cyrilzakka/clinical-trials huggingface dataset:
Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

For patients having a bone or joint infections, with or without device, optimal surgical therapy could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening.

Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way when oral treatment is not available to facilitate ambulatory care, this practice being considered as routine care.

The aim of this study is to evaluate tolerance and efficacy of subcutaneous administration of antibiotics for prolonged suppressive antibiotic therapy in patients having this treatment as part of their routine care.


Eligibility Criteria:
Inclusion Criteria:

* patients having bone or joint infection,
* patients with or without device treated by sub-cutaneous prolonged antibiotic therapy

Exclusion Criteria:

* diabetic foot osteomyelitis
* pressure ulcer-associated osteomyelitis
Extubation in the Operating Room After Living Donor Liver Transplantation

Duration of mechanical ventilation, length of intensive care unit stay, length of postoperative hospital stay, and the incidence rates of complications between the group with endotracheal tube extubation in the operating room (OR-EX) and those without (NOR-EX) in patients who underwent living-donor liver transplantation for end-stage liver failure are going to be compared. Through these results, it is investigated whether endotracheal tube extubation in the operating room is useful in reducing the length of stay in the intensive care unit and the hospital stay after surgery in patients who have undergone living-donor liver transplantation.

Long-term mechanical ventilation after liver transplantation may increase the risk of complications such as pneumonia, sepsis, and multi-organ failure. Recent advances in surgical techniques and the introduction of short-acting anesthetics have accelerated the recovery of liver transplant recipients, and early extubation after liver transplantation is being proposed as a standard method. The results of a study on early extubation in patients undergoing liver transplantation suggested a reduction in the length of stay in the neutralizer room and predictors of early extubation. However, these studies are limited to males, and there is no study in which the definition of early extubation includes extubation in the operating room or extubation in the operating room within 1-3 hours of arrival in the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age or older who underwent living-donor liver transplantation for end-stage liver failure

Exclusion Criteria:

* A score of 26 or higher on the model for end-stage liver disease (MELD) scale
* In case of endotracheal intubation when entering the operating room
* If hepatic encephalopathy is stage 3 or higher at the time of admission to the operating room
* When the arterial blood partial pressure (PaO2)/inhaled oxygen fraction (FiO2) ratio is less than 200 on the Arterial Blood Gas Analysis (ABGA) before the end of the living liver transplantation operation
* Preoperative chest X-ray examination or chest computed tomography shows pulmonary edema
* If patients is diagnosed with hepatopulmonary syndrome before surgery
Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer

This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1 (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80 (CD80).

An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled and assessed for safety before additional participants are enrolled.

The initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants 18 years and older
2. Histologically or cytologically confirmed diagnosis of HNSCC associated with HPV by a p16 immunohistochemistry (IHC) assay or HPV-16 or HPV-18 positive by nucleic acid testing.
3. Recurrent or metastatic disease that has been treated with at least one platinum-containing regimen and lacking a curative treatment option.
4. Participants who are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential.

Exclusion criteria:

1. Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment Active or prior documented autoimmune disease with some exceptions.
2. Current or prior use of immunosuppressive medication within 14 days prior to first study dose, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed.
3. No prior exposure to immune-mediated therapy defined as prior exposure to T-cell and natural killer cell directed therapy (e.g., anti-PD-1, anti-PD-L1, anti-CD137, and anti-CTLA4, etc).
Fecal Transplant for Hepatic Encephalopathy

The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

Subjects receive FMT from a single donor by colonoscopy at week 0 and by enema at weeks 1-4. HE is measured by Inhibitory Control Test (ICT) and Stroop test as well as fasting serum ammonia levels.

Eligibility Criteria:
Inclusion Criteria:

* Adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis
* Abnormal ICT (\>5 lures) or abnormal Stroop test (\>200 seconds)
* Baseline Conn score 0 or 1
* Infectious etiology of HE has been ruled out

Exclusion Criteria:

* those with tense ascites
* those who do not provide assent
* life expectancy \<3 months
* TIPS within the past 3 months
* neurologic disease such as dementia, Parkinson's, structural brain lesions
* pregnancy
* intestinal obstruction
* alcoholic hepatitis
* active alcohol or substance abuse
* those without stable social support
* concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection
* creatinine clearance less that 50% compared to baseline
* hospital admission for HE within one month of enrollment
* active hepatocellular carcinoma
* active GI bleed
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC

Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years-old at the time of consent to participate this trial
* Stage II - III primary triple negative breast cancer patients(TNBC), TNBC is defined as ER \<=1%, PR \<=1%；HER2 receptor IHC=1, or IHC=2 and FISH negative.
* positive ctDNA after curative surgery and/or adjuvant chemotherapy
* ECOG 0-2
* If indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines
* Patient receives adjuvant chemotherapy according to the NCCN guidelines
* Patient has available tumor tissue from the surgical specimen for next generation sequencing(NCS)
* Patient agrees to give blood samples for ctDNA tests every 3 months in 5 years

Exclusion Criteria:

* Patient has previously received any PD1/PDL1 blockage treatment
* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
* Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition)
* Patient participates another interventional clinical trial
* Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization
* Patient with autoimmune disease preventing the use of camrelizumab
* Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
Safety of CHIR-258 (TKI258) in Advanced Solid Tumors

Phase I dose finding study in solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically or cytologically documented, advanced-stage, primary or metastatic solid tumors that are refractory to standard therapy or for which no curative standard therapy exists.
* Evidence of measurable or evaluable disease.
* All acute toxic affects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade ≤1; surgery must have occurred at least 28 days prior to study enrollement.
* Age must be at least 18 years.
* Last dose of antineoplastic therapy (except for hormonal therapy) must be more than 21 days; subjects may continue to receive luteinizing hormone-releasing hormone analog therapy for prostate cancer.
* ECOG performance status must be 0 or 1.
* Life expectancy of at least 3 months.
* Patient must meet protocol-specified laboratory values.

Exclusion Criteria:

* Concurrent therapy with any other investigational agent.
* Intracranial edema, intracranial metastasis, or epidural disease.
* Pregnant or breastfeeing women. Female subjects must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male subjects must agree to use effective contraception or be surgically sterile. The definition of effective contraception will be based on the judgment of the investigator or a designated associate. All at-risk female subjects must have a netative pregnancy test (serum or urine) within 10 days prior to the start of study treatment.
* Clinically significant cardiac disease (New York Heart Association Class III or IV) including pre-existing arrhythmia, congestive heart failure, cardiomyopathy, or subjects with baseline mean QTc interval greater than 450 msec (males) and 470 msec (females) or grade 2 or higher compromised left ventricular ejection fraction (LVEF) as determined by MUGA or ECHO.
* Dementia or altered mental status that would prohibit informed consent.
* Diabetes mellitus (insulin-dependent or -independent disease requiring chronic medication).
* Previous pericarditis; clinically significant pleural effusion in the previous 12 months or current ascites requiring two or more interventions/month.
* Malabsorption syndrome or uncontrolled gastrointestinal toxicities (nausea, diarrhea, vomitting) with toxicity greater than NCI CTCAE grade 2.
* Prior acute or chonic pancreatitis of any etiology.
* Prior intra-or extra-hepatic biliary obstruction wtihin the previous 12 months or history of malignant obstruction requiring a bilary stent, unless stably treated with no prior obstruction or blockage of the stent.
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the subject inappropriate for this study.

Other protocol-defined inclusion/exclusion criteria may apply
A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients

Human genetic studies have shown that loss of function (LOF) mutations in HSD17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as NASH, without significant adverse phenotypes.

VSA006 is a siRNA drug targeting HSD17β13 mRNA in the liver and reduce the protein level of HSD17β13. Based on phase 1 study results in healthy volunteers and NASH/suspected NASH patients, this phase 2 study is designed to evaluate the efficacy, safety, PK profiles and immunogenicity of VSA006 in Chinese NASH patients.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) of 24-35 kg/m2 ;
* NASH patients confirmed by liver histopathology: NAS score is ≥ 4 and CRN fibrosis is F2 or F3 ;
* At screening, ALT is \> ULN;
* At screening, the liver fat content measured by MRI-PDFF is ≥ 8%;
* Weight change \< 5% at least 3 months prior to screening;
* For patient with T2DM, the hypoglycemic agents and HbA1c is stable

Exclusion Criteria:

* Pregnant or lactating women;
* Previous diagnosis of alcoholic liver disease or hepatitis/liver disease due to other causes;
* Previous or current diagnosis of cirrhosis or decompensated cirrhosis;
* Previous or current diagnosis of hyperthyroidism, hypothyroidism, or other diseases that can lead to fatty degeneration of liver;
* Participants diagnosed with type 1 diabetes, or with unstable type 2 diabetes
* Participants who cannot receive an MRI examination;
Risk Stratification Value of Biomarkers in Patients With Myocarditis

The aim of this study is to collect clinical data and biological specimens from patients with myocarditis and construct a predictive model for the prognosis of myocarditis.

The aim of this study is to retrospectively and prospectively collect clinical data and biological specimens from patients with myocarditis who meet the inclusion and exclusion criteria. General molecular biology analysis, genome sequencing, transcriptome sequencing, methylation sequencing, metabolomics analysis, proteomics analysis, genome-wide chromosome conformation capture and other techniques are used to construct a prognosis prediction model for myocarditis.

Eligibility Criteria:
Inclusion Criteria:

* All patients should meet the diagnostic criteria for myocarditis
* Patients who are regularly followed up at the corresponding cardiovascular center

Exclusion Criteria:

* Age \<3 years or \>80 years
* Pregnant or lactating women
* The patient refused to sign the informed consent and refused to participate in the study
* None of the above is consistent, but the patient cannot sign the informed consent temporarily due to coma and other reasons, and there is no legal representative to sign it instead. Depending on the condition, the patient may not wake up to sign the informed consent
Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia

The goals of this study are:

* To determine whether the visual acuity improvement obtained with part-time (6 hours) patching is equivalent to the visual acuity improvement obtained with full-time patching (all or all but one waking hour) for severe amblyopia.
* To develop more precise estimates than currently available for the visual acuity improvement that occurs during treatment of amblyopia with patching.
* To identify factors that may be associated with successful treatment of amblyopia with patching.

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Patching has been the mainstay of amblyopia therapy. It is generally held that the response to treatment is best when it is instituted at an early age, particularly by age two or three, and is poor when attempted after eight years of age.

For severe amblyopia, it is generally accepted that occlusion with patching is the standard of care. Other modalities of treatment, such as atropine penalization and optical penalization, are widely considered insufficient as initial treatments for severe amblyopia. However, controversy exists with regard to how many hours per day of patching should be prescribed. Advocates of full-time patching purport that such a regimen is needed to restore visual acuity more rapidly and more effectively. Advocates of part-time patching believe it to be better tolerated by the child and family, therefore producing less stress on the parent-child relationship and producing better results through better compliance. Part-time patching may also promote the development of binocularity in patients who have "straight-eyes", reduce the chance of a straight-eyed patient developing manifest strabismus or losing stereopsis, and reduce the incidence of reverse- or occlusion-amblyopia.

The study is a randomized trial comparing daily patching regimes for children with severe amblyopia. It will consist of about 160 children. Patients in the severe (20/100 to 20/400) group will patch part-time (6 hours) or full-time (all or all but one waking hour) of each day for the 4 month study period. There are at least two follow up visits during the 4-month period. Visual acuity is the major study outcome. It is assessed at the 4-month exam.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be less than 7 years of age with the original cause of amblyopia as strabismus or anisometropia (a refractive error difference of more than one diopter between the two eyes.)
* Visual acuity in the amblyopic eye must be between 20/100 and 20/400.
* Visual acuity in the sound eye of 20/40 or better.
* There must be at least 3 lines of acuity difference between the two eyes.

Exclusion Criteria:

* Patching treatment (other than spectacles) within six months prior to enrollment and other amblyopia treatment of any type used within one month prior to enrollment.
Effect of Frequent Interruptions of Prolonged Sitting on Self-perceived Levels of Energy, Mood, Food Cravings and Cognitive Function

This study is designed to test the effects of six 5 minute microbursts of physical activity spread across the day as compared to either a sedentary control condition or a single 30 minute bout of moderate intensity physical activity on cognitive function, self-reported energy levels, aspects of eating behavior and measures of metabolic health. The primary hypotheses are:

1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function as compared to a no exercise condition.
2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function more than a single 30 minute AM bout.

Secondary exploratory hypotheses include

1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase self-reported energy levels, reduce orexigenic appetitive measures and improve measures of metabolic health as compared to a no exercise condition.
2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase self-reported energy levels, reduce orexigenic appetitive measures and improve measures of metabolic health more than a single 30 minute AM bout.


Eligibility Criteria:
Inclusion Criteria:

1. All ethnic groups and both genders
2. Age: Lower age limit: 19 years; Upper age limit: 45 years
3. Body-mass Index: Lower BMI limit: 18.5 kg/m2; Upper BMI limit: 29.9 kg/m2
4. Willing to adhere to caffeine restrictions of no more than two 16 ounce beverages in the morning of each study day with no caffeine intake after 12:00pm on any of the three study days

Exclusion Criteria:

1. History of cardiovascular disease, including coronary artery disease, congestive heart failure, \& unstable angina, or uncontrolled hypertension (\>140/90 mm Hg)
2. Currently smoking or stopped smoking in the last 6 months
3. Medications affecting weight, energy intake, or energy expenditure in the last 6 months
4. Use of oral steroids
5. History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushing's syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
6. Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
7. Infectious diseases: Self-reported HIV positivity or active tuberculosis
8. Inability to exercise for more than 30 minutes on a treadmill at moderate intensity
9. Currently pregnant, lactating or less than 6 months post-partum
10. History of a major psychiatric disorder including schizophrenia, bipolar illness or psychotic depression
11. Score of \>25 on Beck Depression Inventory
12. No recreational drug use including marijuana in the past 1 year
Ambu® Aura-ITM Versus Ambu Aura GainTM for Fiberoptic Intubation in Children

The investigators test the hypothesis that fiberoptic intubation (time and success rate) differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric patients


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* age 1.5 - 6 years
* minor surgery
* extraglottic airway device

Exclusion Criteria:

* age (\<18 months, \>6 years)
* weight (\<10 kg, \>20 kg)
* a known difficult airway
* risk of aspiration
Evaluation of a Web-based Virtual Nursing Epilepsy Self-Management Intervention

The purpose of this pilot randomized controlled trial is to evaluate a web-based virtual nursing intervention (ÉPI-TAVIE) in terms of 1) acceptability and feasibility, and; 2) preliminary efficacy.


Eligibility Criteria:
Inclusion Criteria:

* to be a patient of the Clinique d'épilepsie du Centre Hospitalier de l'Université de Montréal
* to be able to read and understand French
* to have access to the Internet

Exclusion Criteria:

* having an uncontrolled psychiatric or cognitive condition
Exploring the Effects of Probiotics on Workplace Related Stress Symptoms

There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period.

This is a double blind, randomized control study, which will be conducted by National Taiwan Sport University. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period. Volunteers will be asked to fill in the Perceived Stress Scale questionnaire before recruiting. Subjects who meet the criteria will be asked to fill the different questionnaires to evaluate their stress, emotions, gastrointestinal tract symptoms, sleep status and blood draw is also needed.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 60 years old
* Perceived Stress Scale (PSS) score is greater than or equal to 14 points

Exclusion Criteria:

* Have used antibiotics or probiotic products in powder, capsule or tablet form within one month
* Those who are taking Chinese medicine or Western medicine to treat severe acute diseases
* Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness
* Pregnant or breastfeeding
* Those who have participated in other interventional clinical studies in the past three months
* Who has conflict of interest with PI or unsuitable to participate in the research such as students directly supervised by the project host and those who are unable to read the consent form