cyrilzakka/clinical-trials huggingface dataset:
Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the TiLOOP® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. It is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. To verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. Erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament.

It is also expected that the patient's quality of life is meliorated after implantation of a TiLOOP® Total 6 mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.

Eligibility Criteria:
Inclusion Criteria:

* Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention. This applies to primary as well as recurrent intervention
* Existence of a cystocele.
* Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
* Patient information has been handed out and all written consents are at hand.
* Patient has attained full age.

Exclusion Criteria:

* Pregnancy or unfinished family planning.
* Known intolerance to the mesh-implants under investigation.
* Patients with acute (last 12 months) carcinoma.
* Patients with history of radiotherapy in the pelvic area.
* Genital descensus without any complaints.
* Patients with implanted pelvic floor mesh.
* Systemic steroid treatment.
* Lack of written patients' informed consent.
* Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
* Patient is institutionalised by court or official order (MPG §20.3).
* Participation in another clinical investigation.
Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)

The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female and aged 2 months to 2 years
* Presenting to ED with mild or moderate dehydration
* Candidate for both parenteral and oral rehydration therapies
* Healthy, except for underlying etiology for dehydration
* Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.
* Pre-dehydration body weight greater than 5th percentile for age

Exclusion Criteria:

* Severe dehydration
* Shock or a life-threatening situation
* Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion
* Medical reason or condition precluding administration of ORT
* Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study
* Anticipated need for hospitalization(other than for rehydration)
* Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
* Known hyponatremia, hypernatremia or hypokalemia
* Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration
* Participation in an investigational drug or device study within 30 days before participation in this study
Clinical Reminder to Improve Appropriateness of Echocardiography

This study will test a clinical reminder to show recent echocardiograms when a new echocardiogram is ordered. The goal is to avoid unnecessary comprehensive echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Echo ordered

Exclusion Criteria:

* None
The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study

Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive function and coping skills. Several studies have recently demonstrated that CR improves cognitive and occupational function in patients with schizophrenia and with depression (e.g. Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what impact this might have on these people's abilities in terms of work, coping strategies, quality of life, and everyday safety.

The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive and socio-occupational function in patients with previous mania and depression who experience persistent cognitive difficulties. Such effects would suggest implementation of CR in future treatment of bipolar disorder in order to facilitate the patients' ability to cope with the responsibilities related to work and everyday life. The hypotheses of the present study are that CR (in comparison to standard treatment) will 1) improve verbal learning and recall; and 2) improve sustained attention, executive function and psychosocial function.


Eligibility Criteria:
Inclusion Criteria:

* Bipolar disorder in complete or partial remission (Hamilton Depression Rating Scale score of max 14 and Young Mania Scale score of max 14)
* Subjective complaints of moderate to severe cognitive problems on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) (Fava et al 2006) (score at least 4 on at least 2 domains)

Exclusion Criteria:

* Current ECT treatment
* Drug and/or alcohol abuse
* Schizophrenia
* Significant risk of suicide
* Use of benzodiazepines equivalent to more than 22,5 milligrams of Alopam
Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

Maxillary nerve blocks have been shown to significantly reduce post-operative pain and analgesic intake during the 24-hour period following sinus surgery. This randomized, double-blinded, placebo-controlled study will investigate blocks of the pterygopalatine fossa using a suprazygomatic approach during septorhinoplasty surgery. It is the investigator's hypothesis that this technique will result in decreased post-operative pain and opioid use, and the morbidity associated with it.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting for open or endoscopic septorhinoplasty
* Age 18-80
* Normal oral food and water intake before surgery
* ASA physical classification 1-3

Exclusion Criteria:

* Refusal to consent
* Patients without a cellular phone or who are unable to accept text messages
* Allergy to opioid narcotics
* ASA physical classification of 4 or higher
* Patient requires other surgery in addition to septorhinoplasty
* Age \> 80 or \<18
* Any underlying chronic pain condition or ongoing opioid use over the preceding 3 months
* Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.
* Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
* Pregnant women
Pediatric Emergency Department Decision Support System to Reduce Secondhand Smoke

This two phase study will develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED.

The study will be the first to develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED. The investigators will conduct a two-phased project to develop, refine, and integrate a Decision Support System into the current electronic medical record system. In Phase I, the investigators will develop a three-part DSS with prompts to: 1) ASK about child SHSe and caregiver smoking 2) Use a software program (REDCap) to ADVISE caregivers to reduce their child's SHSe via total smoking home and car bans and quitting smoking, and 3) ASSIST caregivers to quit by directly connecting them to their choice of free cessation resources (e.g., Quitline, txt2quit, smokefree.gov) during the PED visit. If the investigators discover that a teen participant is a smoker, the investigators will provide them with resources for the Quitline, tx2quit, and teen.smokefree.gov. The investigators will create reports to provide feedback to nurses on their SHSe counseling behaviors. Nurses will provide input on program content, functions, and design. In Phase II, the investigators will conduct a 3-month feasibility trial to test the results of implementing the DSS on changes in nurse SHSe-related behaviors, and child and caregiver outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Nurses who work at least 2 shifts per week
* Current smokers accompanying their 0-18 year old child to the Emergency Department or Urgent Care

Exclusion Criteria:

* Non English speaking families
Evaluation of a 5-a-day Fruit and Vegetable Mobile Phone Application

This is a randomized controlled trial to assess the impact of a novel fruit and vegetable mobile phone application on fruit and vegetable intakes, knowledge and attitudes.

The 5-a-day fruit and vegetable (FV) message from the WHO recommends consumption of five 80g portions of different FV per day for health reasons. Recent research suggests that the details of the message are poorly understood by the population as a whole, by low consumers of FV and by those in demographic groups of traditional low FV consumption, and that this poor knowledge impacts on implementation of the message to result in low FV intakes. To aid implementation of the recommendations, investigators have developed a 5-a-day FV mobile phone application (app) prototype. The basic prototype app will provide information on the 5-a-day message, allow users to input consumption, and provides consumers with accurate knowledge of their adherence to the recommendations. This study will investigate the use and impact of the prototype app on FV intakes over a two or four week period. For significant impacts on health, sustained user engagement and use will be required. Up to 100 participants will be randomised to either receive or not receive the app, and will be asked to use the app for the following two or four weeks. FV intake will be assessed at baseline, 2 weeks, 4 weeks. Measures of app use will also be taken at these time points. Measures of FV knowledge will also be measured at these time points. Measures of FV attitudes were initially planned but not undertaken to reduce demand characteristics for participants. The investigators anticipate that changes in intakes will be mediated by changes in knowledge and attitudes.

Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent
* speaks English, owns an android mobile telephone
* able and willing to use phone and complete all measures

Exclusion Criteria:

* none
From Brain Currents to Interpersonal Flow: Investigating the Social Processing Stream of Schizophrenia

The overall objective of this project is to identify the neural signature of the impaired ability to relate socially seen in individuals with schizophrenia. A hypothesized path from the neural processes of social cognition, to social cognition assessed behaviorally, to real-life social interactions is examined. Secondary aims are to compare electrophysiological measures of high vs low level social cognition; to develop assessment methods of real-life behavior; and to increase the ecological validity of schizophrenia research. Much research within the field is devoid of personal meaning and interpersonal context. This project's use of personalized assessment allows for an ecologically valid approach to the social deficits of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* schizophrenia
* schizoaffective disorder

Exclusion Criteria

* diabetes
* Hyperthyroidism
* severe head trauma
* neurological disease
Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies

The aim of the current work was to evaluate, for the first time in a prospective randomized study, the effect of HBOT on patients with chronic neurological deficiency due to stroke.

Objective: Evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficiency due to stroke.

Methods: A prospective, randomized, control-crossed over trial including patients who had stroke 6-36 months prior to their inclusion. All patients had at least one motor dysfunction. After their inclusion patients were randomized to treated or cross group. The neurologic functions were evaluated by NIHSS, ADL, life quality and brain SPECT. Patients in the treated group were evaluated twice-at baseline and after HBOT. Patients in the cross group were evaluated three times-baseline, after 2 months control period of no treatment and after a consequent 2 month of HBOT. The following HBOT protocol was practice: 40 daily sessions, 90 minutes each, 100% oxygen at 2ATA, 5 days/week,.

Results: The study included 74 patients (8 were excluded). During the control period, in the cross group, NIHSS and the ADL had not changed, while in the treated group both significantly improved. After the cross-over, when the cross group received HBOT, NIHSS and ADL had significantly improved. Same trend of changes were in life quality. The SPECT correlated with the clinical improvement. The improvements were mostly in territories where there was a noticeable discrepancy between the CT and SPECT.

Interpretation: In this study, for the first time, it was demonstrated that HBOT can induce neuroplasticity in patients with chronic neurologic deficiencies due to stroke. The beneficial effect of the HBOT is mostly in territories where there is a brain SPECT/CT mismatch.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older, who had ischemic stroke and 60 patients who had hemorrhagic stroke 6-18 months prior to their inclusion in the study.

Exclusion Criteria:

* Dynamic neurologic improvement or worsening during the last 4 weeks.
* Had been treated with HBO for any other reason prior to their inclusion.
* Have any other indication for HBOT
* Chest pathology incompatible with pressure changes
* Inner ear disease
* Patients suffering from claustrophobia.
* Inability to give written informed consent.
Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
* Born after a gestation period of 36 to 42 weeks, inclusive.
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s) or LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Child in care.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Haemophilus influenzae type b (Hib) disease or vaccination.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature \> 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.
Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.

This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian citizens of who is able to give valid consent
* Patient planned for ERCP (either emergency or elective)

Exclusion Criteria:

* Known hypersensitivity towards Ketamine or Midazolam
* Patient refusal to participate or unable to give consent
* Increased intracranial pressure, acute stroke (\<3 months), intracranial haemorrhage (\<3 months)
* Uncontrolled hypertension (BP\>160/100) and tachycardia (Heart rate \>120)
* Acute myocardial infarction, acute coronary syndrome (\<3 months)
* Tachyarrythmia
* Pregnancy
* IVDU or substance abuse patient
* Patient with history of hallucination
* Child's Pugh Class C
Georgia: Technology and WIC - A Comprehensive Approach to Public Health

With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the Georgia WIC department will be implementing a telehealth solution for nutrition and breastfeeding support. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on the WIC participant through the WIC management information system (MIS). It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with nutrition and breastfeeding support while also reducing the burden of attending in-person care.

Telehealth can reduce barriers and increase access to care, and it can be applied to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC is a federal nutrition assistance program that helps low-income women with children up to age 5. There is a large volume of research that supports remote patient monitoring, and the most benefits are found when telehealth is used for communication and counseling. The USDA awarded Tufts University a grant to test and evaluate the use of telehealth innovations in the delivery of USDA's WIC program. Tufts University then offered the USDA/Tufts Telehealth Intervention Strategies for WIC (THIS-WIC) grant opportunity to WIC state agencies across the US. THIS-WIC selected 7 WIC State Agencies to receive grants, and the GA state agency is one recipient. The THIS-WIC team at Tufts University is leading the evaluation of these telehealth solutions in collaboration with funded WIC State Agencies.

THIS-WIC aims to generate evidence from GA's video-conferencing telehealth solution to inform how the telehealth platform supports WIC services compared to usual in-person care. Evaluation findings will inform stakeholders about the platform's benefits and how viable it is to sustain and adapt more widely.

The purpose of this study is to evaluate the effectiveness of this telehealth solution by having clients complete surveys on their comfortability using telehealth and their satisfaction with the telehealth appointment. Additionally, secondary demographic and other nutrition-related information about study participants is already collected in the MIS and will be utilized.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Breastfeeding women
* postpartum women with children in the age range of 0 to 5 years

Exclusion Criteria:

-
A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.

This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid. Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-59 years of age;
* relapsing multiple sclerosis patients with types 1-4 (established through McDonald criteria);
* \>=1 MS attack or a Gd-enhancing MRI lesion between 1 month and 1 year before enrollment;
* EDSS score of \<=6.5;
* inadequate response to approved treatment(Canada only).

Exclusion Criteria:

* MS attack within 1 month before enrollment;
* systemic corticosteroids within 1 month before enrollment;
* MS treatments (non-symptomatic) within specified periods before enrollment;
* an infection requiring systemic anti-infective treatment or vaccination with a live vaccine within 1 month before enrollment.