cyrilzakka/clinical-trials huggingface dataset:
The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human

The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in reducing the serum cholesterol in human with hypercholesterolemia.

In a randomized, placebo-controlled double-blind mono-centric study,179 subjects with total cholesterol (TC) level above 5.18mmol/L and triglyceride (TG) level lower than 2.25mmol/L were assigned to 500ml of low lactose milk enriched with 1.58g plant sterol esters or 500ml plain milk without plant sterols (placebo) or without any dairy product consumption (control) for 60 days. Subjects were instructed to maintain stable diet pattern and physical activity. Plasma concentrations of TC,TG,LDL cholesterol(LDL-C) and HDL cholesterol(HDL-C) were measured at initial visits, after 30days and after 60 days. The primary measurement was the change in TC. Secondary measurements were changes in TG,LDL-C and HDL-C.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18-65 yrs;
* Serum TC ≥5.18mmol/L, and TG≤2.25mmol/L;
* Normal blood pressure or able to control blood pressure within normal range;
* Willing to consent to study participation and to comply with study requirements.

Exclusion Criteria:

* Pregnant or breastfeeding women;
* Known allergies to dairy and any substance in the study product.For example lactose intolerance;
* Any comorbidity that could,in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes, including but not limited to cardiac disease, hepatic disease, renal disease, hematopoietic system disease and mental disease;
* Recent use (within 2 weeks of screening) of any prescription or OTC medication that affects serum total cholesterol or that may confound study outcomes.
A Study of Evacetrapib in Healthy Female Participants

The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones found in the blood will be measured and compared when taken alone and when taken with evaceptrapib. Each woman will participate in two study periods. Information about any side effects that may occur will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Are pre-menopausal females, and who are healthy as determined by medical history and physical examination
* Have a body mass index of 18 to 30 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* Have known allergies to evacetrapib and Ortho-Cyclen (ethinyl estradiol and norgestimate), related compounds or any components of the formulation
* Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have taken injectable contraceptives within 12 months prior to the first dose of the lead-in period or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of the lead-in period
* Use of any tobacco- or nicotine-containing products within 6 months prior to the lead-in phase and during the study
Light Therapy in the Treatment of Leg Pain

The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.

Tibial stress reactions and fractures are often difficult to treat, and therefore, many soldiers proceed to a medical disability/discharge. It is felt that with the use of the MIRE technology, active duty soldiers with tibial stress reactions and fractures will heal more quickly and completely. All soldiers will have a documented bone scintigraph as evidence for tibial stress reaction or fracture prior to enrollment. In addition, pain-pressure goniometric measures and time to complete the Balke protocol will also be used to assess healing with the MIRE technology.

Comparison: Soldiers with Active MIRE technology, compared to soldiers with Placebo MIRE technology.

Eligibility Criteria:
Inclusion Criteria:

* Active duty soldier
* Exertional leg pain of greater than 3 months duration
* Documented bone scintigraphic evidence for tibial stress reaction or fracture

Exclusion Criteria:

* Known leg Pathology other than stress reaction or fracture
* Service members known to be leaving area within next 6 months
* Pregnant females
* High risk cardiopulmonary patients
* Patients with assisted walking devices
* Patients with two or more cardiac risk factors
Investigation of Protein Biomarkers of Prostate Cancer

This study is looking at biomarkers in prostate cancer.

1. To establish primary culture of epithelial cells isolated from prostatectomy samples
2. To study biomarkers in prostate cancer

Eligibility Criteria:
Inclusion Criteria:

* Patients with prostate cancer.
Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring

Subjects will first have a blood pressure reading recorded on both arms using a non-invasive blood pressure monitoring (NIBP) cuff in the preoperative area. Then blood pressure will be recorded using the ClearSight monitor on each hand over a one-minute period. If mean arterial pressure (MAP) as assessed by either the noninvasive blood pressure (NIBP) monitoring cuff or the ClearSight system differs by more than 10% from arm to arm, the subject will be excluded from the study.

Before induction of anesthesia, the subject will be randomized to either:

ClearSight group + usual clinical care: Information from ClearSight monitor will be available to the clinicians. According to ASA guidelines, usual blood pressure monitoring includes non-invasive blood pressure measurements every 5 minutes during a surgical case.

Non-ClearSight group (blinded) + usual clinical care: Information from ClearSight monitor will not be available to the clinicians.

Both patient groups will have continuous ClearSight monitoring and non-invasive blood pressure monitoring every 5 minutes. The difference will be in the intervention group data from the monitor will be available to the clinicians in the operating room, but in the control group data from the ClearSight monitor will not be available (blinded) to the clinicians. Regardless of the study group assignment, second-by-second ClearSight monitor continuous blood pressure data will be recorded for each study patient and will be used for analysis.

The morning of post-operative day 3 the subject will be given the QoR-15 questionnaire and will complete POMS morbidity surveys.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 45 years
* ASA Physical Status 3 or 4
* Moderate- or high-risk non-cardiac surgical procedures (i.e., orthopedic, spine, urology, and general surgery) in patients in whom invasive blood pressure monitoring is not planned
* Anticipated surgical duration \>2 hours

Exclusion Criteria:

* Any contraindications to the proposed interventions
* Patient with invasive blood pressure monitoring
* Patients with contraindications to oscillometric blood pressure monitoring on one arm and ClearSite monitoring on the other
* Preoperative discrepancy in mean arterial pressure \>10% between the arms
A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF)
* A body mass index (BMI) between 18-30 kg/m2, inclusive
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator

Exclusion Criteria:

* Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator
* Known contraindication or hypersensitivity to Interferon-alpha (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part)
* Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP.
Ultrasound Guided Cricoid and Paralaryngeal Pressure

The primary objective is to study impact of upper airway ultrasonography in guiding anaesthetic assistant into providing accurate cricoid pressure, or both cricoid and paralaryngeal pressure in those with oesophagus deviation, achieving sonographic proven oesophageal occlusion compared to those without ultrasound guidance.

All patients consented for the study were having their airway examined via US. Cross sectional sonography of the airway was performed to determine the anatomic relationship of the oesophagus relative to the trachea:

1. before induction of anaesthesia
2. after GA before external airway pressure manoeuvre
3. after GA with external airway pressure manoeuvre.

US guided CP was applied on subjects with central oesophagus; CP and PLP were applied on subject with eccentric oesophagus anatomy.

PLP was performed by lateral compression on the eccentric oesophagus by fingertips under US guidance. To standardised the application of CP and PLP, only 2 well trained investigators were allowed to performed the CP and PLP, US scan on airway and patient recruitment. The conduct of trial involved 2 investigators where first investigator provide US scan, and second investigator provide compression of CP or PLP using fingertips guided by the instruction of first investigator.

Eligibility Criteria:
Inclusion Criteria:

Elective list Under general anaesthesia Not intubated prior to OT

Exclusion Criteria:

Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery
Metabolomics in Small Intestinal Bacterial Overgrowth

Small intestinal bacterial overgrowth (SIBO) is a condition where a person's own good and useful germs, live in parts of the bowel where there should not be any germs. It may cause difficult tummy and bowel symptoms in a wide variety of patient groups. Increasing evidence suggests that sometimes small intestinal bacterial overgrowth can also trigger or worsen diseases which do not have any bowel symptoms at all.

It is hugely under-diagnosed in clinical practice. Part of the reason for this is that current available diagnostic tests - culture of fluid sampled from the upper part of the gastrointestinal tract or breath testing, are complicated to do, difficult for the patient, and are not completely accurate. Therefore, the potential for a simple, more accurate test to revolutionise the diagnosis and aid with the treatment of this condition is immense.

When it is accurately diagnosed, treatment with antibiotics can cure the patient of their tummy or bowel symptoms.

Based on previous research the investigators have conducted, it is believed that it might be possible to diagnose this condition in a simpler and more accurate way by examining urine samples. This study will also investigate whether the condition could be diagnosed more accurately using a blood test, a different sort of breath test or using a mouth swab.

The proposed study will be conducted at Lincoln County Hospital, in collaboration with Joseph Banks Laboratory at the University of Lincoln. Additional urine, blood, swab and breath samples from patients with and without small intestinal bacterial overgrowth, before and after antibiotic treatment to identify specific molecular markers in urine, blood and saliva samples which diagnosis small intestinal bacterial overgrowth accurately.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged ≥ 18 and ≤ 50
2. Absence of red flag symptoms i.e. unexplained weight loss, a palpable mass, unexplained iron deficiency anaemia or rectal bleeding
3. GI symptoms which are due to possible SIBO
4. Capacity to give informed consent

Exclusion Criteria:

1. Presence of red flag symptoms (specified above in inclusion criteria)
2. Previous GI surgery including cholecystectomy (except appendicectomy, inguinal/femoral hernia repair or Caesarean sections)
3. Past history of inflammatory bowel disease, coeliac disease or pancreatic disease
4. Past history of cancer (except basal cell carcinoma)
5. Female patients who are pregnant
6. Inability to adequately understand verbal or written information
7. Inability or unwillingness to give informed consent
8. Unwilling to consider taking antibiotics to treat SIBO
9. Incapacity to comply with the demands of the study
EuroSIDA As An External Comparator To MOTIVATE Trials

Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. The rates of specific clinical adverse events in this identified patient population will be compared with the rates of these events in the participants of the MOTIVATE trials.

All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 16 at baseline.
* Viral Load (VL) \> 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
* No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
* \> 3 months exposure (sequential or cumulative) to at least 3 of the following;
* Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
* Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
* Protease Inhibitor (PI )
* Enfuvirtide

Exclusion Criteria:

None
The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma

The investigators aim to include 100 local participants over the next 5 years in a two-stage sequential randomized interventional study of intralesional Interleukin-2 (IL-2) and Bacillus Calmette Guerin (BCG) to assess the utility of treating cutaneous metastatic melanoma (CMM).

In the first stage of the study, all consenting CMM patients will be randomized and will receive 4 treatments of either intralesional IL-2 or intralesional IL-2 and BCG. We hypothesize that patients with MM (stage 3C or 4a with a minimum of 4 lesions) that receive combination therapy (IL-2/BCG) in the first stage of treatment will have a higher complete response (iCR) rate compared to IL-2 therapy alone.

Response to stage-one treatment will be monitored and patient response to treatment will be determined and reported according to Immune Response Evaluation Criteria in Solid Tumours (iRECIST) guidelines. Based on response to stage-one treatment, patients will be placed into a response group before entering stage two. For stage two of the trial, patients will be randomized again, and placed into a treatment group; Il-2, IL-2 and BCG, BCG, or Discontinue Treatment. Response to treatment will be monitored and patient response to treatment will be determined and reported according to iRECIST guidelines.

All patients will have lesions biopsied following standard surgical practice techniques and will provide urine and blood for analysis. Tissue samples will be assessed for immune system activity and transcriptome analysis, and urine and blood will be assessed for immune cell populations and markers. All patients will be followed for 5 years post treatment, and patient disease and survival status will be recorded according to iRECIST.

Eligibility Criteria:
Inclusion Criteria:

* Patient with cutaneous metastatic melanoma.
* Has 4 or more melanoma lesions.
* Between18 and 80 years of age.

Exclusion Criteria:

* Immunocompromized.
* Receiving immuno-therapy for other diagnosis.
* Inflammatory disease.
* Autoimmune disease.
* Pregnant
* HIV
* Test positive for TB
Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)

The ROSORC trial is a randomized study comparing the efficacy of a new association (sorafenib and IL-2) versus the standard therapy (sorafenib) in patients affected by different histotypes of metastatic RCC. This study is a first line therapy for the advanced disease. The primary objective is the progression free survival (PFS) in the 2 arms of therapy and the secondary objective is the overall survival (OS) and the response rate (RR) and the safety profile of the combination compared to sorafenib alone.

Patients will be allocated in 2 groups:

ARM A - Sorafenib 400 mg twice daily continuously and low dose of IL-2 administered s.c.

ARM B - Sorafenib alone at the same dosage used in the previous arm

The trial is stratified according to the MSKCC prognostic model (low intermediate high risk) and histology (Clear cell vs other histotypes). The main inclusion criteria are: cytohistological diagnosis of RCC, measurable disease as RECIST criteria, signed written informed consent, life expectancy of greater than 3 months.

The efficacy and safety analysis will be performed on an intent to treat population.

The anticipated median PFS time in the control arm is 6 months and we will expect an increase of 3 months in the experimental arm.

The sample size is 128 patients, 64 in each arm (1:1 randomization)

The study started in November 2006 and is a multicenter Italian trial.

Eligibility Criteria:
Inclusion Criteria:

* Cytohistological diagnosis of RCC
* Written informed consent
* Measurable disease according to RECIST criteria
* Age \>= 18 years
* Karnofsky PS \>= 60%
* Life expectancy of greater than 3 months

Exclusion Criteria:

* Prior medical treatment for metastatic RCC
* Brain metastasis or spinal cord compression
* Chronic treatment with corticosteroids
* Uncontrolled hypertension
Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The primary objectives of the study are:

* To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis.
* To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on Psoriasis Area and Severity Index (PASI).


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with plaque psoriasis for at least 6 months prior to screening
* Have moderate to severe chronic plaque psoriasis as defined by PASI score ≥ 12 and BSA ≥ 10% at baseline
* In the investigator's opinion is a candidate for systemic therapy

Exclusion Criteria:

* Non-plaque forms of psoriasis (e.g., guttate, erythrodermic or pustular)
* Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate)
* History of any of a list of pre-defined cardiovascular diseases
* History or known presence of any significant infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study.
* Previous exposure to any other S1P receptor modulator
* Receipt of a live vaccine within 28 days prior to randomisation
* Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate
* Clinically significant findings electrocardiogram (ECG) findings.
Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography

The study aims to explore the effect of tiotropium on airway remodeling by using Endobronchial Optical Coherence Tomography (EB-OCT). We enrolled patients with GOLD I stage COPD. All the patients will be divided into four groups randomly to receive SABA as needed with or without regular use of tiotropium. Changes of airway morphology (accessed by EB-OCT), pulmonary function, QOL, and SABA usage will be obtained.


Eligibility Criteria:
Key inclusion criteria

* Over 40 yrs; Male or female Diagnosed with COPD
* Pre-bronchodilator FEV1 ≥80% pred ;
* Patients must be able to perform all study related procedures

Exclusion Criteria:

* Patients with other lung diseases (such as bronchiectasis, pneumothorax, pleural effusion, airway deformation, lung surgery, etc.).
* Patients have poor compliance and are unwilling to receive medication regularly.
* Other complications of bronchoscopy or intolerance of bronchoscopy procedure.
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS)
* histologically confirmed diagnosis within 42 days of study treatment
* life expectancy of greater than 5 years
* ECOG performance status of 2 or less
* absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment

Exclusion Criteria:

* current or previous history of muscle invasive bladder tumors (\>T2)
* current or previous history of lymph node and/or distant metastases from bladder cancer
* current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder
* current systemic cancer therapy
* previous immunotherapy for bladder cancer
* previous intravesical chemotherapy treatment
* contraindication to use BCG of known tolerance to BCG
* history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps)
* patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)