cyrilzakka/clinical-trials huggingface dataset:
Role of Adiponectin and Endothelial Progenitor Cells in Reperfusion Injury in Patients With Acute Myocardial Infarction

There is experimental evidence that low levels of adiponectin are associated with more reperfusion injury. In addition experimental studies have demonstrated that endothelial progenitor cells may have a favorable effect on remodeling, mainly through stimulation of neo-revascularisation. Clinical data on these issues are lacking. This clinical project studies the role of adiponectin, endothelial progenitor cells and endothelial microparticles in the ischaemia-reperfusion process and the compensatory ventricular remodelling in a population of 250 infarction patients treated with primary PCI. If the role of these factors could be confirmed in this clinical setting, those factors might represent a new target for therapeutic interventions in AMI patients.


Eligibility Criteria:
Inclusion Criteria:

* STEMI treated with primary PCI

Exclusion Criteria:

* ischemia time \>12h
* use of immunosuppressive therapy
* unsuccessful recanalisation
* not-interpretable ST-T segment
Intra- And Inter-operator Reliability Of Isometric Back And Abdominal Muscle Strength Testing In Healthy Controls And Persons With Nonspecific Chronic Low Back Pain.

Low back pain (LBP) is currently the most common cause of functional impairment with regard to the musculoskeletal system1. LBP occurs in men and women in all age groups and has a peak incidence between 30 and 65 years. Although 10% of the persons with LRP can be diagnosed with a specific underlying pathology (e.g., disc herniation, canal stenosis, spondylolysis, ...), 90% have symptoms with an unclear origin. 23% of the latter group will eventually develop chronic nonspecific low back pain (CNSLBP)2.

Exercise therapy is seen as an important component in the rehabilitation of persons with CNSPLBP3. Because previous research showed reduced muscle strength of the back muscles4, exercise therapy that improves / recovers muscle strength is being investigated. However, there is still a lack of clarity concerning the effect that reduced muscle strength has on the development and further development of back pain5-6. The objective testing of back muscle strength remains a recurring issue. Up to now, back muscle strength has been mainly tested by a battery of clinical tests (eg Sorensen test) or the use of "iso machines"7. These Iso machines contain a dynamometer that can very specifically reflect the isometric or isokinetic force on an axis of rotation. Different types of these iso machines (eg Cybex, Biodex) have already been developed, each with specific designs (eg differences in the hip angle, differences in the stabilization of the participant). However, to date no standardized protocols are available for evaluating both abdominal and back muscle strength. Furthermore, it is also essential that before such systems can be used in clinical intervention studies, the reliability of such systems is investigated and that reference data from healthy subjects are collected with which data from patients can be compared.

The aim of the current research is therefore to investigate the intra- and inter-operator reliability of a standardized protocol drawn up according to the latest scientific evidence. A second goal is to set standard values for healthy persons for the developed protocol using the Biodex 3 dynamometer system.


Eligibility Criteria:
Inclusion Criteria:

1. medically diagnosed with non-specific chronic low back pain,
2. between 25-60 years old,
3. able to understand Dutch (spoken and written).

Exclusion Criteria:

1. invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
2. radiculopathy (uni- or bilateral),
3. co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, pregnancy,
4. ongoing compensation claims and/or (work)disability \> 6 months,
5. rehabilitation/exercise therapy program for LBP in the past 6 months.
Acute Lymphoblastic Leukemia Relapse in Sweden 2003-2007

A minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued. The aim of this population-based study was to assess the results of reinduction treatment and allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden 2003-2007.

This is a national, multicenter, prospective, population-based study of outcome among adult patients aged 19 to 65 years with ALL relapse diagnosed during 2003-2007 in Sweden. Most of the patients had primary treatment according to National guidelines for ALL as recommended by The Swedish Adult ALL Group (SVALL). The guidelines suggest two different treatment protocols for early relapses, and retreatment according to the initial therapy for late relapses, with the intention to proceed to allogeneic SCT in CR2 for eligible patients. The aim of the current study was to assess outcome among adult patients after first ALL relapse, and the utilization and efficacy of recommended protocols and of allogeneic SCT in this setting.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with first relapse of ALL

Exclusion Criteria:

* patients with Burkitt leukemia
A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult females, \>=18 years of age;
* inflammatory breast cancer;
* HER2-positive tumors;
* performance status 0-2.

Exclusion Criteria:

* metastases;
* previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;
* clinically significant cardiovascular disease, or history of thrombotic disorders.
An HIV Status-neutral Microeconomic Intervention

The aim is the current study is to establish feasibility and acceptability of the SeCuRE intervention to improve HIV prevention and care continua outcomes. To meet this aim, the study has the following objectives:

1. To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color.
2. The determine acceptability of the intervention with transgender women of color.

This is a two-arm randomized waitlist controlled trial in which transgender women of color will be randomly allocated to either the enhanced microeconomic intervention that builds on the Trans Sistas of Color Project's existing microeconomic interventions, which includes: (1) $250 in emergency assistance; and (2) peer support to obtain legal gender affirmation (i.e., legal name and gender markers on identification documents). The existing intervention will be enhanced to include (1) 12 weekly educational group sessions on economic empowerment (i.e., job acquisition, income generation through micro-business, and financial literacy) and HIV prevention and care; (2) employment-focused mentoring; and (3) an unconditional grant ($1,200) for use towards acquiring self-led or formal employment. Each condition will complete a baseline survey prior to randomization, a follow-up survey immediately following intervention completion, and 3-month survey after intervention completion. Participants will also complete qualitative exit interviews within one month of completion of intervention completion for both conditions.

Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years old;
2. assigned male at birth;
3. self identifies as female, transgender woman, or another feminine gender identity;
4. self identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white);
5. reports earning less than $32,800 gross annual income (current living wage in Michigan);
6. reports condomless sex in the past 6 months;
7. lives in Detroit, MI greater metropolitan area (\~50 mile radius);
8. speaks English.
Warwick Metal On Metal Study

assess results of metal on metal hip replacements carried out at warwick hospital

Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of this series.

Eligibility Criteria:
Inclusion Criteria:

* All patients with 36mm metal on metal hips

Exclusion Criteria:

-
Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19:Phase 1

The goal of this observational study is to describe the impacts of COVID-19 on primary care chronic condition management in Canada within various patient populations. This will be done by analyzing primary care electronic medial record (EMR) data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) database, including data on primary care encounters, as well as various markers for chronic conditions.

The research questions to be investigated are:

1a) What are the changes to the management of chronic conditions in primary care since the onset of the COVID-19 pandemic?

1b) How do these changes differ by age, health status, and socioeconomic status?

This is a retrospective closed cohort study, using a single-arm, pre-post design. The objectives of this study are to describe the impacts of COVID-19 on access, comprehensiveness and appropriateness among adult patients with chronic diseases, and to determine whether changes were associated with socio-demographic characteristics and multi-morbidity. This will be done using using electronic medial record (EMR) data made available by the CPCSSN network. CPCSSN is a research network supported by a primary care EMR database, comprising over 1500 physicians, and nearly 2 million patients from across Canada.

We will be examining prevention and management activities for several exemplar chronic conditions that have a validated CPCSSN case definition and substantial prevalence in primary care (e.g. diabetes, heart failure, etc.). CPCSSN data between 2018-2021 will be analyzed for changes in management of various chronic conditions prior to, and through phases of the pandemic. Changes will also be examined among specific sub-groups of adults, including those with multi-morbidity and socio-economic vulnerabilities.

The primary exposure is the onset of the pandemic: March 13, 2020 to December 3, 2021 versus the equal time frame prior. March 13, 2020 was selected as the date when Canadian provincial governments began enforcing various public health and safety measures in response to the World Health Organization formally declaring the circulating SARS-CoV-2 as a pandemic on March 11, 2020.

We will be examining whether there have been changes in overall access, comprehensiveness, continuity and appropriateness of care (including potential decreases in burdensome or unnecessary care) by applying indicators that incorporate chronic condition monitoring (physical measures, lab tests and investigations), prescriptions, referrals and preventive care, to chronic condition patient populations.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older as of 2018
* Records included in the CPCSSN database
* Patient had at least one encounter with their clinic between March 13, 2018 and March 13, 2020

Exclusion Criteria:

* Patients aged 105 or older as of 2018 will be excluded due to possibility of data entry error
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy

There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy .


Eligibility Criteria:
Inclusion Criteria:

* patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions
* physical status American Society of Anesthesiologists (ASA) II or III.

Exclusion Criteria:

* Patients who refuse to participate
* patients with body mass index (BMI) \>35 kg/m2
* infection at the site of injection
* coagulopathy, severe thrombocytopenia \<50×103
* spine deformity
* history of opioid dependence
* polytrauma patients with dorsal spine fracture
* urgent abdominal exploration for splenectomy in heamodynamically unstable patients
* history of allergy to opioids or local anesthetics
* history of allergy to opioids, or local anaesthetics.
Photobiomodulation for the Management of Temporomandibular Disorder Pain

Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. Also, we propose to determine if PBM-induced changes in inflammation contribute to PBM's analgesic effects. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.


Eligibility Criteria:
Inclusion Criteria:

* Provides a signed and dated informed consent form
* Is at least 18 years of age (male or female and any race or ethnicity)
* Meets diagnostic criteria for TMD, ( Masticatory Muscle Disorders, 1A: Myalgia)
* Has experienced facial pain for at least 3 months
* At Screening and Baseline Visit (Visit 0), reports an average pain intensity rating over the past week of ≥ 30 on a numerical rating scale (0-100)

Exclusion Criteria:

* Starting a new daily prescription medication for the management of pain within 30 days prior to treatment session;
* Use of any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks prior to the CATI;
* Starting occlusal appliance therapy within 30 days prior to CATI; d) history of facial trauma or orofacial surgery within 6 weeks prior to CATI;
* Active orthodontic treatment;
* Psychiatric hospitalization within one year prior to screening.
* Has known hypersensitivity to laser therapy.
* Currently being treated with chemotherapy or radiation therapy
* Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit
* Is pregnant or nursing
* Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
Implementing eHealth Interventions Into Regular Clinical Practice

The purpose with this study is to test a digital patient-provider communication tool for symptom and needs management among patients with chronic health conditions.

Living with chronic health conditions affects all areas of life. Fatigue, sleeping problems, pain and loneliness are common. In addition to troublesome symptoms that vary in intensity, many experience worry and uncertainty. There is a need to improve the quality of follow-up of patients with chronic health conditions. A digital patient-provider communication tool, which supports shared decision making, can be one way to improve quality.

The digital tool (InvolveMe) will provide patients with the opportunity to complete and submit a symptom and need assessment prior to out-patient visits at the hospital. Also, patients will have the opportunity to use secure e-mail for follow-up from health care providers in between hospital visits. The assessment will allow patient to prioritize what is important to talk with their health care providers about.

Such a tool can help to make changes in symptoms more visible to both patients and health care providers, as well as make it easier to ask for information and guidance to deal with the individual difficulties patients' experience. The goal is to better address symptoms and concerns and to enhance follow up and coordination between consultations as well as increase the quality of life and reduce illness related stress.

The digital communication tool will first be tested in a feasibility pilot study. The tool will be offered to 50 patients (kidney transplant recipients and patients with non-functioning pituitary adenomas). Participants will be given the opportunity to use the digital communication tool with baseline measures and following measures after 3 and 6 months.

After pilot testing of the tool, a larger longitudinal clinical study among 160 patients with non-functioning pituitary adenomas (n=60) and kidney transplant recipients (n=100) will be conducted to assess the clinical utility. The participants will be assigned to use the digital communication tool, and will be followed with repeated measures over 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a renal transplant (RTX) OR patients with Non functioning pituitary adenomas (NFPA)
* Able to read and speak Norwegian
* Have access to a Smart-phone or tablet
* Have their own secure access device (BankID).

Exclusion Criteria:

* N/A
[18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy

This trial studies how well \[18F\]-AraG works in detecting T-cell activation in patients with non-small cell lung cancer that has spread to other places in the body (advanced), who are undergoing PD-1/PD-L1-directed therapy. \[18F\]-AraG is a "radiotracer" which attaches to immune cells directed at the cancer and shines a light that can be seen using a special camera, called a "positron emission tomography" or "PET" scanner. \[18F\]-AraG may improve the ability to detect a response of the cancer in the body to immunotherapy.

PRIMARY OBJECTIVES:

I. To quantify fluorine F 18 Ara-G (\[18F\]-AraG) uptake (standardized uptake value \[SUV\]) in advanced non-small cell lung cancer (NSCLC) tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in both patients treated with PD-1/PD-L1 monotherapy and in patients treated with immunotherapy/chemotherapy combination therapy.

II. To correlate change in \[18F\]-AraG uptake before and after the start of therapy with radiographic response in patients treated with immunotherapy.

OUTLINE:

Patients receive \[18F\]-AraG intravenously (IV) and then undergo PET/CT over 2 hours at baseline and within 2 weeks after starting immunotherapy. Patients may also undergo blood sample collection.

After completion of study treatment, patients are followed for up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* This study is open to all adult subjects with histological confirmation of NSCLC planned to undergo treatment with a PD-1 or PD-L1 inhibitor either as monotherapy or as combination therapy with concurrent chemotherapy as treatment for advanced/metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3 at the time of enrollment
* Patient with life expectancy \>= 24 weeks from the time of screening to the study
* Ability to sign and understand the Institutional Review Board (IRB)-approved consent form in English
* Ability to remain motionless for up to 30 minutes per scan

Exclusion Criteria:

* Patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed)
* Severe impaired renal function with estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2 and/or on dialysis
* Pregnancy
* Breast feeding an infant
* Prior treatment with anti-PD-1/PD-L1 inhibitor
* Localized/locally advanced disease with anti PD-1/PD-L1 given as consolidation
Tarceva. ICORG 08-41

The aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy.

This is a prospective study of serum proteomics as a predictor of response to erlotinib therapy.

Screening/Baseline

1. Routine blood tests (Haematology and Biochemistry) as per hospital practice
2. Research serum sample for proteomic studies (10ml blood sample)
3. Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size

2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment

4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment

1 year Post Commencement of Treatment with erlotinib (as per current standard of care): Routine CT with RECIST/WHO assessment

Response Assessment: CT scans at baseline, at 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.

Follow Up: Subsequent follow-up as per routine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Any patient who is suited to receive CT scans as part of his/her routine care
* Ability to understand and the willingness to sign a written informed consent, given according to ICH/GCP, and national/local regulations. A signed informed consent must be obtained prior to any study specific procedures
* Planned treatment with erlotinib.

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients not foreseen to receive TarcevaTM treatment
Bunionectomy Trial With GRT6005

The purpose of the trial is to determine whether the new centrally acting analgesic is effective in comparison to placebo and an active comparator (morphine).


Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy

Exclusion Criteria:

* Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
* Concomitant inflammatory disease.
* Life-long history of seizure disorder or epilepsy.
* Subjects with impaired renal function
* Subjects with impaired hepatic function
* Female subjects who are pregnant or breastfeeding.
* Resting pulse rate is \<50bpm or \>100 bpm after 5 minutes rest in supine position
* resting blood pressure after 5 minutes rest in supine position: Systolic blood pressure is \<100mmHg or \>140 mmHg Diastolic blood pressure is \<60 mmHg or \> 90 mmHg
Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain

The aim of this study is to estimate the effect of Kinesio tape (KT) combined with supervised exercise programs compared to exercise alone on pain, lumbar range of motion, and self-reported disability of adults with mechanical low back pain (LBP).

Methods: This was a randomized, controlled clinical trial carried out on 60 individuals with mechanical LBP. Participants were randomly assigned to the control group (n=30) that received McKenzie exercises for 7 days or experimental group (n=30) that received KT application in addition to McKenzie exercises for 7 days. Pain measured by visual analogue scale, lumbar range of motion, and the disability measured by Oswestry Disability Index (ODI) were used as outcome measures. Pre and Post measurements were taken at baseline and after 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with mechanical LBP by a physician

Exclusion Criteria:

* Individuals with any structural or pathological changes (spondylitis, spondylolisthesis, cauda equina syndrome, lumbar canal stenosis) in lumbar spine on X-ray or MRI
* Individuals with or without neurological signs in the lower extremity suggestive upper motor or lower motor neuron involvement,
* Individuals with a history of trauma or any surgery in the region of back,
* Individuals with recent aggravation of symptoms,
* Individuals on a waiting list for spinal surgery or had a spinal surgery in the past 6 months