cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of BNS003 on Swelling in Legs Due to Venous Reflux

To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with swelling of calf and ankle due to disorder of leg venous reflux.


Eligibility Criteria:
Inclusion Criteria:

* Manifestation of swelling falling into Class 1 according to Porter's classification
* With more than 2 symptoms of "sensation of heaviness/tiredness (dullness)," "tension," "tingling," "pain," "fever" or "itching" and a total score of \>=3 for severity by symptoms
* Persons aged 20 years or older at the time of obtaining their informed consent and available for hospital visits. Both genders are acceptable
* Persons who have consented to participating in the study in written form with good understanding of the objective of the study, the methods, and notices for the study period

Exclusion Criteria:

* Persons with edema not due to venous diseases of the legs (e.g., lymphedema, latent cardiac or renal insufficiency, etc.)
* Persons with peripheral arterial diseases
* Persons with acute phlebitis, venous ulcer, congenital vascular anomaly, or Behcet's Syndrome
* Persons with "moderate" or "severe" renal, hepatic, cardiac or haematological disorder, or with a history of such disorder (Grade 3 or 4 in Common Toxicity Criteria (CTC))
* Persons with diabetes mellitus (excluding those curable with dietary therapy), neuropathy, hyper-or hypocalcemia, or malignant tumors
* Persons with drug or alcohol abuse
* Persons with immobility
* Persons with pulmonary embolism
* Persons with hypersensitivity to drugs (particularly to the ingredients contained in the investigational drug)
* Persons with clinical indication of requiring venous treatment such as physical application (use of elastic bandage and compression stockings) and phlebectomy (vein stripping surgery to remove vein affected with varicosis and valve insufficiency)
* Persons who received venous sclerosing therapy within the last 4 weeks before starting this study
* Persons who constantly use theophylline preparations, diuretics, cardiac glycosides
* Persons who had changed to or initiated post-menopausal hormone replacement therapy within the last 2 months before starting this study
* Persons unable to suspend the frequent use and exceeded dosage/administration of laxatives (more than 6 times) during the study period
* Persons planned to undergo a surgery requiring systemic anesthesia during the study period
* Women in pregnancy or nursing, or those who wish for a pregnancy during the study period
* Persons who participated in another study within the last 3 months before starting this study, or who plan to participate in another study during the study period
* Persons who were considered to be ineligible to be a subject for the trial by the investigator or sub-investigators
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase 4 study are to evaluate the safety and immunogenicity of a single dose of VAXCHORA (1 x 10e9 cfu/dose) in children ages 2 years to \<18 years of age in developed countries.

This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Between 2 and \<18 years of age on Day 1
* In general good health
* Able and willing to provide informed assent for study participation
* Primary caregiver is able and willing to provide informed consent for study participation
* (for females of childbearing potential) Using an acceptable method of contraception through Day 29

Exclusion Criteria:

* Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit
* Current acute febrile illness
* History of cholera infection
* History of cholera vaccination
* History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA
* Congenital or acquired immunodeficiency
* Pregnancy (for females of childbearing potential)
* Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject
* Any other condition that, in the opinion of the Investigator, will interfere with the conduct of the study or the validity of the data
* Duration of \>2 weeks of abnormal stool pattern, defined as \<3 stools per week or \>2 stools per day in the past 6 months
* Regular use of laxatives in the past 6 months
* History of enterotoxigenic E. coli infection
* Travel to cholera-endemic area in the previous 5 years
* Nursing/Breastfeeding
* Received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination: Any other licensed vaccines, antibiotics, or chloroquine
* Received or plans to receive any other investigational agent throughout the main study (Day 181)
Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery

This is a prospective non-comparative observational study of cohorts. Consists on offering surveys to every patient undergoing groin hernia surgery in our Abdominal Wall Surgery Unit, in Hospital of Navarra.

HYPOTHESIS:

The objective and perceived quality data of the patients under study (adult patients undergoing scheduled inguinal hernia without complications) in Pamplona are within the international quality standards.

OBJECTIVES

Primary objective:

-Obtaining data of objective and perceived quality of patients undergoing elective groin hernia surgery in Pamplona durinag a year to compare them with international quality standards.

Secondary objectives:

* Obtaining data on duration of sick leave (temporary disability due to common contingency) associated with the referred procedures, as well as their possible complications.
* Assess the costs associated with the intervention and its possible complications.
* Raise options (if necessary and feasible) to improve the results exposed obtained by our service.

Eligibility Criteria:
Inclusion Criteria:

* Patients entering surgical waiting list during a year (from March 1st, 2018, to February 28th, 2019).
* Elective surgery.

Exclusion Criteria:

* Age below 16.
* Mental diseases.
* Patients not capable of understanding the study.
* Patients that reject entering the study.
Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)

For this project we propose to refine the psychosocial intervention developed in phase one, based on input from key stakeholders, and to test the feasibility, acceptability and preliminary efficacy of the intervention. The proposed project addresses unmet public health needs for a historically hard-to-reach group of individuals with epilepsy and comorbid serious mental illnesses, and as the intervention is an adjunct to care that individuals with serious mental illness are already receiving, and uses staff already likely to be present in a care system, it is ideally suited for "real-world" implementation in people with epilepsy and serious mental illness (E-SMI).

The purpose of this study is to try and engage individuals with E-SMI to actively participate in illness self-management and treatment adherence that are crucial in minimizing the morbidity and mortality associated with both chronic mental disorders and chronic neurological conditions.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written consent
* Able to speak and understand English
* Age 18 and older
* Diagnosed with epilepsy
* Diagnosed with serious mental illness (DSM IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or chronic/recurrent depression confirmed with the Mini-International Neuropsychiatric Interview (MINI))
* Receive care at a community mental health center or other publicly funded community healthcare entity

Exclusion Criteria:

* Actively suicidal/homicidal individuals
* Individuals with dementia
* Unable to be rated on study rating scales
* Pregnant women
Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients

The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Newly diagnosed male or female patients aged 60 and over
* De Novo or Secondary AML
* Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following:Age ≥75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status \>2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia

Exclusion Criteria:

* Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product
* Administration of LDAC is clinically contraindicated
* Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
* Patients with blast crisis of chronic myeloid leukaemia
Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics

The goal of this clinical trial is to compare efficacy and safety of metformin versus apple cider vinegar in prediabetics . The main question\[s\] it aims to answer are:

* Efficacy of metformin versus apple cider vinegar in prediabetics
* Safety of metformin versus apple cider vinegar in prediabetics

Researchers will compare group of prediabetics taking metformin with group of prediabetics taking apple cider vinegar to see if there is difference in safety and efficacy..


Eligibility Criteria:
Inclusion Criteria:

* Males and Female
* 17-40 years age
* Body Mass index (BMI) overweight and obese
* FBS (100-125 mg/dl)
* HBA1c 5.7% to 6.4%

Exclusion Criteria:

* Concomitant medical problems as established diabetes, hepatic or renal insufficiencies etc.
* Known allergy or intolerance to metformin or apple cider vinegar
Epidemiology of Cardiovascular Risk Factors in Women (Healthy Women Study)

To determine cardiovascular risk factors and the change in risk factors during and following the menopause.

BACKGROUND:

In 1983, when the Healthy Women Study began, there was a paucity of epidemiological studies of cardiovascular risk factor changes and risk of heart disease related to natural menopause. The Healthy Women Study was one of the few in which the status of premenopausal women was followed carefully through and subsequent to the menopause. The study also included detailed behavioral and biological measures, as well as important environmental factors related to the determinants of these risk factors.

DESIGN NARRATIVE:

A cross-sectional study was conducted to determine the relationship between risk factors, behavioral, psychosocial, and other environmental determinants. A five year longitudinal follow-up of the women evaluated changes over time in risk factors related to the perimenopausal and postmenopausal periods. Longitudinal follow-up after the menopause continues in order to determine the relationships among changes in behavior, hormones, habits, and risk factors.

The women had home interviews, baseline examinations, follow-up of menstrual cycles, and a six-month self-administered questionnaire. Risk factors studied included behavioral factors, glucose and insulin, obesity, exercise, cigarette smoking, nutrition, lipoproteins, blood pressure, and hormones. Surgical menopause and the use of exogenous hormones were also studied. Although not part of the original protocol, measurements of fat distribution, coagulation factors, apoproteins, sodium-lithium counter-transport, and sodium-hydrogen exchange in platelets were added.

The study was renewed in 1995 to continue follow-up to determine characteristics of changes in risk factors, behavioral/psychological attributes and to determine the relationship between risk factors, and their changes and atherosclerotic plaque and wall thickness. Studies are conducted on the interrelationship of lifestyle and behavioral attributed to sex-steroid hormones and insulin and the level of hormones to atherosclerosis. A determination is made of the association of lifestyle to amount and distribution of body fat measured by DEXA and CT of the abdomen.

The study has been renewed several times and ends in November of 2007.

Eligibility Criteria:
Inclusion criteria: Women had to be premenopausal and have an intact uterus and ovaries

Exclusion criteria: hypertension, diabetes, heart disease, major cancer or stroke
The Effects of taVNS on Inhibitory Control

The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) improves the ability of inhibitory control in an emotional Go-Nogo task.

A randomized, sham-controlled, between-subject design will be employed in this study. A total of 87 healthy subjects will receive either transcutaneous vagus nerve stimulation via tragus or sham stimulation via the earlobe in the left ear. Brain activity and behavioral data for an emotional Go-Nogo task will be recorded and saliva samples will be collected before, during, and after stimulation.

Some personal traits will be assessed using different kinds of questionnaires, such as the State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), Autism Spectrum Quotient (ASQ) et al.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* pregnant, menstruating, taking oral contraceptives;
* medical or psychiatric illness.
Patient Research In Self-Management of Asthma (PRISMA)

The objective of this study was to investigate if a nurse-led telemonitoring programme is effective and cost-effective in asthmatic outpatients, aged seven years and older.

At the present day asthma is one of the most common chronic illnesses worldwide and the prevalence is still increasing. Asthma can be treated and controlled with guidance of health care professionals, and self-monitoring is an important aspect in this control.

Respiratory nurses have become common caregivers in the treatment and control of asthma. Advances in information and communication technology have created the potential to monitor the asthma status of patients at a distance, named telemonitoring. These two developments come together in nurse-led telemonitoring programmes. Lung function tests, from which the peak expiratory flow (PEF) is the most commonly used, are recorded into an electronic monitor. By transferring monitor data to a central database a nurse can continuously supervise the disease status of individual patients. The use of stepwise protocols can enable nurses to independently adjust the medication by one step.

Design: Randomized controlled trial comparing a nurse-led telemonitoring programme versus regular care in asthmatic outpatients aged 7 years and older.

Primary outcome parameter: asthma-specific quality of life. Secondary outcome parameters: symptoms, generic quality of life, direct and indirect costs, satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* 7 years or older
* Asthma severity of stage I - III as described in the GINA guidelines
* Must be competent to use an asthma monitor
* Must possess a household phone connection

Exclusion Criteria:

* Respiratory co-morbidity
Blinded Resection in Case of the Pancreatic Insulinoma

The blinded resection avoided in case of pancreatic insulinoma

Despite of the technique and technology developement there are still a lot of troubles to verify small benign-looking pancreatic NETs. It can be especially important in case of insulinoma. The organic hyperilsulinism and severe hypoglicemia causeb by the insulin/proinsulin - producing lesion can lead to severe complications and evem death.

There are some cases of the blinded resections of the pancreas in patients with the "hidden" insulinoma when the tumor can't be revealed during the preoperative diagnostics and intraoperatively. Unfortunately, blind resection do not solve the problem of the hypoglicemia but also cause the specific pancreatic complications.

Eligibility Criteria:
Inclusion Criteria:

The blinded resection of the insulinoma

Exclusion Criteria:

Other tumors
The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo

The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with non-segmental vitiligo.

According to available data, statins act through several immunological pathways, potentially reversing undesirable phenomena underlying autoimmune vitiligo pathogenesis. A study has been designed as a single-center, randomized, double-blind, placebo-controlled pilot study with the enrollment of at least 20 active non-segmental vitiligo patients presenting with vitiligous lesions on both upper and lower limbs. Clinical effects of ointments containing 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb will be assessed in comparison with vehicle ointment applied on the opposite limb. All study participants will undergo clinical evaluation using Body Surface Area (BSA) and Vitiligo Area Scoring Index (VASI) scales at baseline, week 4, week 8 and week 12 time points. Precise assessment of skin lesions will be performed using photographic documentation obtained during each study visit and processed with NIS-Elements software.

Eligibility Criteria:
Inclusion Criteria:

1. patients of Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz
2. provision of an informed consent form prior to any study procedures
3. diagnosis of non-segmental acrofacial vitiligo with upper and lower limbs involvement
4. active vitiligo, defined as appearance of new areas of depigmentation or progression of existing areas of depigmentation within 3 months preceding screening
5. male or non-pregnant female patients aged 18 to 80 years
6. confirmed valid health insurance

all inclusion criteria must be met

Exclusion Criteria:

1. pregnancy or breast-feeding
2. diagnosis of segmental, mixed, unclassified or undefined vitiligo
3. hypersensitivity to simvastatin or atorvastatin
4. any statins use within 8 weeks preceding eligibility screening
5. systemic immunosuppressive/immunomodulating i.e. cyclosporine A, corticosteroids within 4 weeks preceding eligibility screening or azathioprine, methotrexate, mycophenolate mofetil, Janus kinase - JAK within 8 weeks preceding eligibility screening
6. phototherapy due to vitiligo or any other medical conditions within the 4-week period preceding eligibility screening
7. any topical or systemic additional vitiligo treatment (e.g. antioxidants, ginkgo biloba, dermo-cosmetics) within 4 weeks preceding screening
8. surgical treatment of vitiligous lesions within past 4 weeks
9. hypersensitivity to statins
10. decompensated autoimmune or internal diseases
11. alcohol or drug abuse
12. skin malignancies (currently or history of skin malignancy within 5 years preceding screening)
13. presence of skin characteristics that may interfere with study assessments
14. patients currently participating in any other clinical study
15. uncooperative patients

none of the above can be met
Post-operative Cardiac Outcome of Non-cardiac Surgery Predicted by INVOS

Research aimed to find a correlation with an invos drop and cardiac events in the peri-operative period of non cardiac surgery.

The investigators postulate that a drop in the Invos numbers (with or without significant drop in BP) is associated with a variable degree of cardiac suffering.

The idea is to prevent per and foremostpost-operative myocardial necrosis complications by acting as soon as we have an INVOS drop during anesthesia.

The "cardiac events" will be monitored and defined according to the EHA (european heart association) guidelines.

(Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored per and post operatively.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Age minimum 18 years old

Exclusion Criteria:

* Chronic renal failure
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions

single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions

A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 18 years of age or older
* BMI ≥ 19.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of chilbearing or nonchildbearing potential

Exclusion Criteria:

• Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
Sexuality in Medically Assisted Procreation Pregnancies

We wish to evaluate sexuality during pregnancy between spontaneous pregnancies and resulting from assisted procreation The literature is poor on thie subject


Eligibility Criteria:
Inclusion Criteria:

* physiological pregnancy
* pregnancy from assisted reproduction
* age over 18
* to understand french
* patient's agreement

Exclusion Criteria:

* pathological pregnancy