cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis

Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).

A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD and active UC.

Eligibility Criteria:
Inclusion Criteria:

* Patient has active Crohn's disease with a score on the Crohn's disease activity index between 220 and 450 points.
* Patient has active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only).

Exclusion Criteria:

* Patient who has previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFα) inhibitor for the treatment of other disease
* Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product
* Patient who has a current or past history of infection with HIV, hepatitis B, or hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled)
* Patient who has acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug
* Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent tuberculosis (TB) at Screening. For Part 2, if IGRA result is indeterminate at Screening, 1 retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.
Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

To date, surfactant is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that surfactant does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of bronchopulmonary dysplasia(BPD) in term and late preterm infants with meconium aspiration syndrome. Therefore, a reasonable speculation is that preterm infants with ARDS do not benefit from one dose of surfactant. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from surfactant. In the era of pre-ARDS, the preterm infants fulfilling the definition of ARDS may have been considered as respiratory distress syndrome (ARDS) in the first three days after birth.

According to the diagnostic criteria of neonatal ARDS, a key procedure for diagnosis of neonatal ARDS is to exclude the newborn infants with RDS. But no detailed procedures are available to differentiate RDS from ARDS according the guideline of european RDS and definition of neonatal ARDS.

Therefore, there are two aim in the present study. 1. to proposel a new definition of RDS; 2. to assess the beneficial effects of surfactant on neonatal ARDS.

Eligibility Criteria:
Inclusion Criteria:

1. infant less than 28 days
2. diagnosis of ARDS or RDS or both
3. informed parental consent has been obtained

Exclusion Criteria:

1. major congenital malformations or complex congenital heart disease or chromosomal abnormalities
2. transferred out of the neonatal intensive care unit without treatment
3. upper respiratory tract abnormalities
ABC Program in Patients With Metabolic Syndrome

Aims: We evaluate the efficacy of the "Active Body Control (ABC) Program" for weight reduction in patients with metabolic syndrome.

Methods: The ABC program combines telemonitoring of the physical activity with a low-calorie diet also preferring carbohydrates with low glycemic indexes. In this 12-month, randomized, clinical trial 60 patients will be treated according to the ABC program and 60 control patients will receive standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome

Exclusion Criteria:

* tumor cachexia
The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient

The aim of this study is to assess the role of portal hypertension of peptic ulcer disease in liver cirrhosis and chronic hepatitis.

Retrospective case-control study

* Investigators will analyze the medical records of hepatic vein pressure gradient (HVPG) and esophagogastroduodenoscopy (EGD) cases who had liver cirrhosis (LC) or chronic hepatitis in a single tertiary hospital (Chuncheon Sacred Heart hospital, Korea) within 2008\~2012.
* Portal hypertension is assessed using HVPG measurement via transjugular approach.
* Peptic ulcer is evaluated through EGD within 3 months of HVPG measurement
* The association of Peptic ulcer with LC, chronic hepatitis and total population (LC or chronic hepatitis) will be assessed by univariate and multivariate analysis
* There is no specific time frame, because this study is retrospective observational study, however EGD data is enrolled if it was done within 3 month from HVPG measurement.

Eligibility Criteria:
Inclusion Criteria:

* The patients who underwent hepatic vein pressure gradient (HVPG) measurement and esophagogastroduodenoscopy (EGD) and also had LC or chronic hepatitis

Exclusion Criteria:

* The patients who have missing or incomplete HVPG or EGD data
* The patients who underwent gastrectomy
* The patients who have systemic malignancy
Association of Protein Intake With Sarcopenia Among Institutionalized Elderly

This study has purpose to investigated the association of protein intake with sarcopenia in the institutionalized elderly at south tangerang

Data were collected using interview with subjects or with care giver to know the basic characteristic of subjects. Anthropometric measurements were done body weight in kilograms was measured using SECA scale. Body height in meters was predicted by knee height measurement using knee height caliper. Body mass index (BMI) was calculated as weight per height square. Fat free mass was examined using bioelectrical impedance analyzer Tanita type SC-330. Independency was assessed using Barthel index. Protein intake was measured using 2x24 hour food recall and analyzed using a computer program Nutrisurvey 2007, data were compare to Recommended Dietary Allowances established for Indonesian 2018. Handgrip muscle strength was examined using Jamar handgrip dynamometer. Physical performance was measured using Short Physical Performance Battery test. Sarcopenia was diagnosed using Asian Working Group on Sarcopenia.

All data collected were analyzed using Statistical Package for the Social Science (SPSS) version 20 for windows. Nominal data were described using frequency, n (%). Normality of data was tested using Kolmogorov-Smirnov test with normal distribution (p\>0.05) described using mean and SD while not normal distribution (p\<0.05) described using median and range minimum-maximum. The investigators used Independent T-test analysis to investigate the association.

Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria were being male or female
2. aged more than 60 years old
3. signed inform consent form and literate with help from companion

Exclusion Criteria:

1. subjects with history of cancer
2. history of upper and lower extremities weakness
3. history of chronic heart failure disease
4. chronic obstructive pulmonary disease
The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke

Poor cardiopulmonary endurance is observed in individuals with acute stroke, even in chronic. In addition, the poor fitness may obstacle activities of daily life, decrease activities of autonomic system, and increase risks of recurrent, therefore, the cardiopulmonary endurance training should be included into the early-stage rehabilitation program. The ergocycling training could improve cardiopulmonary endurance for individuals with stroke. Moreover, the low-intensity exercise training can increase the willingness, and it is safer than the moderate-intensity exercise training. However, it needs to be evaluated whether the low-intensity exercise training can bring sufficient benefits, compared to the moderate-intensity exercise training. Objectives of the study is to compare the exercise benefits between the low-intensity and moderate-intensity exercise training, and then these would offer optimal exercise prescription and considerations in clinical practice.

After giving their signed consent, subjects would be randomly assigned into the control group (traditional rehabilitation), the low-intensity exercise group (traditional rehabilitation plus low-intensity exercise training), or the moderate-intensity exercise group (traditional rehabilitation plus the moderate-intensity exercise training). Frequency of the exercise training is 2-6 times/week, totally 20 times. In the symptom-limit exercise tolerance tests, subjects wear a gas-collecting mask and electrocardiogram, and pre-set graduated loading was offered by the bike. One therapists and one doctor would monitor the test. For resistance and time setting within each exercise training, it is customized by results of exercise tolerance tests in baseline and the allocation. Moreover, a therapist would stay with subject ,monitor the training, and measure the blood pressure before and after the training.

Eligibility Criteria:
Inclusion Criteria:

1. the first-ever stroke
2. period of ischemic stroke onset is longer than two weeks, and less than six months, and the doctors agree with exercise training
3. unilateral hemiplegia
4. no obvious deficits of cognition. Scores of three items in the National Institutes of Health Stroke Scale are zero
5. be willing to join this study and give their consent

Exclusion Criteria:

1. aphasia
2. orthopedic problems (severe arthritis), neurologic injury (eg. peripheral nerve injury) that can interfere with movement of the lower limb, or cannot sit independently
3. with pace maker, severe cardiac arrhythmia, or heart failure
4. abnormal electrocardiography in rest, is not suitable for exercise tolerance test according to the American College of Sports Medicine guidance, for example, the atrioventricular block (AV block).
Validation of Prediction Model of Vitamin D Deficiency

Many studies have pointed out that patients with vitamin D deficiency have a longer stay in the intensive care unit and a poor prognosis. The investigators' previous multi-center prospective observational study in Taiwan reveals that the prevalence of vitamin D deficiency in critically ill patients in northern Taiwan is 59%, and the prevalence of severe vitamin D deficiency is 18%. The investigators used the data of that observational study to train a predictive model for predicting vitamin D deficiency. In addition, the association between vitamin D and the immune regulation of critically ill patients in Taiwan has not been investigated. This study aims primarily to validate the performance of the prediction model of vitamin D deficiency. Moreover, this study will investigate the association between vitamin D level and inflammatory cytokine levels.

This multi-center prospective observational study will enroll critically ill patients admitted to intensive care units (ICUs) less than 28 days. After inform consent, blood will be drawn for examination of vitamin D, interleukin 6, and interleukin 10 levels. The main diagnosis of ICU admission, past medical history, vital signs within 24 hours of admission, disease severity, and laboratory data will be recorded. The predictive model will use the required parameters to predict the patient's risk of vitamin D deficiency and vitamin D severe deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to intensive care units

Exclusion Criteria:

* aged \< 20 years
* admitted to intensive care unit longer than 28 days
* body max index \< 18 kg/m2
* receive vitamin D supplement \> 3000 IU/day
* previously admitted to intensive care unit within 3 months
* have parathyroid disease, rickets, or severe liver cirrhosis \[Child C\]
Real World Evaluation of Advisor Pro in Clinical Practice

To assess the integration of the DreaMed Advisor Pro tool into a real-world clinical practice using both in person and virtual visits to assess benefits in glycemia, as measured by the glucose management indicator and other glucose metrics.

To determine acceptability of the DreaMed Advisor Pro tool both from a person with diabetes as well as a health care provider perspective.

To quantify the potential reimbursement potential that could be generated with use of the DreaMed Advisor Pro.


Eligibility Criteria:
Inclusion Criteria:

1. Participant with Type 1 diabetes
2. Age ≥ 6 years to \<30 years
3. Using Insulin infusion pump (CSII) therapy including those with low glucose suspend and predictive low glucose suspend features

   1. Insulin pump must not use automated insulin delivery (closed loop, artificial pancreas)
   2. Total daily dose of insulin must be greater than 0.5 units/kg/day
4. Participants / parents are required to have minimum computer skills and access to a computer in order to upload their personal devices (Pump, BG meter etc) to Tidepool.
5. Participants using Dexcom sensors will allow access to their account for the study duration
6. Participants not using CGM must agree to test BG at least 4 times a day at appropriate intervals
7. Participants / parents will have to have a smartphone (Apple or Android and Windows)

Exclusion Criteria:

1. An episode of diabetic ketoacidosis within the month prior to study entry
2. Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety,
3. Current participation in any other interventional study
4. Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
5. Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine Society
6. Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
7. Participants suffers from an eating disorder
Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* Between 18 and 75 years of age
* Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
* If of childbearing potential, is practicing birth control
* BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
* If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit

Exclusion Criteria:

* Uses insulin for glucose control or has type 1 diabetes
* History of diabetic ketoacidosis.
* Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
* Active malignancy
* Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
* End state organ failure or status post organ transplant
* History of renal disease
* Current hepatic disease
* History of severe gastroparesis
* Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
* Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
* Clotting or bleeding disorders
* Allergic or intolerant to any ingredient found in the study products
Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population (COVIDiet_Int)

This cross-sectional study will allow to collect eating behaviours data during the COVID-19 confinement, some of them related to the Mediterranean Diet to better understand the eating behaviours of adult population during this novel and exceptional situation.

Hypothesis: The eating habits of the population together with physical activity level will change during the COVID-19 outbreak confinement.

Around thirty thousand adults (18 years old and older) will be recruited from 22 different countries (i.e. including Bosnia and Herzegovina, Colombia, Croatia, Denmark, Egypt, Germany, Greece, India, Ireland, Italy, Kosovo, Kuwait, Lithuania, Montenegro, North Macedonia, Poland, Portugal, Serbia, Slovenia, Spain, Turkey and United Kingdom). A self-administered web-based questionnaire with questions aimed at assessing the dietary behaviours of the adult population during the COVID-19 confinement and before it started, will be distributed using social media and snowball sampling. The questionnaire is based on 44 items including socio-demographic data, MEditerranean Diet Adherence Screener (MEDAS) as a reference of a healthy diet, processed foods intake, changes in their usual food choices and weight gain. All data will be collected online to reach the largest number of participants from all territories.

The main objectives of this study are: 1) to examine whether the COVID-19 outbreak confinement has influenced eating habits among the adult population from the 22 countries previously detailed, and 2) to assess the differences in eating behaviours between the countries involved in the study to have a global overview of the behaviour in the face of confinement that helps in public health decision making related to positive impact on the prevention of chronic diseases and COVID-19-related complications.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged from 18 years old and over living in the countries involved in the study.

Exclusion Criteria:

* People under 18 years of age living in countries different from those involved in the study.
TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.

The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after 6 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female more than 18 year old.
* Diagnosed as Alcoholic Liver Disease (ALD), or Non Alcoholic Fatty Liver Disease (NAFLD), or Liver Function Disorders due to Drugs or Chemicals.
* ALT at baseline is in between 150 U/L to 400 U/L
* Sign the informed consent form

Exclusion Criteria:

* Hepatitis B or C.
* Pregnant or Lactating women
Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer

The use of robotic surgery in the management of gynecologic cancers has increased exponentially in the United States since the implementation of technology in 2005. In Canada, access to the system is limited because of a lack of government funding. The government has been reluctant to fund this technology because robust data, on the true impact to patient care, is lacking.

This project will prospectively examine outcomes of women, with early stage endometrial cancer, treated surgically. Open surgery will be compared to minimally invasive surgery (MIS) which will include conventional laparoscopy and robotic surgery. The data collected will include detailed assessment of surgical data, peri-operative events, quality of life analysis, health economic evaluation and evaluation of MIS rates.


Eligibility Criteria:
Inclusion Criteria:

* Any type of histologically confirmed early stage (stage 1 or 2) cancer of the endometrium
* ECOG Performance status of 0-1
* Suitable candidate for surgery
* Signed approved informed consent
* Female, 18 years of age or older
* Pre-operative health is graded as ASA I-III
* Patients able to complete baseline questions either on their own or with assistance
* Patient willing to comply with scheduled visits

Exclusion Criteria:

* Major abdominal surgery, chemotherapy or radiation within 3 months before the baseline visit
* Evidence of diffuse peritoneal carcinomatosis by imaging or clinical exam
* Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
* Patients who are breastfeeding or become pregnant during the study
MC-5A for Chemotherapy Induced Peripheral Neuropathy

Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer therapy with few treatment options. CIPN is a complex side effect that varies between individuals and can be difficult to describe, difficult to treat and can significantly effect quality of life for patients.

The purpose of this study is to determine if patients with painful CIPN will have a decrease in pain scores after treatment with the MC-5A device.


Eligibility Criteria:
Inclusion Criteria:

* painful peripheral neuropathy resulting from chemotherapy
* pain must be present for minimum of 6 months
* must be able to read/understand English
* stable analgesics regimens allowed (no change for past 7 days)

Exclusion Criteria:

* painful peripheral neuropathy that is not the result of chemotherapy
* pregnant women
* patients unable to wean off anti-epileptics
* patients currently receiving chemotherapy known to cause peripheral neuropathy
* patients with pacemakers or implanted defibrillators
* patients with vena cava or aneurysm clips
* patients with a history of epilepsy
Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone (DengDex Study)

The goal of this randomized double-blinded placebo-controlled trial is to learn about dexamethasone and the treatment of severe dengue population. The main question it aims to answer are steroid therapy may be effective in dengue.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmed Dengue infected patients (Positive NS1 Ag or anti-DENV IgM by Dengue Duo test)
* And still in febrile phase (Body temp\>37.5 C)
* Shock : Sys\<90mmHg or Narrow PP (\<20mmHg) orTachycardia (pulse\>100/min) with Hematocrit decreased ≥20 %
* Fluid accumulation and respiratory distress
* Severe bleeding
* Severe organ involvement

Exclusion Criteria:

* Severe dengue\> 24 hrs
* Dengue without warning signs
* Pregnancy
* Patient who receieved any steroid within 1 week