cyrilzakka/clinical-trials huggingface dataset:
To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).

Study design-Open label randomized controlled trial

Study period-2 years

Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018

All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after screening for exclusion and inclusion criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy + Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF


Eligibility Criteria:
Inclusion Criteria:

- All consecutive patients in age group of 18-70 years with acute on chronic liver failure as defined by APASL criteria shall be included in the study.Only those patients who wish to be enrolled in the trial shall be included in the study.

Exclusion Criteria:

1. Steroid eligible patients with severe alcoholic hepatitis
2. Cirrhosis of liver with previous history of decompensation
3. Patients with severe cardiopulmonary disease
4. Pregnancy
5. Human Immmunodeficiency Virus infection
6. Hepatocellular carcinoma or extrahepatic malignancy
7. Chronic renal insufficiency on treatment with haemodialysis
8. Uncontrolled bleed or patients in disseminated intravascular coagulopathy
9. Patient with expected survival of less than 48 hours
10. Patients with moderate-severe acute respiratory distress syndrome
11. Hemodynamic instability with noradrenaline requirement of more than \>0.5ug/kg/min or requirement of dual vasopressors
12. Patients with leukemoid reaction or total leucocyte count \> 40,000/mm3
13. Patients diagnosed with Hemophagocytic Lymphohistiocytosis
14. Patients with known hypersensitivity to Granulocyte colony stimulating factor
Respiratory Protection Effect of Ear-loop-type KF94 Mask

Ear-loop-type Korean Filter 94 masks (KF94 masks, equivalent to the N95 and FFP2) are broadly used in health care settings in Korea for the COVID-19 pandemic. However, no studies have assessed the adequacy of respiratory protection. In this prospective randomized open-label study, the investigators aimed to evaluate the fitting performance of ear-loop-type KF94 masks by the quantitative fit test according to the occupational safety and health administration (OSHA) protocol. In addition, by quantitatively comparing the "tight-fitting" method using a clip and the "general-fitting" method, the investigators tried to evaluate whether the tight-wearing method improves the fitting performance of KF94 masks.

Sample size: The sample size was calculated based on a pilot study of 10 participants, which examined the FF of general-fitting. The mean FF was 20.3, and the log-transformed FFs were assessed due to skewed data, which was 1.98 (standard deviation 1.34). We assumed that the FF for tight-fitting would increase by 50%, with an α value of .05, and a β error of .10 (power = 90%) for two-sided hypothesis testing. The estimated sample size calculation revealed a required sample of 24 participants. Therefore, 30 participants were enrolled to account for a 20% dropout rate.

Data analyses: Repeated-measures analysis of variance or generalized estimating equations were used to compare the FFs or passing rate of the QNFTs for the three mask types according to the wearing method. Paired t-tests or Wilcoxon signed-rank tests were used to compare the FFs according to the wearing method for each mask type. McNemar's test was used to compare the passing rate of the QNFT according to the wearing method. Bonferroni's correction was performed for all results of each subgroup analysis. SAS ver. 9.4 software (SAS Institute, Cary, NC) was used to perform all statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* healthcare workers with experience in wearing filtering facepiece respirator working in the hospital

Exclusion Criteria:

* Individuals with expected difficulties in wearing masks or undergoing OSHA fit tests because of factors such as a facial anomaly, lung disease, or lower back disorder
Clinical Analysis of Simultaneous Pancreas-kidney Transplantation for End-stage Renal Disease Associated With Diabetes Mellitus

The first pancreas transplantation was performed in 1966, by 2015, more than 40,000 pancreas transplantation have been performed worldwide. Nevertheless, only several Chinese organ transplant centers carry out SPK because of surgery complications. simultaneous pancreas-kidney transplantation is a new and promising therapeutic option for the treatment for type 1 diabetes mellitus patients and end-stage renal disease. the preliminary treatment results are summarized to promote the further development of this work in China.

simultaneous pancreas-kidney transplantation using the surgical technique was performed in our department from September 2016 to January 2023 in the Department of Transplantation of the Second Affiliated Hospital of Guangzhou Medical University. Patients were followed up for 2 to 36 months to summarize the efficacy and complications. we examined the influence of SPK on patient and graft survivals.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Diabetes patients with end-stage renal disease;
2. First time receiving SPKT;

Exclusion Criteria:

1. Pulmonary infection, urinary tract infection, hematuria CMV or BK virus infection occurred during treatment;
2. Using a large number of abnormal biological products (blood transfusion, plasma or coagulation factors) may contain foreign DNA;
3. Loss of graft due to thrombosis or AR;
4. Patients who are pregnant or have malignant tumors or patients with a history of cell therapy, whose tumor signals interfere with dd-cfDNA detection;
5. Patients who have poor compliance during treatment or suffer from mental illness.
REALL: A Retrospective Observational Study to Compare the Effectiveness and Cost-Effectiveness Between Different Step-3 Asthma Treatment Strategies

This is a retrospective observational study utilising anonymised individual patient clinical and prescribing information routinely collected by UK General Practitioners (GPs). This information will be observed for two years, one year pre and one year post- "Index Prescription Date" (IPD). The IPD is the date when a patient was first switched to any option of the step-3 asthma treatment regimen. The one year before the IPD is the baseline period and will be reviewed for risk factors and confounding factors. The one year after the IPD is the outcome period and will be observed to see the outcomes of the new treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a physician diagnosis of asthma who have stepped-up to any option of step-3 asthma treatment (trial therapy), and;
2. Patients with the trial therapy who have data in their records for at least one year for the baseline period and at least one year for the outcome period.

Exclusion Criteria:

1. Patients who were not prescribed with any option of step-3 treatment (the trial therapy) during the study period.
2. Patients treated with the trial therapy, but do not have data in their records for at least one year for the baseline period and at least one year for the outcome period.
3. Patients treated with long-acting anticholinergic drugs, either alone or in combination with other therapy.
4. Patients with a physician diagnosis of COPD with or without asthma.
5. Patients who have resolved from asthma; i.e. patients who were previously diagnosed as having asthma, have now been undiagnosed.
Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine

Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can prolong the woman's stay in the hospital after birth, slow down her recovery time at home, and increase medical costs. Methergine is a medication that is routinely used to stop uterine hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery. Methergine works by contracting (tightening) the uterus. These contractions also help the uterus to expel or remove parts of the placenta that increase the chance of developing a uterine infection.

This research study is being done to learn if routine use of Methergine can lower the chances of developing a uterine infection after cesarean delivery. Half of the women in this study will receive Methergine for a few days during their hospitalization after cesarean delivery. The other half of the women will not routinely receive Methergine.


Eligibility Criteria:
Inclusion Criteria:

1. Female singleton gravidas
2. Patients receiving non-elective cesarean deliveries after trial of labor
3. No evidence of chorioamnionitis

Exclusion Criteria:

1. Diagnosis of chorioamnionitis
2. Elective cesarean section
3. Unable to provide informed consent
4. Immunocompromised patients and those on antiretroviral drugs
5. Patients with known infection
6. Hypertension (blood pressure greater than 140/90 x 2, six hours apart), including those with a past history, gestational or Preeclampsia.
7. Allergic to ergot alkaloids. This would include people allergic to migraine medicine.
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients

This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated time on study is up to approximately 9 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the team and supported with the Autistic Diagnostic Observation Schedule (ADOS)
* Male adults, 18 to 45 years of age
* IQ \> 70 (Wechsler Adult Intelligence Scale-Full scale)
* Body mass index (BMI) 18 to 35 kg/m2 inclusive
* Aberrant Behavior Checklist (ABC) - Irritability subscale score \</= 13

Exclusion Criteria:

* Positive urine test for drugs of abuse
* Alcohol and/or substance abuse/dependence during the last 12 months
* Positive for hepatitis B, hepatitis C or HIV infection
* Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder
* Active inflammatory pulmonary disease
* History of epilepsy/seizure disorder (except for simple febrile seizures)
* Initiation of new or major change in psychosocial intervention within 4 weeks prior to randomization
* Treatment with any investigational agent within 90 days prior to screening
* History of hypersensitivity or allergic reactions
Telemedicine Management of Hypertension

Explore barriers, facilitators, acceptability, feasibility, and fidelity of the telemedicine management of hypertension intervention

The purpose of the current study is to conduct pre-implementation work to understand the determinants of the telemedicine management of hypertension intervention implementation, feasibility of the intervention and its tailoring, and explore potential inequitable implementation factors in African American patients to enhance the intervention's usability to inform future hybrid trial design.

Eligibility Criteria:
Inclusion Criteria Patients:

* \> 18 years of age
* diagnosis of Hypertension (HTN)
* systolic Blood Pressure \> 140mmHg on last two clinic visits
* stable anti-HTN medication in the preceding six weeks
* possess smart phone
* must speak and read English

Exclusion Criteria Patients:

* conditions that diminish the ability to conduct home-based self-assessments of Blood Pressure
* chronic conditions that add complexity in HTN management
* recent acute health changes that increases likelihood of Blood Pressure instability
* terminal illness

Inclusion Criteria Stakeholders:

* identify stakeholders using Mendelow's stakeholder matrix, which helps recognize stakeholders according to their interest and power in using the intervention in their clinic - Stakeholders are from clinic and community health workers
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity

The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.

Both groups will have:

* screening visit
* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans)
* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss.


Eligibility Criteria:
Inclusion Criteria :

* age: ≥18 but ≤70 years
* not pregnant or breastfeeding
* weight stable and sedentary before enrollment
* no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \[MAO\]-Type 2 Diabetes group)
* no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer)
* participants must fulfil all of the following group-specific inclusion criteria below:

Lean group:

* Body mass index (BMI) ≥18.5 but \<25.0 kg/m2
* Intrahepatic triglyceride (IHTG) content \<5%
* fasting blood glucose concentration: \<100 mg/dl
* blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl
* Hemoglobin A1C (HbA1c) \<5.7 %

Metabolically normal obesity (MNO) group:

* BMI ≥30.0 but \<45.0 kg/m2
* IHTG content \<5%
* fasting blood glucose concentration: \<100 mg/dl
* blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl
* HbA1c \<5.7 %

Metabolically abnormal obesity (MAO)-insulin resistance and non-alcoholic fatty liver disease (NAFLD) group:

* BMI ≥30.0 but \<45.0 kg/m2
* IHTG content \>7.5%
* fasting blood glucose concentration: ≥100 but \<126 mg/dl
* blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \<200 mg/dl
* HbA1c: ≥5.7 but \<6.4 %

MAO-type 2 diabetes group:

* BMI ≥30.0 but \<45.0 kg/m2
* clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \>126 mg/dl or blood glucose concentration 2 h after a 75 g oral glucose challenge\>200 mg/dl or HbA1c \>6.4 % without medication if not diagnosed and medically treated for diabetes

Exclusion Criteria:

- Individuals that do not meet all inclusion Criterion
Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores

For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. According to preference, surgeons can be categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim of this prospective, randomized, controlled study to is compare the isokinetic performance and clinical outcome of TKAs with PR and without PR.

Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to either the PR or non-PR groups. The differences between groups with respect to age, BMI, gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated. Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1 year with isokinetic measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 55 to 80 years
* unilateral primary osteoarthritis

Exclusion Criteria:

* bilateral osteoarthritis
* inflammatory arthritis
* post-traumatic osteoarthritis
* previous knee surgery
* neuromuscular diseases
Identification of Celiac Ganglia

Computer-aided image recognition will improve the technique of endoscopic ultrasound-celiac plexus block/celiac plexus neurolysis (EUS-CPB/CPN) and improved pain relief.

All subjects who are undergoing EUS will be eligible. Consecutive patients undergoing EUS will be invited to participate in this study. Subjects must be 18 years old or above at the time of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* all EUS patients

Exclusion Criteria:

* under 18 yrs
Evaluation of Novel Point of Care Coagulation System in Pregnant Women

In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer system to assess coagulation rapidly with ease.

Unexpected bleeding continues to be an issue that confronts anesthesiologists. Obstetric bleeding spearheads as the leading cause of maternal mortality and morbidity. One of the hurdles that clinicians confront is a lack of point of care coagulation system that can hasten the clinical management strategy in the right direction. Conventional methods take considerable time to obtain results. TEG and ROTEM are currently doing the job however these two modalities requires expertise and proficient training to perform test and interpret results. The level of expertise to run the TEG and ROTEM poses hurdles for providing coagulation around the clock as it requires trained operators. What is currently required for efficient and effective management of obstetric hemorrhage is a point of care coagulation system in the operating room and or labor and delivery suite that is user friendly, easy and quick to perform. In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer system to assess coagulation rapidly with ease.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman at 37-41 weeks gestation

Exclusion Criteria:

* Hypertension
* Preeclampsia
* Gestational diabetes
* Preexisting coagulopathy
* History of deep vein thrombosis (DVT)
* Medications that impair coagulation
* History of pulmonary embolism or thrombosis
* Women in active labor receiving intravenous fluids or oxytocin
Effects of Serotonin Inhibitors on Patient-controlled Analgesia Related Nausea and Vomiting

ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or adenoidectomy in children


Eligibility Criteria:
Inclusion Criteria:

* tonsillectomy or adenoidectomy

Exclusion Criteria:

* development delay,
* CNS abnormality
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders

Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in Clinical Global Impression Scale, Young Mania Rating Scale, and HAM-D scores. The following are the hypotheses:

* Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.
* Omega 3 fatty acids will be superior to placebo in improving aggression and irritability associated with autism.
* Omega 3 fatty acids will be superior to placebo in improving functional ability.

This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. The data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Child/Teen has autism.
* He/She is between five and seventeen years of age.
* He/She is not in the hospital.
* He/She has a parent or legal guardian who is willing and able to sign the informed consent.

Exclusion Criteria:

* Child/Teen has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
* He/She has caused visible harm to him/herself or is at risk for suicide.
* He/She has an active seizure disorder or epilepsy (seizures within the past year).
* He/She has an unstable medical illness, including heart disease.
* He/She has experienced brain injury.
* He/She has a history of diabetes.
* He/She has a history of prior treatment with Omega 3 Fatty Acids.
* He/She lives in a far away area and/or does not have regular access to transportation to the clinical facility.
* A pregnant female or unwilling to use acceptable contraception if sexually active.
The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients

The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing

1. gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
2. the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients with hemiplegia over 19 years old
* Ischemic or hemorrhagic stroke patients over 3 months of onset
* Functional Ambulation Category Scale with 3 or more scales

Exclusion Criteria:

* Stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures
* Stroke patients with walking difficulty due to serious cognitive problems
* Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot
* Stroke patients at risk of falling when walking with severe dizziness
* Modified ashworth scale (MAS) Stroke patients over 3
* Pregnant woman
* People with mental illness and psychiatric medication
Suture Techniques to Reduce the Incidence of The inCisional Hernia

The objective of the study is reduction of the incidence of the most frequent complication of abdominal surgery, incisional hernia. In this multi center double-blinded prospective randomized controlled trial, in which a new suture technique using small bites is compared with the traditionally applied large bites (mass closure) technique for midline incisions.


Eligibility Criteria:
Inclusion criteria

* Signed informed consent
* All laparotomies with a midline incision
* Age \> 18 years

Exclusion criteria

* Previous incisional hernia after midline incision
* Previous surgery through a midline incision within 3 months
* Pregnancy (in women)
Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion

The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.

This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, control group.

Eligibility Criteria:
Inclusion Criteria:

* surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age;
* English or Spanish speaking;
* ability to give informed consent

Exclusion Criteria:

* pre-operative use of misoprostol;
* allergy to study medications (lidocaine, prilocaine, versed, fentanyl);
* known uterine anomaly;
* prior cervical surgery