cyrilzakka/clinical-trials huggingface dataset:
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

Anticholinergic drugs have traditionally been used for their antisialagogue properties. But use of anticholinergic drugs can interfere with thermoregulation via inhibition of the parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat elimination, and children's thermoregulation depend more on sweating than adults and they can become hyperthermic when given these agents.

The investigators evaluated the fever-causing effects of adjunctive anticholinergics in children under general anesthesia using ketamine.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status classification I
* underwent surgery between 8 to 9 am
* undergoing ambulatory anesthesia with ketamine

Exclusion Criteria:

* who required endotracheal intubation
* who were administered with medications other than ketamine
Pyrotinib Plus Trastuzumab and Chemotherapy in HER2+ Metastatic Breast Cancer Patients

To evaluate the patterns and treatment outcomes of pyrotinib plus trastuzumab and chemotherapy in the real world.


Eligibility Criteria:
Inclusion Criteria:

* woman, age \> 18 years old
* diagnosed with HER2 +Metastatic Breast Cancer
* received pyrotinib plus trastuzumab and chemotherapy for at least one cycle, starting from 2018.07-2022.09
* available medical history

Exclusion Criteria:

* medical history was incomplete
Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children

Otoacoustic emissions (OAEs) are non-invasive, easy to apply and objective test methods which are widely used to determine the presence of hearing in audiology clinics. Under some circumstances and children, the study should be applied under general anaesthesia. The aim of this study was to find out the influence of propofol (P) and ketamine (K) on OAE measurements. .

Methods: Thirty- healthy children who will underwent adenoidectomy and tonsillectomy will be included in this study after Institutional ethics committee approval and informed consent of parents. Children will be evaluated one day before surgery by tympanometry. Psychologically prepared children will be admitted to the operating room. Following EMLA (Eutectic Mixture of Local Anesthetics ) cream application IV line will be inserted. ECG and non-invasive blood pressure will be monitored. Transient evoked otoacoustic emissions (TEOAEs) and distortion product otoacoustic emissions (DPOAEs) will measured in both ears of each patient (n=20 ears) prior to P or K administration( Pre-P and Pre-K). Propofol will be given 2mg/kg or ketamine 2mg/kg intravenously and 40% O2 in air will be given by mask ventilation. Five minutes later TEOAE and DPOAE measurements will be repeated (Post-P and Post-K). After this measurement the routine general anaesthesia and surgical protocol will be commenced. Heart rate, blood pressures TEOAE and DPOAE measurements will be compared at pre and post stages by paired Student's t- test.


Eligibility Criteria:
Inclusion Criteria:

children ages 4-15 years ASA ( American Society of Anesthesiologists) I-II Tonsillectomy and/or adenoidectomy Normal ear hearing tests

Exclusion Criteria:

Abnormal hearing tests Abnormal laboratory (Electrolyte imbalance, anemia, polycythemia, thrombocytopenia, leucopenia , leucocytosis) Congenital abnormalities and previous systemic diseases Hypo or hyperthermia Ear operations Long term fasting, dehydration or over hydration Upper respiratory disease, acute or chronic otitis,
A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

Radiography of breast specimens is currently the only radiological procedure used to verify removal of microcalcifications and presence of tumor-free margins after breast surgical resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not detected by radiography in resected breast tumor specimens and/or its ability to verify tumor-free margins in breast cancer detected by MRI only.


Eligibility Criteria:
Inclusion Criteria:

* Women with malignant breast disease identified by microcalcifications without clinically evident disease
* Women candidate to breast preserving surgery

Exclusion Criteria:

* Cardiac pacemaker, defibrillators, cardiac monitors
* Brain stimulators, implantable spinal stimulators
* Vascular and aneurismal clips
* Hemostatic clips
* Infusion pumps
* Glaucoma drainage implants
* Metallic foreign body positioned in vital organ of the patients
* Some heart valves
* Some vascular access ports, infusion pumps and catheters
* Permanent contraceptive tubal device
* Kidney disease
Repetitive Transcranial Magnetic Stimulation in Postpartum Depression

Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of postpartum depression.

However, up to current days there have been no studies evaluating the effects of rTMS on neurocognitive and social performance of women suffering from the disorder.

The present study evaluates the impacts of rTMS in clinical, cognitive and social performance.

Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.

The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. Each session lasts up to 30 minutes.

Side effects include scalp discomfort and mild headache. No anesthesia is required.

Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results.

The present technique has never been employed in previous studies, but risks are insignificant.

Eligibility Criteria:
Inclusion Criteria:

* major depression with a puerperal onset, according to the criteria of the DSM-IV-R (APA, 2000), as well as through a structured clinical interview (SCID-1/P v 2.0)
* baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items
* baseline score of at least 13 points on the Edinburgh Postnatal Depression Scale.
* range = 18-36 years
* women who had given birth 1-6 months
* any pharmacological treatment other than clonazepam (1 mg/day)

Exclusion Criteria:

* comprised ferromagnetic metallic implants
* pacemakers
* previous neurosurgery
* history of seizures
* major head trauma
* alcoholism
* drug addiction
* any psychiatric or neurological disorder other than depression and anxiety
* psychotic depression
* suicidal propensities
CSTC1 for Diabetic Foot Ulcers Phase II Study

The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.

This study was designed as a randomized, double-blind, vehicle-controlled, multiple-center, and parallel trial to evaluate the efficacy and safety of CSTC1 in patients with diabetic foot ulcers (DFU). In each study site, eligible patients were randomized in a 4:1 ratio to receive either one of the topical applications of CSTC1 or CSTC1 matched vehicle, topical application on target diabetic foot ulcer (DFU), 2 times daily.

The treatment duration for each subject was 12 weeks or up to confirmed complete ulcer closure, whichever comes first. That was, subjects would receive treatment for at most 12 weeks, which consists of 8 visits located at weeks 1, 2, 3, 4, 6, 8, 10, and 12. Subjects who achieved confirmed complete ulcer closure during the treatment period would be arranged for a 12 week post-treatment follow-up. Subjects failed to achieve complete ulcer closure at week-12 visit would be arranged for 4 weeks of safety follow-up. If confirmation of complete ulcer closure was reached at a week-14 visit, the subject would continue the post-treatment follow-up visit until week-24 visit. Otherwise, the subject would be arranged for safety follow-up until week-16 visit.

Eligibility Criteria:
Inclusion Criteria:

* With either gender aged at least 20 years old;
* With a diabetic ulcer (which is defined as the target ulcer) on the foot and not healing for at least 2 weeks;
* The target ulcer is classified as grade 1 or 2 ulcer according to modified Wagner system;
* The target ulcer should show "infection control" at investigator's discretion;
* Subject should be free of any necrosis or infection in soft and bone tissue;
* Subject has signed the written informed consent form

Exclusion Criteria:

* With active osteomyelitis;
* With target ulcer size decreased by at least 50% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before Randomization visit;
* With poor nutritional status (albumin \< 3g/dl), poor diabetic control (HbA1c \> 12%), anemia (hemoglobin\<10 g/dL), a leukocyte counts \< 1,000/mm3, abnormal liver function (AST, ALT\>3 x upper limit of normal range);
* Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents;
* Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
* Receiving revascularization surgery performed \<8 weeks before entry in the study;
* With known or suspected hypersensitivity to any ingredients of study product and vehicle;
* With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study;
* Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period;
* Enrollment in any investigational drug trial within 4 weeks before entering this study;
* With any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject.
Oral Abuse Potential Study of Nalbuphine

The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated.

This study has 2 parts: Part A and Part B.

This study will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 2-part, 7-way crossover study to determine the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution and placebo, in non-dependent, recreational opioid users. The study will be conducted in a single clinical research unit (CRU).

The purpose of Part A is to find the appropriate doses (a low, intermediate, and high dose) of nalbuphine solution to use in Part B. Part A of the study has two visits to the research clinic: a screening visit and dose selection visit. The visits will involve a 2-night stay (3 days total) in the research clinic.

In the Main Study Treatment Phase in Part B, the total estimated duration between each dose of study drug is approximately up to 7 days, of which the subject will spend 3 days/2 nights in the research clinic and approximately up to 4 days at home.

The primary objective of the Main Study is to evaluate the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution (the active comparator) and placebo in non-dependent, recreational opioid users.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects 18 to 55 years of age
* Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion Criteria:

* Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
* Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
* History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
* History or presence of any clinically significant illness
* History of major mental illness that may affect the ability of the subject to participate in the study.
Videoendoscopic Drainage of Infected Pancreatic Collections

The VARD (Videoendoscopic Assisted Retroperitoneal Drainage) approach as treatment for necrotizing pancreatitis proposes an alternative to standard complicated open abdomen treatment methods.

This treatment involves making a small incision and looking inside the abdomen with a videoendoscope. A videoendoscope is an instrument with a small camera and light on the end. It also has an extension tool that the surgeon can use to clean out any dead and infected tissue in the abdomen.

This approach may reveal a treatment opportunity with faster recovery potential and shorter hospitalizations for patients with necrotizing pancreatitis.


Eligibility Criteria:
* Pancreatic necrosis or peripancreatic fluid collection following acute pancreatitis noted on CT scan
* Infected pancreatic necrosis or pancreatic abscess and determined by + FNA (gram stain or culture), as defined by the Atlanta Symposium
* Not neutropenic or pregnant
* No prior necrosectomy
* No pancreatic pseudocyst, either sterile or infected
Rollover Study Of Lapatinib In Cancer Patients

The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.


Eligibility Criteria:
Inclusion Criteria:

* Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen.
* Ability to understand and provide written informed consent to participate in this trial.
* Is male or female.
* Female and male subjects agree to the protocol specific birth control measures

Exclusion Criteria:

* Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
* Is a pregnant or lactating female.
* Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
* Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2).
* Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
* Has a left ventricular ejection fraction (LVEF) \< 40% based on MUGA or ECHO.
Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-75 years (both inclusive) at the time of signing inform consent
* Body mass index (BMI) 20.0-29.9 kg/m\^2 (both inclusive)
* A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
* History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
* Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
Overactive Bladder Telemedicine Non-inferiority Trial

In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB).

This is a single-center, prospective randomized controlled trial. The study population will consist of two primary cohorts stratified based on the method of follow-up, either traditional in-person clinic visit or telemedicine appointment. The primary outcome will be satisfaction with OAB treatment. Secondary endpoints include rate of progression to third line therapies, changes in OAB symptom scores, safety, and cost. This non-inferiority trial is designed to provide an alternative option for care delivery that may result in improved patient satisfaction and compliance, and decreased cost, time, and travel burden for patients.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic overactive bladder diagnosis, both OAB wet and OAB dry

Exclusion Criteria:

* Active Urinary Tract Infection (UTI)
* Stage 3 or 4 prolapse
* Underlying neurologic condition contributing to OAB
* Use of catheter
Infrared Thermography to Evaluate the Effect of Paravertebral Block

The aim of this prospective observational study was to evaluate the changes of skin temperature after the paravertebral block measured by infrared thermography.

Methods: Patients scheduled for elective surgery with paravertebral block will receive infrared thermography measures 5 min before the block and continous to 20 min after the block. The sensitivity, specificity of infrared thermography as diagnostic methods will be determined by receiver operator characteristic analysis.

Eligibility Criteria:
Inclusion Criteria:

* With informed consent
* American Society of Anesthesiologists physical status Ⅰ-Ⅱ
* Undergo elective surgery with planned paravertebral block

Exclusion Criteria:

* Refusal to participate in the study
* pre-existing infection at the block site
* younger than 18-yr-old
* BMI\>35
* significant thoracic kyphoscoliosis
* Those who had taken vasodilatory drugs before surgery
* history of previous thoracic or breast surgery
* Preoperative analgesic medications
* Any contraindications to peripheral nerve block such as coagulation abnormalities, allergy to local anaesthetics, peripheral neuropathy.
TECPR2 Observational Study

The purpose of this study is to learn more about the disease progression in patients with a TECPR2 mutation.

A mutation in the tectonin beta-propeller repeat containing 2 (TECPR2) gene can disrupt the cellular process of autophagy resulting in neuronal cell death. This disruption leads to a form of spastic paraplegia with the additional disruption to involuntary body processes, such as respiration and thermoregulation. This study will provide valuable information about the natural progression of children with a TECPR2 mutation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (and assent where appropriate) before any study procedures take place;
* Male or female;
* 18 months to 12 years old, at enrollment; and
* Have a diagnosis of TECPR2-Related disorder, as defined by biochemical criteria AND/OR genetic mutation analysis, AND demonstrate clinical findings such as autophagy, developmental delay, hypotonia, or other positive findings.

Exclusion Criteria:

* Subject is unable to comply with study requirements; or
* Have any other concurrent condition that, in the opinion of the investigator, would make the subject unsuitable for the study.
The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest

To this date no clinical evaluation reports of the dynamics in the National Early Warning Score (NEWS) for those patients who suffer an in-hospital cardiac arrest, IHCA, exists. This process needs to be investigated in order to optimize the future care of these patients.

Research Questions H1: Patients that suffer an IHCA has had higher NEWS in the preceding 24 hours from the event compared to those who did not suffer an IHCA.

H2: The dynamics in the NEWS, differs between the patients that suffer an IHCA and those who do not in the preceding 24 hours from the event.

Power:

A sample size of 300 patients in the control group and 150 patients in the group that suffered from an IHCA would generate a power estimate of 80 percent if the difference in the median is one point on the NEWS with a standard deviate of three points.

Analysis of the Research Data:

Categorical and nonparametric data will be presented in median (25-75 percentiles).

A hypothesis testing will be performed where the documented NEWS will be categorized into low-, medium- and high-risk and divided into different timespans. The timespans will be 0-6 h, 6-12 h, 12-18 and 18-24 h preceding the IHCA. In case of multiple NEWS measurements within each timespan, the worst NEWS measurement will be chosen. Each timespan during the 24 hours will not be treated as repeated measures and will be tested by the Chi square test. This test is chosen because the data is categorical. Another hypothesis test where all the NEWS measurements will be included and each documented NEWS on the same patient will be treated as repeated measures. A binary logistic regression analysis will be performed using Generalized Estimating Equations (GEE) and modelled to fit.

In order to select the covariates that is to be included in the regression analysis a non-parametric test including all the parameters in the NEWS will be executed. The level of significance for this test will be set to p=0.2 2. Collinearity within the NEWS parameters that is to be included in the regression analysis will be tested. The level of collinearity that is accepted will be \<+0,6 and \>-0,6. A binomial logistic regression analysis will be executed with the selected parameters in the NEWS The outcome of the regression analysis will be presented as odds ratio (OR).

Eligibility Criteria:
Inclusion Criteria:

All patients ≥18 years of age admitted to the hospitals during a period of 12 months will be reviewed for eligibility

Exclusion Criteria:

-
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.

This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of hypoglycemia in persons with T1D.

This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.

The study will also generate data on the participants' assessment of local tolerability and provide information on immunogenicity of nasal glucagon with regards to the potential development of anti-glucagon antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
* With a history of type 1 diabetes \>1 year
* At least 18 years of age but not older than 75 years
* Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
* PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
* For female subjects, a urine pregnancy test must be negative.

Exclusion Criteria:

* Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
* Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.