cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic genotype 3 HCV infection
* HCV treatment-naive
* HCV RNA \> 10,000 IU/mL at screening
* Absence of cirrhosis or compensated cirrhosis
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Coinfection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months

The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.


Eligibility Criteria:
Inclusion Criteria:

* 2 months old (at a minimum of 6 weeks old) and above healthy people.
* Subject or legal representative who consent and has signed written informed consent.
* Subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required.
* Subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine.
* Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* Subject with a history of a prior bacterial culture of an aggressive disease caused by S. pneumoniae.
* Subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination.
* Subject who are allergic to diphtheria toxins.
* Children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight \<2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis.
* History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
* Subject who diagnosis of thrombocytopenia or other history of coagulopathy.
* Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
* Known or suspected to suffer from: severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease, serious respiratory system disease, acute infection or chronic disease active period.
* Known or suspected to suffer from immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxicity drugs), HIV infection, etc.
* Received blood products or immunoglobulin within 3 months before enrolling (hepatitis B immunoglobulin was acceptable), or planned to use it during the clinical trial period (before blood samples were collected after immunization).
* Subject who plan to participate in or is in any other clinical trial (vaccines, drugs, medical devices, etc.).
* In pregnancy or lactation or pregnant women.
* ≥18-year-old subject with blood routine, blood chemistry or urinalysis laboratory collection abnormalities.
* Any condition that, in the judgment of investigator, may affect trial assessment.
Classical Conditioning to Treat Allergic Airway Diseases

Most clinicians who care for patients with inflammatory airway diseases such as allergic rhinitis and asthma are aware of the negative effects of certain sights, sounds and smells that can precipitate clinical exacerbations in certain susceptible patients. This is thought to be due to subconscious associations between these observable stimuli paired and actual exposure to allergens that induce clinical symptoms. The severity and duration of these symptoms are typically related to levels of anxiety and/or depression in affected patients. Classical conditioning of the immune response has been described in many animal and some human studies in association with administration of immunosuppressive drugs. In successfully conditioned individuals, subsequent exposure to the conditioning stimulus alone produces immunosuppressive changes similar to those caused by the drugs themselves. Since disease exacerbating conditioning appears to be prevalent in allergic patients, these conditions make an excellent human model for understanding the relationships between classical conditioning, psychological stress (particularly anxiety and depression) and immune regulation. Thus this proposal will seek to examine the hypothesis that antiinflammatory effects of pharmacotherapeutic agents can be classically conditioned and are clinically effective due to changes in immunoregulatory imbalances known to occur in patients with allergic airway diseases. The effectiveness of this therapeutic approach will be significantly affected by levels of psychological stress and individual suggestibility. This will be investigated with the following Specific Aims: (1). Determine the relative effectiveness of classical conditioning by a novel gustatory stimulus paired with immunosuppressive doses of corticosteroid on in vivo and in vitro immune responses (allergen - specific vs. general) of patients before, during and after classical conditioning correlated with level of clinical response; (2) Determine the role of neuroendocrine mechanisms (particularly catecholamines) on the inducibility and duration of the conditioned immune responses; and (3) Investigate the influence of psychological stress levels (including anxiety and depression) and/or suggestibility on baseline immune changes, success and duration of the classical conditioning.

These data will help define parameters for classical conditioning in humans, establish a model to investigate mechanisms and serve as the basis for development of future interventional protocols for severe inflammatory diseases involving classical conditioning.


Eligibility Criteria:
Current history of allergic airway disease confirmed by positive skin tests. Included will be only those who have never tasted licorice or do not like the taste of licorice.
Metabolic Syndrome and Contrast Induced Nephropathy

Prevention of contrast induced nephropathy after interventional cardiologic procedures deserves close interest because of its association with prolonged hospitalization, increased cost and increased in hospital and long term mortality rates. An observational prospective cohort study was designed to determine whether metabolic syndrome predicts the development of contrast induced nephropathy after elective percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

Patients must be scheduled for elective percutaneous coronary intervention Clinical diagnosis of metabolic syndrome Patients must give informed consent

Exclusion Criteria:

Acute coronary events Acute renal failure End stage renal failure requiring hemodialysis Contrast allergy and exposure to nephrotoxic agent within 1 week before percutaneous coronary intervention Exposure to contrast agent within 1 week before the procedure.
CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest

The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone healing strength of CopiOs to be equivalent to autograft.

Purpose of the study is to evaluate the in-vivo use of CopiOs bone void filler in a single site trial, providing pre and post-operative evaluations of subjects undergoing spinal fusion with autogenous bone graft, in whom the CopiOs has been used as a bone void filler in the post-harvest iliac crest.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years and older
* Patient must be an appropriate candidate for iliac crest bone harvesting during a spinal fusion.
* Patient must be skeletally mature.
* Patient has signed an IRB approved Informed Consent and HIPAA compliant waiver.

Exclusion Criteria:

* Patient is suffering from any co-morbidities that would excessively increase the risk of surgery, including but not limited to pulmonary or cardiac conditions.
* Patient is pregnant.
* Patient has a severe degenerative bone disease.
* Patient has systemic conditions which would affect bone or wound healing.
* Patient is unwilling or unable to follow postoperative instructions or cooperate in a follow-up program.
* Patient is suffering from mental illness, alcohol abuse or drug abuse.
* Patient has known allergies to bovine collagen.
* Patient has a history of multiple allergies.
* Patient has infection at the surgical site.
* Significantly impaired vascularity proximal to surgical site.
* Sites are in direct contact with articular space.
* Sites where stresses on void will exceed the load strength of fixation hardware.
* Patient has hypercalcemia.
18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer

This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that is given through the vein to take detailed pictures of areas inside the body where the tracer is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how far the disease has spread.

PRIMARY OBJECTIVES:

I. To perform a prospective clinical imaging evaluation of 18F-FMAU PET/CT in addition to multiparametric magnetic resonance imaging (mpMRI) and standard transrectal ultrasound (TRUS)-guided 12-core biopsy for detection and localization of primary tumor in 40 men with suspected prostate cancer based on elevated/rising prostate specific antigen level, abnormal digital rectal exam, or those with prior negative standard biopsy who are now returning for a standard of care follow-up.

II. To examine the associations between the PET derived imaging parameters, serum PSA, mpMRI parameters (apparent diffusion coefficient \[ADC\], Ktrans) and the biopsy histopathology parameters.

OUTLINE:

Patients receive radiotracer F 18 d-FMAU intravenously (IV) over 1 minute and then undergo 18F-FMAU PET/CT on day 1. Patients then undergo standard of care multiparametic MRI and standard of care transrectal ultrasound-guided biopsy.

After completion of study treatment, patients are followed up at 24-96 hours.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo standard of care biopsy for suspected prostate cancer, or re-biopsy with prior negative systemic biopsy or restaging biopsy in patients with known prostate cancer on active surveillance

Exclusion Criteria:

* History of myocardial infarction within 6 months of the enrollment
* Active infection (except mild upper respiratory infections)
* Active prostatitis
* Non-prostate cancers currently on treatment
KCNQ1 Cascade Screening

The objectives of the protocol are to: (1) evaluate the uptake of cascade screening and preventative therapies after the implementation of a simplified screening process and (2) assess proband and family member perspectives about the return of research results and cascade screening for the KCNQ1 Thr224Met variant. The investigators will conduct a mixed methods study in the Old Order Amish community where the KCNQ1 variant is enriched over 100,000-fold compared to other populations. The intervention will offer free, mail-in, saliva-based genetic testing for family members of probands. The rate of uptake of testing and preventative therapy after the intervention is implemented (i.e. when 'simplified' free, mail-in, saliva-based testing was available) will be compared to data from before the intervention (i.e. when 'traditional' $50 blood-based testing was available to family members) when uptake was essentially zero. The primary outcome is the rate of uptake of cascade screening with the intervention ('simplified'). The secondary outcomes include: extent of disclosure of genotype results before and after the intervention, proportion of informed relatives who get screened before and after the intervention, and the uptake of appropriate preventative care (e.g. seeing a cardiologist and/or taking beta-blocker). The tertiary outcomes are demographic characteristics associated with uptake of cascade screening or uptake of preventative therapy. The investigators will also assess qualitative themes surrounding the return of results process and cascade screening using interviews.


Eligibility Criteria:
Inclusion Criteria:

* KCNQ1Thr224Met proband or first degree family member

Exclusion Criteria:

* Family members who have not been contacted by probands
Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients

Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in reducing COPD exacerbation and hospitalization, improving the life quality, and postponing the lung function decline. But for some patients with severe COPD, current treatment only partially alleviates the symptoms and has little role in the lung function decline. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected by echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ score and mMRC/CAT score.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 75
* Gold Ⅲ or Ⅳ stable COPD
* Pulmonary hypertension detected by echocardiography

Exclusion Criteria:

* Acute exacerbation of chronic obstructive pulmonary disease
* Untreated obstructive sleep apnea
* Restrictive (total lung capacity\<60% predicted) lung disease
* Portal hypertension
* Chronic liver disease
* Transaminase increased to normal line more than 3 times; total bilirubin increased 2 times more than the upper limit of the normal value
* Left-sided or unrepaired congenital heart disease
* Patients with other serious heart diseases
* Patients with 1, 2, 4 and 5 categories of pulmonary hypertension
* Unable to complete the 6 minutes walk test
* Patients receiving other endothelin receptor antagonists
* No cooperation to complete
Pap Smear Research Study

The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Ability to speak and clearly understand English
* Female patients

Exclusion Criteria:

* No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.)
* Women who have had Pap smears within the previous 10 months
* Women under the age of 18.
* Women who are pregnant.
* Inability to give informed consent in English
Correlation Between Esophageal Temperature and Skin Temperature in Trauma Patients

The goal of this retrospective data-based study is to investigate the correlation between esophageal temperature and skin core temperature in trauma patients who underwent emergency surgery.

Based on the medical records of patients who applied both temperature measurements simultaneously, the correlation between the skin core temperature and the esophageal temperature was investigated

Hypothermia is known to be one of the factors that increase mortality rate in trauma patients. Therefore it is important to measure and manage the core temperature in trauma patients.

Esophageal temperature is common method to measure core temperature in patients undergoing surgery under general anesthesia. However, it is not applicable in patients who have not been intubated or in patients with suspected esophageal damage. In addition, esophageal temperature probe is twisted in the mouth and does not reflect core temperature properly.

3M™ Bair Hugger™ temperature monitoring system was developed to measure the core temperature by attaching to the skin using zero heat flow mechanism. It is simple to apply, and available at the trauma scene.

Previous studies have reported that skin core temperature reflects core temperature well, but no studies have been conducted on trauma patients with rapid changes in the core temperature and poor perfusion state.

This retrospective data-based study investigate the medical records of trauma patients who underwent emergency surgery. Patients who applied two temperature measurements at the same time were targeted. Since this center has the system that automatically transfer the hemodynamic data of the monitor to the anesthesia record, the investigators use the anesthesia records.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients who underwent emergency surgery from January 1, 2021 to October 31, 2021
* Who applied both a esophageal thermometer and a 3M™ Bair Hugger™ temperature monitoring system at the same time

Exclusion Criteria:

* When more than half of the data is missing
Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)

To compare the impact of selected physical activities on pelvic floor and stress urinary incontinence in sportwoman.

This is an observational comparative pilot study in which we will compare intravaginal and intra-abdominal pressure and an innovative pad test in 5 female athletes with stress urinary incontinence and 5 without incontinence.

Eligibility Criteria:
Inclusion criteria

* nulliparous women
* aged 18-35
* high-intensity physical activity
* performed sport at least three days per week, 90 minutes per day, for more than two years

Exclusion Criteria:

* handicapped sportswomen
* performance of various kinds of sport
* no regular sport activity
* performance of sports for less than two years
* after childbirth
* surgical treatment of gynaecological and urological illnesses
* urinary tract infection
* disease of respiratory tract
* not sufficiently completed questionnaires
* refusal to participate
* body mass index greater than 30 (BMI = m/h2, where m = body weight in kilograms and h = body height in metres)
* symptoms of overactive bladder
Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children

Reducing tobacco consumption is a major public health objective, with the prevalence of active smoking estimated in 2017 at 26.9% of the French population aged 18 to 25. The negative impact of passive smoking on children's health and development has been demonstrated by numerous studies, especially with regard to respiratory pathologies. Parental smoking is also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of 1.72 if at least one of the two parents is a smoker). It has been shown that intervention with parents can reduce the number of children exposed to passive parental smoking by about 5%.

Reducing tobacco consumption is a major public health objective, with the prevalence of active smoking estimated in 2017 at 26.9% of the French population aged 18 to 25. The negative impact of passive smoking on children's health and development has been demonstrated by numerous studies, especially with regard to respiratory pathologies. Parental smoking is also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of 1.72 if at least one of the two parents is a smoker). It has been shown that intervention with parents can reduce the number of children exposed to passive parental smoking by about 5%. The paediatrician's role is therefore to try to make parents aware of the consequences of tobacco consumption on their children's health and to encourage them to stop smoking. Minimal advice (simple, clear, written and oral information on the actors and means of helping to stop smoking) is the first step in triggering an attempt to stop smoking. The paediatrician seems to be a particularly influential actor since he intervenes at a time when parents are trying to improve their child's health. The minimum advice would have an effectiveness of 2-5% on smoking cessation in general. There is no data on the impact of this minimum advice when given by paediatricians. There are also no data on the current prevalence of smoking in France among parents of children with various chronic diseases, such as cystic fibrosis or diabetes. It is also necessary to describe the smoking habits of parents, as children's exposure and its impact on their health depends in particular on where their parents smoke.

Eligibility Criteria:
Inclusion Criteria:

* Parents of legal age, of children being followed for cystic fibrosis or type 1 diabetes or being hospitalized for the first time for bronchiolitis.
* Having given their non-opposition to participate in the research
* Covered by a social security scheme

Exclusion Criteria:

* Refusal to participate
* Parent already in the process of quitting smoking
* Adult person under guardianship/curators or safeguard of justice
System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care

This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015


Eligibility Criteria:
Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015