cyrilzakka/clinical-trials huggingface dataset:
CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps

Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. Glucocorticoids sensitivity is significantly correlated with CST1 level in nasal secretions. The goal of this single-arm clinical trial based on a multicenter platform is to test CST1 in patients with chronic rhinosinusitis and nasal polyps before and after oral glucocorticoid therapy. Endoscopic polyp score, Total Nasal Symptom Score(TNSS), SNOT-22 score and other biomarkers are also evaluated before and after the treatment. Researchers will develop a CST1 predictive model of oral glucocorticoid therapy for Chronic Rhinosinusitis with Polyps.


Eligibility Criteria:
Inclusion Criteria:

1. All meet the diagnostic criteria of CRSwNP in EPOS2020 (Age 18-70 years old);
2. Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);

Exclusion Criteria:

1. Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.
2. Medication history of oral glucocorticoids or immunomodulator within 1 months before enrollment, antibiotics within 2 weeks;
3. fungal sinusitis, allergic fungal sinusitis (AFRS), cystic fibrosis, primary ciliary dyskinesia
Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve Spanish speaking patients' understanding of instructions for use.

The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve, Spanish speaking, diabetic and/or hypertensive patients' understanding of actual prescribed medicines, compared to a standard label format. Spanish-speaking patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive all their prescribed medicines from this location. Recruited diabetic and/or hypertensive subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes for this aim. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study. We anticipate several manuscripts to be developed as a result of this project, supported by the diverse key personnel and collaborating faculty enlisted.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type II diabetes or hypertension in their medical chart
* Spanish speaking
* 30 years or older

Exclusion Criteria:

* Uncorrectable hearing or visual impairment.
* Too ill to participate
Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol

This study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol.

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into unripe Bokbunja extract 600 mg or placebo group. The investigators measured total cholesterol, lipid profile, arteriosclerosis index, anthropometric index, oxidized LDL.

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 65 years,
* Total cholesterol 200-239 mg/dl
* subjects giving written informed consent

Exclusion Criteria:

* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnancy or breast feeding etc,.
Clinical Trial to Evaluate the Efficacy and Safety of DWKH

Randomized, Double-blind, Parellel, Multicenter, Active-controlled


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged between 19 and 80.
* Patients whose BSS score is over 5.

Exclusion Criteria:

* Patients allergic to any ingredients of the study drugs.
* Moderate liver disease (ALT or AST \> UNLx3).
* Moderate lung disease.
* Uncontrolled HTN.
* Uncontrolled DM.
* Uncontrolled thyroidism.
* Patients who is needed antibiotics during the study period.
* In the case of women, pregnant(Urine-HCG positive) or lactating women.
A Food-Effect Study of AND017 in Healthy Participants

The purpose of this phase I study is to evaluate the food effect on the PKs of AND017 following oral single-dose administration in healthy non-elderly Chinese subjects.

This is a single-center, randomized, open-label, two-sequence, two-period crossover study in healthy non-elderly Chinese subjects to evaluate the food effect on the pharmacokinetics, as well as PD and safety of AND017 following oral single-dose administration

Eligibility Criteria:
Inclusion Criteria:

1. BMI between 19.0\~26.0 kg/m2 (both inclusive); Body weight ≥50 kg for male, and ≥45 kg for female.
2. Healthy participants having no clinical significant abnormalities of examinations during screening period and at the time of informed consent
3. Have no pregnancy plan in the next six months and are willing to take effective contraceptive methods.

Exclusion Criteria:

1. Allergic constitution or has a history of allergy to AND017 capsule and its excipient;
2. Subjects with low blood pressure or a risk of low blood pressure: systolic pressure \<90 mmHg, diastolic pressure\<60 mmHg.
3. Subjects with difficulty in venous blood sampling;
4. Subjects with a history of drug abuse within the past five years or who have abused drug within the past three months before screening;
5. Subjects smoking more than five cigarettes a day or nicotine dependent within the past three months before screening;
6. Subjects drinking alcohol more than 14 U/week within the past six months or used any alcohol products in two days pre-dose;
7. Subjects that have received any medication within the past 4 weeks pre-dose;
8. Subjects that have taken food or drink that has the potential to induce or inhibit drug metabolizing enzymes in the liver within one-week pre-dose;
9. Subjects that have taken any food or drink that contains or can be metabolized to caffeine or xanthine from 48 hours pre-dose to the last PK or PD blood sampling;
10. Subjects with diseases or factors of clinical abnormalities that need to be excluded, including but not limited to the nervous system, cardiovascular system, kidney, liver, gastrointestinal, respiratory system, metabolism, and skeletal system diseases, or other factors that may affect drug absorption, distribution, metabolism and excretion;
11. Subjects that have used HIF-PHIs within the past one year;
12. Subjects positive in HIV-Ab, HBsAg or HBeAg, or HCV-Ab, TP-Ab;
13. Subjects that have participated in any other clinical trials within the past three months pre-dose in the study;
14. Female subjects of childbearing age who are pregnant, lactating, or planning pregnancy; or have a positive in pregnancy test during the study;
15. Subjects with a history of blood donation or had a blood loss more than 400 mL within three months before screening;
16. Subjects that have special requirements on diet and cannot follow the dietary program indicated in the study;
17. Subjects that are unable to comply with research requirements or with any factors are considered not suitable for participating in the study according to the opinion of the investigator.
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 10 to 25 years.

Exclusion Criteria:

* Previous vaccination with Hepatitis A virus vaccine
* Previous vaccination with investigational meningococcal B vaccine
* History of culture-proven N. meningitidis serogroup B disease
* Any neuroinflammatory or autoimmune condition
* Any immune defect that would prevent an effective response to the study vaccine
Positive Pressure Ventilation Through a Laryngeal Mask Airway in Pediatrics

The investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair.

Considering blood gas analysis, end tidal carbon dioxide measurements and airway changes, the investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair in this study.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I, being scheduled to undergo laparoscopic inguinal hernia.

Exclusion Criteria:

* Patients, who did not want to participate, patients with severe airway deformities, patients having increased gastroesophageal regurgitation risk, reactive airway hiatal hernia, peripheric vascular disease, mental retardation, neuropsychiatric illness or an lung infection during the last 6 weeks.
Impact on Patient Satisfaction About Realization of Ultrasound Dopplers at the Bed

Organisation and logistic about realisation of vascular doppler ultrasound is something very eclectic . Need to shift patient from their bed , long waiting time and the effect on the hospital cost.

That's why vascular yard aim to practise these doppler ultrasound directly in the patients' room in the bed.

And like that evaluate the patient's satisfaction of this kind of coverage.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized in vascular yard
* indication of ultrasound doppler
* accept to participate

Exclusion Criteria:

* refuse to participate
* without ultrasound doppler indication.
Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer

This research is being done to test an investigational product called Muscadine Plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (PSA) level.

In phase I the investigators are evaluating the safety of the product and checking blood levels of the active components. In phase II the investigators are evaluating the effect of MPX on PSA doubling time

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor.
* Rising PSA on a minimum of 3 time points (including screening psa) within the 12 months prior to study initiation.
* \> 18 years of age.
* Life expectancy of greater than 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
* Testosterone level of ≥1.5 ng/mL at screening.
* Adequate kidney, liver and bone marrow function
* Agrees to abstain from other commercially available MP products while participating in this study.
* Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose(s) while participating in the study.
* Signed a written informed consent document and agrees to comply with requirements of the study.

Exclusion Criteria:

* Known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 2.0 cm maybe considered nonspecific and the patient would be eligible
* Receipt of any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 6 months prior to study
* Prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product
* Consumption of Muscadine Plus over the past 2 months
* Known allergy to muscadine grapes or ellagic acid
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Negative PSA doubling time (1 time point may be excluded per 3e inclusion criteria)
Association Between Pilatis Exercise, Balance and Stability Measurements, and Quality of Life Among Elderly Population

Background: The elderly population in western countries and in Israel is constantly growing. Falls are one of the common problems among this population. Thus there is a need for falls prevention exercise program to be offered in the different settings elderly reside. Most methods for physical exercise are dedicated to muscle strengthening and improving balance by strengthening external muscles. Pilatis exercise program focuses mainly on strengthening the in-depth muscles. The advantage of this method is in its simplicity and availability. This method is suitable also for special populations as patients in acute hospitalization. In this study, the investigators will evaluate if the pilatis exercise can improve balance of elderly population. Physical exercise usually improves the mood. Like any physical exercise, Pilatis exercise has a mental advantage, therefore, this study will also examine if pilatis exercise can improve quality of life of elderly population.

Working hypothesis and aims: Pilatis exercise will improve balance and stability measurements, and quality of life among elderly population.

Methods: Randomized, prospective study among elderly patients aged 65 and above belonging to Clalit Health Services primary care clinic . Participants of the intervention and control group will receive a brochure that will include nutrition and healthy life style recommendations. Intervention group: will receive 12 weeks of pilatis exercise 3 times a week. The control group will be offered the same intervention at the end of the study period. Balance evaluation will be performed using the: Tinetti Balance Gait Scale, Berg Balance Scale, Multidirectional Reach Test, Timed Up and Go, Step execution test. The SF-36 questionnaire will be use to evaluate quality of life.

Importance: This study will examine the influence of pilatis exercise on balance among the elderly. If findings will determine that pilatis does improve balance in the elderly, the investigators can further examine pilatis's influence on falls prevention, and minimizing falls damages.

Probable implications to the welfare and health of the aged population:

Improving balance, falls preventing and minimizing falls damages among elderly; improvement in elderly quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Man and Women aged 65 years old and above
* Able to walk independently without devices (cane is exceptable)

Exclusion Criteria:

1. Unstable diseases (unstable angina; heart failure- NIHA 3 or 4; lung disease with shortness of breath on light effort; end stage liver and kidney diseases; terminal malignant diseases)
2. MMSE less then 24
3. After hip or knee surgery
4. After lower limb amputation
5. Neurological diseases with significant gait and balance instability.
Peer-led Trauma Therapy for Re-entry

The purpose of the research is to learn more about how to treat PTSD for people directly impacted by incarceration (i.e., have spent time in prison or jail). This research will help identify if a PTSD treatment group that is used in community settings, and led by individuals with lived experience, is helpful in reducing PTSD symptoms among people who have been directly impacted by incarceration.

Participants will complete an interview to determine whether they are experiencing PTSD, and if so, will participate in a 6-week therapy group treatment.

Two community Certified Peer Specialists (CPSs) who have experienced incarceration and re-entry from prison, and who have experienced trauma will be trained on delivering group Cognitive Processing Therapy (CPT).

Working with the Wisconsin Department of Health Services (DHS) and community organizations serving formerly incarcerated individuals, researchers will screen individuals for PTSD treatment need, and invite 48 eligible individuals to participate in group CPT co-led by one of the trained CPSs and a trained community therapist or provider.

Eligible participants who are enrolled in the study will be invited to complete a 6-week (12 sessions total) group CPT therapy treatment for PTSD. Participants will also complete pre-, mid-, and post-treatment mental health surveys. Participants will also complete a post-treatment focus group or post-treatment individual interview where they are asked about their experience in the therapy and to provide feedback on the study as a whole.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* completed a prison or jail sentence
* no current psychosis symptoms
* no active self-harm or active suicidal intent
* able and willing to participate in group therapy
* meet criteria for PTSD treatment need

Exclusion Criteria:

* current and active psychosis
* current and active self-harm and suicidality
* no PTSD diagnosis
* current substance use dependence (not including those used as prescribed for medical reasons) on alcohol, cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids
The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia

Patients with several heart arrythmia can potentially be cured by catheterablation. For some arrythmias 95% of the patients are cured. Also patients with atrial fibrillation are cured by catherablation even though the effect is not as impressive as for other cardiac arrythmias. About 70% of patients with paroxystic and persistant atrial fibrillation are cured. Most of the remaining obtain a reduction of their symptoms.

At conventional ablation of atrial fibrillation the catheters are manually navigated to the ideal anatomic position where to isolate the pulmonary veins from the left atrium.

Lately it has been possible to navigate the ablationcatheters using 'remote magnetic navigation' using a magnetic based navigation equipment, Stereotaxis.

The Heartcentre of Rigshospitalet had this Stereotaxis equipment installed in the autumn of 2006.

We will investigate the utility and safety of using this remote magnetic navigation/Stereotaxis.

The purpose on this study is to show the utility and the safety by using the remote magnetic navigation of ablation catheters with the Stereotaxis equipment at ablations of

* atrial fibrillation, atrial flutter and other arrythmias
* childrens arrythmias
* arrythmias of patients with pacemaker or ICD (Implantable Cardiac Defibrillator)

Eligibility Criteria:
Inclusion Criteria:following patients that need catheter ablation:

* Patients with atrial fibrillation
* Patients with artial flutter
* Patients with other tachy arrythmia
* Patients with paceaker/ICD

Exclusion Criteria:

* Patients with anamnestic psycosis or other conditions where information is impossible or insure to give
* Contraindication to magnetic ablation therapy
Use of the Skin Glue in the Placement of Central Venous Catheters Port a Catch

The use of glue as a device in the implantation of central venous catheters has recently been introduced into European clinical practice, initially with the aim of blocking bleeding at the point of exit of the PICCs, but at the same time also to close the cutaneous incision practiced to create the PORT positioning pocket.

It is possible that the surgical incision created for the insertion of the PORT may undergo complications such as: local bleeding, infections or wounds of the surgical wound.

A solution to this problem could be the application of the cyanoacrylate dermal glue on the edges of the surgical wound, after intradermal suture. The glue would have the purpose of sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect and create a potential barrier against infections.

Patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by a numeric code, until hospital discharge.

The parameters analized will be related to:

* essential patient data (identification number, gender, age, height weight)
* basic diseases
* associated diseases and risk factors
* origin of the patient (department or home)
* reason for positioning
* hemorrhagic complications detected in the first 24 hours
* hemorrhagic complications detected in the first 7 days
* non-bleeding complications detected at 7 days (local and systemic infections, wound delescence)

The data wil be transferred to an Excel worksheet, in order to conduct a descriptive analysis related to every variable

Eligibility Criteria:
Inclusion Criteria:

* informed consent signature
* age \> 18 years

Exclusion Criteria:

* Age\> 90 years
* Cianoacrilate allergy
* Presence of bacteraemia
* Informed consent refusal
Instinct™ Ultrasound Device Safety, Efficacy and Usability

Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attached to a commercial smartphone in remote pregnancy assessment. Study aims to evaluate its safety, efficacy and usability.

Study includes women carrying a singleton fetus at 14 to 40 gestational weeks. Women with multiple gestations, non-viable fetus at recruitment and those with a major fetal anatomical malformation or genetic syndrome are excluded. Each participant receives the device for a self-use period of 7-14 days, instructed to preform 1-3 scans a day. Each participant completes a self-assessment questionnaire which aims to evaluate satisfactory and usability (user experience and satisfaction). Each scan will be evaluated for the possibility to properly view fetal heart activity, amniotic fluid volume, fetal tone, fetal body and breathing movements.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18.
* Pregnancy week - 14-40.
* Fetus - single, no known genetic or anatomic defects.
* Able to understand and give informed consent.

Exclusion Criteria:

* Multiple pregnancy.
* Known genetic or anatomic defect to the fetus.
* Inability to understand how to operate the device or give informed