cyrilzakka/clinical-trials huggingface dataset:
The Effect of Education Given to Patients on Pre- and Post-operative Anxiety and Preparation for Discharge

The data of the randomized controlled experimental research were collected at Atatürk University Health Application and Research Hospital Urology Clinics between November 2021 and May 2022. The study sample consisted of 122 patients (61 in the training group, 61 in the control group) who were selected by the simple random sampling method and met the research inclusion criteria.

Ureteroscopy (URS) is an up-to-date method that is widely used in the diagnosis and treatment of ureteral diseases. Apart from the diagnostic purposes of URS, the most common use is to intervene in ureteral stones. The vast majority of ureteral stones are treated endoscopically. A Double-J (DJ) stent is often placed after ureteroscopy. The purpose of the stent is to prevent obstruction, renal colic, and deterioration of renal function. The fact that the DJ stent will remain in the patient for a certain period of time (approximately 3-4 weeks) causes anxiety in the patient. However, approximately 80% of patients with DJ stent implantation have urinary system symptoms that impair their quality of life. Frequent urination (50-60%), sudden urge to urinate (57-60%), pain on urination (40%), incomplete evacuation (76%), flank pain (19-32%), suprapubic pain (30%) , incontinence and hematuria (25%) are the symptoms seen. Patients with DJ stent implanted after ureteroscopy surgery need more information, support, explanation and help to cope with the effects of these symptoms in the clinic and at home. In this context, it is important to provide an individualized and comprehensive education that includes the home care process before and after the URS. It has been determined in the literature that training before surgery reduces anxiety, pain level, complication and depression rates, and increases patient satisfaction in the postoperative period. No study has been found in the literature examining the effects of education given to patients with URS on their post-operative anxiety and readiness for discharge. In this context, this study will provide evidence-based data to the literature by investigating the effects of training given to patients with URS and DJ stent implantation on pre- and postoperative anxiety and readiness for discharge.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research and volunteering,
* Those between the ages of 18-65,
* Having URS surgery for the first time due to stone and temporary DJ stent placed,
* Patients whose cognitive level scales were suitable for application were included in the study.

Exclusion Criteria:

* Having URS surgery for non-stone causes,
* Permanent stent placed,
* Leaving work voluntarily,
* Patients with major hearing and vision problems were not included in the study.
Air Leak Test In Pediatric Intensive Care Unit

Respiratory distress by upper airway obstruction (UAO) is the primary etiology of extubation failure in children hospitalized in pediatric intensive care unit (PICU).

This complication may require various invasive therapeutic which increase morbi-mortality and length of hospital stay.

Cuff leak test (CLT) measured prior extubation to predict post-extubation UAO has been widely used in adult. The test compared expired tidal volume with cuff inflated and cuff deflated in order to predict UAO.

Despite its frequent use in PICU, his predictive value to predict UAO in children is still poorly documented.

Therefore, we conducted the first multicentric, prospective study to evaluate the CLT as a predictor of post-extubation UAO in critically ill children.

The Primary objective is to assess the effectiveness of CLT in predicting severe respiratory distress by UAO within 48 hours of extubation in a critically ill children.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 2 day to \< 18 years of age,
2. Ventilated through a cuffed endotracheal tube,
3. Expected duration of mechanical ventilation ≥ 24 hours,
4. Having a cuff leak test prior extubation,
5. Placed on the assist control setting during CLT,
6. No opposition from parents or patient

Exclusion Criteria:

1. Receiving mechanical ventilation via a tracheostomy,
2. Unplanned extubation,
3. Patient with long-term non-invasive ventilation (NIV),
4. History of upper airways pathology,
5. Surgery of upper airways less than 1 month old,
6. Limitations of medical care in place,
7. Parents or patient opposition,
8. Already been included in this study,
9. Not affiliated with social security.
ADVAIR DISKUS® (Fluticasone Propionate/Salmeterol) Inhaler Versus SEREVENT DISKUS® (Salmeterol) Inhlaer On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease. ADVAIR DISKUS® and SEREVENT DISKUS® Inhalers Are Trademarks of the GSK Group of Companies.

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD.
* Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
* Ex-Smokers with at least a 10 pack-year history.

Exclusion Criteria:

* Current of secondary diagnosis of asthma or current diagnosis of atopy.
* Other respiratory disorders other than COPD.
* Other inflammatory diseases.
* Abnormal and clinically significant chest x-ray or ECG.
* Lung resection surgery within past 1 year.
* History of cancer not in remission within past 2 years.
* Serious, uncontrolled disease.
* Pregnancy or planning to become pregnant during the study.
Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition

The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions

An open label, randomized, single dose, oral bioequivalence study of Isotretinoin capsules 20 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males between 18 and 45 years of age inclusive.
2. Informed of the nature of the study and given written informed consent.
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).

Exclusion Criteria

1. Hypersensitivity to isotretinoin or related compounds.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
3. Recent history of mental illness, drug addiction, drug abuse or alcoholism.
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
7. Regular tobacco use in the 3 months prior to study dosing.
Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

Chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.

Chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity and non-proportional recovery will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.

The primary outcome measure is the Fugl-Meyer Assessment for upper extremity (FM-UE), acquired at baseline, after the intervention period, and at 3 months follow-up. Secondary outcome measures consist of further clinical parameters and biomarkers of corticospinal connectivity.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Chronic stage of stroke (\> 6 months)
* No active finger extension/hand opening of the paretic side

Exclusion Criteria:

* Pregnancy
* Epilepsy
* Metal implants
* Pacemaker
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older.
* Be undergoing open, or minimally invasive LAR for the treatment of a rectal or rectosigmoid neoplasm (Subjects with rectal or rectosigmoid neoplasm(s) may be treated with or without neoadjuvant therapy. Long-course neoadjuvant therapy must have been completed ≥6 weeks prior to LAR surgery (Day 0).
* Have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from the anal verge.
* Have a colorectal or coloanal reconstruction with or without reservoir/pouch.
* Subjects who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at Day 0.
* Have signed an approved informed consent form for the study.
* Be willing to comply with the protocol.

Exclusion Criteria:

* Undergoing stapled anastomosis with the use of an experimental or non-FDA approved stapler.
* Undergoing ileoanal reconstruction, total colectomy or proctocolectomy, abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple synchronous colon resections (e.g., LAR and concomitant right colectomy).
* Has received and completed a course of pelvic radiotherapy ≥ 6 months prior to LAR surgery (Day 0).
* Has previously undergone a left sided colon resection.
* Has previously undergone a rectal resection.
* Has recurrent rectal or rectosigmoid cancer.
* Has a diagnosis of locally advanced rectal or rectosigmoid cancer undergoing extended en bloc operations.
* Has a diagnosis of Stage IV rectal or rectosigmoid cancer with any multifocal metastases or single site metastasis with tumor size of \> 2 cm (Intraoperative incidental finding or preoperative suspicion of Stage IV cancer with isolated (single site) metastasis (≤ 2 cm) or limited metastases (≤3), with largest lesion ≤ 2 cm in size, does not exclude the subject).
* Has a diagnosis of inflammatory bowel disease (IBD). Subjects with rectal or rectosigmoid cancer neoplasms and IBD are excluded.
* Has hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score \>12.
* Renal dysfunction defined as creatinine ≥ 2.0 mg/dL.
* Has known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
* Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
* Is actively participating in another investigational clinical study which, in the Investigator's or Sponsor's opinion, would interfere in this study.
Integral Physiological Adaptations to Carbohydrate Periodization

The purpose of this study is to examine the effect of long-term carbohydrate periodization protocols on sleep architecture, sleep quality, daytime sleepiness, physical performance, body composition, gut microbiome, and miRNA in healthy trained individuals.

Athletic populations have been particularly susceptible to sleep inadequacies, experience several sleep issues, and fall below the age-specific sleep recommendations. However, it is well demonstrated that exercise does not impair sleep by itself, and furthermore, acute post-exercise nutrition could elevate the exercise-induced sleep-optimizing effect, with further benefits for the next physical performance. In line with these findings, in a metanalysis of clinical trials, it was shown that pre-bed carbohydrate availability resulted in significant alterations in sleep architecture. It is of utmost importance to highlight that throughout this metanalysis, it was revealed that no long-term nutrition intervention for sleep optimization has been studied yet. These data raise the question of whether a long-term carbohydrate periodization protocol could optimize sleep and alter gut function in a way that athletic performance will be also enhanced. This would allow elucidating further potential interrelations and biological pathways underlying these adaptations.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes, Age between 18 and 50 yrs old, Regularly participating in sports activities.

Exclusion Criteria:

* Any kind of history of major diseases or medication, Excessive amounts of alcohol and caffeine consumption
Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.

Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially/ethnically diverse samples?

This protocol provides the recommended treatment to achieve smoking cessation (i.e., counseling and nicotine replacement therapy) and randomly assigns individuals to a high-intensity exercise or low-intensity exercise intervention as a strategy to engage the mechanisms relevant to high anxiety sensitive smokers to improve smoking cessation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥ 18);
* High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]);
* Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;
* Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;
* Body mass index \&lt;40;
* Medical clearance to participate.
* Located near a participating YMCA site (within 50 miles)

Exclusion Criteria:

* Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months
* Receiving current intervention for smoking cessation.
* Outstanding debt to the YMCA
* Listed as a sex offender on the National Sex Offender Registry
Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Eligibility Criteria:
Inclusion Criteria:

1. pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.
2. with the measureable lesion of the newly diagnosed the esophageal carcinoma.
3. age 18-75 years old
4. ECOG≤2
5. Expect survival date ≥3 months
6. without serious diseases of important organs
7. signature in the inform consent.

Exclusion Criteria:

1. pregnant or breast-feeding women or using a prohibited contraceptive method.
2. with psychiatric diseases.
3. with serious diseases or uncontrolled infection.
4. with history of other tumors.
5. participation other clinical trials within 1 month prior to inclusion in the trial.
6. not the first antitumor treatment .
A Pilot Study of the Mechanism of Synergism Between FP and Salmeterol in Preventing COPD Exacerbations

The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard treatment.

Our objective is to examine the mechanism of the additive/synergistic properties of b2-adrenoceptor stimulation and corticosteroid receptor activation in:

* Preventing neutrophil adhesion to specific endothelial ligands, e.g. ICAM-1 and
* Undergoing activation as a consequence of this adhesion.

We hypothesize that combination therapy with salmeterol + fluticasone (FP) will:

* Augment the inhibition of adhesion of neutrophils obtained from the peripheral blood of study subjects in vitro, by blocking gIV-PLA2 translocation to the nuclear membrane as for eosinophils;
* Augment the inhibition of transendothelial migration of neutrophils into airways of subjects with chronic obstructive pulmonary disease;
* Augment the numbers and concentrations of pro-inflammatory products in the bronchoalveolar lavage fluid; and
* Decrease the number of neutrophils in the bronchial tissue of endobronchial biopsies of treated patients.

Eligibility Criteria:
Inclusion Criteria:

* Males or females \> 50 years of age
* Physiologic evidence of COPD defined per ATS guidelines as: cigarette smoking history \>20 pack years, FEV1/FVC \<70%
* Patients must have a post-bronchodilator FEV1 \>50% of predicted value at enrollment
* Patient must have an O2 saturation measure by pulse oximetry \>90% on RA
* Must be able to participate in the study, willing to give informed consent, and comply with the study restrictions

Exclusion Criteria:

* Women of child-bearing potential defined as females who are less than 5 years post menopausal unless they have had a hysterectomy or bilateral oophorectomy
* Observation of any solitary nodule in the lung requiring further medical intervention
* Patients on maintenance therapy with oral steroids
* Patients with giant bullous disease
* Significant other medical conditions, which in the opinion of the investigator, will interfere with the patient's ability to perform the study tests
* Presence of a coagulopathy as defined by a platelet count \<100,000/mm3, and PT and PTT \>1.2 x the upper limit of normal
* Concurrent enrollment or participation in any other clinical trials within the past 30 days
* Primary diagnosis of asthma
* History of alpha 1 antitrypsin deficiency
* Any clinically significant and active pulmonary disease that could contribute to dyspnea
* Current systemic and inhaled steroids and theophylline
Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery

Since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management.

The investigators conducted a prospective observational study about efficacy and safety of the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid endarterectomy.

From April 2011 to May 2013, all patients undergoing a carotid endarterectomy were informed of the study and prospectively included. The study was approved by our institutional ethical Review Board (CEPAR, Institut Mutualiste Montsouris Paris France). Oral consent was obtained from patients. Written informed consent of the patients to participate was not necessary according to the French law regarding observational study.

The anesthesiologist in charge of the patient recorded all the parameters of the ultrasound-guided intermediate cervical plexus block: facility and duration of block performance, local anesthetic volume, quality of anesthesia and surgical dissection, and adverse effects of the intermediate CPB. . Neurological status was assessed intraoperatively, in the postoperative setting and at one month after the procedure. Perioperative hemodynamic stability (intraoperative non invasive blood pressure variations) and pulse oxymetry were recorded. As well as ECG and cardiac Troponin I (cTnI) measurments performed the day before surgery and each morning during the 3 first postoperative days. Any clinical coronary or neurological event was recorded at one month.

Statistical analysis was performed on Prism 6 for Mac OS X (Version 6.0c, www.graphpad.com). Data are presented as mean ± standard deviation (SD) for continuous data and number (percentage) for categorical data.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing carotid endarterectomy

Exclusion Criteria:

* None
Remote Video-Delivered Suturing Education with Smartphones

Medical students were randomized to receive live video- or recorded video-delivered feedback on suturing skills. A non-randomized control group received in-person feedback. Pre- and post-feedback recordings of suturing were evaluated to see if the students receiving video-delivered feedback improved just as much as students receiving in-person feedback.

Medical students were randomized to receive live video- or recorded video-delivered feedback on suturing skills. A non-randomized control group received in-person feedback. Pre- and post-feedback recordings of suturing were evaluated by blinded assessors to determine improvement using the University of Bergen suturing skills assessment tool (UBAT) and Objective Structured Assessment of Technical Skills (OSATS). Study arms were compared to the control arm in a non-inferiority analysis. Participants and feedback providers completed questionnaires regarding feasibility and utility of their feedback modality.

Eligibility Criteria:
Inclusion Criteria:

* First and second year students at McMaster University's Degroote School of Medicine

Exclusion Criteria:

* None
Longevity Families of the Netherlands

The demographic life expectancy enhancement of the past 150 years imposes an urgent challenge in Western and economically growing societies to stimulate the healthy lifespan that is lagging behind. Families surviving into exceptionally high ages (longevity) in good physical and mental health illustrate that this is physiologically possible. Such families harbor cross generational socio-genetic mechanisms that mediate healthy aging and protection from (multi)morbidity.

The purpose of our research is: to identify gene variants associated with healthy aging and protection from (multi)morbidity; to study the social-, environment- and behavioral factors of familial longevity, their role in (multi-)morbidity and its interaction with the genetic component.


Eligibility Criteria:
Inclusion Criteria:

* Siblings of Dutch Caucasian descent age 75+ enriched for familial longevity
* Individuals of Dutch Caucasian descent age 75+ who are not enriched for familial longevity

Exclusion Criteria:

-