cyrilzakka/clinical-trials huggingface dataset:
Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Cancer which spreads to the brain (brain metastases) is a common and significant problem. Historically, whole-brain radiotherapy has been used to treat these patients but has a negative effect on cognition. Radiosurgery is an alternative treatment with potential for fewer cognitive side effects. The impact of radiosurgery alone on the cognitive function of patients with multiple brain metastases is not well studied. We propose a pilot study at the Winnipeg Centre for Gamma Knife Surgery to examine this issue.

Patients with \>=4 brain metastases will undergo Gamma Knife radiosurgery to a dose of 15-20 Gy, depending on the maximum tumour diameter and number of metastases. A number of neurocognitive, quality of life, and toxicity assessments will be performed at baseline and at 6 weeks post-radiosurgery, then at months 4, 6, 12, 18, and every 6 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven solid tumour malignancy
* Age \>= 18 years
* Karnofsky performance status \>= 70
* \>= 4 brain metastases, all eligible to be treated with radiosurgery
* All brain metastases \<= 4.0 cm in any diameter
* Pre-treatment contrast enhanced MRI brain \<= 42 days prior to enrollment
* Patient able to provide his/her own written informed consent

Exclusion Criteria:

* Prior radiosurgery, whole brain radiotherapy, or cranial radiotherapy
* Previous surgical resection of brain metastasis (biopsy is allowed)
* Prior chemotherapy ≤ 7 days prior to enrollment
* Planned chemotherapy during radiosurgery
* Leukemia, lymphoma, germ-cell tumour, small-cell lung cancer diagnosis
* Brainstem metastasis
* Leptomeningeal metastases
* Contraindication to MR imaging with contrast
* Pregnant or nursing women
Narrow Implants Vs Standard Implants With Simultaneous GBR

NDI represent an advisable treatment option when the mesio-distal space is compromised. In a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses supported by NDI in the posterior area. They observe a survival rate of 97% and absence of prosthetic complications after the study period time. More recently, Souza et al. performed a prospective randomized split mouth study with 3 years follow-up with the aim of comparing marginal bone level, implant survival and success rates and prosthesis success rates of NDI and SDI placed in the posterior area of the mandible to support single prosthesis. They observed an implant survival rate of 100% for both groups at 1 and 3 years. The prosthesis success rate at 1 and 3 years was of 95.4% and 100%, respectively.

NDI present a high survival rate on the evaluated studies. Therefore, the aim of the first study is to compare the patient related outcomes, implants and prostheses success and survival rates of pure titanium NDI versus SDI with simultaneous bone regeneration in narrow alveolar ridges at posterior areas of the maxilla and the mandible.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* 18 years old
* Healthy periodontal status (absence of generalized probing pocket depth (PPD) \<4mm)
* Oral hygiene levels (FMPS \<20 and FMBS \<20)

Site:

* Ridge width of \>5mm and \<6.5mm and minimum bone height of 10mm prior evaluation on a CBCT scan
* Presence of antagonistic natural tooth or fixed prosthetic restoration
* Presence of adjacent teeth
* One maxillary or mandibular premolars
* Minimum of 3mm of keratinized tissue over the bone crest (20)
* Bone regeneration within the limits of the prosthetic restoration.

Implants:

* Unitary prosthesis
* Screwed retained restorations

Exclusion Criteria:

Patients

* Presence of active chronic or aggressive periodontal disease
* Presence of systemic disease which contraindicate surgery (patients with an ASA ≥ 3)
* Drugs or medications which may alter the results (chronic intake of analgesic medication)
* Smokers (\>10cig/day)
* Pregnant women
* History of head and neck radiotherapy.

Site

* Anterior area (from 1.3 to 2.3 and from 3.3 to 4.3) and molar area
* Previous guided bone regeneration
* Location where there is not sufficient restorative space (mesio-distally \<8mm for every restoration unit and \<5mm from the bone crest to the antagonist)
* Implant dehiscence of more than 2/3 of the implant.

Implant

* Implants which cannot be restored with a screwed restoration
* Implants which doesn't reach a manual implant stability
* implants which after placement doesn't reach a favourable position according to the restoration.
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)

The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.

KESETT is a multicenter, randomized, blinded study to determine whether adding 1 mg/kg or 3 mg/kg dose of KET to 60 mg/kg LEV can terminate status epilepticus (SE) in a larger fraction of subjects with benzodiazepine-refractory SE than those treated with LEV (60 mg/kg) alone.

The primary outcome is termination of SE from 15 minutes after starting the study drug infusion, sustained until 60 minutes from enrollment without using additional anti-seizure medication. Termination of SE is determined by (1) improving consciousness and absence of clinically apparent seizures at 60 minutes or (2) absence of any electrographic SE after 15 minutes in those with EEG monitoring and no improvement in consciousness.

Secondary objectives include determining the relative safety of the treatment arms on defined safety outcomes and all adverse events, analysis of secondary/exploratory efficacy outcomes, and evaluation of both effectiveness and safety in the pediatric subpopulation.

The trial will initially allocate subjects equally (1:1:1) for the first 350 participants (burn-in period) before transitioning to response-adaptive randomization. Interim analyses will be conducted for efficacy and futility beginning when 350 subjects have been randomized, and will occur every 100 subjects thereafter. A maximum of 770 participants will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
* The patient received an adequate dose of benzodiazepines. The doses may be divided.
* The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
* Continued or recurring seizures in the Emergency Department.
* Age 1 years or older
* Known or estimated weight ≥10 Kg

Exclusion Criteria:

* Known pregnancy
* Prisoner
* Opt-out identification or otherwise known to be previously enrolled in KESETT
* Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of SE
* Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of SE(propofol, etomidate, ketamine or other agents defined in the MoP)
* Endotracheal intubation prior to enrollment
* Acute traumatic brain injury clearly precedes seizures
* Scalp injury or burn preventing EEG placement
* Known allergy or other known contraindication to KET or LEV
* Hypoglycemia \< 50 mg/dL
* Hyperglycemia \> 400 mg/dL
* Cardiac arrest / post-anoxic seizures
An Online Compassionate Imagery Intervention for Veterinarian Mental Health

This randomised control trial aims to determine the efficacy of a two-week, online compassionate imagery intervention on improving veterinarian mental wellbeing. Participants will be randomly allocated to receive the intervention immediately or after a 10-week study period. Self-report questionnaires will be used at four time points to measure change on a range of psychological variables.

Background: Research suggests that veterinarians are high-achievers with self-critical, perfectionist tendencies (Holden, 2020). Perfectionism in veterinarians has been associated with stress, anxiety, negative affect and low resilience (Crane, Phillips \& Karin, 2015). However, McArthur et al. (2017) found that veterinarians with higher levels of self-compassion reported greater resilience. A feasibility study by Wakelin, Perman and Simonds (2022) found an online two-week compassion-focused imagery intervention to be acceptible and feasible for a veterinarian sample. Wakelin et al. (2022) also reported indications of preliminary effect as veterinarians illustrated a reduction in perfectionism, work-related rumination and self-criticism over the intervention period.

Aim: This study aims to extend Wakelin et al.'s (2022) research, to determine the efficacy of a two-week, online compassionate imagery intervention on improving veterinarian mental wellbeing.

Design: The study will use a mixed-methods, repeated measures, randomised controlled trial design.

The independent variables will be the intervention group (either treatment or wait list control) and the data collection time point. Six questionnaires will be used to collect quantitative data on the following dependent variables: perfectionism, work- related rumination, fear of compassion, resilience, self-compassion, self- criticism and self-reassurance.

Method: Participants will complete questionnaire measures at four time points: prior to randomisation (baseline), two weeks post-randomisation (post-intervention), six-weeks post-randomisation (one-month intervention follow-up) and ten-weeks after randomisation (two-month intervention follow up). Participants in the treatment group will be asked to watch a 10-15 minute compassionate imagery video every day for two weeks (14 in total). Participants in the control group will gain access to intervention materials upon study completion but their engagement in the videos will not be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Any student, recent graduate or qualified veterinary surgeon will be eligible for participation in the study.

Exclusion Criteria:

* Veterinarians who participated in Wakelin et al.'s (2022) feasibility trial.
* Veterinarians who are currently receiving a compassion- or cognitive-based therapy.
Unmasking the Prevalence of AC in an Unselected Echocardiographic Population

This study will investigate the prevalence of echocardiographic red-flags of amyloid cardiomyopathy (AC) in patients undergoing clinically-indicated echocardiography (observational phase) and the prevalence of AC among AC-suggestive echocardiograms (interventional phase).

Prospective multicenter Italian survey consisting of two phases: observational (echocardiographic screening for amyloid cardiomyopathy among patients ≥ 55 years undergoing clinically-indicated echocardiography) and interventional (specific clinical and instrumental work-up to detect the prevalence of amyloid cardiomyopathy among amyloid cardiomyopathy-suggestive echocardiograms).

Eligibility Criteria:
Inclusion Criteria:

All the following:

* Interventricular septum thickness ≥ 13 mm in men and ≥ 12 mm in women;
* Left ventricular ejection fraction ≥ 50%;
* Indexed end-diastolic left ventricular volume ≤ 85 mL/m2.

AND

At least one of the following criteria:

* "Granular sparkling" appearance of the myocardium defined granular texture with uniform increased brightness of echo-reflections;
* Pericardial effusion regardless of severity;
* Increased interatrial septum thickness (\> 5 mm);
* Restrictive filling pattern (Dec. Time E wave \<120 ms or Dec. Time E wave ≤150 ms e E/A ratio ≥2) or increased ventricular filling pressures (E/E'15);
* Speckle tracking derived global longitudinal strain with apical sparing pattern;
* Increased thickness (\> 5 mm) of mitral and tricuspid valve leaflets.

Exclusion Criteria:

* Patients aged \< 55 years or \> 100 years
* Echocardiography performed due to known or suspected amyloid cardiomyopathy;
* Echocardiography performed due to known hypertrophic cardiomyopathy or phenocopies;
* Refuse to sign the informed consent to the study
A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial

The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.

The COMPASS Trial (TMI-09-01) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the CyPass Micro-Stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. In the study, 505 subjects were randomized to either the CyPass group, who underwent cataract surgery and received the CyPass Micro-Stent, or the Control group, who underwent cataract surgery alone. All subjects randomized were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study.

The COMPASS-XT (TMI-09-01-E) Trial is designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data will be collected at 36 months, 48 months, and 60 months postoperatively for a total of 5 year follow-up across the 2 studies.

Eligibility Criteria:
Inclusion Criteria:

1. Completed the COMPASS Trial
2. Understands study requirements and is willing to follow study instructions and return for study visits

Exclusion Criteria:

1. Systemic disease that would put subject health at risk and/or prevent completion of required study visits.
2. Early termination from the COMPASS Trial.
Gut Health Enhancement by Eating Favourable Food

Within the GEEF om je buik study the effect of 8 weeks intervention with either a diet rich in fiber or fermented food on the gut microbiota will be investigated.

This study is a randomized controlled trial (RCT) with three intervention groups (high dietary fiber group (HDF), high fermented foods group (HFF), and a control group (CG)). The total duration of the study is 5 months and consists of an 8-week intervention ( 2-week ramp up period with dietary guidelines, followed by 6-week period with dietary guidelines + additional consumption of study products) and a follow-up after 3 months. In total 147 subjects will be included.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women, aged ≥18 - ≤70 years;
* Being able to read and speak Dutch;
* Willing to keep a stable dietary pattern throughout the study, apart from the dietary advice in the study;
* Having a smartphone compatible with the Lifedata or PocketQ app to fill out the daily questionnaires.

Exclusion Criteria:

* Having a disease or medical condition which can influence the study results such as diabetes, cancer, diagnosed irritable bowel syndrome, renal disease, liver enzyme abnormality, malignant neoplasm, or a history of inflammatory diseases (such as multiple sclerosis, rheumatoid arthritis, and inflammatory bowel disease);
* Having a history of intestinal surgery that might interfere with study outcomes (this does not include an appendectomy or cholecystectomy);
* Average dietary fiber intake of ≥18 gram (women) or ≥22 gram (men) per day, according to the fiber screen questionnaire (see F1 questionnaires);
* More than 3 servings of fermented foods per day as assessed with the fermented food frequency questionnaire (see F1 questionnaires);
* Having a Body Mass Index (BMI) of ≥ 30 kg/m2 (self-reported);
* Currently following a strict diet and unwilling or unable to change; for example, a gluten free diet or a "crash diet" using meal substitutes;
* Specific food allergies that interfere with dietary intervention (for example, gluten, lactose, etc);
* Use of prebiotics, probiotics and/or synbiotics (this should be stopped 4 weeks before the start of the study) and use of fiber supplements;
* Use of antibiotic treatment less than 3 months before start of the study and/or use of antibiotics during the study;
* Use of medication that can interfere with the study outcomes, as judged by the medical supervisor;
* Alcoholic use of ≥14 (women) or ≥28 (men) glasses of alcoholic beverages per week;
* Use of soft or hard drugs (should be stopped at least 4 weeks before start of the study);
* Being pregnant or lactating;
* Participation in another clinical trial at the same time;
* Student or employee working at either Food, Health and Consumer Research from Wageningen Food and Biobased Research, Microbiology at VU, the MLDS, at WholeFiber, Keep Food Simple or at Cidrani;
* Unable to follow or comply to study rules.
Mitral Valve Screening Survey

This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).

Numerous transcatheter mitral valve interventions have emerged as a treatment option for patients with mitral valve disease. Development of transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) continues to progress with ongoing rigorous clinical trials of several experimental devices. However, despite being referred for TMVI, most patients do not pass stringent screening criteria for these investigational devices and are not offered TMVI.

In this prospective multicenter registry, baseline demographics, anatomical/imaging characteristics, and clinical outcomes of patients who fail screening for TMVI will be prospectively collected into a registry database.

Eligibility Criteria:
Inclusion Criteria:

* Subject failed screening for TMVI

Exclusion Criteria:

* Under 18 years of age
* Subject unable or unwilling to give informed consent
* Subject proceeded with TMVI.
Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia.

Dexmedetomidine, a highly selective α2 agonist is rapidly emerging as the choice of additive to spinal anesthesia in view of its property to provide analgesia however, it may be associated with bradycardia which may affect the hemodynamic stability.

Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor, it produces analgesia and sedation and lesser side effects through antagonism at the mu receptor but, it could be associated with some side effects as: dizziness, bradycardia, nausea, vomiting, and pruritus and may be associated with respiratory depression.

This prospective, double blinded, randomized, controlled study will be held to compare Nalbuphine versus Dexmedetomidine as adjuvants to intrathecal Bupivacaine in spinal anesthesia in patients undergoing lower limb orthopedic surgeries

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 60 years.
* Both genders.
* Patients scheduled for lower limb orthopedic surgeries under spinal anesthesia.
* American society of anesthesiologists (ASA) class I or II.

Exclusion Criteria:

* Patient refusal.
* Age \<20 or \>60 years.
* Contraindications to spinal anesthesia (e.g. bleeding diathesis, spinal cord deformities, infection at injection site).
* History of allergy to any of the study medications.
* Cases with severe cardiac, renal, or hepatic disease.
* American society of anesthesiologists (ASA) class III, IV.
* Patient on regular analgesics or opioid abuse.
* Patient with peripheral neuropathy.
Cognitive Remediation Therapy in Schizophrenia: Effects on BDNF Levels

The main objective of the study is to analyse the role of a neurotrophic factor (BDNF) as a putative biological marker of the cognitive recovery in schizophrenia following a Cognitive Remediation Therapy (CRT). Additionally, the role as outcome predictors of BDNF serum levels and the Val66met polymorphism and data from functional and structural neuroimaging will be studied.

Forty patients with schizophrenia disorder and twenty healthy volunteers will be recruited. Patients will be randomly allocated either the experimental group, undergoing an individual CRT for 40 hours during 16 weeks, or the control group following a psycho-educational intervention without any neurocognitive work, both lasting the same amount of hours and period of time. Blood samples will be obtained from participants in four moments: before treatment, at week 4, at week 16, and at 32 week follow-up. In addition, repeated measurements will be obtained with a neurocognitive battery based on the MATRICS consensus battery and the Positive And Negative Syndromes Scale (PANSS). Assessments will be conducted by trained personnel who will remain blind to the group assignment. A factorial model will be performed conducting a repeated measures analysis of covariance (ANCOVA) to study the effects of CRT on the levels of BDNF, neurocognition, symptoms and social functioning, adding the necessary co-variants. Finally, a linear regression model to determine the predictive role of serum levels of BDNF and data from functional and structural neuroimaging on the effects of CRT will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV-TR and confirmed by the semi-structured interview (SCID) for the axis 1.
* Presence of cognitive deficit confirmed by the neuropsychological battery
* Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment.

Exclusion Criteria:

* Presence of organic-cerebral affectation due to neurological or traumatic conditions
* Abuse of psychotropic substances
* Presence of other psychiatric symptomatology
Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation

People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.

To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.


Eligibility Criteria:
Inclusion Criteria:

1. Have provide written informed consent.
2. Be at least 18 years of age and have full capacity.
3. Have had their stoma for less than 9 months.
4. Have intact skin on the peristomal area (assessed by investigator)
5. Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
6. Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7)
7. Is willing to refrain from use of paste and protective sheets.
8. Have a smartphone applicable for the HeyloTM app.
9. Have been self-managing stoma appliance for at least 14 days.
10. Are able to follow study procedures for 3 months (assessed by investigator)
11. Are willing to receive their ostomy products through Coloplast Charter for the duration of the study.

Exclusion Criteria:

1. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
2. Is breastfeeding.
3. Is pregnant based on urine pregnancy test.
4. Enrolled in another current research study or have previously participated in this investigation.
5. Has known hypersensitivity towards any of the products used in the investigation.
6. Is using/have a pacemaker.
7. Has a complicated stoma at baseline (dehiscence/prolapse/hernia)
8. Has limited life expectancy or receive palliative care.
9. Has stage 4 cancer.
10. Having more than one stoma synchronously
11. Having ongoing non-healed abdominal wounds
12. Reoperation / stoma reversal planned during the study period.