cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects

The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults \>=19years and \<=45 years of age
* BMI \>=17.5 kg/m2 and \<30.5kg/m2, and body weight \>= 55kg for male and \>= 45kg for femlae
* subjects with no abnormal symptoms or findings based on physical examinations
* subjects determined eligible based on the results of lab tests
* subjects who agree to participate

Exclusion Criteria:

* Subjects with medical history that can not be participated
* Subjects with results of lab tests performed at screening which meet any of the following :

  * ALT or AST \> 1.5 times the upper limit of normal
  * Diagnosis of Helicobacter pylori (H. pylori) positive result
* subject who is allergic to IP
* subject with history of serious alcohol or drug abuse within 1 year prior to screening.
Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life

The aim of the study is to determine the effect of Pilates exercises on postpartum fatigue, maternal functioning and quality of life.

the effect of Pilates exercises in reducing postpartum fatigue is not well known however in recent study Pilates exercises alone was quantified which was based on home exercises and had a positive effect, it was conducted in primiparas women, there was also possibility of recall bias due to self report nature of data

Eligibility Criteria:
Inclusion Criteria:

* Multiparous females
* Age 18 to 45 years
* Females with vaginal delivery
* Two weeks after Spontaneous Vaginal Delivery
* Fatigue score of \>11 on Fatigue Assessment scale

Exclusion Criteria:

* Postpartum depression score greater or equal to 10 , based on the Edinburgh Postnatal Depression scale (EPDS)
* Postpartum anemia
* Generalized Anxiety Disorders
* Chronic illnesses (Diabetes /hypothyroidism)
A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood

A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.

A total of \~2000 participants have donated blood samples used for the development and validation of the IONA non-invasive prenatal screening test for Downs, Edwards and Patau syndrome. The IONA Test was CE marked Feb 2013. We are now recruiting a further 800 participants to provide blood samples to further develop and verify the test for other chromosomal abnormalities and to improve test efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Patient/subject is willing and able to give informed consent for participation in the study.
* Female, aged 16 years or above.
* Currently pregnant at time of entry to the study.
* Pregnancy having been identified as 'high-risk' by screening test.

Exclusion Criteria:

* The patient/subject may not enter the study if ANY of the following apply:
* The participant herself has Down's Syndrome or other chromosomal abnormality.
* Children under 16
* Adults with learning disabilities
* Adults who are unconscious or very severely ill
* Adults who have a terminal illness
* Adults in emergency situations
* Adults suffering from a mental illness
* Adults with dementia
* Prisoners
* Young offenders
* Adults who are unable to consent for themselves
* Any person considered to have a particularly dependent relationship with investigators
Safety and Feasibility Study of the Chartis System

The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments during bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo clinically indicated routine diagnostic bronchoscopy

Exclusion Criteria:

* Hyperexcretive chronic bronchitis or excessive sputum secretion
* Active pulmonary infection
* FEV1 \<20% predicted
* FVC \<50% predicted
Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children

Excess consumption of refined sugar and increased use of recreational screen time are risk factors for alterations in the quality of life that have been associated with sleep bruxism in children and that compromise the same mechanisms of alteration of the reward system in the brain. Therefore, the question of this research is: What is the effect of the Intervention "Food, Fun and Family (FFF)" on the frequency of sleep bruxism in children? The general objective of the research is to evaluate the effect of the Intervention "Food, Fun and Family (FFF)" on the frequency of sleep bruxism in 84 children who attend the pediatric dentistry postgraduate clinic of the CES University and the private consultation Dr. Claudia Restrepo and Dr. Adriana Santamaría. The frequency of sleep bruxism will be evaluated with the translated and validated Spanish version of the Children's Sleep Habits Questionnaire (CSHQ), which will be answered by the parents. The consumption of added sugar will be evaluated with the version translated into Spanish of the Health Behavior in School-Aged Children - Food-Frequency Questionnaire (HBSC-FFQ). The time on screens will be recorded through the parents' report, of the time in hours that the child spends using electronic media in a recreational way each weekday for a week and each weekend day for a week.

A decrease in the frequency of sleep bruxism is expected to be found by reducing sugar consumption and screen time in the children evaluated.

The results of this study will be presented at the IADR, ACFO, ACOP and CES University research meetings and will be published in a peer-reviewed scientific journal in category Q1.


Eligibility Criteria:
Inclusion Criteria:

* Children who eat breakfast, lunch and dinner at home.
* Children whose feeding and habits management (upbringing) is in charge of the same group of representative adults.
* Children who live with their parents.
* Children attending the consultation for the first time.

Exclusion Criteria:

* Symptoms of respiratory disorders reported by parents in the CSHQ.
* Food allergies.
* Special diet restrictions.
* Developmental disorder influencing diet or weight.
* Basic endocrinological diseases.
* Being under endocrinological treatment.
* Previously diagnosed sleep disorders.
* Children who miss more than two assigned appointments.
* Parents of children who withdraw informed consent.
* Children who are diagnosed during the study with respiratory disorders.
* Children who are diagnosed during the study with food allergies.
* Children who for personal reasons cannot continue in the study.
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer

The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.

The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years;
* life expectancy of greater than 10 years;
* prostate adenocarcinoma histologically proven;
* prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-2.
* the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);
* the signed consent form.

Exclusion Criteria:

* PSA level \> 20;
* Gleason \> 7;
* clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion);
* prostate volume \> 60 cc;
* pelvic lymph nodes involvement at dissection or imaging (ADP \> 1.5 cm);
* concurrent hormone therapy;
* the presence of distant metastasis (M1);
* history of abdominal or pelvic irradiation;
* history of prostate resection in the previous 6 months and/or not allowing the implantation of markers;
* history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma);
* urinary discomfort with an IPSS (International Prostate Symptom Score) \> 15 (without alpha-blocking);
* inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
* other undergoing study that may interfere with the present study;
* patient under legal protection measure.
A Phase 1/2 Study to Evaluate MEDI4736

This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death ligand-1 (PD-L1)) will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity (IM), and antitumor activity of MEDI4736 in adult participants with solid tumors. A dose exploration cohort will look at the safety profile of Q4W dosing of MEDI4736.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* In the dose-escalation phase: histologically- or cytologically- confirmed advanced solid tumor that is refractory to standard therapy and for which no standard therapy exists.
* In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, participants must have failed, be intolerant to, be ineligible for, or have refused
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
* Adequate organ and marrow function.
* Participants must have at least 1 measurable lesion.
* Available archived tumor tissue sample.
* Willingness to provide consent for biopsy sample (dose-expansion only)

Exclusion Criteria:

* Any prior Grade ≥ 3 immune-mediated adverse event (imAE) while receiving immunotherapy
* Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
* Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
* Prior treatment with immunotherapy agents including, but not limited to, tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural killer (NK) cell inhibitors.
* Active or prior documented autoimmune disease within the past 2 years
* History of primary immunodeficiency
* History of organ transplant that requires use of immunosuppressives
* Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment
* Other invasive malignancy within 2 years
* Women who are pregnant or lactating
* Uncontrolled intercurrent illness
* Known history of tuberculosis
* Known to be human immunodeficiency virus (HIV) positive
* Known to be Hepatitis B or C positive (except HCC participants)
Acute Renal Failure Post Liver Transplantation

Trial to test the effect of administering N-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant

1. To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
2. To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
3. To determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation

Eligibility Criteria:
Inclusion Criteria:

* First liver transplant
* Normal renal function before transplantation \[serum creatinine ≤ 1.5 mg / dl\]
* No requirements for dialysis before transplantation
* Age greater than 18 years

Exclusion Criteria:

* Re-transplant
* Renal dysfunction i.e. serum creatinine \> 1.5 mg/dl
* Need for dialysis before transplantation
* Presence of Hepatorenal or Hepatopulmonary syndrome\*
* Combined liver and kidney transplant
* Peptic ulcer disease
* Pregnancy
EEG Diagnostic for Repetitive Sub-concussive Head Impacts

The purpose of this study is to develop a diagnostic algorithm to help with the detection, diagnosis, and monitoring of sub-concussive head impacts.

This prospective study will investigate the potential effects of soccer ball heading on EEG and oculomotor measurements.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 38 years of age.
* Have at least 1 year of experience playing soccer.
* Played soccer within the prior year.
* Head soccer ball during practice and/or games.

Exclusion Criteria:

* Subjects with a history of TBI during the prior 12 months.
* History of moderate or severe Traumatic Brain Injury (TBI).
* History of seizures.
* Medical or psychiatric history the precludes participation.
* Currently receiving treatment in another research study.
* History of a condition with vestibular, ocular, or vision dysfunction.
Study of Intensive Care Units in India

There is scant data on the casemix and practices in Indian intensive care units (ICUs). Most of the available data comes from single centre studies. There is a dire need to have data from Indian ICUs to reflect the vast spectrum of critical care illness, services and practices. INDICAPS planned to collect data of all patients in the ICU on one particular day, and four such days spread throughout a one-year period were selected: the second Wednesday of July and October this year, i.e. July 14 and October 13, 2010 and the second Wednesday of January and April next year, i.e. January 12 and April 13, 2011. As many ICUs all over the country as possible were asked to participate. The investigators aimed to gather information about ICUs, patients in ICUs, the types and severity of illness, monitoring and therapeutic modalities used, types of infections,mortality rates, etc.

The following information will be analysed:

Case-mix, severity of illness, prevalence of infection, hemodynamic monitoring and therapy, mechanical ventilation practices, nutrition and outcome

* Seasonal and regional variations in the above
* Epidemiology and variations in antibiotic use
* Patterns of microorganisms and outcome
* Prevalence and outcome of specific tropical febrile illnesses, including malaria, dengue fever, leptospirosis, scrub typhus
* Prevalence and outcome of toxins and poisonings
* Relation of ICU and hospital organizational issues to prevalence of infection and outcome
* Organisation of intensive care services
* End of life - Ethical decisions

Eligibility Criteria:
Inclusion Criteria:

* All patients present in the ICU July 14, 2010, October 13, 2010, January 12, 2011 and April 13, 2011
Personalized Fiber and Insulin Sensitivity

In this project the investigators intend to study the therapeutic potential of a personalized fibre mixture in individuals at high risk of developing T2DM, and aim to address the following key objectives:

1. To investigate whether a mixture of fermentable fibres, which differ in DP and side chains, will stimulate a broad range of SCFA-producing bacterial genera, resulting in enhanced chronic SCFA production throughout the whole colon with a large variation between individuals;
2. To unravel whether providing personalized fibre mixtures, selected based on the individuals' initial microbiota and capacity for SCFA production is crucial to successfully improve host insulin sensitivity and metabolic health


Eligibility Criteria:
Inclusion Criteria:

Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 \< 40 kg/m2)

Exclusion Criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
* Gastroenterological diseases or abdominal surgery;
* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
* Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day;
* Plans to lose weight or following of a hypocaloric diet;
* Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
* Intensive exercise training more than three hours a week;
* Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
* Regular use of laxation products;
* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
* Follow a vegetarian diet.
Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million adults in the U.S., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal of this project is to develop a novel, minimally invasive Mucosal Impedance technique for more accurate detection of GERD while reducing costs.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing standard of care EGD with 48-hr pH testing by BRAVO
* Previous diagnosis of reflux
* At least 18 years of age

Exclusion Criteria:

* Those less than 18 years of age
* Unable to give informed consent
* Use of acid suppressive therapy within the last 10 days
* Known history of Barrett's esophagus, gastric surgery, alcoholism, or significant motility condition
Enhanced CJD Surveillance in the Older Population

The purpose of this study to investigate if cases of Creutzfeldt-Jakob Disease (CJD) and other forms of prion disease are being missed in older adults living within Lothian.

The study involves patients aged 65 years or over who have been seen by a neurologist or psycho-geriatrician and identified as having features that are atypical for the known types of dementia. All patients will be invited to an initial meeting with the research team to discuss the study and, if they agree to participate, for clinical assessment and epidemiological review. Participants will be asked to donate blood or a buccal sample for codon-129 polymorphism genotyping and may be offered a MRI brain scan if no such imaging has been previously undertaken. Participants will also be asked to consider if, in the event of their death, they would donate samples of brain tissue to the Edinburgh Brain Bank for use in this and future research. Telephone follow up will be offered within 1 month of joining the study and at 3 monthly intervals thereafter, with further clinical review offered if deemed appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years or above
* Patients accessing NHS Lothian neurology and psychogeriatric services
* Patients who have features atypical for the recognised forms of dementia
* Appropriate informed consent

Exclusion Criteria:

* Patients aged below 65 at time of recruitment
* Patients diagnosed with a clear alternative demonstrable pathology
Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma

The purpose of this study is to determine whether an inhaled corticosteroid (fluticasone) alters the expression of any gene expressed in the lining of the airways of asthmatics. The study uses high density gene chips which allow the study investigators to measures all gene in the human genome. We hypothesize that this approach will identify novel genes that are affected by steroids in asthmatics.

This is a 10 week, randomized, double blind, prospective study comparing the effects of inhaled fluticasone or inhaled placebo on measures of airway function, airway remodeling and airway gene expression in asthmatic subjects. Enrollment has been completed as have all study visits. We are now in the data analysis phase. The study design was as follows: Following a one-week run-in/characterization period, subjects were randomized to receive 2 puffs BID of fluticasone (250µg/puff) or matching placebo for 8 weeks. Beginning with the run-in period, subjects recordes in a daily diary their peak flow measurements twice daily, (symptoms of cough, sputum production, wheeze, dyspnea, and chest tightness. They visited the laboratory for an interval diary review and spirometry and for medication dispensing. Bronchoscopy was performed at baseline (week 1 of the run-in), and 1 week after starting the study drug Weekly telephone contact will be made during the treatment period to monitor subject well being and to ensure compliance with study medication. There was a one-week run-out to allow monitoring of subjects after discontinuation of the study drug.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a history of asthma between the ages of 18 and 70 years.
* PC20FEV1 Methacholine ≤ 8.0 mg/mL.
* At least one of the following symptoms, beta agonist use, or FEV1 criteria:
* Asthma symptoms on at least two days per week or Beta agonist use on at least two days per week or FEV1 \< 85% predicted
* Subjects must be non-smokers (patients who have never smoked or patients who have not smoked for 1 year and have a total pack-year smoking history \< 15 packs).

Exclusion Criteria:

* History of oral or inhaled steroid use in the past 4 weeks.
* FEV1 \< 60% predicted.
* Lung disease other than asthma.
* Patients with a history of a respiratory tract infection in the 4 weeks preceding the study.
* Patients who have experienced a significant exacerbation in their asthma in the 6 weeks prior to the study.
* Patients receiving hyposensitization therapy with the exception of those who are on a stable dose for the last three months.
* Patients with cardiovascular disease (active) peptic ulcer disease or diabetes mellitus.
* Females who are lactating or who are pregnant.
Oxidative Stress in OR Personnel

The purpose of this study is investigate to the effect(s) of chronic occupational exposure to N20 and volatile anesthetics on the extent of oxidative stress (DNA damage and the generation of the biochemical markers) in operating room staff, with different levels of exposure to halogenated hydrocarbons, in comparison to unexposed controls (Intensive Care Staff), and to determine the relationship between the degree of oxidative stress and psychological stress, as assessed by validated psychometric measures.

This is a single blinded randomized, controlled and prospective clinical trial comparing oxidative stress status in two groups.

Subjects in two groups will be matched for gender, age, smoking habit and employment duration and will be randomized into one of the two groups of:

1. Pediatric OR Staff, and
2. control (e.g; ICU staff)

Biomarkers of oxidative stress will be measured in two different time points in each subject, (Monday Morning and, Friday afternoon of that same week-\>40 hours in Operating room or Intensive Care Unit).

The relationship between oxidative stress and psychological stress will also be assessed by validated psychometric measures.

Eligibility Criteria:
Inclusion Criteria:

1. CHOR-Staff who work \> 40 hours per week in the operating rooms (Anesthesiologists, CRNA, Surgeons, Nurses)
2. NOR- Intensive Care Unit Staff who work \> 40 hours per week in Intensive care unit (Physicians, Nurses, APN'S)

Exclusion Criteria:

Staff with the following history will be excluded:

1. Therapeutic exposure to radiation
2. On chemotherapeutic agents
3. History of General Anesthesia during the past two years