cyrilzakka/clinical-trials huggingface dataset:
Development of a Predictive Model of Fetal PH At Birth from Novel Variables Derived from Cardiotocographic Tracing

The goal of this observational study is to build a predictive model of fetal acidosis based on variables from the cardiotocographic tracing recorded during labor in participants undergoing spontaneous or induced delivery with single pregnancy.

Cardiotocography is the current tool used to assess fetal well-being in labor and to identify cases of fetal distress early. We decided to conduct this study because the current interpretation of the cardiotocographic trace has limitations, related to the subjective interpretation of the trace. There are currently no predictive models that can reduce this margin of error. Creating a predictive model of fetal acidosis, based on variables from the cardiotocographic tracing, could be useful in order to enable a better and more timely intervention. It can also be useful in reducing the rate of improper obstetric interventions.

The recording of the cardiotocographic trace will take place throughout the duration of labor as per internal clinical management recommendations. Once delivery has taken place (by cesarean section, obstetric suction or spontaneously), the data derived from the cardiotocographic tracing will be extracted using the Sonicaid Fetal Care Software from the cardiotocograph into a .csv file that will report for each second four measurements of heart rate and intensity of maternal contractions.

The .csv file is converted to a .sav file and the new variables are generated, using a specially created SPSS script, in order to calculate the stability and variability of fetal heart rate. Neonatal outcomes will be considered the dependent variable in this set of variables originated from the fetal heart rate patterns.

The clinical variables that will be collected for the predictive model and/or for descriptive purposes are:

* umbilical artery and vein pH
* excess umbilical artery and vein bases
* Apgar score at birth
* presence of dyed amniotic fluid
* onset of active labor of delivery
* onset of the expulsive period
* fetal expulsion
* cord rounds
* mode of delivery
* neonatal weight.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age between 18 and 45 years;
* Single pregnancy
* Participants undergoing continuous monitoring of labor labor
* Obtaining informed consent for study participation and processing of personal data

Exclusion Criteria:

* None
Effect of Hand-off Skills Training for Students During the Medicine Clerkship

The purpose of this study is to assess the effectiveness of an educational intervention on handoffs implemented during the third year of medical school. It also assesses whether these skills are maintained over time into their fourth year of training and whether there is transfer from the simulated setting into the clinical environment.


Eligibility Criteria:
Inclusion Criteria:

* Third Year Medicine Clerks

Exclusion Criteria:

* None
Urinary Tract Infections in Kidney Transplant Recipients

The purpose of this study is to better estimate the prevalence of urinary tract infections (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR) bacteria. KIT recipients have a higher risk of UTI over the 6 first months following the transplantation. Urine culture was done in a city lab or at hospital. Current data on bacteriuria and candiduria lead mostly to hospital data that are incomplete..

The risk of UTI after a kidney transplantation is higher than in the general population. MDR bacteria, such as extended spectrum betalactamase (ESBL)-producing enterobacteriaceae or MDR Pseumomoas aeruginosa are emerging threats due to antibiotic selective pressure. Epidemiological data are mostly data from hospital laboratories that do not show a complete overview of the current situation. In addition, the different centers which participated to this study received before the beginning of the study a protocol to avoid carbapenem use. The main objective of this study is to assess the prevalence of MDR bacteria in an adult population of KIT recipients. Through this study, the management of UTI in KIT recipients will be improved. Data on bacteria or yeasts responsible for UTI (identification, resistance profile), antibiotic use, patients' outcome, and graft outcome will be collected.

Eligibility Criteria:
Inclusion criteria

* Age ≥ 18 year-old
* Kidney transplanted for less than 5 years
* First symptomatic episode of UTI with bacteria or yeast
* To have a health insurance

Exclusion criteria

* Asymptomatic bacteriuria or candiduria
* Protected people
* Pregnant women -\> 2 bacteria in the urinalysis without external or internal urinary catheter
The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease

The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.

Increasing prevalence of overweight and obese worldwide, non-alcoholic fatty liver disease (NAFLD) is commonly diagnosed in daily clinical practice. Weight reduction has been the only strategy established thus far to reduce hepatic lipid levels. Thus, dietary restriction and exercise focusing on weight reduction is recommended as the cornerstone for managing NAFLD. Recent reports have indicated that increased exercise greatly reduces hepatic fat accumulation and inflammation and the related oxidative stress levels outweigh those achieved by dietary restriction alone. Clear guidelines for such a "lifestyle physical activity" for NAFLD management are currently lacking. The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content remains unclear.The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.

Eligibility Criteria:
Inclusion Criteria:

* Siriraj medical personals
* Ultrasonography show liver steatosis by using ultrasound criteria
* Transient elastography by using the controlled attenuation parameter show moderate degree of fatty accumulation in the liver
* History of alcohol consumption in male \<20 g/d, female \<10 g/d

Exclusion Criteria:

* Liver disease of other etiology
* Medications that caused fatty accumulation in the liver
* Treated with vitamin E or antidiabetic agents
* Cardiopulmonary diseases or orthopedic conditions that are contraindicated for exercise
Delivering Group Support for People With Aphasia Through Eva Park

The project will investigate the feasibility and acceptability of a remote support group intervention for people with aphasia, and will investigate the impact of that intervention on measures of wellbeing, quality of life and communication. The intervention will be delivered to 32 participants in Eva Park, a virtual island specifically designed for people with aphasia.


Eligibility Criteria:
Inclusion Criteria:

* Stroke survivor with aphasia; Score within the aphasic range on the Frenchay Aphasia Screening Test (FAST); Fluent pre-stroke user of English.

Exclusion Criteria:

* Co-morbidity affecting cognition; Severe hearing or visual impairments
FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation

A first-in-human single center, randomized, double-blind, placebo-controlled trial, with primary objective to evaluate safety and tolerability of ex-vivo kidney allograft treatment with TUM012 to reduce ischemia-reperfusion injury in de novo kidney transplant recipients.

Graft ischemia and reperfusion related injury is still the leading cause of graft failure in Deceased Donor kidney transplantation. The aim of the trial is to evaluate the safety of ex-vivo treatment of kidney allografts from deceased-donors with TUM012 to diminish ischemia reperfusion related inflammation, and improve overall transplantat outcome.

Eligibility Criteria:
Inclusion Criteria:

* Standard and extended criteria donor ≥18 years of age, suitable for clinical transplantation and preserved by cold storage.
* Available, personally signed and dated Informed Consent Form (ICF)
* Male or female Chronic Kidney Disease (CKD) patient ≥18 years of age, with Glomerular Filtration Rate (GFR) ≤15 mL/min, awaiting their first kidney transplantation
* ABO-compatible, negative pre-transplant CDC class I and II crossmatch with no Donor Specific Antibodies (DSA), defined as ≤1 000 Mean Fluorescent Intensity (MFI).
* Patient is suitable for surgery, as judged by the investigator
* Completed vaccination program for pneumococcal disease, varicella zoster, measles, and SARS-CoV-2 virus

Exclusion Criteria:

* Surgically induced injuries compromising ex-vivo treatment and/or transplant outcome, as judged by the transplantation surgeon
* Previously undergone any organ and/or cell transplantations
* Patients with positive CDC class I and/or II crossmatch, or negative CDC class I and II crossmatch with pre-existing DSA \> 1,000 MFI
* ABO-incompatible DD KT
* Pregnant or breast-feeding woman
* Woman of child-bearing potential, unwilling to use an adequate contraceptive method
* Prior participation in clinical trial with (approved or non-approved) IMP within one month prior to screening for this trial.
* Prior malignancy diagnosis ≤5 years, except for adequately treated basal cell, or squamous cell skin cancer, and cervical carcinoma in situ
* Positive result for serum Human Immunodeficiency Virus (HIV), active hepatitis B-, or C-infection in pre-transplant evaluation
* Clinical signs of ongoing infectious disease, defined as C-Reactive Protein (CRP) \>10, unless stable since \>4 weeks (\<50% increase)
* Concomitant severe conditions requiring treatment and close monitoring, e.g., cardiac failure \>grade 3 New York Heart Association (NYHA), unstable coronary disease, or oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)
* History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the trial, or influence the results or the patient's ability to participate in the trial
* Patient unlikely to comply with trial procedures, restrictions, and requirements (e.g., caused by substance abuse, concurrent medical condition, etc.), as judged by investigator
Solid State vs. Balloon Esophageal Catheter for Estimation of Pleural Pressure

Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid-state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice.

This method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.

Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice.

This method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.

Subjects will receive a standard balloon esophageal catheter and a solid-state pressure catheter for simultaneous measurements of Pes. Study population will be post-surgical ICU patients. Measurements will be performed during clinical mechanical ventilation settings which include a first phase of passive controlled ventilation (patient is still sedated after surgery) as well a phase of partially-assisted ventilation where the patient's breathing effort has resumed and is assisted by the ventilator. During both phases, 10-15 minutes of tidal breathing will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patient requiring mechanical ventilation at the ICU following cardiothoracic or abdominal surgery
* Age ≥ 18 year

Exclusion Criteria:

* Pregnancy
* Upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
* Nasal bleeding within the last \<2 weeks
* Presence of pneumothorax
* Use of anticoagulants that increase the risk of catheter insertion
Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Dual Mobility Cup

This study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff.

This study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff.

This study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff.

A retrospective cohort study will be conducted at our tertiary care level 1 trauma center .ERC approval wwill taken from Ethical Review Committee of the hospital. Patients of age group more than 60 year who underwent hip arthroplasty (bipolar hemiarthroplasty or THA with dual mobility implant) between 2015 and 2017 for displaced neck of femur fracture with a complete follow up for one year were included.

Both groups will be assessed for postoperative complications including surgical complications (dislocation, periprosthetic fracture and surgical site infection), one year mortality and functional outcome via Harris hip score at the latest follow up.

Data will be analyzed using SPSS version 20.Chi-sqaure test was used to compare categorical variables whereas independent sample T-test was used to compare continuous variables. P-value of \<0.05 was considered significant

Eligibility Criteria:
Inclusion Criteria:

* . Patients of age group more than 60 year who underwent hip arthroplasty (bipolar hemiarthroplasty or THA with dual mobility implant) between 2015 and 2017 for displaced neck of femur fracture with a complete follow up for one year

Exclusion Criteria:

* Patient who underwent hip arthroplasty for other indications, patients younger than 60 years patient with pathological fractures, patient with missing records and patients lost to follow up
An Evaluation of Appearance-based Interventions for the Promotion of Sleep

This study evaluates the efficacy of appearance-based interventions in promoting healthy sleep. One group of participants will receive standard information about sleep (control group), while the other group will receive information about how sleep affects their physical appearance (intervention group).


Eligibility Criteria:
Inclusion Criteria:

* 18-24 years
* \<7 hours of sleep routinely

Exclusion Criteria:

* per-existing medical, sleep, or psychiatric conditions;
* history of substance abuse.
A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability

The main purpose of this research project is to evaluate the safety and effectiveness of a surgically implanted device called the Medtronic Activa PC+S System in patients with medically refractory epilepsy (people who have seizures that are not completely controlled by medical therapy). The system sends small electrical pulses into a part of the brain called the thalamus to help control seizures. It sends this signal in regularly, regardless of if a seizure is occurring. A different version of this device is already approved for the treatment of epilepsy in Australia. This study aims to use the brain's responses to single pulse electrical stimulation to measure the level of seizure susceptibility. The investigators would like to show that this measure can be used to provide more effective deep brain stimulation therapies, to stop seizures.


Eligibility Criteria:
Inclusion Criteria:

Patients with epilepsy with non-resectable pathologies, or clearly defined focal seizures without a defined structural pathology.

Patients will be required to have a seizure diary (of up to 3 months) recording at least five seizures per month that are well separated in time (at least 8 hours apart).

Exclusion Criteria:

Previous diagnosis of psychogenic/non-epileptic seizures
Diabetes Exercise and Lifestyle Trial

The objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin).

Background Rationale: Structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. It has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. The supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. A stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* A1c 0.700-0.099
* ability to read and write English
* signed ICF

Exclusion Criteria:

* participation in previous 6 months in exercise \> 2 times per week for at least 20 min per session
* insulin therapy changes in medication for diabetes, BP or Lipids
An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum

If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. IGIV treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.

We have come to believe that an immature immune system with abnormal signaling and altered apoptotic pathways may result in a process of neuroinflammation with a clinical presentation of Autism Spectrum Disorder. If Autism Spectrum Disorders are the consequence of a chronic inflammatory process that prevents the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. We believe that there is a correlation between immunological abnormalities and the development of the autism.

Eligibility Criteria:
Inclusion Criteria:

* The subject is between the ages of or equal to 4 and 12 years of age, of either gender, and belonging to any ethnic group.
* The subject has a diagnosis, for a minimum of 6 months prior to screening, of either autistic disorder, Asperger disorder, or pervasive developmental disorder (PDD).
* Normal physical test results.
* Immunological lab results showing reduced levels of activated CD40L or abnormal lymphocyte stimulation, or T or B cell dysfunction (hypgammaglobulinemia, primary immunodeficiency (PIDD), or common variable immune deficiency (CVID).

Exclusion Criteria:

* A diagnosis of isolated IGA deficiency
* Allergic reactions to blood products
Efficacy of Curcumin in Oral Submucous Fibrosis

The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF).

200 clinical stage 2 OSMF patients selected randomly by simple random technique with clinically \& histopathologically confirmed diagnosis are divided into 4 groups with 50 patients each.

In Group 1 patients are given 10% of curcumin mucoadhesive gel and are instructed to use it topically twice daily making it a daily dose of 1gm.

In Group 2 patients are given 500mg of curcumin capsules and are instructed to take 2 capsules twice daily making a daily dose of 1gm.

In Group 3 patients will be given 5% of curcumin mucoadhesive gel and will be instructed to use it topically twice daily \& 250mg of curcumin capsules to be taken twice daily making it a daily dose of 1gm.

Group 4 is considered as control group and provided with formulations without the active drug.

The mean scores of 4 groups will be statistically tested using Anova technique.

The differences in clinical parameters at 15 days, 1 month, 3 months \& clinical \& histopathological paramerters at 6 months will be compared between groups 1, 2, 3 \& 4 by using students 't' test \& correlation is also used for knowing the association of variables.

For all tests, a 'p' value of 0.05 or less will be utilized for statistical significance.

Other non parametric tests can also be applied where ever necessary for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* 200 clinical stage 2 OSMF patients

Exclusion Criteria:

* Clinical stage 1 \& 3 OSMF patients, oromucosal disorders with clinical features same as OSMF, patients who are under treatment, clinically diagnosed cases not ready for incisional biopsy, patients suffering from medically compromised conditions.