cyrilzakka/clinical-trials huggingface dataset:
Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer

The purpose of this study is to evaluate the safety and efficacy of preoperative chemoradiotherapy (IMRT) with concurrent high-dose intravenous vitamin C and mFOLFOX6 in locally advanced rectal cancer patients.

Sixty patients with locally advanced rectal cancer (cT3-4N0M0, cT1-4N1-2M0, ≤12cm from anus) will be enrolled and receive preoperative IMRT concurrent with high-dose intravenous vitamin C and 2-3 cycles of mFOLFOX6 chemotherapy, and then after 4 weeks rest, they will continue to complete 3 cycles of preoperative chemotherapy (mFOLFOX6). Radical surgery will be performed at 10-12 weeks after IMRT.

In this study, we will evaluate the safety and effectiveness of the treatment method through the acute toxicity \[during CRT (concurrent chemoradiotherapy )\], PCR (pathologic complete response) rate, sphincter preserving surgery rate, 2-year survival rate and 2-year disease-free survival rate.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years of age with a confirmed histopathologic diagnosis of adenocarcinoma of the rectum and considered suitable for curative resection.
2. Tumors were clinically confirmed (by MRI or CT plus endorectal ultrasound) as stage II (cT3-4N0) or stage III (cT1-4N1-2), with a positive node defined as ≥1.0 cm in diameter on imaging) and a distal border located , 12 cm from the anal verge.
3. Patients were required to have an Eastern Cooperative Oncology Group performance status ≤ 1 and adequate hematologic, liver, and renal function. (HGB≥90g/L, WBC≥3.5×10\^9/L, PLT≥90×10\^9/L；ALT / AST≤2.5× ULN；T BILL≤1.5×ULN，Cr ≤1.5×ULN)
4. Laboratory examination showed that glucose-6-phosphate dehydrogenase (G6PD) was normal.
5. The patient agreed and had signed the informed consent

Exclusion Criteria:

1. With metastatic disease.
2. Prior radiotherapy or chemotherapy.
3. The presence of other cancers.
4. Clinically significant cardiac disease.
5. Known peripheral neuropathy.
6. With intestinal obstruction, intestinal perforation or tumor bleeding who need emergency operation.
7. Rectal cancer with signet-ring cell carcinoma, or with Neuroendocrine tumor.
Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers

The proposed trial aims to assess the effectiveness of Cognitive-behavioural therapy for insomnia (CBT-I) based ecological momentary intervention (EMI) for reducing insomnia symptoms among stroke caregivers.

Existing studies reported that 40-95% of family caregivers had clinically significant insomnia symptoms including reduced total sleep duration, prolonged sleep onset latency, frequent night awakenings, and poor sleep efficiency and quality.

Cognitive-behavioural therapy for insomnia (CBT-I) has shown a large effect in reducing insomnia among adults. Innovative and interactive technologies, such as Internet-delivered CBT-I (iCBT-T), have therefore been incorporated into CBT-I, which was identified to have similar effects to that of traditional CBT-I.

In the proposed trial, screened stroke caregivers will be recruited from community centres, rehabilitation centres, and tertiary hospitals in HK. The intervention group will receive CBTI-based EMI through instant messaging applications as personalised and real-time psychological support led by nurses for 3 months. The control group will only receive stroke and brief sleep hygiene education with chat-based support on the topics.The primary outcomes are Sleep Condition Indicator (SCI) and Insomnia Severity Index (ISI) scores. Secondary outcomes will include sleep quality, depressive symptoms, anxiety symptoms, caregiver's burden, quality of life, and et al. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI.

Eligibility Criteria:
Inclusion Criteria:

* Primary family caregiver (Aged ≥18) of stroke survivor
* Able to read and communicate in Chinese
* Engaged caregiving roles for \> 4 hours per day;
* Able to use a smartphone messaging app (e.g., WhatsApp and WeChat)
* SCI ≤ 21 scores (i.e., clinically significant insomnia)

Exclusion Criteria:

* Has provided care for \<1 month prior to recruitment
* Has a diagnosis of psychiatric disease or is currently taking psychotropic drugs
* Currently taking medication to help with sleep
* Currently participating in any type of psychological intervention
Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.

This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent combined concurrent chemoradiotherapy (CCRT) and immunotherapy. Additionally, It sought to analyze the predictive significance of cardiac parameters to both treatment toxicity and survival prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. had untreated histologically or cytologically confirmed NSCLC
2. be between the age of 18 and 75
3. had unresectable stage IIIA-IIIC disease, as defined by the AJCC 8th edition staging system
4. had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0\~1
5. had adequate bone marrow function (neutrophil count ≥1.5x109/L, hemoglobin concentration ≥90 g/L, platelet ≥100x109/L), kidney function (serum creatinine clearance ≥50 ml/min) and liver function (serum bilirubin ≤1.5 times upper limit of normal (ULN), aspartate transaminase (AST) and alanine transferase (ALT) ≤2.5 ULN)
6. had a forced expiratory volume in 1 second (FEV1) of ≥0.8L.

Exclusion Criteria:

1. mixed small cell and NSCLC histology
2. life expectancy lower than 12 weeks
3. history of another primary malignancy
4. poorly controlled intercurrent illness
5. female in pregnancy or breast-feeding and any situation not suitable for this study judged by researchers
6. patients with contraindications to 6MWT, including unstable angina pectoris or myocardial infarction within the past month, systolic blood pressure (SBP) over 180mmHg, diastolic blood pressure (DBP) over 100mmHg, muscle strength below grade 3, and severe spasm.
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus

Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood.

Aim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction in adults with type 2 diabetes (T2D).

Plan: 518 asymptomatic adults (aged 18-75 years) with T2D will undergo comprehensive evaluation of cardiac structure and function using cardiac MRI (CMR) and spectroscopy, echocardiography, CT coronary calcium scoring, exercise tolerance testing and blood sampling. 75 controls will undergo the same evaluation.

Primary hypothesis: myocardial steatosis is an independent predictor of left ventricular global longitudinal strain. Secondary hypotheses: will assess whether CMR is more sensitive to detect early cardiac dysfunction than echocardiography and BNP, and whether cardiac dysfunction is related to peak oxygen consumption.

Expected value of results: This study will reveal the prevalence and determinants of cardiac dysfunction in T2D, and could provide targets for novel therapies.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged ≥18 and ≤75 years.
* Diagnosed with Stable type 2 diabetes (determined by: i) formal diagnosis in GP case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%).

Exclusion Criteria:

* Angina pectoris or limiting dyspnoea (\>NYHA II),
* Major atherosclerotic disease: Symptomatic CAD, history of myocardial infarction, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease.
* Atrial fibrillation or flutter.
* Moderate or severe valvular heart disease.
* History of heart failure or cardiomyopathy.
* Type 1 diabetes mellitus (T1DM).
* Low fasting C-peptide levels suggestive of adult-onset T1DM.
* Stage III-V renal disease (estimated glomerular filtration rate ≤30ml/min/1.73m2).
* Absolute contraindications to CMR.

Importantly, patients with subclinical CAD, and other common comorbidities such as obesity and hypertension, will not be excluded from this study. This will enable us to evaluate the contribution of CAD to myocardial dysfunction in diabetes and ensures our study group is representative of the general population with diabetes. Similarly, as mild dyspnoea is extremely common and non-specific participants with mild dyspnoea will be included.
The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence

The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.

Study 1: Relapse prevention: This is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive oral NAC (2400 mg: 2x 600mg tablets twice per day) or matching placebo. Trial participants will receive either oral NAC ( dose stated above) or matching placebo for up to 4 weeks.

Study 2: Withdrawal: Trial participants will receive oral NAC (dose stated above) or matching placebo within the first 24 hours of their admission for up to 3 days.

Study 3: Participants from the relapse prevention substudy will also receive 30-minute non-invasive brain imaging session prior to and after completing the treatment regime in Study 1.

Both males and females will be recruited for the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol use disorder (this is an exclusion for the healthy control sample)
* Able to understand and sign written informed consent
* Must have a stable residence and be able to identify an individual who could locate subject if needed
* Admitted for medical detoxification from alcohol (withdrawal study only)
* Blood alcohol concentration of 0.00 (if completing brain imaging session)
* Express a desire to achieve abstinence or to greatly reduce alcohol consumption (relapse prevention study only)

Exclusion Criteria:

* Clinically significant comorbidities or medical disease that might interfere with the evaluation of the study medication or present a safety concern.
* Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control
* Women who are breastfeeding
* Dependence on any substance other than nicotine
* Court-mandated participation in alcohol treatment or pending incarceration (relapse prevention study only)
* Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medications (withdrawal study only)
* Dependence on any substance other than nicotine

The following exclusion criteria are only applicable to participants undergoing the brain imaging session:

* Extreme obesity
* Pregnant or have any reason to believe they are pregnant;
* Previous brain surgery;
* Ever employed as a machinist, a welder or a metal worker;
* Epilepsy
* Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.
Stem Cells Therapy in Advanced Heart Failure

stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous history of myocardial infarction and coronary artery revascularization. These patients, without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in consecutive 30 selected patients the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, and associated to reduction of angina after a treatment with stem cells intra thoracic infusion.


Eligibility Criteria:
Inclusion Criteria:

* heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization.

Exclusion Criteria:

* inflammatory chronic diseases, neoplastic diseases.
Fever Education Given to Parents of Children Presenting to the Emergency Department With Fever

Fever is a common symptom of childhood, especially between the ages of one and five, and is the main reason for emergency room visits. These emergency room visits are due to parents incorrect information and practices regarding fever management. This situation causes an increase in parental anxiety and failure to provide fever management. In line with this information, this study was planned to evaluate the effects of education given to parents of children presenting to the emergency room with fever on parental anxiety level and fever management.

Fever is a common symptom in childhood and is the main reason for emergency room visits. The rate of children applying to the emergency department due to fever in our country is quite high compared to the rest of the world. Parents misinformation and practices regarding fever increase parental anxiety levels and negatively affect fever management. Interventional studies aimed at reducing parents anxiety levels and ensuring fever management are quite limited. This research will evaluate the effect of fever education given to parents on their anxiety levels and fever management.

The research was planned as a randomized controlled study with experimental and control groups. The research will be carried out between April 2024 and April 2025. After the power analysis of the sample, a total of 80 people will be included in the sample, 40 in the experimental group and 40 in the control group. Parents in the experimental group will be given fever training, while parents in the control group will not receive any treatment. Data will be collected with Parent-Child Introductory Information Form, State Anxiety Scale, Parent Fever Management Scale, Visual Analogue Scale (VAS)- Satisfaction with Fever Education Practice Scale and Parent-Education Satisfaction Form Scale. The data will be pre-tested, post-tested 1 month after the training, and permanence tested 3 months after the training, and the research will be terminated. Generalised linear models analysis, robust ANOVA, independent samples t test, Mann Whitney U and chi-square analysis will be used in the evaluation of the data. Mean, s.deviation, median, minimum and maximum will be used for quantitative data and frequency and percentage will be used for categorical data.As a result of the research, it is expected that fever education given to parents will positively affect parental anxiety level and fever management.

Eligibility Criteria:
Inclusion Criteria:

* Having a child between the ages of 1-5
* Able to read, understand and have no problems speaking Turkish
* Having a green triage code in the emergency room triage application

Exclusion Criteria:

* Children diagnosed with or receiving treatment for chronic diseases
* Children with a history of febrile convulsions
* Children dependent on home mechanical ventilation
* Parents with psychiatric diagnoses will be excluded from the study
Cardiovascular Disease Cohort in Guangdong Province

Patients with cardiovascular diseases from Guangdong province will be recruited and followed up for at least 4 years to evaluate the risk factors for cardiovascular-related mortality and disability. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of all-cause and cardiovascular mortality will be investigated during follow-up.

5,000 patients (30-85 years old) with primary hypertension, coronary heart disease, heart failure or peripheral vascular disease and who have been living in Guangdong province for more than 5 years will be recruited. All participants will be prospectively followed up for the incidence of all-cause and cardiovascular mortality. Information about socio-demographic, diet, lifestyle, psychological status, medical history and current medication will be collected by questionnaires. Physical examinations including height, weight, waist and hip circumferences, blood pressure, fat mass and vital capacity will be conducted.Besides, blood, urine and fecal samples will be collected for further analysis. The associations between diet and lifestyle and risks for cardiovascular disease will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Cardiovascular disease patients (30-85 years old) who have been living in Guangdong province for more than 5 years.
* Patients have been diagnosed with primary hypertension, coronary heart disease, heart failure or peripheral vascular disease, etc.

Exclusion Criteria:

* Patients with cardiogenic (acute pericarditis, rheumatic coronary arteritis, hypertrophic cardiomyopathy, etc.) Or non-cardiogenic chest pain.
* any subject who suffer from malignant tumors, infectious diseases, advanced liver disease, major disability and cannot participate in the study.
Evaluating the Effects of Cleansers on the Skin

This will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their upper extremities. One spot will serve as a control and not receive any cleanser. Each spot will be cleansed with the corresponding cleanser for 15 seconds then rinsed off with tap water. Skin barrier will be measured at baseline, immediately after, 30, 60 and 90 minutes after rinse off.

Up to 50 subjects (up to 25 with healthy skin or 25 with atopic dermatitis) meeting the inclusion criteria will be enrolled in this study. A physical exam will be performed to ensure the subjects have healthy skin versus atopic dermatitis. For atopic dermatitis subjects, AD severity will be graded by the EASI score. Site randomization will be performed to determine which cleansers will be used for each of the 8 test sites (one site will be randomized to act as a control and not receive any cleanser). Baseline skin barrier function (TEWL, pH and hydration) will be measured. Then 1ml of each cleansers will be applied to the corresponding test sites, 2ml of tap water will be added, and lathered in a circular motion for 15 seconds. The sites will then be rinsed off with tap water for 15 seconds. Arms will be padded dry. Barrier functions will be measured again immediately after padding dry, and at 30, 60 and 90 minutes after.

Eligibility Criteria:
Inclusion Criteria:

Male and female, at least 18 years of age Subject must be able to comprehend and read the English language. Healthy skin without concurrent atopic dermatitis or diagnosed with atopic dermatitis by a dermatologist

Exclusion Criteria:

Subjects who do not fit the inclusion criteria. Subjects unable to or unwilling to comply with the study procedures Concurrently have other inflammatory skin conditions. Prior known allergy to any components to of the cleansers tested A subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures.

Subject unable to speak or read the English language, since all consents and instructions will be provided in English.

Those that are prisoners or cognitively impaired
Combined Behavioral and Analgesic Trial for Fibromyalgia

This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls.

Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive an inactive pill, called a placebo. There will also be 2 different types of behavioral health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have been recommended for the treatment of patients with FM by the American Pain Society.

There are 4 possible study treatment combinations:

1. Tramadol + CBT,
2. Tramadol + HE,
3. Placebo + CBT,
4. Placebo + HE.

Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there have been no studies that have evaluated the combination of medication and a behavioral health treatment. The primary purpose of this study is to compare the benefits of the 4 combinations listed.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females 21-70
* Diagnosis of Fibromyalgia
* Current primary care physician
* Fluent in English

Exclusion Criteria:

* Rheumatologic disorders
* Drug and alcohol abuse in the past year
* Psychiatric hospitalization in the past 6 months
* Current use of Tramadol
* Certain antidepressant and other pain medications
Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

The primary objective of this study is to evaluate pinch strength improvements and improvements in coordination and functional ability. Pinch strength measurements are made on subjects both with and without the device to evaluate the potential improvements. Also, coordination and functional testing is performed both with and without the device to compare performance under both conditions and evaluate potential improvement.

This study tests the powered hand orthosis device on a small number of participants (up to 6). Research participants with neuromusculoskeletal impairments were recruited for the study and consented with an approved protocol. The study was conducted during 1 visit to LTI in Holliston, MA . The study consists of several assessments. Participants are surveyed for cognitive limitations and self-assessment of difficulties in completing tasks of daily living by completing surveys such as the Quickdash Questionnaire \[1\], the Mini-Mental State test \[2\], and the McGann Feedback form \[3\]. Pinch strength without and with the powered orthosis is evaluated. A selection of functional outcome measures are performed such as the Southampton Hand Assessment Procedure (SHAP) \[4\], the Nine-Hole Peg Test (NHP) \[5\], and the Box and Blocks Test (BBT) \[6\].

Eligibility Criteria:
Participants in this study must meet the following inclusion/exclusion criteria.

* Subjects diagnosed with one of these conditions- ALS, brachial plexus injuries, CVA hemiplegia, multiple sclerosis, muscular dystrophy, spinal cord injury, and traumatic brain injury
* Range of motion (ROM) and strength characterized by one of the following limitations:

  * Range of motion within functional limits (as determined by our OT consultant Deb Latour), but with limited pinch strength measured by a pinch meter of less than 2 pounds or manual muscle test grade of 3.
  * Limited range of motion of the wrist, thumb, index, and middle fingers as determined by a clinical occupational therapist
* Passive ROM within functional limits as determined by our OT consultant Deb Latour
* No tremors in the hand or arm
* Must be able to understand and follow up to 3 step directions for testing
* No other comorbidities that may affect their ability to use the device
* Modified Ashworth Scale assessment for spasticity of less than 2
* Greater than 18 years old
* Must be able to wear a powered hand orthosis device.
* Be able to make the required visit(s) to LTI for testing
* Mini-mental test \[2\] score greater than 18