cyrilzakka/clinical-trials huggingface dataset:
A Study of 6(S)-5-MTHF Among Serotonin Reuptake Inhibitor(SSRI)-Resistant Outpatients With Major Depressive Disorder (MDD)

The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin®) is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhibitors (SSRIs).

The study consists of two sequential phases, each lasting a total of four weeks (8 weeks total), with visits every 10 days. Once patients agree to participate in the study by signing the informed consent document, a full medical and psychiatric history will be taken and a physical examination and blood draw will be performed. Screen rating scales will be performed. Screened and eligible patients will be asked to return two weeks later for a baseline visit when they will be randomized to double-blind treatment with placebo or Deplin (6(S)-5-MTHF). The double-blind treatment will last 60 days, during which patients will be seen every 10 days. Subjects will be randomized to one of three treatment groups: a)Deplin/Deplin, b) placebo/Deplin, c) placebo/placebo. Patients will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study

* For patients randomly assigned to the Deplin/Deplin sequence, the dose of 6(S)-5-MTHF will be 7.5 mg/day during the first phase of the study, and 15 mg/d during the second phase of the study.
* For patients randomly assigned to the placebo/Deplin sequence, the dose of 6(S)-5-MTHF will be 7.5 mg/day during the second phase of the study.
* For patients randomly assigned to the placebo/placebo sequence, both tablets of study medication will be placebo during both phases of the study.

All patients will be asked to take two tablets of blinded study medication in the morning, in addition to their stable dose of ongoing SSRI treatment. Each study medication tablet will be either 7.5 mg of 6(S)-5-MTHF or matching placebo.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Meet criteria for current Major Depressive Disorder
* Currently taking an SSRI

Exclusion Criteria:

* Pregnant women
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
* Prior course of MTHF augmentation, or intolerance to MTHF at any dose
* substance use disorders active within the last six months, any bipolar disorder (current or past), or any psychotic disorder (current or past).
* Have failed more than 2 adequate antidepressant trials during the current Major Depressive Episode.
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT).
* Didanosine (ddI).

Patients must have the following:

* Diagnosis of AIDS as defined by the CDC.
* Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
* Provide written informed consent.

Prior Medication:

Allowed:

* If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
* Required:
* Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Known hypersensitivity to any of the study drugs.

Concurrent Medication:

Excluded:

* Other therapy for mycobacterial disease.

Patients with the following are excluded:

* Known hypersensitivity to any of the study drugs.

Prior Medication:

Excluded within 4 weeks:

* Therapy for mycobacterial disease.
* Antiretroviral drugs, other than zidovudine (AZT) or ddI.
* Investigational drugs, other than ddI.
Fast-track Giant Ventral Hernia Repair

The implementation of an enhanced recovery pathway after giant ventral hernia repair, including preoperative high-dose steroid is examined prospectively and compared with a group of historic controls.

All patients operated on for a large incisional hernia are treated according to the study protocol. Patients are given high-dose glucocorticoid preoperative and the aim is to discharge patients at postoperative day 3.

Morbidity, length of stay, pain, nausea and pulmonary function are among registered outcomes compared with a historic control group.

Eligibility Criteria:
Inclusion Criteria:

* Horizontal fascia defect \> 10 cm on computed tomography scan
* Planned elective open incisional hernia repair

Exclusion Criteria:

* Known allergy against glucocorticoid treatment
* Insulin-treated diabetes
* Gastric ulcer diagnosed within four weeks preoperative
* Steroid-treated immune disease
* Planned intestinal anastomosis concomitant to hernia repair
Ventricular Tachyarrhythmia (VT) Storm, Gene Expression in Implantable Cardioverter Defibrillator (ICD) Patients With Electrical Storm

The purpose of the proposed pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden. This will be performed by analysis of gene expression from peripheral blood samples.

This is a study of patients with ICD implants who present with multiple(\>2), low-level(1-2) or inappropriate therapies to their defibrillator. The purpose of this pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden by looking at gene expression from peripheral blood, in addition to levels of known markers of CHF, including catecholamine levels, B-type natriuretic peptide, and troponin. This study hypothesizes that extrinsic or systemic factors play a role in triggering these events, and if true should yield candidate proteins which would spawn functional studies to prove a role in causation. Additionally, identification of a marker of increased recurrence of events may aid in guiding therapy (starting an anti-arrhythmic versus awaiting the next event).

Eligibility Criteria:
Inclusion Criteria:

* ICD patients at least 18 years of age that present within a 72 hour period: 1) \> 2 therapies for ventricular arrhythmias; 2) 1-2 therapies for ventricular arrhythmias; 3) inappropriate therapies for ventricular arrhythmias
* Able to give informed consent

Exclusion Criteria:

* Inability to give informed consent
Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males

The main purpose of this study is to assess the safety, tolerability, and biological activity of SD-101 compared with placebo in healthy male volunteers.

This is a Phase 1, randomized, single-blind, placebo-controlled study of five escalating dose levels of SD-101 in healthy male volunteers. The objectives of the study are to assess the safety, tolerability, pharmacokinetic profile, and pharmacodynamics of SD-101. Approximately 40 subjects will participate.

Once subjects have been consented, screened, and assigned to one of the dose levels of SD-101, subjects will receive a single subcutaneous injection of either SD-101 or placebo (PBS) in a ratio of 6:2.

Safety and tolerability will be evaluated by occurrence of adverse events, blood and urine laboratory tests, physical examination findings, vital signs , and electrocardiogram findings. Pharmacodynamics will be evaluated by levels of blood biomarkers and serum cytokines, and flow cytometric cell counts. Pharmacokinetics will be evaluated by levels of study drug in serum.

Eligibility Criteria:
Inclusion Criteria:

* Signed, written, informed consent must be obtained from the subjects before any study-specific procedures are performed.
* Subject must be male and 18 years of age or older.
* Subject must be willing to submit to a urine drug screen and agree to abstain from alcohol, caffeine, and tobacco during the required stay in the Phase I Unit.
* Subject must be willing to abide by the rules of the Phase 1 Unit.
* Subjects whose sexual partners are of childbearing potential must agree to use an effective method of birth control (i.e., chemical contraceptives, barrier plus spermicide, intrauterine device) during the treatment phase and for 14 days post treatment.
* Must be negative for Hepatitis B and C and human immunodeficiency virus (HIV).

Exclusion Criteria:

* Females.
* Clinically significant active, acute, or chronic illness.
* History of coagulation or bleeding disorders.
* Clinically significant chronic or recent (within 21 days of dosing) acute gastrointestinal disorder with nausea, vomiting or diarrhea as a major symptom.
* Received any vaccine within 3 weeks of study entry or plans to be vaccinated within 6 weeks after study injection.
* History of significant cardiovascular or cerebrovascular disease.
* History of evaluation for autoimmune disease including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), scleroderma or thyroiditis.
* Significant psychiatric illness that could potentially interfere with the assessments during this study.
* Subjects who have had prior surgery or a major infection within 6 months of dosing.
* History of medications within 7 days of dosing, except vitamins and/or minerals.
* History of Gilbert's disease.
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an informed consent form;
* Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
* Willing to NOT use rewetting/lubricating drops at any time during the study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
* History of eye surgery within the previous 12 months, as specified in the protocol;
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
* Other protocol-specified exclusion criteria may apply.
Safety Study of JTT-302 in Subjects With Low HDL-C Levels

The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or 12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid parameters and CETP activity and mass.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have successfully completed the 4-week treatment period of study AT302-U-06-003

Exclusion Criteria:

* Females who are pregnant or lactating, and females of child bearing potential who are not using an effective method of contraception
* Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol
* Subjects who cannot follow the prescription and OTC medication restrictions defined in the protocol
* Flu-shots not permitted during the study, including the follow-up period.
Ketofol Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients.

This study is a double blind randomized controlled trial. The investigators randomized ASA III and IV patients who underwent cholangiopancreatography. The investigators gave Propofol or Ketofol and compared the outcomes. The primary outcome was security (respiratory depression / hypoventilation).

Randomization is performed by the nurse responsible for preparing the anesthesia drugs. The nurse randomly removes an envelope from a previously prepared container with as many envelopes as the number of patients calculated for the sample. Each envelope, which will be sealed, contains the branch to which the patient belongs (propofol or ketofol) and instructions for the preparation of the respective drugs.

The sample was calculated for a significance level of 5% and a test power of 95%, assuming that, on average, the primary outcome of this study - respiratory depression - is observed in 3% of the population undergoing sedation with ketofol and to 25% of patients undergoing sedation with propofol. The result of the calculation includes 51 patients for each branch of the study (considering the one-tailed hypothesis test).

Data collection is expected to take place over 5 months, taking place between October 2016 and March 2017.

The study is designed to be blinded to the patient and the anesthesiologist/investigator.

The anesthesia nurse, after preparing the drugs according to the instructions on the envelope containing the branch of the study to which the patient belongs, should label each syringe in a non-committal manner.

Statistical analysis was performed using the IBM SPSS Statistics 27.

It will not be necessary to resort to the monitoring committee, since no method or technique different from the one usually practiced will be applied

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* ASA III and IV
* Submitted to retrograde cholangiopancreatography

Exclusion Criteria:

* Patient refuse
* ASA I, II and V
* Ketamine contraindications
* Allergies to Propofol, Ketamine, dexamethasone, paracetamol, metamizole, ondanseteon or other.
* General anesthesia necessary I
* Incapacitaty to sign or absence of patient legal representation.
A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)

Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
* Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
* Male or female outpatients aged 3 to 15 years at the time of providing informed consent.

Exclusion Criteria:

* Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
* Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
* Subjects with repeated epistaxis
* Subjects with coexisting fungal infection in nasal/sinus cavity
* Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
* Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
* Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders.

The objective of this study will be to verify the additional effect of Pain Neuroscience Education, Motor Imagery and Action Observation on primary outcomes pain intensity and craniofacial pain and disability in patients with chronic temporomandibular disorders (TMD). The secondary outcomes will be pressure pain threshold, temporal summation, conditioned pain modulation, central sensibilization, pain catastrophizing, kinesiophobia. This study will be a doble-blinded randomized clinical trial comprising a sample of 50 participants with orofacial pain of both genders and aged between 18 and 60 years. Subjects will undergo a screening process to identify those presenting a diagnosis of painful TMD confirmed by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), and then they will be randomized into two groups (G1: Occlusal Splint, Counselling and Jaw and Neck Exercises vs. (G2: Occlusal Splint, Jaw and Neck Exercises plus Pain Neuroscience Education, Motor Imagery and Action Observation). These volunteers will be recruited from the Alisos Group Dentistry Clinic and University of Gran Rosario, (Rosario, Argentina). All patients will wear an occlusal splint designed by dentists. The interventions will be administered twice a week for 5 weeks by a single therapist. Subsequently, patients will be given instructions to perform the exercises at home for 5 weeks. Primary and secondary outcomes will be measured at baseline, 6 weeks and 12 weeks, and at 3 months after the end of treatment (follow-up). All the evaluations will be performed by a blinded physiotherapist.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of painful TMD using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
* A history of orofacial pain during at least three months prior to the study
* Age ranging between 18 to 65 years, both genders.

Exclusion Criteria:

• Patients with neurological disorders (neuropathic pain or neurodegenerative disease), whiplash associated disorders, specific neck pain (radicular pain), recent dental or physical therapy. If patients are taking medication to relieve pain during the study, they will be encouraged to report it.
Use of PCR-Sars-CoV-2 in Children

The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical criteria (even if no clinical picture suggestive of COVID had been clearly identified). The management of sick young children (with respiratory tract infection that could be attributed to COVID) by pediatricians (infectious diseases specialists, emergency physicians, general practitioners, and outpatients) was facilitated by an algorithm whose objective was to help define the indications for SARS-CoV-2 PCR and subsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing (for PCR or antigenic testing) is delicate and difficult in children, and is therefore a serious handicap for community-based screening, especially since infectious episodes are frequent in children. Since then, nasal self-tests that can be easily used in children have been commercialized and have facilitated screening.

Because of the similarity between the clinical signs of respiratory tract infections in children, it is often impossible to distinguish between different viral respiratory infections and epidemics may overlap in time. However, the identification of the pathogen is the key to improve management of these infectious diseases. The VIGIL study is therefore continuing, still facilitated by the existence of an active pediatric network existing for 20 years. ACTIV AFPA and GPIP have created networks of hospital and ambulatory pediatricians who actively participate in various observatories https://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatories have resulted in the publication of more than 80 articles in international journals (https://www.activ-france.com/fr/publications).


Eligibility Criteria:
Inclusion Criteria:

* Children under 15 years of age
* Prescription of a PCR-Sars-CoV-2
* VIGIL information note given to parents

Exclusion Criteria:

* Refusal to participate by the patient, family member or legal representative (depending on the situation)
A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome

Coronary artery disease and heart attacks are the leading cause of death in the UK. Our population is ageing. The number of older patients suffering heart attacks and having angioplasty procedures to open up blocked heart arteries is increasing. After angioplasty, older patients (80 years of age or over) are at 5 times increased risk of death at one year compared to their predicted normal life expectancy. In addition, many patients present with further heart attacks, stroke and undergo repeat heart catheter test and angioplasty procedures. At present it is not clear who will or will not experience further problems in the future. The ability to predict who will and will not suffer future problems at the time of initial presentation can be helpful in providing additional treatment and close monitoring to those that are at risk of further problems. The ICON 1 study is set out to study just that. In this study, older patients will undergo a comprehensive evaluation of the cardiovascular disease burden by undergoing additional investigations. These results from each patient will be used to develop a risk score that will inform physicians of the patient's future risk of developing adverse events and provide a better understanding of how to manage older patients with coronary artery disease and also help plan future studies looking at treatment strategies that might be beneficial in improving outcomes.


Eligibility Criteria:
Inclusion criteria: Older patients (65+) presenting with ACS for coronary angiography will be recruited into this study.

Exclusion criteria: Those presenting with cardiogenic shock, those with co-existing malignancy with life expectancy less than one year and those with evidence of active infection such as urinary tract infection, pneumonia, sepsis and any wound infection will also be excluded from the study.
Sore Throat After Intubation Using Glidescope With Stylet and Bougie

This is a prospective double-blinded clinical trial aiming to compare the incidence and severity of sore throat after laparoscopic cholecystectomy when using two different techniques of intubation using glidescope

The first technique is loading the endotracheal tube on a stylet the second technique is sliding the endotracheal tube over a bogie that is dragged into the trachea at both techniques, the investigators are using glidescope

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA

Exclusion Criteria:

* ANTICIPATED DIFFICULT INTUBATION
Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Patients treated with inhaled corticosteroid
* FEV1 (forced expiratory volume in 1 second)\>60% to 80%

Exclusion Criteria:

* Respiratory infection within 2 weeks
* Asthma exacerbation within 90 days