cyrilzakka/clinical-trials huggingface dataset:
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

Despite the known damaging effects of alcohol on the developing fetus and the presence of warning labels on alcoholic beverages, many pregnant women continue to drink alcohol. The consequences include a range of physical, neurological, and behavioral effects referred to as fetal alcohol spectrum disorders (FASD). Unfortunately, there are currently no comprehensive treatments for individuals with FASD. This pilot study will examine whether a nutritional intervention could reduce the severity of cognitive deficits associated with prenatal alcohol exposure. Choline is an essential nutrient, necessary for brain and behavioral development. Animal studies have shown that prenatal or early postnatal choline supplementation can lead to long-lasting cognitive enhancement. Similarly, choline supplementation improves cognitive outcomes among rats exposed to alcohol during development, even when administered postnatally and after alcohol exposure has occurred. The present experiment translates these findings to a clinical population of individuals exposed to heavy prenatal alcohol exposure. Subjects will be randomly assigned to receive daily choline supplementation or placebo control for a period of 6 weeks (approximately 20 subjects per group). Performance on neuropsychological tasks that measure cognitive functioning will be measured prior to treatment and at 6 weeks. These data will provide important information regarding a potential nutritional intervention for fetal alcohol spectrum disorders.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed histories of prenatal alcohol exposure (by review of medical, legal, or social service records or maternal report, if available; information about levels and timing of exposure will be inquired, but not necessary for inclusion)
* English as primary language

Exclusion Criteria:

* Significant physical (e.g., uncorrected visual impairment, hemiparesis) or psychiatric (e.g., psychosis) disability that would prohibit participation
* History of neurological condition (e.g., epilepsy)
The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients

This studay evaluates the effect of liraglutide in the treatment of obese patients ande the influence of genetic factors on the curative effect.Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Background:The rapid growth of obese or overweight people in the world has become a major social problem. Obese often associated with kinds of metabolic disorders, especially type 2 diabetes, and Liraglutide can effectively reduce weight and improve blood glucose.Previous studies have indicated that most patients will experience different degrees of weight loss after using Liraglutide, but there is also a small number of patients with no significant weight loss.The gene polymorphism among individuals may affect the weight loss effect of Liraglutide.

Objectives：1.To find the relationships between genetic variants and the response of Liraglutide to treatment of obese patients.2.To investigate the effects of Liraglutide on weight, metabolism (blood glucose, blood lipid, uric acid, etc.) and gut microbiota in obese Chinese patients.

Intervention:Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 65 years (to the date of screening)；
2. The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).
3. Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.
4. Weight stable for more than 3 months (weight fluctuations \<5%).

Exclusion Criteria:

1. Pregnant female.
2. Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.
3. Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.
4. Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.
5. Nearly a month had surgery, trauma, infection and so on.
6. Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.
7. Poor medication compliance or serious side effects (severe rash, syncope, etc.).
Adherence of Stalevo, Entacapone and Levodopa

To test if combining two antiparkinson drugs into a single tablet improves accuracy of medicine intake by the patient.

To test if patients with Parkinson's disease who take medicines at regular time intervals have smoother symptom control.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Parkinson's disease aged between 18 and 85 years fulfilling UK Brain Bank criteria.
* Current levodopa therapy prescribed on a regular basis three or more times per day but requiring entacapone because of 'wearing off'
* Able to manipulate electronic monitoring bottles and complete questionnaires

Exclusion Criteria:

* Current use of compliance aid such that study participation would be detrimental to patient's adherence
* Pregnancy or breast feeding
* Excess alcohol (over 21 units per week for women and 28 units for men)
* Mini mental state examination of less than 26.
* Severe depression (Geriatric depression score over 20)
Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

Title: Efficacy and safety of rivaroxiban compare with vitamin K antagonist warfarin in patients with atrial fibrillation and mitral stenosis among Pakistani population.

Atrial fibrillation is associated with an increase in the risk of ischemic stroke by a factor of four to five and accounts for up to 15% of strokes in persons of all ages and 30% in persons over the age of 80 years. The use of vitamin K antagonists is highly effective for stroke prevention in patients with non-valvular atrial fibrillation and is recommended for persons at increased risk. However, food and drug interactions necessitate frequent coagulation monitoring and dose adjustments, requirements that make it difficult for many patients to use such drugs in clinical practice.

Rivaroxaban is a direct factor Xa inhibitor that may provide more consistent and predictable anticoagulation than warfarin. It has been reported to prevent venous thromboembolism more effectively than enoxaparin in patients undergoing orthopedic surgery and was non-inferior to enoxaparin followed by warfarin in a study involving patients with established venous thrombosis. This trial was designed to compare once-daily oral rivaroxaban with dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation who were at moderate-to-high risk for stroke

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* Age from 18 years up to 55 years
* Rheumatic MS (Mild moderate severe) Hemodynamic ally stable patients
* Associated AF or flutter documented on ECG
* Post PTMC or M com
* Not previously enrolled in any trial or study on NOACS
* Willing to participate

Exclusion Criteria:

* Rheumatic valve other than MS
* Prosthetic Mitral Valve Surgery
* Previous TIA or stroke
* Plan for valve replacement within six months
* Pregnancy
* History of bleeding complication
* High Risk of bleeding complication
* Allergic to study drug
* Anemia (HB less than 10 g/dl)
* Raised SGPT \> 2xUNL
* Creatinine clearance \<30ml/min
* Not willing to participate.
Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder

The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients with diagnosis of generalized anxiety disorder.

Exclusion Criteria:

* Any serious or uncontrolled medical condition.
* Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.
SVC and Its Relationship to CVP Measurements in Liver Transplantation

Consecutive patients undergoing liver transplant surgery will be included in the study. Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during the postanhepatic phase and following closure of the deep fascial layer of the anterior abdominal wall simultaneous measurement of SVC diameter, SBC collapsibility index and CVP will be recorded.

Central venous pressure (CVP) measured invasively through a central venous catheter in the internal jugular vein or through a right atrial port of a pulmonary artery catheter is commonly used during liver transplant surgery. CVP measurements at the SVC-RA junction are a function of circulating blood volume, right ventricle function, intrathoracic pressure. CVP measurements can also be affected by the presence of tricuspid regurgitation. Because central venous pressure measurements are determined by several factors and do not predict the response to subsequent fluid bolus administration, they are considered "static measures" and are poor indicators of fluid responsiveness.

Given the entirely intrathoracic location of the superior vena cava (SVC), its diameter and collapsibility with positive pressure ventilation it is a potentially attractive method of non-invasively estimating CVP.

SVC diameter and collapsibility index, dynamic measures of fluid responsiveness have been successfully utilized as echocardiographic indices for fluid responsiveness in ventilated septic patients. Whether SVC collapsibility is correlated with CVP measurements in liver transplant patients is not known.

Consecutive patients undergoing liver transplant surgery will be included in the study. Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during the postanhepatic phase and following closure of the deep fascial layer of the anterior abdominal wall simultaneous measurement of SVC diameter, SBC collapsibility index and CVP will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* undergoing liver transplantation surgery (cadaveric and living related)

Exclusion Criteria:

* Contraindication to Transesophageal echocardiography
Lower Leg Remote Ischemic Preconditioning in Elective Percutaneous Coronary Intervention (PCI)

The purpose of this study is to investigate if remote ischemic preconditioning by combining limb ischaemia with electric muscle stimulation of the ischemic muscle provokes better results in preconditioning the human heart than limb ischaemia alone does.

It has been demonstrated that protection from ischemia reperfusion can be achieved by brief periods of ischemia applied at a remote site during an injurious ischemic event (remote postconditioning). The purpose of this study is to investigate if the combination of brief periods of limb ischemia in combination with electric muscle stimulation at the same site could exceed the preconditioning effect of limb ischemia alone.

Therefore the investigators thought to perform 2 different forms of remote ischaemic preconditioning in patients undergoing elective coronary angioplasty.

In the first patient group a blood pressure cuff will be applied at the lower leg. Ischemia will be induced by inflating the cuff to a pressure of 200 mmHg for 5 minutes. Afterwards reperfusion will be allowed for further 5 minutes. This cycle will be repeated 3 times.

In a second patient group electric muscle stimulation at the same site (HiToP 191) will be performed additionally throughout the whole preconditioning cycle.

After preconditioning, the percutaneous coronary intervention (PCI) will be performed by 3 PCI-ballon inflations, each lasting for 2 minutes. Between the inflations coronary reperfusion will be allowed for 5 minutes.

The Effects of preconditioning will be evaluated by analysing the ST-deviation, caused by angioplasty in an intracoronary (derived by PCI wire) and surface ecg.

Also the maximum of chest pain during the 3 inflation cycles and troponin levels 24 h after PCI will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* planned PCI of one of the main coronary artery (artery diameter distal of the stenotic area at least 2,5 mm)
* patient age 18 years or older
* stable angina pectoris symptoms

Exclusion Criteria:

* presence of collateral vessels
* electrocardiographic bundle branch blocks
* multiple coronary stenosis
* occlusion of a coronary artery
* renal insufficiency (GFR (MDRD) \< 50 ml/min/1,73 m2)
* presence of coronary bypass grafts
* history or presence of myocardial infarction.
* echocardiographic signs of left ventricular hypertrophy (septal and/or posterior wall diameter greater than 14 mm)
* some sort of medications (adenosine, morphine and derivates, immunosuppressive agents, oral antibiotics, theophyllin, alpha receptor blockers)
* peripheral arterial disease
* exercise tests performed within 24 h before study start.
Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study

Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia).

With an increase in the amount of premature children, we expect an increasing number of children with BPD.

Today we do not have many ways of predicting or treating this condition, and the children are usually in hospital for several months after birth. Many are dismissed with home oxygen. Children with BPD are typically often re-submitted to hospital with respiratory disease the first couple of years, and some of them have problems throughout childhood and into adulthood.

Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary Disease (COPD).

The condition as well as the treatment (steroids), are associated with great risk of adverse effects as Cerebral Palsy, blindness, deafness and mental retardation.

The investigators wish to find a safe way to identify the children in greater risk of developing BPD, who could therefore benefit from a more intensive treatment.An early diagnosis would increase the possibility of predicting the prognosis.

Other studies have proven a connection between both low vitamin A and D and high exhaled nitrogen oxide (NO) with lung disease.

With this trial the investigators wish to make a reference material for NO and vitamins A and D in infants admitted to the neonatal department at two hospitals in Denmark, both with and without treatment with nasal Continuous Positive Airway Pressure.

The investigators furthermore wish to describe an eventual connection between BPD and these factors by examining a large group of children on 7 specific occasions within the first two months of life and at a one year follow up.


Eligibility Criteria:
Inclusion Criteria:

Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit. Gestational Age 24-42 weeks.

Exclusion Criteria:

1. Children with ciliary dyskinesia, as NO is distinguishable lower in these children.
2. Children who can not cooperate to the examination.
3. Children so dependant on oxygen, that the examination/measurement is not possible.
4. Children with pneumothorax
5. Children having a diagnosed pneumonia verified by tracheal secrete.
6. Children with bigger congenital anomalies
Defensive Dentistry Practices and Dentists (DDP)

Medical malpractice claims have been on the rise in recent years due to the growing patient rights movement. This term is defined as an injury caused by a healthcare professional's failure to follow standard practice during treatment, a lack of skill, or failure to provide treatment. Defensive dentistry is on the rise as violence and malpractice claims increase. Defensive dental practices (DDP) refer to minimize legal responsibility of the clinician primarily rather than looking out for the patient's benefit. This study aims to evaluate the knowledge, awareness and attitudes of dentists in terms of DDP.


Eligibility Criteria:
Inclusion Criteria:

* Having worked as a dentist for at least one year;
* Speaking Turkish as their native language;
* Being a member of the Turkish Dental Association;
* Participating in the study voluntarily.

Exclusion Criteria:

-To stop volunteering until the study is completed.
Sexual Health in Breast Cancer Patients

In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment.

In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment. The objectives are as follows:

1. To characterize the sexual well-being of women longitudinally throughout the continuum of care, from initial diagnosis into survivorship.

   We predict that treatment will adversely affect sexual well-being, and that patient factors, clinical factors, and treatment choices will influence changes in sexual well-being.
2. To identify gaps is sexual health education provided at the time of diagnosis or during treatment and to determine the appropriate timing of sexual health education delivery.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 09/01/2019 to present, will potentially be recruited to participate.

Exclusion Criteria:

* Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.
Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession

The study aimed to compare, the effectiveness of Growth Factor Enhanced Matrix (GEM 21s) ® combined either with free connective tissue graft or collagen membrane in the treatment of Miller class II gingival recession.

Materials and Methods: Twenty sites in 10 patients, with class II Miller gingival recession were allocated randomly to be treated by (GEM 21s) ® with free connective tissue graft (groupI) or GEM 21s with collagen membrane (groupII). Plaque index, bleeding on probing, recession width, recession depth, height of keratinized tissue and digital measurements were recorded at baseline, 1, 3 and 6-months'. Probing pocket depth, clinical attachment level, gingival thickness and Radiographic parameters were recorded at baseline and 6 months'. Root coverage percentage were recorded 6 months postoperative and wound healing index were recorded at 1,3 and 6-months' post-operative .

Eligibility Criteria:
Inclusion Criteria:

* lack of any related medical issues that contraindicate periodontal surgery,
* optimum adherence as confirmed by a positive attitude towards oral hygiene, and successfully showing up for treatment appointments.
* No history of any medications in the previous six months that may interfere with periodontal surgery Gingival thickness for the selected sites should be \> 1mm (as measured 2mm apical to gingival margin),
* Clinical attachment level ≥ 4mm measured from cemento-enamel junction till the deepest probing depth.

Exclusion Criteria:

* the presence of class V caries or restoration in the site to be treated,
* previous mucogingival surgery at the selected site.
* Teeth that are tilted, rotated, or have any occlusal abnormalities.
* Smokers and pregnant patients were excluded from the participation.
Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections

The goal of this randomized controlled trial is to compare the effects of a clinical decision support tool consisting of a 48-hour stop order for indwelling urinary catheters versus no clinical decision support in hospitalized patients with indwelling urinary catheters. The main questions it aims to answer are:

- Does the presence of an automated stop order integrated as part of a clinical decision support tool reduce dwell time of urinary catheters and the rate of catheter associated urinary tract infections?

Participants who have indwelling urinary catheters ordered will be randomized to either have these orders automatically expire after 48 hours unless an action is taken or have orders without expiration. Researchers will compare the urinary catheter dwell time and the rate of catheter associated urinary tract infections between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital
* At least 18 years old
* Has order placed for indwelling urinary catheter

Exclusion Criteria:

* Indication for urinary catheter labeled as either "Chronic" or "Placed by urology"
Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia

MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorder prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in a real-life clinical setting.

Currently, there is no recommendation on next-step treatment strategy if the patients remain suffering from residual symptoms, have incomplete remission, or have acute exacerbation of schizophrenia whilst receiving aripiprazole long acting injection at its recommended (maximum) dose, except to switch to other second generation antipsychotics (SGA) or to clozapine if they are in their treatment-resistant course. Such practice may incur risks of full relapse and/or unnecessary side effects to the patients, in particularly to those already showed insufficient treatment response, intolerability to side effects, or non-adherence to other antipsychotics before. On the contrary, adding another SGAs to this special cohort appears to be rational. Especially, brexpiprazole might be an ideal choice for its serotonin-dopamine activity modulator property to achieve better symptom control, and at the same time retaining the benefits from the lower incidence of side effects than other SGAs.

Cases reports on combination therapy with aripiprazole (oral or LAI) with brexpiprazole had demonstrated initial favorable outcomes, albeit lacking empirical evidence from randomized controlled trial or longer term follow-up study. Therefore, the current MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorders prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in an non-interventional, naturalistic real-life clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18- 65 years old at the time of enrollment
* Able to read and communicate in English and/or Chinese
* Able to give informed consent
* Has been diagnosed to have Schizophrenia (DSM-5 or ICD-10 F20 \[except F20.81\], Schizotypal (Personality) Disorder (DSM-5 or ICD-10 F21), or Schizoaffective Disorder (DSM-5 or ICD-10 F25), (Persistent) Delusional Disorder (DSM-5 or ICD-10 F22), Schizophreniform Disorder (DSM-5 or ICD-10 F20.81), Brief Psychotic Disorder (DSM-5) or Acute and Transient Psychotic Disorder (ICD-10 F23)
* Is receiving the combination with Abilify Maintena and brexpiprazole as treatment ≤8 weeks at the time of recruitment

Exclusion Criteria:

* Age \<18 years old
* Unable to read English or Chinese
* Unable to give informed consent
* Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10 F70-73)