cyrilzakka/clinical-trials huggingface dataset:
Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

The study is to evaluate whether the efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week treatment period.


Eligibility Criteria:
Inclusion Criteria:

1. Primary hypercholesterolemia or mixed dyslipidemia
2. Subject meeting All of the following diagnoses at Baseline visit:

   * TG≦350 mg/dL
   * ALT and AST≦ 2.5 times of upper limit of normal (ULN) with no acute liver disease
   * Creatine kinase (CK) concentration≦2 times of UL N
   * Creatinine≦1.5 mg/dL
3. Subject who is willing and able to provide inform ed consent

Exclusion Criteria:

1. Female who is or intends to be pregnant or breast feeding, or has childbearing potential but without effective contraception.
2. Subject with documented HIV
3. Subject with uncontrolled hypothyroidism according to the investigator's judgment
4. Subject with unstable cardiovascular disease (CVD), including but not limited to congestive heart failure (CHF) defined as New York Heart Association class III or IV, unstable angina, unstable arrhythmia according to the investigator's judgment
5. Subject with unstable hepatic or biliary disorders, including but not limited to acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, jaundice , and chronic hepatitis B or C under antiviral therapy
6. Subject with the following medical histories:

   * History of malignancy, exceptions made for the following malignancies: a)those determined to be cured or in remission for ≥ 5 years, b) curatively resected basal cell or squamous cell skin cancers, c) cervical cancer in situ, or resected colonic polyps
   * Acute coronary syndrome with or without cardiac catheterization within the past 9 months
   * Therapeutic cardiac catheterization (due to reasons other than acute coronary syndrome) within the past 6 months
7. Any unstable comorbidities or clinical conditions , including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation , per investigatiors judgment
8. Use any lipid lowering agent within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)
9. Use cyclosporine within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1)
10. Use any investigational product within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)
Auriculotherapy for Smoking Cessation: Pilot

Thirty three percent of our veterans currently smoke. Encouraging smoking cessation continues to be a top priority for the Veteran's Administration as smoking is the single most important preventable risk factor for mortality and morbidity. This study attempts to determine whether auriculotherapy may be used as an effective alternative to usual pharmacological interventions currently offered. Identifying an efficacious alternative method to nicotine patch or bupropion would be highly beneficial to veterans who want to quit smoking. This clinical trial took place at the Veterans Administration Medical Center, in conjunction with the smoking cessation clinic. One hundred twenty five veterans, male and female, age 19 or older, who smoked a minimum of 10 cigarettes per day, were evaluated for enrollment and randomized to two groups- true auriculotherapy and sham auriculotherapy in this 6 week trial.

Methods: This randomized, double-blind, placebo-controlled clinical trial of 125 veterans was conducted to determine whether aural electrical stimulation (auriculotherapy) with the Stim Flex 400A TENS unit once a week for 5 consecutive weeks is associated with a higher rate of smoking abstinence are than observed with sham stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Do not meet any exclusion criteria; age 19 and above.

Exclusion Criteria:

Veterans will be excluded from the study if they:

* have history or current evidence of pathological condition of the ear (e.g. infection, inflammation, or skin disruption of the auricle
* are known to be pregnant (positive urine pregnancy test)
* have an indwelling cardiac pacemaker or defibrillator
* are actively psychotic (as evidenced by delusions, hallucinations, or disorganization), have a severe cognitive impairment, or current significant substance abuse disorder that might prevent full participation in this study. Also excluded are those who score greater than 20 on the PHQ-9 screening tool for depression
* refuse to sign an informed consent form
* have been on bupropion and/or nicotine patch in the past one month or intend to start bupropion and/or nicotine patch in the next 6 weeks.
* Have a urine cotinine level less than 3.
A Mentor-Based Approach to Long-Term Weight Loss

The purpose of this study to examine the effect of having a weight loss mentor on long-term weight loss in overweight adults.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 21-55 years of age
3. BMI = 25-35 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
3. Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.)
4. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
7. History of myocardial infarction or valvular disease.
8. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push

A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using pump or rapid push.


Eligibility Criteria:
Inclusion criteria:

* Adult patients (≥ 18 years).
* Presenting with primary immunodeficiency.
* Having received subcutaneous injections of immunoglobulin at home using an automatic pump or syringe for at least 1 month at the time of inclusion.
* For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Gammanorm® 165 mg/mL at home.
* Freely given written informed consent from patient.
* Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine \[HCG\]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.

Exclusion Criteria:

• Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine

The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.

The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes
* Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1
* Have used:

  * single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
  * insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
  * a combination of the above.
* Are greater than or equal to 21 and less than 80 years of age
* As determined by the investigator, are capable and willing to:

  * comply with their prescribed diet and medication regimen,
  * perform self blood glucose monitoring,
  * use the patient diary as required for this protocol,
  * participate in two 24 hour inpatient assessments

Exclusion Criteria:

* Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
* Are currently treated with a meglitinide without sulfonylurea
* Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
* Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory
* Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1
Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)

This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial.

The aim of this trial is to provide additional data on the driving factors of IFN beta response and the long-term outcomes of Rebif® treatment.

This is a Phase IV trial involving subjects who previously participated in the PRISMS trial. To address the trial objectives, a single visit will be performed, at least 3 months after the onset of the last relapse.


Eligibility Criteria:
Inclusion Criteria:

* Was randomized in the PRISMS study
* Is willing and able to comply with the protocol
* Written informed consent given before any trial-related activities are carried out

Exclusion Criteria:

* Is unwilling or unable to participate in the study
Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy

The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, patients whose preparation was inadequate, will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.

The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, the study will be composed of patients whose preparation was judged to be inadequate in a first colonoscopy by an endoscopist independent of the current study. They will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.

Eligibility Criteria:
Inclusion Criteria:

* Failed colonoscopy due to inadequate preparation
* Able to understand and sign an informed consent
* Preparation for frst colonoscopy consisted of sodium phosphate

Exclusion Criteria:

* Significant heart disease or CHF
* Chronic Renal Failure
* Allergy to any of the purgative ingredients
* Pregnancy
* Alcohol and/or drug abuse
* Vomiting or aspiration
* Suspected bowel obstruction
Demonstrating the Diagnostic Power of an Electronic Nose: Study on Exhaled Air Samples

The investigators don't know yet how the nose and the brain decode the smells. Scientific studies in neuroscience have shown that people who have tumors may have changes in the smell of secretions. Dogs are extremely efficient at detecting these changes, even before imaging studies. A review of the recent literature shows the different work done on the diagnosis of dogs on human pathologies, especially oncology. It is now known that the smell of exhaled gases is representative of the intestinal biotope and that a large number of pathologies are related to the type of microbial populations that inhabit the intestines.

Copying the olfactory organs could thus be of major interest for the early diagnosis of pathologies. More and more works are interested in the diagnostic power of electronic noses. From a technical point of view, these are nano-sensors that mimic the olfactory receptors from the breath gas of the subjects. They analyze the molecules present and compare them with a database to establish a diagnosis according to a probabilistic algorithm.

The use of exhaled air for the diagnosis of cancerous pathologies has already been the subject of scientific work. A classification using the SVM (support vector machine) method using data from 320 sensors made it possible to differentiate patients with lung cancer from controls in 98.8% of cases. The differential diagnosis of obstructive bronchopneumopathy was also very well done in this same study. Another study shows equally encouraging results, highlighting sensitivities and specificities above 80%.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have signed the free and informed consent form or their guardian if applicable. If the state of health of the patient does not allow him to give and sign his consent, it will be sought from the person of trust
* The patient must be an affiliate or beneficiary of a health insurance plan
* The patient is at least 18 years old

Exclusion Criteria:

* The patient participates or has participated within 3 months in another study that may have modified their intestinal biotope
* The patient is in an exclusion period determined by a previous study
* The patient is under the protection of justice
* The patient or guardian or trusted person refuses to sign the consent
* The patient does not read the French language fluently
* The patient claims to be pregnant
* The patient is breastfeeding
Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a MRI Protocol Without Contrast: Validation of the Cambridge Score

The aim of this prospective observational study is to evaluate the accuracy and to validate the Cambridge Score,a Test Index to predict the malignancy of the ovarian lesions on the basis of an MRI examination without contrast


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Indeterminate adnexal masses at the ultrasonography;
* Signed Informed Consent.

Exclusion Criteria:

* Diagnosis of an extraovary mass;
* Synchronous tumors;
* Previous history of neoplasy.
Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels

Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Consistently high blood sugar levels can, over time, lead to complications such as blindness, kidney disease, heart disease, and nerve damage.In addition, low blood sugars may lead to immediate dangers. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics. Currently, there is no commercially available reliable non-invasive glucose measurement device that being marketed.

The GlucoTrack, non-invasive device for determining glucose levels based on the simultaneous measurement of three independent orthogonal parameters.

The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 1, Type 2, or Gestational Diabetes
* Above the age of 10

Exclusion Criteria:

* Does not meet inclusion criteria
* Patients requiring dialysis
* Participation in other clinical investigations within the previous month.
* Pregnancy(excluding patients that intend to participate in the gestational group)
Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain

The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as routinely utilised in the study centre. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population.


Eligibility Criteria:
Inclusion Criteria:

1. Subject of either gender between 18 and 65 years of age
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Subject is able to provide written informed consent
4. Chronic low back pain of at least 6 months
5. History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance)
6. Neurologic exam without marked motor deficit.
7. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS guidelines\*
8. Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline
9. Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre
10. Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. BMI ≥35
4. Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months
5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Severe disc degeneration at the affected level as evidenced by \>50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.
8. Extruded or sequestered herniated nucleus pulposus at the affected level(s).
9. Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s)
10. Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
11. Moderate to severe endplate degenerative changes at the affected levels
12. Grade 1-2 spondylolisthesis
13. Previous Neurostimulation therapy
Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF

Clinical trials in children and adults have suggested that daily consumption of probiotic lactic acid bacteria can reduce caries risk and caries development in primary teeth in preschool and stop root caries in the elderly. However, it is not known whether probiotic bacteria can affect the increased porosity in young permanent teeth in children and adolescents with many cavities.

It can be difficult to measure the increased porosity of the enamel by tooth decay, but this can be done using quantitative laser fluorescence (QLF). The method is based on visible light with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and green color tones and the dominant color of the enamel is green. Increased porosity of the enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the mineral can be quantified by means of a corresponding software.

The purpose of this study is to investigate the effect of a daily supplement of probiotic lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis is that the mineral content will not differ from baseline in either the test group or the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* two sites with white spot lesions in anterior teeth

Exclusion Criteria:

* antibiotic treatment within 2 months
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Singleton 10-14 days of age at randomization
* Term infant with birth weight of minimum of 2500 grams
* Solely formula fed
* Signed informed consent and protected health information

Exclusion Criteria:

* History of underlying metabolic or chronic disease, anemia, or immune compromise
* Feeding difficulties or formula intolerance
Arformoterol/Budesonide for COVID-19

This is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase 2 study to evaluate the efficacy and safety of UI030 in COVID-19 patients

Patients with moderate and severe COVID-19 were randomly assigned (1:1) to receive either UI030 (Budesonide/Arformoterol dry powder inhaler, 2 inhalations b.i.d) or placebo for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adult, aged 19 years or above
* New onset of symptoms suggestive of COVID-19 (fever, cough, soar throat, etc) or diagnosed with COVID-19 within 7 days of participant being seen at visit 1
* In the Investigator's opinion, is able and willing to comply with all trial requirements

Exclusion Criteria:

* A condition requiring invasive oxygen support;
* History of hypersensitivity to budesonide and arformoterol
* Pregnancy, Breast-feeding
* Participation in other clinical studies within 4 weeks prior to enrollment in this study.
* Refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient.