cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will also be assessed.

This study will be a double-blind (neither the Investigator nor volunteer knows the assigned treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the study treatments is inactive), single-dose, 3-way cross over study (all volunteers will receive each of the 3 treatments but in a different order) in healthy Chinese volunteers. Volunteers will be assigned to 1 of 3 treatment sequence groups (ABC, BCA, or CAB). The treatment sequence will be decided by randomization. Treatment A will be a single oral (by mouth) dose of 100 mg of canagliflozin. Treatment B will be a single oral dose of 300 mg of canagliflozin. Treatment C will be a single oral dose of placebo (inactive medication). Each treatment will be given during a treatment period of 5 days duration; each treatment period will be separated by a washout period (a time period with no medication) of at least 10 days. Canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus (T2DM).

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must be non-smokers for at least 6 months before first study drug administration
* Volunteers must consume no more than 4 to 5 cups of coffee or tea or 8 cans of cola each day

Exclusion Criteria:

* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
* Female volunteer is breast-feeding
Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support

The goal of this project is to find a marker expression that the investigators can use to trace symptom progression and develop a more efficient therapy to enhance ARDS patient survival rate and better post-ICU life quality.

The investigators will first identify acute respiratory distress syndrome (ARDS) patients receiving ECMO support in ICU at National Taiwan University Hospital, and then collect blood, urine and bronchioalveolar lavage fluid (BALF) samples at different time points: before setting up ECMO, 2, 6, 12, 24, 72 hours,5 and 14 days after ECMO installment, time to wean ECMO and the day removing ECMO and leaving ICU. From the samples, the free radicals, cytokines (IL-1, IL-6, IL-8, IL-18,tumor necrosis factor-α, transforming growth factor-β), and inflammasome- related markers, immune cell responses and other biochemical markers would be measured. The novel biomarkers to predict the outcome of the patient will be identified.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old
2. ARDS, needing ECMO support

Exclusion Criteria:

1. pre-existing sepsis
2. pre-existing chronic renal failure (dialysis dependent), liver failure other diseases precluding chance of survival.
Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

This project evaluates the effectiveness of an intervention sought to reduce the physical effects of stress related to those issues that individuals cannot successfully communicate with anyone about. To do this, the investigators will be implementing a writing intervention over the course of the 6-week study. The investigators will be asking all participants to complete questionnaires over the course of the study period. The investigators are also asking participants to provide a small blood sample (from a fingerstick procedure) at two times during the study as well as saliva samples during that same time. The primary research question asks if this intervention procedure is effective. The investigators are evaluating total cholesterol, high sensitivity c-reactive protein, and cortisol.


Eligibility Criteria:
Inclusion Criteria:

* 110 pounds in weight
* Ability to fast for 8 hours prior to laboratory visit
* Staff member at Santa Clara University
* Certain level of inclusionary pretest stress measure

Exclusion Criteria:

* Hepatitis
* Endocrine Disease
* Kidney or Liver Disease
* Cancer (in any form)
* Cushing's disorder
* Rheumatological disorders
* Respiratory Disorders
* Diabetes
* High blood pressure
* Low blood pressure
* Heart or cardiovascular problems
* Chemotherapy
* Current use of alpha or beta blockers, steroids, or hormone replacements
* Pregnant and/or breastfeeding mothers
A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years

The goal of this clinical trial is to learn about persistence of immunity of PCV13 in healthy population aged 2 months, 7 months-5 years. The main questions it aims to answer are the percentage of subjects reached the IgG level of ≥0.35 µg/mL, GMCs level for IgG antibody, and SAEs from one month to 12 months after the last injection.


Eligibility Criteria:
Inclusion Criteria:

* Those who have participated in the Phase III clinical study of Beijing Minhai PCV13 and have been fully vaccinated with Minhai PCV13;
* An informed consent was required to sign by their legal guardians;
* Volunteers and their legal guardians/caregivers were able to attend the study visit as required by the protocol.

Exclusion Criteria:

* Those who had any administration history of pneumococcal polysaccharide or conjugate vaccine after participating in the Phase III clinical study;
* Prior to enrollment, patients who had a history of pneumococcal infection with one or more of the well-defined PCV13 serotypes;
* The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
Long-term Effects of Time to Treatment in Subarachnoid Haemorrhage

For patients with spontaneous subarachnoid haemorrhage, it remains to be investigated if there is an association between the time from patients call the Emergence Medical Coordination Center to neurosurgical admission and long-term outcome.

This is a retrospective cohort study with four-year followup. The primary aim is to determine if the time to neurosurgical admission is associated to labour marked affiliation and mortality after four years.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous subarachnoid haemorrhage registered in the Danish National Patient Register and confirmed by medical record review.
* Initially admitted to a hospital in the Capital Region of Denmark between 1 January 2008 and 31 December 2014.

Exclusion Criteria:

* Prior subarachnoid haemorrhage.
* Inhospital symptom onset.
A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced BCC and metastatic BCC
* Patients with adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Patients who had had major surgery within 4 weeks of initiation of study medication
* Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes.
* Patients with concurrent medical conditions that may interfere or potentially affect the interpretation of the study.
* Patients with neuromuscular disorders or are on concurrent treatment with drugs that may cause muscle damage.
* Patients who were on concurrent therapy with other anti-neoplastic agents.
* Patients who had taken part in an experimental drug within 4 weeks of initiation of study medication.
* Pregnant or nursing (lactating) women
* Women of child bearing potential unwilling to use 2 forms of highly effective contraception throughout the study and for 3 months after the last treatment
* Fertile males not willing to use condoms throughout the study and for 3 months after the last treatment.
* Patients who were unwilling or unable to comply with the protocol.
Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.

The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent.
* Any gender.
* Any racial or ethnic origin.
* At least 38 years of age or older.
* Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed.
* Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
* Spectacle sphere power range between +6.00 to -10.00.
* Previously dropped out of contact lens wear due to vision or vision and discomfort.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI

Exclusion Criteria:

* Current or active ocular inflammation or infection as determined by the Investigator.
* Astigmatism ≥ 1.00 D in either eye.
* History of previous eye surgery.
* Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator.
* Demonstration or history of corneal ectasia or keratoconus.
* Pregnant or lactating
Early Prosthetics in Children With Upper Limb Deficiency

For children with congenital upper limb deficiency, introduction of the prosthesis is guided by clinical experience rather than by Evidence Based Medicine.

This study will assess early development in children with upper limb deficiency according to age at the introduction of the prosthesis.

This study will give new keys in these specific prosthesis cares.


Eligibility Criteria:
Inclusion Criteria:

* Male or female child
* Aged from 1 month to 3 months and a half
* Placement of a prosthesis in a patient with isolated upper limb deficiency, type of congenital transverse unilateral amputation of the forearm segment
* Socially insured patient,
* Patient willing to comply with all study procedures and study duration
* Written informed consent from patient's legal guardians

Exclusion Criteria:

* Children with one or more high risk factors for neurodevelopmental disorders:

  * Very prematurity (\<32 weeks of amenorrhea \[SA\])
  * Premature infants \<37 WA with intrauterine growth retardation (IUGR) or low weight for gestational age (PAG) \<3rd percentile or \<- 2 SD for GA and sex according to national reference curves)
  * A presumed hypoxo-ischemic encephalopathy with an indication of therapeutic hypothermia
  * A perinatal arterial cerebrovascular accident (AVC) (diagnosed between the 20th week of fetal life and the 28th day of life including in premature newborns).
  * Cerebral growth anomalies: microcephaly with cranial perimeter \<- 2 SD at birth verified secondarily or macrocephaly\> + 3 SD for the term (persisting after a second measurement).
  * A family history of severe first-degree neurodevelopmental disorder (brother or sister or parent)
  * Symptomatic congenital cytomegalovirus infections and other infectious fetopathies: toxoplasmosis, Zika, rubella, etc.
  * Bacterial and viral herpetic meningoencephalitis
  * Complex congenital heart disease operated on: transposition of the large vessels; left ventricular hypoplastic syndrome.
  * Perinatal exposure to a major toxicant: certain antiepileptics (sodium valproate); severe exposure to alcohol and / or with signs of fetal disease.
  * Major, prolonged and repeated surgery (cardiac, cerebral, abdominal, thoracic).
* Exclusion of all deficiency forming part of a polymalformative, vascular syndrome (Poland syndrome), genetic cause ...
* Exclusion of all other forms of agenesis (bilateral, longitudinal, persistence of hand remains),
* Refusal of consent from one or both parents
Ropinirole 0.25 mg Tablets Under Fasting Conditions

The objective of this study was to compare the relative bioavailability of the test formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under fasting conditions in healthy, non-smoking, adult subjects.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy (physical exam, laboratory tests, medical history and ECG), non-smoker males and/or females who were between 18 and 45 years old

Exclusion Criteria:

* If female, pregnant, lactating or likely to become pregnant during this study.
* History of allergy or sensitivity to ropinirole or other dopamine agonists (e.g. Corolpam®, Dostinex®, Mirapex®, Permax®, Symmetrel®) or history of any drug hypersensitivity of intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
* History of dizziness, lightheadedness or fainting upon standing.
* Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, hyper/hypotension, arrythmia, tachycardia, seizure disorder or glaucoma.
* Presence of gastrointestinal disease or history of malabsorption within the last year.
* History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
* Presence of a medical condition requiring regular treatment with prescription drugs.
* Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
* Receipt of any drug as part of a research study within 30 days prior to dosing.
* Drug or alcohol addiction requiring treatment in the past 12 months.
* Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within the past 14 days prior to dosing.
* Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
* Positive test results for drugs of abuse at screening.
* Tobacco user within 90 days of the first study date.
* Unable, or unwilling to tolerate multiple venipunctures.
* Difficulty fasting or eating the standard meals that will be provided.
Intestinal Dysmotility: Effect of Colonic Load

Abnormal motility patterns in the jejunum can be detected in patients with prominent colonic distension, and it is not clear whether these abnormalities reflect a primary jejunal dysfunction or are due to a reflex distortion. The aim of the study is to determine the effect of colonic filling on jejunal postprandial motility using high-resolution manometry.

Healthy subjects will be studied following a controlled, parallel, randomized, single-blind experimental design. On the study day, nutrients will be continuously infused in the proximal jejunum (2 Kcal/min) during a 2-h period to induce a steady-state postprandial motor pattern. Jejunal motility will be concomitantly recorded using a water-perfused, high-resolution manometry catheter. After 1 hour of postprandial recording (basal period), a gas mixture will be infused during 7.5 minutes via a rectal tube (720 mL or sham infusion), and jejunal motility will be recorded for another hour.


Eligibility Criteria:
Inclusion Criteria:

* No digestive symptoms

Exclusion Criteria:

* Organic diseases
Evaluation of the Fluid Response of SARS-CoV-2 (COVID-19) Patients in Intensive Care; Pleth Variability Index

In this study; We aimed to investigate the role of pleth variability index, which is a noninvasive method, in showing fluid response in SARS-CoV-2 (COVID-19) patients, which we know is appropriate fluid management.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in COVID 19 anesthesia intensive care unit
* Patients over the age of 18

Exclusion Criteria:

* Patients under the age of 18
Lifestyle Intervention for Diabetes and Weight Management in Psychosis

The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with psychotic illnesses than in the general population. Life expectancy of individuals with psychosis is also 20-25 years less than the general population, primarily due to premature onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic illness has been an exclusion criterion in all large-scale studies of diabetes prevention and management. We propose a 3-year randomized controlled trial examining the effectiveness of a lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM. Weight and glycemic control will be the primary outcome variables. It is hypothesized that a significant weight reduction and improvement in glycemic control will be found in those who receive the LI relative to those who do not.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 70 years (inclusive)
2. DSM-IV-TR diagnosis of one of the psychotic disorders listed above
3. Body Mass Index (BMI) \> 25 kg/m2 at the time of enrollment
4. Clearly documented diagnosis of type-2 diabetes mellitus or prediabetes
5. Ability to provide informed consent
6. No medical contraindication to participation in weight reduction / exercise program, determined in consultation with their primary care physician
7. Female participants, of childbearing potential, using a medically accepted means of contraception

Exclusion Criteria:

1. Inability to give informed consent
2. Currently enrolled in a formal structured weight management program
3. Currently being prescribed medication specifically for weight loss
4. Participants with unstable or active cardiovascular illnesses (myocardial infarction, CHF, etc), active or end-stage renal disease, unstable thyroid disease, etc.
5. Recurrent episodes of diabetic ketoacidosis, seizure or coma without warning or severe hypoglycemia
Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) for Multiple Sclerosis

This is a patient-sponsored study that evaluates the safety and efficacy of reduced-intensity immunoablation followed by a single dose autologous hematopoetic stem cell transplantation in patients diagnosed with multiple sclerosis. Patients are followed-up after 1 month, 3 months, 6 months and 12 months post-transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with progressive multiple sclerosis with or without relapses
* EDSS score between 1.5 and 7.0, including documented rapid progression over the previous year unresponsive to conventional therapies or no available treatment options
* Aged between 18 and 60 with a history of at least one enhancing lesion on brain MRI
* With absolute neutrophil count ≥ 1,000/mm\^3, platelet count ≥ 100,000/mm\^3 and hemoglobin ≥ 9.0 g/dL

Exclusion Criteria:

* Patients with cardiac, renal, pulmonary, hepatic, or other organ impairment that would limit their ability to receive dose-intensive immunosuppressive therapy, high-dose chemotherapy, and/or Autologous HSCT
* Patients with any active or chronic infection e.g. uncontrolled viral, fungal, or bacterial infection
* Uncontrolled diabetes
* Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
* Patients whose life expectancy is severely limited by another illness
* Patients with evidence of myelodysplasia or other non-autoimmune cytopenia
* Patients having received a cytotoxic agent within one month prior to this study
* Patients who are pregnant or at risk of pregnancy, including those unwilling to practice
* Patients with psychiatric illness, mental deficiency, or cognitive dysfunction
* Patients unable to give written informed consent in accordance with research ethics board guidelines
Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent

Exclusion Criteria:

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
* Presence of an interfering open wound or edema over any portion of the VP shunt.
Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.

The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis.

The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis by a study of Randomized, Double Blind, Placebo-Controlled, Parallel Group.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women between the ages of 45 and 75 years with a natural menopause ≧ 6 months and serum E2 values \< 20 pg/ml, serum FSH values ≧ 25 mIU/mL;
2. Patients have bone mineral density \<-2.5 SD of T score at the lumbar spine (L2-L4);
3. All patients must sign the informed consent form (ICF) prior to the trial.

Exclusion Criteria:

1. Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis;
2. Any X-ray film that documents bone fracture within 3 month prior to the trial.
3. Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial;
4. Use of other Chinese medicine within 2 weeks prior to the trial;
5. Patients with significant renal function impairment (Creatinine\>2mg/dl) and liver function impairment (AST and ALT \> 2 x the upper limit of normal range);
6. Patients have laboratory test abnormality, which in the investigator's opinion might confound the study;
7. Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV);
8. Patients have life threatening disease;
9. Patients are allergic to any of the composition of Chinese medicine;
10. Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;