cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects

This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Subject who had drug(Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 2 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion in 1 months currently.
Efficacy of Treatment for Generalized Anxiety Disorder

The purpose of these questionnaires is to give us an overview of how GAD has affected your life, and perhaps also to give us some clues about things that may have set you up to experience GAD.

For us to evaluate the efficacy of our treatment programs, we are interested in your responses before and after treatment. We use two methods to evaluate the efficacy of our treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As part of standard clinic procedure, each person in the program completes an in-person interview with a staff member who will determine your suitability for treatment. If you have received this questionnaire packet, it is likely that your concerns will be appropriately addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to assess the severity of your generalized anxiety disorder; its impact on your functioning, and factors that may contribute to the onset or maintenance of your GAD (e.g., depression, intolerance of uncertainty). We will ask you to complete this questionnaire again when you have completed your treatment along with a brief telephone interview with a staff member of the Anxiety Disorders Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the Anxiety Disorders Clinic who receive a primary diagnosis of Generalized Anxiety Disorder, and are accepted for treatment at the clinic.

Exclusion Criteria:

* Individuals who either have not sought treatment for anxiety at the Anxiety Disorders Clinic or patients who did not receive a primary diagnosis of Generalized Anxiety Disorder.
Impact of the Qatar 2022 FIFA World Cup on PED Use and Misuse Patterns

A retrospective cohort study to explore the impact of the FIFA World Cup 2022 Qatar on paediatric emergency department attendance at two tertiary centres during unprecedent winter viral epidemics.

Earlier studies have reported contradictory relationship between major sporting events and paediatric emergency department attendance. None were conducted during an epidemic surge. The FIFA football World Cup 2022 was held for the first time in its history during the winter period in the northern hemisphere during unprecedented cumulative waves of respiratory syncitial virus (RSV), influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemics.

This study aims to measure the impact of such a global major sporting events on the pattern of paediatric emergency department use and hospital admissions during a peak epidemic season in 2 tertiary hospitals. The study hypothesis was that major sporting events, even during an epidemic peak, can reduce the number of paediatric emergency department visits compared with periods without a sporting event. Major sporting events could serve as a model for identifying human behaviours and patterns leading to paediatric emergency department misuse, in order to develop public health interventions to better rationalise health-seeking behaviours.

Eligibility Criteria:
Inclusion Criteria:

* all patients

Exclusion Criteria:

* none
A Study to Compare Analytes in Blood Collected Using an Investigational Collection Device With a Commercial Predicate

This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The TAP20-C device collects small amounts of blood from the forearm which can then be used for blood testing. The study will also involve collecting blood by fingerstick which is a common way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two different blood collection methods. Additional information will be collected about how the TAP20-C device performs.


Eligibility Criteria:
Inclusion Criteria:

Healthy Subject Group

1. Male and female volunteers 18 years of age or older

Diabetic Subject Group

1. Male and female volunteers 18 years of age or older
2. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report

Exclusion Criteria:

1.Subjects who are pregnant or nursing mothers by self report 2.Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins 3.Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested 4.Subjects with a missing index or middle finger on either hand or a missing forearm 5.Subjects who have known allergies to titanium

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Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF)

The purpose of this study is to determine the superiority of the effectiveness of Henagliflozin 10 milligram (mg) daily versus blank control in participants with type II diabetes (T2DM) and symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS).


Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM aged ≥18 years
* 6.5%≤HbA1c≤11%
* Clinically stable symptomatic heart failure

  (a) For HFrEF: (a) Ejection fraction (EF) less than or equal to (\<=) 40% and (b) diagnosis of chronic heart failure within the past 18 months (B) For HFpEF: (a) EF greater than (\>) 40%; (b) Diagnosis of chronic heart failure within the past 18 months
* Symptoms of heart failure at visit 1 (NYHA II-IV)
* KCCQ-OSS score \< 80 at screening visit
* NT-proBNP \> 125 pg/mL, or NT proBNP \> 365 pg/mL in atrial fibrillation patients; Or BNP \> 35 pg/mL, or BNP \> 105 pg/mL in atrial fibrillation patients at screening visit
* Subject must have received (and be receiving) at least one stable optimal dose of guidelines recommended HF drugs (e.g., ACEi, ARB, ARNI, beta blockers, oral diuretics, MRA) prior to visit 1
* eGFR≥30 ml/min/1.73m2 at screening visit (CKD-EPI formula)
* Signed and dated written ICF

Exclusion Criteria:

* Pregnant and lactating women and women of childbearing age who do not want to use reliable contraception
* Known allergy to Henagliflozin
* Hospitalization for acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 4 weeks before the screening visit
* Acute decompensated heart failure or hospitalization for decompensated heart failure within 4 weeks
* History of heart transplantation or ventricular assist device (VAD), or intention to heart transplantation or VAD
* Perinatal or chemotherapy-induced cardiomyopathy within 12 months
* Documented untreated ventricular arrhythmias with syncope within 3 months
* Diagnosed respiratory diseases
* Type I diabetes
* T2DM with history of ketoacidosis (DKA)
* Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening visit
* Symptomatic hypotension and/or systolic blood pressure \<90 mmHg at visit 0 or visit 1, or hypovolemia
* History of recurrent urinary and reproductive tract infections
* Current use or prior use of a SGLT-2i or GLP-1RA within 3 months
* Diagnosed malignant tumors
* Further exclusion criteria apply
Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp

Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric polyp (Ranomized controlled trial)

1. Study design: open labeled RCT
2. Study group H. pylori eradication group (N=17), non-eradication group (N=15)
3. Treatment plan

   1. Baseline EGD

      : 0.3-1cm sized polyp - bx \& CLO test (antrum \& body)

      ==\> if H. pylori positive and eligible patients, randomization
   2. Triple therapy
   3. UBT (4week after eradication)
   4. Follow-up EGD: gross finding, CLO test
4. Evaluation of polyp regression

   1. disappear
   2. regression over 50% (size, number)
   3. no change or increase (size, number)

(A) Study population

1. inclusion HP-realetd polyp polyp size with 0.3cm-1cm 20 yr - 70yr
2. exclusion peptic ulcer, healing stage or acute stage recent use of PPI within 4weeks Liver cirrhosis, renal insufficiency, other serious chronic or acute disease current infection of other bacteria, virus, or fungus cancer, psychologic disease heavy drinker drug abuser pregnant women, Penicillin allergy, digoxin, antifungal, wafarin previosu H. pylori eradication enroll gastric polyp with bleeding or malignant transformation tiny polyp less than 3mm.

(B) Study method

1. Study design: open labeled RCT
2. Study group H. pylori eradication group (N=17), non-eradication group (N=15)
3. Treatment plan

   1. Baseline EGD: 0.3-1cm sized polyp - bx \& CLO test (antrum \& body) ==\> if H. pylori positive and eligible patients, randomization
   2. Triple therapy
   3. UBT (4week after eradication) if eradication failure in triple therapy, 2nd line treatment (metroniazole based quadraple therpay) and the UBT (4week after eradication)
   4. Follow-up EGD (3-9M): gross finding, CLO test
4. Evaluation of polyp regression

   1. disappear
   2. regression over 50% (size, number)
   3. no change or increase (size, number)
5. Statistical analysis

   1. Chi-square test to compare polyp regression between treatment \& control group.
   2. t-test to compare continuous variables between treatment \& control group.
   3. Paired T-test to compare the size between baseline and follow-up EGD.
   4. Regression analysis: univariate \& multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Gastric polyp with current infection of H. pylori
* Gastric polyp size with 3mm-10mm
* Age of 20 yr - 70yr

Exclusion Criteria:

* Gastric ulcer ir duodenal ulcer (healing stage or acute stage)
* Use of PPI within 4weeks
* Liver cirrhosis, renal insufficiency, other serious chronic or acute disease
* Current infection of other bacteria, virus, or fungus
* Any cancer, psychologic disease
* Heavy drinker
* Drug abuser
* Pregnant women
* Penicillin allergy
* Use of digoxin, antifungal, wafarin
* Previous H. pylori eradication
* Gastric polyp with bleeding or malignant transformation
* Tiny polyp less than 3mm.
A Global Approach to Tackle Cognitive Decline

The number of people suffering from dementia in Asia (22.9 million) is more than twice the numbers in Europe (10.5 million) or the Americas (9.4 million), as recorded in the global impact of dementia in the World Alzheimer Report 2015.1 This dementia tsunami will continue to rise and the estimated number is 67 million in 2050 in Asia alone, which will be 2 to 3 times higher than the estimates for Europe (19 million) or the Americas (30 million). Devising and implementing preventive strategies against dementia is of paramount importance. The proposed project will be able to establish the associations between VRFs and cognition across cohorts with cultural, ethnical, and demographical variations. This study will generate data for evidence-based knowledge for globally implementable and effective preventive strategies for cognitive impairment and dementia.

Participants will be retrospectively selected from a Hong Kong Chinese cohort, a Singaporean cohort, a British cohort, two European cohorts, and an Australian cohort.

Subjects from the above listed cohorts who fit the study criteria will be selected for this study.

Demographical information, clinical, vascular risk factors, MRI images and cognitive data will be retrieved from the cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Elderly community-dwelling individuals aged over 60 years old;
2. those with at least 2 time points of detailed cognitive measurements, with 2-3 years of assessment interval;
3. with at least 1 timepoint of MRI (T1, FLAIR, and DTI).

Exclusion Criteria:

1. subjects with stroke, dementia, and other neurological diseases at baseline;
2. those without longitudinal cognitive data;
3. those without MRI data available.
Transtibial Pin Lock Suspension at Varying Distraction Values Using a Modified Air Bladder Casting System

To assess the effects various distraction values have on the 'slippage' effect of a transtibial pin-lock system

This experiment will consist of a total of four visits. The testing process will consist of a series of castings, surveys, data collection, and outcome testing that includes both endurance and aerobic exercises while wearing the check sockets of varying tension values. The outcome measures will be performed in the Nichol Hall Motion Capture Lab.

* The participants will sign consent forms and three casts will be taken on the first visit.
* The second visit will consist of fitting test socket A, which includes socket adjustments and the dynamic alignment. Once the socket is properly fit on the subject, we will begin their three trials (with two to three minute breaks in between trials) of the Time Up and Go assessment (TUG) followed by the Prosthesis Evaluation Questionnaire (PEQ) survey.
* Visit three will be comprised of socket B fitting, alignment, and testing. The subjects will proceed with the same procedure as stated in visit two. Following the outcome measures, participants will take the PEQ survey for socket B.
* Visit four is the final visit of testing and data collection. Socket C will be presented to the subject and they will go through the same dynamic alignment process and outcome testing as the previous visits. Once finished, the subjects will take the final PEQ survey on socket C and receive their compensation.

Eligibility Criteria:
Inclusion Criteria:

* K3-K4 level ambulator (Participants assessed as a K3 level are community ambulators, with the ability to tread on low level barriers and ambulate at variable speed. The highest K-level, (K4), is for high active, athletic ambulators with the ability or potential to ambulate at high impact, stress, or energy levels.)
* 18 years or older
* unilateral trans-tibial amputees with intact skin
* must have worn their prosthesis for at least 5 months

Exclusion Criteria:

* patients requiring a custom liner
* those on dialysis or have heart conditions
* patients requiring an assistive device (Examples of assistive devices would include; canes, walkers, forearm crutches, wheelchairs, hemi walkers, or rollators)
Comparison of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder

The purposes of this study are to determine:

* The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight.
* The safety of olanzapine as compared to quetiapine.


Eligibility Criteria:
Inclusion Criteria:

* You must be 18-75 years of age and be diagnosed with schizophrenia or schizoaffective disorder
* You must be able to visit the doctor's office thirteen (13) times over a twenty-six (26) week period

Exclusion Criteria:

* You are a woman and are pregnant or breastfeeding
* You have an acute or unstable medical illness, such as heart, liver, or kidney disease, or you have a seizure disorder. (Note: If you are uncertain about a particular condition, please discuss it with your physician.)
* You have a history of allergic reaction or intolerance to olanzapine or quetiapine
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥18 years of age.
* Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
* ECOG performance status 0 or 1
* Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
* Adequate organ function

Exclusion Criteria:

* Primary central nervous system (CNS) tumors
* Active brain metastases
* Known impairment of GI function that would alter the absorption
* Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
* Prior therapy with KRASG12C (ON) inhibitor

Other inclusion/exclusion criteria may apply.
Safety Study of AZT-04 for Cosmetic Use

Double Blind, Three Cohort, Placebo-controlled Trial to Assess Safety, Tolerance and Induced Bacterial Colony Counts of Three Ascending Doses of AZT-04 in Healthy Adult Volunteers

This is a single-center, prospective, double-blind, three cohort pilot study to assess the tolerability and induced changes in skin microbiome population and diversity of three ascending doses of test article code AZT-04 in normal, healthy subjects.

The study will consist of up to 7 scheduled study visits. There will be three cohorts in this study, each cohort composed of 6 subjects (total number of subjects is at least 18). Each cohort will be treated with both a placebo ointment and an ointment containing different concentrations of the Staphylococcus epidermidis. Approximately 1 ml of placebo ointment and 1 ml of AZT-04 ointment (test product composed of a commensal strain of Staphylococcus epidermidis) will be applied topically to two separate skin sites on the back, each site approximately 8 x 5 cm. Skin microbiome sampling will be performed before application of any test article (i.e., baseline) and each subsequent day for four (4) consecutive days. Samples will be shipped to a laboratory chosen by the Sponsor for analyses

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English, willing and able to read, understand, and sign the informed consent form
* Ability to complete the course of the study and comply with instructions
* Makes and Females ages 18-65 years, inclusively, in good general health as deemed by the investigator
* Individuals with Fitzpatrick skin type I, II, III, IV
* Individuals free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which, in the opinion of the investigator, could interfere with the conduct of the study, interpretation of results or increase the risk of adverse reactions.
* Females practicing an acceptable method of birth control

Exclusion Criteria:

* individuals with any visible skin disease, skin condition including baseline erythema assessment \> 0.5, or tattoos in the test area
* individuals with abnormal skin pigmentation at the test sites, which might interfere with subsequent evaluations of dermal responsiveness
* individuals with recent prolonged sun or tanning bed exposure in the test area
* individuals with excessive dryness or redness at the sites of application
* individuals with a known hypersensitivity to cosmetic or personal care formulations
* subjects must not have applied any lotions creams, powders, or oils to their backs the morning of the study. Additionally 2 hours must have passed since bathing or showering
* women who are pregnant or nursing
* individuals who have participated on a s study involving the test sites (back) in the previous 14 days
* individuals participating in another clinical study
* individuals with open or healing cuts/incisions abrasions, lesions, pustules, fissures or broken mucosa/skin in the test site
Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy

Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other genes in the cancer cells that are repressed; when the genes are turned back on by the drug, it leads to death of the cancer cells. HDAC inhibitors such as vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in experimental systems. The purpose of this trial is to determine the optimal dose of vorinostat to use in combination with standard chemotherapy alone (or in combination with plus trastuzumab for HER2-positive disease), and to determine whether vorinostat enhances the effectiveness of standard chemotherapy (+/- trastuzumab) in patients with locally advanced breast cancer.

This is a phase I-II trial in which patients with stage IIB-IIIC breast cancer will receive:

1. Neoadjuvant weekly paclitaxel (80 mg/m2 IV weekly x 12 weeks) plus vorinostat (200 or 300 mg PO BID on days 1-3 each paclitaxel dose) and trastuzumab (4 mg/kg loading dose, 2 mg/kg IV weekly x 12 total doses if HER2 positive, followed by:
2. Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 2 weeks x 4 cycles (plus G-CSF), followed by:
3. Surgery (lumpectomy or mastectomy)

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast associated with the following stages: IIB, IIIA, IIIB or IIIC.
* Tumor must be Her2/neu positive
* No prior chemotherapy, radiation or definitive therapeutic surgery

Exclusion Criteria:

* May not be receiving any other investigational agents
* Uncontrolled intercurrent illness