cyrilzakka/clinical-trials huggingface dataset:
The Effects of Dietary Supplement of Coenzyme Q10（CoQ10） on Dyslipidemia

In previous study the investigators found that CoQ10 can improve cholesterol efflux from macrophages in cell model, ApoE mice model and small-scale of healthy volunteers. In addition, CoQ10 has strong antioxidant activity and is an essential factor of mitochondria electron transport chain. So the investigators hypothesize that CoQ10 may have some health promotion effect on dyslipidemia, risk factor of atherosclerosis and other cardiovascular diseases. On this purpose, the investigators are going to recruit 150 dyslipidemia patients to supply CoQ10+vitamin E or CoQ10 alone or placebo in different doses for 24 weeks to explore the effects of CoQ10 on cholesterol efflux and lipid profiles on dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* The subjects were considered to have dyslipidemia if they met 2 of the following 4 criteria:

  * fasting total cholesterol concentration\>200 mg/dL,
  * fasting triglyceride concentration\>150mg/dL,
  * fasting LDL-cholesterol concentrations\>100 mg/dL, or
  * fasting HDL-cholesterol concentrations\>40 mg/dL.

Exclusion Criteria:

* history of CVD or other severe chronic disease or use of any drugs known to affect lipid metabolism.
* use any antioxidant such as Vitamin E, vitamin C,Phytochemicals and coenzyme Q10 within two months before trial.
* pregnant or lactating women
Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product

The purpose of this study is to evaluate the safety and efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus.

same as above

Eligibility Criteria:
Inclusion Criteria:

* Non-responder to conservative treatment for radiographically confirmed (by MRI) osteochondral lesion of talus with ankle pain and/or stiffness and less than 75 of the AOFAS score
* Age between 20 and 70 year-old
* Appropriate function of blood clot PT(INR) \< 1.5, APTT \<1.5×control
* Appropriate renal function Creatinine ≤ 2.0 ㎎/㎗, proteinuria less than trace with Dipstick urine test
* Appropriate hepatic function Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
* No evidence of autoimmue disorder As screening test anti-nuclear antibody and/or anti-thyroglobulin antibody, if positive rheumatologist referral needed to confirm diagnosis
* No surgery or radiotherapy for the same ankle joint within 6 weeks
* Female patients agreeing with maintenance of contraception during study period
* No ligament instability greater than grade II (Grade 0 : none, Grade Ⅰ: 0\~5㎜, GradeⅡ: 5\~10㎜, Grade Ⅲ: \>10㎜) with physical exam
* Patients agreeing with participation in this study and signed on informed consent by their own will

Exclusion Criteria:

* Degenerative ankle arthritis patients
* Patients with autoimmune disease
* Patients with infectious disease needed parenteral antibiotics
* Patients with myocardial infarction, congestive heart failure, other serious heart diseases or uncontrollable hypertion
* Patients with other serious medical illness
* Pregnancy or breast feeding patients
* Past history related with psychiatric illness or epilepsy
* Alcoholic abuse
* Heavy smoker
* Chronic inflammatory disease including rheumatoid arthritis
* Participants of other clinical trial within 4 weeks
* Patients treated with immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
* Unstable ankle joint(lesion site) greater than grade II at physical exam (Grade 0 : none, grade Ⅰ: 0\~5㎜, GradeⅡ: 5\~10㎜, Grade Ⅲ: \>10㎜)
* Other inappropriate patients determined by the prinicipal investigator
Egg Protein Hydrolysate and Vascular Function

The incidence of type 2 diabetes mellitus (T2DM) is rapidly growing. Patients with T2DM are at increased risk of developing long term micro- and macrovascular complications. Subjects with impaired glucose tolerance (IGT) show increased blood glucose levels after an oral glucose load. These subjects have a markedly increased risk of later T2DM development.

T2DM development can be prevented or delayed by lifestyle modifications. To support lifestyle changes and reduce the risk of T2DM development, foods containing functional ingredients are being developed. An interesting functional ingredient is protein hydrolysate. An egg protein hydrolysate has been experimentally shown to improve endothelial function, to inhibit plasma angiotensin converting enzyme (ACE) and to reduce blood pressure in rats. Egg protein hydrolysate could thus be a interesting ingredient to treat the cardiovascular dysfunction associated with T2DM. In the present study, the effects of egg protein hydrolysate will be evaluated in subjects with overweight or moderate obesity and IGT or T2DM.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70 years;
* male and female;
* Body Mass Index (BMI) between 25-35 kg/m2;
* Diagnosed T2DM (subjects are allowed to use oral antidiabetics and/or to be on a diabetes diet) or impaired glucose tolerance (defined as blood glucose \> 7.8 mmol/l and \< 11.0 mmol/L, two hours after ingesting 75 gram glucose in 150 ml water)

Exclusion Criteria:

* known allergy to (chicken) egg proteins;
* active cardiovascular diseases like congestive heart failure or recent (\< 6 months) event (acute myocardial infarction, cerebral vascular incident);
* severe medical conditions related to the intestine that might interfere with the study such as inflammatory bowel disease and celiac disease;
* the use of insulin;
* the use of medication such as antihypertensives, statins or drugs that change gastric motility or emptying;
* abuse of drugs or alcohol (\> 21 units per week);
* pregnant or breast-feeding women;
* current smoker;
* having donated blood at the blood bank within a period of 8 weeks prior to the start of the study
Tracing Changed Production of Red Blood Cells

In competitive sport, it is illegal to manipulate erythropoiesis. Manipulated erythropoiesis can indirectly be identified by atypical fluctuations in key haematological variables. However, this method also has limitations and as it is known that some athletes still manipulate erythropoiesis it is necessary to develop new and more sensitive detection methods.

The primary purpose of the study is to examine the importance of altered erythropoiesis for surface and intracellular erythrocyte proteins, the number of immature reticulocytes, and for the haematological characteristics of the erythrocyte, such as volume, haemoglobin concentration and concentration of glycosylated haemoglobin, to assess whether these can be used to identify changed erythropoiesis. Furthermore, the aim is to examine whether these parameters are affected by freezer storage of erythrocytes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* 18-40 years
* physical fitness rating more than 50ml/kg/min
* non-smokers
* blood pressure \<130/90 mmHg
* hemoglobin concentration 7-10.5 mM.

Exclusion Criteria:

* Blood donor who has donated blood within the last three months
* Participation in other concurrent clinical trials
* To participate in competitive sport during or three months after the study.
International Study of Childhood Obesity, Lifestyle and the Environment

The primary aim of the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) is to determine the relationship between lifestyle characteristics and obesity in a large multi-national study of 10 year-old children, and to investigate the influence of behavioral settings and physical, social and policy environments on the observed relationships within each country.

Data will be collected in 12 countries (500 children per site) from five major regions of the world (Eurasia \& Africa, Europe, Latin America, North America, and the Pacific). Cross-sectional evaluations will be undertaken in each country. The physical characteristics of the children will be directly measured in order to classify their body weight and adiposity status, and physical activity and dietary patterns will be measured with the most objective techniques currently available. A concise set of environmental measures that are feasible, valid and meaningful across the international settings included in this research will also be employed. The results of this study will provide a robust examination of the correlates of obesity and weight gain in children, focusing on both sides of the energy balance equation. The results will also provide important new information that will inform the development of lifestyle interventions to address childhood obesity that can be culturally adapted for implementation around the world.

Eligibility Criteria:
Inclusion Criteria:

* students 10 years of age

Exclusion Criteria:

* has pacemaker or other internal medical devices
AIMS Academy Clinical Research Network - Non Metastatic Rectal Cancer Operated on With Curative Intent

The primary purpose of this registry is to prospectively collect data from different Mini-invasive Colo-rectal Units in Northern Italy with a standardization of the pre-operative, intra-operative and post operative setting for patients operated on for non metastatic rectal cancer with curative intent. The secondary aim is to collect in a registry the compliance to oncological treatments and the oncological outcomes for the same patients

Study parameters

Patients with an histological diagnosis of rectal cancer will undergo pre-operative staging as follow:

* Chest-Abdominal TC scan with e.v. contrast.
* Complete colonoscopy
* Pelvic MRI with e.v. contrast with measurements of all the tumours aspects.
* Endorectal US examination
* Serum level of CEA and CA 19,9 and full nutritional status will be analysed
* Complete oncological and pathological medical history examination.
* Data from place of birth and places where patients lived will be collected.
* Sex and race Charlson Comorbidities Index adjusted for age will be calculated for each patient while Robinson Score will be calculated for aged over 70 patients.

Symptoms at presentation (Haemorrhagic framework ,alvo alteration, pain) will be collected. For Locally advance rectal cancer neo adjuvant chemoradiotherapy will be planned. Grey dose received and total dose of chemotherapy administrated together with eventual toxicity and reasons for non completing the therapy will be collected. Patients will be re-staged with pelvic MRI, endorectal US, colonoscopy. Radiological and endoscopic disease response to neo adjuvant treatment criteria will be noted.

Intraoperative analysed parameters will include :

* time of surgery
* blood loss
* type of analgesia
* type of technique, conversion
* level of IMA ligation
* if splenic flexure lowered down
* type of energy device used
* number and type of cartridge used for rectal stapled line
* size of circular stapler used for the anastomosis
* if loop ileostomy performed Isto-pathological examination will performed according to WHO 2010 guidelines, Quirke score and Dworak grade in patients who will undergo neo adjuvant chemo-radiation therapy will be reported. Mismatch repair proteins will be reported when analysed.

Post operative complication will be described according to Clavien Dindo complication scale. Day of discharge and eventual post discharge complication will be evaluated. Application of an ERAS protocol will be added only for at least 80% of ERAS colo-rectal items satisfied. Indication to eventual adjuvant therapy given within a multidisciplinary setting will be noted. Type of therapy, duration of the treatment and a full description of the compliance to the treatment will be described. Oncological follow up will be performed according to National Comprehensive Cancer Network guidelines. Functional follow up will be done yearly with the Low Anterior Resection Syndrome Score.

Eligibility Criteria:
Inclusion Criteria:

* non metastatic rectal cancer with the indication for a curative treatment

Exclusion Criteria:

* N/A
IMRT With Carboplatin Versus IMRT With Carboplatin and Fluorouracil for Eldly Esophageal Cancer Patients

An open, single-center, randomized controlled phase II clinical trial to compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy

Esophageal cancer is one of the most common malignant tumors in China.To compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy.This trial is an open, single-center, randomized controlled phase II clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age (\> 65 years)
* Histologically confirmed esophageal squamous cell carcinoma, the 8th edition of AJCC stage T3-4NxM0 or TxN1-3M0, without surgical indications after consultation by surgeons.
* PS score \< 2, Chemotherapy risk score is medium and high risk
* No radical thoracic surgery/chemotherapy/radiotherapy/targeted therapy has been performed in the past.
* Diseases measurable according to RECIST standards
* Hematological examination requires Hb (\>90g/L), ANC (\>2.0 \*109/L) and platelet (\>100 \*109/L). Serum albumin (\>3.0g/dL)
* Serum creatinine \< 1.25 times normal upper limit (UNL), or creatinine clearance rate (\>60 ml/min). Total bilirubin \< upper limit of normal value
* Total bilirubin \< the upper limit of normal value, AST (SGOT) and ALT (SGPT) \< 2.5 times the upper limit of normal value, ALP \< 2.5 times the upper limit of normal value (ULN)
* If exploratory surgery is performed, the patient will recover at least 2 weeks after operation.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with fertility without adequate contraceptive measures.
* Anaphylaxis to 5FU and carboplatin is known.
* Anaphylaxis known to exist with any drug in the study
* Other malignant tumors have occurred in the past five years, except cervical carcinoma in situ or non-melanoma skin cancer, which has been properly treated.
* Discovery of esophageal fistula or risk of esophageal bleeding before treatment
* Distant organ metastasis is known
* Symptomatic peripheral neuropathy, according to NCIC-CTC criteria (\> grade 2).
* Other serious diseases or medical conditions: Myocardial infarction (in the past six months), severe unstable angina pectoris and congestive heart failure have occurred.
* Severe complications (including intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, severe respiratory dysfunction of COPD, cardiac dysfunction of pulmonary heart disease, uncontrolled diabetes mellitus, renal insufficiency and cirrhosis of liver, etc.)
* Gastrointestinal bleeding requires frequent blood transfusion.
* It is known to carry human immunodeficiency virus (HIV) or AIDS.
* Suffering from mental illness
* The known neuropathy is of grade 2 or higher severity.
Liposomal Bupivacaine in Vaginal Hysterectomy

The aim of this study is to compare the effects of preemptive analgesia using liposomal bupivacaine mixed with bupivacaine HCl, versus bupivacaine HCl alone for uterosacral ligament injection in patients undergoing vaginal hysterectomy. We hypothesize that the group receiving a combination of liposomal bupivacaine and bupivacaine HCl will report superior postoperative pain management. Enhancement in pain control should confer a decrease in opioid and other analgesic medication requirements, which may contribute to decreased nausea, vomiting, and higher overall patient satisfaction with pain control.

Prior to surgery, patients are assigned by chance (like a coin toss) to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine. Patients and the Principal Investigator cannot choose the study group. Patients will have a 50% chance of being assigned to either group; however, regardless of which group they are assigned to, the medical record will show that they received liposomal bupivacaine. The injections will be given in the vaginal area when the patient is under anesthesia.

After surgery, patients will be asked to record their pain, medication use, pain scores and symptoms in a diary for each 12 hour interval up to 72 hours. Someone will also call twice a day during the 72 hours after surgery to ask about pain level and pain medication use.

Patients will also receive a phone call 7-10 days after the surgery to ask about their recovery and pain level.

Eligibility Criteria:
INCLUSION CRITERIA

1. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona

EXCLUSION CRITERIA

1. Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values
2. Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values
3. Known history of prolonged QT (QTc greater than 500 m/s)
4. Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral equivalents per day for a minimum of 1 month prior to surgery
5. Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron
6. Allergy to both oxycodone and hydromorphone
7. Patients with acute gastrointestinal bleed that has occurred less than 6 months prior to study enrollment
8. Adults lacking the ability to consent
A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects

The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and free from clinically significant illness or disease
* Male Caucasian subjects aged 18 to 55
* A body weight of ≥60 kg

Exclusion Criteria:

* Participation in more than three clinical studies involving administration of an Investigational Medicinal Product in the previous year, or any study within 12 weeks.
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
* Clinically relevant abnormal medical history, physical findings or laboratory values
Characterization of the Facial and Gut Microbiome in Rosacea

Questionnaires will be completed by each member of the twin set. A board-certified dermatologist will examine each member to categorize the type and severity of their rosacea. The facial and gut microbiome will be sampled and sent for microbial analysis.

1. Twin set subjects will be administered a questionnaire regarding demographics (age, gender, state of residence, time lived together, birth order), rosacea duration, prior rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and symptoms suggestive of cardiovascular or gastrointestinal disease/disorder.
2. Subjects will be examined by a board-certified dermatologist and global assessment, inflammatory counts and clinician's erythema score will be performed. Eyes will be examined for signs of ocular rosacea.
3. Facial microbiome sampling will be performed on-site utilizing a kit manufactured by UBiome. The skin with active rosacea will be swabbed and the swab immediately placed in sample medium. The tube is then shipped to the manufacturer for 16s rRNA shotgun metagenomics to identify resident bacterial genera and species. (16) This can be compared to their extensive library of normal controls, to the other member of the twin set and to acne subjects.
4. Subjects will be given a fecal microbiome kit for home sampling. Feces obtained from toilet paper is collected and placed in the sample medium. Subjects can either ship directly or return to the study site for shipping.

Eligibility Criteria:
Inclusion Criteria:

1. Presenting with monozygotic or dizygotic twin
2. One or both twins with facial rosacea
3. Willingness to allow facial and fecal samples to be analyzed -

Exclusion Criteria:

1. Non-twin siblings
2. Absence of facial rosacea in both twins -
Modulation of Muscle Protein Synthesis With Diet and Exercise in Old Aged Women

In this study will measure differences in how muscle responds to both exercise and protein supplements in healthy women aged 60-69. We are studying two different protein supplements- a standard Whey Protein and a Leucine enriched supplement. Each patient would receive either one of these.

One of the factors that plays an important role in the loss of functional performance and, as such, the capacity to maintain a healthy, active lifestyle is the progressive loss of skeletal muscle mass with ageing (i.e., sarcopenia). Indeed, sarcopenia is a more robust predictor of functional status and mortality in the elderly than chronological age or indeed, any other co-morbidity. Sarcopenia is an incipient process whereby lean muscle mass contributing up to \~50% of total body weight in young adults declines to \~25% when reaching the age of 75-80 y. Adequate nutritional intake, and in particular dietary protein, is important for offsetting age-related declines in muscle mass. The aim of this project is to seek the most effective nutrition with which to counteract sarcopenia, specifically in women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy post-menopausal females aged 60-70

Exclusion Criteria:

* • Obvious muscle wasting.

  * A body mass index (BMI) \< 18 or \> 40 kg•m2.
  * Active cardiovascular disease: uncontrolled high blood pressure, angina, heart failure (class III/IV), abnormal heart rhythm, right to left cardiac shunt or recent cardiac event.
  * Taking statin-based medication above 60mg•day-1.
  * Individuals taking beta-adrenergic blocking agents or Non-steroidal anti-inflammatory agents (NSAIDS)
  * Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial).
  * Respiratory disease including pulmonary hypertension, chronic obstructive pulmonary disease (COPD), asthma or a forced expiratory volume (FEV1) less than 1.5 litres.
  * Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes.
  * Active inflammatory bowel disease, renal disease, or malignancy.
  * Recent steroid treatment (within 6 months), or hormone replacement therapy.
  * Clotting dysfunction e.g. Deep vein thrombosis, pulmonary embolus, warfarin therapy and/ or haemophilia.
  * Musculoskeletal or neurological disorders.
  * Any leg amputated
  * Family history of early (\<55y) death from cardiovascular disease.
  * Known sensitivity to SONOVUE (US contrast).