cyrilzakka/clinical-trials huggingface dataset:
Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia

Chronic pain is an undesirable condition that impacts predominantly quality of life at all levels. Chronic pain might occur in healthy young patients when acute postoperative pain is undertreated and persists in time. There are some indexes in the market to evaluate pain, but they assess mainly parasympathetic activity. Hence, it´s a measure of the physiological response to pain, which is still a not well-defined concept. Patients under General Anesthesia might be experimenting unnoticed pain as there is no direct standard method to measure it in clinical practice. This study aims to detect brain oscillatory activity in the intraoperative setting in four situations; awake-no pain, awake-pain, sleep-no pain, and sleep-pain. Pain can be assessed by studying the local and global dynamics of brain activity. A promising upcoming measure of pain could be implemented in clinical practice to detect and treat pain.

This is a pilot study of the presence of neural oscillations during acute pain while awake and in the anesthetized patient with neurophysiological monitoring during a neurosurgery surgical intervention analyzed by electroencephalography.

After the patient's consent, the electroencephalogram is placed in the awake patient and a small painful stimulus is performed based on the channeling of a second venous access. In turn, a recording of the EEG waves is made in order to identify similar neuronal waves during the surgical procedure once the patient is under general anesthesia.

The reason for this intervention is to have a baseline record of each patient without interfering with the oscillations of the different drugs used during total intravenous anesthesia used in these procedures. Normally, after general anesthesia, between 3 and 6 electrodes would be placed on the scalp and 10 electrodes would be placed to carry out this work.

After the intervention, a telephone survey will be carried out on postoperative pain at 3 months and a year.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients that undergo schedule neurosurgery with neurophysiological monitorisation.
* American Society of Anaesthesiologist physical status (ASA) I-IV.

Exclusion Criteria:

* Pregnancy
* Obstructive hydrocephaly with or with a derivative catheter.
* Patients with neurostimulator
* Emergency surgery.
Accuracy of Full Arch Intraoral Scanning

Although an intraoral scanner IOS can offer the clinician a completely digital workflow, achieving trustworthy digital scans in edentulous jaws is challenging because of the lack of fixed anatomical landmarks. From this perspective, several methods have been proposed to improve the accuracy of digital scanning, however, related results remain inconclusive, and previously proposed devices have had limitations, such as bulkiness, excessive manufacturing requirements, and poor commercial applicability.

Thus, this study aims to clinically compare the effect of conventional versus photogrammetry intraoral scanning methods on the passive fit of mandibular all-on four screw-retained frameworks.

The current study will be designed to be a crossover, double-blinded randomized clinical trial. Eighteen edentulous patients will be selected to share in the study to be rehabilitated by screw-retained prostheses following the all-on-4 protocol. After guided implant surgery, patients will be immediately restored by screw-retained acrylic provisionals following the traditional denture conversion technique. The definitive prosthesis will be fabricated after osseointegration starting with the intraoral scanning procedure; each patient will be subjected to three different scanning methods that can enhance the existing IOS workflow; for group I, the Medit i600 will be used to obtain direct intraoral scans while the scan bodies are combined with extra photogrammetry system scanning assistance, for group II, Medit i600 direct intraoral scans will be obtained while applying basic simple splinting along with incorporating a unique tip in the scanning protocol and scanner software, for group III, Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting. The STL file obtained from the different scans will be sent directly to the dental laboratory and three CAD/Milled frameworks will be realized based on the acquired scans. The jigs' passivity will be tested in the patient's mouth by the single screw test followed by the screw resistance test and the screw resistance test parameter will be calculated. The results will be collected for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant prosthesis.
* Patients having a substantial bone height and width at prospective implant sites to install four standard-size implants following the all-on-4 protocol.
* Patients having Sufficient crown height space.

Exclusion Criteria:

* Patients with bad oral hygiene.
* Patients with limited mouth opening.
* Vulnerable groups.
* Uncooperative patients.
* Patients receiving or undergoing radiotherapy or chemotherapy. Patients with systemic diseases affecting bone metabolism. Smokers.
HKT-500 in Adult Patients With Shoulder Pain

The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain

Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or greater who have acute shoulder pain requiring analgesic treatment daily for at least 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The subject has unilateral acute shoulder pain.

Exclusion Criteria:

* The subject is a women of childbearing potential who has a positive urine pregnancy test, or who is lactating, or who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.
Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Japanese men and women aged 20 years or older,
* Patients diagnosed as having Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle),
* Patients with Intraocular pressure (IOP) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization.

Exclusion Criteria:

* Patients with angle-closure due to conditions other than Neovascular glaucoma
* Patients with a known or suspected ocular or peri-ocular infection,
* Patients with severe intraocular inflammation in the study eye,
* Women who are pregnant, suspected of being pregnant or lactating,
* Patients with known allergy to aflibercept.
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer

The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC.

During the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. The right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. In addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. The celiac branch of the posterior vagal trunk is sometimes preserved. All regional nodes except the suprapyloric nodes (No. 5) should be dissected as in the standard D2 procedure. However, there are technical challenges associated with completing all of these procedures.The five-year survival rate after PPG with modified D2 lymph node dissection ranges from 95% to 98%. This rate is comparable to the five-year survival rate after gastric resection for EGC, which ranges from 90% to 98%. In terms of oncologic safety, PPG seems reasonably safe for EGC when the accuracy of preoperative diagnosis can be assured

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 and younger than 75 years
* Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
* cT1-2N0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition
* Expected curative resection via distal subtotal gastrectomy with D2 lymphadenectomy
* Written informed consent

Exclusion Criteria:

* Pregnant or breast-feeding women
* Severe mental disorder
* Previous upper abdominal surgery (except laparoscopic cholecystectomy)
* Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
* Other malignant disease within the past 5 years
* Previous neoadjuvant chemotherapy or radiotherapy
* Unstable angina, myocardial infarction, or cerebrovascular accident within the past 6 months
* Continuous systematic administration of corticosteroids within 1 month before the study
* Requirement of simultaneous surgery for other diseases
* Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer
Effect of Oral Enteral Nutrition in Pierre Robin Syndrome

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Pierre Robin Syndrome (PRS) can cause dysphagia. In China, persistent nasogastric tube feeding (PNG) is the mainstream choice as nutrition support in the dysphagic infants with PRS. However, PNG is associated with various complications, necessitating the exploration for a safer and more effective nutritional support approach. Therefore, this study aims to observe the clinical effect of intermittent oro-esophageal tube feeding (IOE) compared to PNG in the dysphagic infants with PRS who received systemic therapy.

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with IOE, n=25) and the PNG group (with PNG, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria for Pierre Robin sequence based on CT and X-ray examinations, combined with clinical manifestations and physical signs.
* with spontaneous vaginal birth, aged 1 to 12 months.
* with dysphagia screened by the water drinking test and further confirmed by the assessment of Dysphagia Disorders Survey (DDS), Dysphagia Severity Scale (DSS), or Schedule for Oral Motor Assessment (SOMA)
* before the treatment, the tube feeding was required and feasible after evaluation.
* stable vital signs.
* with nasogastric tubes placed before the treatment.
* sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device).

Exclusion Criteria:

* abnormalities in brain development or other neurological lesions.
* dysphagia caused by other diseases.
* other congenital malformations, such as Down syndrome, cleft lip, and palate, etc.
* severe systemic disease (such as severe infection, severe hepatic and renal dysfunction).
* participants who need to receive other therapy which would potentially affect the result of this study.
Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes

Obesity, with a prevalence of over 35% in American adults, is considered the most critical threat to the health and well-being of Americans. Obesity-associated metabolic abnormalities, including hyperglycemia, insulin resistance, and dyslipidemia, contribute substantially to elevated risk of cardiovascular disease (CVD) and diabetes. Although significant and sustained lifestyle modifications in diet and exercise are effective in reducing weight and improving obesity-related metabolic disturbances, long-term compliance to drastic changes in diet and daily activity patterns is often difficult to attain given the hectic lifestyle of modern societies. Health-promoting nutraceuticals - naturally occurring bioactive compounds capable of eliciting targeted molecular responses at the cellular level - may be an effective and convenient strategy to assist in weight reduction and reduce disease risk factors in obese individuals. Furthermore, nutraceutical compounds could prove to be a powerful adjunct to lifestyle and pharmacological weight reduction therapies, as they are relatively safe, cost effective, and possess the ability to modulate specific, and sometimes multiple, molecular targets. As a dietary supplement, alpha-lipoic acid appears to have broad molecular specificity with an impressive array of metabolic health benefits that include weight loss, reduction in blood lipids, and improved glycemic control. As the effects of alpha-lipoic acid supplementation for dyslipidemia, hyperglycemia, and body composition through appetite suppression and increased energy expenditure have been repeatedly confirmed in multiple animal models, it is surprising that there has been limited effort to translate these responses to human subjects. Given the strong pre-clinical data supporting the health benefits of alpha-lipoic acid, there is a clear need to conduct controlled interventions to address the current clinical knowledge gap and assess if the anti-diabetic effect of α-lipoic acid can be translated to humans.

The primary objective of this application is to determine the efficacy of alpha-lipoic acid supplementation on glycemic control and body composition in obese pre-diabetic adults. The investigators hypothesize that alpha-lipoic acid supplementation will improve biomarkers of diabetes and cardiovascular risk and promote changes in body composition in obese adults.


Eligibility Criteria:
Inclusion Criteria:

* sedentary individuals (exercises \< 2 days/week)
* fasting blood glucose between 100-125 mg/dl (pre-diabetes)
* BMI of 25-40.

Exclusion Criteria:

* physically active lifestyle (exercise \> two days/week)
* pregnancy
* history of cigarette smoking
* medication and/or dietary supplement to control blood glucose, lipids, or blood pressure.
Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany

Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years as of study index date; the study index date is date of initiation of treatment with dapagliflozin
* Patient received/receiving treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure (HF) and at timepoint of dapagliflozin initiation with:

  * preserved ejection fraction (HFpEF; EF≥50%) OR mildly reduced ejection fraction (HFmrEF; EF 41-49%)
  * OR reduced ejection fraction (HFrEF EF ≤40%)
* Patient is enrolled within 14 to 90 days following initiation of dapagliflozin
* Signed and dated informed consent prior to enrolment in the study

Exclusion Criteria:

* Patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin
* Prior treatment with dapagliflozin or other SGLT2i treatment
* Initiation of dapagliflozin outside of the local HF label
* Diagnosis of Type 1 diabetes prior to enrolment
* Current or planned participation in a clinical trial using an investigational medical product for treating HF
* Patient is involved in the planning and/or conduction of the study
* Hypersensitivity to dapagliflozin or to any of the excipients listed in the SmPC
Creative Practice as Mutual Recovery

This study explores the hypothesis that mental health service users, their carers and musicians can - through the creative act of music learning and performing - mutually enhance wellbeing through the development of more meaningful and resilient lives. The project seeks to explore three interconnected issues: (i) the extent to which music learning and performing provides a forum for 'mutual recovery' among adult mental health service users, their formal/informal carers, and musicians, (ii) the characteristic features of 'mutual recovery' through music, and (iii) the underlying mechanisms of such 'mutual recovery'.

The study will consist of three different stages. Stages 1 and 2 will examine the effect of a variety of group activities - including participatory music, listening to live music, listening to recorded music and a non-music control - on psychological scales, saliva samples of stress hormones and cytokines, and subjective experience to see which provide the most relaxing, sociable and supportive environments for mutual recovery. Stage 3 will explore the impact of musical interventions over longer periods of time.

A systematic review we have just carried out has revealed a major gap in research comparing different music interventions and testing the effects of different lengths of interventions. As a result, our study should help us answer the following questions:

* Which aspect(s) of music can contribute to mutual recovery?
* Do carers, patients and musicians all respond to the same activities, or do some musical activities suit certain groups more than others?
* Do carers, patients and musicians all recover at the same rate?
* What length of intervention is most effective?

If certain interventions are found to produce stronger results than others, these results could help guide community groups and healthcare settings in their design of music activities and have implications for the spending of arts-in-health budgets.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of either gender and over the age of 18 who are experiencing mild or moderate mental health issues including but not limited to: stress, anxiety, depression etc.
* Individuals of either gender and over the age of 18 who formally or informally care for mental health service users.
* Musicians who are professional workshop leaders and music students training to be professional musicians.

Exclusion Criteria:

* Serious mental health problems which might

  1. prevent an individual from giving informed consent
  2. cause the individual to be a disruption to other participants
* Individuals for whom the music activity might conflict with other routine care.
* Individuals with gum disease which would invalidate saliva samples.
* Total deafness or severely impaired hearing.
* Musicians or music students who apply to participate in the project but who are not deemed to have sufficient experience or expertise.
A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age

This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children.

This purpose of this study will be to assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children. This study is an open-label (all patients will know the identity of the drug) single-dose, pharmacokinetic study in infants and children =3 months to \<18 years of age who are medically stable as judged by the clinical investigator and require therapy with antibiotics. Patients will be given a 2-hour i.v. infusion (given directly into the vein) of 7, 10, or 15 mg/kg ceftobiprole. The study population will be grouped according to the following 4 age groups: =12 to \<18 years of age; =6 to \<12 years of age; =2 to \<6 years of age; and =3 months to \<2 years of age. Every attempt will be made to include patients of both sexes in each age group. Safety evaluations will include clinical laboratory tests (hematology, serum chemistry, and urinalysis), pregnancy testing, vital signs, physical examination, monitoring of adverse events, and recording of concomitant medications. Patients will be given a single 2-hour i.v. (given directly into the vein) infusion of ceftobiprole. The total duration of the study is approximately 18 days, including screening and posttreatment.

Eligibility Criteria:
Inclusion Criteria:

* Infants (=3 months to \<2 years of age) must have been born at =36 weeks of gestation
* Documented or presumed, or be at risk for, bacterial infection(s) and receiving systemic antibiotic therapy
* Stable medical condition

Exclusion Criteria:

* History of drug allergy or hypersensitivity to ß-lactam antibiotics such as penicillins, cephalosporins, or carbapenems
* History of clinically significant cardiac arrhythmia, cystic fibrosis, chronic lung disease associated with abnormal pulmonary function, acute or chronic arthritis
* History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)