cyrilzakka/clinical-trials huggingface dataset:
A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)

This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is divided into Part A and Part B, which are to be conducted simultaneously.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese adults, male and female, aged 18-65 years (both inclusive; subject to the date of signing of ICF).
2. Diagnosis of type 2 diabetes mellitus according to the diagnostic and classification criteria for diabetes mellitus issued by the World Health Organization (WHO) in 1999.
3. Patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs.
4. Hemoglobin A1c (HbA1c) ≥ 7.0% and ≤ 10 % at screening;
5. Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening.
6. Those who have no birth and sperm donation plans, and voluntarily take effective contraceptive measures from the signing of ICF to 3 months after the last dose. A negative pregnancy test for women of childbearing potential at screening.
7. Fully understanding the study objectives, the nature of the study, methods used and adverse reactions that may occur in the study, willing to enter the study and sign the ICF, and capable of communicating well with the investigator, and understanding and abiding by the requirements of the study.

Exclusion Criteria:

1. Diabetes mellitus other than T2DM, such as type 1 diabetes mellitus.
2. Fasting C-peptide \< 0.3 nmol/L.
3. Use of any DPP-4 inhibitors, insulin secretagogues such as sulfonylureas, TZDs and/or GLP-1 analogs within 3 months prior to screening.
4. Continuous insulin use for more than 14 days within 1 year prior to screening (time of insulin use for gestational diabetes mellitus is excluded from this limit).
5. Treatment with growth hormone, diuretics, etc., that may affect insulin levels as judged by the investigator within 6 months prior to screening.
6. Immunoserologic panel test results \[infection screening tests for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), and Treponema pallidum antibody\] assessed by the investigator as abnormal and clinically significant.
Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.

Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section.

ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid

Eligibility Criteria:
Inclusion Criteria:

* Males or females \>/=18 years old
* Adequate venous access for a minimum of 2 I.V. doses of study drug
* Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the clinical syndrome definitions listed below and requiring I.V. antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit

  * Cellulitis/erysipelas
  * Major cutaneous abscess
  * Wound Infection
* Suspected or documented gram-positive infection from baseline Gram stain or culture.

Exclusion Criteria:

* Uncomplicated skin and skin structure infections such as furuncles, minor abscesses
* Infections associated with, or in close proximity to, a prosthetic device
* Severe sepsis or septic shock
* Known bacteremia at time of screening
* ABSSSI due to or associated with any of the following:

  * Suspected or documented gram-negative pathogens in patients with cellulitis/erysipelas or major cutaneous abscess that require an antibiotic with specific gram-negative coverage. Patients with wound infections where gram-negative adjunctive therapy is warranted may be enrolled if they meet the other eligibility criteria
  * Diabetic foot infections, gangrene, or perianal abscess
  * Concomitant infection at another site not including a secondary ABSSSI lesion (eg, septic arthritis, endocarditis, osteomyelitis)
  * Infected burns
  * Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
  * Any evolving necrotizing process (ie, necrotizing fasciitis)
* Use of antibiotics as follows:

  * Systemic antibiotic with gram-positive cocci activity for the treatment of any infection within 24 hours before the first infusion of study drug
  * Patients who failed prior therapy for the primary infection site are also excluded from enrollment
  * Topical antibiotic on the primary lesion within 24 hours before the first infusion of study drug except for antibiotic/antiseptic-coated dressing applied to the clean postsurgical wound
* Administration of Linezolid within 30 days before the first infusion of the study drug
* Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome \[AIDS\])
* Previous exposure to Tedizolid Phosphate treatment
Targeted Treatment With Intercalated Radiotherapy in EGFR-mutant IIIA/IIIB NSCLC

The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.

Chemoradiation therapy is the standard treatment for unresectable, locally advanced NSCLC, but its efficacy reaches a platform, and treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitors (TKIs) produce a dramatic response in patients carrying EGFR activating mutations in the metastatic setting. Multiple prospective trials show that EGFR-TKIs have a better tolerability when compared with chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged ≥18 years.
2. ECOG performance status 0-2.
3. Pathologically diagnosed of non-small cell lung cancer, and staged as unresectable IIIA/IIIB according the TNM staging system (2009).
4. EGFR activating mutations in exon 18, 19 or 21were detected in tumor tissue or plasma.
5. Measurable disease must be characterized according to RECIST 1.1 criteria.
6. Life expectancy ≥12 weeks.
7. Adequate pulmonary function: FEV1.0 \>50% of the normal predicted value, or DLCO \>40% of the normal predicted value.
8. Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3.0 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
9. Adequate renal function: serum creatinine ≤ 1. 5 x ULN, and creatinine clearance ≥ 45 ml/min.
10. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.0 x 109/L, and Platelet count ≥75 x 109/L, and Hemoglobin ≥8 g/dL.
11. Female subjects should not be pregnant or breast-feeding.
12. Written informed consent provided.
13. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Exclusion Criteria:

1. Histologically mixed with small-cell lung cancer.
2. Mutations in EGFR exon 20 are detected.
3. Exposure to prior chest irradiation before the enrollment.
4. Patients with prior chemotherapy or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
5. History of another malignancy in the last 5 years with the exception of the following: Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
6. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
7. Existence of interstitial lung disease.
Healthy for Two, Healthy for You

Investigators conducted a pilot feasibility and acceptability randomized controlled trial of a remotely delivered behavioral health coaching program in pregnancy and postpartum.

Half of pregnant women are overweight or obese. Obesity disproportionately impacts low-income women and women of racial and ethnic minorities. Maternal obesity is linked with adverse perinatal outcomes, including gestational diabetes and preeclampsia, as well as longer-term health problems such as obesity in offspring and maternal cardiovascular disease. Pregnancy provides a unique opportunity to engage women in improving their health behaviors because women are motivated to protect the health of their babies and have frequent interactions with the healthcare system. Advances in behavioral weight management and obesity prevention have not yet been translated into real-world prenatal care settings. Our team was recently supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded Nutrition and Obesity Research Center Pilot and Feasibility program to adapt an evidence-based telephonic health coaching program for pregnant women. Investigators conducted 20 in-depth interviews with patients and providers to gain valuable feedback to inform the intervention design and delivery, and have put together a multi-disciplinary team to adapt the intervention. Investiagtors developed the intervention specific for pregnancy and postpartum based on this feedback and are testing the intervention, Healthy for Two / Healthy for You, to assess feasibility and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Mothers:

  * BMI \>= 18.5 kg/m2 at time of eligibility screening
  * Age \>=18
  * Able to provide informed consent
  * 12 weeks gestation or earlier
  * English speaking
  * Insurance type
  * Willing to provide address and \>=2 contact people
  * Consistent use of a personal smartphone and willingness to use for health behavior tracking as part of the study
  * Patient at a participating prenatal clinical site
  * Access to internet (including public library and smartphone)
  * Demonstrated ability to track caloric intake for 4 days
  * Singleton pregnancy

Infants:

• Born during Mother's enrollment in study

Exclusion Criteria:

* • Type 1 or type 2 diabetes, pre-pregnancy or gestational diabetes, diagnosed prior to start of intervention (14 weeks gestation)

  * Multiple fetuses
  * Prior history of severe preeclampsia, pre-term birth (before 32 weeks gestation)
  * Prior history of or current diagnosis of incompetent cervix
  * Poorly controlled blood pressure (\>160/100)
  * Unable to walk 1 block without pain, shortness of breath
  * Serious medication condition hindering use of recommendations for pregnancy weight gain
  * Not cleared by study's maternal-fetal medicine or treating obstetrician
  * Planning to relocate from areas in next 2 years
  * Psychiatric or substance use related hospitalization in past 1 year
  * (There is no exclusion criteria for the infants)
GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection

Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and potentially increase the risk of chronic rejection (CR) after lung transplantation.

The purpose of this study is to look at how often GER occurs in the lung transplant population and examine how GER may change the immune system and cause CR. In this way, we would be able to better identify patients that may benefit from anti-reflux procedures.

Part of standard pre-transplant work up includes a gastrointestinal (GI) work-up to check for GER. The following procedures will be done pre-transplant.

1. Standard GER questionnaire (RDQ): This is a 12 item questionnaire. This questionnaire will ask questions about any reflux symptoms present.
2. Esophagogastroduodenoscopy (EGD): This test will determine evidence of esophageal reflux and presence of a hiatal hernia.
3. Scintigraphic evaluation of solid gastric emptying: This measures the speed with which food empties from the stomach and enters the small intestine.
4. Twenty-four hour ambulatory pH testing: The ambulatory 24-hour pH monitoring test will monitor the acid in the esophagus during a 24-hour period.
5. Esophageal manometry testing: This procedure is done to evaluate the cause of reflux of stomach acid and contents back into the esophagus, and to determine the cause of problems with swallowing food.

These procedures will be done again at 3 to 6 months post transplant. The results of the EGD, scintigraphic evaluation, answers of RDQ, pH testing, esophageal manometry and bronchoscopy will be collected as well as spirometries and any episodes of rejection.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing pre-lung transplant evaluations at the University of Chicago Hospital
* Patients who are capable of becoming pregnant must have a negative pregnancy test prior to consent.
* All patients must be able to give written informed consent.

Exclusion Criteria:

* Pre-transplant patients in whom study procedures are contraindicated or patients who are unable to complete all the study procedures.
* Patients who are unable to give consent
Limbal Stem Cell Deficiency of Genetic Origin: Genotype-phenotype Correlation

The study aims at searching for a genotype-phenotype correlation in patients with a genetic pathology of the ocular surface, in order to identify genetic abnormalities associated with the most severe clinical situations.


Eligibility Criteria:
Inclusion Criteria:

* genetic pathology of ocular surface

Exclusion Criteria:

* Agonal glaucoma
* Low vision mostly related to retinal pathology
* Pregnant or breast feeding patient
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease

The aim of this study is to find out whether a new image analysis technique called Cortical Disarray Measurement (CDM) could be used to help better diagnose Alzheimer's disease. This study will see whether changes on CDM can be used to identify Alzheimer's disease from a group of people living with memory and thinking problems. The study will also explore how CDM relates to changes in memory or thinking over time.

This is a multi-centre observational longitudinal cohort study to evaluate and optimise the Cortical Disarray Measurement (CDM) technique for diagnosis and prognosis in patients with mild cognitive impairment and prodromal / mild Alzheimer's Disease. CDM is a novel MRI analysis tool that quantifies cortical and regional diffusion tensor imaging signals in grey matter to observe pathological changes related to neurodegeneration. Participants in this study will be monitored for 2 years.

Research Aims:

* Assess the accuracy of CDM in detecting progressive change in cognitive and functional measures over 2 years in participants presenting with mild cognitive impairment or early dementia.
* Determine the relationship between CDM (both cross-sectionally and longitudinally) and change on standard cognitive and functional assessment measures.
* Explore patient and companion views and experiences of the diagnostic journey for dementia and their views on CDM implementation.
* To explore the costs and consequences of introducing CDM-augmented MRI as a form of early diagnosis of Alzheimer's disease in people presenting with MCI or mild AD compared to current practice.

Eligibility Criteria:
PATIENT PARTICIPANTS

Inclusion Criteria:

* Diagnosis of mild cognitive impairment (MCI) or prodromal Alzheimer's Disease (AD) as defined by National Institute on Ageing/Alzheimer's Association (NIA/AA) diagnostic criteria for MCI/prodromal AD, NOT including MCI unlikely due to AD; OR, Diagnosis of Alzheimer's disease as defined by NIA/AA criteria for probable AD
* Clinical dementia rating (CDR) scale global score of very mild or mild (0.5 or 1) impairment
* Ability to undergo and tolerate MRI scans, with no contraindications to MRI
* Ability to tolerate blood draws
* Ability to give informed consent to participate in the study

Exclusion Criteria:

* Do not meet the inclusion criteria
* No study companion available
* Individuals with a non-progressive learning disability
* Pregnant or intending to become pregnant during the study

COMPANION PARTICIPANTS

Inclusion Criteria:

* Aged over 18 years
* Sufficient knowledge on study participant's condition to complete companion assessments of the patient, in the investigator's judgement
* Able and willing to attend all clinical visits for completion of companion assessments or provide the relevant assessments remotely via phone or video call

Exclusion Criteria:

* A condition or reason, in the investigator's judgement, that would question the validity of the acquired companion reported data
* Individuals who are not fluent in English
Metabolic Cost of Suspension Exercise Training (SET-UTH)

In this study, the investigators will be able to estimate the metabolic cost of several foundational suspension training exercises.

Suspension exercise training has become a popular cardiovascular training choice in fitness centers and athletic performance enhancement facilities. Despite widespread use and growing popularity, little is known about the metabolic demands of such a training method. Therefore, the purpose of this study was to quantify the cardiovascular and metabolic cost from various foundational suspension training exercises in order to contribute to a better planning of exercise programs in the real world.

Ten healthy young adults were assigned to execute six suspension training exercises (acute bout) for 30 and 45 seconds. Anthropometric, metabolic, and performance measurements were conducted at baseline. The metabolic cost was estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 35 years
* Physically active individuals
* Free of chronic diseases
* Free of musculoskeletal injuries
* Nonsmokers

Exclusion Criteria:

* Musculoskeletal injuries
* Chronic diseases
* Use of alcohol, caffeine and any type of ergogenic supplements or medication before (≤6 months) and throughout the study.
Filtered Trial for Amlodipine Non-responder

To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Essential hypertensive patients satisfying all of the following criteria;
2. Male or Female
3. Age \> 20 years
4. Outpatient
5. Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
6. Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.

Exclusion Criteria:

1. Taking four or more anti-hypertensive medications
2. Secondary hypertension
3. Mean seated diastolic blood pressure (DBP) \> 114 mmHg and/or mean seated systolic blood pressure (SBP) \> 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP \< 90 mmHg at Visit 3.
4. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
5. Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
6. History of myocardial infarction or cardiac surgery within last 6 months
7. History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
8. History of unstable angina within last 3 months
9. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
10. History of stroke or transient ischemic attack within last 6 months
11. History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy
12. Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
13. Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
14. Hepatic and/or renal dysfunction
15. Diagnosed biliary atresia or cholestasis
16. Hyperkalemia
17. Dehydration
18. Sodium deficiency
19. Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)
20. Patients who cannot change to the restricted administration and dosage during study period
21. Pre-menopausal women who meet any one of the following 1 - 3:

    * Pregnant or possibly pregnant (1)
    * Nursing (2)
    * Desire to become pregnant during study period (3)
22. Drug or alcohol dependency
23. Complication of malignant tumour or a disease requiring immunosuppressants
24. Compliance of \< 80% or \> 120% during the run-in period
25. Receiving any investigational therapy within 3 months
26. Judged to be inappropriate by the investigator or the sub-investigator
Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health

The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.

The äKwä 6-step skincare system is comprised of various skincare products intended to be applied both morning and night. Some of the notable ingredients included in the product formulas are fermented green tea water, other ferments, niacinamide, antioxidants, and a variety of natural plant extracts. The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.

Eligibility Criteria:
Inclusion Criteria:

* Individuals could participate who were at least 18 years old and in good health.

Exclusion Criteria:

* had allergies or contraindications to any ingredient of products,
* had a history of any acute or chronic disease that could interfere with or increase the risk of study participation
* had any medical procedures, such as laser resurfacing, or plastic surgery to the test sites within the last 12 months (including Botox, Restylyn, or other fillers)
* chronic skin allergies (dermatitis, eczema, psoriasis)
* had been treated for skin cancer within the last 12 months or have damaged skin near the facial area (e.g., sunburn, tattoos, scars, or other disfigurations)
* pregnant or planning to become pregnant in the following 12 weeks, or lactating