cyrilzakka/clinical-trials huggingface dataset:
Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery.

The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.


Eligibility Criteria:
Inclusion Criteria:

* patients with coronary artery disease scheduled for elective OPCAB-surgery
* patients willing and able to complete the requirements of this study
* Ejection fraction \>30%

Exclusion Criteria:

* Lack of informed consent
* age \< 18 years
* COPD GOLD \>II
* Renal dysfunction defined as serum-creatinine \>1.5mg/dl
* acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
* single vessel grafting
* disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression, low preoperative cognitive state (MMSE at baseline \<25), history of stroke with residuals, increased intracranial pressure
* Hypersensitivity to the study medication
* Presumed uncooperativeness or legal incapacity
Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy

The Atkins Diet Modified (ADM) is the best alternative treatment for drug-resistant epilepsy, There is a high prevalence worldwide , especially in Latin American countries, including Mexico.

Low income earners, many of which do not have a social security, must meet the high costs by Antiepileptic Drugs (AEDS), which in addition should be used in conjunction or combination therapy, because monotherapy is insufficient .

The diet adkins makes some changes in the traditional food habits by others that are accessible and not necessarily expensive, whose mechanism allows for better control of the seizures.

Objective: To assess the efficacy, tolerability and adherence of the modified adkins diet in adult patients with drug-resistent epilepsy Materials and Methods: Clinical trial, made up of patients with drug-resistent epilepsy, selected by convenience, who will be handled pharmacologically with the standard treatment of this condition for a period of not less than 6 months, after which they will be treated with adkins diet modified, prior informed consent, to establish its effect and a comparative analysis later.

The objective of this work is to analyze the efficacy, tolerability and adherence of the modified atkins diet in adult patients with drug-resistant epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Patients that meet the criteria of drug-resistant epilepsy
* Patients treated with Rational polytherapy, a minimum of 6 months, with no changes in their drug refractory condition.
* Patients with drug- resistant epilepsy with informed consent signed by themselves and their proxy.
* Patients with drug-resistant epilepsy of any etiology, except tumor, metabolic, degenerative or progressive.

Exclusion Criteria:

* Patients with drug-resistant epilepsy simultaneous alternate treatment to the Atkins Diet modified.
* Patients with a neurological entity progressive and fatal
* Patients with congenital diseases and difficulty to metabolize fats or that require high amounts of carbohydrates in the diet.
One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques

The aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5Y-TZP/3Y-TZP).

Introduction: A good relationship between dental restorations and the periodontium is one of the most important aspects to ensure clinical success both in terms of esthetics and function. Dental preparation for fixed prostheses can take various forms classified as horizontal preparation with a defined margin (chamfer), or vertical, or without a margin/finish line. According to some clinical reports, vertical preparation technique provides an increases in the gingival thickness and a greater stability of the gingival margin. Moreover, vertical preparation is characterized by being more conservative with tooth structure. Also, taking impressions is easier since it is a finish area and not a defined line.

Null hypothesis:

1. There will be no difference between vertical and conventional preparations in the clinical behavior of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
2. There will be no difference between vertical and conventional preparations in the patient satisfaction of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. From 21-50 years old, be able to read and sign the informed consent document.
2. Have no active periodontal or pulpal diseases, have teeth with good restorations.
3. Psychologically and physically able to withstand conventional dental procedures.
4. Patients with teeth problems indicated for all ceramic crowns in esthetic zone;

   1. Badly decayed teeth
   2. Teeth restored with large filling restorations
   3. Endodontically treated teeth
   4. Malformed teeth
   5. Malposed teeth (Tilted, over-erupted, rotated, etc.)
5. Able to return for follow-up examinations and evaluation.
6. Thick gingival biotype.

Exclusion Criteria:

1. Patient less than 21or more than 50 years.
2. Patient with active resistant periodontal diseases.
3. Patients with poor oral hygiene and uncooperative patients.
4. Pregnant women.
5. Patients in the growth stage with partially erupted teeth.
6. Psychiatric problems or unrealistic expectations.
7. Patient with periodontal problems.
8. Patients with malocclusion or parafunctional habits.
Laparoscopic Reinforcement Suture (LARS) of Duodenal Stump A Prospective Single Arm Phase II Study

Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted.

We already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.

As the results of recent prospective randomized controlled clinical trials, laparoscopic gastrectomy has been accepted by one of standard treatments for early gastric cancer in Korea, Japan and China.

However, duodenal stump leakage remains one of the fetal complications after gastrectomy until now. The incidence of duodenal stump leakage is reportedly between 1.6% to 5% in Billroth II or Roux en Y reconstruction after gastrectomy for gastric cancer. According to a recent multicenter study, the laparoscopic approach increased the risk of duodenal stump leakage development comparing to open approach.

Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted. I already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven gastric adenocarcinoma that were treated with laparoscopic distal or total gastrectomy and B-II or Roux en Y reconstruction and age of above 19 years

Exclusion Criteria:

* history of previous abdominal surgery except cholecystectomy and would be performed combined abdominal surgery except cholecystectomy. And also patients with advanced gastric cancer with gastric outlet obstruction or cancer invasion to pylorus
Metabolism Informed Smoking Treatment: The MIST RCT

This phase 3 randomized controlled trial will test Metabolism-Informed Smoking Treatment (MIST), a precision approach to smoking treatment that biologically tailors medication selection to nicotine metabolism.

This is a randomized controlled trial to compare effects of MIST versus usual care (UC) interventions on the outcomes below.

Objectives:

* Abstinence as defined by biochemically-verified self-reported 7-day point prevalence abstinence at 6 m (1° study outcome) and 12 m (2° outcome).
* Clinical practice implementation as measured by participant self-reported medication adherence at months 1 and 3, self-reported receipt of prescription for smoking cessation medication after hospital discharge, and whether the prescription was tailored to the NMR result.

Exploratory Objective:

- Longitudinal assessment of health care utilization visits (ER and hospitalization) for 12 months following hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* be 18 years or older
* be enrolled in an insurance plan that supports prescription coverage for smoking cessation medication (such as Medicare part D, Medicaid, or private insurance) to facilitate bedside delivery of medications prior to hospital discharge
* have a regular provider/PCP
* agree to quit or try to quit smoking upon hospital discharge
* be a daily smoker when smoking normally during the month prior to entering the hospital
* be medically eligible to use varenicline
* be medically eligible to use nicotine replacement therapy
* have received discharge medication recommendations from a tobacco counselor
* agree to take smoking cessation medication (i.e., varenicline OR nicotine replacement therapy) home and consider using it
* have a cell phone or landline that can be reached directly (i.e., without transfer)
* have a permanent address where they live and can receive mail
* estimated life expectancy of at least one year or greater

Exclusion Criteria:

* insufficient time to perform and complete the enrollment process
* barrier to effective communication (including low English proficiency)
* not cognitively able to participate in the study
* too ill, on hospice, or physically unable to participate in the follow-up process
* previously completed the MIST study or is currently enrolled in a quit smoking study that involves a medication-based treatment
* estimated life expectancy of less than one year
Merits of Continuous Paravertebral Block in the Management of Renal/Adrenal Surgery by Laparotomy

The paravertebral block is an alternative in the analgesia epidural the major interest of which lives in the catheterisation of the paravertébral space allowing to assure/insure an one-sided continuous analgesia.

The main objective of the study is to bring to light the superiority of the continuous paravertébral block, as a supplement to analgesia, in the care of the renal and\\or adrenal surgery by laparotomy at the adult in terms of consumption of morphine, with regard to the classic analgesia classic.

The main assessment criterion is the consumption of morphine within first 24 postoperative hours at the patients benefiting from a paravertébral continuous block besides the classic systematic analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient scheduled for renal and/or adrenal surgery
* American Society of Anesthesiologists score ASA I, II, III
* Written informed consent given by the patient

Exclusion Criteria:

* Contraindication in the loco-regional anesthesia in the products of local anesthetic
* Surgery as a matter of urgency
* Pregnancy
* Congestive Cardiac insufficiency
* Severe hepatic Incapacity
* Disturbs of the coagulation
* Age \< 18 years
* ASA IV
* Patient already participating in a study or deadline 3-month-old subordinate since the end of a previous study
* Under guardianship Patient
* Psychiatric pathology or limitation of the intellectual abilities making difficult the understanding of the subjective questions.
Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

this study is about evaluating the effect of using normal saline nebulization in preventing re-intubation in extubated neonates , provided that the cause of intubation is mainly due to respiratory cause

Using nebulization is of great debate in neonates especially post extubation as neonates have physiological characteristics such as difficult airway maintenance and clearance, smaller airway caliber, compliant chest wall, poor airway stability, and lower functional residual capacity that account for the diminished delivery of inhaled aerosol.

Nebulized normal saline has historically been used as a placebo typically in studies examining bronchodilator medications and sputum expectorants or used as a carrier to medications. Nowadays, normal saline is a method of enhancing mucociliary clearance has become a clinically accepted adjunct to physiotherapy in the treatment of many chronic lung conditions .

the effect of whether or not nebulization really improves the lung condition is evaluated by lung ultrasound ,It is not only useful in predicting failure of non-invasive ventilation and the need for invasive ventilation, but also has a great value in anticipating extubation success In general, patients with lower lung ultrasound scores show a better chance of extubation success. Each lung will be divided into 3 areas (upper anterior, lower anterior, and lateral) and will be examined using a linear microprobe through both transverse and longitudinal scans. For each lung area, a 0- to 3-point score was given (total score ranging from 0-18).

Eligibility Criteria:
Inclusion Criteria:

* Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation.

Exclusion Criteria:

* Neurological, cardiac, surgical or metabolic problems affecting their respiration.

Upper obstructive air way disease that might affect the success of extubation.
Timing of Energy Availability on Menstrual Cycle Function

The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy availability is maintained at or above 30 kcal/kg lean body mass/ day among women who regularly do running or cycling exercise. A secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol.

Participants will be asked to do the following over a \~3 month enrollment period:

* attend a laboratory visit at the beginning of the study to have their resting metabolic rate, aerobic fitness, and body composition tested
* monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet for \~3 months
* complete 3, 90-minute exercise sessions on a stationary bike or treadmill either fed (consuming a carbohydrate meal 1 h prior and 0.7 g carbohydrate/ kg body mass/ h during exercise) or fasted (consuming no meal prior and no carbohydrates during exercise) during month \~3
* saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol


Eligibility Criteria:
Inclusion Criteria:

* participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week
* accustomed to exercising for 90 minutes or more
* has regular periods every 21-35 days
* have not taken hormonal contraceptives for at least the past 6 months
* is not currently or trying to become pregnant or breastfeeding, and has not been pregnant or breastfeeding in the past 12 months
* does not currently have a diagnosis of a major menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome \[PCOS\], endometriosis, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
* does not currently have a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes, congenital adrenal hyperplasia)
* does not currently have a major cardiovascular or respiratory disease

Exclusion Criteria:

* miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, cross training)
* demonstrate clinical low energy availability as defined as energy availability \<30 kcal/kg fat free mass
* report menstrual cycle lengths \<21 or \>35 days in the first 2 months of at-home monitoring
* do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring
* begin taking a hormonal contraceptive
* become pregnant
* are diagnosed with a menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome \[PCOS\], endometriosis, ovarian cancer, ovarian insufficiency, uterine, or endometrial cancer)
* are diagnosed with a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)
* are diagnosed with a major cardiovascular or respiratory disease
* are unable to follow instructions for any of the procedures
Anatomic Outcomes Following Ozurdex Injections

Ozurdex(TM) has recently been FDA approved for use in macular edema secondary to retinal vein occlusion. It remains unclear how quickly the drug works and for how long as the initial studies did not have frequent anatomic monitoring. This study will utilize frequent Spectral domain OCT imaging to better understand the onset of treatment effectiveness and duration of action on the anatomic thickness of the retina, in addition to distinguishing structural abnormalities of responders from non-responders.

Focal laser therapy has been the gold standard for the treatment of macular edema secondary to branch vein occlusion (BRVO), though it has not been shown to be effective for central vein occlusion (CRVO). Intravitreal corticosteroids have been shown in many case series to be effective at diminishing macular edema secondary to both BRVO and CRVO. Sustained drug delivery models have been sought after to relieve the need for frequent injections. Ozurdex has recently been found to be effective for the treatment of macular edema following BRVO or CRVO and has been approved by the FDA for these indications. The onset of effectiveness and duration of action on the anatomic thickness of the retina have not yet been demonstrated. In addition, it is uncertain as to when the clinician can label the patient as a responder or nonresponder. We also believe this study will help identify patients that may need more frequent dosing schedules.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with BRVO/CRVO who are otherwise eligible to receive treatment with Ozurdex (TM)

Exclusion Criteria:

* Patients younger than 21 years of age, unwilling or unable to grant informed consent, participation in a clinical trial within the 30 days prior to enrollment. Patients receiving any other ocular therapy.
Enhancing Medication-based Analgesia in Humans

This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).

This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with no history of drug use disorder. Study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. All participants completed all sessions. Sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75
* Urine sample tests negative for common illicit substances of abuse, including cannabis
* Medically cleared to take study medications
* Are not pregnant or breast feeding
* Willing to comply with the study protocol.

Exclusion Criteria:

* Meet DSM-5 criteria for alcohol/substance use disorder
* Taking opioids for pain
* Previous adverse reaction to a cannabinoid product
* Prescribed and taking stimulants or benzodiazepines
* Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain
* Self-report any illicit drug use in the past 7 days
* Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
* History of seizure disorder
* Have a known allergy to the study medications or sesame seed oil
* Taking medications contraindicated with hydromorphone or dronabinol
* Have a history of clinically significant cardiac arrhythmias or vasopastic disease
* Have an abnormal and clinically-significant ECG
A Mindfulness-Based Cognitive Therapy for Suicidal Patients

The main goal of this study is to evaluate the effectiveness ofMindfulness-Based Cognitive Therapy aimed at reducing suicidality in adults. This will test the effectiveness by studying the effect on suicidal ideation and related outcomes, compared to Treatment As Usual. The study is a multicentre randomized controlled trial conducted in out-patient Flemish mental healthcare facilities.


Eligibility Criteria:
Inclusion Criteria:

* Speak Dutch
* Be at least 18 years old
* Have access to internet
* Be suitable for group therapy
* Have mild to severe suicidal thoughts (BSS score of minimum 1)

Exclusion Criteria:

* Conditions expected to severely hinder group participation, comprehension of the training content or adherence