cyrilzakka/clinical-trials huggingface dataset:
The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel

Haifa bay region is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region.

The health status will be evaluated using health questionnaires and spirometry.

Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region.

The health status will be evaluated while using health questionnaires and spirometry.

Objective: To evaluate the respiratory health of Haifa bay region children with comparatives, with respect to local air pollution levels.

Material and Methods: Children from Haifa bay region from 10 different communities (1200 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form.

First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be filled in by the parents.

Second step: Spirometry checking of the children. In parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the Haifa District Municipality Association for the Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation window. Additional meteorological data are also collected.

Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region.

The prevalence of pulmonary disease will be evaluated according to the risk maps The health status of the children will be documented from the children's primary clinic files as well.

Eligibility Criteria:
Inclusion Criteria:

* Living in Haifa bay region, Israel.
* Parents signed informed consent.

Exclusion Criteria:

* Children that their parents did not signed the informed consent
* Chronic disease except of asthma: Diabetes mellitus, Cystic Fibrosis, Cardiac diseases, Renal, Rheumatic and Chronic Gastrointestinal diseases, Mental retardation.
Pathogenicity of Species of the Achromobacter Genus in Patients from Reunion Island with Cystic Fibrosis

The pathogenicity of Achromobacter bacteria is not yet well established, but studies show a decline in respiratory function and an increase in mortality associated with chronic colonisation, making it possible to classify the Achromobacter genus as an emerging pathogen in cystic fibrosis. It is possible that certain species or clones are more virulent or resistant, requiring the adaptation of measures to prevent cross-transmission in the centres concerned.

However, until now, the identification of Achromobacter species has involved the use of molecular biology techniques that are not routinely applicable in diagnostic laboratories, limiting studies and the collection of epidemiological data. Recently, a database using MALDI-TOF mass spectrometry has been built for rapid and accurate species identification.

In view of the local epidemiology and the current lack of data, it would be necessary and interesting to use this tool to study a cohort of cystic fibrosis patients in Réunion island (North and South sites) to see whether one species has a greater clinical impact than another (pathogenicity), and/or is more responsible for chronic colonisation.

The research hypotheses are: What is the pathogenicity of Achromobacter species in cystic fibrosis patients? Is the pathogenicity of one species of the genus Achromobacter greater than that of other species in cystic fibrosis patients, depending on the colonization status of this bacterial species? Colonization with a species of the genus Achromobacter is associated with an increased frequency of pulmonary exacerbations in cystic fibrosis patients.

Investigator will therefore assess the frequency of pulmonary exacerbations as a function of the Achromobacter species colonizing/infecting cystic fibrosis patients.

As this is an exploratory study carried out mainly on bacterial strains from patients, it presents no risk to patients.

the results of the study will enable clinicians to improve their knowledge of the different species of bacteria in the Achromobacter genus, in terms of pathogenicity, ability to colonize the respiratory tract, resistance and virulence.

As far as patients are concerned, the knowledge gained from this study will help improve the overall management of their disease. It will also provide food for thought on the establishment of guidelines and recommendations for dealing with Achromobacter spp. colonization and therapeutic strategy.

Eligibility Criteria:
Inclusion Criteria:

* Minor or major cystic fibrosis patients
* Patients with at least one sputum cytobacteriological test positive for Achromobacter spp. during the inclusion period.
* Patients living in La Réunion island.
* Patients for whom a non-opposition was obtained orally (if applicable from both one of the child's legal guardians and the child him/herself)

Exclusion Criteria:

* Patients without cystic fibrosis.
* Patients with cystic fibrosis but no Achromobacter-positive ECBC during the study inclusion period
Randomized Comparison of Radiation Exposure to Operators in Coronary Intervention Between Right Radial and Left DRA

The purpose of this study is to show that the radiation exposure of the left distal radial artery approach is superior to the conventional right radial artery approach in terms of less radiation exposure.

The conventional radial approach is now recognized as the basic technique in coronary artery surgery. Compared to the femoral artery access, the main advantage is the increased stability due to the reduction of massive bleeding. Due to these advantages, recent guidelines recommend the conventional radial approach as the basic approach for all acute myocardial infarction (AMI) cases with or without ST-segment elevation. In particular, in the case of ST-segment elevation myocardial infarction (STEMI), new antiplatelet agents such as Ticagrelor and Prasugrel and strong antiplatelet agents such as Glycoprotein inhibitors have been used to prevent major vascular complications. For these many operators, primary percutaneous coronary intervention (PCI) through the radial artery is recommended. At this time, the operator prefers the right radial artery approach because of the comfort of performing the procedure on the patient's right side. However, the operator sometimes has to substitute the left radial artery or femoral artery access due to difficulty in manipulating the catheter due to severe tortuousness of the right subclavian artery. Although the left radial artery approach requires less operation time and radiographic imaging time due to less tortuousness of the left subclavian artery, the right conventional radial approach is still preferred due to the ergonomic inconvenience of having to lean toward the patient. Patients undergoing coronary angiography (CAG) were randomly assigned to the left snuffbox approach and the right conventional radial approach, and the surgeons' radiation exposure between the two approaches was evaluated and compared.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 20 years or older
2. Patients scheduled for coronary angiography and intervention

Exclusion Criteria:

1. When the pulse of the Left distal radial artery cannot be palpated
2. When the pulse of the right conventional radial artery cannot be palpated
3. In case of arteriovenous fistula
4. Acute myocardial infarction (AMI) patients
5. In case femoral artery access must be performed (state of shock, etc.)
6. In case of atrioventricular block
7. When an ergonovine provocation test is required
8. When the patient refuses to consent to the study
9. a pregnant or nursing woman
Efficacy and Safety of S 47445 Versus Placebo as Adjunctive Treatment in Depressed Patients Not Fully Recovered From Depressive Symptoms With a Current Antidepressant Treatment

The purpose of this study is to assess the efficacy and safety of S47445 versus placebo as adjunctive treatment of Major Depressive Disorder in patients with an inadequate response to antidepressant therapy.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Fulfilling DSM-5 criteria for Major Depressive Disorder confirmed by the brief structured interview M.I.N.I. (single or recurrent episode, current episode ≤ 12 months, current depressive episode of moderate or severe intensity, with or without anxious distress, with or without melancholic features, without mixed features or atypical features, without seasonal pattern, without psychotic features, without catatonic features, without peripartum onset for the current episode)
* Patients treated for the current depressive episode with an antidepressant treatment with SSRI (fluoxetine, citalopram, paroxetine, escitalopram or sertraline) given in monotherapy at recommended dose for at least 6 weeks and no more than 4 months and with a stable dosage for at least 3 weeks
* HAM-D total score ≥ 20
* Clinical Global Impression Severity of illness (item 1): 6 ≥ CGI-S ≥ 4
* Antidepressant Treatment Response Questionnaire (ATQR) \< 50% for the current SSRI
* Absence of any abnormalities likely to interfere with the conduct of the study (ECG, vital signs, laboratory tests, medical history)

Exclusion Criteria:

* Depressive episode of mild intensity according to DSM-5 criteria
* All types of depressive episodes other than those occurring in a Major Depressive Disorder (Persistent Depressive Disorder (Dysthymia) according to DSM-5 criteria, including persistent depressive disorder with intermittent or persistent major depressive episode according to DSM-5, Premenstrual Dysphoric Disorder, Substance Induced Depressive Disorder, Depressive Disorder due to another Medical Condition, Other Specified or Unspecified Depressive Disorder, Bipolar Disorder I or II, depressed episode, Schizoaffective Disorder (Depressive or Bipolar type))
* Depression onset within 12 months after a stroke
* Suicidal risk defined as a score \> 3 on the item 3 of the HAM-D scale or in the investigator's opinion
* Lactose intolerance
* Patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Resistant depression for the current episode (patients who have not responded to 1 previous antidepressant treatment before the SSRI taken at an appropriate dose)
* Current panic disorder
* Obsessive compulsive disorder
* Current post traumatic stress disorder, current acute stress disorder
* Current or past psychotic disorder
* Any severe personality features
Tinnitus Treatment by Structured Cognitive Behavioral Therapy

Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral therapy intervention procedures that are manualized and structured within the disease management program TCP are effective.

Intervention:

Individual application of structured and tinnitus specific cognitive behavioral therapy intervention procedures in the clinical setting of the structured therapy program "tinnitus care program (TCP)"

Duration of intervention per patient: 1-15 treatment sessions plus self treatment up to 16 weeks

Control intervention: Waiting group (16 weeks)

Eligibility Criteria:
Key Inclusion Criteria:

* Persistent and stable tinnitus of more than 11 weeks
* Gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale

Key Exclusion Criteria:

* Psychiatric or neurological comorbidity
* Tinnitus as concomitant symptom of an otherwise treatable disease
* Drug treatment for tinnitus 24 hrs. prior or during therapy
Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function

This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written and dated informed consent prior to any study specific procedures.
* Male or female volunteers aged 18 to 80 years (inclusive) having normal renal function, or suffering from moderate or severe renal impairment or ESRD.

Male subjects who are sexually active must be willing to use a barrier method of contraception (condom). Women must be of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test (at screening and at each admission) and be using a highly effective form of birth control for 3 months before enrollment and be willing to use a highly effective form of birth control during the study and until 3 months after their last dose of IP.

* Have a BMI between 18 and 40 kg/m2 (inclusive) and weigh at least 50 kg.
* Subjects must be able to understand and to comply with study procedures, restrictions and requirements.

Exclusion Criteria:

* History of any clinically significant medical history which, in the opinion of the Investigator and Sponsor, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
* History or presence of gastrointestinal hepatic or other condition known to interfere with disposition of the study drug (except for renal function impairment).
* Subjects who have a functioning kidney transplant.
* Acute illness, surgical procedures or trauma from within 2 weeks before enrollment until first administration of study drug
* Known or suspected history of drug abuse as judged by the Investigator.
The Effects of Specialized Footwear in Osteoarthritis

This study evaluates the effects of specialized footwear on pain and knee loading in knee osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give informed consent and to comply with the study protocol and follow-up instructions.
* Symptomatic OA of the knee, as defined by the American College of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are bilateral, then the knee identified by the subject as more symptomatic will serve as the index knee.
* Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the WOMAC.
* Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren and Lawrence (K-L) grading scale.
* Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.

Exclusion Criteria:

* Inability or unwillingness to wear study shoes for at least 6 hours/day for 6 days/week
* Knee flexion contracture of \> 15 degrees or inability to ambulate without assistance.
* Presence of clinically significant OA of the hip or ankle or pain greater than 20 mm at these sites (WOMAC).
* \> 3 degrees valgus or \>12 degrees varus deformity of either knee, defined by the mechanical axis (hip-knee angle).
* Predominant lateral compartment OA, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either the index or the contralateral knee.
* Concurrent systemic inflammatory arthropathy,
* Prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous 3 months or history of fracture of either lower extremity within 6 months of study entry.
* Intrinsic foot disease including hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated by particular footwear.
* Intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan derivatives within 4 months.
* Pregnant subjects will be excluded because of the X-rays required.
* Any medical condition that, in the opinion of the PI, would render the subject unable to complete the study.
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria \>=12 weeks prior to screening
* Anti-nuclear antibody (ANA) \>=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
* Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening
* High disease activity at screening, based on; BILAG-2004 (Category A disease in \>=1 organ system and/or Category B disease in \>=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score \>=8) and Physician's Global Assessment (PGA) (score \>=1.0 on a 0 to 3 visual analogue scale \[VAS\])
* High disease activity on Day 1, based on; SLEDAI-2K (score \>=8) and PGA (score \>=1.0 on a 0 to 3 VAS)
* Current receipt of \>=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
* Other inclusion criteria may apply
* The Medical Monitor may be consulted if there are any questions related to eligibility criteria

Exclusion Criteria:

* Pregnancy or breastfeeding
* Presence of significant lupus-associated renal disease and/or renal impairment
* Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
* Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
* Known active infection of any kind or recent major episode of infection
* Intolerance or contraindication to study therapies
* Other exclusion criteria may apply
Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies

This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.

This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.

In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.

The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.

Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing remitting Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
* Disability equivalent to EDSS of 6.0 or less
* Clinical activity defined as at least one relapse rate within the last 12 months
* NAb titre \>20 (measured at least 48 hours after last interferon-beta injection
* has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment

Exclusion Criteria:

* Any condition that might give rise to similar symptoms as MS
* Immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
* Treatment with glucocorticoids or ACTH less than one month prior to inclusion into the trial
* History of major depression
* Alcohol or drug dependency
* Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
* hypertension (BP \> 180/110 mmHg)
* Renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit
* Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
* Gastro-intestinal ulcers, gastritis, or dyspepsia
* Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
Laparoendoscopic Single-site Radical Nephrectomy for Localized Renal Cell Carcinoma

Surgical resection is the only potential curative treatment available for renal cell carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with localized renal cell carcinoma

Exclusion Criteria:

* Patients with lymph node or distant metastasis
Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder

The purpose of this study is to learn more about how the hormone, oxytocin, impacts social behavior in terms of cooperation with others, attention processing, and reward processing, among patients with social anxiety disorder. Based on available research, the investigators predict that in patients with social anxiety disorder, oxytocin will improve social cooperation during an online ball-tossing game called Cyberball, reduce attention toward socially threatening cues during a dot-probe task, and lead to greater willingness to work for monetary rewards for others rather than themselves during an effort expenditure task.


Eligibility Criteria:
Inclusion Criteria:

* Males \> 18 years of age with a primary (or co-principal) psychiatric diagnosis of social anxiety disorder (SAD), as defined by Diagnostic and Statistical Manual-IV (DSM-IV) criteria;
* Current Liebowitz Social Anxiety Scale (LSAS) score \> 60, which is a clinical threshold for SAD symptoms;
* Comorbid present DSM-IV Major Depression, Dysthymia, Specific Phobia, or any of the other anxiety disorders as diagnosed by DSM-IV criteria will be permitted as long as SAD is primary (the disorder that is most distressing to the patient). Inclusion of patients with comorbidity will permit accrual of a more clinically relevant patient population;
* Willingness to participate in and comply with the study procedures as indicated by signing the informed consent form.

Exclusion Criteria:

* Subjects with a serious medical illness for which hospitalization may be likely within the next three months;
* Subjects with a current diagnosis of schizophrenia, psychotic disorders, bipolar disorder, mental disorder due to a medical condition or substance, substance abuse or dependence, as diagnosed by DSM-IV criteria;
* Concurrent use of other psychotropic medications is excluded, except for antidepressants that have been taken at a stable dose for at least 2 weeks;
* Active suicidal or homicidal ideation or suicide attempts within the past six months requiring hospitalization;
* Subjects with significant nasal pathology (atrophic rhinitis, recurrent nose bleeds, or history of hypophysectomy);
* Smokers who smoke more than 15 cigarettes per day;
* Those who smoke cigarettes or have caffeine or alcohol within 24 hours of the study visit.