cyrilzakka/clinical-trials huggingface dataset:
Trigeminal Nerve Cardiac Reflex During Resection of Cerebellopontine Angle Tumors and Postoperative Myocardial Injury

Myocardial injury after noncardiac surgery is significantly related to postoperative 30-day mortality. Trigeminal cardiac reflex is one of the main causes of perioperative cardiac emergency. Therefore, the investigators' aim is to test the hypothesis that trigeminal cardiac reflex associates postoperative myocardial damage in participants undergoing skull base tumor surgery. The investigators will observe the association between trigeminal cardiac reflex and myocardial injury by measuring the concentration of plasma high sensitivity cardiac troponin (hs-cTnT) in participants after skull base tumor surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective skull base tumor surgery.
* Age ≥ 18 years old.
* ASA class I to III.
* All those who sign the informed consent form.

Exclusion Criteria:

* Patients with severe heart disease (including patients with preoperative heart rate \< 50 beats / min, severe arrhythmias, such as premature beats, paroxysmal supraventricular tachycardia, atrial flutter or fibrillation, patients with myocardial ischemia \< 6 months, heart failure, myocarditis, pericarditis or cardiomyopathy).
* Patients unable to complete preoperative cardiac assessment.
* Patients with chronic kidney disease.
Testing the Elevation as Sleep Apnea Treatment

The purpose of this study is to determine if the elevation of the head of the bed in patients with obstructive sleep apnea can decrease the apnea-hypopnea index. First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.

There are many researches that demonstrate that the position of the patient modified the apnea-hypopnea index(IAH). In supine position the IAH will increase comparing with lateral position during th sleep. However few studies were done with the elevation of the head of the bed.

First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.The main outcome will be to analyze the apnea hypopnea index comparing standard polysomnography (sPSG) with elevated polysomnography (ePSG).

Eligibility Criteria:
Inclusion Criteria:

* Berlin questionnaire high risk
* Epworth score \> 9
* Obstructive Sleep Apnea with an index ≥ 5 events/hour on the polysomnography (The American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events: rules,terminology and technical specifications. American Academy of Sleep Medicine, 2012)

Exclusion Criteria:

* younger than 18 years and older than 80 years
* BMI more than 40 Kg/m2
* heart failure
* renal failure
* uncontrolled respiratory disease
* uncontrolled neurological disease
Implementation of the Golden Hour for Preterm Infants : a Quality Improvement Study

Effective initial stabilization of preterm neonates in the initial 60 minutes of life ("golden hour") was shown to improve outcomes. Keys components include anticipative and collaborative approach, respiratory support, thermal regulation and early initiation of parenteral nutrition. The objective is to complete the admission within 60 minutes of delivery.


Eligibility Criteria:
Inclusion Criteria:

* Premature infants (\< 31 weeks' gestation)
* Infants with expected weight less than 1300 g
* Inborn babies

Exclusion Criteria:

* Infants outborn
* Infants with major congenital anomalies (laparoschisis, omphalocèle, diaphragmatic hernia, ...)
* Parental refusal
Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial

Background: Gastric glitch is a new functional disease characterized by severe and transient epigastric pain occurring after challenges such as drinking alcohol and eating specific foods. Aims: In this N-of-1 trial, we first characterized the clinical and gastric tomographic images of a patient with gastric glitch highly reproducible after alcohol challenging, and then tested the effect of prucalopride and buspirone on the prevention of gastric glitch crises.

Objective: To evaluate the effect of prucalopride and buspirone, compared to placebo, in the prevention of gastric pain crises, in a double-blind clinical trial of a single patient. Methods: Female, 35 years old, with signed consent to participate in the study, received 15 capsules to take 1 capsule 60 minutes before ingesting 200 ml of red wine at home (≈20 grams of alcohol), twice a week, according to her routine food, totaling 15 meals. Thus, the experimental phase lasted about eight weeks. The 15 capsules contain placebo (5 capsules), prucalopride 2 mg (5 capsules) or buspirone 10 mg (5 capsules), prepared by a specialized pharmacy in such a way that their physical characteristics do not allow the identification of which agent is being administered, neither by the patient nor the investigator controlling the trial (double-blind). The aforementioned pharmacy generated a code for each pill, randomly, and provided a sealed list with the 15 codes and their respective drugs, for disclosure after the end of the study. The patient was instructed to record in a standardized diary the occurrence of pain crises after the wine challenge, as well as their duration and intensity (Likert 0 to 10: maximum pain), and accompanying symptoms. The patient was asked to contact the researchers directly (WhatsApp) throughout the trial, to clarify any doubts or need for some assistance due to the occurrence of symptoms related to the study. The study statistics will be descriptive in terms of pain events, and the effect of the drugs will be evaluated in a statistical model suitable for the N-of-1 trial. Prucalopride is a 5-HT4 receptor agonist that accelerates gastric emptying, while buspirone is a 5-HT1A receptor agonist that enhances gastric accommodation function. The presumed pathophysiology underlying the patient's pain is retention of wine in the gastric lumen, causing pain. Stimulating gastric emptying with prucalopride or increasing the accommodation of the gastric fundus with buspirone could prevent or alleviate the pain crisis.

Eligibility Criteria:
Inclusion Criteria:

* adult patient suffering from severe gastric pain after ingestion of a small amount of wine

Exclusion Criteria:

* N/A (N-of-1 trial)
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants

This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D \[25(OH)D\] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day.

The specific aims of this study are to determine levels of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled trial, infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these infants.

Eligibility Criteria:
Inclusion Criteria:

* NICU hospitalized infants
* 23-32 weeks gestation

Exclusion Criteria:

* congential anomalies
* disorders of calcium metabolism
* inborn error of metabolism
* kidney disease
* liver disease
* use of steroids
A Placebo-controlled Study of Clenbuterol in Spinal and Bulbar Muscular Atrophy

There is no cure to arrest or delay SBMA progression. It is estimated that \~1000 individuals are affected by SBMA in Italy at any given time (prevalence: 1.5/100000) with an annual incidence of 0.19/100000 males. Here, we are going to test the potential of beta2-agonist stimulation on muscle as a therapeutic avenue for SBMA. We have provided pre-clinical evidence that β-agonist stimulation may be a therapeutic strategy for SBMA. Moreover, we have shown that beta2-agonists are effective in improving motor function without relevant adverse events in a small cohort of SBMA patients. To establish safety and efficacy of clenbuterol as a cure for SBMA, we are conducting a multicenter, phase II, randomized, double-blind, parallel-group, single dose, placebo-controlled trial. Indeed, based on our preliminary data, some concerns remain to be addressed.


Eligibility Criteria:
Inclusion Criteria:

1. males who have received a genetically confirmed diagnosis of SBMA (AR CAG repeat number \>= 38);
2. aged between 18 and 75 (+364 days) years;
3. displaying one or more of the following clinical symptoms: muscle atrophy, limb weakness, bulbar palsy;
4. able to walk independently with or without a cane or other supporting device (all supporting devices are acceptable except on wheelchair);
5. providing a written informed consent.

Exclusion Criteria:

1. a documented cardiovascular disease precluding the use of beta2 agonists (in the judgment of the investigators);
2. glaucoma, severe prostatic hypertrophy, hyperthyroidism, pheochromocytoma, and other medical conditions that, in the judgment of the investigators, would expose the patient to undue risk of harm or prevent the patient from completing the study;
3. concomitant treatment with either beta-blockers or sympathomimetic drugs (If a beta-blockers concomitant medication is ongoing before the study inclusion, the patient can be enrolled if the beta-blocker is discontinued for 3 weeks prior to randomization visit);
4. inability to walk or walking only with the support of a caregiver;
5. use of beta2 agonists in the preceding 6 months;
6. participation to an interventional trial in the preceding 3 months;
7. neuromuscular disease other than SBMA.
Attenuation of Pain in Men and Women

The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.


Eligibility Criteria:
Inclusion Criteria: Healthy men and women

-

Exclusion Criteria:

* current cardiac or other chronic diseases (e.g., cancer, diabetes, hypertension, kidney disease); routine use of prescriptive medications; history of vasovagal response to phlebotomy; an allergy to naltrexone; pregnancy; current smokers; current use of recreational drugs; history of substance abuse
Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy

This study assesses the effectiveness of transbronchial cryobiopsy guided by 3-dimensional fluoroscopy. Transbronchial cryobiopsy is a procedure to collect lung tissue. The main side effect seen after a transbronchial cryobiopsy is pneumothorax (air leaking out of the lung, which may cause a completely or partially collapsed lung). The standard imaging scans used during this procedure are 2-dimensional (like a photo), which can make it difficult for the doctor to know exactly where the biopsy tool is during the procedure. If the exact location of the device is not clear, a patient can be at a higher risk of pneumothorax. Using a 3-dimensional imaging technique may help to decrease the risk of pneumothorax during transbronchial cryobiopsy.

PRIMARY OBJECTIVE:

I. To determine if transbronchial cryobiopsy guided by three-dimensional fluoroscopy reduces the incidence of pneumothorax up to 72 hours after transbronchial cryobiopsy.

SECONDARY OBJECTIVE:

I. To describe outcomes of cryobiopsy, need for interventions related to transbronchial cryobiopsy, radiation dose, and any complications or adverse events after transbronchial cryobiopsy guided by three-dimensional fluoroscopy.

OUTLINE:

Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy
* Ability to provide informed consent

Exclusion Criteria:

* Acute respiratory failure (defined as oxygen requirement \> 4 L/min by nasal cannula above baseline, or need for any intervention to support ventilation and/or gas exchange for any duration, including invasive and non-invasive positive pressure ventilation, high-flow therapy, non-rebreather mask, or Venturi mask)
* Intensive care unit (ICU) admission
* Forced vital capacity (FVC) \< 50% or diffusing capacity of the lung for carbon monoxide (CO) (DLCO) \< 35% (if pulmonary function tests are available)
* Known or suspected pulmonary hypertension (defined as elevated right ventricular systolic pressure on echocardiogram, if available)
* Acute renal failure or chronic kidney disease
* Platelets \< 100,000/uL
* International normalized ratio (INR) \> 1.5
* Use of anticoagulant therapy that cannot be held for 2 days
* Use of antiplatelet therapy (other than baby aspirin) that cannot be held for 5 days
* Any bleeding diathesis
* Pregnancy
Electro-Neuro-Muscular Stimulation in ICU

We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in critical care patients, can decrease the impact or severity of the critical illness myopathy (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect the incidence density rate of nosocomial pneumonia in the ICU.

Patients will be divided into two groups, Group A and Group B chosen at random. In Group A conventional physiotherapy will be applied while in Group B, ENMS will also be applied additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will be 1 hour, it will be applied before the start of the physiotherapy per day of hospitalization and for 10 days in each patient.

The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori Trichrome will be used to determine the existence or absence of myopathy. In addition the ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3), thus achieving a separation of myopathy and neuropathy.

The primary outcome of the study will be the incidence of myopathy in both groups, at day 12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing this rate by 50% in the intervention group using statistical power equal to 0.80 up to a level of p \<0.05, 12 number of patients will be required in each group.


Eligibility Criteria:
Inclusion Criteria:

Patients aged\>18 years old and \<85 years old, hospitalized in the ICU for at least 96 hours

Exclusion Criteria:

pregnancy, autoimmune disease, pre-existing known neuromuscular diseases, presence of bone fractures on the lower extremities, use of corticoids
Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

The current first-line treatment for opioid use disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal symptoms prior to induction, which can be a major barrier in starting treatment. Rapid micro-induction (also known as micro-dosing, low-dose induction) involves the administration of small, frequent does of bup/nx and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of bup/nx in patients with OUD.

This is a randomized, controlled, open-label superiority trial involving 50 individuals with OUD. Participants will be randomized into two arms: rapid micro-induction and standard induction (based on the American Society of Addiction Medicine Practice Guidelines and product monograph) of bup/nx.

Eligibility Criteria:
Inclusion Criteria:

1. Opioid Use Disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria;
2. Individuals seeking Opioid Agonist Treatment (OAT);
3. Be 19 years of age or older;
4. Be willing and able to adhere to the study protocol and follow-up schedule;
5. Be able to provide written informed consent to participate in the clinical trial.
6. If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study.

Exclusion Criteria:

1. Diagnosis of severe medical or psychiatric conditions contraindicated for buprenorphine/naloxone or hydromorphone treatment;
2. Anticipated deterioration of health due to discontinuation of medications that are contraindicated with buprenorphine/naloxone and/or hydromorphone;
3. Positive pregnancy test for women of childbearing potential;
4. Methadone use in the past 5 days;
5. Buprenorphine use in the past 5 days;
6. Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone;
7. Anticipation that the patient may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion;
8. Unwilling or unable to use an effective method of birth control approved by the study investigators throughout the study.
Nurses' Foot Health and Work Well-being

This study supports and promotes work well-being of nursing personnel from the perspective of foot health in health care organizations. Half of the participants will receive an electronic foot health education program to improve their foot self-care knowledge, while the other will receive anything. The outcomes of this project include recommendations and tested educational program to occupational health care for improving foot health of nurses.

An electronic Foot Health Promoting Program (FHPP) will be tested with nurses using quasi-experimental study design.

The participants will be assigned to experimental (N=130) and comparison (N=130) groups. The experimental group will receive an electronic intervention (Foot Health Promotion Program) for 8 weeks consisting of foot self-care guidance (skin and nail self-care), foot exercises, foot stretching and professional footwear guidance. Detailed components of the intervention will be produced on the bases of survey (part 1) results. The intervention (Figure 3) will be electronic via internet (Moodle platform) where a material package of foot health care will be delivered. Each participant will receive a user account to platform. The platform is divided into four main themes all related to foot health. Each theme consists of two topics of foot health. Each topic includes lectures (delivered via Adobe Presenter) and self-directed learning where participant will go through a list of links to websites (will be evaluated with certain criteria beforehand) and watch videos about foot self-care. In addition, the learning will be evaluated using four individual tasks related to foot self-care. By responding to task a participant will receive an example of the correct answer and using that he/she can evaluate own response and learn by that. Participants' use of different links (quantity) and their paths in the intervention platform will be calculated and analysed. The participants will be tested before the intervention (baseline) and one month (follow-up 1) and four (follow-up 2) months after the intervention. The primary outcome is foot health knowledge and secondary outcomes are foot health, musculoskeletal problems, work ability, health-related quality of life and work satisfaction. Hypothesis is: Increasing nurses' knowledge about foot health will improve their foot health and work ability. Ultimate goal is to develop tools for the occupational health care and improve the attention paid to feet as part of the work ability among nurses.

Eligibility Criteria:
Inclusion Criteria:

* nurses (registered nurses, licensed practical nurses, public health nurses) working in the operating theatre

Exclusion Criteria:

* other health care professionals
Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. Then it will depends which regimens the patient would receive according to his or her pathological results.


Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed adenocarcinoma
* clinical stage T3-4 and/or N+
* the distance from anal verge less than 12 cm
* without distance metastases
* performance status score: 0\~1
* UGT1A1\*28 6/6 or 6/7
* without previous anti-cancer therapy
* sign the inform consent

Exclusion Criteria:

* pregnancy or breast-feeding women
* serious medical illness
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
* DPD deficiency
* UGT1A1\*28 7/7