cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in CABG

In post cardiac surgery, many cardiovascular and other complications may occur that lead to increase in mortality and hospital stays. Meticulous perioperative management is important to avoid these adverse events. Tachycardia is the main cause of post coronary artery bypass graft (CABG) myocardial ischemia which can be decreased by sedation and analgesia.

Dexmedetomidine is a highly specific alpha 2 adrenoreceptor agonist. Its sedative effect results from stimulation of alpha 2 adrenoreceptors in the central nervous system (in the locus coeruleus) independent of GABA system contrary to other drugs.Dexmedetomidine has better sedative effect and similar respiratory and hemodynamic effects to midazolam. It does not depress respiratory drive or decrease arterial oxygen saturation so intravenous (IV) continuous sedation with dexmedetomidine does not change the normal course of ventilator weaning and extubation. It produces a unique EEG pattern of sleep that closely resembles that of normal physiological sleep that allows easy arousal. Dexmedetomidine also has analgesic effect. All these properties make dexmedetomidine a first line drug for the cooperative sedation management in the Intensive Care Unit (ICU). Ketamine is a phencyclidine nonbarbiturate derivative that binds with N methyl d aspartate and sigma opioid receptors to produce dissociative anesthesia, analgesia, and amnesia with little or no respiratory or cardiovascular depression. Ketamine inhibits endothelial nitric oxide production leading to positive inotropic action and vasoconstriction which preserves hemodynamic stability. Dexmedetomidine can effectively and safely attenuate the ketamine induced hemodynamic pressor response and psychomimetic effects. Dexmedetomidine expected to prevent the tachycardia, hypertension, salivation, and emergence phenomena associated with ketamine. Ketamine may prevent the bradycardia and hypotension that have been reported with dexmedetomidine. Review of literature has shown that there are very few studies present on the comparison of combination of Ketamine and dexmedetomidine with dexmedetomidine alone especially in post cardiac surgery patients and therefore further studies are required to ascertain the role of dexmedetomidine in terms of hemodynamic effects after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients of 40-60 years old Hemodynamically stable with normal or moderately impaired left ventricular function Ejection fraction \>40% that underwent elective surgery CABG surgery for single vessel

Exclusion Criteria:

Hemodynamic instability intraoperative. Patients on moderate to high vasopressors or ionotropes. Ejection fraction less than 40%. Off pump surgery. Patient on mechanical supports.
Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM

The aim of study was to evaluate the effect of dental operating microscope use on the healing outcome of non surgical endodontic treatment of maxillary molars.

Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient and written informed consent was taken after explaining the procedure, risks and benefits. Mature maxillary first permanent molar with diagnosis of periapical periodontitis (as confirmed clinically \& by periapical radiograph) was chosen for the study. Fifty participants were randomly assigned to either the dental operating microscope group or to control group (without using dental operating microscope) for the treatment.

After administration of local anesthesia and rubber dam isolation of the involved tooth ; access cavity was prepared using carbide bur and refined using ultrasonic tip in both groups. In both the groups similar protocol for irrigation, obturation and post operative restorations was followed. Immediate post-operative radiograph was taken using preset exposure parameters and follow up clinical and radiographic examination was carried at 12th month.

Eligibility Criteria:
Inclusion Criteria:

* Patient willing to participate in the study
* Age \> 18 years
* Maxillary permanent first molar having apical periodontitis requiring primary endodontic treatment
* Radiographic evidence of periapical radiolucency (minimum size 2 mmx 2 mm) and a diagnosis of pulpal necrosis as confirmed by negative response to cold and electrical tests and absence of bleeding on entering the pulp chamber

Exclusion Criteria:

* Unwillingness of patient.
* Retreatment cases
* Presence of internal or external resorption ,root canal perforations during endodontic treatment and immature teeth.
* Periodontally compromised teeth
* Immunocompromised, diabetic, pregnant and hypertensive patients
* Vertical root fractures
* Teeth those are not suitable for rubber dam application
Probiotic in Dry Eye Syndromes

This study will evaluate efficacy and safety of systemic and ophthalmic probiotic from bacterial lysate of Lactobacillus sakei on microbiota, immunological and clinical outcomes of patients with Dry Eye Syndrome.

The ocular surface is comprised of the cornea and its overlying tissue, the conjunctiva. The ocular surface is continuously exposed to the external environment and, therefore, to different microbial species. A resident ocular surface microbiota has been found in various studies. Although little is known so far, some elements of this microbiota and/or its metabolites could represent protective cofactosr in the pathogenesis of common ocular diseases.

On the other hand, the gut microbiota is known to influence host homeostasis in distal tissues, such as brain (gut-barin axis), lungs (gut-lungs axis) and skin (gut-skin axis). However, little is known about distal effects of the gut microbiota on the ocular surface.

In this study we sought to evaluate the efficacy and safety aspects of L.sakei as both ophtalmic probiotic lysate and oral live probiotic on Dry Eye Syndrome, using a factorial design, against placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 18\<age\<60
* BCVA (Best Corrected Visual Acuity) \>=9/10
* At least 2 subjective complaints compatible with dry eye
* TBUT (Tear Break-Up Time) \<= 10 sec, Schirmer's test \<= 10mm
* Signed informed consent, voluntary adherence to treatment

Exclusion Criteria:

* Pregnancy/breastfeeding
* Conjunctivitis
* Thyroid disease
* Diabetes
* Rheumatologic diseases including Sjogren's syndrome
* Neurologic conditions, including stroke, Bell's palsy, Parkinson's, trigeminal nerve problem
* Refractive surgery (LASIK or PRK)
* Other Eye Surgeries
* HSV Keratitis
* Medication/supplement use, including psychiatric medicines, OTC cold medicines, anti-histamines, beta-blockers, pain relievers, sleeping pills, diuretics, Hormones replacement, and oral contraceptives
* Chemical splashes / injuries to the eyes
* Contact lens use
* Environmental (dusty, windy, hot/dry)
* Any treatment for dry eye in previous 4 weeks (including lubricants, steroids, cyclosporine)
Intraoral Imaging at Clinical Crown Lengthening

Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth breaks off at the gum line, or when a crown or filling falls out of a tooth and there is decay underneath. To place a crown, the dentist needs to expose more of the tooth. This is done by removing some gum tissue or bone.

After surgery, the area will heal in about three months. Then, making a crown can begin. This healing period often delays the delivery a final crown. This study is investing a way to make the final impression at the surgery to expedite the delivery of a final crown.

The purpose of this prospective study is to evaluate clinical and radiographic outcomes of single unsplinted fixed restorations made with digital intraoral imaging in conjunction with clinical crown lengthening procedures (CLPs) compared ones fabricated by the conventional protocol.

Specific Aim 1: To evaluate the clinical outcomes between the experimental group (the digital impression taking at clinical crown lengthening procedures) and the control group (the conventional protocol) Hypothesis: There will be no differences in clinical parameters around the teeth between the two groups.

Approach: The investigators will conduct a prospective clinical study and will compare the changes in gingival recession, the width of keratinized gingiva, and pocket depths around the teeth between the two groups.

Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Hypothesis: There will be no difference in crestal bone level around teeth between the two groups.

Approach: The study will investigate the difference in crestal bone level around the teeth at baseline and 12 months between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* a single-unsplinted crown needed
* the tooth must be in the area from the canine to the second molars
* a clinical crown lengthening is required to fabricate a crown

Exclusion Criteria:

* uncontrolled hypertension
* diabetes mellitus
* subjects with a history of a long-term use of corticosteroid (\> 6 months)
* subjects with a history of taking oral/IV bisphosphonates within the past 2 years
* smokers.
Comparison Manufactured Rib Splint With Hand-made Rib Splint

A pilot study for a prospective randomized clinical trial was conducted to compare subjects using the CCO (Group-A) with those using the ER-splint (Group-B) before and after the intervention.

The primary outcome was difference in the level of pain based on the visual analogue scale (VAS) between before and after intervention in each group during forceful and resting respiration.

VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis

Investigators performed VAS assessments to determine the level of pain in the subjects with RFs during resting and forceful respiration. Investigators applied either the CCO rib splint or the ER splint to the RF subjects in a randomized order. At 30 minutes after splint application, investigators repeated the VAS assessments during resting and forceful respiration. Subsequently, additional pain control was provided via intravascular drug injection.

RF : Rib fractures VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have rib fractures and age was over 18 years old

Exclusion Criteria:

* Investigators excluded subjects with cardiopulmonary dysfunction, poly-trauma, flail chest, damage to an internal organ, or alcoholism and subjects who did not consent to participate.
Effect of Canned Beans of Multiple Varieties in Daily Amounts of 1 Cup and 1/2 Cup on Serum LDL Cholesterol and Other Cardiovascular Disease Risk Biomarkers in Adults With Elevated LDL Cholesterol

The Bean Study will examine the effects of consuming two daily amounts of canned beans of multiple varieties on fasting serum cholesterol profile in adults with elevated LDL cholesterol.

The Bean Study (TBS) is a a multi-centre, randomized, crossover design study which will examine the effects of consuming two daily amounts of canned beans of multiple varieties on fasting serum cholesterol profile in adults with elevated LDL cholesterol. Participants will consume daily amounts of 1 cup canned beans, ½ cup of canned beans and 1 cup of white rice for 4 weeks each, separated by minimum 4-week washout periods. At the start and end of each 4-week treatment period, fasting blood samples will be collected and analyzed for lipids, glucose insulin and short chain fatty acids (SCFAs). Fecal samples will also be collected and analyzed for SCFA, bile acids and gut microbiota. Body weight and BMI will be also be measured at the start and end as well as mid-way of each treatment period. Finally 3-day food records will be completed mid-way during each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults (≥18 years)
* BMI 18.5-35 kg/m2
* LDL cholesterol 3.0-5.0 mmol/L

Exclusion Criteria:

* Triglycerides ≥3.0 mmol/L
* Diabetes (fasting blood glucose ≥7.0 mmol/L)
* Blood pressure \>140/90 mmHg
* Major medical conditions
* Medical or surgical events requiring hospitalization within the last 3 months
* Medication use that would interfere with the study outcomes (e.g. cholesterol-lowering medications, diabetes-related medications, steroids). All other medications are okay if at a stable (3-month) dose
* Antibiotic use within the last 3 months
* Tobacco product use (\>5 times per week)
* Cannabis use during the study
* Probiotic supplement use (could do a 1-month washout before study)
* Dietary fibre supplement use (could do a 1-month washout before study)
* NHPs used for cholesterol lowering or glycemic control. All other NHPs are okay if at a stable (3-month) dose.
* Pulse consumption \>4 servings per week
* Food allergy or non-food life-threatening allergy
* Pregnant or breastfeeding
* Alcohol consumption (\>14 drinks/week or \>4 drinks/sitting)
* Recent or intended significant weight loss or gain (\>4 kg in previous 3 months)
* National-level or professional athlete
* Overnight shift worker
Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old

The purpose of this study is to determine the safety, efficacy, predictability, and stability of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15 years old in whom conventional treatments have failed.

Nine eyes of nine patients (3 male and 6 female) with high anisometropia (\>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.

Eligibility Criteria:
Inclusion Criteria:

* High anisometropia (\>3.50 D)
* Patients 8 to 15 years old
* Conventional treatments have failed

Exclusion Criteria:

* Diabetes
* Autoimmune diseases
* Topographic abnormalities
Pharmacokinetics of ZSP1273 in Elder Participants

The purpose of this study is to assess the safety, tolerability and PK of ZSP1273 in elder Participants


Eligibility Criteria:
Inclusion Criteria:

1. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
2. Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
3. Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI\<28 kg/m2,BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
4. Heart rate between 50-100 beats/min, Body temperature between 35.7-37.5℃

   Young Participants Only:
5. Participants must be ≥18 to ≤45 years old

   Elder Participants Only:
6. Participants must be ≥65 years old

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies)
2. Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months.
3. Participants with clinically significant disease, such as gastrointestinal disease, infection (e.g., respiratory or central nervous system infection), within 2 weeks before screening;
4. Participants who could not tolerate blood collection by venipuncture and/or had a history of dizzy with blood and needles

   Young Participants Only:
5. Participants had taken or planned to take any prescription medication, over-the-counter medication, vitamin product, or herbal medicine within 2 weeks before screening;
6. Physical examination, vital signs, laboratory tests (blood routine +CRP, urine routine + urine sediment, blood biochemistry, coagulation function, infectious disease test, glycosylated hemoglobin test), 12-lead electrocardiogram, chest CT, abdominal color Doppler ultrasound and other examinations have clinical significance

   Elder Participants Only:
7. Participants had a history of or evidence of cardiovascular disease before screening: uncontrolled hypertension, orthostatic hypotension, severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the past 6 months before screening, or history of tachycardia/bradycardia requiring medical treatment, and degree II-III atrioventricular block.
8. Participants who had other serious organ-systemic serious diseases at screening, including but not limited to respiratory, neurologic, hematologic, endocrine, oncologic, immunologic, psychiatric, or cardio-cerebrovascular diseases, and was judged by the investigator to be ineligible for participation in the trial
Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

To study the effect of midodrine against the symptoms of orthostatic hypotension

The efficacy of midodrine will be assessed in those subjects who have severe symptoms of orthostatic hypotension when not taking midodrine and are controlled when taking midodrine. The study will involve approximately 9 overnight stays.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects must be 18 years of age or older and ambulatory.
2. Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test.
3. A documented history of severe Symptomatic Orthostatic Hypotension (SOH) that, in the judgment of the treating physician, has required treatment with midodrine HCl, and has been at a stable dose for at least 3 months.
4. The subject has manifested at least 1 of the following symptoms while standing or had a medical history of 1 of the following when not treated for orthostatic hypotension (OH): dizziness, lightheadedness, feeling faint, or feeling like they might black out.

Exclusion criteria

1. The subject is a pregnant or lactating female.
2. The subject has pre-existing sustained supine hypertension greater than 180mmHg systolic and 110mmHg diastolic BP or had these measurements at the Screening Visit. Sustained is defined as persistently greater at 2 separate measurements at least 5 minutes apart with the subject supine and at rest for the 5 minutes.
3. Subjects taking concomitant medications of interest are excluded unless those medications are reviewed and discussed with the Medical Monitor or Study Physician and documented prior to enrolling the subject. If agreement is reached between the Investigator and Sponsor for the subject to continue in the study, all allowed medications should be maintained at a constant dose throughout the study.
4. The Principal Investigator deems any clinical laboratory test (at the Screening Visit) abnormality to be clinically significant
5. The subject has participated in other studies of investigational drugs or devices within 30 days prior to enrollment in this study (other than Study SPD426-406).
6. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
7. The subject has a concurrent chronic or acute illness, disability, or other condition (including significant unexpected laboratory or electrocardiogram \[ECG\] findings) that might confound the results of the tests and/or measurements administered in this study, or that might have increased the risk to the subject.
8. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.
9. Prior enrollment failure or randomization in this study.
10. History of alcohol abuse or other substance abuse within the last year.
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.

The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of \< 30 ng/ml. The primary endpoint will be point prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. The point prevalence abstinence rates will also be obtained. The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-64
* Regular ten cigarette per day smoker for one year
* Nicotine Dependency Score greater than or equal to four
* DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
* Psychiatric medication regimen unchanged for at least 90 days
* Psychiatric medication dosage unchanged for at least 30 days

Exclusion Criteria:

* Psychiatric hospitalization in last 6 months
* Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
* Suicide or homicide ideation with a plan in the last six months
* Life time history of suicide attempt
* Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
* Current treatment with Bupropion SR
* DSM-IV diagnosis of alcohol or substance dependence within last 6 months\*
* DSM-IV diagnosis of alcohol or substance abuse within three months \*
* Pregnancy or lactation in females (+HCG)
* Use of tobacco product other than cigarettes
* Use of nicotine replacements
* Unstable or serious medical condition in last 6 months
* Regular use of cimetidine (OTC or Rx) \*Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.