cyrilzakka/clinical-trials huggingface dataset:
Cognitive and Blood Biomarker Assessment After CO Exposure

Carbon monoxide (CO) is reported to cause around 30 deaths, 200 admissions and 4000 presentations to Emergency Departments each year in the UK. In the longer term, CO poisoning is recognised to cause persistent neurological problems (including impairments of thinking and behavioural changes), which can develop days to weeks after the initial exposure. However, the incidence of these long-term sequelae is unknown. In addition, there is evidence of long-lasting inflammatory changes in the brain and on-going brain cell injury, although how long this persists is also unknown.

Initial assessments of CO exposure can be unreliable if blood tests are not carried out within a relatively short period after the exposure and other biomarkers (such as imaging) are insensitive to detecting previous CO exposure. Certain proteins that are found in brain cells can be detected in the blood of individuals following brain injury and brain cell death. These proteins have been found to be raised in the acute period after minor head injury, persistently raised in patients with a traumatic brain injury and evidence of on going neurodegeneration (i.e. on going brain cell death) and in patients with various types of dementia.

The investigators will assess the presence of these proteins in the blood of 50 participants with proven CO exposure in the sub-acute to chronic timescale (2 weeks to 2 years). This has not been done before and will allow assessment of the presence of on going brain injury in these participants. The investigators will also assess cognitive (e.g. memory, attention and speed of thinking) and behavioural impairments in these participants to help characterise the common impairments suffered following CO exposure and relate these to evidence of persistent brain injury and severity of CO exposure.


Eligibility Criteria:
Inclusion Criteria:

Individuals identified as having confirmed exposure to CO between 2 weeks to 2 years at time of assessment. CO exposure determined by either;

* documented COHb levels above 1.6% in non-smokers and above 6.3% in smokers.
* or, individuals with evidence of being exposed to raised levels of CO and symptoms

Exclusion Criteria:

* age \<18 years
* actual or suspected smoke inhalation
* significant neurological or psychiatric illness prior to CO exposure
* inability to provide consent
Alvimopan and Ileus in PSF

The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.

Posterior spinal fusion (PSF) is a common orthopaedic procedure associated with a high incidence of post-operative ileus (POI) and concomitant increased length of hospital stay (LOHS). POI is exacerbated by high dose opiate consumption often required by these patients post-operatively. We propose a randomized, double-blinded, placebo-controlled pilot trial studying the use of alvimopan, a peripherally-acting mu-opioid receptor antagonist known to reduce POI in bowel resection. We hypothesize that alvimopan will shorten POI in spine fusion patients without negatively affecting post-operative pain control. Treatment efficacy will be assessed by recording time to first bowel movement, time to hospital discharge, and post-operative pain control.

We hypothesize that acute administration of alvimopan, a peripherally-acting mu-opioid antagonist, shortens the duration of post-operative ileus (POI) in patients undergoing long-segment (5 or greater thoracolumbar levels) posterior spinal fusion (PSF). The study will be a randomized, double-blinded, placebo-controlled pilot trial. Reducing the morbidity of POI in patients undergoing PSF will decrease hospital stay and costs, and also improve patient satisfaction and post-operative care after major orthopaedic surgery.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis

Exclusion Criteria:

* pregnant women
* ischemic heart disease
* chronic liver or renal disease
* prior bowel resection
* presence of colostomy or ileostomy
* gastroparesis
* complete bowel obstruction
* inflammatory bowel disease (ulcerative colitis or Crohn's disease).
A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Clinical Trial for the safety and efficacy of BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

In this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo BCMA CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of BCMA CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on BCMA CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically confirmed diagnosis of multiple myeloma (MM):

  1. Patients with BCMA positive relapsed/refractory MM;
  2. Relapsed after hematopoietic stem cell transplantation;
  3. Cases with recurrent positive minimal residual disease;
  4. Repeated MRD(+) refractory resistant cases
  5. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

     2. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 4. Those who voluntarily participated in this trial and provided informed consent.

     Exclusion Criteria:
* Subjects with any of the following exclusion criteria were not eligible for this trial:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. With a graft-versus-host response, immunosuppressants are required;
  5. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  6. Active infection of hepatitis B virus or hepatitis C virus;
  7. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  8. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  9. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
  10. Other uncontrolled diseases that were not suitable for this trial;
  11. Patients with HIV infection;
  12. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
the NMFACT Caries Index

the NMFACT is a new caries index to overcome the drawbacks of DMF cries index the ''N'' is for non carious lesion, the ''M''for missed teeth,the ''F''for filled teeth,the''C''for carious teeth,the ''A''for alignment and the ''T''for dental trauma.

each problem will be scored from 0(normal).

the new caries index will be used to record the dental problem . the validation will be recorded against the gold standard DMF index

Eligibility Criteria:
Inclusion Criteria:

* any patient suffering form dental problem

Exclusion Criteria:

* edentulous patient children adolescents
Assess Safety, Tolerability and PK of AZD3199 in Japanese

The primary objective of the study is to investigate the safety and tolerability of single and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler inhaler in healthy male Japanese subjects by assessment of incidence and nature of adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis). The secondary objectives of the study are to investigate the pharmacokinetics (PK) of single and multiple ascending doses of AZD3199 by assessment of the degree of accumulation, dose proportionality and time linearity in healthy Japanese subjects, and to investigate systemic β 2- adrenoreceptor mediated effects of single and multiple ascending doses of AZD3199 by assessment of potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure and FEV1.


Eligibility Criteria:
Inclusion Criteria:

* Be healthy Japanese volunteers, both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for for more than 5 years.
* BMI 18 - 27, Weight 50 - 85 kg
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.
* Clinical normal physical findings

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, ECG or lung function at baseline
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
* Use of any medication (including OTC), herbal preparations, vitamins or nutritional supplements within 2 weeks prior to Visit 2, except for occasional intake of paracetamol (maximum daily dose of 4 g)
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes

The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.

Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.

Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).

Eligibility Criteria:
Inclusion Criteria:

* Age 12 - 80 years
* Type 1 Diabetes Mellitus diagnosed at least 1 year ago
* Using insulin infusion pump for past 6 months minimum
* Performing minimum 4 blood glucose tests per day
* Agree to treat to A1c targets
* Read and understand English

Exclusion Criteria:

* Pregnant or planning pregnancy
* History of unresolved tape allergy or skin conditions
Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals

The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.

The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.

The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels.


Eligibility Criteria:
Inclusion Criteria:

* Age 65+
* No healthcare provider-imposed limitations on physical activity
* English-speaking

Exclusion Criteria:

* Symptoms suggestive of coronary artery disease (CAD) or congestive heart failure (CHF) (i.e. chest pain, dizziness, syncope, excessive dyspnea on exertion)
* Myocardial infarction within the last 12 months
* Revascularization within the last 12 months
* Stroke/transient ischemic attack (TIA) within the past 12 months
* Unstable angina
* Congestive heart failure (New York Heart Association (NYHA) Class II, III or IV)
* Ventricular arrhythmia
* Clinically significant cardiac valve disease
* Blood pressure \>160/100 mmHg
* Uncontrolled seizure disorder
* Major surgery within the past three months
* Severe or frequent hypoglycemia
* Inability to independently manage blood glucose during activity
* Severe autonomic or peripheral neuropathy
* Active foot ulcers
* Unstable retinopathy.
Chronic Pain in Post-Mastectomy Patients; The Difference Between Pectoral Nerve (PECS I-II) and Erector Spinal Plane (ESP) Blocks

This study looks at two types of injections (called PECS and ESP blocks) to see which one works better for reducing pain after breast cancer surgery (mastectomy).

The main question it asks is: Which block is better at reducing pain after surgery - PECS or ESP? Women who had this surgery and received one of the two blocks were followed for three months. We looked at how much pain they felt, how much pain medication they needed, and whether they still had pain months later.

The results showed that both blocks helped with pain right after surgery. The ESP block lasted a little longer at first, but in general, both groups needed about the same amount of pain medicine. Three months later, about half of the patients still had some pain - especially those who had more extensive surgery or had nerve pain early on. There was no big difference between the two blocks when it came to long-term pain.

Despite advancements in breast cancer treatment, chronic postoperative pain-known as post-mastectomy pain syndrome (PMPS)-remains a common complication, with reported rates between 40-50%. It is typically neuropathic in nature and linked to factors such as axillary lymph node dissection, radiotherapy, and high levels of acute postoperative pain. Younger patients are at higher risk, and early neuropathic symptoms may predict long-term pain.

Regional anesthesia techniques, including PECS and erector spinae plane (ESP) blocks, are widely used to improve perioperative pain control and potentially reduce the incidence of chronic pain. These techniques are considered effective and low-risk adjuncts to general anesthesia.

This prospective observational study compares the impact of PECS I-II and ESP blocks on chronic pain development in patients undergoing modified radical mastectomy (MRM). The primary outcome is the incidence of pain at 3 months postoperatively (NRS ≥1). Secondary outcomes include acute pain scores, intraoperative fentanyl use, postoperative morphine requirements, and time to first analgesic. The study also explores associations between chronic pain and variables such as lymph node dissection, radiotherapy.

Findings aim to guide clinical practice in selecting regional anesthesia techniques that provide both immediate and long-term pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo modified radical mastectomy due to breast cancer
* Decision to perform PECS I-II or ESP block made independently from the study, as part of standard pain management
* Aged between 18 and 65 years
* American Society of Anesthesiologists (ASA) physical status classification I or II
* Female

Exclusion Criteria:

* Inability to perform the block (e.g., coagulation disorder, allergy to local anesthetics, infection at the injection site)
* Obesity (Body Mass Index \> 35 kg/m²)
* Pre-existing neurological deficits
* Younger than 18 or older than 65 years
* ASA physical status classification III or IV
* Refusal to give informed consent
Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia

To evaluate the affect Oxtellar XR (Extended Release) has on neurology patients with trigeminal neuralgia (TN), and if it impacts their quality of life.

Oxcarbazepine has been used off-label for TN for many years, but has a twice daily dosing. With the once daily dosing it should theoretically help with patient adherence and possibly decrease side effects, which is common with extended release formulations. Specifically the investigators are looking at how well tolerated Oxtellar XR is, and if it has the same efficacy as standard treatments. It is a pilot study, so it will be difficult to gather data and have powerful outcomes, but this will give pilot data for future trials. Patients will be screened for inclusion and exclusion criteria and after will participate in 3 visits following the initial one. Various tests will be administered to measure treatment satisfaction and tolerability throughout the visits. The patients will not have to pay for any of the study visits or medications. A parking voucher will be provided as needed.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 to 75
* Subject reported history of trigeminal neuralgia average pain rated as \> lower end of moderate on the VAS
* Trigeminal neuralgia diagnosis (Primary or type 1 or Idiopathic TN)
* History of pain rated as at least a 4 on the visual analog scale (VAS)
* Treatment naïve
* Patients who do not tolerate carbamazepine
* Women of reproductive age who agree to highly effective birth control
* Complete Blood Count (CBC) 30 days prior to entering study
* Comprehensive metabolic panel (CMP) 30 days prior to entering study

Exclusion Criteria:

* Intolerance/Hypersensitivity to Trileptal, Oxcarbazepine, or Oxtellar
* Psychosis, drug/alcohol misuse, or malignancy (except skin cancer) within the last 2 years
* Any clinically significant medical condition that would prevent study from being completed safely (determined by subjects current neurologist)
* Current seizure disorder or history of seizures
* Pregnant females
* Breastfeeding females
* Women of reproductive age not using or unwilling to utilize highly effective contraception (defined as double-barrier method)
* A severe pain condition, other than trigeminal neuralgia, which may impair the self-assessment of pain due to trigeminal neuralgia
* Concurrent medication treatment with: Equetro, Phenytoin, Dilantin, Phenytek, Oxcarbazepine, Trileptal, Rifampin, Rifadin, Rimactane and St. John Wort
* Renal impairment or hemodialysis
* Hepatic impairment
* History of hyponatremia (serum sodium \< 125 ng/dL)
Hindfoot Fusion Using Intramedullary Nail in Diabetic Ankle Arthropathy

The aim of this study is to evaluate the outcome of healing rate of ankle fusion using modified retrograde IM femoral nail with plate in charcot ankle

Charcot neuroarthropathy, is a progressive, noninfectious, and destructive joint disorder following trauma to a neuropathic extremity.The disorder mainly occurs in the foot and ankle joints. The process consists of bone and joint destruction, joint deformity, ulceration, and, if left untreated, may lead to amputation. The majority of the Charcot joint cases are associated with a neuropathic complication in patients with diabetes. Thus, with the increase in the current incidence of diabetes, the increase of Charcot joint cases is also expected.

The treatment of Charcot joint is variable including non operative, such as total contact casting, modified shoe, medication, and operative treatment. However, when the deformity is severe and unstable, the operative management is necessary. There are some surgical approaches to manage Charcot joint, such as exostectomy, Achilles tendon lengthening, arthrodesis with internal or external fixation, and amputation.

Arthrodesis is indicated in severe Charcot joint with significant instability. For Charcot ankle arthrodesis, internal fixation is more popular than external fixation in the absence of infection, significant bone defect, and poor soft tissue coverage. Some of the methods of internal fixation for ankle arthrodesis include the use of retrograde intramedullary nails, screws, and plates. many surgeons chose retrograde intramedullary nail fixation as the main method of internal fixation. However, limited compression and high nonunion rates have been found with intramedullary nail fixation.so using Plate with intramedullary nail will offer stiff constructs, more stability and better union rates. however, studies evaluating the use of combination fixation in the ankle arthrodesis for Charcot ankle, particularly nail with plate, are limited. \[13\] So, in this study the investigators will evaluate the outcomes of ankle arthrodesis using a combination of an intramedullary nail with plate in patients with diabetic Charcot ankle.

Eligibility Criteria:
Inclusion Criteria:

* Adult diabetic Patients who have (Brodsky type 2 and type 3A) Charcot ankle and HbA1c below 8

Exclusion Criteria:

* Prescence of active infection
* prescence of ulcers
* significant bone defect
* Vascular insufficiency
Study to Explore Drug-drug Interactions Between DWC20155 and DWC20156 in Healthy Subjects

A randomized, open-label, oral dose, crossover study to explore drug-drug interactions between DWC20155 and DWC20156 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Accepts healthy volunteers.

Exclusion Criteria:

* Who has allergy to investigational product
National Nurses Health Cohort Study (NNHS): a Web-based Ambispective Cohort Study in China

The purpose of the current study was to build an ambispective cohort study of female nurses, based on existing physical examination and nurse work schedule data and a web-based questionnaire system, focusing on the effects of occupational, environmental, and lifestyle risk factors on the health of Chinese women.


Eligibility Criteria:
Inclusion Criteria:

* Female registered nurses, licensed practical nurses and/or midwives with informed consent are included in this study

Exclusion Criteria:

* student nurses
* training nurses
Effect of Manipulation of the Ankle Joint on Gait

The purpose of this study is to determine if manipulation of the ankle improves some measurable characteristics of how a person walks. The investigators hypothesize that the ankle will be able to bend better after manipulation and thus improve walking speed and reduce differences between the two limbs.


Eligibility Criteria:
Inclusion Criteria:

* Students will be screened for eligibility by testing their ability to perform a squat.

Exclusion Criteria:

* a recent (within one month) ankle sprain
* evidence of ankle instability
* cardiac condition