cyrilzakka/clinical-trials huggingface dataset:
The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study

The aim of the study is to assess whether a decision aid that is currently used in hospitals across Greater Manchester to determine how likely it is that a patient has a serious heart problem is still accurate in the pre-hospital environment.

The Investigators will aim to recruit up to 700 participants, aged 18-100, who call 999 with a complaint of chest pain and are subsequently attended by the ambulance service. A blood sample will be taken in the ambulance as well as information about the participant's symptoms, past medical history, physical examination findings and heart tracing findings. The participant will then be transferred to hospital, where another blood sample will be taken. Both of these blood samples will be analysed at a later date for the cardiac marker, troponin.

Participants will then be followed up after 30 days via screening of their clinical records and contacting their GP. The investigators will gather information on the participant's initial admission to hospital, as well as any further hospital admissions and investigations that have occurred within the 30 days since this admission. The information collected will include data on serial cardiac marker testing; other laboratory analyses; length of stay; all imaging investigations and procedures; and details of any haemorrhagic complications.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* Called 999 for an emergency ambulance because they have experienced pain, discomfort or pressure in the chest, epigastrium, neck, jaw or upper limb without an apparent non-cardiac source
* Treating paramedic suspects these symptoms may be caused by acute coronary syndromes.

Exclusion Criteria:

* Patients with unequivocal evidence of ST elevation myocardial infarction who are being immediately transferred for primary percutaneous coronary intervention
* Patients in whom an alternative diagnosis (other than acute coronary syndromes) is suspected, which would necessitate transfer to hospital
* Patients who have not experienced symptoms in the previous 24 hours
* Patients who lack the capacity to provide written informed consent, either because they lack the mental capacity to provide written informed consent or because effective communication is not possible (e.g. non-English speakers in the absence of adequate translation services)
Symptom Management for Irritable Bowel Syndrome

The objective of this study is to test the efficacy of a symptom management treatment strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in adults.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 70 years of age.
* Diagnosis of IBS based on ROME III criteria.
* Complete symptom diaries and return completed diaries at all sessions.

Exclusion Criteria:

* History of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology.
* Alarm symptoms according to ROME III.
* Individuals currently receiving other types of complementary therapies.
* Individuals with an acute medical condition requiring acute medical attention.
Role of ASICs in Human Inflammatory Pain

In recent years, ion channels have emerged as new therapeutic targets for pain. Among these channels, ASICs (Acid Sensing Ion Channels) are of particular interest because they are directly activated by extracellular acidity, which is a major cause of pain. Indeed, many painful conditions such as ischemia, inflammation, tumor development or tissue incision are accompanied by tissue acidification. ASIC are excitatory ion channels that are expressed in neurons, including nociceptive sensory neurons. In humans, the use of amiloride, a nonspecific inhibitor of ASICs, has demonstrated their role in the perception of pain induced by subcutaneous injections of acidic solutions. ASICs thus appear as new candidates capable of mediating pain in humans. A growing number of data suggests that, in addition to protons, ASICs may also be activated by one or more endogenous compounds produced during inflammation. The purpose of this research project is to identify these compounds by testing the effects of human inflammatory exudates on ASICs activity. The discovery of such compounds would definitely validate ASICs as novel therapeutic targets for pain treatment in humans


Eligibility Criteria:
Inclusion Criteria:

* septic arthritis
* gonarthrosis in push-inflammatory
* microcrystalline arthropathies
* chronic inflammatory rheumatism

Exclusion Criteria:

* refusal to participate in the protocol
Biomechanical Taping on Low Back Pain With Increased Foot Pronation

It is stated that abnormal lower extremity posture and biomechanics are effective in the development and progression of Low Back Pain (LBP). Exercise, electrotherapy, insoles, and orthoses are used for the prevention and treatment of low back pain.The use of orthosis, insoles, and taping techniques stands out in the correction of foot posture and dysfunctions, which are stated to cause LBP. In studies examining the application of taping to improve foot posture and biomechanics, it is stated that taping is effective in improving foot posture and biomechanics in the short term.

Biomechanical taping has been used in the treatment of musculoskeletal disorders in recent years. It is aimed to correct the impaired joint biomechanics by reducing the load on the joint, supporting strength, and providing movement modification.

In this study, it is assumed that correction of "increased foot pronation" with dynamic taping will result in the recovery of increased internal rotation and decreased shock absorption during weight-bearing, which is stated to cause pain. The study aims to investigate the effects of biomechanical tapping in combination with a home exercise program on LBP.

Participants with a diagnosis of LBP and bilateral increased flexible foot pronation will divide into two groups (Biomechanical Taping (BT) group or Placebo Taping (PT) group). Tape applications will repeat twice per week, for 4 weeks. And also a home-based exercise program will apply to both groups.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical low back pain for at least 6 months
* Age between 18-65 years
* Increased, bilateral, flexible pronation of the feet (Foot Posture Index-6 score\> 0)

Exclusion Criteria:

* Rigid pes planus, pes cavus, equinus deformity, hallux valgus, hallux rigid or calcaneal epin in the feet
* Lower extremity injury or surgery in the last 6 months
* Radicular type back pain (patients with leg pain\> low back pain)
* Body Mass Index (BMI)\> 30,
* Use of analgesics
* Pregnancy
* Presence of symptoms related to a history of spinal surgery in the last 5 years.
* Neurological impairment or cognitive dysfunction (stroke, dementia, etc.)
* Rheumatological diseases
* Peripheral vascular diseases
* Difference in length between extremities
The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain

Introduction:

The McKenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of persistent symptoms originating from a diskus in the low back.

Methods:

After clinical screening 350 patients with or without leg pain who presented with centralization of symptoms or signs of disc herniation were randomized to the McKenzie group or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11 point numerical pain scale, 6 point global perceived change scale, and quality of life (Short Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.

In 1998, Cherkin et al. published a study showing no difference between outcomes following the McKenzie method, chiropractic manipulation, or the provision of an educational booklet for the treatment of patients with acute non-specific low back pain. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of disc-related symptoms for duration of more than 6 Weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age
* suffering from low back pain (LBP) with or without leg pain for a period of more than 6 weeks
* able to speak and understand the Danish language
* with a presentation of clinical signs of disc-related symptoms.

Exclusion Criteria:

* positive non-organic signs
* serious pathology suspected based on physical examination and/or magnetic resonance imaging
* application for disability pension or pending litigation
* pregnancy
* comorbidity
* recent back surgery
* problems with communication
Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery

The goal of this observational study is to keep track of the cardiological follow-up of patients who have undergone back surgery because of symptomatic narrowing of the spinal canal and in whom microscopic examination of the tissue removed during this surgery showed a high amount of local deposits of small proteins. This finding may be an early sign of a condition in which other organs (especially the heart) may also be affected by these proteins, called amyloidosis.

Patients who participate in this study, will be followed up for life. During the first routine consultation with the cardiologist, the physician-investigator will collect information, such as demographics (age, weight, height, gender), medical history, medication, symptoms and the results of prescribed examinations. These examinations include microscopic examination of tissue removed during the surgery, blood tests, electrocardiography, echocardiography and a bone scan. These examinations are clinically necessary and appropriate, and patients should undergo them even without participating in the study.

Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, severe, yet treatable disease. Lumbar spinal stenosis (SS) in elderly is a red flag for ATTR-CM, often preceding cardiac diagnose by many years. Yet, optimal screening strategies for early ATTR-CM detection at time of SS diagnosis are underused.

Study aim: Multi-centric validation of the diagnostic yield of a standard-of-care prospective screening strategy for early ATTR-CM detection in the elderly, based on ligamentum flavum biopsy assessment at SS surgery.

Design: International, multi-centre, prospective, observational, multi-disciplinary, diagnostic registry.

Methods: All consecutive patients ≥60 years old undergoing standard-of-care ligamentum flavum biopsy as part of symptomatic SS surgery within 12 heart centres are included. The burden of ATTR amyloid deposition (positive Congo-red and pre-albumin staining) is assessed semi-quantitatively by visual Westermark grading. Patients with significant ATTR amyloid burden (grade 3 (≥5-10%) or 4 (\>10%) ATTR amyloid on biopsy specimen) undergo standard-of-care work-up to exclude ATTR-CM, conform state-of-the-art clinical practice and ESC recommendations (i.e. baseline cardiac biomarkers, ECG, transthoracic echocardiography, monoclonality assessment and bone-scintigraphy with SPECT; additional CMR and/or endomyocardial biopsy as needed). The diagnostic yield of this biopsy-based strategy will be evaluated.

Conclusion: This trial will validate the diagnostic yield of selective ligamentum flavum biopsy analysis in SS surgery patients as a simple and valuable prospective screening strategy for early ATTR-CM detection.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 60 years old
* Lumbar spinal canal stenosis, undergoing spinal surgery
* Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy

Exclusion Criteria:

* Prior diagnosis of cardiac amyloidosis
* Unwilling to provide informed consent
Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients

Oxaliplatin-induced chronic peripheral neuropathy is of major concern to oncologists and patients as it has been shown to affect patients' health-related quality of life. Although a number of interventions have been implicated, none of them can be recommended for clinical use. This therapeutic failure reflects a poor understanding of the real mechanism of oxaliplatin-induced neuropathy. However, oxidative stress is identified to be one of the main biomolecular dysfunctions in this neuropathy. Rood's approach is a neurophysiological approach that is based on reflexes of the central nervous system in which the sensory stimulation provides desired muscular response and was specially designed for patients with motor control problems. It was developed by Margeret Rood in 1940. According to Rood, sensory stimulation can activate or deactivate the receptor by facilitation or inhibition, which makes it possible to get the desired muscular response.

So, the purpose of the study is to investigate the efficiency of Rood's approach on oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* The patient can participate in the study if they had at least one cycle of oxaliplatin chemotherapy.
* Colorectal cancer patients who have oxaliplatin-induced peripheral neuropathy, the patients included in the study with mild to moderate neuropathy according to mTNS.
* Patients from both genders.
* Their ages range from 18 to 60 years old.

Exclusion Criteria:

* Patients who had a history of any other neuropathy as diabetic neuropathy.
* Patients with an unstable medical condition during chemotherapy.
* Patients who are starting new therapy or dose modification during the study period.
* Patients with morbid obesity "body mass index \>40%".
* Patients with a history of non-surgically repaired nerve compression injuries such as carpal tunnel, brachial plexopathy, spinal stenosis, and spinal nerve root compression.
* Patients with a history of central nervous system primary or metastatic malignancy.
Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation

In this trial, we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade.


Eligibility Criteria:
Inclusion Criteria:

* 135 patients underwent bilateral ETSB procedure under general anesthesia

Exclusion Criteria:

* patients who underwent one sided ETSB
* patients under the age of 18
* Patients over 65 years of age
Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy

This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a computer-delivered screening and brief intervention (SBI) that simultaneously targets sexually transmitted infection (STI) risk and alcohol/drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.


Eligibility Criteria:
Inclusion Criteria:

* At least one unprotected vaginal (or anal) sex occasion in the past 30 days
* Having more than one male sex partner in the last 6 months and/or having uncertainty about current partner's monogamy.
* Pregnant
* Current alcohol/drug use risk.

Exclusion Criteria:

* Unable to understand English
Get In Touch Phase 2

The objective of the Get In Touch - Phase 2 (GIT-2) study was to evaluate a diabetes care support intervention facilitated by cellular-enabled glucose meters in adults with persistent poor control of type 2 diabetes.

A 2-group randomized crossover trial comparing usual care to a diabetes care support intervention among patients with repeated HbA1c recordings greater than 8.0 percent during the previous 12 months. The intervention included 6 months of enrollment in Livongo for Diabetes, a Certified Diabetes Educator (CDE) based remote diabetes monitoring program facilitated by cellular-enabled glucose meters, with additional remote monitoring by their usual care team. HbA1c levels were recorded at enrollment and 3, 6, 9, and 12 months post enrollment. Questionnaire data were collected at baseline, 6 months, and 12 months post enrollment. Primary outcomes evaluated were change in HbA1c and treatment satisfaction at the 6 month endpoint with secondary outcomes of change in HbA1c and treatment satisfaction at the 12 month endpoint.

Eligibility Criteria:
Inclusion Criteria:

* speak English, having type 2 diabetes with two consecutive HbA1c recordings greater than 8.0% over the previous 12 months at the time of recruitment

Exclusion Criteria:

* excluded if they were cognitively impaired, pregnant, or prisoners.
Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer

This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.

PRIMARY OBJECTIVE:

I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI).

SECONDARY OBJECTIVES:

I. To correlate PSMA imaging changes with prostate specific antigen (PSA) kinetics.

II. To correlate PSMA imaging changes with progression free survival. III. To evaluate the changes in PSMA PET staging (miTNM Prostate Cancer Molecular Imaging Standardized Evaluation \[PROMISE\] criteria) under ARSI.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) intravenously (IV). After 50-100 minutes, patients undergo positron emission tomography (PET)/computed tomography (CT) over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer
* Know metastatic disease on previous imaging, or PSA value ⩾ 1 ng/ml;
* Castration resistant disease with confirmed testosterone level =\< 50 ng/ml under prior first-line androgen deprivation therapy (ADT)
* New planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide
* Willingness to undergo ARSI throughout the duration of the study as prescribed by the treating uro-oncologist
* Stated willingness to comply with continuation of ARSI treatment for the duration of the study
* Provision of signed and dated informed consent form

Exclusion Criteria:

* Inability to provide written informed consent
* Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
* Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
* A baseline superscan pattern on bone scan
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible
Magnetic Resonance Elastography in Glioma: Exploring Tumor Stiffness and Adhesion

this study will investigate the relationship between tumor stiffness and adhesion in gliomas using MRE. By utilizing preoperative MRE and Intraoperative neuronavigation, followed by comprehensive molecular pathology analysis, we aim to explore the correlation of tumor stiffness and adhesion with molecular and genetic characteristics of gliomas. Additionally, the predictive value of MRE in terms of pathological staging and prognosis will be determined. This research may pave the way for improved clinical decision-making, personalized treatment approaches, and more accurate clinical trials for glioma patients.

Magnetic Resonance Elastography (MRE) is an advanced imaging technique that measures the mechanical properties of tissues, providing valuable information about tissue stiffness, elasticity, and adhesion. In the case of gliomas, a type of brain tumor arising from glial cells, MRE has shown promising potential in the diagnosis, classification, and prediction of pathological and molecular features.

This clinical trial aims to investigate the relationship between tumor stiffness, adhesion, glioma grading, and genetic alterations by combining magnetic resonance elastography (MRE) imaging findings with molecular pathological analysis. Moreover, the study aims to predict patient survival based on the physical properties of the tumor.

Preoperatively, we will use MRE to enhance the accuracy of navigation and determine tumor stiffness and adhesion properties. Intraoperatively, under the guidance of neuronavigation, tissue samples will be obtained, and the operating surgeon will assess the tumor's stiffness, elasticity, and degree of adhesion.

Postoperatively, all tissue specimens will undergo molecular pathological analysis. The integration of MRE findings with molecular pathology data will enable precise classification and subtyping of gliomas.

Furthermore, all patients will receive systematic treatment after surgery, and long-term follow-ups will be conducted. This comprehensive approach combining MRE, molecular pathology analysis, and clinical follow-up aims to investigate the predictive value of MRE in terms of molecular pathological features and prognosis in gliomas.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing glioma resection surgery are eligible for inclusion in the study cohort.

Exclusion Criteria:

* Patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who cannot remove dentures, insulin pumps, or contraceptive rings)
* Pregnant women in the first trimester (within three months)
* Patients with severe claustrophobia or anxiety
* Patients with severe fever
* Patients who can not tolerate MRE
* Patients with vascular malformations and aneurysms.
* Patients who do not sign an informed consent
DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer

Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Stage III colon cancer
* Undergone complete resection of primary tumor
* Completed standard adjuvant chemotherapy
* ECOG performancer status 0-2
* Adequate hematologic, hepatic and renal functions

Exclusion Criteria:

* HIV positive or other Immunodeficiency disease
* Uncontrolled hypertension
* History of recent cancers in the past 5 years
* Patients with previous or concurrent malignancy or any anti-cancer therapy
* Patients who were allergic to platinum drugs or fluorouracil
* Pregnant patients