cyrilzakka/clinical-trials huggingface dataset:
Error Based Learning for Restoring Gait Symmetry Post-Stroke

Many of the 780,000 people affected by stroke each year are left with slow, asymmetric walking patterns. The proposed project will evaluate the effectiveness of two competing motor learning approaches to restore symmetric gait for faster, more efficient, and safer walking.

Walking after stroke is characterized by reduced gait speed and the presence of interlimb spatiotemporal asymmetry. These step length and stance time asymmetries can be energy inefficient, challenge balance control, increase the risk of falls and injury, and limit functional mobility. Current rehabilitation to improve gait is based on one of two competing motor learning strategies: minimizing or augmenting symmetry errors during training. Conventional rehabilitation often involves walking on a treadmill while therapists attempt to minimize symmetry errors during training. Although this approach can successfully improve gait speed, it does not produce long-term changes in symmetry. Conversely, augmenting or amplifying symmetry errors has been produced by walking on a split belt treadmill with the belts set at different fixed speeds. While this approach produced an 'after-effect' resulting in step length symmetry for short periods of time, with some evidence of long term learning in people with stroke, it had no influence on stance time asymmetry. The investigators propose that patients need real-time proprioceptive feedback of symmetry errors so that they are actively engaged in the learning process. For this project, the investigators developed and validated a novel, responsive, 'closed loop' control system, using a split-belt instrumented treadmill that continuously adjusts the difference in belt speeds to be proportional to the patient's current asymmetry. Using this system, the investigators can either augment or minimize asymmetry on a step-by-step basis to determine which motor learning strategy produces the largest improvement in overground spatiotemporal symmetry.

Eligibility Criteria:
Inclusion Criteria:

* ability to walk \>10 m overground without physical assistance
* overground comfortable gait speed (CGS) \< 1.0 m/s (using assistive devices and bracing below the knee as needed)
* able to walk independently on the treadmill at \>80% CGS
* exhibits stance time and/or step length asymmetry during CGS

Exclusion Criteria:

* cerebellar lesion
* uncontrolled cardiorespiratory/metabolic disease (cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema)or other neurological or orthopedic disorders that may affect gait training
* botulinum toxin to the lower limb in the past 6 months
* a history of balance deficits or unexplained falls not related to the stroke
* uncontrolled seizures
* concurrent physical therapy
* Mini-Mental Status Exam (MMSE) \< 24
* communication impairments which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures
Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer

This study will assess whether the Sienna+/Sentimag system, which involves a magnetic tracer, is effective in identifying the sentinel lymph node in rectal cancer and whether it is then feasible to remove this lymph node during surgery to locally excise early rectal cancer.

One issue in managing rectal cancer is identifying which patients will benefit from less radical surgery, which is much safer and better tolerated. However it does not remove lymph nodes where cancer cells may have spread. If lymph nodes containing cancer are left behind, the cancer may recur. So this surgery is only suitable in early rectal cancers not involving lymph nodes. Unfortunately, current investigations do not always accurately identify involved lymph nodes.

Sentinel lymph node biopsy (SLNB) is a technique to surgically remove the first lymph node where cancer cells spread. If this lymph node contains cancer, radical surgery is needed to reduce the risk of recurrence. However if it is clear, less radical surgery should be sufficient. This is standard practice for breast cancer and avoids unnecessary major surgery in many patients.

The investigators aim to assess whether SLNB is useful in rectal cancer. The investigators will determine whether the Sienna+/Sentimag system effectively identifies the sentinel lymph node, and whether the node can then be removed surgically.

The investigators will recruit patients in Oxford hospitals about to undergo surgery for rectal cancer. Patients will receive an injection of magnetic tracer during endoscopy prior to surgery. Some patients will have an extra MRI scan. During or after surgery, depending on the type of operation planned, a magnetic probe will be used to locate the sentinel lymph node in the tissue around the rectum. The removed specimen will be examined by a pathologist. Funding to undertake this study has been granted by the National Institute for Health Research (NIHR). Endomagnetics, the manufacturer, will supply the magnetic tracer and probe for use in this study.

If successful, the investigators will plan a larger clinical trial. This could have a major impact on improving outcomes for patients by allowing less radical surgery to be used where it is most appropriate.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with operable rectal cancer
* case discussed at Oxford Colorectal Cancer multi-disciplinary team (MDT) meeting
* willing and able to give informed consent
* willing and able to comply with all trial requirements, in the investigator's opinion

Exclusion Criteria:

* females who are pregnant or lactating
* known intolerance or hypersensitivity to iron, dextran compounds, magnetic tracers or superparamagnetic iron oxide particles (SPIO)
* cancer involvement of anal sphincter complex
* adults who are not able to give consent or are deemed vulnerable
A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes Association) definition, April 2013), b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m\^2 per CKD-Epi (Chronic Kidney Disease Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL \[below or equal to 3.9 mmol/L\])) within the last 12 weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m\^2 Exclusion Criteria: - Treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1
Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents

Background. Classical Hodgkin's lymphoma (cHL) in adolescents between 15 and 18 years shows a higher disease-related mortality and the overall prognosis is worse than both children and adults.

Objectives. To investigate the immune checkpoint inhibitors (ICPI) therapeutic targets and specific T-regulatory and cytotoxic T-cell subsets, in the subgroup of adolescent cHL patients and to investigate their prognostic power.

Methods: Retrieved formalin-fixed paraffin-embedded (FFPE) of adolescent patients diagnosed with cHL with available clinical and tested by immunohistochemistry the immune checkpoint molecules CTLA-4, LAG-3, PD-1 and PDL1 and the biological markers FOXP3 and CD8.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 to 18 years at diagnosis of Classical Hodgkin lymphoma.

Exclusion Criteria:

* Unavailability/insufficiency of histological material for diagnosis.
Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient

The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.

Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients diagnosed with breast carcinoma based on histology
* 2.Evaluable lesions on imaging study
* 3.Without known immunodeficiency
* 4.Age \>18 and \<80 years ago

Exclusion Criteria:

* 1.Patients is unable or unwilling to sign informed consent
* 2.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
* 3.Positive HIV and/or RPR (rapid plasma reagin)
* 4.Female patient who is pregnant or breast feeding
* 5.Patients, based on the opinion pf the investigator, should not be enrolled into this study
* 6.Prior anti-cancer vaccine or biological immunotherapy
* 7.Allergic to any known ingredient of the MV compound
Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes

This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean intervention for health improvement in patients with type 2 diabetes.

The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients will be assigned to control or intervention group (A diet including triticale and mung bean; B diet including adzuki bean). Blood and urine samples will be collected at baseline and after 30 days of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients between the ages of 30 and 65 years
2. patients has been diagnosed as type 2 diabetes mellitus
3. Patients who like to be followed up for 2 months.

Exclusion Criteria:

1. Women in pregnancy or lactation.
2. Individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.
Breastfeeding Education Support Tool for Baby

This study will compare data associated with breastfeeding experiences and outcomes--specifically, breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration--among 120 subjects recruited late in pregnancy and provided peer counseling and education services incorporating mobile health (mHealth) tools during a period of at least 6 months post-delivery with the data collected from a control group of approximately 120 mothers that did not receive the study intervention.

Approximately 24 women that are experienced in breastfeeding will be recruited to serve in the role of breastfeeding peer counselors. These women will assess usability and acceptability of mobile health (mHealth) education tools designed following a series of focus groups for the project, Breastfeeding Education Support Tool for Baby. The mHealth tools will be used during the training and education of the peer counselor subjects. Following appropriate modification, some of the mHealth tools will be used with a total of approximately 120 women recruited late in pregnancy for initial breastfeeding counseling before delivery and the subsequent provision, for at least 6 months post-delivery, of home visits for peer counseling and education that integrates use of mHealth tools. Peer counselors and research staff will gather data from mothers receiving the intervention about breastfeeding experiences and outcomes, including breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration. This data will be compared to data obtained through surveys administered to a control group of approximately 120 maternal subjects that received standard pre- and post-delivery care but not the study intervention of peer counseling and education using mHealth tools.

Eligibility Criteria:
A. Peer counselors

Inclusion Criteria:

Personal experience with breastfeeding - Residence in an intervention cluster

Exclusion Criteria:

- Failing to participate in peer counselor education/training provided for the study

B. Intervention Pregnant women-mothers

Inclusion Criteria:

* Willingness to consent to assignment to a breastfeeding peer counselor and to participate in counseling and education visits
* Residence in an intervention cluster and intent to remain in the intervention area for a minimum of 6 months post-delivery

Exclusion Criteria:

- Pregnant women-mothers that indicate before delivery that they will not initiate breastfeeding

C. Control Subjects

Inclusion Criteria:

* Mothers delivering during the study period that live in a non-intervention area that has been designated for recruitment of control subjects
* Willingness to participate in a survey enabling collection of data for comparative purposes

Exclusion Criteria:

- None
Evaluation of the Effects of Preoperative Breathing Exercises on Preoxygenation Period

The aim of this observational study is to compare the effects of preoperative breathing exercises during the preoxygenation period in patients undergoing abdominal surgery.

Patients who are planned for abdominal surgery under elective conditions and who meet the inclusion criteria will be divided into 2 groups after routine preoperative preparations. The 1st group will start at least 5 days before the preoperative period and until the preoperative period, a minimum of 5 minutes of effective triflo exercise will be performed 4 times a day under the supervision of a nurse, and the 2nd group (control group) will not be exercised except for routine preoperative preparation. Age, existing chronic diseases, body mass index, haemoglobin levels, smoking status, presence or absence of lung disease, SpO2 values before and at the end of respiratory exercise (in the preoperative respiratory exercise group) will be recorded. All patients will be monitored with ECG, SpO2, non invasive blood pressure, Masimo. After the patients are taken to the operating table, they will be preoxygenated with oxygen at FiO2 100% at 10 L\\min in supine position, with the anaesthesia mask placed on the patient's face so that there is no leakage. Patients will be preoxygenated until ETO2 concentration reaches 85%. When preoxygenation is started, the timer will be started and the time to reach ORI:0.55 and the time to reach ETO2 85% will be measured and recorded with a timer. Preoxygenation time will be limited to a maximum of 5 minutes and patients who do not reach ETO2 concentration 85% or ORI:0.55 within 5 minutes will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo elective abdominal surgery under general anesthesia
* Between the ages of 18-65
* Both genders
* ASA I-III risk group
* Patients who accept and give consent to participate in the study

Exclusion Criteria:

* Patients who did not agree to participate in the study
* Patients younger than 18 years old and older than 65 years old
* Patients with advanced heart failure
* Conditions where the patient is uncooperative (e.g. dementia, Alzheimer's)
* Patients who refuse to breathe through the mask before EtO2 reaches 85% or more after the preoxygenation process begins
* Patients who cannot reach the EtO2 level of 85% within five minutes
* Deeply Anemic Patients (Hb\<8 gr/dl)
* Patients with neurological sequelae
* Patients with conditions that may prevent effective preoxygenation (those with long beards, patients with a nasogastric tube, etc.)
Placebo Effect About Fatigue in Obesity

Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels.


Eligibility Criteria:
Inclusion criteria:

• Right-handed diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
Quality of Recovery After Childbirth

In this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. The investigators will identify risk factors, especially those that are modifiable and associated with a poorer ObsQoR score and hence a poor quality of recovery after delivery. This data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.

Traditional postpartum outcome measures do not describe the patient experience or quality of recovery (QoR) after childbirth. A recent obstetric-specific recovery tool (ObsQoR-10) has been developed to assess the quality of recovery in patients in various mode of delivery on aspects of pain, drug side effects, comfort, control, ability to hold and feed the baby, independent mobilization and achievement of personal hygiene. However, this questionnaire is not yet validated in Asian population, especially in Chinese- and Malay-speaking patients.

The investigators aim to investigate the validity, reliability, feasibility, and responsiveness of the Chinese and Malay translated versions of ObsQoR-10. The investigators will first perform a pre-test in 5-10 patients for each language, of which an interview will be conducted to seek for their feedback and suggestions. Modification of questionnaire will be done if necessary, followed by recruitment of 112 patients at postpartum day 1 to fill in the Chinese/Malay translated ObsQoR-10 and other questionnaires related to their mood, anxiety and pain. In this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. The investigators will identify risk factors, especially those that are modifiable and associated with a poorer ObsQoR score and hence a poor quality of recovery after delivery. This data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21-50 years old;
* Able to read and understand written Chinese;
* Primiparous and having singleton pregnancy;
* Delivered via spontaneous vaginal delivery, or elective cesarean delivery;
* ≥38 gestational week.

Exclusion Criteria:

* Failed neuraxial analgesia in those receiving elective cesarean delivery;
* General anaesthesia;
* Intrapartum cesarean delivery;
* Women whose infants have died;
* Mother or baby requiring ICU after delivery;
* Assisted/ operative vaginal delivery.
Life-dependent Home Mechanical Ventilation

In Denmark, life-dependent home-mechanical ventilation (HMV) is given under the surveillance of a specifically trained respiratory patient caregiver (tPCG). The HMV can be invasive through a tracheostomy or non-invasive via a mask.

The purpose of this study is to uncover experiences and challenges associated with having a trained respiratory patient care giver (tPCG) to surveil home-mechanical ventilation (HMV) from the perspective of the patients and their families and to gather information about the expirence of working in a home as a tPCG


Eligibility Criteria:
Inclusion Criteria:

Patient Age \> 18 years Has trained patient care givers to surveil the respiratory treatment and working on the responsibility of the Respiratory Center East

Parent Age \> 18 years Has a child less than 18 years old with tPCG, working on the responsibility of the Respiratory Center East, to surveil the home-mechanical ventilation

Other relative:

Age \> 18 years Involved in the treatment or support of a relative with tPCG, working on the responsibility of the Respiratory Center East, to surveil the home-mechanical ventilation

Trained patient caregivers (tPCG) Age \> 18 years Employed by an external agency or by the patient (BPA) to surveil home-mechanical ventilation Certified as tPCG working on the responsibility of the Respiratory Center East

Exclusion Criteria:

* No informed consent to participate