cyrilzakka/clinical-trials huggingface dataset:
Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women

The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients.

The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. Patients' enrollment will be conducted according to inclusion criteria.

At the first visit, periodontal parameters will be recorded: Plaque Index (PI), recession (R) Bleeding on Probing (BoP), modified Marginal Gingival Index (mMGI), Papillary Marginal Gingival (PMGI), Plaque Control Record ( PCR %), Approximal Plaque Index (API), Clinical Attachment loss (CAL) and Probing Pocket Depth (PPD).

Professional debridement will be conducted with piezoelectric instrumentation and air-flow administration with glycine powders.

Subsequently, patients will be randomly divided into two groups:

* the Probiotic group, in which patients will undergo daily probiotic supplementation in addition to the standard treatment
* the Control group, in which patients will undergo standard treatment

Professional debridement will be repeated every 3 months. Periodontal index evaluation will be conducted at the baseline (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3).

Eligibility Criteria:
Inclusion Criteria:

* women at the 4th month of pregnancy

Exclusion Criteria:

* presence of cardiac pacemaker
* neurological and psychiatric diseases
* patients taking bisphosphonates during the previous 12 months from the beginning of the study
* patients undergoing anticancer therapy.
* patients with poor compliance.
Clinical Usefulness of a Magnifier for Insulin Pen

Insulin treatment is crucial for glucose control. Many patients with type 2 diabetes exhibit inadequate glycemic control in spite of combination of oral antidiabetic drugs and eventually need insulin therapy. Patients who need insulin therapy are older and have poor visual acuity, which predispose to inaccurate dosing and consequent hyper or hypoglycemia.In this study, the investigators examined the clinical usefulness of a magnifier for elderly diabetic patients who had used insulin pens.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of diabetes mellitus
* over 60 years old
* who have self-injected insulin with insulin pens

Exclusion Criteria:

* who have visual acuity less than 20/200 for each eye
* who had surgery on his/her eyes within a week
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.

Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury

Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, IV

Comparison: cerebrolysin group versus control group

Outcome: Coma Recovery Scale-revised, FDG-PET signal


Eligibility Criteria:
Inclusion Criteria

1. Patients with hemorrhagic stroke confirmed by CT or MRI
2. Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke
3. Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment)
4. Age: 19 to 80 years of age
5. Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.

Exclusion Criteria

1. Patients with confirmed epileptiform discharges on EEG
2. Patients with brain parenchymal defects
3. Patients with advanced liver, kidney, cardiac, or pulmonary disease.
4. Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
5. History of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension.
6. Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
7. Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.
8. Administration of a contraindicated drug is essential for medical purposes.
9. Contraindications to the study drug (cerebrolysin).
10. Participation in another therapeutic study
Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients

Organic nitrates increase levels of circulating endothelial progenitor cells (Thum et al., Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54). Here, we want to test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function.

In this pilot study we test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function. These parameters will be measured before and after 14d of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease, 2- or 3-vessel disease

Exclusion Criteria:

* Acute myocardial infarction, acute heart failure, cancer, acute infections
Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer

The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.


Eligibility Criteria:
Inclusion Criteria:

* Documented colorectal cancer which is EGFR-positive and is metastatic.
* Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.

Exclusion Criteria:

* A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy.
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Known metastases in the central nervous system.
* Symptomatic sensory or peripheral neuropathy.
* More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
* Prior oxaliplatin therapy.
* Prior cetuximab or other therapy which targets the EGF pathway.
* Prior chimerized or murine monoclonal antibody therapy.
SYSTANE® Family - Meibomian Deficiency

The purpose of this study was to assess the efficacy of the SYSTANE® family of products (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on meibomian gland functionality in subjects with lipid deficiency related to evaporative dry eye as compared to the standard of care warm compresses.


Eligibility Criteria:
Inclusion Criteria:

* Must have a clinical diagnosis of lipid deficient Evaporative Dry Eye;
* Meibomian Gland Functionality - Not more than 6 glands yielding liquid secretion;
* Must be willing to discontinue the use of all other Meibomian Gland; Dysfunction management prior to receiving the study test article at Visit 1, up until the end of the study period;
* Must have best corrected visual acuity of 20/40 Snellen or better in each eye;
* Must be able to follow instructions and be willing and able to attend required study visits;
* Must read, sign, and date an Ethics Committee reviewed and approved informed consent form;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months;
* Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
* History of intolerance or hypersensitivity to any component of the study medications;
* History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
* Pregnant or lactating at the time of enrollment;
* Not willing to take adequate precautions not to become pregnant during the study;
* Use of any concomitant topical ocular medications during the study period;
* Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
* Ocular conditions that may preclude the safe administration of either drop under investigation;
* Unwilling to discontinue contact lens wear during the study period and for at least 1 week prior to Visit 1;
* Participation in an investigational drug or device study within 30 days of entering this study;
* Other protocol-defined exclusion criteria may apply.
Deep-Learning for Automatic Polyp Detection During Colonoscopy

The primary objective of this study is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine whether a combination of colonoscopy and an automatic polyp detection software is a feasible way to increase adenoma detection rate compared to standard colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for routine colonoscopy for screening and/or surveillance purposes.
* Ability to provide written, informed consent and understand the responsibilities of trial participation

Exclusion Criteria:

* People with diminished cognitive capacity.
* The subject is pregnant or planning a pregnancy during the study period.
* Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
* Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
* Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
* Patients with inflammatory bowel disease
* Patients with any polypoid/ulcerated lesion \> 20mm concerning for invasive cancer on endoscopy.
Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

The aim of the study is to evaluate clinical and economic impact of Goal Directed Fluid Therapy according to NICE haemodynamic protocol. Haemodynamic parameters were assessed using automated pulse contour analysis (Flotrac/Vigileo®). A specific dedicated software has been developed to perform clinical and expenditures data collection, both retrospective and prospective data are archived.


Eligibility Criteria:
Inclusion Criteria:

* Patients selected for major abdominal surgery

Exclusion Criteria:

•Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders
Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients

This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-75 years of age
* Kidney transplant 30-180 days post-transplantation
* Receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than 14 days prior to study entry
* No known contraindications to sirolimus

Exclusion Criteria:

* Multiple organ transplant recipients or secondary kidney transplant recipients
* Corticosteroid-resistant rejection episode within 90 days prior to study entry or corticosteroid-sensitive rejection episode within 30 days prior to study entry
* More than 1 biopsy-proven episode of acute rejection prior to study entry
* Treated with sirolimus before the study
* Organ transplant or expected organ transplant, other than kidney
* History of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
Virtual Reality for Pain Management Study

Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective means of decreasing pain levels following treatment, and for significant periods of time. Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity associated with pain. While VR is clearly a promising, drug-free option for pain treatment, existing VR systems are expensive and use unconvincing graphics. Recent advances in VR technology (i.e., improved realism and immersion using 360-degree 3D technology and more affordable delivery systems) allow the development of more realistic and more cost-effective applications. Capitalizing on these advances and the investigators' experiences with VR intervention development and evaluation, the current study will test a state-of-the-art VR experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and compare it to established standard computer generated imagery (CGI) 360° VVR content for pain management intervention in a medical setting. The participant's participation will help the investigators determine which VR intervention is most effective in reducing acute pain in hospital patients.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65
* Reports experiencing current pain not typical of day-to-day experience during Pre-Treatment Pain Questionnaire at the onset of study visit by answering "Yes" to the first question of the questionnaire. There is no specific threshold of how much pain the participant must be in to be eligible for this study. The participant must be experiencing current pain that is not related to day-to-day, normal experiences (such as minor headaches, sprains, and toothaches).
* Scores a 15 on the Glasgow Coma Scale and a 7 or above on the abbreviated Mini Mental Status Exam.
* Patient in the acute and critical palliative care units, post surgical units, or acute care orthopedic units at University Medical Center Brackenridge in Austin, TX.
* Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.

Exclusion Criteria:

* Hearing or visually impaired where participant cannot use the Samsung Gear VR.
* Does not report experiencing current pain during Pre-Treatment Pain Questionnaire at the onset of study visit.
* Scores below a 15 on the Glasgow Coma Scale and/or below a 7 on the abbreviated Mini Mental Status Exam
* Limited mental competency and the inability to give informed, voluntary, written consent to participate.
Enhanced and Attendance-based Prize CM in Community Settings

The purpose of this study is to address the conditions under which prize contingency management (CM) for abstinence and attendance may improve outcomes of cocaine-dependent patients.

For patients who initiate treatment with a cocaine-positive urine specimen, we will evaluate the efficacy of two CM procedures relative to standard, non-CM treatment. The two CM procedures will be provided as additions to standard care and will reinforce drug abstinence but will differ in expected magnitudes of prizes patients can earn, especially during early stages of abstinence. They will provide expected magnitudes of winning about $250 and $560, respectively. We expect that both CM conditions will improve retention and abstinence relative to the standard treatment, non-CM condition. If the enhanced CM condition engenders better outcomes than the $250 CM condition, this finding would suggest that patients initiating treatment while actively using cocaine may best be treated with relatively high reinforcement prize CM as an adjunct to standard care.

For patients who initiate treatment with a cocaine-negative urine specimen, we will evaluate the efficacy of a CM procedure that reinforces treatment attendance. The expected magnitude of winnings will be about $250, and again CM treatment will be in addition to standard care. This CM condition will be compared to standard treatment without CM as well as to a CM treatment that provides a similar magnitude of reinforcement, but contingent upon abstinence. Results from this study will inform an important clinical question of whether simply reinforcing attendance can improve clinical outcomes. Increased retention may result in greater exposure to therapeutic processes that may reduce drug use, especially among patients who begin treatment having already achieved some abstinence. We will also evaluate the cost-effectiveness of CM by examining the effects of the interventions on hospitalizations, medical and psychiatric care, criminal justice costs, and productivity.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Current DSM-IV diagnosis of cocaine dependence
* A cocaine-positive urine sample submitted during the first two scheduled treatment days at the center
* Willing to provide names, addresses and phone numbers of individuals to assist in locating the patient for follow-up evaluations
* English speaking
* Willing to sign informed consent.

Exclusion Criteria:

* Serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk)
* Dementia (\<23 on the Mini Mental State Exam; Folstein et al. 1975)
* In recovery from pathological gambling
Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study

In this protocol, investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology clinic over traditional culture methods alone and decreases retreatment rates in this population.

The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by the previous prospective comparison study. Additionally, conventional methods are often inadequate in the case of polymicrobial infections. More accurate and timely pathogen identification allows for prompt and more targeted treatment with less reliance on empiric therapy and decreased rates of antibiotic therapy changes and retreatment. This leads to more favorable patient outcomes and decreases the development of resistant organisms.

Eligibility Criteria:
Inclusion Criteria:

* • Patient Informed Consent form completed

  * Male and Female Subjects may participate with no predetermined quotas or ratios for gender participation.
  * All patients must be ≥60 years old. For patients presenting with a diagnosis of interstitial cystitis, patients may be of any age.
  * Patients must be presenting for treatment of acute UTI, complicated UTI, persistent UTI, or recurrent UTI's.
  * Including prostatitis, pyelonephritis, and/or interstitial cystitis.
  * Data pertaining to the times at which the specimen samples are collected and stabilized needs to be documented.
  * Specimen samples obtained need to have a sufficient volume necessary to perform a urine culture and Guidance 4.0.

Exclusion Criteria:

* • Do not provide written informed Consent with HIPAA authorization form.

  * Taking antibiotics for any reason other than UTI at the time of enrollment
  * Patients with chronic (\> 10 days) indwelling catheters
  * Self-catheterized patients
  * Patients with neobladders
Liposomal Bupivacaine in Rotator Cuff Repair

To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing outpatient arthroscopic rotator cuff repair
* Greater than or equal to 19 years of age at the time of surgery

Exclusion Criteria:

* Planned operative fixation of the biceps tendon or acromioclavicular joint
* Opioid use 6 weeks before surgery
* Gabapentin use 6 weeks before surgery
* History of prior shoulder surgery on the operative limb
* Severe pulmonary dysfunction
* Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
* History of radicular pain or neuropathy in the operative limb
* Patients who are currently incapacitated for medical decision making
Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)

Alterations of functional brain networks have been frequently demonstrated in schizophrenia, although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to exert its schizophrenia-like effects through modulation of the glutamatergic system, thus facilitating the investigation of the impact of this specific transmitter system on resting state functional brain networks. The aim of the study is therefore to use pharmacological functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved in schizophrenia in response to ketamine application compared to placebo. 30 healthy subjects (15 females) will be examined twice using a double-blind, placebo-controlled, randomized, crossover, counterbalanced-order design. Resting state fMRI will be investigated before, during and after either placebo or ketamine intravenous infusion for 20 minutes. Prior to the main trial 10 additional participants will be included in an open pilot trial.

Hypothesis: Ketamine application will induce changes in resting state networks previously associated with schizophrenia and in the connectivity of relevant brain regions such as the striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed before and after ketamine infusion.


Eligibility Criteria:
Inclusion Criteria:

* general health based on history, physical examination, ECG, laboratory screening and structured clinical interview for DSM-IV(SCID)
* willingness and competence to sign the informed consent form
* aged 18 to 55 years

Exclusion Criteria:

* any medical, psychiatric or neurological illness
* current or former substance abuse
* any implant or stainless steel graft and any other contraindications for MRI
* pregnancy
* first degree relatives with a history of psychiatric illness or substance abuse
* failures to comply with the study protocol or to follow the instructions of the investigating team
* lifetime use of antipsychotic drugs
* treatment with psychotropic agents such as SSRIs within the last 6 months