cyrilzakka/clinical-trials huggingface dataset:
Agreement and Reliability of Transient Elastography

The aim of this study is to assess agreement, smallest detectable change, and reliability of repeated measurements of liver stiffness of transient elastography in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Previous studies have reported excellent test-retest reliability for transient elastography (TE) in viral hepatitis. Reliability refers the ability of an instrument to discriminate between study subjects and may be excellent even if considerable measurement-error exists, if the population is heterogenous. Agreement, in contrast, refers to differences of measurements on the original scale (kPa for TE). Whether agreement is acceptable is situation-dependent and can be related to the smallest detectable change (SDC).

Agreement metrics or SDC have not been addressed in previous studies for chronic viral hepatitis. The aim of this study is to assess agreement, SDC, and reliability of repeated measurements of liver stiffness of TE in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Eligibility Criteria:
Inclusion Criteria:

* Patients at the departments of infectious diseases in Malmö, Lund and Helsingborg with chronic viral hepatitis.
* Adult patients
* Signed informed consent to participate in the study.

Exclusion Criteria:

* suspected or confirmed pregnancy.
* patients unable to speak Swedish
* inability to sign informed consent.
Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

A prospective randomized trial will be performed. Patients undergoing gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia, and patients receiving only postoperative intravenous analgesia (Group 2).

Postoperative pain will be assessed with a Visual Analogic Scale 24h after surgery and morphine needs will be quantified.

A prospective randomized trial will be performed. Patients undergoing laparoscopic Roux-en-Y gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided TAP block with 30 ml Bupivacaine 0.5%, as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h), and patients receiving only postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h) (Group 2).

Postoperative pain will be assessed with a Visual Analogic Scale 24 hours after surgery and morphine needs will be quantified.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>40 Kg/m2
* BMI \>35 Kg/m2 and obesity associated comorbidities
* Patients undergoing laparoscopic Roux en Y gastric bypass

Exclusion Criteria:

* Patients undergoing other bariatric procedures, different than Roux en Y gastric bypass
* Patients undergoing open bariatric surgery
Glider PTCA Balloon Catheter Registry

The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon Catheter for crossing during the treatment of coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing PCI who are at least 18 years old
* PCI procedure included the use of at least one Glider PTCA Balloon Catheter
* Patient has been informed, in accordance with local requirements, that their data will be used in the Glider Registry

Exclusion Criteria:

* N/A
Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli

In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.

In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.The primary outcome is clinical response and secondary outcomes are microbiological response and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yr.
* Hospitalized to Siriraj Hospital
* Infections with ESBL-producing E.coli or K.pneumoniae
* Consent informed consent

Exclusion Criteria:

* Pregnancy or lactating mother
* Colistin allergy
* Neurologic diseases
Virta Health Registry

The purpose of this registry is to establish a research data repository, comprised of data generated in the course of providing clinical services to patients treated by Virta Health, to conduct secondary research on clinical interventions and chronic diseases.

The purpose of this registry is to establish a research data repository, comprised of data generated in the course of providing clinical services to patients treated by Virta Health, to conduct secondary research on clinical interventions and chronic diseases.

The scope of research under this protocol includes the following:

1. Examining the effectiveness, safety, and sustainability of Virta Health clinical interventions for treating chronic diseases and prevention of or regression of associated adverse health outcomes.
2. Examining the cost-effectiveness and economic impact of Virta Health clinical interventions for treating chronic diseases and preventing or regressing associated adverse health outcomes.
3. Identifying demographics, clinical characteristics, comorbidities, concomitant treatments, genetic variants, and behavioral phenotypes that predict more or less favorable clinical outcomes of subjects to Virta Health clinical interventions for chronic diseases.
4. Examining the impact of mental health and the behavioral modification components of Virta Health clinical interventions on disease markers, comorbidities, and adverse health outcomes associated with Virta Health clinical interventions.
5. Characterizing typical presentation patterns, genetic determinants, biochemistry, and pathophysiology of the chronic diseases treated by Virta Health.
6. Exploring relationships between dietary composition and physiologic characteristics of chronic diseases.
7. Exploring the interrelationship and common clinical/biological features of the various chronic diseases under treatment by Virta Health.
8. Compiling case reports and case series of interesting disease presentations and outcomes, of the chronic diseases Virta Health treats, that may inform about the disease state and treatment responses.
9. Validating the integration of technological aids into Virta Health clinical interventions. Where the impacts of devices are examined, devices will be FDA-approved and approved, marketed devices. No safety data will be collected on devices; rather, research will focus only on the feasibility of adding the device to the treatment program, its relationship with participant behaviors and health outcomes, and patient satisfaction attributable to the device.
10. Understanding the relationships of patient needs, educational methods, and use of the Virta Health online Application, to subsequent patient satisfaction/clinical outcomes.

Eligibility Criteria:
Virta Health Patients
Multiple Myeloma (MM) Quality of Life (QOL) Study

The main purpose of this study is to examine differences in quality of life and psychological distress for both Multiple Myeloma patients receiving treatment and their caregivers and to assess patient and caregiver prognostic understanding (understanding of the likely course of a disease over time) of Multiple Myeloma to guide development of more personalized treatment plans.

This study looks to further understand quality of life changes throughout multiple myeloma therapy for both patients and caregivers to help determine ways to improve patient and caregiver understanding of illness and in turn, tailor customized treatment that best aligns with patient preferences.

The study will use a series of questionnaires to measure quality of life, mood, coping strategies, and prognostic understanding.

This research study's procedures include screening for eligibility, participant designation of a caregiver and a series of questionnaires.

- It is expected that about 180 people undergoing treatment for multiple myeloma and up to 180 of their caregivers will take part in this research study.

-- The questionnaires are completed one time only and measure quality of life, mood, coping strategies, and prognostic understanding and can be completed in the hospital, clinic, over the email, or telephone with assistance provided as needed.Questionnaires take approximately 20 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

Patient Eligibility criteria:

* Adult patients (greater than 18 years) receiving active therapy for MM.

  * For patients with newly diagnosed MM, patients are eligible while undergoing induction therapy prior to received autologous stem cell transplant but not after.
* Ability to read questions in English or willing to complete questionnaires with the assistance of an interpreter.

Caregiver Eligibility criteria:

* Adult (greater than 18 years) relative or a friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with him or her at least twice per week.
* Ability to read and respond to questions in English or to complete questionnaires with minimal assistance of an interpreter

Exclusion Criteria:

* Patient Exclusion criteria:

  * Patients receiving maintenance therapy only.
  * Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits informed consent or participation in the study.
Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic.

Sepsis is an inflammation response produced by the host's immune system, which is agrravated by oxidative stress. One of the adjuvant therapy according to Surviving Sepsis Campaign Guideline is albumin, which has anti-inflammatory and anti-oxidant effects. However, human albumin is quite expensive, and other forms with similar potency and less costs are needed, one of which is Channa striata extract. Therefore, this study is conducted to compare albumin and human albumin, specifically their anti- inflammatory and anti-oxidant properties by assessing the eNOS marker, neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio (PLR) in patient with sepsis.

In summary, this study showed that Channa striata extract has a better outcome in stabilizing eNOS level in patient with sepsis than human albumin 20%, and it has a potential benefit in stabilizing NLR values. However, further studies with a larger sample and a more advanced phase of sepsis are needed.

Eligibility Criteria:
Inclusion Criteria:

* patients sepsis who met the qSOFA criteria ≧ 2 \[two of which: unconsciousness (Glasgow Coma Scale ≤14)
* respiratory rate \> 22 and systolic blood pressure ≤ 100 mmHg\],
* aged ≧ 18 years
* admitted to intensive care unit and high care unit at Dr. Moewardi General Hospital

Exclusion Criteria:

* patients with severe trauma
* blood loss in stage three or higher
* stress ulcers
* a history of nephrotic syndrome
* refusal to participate
Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.

The objective of this study was to study the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.

Eligibility Criteria:
Inclusion Criteria

* Subjects were male or female outpatient subjects,
* 3.0 - 7 years 11 months of age
* Bipolar I or II Disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to DSM IV criteria (American Psychiatric Association 1994)
* with a score \> 20 on the Young Mania Rating Scale (YMRS.

Exclusion Criteria

* clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions;
* neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests:

  * CBC with differential,
  * electrolytes,
  * BUN,
  * creatinine,
  * hepatic transaminases,
  * urinalysis,
  * thyroid indices (T3, Total T4, Free T4, TSH) and
  * EKG
* mania due to a general medical condition or substance-induced mania
* mental retardation (IQ \<70),
* evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder,
* Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium

Anesthesia induction with sevoflurane is not associated with an increased incidence or severity of laryngeal injuries compared with an anesthesia induction with a muscle relaxant.


Eligibility Criteria:
Inclusion Criteria:

* ear-nose-throat surgery
* orotracheal intubation for surgery of the ear

Exclusion Criteria:

* obesity
* allergy against the study drugs
* patients with a known or suspected difficult airway (Mallampati score 3 or 4 and a mouth opening \< 3.5 cm).
* all patients were examined by stroboscopy one day before surgery and were excluded from the study when preexisting pathologies of the vocal cords were found
COVID Booster in Pregnancy and Lactation

This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.

We will enroll 100 pregnant patients who have received COVID-19 mRNA booster as well as 100 breastfeeding patients who have received COVID-19 mRNA booster. Participants will be following longitudinally through 3 months post partum, or 3 months post enrollment for those in the breastfeeding cohort. Maternal blood will be collected, as will cordblood at delivery, breastmilk, and infant samples.

Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation
* Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding

Exclusion Criteria:

* Multifetal gestation
* Unable to provide consent
A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies

The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

The primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of AI devices. The data will be collected during routine colonoscopy procedures. Biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination. The histopathological results will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study
* Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam

Exclusion Criteria:

* Patients for whom endoscopic submucosal dissection is planned
* Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc.
* Patients who have to receive an urgent colonoscopy procedure
* Patients who underwent total colectomy of the large intestine
* Patients who are judged by a physician to be contraindicated for colonoscopy procedures
* Patients who have participated in another clinical study within the last 30 days
Rapid HCV Treatment Access for Persons Who Use Drugs

This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups:

1. Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection.
2. Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness of participant to provide written informed consent
* Men and women age ≥18 to ≤70 years at study entry
* HCV antibody positive/detectable HCV RNA
* HCV treatment naïve (no prior treatment with an approved or investigational oral DAA therapy)
* Negative pregnancy test at screening or at the day of treatment initiation (females of childbearing potential only)
* If co-infection with Human Immunodeficiency Virus (HIV) is documented, the subject must be anti-retroviral treatment (ART) naïve with CD4 T cell count \>500 cells/mm3 OR on a stable ART regimen (containing only permissible ART - Raltegravir; dolutegravir; Rilpivirine; Elvitegravir/cobicistat; Tenofovir disoproxil fumarate; Tenofovir alafenamide; Emtricitabine; Lamivudine and/or Abacavir, bictegravir)

Exclusion Criteria:

* Women who are pregnant or breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug
* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
* Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry
* History of hepatocellular carcinoma (HCC)
* Any history of active Hepatitis B or positive HBsAg test
* Platelet count \< 150,000/mm3
* HCV RNA undetectable
* History of clinically significant abnormalities or co-morbidities that make the subject an unsuitable candidate for this study, in the opinion of the investigator.
* Women of childbearing potential that are not practicing at least one specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
* Subject is currently taking any of the following prohibited medications: red yeast rice (monacolin K), St. John's Wort, carbamazepine, dabigatran, efavirenz, phenytoin, pentobarbital, phenobarbital, primidone, rifabutin, rifampin.
* Subject is not able or willing to safely discontinue the prohibited medications or supplements listed below at least 14 days prior to the first dose of GLE/PIB: some HMG-CoA reductase inhibitors, astemizole, cisapride, terfenadine, ethinyl estradiol.
Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure

Electrical impedance tomography (EIT) is a non-invasive, bedside monitoring technique that provides continuous, real-time information about the regional distribution of the ventilation.

There are very few data in children admitted to the PICU (pediatric intensive care unit) and the aim of the study is to describe the distribution of the ventilation in children with acute respiratory failure and to study the impact of the interventions in the PICU (change in ventilatory settings, change in position, suction, respiratory kinesiotherapy,...)

Children with acute respiratory failure admitted to the PICU (pediatric intensive care unit)

Eligibility Criteria:
Inclusion Criteria:

Groupe A

* children \< 18 years
* Admitted to the PICU with acute respiratory failure
* Monitoring with EIT
* non opposition of parents or legal representative Groupe B
* children \< 18 years
* With general anesthesia and mechanical ventilation
* Monitoring with EIT
* non opposition of parents or legal representative

Exclusion Criteria:

* Monitor not available
* contra indication to the use of thoracic belt
* Intraoperative period with use of electrocautery
* Child not affiliated to a social security system and under protective measures legal
The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris

This study, taking stable angina pectoris as a research carrier, aims to explore the preventive value of acupoint sensitization by conducting a double-blind multi-center randomized controlled trial to compare the effect of stimulating acupoints with different sensitivity on the prevention of angina pectoris.

After the inclusion of eligible patients, the pressure-pain threshold of disease-related acupoints will be detected by using Von Frey detector. Then, the patients will be randomly divided into experimental group and control group. The patients in experimental group will be given acupoints pressure on the five acupoints with the lowest pressure-pain threshold, while the patients in control group will be given acupoints pressure on the five acupoints with the five acupoints with the highest pressure-pain threshold. The two groups will be treated with acupoints pressure 12 times within 4 weeks. The patients will be evaluated three times at baseline, the end of treatment and four weeks after the end of treatment respectively, including angina attack frequency, CCS classification and SAQ score.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable angina pectoris and symptoms of chest pain
* The duration of onset was more than 3 months, and the number of angina attacks in the past month was not less than 2
* Not younger than 35 years old and not older than 80 years old
* Patients will participate in the study voluntarily and have signed the informed consent

Exclusion Criteria:

* Patients with mental retardation
* Patients were contraindicated or unable to complete acupoint sensitization test
* Patients with cardiovascular, digestive, urinary, respiratory, blood, nervous, endocrine system and other serious primary diseases
* Patients with bleeding, allergy constitution
* Patients with abnormal skin or peripheral nerve sensation, abnormal pain sensation, skin ulceration at the sensitization detection site
* Patients with unsatisfactory clinical treatment of hypertension and diabetes
Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial.

The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group).


Eligibility Criteria:
Inclusion Criteria:

* Both gender with age higher than 18 years.
* Documented cancer of the gastrointestinal tract: oesophagus, stomach, pancreas, biliary tract
* Candidate for major elective surgery.
* Preoperative nutritional risk score ≥ 3
* Written informed consent.

Exclusion Criteria:

* Age \< 18 years
* Karnofsky index \< 60
* Renal insufficiency (Ongoing haemodialysis or plasma creatinine \> 3 mg/dL)
* Respiratory insufficiency
* Child-Pugh class C
* Short Bowel Syndrome
* Pregnancy
* Emergency operation
* Foreign residence or residence in Italian region with no regulation designed for home artificial nutrition