cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Oct

The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of multiple sclerosis or neuromyelitis optica
* age between 15 and 60 years
* BCVA better than 20/400
* no optic neuritis crisis in the last 6 months

Exclusion Criteria:

* diagnosis of glaucoma, opacities or disc anomalies
* diagnosis of macular disease
* disc swelling at fundoscopy
The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China

The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.

To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of acute lymphoblastic leukemia;
2. Age 1-18y at time of initial diagnosis;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Informed consent signed by the patients parents or guardians before initiation of the study.

Exclusion Criteria:

1. Ph-positive ALL, matrue B-cell ALL, BC-CML;
2. Secondary to immunodeficiency, second cancer；
3. Abnormal liver and kidney function;
4. Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015;
5. Patients who enrolled in another clinical trial;
6. Expected survival time less than the treatment cycle;
7. Patients with other factors that researcher considers unsuitable for inclusion
A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer

A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival time, and treatment safety were subsequently evaluated.

This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.

After providing full informed consent and signing the informed consent form, eligible participants will enter the trial period upon screening. Within 72 hours of enrollment confirmation, participants will begin neoadjuvant therapy. Patients in the control group will receive a neoadjuvant systemic therapy regimen selected by their physician, followed by surgery and adjuvant radiotherapy. Patients in the experimental group will receive both neoadjuvant systemic therapy and neoadjuvant radiotherapy. The radiotherapy regions will include the whole breast, supraclavicular and infraclavicular areas, and internal mammary regions, with a dose of 50 Gy over 25 fractions, plus a tumor bed boost of 10-16 Gy over 4-8 fractions.

Primary Endpoint:

Residual Cancer Burden (RCB) 0/I.

Secondary Endpoints:

Event-Free Survival (EFS) Invasive Disease-Free Survival (iDFS) Overall Survival (OS) Quality of life scores ECOG performance status scores Surgical incision healing scores Adverse Events (AEs)

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for the trial:

1. Female patients aged ≥18 years and ≤65 years with newly diagnosed breast cancer;
2. Early-stage or locally advanced invasive breast cancer confirmed by histopathology according to the latest ASCO/CAP guidelines, meeting the following conditions:Axillary lymph node biopsy-positive;ECOG performance status score of 0-1;
3. Presence of at least one measurable lesion based on RECIST 1.1 criteria.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged ≥18 years and ≤65 years；
* newly diagnosed breast cancer;
* Axillary lymph node biopsy-positive;
* ECOG performance status score of 0-1;

Exclusion Criteria:

* metastatic breast cancer or bilateral breast cancer;
* inflammatory breast cancer;
* Pregnancy and Lactation;
Benchmarking Integrated Care for People Living With Huntington's Disease in England

The survey and full study information can be accessed here: https://southampton.qualtrics.com/jfe/form/SV_8iEedDJZy4xaiI6

The goal of this anonymous survey is to benchmark integrated care from the perspective of service users in adults living with Huntington's Disease, including informal caregivers. The main question it aims to answer is: Is standard of care for people living with HD in England person-centred integrated care from the perspective of service users?

Participants will complete a one-time anonymous survey either online or on paper, according to their preference, that takes an average of 20-30 minutes. Participants can take breaks as needed, picking up the survey from where it was paused.

Huntington's disease (HD) is a rare brain disease that affects people's coordination, thinking and behaviour. It is a hereditary condition, affecting families across generations. Because its complex, it requires different sectors working together. Different surveys can be found in long term neurological conditions indicating care fragmentation and unmet severe needs, but evidence in HD is sparse.

Two surveys were identified covering people's needs in the UK, dated from 2006 and 2010. When looking for models or approaches tested to improve outcomes for people living with HD, no studies were found. This is an underserved population with complex needs and care gaps that remain unaddressed.

Little is known about to what extent people living with HD are experiencing care coordination between services and sectors in England. Integrate-HD aims to find out what good, joined-up care looks like. The study will explore the views and experiences of people living with HD, to identify the changes needed to improve people's care and quality of life.

Integrate-HD is a national survey to benchmark integrated care from the perspective of people living with HD, including informal caregivers.

The study objectives are to:

1. Characterise and classify systems/organisations in England involved in HD care in relation to person-centred integrated care from the perspective of users.
2. Identify areas considered integrated by service users.
3. Identify areas considered fragmented by service users.
4. Map care resources used by people living with HD in England.
5. Identify unmet care needs that need improvement.

Eligibility Criteria:
Inclusion Criteria:

Adults with capacity living in England and fluent in English that are:

* A person at risk of HD (where at least one parent is diagnosed with HD, therefore their offspring has 50% chance of developing the disease);
* A person diagnosed with HD symptomatic or asymptomatic (after undergoing gene testing and having a positive result);
* An informal caregiver supporting someone living with HD;
* A former informal caregiver with experience of supporting someone living with HD in the last 3 years.

Exclusion Criteria:

* Below 18 years old;
* Not fluent in English;
* A person without capacity.
Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

Aim: Pseudoexfoliation syndrome (PEX) is a systemic disease of connective tissue, it can also contribute to sarcopenia and chronic musculoskeletal pain with common pathways.

1. First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
2. Second aim was to investigate the association between PEX, sarcopenia parameters and chronic musculoskeletal pain.

Methods: A total of 96-patients were enrolled in this study and divided into two groups: PEX-positive (n=48) and PEX-negative (n=48) patients. The variables: the demographic data, sarcopenia parameters (SARC-F-questionnaire, hand-grip strength, chair-rise test, gait speed) and pain parameters (having any chronic musculoskeletal pain, pain regions and visual analogue scale-pain).

Sarcopenia is defined as a decreased muscle mass, muscle strength and muscle function, which leads to lower physical performance, disability and quality of life. Pseudoexfoliation syndrome (PEX) is an age-related, genetic and systemic disease characterized by the accumulation of abnormal extracellular fibrillar material in many ocular and extraocular tissues Aim: Pseudoexfoliation syndrome (PEX) is a systemic disease of connective tissue, it can also contribute to sarcopenia and chronic musculoskeletal pain with common pathways.

1. First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
2. Second aim was to investigate the association between PEX, sarcopenia parameters and chronic musculoskeletal pain.

Methods: A total of 96-patients were enrolled in this study and divided into two groups according to having pseudoexfoliation material in ocular tissues: PEX-positive (n=48) and PEX-negative (n=48) patients. The variables: the demographic data, sarcopenia parameters (SARC-F-questionnaire, hand-grip strength, chair-rise test, gait speed) and pain parameters (having any chronic musculoskeletal pain, pain regions and visual analogue scale-pain).

Eligibility Criteria:
Inclusion Criteria:

* Being over 60 years

  * Undergoing a detailed complete ophtalmic examination by an experienced physician within 1 month at the Department of Ophtalmology in the same university hospital.

Exclusion Criteria:

* having ophtalmic diseases that cause vision loss and reduce quality of life and mobility smoking, acute/subacute pain, amputation, infection, active arthritis, active cancer, having any protesis or surgery in lower extremities and low back, neurological disorders, malabsorption, weight loss, uncontrolled major systemic diseases, impaired cognitive function and being immobilised.
Synchronous Effect of Anesthetics on fMRI, EEG and Clinical Responses

Background: The mechanisms of action of intravenous anesthetics are unclear and the current monitors have limitations.

This signifies difficulties when assessing the correct dosage due to the considerable inter-individual variability of the patients, particularly in the elderly or seriously ill. It is necessary to customize the administration of anesthetics as underdosage can lead to the patient awareness during aggressive procedures, and over-dosage can cause serious complications and even augment mortality.

Objective: To design a new monitoring system of the levels of consciousness and analgesia in anesthetized subjects which is more accurate than those currently employed. It will be based on the synchronic changes of functional magnetic resonance (fMR) and electroencephalograph (EEG) readings, and clinical responses.

Methodology: Thirty healthy volunteers will be given propofol and remifentanil in different combinations, and painful stimuli will be also applied. The principal variable will be fMR images obtained by echo-planar imaging sequences. Real time will be correlated with cortical connectivity maps, EEG parameters (qCON, qNOX), clinical responses, and concentrations of anesthetics measured by pharmacokinetic and pharmacodynamic models (TCI).

Main goal:

Develop a system for monitoring the effect of anesthetics on consciousness and pain, based on synchronous changes in functional neuroimaging, EEG and clinical responses.

Secondary objectives:

* Analyze the changes produced in the cortical connectivity map during the induction of anesthesia to understand the process of "advancement".
* Know more accurately the neuronal circuits involved in propofol-induced sleep.
* Study if the application of a known painful stimulus modifies in any way (clinical, EEG or by RMf) the LOC that has just been reached.
* Establish propofol dosing guidelines adjusted to each patient, studying if they reach the LOC at "sedative" or "hypnotic" doses.
* Establish remifentanil dosing guidelines, adjusted to each patient, studying the concentration of remifentanil to which the pain response in neuroimaging is inhibited (activation deactivation neuronal in fMRI).
* Validate existing mathematical models in relation to plasma and brain concentrations of propofol and remifentanil.
* Validate the value of clinical signs to predict whether a patient feels the painful stimulus received.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers (ASA 1 physical state) who agree to participate voluntarily in the study, previous information about it by the Principal Investigators (IP).

Exclusion Criteria:

* Psychological, psychiatric or neurological disorders. Consumption of drugs. Alterations cutaneous or anatomical cranial. Idiomatic or communication barrier. Allergy to propofol, remifentanil or to some of its excipients. Body mass index (BMI) \<18 or\> 30 kg / m2. Pregnancy. Airway or ventilation criteria hard. Absence of accompanying adult at the end of the study.
A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma

Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.


Eligibility Criteria:
Participants must satisfy the following criteria to be enrolled in the study:

Inclusion

* Participant is ≥ 18 years of age at the time of signing the ICF.
* Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease
* Participant must have measurable disease.
* Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Exclusion Criteria

* Participant has symptomatic central nervous system involvement of MM.
* Participant had a prior autologous stem cell transplant ≤ 3 months prior to starting CC-99712.
* Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99712 or is on systemic immunosuppression for graft-versus host disease.
* Subject is a pregnant or lactating female.
* Subject has known human immunodeficiency virus (HIV) infection.
* Subject has active hepatitis B or C (HBV/HCV) infection.

Other protocol-defined inclusion/exclusion criteria apply
Quadratus Lumborum Block for Abdominoplasty

Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and sterile sodium chloride in the control group. The aim of study is to investigate the effect of a QL Block on the perioperative pain during postbariatric abdominoplasty.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Classification Status (ASA) I-II
* Age 18 to 64
* Weight above or equal to 60 kg
* Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr Frøyen
* Patient is expected able to cooperate during the treatment and follow up.
* Signed informed consent obtained and documented according to the International Conference on Harmonization (ICH) good clinical practice (GCP), and national/local regulations.

Exclusion Criteria:

* A history of anaphylactic shock
* Cardiovascular disease other than hypertension and/or hyperlipidemia
* Known allergy to ropivacaine or morphine
* A history of chronic pain
* Psychiatric comorbidity
* Scheduled opioid pain medication or neuroleptic drugs
* Coagulation disorders or treatment with platelet inhibitors
* Pregnancy or breastfeeding
* Treatment with class III antiarrhythmics, sertindole, ziprasidone, amisulpride, ceritinib, hydroxyzine, fluvoxamine
* Any medical contraindication to the study intervention by the attending anaesthetist or surgeon (to be specified in screening form).
Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients

Advance care planning involves thinking about choices if the patient becomes sick, and is important for everyone. It does not matter if the patients are ill or healthy. It is especially important for people who have diseases that cannot be cured. It allows people to make sure their wishes are respected if they become very sick or are dying. Thinking about these issues can be upsetting. But, for many people, it is helpful. This type of discussion can help the family learn what the patient may want but cannot tell them when these decisions need to be made


Eligibility Criteria:
Inclusion Criteria:

* Primary pancreatic or hepatobiliary cancer (including ampullary carcinoma)as well as gastric and/or esophageal cancers, excluding neuroendocrine histology
* Progressive disease: Locally advanced or metastatic disease with progression on at least one course of treatment (surgery, radiation, or chemotherapy), or untreated patients unfit for therapy because of comorbidities or ECOG performance status \>2, and finally, patients with ECOG performance status 2 -- patients must have discussed on at least one occasion with the treating investigator oncologist that their cancer cannot be cured
* In the estimation of the treating physician investigator, life expectancy ≤ 1 year
* Known to a GI medical oncology MSKCC clinic: Patients who have already established a relationship with a GI medical oncologist (who is an investigator on this protocol) after at least one new visit in the clinic (or as an in-patient), have MSKCC pathologist confirmed cancer of an above histology, and express an initial intent to be followed primarily at MSKCC
* English speaking\*
* Able to provide informed consent
* Age greater than or equal to 18 years
* Do not have an advance directive or living will \* English is the validated language in one of the study tools, and the language in which information is communicated in the narrative and video.

Exclusion Criteria:

* Short Portable Mental Status Questionnaire (SPMSQ) score of less than "intact mental functioning" (3 or more errors). SPMSQ in appendix.
* Any patient psychological state deemed by the treating physician to pose any risk of psychological harm by issues raised in a discussion of the trial, or in its testing procedures. Any subject who may become upset during any aspect or discussion of the study will be offered counseling services.
Comparison of Spencer's Muscle Energy Technique and Post-facilitation Stretch in Patients With Adhesive Capsulitis

Adhesive capsulitis is one of the most common problems of the upper limb. Adhesive capsulitis (AC) and frozen shoulder syndrome (FSS) are two terms that have been used to describe a painful and stiff shoulder.

Conservative treatment includes transcutaneous electrical nerve stimulation (TENS), Ultrasound, LASER, Range of Motion, stretching and strengthening exercises, patient education, and home exercises. Manual therapy includes mobilization, Spencer's Muscle Energy Technique and Mobilization With Movement.

The American Academy of Orthopedic Surgeons defines this condition as: "A condition of varying severity characterized by the gradual development of global limitation of active and passive shoulder motion where radiographic findings other than osteopenia are absent." Patients with frozen shoulder typically experience insidious shoulder stiffness, severe pain that usually worsens at night, and near-complete loss of passive and active external rotation of the shoulder.

Although spencer's Muscle Energy Technique is a very effective technique, still it was rarely used. It is a standardized series of steps of shoulder treatments with broad application in diagnosis, treatment, and prognosis developed by Spencer in 1961 and is a well-known osteopathic manipulative technique that focuses on mobilization of the glenohumeral and scapulothoracic joints. It is an articulatory technique in which passive, smooth, rhythmic motion of the shoulder joint is done by the therapist to stretch contracted muscles, ligaments, and capsule. Most of the force is applied at the end range of motion. This technique increases pain-free Range of Motion by stretching the tissues, enhancing lymphatic flow, and stimulating increased joint circulation.

On the other hand, "post-facilitation stretch (PFS)" is a muscle energy technique developed by Dr.Vladimir Janda to lengthen chronically shortened muscles that involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a 20-second static stretch. This technique is more aggressive than Post Isometric Relaxation and based on the concept of autogenic inhibition

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary unilateral adhesive capsulitis
* Stage II and III adhesive capsulitis
* Patients with limited active and passive Range of Motion of the affected shoulder (globally loss of at least 50% compared to non-involved shoulder in one or more directions)
* Patients with controlled diabetes

Exclusion Criteria:

* Patients with a positive history of trauma, fracture, or surgery of the cervical spine
* Corticosteroid injection in the affected shoulder in the preceding 4 weeks.
* Malignancy/Avascular Necrosis of shoulder
* Post-traumatic shoulder stiffness
* Thoracic outlet syndrome/neurological disorder
* Patients with cervical radiculopathy