cyrilzakka/clinical-trials huggingface dataset:
Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods

The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Two different cement fixation methods are used in order to insert THR implants. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. Gait analysis preoperative and 2 year after surgery.

The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Patients with radiological signs of osteoarthritis of the hip, hip pain and functional disability may be treated with insertion of a THA.

Two different fixation methods are used in order to insert THR implants. Cemented fixation using bone cement, polymethyl methacrylate (PMMA) is the most commonly used fixation method in Sweden. A new bone cement, Refobacin®, already marketed in Germany is planned to be introduced in Sweden in late 2018.

The hospital is also equipped with a modern gait laboratory were the functional gait performance can be evaluated. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. The subjects will undergo gait analysis befor and 2 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* hip arthritis

Exclusion Criteria:

* no hip arthritis
Star-Close Early Ambulation Trial

To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.

To confirm that patients who receive the Star-Close vascular closure system (VCS) after diagnostic cardiac catheterization can safely ambulate within 30 minutes of catheterization.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to for an outpatient left heart catheterization
* Catheterization through the femoral artery
* Able to ambulate at least 20 feet
* Able to receive the Star-Close Vascular Closure System
* Be a candidate for hospital discharge following catheterization

Exclusion Criteria:

* Known peripheral arterial disease
* Blood pressure greater than 180/110
* Pregnant or lactating
* Anemic or low blood count
* Blood thinning medication within 5 days before catheterization
* Unable to walk 20 feet with out rest
* Complications during catheterization procedure
Efficacy and Safety of ADVATE Standard Prophylaxis to Hemophilia A

Hemophilia A is an X-linked recessive, congenital bleeding disorder caused by deficient or defective coagulation factor VIII (FVIII). Prophylaxis is recommended as the standard of care for boys with severe haemophilia by WHO and World Federation Of Hemophilia (WFH). The efficacy and safety of prophylaxis in preventing bleeds and arthropathy in patients with hemophilia has been confirmed in well-designed clinical studies.To keep the factor level above 1%, the standard dosage for patients with severe hemophilia A is 20-40 Units /kg/infusion (average 30 Units /kg) every other day or three times a week. This dosage has a very high consumption of factor, up to 5000-6000 international unit (IU)/kg/year. The high consumption of factor and cost present a major barrier to use the standard prophylaxis in many countries particularly in the developing world.

In China the majority of boys with severe hemophilia A can only pay for on-demand treatment or low-dose prophylaxis. Ao after the affordability of patients was solved and many patients will get more chance to receive standard prophylaxis.

This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and QoL outcomes in subjects using ADVATE(Recombinant Human Coagulation Factor VIII for injection) standard prophylaxis under the conditions of routine practice.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has hemophilia A with FVIII≤2 %.
2. Previously treated patients (PTPs).
3. Age from 2 to 18 years.

Exclusion Criteria:

1. Subject has known hypersensitivity to the active substance or any of the excipients.
2. Subject has known allergic reaction to mouse or hamster proteins.
3. Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study.
4. Subject is planned, or likely to have surgery during the study period.
5. Subject has end-stage renal failure or evidence of a severe or uncontrolled systemic disease as judged by the investigator.
6. Subject has full-blown Acquired Immuno Deficiency Syndrome (AIDS),determined by Cluster Determinant 4+(CD4+) and clinical presentation.
7. Subject has active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 5 times the upper limit of normal).
8. Subject has clinical or laboratory evidence of severe liver impairment including (but not limited to) a recent and persistent international normalized ratio (INR)\> 1.4, and/or the presence of splenomegaly and/or significant spider angioma on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices.
9. The subject in the opinion of the investigator is unable or unwilling to comply with study protocol
10. Subject is a family member of the investigator or site staff
Intramyocellular Fatty Acid Trafficking in Insulin Resistance States - Effects of Intestinal Delivery of Lipids

Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM). It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficking is responsible for muscle insulin resistance, although it has been shown that raising FFA with Intralipid can cause muscle insulin resistance within 4 hours. The investigators do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. The investigators propose to alter the profile and concentrations of FFA of healthy, non-obese adults using an overnight, intra-duodenal palm oil infusion vs. an overnight intra-duodenal Intralipid infusion (both compared to saline control). The investigators will compare the muscle FFA storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates, providing the first measure of how different FFA profiles alter muscle FFA trafficking and insulin action at the whole body and cellular/molecular levels. By identifying which steps in the insulin signaling pathway are most affected, the investigators will determine the site-specific effect of ceramides and/or DG on different degrees of insulin resistance.

Hypothesis 1: Palm oil infusion will result in abnormal FFA trafficking into intra-myocellular ceramides and abnormal insulin signaling.

Hypothesis 2: Intralipid infusion will result in abnormal FFA trafficking into intra-myocellular saturated DG and abnormal insulin signaling.


Eligibility Criteria:
Inclusion Criteria:

* Women and Men (Women premenopausal)
* BMI 18-27
* Weight stable
* Not pregnant/nursing

Exclusion Criteria:

* Ischemic heart disease
* Atherosclerotic valvular disease
* Smokers (\> 20 cigarettes per week)
* Bilateral oophorectomy
* Concomitant use of medications that can alter serum lipid profile (high dose fish oil, statins, niacin, fibrates, thiazolinediones, beta-blockers, atypical antipsychotics)
* Lidocaine allergy
Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials

The objective of this survey is to assess the knowledge of HCPs in relation to the recommended posology and biological monitoring for Exjade, based on the current locally valid Exjade educational materials (including the physician's reference checklist)


Eligibility Criteria:
Inclusion Criteria:

Physicians will be required to meet all of the following inclusion criteria:

* Must provide consent for participation
* Must spend ≥50% of time in direct patient care
* Have treated patients with transfusional iron overload or non-transfusion-dependent thalassemia with chelation therapy during the last 12 months.
* Have prescribed Exjade and/or generic deferasirox within the last 12 months.

Exclusion Criteria:

Physicians meeting the following criterion will not be eligible to take the survey:

• Currently employed by a pharmaceutical company, health care company, market research company, advertising agency, or government agency involved in pharmaceutical research or marketing.
Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).


Eligibility Criteria:
Inclusion Criteria:

* Active noninfectious uveitis involving the intermediate and/or posterior segment (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified.
* Subjects must be:

  * Capable of understanding the purpose and risks of the study.
  * Able to give written informed consent.
  * Able to comply with all study requirements.

Exclusion Criteria:

* Ocular Disease/Conditions
* The following conditions are exclusionary if present:

  * Uveitis limited to only the anterior segment of the study eye.
  * Confirmed or suspected infectious uveitis in either eye.
* Prior and Current Treatment:

  - As defined in the protocol
* Extraocular Conditions:

  - As defined in the protocol.
* Laboratory, Blood Pressure and ECG Evaluations:

  * As defined in the protocol.
Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)

Pericardial effusion is a common complication in patients with metastatic malignancy. While pericardiocentesis provide effective relieve from life-threatening situation such as cardiac tamponade, recurrence of pericardial effusion after pericardiocentesis is common. We hypothesize that percutaneous balloon pericardiotomy in addition to standard pericardiocentesis with prolonged drainage can prevent pericardial effusion recurrence in patients with malignant pericardial effusion.

Pericardial effusion is a common complication in patients with metastatic malignancy with an incidence as high as 21%. The occurrence of malignant pericardial effusion significantly impacts on patient's survival and quality of life. While pericardiocentesis provide effective relieve from life-threatening situation such as cardiac tamponade, recurrence of pericardial effusion after pericardiocentesis is common and occurs in as high as 31% of patients. Retrospective data has shown that prolonged pericardial drainage might reduce the recurrence rate but at the cost of increased risk of infection and prolonged hospital stay. Surgical pericardiotomy was used in the past but was not shown to reduce recurrence over prolonged pericardial drainage and is associated with a higher rate of complications. Surgical pericardial window creation via a mini-thoracotomy might be an effective treatment and can be considered in patient with pericardial tamponade. The safety and feasibility of Percutaneous Balloon pericardiotomy (PBP) has been first described 1993 and has been shown to be an alternative treatment for patient with malignant pericardial effusion. However, no data is available on the efficacy of PBP in reducing the recurrence of pericardial effusion, in comparison with standard pericardiocentesis with prolonged drainage. We aim to perform a single centre, randomized, prospective, open label controlled pragmatic trial to compare percutaneous balloon pericardiotomy (treatment) to standard pericardiocentesis with prolonged drainage (control) in preventing pericardial effusion recurrence in patients with malignant pericardial effusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed active malignancy AND,
* Presence of at least moderate (\>10cm) pericardial effusion on CT or Echocardiography

Exclusion Criteria:

* Patients unable to give an informed consent,
* Previous history of open-heart surgery
* Previous history of pericardial window or pericardial instillation of sclerosing therapy.
* Scheduled thoracic or cardiac surgery within the next 3 months
* Patients with contraindications for endovascular procedure such as disseminated intravascular coagulopathy or significant ongoing bleeding tendency, and systemic septicaemia.
* Patient with small or loculated pericardial effusion that is not accessible by subxiphoid approach.
Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation

Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB

Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-65 and match one of below
2. Waiting renal transplant or status post renal transplant
3. Receiving long term dialysis

Exclusion Criteria:

1. Not agree to be enrolled
2. Suspected active TB
3. HIV patients
4. Viral hepatitis
5. Using immunosuppressants within 3 months before enrollment
6. Receiving lymphokine therapy
7. Hemoglobin \< 8 g/dL
8. Serum bilirubin \> 2.5 mg/dL
9. AST or ALT \> 2 times of upper normal limit
10. Lactation or pregnancy
A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ


Eligibility Criteria:
Inclusion criteria

* Male or female patients ≥18 years of age
* Non-diabetic patients must have MSSBP of ≥140 mmHg and/or MSDBP ≥90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP ≥130 mmHg and/or MSDBP ≥80 mmHg at Visits 1 and 2
* Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1

Exclusion criteria

* Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure.
* MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg (MSSBP ≥160 mmHg and/or MSDBP ≥100 mmHg for diabetic patients) at any time between Visit 1 and Visit 2.
* Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* Other exclusion criteria apply
Prospective Study of Clinical Utility of Acupuncture in Back Pain

The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical, thoracic and lumbar pain, under conditions of usual clinical practice as the medical acupuncturist performed acupuncture, with and without supplementary pharmacological treatment during the first 4 weeks of follow up.

Epidemiological, observational, prospective, with two cohorts, naturalistic and non-interventionist study.

The disease to be studied is Back pain (cervical, thoracic or lumbar) caused by musculoskeletal pathologies and previously treated with conventional medical treatment with or without treatment currently.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged 18 and over
* Patients diagnosed with back pain: cervical, thoracic or lumbar.
* Patients who has received appropriate medical treatment for their disease: analgesics, anti-inflammatories, or other treatments, but painful and symptoms persist
* Patients that could receive acupuncture treatment in order to reduce the symptoms and reviewed by a medical acupuncturist
* Patients with sufficient cultural and educational level to complete the health questionnaires required in the study
* Patients who have given their written informed consent to participate in the study

Exclusion Criteria:

* Patient with any illness and that medical opinions recommended not to participate in the study
* Patient can not respond to questionnaires administered during the study
Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breast Cancer

Low-dose metronomic(LDM)chemotherapy as well as anti-inflammatory agents and bisphosphonates have shown anti-angiogenic properties on tumor vasculature.

This study is meant to test the therapeutic potential of an anti-angiogenic treatment strategy by combining all these agents for metastatic breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of infiltrating duct carcinoma of breast.
* Her-2 negative tumors.
* ECOG performance status: 0-1.
* Presence of measurable disease: primary and/or metastatic.
* CBC showing normal values or any toxicity limited to grade I.
* SMA showing liver and renal functions \< 1.5 normal values
* previous treatment with an anthracycline and with a taxane is mandatory either as neoadjuvant/adjuvant treatment or for metastatic disease.
* previous treatment by chemotherapy for metastatic disease is allowed (up to three lines, allowing for MTD Capecitabine to be one of them).
* previous treatment by a bisphosphonate is allowed. However,those patients who up to the study had not received any bisphosphonate and those who had received Clodronate- will receive Pamidronate; those who had been under Pamidronate- will receive Zoledronate; those who had been under Zoledronate- will continue with it."
* The patient's signature on the informed consent.

Exclusion Criteria:

* Her-2 neu positive tumor
* Inability to visit the clinic for outpatient treatment and evaluation
* Active/symptomatic brain metastases.
* ECOG performance status: 2-4.
* Presence of Hand -Foot syndrome, at grade \> 2.
* CBC with any grade \>2 toxicity
* SMA showing liver functions \> 1.5 normal values
* SMA showing renal functions \> normal values -Current continuous treatment by steroids or by NSAIDs, or by anti- coagulants for "non protocol" reasons.
* presence of exclusively non-measurable disease (I/E: exclusive bone disease with non-representative tumor markers).
* previous radiotherapy to the "only measurable disease".
* pleural or peritoneal effusion that may represent a "third space".
* history of active peptic ulcer.
* symptomatic coronary heart disease.
F.A.S.T.-BE FAST Stroke Warning Signs Study

The goal of this randomized controlled trial is to learn whether the BE FAST (Balance, Eyes, Face, Arm, Speech, and Time) acronym works at least as well or better than the F.A.S.T. (Face drooping, Arm weakness, Speech difficulty, Time to call 911) acronym in helping participants learn and remember the warning signs of a stroke. The main questions it aims to answer are:

* Does the BE FAST acronym increase understanding among participants that calling 911 is the right first step they should take if a stroke is suspected?
* Does the BE FAST acronym perform as well as or better than the F.A.S.T. acronym in helping participants remember stroke warning signs on a letter-aided open-ended basis? Researchers will compare the BE FAST acronym to the F.A.S.T. acronym to see if the BE FAST acronym works at least as well as the F.A.S.T. acronym in teaching participants about the warning signs of a stroke and the importance of calling 911 if they suspect a stroke.

Participants will:

* Take a survey about their knowledge of stroke and its symptoms
* Watch a short video about one of the acronyms and then answer more questions about what they learned
* Take another survey after 30 days about the acronym they learned about


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent;
* Have access to a computer, tablet or mobile device with internet services;
* Proficient in reading and writing the English language; and
* Reside outside a medical facility.

Exclusion Criteria:

* Not able to provide written informed consent;
* Do not have access to a computer, tablet or mobile device with internet;
* Not proficient in reading and writing in English language; or
* Reside in a medical facility.
Detection of Annexin A2 in Systemic Lupus Erythematosus

There is substantial clinical and biological intra and inter-patient variability in SLE. Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening, leading to increased morbidity and mortality.

Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE patients.

Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR expression in SLE is significantly higher and significantly correlated with disease activity.

Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or heterotetramer and is implicated in several biological processes. Most notably, it binds to ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated with SLE.

ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out in Amiens' University Hospital showed that vascular lesions in lupus nephritis were associated with a significant increase in vascular expression of ANXA2.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients :

* Age ≥ 18 years old
* All SLE patients fulfilling the 1997 ACR criteria, followed at the Departments of Internal Medicine and Nephrology at CHU Amiens-Picardie, regardless of clinical status, treatment, and disease activity.
* Written informed consent

Inclusion criteria for control subjects :

* Age ≥ 18 years old
* Written informed consent

The patients will be compared with age- and sex-matched control subjects.

Exclusion Criteria:

* drug-induced lupus erythematosus
* refusal or incapacity to provide a written informed consent
The Influence of Breathing in Writing

Purpose: To examine whether nasal breathing influences the perception of sound causing trade between hard and soft consonants in the writing of children in school age and the incidence of trade.

To achieve the above goal explained, it was used:

Methods: The sample was consisted of 200 children, 100 previously diagnosed with oronasal breath (51 females and 49 males) who participated in the study group and 100 nasal breathers (54 females and 46 males) which were the control group. 36 words were dictated as minimal pairs to be written. Then a story was submitted in sequence of six figures from which the subjects produced a text.

Eligibility Criteria:
Inclusion Criteria:

* Mouth Breather/Nasal Breather
* Literate

Exclusion Criteria:

* Hearing trouble
* Speech trouble