cyrilzakka/clinical-trials huggingface dataset:
Microbiome, Anxiety and Cognitive Orientation Study

Mounting evidence shows that the gut microbiome plays an important role in communication within the gut-brain axis. However, the relationship between gut microbiota and their influence on anxiety is still not fully understood. Recent studies on mice found a specific microbe-produced molecule, 4-ethylphenyl sulfate (4EPS), can induce anxious behavior. 4EPS is produced by gut microbes in mice and humans. Research suggests higher 4EPS levels may strongly be associated with anxiety levels. However, anxiety is far more complicated than changes in a single molecule. There are many more factors to consider when it comes to anxiety, including various aspects of one's lifestyle and how humans perceive their environment (cognitive orientation). The primary research goal is to better understand the effects 4EPS has on human anxiety behavior and the role cognitive orientation has in connection to anxiety.

This study aims to expand and improve upon previous research on gut bacteria and their connections to anxiety. The Investigators will examine the gut microbiota and its vital role in the gut-brain axis, the link between a gut-derived bacteria (4EPS) and anxiety, and the connections between cognitive orientation and anxiety. It is hypothesized that even though higher 4EPS levels may be associated with anxiety levels in humans, such levels may be more prominent (severe) or less pronounced (less severe) in humans with variations in lifestyle and cognitive orientation.

Cross-sectional data will be compiled from a cognitive assessment (COSEC), a health/lifestyle survey, a generalized anxiety questionnaire, a depression questionnaire, and a stool sample. Stool samples will be analyzed for 4EPS levels. Using the COSEC assessment, we will divide the subjects into nine groups of unique cognitive styles based on their perception and conception scores. Then, depending on their 4EPS level and their survey responses, the relationship between the level of 4EPS and their cognitive traits will be analyzed. COSEC is a cognitive propensity and behavioral preference diagnostic tool designed to understand people's various tendencies that occur during the process of perceiving the environment and responding in action.

The long-term goal of this project is to find connections in the gut-brain axis and gain a deeper understanding of microbiome metabolites as neurodegenerative agents, as they affect anxiety levels in humans. No other studies have been performed to date combining these research areas or their impacts on humans.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years of age and older
* Participants must be able to read and write English
* Participants must be able to provide consent independently
* Participants must provide a legitimate postal address/P.O Box
* Participants must have access to a device such as a computer or a smartphone

Exclusion Criteria

-Unable to provide a stool sample due to health status or functional impairment
Incidence Rate of Perioperiative VTE in Colorectal Cancer Patients : a Multicenter Prospective Observational Cohort Study

This is a multi-centered, prospective, observational study aimed at observing the Incidence Rate of Perioperiative VTE in Colorectal Cancer Patients


Eligibility Criteria:
Inclusion Criteria:

* Patients in colorectal surgery ward Clinical diagnosis of colorectal cancer Prepare for radical colorectal surgery.

Exclusion Criteria:

* Patients prepare for emergency surgery Clinical diagnosis of benign colorectal disease Patients who have joined other clinic studys
Acetaminophen and AKI After Aortic Surgery

Acute kidney injury is commonly accompanied major complication after aortic surgery.

Cardipulmonary bypass lyses erythrocyte and induces lipid peroxidation. This increases plasma free hemoglobin, F2-isoprostane, and isofuran concentration. Cell free hemoglobin have been reported to be associated with poor prognosis such as acute kidney injury, myocardial infarction, and death.

Acetaminophen is reported to attenuate hemeprotein mediated lipid peroxidation. Thus, investigators hypothesized that acetaminophen might have protective effect on the incidence of acute kidney injury in patients undergoing aortic surgery with moderate hypothermic circulatory arrest.


Eligibility Criteria:
Inclusion Criteria:

1) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.

Exclusion Criteria:

1. patients with chronic kidney disease or with dialysis, eGFR \< 15ml/min/1.73m2
2. allergy to acetaminophen or propacetamol HCl
3. history of liver cirrhosis or total bilirubin \> 2.0mg/dL

3) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent
Paediatric Rural vs Urban Trauma

Retrospective cohort study examining paediatric trauma admission over 1 year in a rural hospital vs urban centre

As above. All patient data was anonymised.

Eligibility Criteria:
Inclusion Criteria:

* All paediatric trauma in each centre over the above time frame, treated operatively, seen on an acute orthopaedic take

Exclusion Criteria:

* Adults, non-operative trauma
NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines

NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.


Eligibility Criteria:
Main Inclusion Criteria:

• Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on a 4-point facial wrinkle scale) as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'.

Main Exclusion Criteria:

* Marked facial asymmetry.
* Ptosis of eyelid and/or eyebrow.
A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants

This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.


Eligibility Criteria:
Inclusion Criteria:

* Female participants who can potentially get pregnant:

  * Must have a negative pregnancy test at the time of screening
  * Agree to continue to use a reliable method of birth control until the end of the study
* Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²), inclusive, at screening
* Are nonsmokers, have not smoked for at least 2 months before entering the study

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have known allergies to insulin lispro, related compounds, or any components of the formulation
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, before dosing (apart from vitamin/mineral supplements, occasional paracetamol, hormonal contraception, or thyroid-replacement therapy)
* Have used systemic glucocorticoids within 3 months prior to entry into the study
* Have donated blood of more than 450 milliliters (mL) or more in the last 3 months or provided any blood donation within the last month before screening
IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female participants ≥ 18 years old;
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Has an anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function:
5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.

Key Exclusion Criteria:

1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
5. Known symptomatic central nervous system (CNS) metastases.
6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
7. History of endotracheal or gastrointestinal stent implantation;
8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
9. Esophageal or gastric varices requiring immediate intervention;
10. Not eligible to participate in this study at the discretion of the investigator;
11. Do not have adequate treatment washout period before study drug administration. -
Tegmen Defect Management During Mastoidectomy

In this study, we aimed to discuss our clinical experience on the management of the tegmen defects which were revealed during the mastoidectomy surgeries.


Eligibility Criteria:
Inclusion Criteria:

* underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.

Exclusion Criteria:

* patients who did not come to follow up
Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth

An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma

Patients with previous oropharyngeal cancer and radiation-induced hyposalivation and xerostomia (dry mouth syndrome) will receive intraglandular injections of allogeneic adipose-derived MSCs into the submandibular and parotid glands. The trial will be Good Clinical Practice (GCP) Monitored. From healthy donors, MSCs will be produced at a Good Manufacturing Practice (GMP) Facility.

The patients will be followed for four months for safety, tolerability, and efficacy registration. Changes in quality of life, unstimulated, and stimulated whole saliva flow rate, salivary gland function will be assessed. Immune response towards receiving allogeneic MSCs will be evaluated in plasma and saliva. Changes in the composition and quality of the whole saliva will be investigated.

Saliva from the participants will altså be compared to saliva from ten healthy controls.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-75 years
2. Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017)
3. 2 years' follow-up without recurrence
4. Clinically reduced salivation and hyposalivation, evaluated by a screening
5. Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min
6. Grade 2-3 xerostomia (CTCAEv5.0)
7. WHO Performance status (PS) 0-1
8. Informed consent

Exclusion Criteria:

1. Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas)
2. Xerogenic medications
3. Penicillin or Streptomycin allergy
4. Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis
5. Previous parotid or submandibular gland surgery
6. Previous treatment with any type of stem cells
7. Breastfeeding, Pregnancy or planned pregnancy within the next 2 years
8. Smoking within the previous 6 months.
9. Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines3)
10. Any other disease/condition judged by the investigator to be grounds for exclusion
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults

Overweight and obesity can lead to the occurrence of many chronic diseases. In addition to the body mass value (BMI), the excess body fat can also be used as criteria for assessing obesity. Citrus peels are rich in many substances including limonene, Nobiletin, 3-methoxynobiletin, and flavonoids. They could be used for lowering blood pressure and reducing blood pressure, anti-anxiety and sleep aid and etc. Fermentation technology is used to ferment the peel to increase the content of neutral components in citrus peel. Therefore, I want to evaluate whether the fermented orange peel enzyme has the effect of reducing fat.


Eligibility Criteria:
Inclusion Criteria:

1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
2. For those with BMI ≥ 24 or fatty liver, men's body fat ≥ 25%, women's body fat ≥ 30%
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. Those who have no history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental disease, alcohol or drug abuse, and other major organic diseases (according to medical history).

Exclusion Criteria:

1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
2. Those who had undergone major surgery or bariatric surgery (according to medical history).
3. Currently or within 3 months before participating in the screening, those subjects used drugs that can affect body fat or increase weight significantly, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability Drugs (according to medical history) will be excluded.
Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

This study aims to determine the sensitivity, specificity, and practical value of two new molecular diagnostic assays compared to a more classical nested molecular diagnostic assay and the routine microscopy (both of which are the current gold standard) in detection of P. knowlesi.


Eligibility Criteria:
Inclusion Criteria:

* Suspected for malaria infection; fever (axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C) with chills, worsening malaise, headache lassitude, fatigue, abdominal discomfort, muscle and joint aches, anorexia, perspiration, or vomiting at the time of evaluation or within the past 48 hours
* Written informed consent is obtained.
* For Children (\>7 to \<18 years): parent or legal guardian provides written informed consent.

Exclusion Criteria:

* Patients living in, or returning from malaria endemic area outside of Sarawak within 2 weeks of illness onset
* They have a clear alternative diagnosis other than malaria by a trained health care professional.
NGAL and Its Association With the No-reflow Phenomenon in ST-elevation Myocardial Infarction

The aim of this study is to investigate the association between NGAL plasma levels in ST-elevation myocardial infarction and the no-reflow phenomenon, adverse events during hospitalization and at 30-day follow-up.

Neutrophil Gelatinase-associated Lipocalin (NGAL) is a acute phase protein which is elevated in conditions like acute kidney injury and myocardial infarction. When a coronary artery is occluded, detrimental changes occur in myocardial vessels. After relief of the occlusion, blood flow to the heart may still be impeded, a phenomenon known as "no-reflow". Data is lacking on factors associated with early detection of patients at risk for this phenomenon, and early stratification of this group seems vital since the no-reflow phenomenon is associated with worse outcomes. The investigators hypothesized that there might be an association between higher NGAL levels and the occurrence of no-flow findings, and that NGAL might serve as a marker of worse prognosis in this population. The investigators also hypothesized that NGAL levels might serve as a marker of early acute kidney injury and that there might be specific patterns of NGAL levels over time in different subsets of patients. The aim of the study is to determine the association between NGAL levels at admission and during the first days after a ST-elevation myocardial infarction, the occurrence of the no-reflow phenomenon, the extent of myocardial damage ascertained by cardiac imaging techniques (echocardiography and cardiac resonance imaging). Data regarding patients' clinical, laboratory, electrocardiogram, coronary angiography and percutaneous coronary intervention, in-hospital and 30-day follow-up after discharge will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old presenting with ST-elevation myocardial infarction and undergoing urgent coronary angiography with or without PCI.
* Signed informed consent to participate in the study.

Exclusion Criteria:

* Inability to sign written informed consent.
* Chronic renal failure (eGFR \< 30 ml/min/1.73m2).
Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis

The purpose of this study is to determine whether \[18F\]FHBG is suitable for use as an imaging probe in cancer or rheumatoid arthritis patients enrolled in cell or gene therapy trials. In this phase 1 study we will assess the safety and biodistribution of \[18F\]FHBG in patients.

The success of cell and gene therapy depends on specific targeting of the therapeutic gene or cell that is administered to the patient. Our goal is to develop an imaging method to non-invasively monitor the location of the therapeutic gene or cell. Imaging should help in the design of better protocols and potentially reduce side-effects of cell and gene therapy.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

- Below 18 years of age
RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy

A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
The Passy Muir Swallowing Self Training Device

This is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).

Participants were recruited who had chronic moderate to severe dysphagia following stroke or radiation treatment for head and neck cancer. Their frequency of swallowing was transduced with an accelerometer placed on the skin over the thyroid cartilage and inductive plethysmography bands placed over the rib cage and abdomen. When laryngeal elevation coincided with respiratory apnea a swallow was marked. Five different motor frequencies were evaluated to determine their effect on participants frequency of swallowing (swallows per minute). Frequencies were 30, 70, 110, and 150 Hz and a combination of 70 and 110 Hz. For each vibratory frequency the number of swallows per minute occurring during stimulation was compared with sham when the participant was wearing the device but the motor was not turned on. The frequency fo swallowing during stimulation was compared with the frequency of swallowing between stimulations. Visual analogue ratings of the urge to swallow and discomfort were also measured after each condition. Other parameters were the pressure between the motor and the skin (0, 2, 4, and 6 kPa) and swallow initiation time when stimulation was on and when it was not. Swallowing frequency with continuous versus pulsed stimulation was also compared.

Eligibility Criteria:
Inclusion Criteria:

* Stroke or post radiation for the treatment of head and neck cancer
* Dysphagia with a score of 2 or greater on the Penetration/Aspiration Scale OR a Mann Assessment of Swallowing Ability ordinal risk rating of "probable" or "definite"

Exclusion Criteria:

* Neck injury
* Epilepsy
* Neurological disorder other than stroke
* Psychiatric illness other than depression
* Uncontrolled gastroesophageal reflux disease
* Inability to communicate secondary to significant speech or language problems
* Inability to maintain alertness for 1 hour
* Significant health concerns that would put the participant at risk
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.

* MRI using an endorectal coil done prior to treatment for staging.
* Baseline Quality of Life (QOL) assessment will be completed prior to treatment.
* Total androgen suppression is initiated and will continue for at least 6 months.
* Prostate Immobilization Device (PID) placed during the planning session.
* PID will be placed daily for the first 15 3D external beam radiation treatments.
* QOL assessment and follow-up will take place every 6 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate cancer
* Clinical Stage T1 - T4
* Negative bone scan
* PSA and routine blood work
* \>30 years of age
* ECOG Performance 0,1, or 2
* No prior pelvic radiation
* No pacemaker

Exclusion Criteria:

* Inflammatory bowel disease (Crohns, or Ulcerative Colitis)
* Prostatic rectal fistula
* Stricture of anal canal