cyrilzakka/clinical-trials huggingface dataset:
Dyslipidemia International Survey-China

This cross-sectional, non-interventional, and observational study will assess the lipid profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients achieving treatment to goal according to national and international lipid management guidelines) during a single visit to their physicians on an outpatient basis in 6 representative geo-economic regions in China: Northeast, North, East, South, Southwest, and Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community hospitals/health centers). The investigators will primarily be cardiologists, endocrinologists, neurologists, gerontologists, internists, or other physicians who are representative of the general population of physicians managing patients with dyslipidemia and/or at high risk for cardiovascular events likely to be treated with lipid-modifying drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease and cardiovascular treatments will be documented in a single visit through patient clinical examination and chart review.

DYSIS-China is part of a string of epidemiological studies that share the same master protocol, which has been conducted in different countries mainly in Europe and Canada. The analysis of the pooled studies including overall data and cross-country comparisons is the subject of a distinct protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is an outpatient \> 45 years of age
2. Patient is currently\* treated with a statin
3. Patient has a documented fasting lipid profile (\> 1 lipid parameter within the last 12 months) performed while on lipid-modifying therapy for at least 3 months
4. Patient agrees to participate in the study by giving informed consent.

   * Patient is already being treated with a lipid-modifying drug just before the visit. Patient for whom a lipid-modifying therapy is initiated at the time of the visit must not be included.

Exclusion Criteria:

1. Patient is currently participating in a clinical trial.
Status of Dental Care Practices in Patients With Hereditary Angioedema

Hereditary angioedema (HAE) is a rare genetic disease, it can occur at any age and evolves in flare-ups. These are subcutaneous or submucosal edemas responsible for tightness and pain. All areas can be reached. In addition, all their life, patients have an unpredictable risk of death from asphyxiating angioedema (25% mortality in the absence of specific treatment).

Surgical procedures, endoscopies and dental procedures can trigger laryngeal AE. Thus, the national reference center for angioedema (CREAK) and the latest international consensus1 recommend that all these procedures be preceded by short-term prophylaxis. The reference treatment is the C1 inhibitor 2 concentrate. But to date, there is no prospective study that has demonstrated the effectiveness of this short-term prophylaxis before dental treatment. Only a retrospective study has shown that its implementation made it possible to reduce the risk of crisis by 42% after tooth extraction 3 and that the risk of crisis was greatest within 8 hours following tooth extraction.

The C1 inhibitor concentrate must be administered IVL by a nurse within 6 hours before the procedure and therefore implies, in addition to its high cost (1500 €), an organizational burden for the patient who must plan for the passage of an IDE, the availability of the product and this sometimes for a simple dental treatment.

These constraints have two consequences for dental care: patients avoid going to the dentist to the detriment of their dental health or do not take prophylaxis with the risk of a fatal attack.


Eligibility Criteria:
Inclusion Criteria:

* Patient with HAE with or without C1 Inhibitor deficiency
* Patient over 18 years old

Exclusion Criteria:

* Patient opposed to the use of their data or refusing to answer the questionnaire
* Adult patients protected by law
The Effect of Cold Application on Pain Developed Due to Drain Removal in Patients With Kidney Transplantation

The study was planned as a prospective, randomized controlled study to examine the effect of cold application on pain due to Jackson Pratt drain removal in kidney transplant patients.

During kidney transplant surgery, a Jackson Pratt Drain (JP) is placed in the surgical field to monitor lymphocele and urinary leakage. This drain is a closed system that opens outward from the skin at a point close to the incision line. This drain is removed by pulling when the drainage amount falls below 30 ml. This procedure is known to cause serious pain. In our study, which was planned as a prospective, randomized controlled study, it was aimed to examine the effect of cold application in the pain caused by the removal of the JP drain in patients with kidney transplantation. The population of the study will be patients who had a kidney transplant in İstinye University Hospital Liv Hospital Organ Transplant Center (n=76). In the study, patients will be assigned to the experimental and control groups by the block randomization method. "Patient Information Form" and "Visual Analog Scale" (VAS) will be used as data collection tools. In the experimental group, cold application will be made until the skin temperature of the drain exit area reaches 13.6 °C. Then, the drain removal process will be performed by the physician. In the control group, no application will be made. In both study groups before drain removal, immediately after drain removal and 15 minutes later, pain levels will be measured with VAS and analgesic needs will be questioned. Chi-square and t-tests will be used to compare demographic data in the analysis process of the data. ANOVA test will be applied to compare pain scores between groups.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Being conscious, oriented to person, place and time,
* No history of mental pathology,
* No history of drug or alcohol use,
* Having a body mass index of \<30 kg/m2,
* Not using any analgesic or sedative medication one hour before drain removal.

Exclusion Criteria:

* IV analgesic or sedative treatment during cold application,
* Having a history of chronic pain,
* Having previous drain removal experience,
* Anxiety,
* Refusal to participate in the research,
* Unstable hemodynamic status.
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.

This study is partially Double-Blinded in that the participants' parents/guardians, investigator/study site personnel, and Sponsor's representatives will be blinded to the lot of V419 the participant is randomized to receive, but not to the participant's treatment group (V419 or control).

Eligibility Criteria:
Inclusion Criteria :

* Participant is a healthy infant
* Participant has received one dose of monovalent hepatitis B vaccine prior to 1 month of age

Exclusion Criteria :

* Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
* Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines or any combination of the above
* Participant has had an illness with fever within 24 hours of study enrollment
* Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or live virus vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 15 days or more prior to enrollment
* Participant or his/her mother has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)
* Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection
Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris

Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe facial acne vulgaris
* 20 to 60 facial inflammatory lesions
* 10 to 200 facial non-inflammatory lesions
* No more than 3 facial nodular cystic lesions

Exclusion Criteria:

* Uncontrolled systemic disease
* Use of systemic or topical acne therapy within 14 days of study
* Use of systemic retinoids within past 2 years
* Skin diseases that interfere with acne counts
* Active liver disease
* Screening elevations in liver function tests
* Positive serology for hepatitis B or C
* Use of theophylline, warfarin, or propranolol within 7 days of study
* Use of Singulair or Accolate within 14 days of study
* Female patients who are pregnant or nursing
A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension

Other protocol-defined exclusion criteria may apply.
Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity

Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible for the improvements in metabolic health after a single session of endurance exercise. The investigators will determine the effect of a single session of endurance exercise on whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise, effect insulin signalling and insulin sensitivity. Every effort will be made to recruit subjects from ethnic and minority groups. Before participating in the study, subjects will be informed of all the procedures and potential risks, and they will sign an informed consent form approved by The University of Michigan Institutional Review Board. Eligible volunteers will participate in three separate trials, in a randomized order. In two trials subjects will eat exactly the same amount of calories, except in one trial they will exercise (eucaloric + exercise) and in the other trial they will remain sedentary (hypercaloric). In a third trial subjects will again remain sedentary but instead they will ingest appropriate calories to maintain caloric balance (eucaloric + sedentary). By doing this the investigators are also able to investigate the effect of acute caloric perturbations on insulin sensitivity, because it is possible that the enhanced insulin sensitivity evident after exercise, as compared to the sedentary state, is due to caloric deficit and not the exercise bout, per se.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal; Body mass index 30-40 kg/m2; Waist circumference \>88 cm

Exclusion Criteria:

* Evidence of metabolic or cardiovascular disease; Pregnancy; Hyperlipidemia (fasting plasma triglyceride concentration \> 150 mg/dl); Hematocrit \< 34%; Undertaking regular exercise (i.e., \>2 times/week)
PRP Treatment of Osteoarthritic Knee With a New Autologous Blood Product (CytoRich)

This study is aimed at evaluating the efficacy and safety of Cytorich compared to platelet-rich plasma (PRP) in alleviating pain and improving function in subjects with knee OA.

This active-controlled, randomized, double-blind, prospective study will enroll subjects with knee OA. Subjects will be randomized equally to treatment with 4 injections of ABP (test treatment) or 4 injections of PRP (active control).

Eligibility Criteria:
Inclusion Criteria:

* Radiographic confirmation of OA in the knee and screening knee pain score of \>50 mm on a 100 mm visual analog scale (VAS) for at least one knee.

Exclusion Criteria:

* Female who is pregnant, lactating, or unwilling to use adequate contraception during the clinical study.
* Subject who had viscosupplementation within 3 months of screening.
* Subject treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 72 hours of screening.
* Subject who received steroid treatment within 8 weeks of screening.
* Subject who had an acute disease or trauma within 6 weeks of screening.
* Subject with any major surgery, arthoplasty or arthroscopy in the target knee or lower extremities within 6 weeks of screening (or any planned surgeries throughout the duration of the study).
* Subject with a major dysplasia or congenital abnormality of the knee or a condition which may affect the knee (i.e., osteonecrosis, chondrocalcinosis).
* Subject with a primary inflammatory arthropathy (i.e., rheumatoid arthritis, psoriatic arthritis, gouty arthritis).
* Subject with knee joint infection, skin diseases, or infections in or near the area of injection.
* Subject with any musculoskeletal condition that would impede measurement of the effectiveness at the knee (in particular symptomatic hip OA).
* Subject with any claudication or peripheral vascular disease.
* Subject with active malignancy or that has been in treatment for a malignancy within the past 3 years.
* Subject with uncontrolled diabetes mellitus, diabetic neuropathy, or complications from infection.
* Subject with known sensitivity to citric acid.
* Subject taking oral or parental anticoagulant therapy other than acetylsalicylic acid 325 mg per day or less.
* Subject with active disease that may require periodic treatment with systemic steroids during the study period.
* Subject with other diseases or conditions as assessed by the Investigator that may limit the ability to perform necessary study evaluations (e.g., active alcohol abuse, active drug abuse, significant psychiatric or neurological disorders, planned relocation, etc.) or any other factors (e.g., ongoing litigation for workers compensation for musculoskeletal injuries or disorders) that may compromise the subject's ability to participate in this study
Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation

The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir.

A multi-center two phase, double-blind, placebo controlled, randomized prospective study of 130 lung transplant recipients. Patients will be screened and consented prior to transplant. All consented patients will receive IV ganciclovir within 24 hours of transplant for not more than 14 days. Patients will enroll in Phase I of the study is an open label safety and efficacy analysis of three months of oral valganciclovir in adult transplant recipients who are at risk for CMV. After completion of 3 months of open label therapy, patients that meet the criteria for Phase II of the study will be randomized to 9 months of blinded therapy (Placebo/Valgan). Phase II of the study is designed to assess the efficacy of short course sequential IV ganciclovir followed by oral valganciclovir as compared to the extended period of oral valganciclovir prophylaxis in the prevention of CMV disease in at risk lung transplant recipients

Eligibility Criteria:
Inclusion Criteria for Phase I:

* Adult lung transplant recipients age 18 or older
* At risk for CMV (donor or recipient serology must be positive for CMV)
* Adequate hematological and renal function,
* On intravenous (IV) ganciclovir within 24 hours of surgery
* Agreement to use effective methods of contraception
* Negative pregnancy
* Tolerate oral medications within 2 weeks of transplant
* Negative baseline CMV PCR
* Able to understand and sign the informed consent

Exclusion Criteria for Phase 1:

* Repeat transplantation
* Mechanical ventilation at study entry
* Oral or intravenous ganciclovir treatment outside the study protocol
* Invasive fungal infection
* Participation in another investigational study
* Acute CMV infection or disease
* Anti-CMV therapy within 30 days before enrollment
* Uncontrolled diarrhea or malabsorption
* Allergic reaction to study drug
* Required use of prohibited medications
* Lactating women
* Pregnancy
* Renal failure

Inclusion Criteria for Phase II:

* Negative serial post transplant PCRs at day 75
* Negative bronchial cultures for CMV
* Adequate hematological and renal function at day 75
* IV ganciclovir for up to 2 weeks post operation and open label up to day 90
* Effective contraceptives
* Negative pregnancy

Exclusion Criteria Phase II:

* Renal failure
* Serious adverse events (SAE) related to study drug
* CMV disease (study endpoint)
* Withdraw consent for Phase II
CAPTURER PMCF Study ( rEPIC04D )

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of CAPTURER to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with CAPTURER .

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the CAPTURER in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with CAPTURER according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

* Not meet inclusion criteria
A Study of IBI353 (Orismilast) in Chinese Healthy Adults

This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female 18 to 45 years of age at the time of consent
2. BMI of 19-27Kg/m2 and weight of 50-100kg (male) or 45-100kg (female)
3. Participants are in good health condition at screening stage based on past history, lab tests, EEG, physical examinations, and vital signs.
4. Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements

Exclusion Criteria:

1. Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine system;
2. Subjects who have a history of relapse or chronic infection, or a history of acute infection treated by antibiotics within 3 months;
3. Subjects who have previously used PDE4 inhibitor dugs;
4. Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
5. Subjects who are not suitable for this trial due to other reasons In the investigator' opinion
Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients

The purpose of this study is to investigate the role of the pulmonary vasculature in the development and progression of chronic obstructive pulmonary disease (COPD). To accomplish this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in oxidative stress and lung volumes during exercise will be measured.

Chronic obstructive pulmonary disease (COPD), the 3rd leading cause of death in the US, is a progressive disorder for which new treatments are urgently needed, as existing therapies are focused primarily on symptom relief. Oxidative stress, in part arising from inducible nitric oxide synthase (iNOS) released by the pulmonary vasculature, is critical for the development and progression of COPD; a treatment strategy focused on the pulmonary vasculature is hypothesized to be beneficial in COPD patients. This will be studied with the use of an inhaled prostacyclin analogue, iloprost, which has been approved for pulmonary hypertension and investigated in small studies of COPD patients. Potential mechanisms include reductions in dynamic hyperinflation during exercise in COPD patients or improvements in oxidative stress

Eligibility Criteria:
Inclusion Criteria:

* 40 years old or older
* Physician diagnosis of chronic obstructive pulmonary disease
* 10 or more pack-year smoking history
* FEV1/FVC \<0.70
* FEV1 35-80% of predicted

Exclusion Criteria:

* Acute exacerbation of COPD within the last 30 days
* Pregnant or breast-feeding
* Contraindications to cardiopulmonary exercise testing
* Known intolerance or allergy to iloprost
* On oral corticosteroids (may be included if off for 7 days prior to testing)
* Supplemental oxygen need
* Known inflammatory disease other than COPD
* Active solid organ/hematologic malignancy