusion Criteria:

1. Indication for TAVR according to current guidelines
2. Written informed consent

Exclusion Criteria:

1. Pre-existent intracardiac device as pacemaker, implanted cardioverter defibrillator or CRT-P/CRT-D device
Modified Ketogenic Diet in Patients With McArdle Disease Part A

McArdle disease, glycogen storage disease type V, is a rare metabolic disease. Affected individuals are unable to utilize sugar stored as glycogen in muscle.

We hypothesize that a modified ketogenic diet could be a potential treatment option, by providing ketones as alternative fuel substrates for working muscle.

In this open interventional pilot study we wish to investigate 3 different modified ketogenic diet regimes, to find an optimal composition of a modified ketogenic diet that ensures adequate degree of ketosis and at the same time is well tolerated for patients with McArdle disease.

Open interventional study to investigate 3 different modified ketogenic diet regimes, to find an optimal composition of a modified ketogenic diet for patients with McArdle disease

McArdle disease, glycogen storage disease type V, is a rare metabolic disease caused by mutations in the PYGM gene resulting in absence of the enzyme muscle phosphorylase. Affected individuals are unable to utilize sugar stored as glycogen in muscle, leading to exercise intolerance, exercise-induced muscle pain, contractures and rhabdomyolysis, which may cause renal failure. Currently, there are no satisfactory treatment options for McArdle disease. Ketones are feasible fuel alternatives to muscle glycogen when muscle glycogenolysis is blocked as in McArdle disease.

A key element of alleviating symptoms in McArdle disease is to provide alternative fuels for energy metabolism. Ketosis can potentially provide alternative fuel substrates by provision of endogenous ketone bodies (KBs) which are desirable fuels for skeletal muscle and brain. Ketosis can be reached by fasting and can be induced by adhering to a modified ketogenic diet, which entails a high-fat, low-carbohydrate diet, which simulates the metabolic effects of fasting.

The optimal modified ketogenic diet composition, that ensures adequate degree of ketosis and at the same time is well tolerated, has not been investigated in patients with McArdle disease. Therefore this pilot study seeks to investigate which of 3 different diets is the most optimal ad effective for patients with McArdle disease. The 3 different diets will have carbohydrate percentages ranging from 5-25%, and fat percentage from 60-80%.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed GSDV
* Patient is willing and able to provide written informed consent prior to participation.
* Patient is ambulatory.
* Women in fertile age must be willing to practice the following medically acceptable methods of birth control

Exclusion Criteria:

* Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
* Pregnancy or breastfeeding
* Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments
* Patients with porphyria or disorders of fat metabolism (primary carnitine deficiency, carnitine palmitoyltransferase I or II, β-oxidation defects etc.).
Detection of Thyrotrophin Receptor in Human Myometrium

It has been recognized for many decades that high thyrotrophin (TSH) levels in pregnant women are associated with poor obstetric outcome. Also, there is evidence that high TSH is related to fetal position at term, including breech which in turn is associated with obstetric complications.

However, the mechanism behind remains to be elucidated.

The current project is of basic-fundamental nature. It is used to better understand basis physiological processes. As in many other studies of similar basic nature, few numbers are always included.

If a TSH receptor will be detected, future randomized controlled trials (RCT) might be worthwhile with large numbers of women who will be treated with thyroxine to possibly prevent abnormal fetal position during normal pregnancy.

The aim of the current study is to evaluate whether a TSH receptor can be demonstrated in human myometrium. If so, the pathophysiology of high TSH in relation to obstetric outcome will become more clear. Furthermore, the aim is to test the myometrium in vitro for its relaxation and contractility and for the conductance of electropotentials.

It has been recognized for many decades that high thyrotrophin (TSH) levels in pregnant women are associated with poor obstetric outcome. Also, there is evidence that high TSH is related to fetal position at term, including breech which in turn is associated with obstetric complications.

However, the mechanism behind remains to be elucidated. It has been shown that high TSH affects relaxation and contraction of the smooth muscle in large blood vessels in human. In animals, there is some evidence that TSH interferes with uterine contractility. Although a TSH receptor has been demonstrated outside the thyroid in bone, brain and heart, so far no research on a possible TSH receptor in human uterine tissue has been published.

The current study is a pilot study in which in a limited number of participants (pregnant women, n=10) during elective Caesarean section a uterine specimen will be collected for analysis in a immune-laboratory.

Another part of the specimen will be analysed in a technical laboratory(Technical University of Eindhoven)for analysing the relaxation and contractility of the myometrium and for studying the conductance of electropotentials.

Eligibility Criteria:
Inclusion Criteria:

* Elective caesarean section
* Term pregnancy \> 37 weeks
* Age \> 18 years

Exclusion Criteria:

* Previous caesarean scar
* Gestational age \< 37 weeks
* Maternal temperature \> 37.8 degrees Celsius
* Meconium stained liquor
* Foetal distress
* Maternal diabetes
* Seropositivity
* Use of thyroid medication
* Maternal thyroid disease
* Age \< 18 years
An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.

The Wingspan™ Stent System and Gateway™ PTA Balloon Catheter have CE mark and are commonly used in Europe. All the data collected in this registry will be from patients treated according to the physician's choice, per instructions for use, per approved indications and per local standard of care. The results from this registry will provide an understanding of the use and outcomes associated with the Wingspan™ Stent in a real world setting.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic stenosis of one of those intracranial arteries: Internal carotid artery (ICA ), M1 segment of the MCA, V4 segment of vertebral artery, basilar artery
* A Modified Rankin Score of ≤ 3
* A target vessel diameter between 2mm and ≤ 4.5mm
* Length of the target lesion of ≤ 14 mm
* Patient older than 40 years old

Exclusion Criteria:

* Patient previously stented at the target lesion
* Intracranial stenosis related to disease such as: arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy or fibromuscular dysplasia
* Complete occlusion of the artery on the imaging assessment
* Contraindications to antithrombotic and/or anticoagulant therapies
* Women who are pregnant or breast-feeding
* Patient not likely to be available for follow-up
* Patient protected by the law (safeguard of justice, supervision or trusteeship)
Effects of Arom Digest Slim on Metabolic Profile and Food Behaviour in Overweight Persons

The present study aims to evaluate the efficacy of Arom Digest Slim in facilitating weight reduction along with a series of minimal nutritional interventions.

Arom Digest Slim is a blend of fish collagen and essential oils. It will be administered in a group of overweight females wich also undertake minimal nutritional changes. The group will be compared with a group following only minimal nutritional changes.

Eligibility Criteria:
Inclusion Criteria:

* females 18 to 60 years old

Exclusion Criteria:

* cardiovascular, psychiatric and neurologic chronic conditions and medication
* acute conditions
* patients with hypersensitivity to any components of the product
Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte application on the lipid and stability of the tear film in dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 20 years(range from 20 year to 25 years)
* The value of OSDI is over 12
* NBUT is less 5 seconds
* Schirmer 1 test is less 10mm
* The basical lipid layer grade is 1-2

Exclusion Criteria:

* Any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular infection; photophobia that may cause reflex tearing or difficulty in evaluating the patient's lipid layer;
* Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte
Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience

COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV-2) and causes significant morbidity and mortality. This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study the investigators will analyze the data collected during treatment.

COVID-19 is a novel respiratory disease caused by coronavirus (SARS-CoV-2) and results in significant morbidity and mortality. To date there is no approved medication for the treatment of patients with COVID-19. Remdesivir is a broad-spectrum antiviral nucleotide analogue that inhibits RNA-dependent RNA polymerase activity among a diverse group of RNA viruses. Non-clinical and clinical data suggest that Remdesivir may be useful for the treatment of COVID-19. WHO has identified Remdesivir as a candidate drug of interest to be studied in clinical trials. This retrospective study is designed to analyze the data collected during the routine care of patients who have benefited from this therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥ 18 years old.
2. SARS-CoV-2 infection confirmed.
3. Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
4. Hospitalized patients who received at least one administration of Remdesivir therapy (Dose: 200mg day one then 100mg daily for up to 10 days).

Exclusion Criteria:

1. Presences of chronic renal failure \> 4 stage, GFR \< 30ml/min.
2. ALT/AST \> 5 times than normal values.
3. Pregnant women.
Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 years or older with suspected OP or carbamate insecticide self-poisoning admitted to medical wards with the cholinergic toxidrome requiring atropine.
* Diagnosis will be made on the basis of the cholinergic toxidrome clinical features (eg. small/pinpoint pupils, bronchorrhoea, sweating) or on the history of atropine administration with beneficial effect. The insecticide involved will be identified where possible from the history, the bottle brought in by the patient or relative, the patient/relative identifying the pesticide on a chart showing all locally available pesticides, and/or relatives sending a photo of the bottle by eg. WhatsApp.
* Patients who ingest combination products containing OP or carbamate insecticides will also be included.
* Inhibited blood cholinesterase activity as shown by routine clinical bedside test

Exclusion Criteria:

* Children aged \<16 years.
* Patients who do not require atropine and have not had it prior to presentation during this episode.
* Normal blood cholinesterase activity
* Self-reported known pregnancy (as per South Asian practice, no attempt will be made to formally test for pregnancy in the patients due to the issue of confidentiality in the acute care situation in these hospitals and the social consequences of an unexpected positive response)
* Known occupational and homicidal poisoning
* Past medical history of severely impaired renal function
* Hypersensitivity to magnesium and its salts
* Patients who have had a myocardial infarction or unstable angina in the last month
* Patients with traumatic subarachnoid haemorrhage
* Lack of informed consent (unaccompanied unconscious patients and others)
Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation

The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.

A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.

Eligibility Criteria:
Inclusion Criteria:

* Overall healthy subjects, non-childbearing females included.

Exclusion Criteria:

* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Pregnant or breast-feeding female.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

Vancomycin is a widely used antibiotic in the treatment of complicated gram positive infections. Approaches to vancomycin therapeutic drug monitioring (TDM) vary. This clinical trial aimed to compare the pharmacoeconomic outcomes between various vancomyicn TDM approaches.

Research questions: Which vancomycin therapeutic drug monitoring (TDM) approach is associated with superior economic outcomes?

-Objectives: In this proposed multicenter randomized controlled trial (RCT), we aim to compare the pharmacoeconomic outcomes of various vancomycin TDM approaches.


Eligibility Criteria:
Inclusion Criteria:

* adults at least 18 yrs who are hospitalized and initiated on IV vancomycin

Exclusion Criteria:

* renal instability
* immunosuppression;
* vancomycin allergy;
* history of recurrent peritonitis
* administration of \< 4 doses of vancomycin
* pregnancy;
* hemoglobin \< 8 g/dL.
Risk Reduction for Drug Use and Sexual Revictimization

The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors and revictimization. The principal purpose of this research proposal is to evaluate the efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and revictimization among adolescents who have been sexually assaulted. The Research Plan will be conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program as described in Rounsaville, Carroll, \& Onken (2001). The final phase of the research will involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents, comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in the community. Participants will be adolescents (12-17 years) who have experienced a sexual assault. Assessment of substance use and other risk behaviors, trauma-related psychopathology, and incidents of revictimization will be collected at pre- and post- treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the primary method used to test study hypotheses. Development and evaluation of the proposed intervention will have significant implications for addressing public health problems in adolescent substance abuse and related high risk behaviors.

See above summary

Eligibility Criteria:
Inclusion Criteria:

* memorable sexual assault

Exclusion Criteria:

* active psychosis
* active suicidality
Surgical Capacity in Zimbabwean Public Hospitals

This study aimed to understand how ready Zimbabwe's public hospitals are to perform essential surgeries, which are critical for treating a wide range of health issues from emergencies like car accidents to planned procedures such as childbirth by caesarean section. The researchers looked at hospitals across Zimbabwe to see what kind of surgery facilities, equipment, and specialists were available.

Abstract Background: Access to surgical care is an essential component of universal health coverage, but surgical capacity is lacking in many low- and middle-income countries. Surgical capacity in Zimbabwe, a lower-middle income country, is undocumented. The objective of this study was to assess surgical capacity in public hospitals in Zimbabwe.

Methods: A national hospital survey was performed in 2019 using a validated surgical situational analysis tool. the investigators included district, provincial and central hospitals in the public sector across all 10 provinces of Zimbabwe. Data was collected from key informants using an online survey. information gathered included an inventory of infrastructural components required to perform essential surgical services, a survey of healthcare workers involved in surgical care (the Surgical Anaesthetic and Obstetric workforce); a submission of the number of surgical procedures including bellwether procedures performed over the course of the last year and also surgical sundries and consumables required to perform surgical services.

Eligibility Criteria:
Inclusion Criteria:

* Hospitals were considered eligible if there was any major or minor surgical activity occurring in the facility

Exclusion Criteria:

* hospitals dedicated to a non-surgical pursuit
* private hospitals
Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men

Low testosterone is a common male problem. The diagnosis of low testosterone often requires blood sampling and expensive testing. We want to know if measuring saliva testosterone can be used in place of blood sampling. Study participants will be asked to provide samples of blood and saliva for the measurement of testosterone. These results may lead to the development of a saliva test for testosterone.

Testosterone is required for normal male health that is known to decline in aging or other conditions. Physiologically active testosterone, also known as "free" testosterone, is present as a small percentage of the total blood level, mostly bound to sex hormone binding globulin and albumin. Estimation of serum free testosterone is difficult and costly, requiring equilibrium dialysis of a serum sample. These binding proteins are not normally present in saliva. It is hypothesized that the free fraction of testosterone in blood is in equilibrium with the extravascular space, notably saliva. The sponsor proposes to test this hypothesis by sampling saliva and serum and measuring testosterone. Serum free testosterone will be measured following equilibrium dialysis. To perform this study approximately 40 eugonadal and 20 hypogonadal males will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Normal male subjects aged 20-65 years

Exclusion Criteria:

* Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol