cyrilzakka/clinical-trials huggingface dataset:
Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry

The purpose of this study is to determine whether heart rate variability levels and pupillometric measures are effective objective predictors of anxiety among patients before surgery.

The prevalence of preoperative anxiety in adults is estimated between 60 and 80% and prevents a good integration of the information delivered, while seeking more attention from caregivers. In addition, anxious patients require the administration of higher doses of hypnotics at anesthetic induction. The pain expressed in the postoperative period is proportional to preoperative anxiety, with a slower recovery kinetics responsible for prolonged stay in the recovery room. Finally, the incidence of chronic pain is correlated with the intensity of preoperative anxiety.

While the recommendations of the European Anesthesia Society (ESA) emphasize the importance of managing preoperative anxiety, this dimension is often overlooked and existing methods of assessment are time consuming and sometime inaccurate.

Objective screening with dynamic monitoring of the level of anxiety in real time is the necessary step to ensure accurate detection and personalized management of the emotional state of patients before performing an invasive procedure.

Anxiety is an emotional state reflecting an imbalance of cortico-frontal regulation on the limbic system. The interaction between these two neuronal systems is expressed in particular by the intensity of the vagal tone and the autonomic nervous system. Exploring the balance between sympathetic and parasympathetic systems is a promising avenue of exploration for identifying, predicting, and treating anxiety.

Two reliable and easy-to-use devices analyzing the expression of the autonomic nervous system validated in the analysis of nociception in the awake patient or under general anesthesia are marketed:

A. Analgesia Nociception Index (ANI) (MDoloris Medical Systems) analyzing oscillatory changes in heart rate as a function of respiratory time, namely the heart rate variability (HRV) B. Algiscan (IDMed) analyzing pupil responsiveness to nociception

The use of these devices in conscious pre-operative patients could allow a reliable and objective detection of anxiety while following its kinetic evolution over time. The purpose of this project is to evaluate the validity of these two devices in the context of preoperative anxiety. After receiving clear information and giving their written agreement, patients will be included in the study by the anesthetist physician. During the anesthesia consultation, the included patients will be subjected to a Surgical Fear Questionnaire (SFQ) questionnaire of level of anxiety.

A secondary study will consist of connecting a lighting device connected to the heart rate variability to emit a relaxing light in the preoperative waiting room.

Eligibility Criteria:
Inclusion Criteria:

-Day case surgical patients

Exclusion Criteria:

* \<18yo
* psychiatric disorders
* participating refusal
Online Interventions for Gamblers With and Without Co-occurring Problem Drinking

Many problem gamblers are also problem drinkers,with lifetime prevalence in nationally representative samples ranging from 45% to 73%. Heavy drinking often occurs while problem gamblers are engaging in gambling activities, resulting in increased risky gambling behaviour. Further, co-occurring problem drinking negatively impacts on the treatment outcomes of problem gamblers. Thus, targeting problem drinking among problem gamblers may have the dual benefits of reducing both the problem drinking itself, and of acting as a mediator for reductions in problem gambling behaviour. The present study seeks to determine whether providing simultaneous access to help for gambling and drinking is of benefit for those with these co-occurring problems.

Problem gambling and problem drinking frequently co-occur. Further, the treatment needs of people with co-occurring gambling and drinking problems may be different from those of problem gamblers who do not drink alcohol in a hazardous fashion. The current project will evaluate whether there is a benefit to providing access to a problem drinking Internet intervention (G+A intervention) in addition to an Internet intervention for problem gambling (G-only intervention) in participants with gambling problems who do or do not have co-occurring problem drinking.

People with gambling concerns will be recruited using targeted advertisements. Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of alcohol consumption will be assessed. Eligible participants who agree to take part in the study will be randomized into one of two online interventions for gamblers - an intervention that only targets gambling issues (G-only) versus one that contains an intervention for drinking (G+A). It is predicted that for problem gamblers with co-occurring problem drinking, participants provided access to the G+A website will display significantly reduced gambling outcomes at three- and six-month follow-ups as compared to those provided access to the G-only website. However, for problem gamblers without co-occurring problem drinking, it is predicted that participants will display no significant difference between the G-only and G+A websites at three- and six-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* Score of 3 or greater on the Problem Gambling Severity Index of the Canadian Problem Gambling Index (PGSI- CPGI)

Exclusion Criteria:

* None
Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis

The objectives of this study are four-fold:

1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient.
2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar III Prosthesis under in vivo, weight-bearing conditions during multiple activities (gait, stair descent, deep knee bend and chair rise).
3. To determine if there is a correlation between in vivo kinematic data obtained using fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine if variability occurs between these two TKA types.
4. To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be at least three months post-operative.
2. Potential subjects will have a body weight of less than 250 lbs.
3. Candidates must have had a HSS score \>90 post-operatively.
4. Patients must have passive flexion of at least 100.
5. All potential subjects will have a Press Fit Condylar (PFC) Rotating Platform Total Condylar III Prosthesis (Depuy Orthopaedics, Warsaw, IN) or fixed-bearing Total Condylar III Prosthesis.
6. Must be willing to sign both Informed Consent and HIPAA forms.

Exclusion Criteria:

1. Pregnant females.
2. Patients that do not meet study requirements.
Clinical Evaluation of No Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery

The purpose of the study is to evaluate two different ways to administer the numbing solution. One is with a conventional needle and syringe the other method iontophoresis is a machine that supplies a weak current through electrodes that touch your teeth. Both methods use an anesthesia solution to make your teeth numb but the iontophoresis system contains no needle and the delivery device does not penetrate the gum.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age at the time of consent

Subject is able to provide their own informed consent

Subject has a minimum 24 teeth/subject and 6 teeth per quadrant

Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents

Subject must be able to speak and understand English

Subject is able and willing to return for all scheduled study visits

Subject to able to make dental appointments

Subject should not be a pregnant female

Subject meets the Level-I or Level-II classification criteria of the American

Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care

Exclusion Criteria:

* Subject has any of the following:

  * rampant caries
  * chronic periodontitis
  * salivary gland dysfunction

Subject is unable, for any reason, to tolerate the procedure time required to place the restorations

Subject has unacceptable oral hygiene (e.g., chronic moderate to heavy plaque accumulation along the gumline)

Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study

Subject is using a whitening agent at any time during this study.

Subject has history of allergic reaction to anesthetic medications

Subject with uncontrolled systemic disease or conditions

Subject is having acute or chronic myofascial pain or neuropathic conditions

Subject taking long-term analgesics for their systemic conditions

Subject presenting with acute dental pain

Subject requiring IV sedation or nitrous oxide sedation or oral sedation for anxiety
Appropriate Gestational Weight Gain in Overweight/Obese Women

The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Pregravid BMI 25 to \<40 (as determined from a measured pregravid weight in electronic medical record)

Exclusion Criteria:

* Diabetes
* Cardiovascular disease
* Gastrointestinal disease
* Bariatric surgery
* Lung disease
* Thyroid disease
* Eating disorder
* Cancer
* Bed rest or Gestational Diabetes in the current pregnancy
* Planning to get pregnant again or move within 1 year of delivery
* Substance abuse
* Serious mental health disorders
Evaluation of Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects Diabetic Patients.

Mellitus type 2 diabetes (T2MD) is a chronic disease characterized by high glucose plasmatic level due to an alteration of insulin function. Several authors have correlated this altered function to an inositol depletion. The main present member of inositol family in biological systems is undoubtedly myo-inositol, a precursor of several second messengers, widely involved in insulin signalling. For this reason this molecule is considered an insulin-sensitizer. The high excretion of inositol in T2MD patients is frequent, inducing a myo-inositol depleted state that favours the onset of insulin resistance, impairing the activity of this hormone. The aim of this study is to evaluate the efficacy and the safety of a food supplement containing myo-inositol in T2MD patients.


Eligibility Criteria:
Inclusion Criteria:

* With diagnosis of Type 2 Mellitus Diabetes for at least 1 year
* Levels of Hb1Ac ranging from 7.5% to 9.0%

Exclusion Criteria:

* Patients that require insulin treatment
* Treated at baseline with food supplements or drugs containing Myo-inositol, D-chiro-inositol, alphalactalbumin, zinc, or Gymnema Sylvestre;
* Any contraindications to the treatment or to any substance used for the treatment
* Subjects with intestinal malabsorption
* Patients subjected to surgery within 6 months before baseline;
* Chronic treatment with systemic corticosteroids
Visual and Auditory Breathing-swallowing Coordinated Training

Dysphagia is caused by multiple factors, and respiratory-swallowing discoordination is considered to be one of the factors. The investigators recently developed a visual and auditory breathing-swallowing coordinated training device. In this study, investigators examined the validity of a this device for healthy subjects. The investigators will examine which respiratory phase the swallowing occurs when the swallowing is started in accordance with the signal lighting and voice of this device.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with written informed consent to participate in the study

Exclusion Criteria:

* Subjects with an apparent swallowing disorder
* Subjects with clinically evident cerebrovascular diseases
Optimize the Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathic Pain

Neuropathic pain (NP) is one type of refractory chronic pain condition,medical treatments for NP is limited because of its poorly response.Repetitive transcranial magnetic stimulation (rTMS) can induce neuroplastic changes which has been used to manage chronic pain conditions. Indeed, high-frequency (≥ 5 Hz) rTMS over the primary motor cortex (M1) is suggested to be able to reduce neuropathic pain in randomized controlled studies. Overall, the clinical application of rTMS in chronic pain is still limited by the response rate, whereby it is close to moderate and far from being excellent at its best. Therefore this project designed a series of clinical trials to optimize the analgesic efficacy of rTMS. According to the research results of investigators previous project, patients with neuropathic pain were divided into responders and non-responders after 5 consecutive days of 10HZ rTMS or pcTBS intervention (see project ID:2021-0751)according to the change of pain intensity, and then different trials will be applied to responders and non-responders to optimize the analgesic effect of rTMS.

For non-responders (whose visuo-analogic scale (VAS) decreased less than 20 mm or T1-T0/T0×100%\<30%), a feasible method is to switch stimulation targets. So the investigator will change the stimulation target from M1 to dorsolateral prefrontal cortex (DLPFC), and then delivered another 5 days consecutive interventions to assess the efficacy.

For responders (whose VAS decreased an average of 20 mm or more or T1-T0/T0×100%≥30%), the investigator further investigate the long-lasting effect of rTMS. the patients will participate a continuous trials (2 sessions weekly for 2 weeks) and 4 weeks follow up.

Eligibility Criteria:
Inclusion Criteria:

* （1）woman or man over 18 years and under 85 years; （2）Clinical diagnosis of neuropathic pain (3) pain for at least 3 months, at least moderate intensity (≥ 4/10 assessed by VAS) ; (4) stable pharmacological treatment for pain at least 2 weeks before inclusion; (5) able to cooperate in completing questionnaire.

Exclusion Criteria:

* (1)Any clinically significant or unstable ongoing medical or psychiatric disorder including major depression; (2) History of substance abuse (alcohol, drugs); (3) Past treatment with repetitive transcranial magnetic stimulation (rTMS); (4) Contraindications to rTMS (previous severe head trauma or neurosurgical intervention, past or current epilepsy, active brain tumor, intracranial hypertension, implanted ferromagnetic devices, e.g., cardiac pacemaker, neurostimulator, or cochlear implants); (5) other type of pain more severe than neuropathic pain; (6) Any difficulty to fill out questionnaires (due to language or cognitive problems); (7) impossibility to be followed during the time course of the study;
Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).

The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
* Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
* Rosen Modified Hachinski Ischemic score \< or equal to 4 at screening.

Exclusion Criteria:

* Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
* Current major depressive disorder or other current major psychiatric disorder.
* History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
* Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.
Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)

This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.

Chronic subdural hematoma (cSDH) is a prevalent neurosurgical condition marked by the accumulation of blood in the subarachnoid space. Primarily affecting elderly individuals, cSDH is associated with significant morbidity and mortality rates. Current standard treatments for cSDH involve surgical evacuation through burr hole craniotomy or twist-drill craniotomy; however, recent research has illuminated the potential significance of the middle meningeal artery (MMA) in cSDH pathogenesis, suggesting an innovative minimally invasive treatment avenue. The investigator team is attempting to determine whether MMA embolization has demonstrated a favorable safety profile with a low incidence of treatment-related complications.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients (18 yrs. of age or older)
* Endovascular embolization of middle meningeal artery using any embolization material:

PVA particles; Onyx, nBCA glue; dimethyl sulfoxide, microcoils, PVA with microcoils

Exclusion Criteria:

* Endovascular embolization of middle meningeal artery using any other embolization material
A Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma

Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma.

Methods and design:

The study is a three-phase sequential mixed-method feasibility study. The overall framework is guided by the British Medical Research Council framework for developing Complex Intervention. The study will apply Patient and Public Involvement (PPI) to design and develop the intervention. The study will test the feasibility of the newly designed group intervention.

Participants:

Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered standard oncological treatment. Participants must be able to understand, read, and speak Danish.

Intervention:

The intervention runs over 12 weeks. Caregivers are offered weekly online meetings in a group of 12 caregivers facilitated by a HCP. Moreover, they are offered access to a website with 15 videos. 8 videos where HCPs share information knowledge relevant for the disease- and treatment trajectory. And 7 videos where other caregivers sharing their care experiences. The intervention also includes a box of reflection cards, that caregivers are given, when they are included in the intervention. The reflection cards present a question for the caregiver, followed by a quote from a caregiver and knowledge regarding the subject of the card. Caregivers are also invited into a closed online group on FaceBook, where they can write within the group.

Data collection:

Primary outcome is feasibility of the intervention. Secondary outcomes are following reported outcome date at baseline and post-intervention:

Caregivers will complete following three questionnaires: The Caregiver Role and Responsibility Scale (CRRS), to assess broad life impacts for caregiver, the Iceland-Family Perceived Support Questionnaire (ICE-FPSQ) to measures families perceived support from nurses and other healthcare professionals providing the intervention. The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression.

Patients will complete following three questionnaires: the Functional Assessment of Cancer Therapy - Brain (FACT-Br) to assess the patients' health related QOL, the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) to measure patients' symptom prevalence, intensity, and interference with the daily life. The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression.

Data will be collected electronically using RedCap. Demographic data of the participants will be completed at baseline and information on patient histology will be obtained from the patient's medical journal and stored in RedCap.

The intervention will also be evaluated qualitatively by individually semi structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered Stupps treatment regime.

Exclusion Criteria:

* Participants who do not understand, read, and speak Danish.