cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia

Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent;
2. Males or females aged 18-75 years of age inclusive;
3. Outpatient, Patients can not stay in the hospital overnight;
4. Patients must have pain present for more than 1 months after the healing of the herpes zoster skin rash;
5. At Screening, pain scale (VAS) of ≥40 mm;

Exclusion Criteria:

1. Peripheral neuropathy or pain unrelated to PHN that may confuse the assessment of PHN;
2. Skin conditions in the area affected by neurupathy that could alter sensation;
3. Chronic systemic diseases that may affect subjects' participation in the study;
4. Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:1)Neutrophils \< 1.5 × 109/L, or platelet \< 90 × 109/L, or hemoglobin \< 100 g/L, or 2)AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or 3)Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m2, or 4)Creatine kinase \> 2.0 × ULN.
5. Uncontrolled diabetes(HbA1c≥11.0% at screening) ;
6. History of substance abuse or alcohol abuse;
7. Any active infections at screening;
8. HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive;
9. Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3);
10. Patients who have undergone neurolytic or neurosurgical therapy 1 week before screening for postherpetic neuralgia;
11. Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of PHN;
12. History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds;
13. History of suicidal behavior or attempted suicide;
14. Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period;
15. Mechanical operators who are engaged in high-altitude operations, motor vehicle driving and other dangerous machinery operators;
16. Participated in another clinical study within 30 days prior to screening;
17. Other conditions unlikely to participate in this trial.
Effect of Phenolic Acids on the Human Vasculature

This study evaluates effects of different doses of phenolic acids on healthy volunteers.

It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).

Eligibility Criteria:
Inclusion Criteria:

* Male or postmenopausal female healthy volunteers aged 45-65 years old
* Willing and able to sign written informed consent prior to trial entry
* Healthy as determined by the medical history and physical examination

Exclusion Criteria:

* Premenopausal women
* Current smokers
* Abnormal blood pressure as defined as follow: systolic \<90 or \>140 mmHg and diastolic \<60 or \>90 mmHg
* Regular consumption of cholesterol-lowering medication
* Regular consumption of antihypertensive medication
* Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
* Any food allergies
* Any intakes of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study
* Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
* Acute or chronic major psychiatric illness or other major illness that in the opinion of the investigator would make the subjects' participation in the study unsafe or prevent them from fully complying with the study procedures
* Body mass index (BMI) outside 18-32 kg/m2 range
Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.

Bacterial infection of the amniotic cavity, termed "chorioamnionitis", is a major cause of perinatal mortality and maternal morbidity. Early administration of broad-spectrum antibiotic therapy in the laboring patient with chorioamnionitis has both neonatal and maternal benefits. Less known is the ideal postpartum antibiotic regimen - or if postpartum antibiotics are even required at all - needed to decrease febrile morbidity. Current practice has seen a wide range of practice styles ranging from no treatment to antibiotic prophylaxis for up to 48 hours after delivery.

If antibiotics are prescribed, there is good evidence to support one additional dose of antibiotics as compared to 24 hour dosing to decrease the rate of endometritis. Less clear is whether antibiotics are required at all for the properly treated patient with chorioamnionitis who requires a cesarean delivery. One study comparing continued antibiotics versus no-treatment failed to show a difference in the rate of postpartum endometritis. The conclusion from this study was that continuation of preoperative clindamycin and gentamicin in the postoperative period did not reduce the risk of endometritis compared to a single preoperative dose however this study was terminated early due to failure to recruit their stated sample size.

Puerperal endometritis rates vary by mode of delivery but it is known that the rate is lower in vaginal deliveries as compared to cesarean delivery. The patient with chorioamnionitis that requires a cesarean delivery makes an excellent study target. Given the lack of studied protocols, there currently are many acceptable methods for treating the patient with chorioamnionitis. Our proposed study plans to evaluate the two most common methods of treatment to determine the most effective regimen. If post-delivery antibiotics do not show a benefit to these highest risk subjects, it is likely inferred that patients that undergo a vaginal delivery will not require antibiotics as well.

Specific Aims There is conflicting data regarding the necessity of post-delivery antibiotics for patients with chorioamnionitis who undergo cesarean delivery. The primary objective of this study is to determine if postpartum antibiotics are necessary for antepartum treated cases of chorioamnionitis in patients undergoing a cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chorioamnionitis
* Undergoing cesarean section for delivery

Exclusion Criteria:

* Multiple gestations,
* Allergy to beta-lactam antibiotics
* Patients with estimated creatinine clearance (ClCr) less than 70 mL/min
* Maternal fever explained by etiology other than chorioamnionitis
* Inability to comply with the study protocol.
Multiparametric SCores for Prediction of Myocardial FIbrosis in Patients with MITral VAlve PRolapse

This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.

Patients with mitral valve prolapse and non-significant mitral regurgitation generally have a good prognosis. A minority of patients with MVP suffers from ventricular arrhythmias. Different demographic, clinical, and electrocardiographic characteristics, as well as morphological and structural features of the MV were described as potential risk factors for ventricular arrhythmias, among which fibrosis of the left ventricular inferolateral wall and posterior papillary muscle as detected by cardiac magnetic resonance.

As cardiac magnetic resonance has some limitations, it is unknown if and which patients with mitral valve prolapse should undergo cardiac magnetic resonance in routine clinical practice, to search for late gadolinium enhancement as a surrogate for myocardial fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views

Exclusion Criteria:

* age\< 18 years
* coexistence of other cardiomyopathies or other ≥ moderate valve diseases
* scarce acoustic transthoracic echocardiographic window
* usual contraindications for cardiac magnetic resonance
Home-based Conservative Care Model for Advanced Kidney Disease

This is a randomized pilot study to test the feasibility and acceptability of a novel conservative care (CC) pathway among patients with advanced chronic kidney disease (CKD) who have chosen to forgo initiation of maintenance dialysis, their caregivers and providers.

This study is a randomized pilot study to test the acceptability and feasibility of a CC pathway, called the Kidney Care at Home Program, with patients with advanced CKD who have chosen to forgo dialysis, their caregivers and providers. The novel CC program will be developed upon an existing home-based multidisciplinary care (MDC) program in the Veterans Affairs (VA) called the Home-Based Primary Care (HBPC) program. HBPC provides for Veterans with multimorbidity and functional limitation with the goal of supporting Veterans' quality of life and mitigating the complications of illness through to the end of life.

The investigators hypothesize that HBPC serves as the ideal starting ground to build the VA's first CC program for Veterans with advanced CKD. The investigators will use implementation science and ethnographic research methods, including field observations, interviews, medical record review, and serial structured surveys on quality of life, symptom burden, care satisfaction and goal concordant care to assess the feasibility and acceptability of the Kidney Care at Home Program (intervention) vs. usual care (control).

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Receives primary +/- nephrology care from VAPS as defined as having at least 1 outpatient primary or nephrology visit in the prior year
* Advanced CKD as defined as defined as having 2 or more outpatient measures of an eGFR 20 ml/min/1.73m2 separated by 90 or more days
* Unsure or do not wish to undergo maintenance dialysis
* Agreement by their VA primary +/- nephrology care provider that patients can participate in the study

Caregivers:

* Nominated by enrolled patient as a caregiver whom patient agrees to participate in the study

Clinicians:

* Employed at VAPS
* Identified by enrolled Veterans as important to their CKD and nominated by the Veteran to be interviewed for the study

Exclusion Criteria:

Patients:

* Unable to complete "teach-back" method of informed consent
* Currently receiving maintenance dialysis
* Currently enrolled in HBPC Program

Caregivers:

* Unable to complete "teach-back" method of informed consent
* If a Veteran withdraws from the study, their caregivers' participation in the study is also terminated at that time

Clinicians:

* If a Veteran withdraws from the study, their clinicians will no longer be eligible to participate in interviews
Anemia and Red Blood Cells Transfusion in Oncological Surgery

Oncologic patients experience anemia and anemia is associated with poor prognosis. Transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality.

Between 36 and 75% of oncologic patients experience anemia and anemia is associated with poor prognosis. Up to 40% of surgical oncologic patients receive red blood cells (RBC). However, transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality. This is a retrospective, single center study. All adults admitted to the intensive care unit (ICU) after oncologic surgery within the study period are eligible.

Eligibility Criteria:
Inclusion Criteria:

* Surgery for cancer
* Admission to intensive care

Exclusion Criteria:

* no consent
A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)

This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose, for 12 months (12 months of treatment in the test group, and 6 months of no treatment and then 6 months of treatment in the control group).


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 5 years
* Pre-pubertal; testicular volume less than 4 milliliter (in males) and breast Stage 1 (in females)
* The official records of height (for example records measured in hospitals or schools) during previous 6 months or more preceding inclusion in the study (self-measurement of the height at home will not be considered as a valid record)
* Height less than or equal to 3rd percentile compared to same sex, same age
* Peak serum growth hormone (GH) greater than 10 microgram per liter (mcg/L) in GH stimulation test (results of peak serum GH greater than 10 mcg/L in GH stimulation test within 1 year can be used instead)
* Naive to GH therapy
* Normal birth weight (that is greater than or equal to 3rd percentile when compared to same sex)
* Normal thyroid function
* Normal karyotype in girls
* Written informed consent from parent/guardian
* Written informed consent from the subject who speaks, understand, read, and write Korean
* Bone age less than 10 years in boys and less than 9 years in girls, whose difference between the bone and chronological age is no more than 3 years

Exclusion Criteria:

* Puberty development (Tanner stage greater than or equal to 2)
* Skeletal dysplasia or abnormal body proportions
* Chronic systemic illness
* Dysmorphic syndrome
* Growth Hormone Deficiency
* Small for Gestational Age (SGA)
* Current medication for Attention deficit hyperactivity disorder (ADHD) or hyperactivity disorder
* Current medication with drugs that may influence secretion or action of growth hormone (such as estrogen, androgen, anabolic steroid, corticosteroid, thyroxine, aromatase inhibitors)
* Diabetes mellitus
* Kidney transplantation
* Acute critical illness, including complications following open heart surgery, abdominal surgery or multiple accidental trauma
* Acute respiratory failure
* Malignancy or previous therapy for malignancy
* Known hypersensitivity to somatotropin or any of its excipients including cresol or glycerol
* Closed epiphyses, progression or recurrence of an underlying intracranial tumor, chronic renal disease
* Endocrinologic or metabolic disorders such as Prader-Willi syndrome; Russel-Silver syndrome; Seckel syndrome; Down syndrome; Cushing syndrome; Noonan syndrome; short stature caused by other chromosomal abnormalities
* The disorders that explain short stature such as psychiatric disorders, nutritional disorders, and chronic debilitating diseases
* Participation in another clinical trial within the past 3 months
* Status of legal incapacity or limited legal capacity of the parents or legal guardian
Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland

The PICCOLINO is a randomized health services study performed within the framework of the Polish Colonoscopy Screening Program (PCSP) in Poland.

Within the study 12,298 eligible persons between 55 and 64 years of age will be drawn from the Population Registry and randomly assigned in a 1:1:1 ratio to receive an invitation to participate in one of the three screening strategies: (I) postal invitation to colonoscopy and a re-invitation to colonoscopy for initial non-responders, (II) postal invitation for screening using fecal immunochemical test (FIT) for non-responders and subjects refusing a colonoscopy, or (III) postal invitation offering a choice between FIT and colonoscopy.

Colonoscopies will be performed in seven local centers participating in the study. FITs will be analyzed in the central laboratory. Subjects with positive FIT result will be recommended to undergo colonoscopy.

The primary outcome is participation with CRC screening within 18 weeks after enrollment, defined as completion of colonoscopy, or completion of FIT along with colonoscopy for positive FIT result. Secondary outcome will be diagnostic yield for advanced neoplasia (CRC or advanced adenoma). The study has been approved by a local bioethics committee.


Eligibility Criteria:
Inclusion Criteria:

Men and women aged 55 to 64 years residing in Poland and assigned to be invited to screening within the Polish Colonoscopy Screening Program .

Exclusion Criteria:

* information of a selected subject death informed by family, neighbors or post office that has not been included in the Personal Identity Number (PESEL) system.
* addressees of letters that have been returned by the post office.
* subjects requiring long-term care due to somatic, psychosocial reasons or with mental disability.
* history of colorectal resection.
Functional Goat Cheese Effect in Lipid Profile Change

The purpose this study was to evaluate the therapeutic effect of a functional goat cheese on obese and overweight people with altered lipid profile. The functional goat cheese containing polyunsaturated fatty acid, in amounts exceeding other cheese, was developed to benefit cardiovascular health of people who need to normalize lipid profile; which in the long term can contribute to the prevention of cardiovascular diseases.

A randomized, parallel, double-blind, controlled is being performing to evaluate the effect of a functional goat cheese on lipid profile in overweight or obese volunteers who need a special diet.

Were included 60 volunteers (men and women) aged between 18 and 65 years (IMC ≥27\<40 Kg/m2) with a cardiovascular risk (\<10%). The volunteers are being followed at La Paz University Hospital of Madrid. For 12 weeks, the volunteers should consume 60 g of cheese daily (functional cheese or control cheese) and to receive advice to follow a balanced and individualized hypocaloric diet as well as physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers with overweight type II or obesity type I or II (IMC ≥27\<40 Kg/m2).
* Cardiovascular risk \< 10% and almost two of follow factors:

Men ≥ 45 years old or women ≥ 55 years old; Familiar background of premature cardiovascular disease; HDL cholesterol \<40 mg/dL for men and \<50 mg/dL for women; Total cholesterol ≥ 200 mg/dL; Triglycerides ≥ 150 mg/dL and \< 200 mg/dL; LDL ≥ 130 mg/dL and \< 160 mg/dL; Smoker

* Accept advises to perform a balanced hypocaloric diet and regular practice of physical activity.
* Signed informed consent.

Exclusion Criteria:

* Individuals with Diabetes Mellitus type 1;
* Individuals with Diabetes Mellitus type 2, using medication;
* Individuals with Dyslipidemia, using drug;
* Individuals with high blood pressure, using medication;
* Individuals with allergies to dairy protein;
* Individuals with severe diseases (hepatic, kidney, cancer...);
* Individuals with drugs or supplements consumption to weight lost;
* Individuals that consume drugs, ω-3 supplements or supplement that can modify the lipid and / or glucose profile (statins, fibrates, diuretics, corticosteroids, insulin...);
* Individuals who have participated in programs and / or clinical trials of weight control in the last 6 months;
* Individuals with increased alcohol consumption 30g/day;
* Individuals that stop smoking in the next 20 weeks (during the study);
* Individuals with mental disease or low cognitive function;
* Pregnant women or breastfeeding;
* Individuals with intensive physical activity;
* Individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users

In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

Comparisons:

A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.

D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.

Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.

Eligibility Criteria:
Inclusion Criteria:

* non-smokers, 18 to 50 years of age.
* Habitual use of \> 7 portions snus daily since minimum 1 year.
* Healthy according to the health declaration and interview.
* Written informed consent given.

Exclusion Criteria:

* Concurrent participation in another clinical trial.
* History of allergy.
* History of allergy.