cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3437943 in Participants With Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes (T2D)
* Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.

Exclusion Criteria:

* Have type 1 diabetes mellitus (T1DM)
* Have ketoacidosis
* Have retinopathy, maculopathy
* Have history of pancreatitis
* Have obesity induced by other endocrine disorders
* Have uncontrolled hypertension
* Have acute or chronic hepatitis
* Have chronic kidney disease
* Have an autoimmune abnormality for example, lupus or rheumatoid arthritis
* Have an active or untreated malignancy
Metabolic Effects of Olanzapine in Healthy Males

The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer
* Male
* Aged 18-35 years
* Body Mass Index (BMI): \<30 kg/m2

Exclusion Criteria:

* Presence of any medical disorder that may confound the assessment of relevant biological measures
Suvorexant and Alcohol

This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.


Eligibility Criteria:
Inclusion/Exclusion Criteria:

1. Able to speak and read English.
2. Not seeking treatment at the time of the study.
3. Between the ages of 21 and 55 years.
4. Engaging in at least one binge drinking episode, per the NIAAA definition, in the last 30 days.
5. Fulfillment of moderate or severe DSM-5 diagnostic criteria for AUD based on computerized SCID results reviewed by a psychiatrist or psychologist.
6. ECG, read by cardiologist, within normal limits.
7. Body mass index of 19 - 35.
8. Birthing individuals using an effective form of birth control and not pregnant or breast feeding.
9. Judged by the medical staff to be psychiatrically and physically healthy (i.e., no current severe SUD or psychiatric diagnoses other than AUD or Tobacco Use Disorder; no current physical diagnoses that would interfere with study participation according to study physician judgment).
10. Not currently physiologically dependent on any substances.
11. Able to abstain from alcohol during admission (i.e., not physically dependent on alcohol and scores less than 8 on Clinical Institute Withdrawal Assessment for Alcohol \[CIWA-Ar\] at screening).
12. Not currently taking any prescribed medications for a chronic condition (other than birth control).
13. No indication of sleep apnea on the STOP-Bang questionnaire (score of 5 or greater).
14. No contraindications/allergies to suvorexant.
Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood

This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of breast, colon or prostate cancer
* No prior cancer therapy or failed first line therapy
* \>= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment
* \> 1 month life expectancy
* Adequate baseline hematological function as assessed by the following laboratory values:

  * Hemoglobin \> 9 g/dl
  * Platelets \> 100,000/mm3
  * WBC \> 3,000/mm3
  * Absolute Neutrophil Count \> 1,500/mm3

Exclusion Criteria:

* Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism
* Patients with known immunodeficiency virus (HIV)
The Impact of a Regular Borjomi® Consumption on an Anaerobic Performance

The effects of 2 weeks 1000 ml daily mineral water Borjomy® consumption of anaerobic performance and acid-base balance in comparison with purified electrolite smart-water and still drinking water.

Bicarbonate supplementation increases the efficiency of the body's buffer systems and improves anaerobic performance in athletes when taking bicarbonate just before training. In the course of studies, a similar effect was confirmed for professional swimmers at a distance of 200 meters freestyle, cyclists at distances up to 3 km and track and field athletes in steeplechase. However, these studies were conducted on professional male athletes, and it is interesting to compare the effects with non-athletes population.

Borjomi® is a natural bicarbonate sodium mineral water with high taste qualities. The effects of Borjomi® as bicarbonate source on physical performance are another research interest.

The aim of this study was to evaluate the comparative effectiveness of the regular use of bicarbonate-containing mineral water (Borjomi®) on anaerobic performance and acid-base balance during short-term physical activity of high intensity in comparison with purified electrolite smart-water and still drinking water.

Eligibility Criteria:
Inclusion Criteria:

* Normal body weight (BMI ≥18-24.90 kg/m2).
* Regular physical activity - at least 150 minutes of exercise per week in 2 and more trainings.

Exclusion Criteria:

* Peak oxygen consumption less than 50% of the norm (adjusted for sex and age).
* Allergic reactions to latex.
* Smokers or quit-smokers (less than 6 month of withdrawal).
* Any vitamin, sport or food supplementation in 3 month prior to participation.
* Any low-limb trauma in 6 month prior to participation.
* Any chronic diseases on permanent treatment.
Effects of Gargling With Green Tea on Oral Health of Stroke Patients

1. Compare the effects of gargling with green tea on the oral health of stroke patients?
2. Compare whether gargling with green tea can reduce halitosis in stroke patients?
3. Compare whether gargling with green tea can reduce plaque index in stroke patients?

Before the intervention of green tea mouthwash, patients in the experimental group and the control group were tested for oral health status, bad breath and plaque degree, and received routine brushing guidelines. Patients in the experimental group received green tea mouthwash intervention twice a day for 7 day

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients over 20 years of age with acute cerebral stroke admitted by medical institutions.
* Stroke patients diagnosed by medical institutions were treated with the National Institute of Health Stroke Scale; NIHSS) score is 5-15, which is a moderate degree of stroke
* Able to perform mouthwash.
* Those who have passed the three-stage swallowing function screening.
* Those with stable medical condition.

Exclusion Criteria:

* Those who of medical institutes in the diagnosis of severe alzheimer.(ICD-10 code： G30.9)
* Those who severe mental retardation.
* Those has a history of mental illness.
* Those has unable to clearly express their wishes.
* Those has full mouth teeth less than six.
* Those has in the past more than a month use mouthwash.
* Those has treatment of the patients with gingivitis and periodontal disease, oral antibiotics or anti-fungal drugs.
* Those has unable to cooperate or applicable except of assessment tools.
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with local label.
* If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
* Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her pseudonymized health data prior to inclusion into the study
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

• Adolescents; people not treated according to label
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers

The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy adults aged 18-55 years of age.

Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. Hospital outbreaks of Clostridium difficile-associated diarrhea (CDAD) are associated with substantial patient morbidity and mortality. Conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course. New strategies are needed to limit the impact of this opportunistic pathogen. Considerable evidence exists that immunity against C. difficile toxins may be effective in controlling CDAD. 48 subjects will be enrolled to receive one of three dose levels of modified C difficile vaccine or placebo administered on a 3-dose schedule. The study consists of a 30-day screening period, a 70-day treatment period, one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic visit 6 months after the last vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Adult males or females, 18-55 years (inclusive)
* In good general health
* Clinical lab tests within normal range
* Non-pregnant female subjects
* Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine

Exclusion Criteria:

* Evidence of C. difficile infection
* Evidence of any previous antibiotic-associated diarrhea
* Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
* History of malignancy within 5 years
* History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
* Known or suspected history of immunodeficiency;
* Active or inactive immune-mediated or inflammatory disease;
* Pregnant or lactating female subjects;
* History of drug or alcohol abuse disorders;
* Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* Receipt of antibiotic therapy or an investigational drug within prior 30 days
* Blood or organ donation within prior 30 days
QT-prolongation in Psychiatric Hospitals

Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug. An ECG is taken before the administration of the new drug and a week after starting the new drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation and blood concentrations of potassium and creatinine are documented.


Eligibility Criteria:
Inclusion Criteria:

* inpatient in one of the 6 participating psychiatric hospitals
* QT-prolonging drug in the medication profile and the doctor prescribes another QT-prolonging drug

Exclusion Criteria:

* age \< 18 year
The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)

This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study

Exclusion Criteria:

* Patients who are or are suspected in pregnancy or nursery
* Patients with the contraindications for Ultravist
* Patients with the contraindications for cardiac catheterization
Psychological Assessment and Skills Training by Simulation in Neurosurgery

The subject of Safety in Health is assuming in time a predominant position with those of high social, economic and political relevance. Numerous medical-surgical procedures are frequently learned as they are performed directly on the patient. The scope of our research, hence, is to recruit 5th- and 6th-year students of Medicine of the University of Milan who will have the opportunity to use two state-of-the-art 3-D virtual reality neurosurgical simulators at the Besta NeuroSim Center. Psychological Evaluation instruments will be used in order to select the personality profile most fit for a career in neurosurgery and to understand what training method is the most appropriate to achieve the best results in neurosurgery.


Eligibility Criteria:
Inclusion Criteria:

* 5th - 6th year medical students.
* Signed informed consent.

Exclusion Criteria:

• Medical students with any previous surgical experience or simulation training (mechanical, PC-based and/or others).
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

This study is designed to investigate the ability of patients with asthma to properly use a new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary
* Patients who have a current diagnosis of asthma
* Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a \>12% increase in FEV1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at Visit 1. The administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.

Exclusion Criteria:

* Patients who were enrolled in study CFOR258F2304 or CFOR258F2306, or who have any experience using the Certihaler® device.
* QTc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ECG) that in the opinion of the investigator would present a safety hazard for continuation in the study
* Patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies
* Other protocol-defined inclusion and exclusion criteria apply
Novaferon for COVID-19 Treatment Trial (NCTT-005)

A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent has been obtained from the participants with age of over 20 years at the time of signing the informed consent.
* SARS-CoV-2 infection is diagnosed by the positive SARS-CoV-2 detection of RT-PCR tests within 72 hours before the start of administration of the investigational drug
* Less than 6 days from onset of COVID-19 symptoms to starting the administration of the investigational drug. The symptoms are defined as one or more of the following: fever (37.5 ºC or higher), respiratory symptoms (cough, shortness of breath, chest pain, sore throat, running nose, nasal congestion, etc.), headache, malaise, abdominal pain, diarrhea, nausea, vomiting, loss of smell, loss of taste, or other COVID-19 symptoms defined by investigators or physicians.
* Have at least one of the following findings.
* Oxygen saturation (SpO2) measured by pulse oximeter is less than 96% and more than 93%.
* Chest X-ray or CT scan shows pneumonia findings suggestive of COVID-19 infection
* Need hospitalization and COVID-19-related medical care.
* Require no supplemental oxygen.
* Women (less than 12 months after the last menstrual period) who have a negative pregnancy test (urine hCG qualification) and agree to take oral contraceptives or use condom during study period.

Exclusion Criteria:

* History of hypersensitivity to interferon or Novaferon or any excipients of interferon or Novaferon.
* Having received other antiviral treatments (Favipiravir, Remdesivir, Interferon, etc.).
* CTCAE Grade 3 or higher liver dysfunction (ALT / AST\> 5ULN) or renal dysfunction (eGFR \<30 mL / min / 1.73 m2).
* Active infections or other medical conditions that contraindicate inhalation therapy.
* Inappropriate for inclusion in the clinical trial as determined by investigators.
Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.

Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitment time is up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Has a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
* Has a Hamilton Anxiety Scale total score ≥ 20.
* Has a Hamilton Anxiety Scale score ≥ 2 on both item 1 (anxious mood) and item 2 (tension).
* Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.

Exclusion Criteria:

* Has 1 or more of the following:

  * Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview \[MINI\]).
  * Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
  * Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR and participant must have a negative urine drug screen prior to Baseline.
  * Presence or history of a clinically significant neurological disorder (including epilepsy).
  * Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc.).
  * Any Axis II disorder that might compromise the study.
* Is taking excluded medications.
* Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
* Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
* Has received electroconvulsive therapy within 6 months prior to Screening.
* Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
* Has a clinically significant unstable illness.
* Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level \> 1.5 times the upper limit of normal.
* Has a serum creatinine of \> 1.5 × the upper limit of normal.
* Has a previous history of cancer that had been in remission for less than 5 years.
* Has thyroid stimulating hormone value outside the normal range.
* Has an abnormal electrocardiogram.
Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention

There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR).

Current nationwide cohort study conducted using Korean National Health Insurance Service database evaluated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis with deferred revascularization based on negative FFR (FFR\>0.80).

This study was nationwide cohort study conducted using Korean National Health Insurance Service database. From 2013 to 2020, reimbursement criteria of FFR were patients with no previous evidence of myocardial ischemia and intermediate coronary artery stenosis (50-70%). Patients who were evaluated by coronary angiography and FFR but did not undergo revascularization were selected and classified according to the use of antiplatelet agents after index procedure. Patients with previous history of atherosclerotic cardiovascular disease were excluded. Eligible patients were matched using propensity score in a 1:1 ratio. Primary efficacy outcome was major adverse cardiac and cerebrovascular events a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke at 5-year. Primary safety outcome was gastrointestinal bleeding, regardless of the need of transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 50-70% intermediate stenosis by quantitative coronary angiography in a vessel greater than 2.5 mm
* Patients who underwent invasive coronary angiography and FFR measurement
* Patients whose revascularization was deferred based on FFR\>0.80

Exclusion Criteria:

* Patients who underween FFR measurement after expansion of reimbursement criteria of FFR (since 2021)
* Patients with history of any bleeding with blood transfusion
* Patients with use of non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin
* Patients with previous atherosclerotic cardiovascular disease
* Patients with already on antiplatelet agents including dual antiplatelet agents