cyrilzakka/clinical-trials huggingface dataset:
Head Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect

Head-mounted display based virtual reality rehabilitation for hemispatial neglect.

The investigators examine about the efficacy of field-of-regard-focused visual exploration therapy implemented using a head-mounted display virtual reality system for hemispatial neglect rehabilitation following stroke.

Eligibility Criteria:
Inclusion Criteria:

* presence of left hemispatial neglect as demonstrated by a score above the cut-off on the line bisection test or star cancellation test of the Behavioral Inattention Test, or mild-to-moderate neglect-related functional impairment defined by a score of 1-20 points on the Catherine Bergego Scale
* age 19 to 65 years
* first-time right hemispheric ischemic or haemorrhagic stroke as evidenced by brain imaging and medical records
* a score \>25 on the Mini-Mental State Examination

Exclusion Criteria:

* presence of oculomotor palsies or visual defects as assessed via standard neurological examination
* orthopaedic disorders affecting neck movement
* inability to maintain a seated position.
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

The detection of minimal residual disease (MRD) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of adult ALL. No standard treatments are available for patients with MRD-positive B-precursor ALL. Blinatumomab (MT103) is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against cluster of differentiation (CD)19 expressing cells. The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

Participants will receive up to four 4-week cycles of intravenous blinatumomab treatment followed by an infusion-free period of 14 days. A safety follow-up will be performed 30 days after the end of the last infusion and efficacy follow-ups will occur until 24 months after treatment start. Participants will be followed for up to 5 years after the start of treatment for survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks
* Presence of minimal residual disease at a level of ≥ 10\^-3
* Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment
* Negative human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
* Negative pregnancy test in women of childbearing potential
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Presence of circulating blasts or current extra-medullary involvement by ALL
* History of relevant central nervous system (CNS) pathology or current CNS pathology
* Prior allogeneic hematopoietic stem cell transplant (HSCT)
* Eligibility for treatment with tyrosine-kinase inhibitors (TKI)
* Systemic cancer chemotherapy within 2 weeks prior to study treatment
* Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
* Previous treatment with blinatumomab
Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery

Observational study.

Blood transfusion is expensive, and has medical and safety consequences for patients who benefit from it. In cardiac surgery, the data concerning the level of perioperative transfusion are very heterogeneous from one center to another. In a large US cohort study of 798 cardiac surgery centers and 102,470 patients undergoing coronary artery bypass surgery, the rate of blood transfusion varies from 8 to 93% depending on the center. It would appear that the largest and most experienced centers have a blood transfusion rate of around 60%.

In addition to its beneficial role in reducing mortality induced by deep or poorly tolerated anemia, current data from the literature also raise morbidity and mortality related to blood transfusion. Murphy et al. Have shown, in an English cohort of cardiac surgery, that transfusion of CGR was correlated with the occurrence of postoperative infections and ischemic events, as well as early and late excess mortality. These effects appear as early as the first transfused red blood cell, which is confirmed by a prospective Brazilian study with a hazard ratio of death occurrence of 1.2 for each RBC transfused after cardiac surgery.

Preoperative anemia is found in 25% of patients in programmed cardiac surgery and its etiologies are varied. Iron deficiency appears to be at the forefront, especially in coronary patients for whom studies report up to 48% iron deficiency anemia. It may also be vitamin B12 deficiency or folate, chronic pathologies such as renal insufficiency, or any other common cause of anemia.

According to the latest European recommendations, iron deficiency should be defined as \<100 ng / mL ferritin or \<300 ng / mL ferritin combined with a transferrin saturation \<20%.

In cardiac surgery, iron deficiency affects 37% of preoperative patients and is associated with more frequent preoperative and postoperative anemia. It is an independent risk factor for postoperative blood transfusion, even in the absence of preoperatively associated anemia It is currently recommended to seek iron deficiency preoperatively during the discovery of any microcytic anemia and to achieve iron substitution if found. And also to seek supplemental iron deficiency in all patients with cardiac insufficiency.

Eligibility Criteria:
Inclusion Criteria:

All adult patients programmed for cardiac surgery in the cardiothoracic surgery departments of Rennes, Poitiers, and Brest.

Exclusion Criteria:

* Children \<18 years;
* Procedures for endovascular surgery;
* Vascular surgery other than ascending aorta and lacrosse;
* Non-cardiac thoracic surgery;
* Persons of full age who are subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.

Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.

Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥18 years;
* Patients with a Body Mass Index (BMI) included in the interval \[18.5-33.0\] kg/m²;
* Patients who received a primary kidney transplant at least 12 months prior to study entry

Exclusion Criteria:

* Evidence or suspicion of ongoing or persistent, acute or chronic rejection;
* Requirement for dialysis within the six months prior to study entry;
* Glomerular filtration rate (GFR) \<30 mL/min
* Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test;
* Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;
Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System

The purpose of this study is to find out if patients having the ON-Q post-op Pain Relief System for pain management of multiple rib fractures will require fewer ventilator days, and will need less IV pain medicine to control their pain, and as a result have improved respiratory function during their recovery.

The standard of care for providing pain relief for rib fractures is to use an opioid drug that is injected into the vein but also has side effects. Increased doses can lead to over sedation and consequently lead to difficulty with breathing. The ON-Q pain relief systems uses a local anesthetic under the skin. The anesthetic is called bupivicaine, and it is delivered from a thin tube approximately 10 inches long is tunneled under the skin along the back and parallel to the spine. The medication is stored in an elastic pump which delivers a slow continuous drip of medication from multiple holes in the tubing. Subjects will be randomized to either standard intravenous opioid pain management or the ON-Q pain relief device with supplemental opioid medication if needed. The device will remain in use until the subjects are able to breathe without the ventilator.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* 3 or more rib fractures
* Intubated ready for weaning from ventilator support
* FI02 \< 50%
* Peep \< 10cm H2O

Exclusion Criteria:

* \< 18 years of age
* Pregnant
* Unable to communicate pain status
* Allergy to local anesthetics
* Coagulopathy
* Skin lesions or abnormalities from previous injury or surgery
* \< 3 rib fractures
SAFEWALKER Contribution to the Rehabilitation of Older People After a Post-fall Syndrome

The main objective of this study is to evaluate the feasibility and acceptability of the use of the robot "SAFEWALKER" complement classical rehabilitation in a group of elderly patients over 70 years during the rehabilitation of post-fall syndrome.

The post-fall syndrome is an acute functional complications of falls that affects nearly one in five elderly fallers. It combines phobia of the previous vacuum, axial and hypertension astasia abasia.

Unrecognized and untreated, it progresses to a major regressive syndrome, severe physical, psychological and social implications. Only an early rehabilitation for an early resumption of walking, prevents such a development.

The main element is to support and encourage the subject to walking. In practice, it was found that the physiotherapist can not be present daily and the duration of its intervention is often short-lived.

This study will examine the contribution of a medical device of a walking aid (SAFEWALKER the robot) in the rehabilitation and empowerment of seniors with a post-fall syndrome. The SAFEWALKER, which is a walking aid device (http://www.safewalker.com), completes the support action exercised by a third person, by reducing support and securing travel. It allows the subject to move alone at will and is a continuity in relation to the management of the physiotherapist, a potential source of motivation.

The hypothesis is that the SAFEWALKER device can be complementary to the walking rehabilitation in post-fall syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for the treatment of post-fall syndrome

Exclusion Criteria:

* Demential pathology (Mini Mental State \<20)
* Parkinson's disease and other degenerative neurological disorders
* Stroke sequelae
* Fractures members in the previous 12 months
* Lower limb prostheses in place within 6 months prior
* Psychiatric disease
* Presence of mucocutaneous lesions perineal
* Obesity (weight \>120 kg)
Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)

Eligible candidates will be adults with aggressive or very aggressive NHL (WHO classification diagnosis confirmed by histological tumor examination). Patients must have failed one or more prior NHL chemotherapy or antibody therapy with curative intent, and the disease must not have progressed within 60 days of last therapy. In addition, patients must not be candidates for potentially curative therapy, such as HSCT, or they must have refused these alternative therapies. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. Intravenous ascorbic acid will be given in a dose based on the plasma vitamin C level to reach a level in the range of 300 to 350 mg/dL. Vitamin C infusions will be given three times a week on a schedule that allows at least 24 hours between each infusion, for a total of ten weeks (30 infusions). If disease progression occurs before or at the ten week assessment, then we discontinue protocol, based on futility. Toxicity and adverse events also will result in immediate discontinuation (details available in full protocol). If there is lack of disease progression or disease improvement, proceed and reassess again at 10 week intervals, for a total of three 10 week intervals. Initial criteria are based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson et al., Report of an international workshop to standardize response criteria for non-Hodgkin's lymphoma, Journal of Clinical Oncology, 1999, Vol. 17, No4, 1244-1253); response for this study will utilize PET in accordance with revised criteria (Cheson et al. Revised response criteria for malignant lymphoma. J of Clin Oncol 2007; 25(5): 579-586). We select 20 patients as an appropriate study size to evaluate a true response rate to therapy, compared to just the observed response.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years old
* Aggressive or very aggressive NHL
* Failed one or more therapies
* Patients must not have progressed within 60 days of last therapy
* Not received allogeneic stem cell transplant
* No reasonable standard therapeutic options available
* Glucose 6 phosphate dehydrogenase status normal
* ECOG performance status 0-2
* Normal creatinine and transaminase
* Women of child-bearing potential confirm negative pregnancy test

Exclusion Criteria:

* Significant co-morbid disorders
* Significant psychiatric symptoms
* Smoking
* Excessive alcohol or drug use
* Enrollment in other experimental therapy
* Active infection
* Patients experiencing ongoing response to recent treatments
* Patients who have received chemotherapy within 30 days or biological therapy within 6 weeks
Systematic Case Series Investigating Eye Movement Desensitization Reprocessing (EMDR) Efficacy With Childhood Sexual Abuse Survivors

This study investigates the effectiveness of EMDR for survivors of childhood sexual abuse. All participants will undertake a standard course of EMDR via the National Heath Service program, alongside a number of questionnaires and a follow-up interview.

The aim of this study is to investigate the effectiveness of Eye Movement Desensitisation Reprocessing (EMDR) via investigation of the changes in the individual trauma stress response on sexually abused adolescents and young adults, aged between 18 and 25 during EMDR treatment. The findings of this mixed methods study will explore (a) neuropsychological, emotional (namely low self-esteem, anxiety and depression), behavioural functioning and quality of life issues via quantitative measures conducted before, during and after treatment and (b) client perspectives of such changes through qualitative interviewing (interview guide is in Appendix 7) at one month follow-up using Interpretative Phenomenological Analysis \[IPA\]. The study setting will be conducted within the Improving Access to Psychological Therapies (IAPT) program framework, established to ensure service users accessing NHS treatment are presented with choice in their treatment. Therapy will routinely be delivered within GP Surgeries or Health Centres.

Within this two-fold study, the following key research questions will be considered in relation to the effectiveness of EMDR:

1. Qualitative data will sought to identify; In what ways was EMDR helpful? In what ways was EMDR perceived as being unhelpful?
2. Quantitative data will sought to identify; Are there changes in emotional and behavioural functioning (in relation to trauma, anxiety and depressive symptoms)? Are there changes in neuropsychological functioning (memory, attention, executive functioning)? Are there changes in quality of life issues? Are there changes in self-worth?

Eligibility Criteria:
Inclusion Criteria:

Participants, both male and female, aged between 18 and 25, whom;

* have experienced CSA before the age of 16
* exhibit PTSD symptomology
* ensure PTSD symptomology is present for over three-months and primarily derived from pre-16 aged trauma
* be available for treatment-sessions on a weekly basis for up to 16-sessions - have good understanding of the English language to avoid language barriers/additional time spent with interpreters
* if taking medication, this will have been stable for a period of at least 2-months prior to therapy
* EMDR is the sole treatment for PTSD from baseline until follow-up to avoid conflict of interest

Exclusion Criteria:

Participants exhibiting;

* significant psychiatric comorbidity
* comorbid psychotic disorder
* bipolar disorder type 1
* alcohol or drug dependence
* acute suicide risk, acute PTSD from trauma within the past 6 months
* PTSD focused treatment within the past 3 months or scheduled to begin another form of PTSD treatment will be excluded
* those currently participating in research or have recently participated in conflicting research
Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This

Peritoneal Dialysis (PD) is a commonly used treatment for end stage renal failure, and the most commonly used dialysate contains unphysiological amounts of glucose, a high proportion of which is absorbed. Recent analysis of the Global Fluid Study, has established that in non-diabetic prevalent patients on PD a random glucose level is dependent on dialysate glucose load and is a predictor of death. By utilising clinical data and additional biosamples collected for the NIHR funded PD-CRAFT study, the investigators aim to confirm this finding, define the relationship between dialysate glucose exposure according to prescription regimes and glycaemia, define the most useful biomarker to monitor glycaemia , and establish the role that impaired insulin sensitivity plays in blood glucose levels. Furthermore the investigators will explore the hypothesis that insulin resistance is associated with disturbance of the carnitine/acetyl-carnitine equilibrium that might benefit from intra-peritoneal carnitine supplementation.

PD-CRAFT is an observational cohort study of 3000 prevalent PD patients collecting detailed clinical data, including glucose exposure and samples of dialysate. and blood which will be stored in the UK BioCentre. Follow up is for up to 2 years or endpoint (death, technique failure).

Multivariate regression will be used to establish determinants of the non-fasting blood glucose and other measures of glycaemia, in particular different dialysis regimes, (e.g. modality, dwell lengths, fill volumes, and dialysate type and concentration specifically seeking to identify prescriptions that minimise the systemic effects) combined with measures of insulin resistance. The investigators will establish whether blood glucose predicts survival in an adjusted analysis (\~300 endpoints needed) using Cox regression and explore the relationship of other biomarkers to survival.


Eligibility Criteria:
Inclusion Criteria:

* On peritoneal dialysis

Exclusion Criteria:

* Not providing informed consent.
* Diabetes.
History of Polycystic Ovary Syndrome in First-degree Relatives

The aim of this study was to investigate the semen analysis results of male patients with first-degree relatives meeting the diagnostic criteria for PCOS.

Polycystic ovary syndrome (PCOS) is an endocrine metabolic disorder characterised by menstrual irregularity, anovulation, clinical and/or biochemical signs of hyper androgenism (hirsutism and/or acne), micropolycystic ovaries and metabolic abnormalities.

This syndrome is clustered in family members and appears to be inherited through an oligogenic mechanism (1,2). As a result of familial clustering of the PCOS phenotype, metabolic risks have been shown to increase in family members, independent of gender.

The presence of a genetic background in the etiopathogenesis of PCOS means that men may also have signs and symptoms equivalent to PCOS. In addition, the genes responsible for PCOS susceptibility in women are also transferred to male relatives of these individuals. Hormonal and metabolic abnormalities have been identified in male relatives of women with PCOS. These men have shown a higher prevalence of early-onset (\<35 years) androgenetic alopecia (AGA), type 2 DM and cardivascular diseases. In addition, prostate cancer, benign prostatic hyperplasia (BPH) and prostatitis have also been defined more frequently in this group of individuals (1,3).

In addition, differences in responses to gonadotropin-releasing hormone (GnRH) and FSH and LH levels were found in the brothers of women with PCOS compared to control groups.

According to genome studies (GWAS), FSHB gene on chromosome 11p14.1 represents the PCOS susceptibility focus in women (1). Genetic variations in FSHB affect male reproductive function. In fact, polymorphisms of the FSHB promoter have been associated with lower sperm count, higher LH, lower FSH and lower testicular volume (3,4).

In the light of this information, in this study, it was planned to evaluate the comparison of semen analysis results of male patients with a first-degree relative diagnosed with PCOS with the control group.

Eligibility Criteria:
Inclusion Criteria:

* The study will include male partners between the ages of 18-40 who have no known disease, who give spermiogram test for the evaluation of infertile couple in our hospital and who have accepted the consent form verbally and in writing.

Exclusion Criteria:

* Exclusion criteria;

  1. History of any chronic disease, urinary tract or reproductive disease, neurological or psychiatric condition in the male patient and recent fever (≥38°C in the last 3 months)
  2. Those with a history of vasectomy, cryptorchism, radiation history, chemotherapy, infections, sexual dysfunction and endocrine hypogonadism
  3. Especially those with a history of finasteride and dutasteride drug use.
Non-invasive BCI for Cognitive Enhancement

People's perceptual skills can significantly affect their abilities to make optimal decisions, judgments, and actions in real-world dynamic environments. Perceptual learning refers to training and experiences to induce improvements in the ability to make sense of what people see, hear, feel, taste or smell based on ambiguous sensory information. In this study, investigators hypothesise that there exist neural signatures that robustly encode the conscious visual perception of rotations of a cursor and the magnitudes of these rotations in a novel, rotation-based perceptual learning task. Investigators also hypothesise that online, instantaneous EEG-based feedback on subjects' visual perceptions of rotations with an EEG-based Brain Computer Interface (BCI) can foster perceptual learning much more effectively than behaviour perceptual training, especially in very small rotation magnitudes that represent extremely difficult perceptual tasks.


Eligibility Criteria:
Inclusion Criteria:

Able-bodied volunteers:

* good general health
* normal or corrected vision
* no history of neurological/psychiatric disease
* ability to read and understand English
* ability to understand information and ability to give a free and informed consent

Subjects with neuropsychiatric diseases

* Subjects with neuropsychiatric diseases such as bipolar disorder and schizophrenia.
* normal or corrected vision
* ability to read and understand English
* ability to understand information and ability to give a free and informed consent

Exclusion Criteria:

* short attentional spans or cognitive deficits that prevent to remain concentrated during the experimental sessions
* concomitant serious illnesses (e.g., metabolic disorders, cardiac arrest)
* factors hindering proper EEG acquisition (e.g., scalp wound, uncontrolled muscle activity)