cyrilzakka/clinical-trials huggingface dataset:
Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

Background:Hyperglycemia and hypoglycemia both cause detrimental side effects for pediatric patients. Prolonged fasting time, age dependent physiological diffences and individual differences of patients make complicated the perioperative fluid therapy. Isotonic electrolyte solutions without glucose or with lower glucose concentrations recommended for intraoperative period in pediatric patients.

Objective: The aim of this prospective study is to evaluate the different glucose concentrations(without dextrose, 1 % dextrose+LR, 2 % dextrose+LR) in perioperative infusion solutions according to preoperative blood glucose level to maintain normoglycemia in pediatric patients.

Method: The consecutive 250 eligible pediatric patients aged between 6 months- 12 years with ASA risk score of I-II undergoing surgery lasting less than four hours were enrolled the study in six months period. Patient demographics, procedure, preoperative fasting time, preoperative and postoperative glucose levels were documented. Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL.

Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL

Eligibility Criteria:
İnclusion criteria;

* 6 months- 12 years old, ASA I-II children
* Undergoing surgery lasting less than four hours were enrolled the study

Exclusion Criteria:

* Diabetes mellitus
* Parenteral nutrition or enteral nutrition
* Patient with metabolic disorders,
* ASA III-IV patients
Bone Fixation of Mpact Double Mobility Cup

This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.


Eligibility Criteria:
Inclusion Criteria:

* primary hip replacement
* patients 18 to 80 years old
* patients who accept the follow-up schedule

Exclusion Criteria:

* femoral neck fracture
* patients requiring grafts
* progressive local or systemic infections
* patients presenting muscular deficiency, neuromuscular disease or vascular insufficiency of the involved limb
* patients suffering from diseases that can compromize the recovery to independent mobility
* patients with BMI \> 40
* patients with cognitive diseases that can compromize their participation in the study
* patients living in geographical area not allowing the clinical follow-up to be performed
* patients participating in other biomedical research
* patients \<18 years old
* patients \> 80 years old
* pregnant or breast feeding women
Changes in High Sensitive C Reactive Protien With Different Treatment Modalities in Acute Pancreatitis

changes in high sensitive C reactive protien with different treatment modalities in acute pancreatitis


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18 years
* Diagnosis of acute pancreatitis confirmed by at least 2 of the following:

  1. Typical epigastric abdominal pain
  2. Elevation amylase/lipase \>3 times upper limit normal and/or
  3. Confirmatory findings on cross-sectional imaging
  4. Enrollment within 8 hours of presentation

Exclusion Criteria:

* Class II or greater NYHA heart failure
* Oxygen dependent COPD
* Chronic kidney disease\>stage 2
* Existing necrosis on abdominal CT
* Organ dysfunction prior to enrollment
* Sepsis
* Acute respiratory distress syndrome
* Malignancy not in remission for at least 5 years
* Active drug use
* Known allergy to dexamethasone
* Altered mental status
* Insulin-requiring diabetes
* Abdominal surgery within 60days
Development of Dietary Supplements for Mood Symptoms in Postpartum

The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood in postpartum.

The specific aim of this open-label study is to assess whether the proposed dietary supplement can reduce the intensity of sadness in women vulnerable to sadness (day-5 postpartum women and women within the first 18 months postpartum with crying spells).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45
* The subject, as reported by them, should be in a good health.
* The subject is not taking any medication.
* The subject is not taking any investigational medicinal product within 8 weeks.
* BMI 19 to 40 (kg/m2)
* Resting pulse between 45 and 100 bpm
* Systolic blood pressure between 91 and 139 mmHg (inclusive)
* Diastolic blood pressure between 51 and 90 mmHg (inclusive)

Exclusion Criteria:

* The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for DSM-IV interview.
* Substance abuse disorder
* Subjects who have been smoking in the past 5 years.
Efficacy and Safety of Sublingual Immunotherapy (SLIT)

The purpose of this study is to evaluate the efficacy and safety of specific sublingual immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic rhinitis .


Eligibility Criteria:
Inclusion Criteria:

* Positive history of allergen specific seasonal allergic rhinitis
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,

Exclusion Criteria:

* Previous immunotherapy within the last 3 years,
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Afatinib in Subjects With Kidney Dysfunction

The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal function.

The assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.


Eligibility Criteria:
Inclusion criteria:

* Despite renal impairment (group 1 and 2) healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
* Glomerular filtration rate (GFR), estimated according to:

  -- MDRD (Modification of Diet in Renal Disease)-formula:
  * eGFR (estimated Glomerular Filtration Rate) \[ml/min/1.73m²\]= 175 x Serum Creatinine-1.154 x age-0.203 (if male)
  * eGFR\[ml/min/1.73m²\]= 175 x Serum Creatinine-1.154 x age-0.203 x 0.742 (if female)
  * 30 to 59 mL/min for moderate renal impairment group 1
  * 15 to 29 mL/min for severe renal impairment group 2
  * = 90 mL/min for healthy volunteers group 3
* Age =18 and =79 years

Exclusion criteria:

* Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance, e.g. repeated measurement of systolic blood pressure \< 90 mmHg (millimeter of mercury) or \> 140 mmHg, diastolic blood pressure \< 50 mmHg or \> 90 mmHg, repeated measurement of pulse rate \< 45 bpm (beats per minute) or \> 90 bpm.
* Any evidence of a clinically relevant concomitant disease.
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological or hormonal disorders.
* Relevant gastrointestinal tract surgery (except appendectomy).
* Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders.
* History of photosensitivity or recurrent rash.
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma

This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* 18-75 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1；
* Life expectancy ≥ 12 weeks.

Exclusion Criteria:

* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
The Factors That Inhibit Women Who Smoke to do Pap Smear Test

Discovery of factors affect the decision of the woman to perform or not to perform a Pap test.Participate in the study 100 women who smoke. Age range 18-60

The data collected through questionnaires to the women. Data analysis will be performed by using Statistical Analysis- SPSS

Eligibility Criteria:
Inclusion Criteria:

* smoking woman 18-60 years old

Exclusion Criteria:

* not smoking Not want to participate in the study
The Effect of Paternal Skin-to-Skin Contact on Breastfeeding Process After Cesarean Section

This study aims to investigate the effect of paternal skin contact on breastfeeding after cesarean section.The research was conducted at Ağrı Training and Research Hospital, Gynecology and Obstetrics Clinic between April 2023 and August 2023.A total of 126 mothers who gave birth by cesarean section, their spouses and newborns, 61 in the skin-to-skin contact group and 65 in the control group, participated in the study. Randomization of the groups participating in the study was done by simple random method using the website www.random.org.The socio-demographic characteristics introduction form, the questionnaire regarding skin-to-skin contact and breastfeeding process, and the LATCH Breastfeeding and Diagnostic Measurement Tool were used to collect research data.

The research was conducted in two groups: skin contact group and control group. This study aims to investigate the effect of paternal skin contact on breastfeeding after cesarean section.The research was conducted at Ağrı Training and Research Hospital, Gynecology and Obstetrics Clinic between April 2023 and August 2023.A total of 126 mothers who gave birth by cesarean section, their spouses and newborns, 61 in the skin-to-skin contact group and 65 in the control group, participated in the study. Randomization of the groups participating in the study was done by simple random method using the website www.random.org.The socio-demographic characteristics introduction form, the questionnaire regarding skin-to-skin contact and breastfeeding process, and the LATCH Breastfeeding and Diagnostic Measurement Tool were used to collect research data.

Eligibility Criteria:
Inclusion Criteria:

* Caesarean section
* single and live birth
* giving birth between 38-40 weeks
* not having a mental or physical barrier to breastfeeding,
* not having a need for neonatal intensive care in the baby,
* not having a condition that prevents breastfeeding in the baby,
* not having a condition that prevents skin contact with the baby
* agreeing to participate in the research

Exclusion Criteria:

* Having a vaginal birth
* Having a premature birth
* Having a mental or physical disability that prevents breastfeeding
* Having the baby referred to neonatal intensive care
* Having a condition that prevents breastfeeding
* Having a condition that prevents skin-to-skin contact
ACT Lung Health Intervention: Phase Two

This study aims to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer.

This two-arm stratified randomized clinical trial is to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer.

Participants will be randomized into one of two groups: Group A: ACT Lung Health Intervention versus Group B: Standard Care. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, questionnaires, and saliva tests.

It is expected participation in this study will last about 6 months.

About 128 participants are expected to take part in this research study.

The National Cancer Institute is providing funding for this trial.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as either Chinese or Korean
* Speak either Korean, Mandarin, or English
* Eligible for LDCT screening (50-80 years of age and 20- pack-year smoking history)
* Currently smoking (i.e., having smoked within the prior 30 days),
* Currently have active health insurance coverage and a primary healthcare provider and
* Have access to a video-call device with internet or wireless connection.
* Eastern Cooperative Oncology Group functional status \<2
* Live in the United States for the next 12 months

Exclusion Criteria:

* Had LDCT screening done within the last 2 years.
* Hospitalization due to a serious mental illness (e.g., psychotic disorders) during the prior 6 months.
* Previous history of lung cancer.
* We will not include any of the following special populations:

  * Adults unable to consent.
  * Adults younger than 50 or older than 80 years
  * Individuals who are not yet adults (infants, children, teenagers)
  * Pregnant women
  * Prisoners
Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers

The investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. We plan to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.

Ultrasound measurement of optic nerve sheath diameter (ONSD) had been considered as a non-invasive way to distinguish the presence of elevated intracranial pressure (ICP). Besides detecting elevated ICP in various neurological diseases, ONSD can also be applied to cardiac arrest survivors as one of the prognostic factors. It is a simple, quick, repeatable technique without the need of contrast medians. In order to make precise interpretations, the database of the normal distribution of ONSD and its associated factors in healthy volunteers is necessary. The majority of previous reports are from Western countries, and limited reports of ONSD in the Asian population have high variability.

Therefore, collecting local data of ONSD in Taiwan is important. In this study, the investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. The investigators planed to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.

Eligibility Criteria:
Inclusion Criteria:

adult volunteer aged more than 20 years

Exclusion Criteria:

aged less than 20 years
Liraglutide Efficacy on Glucocorticoid Induced Hyperglycemia in Patients High Risk for Diabetes

Glucocorticoids therapy exposes the patient to an increased risk for diabetes morbidity. However, there is no proven preventive therapy. GLP-1-RA has shown to improve glucose metabolism in healthy volunteers treated with glucocorticoids. We assume that GLP-1-RA will improve glucose metabolism in patients with high risk for diabetes morbidity, treated with glucocorticoids.


Eligibility Criteria:
Inclusion criteria:

* Planned treatment with T. Prednisone in dosage \>0.5 mg/kg for two weeks or more.
* Age \>18 years
* Body mass index \>27 kg/m2 OR 1st degree relative with type 2 diabetes mellitus OR hypertension OR hyperlipidemia OR gestational diabetes in the past OR diagnosis of polycystic ovary syndrome.

Exclusion criteria:

* Glycosylated hemoglobin A1c \>6.5%
* Diagnosis of diabetes mellitus or treatment with anti-glycemic drug
* Pancreatitis (acute or chronic) in the past
* Active malignancy
* Medullary thyroid carcinoma or multiple endocrine neoplasm type 2 of the patient or of 1st degree relative
* Pregnancy
Individual- and Group-based Postoperative Education for Patients Sternotomy

Cardiac surgery via sternotomy is performed on more than one million people annually. Patient education may promote engagement in daily activities postoperatively. It is unknown if there is any difference in patients' feedback and outcomes when the education is delivered individually or in a group format.

The aim of this study is to collect participants' feedback and therapists' time spent on individual- and group-based Education in Daily Activities Engagement - Post-Sternotomy.

This single-site non-randomised controlled study was conducted at Liverpool Hospital, NSW, Australia. All patients aged 18 or above who had received cardiac surgery via sternotomy at Liverpool Hospital cardiothoracic ward were consecutively allocated to the individual- or group-based postoperative education. Outcomes included a survey to obtain participants' feedback, the time spent by therapists delivering the education per participant, and participants' length of postoperative hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* had received cardiac surgery via sternotomy
* were medically ready for discharge

Exclusion Criteria:

* under the age of 18
* unable to provide consent
* did not speak English
* could not obtain a translator prior to discharge
* were infectious and required to isolate
Effects of BIONESS in Rehabilitation of Stroke

A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.

Prediction of motor recovery in the upper-limb (UL) / lower-limb (LL) in patients with stroke is generally based on clinical examination. However, according to former studies neurophysiological measures may also have a predictive value. In the acute phase, the combination of the motor score and SEPs are best predictive of outcome. Neurophysiological measures alone are of limited value in predicting long term outcome. However, predictive accuracy is substantially improved through the combined use of both of these measures and clinical variables.

A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 and 75
* Inadequate ankle dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance
* Medically stable for at least one week following the last episode of stroke
* Stable medication for four weeks
* Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device, and give adequate feedback
* Ability to walk with or without an assistive device (except parallel bars) at least 10 meters

Exclusion Criteria:

* • Lower motor neuron injury with inadequate response to stimulation

  * History of falls greater than once a week
  * Severe cardiac disease such as myocardial infarction, congestive heart failure, or a demand pacemaker
  * Patients who have other electrical stimulation devices implemented
  * Patients with epilepsy and with autoimmune diseases
Inspiratory Muscle Training Immediately After Lung Transplantation

Following lung transplantation (LTX), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (ADL) and decrease quality of life.

Inspiratory muscle training (IMT) has been extensively studied in a variety of non-LTX populations and research has shown that IMT improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease.

The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following LTX. Patients targeted for enrollment will be those with any type of advanced lung disease requiring LTX with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.


Eligibility Criteria:
Inclusion Criteria:

* Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study
* Active on the waiting list for lung transplantation
* Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device

Exclusion Criteria:

* Already participating in a regular IMT program
* Impaired cognition with inability to follow commands
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections

The purpose of this study is to assess the safety and effectiveness of doripenem treatment among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infection.

This is an open-label study (all people know the identity of the treatment assigned), multi-center (conducted at multiple sites), and observational (study in which the investigators/physicians observe the patients and measure their outcomes) study to evaluate the safety and effectiveness of doripenem for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infection among Filipino patients. Safety evaluations for adverse events, clinical laboratory tests, physical examination, and concomitant medications will be monitored throughout the study. The total duration of study for each patient will be approximately for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with nosocomial pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections or complicated urinary tract infection
* Patients who are eligible for doripenem treatment

Exclusion Criteria:

* Pregnant or lactating females
* Patients with hypersensitivity to doripenem and/or its derivatives
* Known at study entry to have an infection caused by pathogen(s) resistant to doripenem
* Patients taking probenecid
* History of severe allergies to certain antibiotics such as penicillins, cephalosporins, and carbapenems
* Severe impairment of renal function including a calculated creatinine clearance of less than 10 mL per minute, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours)