cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Novel Bionic Foot, AMPfoot 4+

Background: Evaluating the use of a novel motorized ankle prosthesis during walking and under dual task circumstances is an important step in product development.

Objective: To iteratively evaluate the effectiveness of a novel bionic foot, the Ankle Mimicking Prosthetic device 4+ (or AMPfoot 4+), during walking.

Study design: Case study (crossover) research design.

Methods: One male subject will conduct a baseline experimental trial with the current prosthetic device and several experimental trials with the AMPfoot 4+ to evaluate the effectiveness of the novel device and investigate the adaptation period. Prior to baseline experiments, a familiarization trial will be performed to determine intra-subject variability of the dual task. An experimental trial consists of 2 walking tasks, i.e. the 6-minute walk test (6MWT) and the 10-meter walk test. The 6MWT will be combined with a cognitive task, i.e. backwards counting, to create dual task circumstances. The outcome measurements for the dual task are the distance covered and the walking speed, heart rate (HR) (Polar), rating of perceived exertion (RPE), VO2 (Cosmed K5), electro-encephalography (EEG), electro-myography (EMG), electro-cardiography (ECG), electrodermal activity (/skin conductance),accuracy and total duration of the cognitive task, BodyMedia (physical activity) and the visual analogue scale (VAS) for fatigue and comfort. A 10-meter walk test will be evaluated on duration.

Expected findings: In a first phase the novel device will probably reduce walking and cognitive performance, whereas fine-tuning the mechatronics (after several retests) should improve walking and cognitive performance during walking.


Eligibility Criteria:
Inclusion Criteria:

* unilateral transtibial (below knee) amputee
* healthy subject
* K4-level (Medicare), which means highest ambulation level

Exclusion Criteria:

* comorbidities
* pain in stump
A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)

Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV.

Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life.

Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire.

Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.


Eligibility Criteria:
Inclusion Criteria:

* VCF on X-ray of the spine (minimal 15% loss of height)
* level of VCF Th5 or lower
* back pain ≥ 12 weeks at time of X-ray
* ≥ 50 years of age
* bone edema on MRI of the fractured vertebral body
* focal tenderness on VCF level
* decreased bone density T-scores ≤ -1

Exclusion Criteria:

* severe cardio-pulmonary condition
* untreatable coagulopathy
* systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
* suspected alternative underlying disease (malignancy)
* radicular and/or cauda compression syndrome
* contra-indication for MRI
Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor in Increasing Pregnancy Rate in ICSI

Intrauterine Granulocyte colony stimulating factor (GCSF) was compared with intrauterine Human Chorionic Gonadotropin (HCG) in increasing clinical pregnancy rate as a primary outcome and ultrasound imaging of gestational sac as a secondary outcome.

Two hundred females with history of recurrent implantation failure and undergoing Intracytoplasmic Sprem injection (ICSI) were randomized into two groups; the first group (100 patients) received intrauterine Granulocyte colony stimulating factor (GCSF) and the second group (100) received intrauterine Human Chorionic Gonadotropin (HCG) at ovum pick up day. The clinical pregnancy rate was evaluated as a primary outcome after 14 days and ultrasound imaging of gestational sac was evaluated as a secondary outcome after 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion Criteria:

* presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders
Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)

This research study proposes to embed HIV testing outreach workers from a young adult focused medical and HIV treatment program into an alternative sentencing program to deliver a new service delivery model (Link2CARE) that integrates evidence-based protocols for justice-involved young adults to: a) promote HIV and STI testing, and HIV and SU risk screening, b) provide onsite intervention, and c) cross-system linkage to HIV, STI, and SU care. Phase 1 has already been completed. In phase 1, the intervention components were adapted for use among justice involved young adults and the resulting protocols were piloted with justice involved young adults, finalizing the resulting 4-session Link2CARE intervention. In phase 2, we will test Link2CARE among N=450 justice-involved young adults enrolled at the alternative sentencing program and conduct process evaluations with N=15 alternative sentencing program staff.


Eligibility Criteria:
Young Adults

Inclusion Criteria:

* Between 18-24 years of age
* Currently enrolled at the alternative to sentencing program
* Conversant in English
* Engaged in any unprotected or vaginal sexual activity (in the past 12 months)

Exclusion Criteria:

* Cognitively unable to complete the interview
* HIV positive

Alternative to Sentencing Staff

Inclusion Criteria:

* Currently employed at the alternative to sentencing program
* Between ages of 18-80

Exclusion Criteria:

* None
Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBM

Positron Emission Tomography-Computed Tomography (PET-CT) with injection of 18F-fluoroethylcholine (FEC) could be a useful tool in the evaluation and follow-up of patients who have been diagnosed with glioblastoma multiforme (GBM) and who are treated with radiotherapy and temozolomide by allowing, for example, the distinction of necrosis from tumour tissue. This tool could help the clinician in making therapeutic decisions for GBM patients.


Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 70 years of age
* Histological diagnosis of GBM (grade IV astrocytoma based on the World Health Organization \[WHO\] classification)
* No previous radiotherapy or chemotherapy
* No history of previous neoplasms
* Inoperable patients (tumour in place, biopsy only)
* KPS ≥ 70
* Adequate hematological, renal and hepatic function

  * Absolute neutrophil count ≥ 1,500/mm3
  * Platelets ≥ 100,000 per mm3
  * Serum creatinine ≤ 1.5 times the upper limit of normal of the laboratory where it is measured
  * Total bilirubin ≤ 1.5 times the upper limit of normal of the laboratory where it is measured
  * Liver enzymes \< 3 times the upper limit of normal of the laboratory where they are measured
* Patients under corticosteroids must have received a stable or decreasing dose in the 14 days preceding randomization
* Consent form signed by the patients
Brain Training for Substance Use Disorders

Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game difficulty.

The main purpose of this project is to gather pilot data on neurofeedback games that use electroencephalogram (EEG)-based Attention Bias Modification (ABM) to reduce cue-induced drug craving processes in individuals with Opioid Use Disorder (OUD). The project will involve the use of three empirically-supported and potentially therapeutic games that include drug- (such as pill bottle and syringe) and non-drug-related stimuli (such as food and smiling faces). An EEG system will be used to monitor brain activity during gameplay.

The neurofeedback loop for attention training will be synchronized to cue presentations using EEGs which monitor visual Event-Related Potentials (ERP) signatures of attention. The degree of difficulty (i.e., cue content) on subsequent trials of the game will be determined based on the level of attention measured in the neurofeedback loop.

Eligibility Criteria:
Inclusion Criteria:

OUD patient participants:

* Admitted into chemical treatment with opioid use being a reason for treatment;
* DSM-IV-TR diagnosis of OUD;
* Ability to provide informed consent;
* A minimum of a 6th grade reading level; and
* Able and willing to provide own contact information for follow-up visit(s).

Control participants:

* Age- and gender-matched to an OUD patient participant in the study;
* Ability to provide informed consent;
* A minimum of a 6th grade reading level;
* Able and willing to provide own contact information for follow-up visit(s).

Exclusion Criteria:

OUD patient participants:

* Refusal or inability to consent;
* Pregnant;
* History of serious neurological illness (e.g., Chronic seizure disorder, Wernicke-Korsakoff Syndrome, Epilepsy, Any history of seizures not caused by withdrawal from substances, Other \[please specify\]);
* Inability to see text and photos clearly on the computer display; and
* Unwillingness to change hairstyle (e.g., braids, pony tails, dreadlocks) or remove wig to accommodate application of the EEG headset, if necessary.

Control participants:

* Refusal or inability to consent;
* Pregnant;
* History of serious neurological illness (e.g., Chronic seizure disorder, Wernicke-Korsakoff Syndrome, Epilepsy, Any history of seizures, Other \[please specify\]);
* Inability to see text and photos clearly on the computer display;
* Current or previous problems using opioids, other prescription (prescribed or not prescribed) or illicit drugs;
* Regular nicotine user (e.g., cigarette smoker, e-cig user) within the past 12 months; and
* Unwillingness to change hairstyle (e.g., braids, pony tails, dreadlocks) or remove wig to accommodate application of the EEG headset, if necessary.
Visual Training for Improving Intermittent Exotropia Visual Function

The goal of this clinical tral is to investigate that if VR/AR visual training can improve the visual function in children with intermittent exotropia.

The main question it aims to answer is :

Does the VR/AR visual training can enhance stereoscopic vision function in children with intermittent exotropia.

Researchers will compare intervention group to control group to see if VR/AR visual training could enhance stereoscopic vision function in children with intermittent exotropia.

Participants will:

The intervention group will receive 20 minutes of VR/AR visual training once a day for a period of one year.

Follow up check ups at the hospital every 3 months. Keep a diary of the values of stereoscopic vision function and Newcastle Control Score.


Eligibility Criteria:
Inclusion Criteria:

Aged 6 to 14 years. Intermittent exotropia meeting all of the following criteria: Exodeviation at least 10Δ at distance measured by the prism and alternate cover test, near deviation does not exceed distance deviation by more than 10Δby prism and alternate cover test, mean distance Newcastle Control Score (NCS)≥2 points (mean of 3 assessments during the examination).

Refractive error between -5.00 D \< spherical equivalents (SEs) ≤ -1.00 D, astigmatism ≤1.50D, anisometropia ≤1.5D, best visual acuity in each eye of 1.0.

Not receiving any other form of strabismus or myopia treatment within 3 months. Willing to follow the research plan and participate in the entire research process.

Participants and guardians agree to be randomly assigned and sign an informed consent form.

Exclusion Criteria:

Vertical strabismus; Diagnosed with other eye diseases or visual abnormalities such as strabismus, amblyopia, etc; Existence of cognitive or learning disabilities that may affect the effectiveness of training; patients with neurological disorders; Unable to cooperate with eye examination and follow-up work.
Administration of Protein C Concentrates in Adult Critically Ill Septic Patients

Severe sepsis and septic shock are life threatening medical emergencies and are among the most significant challenges in critical care. Case reports and case series suggest that plasma-derived protein C concentrate may improve the outcome of patients with acquired protein C deficiency. Evidence has accumulated on the clinical relevance of the PC pathway in modulating overwhelming inflammation and preventing coagulation derangements, two key mediators of organ damage, and thus of mortality and morbidity, in sepsis. The experience collected through these studies shows that PC is safe, in that it is not associated with bleeding or severe allergic complications,and possibly useful, at least to improve the coagulation abnormalities brought about by sepsis. Unfortunately, however, all we know comes from case series or case reports or an underpowered randomized controlled study. A randomized clinical trial, adequately powered for mortality or clinically relevant outcome, is necessary to confirm PC efficacy.The aim of this study is to demonstrate that Protein C zymogen has clinically relevant implications in terms of reduction of thromboembolic events, 30 days mortality, length of intensive care and hospital stay, time on mechanical ventilation, length of ICU and hospital stay. The study will also confirm that there is no bleeding concern with the use of Protein C concentrates.The study drug will be administered in the Intensive Care Unit for 72 hours and the patients observed till ICU discharge. Telephone followup will be performed at 30 days and at one year.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* At least one of the following 3 criteria:

  * venous-venous extra corporeal membrane oxygenation (ECMO) for septic adult respiratory distress syndrome (ARDS)
  * septic disseminated intravascular coagulopathy (DIC)
  * sepsis induced organ dysfunction associated with a clinical assessment of high risk of death

Exclusion Criteria:

* Previous unusual response to PC or any of their components (murine proteins and heparin)
* PC administration or inclusion in other randomized protocols in the previous 30 days
* Do not resuscitate orders
* Refractory cardiogenic shock
DKI Combined With APT for Post-treatment Assessment of Ovarian Malignancies and Correlation With XRCC2 Gene

Ovarian cancer is one of the common causes of cancer death in women worldwide. Despite the continuous development of diagnostic and treatment techniques, the survival rate of ovarian cancer patients has not improved significantly, and the important reason for the high mortality rate and poor prognosis is the lack of effective means to assess the effectiveness of treatment. The methods to monitor the effectiveness of ovarian cancer treatment and dynamic risk stratification by conventional imaging or single tumour marker levels are rather limited. In recent years, DKI and APT imaging have made some achievements in evaluating the post-treatment outcome of tumours, and the quantitative parameters of DKI combined with APT as a non-invasive biological marker are expected to be an effective way to address the limitations of assessing the treatment outcome by non-invasively detecting the changes in the signal of water protons and the diffusion information of non-normally distributed water molecules in the tumour tissue to observe the changes of protein and microstructure in the tumour cells. This project aims to collect patients who have come to our hospital for treatment. This project aims to collect patients with ovarian malignancies who come to our hospital and perform DKI, APT sequence and XRCC2 gene examination before and after treatment, and to statistically analyse the obtained parameters to assess the value of DKI combined with APT in monitoring the treatment effect of ovarian malignancies and the correlation with XRCC2 gene. This will help to promote individualised and precise treatment of ovarian cancer and improve prognosis.


Eligibility Criteria:
Inclusion Criteria:

No previous history of ovarian tumours or ovarian surgery; no concurrent other tumours, no history of oncology or treatment such as radiotherapy or chemotherapy; confirmed by pathological histology; receiving chemotherapy with a combination of platinum and purple shirt for at least 3 cycles; no contraindications to MRI

Exclusion Criteria:

Recurrent ovarian malignancy; too old, poor physical infrastructure; severe medical comorbidity; incomplete patient data collection; lost to follow-up
Registro Malattia Diverticolare (Registry of Diverticular Disease)

To determine the clinical characteristics and risk factors for the onset of diverticular disease and its complications in the Italian population.

Diverticulosis and diverticular disease present a high prevalence rate in the world population, especially in the Western world. Diverticulosis of the colon is an extremely common condition in industrialized countries and its prevalence rate increases with age, and exceeds 60% in patients aged over eighty. Although the course of diverticulosis is normally free of symptoms and complications, about 15% of patients develop symptoms often undistinguishable from those of the irritable bowel syndrome, such as abdominal pain, bowel disorders and bloating. About 5% of patients with diverticular disease develop an episode of uncomplicated acute diverticulitis with abdominal symptoms accompanied in some cases by systemic symptoms, such as fever or malaise and laboratory evidence of activation of the inflammatory process. In a minority of these cases, the patient suffers major complications such as the development of abscesses, fistulae, haemorrhage or stenosis (1).

The pathogenesis of diverticulosis and diverticular disease remains unclear. Genetic predisposition, risk factors (2), relationships with the irritable bowel syndrome (3-5), a low-fibre diet, involvement of intestinal microbiota and the mucosal immune activation (6-7) remain elements whose significance is yet to be confirmed. The management, medical and surgical approach and the prevention of relapses of diverticular disease remain above all empirical and supported by few controlled clinical studies (8-9). This scenario of uncertainty may result in waste and diagnostic/therapeutic pathways not always suitable for a disease with such a high prevalence rate. On the basis of these considerations, there is a need to collect systematic information useful for determining aetiopathogenetic aspects and outcomes with greater accuracy.

OBJECTIVES OF THE STUDY

The purpose of the study is to structure a national register on an IT platform useful for determining:

1. The clinical aspects of diverticulosis/ diverticular disease
2. The risk factors of diverticulosis/ diverticular disease
3. The risk of complications of diverticular disease and the factors of risk and protection against complications.
4. The management of medical and surgical treatments

Eligibility Criteria:
Inclusion Criteria:

All consecutive patients satisfying the following inclusion criteria are recruited:

1. Acceptance to sign the Informed Consent form
2. Age \>18
3. Instrumental evidence (endoscopic or radiological) of diverticula in the colon.

Exclusion Criteria:

1. Refusal to sign the Informed Consent form
2. Inability to comply with the study procedures
Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote

The hypothesis is that the characteristics of extended release Depakote will allow overnight conversion of immediate release to extended release form of Depakote. This has been tested successfully in younger patients but not in individuals over the age of 60. We will include individuals between 60 and 80 years old.

Twenty patients will be randomily assigned to convert overnight (10 pts) or over six days (10 pts). Side effects will be formally evaluated by the UKU side effect rating scal which will be done 7 days before conversion (day -7), the day of conversion (day 0)and then at the start of days +2, +7 and +14. This investigator conducting the evaluation will be blinded to the conversion status of the patient. Secondary measures to be obtained will be a Quality of Life measure (QOLIE-89) on Day 0 and +14. Plasma samples will be obtained on Day 0 and +14 before dosing for total and free valproic blood level.

Eligibility Criteria:
Inclusion Criteria:

* 60 yo and older on stable dose of valproate (Depakote DR)

Exclusion Criteria:

* Unstable neurolgical, medical or psychiatric disorder
From Great Surgeons to Brilliant Observators, Evolution of Penetrating Neck Trauma in a Single Center Reference in Spain

Penetrating neck trauma ranges from 5 to 10% of trauma patients and its management has been changing in the las 20 years and not all surgeons that attend this patients are trauma surgeons. The aim of the study is to describe the evolution of the management in a referal center and the complications of two periods, with and without a simplified protocol.

Penetrating neck trauma ranges from 5 to 10% of trauma patients and its management has been changing in the las 20 years and not all surgeons that attend this patients are trauma surgeons.

Traditionally, the management was followed by surgical treatment, but the non-therapeutic cervicotomies were ascendent to the 89%, the zone approach was established, following the Monson anatomy zones, with different indications for surgery in every zone, and finally, after the year 2000, started to publish articles on where the injury was not correlated with the zone in about a 23% of the patients.

The aim of the study is to describe the evolution of the management in a referal center and the complications of two periods, with and without a simplified no zone approach protocol.

Eligibility Criteria:
Inclusion Criteria:

* All penetrating trauma patients admitted in the emergency department.

Exclusion Criteria:

* All patients with any other diagnostic different from penetrating trauma
* Blunt trauma patients admitted in the emergency department