cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Pharmacokinetic and Safety Profiles of Different Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate the pharmacokinetics and safety of two formulations of SHR-1314.

This study will be a single-center, randomized, parallel, open-label, single dosing (SHR-1314 240mg) bridging study in healthy subjects to evaluate the pharmacokinetics and safety of two formulations of SHR-1314.

The study will consist of a 14-days screening period (-14\~-1 days); an observation period (1-3 days) and the follow-up period (4-113 days); Subjects will be randomly assigned to three group.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
* Men or women at least 18 years and no more than 45 years of age at time of screening.
* Men with a body weight ≥50 kg or women with a body weight ≥45kg, with BMI range from 18 to 25.
* Subjects with normal physical examination results and with normal laboratory results (blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray chest test are normal or with certain abnormal without clinical significance.

Exclusion Criteria:

* Presence of significant medical problems, with investigator's judge that not proper to participate clinical study
* History of hypersensitivity to any of study drug constituent
* History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years
* History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection.
* Those who have participated in any clinical study for any drug or medical device within 3 months before screening
* Those who have been vaccinated with live attenuated vaccine within 12 weeks prior to screening
* History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Subjects judged by the investigator as unsuitable for participating in this study.
Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)

The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.

During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates.

The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.

Eligibility Criteria:
Inclusion Criteria:

* Able to sign Informed Consent and Release of Medical Information Form
* Age ≥ 18 years
* Undergoing cardiac surgery with complete sternotomy (including re-operations)

Exclusion Criteria:

* Evidence of active infection (any culture positive or blood positive infection)
* Undergoing organ transplantation
* Patients with known hypersensitivity to vancomycin
* Pregnant or nursing women
* Mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study
Impact of Hibiscus on Cardiovascular Disease Risk

Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a cold or hot drink and is available in the United Kingdom (UK) markets in different forms including tea bags. There is preliminary data that support the hypothesis that HSC extract consumption has beneficial effect on blood vessel health and blood pressure reduction. Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the effect of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa calyces (HSC) compared with a matched control (water) on blood pressure and blood vessels function will be investigated after a high - fat mixed meal. This is with a view to determining the impacts of the extract on postprandial (after meal) blood pressure and other CVD risk factors. Results from the PHYTOVAS study could lead to identification of more dietary approaches that will contribute to CVD risk prevention and management.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 30 - 65 years
* 1 to 10 % Cardiovascular disease risk in 10 years
* Not taking blood pressure medication
* Not having liver or kidney disease
* Not anaemic
* A signed consent form

Exclusion Criteria:

* Female
* \<30 or \> 65 years
* \<1 or \>10 % Cardiovascular disease risk in 10 years
* Taking blood pressure medication
* Having liver or kidney disease
* Anaemic
* Lack of signing consent form
* Vegan
* Individual with food allergy
* Sufferers of chronic illness
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes

Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels. the one-hour glucola test is currently used to screen pregnant patients for gestational diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour later. We wish to compare 7-day continuous glucose monitoring to the one-hour glucola test, and determine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes.

All pregnant patients without pre-existing diabetes will be eligible for the study. Interest in participation will be determined at their initial prenatal visit. Those that are interested will be consented. Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. She will perform the routine glucola test sometime between days 2 to 7 . Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS. Results of CGMS will not be available to the patient or her physician until after completion of the pregnancy. The patient will be treated routinely, based on the results of the routine glucola test.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients
* Age 18-50
* Gestational age less than 28 weeks

Exclusion Criteria:

* Minors less than 18 years of age
* Multiple gestation
* Known fetal anomalies
Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)

This study will enroll 60 patients with mild to moderate active ulcerative colitis as subjects. They will be randomly divided into two groups: the TCM group received QHQYP rectal instillation, while the control group received mesalazine enema. The treatment period for both groups was 8 weeks. The modified Mayo Activity Index will be used as the main evaluation index. Secondary evaluation indices will include the Underwater Endoscopic Severity Index (UCEIS) score, endoscopic Baron score, mucosal histological score (Geboes index), Chinese medicine syndrome efficacy evaluation, quality of life score, physicochemical indicators reflecting disease activity or remission, intestinal microbiota indicators, and changes in inflammation and immune-related indicators in colonoscopy biopsy tissues. Safety indicators were also monitored.


Eligibility Criteria:
Inclusion Criteria:

1. Meets the diagnostic criteria for active ulcerative colitis, with clinical severity being mild or moderate and the lesion range being limited to the rectum or left colon and not extending beyond the splenic flexure.
2. Traditional Chinese medicine diagnosis indicates the presence of damp-heat syndrome in the large intestine.
3. Between the ages of 18 and 65, regardless of gender.
4. Informed consent and voluntary participation are required. The process of obtaining informed consent should comply with GCP regulations.

Exclusion Criteria:

1. Patients with severe disease condition.
2. Patients with infectious colonic diseases such as chronic schistosomiasis, bacterial dysentery, amoebic dysentery, intestinal tuberculosis, as well as non-infectious colonic diseases such as Crohn's disease, ischemic bowel disease, and radiation enteritis.
3. Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic megacolon, colon cancer, rectal cancer, and anal diseases.
4. Pregnant or lactating women.
5. Patients with severe primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival.
6. Patients with disabilities as defined by law (blind, deaf, mute, intellectually disabled, mentally ill, physically disabled).
7. Patients with suspected or confirmed history of alcohol or drug abuse.
8. Other conditions that may reduce the likelihood of enrollment or complicate enrollment, as determined by the researcher, such as frequent changes in work environment that may lead to loss of follow-up.
9. Patients with allergies to two or more drugs or foods, or with a history of allergy to the components of this medication.
10. Patients currently participating in other clinical trials of medications.
The Effects of Peanuts and Peanut Products on Glucose Control and Vascular Function

Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and insulin response when incorporated into an acute high fat/high glucose meal. However, it is unclear whether acute consumption of peanuts can also influence vascular function. This study will therefore evaluate the effects of acute peanut consumption on vascular function, glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve endothelial function as measured by flow-mediated dilation (FMD).


Eligibility Criteria:
Inclusion Criteria:

* 20-50 years of age
* LDL-C below 160 mg/dL
* Triglyceride below 350 mg/dL
* Blood pressure within normal ranges (below 140/90 mmHg)
* Not taking medication for elevated lipids, blood pressure or glucose

Exclusion Criteria:

* Allergies to peanuts or dairy products
* Known intolerance for high fat meals
* History of cardiovascular disease (CVD), kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis
* Use of non-steroidal anti-inflammatories or immunosuppressants
* Conditions requiring the use of steroids
* Use of medication or supplements for elevated lipids, blood pressure or glucose
* Donation of blood or plasma during the study
* History of thyroid disease
* Women
* Lactose intolerance
Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention

The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural myocardial infarction and major cardiac and cerebral events in patients undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy (Mehran Score ≥ 5)

Exclusion Criteria:

* Primary percutaneous coronary intervention
* Low risk for contrast induced nephropathy (Mehran Score \< 5)
* Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
* Infection
* Pregnancy, Lactation
* Renal failure requiring dialysis
* Hepatic failure
* History allergy for NAC
* History of Asthma
* Chronic nitrate usage
* Malignancy
* Use of corticosteroids
* Leukocytosis,Thrombocytosis,Anemia
* Blood pressure of \>180/100mmHg despite anti-hypertensive therapy
Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient

Due to minimal volitional activation of the impaired arm, these individuals are less able to engage in activities of daily living (ADL's). Moreover, simultaneous use of the hand and arm are needed throughout ADL's. The effects of these two approaches (circuit class training and individual task-specific training) on upper extremity function and activities of daily living (ADL's) have not yet been clearly identified, and studies on its effects on chronic stroke patients are limited.

several research found that circuit training improved various functional parameters after stroke. And most of the circuit based tasks from the published studies were focused on the leg strength, walking speed, distance and balance etc. Previous literature found that circuit class training is effective in improving upper extremity function in chronic stroke patients disregarding the type of stroke and the results of that study are not generalized for chronic stroke patients with upper extremity deficit. Secondly, circuit class training and task-specific training are effective for improving upper limb function following a stroke but in the acute stage. In fact, there is no evidence in which comparison of these two approaches has been done in chronic stroke patients and thirdly, between these two approaches which approach is more effective towards improving upper limb function in chronic stage.

Eligibility Criteria:
Inclusion Criteria:

* Mini-Mental State Examination score more than 24
* Chronic stage (i.e. post-stroke duration of 6 months)
* Single episode of stroke
* MAS of 1 to 3 at upper extremity.
* MRS of ≤ 3 at lower extremity.
* MCA stroke
* Scores 32 to 47 on Fugl-Meyer Upper Extremity Scale (FMA-UE)

Exclusion Criteria:

* Orthopedic conditions that affect the UE function.
* Other neurological conditions, like PD, MS etc.
Effects of Levothyroxine Treatment on Hemodynamic and Renal Functions in Subclinical Hypothyroidism

Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies.

The investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved.

Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution.

Animal experimental hypothyroidism is associated with renal and hemodynamic abnormalities. In human, exact measurements of GFR showed a decline in GFR after thyroidectomy and an increase in GFR and renal blood flow after hormone replacement. Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies. A retrospective study suggests that treatment of subclinical hypothyroidism may slow the degradation rate of renal function estimated by MDRD. However, the potential hemodynamic benefit of treatment has not yet been studied.

The investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved.

Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution. This open prospective study will include 16 patients in order to detect an increase of 1.2 standard deviation for the measured glomerular filtration.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* chronic kidney disease
* subclinical hypothyroidism

non-inclusion Criteria:

* insulin-dependent diabetes
* dialysis
Effect of 3D-printed Reconstruction System in Size of Left DLT

The precise and accurate size of DLT is a prerequisite to ensure its accurate position of its placement. Three-dimensional (3D) reconstruction technology can accurately reproduce the tracheobronchial structure to improve the correct size selection of DLT. To make it simpler, the investigators developed an automatic comparison software for 3D reconstruction based on computed tomography data (3DRACS). In this study, the investigators aimed to prove that 3DRACS is much more efficient in endobronchial intubation compared to the traditional method.

Lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients undergoing various intra-thoracic procedures. Lung isolation is primarily accomplished with a double-lumen tube (DLT) or bronchial blocker. One published study showed that residents with limited experience had a 40% error rate in accurately placing a DLT. The accurate choice of the size of DLT is a prerequisite for good lung isolation.Currently, There is lack of proper objective criteria for selecting size of DLT. DLT size selection is estimated empirically using the patient's height and sex, and studies have shown that the size of DLT according CT images of the chest is more accurate than experience. The investigators have developed an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size of the DLT for lung isolation. The aim of this study was to compare whether the use of 3DRACS to select a DLT size compared to conventional empirical selection methods could improve incidence of DLT intubation success and reduce airway injury.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 75 years.
2. American Society of Anesthesiologists Physical Status (ASA-PS) I-III.
3. Planned to receive lung resection surgery during lung isolation techniques by using DLT.
4. Signed informed written consent.

Exclusion Criteria:

The participant experiences any of the following：

1. Spinal malformation,
2. Expected difficult airway
3. Tracheal stenosis
4. Tracheal tumor
5. Bronchial tumor
6. Distorted airway anatomy
7. Tumors of the mouth or neck
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome

The intent of this clinical study is to answer the questions:

1. Is the proposed treatment safe
2. Is treatment effective in improving the health of patients with human frailty syndrome.

This will be an open-label, non-randomized multi-center patient sponsored study of Autologous Adipose-Derived Stem Cells (ASC) implantation after liposuction using an IV delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females Age \>55.
* Frailty syndrome defined by:

BMD\< T-1 (Based on QCT results) Body Mass: males \<8% or \>17% fat, females\<10% or\>24% fat (Lean Body Mass=Total Body Mass- %Body Fat)

* Ability to participate in the short physical performance battery
* Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria:

* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Active clinical infection being treated by antibiotics within one week of enrollment.
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Unwilling and/or not able to give written informed consent.
Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.


Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
* Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
* Adequate renal, hepatic and cardiac function

Exclusion criteria:

* Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. \[Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
* Patients with active brain metastases
* Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.