cyrilzakka/clinical-trials huggingface dataset:
Serum Ferritin and Hepicidin Concentration in Chronic Periodontitis Patients With T2DM

serum level of ferritin and hepicidin were evaluated in periodontitis patient with and without type 2 diabetes before and after non surgical periodontal treatment to clarify their in periodontal disease


Eligibility Criteria:
Inclusion Criteria:

* patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm with T2DM
* systemically healthy patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm
* healthy subjects had clinically healthy gingiva with ≤ 3mm pocket probing depth (PPD), nearly zero plaque index (PI), gingival index (GI), zero CAL.

Exclusion Criteria:

* (I) Pregnancy or lactation, (II) History of receiving professional periodontal treatment during the past 6 months; (III) Treatment with any type of medications and/ or antibiotics during the past 3 months and (IV) Current or former smokers.
Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

This clinical trial compares two psychological treatments for back pain.

The primary objective is to examine the incremental efficacy of a patient-centered and tailored self-management treatment approach, Tailored Cognitive-Behavior Therapy (TCBT), for persons with chronic musculoskeletal pain. TCBT will be compared with a Standard Cognitive- Behavior Therapy (SCBT) condition. The hypothesis is that TCBT will be associated with improved outcomes following treatment. Outcome will be assessed by multiple standardized measures of key domains of the chronic pain experience. Secondary objectives are to examine the process of successful self-management treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic back pain for at least 6 months
* Treatment by medication or physical therapy

Exclusion Criteria:

* Acute or life threatening physical illness
* Current alcohol or substance abuse or dependence
* Current psychosis or suicidal ideation treatment by anesthesiology, chiropractic care or surgery
Video Discharge Instructions for Fever and ED Recidivism

To evaluate the effect of video discharge instructions on return visits to the ER or ED within 72 hours of the original visit for children with febrile illnesses.

This is a randomized prospective convenience study of children presenting to the ED. Children greater than 8 weeks and up to and including their 18th birthday are enrolled. Patients were randomly assigned to one of two study groups: video + written fever specific discharge instructions and only written fever specific discharge instructions. Parents assigned to the video group watched the DVD in the emergency department (ED) and take it home along with the written instructions. At 72 hours both groups received a phone call asking whether they returned to the ED and the usefulness of discharge instructions (DVD and/or written). Critically ill children and those with chronic medical conditions were excluded. The primary outcome is a return ED visit for fever confirmed in our electronic medical record and questionnaire response. The secondary outcome is reported parental usefulness of the discharge instructions.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 8 weeks to 18 years
* Presented to the ED with a chief complaint of fever. Fever was defined as a temperature greater than or equal to 100.4⁰F
* English or Spanish speaking
* Working telephone for follow-up call
* Venue to view DVD at home (TV, computer, etc)

Exclusion Criteria:

* Children with a chronic medical illness
* Children with immune-compromising conditions
* Allergies to acetaminophen or ibuprofen
* Previously enrolled
* Admitted at the time of their index ED visit
Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms

Ketamine has been shown to have an antidepressant effect when given intravenously in doses of 2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known in this instance to decrease postoperative pain. No one has studied whether or not ketamine when given in doses used during general anesthesia (0.5mg/kg intravenous) has an antidepressant effect on surgical patients who suffer from depression. The study is designed to determine whether or not a small dose of ketamine when given at the induction of anesthesia could have an antidepressant effect on surgical patients with depression.

Non-pregnant females between the ages of 18-65 who are being admitted for gynecological surgery will be given a bedside Goldberg depression screen as part of their routine preanesthetic assessment. If the patient scores five or above on the Goldberg depression screening, they will be asked if they would like to enroll in the study. Exclusion criteria include uncontrolled hypertension, pregnancy, or allergy to ketamine.

Once the patient is consented they will be randomized to one of two groups. Every patient will receive an antianxiety medication Midazolam and a narcotic fentanyl prior to going to the operating room. Group A will receive ketamine 0.5mg/kg intravenous as part of their induction for general anesthesia. Group B will not receive ketamine as part of their anesthetic. All other induction drugs will be at the discretion of the anesthesiologist performing the anesthetic.

The patients will be seen by a separate anesthesia provider (who is blinded to the group the patient is in) and the results of the depression screening will be added to the patient's data sheet.

The patients will be followed again one week after their surgery either in their hospital room (if still hospitalized) or by phone. They will again be given the Goldberg Depression screen and the data will again be added to their data sheet.

Several times during the study and at its conclusion the data will be matched with the patients group in order to assess for adverse events such as suicidal ideations, nausea and vomiting. If adverse events are noted, the study design will be altered to take into account the adverse events.

Eligibility Criteria:
Inclusion Criteria:

* History of or current depression scoring five or above on Goldberg Depression Screen

Exclusion Criteria:

* Uncontrolled hypertension, allergy to ketamine,pregnancy
A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer.
* Patients with urge predominant mixed incontinence.
* Patients will need to have answered at "Yes" to "leakage related to feeling urgency" on the UDI 6 questionnaire.
* Female
* Over 18 years of age.
* English speaking who are able to give informed consent to participate in the study.
* Patients who have four urinary incontinence episodes.

Exclusion Criteria:

* Stress incontinence desiring surgical management.
* Previous treatment of refractory urge incontinence such as PTNS, SNS, or Intradetrusor onabotulinumtoxin A injections.
* Neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair.
* Urethral diverticulum.
* Daily catheterization due to urinary retention.
* The use of anticholinergic medications for less than 6 weeks.
* Patients who have pacemakers in place.
* Patients with limited mobility requiring a wheelchair.
* Elevated PVR \> 200 cc
* Untreated urinary tract infection, defined as symptoms and a urine culture with greater than 100,000 cfu/ ml within the last 1 month prior to treatment.
* Uncorrected Stage 3 prolapse.
Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery

The aim of this observational study is to investigate if preoperative quantitative sensory testing, anxiety and depression symptoms, and biological markers are associated with the risk of developing acute and chronic postoperative pain after video-assisted Thoracoscopic surgery (VATS).

This observational study examine acute and chronic postoperative pain in patients undergoing VATS. In the study preoperative biomarkers, quantitative sensory testing and questionnaires are used to create prediction models for acute and chronic postoperative pain. The study will serve as background information on the risk factors and predictive factors as well as an exploration of the impact of surgical stress from VATS on circulation microRNA and inflammatory mediators.

Eligibility Criteria:
Inclusion Criteria:

* Adults independent of sex with an age of ≥ 18 years
* Patients scheduled for VATS as a part of either examination or radical treatment of lung cancer

Exclusion Criteria:

* Patients who are unable to understand oral and written information.
* Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
* Pregnant and nursing women.
* Patients receiving a planned preoperative epidural blockade during their stay.
* Patients converted to open surgery.
Reading Problems in Children Living in Urban Areas

The first line of defense against reading disabilities is good classroom reading instruction. This study describes how characteristics of students, teachers, and instruction relate to academic achievement in inner-city kindergarten through Grade 4 classrooms.

Recent studies show that the incidence of reading disability can be significantly reduced by improving classroom instruction. Effective reading instruction in the primary grades includes explicit instruction in the alphabetic principle, reading for meaning, and opportunities to practice reading and writing. To learn more about the development of literacy skills in urban settings, students in 17 schools in Houston and Washington, D.C., were followed from kindergarten through Grade 4. Schools were selected based on similar demographics: predominantly African-American student population (95%) and high participation in the federal lunch program (85% to 100%). Each school was provided with grade-appropriate reading programs that focused on phonics and spelling. These programs included direct, integrated, classroom, and individual instruction modules.

Approximately 1400 children and 114 teachers participated each year in this four-year study. The design was cross-sequential so that the majority of teachers in a grade participated for two years. All children participating in regular education were included in the study. Children below the 25th percentile on a standardized reading test were tutored individually by retired teachers, using materials from the classroom reading program. A variety of reading curricula were in place in the classrooms across these two sites. In order to help teachers implement these materials effectively, an ongoing research-based professional development model was employed, with curriculum consultants and coaches working with the teachers in the classroom. Researchers observed in each classroom four to six times during the year using on-the-minute recordings of content. Observers also completed ratings of teaching competencies. Teachers completed surveys of knowledge, experience, attitudes, and instructional strategies. A random selection of eight to ten students were assessed four times during the year for growth in literacy-related skills and once at the end of the year for achievement in reading, spelling, and writing.

Eligibility Criteria:
Inclusion Criteria

* Student in participating school
* Kindergarten through Grade 4
Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation (PREHAB HTx Study)

This study evaluates the addition of high-intensity interval training to the standard pre-heart transplantation clinical care. Participants will be randomised into 2 arms: one arm will receive high-intensity interval training, and the other arm will be encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

Heart failure affects more than 6.2 million people living in North America. Approximately 10% of patients with heart failure have advanced heart failure. Heart transplantation is an effective life-saving treatment for patients with advanced heart failure. The cardiovascular rehabilitation programs are integral to heart failure management.

This study is being done to evaluate, in adults with advanced heart failure awaiting heart transplantation, the effects of cardiovascular rehabilitation (including high-intensity interval training, stress management and nutrition workshops) on functional capacity, aerobic power, frailty, quality of life, and mental health.

This study compares pre-transplant cardiovascular rehabilitation with usual pre-transplant care in patients with advanced heart failure awaiting heart transplant.

All participants will be randomized into 2 study groups: Group 1 (rehab), and Group 2 (no rehab). Those randomized to Group 1 will receive usual care, 12 weeks of rehab (exercise training, and attend stress and nutrition course through the Heart Failure Clinic and the Division of Prevention and Rehabilitation at the University of Ottawa Heart Institute). Those randomized to Group 2 will receive regular visits through the Heart Failure Clinic; patients are encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced heart failure and listed for heart transplantation.
2. Able to perform a symptom-limited exercise test.
3. Age =\>18 years old.
4. Able to provide informed consent.

Exclusion Criteria:

1. Currently participating in a structured exercise training program (\> 2 times per week)
2. Status 4 priority listing for heart transplantation.
3. Myocardial infarction =\<7 days.
4. Heart failure with hemodynamic instability.
5. Hypertrophic obstructive cardiomyopathy with symptomatic left ventricular outflow tract gradient =\>30 mmHg.
Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
* Moderate or tense ascites
* Serum sodium of \>130 mmol/l.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Attention Bias Modification Treatment (ABMT) for Patients With Post Traumatic Stress Disorder (PTSD)

Patients with Post Traumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to normalize threat-related attention biases or a placebo control condition not designed to change attention patterns. Outcome measures will be Post Traumatic Stress Disorder (PTSD), depression, and anxiety symptoms as measured by gold standard questionnaires and symptom counts derived from structured clinical interviews.

We expect to see significant Post Traumatic Stress Disorder symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected.


Eligibility Criteria:
Inclusion Criteria:

* Combat-related PTSD diagnosis

Exclusion Criteria:

* Other treatment
Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis

Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers volunteers could improve clinical parameters when compared to metronidazole tablets + periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly assigned into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal debridement combined with daily topical application of 3 g metronidazole benzoate gel (15%); and periodontal debridement combined with a daily single dose of 750 mg metronidazole. Clinical parameters evaluated were visible plaque, gingival bleeding, probing pocket depth and relative attachment level.

Background. The benefit of adjunctive metronidazole on periodontal procedure in smokers with chronic periodontitis (CP) is uncertain. The authors compared the effect of metronidazole (Mtz) on full-mouth periodontal debridement (PD= 1 hour of ultrasonic calculus/plaque removal) in smokers with CP.

Methods. This pilot study involved 30 Individuals (having at least six teeth with a clinical attachment loss of ≥ 5 mm and probing pocket depth (PPD) of ≥5 mm) that were randomly assigned into three groups (n=10): 1) PD plus 3 g of placebo gel daily topical application 2) PD plus daily topical application of 3 g of 15% Mtz benzoate gel; and 3) PD plus a daily single dose of 750 mg Mtz (Flagyl®). Clinical parameters visible plaque index (VPI), gingival bleeding index (GBI), relative attachment level (RAL) and PPD; and the quantitative analysis (real-time PCR) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia were assessed baseline, 1, 3 and 6 months after PD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic periodontitis
* presence of at least 6 periodontal pockets with a clinical attachment loss of ≥5 mm
* bleeding on probing (BOP)
* radiographic bone loss
* probing pocket depth higher or equal to 5 mm in at least six teeth
* at least 20 teeth in mouth (third molars excluded)
* an established smoking habit (at least 10 cigarettes per day for the past 4 years)

Exclusion Criteria:

* periapical alterations in qualifying teeth
* medical disorders requiring prophylactic antibiotic therapy or interfering with the treatment
* periodontal treatment in the past 6 months
* use of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) within the past 6 months
* orthodontic therapy
* pregnancy and lactation
* allergy to metronidazole
* any systemic diseases (e.g.: diabetes and immunological disorders)
Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

The investigators are purposing a study to evaluate the use of acetaminophen given prior to an electrophysiology procedure and post procedural pain control.

Atrial arrhythmias are very common and widespread. Recent reports suggest that 9% of patients over the age of 65 currently have atrial fibrillation. In individuals of European descent the lifetime risk of atrial fibrillation is as high as 26%. Atrial fibrillation carries significant risk of complications including: a fivefold increase in risk of stroke, a threefold risk of heart failure, a twofold risk of dementia and a twofold risk of mortality. As treatment options continue to evolve, the use of catheter ablation procedures are becoming increasingly common within the United States. Currently, ablation has a class 1A recommendation for patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one class I or class III antiarrhythmic medication and a class 2B indication before initiation of antiarrhythmic drug therapy. One of the known complications of catheter ablation procedures is pain following the procedure. Severe pain has been reported in up to 55% of patients undergoing ablation procedures. IV acetaminophen has been proven to be effective at controlling pain in post intra-abdominal surgery, however, its use is limited due to the cost of this medication. Other studies have suggested that there is no clear indication for IV over oral acetaminophen in patients who are able to take oral. Empirically the investigators have seen patients complaining of pain after all electrophysiology procedures, not limited to just ablation procedures. To the best of the knowledge of the investigational team, at this time, no studies have looked at using oral pre-procedural acetaminophen to assist with pain control following electrophysiology procedures. The investigators are looking to perform a randomized, double blind, placebo controlled study to evaluate the use of pre-procedural oral acetaminophen to help control post procedural pain.

Eligibility Criteria:
Inclusion Criteria:

* Age: Over 18
* Weight: Greater than 50kg
* Scheduled for an EP procedure
* Be able to take oral medications
* Provide signed written informed consent

Exclusion Criteria:

* Have chronic pain requiring the use of chronic pain medications including narcotic pain medications or chronic acetaminophen use greater than seven consecutive days prior to the procedure
* Known hypersensitivity to acetaminophen
* Known or suspected history of alcohol or drug abuse/dependence within the previous 2 years
* Known impaired liver function
* Active pregnancy