cyrilzakka/clinical-trials huggingface dataset:
Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values

The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.

Mannitol is frequently used to treat intracranial hypertension after TBI. However, it can be deleterious, particularly through hyperdiuresis and risks of hypovolemia. It also needs volume compensation and induces logistical problem because of needs of high infused volume to achieve osmolar load and avoid hypotension. Finally, some recent studies tend to prove superiority of hypertonic saline versus mannitol on the prognosis of TBI. especially through modulation of inflammatory reactions mechanisms and apoptosis.

We would like to prove non inferiority of hypertonic saline versus mannitol after TBI to allow its large utilization, especially by field military doctors with specific logistical problems. For that, more than the single Intracranial Pressure, we want to study effects of HS vs mannitol not only on PtiO2 but also on cerebral microdialysis which gives informations on focal metabolism with profiles of ischemia, metabolic crisis, hyperglycolysis (possible reflect of neuronal restoration) and normality.

Eligibility Criteria:
Inclusion Criteria:

* Severe Traumatic brain injury monitored with ICP, PtiO2 and cerebral microdialysis
* And ICP\> 20 mm Hg needing osmotherapy
* And approval of the next of kind

Exclusion Criteria:

* Bilateral fixed dilated pupils
* Contra-indication to multimodal neuromonitoring
* Previous CNS disease
* Contra-indication to HS (cardiac insufficiency,...)
* Natremia \> 155 mmol/L or osmolarity \> 320 mOsm/L
Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament

A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced calcium hydroxide medicament was utilized while in group B, calcium hydroxide medicament without nanoparticles was used. Post-operative pain was assessed after 4 hours, 24 hours, 48 hours, 72 hours, 96 hours.

This triple-blind parallel group, randomized clinical trial was conducted at the department of Operative Dentistry and Endodontics, School of Dentistry from April 24, 2024 to September 25, 2024. Participants were randomly distributed into two groups by Lottery method. A consecutive non-probability sampling technique was used. Before initiating treatment, participants were briefed about the intervention and their preoperative pain score was recorded. In both groups, endodontic treatment was initiated under rubber dam isolation. Access opening done and canals explored. Working length taken by radiographic method and reconfirmed by an electronic apex locator. Afterwards, canals were prepared till Master Apical File size F2 (4% Taper). In group A, Nano-reinforced calcium hydroxide medicament was placed while in group B, calcium hydroxide without nanoparticles was utilized. Participants were instructed to rate their postoperative pain record after 4hrs, 24hrs, 48hrs, 72hrs and 96hrs.

Eligibility Criteria:
Inclusion Criteria:

* Participants with good general health status
* Necrotic pulp with Symptomatic Apical Periodontitis
* Single rooted teeth

Exclusion Criteria:

* Non-restorable teeth
* Teeth associated with acute or chronic apical abscess
* Teeth with chronic periodontitis
* Teeth with anatomical complexities or complications like open apex, calcified canal, severe root dilaceration, root resorptive defects
* Participants who received antibiotic treatment during the last 3 months
* Pregnant females
* Participants on pre-treatment analgesics
The Effect of ß-cell Specific Glucokinase Mutation on Glucose Homeostasis and Insulin Secretion in a MODY-2 Family

Type 2 diabetes mellitus patients exhibit many glucose homeostasis abnormalities in different tissues and organs. Among the more important defects are disturbed hepatic glucose metabolism and defective pancreatic β-cell function. Hexokinase IV, commonly known as glucokinase, is the predominant hexokinase expressed in the liver, the pancreatic β-cells (where it functions as the glucose sensor for insulin secretion) and in glucose-sensory cells in the hypothalamus and gut.

The glucokinase gene contains two distinct promoters. The downstream one is active only in hepatocytes and the upstream promoter is active only in extrahepatic glucose sensory-cells. Alternative promoters enable differential regulation of gene transcription in liver and extrahepatic sites. In pancreatic β-cells, glucokinase expression at the mRNA level is largely constitutive, whereas in the liver it undergoes large adaptive changes in response to nutritional states, enabling larger changes in glucokinase activity than would otherwise be possible by post-transcriptional regulation alone.

Most of the MODY-2 patients were found to have glucokinase mutations located in areas that are common to the liver and pancreas. The diabetes in these patients is related both to defect in insulin secretion and abnormal hepatic glucose metabolism. Point mutation in the pancreatic specific promoter was recently described as a cause for impaired fasting glucose \[Diabetes 58:1929-1935, 2009\]. The investigator have recently identified a MODY-2 family with a genetic defect that is located in the pancreatic promoter, sparing the liver promoter. This family demonstrates that abnormal insulin secretion alone (perhaps together with other extrahepatic glucose sensors) is enough to cause diabetes.

In this study, the investigators would like to use an oral glucose tolerance test (OGTT) and continuous glucose monitoring (CGM) technique in order to elucidate the relative roll of the hepatic glucokinase in normal glucose homeostasis. This issue is complicated by the fact that in addition to glucokinase, hexokinase isoenzymes I, II and III are also expressed at very low levels in hepatocytes. They are an important back-up mechanism when glucokinase activity is compromised, as in liver cirrhosis or murine models with liver-specific glucokinase knock-down. However, impaired hepatic glycogen synthesis was demonstrated in MODY-2 subjects (JCI 1996:98:1755). By comparing members of the investigators MODY-2 family with members of other MODY-2 families and normal controls the investigators hope to shade some light on this question.


Eligibility Criteria:
Inclusion Criteria:

1. MODY 2 patients with documented mutations in the glucokinase promoter or coding region.
2. Healthy non-diabetic individuals matched for age, sex and BMI with recruited MODY2 patients.
3. Age range - 12-80; males and females

Exclusion Criteria:

1. Unable to provide written informed consent.
2. Unable to safely stop glycemia related medications for the duration of the test + wash-out period.
Feasibility of a Smart-Phone App for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy

The purpose of the study is to test and understand acceptability and preliminary effectiveness of a mobile educational app specifically customized to patients with advanced Renal Cell Carcinoma (RCC) receiving therapy with combination immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage IV Renal Cell Carcinoma
* Within 3 weeks from starting combination immune checkpoint blockade with tyrosine kinase inhibitor or multikinase inhibitor
* Estimated survival of 6 months or more
* Able to read and speak English

Exclusion Criteria:

* Unable to read or speak English
* Enrolled in another clinical trial
Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors

Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors. This study is a retrospective cohort aimed to predict the nerve origin of neck peripheral nerve sheath tumors. Accurate preoperative identification of the nerve origin can improve surgical outcomes and patient counseling

Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors (PNSTs). Accurate preoperative identification of the nerve origin (NO) can improve surgical outcomes and patient counseling. This study aims to predict the NO of neck PNSTs with radiographic analysis. This study is a retrospective cohort analysis. Radiographic parameters will be reviewed and the sensitivity, specificity, accuracy of NO prediction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of neck peripheral nerve sheath tumors.
* Patients received surgery January 2008 and December 2022.
* The nerve origin of peripheral nerve sheath tumor must be intraoperatively confirmed.

Exclusion Criteria:

* Previous anterior neck surgery.
* Malignant disease.
* Prior neck radiation.
* Undetermined intraoperative nerve origin.
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study

The purpose of this extension study is to continue to follow the participants who completed the CLVer RCT for up to 3 additional years. The goal for Cohort A is to evaluate the longer-term effects of verapamil on preservation of β-cell function as measured by C-peptide levels obtained during a mixed meal tolerance test (MMTT). For both Cohorts A and B, the goal is to determine if the high degree of glycemic control achieved during CLVer with HCL can be maintained once the intensive engagement of the study team is discontinued. At the completion of the RCT, study treatments end. Thus, during the extension study, diabetes management is performed as part of usual care and there is no study treatment.

Participants who complete the CLVer RCT will be eligible to enroll in the CLVer Extension Study. Informed consent and assent, when applicable, will be obtained. Participants will be contacted every 3 months at which time continuous glucose monitoring (CGM) data will be obtained if a CGM device is being used and medical history (including recent point-of-care or local laboratory HbA1c values) will be reviewed; a usual care visit performed by study staff may be considered a study contact. A study visit will occur yearly to update the diabetes and medical history, measure height and weight, determine Tanner staging, download CGM data if available, perform an MMTT, and obtain blood samples for central lab measurement of HbA1c and plasma for storage if consented. Other than the central lab samples, there are no study-specific procedures or data collection that would not be performed as part of standard care.

Eligibility Criteria:
Completed CLVer RCT 12 month visit and willing to join observational extension.
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.

The INSPIRE CHILD-study is a clinical research project focused on understanding lung diseases in children. The study aims to explore how the presence of certain bacteria, immune responses, and inflammatory markers in the lungs are connected to different lung diseases in pediatric patients.

Background:

Lung diseases in children can have long-lasting effects on their health, not only during childhood but also as they grow into adults. However, the specific causes and mechanisms behind these diseases are not yet fully understood. The INSPIRE CHILD-study is designed to investigate whether children with various lung conditions have distinct differences in the types of bacteria, immune system activity, and inflammation in their lungs.

Hypothesis:

Different lung diseases in children are hypothesized to be associated with unique patterns of bacteria, immune responses, and inflammation in the lungs By studying these patterns, the investigators hope to gain new insights that could lead to better diagnostic tools and more personalized treatments for children suffering from lung diseases.

Children already scheduled to undergo bronchoscopy are included in the study. A small sample of fluid from the lungs is collected, and the sample is analyzed for bacteria, immune markers, and signs of inflammation. This research could pave the way for improved care and treatment for young patients with lung conditions.


Eligibility Criteria:
Inclusion Criteria:

* Age ranging from new-born to 17 years of age.
* Diagnosed with or being assessed for a lung disease.
* Possible to sample at least 2 ml of BAL-fluid besides the scheduled amount during the bronchoscopy.

Exclusion Criteria:

* Age older than 17 years.
* Not undergoing diagnosis at Childrens Center for Pulmonary and Allergic diseases.
* Failure to meet the requirement of being able to sample an additional 2 ml of BAL-fluid.
The Effect of Probiotics on Depression Syndrome and Risk Factors of Cardiovascular Disease in Hemodialysis Patients

As the investigators know, only few researches focus on the effect of probiotics on depression in hemodialysis patients. Besides, probiotics also have benefit effect on dyslipidemia and hypertension in general population. Both of them are the risk factors of cardiovascular disease which is the major cause of death in hemodialysis patients. Therefore, this study looks for the effect of probiotics on depression syndrome and risk factors of cardiovascular disease in hemodialysis patients. This is a randomized controlled trial. All patients will be assigned at random to intervention group or control group. This study plans to recruit 70 hemodialysis patients and expects at least 30 patients in each group at the end of study period. The investigators provide probiotics (C. butyricum MIYAIRI 588) to intervention group and provide nothing to the control group.

All patients need to maintain the lifestyle during study period. Genomic analysis of gut microbiota on patients' fecal samples will be used to evaluation their compliance.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 20 years or older undergoing hemodialysis (at least 3 months), 3 times per week, and URR ≥65%

Exclusion Criteria:

1. allergic to the components of the intervention drug, low tolerance of milk or dairy products
2. Has the diagnosis of dementia, delirium, bipolar disorder, schizophrenia, or liver failure
3. Beck Depression Inventory Chinese version 2.0 score higher than 14, or has significant suicide risk during study
4. Following significantly clinical syndrome: obsessive compulsive disorder, schizoid personality disorder, schizotypal personality, paranoid、antisocial Personality Disorder, histrionic personality disorder
5. With addiction to alcohol or drugs, terminal cancer, severe infection, heart failure, central venous catheter in the past 6 months
6. Taking antibiotics, anti-oxidant vitamin supplement, probiotics, prebiotics, antidepressants, anti-anxiety medicine, yogurt and the products in the past 3 months
7. Pregnant or lactating
Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

We want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol (a beta-agonist) on long function in patients with Chronic Obstructive Pulmonary Disease (COPD). There are more and more clues that a beta-blocker, when well chosen and in the right dosage, won't harm the long function in patients with COPD. Since a beta-blocker can be a valuable addition to treating patients with heart problems we would like to see if this category of medication can be available for COPD patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* male/female aged between 40-70 inclusive
* COPD defined by GOLD criteria
* FEV1 greater or equal to 60% of predicted without medication
* baseline FEV1 greater or equal than 1.2L
* 10 or more pack years
* no hard contraindications for use of beta blockers
* being able to perform technically acceptable pulmonary function tests
* signed informed consent
* systolic blood pressure equal to 130 or greater

Exclusion Criteria:

* instable COPD during the month before visit 1
* usage of corticosteroids during the month before visit 1
* significant pulmonary diseases other than COPD
* a history of cancer within the last 5 years (basal cell carcinoma or cutaneous squamous cell carcinoma allowed)
* a recent history of myocardial infarction
* use of an investigational drug within one month or six half lives (which ever is greater) of visit 1
* contra-indications for the use of ipratropium-bromide
Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis

To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18F\]F-DCFPyL.

\[18F\]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[18F\]F-DCFPyL PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 90 years old;
* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
* simultaneous \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL examinations within two weeks;
* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
* Sign informed consent.

Exclusion Criteria:

* Patients who cannot cooperate with the examination;
* Concurrent malignant tumors;
* Previous alcohol allergy;
* Patients with liver and kidney dysfunction;
* Other circumstances deemed by the investigator to be inappropriate for trial participation.
Compare Wound Sampling Methods Efficacy in Microbiology Culture

Slough was a visible indicator of biofilm, which was the most available specimen from acute and chronic wounds. However, studies believed that slough were poorly accurate, and that the Levine swab was more recommended for sampling bacterial culture. This study aimed to compare slough with swab sample and analyze the consistency.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute and chronic wounds who were first seen at the Wound Care Centre of Peking University Third Hospital from October 2022 to October 2023;
2. Patients who have followed the wound sample collection SOP to simultaneously take wound swabs and putrefactive samples and send them for bacterial culture;;
3. Patients aged 18 years or older;

Exclusion Criteria:

1. Patients who had been taken only one of the wound samples, either swab or slough;
2. The swab collection did not meet the deifinitions for the exudate method or the Levine technique；
3. Bacterial culture profile was incomplete didn't meet the requirement of the trial.
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.

Eligibility Criteria:
Inclusion Criteria:

* Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
* Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin

Exclusion Criteria:

* History of another primary malignancy that has not been in remission for at least 3 years
* Known cerebral/meningeal disease
* Peripheral neuropathy of grade 2 or greater
* Females who are pregnant or breastfeeding
Latent Tuberculosis Infection in Bone Marrow Transplant Recipients

The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone marrow transplant recipients. For this purpose, the investigators enrolled bone marrow transplant recipients and observed the developement of tuberculosis after the transplantation.

All adult bone marrow transplant recipients admitted to Asan Medical Center will be enrolled.

Quantiferon-Gold In-Tube assay will be performed.

Isoniazid prophylaxis will be given only to patients with clinical risk factors (i.e. recent contact with active pulmonary TB patient or inadequate treatment history with abnormal CXR). However, isoniazid prophylaxis will be not given based on positive TST or positive Quantiferon-Gold In-Tube assay.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 or more
* Bone marrow transplant recipients

Exclusion Criteria:

* Recent contact of patients with active pulmonary tuberculosis
* Suspected active tuberculosis
Antiviral Therapy in Decompensated Hepatitis C Virus (HCV) Cirrhosis

To evaluate:

1. the impact of combined antiviral therapy (Peginterferon plus ribavirin) on natural history of patients affected with HCV decompensated cirrhosis, after sustained virological response. A controlled study.
2. safety and efficacy of antiviral therapy in this population by using a statistically significally number of patients as controls.

Decompensated HCV cirrhosis is a relevant problem as its clinical evidences predisposes to an high mortality risk, with a survival rate of 50% at 5 years (1,2). Davis et. al processed a mathematical model of the natural history of chronic hepatitis C and projected the total number of cases with cirrhosis increased by more than 50% by 2010 and then plateaued (3). As a result, there will be a dramatic increase in the number of cases with complications of liver failure and decompensated events of cirrhosis will increase to 25% in 2010, 32% in 2020, 36% in 2030, and 38% in 2040 (3, table 1).Liver transplantation is the treatment of choice but the limited number of organ donor makes not realizable for the major of patients. Furthermore, age over 65 years correlated disease is not accepted to enter into the list of liver transplant. To prevent these patients from worsening their liver disease has positive economic implications in terms of health care resources used as diagnostic tests, clinic visits, drug therapy, hospitalization for management of complications, and later on, liver transplantation, and indirect costs related to lost work time and impaired quality of life. our controlled study on antiviral treatment of decompensated cirrhotics has shown that HCV clearance by therapy can be life-saving, improves hepatic function, and reduces disease progression. Treatment should be encouraged in CTP classes A and B, and especially in patients infected by genotype 2. The benefit of treating patients with genotype 1 remains unproven.

Eligibility Criteria:
Inclusion Criteria: HCV cirrhotics admitted to hospital for a decompensated event, such as ascites, variceal bleeding, and hepatic encephalopathy -

Exclusion Criteria: rapid deterioration of liver and/or renal function, detection of hepatocarcinoma, infection with HIV or HBV viruses, current alcohol or drug abuse, chronic invalidating disease, bacterial infections, platelets \<35,000 cells/μL, neutrophils \<1,000 cells/μL, haemoglobin level \<10 g/dL, total bilirubin \>3 mg/dL, and serum creatinine \>2.0 mg/dL.

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