cyrilzakka/clinical-trials huggingface dataset:
Steroid Injection vs. BioDRestore for Patients With Knee OA

This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 80 years.
* Willing and able to give voluntary informed consent to participate in this investigation.
* Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray).
* Candidate for intra-articular knee injection.
* BMI \< 40

Exclusion Criteria:

* Patients who have received intra-articular injection(s) in the last 3 months.
* Patients who have undergone arthroscopic surgery on the study knee in the past year.
* Patients who have undergone arthroplasty on the study knee.
* Ligament instability
* Diabetes (Type 1 or II)
* Inflammatory arthropathies.
* Fibromyalgia or chronic fatigue syndrome.
* Female patient who is pregnant or nursing.
* Chronic use of narcotics.
* Any other reason (in the judgment of the investigator).
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerised With House Dust Mite in pediatric allergic patients

This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients in routine medical care.

Patients receive a rush schedule administration every month for a year. They attend at least 5 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
* Positive skin testing
* Positive Serum-Specific IgE determination
* Parental or legal representative informed consent
* Clinical sintomatology on the inclusion period

Exclusion Criteria:

* Patients suffering from acute or chronic infections or inflammations
* Patients suffering from uncontrolled and severe asthma
* Patients with a known autoimmune disease
* Patients with active malignant disease
* Patients requiring beta-blockers
* Patients having any contraindication for the use of adrenaline
* Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
* Patients with immunotherapy treatment at the time of inclusion
Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants

The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elderly and pregnants. The primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21 days after vaccination. Volunteers will be recruited based on inclusion and exclusion criteria. Vaccine composition is: 15 micrograms of split inactivated virus (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers able to understand and agree to participate in the study.

Exclusion Criteria:

* Have egg allergy
* Have past history of allergy to seasonal influenza vaccine
* Have received another inactivated vaccine within the prior 2 weeks or live vaccine in the past four weeks to his/her participation in the study
* Acute infectious disease during seven days prior vaccination
* Confirmed prior infection by pandemic influenza A (H1N1)
* Have participated in another clinical trial in the last 6 months
* Any other condition identified by the principal investigators which is considered not safe for enrollment of the volunteer.
Prognostic Impact of NLR, PLR, and MPV in Patients Undergoing AAA Open Repair

Abdominal aortic aneurysm (AAA) is a multifactorial degenerative disorder, which if untreated might lead to catastrophic complications. The treatment for AAA includes open and endovascular repair, both of which carry a significant degree of risk. Thus, researchers have performed several studies addressing simple and readily available risk stratification markers, such as complete blood count in patients undergoing open AAA repair.

The neutrophil to lymphocyte ratio (NLR) has been frequently used as a marker of systemic inflammatory response, which reflects neutrophilia and lymphopenia. The primary pathophysiology of AAA involves chronic inflammation in the aortic wall and atherosclerosis, accompanied with thrombosis. NLR was proposed as a fair indicator for poor prognosis in patients with AAA. The mean platelet volume (MPV) is the marker of platelet activation and an indicator of the activation of thrombus formation. Moreover, it is reportedly associated with the prognosis of patients with cardiovascular diseases. Moreover, the platelet to lymphocyte ratio (PLR) suggests thrombosis and inflammation and indicates a high risk of cardiovascular events in various groups of patients. The PLR is associated with poor prognosis following AAA repair. Despite accumulating evidence for the prognostic value of white blood cell counts in abdominal aortic aneurysm, few studies have investigated the value of these parameters, including NLR, MPV, and PLR, in patients undergoing AAA open repair.

The investigators aimed to investigate if preoperative neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), or mean platelet volume (MPV) could be used to predict 1-year mortality in patients undergoing open abdominal aortic aneurysm (AAA) repair.

The investigators will retrospectively review medical records who underwent open abdominal aortic aneurysm repair between Jan 2008 and July 2019. The investigators will divide the patients into two groups according to the occurrence of 1-yr mortality. Then the investigators compare complete blood count including NLR, PLR and MPV between the groups. Furthermore, the patient will be divided into tertiles according to the preoperative NLR, PLR, and MPV values to compare the incidence of 1-yr mortality and other morbidities. Multivariable logistic regression analysis will be performed to investigate possible prognostic factor for 1-yr mortality in these patients.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent open repair of abdominal aortic aneurysm.

Exclusion Criteria:

* patients with previous aortic repair within 6 months.
* mycotic aneurysm.
* iliac artery aneurysm.
* aorta occlusive disease.
* incomplete data.
High-Dose Steroid for Knee Arthroplasty

The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Kneesurgery with Arthroplasty and the effect on postoperative pain and postoperative inflammation.

This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Knee Arthroplasty in a Fast-Track setting.

The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts.

The hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral Knee Arthroplasty.

Patients referred to Unilateral Total KneeArthroplasty because of knee-osteoarthritis on Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are screened and offered inclusion in the study.

The two groups will be randomized and doubleblinded. One group will be treated, as the current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).

The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg bodyweight).

The patients will be monitored the first 7 days after surgery, during the admission to the hospital, and by a Pain-diary in the patients own home.

Blood tests will be taken preoperatively and postoperatively to determine the effect of the highdose steroid on the inflammatory response. Also a series of blood tests determining the glucose-metabolism after the steroid-admission.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 90.
* Booked for unilateral knee-arthroplasty.
* Is able to take part in the investigation(selfreported pain and nausea/vomiting)
* Understands Danish or English, or has a translator available.
* Signed written consent.

Exclusion Criteria:

* Insulin-dependent diabetes melitus.
* Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids).
* Pregnancy/Breastfeeding
* Allergies for the investigational drug.
* Daily use of opioids.
* A pain catastrophizing scale(PCS) score of \>20.
* A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.
Assessment of the Effectiveness of Continuous Labour Support by a Trained Companion of Choice on Events of Labor and Maternal Satisfaction in the Bugisu Sub Region, Uganda

A randomized control trial employing a cross sectional stepped wedge design. Women with anticipated vaginal delivery, receiving usual care for the control group while women receiving usual care plus support from a trained companion will constitute the experimental group. Events and outcomes will then be assessed during and after birth.

The order of introduction of the intervention will be determined randomly. Control data will be obtained from the first health facility until the sample size for the control for that facility is achieved. Following collection of control data for the first facility, the intervention will be introduced to the same facility to a new group of participants. Simultaneously control data from the other facilities will be collected and this will be done until all the facilities are covered in a step wedge manner.

The intervention will consist of a session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed.

Eligibility Criteria:
Inclusion Criteria:

1. Women with a singleton fetus and a supposed cephalic presentation.
2. Women with a female friend or relative willing to stay with them through the process of labor and birth.

Exclusion Criteria:

* Women with a multiple pregnancy.
* Women with a previous cesarean section
* Women who are mentally incapacitated or deaf and dumb
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells

PRIMARY OBJECTIVES:

I. Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer.

SECONDARY OBJECTIVES:

I. Determine the duration of response in patients treated with this regimen. II. Determine the toxicity of this treatment regimen in this patient population.

III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient population.

V. Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression.

OUTLINE:

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression or death.

PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IIIB or IV non-small cell lung cancer

  * Supraclavicular node involvement allowed
  * Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative)
* No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy
* Recurrent disease allowed
* HER2 overexpression (2-3+)
* At least 1 unidimensionally measurable lesion

  * At least 20 mm by conventional techniques
  * At least 10 mm by spiral CT scan
  * The following are not considered measurable:

    * Bone lesions
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Abdominal masses not confirmed and followed by imaging
    * Cystic lesions
* No CNS metastases
* Performance status - ECOG 0-2
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Creatinine no greater than 1.5 times ULN
* LVEF at least 45% (by echocardiogram or MUGA)
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No concurrent immunologic disease (e.g., autoimmune disease)
* No history of allergy to murine products
* No prior murine antibodies
* No prior anthracyclines
* No more than 1 prior chemotherapy regimen for lung cancer
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
* No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic
* No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)
* At least 6 months since prior radiotherapy
* No concurrent palliative radiotherapy
* At least 4 weeks since prior major surgery
Probiotics Regulates Skin Care in Children

Probiotics, a component that is generally referred to as a living microorganism or a microorganism present in a host. Most studies have shown that probiotics can regulate immune function in the body. Many studies have attempted to understand whether the use of probiotics can prevent allergic diseases or not.


Eligibility Criteria:
Inclusion Criteria:

* Estimated by PI.

Exclusion Criteria:

* Be allergic to medicine
* Take medicine like immune inhibition, or steroid injection in two weeks
* Participate in another clinical research or immune therapy in one month
* Have severe disease
* Inappropriate for this trial judged by PI
Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics

The study will be conducted in department of Hepatology at ILBS, the patients will be recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for standard of care and also patients who undergo IGB placement as part of weight reduction policy in these group of patients and will undergo an UGI endoscopy followed by placement of intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 18 and 65 years
* NASH (Non Alcoholic SteatoHepatitis) cirrhosis
* BMI \> 30 and failure to control weight despite full dietary and life style modifications.
* Compensated : CTP 6 \& 7 without any evidence of decompensation in form of Hepatic encephalopathy, ascites, GI bleed or prolonged jaundice.
* Small varices: Grade I varices

Exclusion Criteria:

* Alcoholic liver disease
* Advanced liver disease with ascites, hepatic encephalopathy
* Other liver diseases such as chronic hepatitis B, chronic hepatitis C, Wilsons' disease, Hemochromatosis, glycogen storage diseases etc.
* Pregnancy
* Unwilling patients
* Large varices
* Past h/o GI bleed
* Hiatus hernia
* Gastric ulcer
* Severe esophagitis (Grade B and above)
* Severe PHG or gastric erythema
ARIpiprazole in Anorexia NErvosa

Evidence is lacking on the effects of different psychotropic drugs in the treatment of anorexia nervosa (AR). However, HVA levels seem to be elevated in this disease, therefore suggesting a role for drugs with a partial agonist profile on dopaminergic receptors. This is a pilot study assessing the effects of aripiprazole in teenagers with AR, compared with a placebo.


Eligibility Criteria:
Inclusion Criteria:

* age between 12 and 18
* diagnostic criteria for anorexia Nervosa (DSM-IV-TR (includes BMI below 17.5kg/m2 and above 14 kg/m2) confirmed by a Psychiatrist and validated by K-SADS-PL interview
* severity criteria requiring Hospital admission
* Consent given by parents and patients

Exclusion Criteria:

* psychotic illness
* antipsychotic therapy at inclusion
* pregnancy and breastfeeding
* antipsychotic drug allergy
* prior head trauma, malignant neuroleptic syndrome or epilepsy
* relevant comorbidities requiring therapy
* detection of abuse drugs in urine test
* treatment with neuroleptic, antidepressant or mood stabilizers during 2 weeks prior to randomization (4 weeks in case of fluoxetine)
* suicidal or homicidal thoughts
* IQ below 70
Trial of Two Techniques to Assess Postoperative Voiding Function

Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many surgical procedures have been developed to treat SUI, and midurethral slings have gradually become the first line treatment. Voiding dysfunction, or inability for a patient to empty her bladder, immediately after surgery is common. A bladder test is often performed in the recovery area to see if the patient is able to empty her bladder. This typically consists of filling the bladder with 300 mL of saline through the foley catheter. The catheter is then removed and the patient is asked to void. The investigators then measure the voided volume and the residual left inside the bladder to determine if she is able to empty her bladder sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding trial that is initiated in the operating room. Our hypothesis was that a retrograde postoperative voiding trial initiated in the operating room would be as effective as a standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction while allowing for patients to spend less time in the recovery unit.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Women over the age of 18
* Patients with stress urinary incontinence planning to undergo midurethral sling placement

Exclusion Criteria:

* Prior incontinence surgery
* Concomitant surgery for pelvic organ prolapse except for anterior repair
* Intraoperative cystotomy
* Patients taking anticholinergic medication
Psychological Characteristics of Patients With Severe Asthma

Like any chronic disease, asthma exposes individuals to stressful and threatening situations that require ongoing cognitive, emotional, behavioral and social adaptation. Approximately 5-10% of patients with asthma have a treatment-resistant disease, with frequent emergency room visits and hospitalizations. These patients are responsible for the majority of the overall asthma-related disease burden and also represent more than half of the total direct costs of asthma management. The scientific literature shows that personality traits, attachment type and psychological disorders will significantly influence disease coping strategies, disease experience, quality of life, adherence and therapeutic alliance. Although some data exist in asthma, there are currently no studies that have evaluated the overall psychological profile of asthma patients, and we have no data specifically on the population of severe asthmatics, who are the most difficult to manage. A better understanding of the overall psychological dimension of asthma patients will make it possible to offer therapeutic education programs that are more targeted according to the psychosocial skills of the patient and finally improve the overall management of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years and followed in the Respiratory Department of the Besançon University Hospital for an asthmatic disease diagnosed for more than 12 months. Will be considered as severe patients, asthma patients with uncontrolled asthma despite high therapeutic pressure (GINA levels 4 and 5) and patients requiring to be controlled high doses of inhaled corticosteroids and long-acting beta-2-agonists (or anti-leukotriene/theophylline) in the past year or systemic corticosteroid therapy (\>50% in the previous year) (ATS-ERS 2014 criteria).
* Patient able to understand the objectives of the research
* Patient who has signed a research consent form
* Patient affiliated to a French social security system or beneficiary of such a system

Exclusion Criteria:

* Patient with reading and comprehension difficulties that prevent them from completing the questionnaires
* Motor disability that prevents the patient from completing the questionnaires
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the the investigator
* Subject without health insurance
* Subject under court protection, guardianship, conservatorship, or protective supervision. protection.
A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus.
* Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis.
* Able to tolerate topical corticosteroids for atopic dermatitis lesions.

Exclusion Criteria:

* Prior exposure to any Janus kinase (JAK) inhibitor.
* Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study.
* Requirement of prohibited medications during the study.
* Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.