cyrilzakka/clinical-trials huggingface dataset:
Effects of Electroconvulsive Therapy (ECT) on Serotonin-1A Receptor Binding

In treatment-resistant depression, electroconvulsive therapy (ECT) has been shown to effectively reduce depressive symptoms, though the underlying neurobiological mechanism is still unclear. The serotonergic system, and in particular the inhibitory serotonin-1A (5-HT1A) receptor, appears to be significantly involved in the effectiveness of ECT. The aim of the study is to assess the effects of ECT on the 5-HT1A receptor binding potential (BPND) and distribution in humans in vivo using positron emission tomography (PET) and the radioligand \[carbonyl-11C\]WAY-100635.

12 patients suffering from severe, therapy-resistant unipolar depression will undergo 3 PET scans, two of these scans taking place before the ECT treatment, consisting of 6-14 ECTs, the third scan taking place after the ECT treatment.

This imaging study hypothesizes that upon completion of the ECT, the overall 5-HT1A receptor BPND in the brain of depressed patients will significantly change.

This study would be the first to demonstrate an effect of electroconvulsive therapy on the 5-HT1A receptor binding in humans in vivo. Given the involvement of the 5-HT1A receptor in the pathophysiology of mood disorders, the present study would be an important step towards a better understanding of antidepressant treatment and treatment response. By comparing treatment effect and the underlying biological mechanism, the study might help to identify biomarkers that distinguish patients who are likely to benefit from ECT from patients who will rather be non-responders. Finally, by investigating the role of the 5-HT1A receptor in ECT, is highly discussed relevance for antidepressant action will be further elucidated and might prepare the ground for new therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 - 65 years
* ICD-10 diagnosis of severe unipolar depression (ICD-10: F32.2, F32.3; F33.2, F33.3)
* A score of 23 or greater on the 17-item HAM-D
* Signed informed consent form
* Negative urine pregnancy test in women at the screening visit and at PET days
* Antidepressive and antipsychotic medication in a steady state for at least 10 days prior to inclusion
* Anesthesiological approval for ECT

Exclusion Criteria:

* Concomitant major internistic or neurological illness
* Clinically relevant abnormalities on a general physical examination and routine laboratory screening
* Current substance abuse, addiction
* Current or past history of schizophrenia or schizoaffective disorder
* Exposure to artificial radiation as volunteer in clinical studies within 10 years prior to inclusion into the present study
* Previous treatments with electroconvulsive therapy
* Treatment (\< 1 months before screening) with the following drugs: Aripiprazole, Risperidone, Ziprasidone, Clozapine, Chlorpromazine, Amitryptyline, Nefazodone, Trazodone, Buspirone, Pindolol, Penbutolol, Tertatolol, Alprenolol, Quetiapine
* Investigations using PET or SPECT within 10 years prior to the inclusion
Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses

Multiple intraocular lens are nowadays available for implantation after cataract surgery. They use different technology to try to improve patient spectacle independence. It is necessary to better characterise the performence of each type of lens, as well as to define how they are affected by residual refractive errors. The purpose of this study is to evaluate visual function in patients implanted with different lenses (advanced monofocals, trifocals) in order to be able to recommend the best type of lens for each patient.


Eligibility Criteria:
Inclusion Criteria: Bilateral cataract surgery Bilateral implantation of one of the intraocular lens models included in the study

Exclusion Criteria:

Intrasurgical complications Postsurgical complications Ophthalmological disease that limits visual potential as estimated by investigator
Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors

Although nerve-sparing surgery has been introduced for female patients with the pelvic tumors, its success rate depends on operators. To achieve consistency of surgical procedure, It is necessary to adopt pelvic autonomic nerve monitoring technique.

The Aims of this study is

1. Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system.
2. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I
3. Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)

After surgery for pelvic tumor, most of patients complain voiding dysfunction, defecation dysfunction and sexual dysfunction which lead to decrease quality of life. Recently, nerve-sparing surgery has been introduced. But it is difficult to establish standard surgical procedure for nerve-sparing. And it is the concern that performing nerve sparing surgery may reduce radicality of surgery which influence prognosis.

Through pelvic autonomic nerve monitoring system (PAMS I), this trial is expected to raise the possibility of nerve-sparing with maintaining radicality of surgery.

Pressure sensor of PAMS I and needle prove of IOM are very thin and these instruments have been used clinically. Taking this into consideration, additional risk by nerve monitoring is considered to be minimal.

Eligibility Criteria:
Inclusion Criteria:

* Female, Age ≥ 18 years
* Patients with pelvic malignant tumor who need surgery.

  * Gynecologic cancer; cervical cancer, uterine cancer, ovarian cancer
  * Colorectal cancer
  * Pelvic sarcoma and metastatic pelvic malignant tumor
* Patients who signed an approved informed consent.

Exclusion Criteria:

* Female, Age \< 18 years
* Patients with pelvic malignant tumor, but surgery is not indicated.
* Patients who refused to sign informed consent
Effects of Whole-Body Vibration in Patients with Knee Osteoarthritis.

Knee osteoarthritis is a chronic joint disease with an impact on quality of life and an increasing incidence what leads to huge costs and burden on the economy.

The present study investigates immediate effects of whole-body vibration on pain, neuromuscular performance, and gait quality in patients with knee osteoarthritis. Eligible patients (n=20) with knee osteoarthritis grade 2 or 3 on Kallgren Lawrence will complete a 5 minute WBV training and a control condition in a randomized order (cross over design). Pain, maximum strength of the leg flexors and extensors, the chair rise test and gait parameters will be measured directly before and after the intervention/control.


Eligibility Criteria:
Inclusion Criteria:

* x-ray confirmed knee osteoarthritis (Kallgren-Lawrence 2-3)
* knee pain (NRS 0-10 \&amp;gt;2) for 3 months and at least 50% of the last 30 days

Exclusion Criteria:

* contraindications for WBV (acute injuries of the musculoskeletal system, new joint endoprosthesis, pregnancy, acute thrombosis, Epilepsia, cholecystolithiasis, nephrolithiasis, heart pace maker),
* other pathologies affecting gait or neuromuscular performance (rheumatic
* opioid medications, cortisol medications and intraarticular injections in the knee during the ist 3 months.
The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex

Sugammadex administration may increase the bispectral index (BIS) values during general anesthesia. The purpose of this study was to investigate the influence factors leading to increase in BIS value caused by sugammadex administration when continuous use of general anesthetics.

Sugammadex administration may increase the bispectral index (BIS) values during general anesthesia. The purpose of this study was to investigate the influence factors leading to increase in BIS value caused by sugammadex administration when continuous use of general anesthetics. Patients undergoing elective surgery were included in this study. After surgery was completed while the train-of-four ratio was zero, a steady-state intravenous anesthesia was maintained to keep a BIS value within the range of 40-60 for at least 5 minutes. Patients received sugammadex 2 mg.kg-1 after completed surgery. BIS values were recorded every minute and clinical signs of awaking was also noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists (ASA) physical status Ⅰ - Ⅱ scheduled for elective surgery who agreed to participate and who signed the informed consent were included. Other inclusion criteria were age between 18 and 80 years and scheduled for elective non-cardiothoracic and non-neurological cancer surgery under general anesthesia (GA)

Exclusion Criteria:

* Known hypersensitivity to sugammadex; severe renal insufficiency (creatinine clearance \< 30 ml.min-1); treatment with toremifene, flucloxacillin or fusidic acid in the pre-operative or immediate postoperative period; and neuropsychiatric disorders or treatment with a psychotropic agent.
Impact Evaluation of Separating Women and Men in the Metro of Mexico City

The purpose of this study is to determine whether the separation of men and women in the metro of Mexico City leads to an improvement in the violence and perception of violence towards women.

The purpose of this study is to determine whether the separation of men and women in the metro of Mexico City leads to an improvement in the violence and perception of violence towards women.

The separation of men and women will take place in the Line 5 of the metro system. The separation will operate between 6:00am-10:00am and 2:00pm and 10:30pm. Line 4 and 6 will be used to estimate the counterfactual.

Women eligible to participate in the study will be those aged 18 and 65 years who use lines 4, 5, and 6 between 7am and 9am or between 11am and 1pm before the separation between men and women is implemented. Eligible women must reside in Mexico City or the metropolitan area of the Valley of Mexico (60 municipalities agglomerates in the State of Hidalgo and Mexico State).

Women will be recruited in the metro before the separation between men and women is implemented. They will be asked for their name, e-mail and telephone number. Also before the separation is implemented, they will be asked to answer a telephone survey to collect baseline information. The same women will be contacted again in the following 12 to 15 months to collect the endline survey, also by phone. The implementation of the separation will take place after the baseline survey has been collected.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-65 who reside in Mexico City or the metropolitan area of the Valley of Mexico and that are users on the Metro lines 4, 5 and 6 between 7 and 9 or 11 and 1pm at baseline

Exclusion Criteria:

-
Neurodynamics to Improve Jump Functionality in Trampoline Jump Gymnasts

The goal of neurodynamics is to restore homeostasis of peripheral nerves. In the current context there is varied evidence that links neurodynamics with clinical pain treatments or different pathologies, but little evidence regarding changes in the functionality of athletes, which could be related to improvements in performance.

The main objective of the study is to determine if the neurodynamic technique is effective in increasing the range of hip mobility and in increasing the jump with counter movement.

Randomized, simple blind clinical study. 15 trampoline jumping gymnasts will be randomized to the two study groups: experimental (active sciatic neurodynamics techniques) and control (without intervention). The intervention will last 4 weeks, with 3 weekly sessions of approximately 5 minutes each. The study variables will be the range of hip flexion movement (goniometry) and the countermove jump (My Jump® application). A descriptive statistical analysis will be performed calculating the main statistical characteristics. The sample distribution will be calculated using a Shapiro-Wills analysis. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.

It is intended to observe improvement in the range of hip flexion movement and in the jump with countermovement.


Eligibility Criteria:
Inclusion Criteria:

* Trampoline jumping gymnasts
* Male
* Aged between 18 and 30 years
* Who train at least 2 days a week
* Federated in the Madrid Gymnastics Federation

Exclusion Criteria:

* Subjects who have a medical diagnosis of musculoskeletal pathology at the time of beginning the study
* Neural pathology in the last 6 months
* With cognitive deficit that prevents them from understanding physical tests and questionnaires
* Have not signed the informed consent
Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery

The purpose of this study is to investigate whether benefits of training the affected hand in patients with stroke can be improved by combining training with a painless, noninvasive technique called Transcranial Direct Current Stimulation (TDCS). TDCS will be applied over the part of the brain responsible for movements of the affected hand. Also, the investigators will study the changes in the brain that favor recovery of hand function following combination of training and tDCS.

The overall goal of this study is to develop a novel rehabilitative method, in chronic stroke, which minimizes residual deficits by maximally utilizing the potential for cortical plasticity.

Despite extensive rehabilitation, approximately 60-80% of patients with stroke experience residual dysfunction of the upper limb. Deficits are believed to linger due to neurophysiologic imbalance between the ipsilesional (stroke-affected) and contralesional (intact) motor cortices. Specifically, the ipsilesional motor cortex loses its normal inhibitory control over the contralesional areas, which, in return, intensify their inhibitory influence upon the former. Constraint-Induced Movement Therapy (CIMT) represents a family of techniques that alleviates residual deficits by rectifying these neurophysiologic imbalances. By reinforcing use of the paretic upper limb in daily life during restraint of the non-paretic limb, CIMT initiates use-dependent neuroplastic reorganization implicating the ipsilesional motor areas, which demonstrate return-of-activity and regain territory in the surviving regions, mitigating the exaggerated inhibitory influence exerted by the contralesional areas.

Despite promising evidence, however, clinical utility of CIMT is limited due to its labor-intensive protocols and inadequate gains. Our objective is to address gaps in existing clinical rehabilitative research. The investigators propose to 1) combine CIMT with targeted stimulation of the ipsilesional motor cortices, 2) Use a novel, noninvasive method of stimulation, called transcranial direct current stimulation (tDCS), 3) Use multimodal imaging to determine comprehensive mechanisms of recovery in patients. Our central hypotheses are 1) ipsilesional motor cortices would be an ideal site for delivering stimulation during CIMT, 2) tDCS will be easy, safe and inexpensive to apply and will target multiple maps concurrently during rehabilitation as demonstrated in our elemental research. 3) structural and functional imaging methods will demonstrate complementary cortical, corticospinal and cortico-muscular markers of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stroke that occurred at least 6 months ago

Exclusion Criteria:

* Pregnant
* Ongoing use of Central Nervous System activating medications
* Presence of an electrically, magnetically or mechanically activated implant, including cardiac pacemaker, cochlear implant
* Metal in the head
* A history of medication-resistant epilepsy in the family
* Past history of seizures or unexplained spells of loss of consciousness
Risk Factors for Stress-induced Alcohol Misuse: Genetic Predictors and Mediation by Personality Type

To examine whether variation in 'risk-taking' personality and linked genetic variants predicts susceptibility to, and resilience against, stress-induced alcohol misuse.

Alcohol misuse is a global health issue responsible for over 1 million hospital admissions per annum in the UK with a combined cost of approximately £21 billion. Chronic alcohol misuse in patients who attend hospital for alcohol-related illness/injury is common, with relapse and recidivism almost ubiquitous. Patients often report that 'stress' was a catalyst for their drinking episodes, but we do not know exactly who is most at risk, how stress leads to drinking, or the genetic basis for this risk. This research aims to seek to identify patients at higher risk of stress-induced alcohol misuse, or who are more resilient to stress in this context, using a combination of analyses ranging from genetic variants to personality tests and clinical follow-up. The ultimate goal is that patients engaging with alcohol services can receive personalised and focussed treatment and enhance recovery

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged (min) 18 years
* Attended Portsmouth Hospitals University Trust following illness/injury related to alcohol use
* Has a maximum AUDIT score of 15
* Is willing and able to comply with study procedures
* Willing and able to give informed consent for participation in the study.
* Must be recruited within 24 hrs of ASNS referral, and able to be tested within 48 hours of referral

Exclusion Criteria:

ny reported/suspected intellectual/learning disabilities (e.g., Down's Syndrome), neurodevelopmental disorders (e.g., Autism, Asperger's) or acquired brain injury

* Has previously participated in this study
* Should not be under the influence of alcohol during the study (12hrs previous to taking part) - to be determined via breathalyser.
* Any history of advanced liver disease (clinical diagnosis of cirrhosis, jaundice, encephalopathy, ascites, variceal haemorrhage)
Internalized Stress in Relation to Alcohol Consumption

The proposed study uses an experimental design to establish causal support for the role of internalized stress, pertaining to uncertainty with regard to one's sexual orientation, in contributing to heavy drinking behavior. Following exposure to internalized sexual stigma, physiological and psychological stress responses are expected to increase alcohol consumption in adults who are uncertain about their sexual orientation, especially among females, and following consumption, the physiological effects of ethanol and beliefs about the effects of alcohol are expected to alter relations between exposure to sexual stigma and the alleviation of psychological distress. Showing that physiological stress responses, whether driven by the pharmacological effects of ethanol or expectancies regarding its effects, can account for known alcohol-use disparities, particularly in bisexual/bi+ communities, would contribute a great deal to knowledge on the biology of addiction and inform subsequent interventions that seek to regulate stress reactivity.


Eligibility Criteria:
Inclusion Criteria:

* Cisgender
* Age 21-29
* Sexual Identity Uncertainty (SIU; non-zero scores on a published measure). Among those with a zero level of SIU, only those who report sexual attractions and/or behaviors to both female and male partners (i.e., bisexual/bi+) will be invited to lab sessions.
* Scores on the Alcohol Use Disorders Identification Test (AUDIT) that indicate mild or moderate risk for potential alcohol use disorder

Exclusion Criteria:

* Alcohol naive persons (i.e., those without a history of alcohol use in their lifetime ).
* Female persons who are currently pregnant (established with urine pregnancy test) or actively trying to get pregnant (self-report in the screening survey).
* Persons who are currently in treatment or who have ever been in treatment for a substance use disorder.
* Persons who have essential medications that disallow the consumption of alcohol.
* Persons with scores on the Alcohol Use Disorders Identification Test (AUDIT) that indicate high risk for potential alcohol use disorder; National Institute of Alcohol Abuse and Alcoholism (NIAAA) standard drink equivalencies will be provided in the survey,
Adjunctive Effect of Photodynamic Therapy on Halitosis

The present study aims to evaluate bad breath in patients undergoing gingival treatment combined with tongue scraping and laser and to assess its potential benefits for both periodontal and microbiological condition. Firs patients will be selected among those who participated in a privies study. Additional patients will be also invited. They must have gum disease and bad breath. Treatments will be completed within 24 hours and oral samples will be collected with thin paper points. Bad breath will be evaluated by a professional and a specific gas machine.

The present study aims to evaluate halitosis in patients undergoing non-surgical periodontal therapy \[(Full-mouth disinfection (FMD) combined with tongue scraping and antimicrobial photodynamic therapy (aPDT), and to assess its potential benefits for both periodontal and microbiological condition. A pilot study will be performed with participants who took part almost 10 years ago in the study NCT02368678. They will be invited by phone contact. In addition, new participants will be recruited by convenience in dental clinics from the Federal University of Minas Gerais until completion of 20 participants per group. Individuals with stage III periodontitis and halitosis (organoleptic method \> 2), will be allocated into two periodontal treatment groups. Halitosis will be assessed using the organoleptic method and gas chromatography (OralChroma device) at three time points: before and after treatments. Microbiological samples will be collected before and after treatments from periodontal pockets and pooled samples from the tongue dorsum. These samples will be analyzed by using real-time PCR (q-PCR) aiming at detecting target bacterial species.

Eligibility Criteria:
Inclusion Criteria:

* self-reported halitosis;
* organoleptic score \>2;
* stage III periodontitis;
* at least 14 teeth.

Exclusion Criteria:

* smokers or former smokers;
* individuals diagnosed with diabetes and/or immune diseases;
* pregnant or lactating women;
* individuals with removable partial dentures and/or fixed or removable orthodontic appliances;
* systemic use of antibiotics or anti-inflammatory drugs in the last three months; - individuals who required prophylactic antibiotics for periodontal exams and treatments;
* individuals who regularly used or had used any type of mouthwash in the past three months;
* individuals who underwent periodontal treatment in the six months prior to the study.