cyrilzakka/clinical-trials huggingface dataset:
The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.

Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these findings are relevant to humans but the issue has become a major concern. Recent data have found that monkeys exposed to anaesthesia as infants grow up to have slower learning than those not exposed.

The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.

Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these findings are relevant to humans but the issue has become a major concern. Recent data have found that monkeys exposed to anaesthesia as infants grow up to have slower learning than those not exposed.

The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.

An alternative anaesthetic regimen comprises a dexmedetomidine-based anaesthetic, augmented with an opioid (remifentanil) and a regional nerve block (such as a caudal).

This open label prospective single arm pilot study will enrol 60 infants aged 1-12 months scheduled for lower limb, urologic, or lower abdominal surgery. After sevoflurane induction, the infants will have a caudal anaesthetic and intravenous dexmedetomidine and remifentanil.

The outcome will be need for intervention for light anaesthesia, intervention for haemodynamic changes and rate of abandoning the protocol. Recovery times will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 1 to 12 months (corrected age)
* ASA I or II
* Infants undergoing lower abdominal/lower extremity surgery anticipated to be \> 120 minutes in duration
* Surgery requires caudal regional nerve block

Exclusion Criteria:

* ASA III or higher
* Any contraindication to caudal analgesia
* Any contraindication to an inhalational induction with sevoflurane
* Allergies to any medication in study protocol
* Planned admission to an ICU postoperatively (except level II or III neonatal ICU)
* Planned tracheal intubation postoperatively
* Mechanical ventilation postoperatively
5-Day Preoperative Radiation for Soft Tissue Sarcoma

The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
2. Has been offered preoperative radiation and surgery as part of standard-of-care treatment
3. Age ≥ 18
4. KPS ≥ 70 or ECOG 0 to 2
5. Life expectancy ≥ 6 months
6. If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.
7. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Exclusion Criteria:

1. History of prior radiation to the area to be treated.
2. Active use of other anti-cancer investigational agents.
3. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
4. Pregnancy.
Assessment of Factors That Affected Respiratory Parameters in Mucopolysaccharidoses Patients

Respiratory system affects in mucopolysaccharidosis (MPS) disease. Respiratory system symptoms are seen in almost every MPS patients and respiratory failure is one of the most common causes of death in this population. The aim of the study was to evaluate respiratory muscle strength and endurance, cough effectiveness and functional capacity in MPS patients and to defined the factors that affected the respiratory problem in this.

This study was participated MPS patients. Patients' pulmonary function test, functional capacity, respiratory muscle strength and endurance, peak cough flow was assessed and recorded.

Pulmonary function test was assessed with spirometry, functional capacity was evaluated with 3-minute step test and six minute walk test (MWT). Respiratory muscle strength was evaluated mouth pressure measurement (MIP- maximal inspiratory pressure and MEP- maximal expiratory pressure) and Sniff nasal inspiratory pressure (SNIP). Respiratory muscle endurance was assessed Powerbreathe. And cough effectiveness was evaluated peak cough flow.

Eligibility Criteria:
Inclusion Criteria:

* People who diagnosed Mucopolysaccharidoses disease in Hacettepe University.
* Cooperation

Exclusion Criteria:

* Patients who were not walking ability.
Prevalence Of Microalbuminuria Among Children Suffering From Sickle Cell Nephropathy and Sickle Cell/Beta-Thalassemia

Sickle cell nephropathy is a known complication of sickle cell anemia (SCA) manifested by increase in glomerular filtration rate (glomerular hyperfiltration) and results in proteinuria and chronic renal failure.

Our goal is to examine the prevalence of proteinuria and microalbuminuria as an early predictive factor of glomerular injury, among young people who suffer from SCA as well as those who suffer from combined sickle cell/beta-thalassemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with sickle cell anemia
* Patients diagnosed with combined sickle cell anemia/beta-thalassemia

Exclusion Criteria:

* Diabetes mellitus
* Hypertension
* Reduced renal mass (single kidney)
* Overweight
* History of UTIs
Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders

This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs). This will be done using a stable isotope to assess nitrogen metabolism in the blood, urine, and stool. The study will also assess the safety and tolerability of KB195 in patients with UCDs.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed UCD patient at any age ≥ 14 years
* Parental/legal guardian permission or patient's written informed consent or assent, as applicable
* Be willing and able to comply with study requirements

Exclusion Criteria:

* Any medical condition unrelated to the sequelae of UCD
* Patient has N-acetylglutamate synthase (NAGS) deficiency
* Recent hospitalization or risk for metabolic decompensation
* Liver transplantation
* Systemic antibiotics, probiotics or prebiotics that do not align with study guidances
* Change in dose or frequency of any drug or other compound to modulate GI motility
* Contraindications or known allergy/sensitivity to the use of the study products
* Use of an investigational drug, product or device within 30 days prior to Screening Visit, or current enrolment in another investigational drug, product, or device study
* Considered to be at risk for noncompliance or unlikely for any reason to be able to comply with the study procedures
The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT

Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely affecting the function of kidneys. This is turn can aggravate the condition of patients with CKD.

The study hypothesis is that periodontal therapy can improve renal function in patients with CKD and lower the blood levels of markers for systemic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease (Stage I, II, III, IV)
* At least 12 teeth present in the oral cavity
* Moderate to severe chronic periodontitis, which is defined as: at least 8 surfaces with periodontal pocket depth (PPD) ≥5mm and at least 4 surfaces with Clinical Attachment Loss (CAL) ≥4mm, distributed in at least two quadrants.

Exclusion Criteria:

* Patients that have had a renal transplant or undergoing dialysis
* Acute infections or use of antibiotics in the past 3 months.
* Auto-immune diseases, conditions that cause immunosuppression or use of immunosuppressant medication.
* Systemic conditions that require antibiotic prophylaxis for routine periodontal therapy.
* Non-surgical periodontal therapy in the past 6 months or surgical periodontal therapy in the past 12 months.
* Use of medication that can cause gingival hyperplasia such as cyclosporine or fenintoin.
* Myocardial infarction or cerebral vascular incident in the past 12 months or uncontrolled angina.
Radiation Biodosimetry in Children Undergoing Total Body Irradiation

The purpose of this study is to develop fecal tests that will determine the extent of radiation exposure in patients undergoing radiation treatment for cancer. This project will determine whether fecal biomarkers can be used to diagnose exposure to radiation.

Patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have feces collected for use in the validation and refinement of new methods for rapid radiation biodosimetry. The stool samples will be collected before, and at defined times after TBI. Stool sampling will occur in the same manner that it does during routine patient care during HSCT.

Eligibility Criteria:
Inclusion Criteria:

* All races are eligible
* 2 years to 21 years old
* Must be undergoing hematopoietic stem cell transplantation (either autologous or allogeneic) in conjunction with a conditioning regimen that includes total-body irradiation (TBI) (single or multiple fraction).
Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Eligibility Criteria:
Inclusion Criteria:

* Untreated, biopsy proven B-cell non-Hodgkin's lymphoma
* Age \>/= 18 years
* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. The patient cannot have been exposed to chemotherapy to treat any of these diseases for at least 3 years prior to study entry.
* Meet staging studies and laboratory tests prior to induction, consolidation and radioimmunotherapy.

Exclusion Criteria:

* Significant medical and/or psychiatric illness which may compromise planned treatment;
* Pregnant or lactating;
* HIV-infection.
* Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.
High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis

This is a research to study primarily the effect of rapidly infused high strong ion difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID fluid, while the other half will get Hartmann's solution.

Balanced fluids are preferred in initial resuscitation of septic patients based on several recent studies.

The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level.

High SID fluid are specially formulated by adding sodium bicarbonate into half saline solution, the resultant fluid contains sodium= 145mmol/L and chloride=70mmol/L (SID= 75) as compared to Hartmann's solution with the SID of 20.

Eligibility Criteria:
Inclusion Criteria:

* age≥18 years
* fulfills 2/3 qSOFA criteria
* presumed infection
* a blood pH at presentation ≤ 7.35
* hyperlactatemia (blood lactate level, \>2mmol/L )

Exclusion Criteria:

* existing cardiac failure, major cardiac arrhythmia, advanced chronic kidney disease or end stage failure
* known pregnancy
* suspected dengue
* primary diagnosis is related to burn, trauma, or drug overdose
* if more than 500cc of resuscitation fluid was administered before enrollment.
Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects (based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator)
* Age between 18 and 55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 20 and 30 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1 % per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device) or sexual abstinence or vasectomised partner
* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
* Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
* History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
* History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
* Smoking or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive nicotine test
Meta-Analysis on Damage Control Surgery in Patients With Non-Traumatic Abdominal Emergencies

This systematic review and meta-analysis aims to investigate the effect of damage-control surgery on mortality in patients with non-traumatic abdominal emergencies. Literature search will be conducted using PubMed. Two meta-analyses will be performed comparing (1) mortality in patients with non-trauma damage control surgery vs. non-trauma conventional surgery and (2) the observed vs. expected mortality rate in patients undergoing non-trauma damage-control surgery.

After the successful implementation in trauma patients, damage control surgery (DCS) is being increasingly used in patients with non-traumatic abdominal emergencies, too. However, non-trauma DCS is an ongoing matter of debate as the open abdomen treatment typically performed in DCS is a non-anatomical situation and associated with potentially severe side effects. To date, DCS in patients with non-traumatic abdominal emergencies has not yet been comprehensively assessed in meta-analysis.

A systematic literature search will be conducted using the National Library of Medicine's Medline database (PubMed). The search strategy will be based on the PICOS process. Original research articles in English language addressing (1) mortality in patients undergoing non-trauma DCS vs. non-trauma conventional surgery or (2) the observed vs. expected mortality in non-trauma DCS will be included.

Two meta-analyses will be performed, comparing (1) mortality in patients undergoing non-trauma DCS vs. non-trauma conventional surgery and (2) the observed vs. expected mortality rate in patients undergoing non-trauma DCS based on outcome prediction scores. Meta-analysis will be performed using a random-effects model. The estimated effect size for mortality will be reported as risk difference with 95% confidence intervals. Sensitivity analysis will be performed by repeating the analysis in the subgroups of studies with the same study design and studies that applied the same outcome prediction score.

Eligibility Criteria:
Inclusion Criteria:

* Articles on damage control surgery in patients with non-traumatic abdominal emergencies
* Reported in-hospital or 30-day mortality in patients undergoing non-trauma damage control surgery vs non-trauma conventional surgery or
* Reported observed in-hospital or 30-day mortality vs expected mortality in patients undergoing non-trauma damage control surgery
* Articles published from 2000 to 2020
* Articles including patients older than 18 years
* Original research articles
* Articles in English language

Exclusion Criteria:

* Articles describing trauma patients exclusively
* Articles describing pediatric patients (age below or equal to 18 years)
Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship

The current study combines both clinical trial and daily process methodology to examine the dynamic longitudinal relationships between daily approach and avoidance inclinations (i.e., craving) and drinking behaviors in those diagnosed with an Alcohol Use Disorder (AUD) prior to, during, and after receiving a brief alcohol intervention. It is hypothesized that daily avoidance inclinations will significantly moderate the effect of daily approach inclinations on drinking behaviors, and that significant increases in avoidance inclinations will be observed prior to treatment entry, followed by significant decreases in approach inclinations during treatment.


Eligibility Criteria:
Inclusion Criteria:

* current diagnosis of alcohol dependence
* live within commuting distance of the program site,
* regular access to a phone to call into an IVR system and
* provide informed consent

Exclusion Criteria:

* acute psychosis or severe cognitive impairment
* current or previous treatment for an alcohol use disorder within the past 6 months,
* taking medications that may modify alcohol use,
* current drug use diagnosis other than nicotine or marijuana abuse,
* lack of sufficient familiarity with the English language to comprehend the recruitment and consent procedures, and
* legally mandated to attend treatment
Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma

The growth of gliomas often infiltrates important brain tissues and impairs subcortical fiber transmission, resulting in changes in global brain network connectivity. Most of the current anesthesia depth monitoring methods are based on healthy brain function population，which is difficult to reflect the sedation depth of glioma patients accurately. Therefore, this study aims to explore the characteristics of brain network connectivity in glioma patients under different sedation depths by electroencephalogram (EEG) and auditory event-related potential (AERP) methods, which may provide a research basis for sedative titration and anesthesia depth identification in glioma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 60 years old;
2. American Society of Anesthesiologists (ASA) physical status rating I-II;
3. Supratentorial glioma (frontal, temporal, parietal, insular ；WHO grade I-III);
4. Native Chinese speaker;
5. Signed informed consent.

Exclusion Criteria:

1. Mallampati airway class≥III;
2. BMI\>30kg/m2;
3. Combined OSAS or Stop-BANG score≥3;
4. Hearing impairment
5. Combined epilepsy symptoms
6. Recurrent or multiple intracranial tumors
7. Concomitant other psychiatric or neurological disorders
8. Pregnancy and lactation
Adverse Drug Reactions to Anti-TB Drugs in the Treatment of Latent Tuberculosis Infection

The investigators aim to study the prevalence of adverse reactions of anti-tuberculosis (TB) drugs in latent tuberculosis infection (LTBI), and determine the risk factors of anti-TB drug-related toxicity in LTBI in Korean health care workers(HCWs).

Further study details as provided by Hanyang University Hospital

This study is prospective study of newly diagnosed LTBI in HCWs at Hanyang University Hospital, a tertiary referral hospital in South Korea, between 2017 and 2018. This study aimed to identify the prevalence of adverse reactions of treatment regimen for LTBI. The diagnosis of LTBI was made on the basis of interferon-gamma releasing assay. Information on demographic characteristics, comorbidity and treatment outcomes was collated from questionnaires. Treatment regimen for LTBI was chosen by patients' preference among 3 months of INH(isoniazid) plus RFP(rifampin), 4 months of RFP and 9 months of INH. All PTB patients were observed 2 weeks after the initiation of medication, and monthly thereafter, and were asked about any drug side effects at these visits. Serious adverse drug reaction (ADR) was defined as any severe side effect that resulted in discontinuation or change (either temporally or permanently) of anti-TB medication, and/or directly resulted in hospitalization. Drug-induced hepatitis was defined as liver transaminases more than three times higher than the upper limit of normal in the presence of symptoms such as anorexia, nausea, vomiting, or abdominal pain, or transaminases more than five times the upper limit of normal without symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 19 years or more
* Identified latent tuberculosis infection (LTBI) in Korean health care workers, using whole-blood interferon-r release assays

Exclusion Criteria:

* Subjects who do not want to participate the present study
* Subjects who do not receive LTBI treatment due to abnormal liver function test (i.e, liver cirrhosis etc)
* Subjects with history of previously treated TB
* Subjects with active tuberculosis infection