cyrilzakka/clinical-trials huggingface dataset:
Research on Innovative Diagnosis and Treatment System of Syndrome Differentiation of Zang-fu Viscera and Effectiveness Evaluation Based on Inter-Arm Blood Pressure Measured Simultaneously

By combining the measurement of blood pressure in both arms with the information of the four diagnoses of TCM, we try to form a diagnostic model of "five diagnoses combined with ginseng" based on TCM Zang-fu syndrome differentiation. It can further objectify and visualize the fuzzy four diagnostic indicators of TCM. In order to solve the problem of data differentiation of TCM four diagnoses, and optimize the five diagnoses of TCM conjunctive index, explore the establishment of TCM intelligent diagnosis and treatment and contact evaluation computer system


Eligibility Criteria:
Inclusion Criteria:

Case inclusion Criteria:

* Patients were treated with epigastric pain and / or insomnia, which met the above diagnostic criteria for diseases, liver and spleen;
* diagnostic criteria for diseases, liver and spleen;
* Age 18-65 years old;
* It can combine mild and moderate depression, anxiety Sign the informed consent form.

Healthy control inclusion criteria:

* PSQI \< 5 points;
* No hypertension, diabetes, hyperlipidemia, coronary heart disease and other underlying diseases;
* No depression, anxiety, malignant tumor, syphilis, HIV and other infectious diseases;
* Over 18 years of age;
* Volunteer to participate in this study, cooperate with the measurement of blood pressure in both arms, and sign the informed consent.

Exclusion Criteria:

Case exclusion criteria:

* Patients with insomnia disorder caused by uneffectively controlled or serious diseases, such as malignant tumor, persistent pain, cardiovascular and cerebrovascular diseases, endocrine diseases, etc.;
* patients with severe depression and mental illness;
* Pregnant and lactation patients.

Healthy controls exclusion criteria:

* sleep apnea syndrome or restless leg syndrome and other sleep disorders;
* Pregnant and lactation;
* Abnormal symptoms and abnormal tongue pulse occur in the body, such as facial acne, dysmenorrhea, thick and greasy tongue coating, loose stools, fat tongue, teeth marks and tongue.
Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients

Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently, clinical research about the triple antiplatelet therapy including cilostazol is actively conducted. But, clinical research about triple antiplatelet therapy for acute myocardial infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous intervention with drug eluting stent compared with dual antiplatelet therapy and investigate ideal duration of triple antiplatelet therapy through this research.

Drug-eluting stents (DES) have drastically changed the landscape of percutaneous coronary intervention (PCI), with significant reductions in the angiographic restenosis rate and need for repeated revascularization. However, several studies showed that DES is associated with a higher incidence of in-stent thrombosis compared with bare metal stents. Therefore, the latest guideline for antiplatelet therapy after PCI with DES suggests that the dual antiplatelet therapy (aspirin plus clopidogrel) be administered for at least 12 months.But is it enough for high-risk patients? Some studies showed that as many as 50% of the patients who received PCI did not react positively to aspirin or clopidogrel.Furthermore, there is increased platelet activity in acute coronary syndrome, especially in acute myocardial infarction (AMI). compared with aspirin or clopidogrel.A recent study suggested that cilostazol could ameliorate platelet responsiveness to clopidogrel in patients who underwent primary PCI. Furthermore, some other studies showed that the administration of cilostazol after PCI could significantly lower the incidence of in-stent restenosis. Therefore, the present study is designed to evaluate the safety and efficacy of additional administration of cilostazol with aspirin and clopidogrel in a real-world cardiology practice among patients presenting with AMI who received primary PCI with DES.

Eligibility Criteria:
Inclusion Criteria: Acute Myocardial Infarction Undergoing Primary percutaneous coronary intervention.

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol
2. Uncontrolled hypertension
3. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.
4. Baseline hemogram with Hb\<10g/dL or PLT count\<100,000/μL
5. Patients already taking warfarin, cilostazol or any other type of anti-platelet agents except aspirin and clopidogrel
6. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
7. Pregnancy
A Food Effect Study of SPH5030 Tablets.

The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Fully informed subjects who voluntarily sign the ICF；
2. Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.

Exclusion Criteria:

1. Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study;
2. Subjects with abnormal test results during the screening period；
3. Subjects who have difficulty in venous blood collection;
4. Subjects who cannot accept uniform diet or have difficulty swallowing;
5. Other situations that meet the exclusion criteria.
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* History of gout
* sUA \> 7 mg/dL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History of kidney stones
Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.

Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label

Eligibility Criteria:
Inclusion Criteria:

* Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
* Subjects must be in good health as determined by medical history, physical examination and clinical judgment.

Exclusion Criteria:

* Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
* History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
* Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
* Receipt of immune-globulin within the past 3 months.
* Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.
Open Label Regorafenib Study to Evaluate Cardiovascular Safety Parameters, Tolerability, and Anti-tumor Activity

Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability and anti-tumor activity in patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \>/= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
* Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:

  * Hemoglobin (Hb) \>/= 9.0 g/dL, Absolute neutrophil count (ANC) \>/= 1500/mm³, Platelet \>/= 100,000/mm³, Total bilirubin \</= 1.5 times upper limit of normal (ULN), Alkaline phosphatase \</= 4 x ULN
  * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \</= 2.5 times ULN (\</= 5.0 x ULN for subjects with liver involvement of their cancer), International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) \< 1.5 x ULN, Serum creatinine \</= 1.5 times ULN and glomerular filtration rate (GFR) \>/= 30 ml/min/1.73 m² according to the MDRD (Modified Diet in Renal Disease) abbreviated formula, Lipase \</= 1.5 x ULN
  * Left Ventricular Ejection Fraction (LVEF) \>/= 50 % as assessed at the Baseline Multigated Acquisition (MUGA) scan
  * QTc (Q-T corrected) \</= 470 msec at Screening
* Having advanced, refractory disease
* Life expectancy of at least 3 months
* Recovery from any previous drug/procedure-related toxicity to Common Toxicological Criteria (CTC) Grade 0 or 1 levels (except alopecia), or to baseline preceding the prior treatment.

Exclusion Criteria:

* History of cardiac disease: congestive heart failure \> New York Heart Association (NYHA) Class II; active coronary artery disease (unstable angina \[anginal symptoms at rest\] or new-onset angina \[began within the last 3 months\] or myocardial infarction within the past 6 months).
* Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of \>/= 3 antihypertensive drugs or systolic blood pressure greater than 150 mmHg)
* History of or known human immunodeficiency virus (HIV) infection or active hepatitis B or C.
* Subjects with serious non-healing wound, ulcer, or bone fracture
* Subjects with arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 6 months before start of study medication
* Persistent proteinuria of CTC Grade 3 or higher (\> 3.5 g/24 hours, measured by urine protein/creatinine ratio on a random urine sample)
* Symptomatic metastatic brain or meningeal tumors unless the subject is \> 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry
* Clinically significant bleeding (CTC AE Grade 3 or higher) within 30 days before start of study medication.
* Subjects with seizure disorder requiring anticonvulsant medication
* History of organ allograft
Effects of Yakult Ingestion in Residents and Staffs at Indonesian Elderly Houses

A study to investigate the effect of Yakult® containing L. casei Shirota on the intestinal microbiota, intestinal environment, and stool frequency in healthy adult and elderly subjects in Indonesia. The clinical phase of this study was conducted for 26 weeks in three different elderly houses. The subjects were grouped into two categories: probiotic and placebo group, according whether the subjects consumed product or placebo samples. Fecal sampling were taken three times during the study.

The study investigates the ingestion effect of a commercialized probiotic milk drink, Yakult®, for residents and staffs at Indonesian elderly houses (age limit: 18 - 95 years old). The study will be conducted as a double blind, placebo controlled parallel comparison study. There will be 26 weeks used for the study, comprised of: A 2-week baseline assessment period, and 24-week probiotic or placebo intake period.

From 112 subjects, the participants will be grouped into two: probiotic and placebo group. Those in probiotic group will consume Yakult® (Fermented milk drink containing over 6.5×10\^9 CFUs of L. casei Shirota/65 ml), while placebo group will consume the placebo product (taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product). The treatment intake will be done for 24 weeks (182 days).

During the study, the participants are expected to fill questionnaire of frequency of bowel movements and Chinese Constipation Questionnaire to obtain the defecation frequency (Bristol Stool score) and abdominal symptom scores. Fecal samples will be collected three times: on the last day of the baseline period (day 14±1), 12 weeks (day 98±1) after intake period, after the 24-weeks intake period (day 182±1). Afterwards, the obtained fecal samples will be further analyzed for its microbial composition, level of short-chain fatty acids and putrefactive compounds.

Eligibility Criteria:
Inclusion Criteria:

* Understand and sign written informed consent
* Healthy adult and elderly subjects (adult: between 18 - 69 years old; elderly at least 70 years old.
* No history of an adverse reaction to any of the components of the active or placebo versions of the probiotic product.
* Can eat, regularly.
* Has been diagnosed by doctors as healthy both physically and mentally.
* Can abide by the experimental protocol.

Exclusion Criteria:

* Excessive alcohol consumption (defined as follows: male; over 28 glasses a week, female; over 21 glasses/week).
* Consume antibiotics or laxatives at least 2-week prior screening period.
* Consume ingestion of fermented dairy foods (yogurt), probiotic foods and/or prebiotic at least 2 weeks prior to the study.
* Reported current usage of Narcotics and Psychotropic,
* History of GI surgery i.e. Colectomy and Enterectomy.
* Symptoms meeting to Rome IV diagnostic criteria for irritable bowel syndrome
* Pregnant or childbearing women
Analysis of the Understanding of the French Version of the Vulvar Pain Assessment Questionnaire

Prior to the current study, a translation into french of the screening version of the VPAQ (VPAQscreen) and its supplemental scales (VPAQdesc, VPAQcope, VPAQpartner) was performed according to the recommended process. The present study aims to evaluate the understanding of this translation on a panel of 30 women suffering from provoked or mixed vestibulodynia.

The Vulvar Pain Assessment Questionnaire (VPAQ) is a self-assessment questionnaire for chronic vulvar pain. The English-language version has been validated on patients suffering from chronic pain of various causes, mainly vulvodynia. It explores the biopsychosocial dimensions of chronic vulvar pain: description, intensity, temporality, associated symptoms, emotional and cognitive functioning, coping strategies and interpersonal relations with the partner. The VPAQ inventory is divided into a main questionnaire (VPAQfull or a shorter version, VPAQscreen) and 3 supplementary questionnaires exploring Pain Descriptors (VPAQdesc), coping strategies (VPAQcope) and partner factors (VPAQ partner). The VPAQ inventory can be used both for research purposes and clinical practice. Indeed, it helps the patients to better express their symptoms and the providers to cover with one tool all the dimensions of chronic vulvar pain. A french translation would make the VPAQ inventory available for french speaking health care professionals and patients.

The aim of our study is to validate a french translation of the VPAQscreen and its three supplementary questionnaires. Prior to this study, a french translation of these questionnaires was performed according to the recommended process.

Whereas the English VPAQ inventory has been validated on patients with chronic vulvar pain, whatever the cause, the investigators have chosen to carry out this validation on a homogeneous population of women suffering from provoked or mixed vestibulodynia (i.e, pain located on the vulvar vestibule, triggered by local contacts and associated or not with spontaneous pain). Indeed, provoked vestibulodynia is the most frequent and the best-defined clinical subset of vulvodynia (i.e, chronic vulvar pain with no identifiable cause). The investigators excluded patients suffering from vulvodynia involving other sites than the vestibule as well as chronic vulvar pain related to specific causes (neurological, myofascial, etc..) The understanding of this french translation of the VPAQ will be tested on a panel of 30 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* with a diagnosis of provoked or mixed vestibulodynia confirmed by an expert gynecologist or vulvar dermatologist
* Have signed a consent form
* French mother tongue and able to read
* Affiliated to a social security scheme

Exclusion Criteria:

* Patient with vulvar pain associated with other pathologies
* Deprived of liberty or under guardianship.
Medication Adherence in Patients With Liver Cirrhosis

With this unfunded, investigator-initiated prospective, observational, explorative, single-arm and diagnostic single-centre study the investigators aim to evaluate medication adherence in patients with advanced liver cirrhosis

The main objective of the study is to investigate drug adherence in cirrhotic patients and to gain a better understanding of the causes of deficient adherence including evaluation for medication beliefs, satisfaction, depression, anxiety and health-related quality of life. A number of long-term medications have been approved for this group of patients in various indications and / or recommended by guidelines. However, adherence has not been adequately investigated yet. The investigators aim to focus on the following groups of ingredients / classes:

* Primary and secondary antibiotic prophylaxis (e.g. Norfloxacin)
* Non-selective beta-blockers (e.g. Carvedilol and Propranolol)
* diuretics (Spirolactones \[e.g. Spironolacton\], loop diuretics) Methodically, this is will be investigated in particular by taking into account the patients history, standardized questionnaires and validated interviews.

Eligibility Criteria:
Inclusion Criteria:

* Treatment at Dept. of Gastroenterology, Hepatology and Endocrinology at Med. School of Hannover
* Liver cirrhosis
* Written consent for the use of personal data and health data for the purpose of this study

Exclusion Criteria:

* lack of written consent
* No consent ability
* Lack of literacy
* Inadequate knowledge of German language
Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part II

The purpose of the present study is to evaluate the influence of the post-surgical chlorhexidine indication in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues.

The main hypothesis is that the post-surgical use of chlorhexidine affects the gene expression and the celular behavior in the early wound healing process of the soft oral tissues.

The bacterial infection control in the wound healing is a very important aspect to considerer. Local antiseptic administration after the surgical procedures has been used to control the bacterial contamination.

Chlorhexidine (CHX), widely used as antiseptic, especially as post-surgical indication, has a toxic effect both in vivo and in vitro and their influence on wound healing has been studied for a long time. One of the first animal studies, in 1980, concluded that intensive rinsing with high concentrations of chlorhexidine after oral surgical operations, could result in delay and disturbance of wound healing. Another more recent animal study concluded that CHX induces apoptosis or necrosis in the fibroblasts.

Mariotti and Rumpf, in 2016, carried out a studied incubating human gingival fibroblasts in CHX. The results have been suggested that chlorhexidine could induce a dose dependent reduction in cellular proliferation and that concentrations of chlorhexidine that have little effect on cellular proliferation can significantly reduce both collagen and non-collagen protein production of human gingival fibroblasts in vitro. Hence, the introduction of commercially available concentrations (0.12%) or diluted commercial concentrations (as low as 0.00009%) of chlorhexidine to surgical sites for short periods of time prior to wound closure can conceivably have serious toxic effects on gingival fibroblasts and may negatively affect wound healing.

All the previous mentioned studies permit understand that the CHX is not harmless to the oral tissues. However, its effect is not entirely clear and should be evaluated in depth taking into account that it is one of the most indicated antiseptics after surgery. Currently, there are no studies that evaluate if the post-surgical use of CHX affect the gene expression in the early wound healing.

Eligibility Criteria:
Inclusion Criteria:

* patients that required periodontal surgery;
* patients age between 30-60 years;
* patients with full mouth plaque score and full mouth bleeding score \< 15%;
* patients with a good general healthy status;
* patients without any medicaments or drug consumption that can affect the healing process;
* non-smoking patients.

Exclusion Criteria:

* patients in pregnancy;
* patients in lactation period;
* patients with consumption of antibiotics or anti-inflammatory drugs in the previous six months;
* patients with systemic diseases.
The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis

The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with psoriatic disease.

Sixty patients with psoriatic disease, who are referred to the outpatient psoriasis clinic of the Attikon University Hospital, will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian patients with psoriatic disease (plaque-type psoriasis or psoriatic arthritis)
* Body mass index ≥18.5 Kg/m2
* If female, patients must be non-pregnant and non-breastfeeding

Exclusion Criteria:

* History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.
* Moderate or severe valve disease
* Primary cardiomyopathies
* Chronic obstructive pulmonary disease
* Asthma
* Chronic kidney disease
* Liver failure
* Malignancies
Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation.

After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to pediatric burns care unit
* Burnt skin area 5-40%
* Scheduled for a dressing change under ketamine sedation

Exclusion Criteria:

* Neurologic or ophthalmic disease