cyrilzakka/clinical-trials huggingface dataset:
China Stroke Secondary Prevention Trial

The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary stroke prevention trial in China to determine whether the addition of folic acid and vitamin supplements will reduce recurrent stroke events and other combined incidence of recurrent vascular events and vascular death.

The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary stroke prevention trial in China to determine whether the addition of folic acid and vitamin supplements will reduce recurrent stroke events and other combined incidence of recurrent vascular events and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within one months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blinded fashion to receive multi-vitamins or placebo. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the two years with a median follow-up of 3 years. Recruitment to the trial began in July 2011 and is planned to continue until December 2013. The investigators aim to complete final follow-up by the end of 2016.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting within one months of ischemic stroke (ischemic or hemorrhagic) or TIA
* Homocysteine level ≥ 15μmol／L
* Agree to take study medication;Be geographically accessible for follow-up
* Provide written informed consent

Exclusion Criteria:

* Other cause of ischemic stroke (cardioembolism; stroke of other determined etiology, and stroke of undetermined etiology according to TOAST subtypes) or hemorrhagic stroke (intracranial vascular malformations; cerebral amyloid angiopathy; trauma and bleeding disorders etc)
* Use of vitamin supplements containing folate, B6 or B12
* Pregnancy or women of child-bearing potential who are at risk of pregnancy
* Limited life expectancy
Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray

Pragmatic clinical trial of an add-on therapy regarding the use of edupression.com® - a licensed computer based self-help program - on patients with therapy-resistant depression receiving esketamine nasal spray

edupression.com® - is a medical product and computer based self-help program based on cognitive behavioral therapy, psychoeducation and mood tracking. Patients included in the interventional arm of this study are receiving full access to edupression.com®.

Due to limited resources regarding face-to-face therapy and a high prevalence of Major Depressive Disorder - of which 37% can be identified as therapy-resistant depression (TRD) according to the definition of the European Medical Agency (EMA) - low-intensity psychosocial interventions such as edupression.com® are recommended as first-line digital therapeutic agent by international guidelines such as National Institute for Health and Care Excellence (NICE) guidelines. Studies have shown that digital interventions - such as edupression.com - show comparable clinical efficiency to face-to-face therapy and therefore could be able to fill the gap in limited ressources. In this study patients with therapy-resistant depression are receiving therapy with edupression.com® in addition to their treatment-as-usual with esketamine nasal spray. Comparable studies have shown that patients receiving psychotherapy in addition to their medical therapy benefit in regards to their clinical outcome. Considering these findings, this study is aimed to investigate potential clinical benefits in patients receiving digital therapy with edupression®.com as an add-on therapy to their treatment-as-usual therapy with esketamine nasal spray.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Initial MADRS-Score of 22 or above
* Diagnosis of a therapy-resistant depression following the definition of the European Medicines Agency (EMA) - absence of remission after two or more guideline-oriented therapies
* Patients assigned to treatment with nasal esketamine spray Spravato®
* Signed informed consent
* Native German speaker
* Basic knowledge in using computers/smartphones operationalized as daily use of at least two devices (such as tablets, computers, smartphones etc)

Exclusion Criteria:

* Contraindication regarding the use of Spravato®
* Diagnosis of one of the following psychiatric comorbidities: substance abuse, schizoaffective disorders, schizophrenia, bipolar disorder, organic disorders diagnosed via Mini International Neuropsychiatric Interview (MINI)
Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia

This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging to qualitatively assess adequate distal perfusion after endovascular revascularization in Critical Limb Ischemia


Eligibility Criteria:
Inclusion Criteria:

* Age 20 and above
* Critical limb ischemia with ulcer
* Ankle brachial index(ABI) ≤ 0.9 or Toe brachial index (TBI) ≤ 0.5 or Transcutaneous oxygen pressure (TcPo2) ≤ 40mmHg
* ≥ 70 percentage of stenosis of infrapopliteal artery on lower extremity computed tomography angiography or lower extremity doppler
* Subject understands protocol and provides written, informed consent

Exclusion Criteria:

* Post-traumatic critical limb ischemia
* Neurogenic limb ischemia
* Life expectancy ≤ 2 years
Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities

The purpose of this study is to examine the effect of supplementary polyunsaturated fatty acids on nerve damage in the body's extremitites of patients treated with oxaliplatin containing chemotherapy after surgery for colorectal cancer.

The primary objective of the present study is to examine if a high dosage of n-3 PUFA reduces the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) 8 months after adjuvant oxaliplatin following surgery for high-risk colorectal cancer.

An additional aim is to investigate whether n-3 PUFAs have an effect on nutritional status, cognition and mental status. Inflammatory mechanisms and biomarkers of CIPN in skin biopsies and in blood will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically verified adenocarcinoma of the colon or rectum and planned standard adjuvant treatment with capecitabine in combination with oxaliplatin.
* ECOG performance status 0-2 (measurement of a patient's function in terms of self-care, daily activity and physical ability.
* Written and orally informed informed consent

Exclusion Criteria:

* Inability to speak, read, and understand Danish.
* Previous treatment with neurotoxic chemotherapy.
* Neurological (including neuropathy) or psychiatric disorders, diabetes or other significant medical conditions.
* Alcohol or drug abuse.
* Sensory disturbances in the feet
* Spinal stenosis.
* Vascular disease (Fontaine grade II or more).
* Known allergy to fish, fish oil or corn oil
* Fertile patients not willing to use effective methods of contraception during treatment or abstinence.
* Daily intake of oil supplements and not willing to stop during the trial period.
* Lack of consent to skin biopsy
Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)

The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge.

We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18 years or older),
* Presented to the ED with pain in the neck and/or back,
* A diagnosis of musculoskeletal pain as determined by an ED provider,
* Able to read and understand the consent form in English.

Exclusion Criteria:

* Suspected to have a non-musculoskeletal cause of pain;
* Unable to provide informed consent or to comprehend or complete study measures or procedures due to cognitive impairment, including evidence of drug, medication or alcohol intoxication, or due to severe hearing or speech impairment;
* Unable to safely participate due to critical illness, emergent surgical need, other serious medical condition (including active COVID-19 infection),
* ED provider judgment.
Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.


Eligibility Criteria:
Inclusion Criteria:

* Living in the United States (contiguous states)
* Aged 21 years or older
* Able to provide documentation of +Polymerase Chain Reaction (PCR) or +antigen test for COVID-19 within the past 48 hours
* Self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily
* Able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up.

Exclusion Criteria:

* Under the age of 21
* Received a positive test result more than 48 hours prior to contacting study staff or has a pending test for COVID-19
* Cannot confirm a PCR or antigen positive test for COVID-19
* Is unable to read English
* Is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire
* Is unwilling or unable to provide baseline data required for entry into the study
* Is unable to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow-up
* Heavy tattooing on both upper arms
* Known atrial fibrillation (permanent or paroxysmal)
* Has taken/is taking part in a COVID-19 vaccine or treatment trial
Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program

This study investigates the effectiveness of a Finnish Tulppa outpatient rehabilitation program. Tulppa is a group-based secondary prevention program for patients with vascular diseases. The program is developed by the Finnish Heart Association. The intervention is implemented at the local primary health care centers in 12 health districts in Finland.

A longitudinal controlled study is used to investigate the effects of the intervention on participants' level of cardiovascular risk factors (e.g. lipids, blood pressure, body mass index), functional capacity (e.g. 6 minute walk test), life style as well as psychosocial factors (e.g. smoking, diet, physical activity, health-related quality of life and depression). The data will be collected at baseline (i.e. before the intervention), and 6 and 12 months after the intervention started.

The participants (n = 300) are patients diagnosed with coronary heart disease. The study group (n = 150) is recruited from participants of Tulppa rehabilitation in three health care districts (Pirkanmaa, South Karelia, Päijät-Häme). The control group (n = 150) is recruited from two health care districts (Turku and Hyvinkää) that do not provide Tulppa rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Study group: Patients diagnosed with coronary heart disease taking part in the Tulppa cardiac rehabilitation program at Pirkanmaa, South Karelia and Päijät-Häme health districts
* Control group: Patients diagnosed with coronary heart disease, living in the area of Turku or Hyvinkää which are health districts that do not provide Tulppa rehabilitation.

Exclusion Criteria:

* Acute and severe mental health problems, alcohol abuse, major limitations in physical activities
Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography

The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute coronary syndrome.

A prospective, randomized and controlled study comparing the coverage of the BAS and EES implanted in acute coronary syndrome.

Clinical follow-up at 1, 6, 12 and 18 months. OCT analysis at the time of the 6 to 8 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old;
* The patient is presenting with acute coronary syndrome, and according to hospital routine practice, eligible for percutaneous coronary intervention;
* Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Lesions in coronary artery bypass grafts
* Left main disease
* Killip class III-IV
* Allergy to aspirin / thienopyridine
* Patient in anticoagulation therapy
* No suitable anatomy for OCT scan
* Ostial lesion
* Tortuosity anatomy
* Very distal lesion
* Vessel size \> 3.75 mm
Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients

The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin hydrocloride on metabolic control in mexican type 2 diabetes patients without prior pharmacological treatment.


Eligibility Criteria:
Inclusion Criteria:

* Ages eligible for study: 40 to 60 years
* With type 2 diabetes evolution \< 5 years without pharmacological treatment 1 month prior to the screening
* Fasting glucose = 130-200 mg/dL
* HbA1c of 7% to 9%
* Blood pressure \< 140/80 mmHg
* Ability to communicate and meet the requirements of the study
* Signed Written Informed Consent before to conducting any study
* Body mass index (BMI) of 25 kg/m2 to 35 Kg/m2

Exclusion Criteria:

* Suspected or confirmed pregnancy
* Nursing
* Inability to secure the non-pregnant during the study duration
* Hypersensitivity to any biguanides
* Use of an investigational drug within 30 days prior to the screening
* Liver failure, heart failure, kidney failure or thyroid disease
* Periods of acute or chronic diarrhea or vomiting
* Chronic hepatic disease
* Total Cholesterol \>300 mg/dL
* Triglycerides \>400 mg/dL
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

Peripheral T cell lymphoma and advanced cutaneous T cell lymphomas are aggressive and refractory diseases that are generally treated with chemotherapy. Despite current treatment modalities, only a subset of patients will be cured by the treatment. In this study, four chemotherapeutic agents (L-asparaginase, Methotrexate, Doxil, and Prednisone) will be administered in a combination regimen for patients with relapsed or refractory Peripheral and/or advanced cutaneous T cell lymphoma. Each one of these individual drugs have been shown to have activity to lymphomas. The objective of the study is to determine if the combination of these chemotherapy agents results in higher response and cure rates in this patient population. This will be a single institutional study which will included 32 patients in the Peripheral T cell lymphoma group and 32 patients in the Cutaneous T cell lymphoma group.

Peripheral T cell lymphoma and advanced cutaneous T cell lymphomas are aggressive and refractory diseases that are generally treated with chemotherapy. Despite current treatment modalities, only a subset of patients will be cured by the treatment. In this study, four chemotherapeutic agents (L-asparaginase, Methotrexate, Doxil, and Prednisone) will be administered in a combination regimen for patients with relapsed or refractory Peripheral and/or advanced cutaneous T cell lymphoma. Each one of these individual drugs have been shown to have activity to lymphomas. The objective of the study is to determine if the combination of these chemotherapy agents results in higher response and cure rates in this patient population. This will be a single institutional study which will included 32 patients in the Peripheral T cell lymphoma group and 32 patients in the Cutaneous T cell lymphoma group.

Eligibility Criteria:
Inclusion:

Patients must be at least 18 years of age. Histologically confirmed (including immunohistochemistry) diagnosis of T-Cell Lymphoma by skin biopsy or visceral/lymph node biopsy or bone marrow aspirate/biopsy Life expectancy of more than 3 months.

Exclusion:

Uncontrolled diabetes mellitus Active or serious infections uncontrolled with antibiotics Concurrent treatment, radiation or investigational treatment. 5.2.6 Significant underlying cardiac disease, including unstable angina, myocardial infarction less than 6 months before starting study, congestive failure of any cause
Fear of Fall Related Factors in Chronic Stroke

Some stroke survivors develop a fear of falling(FoF) which may exist with or without a prior fall. Fear of fall can be defined as decreased perceived self efficacy or confidence in maintaining balance while completing regular activities. FoF may impair rehabilitation and recovery. Determination of FoF related factors will help to identify interventions needed to decrease FoF. Mostly fear of fall related factors have been studied in acute stroke patients, limited data are available for patients with chronic stroke. The objective of this study is to evaluate frequency of FoF in chronic(\>6 months) stroke patients and investigate relationship between FoF and balance, posture,spasticity and activities of daily living. The Turkish Version of the Modified Falls Efficacy Scale was used to measure FoF. Also a single-item dichotomous question "Are you afraid of falling? (Yes/No)" will be asked.

In this observational study, chronic(\>6 months) stroke patients who admitted to Physical Medicine and Rehabilitation outpatient clinic, older than 50 years old will be included. Sociodemographic and medical data including patients' age, gender, height, weight, body mass index, contact information, marital status, educational status, plegia side, stroke etiology, time after stroke, accompanying diseases, medications used, fear of falling (yes/no), history of falling (yes/no), and the use of walking aids will be recorded. In the evaluation of patients, Brunnstrom Hemiplegia Recovery Staging, Functional Ambulation Classification (FAC), Mini Mental State Examination(MMSE),Turkish Version of Modified Falls Efficacy Scale(MFES), Berg Balance Scale(BBS), Postural Assessment Scale for Stroke Patient Turkish Version (PASS-Turk), Modified Ashworth Scale (MAS), Modified Barthel Activities of Daily Living Index will be used. Fear of falling will be evaluated by the same researcher using the MFES. Also a question " Are you afraid of falling? (Yes/No)" will be asked. The patients will be divided into two groups as Group 1 =MFES\<5 and Group2 =MFES ≥5. Balance, posture, ambulation status, spasticity, daily living activities and Brunnstrom staging will be compared between two groups. Correlation between MFES and balance, posture and activities of daily living will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 and over
* More than 6 months after the stroke
* Able to follow 3-digit orders
* Able to approve the consent form in writing
* Patients with a score of 23 and above on the Mini-Mental State Test will be included

Exclusion Criteria:

* Bed-dependent, wheelchair-dependent patients
* Patients diagnosed with Alzheimer's, Dementia
* Patients who are cardiovascularly unstable
* Patients with diseases that affect balance (such as Parkinson's disease, Cerebral trauma, Meniere, ear infection, Benign paroxysmal positional vertigo, Multiple sclerosis) and those who use drugs that disrupt the balance
Risk Factors for Low Back Pain in Adults a 23-year Prospective Cohort Study of 14-15-year-old Schoolchildren.

The incidence of low back pain (LBP) is increasing and prognostic factors for developing LBP are unclear. Based on questionnaires, different prognostic factors are being explored over time.

Despite the massive efforts of trying to find predictors and prevention for LBP, it remains to be clarified, why some individuals develop severely disabling low back pain while others never experience noteworthy back pain.

There is no evidence that numbers of chronically affected individuals have diminished; rather, the incidence of LBP has increased continuously over the last 20 years, which is also reflected in rising numbers of lumbar surgical treatments and rising costs due to health care expenses and sick leave. Hence, prevention of LBP in the working population seems more urgent than ever.

As LBP is undoubtedly a multifaceted disorder that tends to fluctuate throughout life, there is a need for longitudinal research, exploring the effect of both lifestyle and psychosocial factors on the development of chronic low back pain.

The main aims of this study is to identify the prevalence of low back pain and identify whether a history of low back pain during adolescence represents an increased risk of experiencing low back pain later in life.

Eligibility Criteria:
Inclusion Criteria:

* Being a member of the original Western Zealand cohort
* Ability to understand and write in Danish
* Having access to the Danish digital mail system "e-Boks". (Access to e-Boks is mandatory in Denmark unless you have special needs)

Exclusion Criteria:

We have no formal exclusion criterias
Hypoglycemia and Autonomic Nervous System Function

The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.


Eligibility Criteria:
Inclusion Criteria

* Healthy volunteers
* Males and females age 18 to 50 years

Exclusion Criteria

* Pregnancy
* Lactation
* Subjects who smoke or are on other forms of nicotine will be excluded
* Clinically evident coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include diabetes mellitus, congestive heart failure, hypertension, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
* Current major depressive illness
* Any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
* Use of medications other than thyroxine