cyrilzakka/clinical-trials huggingface dataset:
Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).


Eligibility Criteria:
Inclusion Criteria:

* Patients who speak English and are willing to sign the consent form
* Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms \< 4 weeks in duration) and acute hematogenous infection (greater than 4 weeks from surgery; symptoms \< 3 weeks in duration) of a primary total knee or total hip arthroplasty, defined as:

  * A sinus communicating with the prosthesis OR
  * Two positive cultures obtained from the prosthesis OR
  * 4 of 5 criteria: Elevated ESR (\> 30mm/hr) and CRP (\> 10mg/L); Elevated synovial leukocyte count (\>3000 cells/μL) or change of ++ on; leukocyte esterase strip; Elevated synovial neutrophil percentage (\> 80%); One positive culture; Positive histological analysis of periprosthetic tissue (\> 5 neutrophils per high; Power field in 5 high power fields x 400).
* OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR

Exclusion Criteria:

* Patients with a chronic PJI, defined as: presentation of symptoms \> 4 weeks in duration.
* Revision surgery or previous two-stage reimplantation.
Safety and Efficacy Study of XELOX vs. Oxaliplatin+5-FU CI as First Line Treatment in Metastatic Colorectal Cancer

The purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer

The purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer

Eligibility Criteria:
Inclusion Criteria:

Written informed consent. Men and women \> or = 18 years Karnofsky functional status \>or=70% at the time of enrollment in study Histologically confirmed diagnosis of CRC Patients must not have received chemotherapy (exception: adjuvant treatment \> 12 months following conclusion of treatment) Presence of at least one lesion detectable by two-dimensional measurement.. Life expectancy greater than 3 months.

Exclusion Criteria:

Pregnant or nursing woman Prior administration of systemic immunotherapy, chemotherapy (exception: 5-FU as adjuvant treatment \> 12 months following conclusion of treatment) Evidence of allergic reaction to any of the treatment components Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months Documented or suspected cerebral and/or leptomeningeal metastases. Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.

Neutrophil count \< 1.5 x 109/l , platelets \< 100 X 109/l serum creatinine \> 1.5 x ULN. Total bilirubin count \> 2 x ULN Alkaline Phosphatase \> \> 2.5 x ULN (\> 5 x ULN if there are hepatic metastases) Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \> 2.5 x ULN (\> 5 x ULN if there are hepatic metastases, \> 10 x ULN if there are bone metastases) Creatinine clearance \< 30 ml/min Surgery within 4 weeks prior to enrollment in the study. Any investigational drug during the 4 weeks prior to enrolment. Uncontrolled active infection Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent

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Immunological Mechanisms in Sarcoidosis

There is no cure for the inflammatory disease sarcoidosis. Virtually any part of the body can be affected but most often the lungs and lymph nodes. Outcomes after diagnosis vary widely among sarcoidosis patients, with some experiencing resolving disease and others developing chronic disease and lung fibrosis. Cardiac sarcoidosis can lead to life threatening arrythmias and calcium metabolism disturbances can lead to renal impairment.

Treatment with different forms of immunosuppressants are usually tried to dampen symptoms but are not effective in all patients. Furthermore, the disease usually flares up after cessation of treatment. The variability in diseae course and treatment response is thought, at least to some degree, to be explained by individual differences in genetics, immune cells and signaling pathways. But existing evidence is limited. In other inflammatory diseases the gut microbiome is of importance for disease course but its role in sarcoidosis has not been clarified.

In this prospective project the investigators will study genes, inflammatory cells and signaling molecules in the lung, upper airways and blood, and to some extent microbes, also in faeces. Healthy volunteers will be included for comparative studies. Most samples will be taken during normal diagnostic work-up and follow-up of patients with/with suspected sarcoidosis. The findings will be correlated to disease course and effects of different treatments. By linking to national health data and demographic registries, comorbidities and environmental factors will be correlated to data.

By this, the investigators hope to improve understanding of which genes, cells and signaling molecules that are of importance for resolving vs non-resolving disease and why some patients respond to a certain treatment and others don´t. The overall goal is to assess and predict sarcoidosis outcomes. We hypothesize that blood-based biomarkers including those taken during routine care as well as novel cell, signaling molecules and genetic markers, in combination with clinical characteristics can be used to predict outcomes, also treatment response, in sarcoidosis. The results can lead to tailored treatment and individual follow-up for each patient with sarcoidosis.


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of sarcoidosis
* Swedish speaking
* Able to understand and approve of study protocol
* No contraindications for planned interventions
* For inclusion of healthy controls they need to be healthy and the same criteria as listed above for patients.

Exclusion Criteria:

* No suspicion of sarcoidosis
* Not Swedish-speaking
* Not able to understand study protocol
* Not approving of study protocol
* Contraindications for planned interventions
Evaluation of a Novel Method for Increasing Intraocular Pressure in Healthy Subjects

Adequate perfusion is necessary for maintaining tissue function. This applies also for the eye, in which ocular perfusion pressure (OPP) is generally estimated as the difference between mean arterial pressure (MAP) and intraocular pressure (IOP). In the latter formula, IOP substitutes for central retinal venous pressure (CRVP), which is assumed to be slightly higher than IOP to allow blood flow to exit the eye. It has, however, been found that in some patients CRVP is elevated and significantly higher than IOP, which would lead to a decrease in OPP which is not taken in account with the proposed formula. Therefore, techniques for measurement of CRVP are warranted. Recently, a new, method for measurement of this parameter without corneal contact has been introduced. Briefly, with this method, IOP is elevated until the vein collapses, which then equals CRVP. In the present study this technique will be applied in 12 healthy subjects to validate whether the values that are preset by the device correlate to measurements obtained with standard Goldmann applanation tonometry. For this purpose, IOP will be experimentally increased in steps of approximately 5mmHg until it reaches 40mmHg as measured by applanation tonometry. After a resting period of 30 minutes, IOP will be again increased stepwise to 40 mmHg while retinal vessel diameters will be monitored using dynamic vessel analyzer. During this session CRVP will be measured. After another resting period of 30 minutes IOP will be stepwise increased a third time and after each step OCT, OCT-A and OCT EDI will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Non-smokers
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 1 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnancy, planned pregnancy or lactating
Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy

Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.

log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.

In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.


Eligibility Criteria:
Inclusion Criteria:

Pathologically confirmed AA patients without distant metastasis treated with curative-intent resection

Exclusion Criteria:

patients who received neoadjuvant therapy or radiotherapy, as well as those with missing clinical pathological or follow-up information
Effectiveness of Modified Diaphragmatic Training for Gastroesophageal Reflux Disease Post Covid-19

The study titled "Effectiveness of Modified Diaphragmatic Training for Improving GERD-Q Score, Diaphragmatic Excursion, Maximum Inspiratory Pressure and Lung Function in Adults With Gastroesophageal Reflux Disease After Covid-19: a Single-blinded Randomized Control Trial" is a clinical trial that aimed to investigate the effectiveness of 4 weeks modified diaphragmatic training (MDT) compare with standard diaphragmatic training for improving GERD-Q score, diaphragmatic excursion, maximum inspiratory pressure, and lung function in adults with gastroesophageal reflux disease (GERD) after COVID-19. The trial was single-blinded and randomized, and it included a total of 50 participants. The results of the study showed that MDT was effective in improving GERD-Q score, diaphragmatic excursion, maximum inspiratory pressure, and lung function in adults with GERD after COVID-19.

The study aims to investigate the effectiveness of modified diaphragmatic training compared with standard diaphragmatic training in adults with gastroesophageal reflux disease after covid-19. The design is a single-center in a national respiratory referral center in Indonesia, single-blinded randomized control trial. A central randomization center used computer-generated tables to allocate treatments. The study will involve a randomized controlled trial with a sample size of 50 adult patients with GERD after covid-19. Participants will be randomly assigned to either a modified diaphragmatic training group or a control group.

Four weeks of training with diaphragmatic training followed by modified diaphragmatic training (MDT) or standard diaphragmatic training. Follow-up 30 days

Eligibility Criteria:
Inclusion Criteria:

* Male and female after recover from moderate COVID-19.
* Six month post COVID-19
* Age 18 to 60 years old
* GERD-Q Score more than 7
* Agree to participate in the study
* Well understanding of the study procedure.

Exclusion Criteria:

* History of ventilator used while COVID
* History of uncontrolled cardiac problems and chronic pulmonary
* Pregnancy or lactation
* History of surgery in the abdomen of the thoracic area
* Severe scoliosis or Kyphotic
* HIV/ AIDS, Autoimmune
* Prolonged use of dyslipidemia drug more than 1 year
* Prolonged use of prokinetic gastric drug more than 4 weeks
Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil

The overall goal of this feasibility study is to make adaptations to these evidence-based approaches in collaboration with PLWH and health care providers working with this population, and develop, implement, and evaluate the feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil (Londrina). This proposal will focus on the intervention development, pretesting, and feasibility testing. The primary outcome will be a 7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.

This study aims at developing and examining feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil. It consists of three phases: formative assessments with patients and health care providers to inform relevant components of the intervention, pretesting of the intervention components, and pilot testing of the intervention (feasibility).

Eligibility Criteria:
Inclusion Criteria:

* PLWH (that is, patients with a confirmed HIV diagnosis) receiving care at the reference center in Londrina
* 18 years of age and older; (c) smoke at least 5 cigarettes (industrialized or hand-rolled) per day Smoked within the past seven days.
* No intent to move from the area served by reference center in Londrina within the next 12 months.

Exclusion Criteria:

* History of hypertension
* History of angina
* History of asthma
* On medication for depression.
Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction

* Determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct and indirect ultrasonographic signs, in the obstructive diseases of iliac venous segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering the intravascular ultrasound (IVUS) as the gold standard for this diagnosis.
* Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).


Eligibility Criteria:
Inclusion Criteria:

* Advanced Chronic Venous Insufficiency (CEAP 3-6) submitted to clinical treatment for at least 1 year with no response.
* Subject must be \> 18 and \< 80 years of age
* Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure
* On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg

Exclusion Criteria:

* Subject cannot or will not provide written informed consent
* Previous venous stent implantation involving the study leg or inferior vena cava
* Previous venovenous bypass surgery involving the study leg
* Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
* Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
* Acute deep venous thrombosis involving either leg
* Known history of chronic total occlusion of the common femoral vein of the study leg.
* Known history of thrombophilia (e.g., protein C or S deficiency, anti-thrombin III deficiency, presence of lupus anticoagulant, etc.)
* Venous compression caused by tumor encasement
* Venous outflow obstruction caused by tumor thrombus
* Life expectancy of less than 6 months
* Lower Extremity Arterial Insufficiency
* Elevated baseline blood creatinine (value greater than the upper limit of the normal range)
* Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study; examples include but are not limited to the inability to lie supine for the index procedure (e.g., severe congestive heart failure), thrombocytopenia or other hematological disorders associated with an unacceptable risk of bleeding, implanted orthopedic hardware that precludes proper imaging, etc.
The Direct-Physio Trial

Previous research showed that direct access to physiotherapy, and the associated early physiotherapeutic treatment of patients with low back pain (LBP), results in improved clinical outcomes, as well as reduced health-related costs. However, despite these results, the effectiveness of direct access to physiotherapy and its impact on costs has never been investigated in Belgium. Therefore, the goal of this study is to compare the (cost-)effectiveness of direct access to physiotherapy compared to usual care by the general practitioner (GP) for patients with acute LBP.

In this study, 600 patients with acute LBP (lasting \>24 hours and \<6 weeks) will be divided into two groups (Dutch-speaking: n=2x150; French-speaking n= 2x150). One group will receive treatment through direct access to the physiotherapist, without prescription by a GP. The other group will follow the traditional care pathway through the GP. Th effects on pain, disability and cost-effectiveness will be analysed using questionnaires obtained before and at the end of treatment, after 3 months, after one and after two years. Primary outcomes include pain and disability. Secondary outcomes include clinical outcomes, beliefs related to LBP, quality of life, patient satisfaction, but also direct health care costs, health care resource use, as well as absenteeism and productivity loss.

The results of this study will answer the question whether direct access to physiotherapy is (cost)effective for acute LBP. In the long term, these results might be used to optimize the care pathway in Belgium for patients with acute low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific acute LBP defined as (based on Nicol et al. 2020):

  * pain between the 12th rib and buttocks
  * associated or not with non-dominant leg pain
* looking for LBP care for the first time in case of first episode, OR for the first time for the current episode in case of recurrent or persistent LBP
* lasting \> 24 hours and \< 6 weeks
* with an average pain intensity during the past 24 hours of ≥ 3 on an 11-point Numerical Pain Rating Scale
* with an Oswestry Disability Index score (version 2.1a) of at least 20% (Denteneer et al. 2018).
* Patients aged between 18 and 65 years

Exclusion Criteria:

* Recent lumbar surgery (\< 1 year)
* Pregnancy
* History of (any) treatment for the current pain episode
* Red flags suggesting specific LBP (e.g. resulting from infection or neoplasm, cauda equina), based on the Belgian Health Care Knowledge Center (KCE, BEL) who published evidence-based guidelines to manage LBP and radicular pain (Van Wambeke et al. 2017), leads to exclusion from treatment within the study.
* Generalized musculoskeletal pain (based on fibromyalgia criteria) (Galvez-Sánchez and Reyes del Paso 2020).
Function of Regulatory T Cells Improved by Dexamethasone in Graves' Patients

Antithyroid drugs is the first choice treatment of Graves' disease in China and Europe. However,the relapse rate is very high (40-60%) after therapy withdrawal, and many patients need further treatment. In our previous study, a new treatment strategy for GD has been introduced. After methimazole (18 months) combined with intrathyroid injection of dexamethasone (DEX) (3 months) treatment, the relapse rate of hyperthyroidism was markedly reduced compared with methimazole treatment alone (7.4% versus 51%) during the 2-year follow-up period. The results have been published in the 'J Clin Endocrinol Metab, 2009,94:4984-4991'. However, the mechanism by which the DEX reduces the relapse rate of GD is not fully understood. In vitro study, we have proven that DEX could effectively improve the function of regulatory T (Treg) cells and set up a new balance of T helper 1(Th1)/Th2 in GD patients(this results have been in press in the Eur J Endocrinol). In order to elucidate mechanism of this treatment strategy in vivo, we plan to recruit 20-30 patients with GD and treat those patients by intrathyroid injection of DEX combined with methimazole, and the function of Treg cells and balance of Th1/Th2 will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* GD patients will have been trated with methimazole and serum levels of TSH and FT4 should be in the normal range.

Exclusion Criteria:

* Pregnancy
* Allergy to antithyroid drugs (ATD)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than two times the upper normal range
* Patients with coexistent endocrine or organ-specific autoimmune diseases (such as those with atopic dermatitis or bronchial asthma)
* Patients taking medications that could affect the immune system (such as corticosteroids), noncompliance because of psychiatric or other serious diseases
* Unwillingness to participate in the study.
Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study

The purpose of this study is to investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* At least 12 months of muscular-skeletal, non-neuropathic pain

Exclusion Criteria:

* Malignancy causing or influencing chronic pain
* Radiation or chemotherapy, or metastatic cancer of any type
* Reflex Sympathetic Dystrophy (RSD) and/or neuropathic pain
* Neurological disorders such as epilepsy or stroke, or other medical conditions
* Psychiatric disorders
* Opioid medication use for pain management
* Past year history of illicit drug use that can result in altered cognition
* Pregnancy
* Exceeding weight limit of the MRI scanner
* Incompatible implants due to MRI safety
* Awaiting pain related surgical procedure
* Involved in pain-related litigation