cyrilzakka/clinical-trials huggingface dataset:
A Study To Compare The Pharmacokinetics Of Different Formulations Of PF-04937319 In Healthy Subjects

This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
* Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.
* Body Mass Index (BMI) of 23 to 33 kg/m2 and a total body weight \>=50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated seasonal allergies).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Significance of Immunohistochemical Expression of Fascin-1 in Colorectal Carcinoma

Colorectal carcinoma is a major health problem. As a malignant tumor, the malignant potential of colorectal carcinoma is based mainly on its ability to metastasis to different sites. Fascin-1 is an actin binding protein which is involved in reconstruction of intracellular actin network, the latter enforces the neoplastic cell to invade surrounding structures.

colorectal carcinoma is an aggressive malignant tumor. It has high incidence of cancer-related morbidity and mortality. the malignant potential of a given neoplasm is based mainly on its ability to invade the surrounding vasculature and reach to distant sites, the latter is called metastasis. in order to metastasize to distant sites, the neoplastic cells must re-arrange the intracellular actin filaments into well formed intracellular assembly which enable the neoplastic cells to reach to distant sites. Fascin-1 is an actin binding protein, it is involved in reconstruction of actin assembly. fortunately, Fascin-1 could be blocked by newly developed medications, blocking of Fascin-1 may limit the metastasis of colorectal carcinoma. in current study the investigators detect Fascin-1 in colorectal carcinoma by immunohistochemical approach, then they correlated different levels of Fascin-1 expression to tumor clinical and pathological criteria as patients' ages, sexes, tumor stages, nodal metastasis, vascular and per-ineural invasions.

Eligibility Criteria:
Inclusion Criteria:

* All cases of colorectal carcinoma.

Exclusion Criteria:

* cases diagnosed on basis of lower endoscopic biopsies or local resections without radical colectomy.
* Patients with preopoerative history of chemo or radiotherapy.
* Patients with poor clinical data.
The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI

The purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency PCI in patients with STEMI.

150 STEMI patients planned for emergency PCI were randomized to three groups, Group 1:received atorvastatin 80-mg loading dose before PCI then followed by 40-mg daily for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 2:received atorvastatin 40-mg qd after PCI for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 3: received atorvastatin 20-mg qd after PCI (n=50).Before PCI,all subjects received oral administration of aspirin 300mg and clopidogrel 300mg.Levels of creatine kinase,CK-MB(creatine kinase-MB),were measured to estimate myocardial damage degree.HS-CRP(high sensitivity C -reactive protein),NO(NO synthase),SAA(Serum amyloid A) were measured at preoperation 1 hour,postoperative 24 and 72 hours,7days after PCI. To compare echocardiography changes among three groups.Patients enrolled in the study need to receive follow-up survey which was carried out by clinical doctors.Hence,MACEs were analyzed during 6-month follow-up.So, the aim of our study is to evaluate the clinical significance of loading dosage of atorvastatin therapy and analyze the mechanism underlying it.

Eligibility Criteria:
Inclusion Criteria:

* 1.Clinical diagnosis of STEMI less than 12 hours 2.Eligible for emergency PCI

Exclusion Criteria:

* 1.Contradiction to atorvastatin 2.Contradiction to aspirin, clopidogrel and contrast medium 3.Life expectancy less than 3 months 4.Tumor or inflammatory diseases
N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Acute alcoholic hepatitis (AAH) is the most severe form of alcoholic liver disease (ALD) and is associated with a high risk of dying in the short term. Corticosteroids are generally recommended in patients with severe AAH, but its use is still controverted and contraindicated in case of active infection or gastrointestinal bleeding. Therefore, alternative therapeutic options are needed.Ethanol consumption results in the depletion of endogenous antioxidant capabilities and patients with ALD have evidence of antioxidant deficiencies.Due to its effects on glutathion stores restoration and as such the limitation of the oxidative stress and its good tolerance and safety profile, N-acetylcysteine (NAC) is an attractive agent for the treatment of AAH.In this context, we hypothesized that NAC might be beneficial in severe AAH.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven alcoholic hepatitis
* Severe disease defined by a Maddrey score superior to 32

Exclusion Criteria:

* Neoplastic disease compromising 6 months survival
* HIV patients
* Hepatorenal syndrome
Study of MSC-Exo on the Therapy for Intensively Ill Children

At present, a number of projects related to MSCs have been approved for graft-versus-host disease, myocardial infarction, Crohn's disease and other diseases, indicating a strong therapeutic potential of MSCs. However, the efficacy of MSC-Exo for severely infected children is not fully evaluated. In our study, patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. This study will evaluate the application and therapeutic effect of MSC-Exo in severely infected children, and determine the Optimal dosage and infusion.

Mesenchymal stem cells (MSCs) are pluripotent stem cells with high self-renewal ability and multidirectional differentiation potential. studies revealed that local or systemic administration of mesenchymal stem cell-derivrd exosomes (MSC-Exo) efficiently suppressed detrimental immune response in inflamed tissues and promoted survival and regeneration of injured parenchymal cells. European Union countries have written MSCs into treatment guidelines for refractory graft-versus-host disease.

In China, the technology for isolation, in vitro culture and expansion of MSCs is already mature. With further research on the therapeutic efficacy of MSC-Exo and the development of clinical trials, it is expected to become a treatment for severe illness.

A predictable infection plan is going to be widely used in clinics to provide individualized treatment for patients, improve the prognosis of patients and improve the quality of life.

The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* children hospitalized in PICU of Children's Hospital of Fudan University

Exclusion Criteria:

* discharge within 48 hours
* patients without informed consent
* incomplete clinical and demographic data
CABALA Diet & Health Study

During digestion of fatty foods, the liver produces a substance called bile which helps with the absorption of fat in the gut (small intestine). Some research studies have shown that friendly bacteria that live in our gut can change the makeup of bile (referred to as bile acids) leading to a lowering of blood cholesterol levels, an important risk factor for developing heart disease. This finding has been found in people who consume diets high in dietary fibers and probiotics that enhance the growth of friendly gut bacteria, and also plant rich foods high in polyphenols (such as apples). At present, very little is known about how the makeup of bile acids can regulate blood cholesterol levels and if their measurement in blood, urine or stool samples can be used as an indicator of human health.

The aim of this study is to explore how consumption of foods which enhance the growth of friendly gut bacteria (such as probiotics, prebiotics, and plant rich foods high in polyphenols) can change the makeup of bile acids after 8 weeks. Changes in the bile acids measured in blood and stool samples will then be related to markers of health, such as blood cholesterol, glucose, insulin, vascular health and inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged 25-70 years
* BMI: 23-32 kg/m2
* Fasting glucose \< 7 mmol/l
* Total cholesterol \< 7.5 mmol/L
* Triglycerides \< 2.3 mmol/L
* Habitual breakfast consumers
* Weight stable in the last three months

Exclusion Criteria:

* Smoker
* Diabetes
* Endocrine disease
* Cardiovascular disease diagnosis
* Gastrointestinal diseases
* Pancreatic, hepatic or renal diseases
* Medications that could influence study outcomes (e.g. lipid lowering medications, anti-depressants, anticoagulants)
* Antibiotic use within the last three months
* Food allergies (e.g. gluten, dairy, apples) and intolerances (e.g. lactose)
* Alcohol or drug abuse (Drink more than 14 units of alcohol per week)
* Anemia (men:haemoglobin\<130g/ L and women \<120 g/L
* Planning or currently on a weight reducing program
* Pregnancy, planned pregnancy in the next year or lactating
* Irregular menstrual cycle
* Planning or currently on a weight reducing program
* Currently taking part or participation in other research studies within the last three months
* Recent blood donation or unwilling to refrain from donating blood during the study
* Regular consumption of probiotic or prebiotic food supplements or fiber based laxatives and unwilling stop consuming these for the duration of the study
Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients

Knee osteoarthritis (OA) is highly prevalent and a leading cause of pain that limits physical functioning in older adults. Clinical practice guidelines recommend physical exercise for managing symptoms of knee OA. As a result, several evidence-based exercise programs have been implemented in community centers. However, access to these programs is severely limited in rural settings. Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA. Accordingly, we aim to engage rural primary care practices (including medical directors, clinicians, and staff) to develop a clinical pathway that refers patients to an evidence-based exercise program, called Enhance Fitness® (EF), which we have adapted for remote delivery (tele-EF). Enhance Fitness is a group exercise program that is recommended by the CDC for OA management. It is available in over 800 sites nationally and is covered by Medicare Advantage plans, but it is generally not available in rural communities. In addition, we will assess the feasibility and acceptability of implementing the clinical pathway that identifies physically inactive older patients with knee OA, facilitates exercise prescription, and streamlines referral to tele-EF in a rural primary care clinic over a 5-month period.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* Community-dwelling
* English-speaking
* Physician diagnosed knee osteoarthritis
* Physically inactive as determined by the 2-item Physical Activity Vital Sign questionnaire

Exclusion Criteria:

* Cognitive impairment determined by a Mini Montreal Cognitive Assessment score of \<11
* Significant, non-corrected visual or hearing impairment
* Plans to move out of the area in the next 6 months
* Cancer requiring treatment (except for non-melanoma skin cancer) in the past 6 months
* Heart attack in the past 6 months
* Stroke in the past 6 months
* Hip fracture in the past 6 months
* Hip/knee replacement in the past 6 months
* Spinal surgery in the past 6 months
* Heart surgery in the past 6 months
* Deep vein thrombosis in the past 6 months
* Pulmonary embolus in the past 6 months
* Hospitalization within the last month
* ≥3 falls within the past month
Measurement of HTL0016878 in Cerebrospinal Fluid

A Phase 1, open-label, randomised, single oral dose study to determine the concentration of HTL0016878 in CSF and plasma in healthy male subjects following dosing with HTL0016878 10 mg or 20 mg oral solution

Up to 24 healthy subjects will be enrolled into 4 groups, with 6 subjects per group. Each subject will be randomised to receive a single oral dose of 10 mg or 20 mg HTL0016878 solution and will have a single CSF sample taken via lumbar puncture at either 2 or 6 hours post-dose. Pharmacokinetic blood sampling and safety measures will continue until 24 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive. Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, C-SSRS responses, and clinical laboratory evaluations.

Willingness to comply with requirements or the trial, including contraception requirements.

Able to give fully informed consent.

Exclusion Criteria:

Positive tests for hepatitis B \& C, HIV. Clinically relevant history of abnormal physical or mental health. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry or coagulation panel and urinalysis), 12-lead ECG and vital signs, or physical findings.

History of severe adverse reactions or allergies, or history of an anaphylactic reaction to prescription or non-prescription medication or food.

Drug or alcohol abuse. Smoking. Use of medication that inhibits CYP2D6. Participation in other clinical trials of unlicensed medicines in the previous 3 months. Loss of more than 400 mL blood in the previous 3 months. Vital signs, QTcF interval or laboratory values outside the acceptable range. Predicted poor and intermediate CYP2D6 metabolisers. Clinically relevant abnormal findings at the screening assessment. History of epilepsy or seizures. Clinically relevant abnormal medical history or concurrent medical condition disease associated with cognitive impairment and/or psychosis. History of suicidal thoughts or ideation, or any history of insomnia. Use of tobacco and/or nicotine containing products within 90 days of dosing. Habitual and heavy consumption of caffeinated beverages. Consumption of cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 3 days before admission. Objection by General Practitioner
Reversal of Complete Heart Block With Aminophylline in Inferior Wall Myocardial Infarction Patients

In this study we will evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall myocardial infarction (MI)

Administration of Aminophylline can result in reversal of complete heart block in a significant number of atropine resistant patients with inferior wall MI. Hence, in this study our primary aim is to evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall MI.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted with recent acute inferior wall myocardial infarction (MI)
* Hemodynamically stable blood pressure
* Complete heart block with Narrow QRS \< 120 ms and ventricular rate \>40/min persisting for at least 6 hours resistant to atropine
* Temporary pacemaker (TPM) already placed
* Patient asymptomatic with mean arterial pressure of greater than 65 mmHg with TPM rate placed at 40/min

Exclusion Criteria:

* Patients with cardiogenic shock
* Patients with preexisting permanent pacemaker and Implantable Cardioverter Defibrillator (ICD).
* Patients with prior history of AV block
* Drugs with dromo-tropic effects (beta blocker, calcium channel blocker, inotropes)
* Known liver disease (cirrhosis, hepatitis)
* Hypothyroidism
* Unable to consent
Protein S and Myocardial Infarction

To test the hypothesis that low levels of free protein S, a natural anticoagulant protein in plasma, were associated with an increased incidence of myocardial infarction in middle aged men and women.

BACKGROUND:

Free protein S (that portion of plasma protein S which is not in complex with C4b binding protein) is a cofactor for the anticoagulant effect of activated protein C. Patients presenting with acute myocardial infarction have significantly reduced levels of free protein S. If the major hypothesis proved correct, patients at high risk of myocardial infarction could be identified and could be targeted for future studies to examine specific intervention therapy.

DESIGN NARRATIVE:

The blinded and prospective study began in 1992, although the grant was first awarded in 1983. The goal was to determine if low levels of free protein S were associated with an increased incidence of myocardial infarction. Plasma samples were obtained yearly from 2,224 men aged 50-59 years who were participants in the Second Northwick Park Heart Study sponsored by the British Medical Research Council Epidemiology and Medical Care Unit. Clinical endpoints for the study were documented fatal and non-fatal myocardial infarction. To prevent potential bias, this laboratory was blinded to the clinical endpoints until all samples had been collected and all causes of death in the study population had been adjudicated. ln addition to free protein S, total protein S and C4b binding protein were measured. The study design permitted the assessment of the temporal relationship between the development of low free protein S levels and the occurrence of myocardial infarction and the presence or absence of a biologic gradient (dose-response) between levels of free protein S and the frequency of infarction. These two analyses were important in assessing whether the observed association was causal or whether low protein S occured as a consequence of myocardial infarction. Three levels of free protein S had been defined prior to initiating the study to determine if the frequency of myocardial infarction did follow a biologic gradient. The measurement of other potential markers of risk by other laboratories, such as prothrombin fragment Fl+2 and factor X activation peptide, permitted a comprehensive evaluation of hemostatic risk factors in myocardial infarction. A second study was conducted in women to examine protein S as a risk factor for myocardial infarction.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes

The purpose of this study is to determine the short-term effects of the antimalarial medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.

Diabetes is approaching epidemic proportions in the United States. This study evaluates the mechanisms of action of a generic drug that may have effects on glucose metabolism.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> or = 18, able to provide informed consent
2. Body-mass index greater than or equal to 25
3. Presence of at least one indicator of insulin resistance from the following list:

   * Family history of Type 2 diabetes (parent, sibling)
   * Fasting glucose 100 - 125 mg/dl
   * Fasting serum insulin greater than or equal to 7uU/ml
   * Personal history of gestational diabetes
4. Negative pregnancy test for women with childbearing potential

Exclusion Criteria:

1. Diagnosis of diabetes mellitus Type 1 or Type 2
2. Active autoimmune disease, chronic infection, current malignancy (excluding basal cell carcinoma), or other active inflammatory state that, in the opinion of the investigators, would affect insulin sensitivity
3. Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months
4. Known allergy or intolerance to HCQ
5. Known glucose-6 phosphate dehydrogenase deficiency
6. Known eye disease associated with retinal pigmentation abnormalities
7. Known diabetic retinopathy requiring past or planned laser therapy
8. Inability to comply with visit schedule and protocol requirements
9. Inability to manage and take medication as instructed
10. Current or planned pregnancy in upcoming 12 months
11. Inability or unwillingness to use reliable method of contraception (for women of childbearing years, men, or men's partners with childbearing potential), such as oral contraceptive pills, barrier method (diaphragm and condom with spermicide), intrauterine device, or depo-provera injections for 3 months prior to enrollment
12. Anemia (HGB \< 9)
13. Any history of bariatric (weight loss) surgery
14. Current use of the medication Glucophage (metformin)
15. Weight changes of 6 pounds or more in the past 4 weeks
16. Any other underlying or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk
Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery

patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.


Eligibility Criteria:
Inclusion Criteria:

* . Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.

Exclusion Criteria:

1. Patients with acute infection at surgery site.
2. Patient with Systemic disorders contraindicating surgery.
3. Smokers.
4. Alcohol or drug abuse is prohibited.
5. patients who suffered from craniofacial syndrome.
6. patients who had previous orthognathic surgery.
7. patients who had previous maxillary or mandibular trauma
Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation.


Eligibility Criteria:
Inclusion Criteria:

* Any participant less than 18 years old after blunt trauma
* Seen by trauma service
* With cervical spine imaging (XR, CT, or MRI)

Exclusion Criteria:

* CT scan from outside facility is poor quality and not repeated (\<63-channel, cuts \>3mm, no reformats, motion artifact)
* No radiology over reads by participating institution