cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Esmketamine Versus Dexmedetomidine

A comparative study on the safety and efficacy of esmketamine versus Dexmedetomidine during drug induced sleep endoscopy in children with positional obstructive sleep apnea: A consort-prospective, randomized, controlled clinical trial

Methods: Eighty ASA Ⅰ - Ⅱ patients aged 3-13 years underwent elective surgery under general anesthesia. No serious cardiovascular disease, no liver and kidney dysfunction, no central nervous system disease and mental disease. Patients undergoing tonsillectomy under general anesthesia were selected as the research objects.

80 patients were randomly divided into dexmedetomidine group D (n = 40) and ketamine Group K (n = 40). Both groups were given midazolam 0.2mg/kg intravenously

Group K: induction: intravenous injection of 1.0mg/kg esmketamine, nasal endoscopy started 3 minutes later, maintained 1.0mg/kg/h esmketamine;

Group D: induction: Dexmedetomidine 1 μ G / kg at least 10 min after intravenous injection + maintain 1 μ After 5 minutes of intravenous injection of dexmedetomidine 1 ug / kg, sufentanil 0.05 mg / kg was given.

Propofol 0.5 mg · kg-1 was injected intravenously when the patient had body movement

Heart rate (HR), mean arterial pressure (map), electrocardiogram (ECG), respiratory rate (RR), pulse oxygen saturation (%, SpO2) and BIS were recorded before (T1), during (T2), after (T3), 1 min after tracheal intubation (T4), 1 min after extubation (T5) and 30 min after extubation (T6).

3.2 onset and maintenance time: the time from administration to endoscopic examination (min); Recovery time (min)

3.3 observation and treatment of adverse reactions during and after dis

3.4 observe the sedation score of the two groups during the dis phase and the awake score 30 minutes after waking up

Objective To observe the application of dexmedetomidine and esmketamine in drug-induced sleep nasal endoscopy, and to explore the best medication scheme, so as to better guide clinical medication.

Eligibility Criteria:
Inclusion Criteria:

* Eighty ASA Ⅰ - Ⅱ patients aged 3-13 years underwent elective surgery under general anesthesia. No serious cardiovascular disease, no liver and kidney dysfunction, no central nervous system disease and mental disease. Patients undergoing tonsillectomy under general anesthesia were selected as the research objects.

Exclusion Criteria:

* ASA grade III and above, abnormal heart, lung, liver and kidney function before operation; There were central nervous system diseases and mental diseases, preoperative allergy to anesthetics (dexmedetomidine, esmketamine), family history of malignant high fever, tracheostomy and other artificial airway.
Local Anesthetic Infusion and Sternotomy

Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are well known to enhance postoperative hyperalgesia (HA) and a perioperative local anesthetic agent infusion is one of the therapeutic strategies used to limit this phenomena. The aim of this study was to evaluate the effectiveness of a continuous Ropivacaïne sternal infusion compared with a saline serum infusion to limit postoperative HA, pain and morphine consumption (M) after sternotomy in cardiac surgery.

This strategy could lead to lower postoperative morphine consumption and opioïd induced hyperalgesia.

* Principal Objective: comparison of peri-incisionnal dynamic hyperalgesia extend evaluated by Von Frey filament during the first postoperative week between the two groups.
* Secondary Objective: comparison of peri-incisionnal static hyperalgesia (pain threshold) extend evaluated by Von Frey filament, postoperative pain scores, morphine consumption, hemodynamic and respiratory parameters during the first postoperative week and incidence of chronic pain and dysesthesia at six month between the two groups. Ropivacaïne plasmatic concentration will be monitored, during infusion.
* Study design : monocentric, double blind randomized clinical trial comparing two groups of patients with a same intraoperative anesthetic management :

  * Group 1: Ropivacaïne infiltration before skin incision followed by a 48 hours Ropivacaïne continuous infusion after surgery through a sternal fenestrated catheter
  * Group 2: same protocol with pre and postoperative saline infusion

Postoperative pain management is identical in the two groups based upon a Morphine sulfate PCA pump for the first 48 hours.

• Number of subjects : 40 patients, 20 in each group

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 50 to 75 years old
* ASA score : 1-3
* Cardiac surgery with median sternotomy for:

  * single valve replacement, Bentall, Bahnson, Tyrone David procedure
  * single or multiple Cardiac Artery Bypass Grafting (CABG)
  * combined surgery (valve replacement + CABG)
  * without predicted risk of postoperative complication
* Informed consent obtained from the patient
* Patient beneficiating of social insurance

Exclusion Criteria:

* patient refusal to participate in the study
* Drug or alcohol abuse history
* Analgesic or opioid consumption within the 12 hours preceding the surgery
* Chronic use of analgesic drugs or history of chronic pain
* Disability to understand morphine PCA use
* Allergy to ropivacaine or other local anaesthesia
* Patient treated by fluvoxamine or enoxamine
* Patient suffering for liver insufficiency (child score \>A)
* Patient with major preoperative hypovolemia
Feasibility Trial of rTMS for Cannabis Use Disorder

This small pilot trial will recruit 10 cannabis use disordered participants and apply 20 sessions of rTMS in conjunction with a two session Brief Marijuana Dependance Counseling treatment paradigm. The investigators are primarily seeking to determine if the proposed paradigm is feasible and well tolerated.

The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS is feasible and well tolerated by a group of treatment seeking CUD patients (Aim1). The investigators are also hoping to preliminarily determine if a course of rTMS reduces cannabis cue-induced craving (Aim2). Additionally the investigators want to preliminarily explore the mechanistic underpinnings of any observed effect by collecting functional magnetic resonance imaging (fMRI) data during cannabis cue-administration before and after the treatment course (Aim 3). These aims will be addressed through an open label study in which 10 treatment seeking cannabis use disordered participants will be given 20 sessions of Active excitatory rTMS applied to the DLPFC. TMS will be delivered in an accelerated fashion over two weeks (2 sessions each day, five days each week). TMS will be applied in conjunction with a validated two-session Motivational Enhancement Therapy (MET) behavioral intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
2. Participants must be between the ages of 18 and 60.
3. Participants must meet DSM-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 / last 28 days.
4. Participants must express a desire to quit cannabis.
5. Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users).

Exclusion Criteria:

1. Participants must not be pregnant or breastfeeding.
2. Participants must not test positive for any substance other than cannabis on UDS during their enrollment visit.
3. Participants must not meet moderate or severe use disorder of any other substance with the exception of Tobacco Use Disorder.
4. Participants must not be on any medications that have central nervous system effects.
5. Participants must not have a history of/or current psychotic disorder or bipolar disorder.
6. Participants must not have any other Axis I condition requiring current treatment and must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms.
7. Participants must not have a history of dementia or other cognitive impairment.
8. Participants must not have active suicidal ideation or a suicide attempt within the past 90 days.
9. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the head, history of seizure, any known brain lesion).
10. Participants must not have any unstable general medical conditions.
The Application of Analgesia Nociception Index as an Objective Labor Pain Assessment During Epidural Analgesia

Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.

Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. Without a convincing objective tool for obstetric pain evaluation during epidural analgesia, the clinicians are hard to adjust adequate epidural drug dosage. Establishing an objective pain index would help the clinicians to have a better pain management during labor.

In 2012, M. Le Guen et al. demonstrated a linear relationship between visual analogical pain scores(VAS) and Analgesia Nociception Index (ANI) values during labor. Their efforts started the application of ANI in obstetric pain monitoring. However, the reliability of ANI in obstetric pain monitoring under epidural analgesia have not yet been verified. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Parturients with gestational age more than 35 weeks
* Ages between 20 to 50
* Received epidural analgesia
* American Society of Anesthesiologists classification I or II.

Exclusion Criteria:

* 1. Who refused to join the study
* 2. With a history of arrhythmia
* 3. American Society of Anesthesiologists (ASA)Classification \>= III
* 4. With a history of cardiovascular, pulmonary, endocrine, neurologic or psychiatric disease
* 5.Using medications that affecting heart rate
* 6. Cannot understand the explanation of the study
* 7. High-risk gestation
* 8. Known fetal anomaly
Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout

Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists

The study will be a randomized controlled trial of attending and resident otolaryngologists who will be randomized to either wearing a WHOOP fitness tracker or a control group. Participants will take two Maslach burnout inventory (MBI) surveys prior to the start of the intervention to set a baseline burnout score, and then at 3 months and 6 months into the study. Baseline cardiac status will also be established by taking a pre-intervention heart rate and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* All attending and resident Otolaryngologists at Wake Forest Baptist Health

Exclusion Criteria:

* Users of a WHOOP device currently
* Current interns will be excluded given they do not work with the Otolaryngology team the whole year
Patient Understanding of Handouts at Different Reading Levels

The goal of this randomized clinical trial is to learn if participants are better able to understand medical handouts written at below a sixth grade reading level compared to those written at above a sixth grade reading level. The main question it aims to answer is:

• Do participants score higher on a knowledge test after reading a handout written at below a sixth grade reading level compared to after reading a handout written at above a sixth grade reading level?

Researchers will compare knowledge scores on pelvic organ prolapse after participants read a handout written at an eight grade reading level compared to the same handout re-written to be at a fifth grade reading level.

Participants will:

* Read a one page handout (written at either above or below a sixth grade reading level) on pelvic organ prolapse
* Complete a one page multiple-choice test on pelvic organ prolapse

The secondary objective is to determine characteristics of patients whose knowledge levels are higher after reading educational material written below a sixth grade reading level compared to material written above a sixth grade reading level.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to complete pen and paper questionnaire

Exclusion Criteria:

* Unable to understand or read English
Enhancing Neuroplasticity and Frontal Lobe Function in Patients With Mild Alzheimer's Disease

The purpose of this study is to determine if a novel brain stimulation approach using magnetic stimulation (Transcranial Magnetic Stimulation \[TMS\]) can improve memory and thinking processes in individuals with mild Alzheimer's disease (AD).

In this study, the investigators aim at assessing and then enhancing neuroplasticity in the dorsolateral prefrontal cortex (DLPFC) and working memory - a key function of DLPFC - in patients with mild AD. The investigators will use a novel non-invasive brain stimulation approach, Paired Associative Stimulation (PAS). PAS simulates in humans the induction of long-term potentiation (LTP), a prototype of synaptic neuroplasticity. PAS involves the repetitive pairing of electrical stimulation of the median nerve with - 25 ms later - transcranial magnetic stimulation (TMS) of the contralateral DLPFC. As such, these two stimulations arrive simultaneously in the DLPFC and result in potentiation of TMS induced cortical evoked potential, analogous to in vitro LTP.

Specific Aim 1: To compare LTP in the DLPFC among patients with mild AD and healthy subjects.

Specific Aim 2: To assess the effect of a 2-week course of PAS (rPAS) as applied to the left DLPFC on LTP and performance on working memory in patients with mild AD in comparison with a 2-week course of PAS control condition (PAS-C, described below) (rPAS-C).

Eligibility Criteria:
Inclusion Criteria for patients:

* Age 65 or above
* Meet NINCDS-ADRDA and DSM-IV TR criteria for a current diagnosis of Alzheimer's Disease
* Stable does of acetylcholinesterase inhibitors for at least 3 months
* Willingness and ability to speak English
* Willingness and ability to provide informed consent
* Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.

Exclusion Criteria for patients:

* Meets criteria for an Axis I diagnosis within the past 12 months other than Dementia of the Alzheimer type.
* Mini Mental Status Examination score of 16 or less as described above
* Meets diagnostic criteria for current alcohol or other drug dependence within 6 months of testing
* Electroconvulsive Therapy (ECT) within 6 months of testing.
* Left handedness.
* Incompetency to consent
* Any contraindication for TMS

Inclusion Criteria for healthy controls:

* Age 65 or above
* Willingness and ability to speak English
* Willingness and ability to provide informed consent
* Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.

Exclusion Criteria for healthy controls:

* Meets criteria for an Axis I diagnosis other than simple phobias or adjustment disorder.
* Other neurological disorder affecting central nervous system.
* Psychotropic medication except for sedative /hypnotics at a stable dose for at least 4 weeks.
* Left handedness
* Any contraindication for TMS
Headache Provocation of People Who Are Unable to Have Headache

Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.

The aim of the study is to identify factors that protect against headache by studying headache after provocation in people who never have had a headache (headache resistant) versus non-resistant controls.

The investigators will use isosorbide mononitrate as a pharmacological trigger of headache. The provocation is performed by investigators who are blinded to the grouping of the participants.

The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.


Eligibility Criteria:
Inclusion Criteria:

* Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
* Weight: 45 kg to 95 kg

Exclusion Criteria:

* Daily consumption of any medication.
* Consumption of any medication less than 12 hours prior to the study day.
* Headache on the study day or 48 hours prior to the study day.
* Amnestic or clinical signs of hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg).
* Any severe cardiovascular disease, including cerebrovascular illness.
* Amnestic or clinical signs of current mental illness.
* Amnestic or clinical signs of current substance or drug abuse.
* Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.
Stroke Cincinnati Prehospital Stroke Severity Scale Evaluation iN prEhospital

The effectiveness of acute ischemic stroke (AIS) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (MT). Currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified interventional neuroradiologists. In the Rhone area, only one hospital has the authorization to perform mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke patients for mechanical thrombectomy to this center constitutes an important stake of the triage of suspected acute ischemic stroke patients. Some validated scores for the identification of severe strokes and large vessel occlusion, including the Cincinnati prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in order to identify patients potentially eligible for mechanical thrombectomy and address them to a stoke unit with interventional radiology center.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients calling emergency medical services for suspected acute ischemic stroke

Exclusion Criteria:

* Symptom onset (or the last time the patient was seen without deficit ) of more than 6 hours
Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height

This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age


Eligibility Criteria:
Inclusion Criteria:

* Participation in the 90-080 study

Exclusion Criteria:

* Any severe, acute or chronic disease
* Any other identifiable reason for short stature
Cystogram Before Removal of Foley Catheter After Repair of Colovesical Fistula

Colovesical fistulas are well-recognized but relatively uncommon pathology to both the general and colorectal surgeon. It is a complication arising from an underlying primary acute to chronic inflammatory process. Although colovesical fistulas are uncommon, they are associated with significant morbidity, affect quality of life, and may lead to death, usually secondary to urosepsis. Early diagnosis and management is essential.

The purpose of the study is to determine the objective use of cystographic evaluation on postoperative day two to guide early Foley catheter removal post colovesical fistula takedown. The hypothesis is that a cystogram showing no extravasation of contrast on postoperative day two will predict safe removal without increased morbidity.

This is an uncontrolled, single arm trial. Patients who meet criteria to undergo either minimally invasive or open colovesical fistula takedown with sigmoid colectomy, without evidence of the need for bladder repair will be eligible to participate. An indwelling Foley catheter is placed intraoperative and continued postoperative. All patients who consent to participate would undergo a cystogram on postoperative day two. The cystogram will be conducted by a radiologist and technician well-trained in the techniques and interpretation of the study. The colorectal surgery enhanced recovery protocol will be followed on all patients with the exception of the cystogram being conducted on post-op day two. If there is no evidence of extravasation of dye is seen on the cystogram the Foley catheter will be removed. Patients will be monitored closely following catheter removal to ensure self-diuresis.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with clinical, radiographic, or endoscopic confirmation of a colovesical fistula
* patients undergoing either minimally invasive or open colovesical fistula takedown with sigmoid colectomy, without evidence of the need for bladder repair

Exclusion Criteria:

* malignant disease
* Crohn's disease
* radiation-induced colovesical fistula
* current pregnancy
Superior Cluneal Nerve Entrapment Syndrome, Kinesiotaping and Myofascial Release Techniques

Myofascial release techniques and/or kinesiotaping may be effective in the treatment of superior cluneal nerve impingement syndrome ?


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with superior cluneal nerve entrapment syndrome

Exclusion Criteria:

* those with communication problems
* those who also described pain in the mid-lumbar region