cyrilzakka/clinical-trials huggingface dataset:
Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

* The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT)
* This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations
* The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations


Eligibility Criteria:
Inclusion Criteria:

* Right-handed Female/Male, \[13-60 y.o.\],
* Schizophrenia (DSM-IV-TR diagnosis),
* Drug-resistant hallucinations (Kinon \& Kane criteria, 1993),
* Unmodified antipsychotic dosage during the 30 days preceding rMTS,
* No anticonvulsive medication,
* No neurological disorder, no addictive behavior,
* Matched for sex, age and PANSS scores,
* Consent to participate to the study,

Exclusion Criteria:

* Pregnancy
* Contraindication to MRI scan
* Contraindication to rTMS treatment
* Claustrophobia
* No social insurance
Decentralized Dietary UC Pilot Trial

This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions and their impact on UC. The study will activate one site with a Principal Investigator who will utilize each subject's local care system (local Gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.
2. Ability and willingness to provide documented informed consent and to comply with the study procedures, including in-person visits for Arm 1 and video visits for Arm 2.
3. Documented history of moderate to severe active UC
4. Disease duration of ≥12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)
5. Screening fecal calprotectin\>350 mg/g
6. Diagnosis of moderately to severely active UC, including historical endoscopy sub score ≥2; a rectal bleeding sub score ≥1 and disease activity a minimum of 25 cm from the anal verge.
7. Documented (via video or report) endoscopy performed within 2 years prior to randomization.
8. Access to a computer or mobile device with internet connection and an active email address.

Exclusion Criteria:

1. Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
2. Past or present ileostomy or colostomy
3. Short bowel syndrome
4. Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon
5. Past or present fistula or abdominal abscess
6. History or current evidence of colonic mucosal dysplasia
7. Use of tube feeding, defined formula diets or parenteral alimentation/nutrition which has not been discontinued ≥3 weeks prior to study enrollment
8. Use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the study
9. Crohn's Disease
10. Significant uncontrolled co-morbidity, such as neurological, cardiac (e.g., moderate to severe heart failure NYHA class III/IV), pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
11. History of alcohol, drug or chemical abuse within 6 months prior to screening
12. Pregnant females, those intending to become pregnant, and those who are lactating
13. Current participation in any other clinical trial
Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

It is not known in the literature how much sonication affects the patient's treatment. Another important issue is that the place of this method in diagnosis is not clear. The aim of this study is to contribute to the literature on this issue and to determine the sensitivity and specificity of sonication prospectively using the new definition and effect of sonication on the treatment strategy in terms of infection in patients with PJI.

Total knee and hip arthroplasties are successful surgical procedures that are widely applied all over the world and provide high patient satisfaction and increased quality of life. Periprosthetic joint infection (PJI), is a serious complication that negatively affects the targeted result, decreases patient satisfaction, and increases morbidity and mortality after total joint replacement. Another important issue, the previous infection is the most important reason for the failure of surgery in revision arthroplasty. It is known that the success of PJI treatment seriously can be affected by the type of microorganism and antibiotic sensitivity. Therefore, microbiological examination methods are always of interest, and one of them is the sonication method.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for revision arthroplasty (aseptic revision, septic revision, instability, and periprosthetic fracture)

Exclusion Criteria:

* who do not accept to participate in research
* insufficient data for new definition criteria
* acute periprosthetic infections
* patients with systemic inflammatory disease
Impact of the Virtual Human Project on Team-based Learning: A Randomized-controlled Trial

Team-based learning (TBL) is a learner-centered, instructor-directed strategy for small group active learning in large group educational settings. When TBL is conducted correctly, the students' performances are equivalent or improved in comparison to either lecture-based formats or more traditional small group learning models.1 Nevertheless, few studies have been published regarding the insertion of innovative audiovisual tools in the TBL context. The Virtual Human Project is described as powerful sequences of three dimension (3D) computer graphics video of the human body that aids learning by facilitating an understanding in relation to a specific subject. The Virtual Human is composed by video sequences combining anatomy, physiology, and morphology in the context of various diseases. There are video sequences available for many disciplines, including dermatology and with capacity to produce anatomical structures by 3D printer. Despite the incredible potential applications of the Virtual Human, few studies have assessed its impact on medical education. The investigators did not find any study evaluating TBL with the insertion of iconographic educational material that assessed whether this intervention could change the learning progress of students. This is the aim of the present study, by comparing students tests scores after a TBL session with the VIrtual Human videos about leprosy or a standard TBL session, and to evaluate the student's satisfaction with the Virtual Human videos.


Eligibility Criteria:
Inclusion Criteria:

* undergraduate medical students in the third year of Medical School at the Federal University of Mato Grosso do Sul.

Exclusion Criteria:

* students previously exposed to dermatologic research, extracurricular activities involving dermatology or dermatology rotation in that year
Feasibility of an Exercise Intervention

The overall purpose of this research is to evaluate the effect of a home-based exercise program on physical function and to improve the health and quality of life for the HIV-infected older adult community.

Subjects are being asked to participate in this study if they are infected with the human immunodeficiency virus (HIV), and they are 45 years of age or older.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive, both genders, all races, English speaking individuals, age 45 years or older, on HAART before enrollment. .

Exclusion Criteria:

* Subject will be excluded if he/she has history or currently has severe cardiopulmonary illness, severe orthopedic or neuromuscular impairments, significant cognitive or sensory impairments, history of active malignancy, untreated depression, manic or psychotic disorder, and normal PPT score.
Acupressure in Pruritus for Atopic Dermatitis

The purpose of this study is to see if acupressure will be effective at reducing itch in people with atopic dermatitis (AD).

Atopic dermatitis (AD) is recognized as a major and common problem worldwide. In the United States, AD and related eczematous symptoms affect 17% of the population; 1 in 10 individuals report having experienced symptoms causing quality of life (QOL) distress, including itching/scratching, red/inflamed rash, excessive dryness/scaling, and/or symptoms lasting ≥ 14 days. Two-thirds of these subjects noted at least moderate to severe symptoms, with itch being the most disturbing. Effective treatment of AD and of pruritus (itching) are interconnected. Treating AD will decrease the stimulus for the itch, whereas treating pruritus will decrease the feedback cycle brought on when a patient scratches the skin continually. Effective medications for AD and related symptoms include topical corticosteroids and calcineurin inhibitors. Oftentimes, these remedies are insufficient at treating the itch component of the disease. There is demand for alternative, complementary treatments for AD-related pruritus.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD by dermatologist
* Not currently using acupressure or acupuncture for treatment of AD
* Able to read, write, and understand study materials
* Age 18 or older

Exclusion Criteria:

* Unable to physically perform acupressure technique
* Significant comorbidities causing itch such as chronic urticaria, renal failure, notalgia paresthetica, and tinea
Evaluating the Impact of the McMaster Optimal Aging Portal on Cancer Prevention Behaviours in Underserved Populations

The goal of the McMaster Optimal Aging Portal is to be a trustworthy source for health information. The Portal team can see (through measuring analytics of website use) that thousands of people are using the Portal and the knowledge-sharing strategies in place (email alerts, Twitter and Facebook), with many more users added each month. Previous studies have measured the quality and trustworthiness of health information available online; others have studied the numbers and populations who use different types of information and how easy it is to use and understand. This study builds on that knowledge to find out: if easy-to-understand evidence-based messages reach members of the public, do these messages change what people know and think to do to stay healthy (in this case, what they know and think to do to lower their risk of cancer)?

Half of cancers are preventable through lifestyle modification such as smoking cessation, healthy eating, increasing physical activity and reducing alcohol intake; however, few Canadians engage in behaviours that are in line with cancer prevention guidelines. This may be in part due to lack of access to evidence-based information and the mixed messages on effective cancer prevention strategies that are propagated in the popular media.

The McMaster Optimal Aging Portal (the Portal) is a knowledge translation (KT) tool launched in 2014 to increase public access to trustworthy health information. Citizen-friendly content (blog posts, evidence summaries, web resource ratings) provide easy-to-read 'bottom line' messages appropriate for all audiences. Investigators would now like to know if and how KT strategies used to disseminate citizen-targeted information on cancer prevention impact knowledge, behavioural intentions and health behaviours of Canadian adults.

This study will use a sequential mixed-methods design consisting of a two-arm randomized controlled trial (RCT) and a qualitative process study to explore RCT findings in depth. This formative approach will allow for a deeper analysis of the outcomes of interest (knowledge, intentions and behaviours), and the KT process. Following baseline data collection, eligible participants will be randomized to a 12-week intervention or control group.

During the intervention, participants will have access to the Portal, be invited to follow a Twitter and Facebook feed, and receive tailored weekly email alerts including blog posts and evidence summaries on cancer prevention. Control group participants will have access the Portal in a 'self-serve' fashion, but will not receive KT strategies.

Eligibility Criteria:
Inclusion Criteria:

* English speaking

Exclusion Criteria:

* Previous cancer diagnosis
Living Well with Chronic Pain

The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain.

Chronic pain conditions are common and difficult to cure. As much as 30% of adults in Norway experience moderate-to-severe chronic pain, i.e., pain having lasted more than 3 months. Chronic pain is also the most common cause of sick leave and disability pension in Norway. Despite a clear request from the authorities, e-health interventions for chronic pain has not yet been tested and implemented.

The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain, using outcome measures such as pain intensity, pain acceptance, anxiety/depression and quality of life.

The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses. The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material. The 9 modules will be distributed over minimum 27 days (minimum 3 days per module). The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group. Both groups will receive outcome measures to complete at baseline and at 3, 6 and 12 months.

Post-RCT, the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pain (pain \> 3 months)
* \> 18 years of age
* Able to write/read/speak Norwegian
* Have their own smart phone, PC or tablet

Exclusion Criteria:

* Cancer related pain
* Migraine
Effect of Benadryl Sedation During ERCP or EUS

The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.

The usual sedatives used for endoscopy are meperidine (Demerol) and midazolam (Versed). Benadryl (Diphenhydramine) is often used in addition to these medications in an effort to improve sedation. There is little published information regarding the use of diphenhydramine in conscious sedation. It is recognized that certain patients have features that predict difficult sedation such as prescription sedative use or heavy alcohol use. In addition, prolonged procedures like ERCP and EUS require higher doses of sedatives. Diphenhydramine may improve the quality of sedation in patients undergoing endoscopic retrograde cholangio-pancreatography (ERCP) or endoscopic ultrasound (EUS) procedures. You are being asked to participate because you are already scheduled to undergo one of these procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 65 years of age who present for outpatient ERCP or EUS at Strong Memorial Hospital Endoscopy Center will be included

Exclusion Criteria:

* Allergy to diphenhydramine, narrow angle glaucoma, or inability to consent
Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy

This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with spastic diplegia cerebral palsy.

Cerebral Palsy (CP) is the leading cause of disability in children, with the most widespread type of CP being spastic CP which negatively affects physical function. Specifically it is reported that there is an increase in energy expenditure and oxygen consumption in children with CP. Single event multi level chemoneurolysis with abobotulinumtoxinA has been found to be an effective treatment for patients with spasticity to reduce energy expenditure by increasing walking efficiency; however many of these studies have conflicting methodological approaches. Therefore this study aims to evaluate the single event multilevel chemoneurolysis with Dysport® on energy expenditure and gait in children with spastic diplegia CP.

Eligibility Criteria:
Inclusion Criteria:

* Age: 5-17 years. Must be \<18 prior to injection.
* \>10 kilograms at screening and injection visits
* Diagnosis of spastic diplegia or mild- to moderate spastic quadriplegia Cerebral Palsy
* Gross Motor Function Classification System level: I, II, III
* Ability to ambulate independently without aid, equinus gait
* Absent of joint or bone deformities
* Eligible to receive single-event multi-level chemoneurolysis (SEMLC)
* Cooperative and tolerant to testing procedures during clinic screening
* Presence of spasticity in one or both legs
* Be on a stable dose and regimen if on any prescribed medication/s
* Parent must have signed written informed consent and the Patient Authorization for Use and Release of Health and Research Study Information

Exclusion Criteria:

* Ankle contractures no more than -10 degrees with the knee extended
* Hemiplegia
* Wheelchair dependent
* Received Botulinum toxin within previous 4 months
* Uncontrolled epilepsy or certain types of seizures
* Fracture in the study limb within previous 12 months
* Infection or skin disorder at planned injection site
* Shortness of breath or other respiratory issues
* Uncontrolled clinically significant medical condition
* Received phenol or alcohol block in the study limb within previous 6 months
* Surgery in the study limb within previous 12 months
* Serial casting within previous 12 months
* New physiotherapy and/or orthotic regimen \<1 month before study start. (physiotherapy and/or orthotic regimen will be permitted if it began \>1 month before study start and maintained throughout study)
Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis

A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).

Herpes simplex labialis is a common, worldwide affliction for which neither public health procedures, vaccines, nor antiviral chemotherapy have had a major impact. The present study has been proposed because it has become clear there are marked limitations to the benefit of antiviral therapy in herpes labialis. Recently, a pilot trial of the combination of famciclovir and topical 0.05% fluocinonide vs famciclovir alone showed that the addition of corticosteroids to the antiviral drug treatment caused a marked and statistically significant reduction in lesion size and a trend to more aborted lesions.

This study is designed as a randomized, placebo-controlled, , patient-initiated study. The objective of this study is to evaluate the safety and efficacy of oral valacyclovir 2grams BID for one day and topical temovate 0.05% gel BID for three days compared to placebo capsules and placebo gel in the episodic treatment of a single episode of recurrent herpes labialis in immunologically normal patients.

Subjects will be screened, randomized to study drug and instructed to start using study drug within one hour of the first sign or symptom of their next episode of herpes labialis. Data on the treated lesion will be collected by clinic visits and a patient diary card.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* A history typical for recurrent herpes labialis. The subject must have experienced three or more cold sores in the last 12 months.
* In general good health, without other serious medical conditions, as determined by the patient's account of his/her medical history.
* Signature on the informed consent document.

Exclusion Criteria:

* Patients who have participated in an investigational drug study in the four-week period prior to enrollment.
* Previous herpes vaccine at any time.
* Patients with major medical conditions such as chronic heart, pulmonary, renal or hepatic diseases.
* Patients with immunodeficiency disorders such as HIV infection or cancer chemotherapy.
* Patients using topical steroids on or near the face or systemic steroids within 30 days of enrollment.
* Women who are pregnant, lactating or breast feeding.
* Women of childbearing potential not using adequate contraception as judged by the Investigator.
* Recent history of alcohol or drug abuse, which in the opinion of the investigator, may interfere with that study patient's compliance with study requirements.
* Significant skin disease such as atopic dermatitis, acne, or rosacea that would interfere with the assessment of lesions.
* Allergy or hypersensitivity to steroids, acyclovir, penciclovir and/or other nucleoside analogues.
* Subjects with impaired renal function as defined as a serum creatinine above the upper limits of normal.
Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After UKA

The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.

The purpose of the study is to compare the percentage of early micromobilisation by static radiostereometric analysis (RSA) - primary outcome, gait analysis by inertial sensors to assess gait kinematics, and clinical perdormance measured by american knee society score (AKSS), oxford knee score (OKS), patient satisfaction score (PSS) and EQ5-D - secondary outcomes, among 2 groups of patients, of 25 individuals each, whi undergo medial unicompartmental knee arthroplasty.

The first group will be operated with a robot-assisted technique (with CORI Surgical System, Smith and Nephew, USA), the other with standard technique and the same implant (Journey UNI II, Smith and Nephew, USA).

The study will be a randomized and controlled blind superiority trial. Patients will not be informed about performing the surgery with one technique or the other in order to avoid potential biases in the data analysis.

Patients will be recruited at the orthoaedic and traumatologic 2nd clinica (head prof S. Zaffagnini) at IRCSS Istituto Ortopedico Rizzoli in Bologna, Italy.

Eligibility Criteria:
Inclusion Criteria:

* Unicompartmental Knee Arthrosis
* Femoral condyles or medial tibial plate osteonecrosis
* Healthy anterior cruciate ligament, posterior cruciate ligament and collateral ligaments of the affected knee
* Post traumatic loss of joint configuration
* Moderate varism deformity
* Patients between 50 and 80 years old
* Patients able to undergo a 2-year follow up after surgery

Exclusion Criteria:

* Bi or Tricompartmental arthrosis
* Unhealty anterior or posterior cruciate ligaments or collateral ligaments
* Patients with neuromuscolar, degenerative and joint-related conditions
* Patients younger than 50
* Patients older than 80
* Patients unable to undergo a 2-year follow up after surgery