cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)

The purpose of this study is to determine whether curcumin, a drug and naturally-occurring plant compound, is safe and effective in the treatment of primary sclerosing cholangitis (PSC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary sclerosing cholangitis (PSC) established by all of the following criteria:

  * Alkaline phosphatase \>1.5x upper limit of normal for at least 6 months prior to study enrollment
  * Cholangiography demonstrating intrahepatic and/or extrahepatic biliary dilation, beading, and/or strictures consistent with PSC
  * Liver histology (if available for review) consistent with or diagnostic of PSC
* Women of child-bearing potential willing to use birth control for the duration of the study.

Exclusion Criteria:

* Treatment with any investigational agents within three months prior to or during the study
* Treatment with systemic antibiotics, azulfidine, systemic corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, or vitamin E within three months prior to or during the study.
* Concomitant treatment with NSAIDS, antiplatelet agents, antihyperlipidemics, and anticoagulant warfarin.
* Anticipated need for liver transplant within one year as determined by Mayo PSC risk score (\<80% one-year survival without transplant)
* Active drug or alcohol use
* Findings suggestive of liver disease of an alternative or concomitant etiology, such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis (e.g., post-liver transplantation biliary stricture)
* Pregnancy or lactation
* Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.
Emphasizing the Personal Versus the Social in Educational Interventions For Decreasing Vaccine Hesitancy

This experimental study aims to investigate the effect of different types of educational interventions on overcoming Coronavirus disease 2019 (COVID-19) vaccine hesitancy among the Higher School of Economics (HSE) bachelor students in Russia.

The researchers aim to investigate the effectiveness of three types of educational interventions on overcoming COVID-19 vaccine hesitancy among the HSE bachelor students. The study design implies the comparison of three types of educational interventions which differ in the message that they deliver to the participants: the personal, the social, and a combination of the two. The effects of these interventions will be compared to the control group with no intervention.

Participants in these three experimental groups will receive a link to an educational video about the benefits and costs of vaccination against COVID-19. The videos for the three groups will contain information about vaccination, but each of them will have a different focus.

The participants will be hired on a voluntary basis. All the participants will sign the informed consent form, and the measures will be taken to ensure that their personal data will be protected.

Eligibility Criteria:
Inclusion Criteria:

* HSE bachelor students from 18 to 25 years old, who agreed to participate in the study.

Exclusion Criteria:

* Students who have got vaccinated already.
Virtual Lifestyle Medicine Comparative Effectiveness Research

This study evaluates the effectiveness of two online Lifestyle Medicine programs. Participants will be randomized by residence, urban vs. rural, into one of two Lifestyle Medicine programs.

This study compares the effectiveness of two virtual Lifestyle Medicine programs across two settings: urban and rural. Program materials include nutritional education, methods to reduce personal stress, and incorporation of physical activity in daily routine. Bio-marker and subjective/self-reported survey measures will be collected at baseline, 5-weeks and six-months from baseline. Study seeks to measure variations in participant outcomes across two lifestyle interventions, participant engagement and level of adherence.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to read and write English
* Access to high-speed Internet
* Taking medication for at least one chronic disease condition such as high blood pressure, OR are overweight (BMI of 25 or greater)
* Willing to provide blood samples at three time points
* Willing to complete online surveys at three time points

Exclusion Criteria:

* Advised by physician to limit physical activity
* Previous experience with lifestyle medicine programs, specifically Lifestyle Medicine Clinic, Complete Health Improvement Program, Full Plate Diet
* Household includes someone who has previous experience with a Lifestyle Medicine program
COVID-19 Patients Admitted to the ICU

A retrospective analysis of the adult COVID-19 patients admitted to the ICU. A chart review will be conducted and multiple baseline characteristics, demographics, and treatments given will be recorded.

Variables collected will include Age, Gender, BMI, Smoking status, Past medical history, Vital signs on admission, symptoms on admission, duration of symptoms, laboratory results on admission, treatment given. Treatment options will include (Steroids, plasma exchange, IVIG, antibiotics, mode of respiratory support).

Primary outcomes will include; Death, duration of ICU stay, duration of mechanical ventilation, in-hospital complications.

A regression model will be used to predict poor prognostic factors. Inclusion criteria: patients with confirmed PCR results for COVID-19 AND require ICU admission. Exclusion criteria: those with negative results, pediatric patients and those not requiring ICU admission.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Positive PCR test for COVID-19
* Require admission to ICU

Exclusion Criteria:

* Pediatric patients\\
* Any patient not requiring admission to ICU
Correlation of Microbiome and Metabonomics With IgA Nephropathy

IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to commensal or pathogenic bacteria, involved in the initial step in the pathogenesis of IgAN. Similar to intestinal flora, a disruption in oral flora is closely associated with the occurrence of many malignant tumors and autoimmune diseases. The relationship between oral and throat microflora and the occurrence of IgAN is unclear at present. The aim of the present study was to develop a preliminary model based on mucosa -specific microbes and clinical indicators to facilitate the early diagnosis of IgAN and obtain insights into its treatment.

IgAN-microbiome is an investigator-initiated，multi-center，Observational study. This study will recruit IgA nephropathy patients who have not been treated with glucocorticoids and immunosuppressants for 6 months and have not taken antibiotics for 1 month and their family members. Feces, urine, blood, oral mucosal swabs, and pharyngeal swabs will be collected and tested for microflora and metabolites in these areas.

Similar samples from IgA nephropathy patients were collected after 2 months and 6 months, respectively, for bacterial community detection and metabolite detection, and the relationship between bacterial community change and metabolite change and disease progression was analyzed.

Eligibility Criteria:
Inclusion Criteria:

* (1) Pathological changes of IgAN were confirmed by renal biopsy (2) Age ≥16 years (3) IgA deposition caused by secondary factors such as non-purpura glomerulonephritis, liver cirrhosis, SLE, HIV infection and hepatitis B virus associated nephritis (4) No antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month prior to sampling (5) No hormone or immunosuppressant treatment in the six months prior to sampling (6) No significant changes in diet or medication for at least one month (7) No other immune or autoimmune diseases, such as systemic lupus erythematosus (8) Signed informed consent

Exclusion Criteria:

1. Type I or type II diabetes
2. Pregnancy and menstrual period
3. Mental illness and inability to assess follow-up
4. Medically diagnosed intestinal diseases such as irritable bowel syndrome and inflammatory bowel disease
5. Viral hepatitis or other infectious diseases
6. One month before specimen collection, use laxatives including but not limited to polyethylene glycol electrolyte dispersant, enema and other laxatives
Endothelial Function and Vein Graft Remodeling

The purpose of this study is to better understand why some vein bypass grafts develop narrowing. Evidence suggests that there is a relationship between inflammatory markers in the blood and the narrowing that occurs in blood vessels. In this study, we will look at inflammatory markers in the blood and how well the vein graft functions.

Despite the acceptance of catheter-based approaches to lower extremity reconstruction, bypass with autogenous vein remains the most durable option. In the United States alone there are approximately 100,000 lower extremity bypass procedures performed yearly. However, 30-50% of these grafts either occlude or require revision in the first 5 years.

Traditional Framingham cardiovascular risk factors such as dyslipidemia and diabetes do not predict which grafts are at risk for failure. Therefore other variables such as hemodynamic factors or endothelial function may be important in identifying vulnerable vein grafts. The applicant has previously noted that vein grafts undergo dramatic geometric remodeling within the first month after implantation into the arterial circulation. This is partly driven by hemodynamic forces such as shear stress and is thought to be related to endothelial function. Shear stress is positively correlated with early (0-1 month) luminal enlargement. This adaptive response is important to maintain bypass graft patency. However, there is considerable amount of variability in this response unaccounted for by shear stress alone. The applicant has further shown that baseline systemic inflammation dampens the ability for adequate vein graft luminal expansion and therefore may uncouple the mechano-chemical signal transduction at the endothelial level. Therefore, this study will examine the relationship between circulating levels of inflammatory mediators and endothelial function in a cohort of patients undergoing lower extremity arterial reconstruction with autogenous vein.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 22 or \< 90 years
* Undergoing lower extremity (infrainguinal) bypass using autologous vein for the treatment of disabling claudication or critical limb ischemia secondary to chronic atherosclerotic occlusive disease
* Able to understand, give, and take part in the consent process

Exclusion Criteria:

* Age \< 22 or \> 90 years
* Grafts employing prosthetic or other non-autologous vein material in any part (e.g. composite grafts). \[Patch angioplasty of inflow and outflow vessel permissible with any material\]
* Vasculitis, trauma, acute embolic disease as etiology of limb ischemia
* History of diagnosed hypercoagulable state
* Evidence of active infection - pneumonia, urinary tract, etc., requiring medical therapy
* Evidence of significant local sepsis in foot or limb prior to bypass
* Patients taking immunosuppressant medications (steroids, chemotherapeutic agents)
* Other concurrent significant illness within 30 days
* Non-English speakers
Neutrophil-to-Lymphocyte and Platelet-to-lymphocyte Ratios as a Predictor Factors for Chronic Kidney Disease Progression

In this study, we aim to investigate whether NLR and PLR levels are associated with decline of kidney function in patients with CKD.

Chronic inflammation is closely associated with various chronic diseases, such as diabetes mellitus, cardiovascular disease, and chronic kidney disease (CKD) (1). Patients with CKD tend to have elevated levels of inflammatory mediators, including high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF alpha), and interleukin (IL)-6 (2).These mediators stimulate inflammatory pathway, leading to glomerular hypertension, tubulointerstitial fibrosis, kidney scarring, and, finally, CKD progression and increased cardiovascular events (3,4). Therefore, it is important to evaluate and decrease the extent of chronic inflammation in patients with CKD. Patients with CKD have higher levels of proinflammatory cytokines, but it remains unclear which biomarker is the best indicator of inflammation in patients with CKD.

The neutrophil-to-lymphocyte ratio (NLR), obtained by dividing the absolute number of neutrophils to the lymphocyte count, is increasingly studied as a new inflammatory marker. An elevated NLR has recently been reported to be an independent predictor of mortality in patients with cardiovascular disease or cancer \[5-8\]. As CKD is a chronic inflammatory disease, high NLR can predict CKD progression, cardiovascular disease and cancer. However, significantly few studies have investigated the association between high NLR and CKD progression \[9-12\].

Platelet-to-lymphocyte ratio (PLR) has recently been recognized as a novel inflammatory marker and has been shown to be associated with the prognosis in CKD patients \[13\].

In 2012, Kidney Disease: Improving Global Outcome (KDIGO) classified CKD in six categories by GFR estimation (in mL/min/1.73 m2).

Eligibility Criteria:
Inclusion Criteria:

* 200 Patients diagnosed with CKD and their age range between 18-65 years old who will be admitted at AUH.

Exclusion Criteria:

1. Pediatric patients aged below\< 18 or elderly patients aged above 65.
2. Pregnant females.
3. Patients with Diabetes Mellitus.
4. Acute kidney injury (AKI).
5. Patients with current infections.
6. Patients who have any type of malignancy.
7. Patients who have any type of multi-organ failure.
8. CKD patients on dialysis
Systemic Consequences and Comorbidities in Mild/Moderate Chronic Obstructive Pulmonary Disease (COPD), Time for Action!

The aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.

Three groups will be included in this study:

* Patients with COPD (cases)
* Patients with smoking history but no COPD (smoking controls)
* Patients with no smoking history and no COPD (non-smoking controls)

An extensive test battery will be performed at baseline and after 3 years:

Clinical assessment (height, weight and blood pressure)\*

Complete pulmonary function ((post-bronchodilator)spirometry + diffusion)\*

Sputum Induction

Fasting venous blood sample (fasting glucose, cholesterol, triglycerides, inflammatory markers, creatinine, NT pro BNP, hemoglobin, testosterone, vitamin D)

Vascular screening (arterial stiffness - arterial stenosis - CIMT)

Muscle force (peripheral + respiratory)\*

Functional exercise capacity (6 MWT)\*\*

Maximal exercise capacity (incremental cycle test)\*\*

Dexa scan (osteoporosis - body composition)

Spiral CT scan of the chest

RX thorax - RX lumbar

Questionnaires (MRC, CCQ, SF-36, EQ5D, HADS, Exacerbation, CATZ)\*\*

Physical activity monitoring (sensewear armband)\*

\* test will be repeated every 6 months

\*\* test will be repeated every year

!!!! Remark (26/9/2013) Based on the last data analyses, in contrast to our expectations, we concluded that the two groups with a smoking history, with or without COPD change in a similar way over time. The length of the study will therefore be prolonged with 3 more years (6 years in total).

After 3 years the patients with a smoking history will be evaluated yearly, unless they were hospitalized for \>5 days. In that case we will sooner contact these patients in order to pick up comorbidities in these patients.!!!

Eligibility Criteria:
Inclusion Criteria:

* age 40-80 years old

cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment.

smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment.

non-smoking controls: no COPD (spirometry based) + \< 1 pack year

Exclusion Criteria:

* Respiratory disorder other than COPD
* α1-antitrypsin deficiency
* Known history of significant inflammatory disease other than COPD
* COPD exacerbation within 4 weeks prior to study
* Lung surgery
* Recent diagnosis of cancer
* Therapy with oral corticosteroids in the last 6 weeks
* Significant cardiovascular comorbidity
* Significant orthopedic/musculoskeletal problems
The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea

Apnoeic oxygenation refers to oxygenation that occurs through the insufflation of oxygen into the lungs in the absence spontaneous respiration or positive pressure ventilation. It is used to extend the time to desaturation at induction of anaesthesia and as a primary oxygenation technique during airway surgery. The impact of high-flow nasal oxygen flow rate selection on gas exchange is poorly understood. Participants in this study will be randomised to receive a certain nasal oxygen flow rate during apnoea and its effect on gas exchange will be measured by blood gas analysis.

Apnoeic oxygenation with high-flow nasal oxygen has been proposed to result in carbon dioxide clearance. However, this has been poorly quantified.

This study will compare use of nasal oxygen at different flow rates during apnoea with that of a control that does not receive nasal oxygen. Participants are anaesthetised after standardised pre-oxygenation with high-flow nasal oxygen, after which they will receive one of three nasal oxygen flow rates (0, 70, 120 L/min).

The rate of carbon dioxide elevation will be measured by arterial blood gas analysis after the onset of apnoea and compared between the three groups to discern the relative rates of carbon dioxide clearance after the first minute of apnoea. The effect of nasal oxygen flow rate on oxygenation will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* ASA 1 or 2
* Receiving a general anaesthetic for non-emergent surgery

Exclusion Criteria:

* ASA score ≥3
* BMI ≥ 30 kg/m2
* Nasal obstruction
* Baseline SpO2 ≤95% on room air
* Anticipated difficult airway management
* Requirement for awake intubation
* Pregnancy
* Positive PCR test for coronavirus in preceding 14 days.
Analgesia in Inguinal Hernia Repair Using a Cyclooxygenase-2-specific Inhibitor

Acute pain is the result of activating nociceptive pathways in both the peripheral and central nervous system. The origin of most acute pain from surgical stimulation is the mechanical trauma of the local tissue and the subsequent acute inflammatory response.

No studies have investigated the combined use of anti-inflammatory analgesics with spinal anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients undergoing day-case IHR. The aim of the investigators study is therefore to assess the efficacy of preoperative combined administration of etoricoxib and standard spinal anaesthesia in the reduction of postoperative pain following IHR.

Acute pain is the result of activating nociceptive pathways in both the peripheral and central nervous system. The origin of most acute pain from surgical stimulation is the mechanical trauma of the local tissue and the subsequent acute inflammatory response. Open inguinal hernia repair is one of the commonest surgical procedures which may provoke pain of variable intensity and duration.

Etoricoxib (Arcoxia®) is a NSAID with anti-inflammatory and analgesic properties mainly achieved via selective peripheral COX-2 inhibition. Spinal anaesthesia using local anaesthetics combined with opioids affects the transmission, modulation and modification stages of nociceptive afferent impulses and its analgesic qualities are superior to local anaesthesia alone.

No studies have investigated the combined use of anti-inflammatory analgesics with spinal anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients undergoing day-case IHR. The aim of the investigators study is therefore to assess the efficacy of preoperative combined administration of etoricoxib and standard spinal anaesthesia in the reduction of postoperative pain following IHR.

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiology Class I and II

Exclusion Criteria:

* Under treatment with Non Steroid Antinflammatory Drug
* Under Opioid treatment
* Peptic ulcer
* Liver insufficiency
* Renal insufficiency
* Asthma
* Cardiovascular disease
The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with T2DM aged 19 to 80 years
2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
3. Subjects with BMI of 20-45 kg/m2
4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
3. Urinary tract infections or genital infections within
4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
5. eGFR \< 60 mL/min/1.73 m2
6. Severe heart failure (NYHA class III/IV)