cyrilzakka/clinical-trials huggingface dataset:
Testing Whether a Short Training Program Designed to Improve Cognitive Skills Improves 4-year-olds' Maths Skills

This study will test whether a short training program - designed to improve memory and attention skills - will benefit mathematical reasoning in preschoolers from a range of socio-economic backgrounds. The investigators will test how long any benefits last for and whether any intervention effects are greater for children from disadvantaged backgrounds. The aim is to test interventions that aim to close the achievement gap by improving skills known to underpin academic skills, at an age children may benefit most from training.

Children's academic success across a range of domains is related to their executive function skills - specifically by their ability to maintain and update information (working memory) and to suppress inappropriate responses (inhibitory control). These skills undergo significant development during the preschool years. Notably, preschool executive function skills strongly predict school readiness, as well as concurrent and later academic achievements in mathematics. The aim of this project is to test an intervention that is specifically designed to improve preschoolers' executive functions - crucially, before the achievement gap sets in. The study will be carried out, following CONSORT (2010) guidelines, with typically developing preschoolers (aged approximately 4 years of age). The study will include children from socioeconomically advantaged and disadvantaged families. Children will be randomly assigned to either an executive function training group or an active control group. A nominated person external to the project will conduct the random allocation process. The random allocation will be done for each nursery to ensure roughly even numbers in each group from each nursery. Children in both groups will complete computerized tasks lasting 15-20 minutes once a week for four weeks. The investigators will compare the trained children to an active control group that closely matches the training in terms of activity. To check for improvements, the investigators will measure cognitive and maths skills at baseline (one week before training); one week post-training; three months post-training; and one year post-training. These assessments will be conducted by testers blind to the child's group.

Eligibility Criteria:
Inclusion criteria:

* Must be attending a nursery school attached to a primary school.
* Must speak and understand English (class teachers will advise on this).
* Must have at least one measure of working memory completed at baseline and one measure of inhibitory control completed at baseline.

Exclusion criteria:

* Must not have a significant diagnosed or known physical, mental or learning disability.
Cognitive Remediation Therapy in Schizophrenia: Effects on Epigenetics

This study is a randomised and controlled trial that aims to investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene in patients with Schizophrenia.

OBJECTIVES: To investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene. It also aims to test whether BDNF valine-66-methionine (Val66Met) polymorphism influences CRT treatment outcome among people with schizophrenia.

SAMPLE AND METHODS: A randomized and controlled study will be carried out with two groups: patients receiving CRT and patients in control condition without any cognitive intervention and receiving Treatment as Usual (TAU). Methylation levels of BDNF gene at different sites will be contrasted before and after treatment. Additionally, neurocognition profile, level of symptoms and psychosocial functioning will also be tested. CRT outcomes will be investigated in a mixed model for repeated measures.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-5 and confirmed by the semi-structured interview (SCID) for the axis 1.
* Presence of cognitive impairment 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
* Antipsychotic dose change \>10%
* Abuse of psychotropic substances
* Presence of other psychiatric symptomatology
tDCS Effects on Associative Learning in Younger Adults

The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals."


Eligibility Criteria:
Inclusion Criteria:

* Age: young (18-30 years)
* Right handedness
* unobtrusive neuropsychological screening

Exclusion Criteria:

* Mild cognitive impairment (MCI) or other neurological diseases.
* History of severe alcoholism or use of drugs.
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).
Preoperative RRI and Long-term Risk for CKD

Renal resistive index (RRI) is calculated from ultrasonographic Doppler measurements of flow velocities in intraparenchymal renal arteries. Normal values are around 0.60, and 0.70 is considered the upper normal threshold in adults. Both preoperative and postoperative elevation of RRI has shown promise in early detection of AKI after cardiac surgery. Further, elevated RRI before coronary angiography is associated with an increased risk of cardiovascular complications up to 1 year after the procedure. The role of preoperative RRI in predicting long-term renal and cardiovascular complications after elective surgery is however not known. The aim of this study is to assess the role of preoperative RRI to predict the risk of persistent renal dysfunction as well as renal- and cardiovascular complications up to 5 years after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Elective coronary artery bypass grafting, heart valve surgery, or aortic surgery performed at Karolinska University Hospital between September 2014 and April 2015
* Preoperative measurement of RRI performed with satisfactory Doppler reading
* Written informed consent

Exclusion Criteria:

* Kidney transplant
* Dialysis-dependent kidney disease
* Cancelled surgery
* Missing follow-up data
HCC Staging Modified by Tumor Micronecrosis

Tumor micronecrosis is a pathological feature that reflects malignant biological behavior in hepatocellular carcinoma (HCC). This study aimed to evaluate the prognostic significance of tumor micronecrosis based on the current BCLC and TNM staging systems, and futher improve the performance of the staging models by establishing modified new staging models including tumor micronecrosis.


Eligibility Criteria:
Inclusion Criteria:

* primary and histologically confirmed HCCs
* patients who underwent curative liver resection

Exclusion Criteria:

* simultaneous presence of other tumors
* patients who had received preoperative antitumor therapies
* no available surgical specimens for evaluating micronecrosis status
* gross tumor necrosis and Nscore = 3
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study

This observational research study aims to answer the question: 'Which aspects of human biology play an important role in recovery from symptomatic malaria?'

In particular, the researchers aim to identify human genes for which the level of gene activity reflects the patient's overall rate of recovery. The researchers believe this approach may reveal new targets for adjunctive therapies.

The researchers aim to recruit 240 people, of all ages, who have been diagnosed with symptomatic malaria at selected hospitals in London. Blood samples, urine samples, and clinical information will be collected over the 14 days following malaria diagnosis.


Eligibility Criteria:
Inclusion Criteria:

Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film.

Exclusion Criteria:

Patients with asymptomatic malaria; Patients with congenital malaria; Patients with Plasmodium gametocytaemia only; Patients with known HIV; Patients who have received antimalarial treatment for symptomatic malaria in the 28 days prior to hospital presentation; Patients who explicitly deny consent.
Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH）

This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old.
* The diagnosis of cardiomyopathy was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
* Patients or their families agreed to participate in the study and authorized informed consent.

Exclusion Criteria:

* Incomplete clinical data.
* Do not agree to the inclusion or refuse to authorize the informed consent.
Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device

Sorin Group has developed a new atrial lead which is under evaluation during this study. The SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature; interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization.

The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the physician in his diagnosis avoiding potential lost of capture.

The ICD device has also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.

Finally, the study will report the electrical and handling performances of the new left ventricular lead.

In this study, the sponsor aims at:

* Demonstrating the safety of the atrial SonR lead;
* Demonstrating the performances of the right ventricular autothreshold algorithm ;
* Reporting the adverse events documented in the study;
* Reporting electrical performances of Sorin Group PARADYM ICD, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
* Reporting the Sorin atrial SonR and Situs 2 MV left ventricular leads performances;
* Reporting the SonR atrial lead mechanical handling.
* Reporting all information from SonR sensor to validate the SonR data exploitation and the AVD/VVD optimization.
* Reporting the Situs 2 MV LV lead mechanical handling.
* Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.

Thus, this study intends to show that PARADYM RF ICD operate safely and appropriately in intended-use as part of an ICD system.

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for implantation of a CRT 9770 device accordingly to the relevant currently-approved ACC/AHA/ESC guidelines or any relevant currently approved local guidelines for the implantation or replacement of triple-chamber ICD
* Implanted with atrial SonR lead
* Signed and dated informed consent

Exclusion Criteria:

* VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
* VT/VF occurred during the acute phase of infarction (\< 3 weeks) or during an unstable ischemic phase;
* VF was caused by electrocution;
* Incessant VT/VF;
* Patient is unable to attend the scheduled follow-ups at the implanting centre;
* Patient is already enrolled in another ongoing clinical study;
* Patient is unable to understand the aim of the study and its procedure;
* Patient refuses to cooperate;
* Patient is unable or refuses to provide informed consent;
* Patient is minor (less than 18-year old);
* Patient is pregnant;
* Patient has life expectancy of less than 1 year;
* Patient is forfeiture of freedom or under guardianship.
Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors

This study is an early exploration clinical study with one arm. The study consists of two stages, namely the dose escalation stage and the dose extension stage:


Eligibility Criteria:
Inclusion Criteria:

1. The Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
2. The physical fitness status score of the ECOG is 0 or 1
3. At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

1. The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
2. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
3. Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
5. Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin)
Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training

Spinal Cord Injury (SCI) disrupts signals between the brain and the rest of the body, this includes signals needed to control the bladder and bowels. Spinal cord stimulation (SCS) (electrical stimulation through electrodes placed on the skin over the spine) has shown potential to improve bladder function. Additionally pelvic floor muscle training (PFMT), has been shown to help control bladder overactivity and reduce incontinence in people with a SCI.

This study will investigate PFMT with SCS, and its effects on restoring bladder function, and continence. We aim to recruit 25 participants. Those eligible will be patients from the London Spinal Cord Injury Centre with a supra-sacral SCI (\>6 months post-injury), aged 16 years old and above.

The first five participants who volunteer will be invited to complete 'SCS optimisation'. Testing different SCS electrode positions and stimulation parameters with pelvic floor exercises and during urodynamics (measurement of pressure changes during filling and emptying of the bladder).

For the main study, all participants will complete baseline assessments (week 1) which include: bladder, bowel, sexual function, and quality of life questionnaires, a pelvic floor assessment, and urodynamics. Assessments will be repeated at week 8, and week 14.

After baseline assessments, participants will be randomly allocated to one of two groups. The intervention group will receive 8-weeks of at home PFMT, this will include 3 face-to-face visits, daily text reminders, and a weekly phone call. The control group will continue with usual care for 8-weeks.

At the end of the 8-weeks, all participants will be re-assessed, and will then complete a single session of SCS with urodynamics. Participants will return for their final assessment 6-weeks later (week 14). Participants allocated to the control group will be offered PFMT at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Supra-sacral spinal cord injury over 6 months ago
* Previous urodynamics and management by the Neuro-urology Consultants
* Proven NDO from latest urodynamics

Exclusion Criteria:

* Participants under 16 years of age
* Non-stable SCI or metastatic cord disease
* Intra-detrusor botulinum toxin injections in previous 6 months
* Bladder infection on day of investigation
* Pregnant or trying for a baby (females)
* Cardiac pacemaker, bladder stimulator or baclofen pump in situ
* Metal work at thoraco-lumbar level of stimulation
* Poorly controlled Autonomic Dysreflexia
* Currently involved in a clinical trial
* Previous surgical intervention on bladder/sphincters
* Active sepsis
* Poorly controlled epilepsy. Acceptable where epilepsy is controlled by drugs or there have been no fits experienced for a reasonable period
* Patients with a cancerous tumour in the area of the electrical stimulation
* Patients without the capacity to consent
Chronotherapy in Children With Chronic Kidney Disease

This is a pilot, crossover trial in which the investigator will determine if retiming of one anti-hypertensive medication from morning to evening can effectuate normal blood pressure dipping patterns in children and adolescents with chronic kidney disease.

Normally blood pressure declines by at least 10% from daytime to nighttime. In children with chronic kidney disease (CKD), often this does not happen (termed "non-dipping"). This study is a pilot, randomized cross-over trial. The main purpose of this study is to investigate whether non-dipping can be modified with retiming of anti-hypertensives in children with CKD. This is important because in adults, non-dipping has been associated with increased cardiovascular disease risk and more rapid progression of kidney disease. Thus, identification of how to modify this in children with CKD, may lead to future randomized controlled trials to evaluate whether chronotherapy improves outcomes in this population, which is at high risk for morbidity and mortality in adulthood.

The primary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal systolic blood pressure change (%) in children with CKD, hypertension and non-dipping.

The secondary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal diastolic blood pressure change (%) in children with CKD, hypertension and non-dipping. Another secondary objective is to determine if the proportion of subjects classified as having a non-dipping pattern is significantly lower on evening dosing of anti-hypertensives.

Eligibility Criteria:
Inclusion Criteria:

* Male or female child/adolescent up to 18 years of age with CKD
* estimated glomerular filtration rate (eGFR) of 30 to 90 ml/min/1.73 m2
* diagnosed with hypertension and on a stable dose of anti-hypertensive medication(s) for at least 3 months
* Non-dipping identified on ABPM

Exclusion Criteria:

* history of organ transplantation, oncological disease, or dialysis
* inability to complete 24-hour ABPM or 24-hour urine collection
* Children less than 6 years of age will be excluded, as they often are unable to complete a successful ABPM study (≥ 40 readings, with 1 reading per hour of sleep)
* Currently on diuretic medications.
Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia

The aim of the present prospective randomized study was to challenge the ability of SSI to detect painful stimulation during sevoflurane - remifentanil anesthesia.

General anesthesia can be considered as a combination of hypnosis, antinociception and immobility. Whereas monitoring of depth of hypnosis, and muscle relaxation can be regarded as accepted, determination of the nociception is based on clinical signs like somatic or autonomic responses.

Recently, the multivariate surgical stress index (SSI)has been demonstrated to correlate with surgical stress intensity. Thus, SSI might be a useful variable to adjust analgesic drug administration in individual patients.

We want to investigate whether SSI is able to indicate nociception following standardized noxious stimulation during balanced sevoflurane - remifentanil anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* ASA physical status 1-2
* elective surgery in general anesthesia of 1 to 2 hours
* written informed consent

Exclusion Criteria:

* pregnancy
* history of cardiac arrhythmia
* presence of any neuromuscular or neurological disease
* use of CNS-active medication or abuse of alcohol or illicit drugs