cyrilzakka/clinical-trials huggingface dataset:
The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy

According to previous studies, the effect of PRP to patellar tendinopathy could last longer. However, the type, concentration, time and frequent of injection are still debated。 This study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the relation between efficacy of PRP and the growth factor in PRP.

Patellar tendinopathy, also known as jumper's knee，is clinically common characterised by anterior knee pain, activity-related pain、local tenderness over inferior pole of patella. The discomfort can result in decreasing athletic performance and be one of the most challenge for sports medicine doctor.

The patellar tendon suffer from repetitive microtrauma，result in reactive patellar tendinopathy. The overload tendon combining with risk factors of patellar tendinopathy will not recover timely and progress to chronic patellar tendinopathy. Hence, to reverse the progression is our aim.

According to previous studies, several nonsurgical treatment options have been proposed such as medication, eccentric exercise, corticosteroid injection, shockwave and platelet-rich plasma (PRP). Among all the options, the effect of PRP could last longer. However, the type, concentration, time and frequent of injection are still debated。Moreover, there is no study about the relationship between efficacy and the ratio and concentration of growth factor in the PRP.

The aim of this study is to understand (1) The effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy. (2) The effect of leukocyte-rich PRP in chronic patellar tendinopathy (3) Analyze the relation between efficacy of PRP and the growth factor in PRP.

Eligibility Criteria:
Inclusion Criteria:

Chronic patellar tendinopathy

Exclusion Criteria:

1. Corticosteroid injections within 12 months
2. Previous knee surgery
3. Any confounding diagnosis to the knee joint
4. Arthritis
5. Rheumatoid arthritis
6. Diabetes
7. Infections of knee joint
8. NSAIDs in the 10 days before the procedure
Buprenorphine Group Medical Visits in Primary Care

The primary goal of this research is to improve the effectiveness of buprenorphine maintenance treatment (BMT) within primary care.

Investigators propose that providing BMT as part of a group medical visit (instead of an individual visit) will improve treatment outcomes for patients with persistent opioid abuse, because members become accountable to the group, are exposed to beneficial habits of others (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly with medical management

Investigators have developed a preliminary model of BMT group medical visits, conducted focus groups with BMT patients and providers, and will use this data to develop a manualized group-based BMT intervention (G-BMT). Investigators will then conduct a randomized controlled trial (RCT) of the G-BMT intervention within primary care to preliminarily test its efficacy, acceptability, and feasibility. Participants who have persistent opioid abuse while receiving BMT in primary care will be randomized to the G-BMT intervention (40 participants in 5 groups) or to intensify BMT (treatment as usual) with their individual primary care physician (40 participants).

Hypothesis: In a 16-week RCT of G-BMT, participants who receive the G-BMT intervention (vs. treatment as usual) will have higher abstinence rates (primary outcome, efficacy), fewer HIV risk behaviors (efficacy), and greater satisfaction with treatment (acceptability) and adherence to medical visits (feasibility).

Eligibility Criteria:
Inclusion Criteria:

1. Currently receiving BMT at Montefiore community health center (CHC).
2. Received BMT for 12 or more weeks.
3. Persistent opioid abuse (positive toxicology for an unprescribed opioid at most recent test or in 50% or more of collected tests in the previous 6 months.)
4. Fluent in English of Spanish

Exclusion Criteria:

1) Pregnancy
Food Assistance, Diabetes, and HIV

Diabetes prevalence is increasing among people living with HIV (PLWH), yet blood glucose control is less successful in this population who are also often food insecure. Food assistance programs often provide nutrient-poor foods. This proposal asses the feasibility of monitoring diabetes-related health outcomes among food insecure PLWH who are receiving food boxes higher in dietary protein and fiber and lower in simple carbohydrates.

The objective of this investigation is to develop and assess a study protocol to evaluate the impact of food assistance on diabetes-related health outcomes in food insecure people living with HIV (PLWH). Compared to the general population, PLWH have increased risk for type 2 diabetes and worse glycemic control when using similar pharmaceutical treatments. Interventions to improve diet quality could thus have a clinically meaningful impact on diabetes treatment in this population. However, many PLWH are food insecure and rely on food assistance to meet basic nutrition needs. This proposal will determine the feasibility of a protocol to evaluate diabetes-related health outcomes in food insecure PLWH and diabetes who receive high protein, high dietary fiber food boxes from Birmingham AIDS Outreach. The study will consist of retrospective analysis of electronic medical record data and stored specimens, and prospective cross-sectional analysis of food security and diet quality in PLWH who do versus those who do not receive the food boxes.

Specific Aim 1: To determine the feasibility of recruiting, enrolling, and collecting dietary intake data from people living with HIV who are food insecure.

Specific Aim 2: To compare changes over twelve months in glycemic control, food security, and diet quality in B-FED participants compared to non-participating 1917 clinic patients.

This proposal aligns with the UAB Diabetes Research Center's goal to facilitate development of new methods to treat diabetes and its complications. The investigators will determine the effect size for scale-up of larger, longer-term assessment through an NIDDK-R18 grant to evaluate the real-world impact of B-FED on glycemic control and food security.

Eligibility Criteria:
Inclusion Criteria:

* CNICS participants aged 18 and over
* Currently prescribed antiretroviral therapy
* Have a diagnosis of diabetes, or documented hemoglobin A1c \>7.0%, or glucose \>125gm/dL

Exclusion Criteria:

* Not diagnosed with HIV
* PLWH who are not patients at 1917 Clinic
* Under age 18
* Pregnant women
* Recent cancer diagnosis Current serious illness or trauma Persons with an active secondary infection including tuberculosis or untreated Hepatitis C.
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

The incidence of caesarean section has reached 15-20% in most developed countries. Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component of a strategy to reduce the caesarean section rate. Most medical literature has focused on the efficacy of VBAC in reducing the caesarean section rate and the physical safety of successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little is known about how the uncertainty of labour outcome and a failed VBAC impact on the psychosocial function of these women. What we do know is that antenatal depression and unplanned caesarean section are major risk factors for postpartum depression, which in turn is the major cause of maternal mortality in many developed countries including Hong Kong. We propose to study a cohort of women with a prior caesarean section and presenting with a subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received, and the short-term psychosocial function of these subjects will be studied. The result of this study will provide important information that would be useful in assisting women to decide the mode of delivery after a prior caesarean section. The Hypothesis is that there is a significant difference in psychosocial function between these 2 groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* women who agree for vaginal birth after prior cesarean section and who had no previous history of vaginal delivery

Exclusion Criteria:

* Inability or unwillingness to give informed consent. Multiple pregnancy, more than one previous caesarean section, and a previous classical caesarean section, presence of other contra-indications to vaginal birth
Effect of Fully Blocking Type 1 Angiotensin Receptor on Target Organ Damage of Postmenopausal Hypertensive Women

This study compared the improvements of blood pressure levels, left ventricular hypertrophy, left ventricular diastolic function, vascular function and cognitive function between postmenopausal hypertensive women and age-matched hypertensive male patients through the evaluation of the effects of fully blocked AT1 receptor by valsartan. Additionally, the differences of the above indexes between the patients who were fully blocked AT1 receptor by valsartan and the patients who were treated with a single dose of valsartan treatment were assessed, so as to provide theory basis for clinical treatment of postmenopausal hypertensive women.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertension
* Women are all postmenopausal
* Must provide written informed consent

Exclusion Criteria:

* Secondary hypertension
* Coronary disease
* Heart failure
* Arterial fibrillation
* Previous myocardial infarction
* Previous stroke
* Malignant disease
* Kidney failure
* Liver failure
* Neoplastic disease
* Severe neurological diseases
* Severe metabolic or organic decompensation
* Refuse to sign the informed consent form
Combined Immunosuppression for Pediatric Crohn's Disease

This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

1. 6-18 years old
2. diagnosis of Crohn's Disease
3. Pediatric Crohn's disease Activity Index (PCDAI)\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \>10 before treatment
4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)\>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids
5. The patient or legal guardian sign the informed consent documents

Exclusion Criteria:

1. history of biological agents targeting at tumor necrosis factor (TNF)
2. Crohn's Disease-related surgery
3. infections
4. tumors
Pain Neuroscience Education in Total Knee Arthroplasty

To determine if education about pain given prior to Knee Arthroplasty will result in better outcomes following surgery

To determine if a preoperative pain neuroscience education (PNE) program would result in superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA). Patients will receive traditional hospital preoperative TKA program (usual care group) or receive the same program plus an additional 30-minute PNE program (experimental group). Pre and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain catastrophization. We will also compare opioid usage, healthcare expenses and patient satisfaction between groups.

Eligibility Criteria:
Inclusion Criteria:

* be scheduled to have a TKA and their standard preoperative TKA education program, indicate their willingness to participate in the study, ability to read and understand English, as the study included the use of an educational booklet, and be able and willing to complete outcome data for 6 months after TKA

Exclusion Criteria:

* Because all potential participants for this study had been screened and cleared for their orthopedic surgery, the only exclusion criterion was an unwillingness to participate in the study and having had a previous TKA or scheduled for a bilateral TKA.
Could HRV be a Valuable Predictor for CPAP Adherence?

This study aim to evaluate if the improvement of heart rate variability for the continuous positive airway pressure titration night can predict the short and long term continuous positive airway pressure adherence for patients with moderate to severe OSA.

Heart rate variability (HRV) represents autonomic regulation and had been used in varies situation, especially the associated with cardiovascular outcomes and psychological diseases. HRV was also well known associated with the severity of obstructive sleep apnea (OSA) and could be improved after adequate treatments for OSA. Continuous positive airway pressure (CPAP) is the first choice of treatment for OSA and had been proved to able to improve HRV in OSA patients. However, the CPAP adherence is always problematic. Many CPAP predictors had been well documented but the HRV is never evaluated to be a potential predictor of CPAP adherence.

Therefore, this study will evaluate the changes of HRV for polysomnography (PSG) night, for CPAP titration night to see if the changes of HRV in the CPAP titration night could predict CPAP adherence for OSA patients in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. aged:20\~75y/o
2. PSG revealed moderate to severe OSA (apnea hypopnea index \[AHI\] ≧15/hour)
3. had been completed CPAP titration test

Exclusion Criteria:

1. aged\<20y/o or \>75 y/o
2. mild OSA, (AHI \<15/hour), or no OSA (AHI\<5/hour)
3. unstable cardiopulmonary disease, psychological diseases, using sleep pills.
REVIparin-BRIDging-in a General Practice Setting in GErmany

In view of the fact that little is known about the pre- and post-interventional coagulation management of phenprocoumon patients with reviparin at general practices in Germany, an observational study is being initiated to evaluate the effectiveness and tolerability of reviparin in the area of outpatient, general practice-based care in the context of bridging therapy. Patients for whom bridging therapy with low-molecular weight heparin (LMWH) was specified and for whom the LMWH reviparin was chosen for this purpose shall be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Requiring prophylaxis/bridging treatment with reviparin, e.g. for the prevention of venous thromboembolism in general and orthopaedic surgery, due to the decision of the treating physician

Exclusion Criteria:

* Hypersensitivity to reviparin or one of the excipients of Clivarin® or other low-molecular-weight heparin preparations and/or heparin, e.g. confirmed or suspected immune-mediated heparin-induced thrombocytopenia (type 2)
* Severe renal impairment (creatinine clearance \< 30 ml/min)
* Bleeding: like other anticoagulants, reviparin should not be used in conditions associated with an increased risk of bleeding, e.g. acute bleeding, haemorrhagic diathesis, coagulation factor deficiencies, severe thrombocytopenia, untreated arterial hypertension, bacterial endocarditis and subacute endocarditis, acute-onset gastrointestinal ulcers or haemorrhages, brain haemorrhage, spinal or ear or eye surgery, intraocular bleeding or corresponding injuries within the past 6 months
* Severe hepatic or pancreatic impairment
* Children
* Patients with a body weight \< 45kg
* Life expectancy of less than 3 months
* Pregnant women (due to the generally very long duration of treatment with LMWH in female patients who are already on anticoagulation therapy)
Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease

This study will improve our understanding of the mechanisms underlying anorexia in persons with Crohn's disease flare-ups. The practical spin-off from this research is potentially very important for the management of nutritional disorders associated with the disease by guiding diets towards foods that correspond to patients' preferences and/or to modified tastes. In addition, the results could lead to the identification of sensory markers that herald an inflammatory flare-up of the disease.


Eligibility Criteria:
For patients :

Inclusion Criteria:

* Age between 18 and 60 years,
* Diagnosis of Crohn's disease according to clinical, endoscopic, histological, radiological and biochemical criteria as defined by the European Consensus Conference,
* Men or women who have provided consent and willing to cooperate.

Exclusion Criteria:

* Chronic inflammatory intestinal disease (CIID) other than Crohn's disease: haemorrhagic rectocolitis, undetermined colitis, microscopic colitis.
* Intercurrent disease (diabetes and metabolic disease, liver cirrhosis, progressive cancer, acute or chronic infection, Human Immunodeficiency Virus HIV),
* Organ failure (respiratory, heart, or renal failure, neurological disorders),
* Intolerance to gluten,
* Treatments (other than those used for Crohn's disease) able to interfere with food intake,
* Aversion to foods consumed or smelled,
* Poor understanding of cognitive tasks required.
* Crohn's disease complicated by an abscess or infectious complication
* Acute Crohn's disease defined by a CDAI score \> 150

For Controls:

Inclusion Criteria:

* Adult person
* Without follow-up for a chronic pathology
* Having given its consent

Exclusion Criteria:

* Protected adult
* Person not affiliated to a social security system
* Pregnant or breastfeeding woman
* Active smoker
* No one who does not speak French
* Taking treatment that interferes with taste or acts on the central nervous system
Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The primary objective of the study is to evaluate the safety and tolerability of 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid Arthritis despite methotrexate therapy.

Trials with a new, first -in-class drug will be done to ascertain safety, tolerability, and to explore efficacy in the treatment of rheumatoid arthritis, including its effects on biomarkers. Approximately 240 adult patients with rheumatoid arthritis despite the use of methotrexate therapy will be recruited for the study. They will be randomly assigned to one of 4 treatment arms; each patient has an equal chance of receiving the placebo, or 100 mg, 200 mg, 300 mg dose of RWJ-445380. Patients will take the medication daily for up to 12 weeks. Patients will receive study medication in a blinded fashion, i.e. the patient, the doctor and the study sponsor will not know what group the patient is in until all patients complete the study. The investigator and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will have visits every week for the first 2 weeks then every 2 weeks until 12 weeks of treatment. After 12 weeks, there will be a followup visit 4 weeks after the last dose of study drug is taken. Medical history, physical examination, blood pressure, heart rate, temperature, and ECGs are checked periodically. Joints will be assessed to explore whether the drug might affect tender and swollen joints. Blood samples will be taken for standard safety laboratory tests as well as special tests of the drug blood level, biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation, and other markers for rheumatoid arthritis. Samples will also be taken to see whether certain types of immune cells are affected by taking the drug. Immunization with tetanus vaccine will be done to see if taking the drug might affect immune responses to this agent Patients will receive RWJ-445380, 100, 200, 300 mg, or placebo. Patients will receive oral capsules daily for up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints
* methotrexate treatment for 6 months
* at least 10mg/wk and stable dose for at least 8 weeks
* negative TB screening

Exclusion Criteria:

* Use of other disease-modifying anti-rheumatic drugs (DMARDs) (other than Methotrexate MTX)
* previous use of more than 1 anti-TNF (tumor necrosis factor) agent
* previous use of cytotoxics, p38 MAPkinase inhibitor, anti-CD4 antibody
* receipt of live vaccine within 1 month of study drug
* serious infection in previous 2 months or history of chronic or recurrent infectious disease or history of opportunistic infection
* other clinically significant disease of other organ system
Inflammatory Response to Aortic Valve Replacement

A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.

18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included.

A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction.

A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for aortic valve replacement without need for concurrent surgery

Exclusion Criteria:

* known inflammatory disease and anti-inflammatory treatment
Young Donor Plasma Transfusion and Age-Related Biomarkers

The purpose of the study is to evaluate the beneficial effects of infusions of plasma from young donors using blood biomarkers.

Each patient will receive an infusion of plasma derived from a young donor (16-25 years of age). A panel of age-associated biomarkers will be measured before and after treatment.

We have drawn biomarkers from clinical measures of aging and physiology, biomarkers of disease advancement, as well as biomarkers of aging from animal and human studies. These will represent a spectrum of physiologic pathways with evidence-based connections to aging. They include the physiologic processes of inflammation, neurogenesis, stem cell proliferation, blood clotting, immune function, and amyloid plaques. Organ function which will be specifically measured includes the liver, bone marrow, kidneys, pancreas, muscles, cardiovasculature, cerebrovasculature, and the thyroid. Specific disease states connected to these biomarkers include anemia, neutropenia, thrombocytopenia, obesity, diabetes, high cholesterol, elevated risk of cancer, atherosclerosis, dementia, and cataracts.

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Eligibility Criteria:
Inclusion Criteria:

* 35 years of age or older