cyrilzakka/clinical-trials huggingface dataset:
Wheelchair Use in Patients With Amputation

There are no specific criteria for wheelchair use in patients with lower extremity amputations. The main purpose of this study is to determine the characteristics of wheelchair use in lower extremity amputee patients. In addition, it is aimed to determine the reasons for using and not using a wheelchair, and what type of wheelchair is needed.

There are no specific criteria for chair use in patients with lower extremity amputations. The main purpose of this study is to determine the characteristics of wheelchair use in lower extremity amputee patients. In addition, it is aimed to determine the reasons for using and not using a wheelchair, and what type of wheelchair is needed. Thus, it is thought that the main points to be considered while prescribing a wheelchair in patients with amputation can be determined.

Patients with traumatic unilateral or bilateral lower extremity amputation who are hospitalized or applied to outpatient clinics will be included in the study. Demographic and clinical characteristics of the patients will be recorded. Current age, time since the injury (in months), occupation, etiology (mine,rocket launcher, rifle, shrapnel, etc.), amputation level, amputation side, accompanying upper extremity problem, last operation reason, and activity level, knee joint type (hydraulic, simple microprocessor, other microprocessor), foot type (carbon, hydraulic, microprocessor controlled), socket-suspension type, daily use of prosthesis (hour/day), use of assistive device or AFO, how long he/she has been using a wheelchair, the type of wheelchair (light manual, active, battery powered), the reason for using a wheelchair, the reason for not using, the frequency of using a wheelchair, the upper extremity problem/pain while using the chair will be recorded.

Eligibility Criteria:
Inclusion Criteria:

age between 18 and 65 years, time since amputation ≥ 6 months, unilateral or bilateral LLA above the ankle level

Exclusion Criteria:

None
Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis

This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year
* BSA of 3% to 20% and a vIGA-AD score of ≥3

Exclusion Criteria:

* Other active skin diseases associated with chronic pruritus
* Clinically infected atopic dermatitis that requires antibiotic therapy
* Use of specific treatments for atopic dermatitis
The Value of the Neutrophil to Lymphocyte Ratio in the Diagnosis of Bacterial Infections

The "gold standard" for diagnosing a bacterial infection is isolation of the pathogenic germ, which is not easy in routine clinical practice.

Conventional markers do not have sufficient diagnostic value for making a rapid diagnosis on admission. A 2004 literature calculated the diagnostic values of C-reactive protein (CRP) and procalcitonin (PCT) levels for the diagnosis of bacterial infections, relative to other causes of inflammation. For CRP, the sensitivity was 75% (95% CI: 62%-84%) and the specificity was 67% (95% CI: 56%-77%). For PCT, the sensitivity was 88% (95% CI: 62%-84%) and the specificity was 81% (95% CI: 67%-90%).

The first cellular immune response to infection consists of the mobilization of polynuclear neutrophils from the bone marrow to the infection site under the effect of pre-inflammatory cytokines, as well as the apoptosis of lymphocytes and their sequestration at the infection site. This results in lymphopenia and the elevated polynuclear neutrophil count (PNN) observed in bacterial infections.

Hence, it is legitimate to hypothesize that the neutrophil to lymphocyte ratio (NLR) can be used in the diagnosis of bacterial infection. This ratio's value in the diagnosis of sepsis in the emergency department was studied and the researchers found higher diagnostic values than for CRP and PCT.

The NLR's potential value in the diagnosis of a bacterial infection in a context of fever or hyperthermia (regardless of the presence or absence of bacteraemia) has not been studied before. This ratio could also be compared with standard biomarkers (CRP and PCT levels, the white blood cell count and the PNN).


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients admitted for fever/inflammatory syndrome to the internal medicine department at Amiens University Hospital between January 1 st 2011 and December 31 st 2014 (hyperthermia \&gt; 38°5 and/or inflammatory syndrome, defined as an increase in CRP \&gt;10 mg/L).

Exclusion Criteria:

* Known conditions or treatments that may influence the blood count (haematological and neoplastic diseases, seropositivity for HIV, chemotherapy, and corticotherapy).
* Pregnancy.
* A course of antibiotics administered in the 48 hours before the
* blood count (risk of sample negativity).
A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen

The main goal of this trial is to learn more about the safety of repeated dosing with Lu AG09222. The trial doctors will keep track of the participant's overall health by asking them how they are and by analyzing blood and urine samples.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.0 and ≤30 kilograms (kg)/square meter (m\^2) at the screening visit.
* The participant has a clinical history of grass pollen allergic rhinitis of at least 2 years' duration as diagnosed by a physician.
* The participant has a positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kilounits \[kU\]/liter \[L\]) against Phleum pratense at screening.
* The participant has a positive skin prick test with a wheal size ≥3 mm to Phleum pratense at screening.
* The participant is, in the opinion of the investigator, generally healthy based on medical history (despite the allergic rhinitis), a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant has received sublingual or subcutaneous immunotherapy with Phleum pratense within the last 5 years.
* The participant is receiving ongoing treatment with any allergy immunotherapy product.
* The participant has a clinically relevant history of symptomatic (seasonal or perennial) allergy caused by an allergen source overlapping with the allergen challenge period.
* The participant has taken disallowed medication or received a COVID-19 vaccination within the protocol-specified amount of time before Day 1.
* The participant has a relevant history of systemic allergic reaction, for example anaphylaxis with cardiorespiratory symptoms, generalized urticaria, or severe facial angioedema, which in the opinion of the investigator may constitute an increased safety concern.

Other inclusion and exclusion criteria may apply.
Phase I Trial of DAR-901

This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.


Eligibility Criteria:
Inclusion Criteria:

All subjects: age 18-65, prior BCG vaccine (scar)

56 HIV negative subjects: negative ELISA for HIV (48 subjects with negative IGRA, 8 subjects with positive IGRA)

21 HIV positive subjects: positive ELISA for HIV, on ART (13 subjects with negative IGRA, 8 subjects with positive IGRA)

Exclusion Criteria: pregnancy, positive serology for hepatitis B or C, active tuberculosis immunosuppression, severe medical illness

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Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program

This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion Criteria:

* Patients who are contraindicated based on the product label
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)

The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration of placebo during the sham procedure.

It is planned to enroll 105 patients into N-O CLI trial with randomization into active (CardioCell) therapy and sham procedure/placebo administration with 2:1 ratio.

The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with N-O CLI.

There are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe in each studied indication and way of CardioCell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.

Eligibility Criteria:
Inclusion Criteria:

* Patients able to walk
* Male and female patients, aged 18-80 years
* No-option CLI (definition: exhausted revascularization options including surgery or endovascular treatment) in Rutherford stage 4-5
* In case of bilateral N-O CLI, the limb with shorter claudication distance will be treated
* Presence of adequate inflow (patent iliac and common femoral arteries)
* Run-off through at least one (even partially seen) below-the-knee (BTK) artery
* Signed informed consent

Exclusion Criteria:

* Malignancy
* Moderate or severe immunodeficiency
* Acute or chronic bacterial or viral infectious disease
* Soft tissue disease or local infection in a place of required artery puncture
* Pregnancy or breastfeeding
* Any objective or subjective reason for inability to attend follow-up visits
* Females of childbearing potential, who does not want to use a highly effective method of contraception
* Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test
* Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this project
* Life expectancy \< 1 year
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
Caudal Epidural Injection of Dextrose For Low Back Pain

Objective: The purposes of the study are to

1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.
2. Determine if cumulative benefit results from caudal dextrose injection.
3. Evaluate accuracy of a small needle vertical approach caudal injection that will allow for blind injection of D5W.

Injection of dextrose into the epidural space as an admixture with various steroids and anesthetic has been utilized for years for purposes of altering the specific gravity of the injectate. No safety issues or concerns have been raised about the dextrose component inclusion but a separate therapeutic effect of dextrose has not heretofore been considered. Recently dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). An analgesic effect of dextrose on chronic pain in the presence of painful sensory nerves has been observed with injection of D5W without anesthetic. That effect begins within seconds clinically. Physicians have empirically trialed D5W for epidural injection in a 10 ml volume and found that marked or complete analgesia of chronic low back and leg pain results in the majority of patients within 15 minutes. An empirical consecutive patient date collection has demonstrated that this initial effect lasts for 2 to 48 hours, and that the effect begins to sustain after 2-3 sessions. For this reason, the current study is designed with the the first two objectives:

1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.
2. Determine if cumulative benefit results from caudal dextrose injection.

In addition to determining potential benefit from caudal epidural of dextrose, the accuracy of a simple vertical approach to injection of dextrose is to be evaluated. If this vertical approach is accurate it will allow for

1. More comfort with injection.
2. Less need for radiographic exposure, in that needle placement is quicker and easier, allowing for less fluoroscopy time.
3. Potential for blind injection of solutions that do not include anesthetic or particulate matter, increasing potential applicability of caudal dextrose injection to situations in which fluoroscopy is not available.

Eligibility Criteria:
Inclusion Criteria:

* More than 3 months of back pain
* Some pain below the iliac crest (Either in buttock or in leg)
* At least one conservative (non-injection) modality of treatment to include physical therapy, chiropractic/osteopathic manipulation, exercises, drug therapy, and relative rest.
* Opiate use absent or controlled
* Psychiatric history absent or controlled
* Current medical stability
* Absent steroid use history or no allergy or intolerance to steroid use

Exclusion Criteria:

* Unstable neurologic function
Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide

Primary Objective:

Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population.

Secondary Objectives:

* Assess the effect of teriflunomide on immunoglobulin levels;
* Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide.

The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.

The maximum duration of the study period for a participant was approximatively 49 days broken down as follows:

* Screening period of up to 21 days;
* Influenza vaccination at Day 1;
* Follow-up period of 28 days (±2 days).

MS treatment (Teriflunomide or interferon-β-1) was to be continued during the course of the study.

Eligibility Criteria:
Inclusion Criteria:

- Male or female patient \<60 years old with relapsing multiple sclerosis (RMS) either treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048 or LTS6050, or treated with a stable dose of interferon-β-1 for at least 6 months.

Exclusion Criteria:

* Concomitant infectious pathology at the time of vaccination;
* MS relapse within 1 month before vaccination;
* Systemic corticosteroids within 1 month before the vaccination;
* Any contraindication to influenza vaccine;
* Any vaccination within the last 6 months;
* Prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon-β-1);
* Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri®), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development;
* Prior or concomitant use of glatiramer acetate within 1 year before study entry;
* Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry;
* Pregnant or breast feeding women;
* Woman of childbearing potential without adequate contraception.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
BPX-501 T Cells Infused Post Stem Cell Transplant in Pediatrics With Non-Malignant Disorders Ineligible for BPU004 Study

Providing access of BPX-501 gene modified T cells and rimiducid to pediatric patients who do not meet the eligibility criteria of the BP-U-004 study.

This is an expanded access protocol of BPX-501 T cells infused after T cell-depleted HSCT in pediatric patients with non-malignant hematologic disorders eligible for treatment on the BP-U-004 study.

The purpose of this protocol is to provide access to the CaspaCIDe system combination product (BPX-501 gene modified T cells and rimiducid) to patients on a case by case basis who do not meet the BP-U-004 protocol eligibility criteria. BPX-501 infusion can enhance immune reconstitution with the potential for reducing the severity and duration of severe acute GVHD.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females
2. Age \< 21 years and \> 3 months
3. Life expectancy \> 10 weeks
4. Patients deemed eligible for allogeneic stem cell transplantation.
5. Non-malignant disorders including:

   1. inherited metabolic disorders such as adrenal leukodystrophy;
   2. lysosomal storage disorders such as Hurler syndrome or metachromatic leukodystrophy
   3. other inborn errors of metabolism
6. Lack of suitable conventional donor (HLA identical sibling or HLA phenotypically identical relative evaluated using high resolution molecular typing).
7. A minimum genotypic identical match of 5/10 is required.
8. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
9. Lansky/Karnofsky score \> 50
10. Signed written informed consent

3.2 Subject exclusion criteria

1. Age \< 3 months or \>21 years
2. Patients with non-malignant disorders eligible for treatment on the BP-U-004 study:

   1. primary immune deficiencies,
   2. severe aplastic anemia not responding to immune suppressive therapy,
   3. osteopetrosis,
   4. selected cases of hemoglobinopathies and
   5. congenital/hereditary cytopenia, including Fanconi Anemia before any clonal malignant evolution (MDS, AML)
3. Greater than Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at the time of inclusion
4. Patient receiving an immunosuppressive treatment for GVHD treatment due to a previous allograft at the time of inclusion
5. Dysfunction of liver (ALT/AST \> 5 times normal value, or bilirubin \> 3 times normal value), or of renal function (creatinine clearance \< 30 ml / min)
6. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \< 40%)
7. Current active infectious disease (including positive HIV serology or viral RNA)
8. Serious concurrent uncontrolled medical disorder
9. Pregnant or breast feeding female patient
10. Lack of parents'/guardian's informed consent.

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Food Effect Study For New Formulation

The main objective of this study is to estimate the effect of food on sildenafil pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of sildenafil citrate.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).

Exclusion Criteria:

* Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in systolic blood pressure (SBP), a ≥10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
* Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
AirSonea Wheeze Detection Study

The purpose of this study is to determine if the AirSonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments.


Eligibility Criteria:
Inclusion Criteria:

* Part I: Participants presenting to an Acute Care Setting with an exacerbation of asthma or chronic obstructive pulmonary disease symptoms
* Part II: Volunteer participants without asthma
* Part III: Participants with asthma
* For all parts of study

  * Age: 18 years or older
  * Participant has signed an Informed Consent after having the Study explained to them.

Exclusion Criteria:

* Any medical finding by the physician that would exclude the patient from participating.
* \< than 18 years of age