cyrilzakka/clinical-trials huggingface dataset:
Pain Prevalence After Cesarean Section in Siriraj Hospital

Spinal morphine has been widely provided for acute postoperative analgesia. However, the analgesic effect of spinal morphine usually last 12-24 hours. Therefore the investigators are interested in the pain characteristics during the 2nd postoperative day. The investigators will also explore the regimens for pain therapy in our hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Cesarean section

Exclusion Criteria:

* History of drug addict
A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died

This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems.

It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful.

This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication).

Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis.

It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis.

Approximately 240 patients will take part in this study.

Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of necrotizing pancreatitis within 120 hours following onset of symptoms/first reported symptoms.
* Primary diagnosis to be confirmed by contrast-enhanced CT evidence of 30% necrosis of the pancreas.
* Or if \> or equal to 30% necrosis is not present or cannot be confirmed, a contrast enhanced CT scan showing extensive or multiple pancreatic fluid collections and pancreatic edema (Balthazar Grade E) with either C-reactive protein (CRP). 120 mg/L or a MOD score of \> 2 is acceptable.

Exclusion Criteria:

* Received an investigational drug or device within 30 days prior to entering study.
* Received \> 48 hours of antibiotic therapy between onset of symptoms of pancreatitis and diagnosis of necrotizing pancreatitis.
* The subject has known or suspected anaphylactic or other type 1 (immediate) hypersensitivity reactions to cephalosporins, penicillins or carbapenems.
* The subject is receiving, or will require, probenecid therapy.
* The subject is neutropenic (absolute neutrophil count \< 1000/mm 3).
* The subject has cirrhosis, severity of Child's grade C.
* There is not a commitment on the part of the clinical care team, the subject, or the subject's family to full, aggressive support including operative intervention if needed.
* The subject is a pregnant and/or nursing female
Micronutrient Dose Response Study in Bangladesh

The recommended daily amounts of vitamins and minerals, referred to as micronutrients, are based on data from high income settings and for healthy populations do not fully correct nutritional deficiencies in undernourished settings. This study will determine the minimum acceptable doses across a range of nutrients at which sufficiency is achieved with supplementation using biochemical indicators of nutritional status in non-pregnant (non-lactating) women of reproductive age and pregnant women in Bangladesh. In this double-masked randomized controlled trial, a dose response study will be undertaken using increasing levels of doses provided as supplements to women (pregnant or non-pregnant) with nutritional indicators as outcomes.

The primary aims of the study are to:

1. To characterize the time-course of in vivo exposures (dose response) of several micronutrients in pregnant and non-pregnant and non-lactating women of reproductive age (WRA) in a real-life situation.
2. To characterize any clinically meaningful prognostic factors that can explain the between-subject variability.
3. To investigate whether the micronutrients follow dose-proportional pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

Either

* Women (non-pregnant and non-lactating) and not planning a pregnancy in the next 6 months

OR

* Pregnant women (gestational age at enrollment of 12-14 weeks)

Exclusion Criteria:

* Eligible women not consenting to participate
* Based on point-of-care clinical indicators after enrollment and prior to starting the intervention that is indicative of pre-existing liver or kidney conditions and severe anemia
Effect of Ketamine (Ketalar) on Intracranial Pressure

Objectives: Ketamine is an effective, short-acting anesthetic drug, which does not decrease blood pressure. It is widely stated that Ketamine increases intracranial pressure (ICP), which prevents its use in many emergency situations, specifically in patients with traumatic brain injury (TBI) and with increased ICP. Based on previous clinical experience, we hypothesized that Ketamine decreases - rather than increases - ICP.

Methods: Prospective, controlled, clinical trial. Children with ICP monitoring will receive a single Ketamine dose (1-1.5 mg/kg) either for increased ICP and/or before a potentially distressing activity. Hemodynamic variables, ICP and cerebral perfusion pressure (CPP) will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration (Before/after design).

Objectives: Ketamine is an effective, safe, rapid, short-acting anesthetic drug, and - contrary to all other anesthetic drugs - it does not decrease blood pressure. It is widely believed that Ketamine increases intracranial pressure (ICP), which prevents its use in many emergency situations, including trauma and specifically in patients with traumatic brain injury (TBI) and with increased ICP. Based on our previous clinical experience in patients with ICP monitoring, Ketamine did not increase ICP. We therefore hypothesize that Ketamine decreases - rather than increases - ICP.

Methods: Prospective, controlled, clinical trial performed in a Pediatric ICU of a regional trauma center. Children with ICP monitoring receive a single Ketamine dose (1-1.5 mg/kg) either for increased ICP and/or before a potentially distressing activity. Hemodynamic variables, ICP and cerebral perfusion pressure (CPP) will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration (before/after study design).

Parents/guardian of patients will be informed and asked to sign an informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Children who have an ICP monitoring device, who either have increased ICP and/or who should undergo a potentially distressing activity (suction, position change etc.).
Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers

A considerable proportion of patients with clinically suspected coronary artery disease (CAD) do not have angiographic signs of luminal narrowing caused by coronary atherosclerosis. In patients with suspected CAD, we will assess the ability of cardiovascular biomarkers to identify patients with (a) angiographically normal epicardial coronary vessels (b) absence of significant epicardial coronary stenosis, as assessed by coronary computed tomography angiography (CCTA). Patients will be stratified according to the presence or absence of dynamic changes of high sensitivity cardiac troponin T levels above the 99th percentile.

This is an observational study of patients with suspected coronary artery disease referred to coronary computed tomography angiography (CCTA). The plan is to include 1000 patients prior to CCTA at two centers.

Blood samples for biomarker measurement will be obtained prior to the procedures. The diagnostic results of the imaging tests will be compared to the levels of circulating troponins. Patient will be followed for a minimum of 12 months and the incidence of cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart failure, stroke and cardiac arrhythmias requiring rehospitalization. Symptoms of angina pectoris according to the Canadian Cardiovascular Society grading of angina pectoris and symptoms of chronic heart failure according to the New York Heart Association classification of chronic heart failure will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Consenting patient over the age of 18 referred to CCTA for suspected coronary artery disease

Exclusion Criteria:

* Inability to provide informed consent.
* Short life expectancy (\<12 months) due to non-cardiovascular disease
Sugar-Sweetened Beverage Portion Limit Study

This present study is an evaluation of de-identified data collected previously during a randomized controlled study (RCT). The objective of the original RCT titled "Sugar-Sweetened Beverage (SSB) Portion Limit Dining Lab RCT" was to examine the impact of limiting the portion size of SSB to 16 oz in a laboratory dining setting. The RCT was designed to assess the impact of limiting the size of SSB offered on a restaurant menu and the availability of free fills on beverage and food purchases, consumption and caloric intake at the test meal and subsequent meals (over a 24-hour period).

Briefly, the data for this evaluation were collected from adults recruited from the Boston / Cambridge area to participate in an RCT conducted at an eating behavior lab at the Landmark Center (Lab). Participants were masked to the purpose of the study and were randomized to one of four conditions. To conceal the purpose of the study, participants were asked to participate in a pseudo-focus group pretending to conduct consumer research on restaurant preferences. Participants were asked not to eat after 3 pm prior to the 5:30 pm focus group. Participants were seated at individual dining tables and were asked to order and purchase dinner from a restaurant menu and consumed the meal while in the restaurant Lab. After the focus group, participants completed electronic questionnaires (e.g., demographic information, eating behaviors, and perceptions of the meal). Participants returned to the Lab the following day to complete a brief dietary recall interview. After they completed the study procedures, they were debriefed about the purpose of the study and provided the opportunity to withdraw from the study.

The current evaluation will be conducted under an IRB-approved, apriori, statistical analysis plan using the data collected during the Sugar-Sweetened Beverage (SSB) Portion limit Dining Lab RCT.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and older
* Ability to speak and read English
* Willing to participate and follow protocol specified activities

Exclusion Criteria:

-Severe food allergies
Persistent Dyspnea in Post COVID_19 and Pulmonary Function

COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU)

COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU) Many patients with mild or severe COVID-19 do not make a full recovery and have a wide range of chronic symptoms for weeks or months after infection.

Post-COVID-19 syndrome is defined by persistent clinical signs and symptoms that appear while or after suffering COVID-19, persist for more than 12 weeks and cannot be explained by an alternative diagnosis.

Dyspnea is one of the most prevalent symptoms in post-covid-19 patients in up to 29% of patients with post COVID-19 syndrome.

Also, persistent dyspnea in post COVID-19 infection is frequent, it is so far, of unknown mechanism. Cardiopulmonary Exercise Test (CPET) is currently the gold standard technique in the differential diagnosis of dyspnea.

Cardiopulmonary exercise testing (CPET) is useful in the assessment of subjects with chronic lung conditions as it may help to: 1) recognize physiological factors limiting exercise (with or without the presence of psychogenic limiting factors); 2) identify these factors as potential therapeutic targets; 3) allow quantification of the level of impairment; 4) assess the effects of an intervention; and 5) provide prognostic information.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or clinically and radiologically highly suspected Covid19-infection
* Symptom duration at least 12 weeks following first occurrence of symptoms
* Patients with dyspnea score 2, 3 and 4 on mMRC
* No other disease that better could explain the symptoms (dyspnea) than Covid-19

Exclusion Criteria:

* Age \<18
* pregnant women
* terminally ill patients
* active covid-19 infection
* previous known severe pulmonary or heart disease
* inability to perform pulmonary function or cardiopulmonary exercise tests.
Influence of Daylong Glycemia on Detraining Induced Metabolic Changes

Aim of the study is to investigate the impact of glycemic index (provided as soft drinks) on changes in insulin sensitivity, metabolic flexibility, and arterial stiffness in response to detraining.

The investigators hypothesize that low glycemic soft drinks decrease the detraining-induced impairment of insulin sensitivity, metabolic flexibility and arterial stiffness.

The duration of the study is 7 weeks: two x 2 weeks intervention (phase A and phase B) with 3 weeks washout phase inbetween. Each 2-week intervention phase consists of an active week followed by an inactive week.

in phase A subjects consume high GI (maltodextrin and sucrose) soft drinks during the inactive week. In phase B subjects consume a low GI soft drink (palatinose) during the inactive week.

subjects were randomly assigned to either start with phase A or with phase B (cross over design).

During the whole study duration all food is provided (55% CHO, 30% fat, 15% protein)

Physical activity will be assessed by a step counter (active phase 7000-10000 steps/d and inactive phase 3000-4000 steps/d).

Eligibility Criteria:
Inclusion Criteria:

* normal weight men,
* age 18-35 y,
* active life style,
* \> 300 min sports/week

Exclusion Criteria:

* food allergies,
* regular use of medication,
* smoking,
* chronic disease,
* vegan/vegetarian diet
Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer

The purpose of this study is to construct an auxiliary diagnostic model for breast cancer by methylation markers. The study will collect blood and tissue samples from participants with breast cancer and benign disease for whole-genome methylation sequencing. It will screen methylation markers and develop a methylation auxiliary diagnosis model to distinguish between breast cancer and non-cancer.


Eligibility Criteria:
Inclusion Criteria for All the Participants:

* With confirmed pathological diagnosis and molecular subtyping results
* Ability to provide a written informed consent

Exclusion Criteria for Cancer Arm Participants:

* Patients with a history of or currently suffering from other malignancies
* Pregnant or planning to become pregnant female patients
* Patients who have received cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy, before blood draw
* Patients with a history of blood transfusion within the past month
* Patients with a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* Patients with persistent fever or undergoing anti-inflammatory treatment within 14 days before blood draw
* Any other conditions that the researcher deems may make the patient unsuitable for inclusion in the study or may interfere with the completion of the study
* Patients in poor physical condition who are not suitable for blood draw
* Patients who cannot provide informed consent or refuse blood draw

Exclusion Criteria for Benign Diseases Arm Participants:

* History of malignancies
* Current malignancies or precancerous lesions
Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage (PTBD) Procedures

Percutaneous transhepatic biliary drainage (PTBD) procedures are associated with an elevated radiation exposure for the patient. In the recently published guideline of the Federal Ofﬁce for Radiation Protection in Germany diagnostic reference levels (DRLs) for dose area products (DAP) are not defined for PTBD procedures due to insufficient data. The aim of this retrospective study is to give a nation-wide survey on patients radiation exposure in different PTBD procedures considering factors that may have an impact on increased radiation exposure like fluoroscopic-guided versus ultrasound-guided bile duct puncture.

Percutaneous transhepatic biliary drainage (PTBD) procedures are associated with an elevated radiation exposure for the patient. Usually, radiation exposure in radiological interventions is measured by the dose area product (DAP). Diagnostic reference levels (DRLs) are based on the third quartiles (Q3) of the pooled dose area product (DAP) for the known interventional procedures. They have been introduced in the 1980s by the International Commission on Radiological Protection's (ICRP's) to reduce patients radiation exposure. In the recently published guideline of the Federal Ofﬁce for Radiation Protection in Germany in 2016 DRLs are not defined for PTBD procedures due to insufficient data. Procedure complexity due to different techniques, patient anatomy, lesion characteristics and disease severity makes it difficult to define DRLs in this fluoroscopy-guided intervention. The ICRP recently published some recommendations on DRLs in medical imaging including radiological interventions. As DRLs are often missing in this field, it was suggested to analyze national data sets comprising dosimetric data from a large number of facilities. The aim of this retrospective study is to give a nation-wide survey on patients radiation exposure in different PTBD procedures considering factors that may have an impact on increased or decreased radiation exposure like fluoroscopic-guided versus ultrasound-guided bile duct puncture. A questionnaire was sent to 200 gastroenterological and radiological departments in university and non-university hospitals to analyze the last 10 - 30 consecutively performed PTBD procedures.

Eligibility Criteria:
Inclusion Criteria:

* 10 up to 30 consecutively performed PTBDs are documented in the study center
* body weight of the examined patients is about 60 - 80 kilogramms
* returned questionaire is complete in regard to DAP, fluoroscopy time, number of still images, characters of the intervention, characterization of the fluoroscopy device (manufacturer, date of first registration)

Exclusion Criteria:

* the study center performs less than 10 PTBDs/year
* returned questionaire is incomplete
Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery: A Randomized Clinical Trial

Pancreatic cancer has the most dismal prognosis with a 5-year survival of 8%. The only curative treatment is surgery which is accompanied by great morbidity and mortality. Recent research indicates that Magnetic Resonance Imaging (MRI) is superior in detecting liver metastases compared with today's gold standard computed tomography (CT), which usually is a contraindication to surgery.

Investigators want to randomize patients with pancreatic cancer, who are eligible for surgery to a pre-operative MRI. The investigators want to examine if MRI is as good for the staging as CT and if MRI is better for the identification of liver metastases. Patients will have a follow-up period of 1 year to see if MRI changes the overall survival.

Currently, CT is the state of art for assessing and staging pancreatic cancer. However, it has its limitations when it comes to detecting small liver metastases, which are often found in pancreatic cancer. Recent research indicates that MRI is superior to CT when it comes to the detection of liver metastases. Thus, the investigators want to examine MRI's role in the assessment of pancreatic cancer.

The investigators want to conduct a nationwide RCT to examine the feasibility of using MRI for tumor staging and identification. The overall aim is to improve the selection of patients going to surgery so futile resections are avoided and increase the overall survival. Patients who are deemed eligible for pancreatic resection after being reviewed at a local multidisciplinary tumor board will be, upon consent, electronically randomized to one of two treatment arms (each arm will contain 100 patients). Patients within the control arm will as per usual proceed to surgery, whereas patients in the intervention arm will receive a pre-operative MRI scan. The MRI will be read by experienced gastroenterology radiologists who are blinded to the patient's identity and the initial CT findings. Treatment will be based on MRI findings. There will be a follow-up period of 1 year to see if MRI changes the overall survival. Within this RCT we will conduct three studies.

Study 1) The investigators want to compare pancreatic tumor staging with MRI versus standard upper abdominal CT, we hypothesize that MRI is not inferior to CT.

Study 2) The investigators want to assess MRI's ability to detect liver metastases vs standard upper abdominal CT, in patients otherwise deemed eligible for surgery. We hypothesize that MRI is superior to CT in the detection of liver metastases.

Study 3) The investigators want to assess the impact of MRI, thus patients will be followed for 1 year. We want to see if MRI changes the overall survival, treatment allocation, and recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Must be eligible for curative pancreatic resection based on CT
* Must accept randomization

Exclusion Criteria:

* Not eligible for curative pancreatic resection
* Unable to undergo MRI.
* Did not accept randomization.
Incidence Rate and Risk Factors of Malnutrition in ICU

To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition

To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition by assessment of the type of nutrition, caloric adequacy, and actual caloric intake, laboratory Investigations twice weekly

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who will be admitted to surgical ICU.
* Both sexes.

Exclusion Criteria:

* • Referral from another hospital or other ICU