cyrilzakka/clinical-trials huggingface dataset:
Uromune in Treating Recurrent Urinary Tract Infections in Women

To determine the effectiveness and safety of the vaccine Uromune in Canadian women with recurrent urinary tract infection.

The proposal is for a real life clinical practice study in which female participants with a predefined history of recurrent UTIs in the previous year will be treated with 3 months of oral vaccine with a further 9 months of follow-up. The primary outcome will be no UTI in the 9 month efficacy period following completion of the vaccine (definition of a responder). A clinically significant and important outcome will be defined as a responder rate of 50% (50% of participants who had at least 3 UTIs in the previous year reporting no UTIs after therapy initiated.

Eligibility Criteria:
Inclusion Criteria:

* Can provide written consent and willingness to comply with all aspects of study treatment and study requirements.
* Individuals who have had at least 3 episodes of a UTI in the past 12 months or 2 UTI episodes in the past 6 months. At least one of the UTI episodes must be associated with a positive urine culture with a traditional uropathogen including Escherichia coli, Proteus spp. Staphyloccous sp. Enterococcus sp. Klebsiella sp. or Pseudomonas aeruginosa.
* Post-menopausal for a minimum of 1 year or negative pregnancy test if participant is of child bearing potential and agreement to acceptable contraceptive use from Screening Visit 1 to final follow up visit if participant is sexually active. Medically acceptable methods of contraception include hormonal contraception (i.e. estrogen, and/or progesterone or preparations that contain a combination of these hormones), non-hormonal intrauterine device or double barrier method (i.e. condom with foam or vaginal spermicidal suppository, or diaphragm with spermicide) or vasectomy of sole sexual partner. Complete abstinence alone can be used as a method of contraception.
* Free of a urinary tract infection at the time of trial inclusion.

Exclusion Criteria:

* History of bladder tumours including uterine, cervical, vaginal or urethral cancer.
* Worrisome post-voiding residual (investigator's discretion).
* Infection related to urinary lithiasis.
* Any immunological disease requiring active therapy.
* Currently receiving Immunotherapy.
* Taking any prophylactic antibiotics at screening. Any prophylactic antibiotics must be stopped the day of the screening visit.
* Any known intolerance to the ingredients of the Uromune® Immunotherapy.
* Have any other condition or disease which, in the opinion of the investigator, could compromise participant safety or interfere with the participant's participation in the study or in the evaluation of the study results.
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease

This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Current use of an artificial tear product
* Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
* Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months
* Current eye infection or inflammation
Short Chain Fatty Acid Metabolism and Energy Metabolism

Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the differential availability of SCFA impacts human metabolism differently.

In this placebo controlled, double-blind, randomized crossover pilot study the investigators will validate in overweight/obese healthy male volunteers whether rectal administration of SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be investigated if site of administration (in distal or proximal colon) of SCFA differentially affects parameters of substrate and energy metabolism and to test the duration of short-term effects of SCFA administration.


Eligibility Criteria:
Inclusion Criteria:

* Overweight, obese men

Exclusion Criteria:

* athletes
* diabetes mellitus
Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients

The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in Acute Decompensated Heart Failure patients.


Eligibility Criteria:
Major Inclusion Criteria:

1. Chronic heart failure patients, hospitalized due to decompensated heart failure (ADHF) with NYHA Class III-IV symptoms (ADHF is defined by the presence of at least one of the following symptoms/signs: dyspnea w/orthopnea, jugular venous distension, peripheral edema +2, abdominal ascites, signs of CHF on chest X-Ray)
2. LVEF ≤ 40 % within the past 3 months

Major Exclusion Criteria:

1. Acute Q-wave myocardial infarction or Acute coronary syndrome within past 30 days
2. Cardiac surgery within the past 30 days
3. Implantation of cardiac resynchronization device within past 30 days or a possibility of implanting a biventricular pacer within 90 days of randomization
High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients

This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 19 to 75 years
2. Patients diagnosed with ASCVD (coronary artery disease)

   * acute coronary syndrome
   * history of myocardial infarction (MI)
   * stable or unstable angina
   * history of coronary revascularization
   * stroke or transient ischemic attack (TIA)
   * peripheral arterial disease, history of peripheral arterial revascularization
3. Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization
4. Written informed consent

Exclusion Criteria:

1. Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit
2. Fasting triglyceride ≥ 400 mg/dL
3. History of muscular disease or rhabdomyolysis due to use of statin
4. Hypersensitive to rosuvastatin or ezetemibe
5. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:

   ① Severe renal disease (CrCL \< 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) \< 30mL/min/1.73m2)

   ② ALT, AST \> 3x ULN or history of active liver disease

   ③ CPK \> 3x ULN
6. Administration of other investigational products within 30 days prior to screening visit
7. Other than the above who is deemed to be ineligible to participate in the trial by investigator
Stiripentol in Dravet Syndrome

The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.


Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease

The objective of this study is to evaluate the pharmacokinetics (PK) in adult Chinese subjects with dry eye disease (DED)1 after bilateral nasal spray administration of OC-01 (varenicline solution) Nasal Spray at a concentration of 0.6 mg/mL.


Eligibility Criteria:
Inclusion Criteria:

Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit

Exclusion Criteria:

* Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g., laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within 12 months of the Screening Visit
* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, acute conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Have a known hypersensitivity to any of the procedural agents or investigational product components
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.
International Travel Patterns and Risk Behaviour of Breast Cancer, Lymphoma Patients and Bone Marrow Transplant Recipients

This study also aims to raise awareness among both patients and health-care providers about the importance of pre-travel health consultation and preventive interventions prior to international travel.

Through appropriate health counseling, cancer patients will have less risk of having travel -related health complications and thus have a better quality of life and overall improved sense of wellbeing.


Eligibility Criteria:
Inclusion Criteria:

* Hematopoietic Stem Cell Transplant (HSCT) recipients
* Age \>18 years
* Status post bone marrow transplant within last five years Breast Cancer patients: Criteria 1 and Criteria 2 and/or 3
* Female age \>18 years and current or past history of breast cancer
* Received systemic chemotherapy in the last five years
* Metastatic breast cancer disease (stage IV) Lymphoma: Criteria 1 and Criteria 2 and/or 3
* Age \>18 years and current or past history of lymphoma
* Received systemic chemotherapy within 5 years
* Had active disease at any time within the last 5 years

Exclusion Criteria:

* Patients age\< 18 years
* Breast cancer and lymphoma patients in clinical remission in the past 5 years
* Patients unable to fill the questionnaire due to language barriers
Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare re-PDT with sd-PDT in ICU patients

Percutaneous dilatational tracheostomy (PDT) is a popular airway management technique in the intensive care unit (ICU).Occasionally the first dilation may be challenging when using Ciaglia and colleagues' method, and a second dilation may be needed to insert the tracheostomy tube. In these circumstances, potentially life-threatening complications, such as hemorrhage and hypoxia, may arise. The investigators found the reasons for difficulty in achieving smooth dilation of the stoma.The investigators compared the traditional method with the improved method.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years;
* requirement for long-term mechanical ventilation;
* failure of weaning from mechanical ventilation.

Exclusion Criteria:

* age \<18 years;
* pre-existing infection at the tracheostomy site;
* pre-existing malignancy at the tracheostomy site;
* difficulty in identifying the anatomic landmarks;
* unstable cervical spine fracture;
* international normalized ratio (INR) \>2;
* platelet count \<50 000 mm3.
Personalized Assessment of Client Experiences

The purpose of this study is to compare two clinical approaches to youth mental health care.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female youth between the ages of 11-17 years receiving mental health services at the participating clinics.
2. The treating clinician is participating in the study and determines that Measurement-Based Care (MBC) is appropriate for the youth.
3. If the family consents to complete additional research measures, one parent and/or primary caregiver must be available and willing to participate in all study assessments.
4. Adolescent and at least one parent/guardian are able to complete all study procedures in English or Spanish.

Exclusion Criteria:

* no other exclusion criteria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)

A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.

Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or a single oral anti-hyperglycemic agent
* Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, throughout the study and until the post study visit
* Subject has been a nonsmoker and/or has not used nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma, carcinoma in situ of the cervix, other malignancies successfully treated at least 10 years prior to screening, or malignancies deemed highly unlikely to recur.)
* Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis
* Subject has a history of contact lens use within approximately the previous 6 months
* Subject has been diagnosed with dry eye syndrome
* Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable monotherapy dose of statins may be included)
* Subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of starting in the study
Clobazam in Subjects With Lennox-Gastaut Syndrome

The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment.

More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject must have been \<11 years of age at the onset of LGS
* Subject must have LGS
* Subject must be on at least 1 stable dose AED
* Parent or caregiver must be able to keep an accurate seizure diary

Key Exclusion Criteria:

* Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation
* Subject has had an episode of status epilepticus within 12 weeks of baseline
* Subject has had an anoxic episode requiring resuscitation within 1 year of screening
* Subject has had a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines
* Subject is taking more than 3 concurrent AEDs. Note: Vagal Nerve Stimulation (VNS) or ketogenic diet is allowed and each will be counted as one of the three allowed AEDs
* If the subject is on the ketogenic diet, has been for less than 4 weeks prior to screening or suffers from frequent stooling
* If the subject has a VNS, the settings have not been stable for at least 4 weeks prior to screening
* Subject has taken corticotropins in the 6 months prior to screening
* Subject is currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for urinary tract infections or asthma
* If the subject is taking felbamate, has been taking it for less than 1 year prior to screening or previous treatment with felbamate resulted in withdrawal due to liver or bone marrow adverse events
Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

Researchers are trying to determine if knee pain can be reduced by proactively protecting the free end of the saphenous nerve versus leaving it in the standard position during total knee arthroplasty.

Subjects scheduled for total knee arthroplasty will be randomized to two arms. One arm will have the standard saphenous nerve neurectomy during their surgery. The other arm will have the same neurectomy procedure with the free end of the nerve tucked into soft tissue to protect the nerve ending.

Eligibility Criteria:
Inclusion Criteria:

* Primary unilateral total knee arthroplasty candidate

Exclusion Criteria:

* Body Mass Index (BMI) \>40
* Inflammatory arthritis
* Unable to follow up visits (long distance from Mayo Clinic)
* Poor compliance risk
* Health condition deemed by physician to preclude patient's ability to participate in the trial
Treatment of Recurrent Hepatitis C After Liver Transplantation

In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. The interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. The objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis C recurrence in the transplanted liver.

Several therapeutic patterns have been described for the treatment of hepatitis C post-transplantation recurrence. A combination treatment associating interferon-α and ribavirin has shown some efficacy, but this efficacy has not been assessed yet in a placebo-controlled double-blind clinical trial. In our study, all included transplanted patients will be treated during 1 year with interferon-α and ribavirin. At the end of this period, they will be randomized to receive a maintenance treatment with ribavirin or a placebo for 1 additional year. Efficacy will be assessed on virological response after 30 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* First liver transplantation or retransplantation in the month after initial transplantation
* Patients aged over 18 years
* Post-hepatitis C cirrhosis
* Equilibrated immunosuppressive treatment
* Positive PCR for hepatitis C virus
* Liver biopsy between 6 months and 5 years after the transplantation with a fibrosis Metavir score at least F1
* Hemoglobin ≥ 10 g/dl
* Platelet count ≥ 50.000/mm3
* Normal TSH value
* Serum creatinine \< 200µmol/l
* Informed written consent

Exclusion Criteria:

* Chronic rejection
* Acute rejection at inclusion
* Multi-visceral transplantation
* Renal or cardiac failure, severe sepsis
* Uncontrolled diabetes
* Positive serology for hepatitis B or HIV at inclusion
* EBV virus replication at inclusion
* Hepatocellular carcinoma at inclusion
* Cirrhosis with a fibrosis Metavir score F4 at inclusion
* Inclusion in another clinical trial less than one month ago
* Pregnancy
* Contra-indication to ribavirin or interferon
* History of or current psychiatric troubles
* Thyroid disease uncontrolled by treatment
Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema

This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL).

This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema (BCRL), hereby improving the quality of life of patients with breast cancer. Furthermore, we will perform exploratory analyses to investigate the predictive values of patient plasma cytokines to the occurrence and development of BCRL.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in this clinical trial. Fully understand and be informed about the study and sign an informed consent form (ICF). Willing to follow and able to complete all test procedures;
* Female, ≥18 years old and ≤70 years old at the time of signing the ICF;
* Patients with unilateral breast cancer diagnosed by histopathology or cytology;
* No distant metastasis;
* To undergo unilateral axillary sentinel lymph node biopsy or unilateral axillary lymph node dissection;
* Have not received any treatment for arm lymphedema;
* No lymphangitis and other infections.

Exclusion Criteria:

* Breast malignancy derived from other tumors rather than the primary breast cancer;
* Patients with second primary tumor;
* Contraindication to airwave compression therapy: Acute venous thrombosis; Acute inflammatory skin disease; Erysipelas; Arrhythmia; Pulmonary edema; Unstable hypertension; People with artificial pacemakers; Deep thrombophlebitis;
* Have a history of mental illness or other reasons can not cooperate with treatment;
* Embolism, cardiogenic edema, hepatogenic edema and the history of upper limb trauma and other related complications;
* Patients using any medication that affects fluid or electrolyte balance.