cyrilzakka/clinical-trials huggingface dataset:
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study

Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)

This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects, randomly selected from the full cohort. The analysis population will consist of all subjects in the sub-cohort, combined with all subjects with erosion events who are not in the sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this analysis population.

Eligibility Criteria:
Inclusion Criteria:

To participate in this clinical investigation, the patient must meet all of the following inclusion criteria:

1. Patient indicated for ASD closure who has echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is implanted with the ASO device Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure
2. Patient is willing and able to complete the follow-up requirements of this study
3. Patient signs the informed consent (or a legal representative signs the informed consent.)

Exclusion Criteria:

Patient is not eligible for clinical investigation participation if he/she meets any of the following exclusion criteria:

1. Patient is known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery
2. Patient is known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
3. Patient is known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy (unless another anti-platelet agent can be administered for 6 months)
4. Patient is known to have a demonstrated intracardiac thrombus on echocardiography
5. Patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization
6. Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves or right upper lobe pulmonary vein
Heat Application to Quadriceps Effect on Pain After a Total Knee Arthroplasty

The goal of this study is to explore an under-researched aspect of recovery. Typically, post-operative care after a knee arthroplasty consists of compression (stockings), medications, rest, ice, elevation, physical therapy, and wound care. All of these treatments perform their role well, however, medications such opiates run the risk of addiction. An additional method of pain management such as heat application to the surrounding musculature warrants exploration.

The goal of this study is to reduce the amount of pain, and improve the quality of life in post-operative patients. Pain, stiffness, symptoms, quality of life and function of the knee will be evaluated utilizing patient-reported measures and range of motion. Patients will be assessed using the Knee Injury and Osteoarthritis Outcome survey (KOOS Jr), Visual Analogue Scale (VAS) and PROMIS. Patients will be given these surveys during their two and six week check-in with the surgeon. In addition to these patient-reported measures, the investigators will also be tracking range of motion (ROM) and opioid usage. The data will then be collected via the patient's electronic health record, or by the researcher directly. The treatment group will be given a written order to apply heat to the quadriceps at least three times per day for 10-15 minutes each. This can be done in four hour increments or when patients symptoms begin to worsen. The patient will receive a rice sock for heat application. The control group will not be withheld from heat application, but will not be instructed to do so. The control group will instead follow the current standard of care as advised by the physician.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a total knee arthroplasty ages 18 and older at Saint Alphonsus Hospital and at The Idaho Clinic between the months of June-February, or until the estimated sample size (150) is reached. Must be able to withstand heat to thigh. Must consent to research.

Exclusion Criteria:

* Anyone unable to give informed consent, pregnant individuals, children, or anyone whom the intervention may be harmful to.
Experiences and Health-related Quality of Life of Informal Caregivers of Dialysis Patients

The goal of this prospective, observational, multicentre cohort study is to assess the trajectory of the experiences (both positive and negative) and health-related quality of life (HRQOL) of informal caregivers of patients who start home dialysis, and compare these to experiences and HRQOL of informal caregivers of patients who start in-centre hemodialysis. The investigators hypothesise that informal caregivers of home dialysis patients experience more positive experiences, but also more negative experiences, and still have better HRQoL, compared with caregivers of in-centre HD patients. Participants will fill in five different validated questionnaires and questions on required support. Participants are asked to fill in the questionnaires after inclusion (i.e., start of dialysis), and at 6 and 12 months after start dialysis.

End-stage kidney disease, the need to start dialysis, and the choice for a home-based treatment or a centre-based treatment does not only have an effect on patients, but also on their informal caregivers like spouses and adult children providing care to the patient. In order to properly inform patients with end-stage kidney disease and their informal caregivers about the start of dialysis therapy and the choice of dialysis modality, it is important to discuss also what the caregiver can expect after the start of dialysis. However, available evidence regarding the course of caregiving experiences after start of dialysis is limited. The aim of this study is to assess the trajectory of the experiences (both positive and negative) and health-related quality of life (HRQoL) of caregivers of patients who start home dialysis, and compare these to experiences and HRQoL of caregivers of patients who start in-centre hemodialysis (HD). The investigators hypothesise that (co-residential) caregivers of home dialysis patients experience more positive experiences, but also more negative experiences, and still have better HRQoL, compared with caregivers of in-centre HD patients.

This study is a prospective, observational, multicentre cohort study which is an extension of the ongoing DOMESTICO study. DOMESTICO is a nationwide study in incident dialysis patients, investigating the effects of home dialysis on HRQoL in relation to clinical outcome and costs, in comparison to in-centre HD. Participants will fill in five different validated questionnaires and questions on required support. Participants are asked to fill in the questionnaires after inclusion (i.e., start of dialysis), and at 6 and 12 months after start dialysis.

Eligibility Criteria:
Inclusion Criteria:

* Informal caregivers who care for a partner, family member, friend or loved one with end-stage kidney disease who is starting dialysis therapy and is included in the DOMESTICO study
* 18 years or older
Polish Atrial Fibrillation (POL-AF) Registry

Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients with atrial fibrillation (AF).

Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular mortality. An important element of management of patients with AF is anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) are two main drugs groups used in thromboembolic events prevention.

Primary objective of the study is to assess the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.

Secondary objective of the study are as follows: assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients and assesment of the number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc score.

The POL-AF Registry is a multicenter prospective analysis of hospital records of patients with AF managed in ten cardiology centers.

Collected data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, laboratory tests, echocardiographic parameters and concomitant medications.

Each patient will be evaluated regarding to common scales assessing risk of thromboembolic (CHA2DS2-VASc) and bleeding (HAS-BLED, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for AF treatment) events.

Eligibility Criteria:
Inclusion Criteria:

- patients with AF hospitalized in a participating center during study period

Exclusion Criteria:

* hospitalisation for atrial fibrillation ablation
* death during hospitalization
How Often and What Type of Deformity is Detected in All Spine Radiographs?

The study will be done retrospectively.The aim of this study is to retrospectively examine the spinal pathologies of patients with a prediagnosis of spinal deformity and for whom spinal radiography is requested and to evaluate the clinical features of these patients.

Spinal radiography for scoliosis is the gold standard in the diagnosis, treatment and follow-up of spinal diseases. There are studies showing that unnecessary and repetitive radiographs of patients increase the risk of cancer in older ages. Patients should be thoroughly examined before a spine radiograph is taken. Adam's test should be applied to the patient with scoliosis findings in the physical examination. Spinal radiography for Scoliosis should be requested from those whose trunk rotation angle is 5 degrees or more during Adam's test. The diagnosis of scoliosis is made when the Cobb angle measured on posterior-anterior radiographs is greater than 10 degrees. The diagnosis of kyphosis is made when the Cobb angle measured on lateral radiographs is greater than 50 degrees. Patients with a prediagnosis of spinal deformity and spinal radiographs taken between January 2019 and September 2019 in the Radiology clinic of our hospital will be included in the study. Demographic characteristics of the patients, presence and degree of scoliosis on posterior-anterior radiographs, if present, degree of kyphosis on lateral radiographs, structural pathologies in the spine and clinical features will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 and under
2. Those who requested spine radiographs for scoliosis and kyphosis

Exclusion Criteria:

1. Having a history of previous spinal surgery or trauma
2. Repeated radiographs in the same patient
Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Males or females age 18-70 years
* Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
* On a stable (\> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
* Fasting plasma glucose \< 240 mg/dL at Screening Visit 1
* HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

Exclusion Criteria:

* Prior treatment with exenatide
* Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
* History of type 1 diabetes and/or history of diabetic ketoacidosis
* Body mass index ≥ 40 kg/m2;
* History of organ transplantation
Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy

This work is designed as a randomized clinical trial, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon and low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 40 patients will participate, randomly divided into two groups. Group A will be instructed to perform a training protocol in combination with ESWT according to selected parameters. Group B only completes the same training protocol.

This work is designed as a randomized clinical trial, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon and low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 40 patients will participate, randomly divided into two groups. Group A will be instructed to perform a training protocol in combination with ESWT according to selected parameters. Group B only completes the same training protocol.

The research within one patient will last a total of 39 weeks from the initial to the final examination and will include several control measurements: at 6, 12, 26 and 39 weeks from the beginning of therapy. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software. At the end of the initial examination, the participant will be randomly assigned to group A or B. The study program for a specific participant will depend on the assigned group.

Eligibility Criteria:
Inclusion Criteria:

* the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities,
* the patient is in the age group of 18-60 years,
* the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference,
* the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury),
* the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.).

Exclusion Criteria:

* patient has been diagnosed with a rheumatic disease or a disease of the central nervous system
* patient has any condition which is contraindication for ESWT application
* patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.
Study of SPG302 in Adults With Schizophrenia

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks.

This study will entail weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Primary diagnosis of schizophrenia
* Clinical laboratory values within normal range or \< 1.5 times ULN
* Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks
* Able and willing to provide written informed consent

Exclusion Criteria:

* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* History of clinically significant CNS event or diagnosis in the past 5 years.
* Receipt of investigational products within 30 days
* Blood donation within 30 days
Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL

Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites to avoid life threatening complications.

The NOPHO ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and with the aim to reduce and prevent toxic treatment complications with high-dose methotrexate (HD-MTX).

The specific and primary objectives of the randomized study is:

1. Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites and lowers the serum concentration to avoid life threatening complications. Glucarpidase should be given if the 24 hour levels of MTX is \> 250 µM, 36 hour levels \> 30 µM or 42 hours levels \> 10 µM together with a reduced kidney function. Glucarpidase treatment should take place within 48 hours from the start of HD-MTX treatment.
2. To evaluate if the early intervention with Glucarpidase reduce the number of days the patients have to stay at the hospital.
3. Evaluate the reduction of health costs of early intervention in patients with delayed MTX-clearance and renal dysfunction.

Eligibility Criteria:
Inclusion Criteria:

Children and adolescents who experience delayed MTX-clearance and renal dysfunction during high-dose methotrexate treatment in NOPHO ALL-2008.

Exclusion Criteria:

Children and adolescents with earlier anaphylactic reaction to Glucarpidase. Pregnant patients.
Effect of Polyherbal Formulation in Chronic Inactive Carriers of Hepatitis B Virus

This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months

A placebo controlled randomised trial. 3 herbs that have proven effect on eliminating the virus and normalizing liver function will be given. Equally matched placebo (blinded) will be given randomly to patients. All parameters of hepatitis B infection will be compared between the randomized groups

Eligibility Criteria:
Inclusion Criteria:

* Adults aged above 18 years of age, with inactive chronic hepatitis B (HB) or immune tolerant phase, with or without dyslipidaemia and having all of the following

  1. HBsAg +ve for \>6 months and anti-HBs negative
  2. Alanine amino transferase ≤ 2 upper limit of normal
  3. HBeAg positive or negative irrespective of viral DNA load
  4. Not currently on antiviral therapy for Chronic hepatitis B

Exclusion Criteria:

* Any one of the following

  1. Patients with decompensated liver disease of any etiology(characterized by elevated bilirubin, raised International normalized ratio, or a history of ascites, variceal hemorrhage,hepatic encephalopathy, Spontaneous bacterial peritonitis, hepatorenal syndrome or Hepatocellular carcinoma)
  2. Family history of hepatocellular carcinoma
  3. Patients with HIV and Hepatitis C virus co-morbidity
  4. Pregnant, attempting to conceive, or lactating women
  5. Patients with diabetes mellitus
  6. Recent history of acute coronary syndrome (\<6months) or chronic coronary artery disease with poor left ventricular function (by physician / cardiology opinion)
  7. Patients with renal failure ( Creatinine clearance less than 60 ml/min)
  8. Active substance or alcohol abuse and concurrent use of corticosteroids or immunosuppressive agents.
  9. Presence of extra hepatic manifestations
  10. Previously treated with pegylated interferon within the last 2 years
  11. Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above)
  12. Current or former employees of organic India
  13. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
  14. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
Dendritic Cells in Lung Cancer

Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara cream will be used as adjuvant for induction of inflammation at the injection site, and the lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The treatment aims at boosting the patient's specific immune system against the cancer cells.

Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara cream will be used as adjuvant for induction of inflammation at the injection site, and the lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The treatment aims at boosting the patient's specific immune system against the cancer cells.

Patients with disseminated, inoperable NSCLC after chemotherapy and patients not wanting chemotherapy for which no other systemic treatments can be offered.

Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro.

Secondary objectives: to estimate the patients' survival time, to estimate response according to RECIST criteria, and to estimate the patients' quality of life during the study period.

The study is designed as an open, phase II, clinical study and will be carried out in accordance with the present protocol, ICH/GCP Guidelines and national, regulatory requirements.

The first patient is expected to be included towards the end of 2006. Inclusion period will continue for 2 years. Follow-up will continue for approx. 6 months prior to reporting.

Fifty patients are planned for inclusion. In case none of the first fourteen (14) evaluable patients will respond, the inclusion and the study will be discontinued.

Eligibility Criteria: