cyrilzakka/clinical-trials huggingface dataset:
Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration.
* Diagnosis of pulmonary disease requiring flexible bronchoscopy
* Greater than 18 years of age.

Exclusion Criteria:

* Any intervention beyond flexible bronchoscopy and endobronchial ultrasound
* Inability to tolerate bronchoscopy.
* Patients that receive paralytics.
* Patients with neuromuscular diseases.
* Inability to consent for procedures.
* Allergies to lidocaine or any other drugs used in protocol.
* Existing renal insufficiency or liver disease
Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species

Mold allergies are becoming increasingly important among the population. Increasing amounts of fungal spores are analyzed in air-samples because of urbanization, industrialization of food products and climate change. Mold also grows indoor and hence lead to additional health complaints.

Alternaria alternata, and its only major allergen Alt a 1, is the most important fungus for allergy sufferers. Alternaria alternata can not only cause allergic symptoms but can also cause intensified asthmatic symptoms.

Besides Alternaria alternata, there are over 700 other species of the genus Alternaria. The influence of these other species on allergic symptoms is poorly understood.

Furthermore, prevalence and incidence of an allergy to Alternaria alternata among the Austrian population is not known. Estimates range between 1-5% among the Austrian population.

This study aims to further investigate the incidence and characteristics of an allergy to Alternaria in Austria. This will be investigated with the help of participants (50 Alternaria allergy sufferers and 20 non allergic participants), spore counts in Austria and crowd-sourced symptom data.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be healthy people over 18 years of age. Allergic participants should have an allergic reaction against Alternaria, visible in the Skin-Prick-Test. Furthermore symptom data in the pollen diary of the Austrian Pollen Information Service should be existing

Exclusion Criteria:

* Subjects participating in a pharmacological study, pregnant subjects and subjects with an existing infectious- and/or autoimmune disease
Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab

The aim of this study was to describe the effect of direct IL-17A inhibition with secukinumab as compared with the selective inhibition of IL-23 with guselkumab (p19 subunit blocker) in controlling inflammation in psoriatic plaques that remain active despite treatment with the non-selective IL-23 inhibitor ustekinumab (blocker of p40 subunit, shared by IL-12 and IL 23).

This was a 16-week, randomized, open-label, parallel-group, active-control, Phase 2a study comparing secukinumab 300 mg s.c. versus guselkumab 100 mg s.c. in subjects with plaque psoriasis who had an inadequate response to ustekinumab. Forty subjects will be randomized 1:1 and treated for 16 weeks. In each patient, a target active refractory skin plaque (TCS ≥6) is described and biopsied at baseline and at study end. The objective of the study was to assess the superiority of secukinumab over guselkumab in achieving clear/almost clear status (TCS 0-2) of the target plaques; and to describe the molecular mechanisms behind this difference

Eligibility Criteria:
Inclusion Criteria:

Chronic plaque-type psoriasis considered inadequately controlled after treatment with ustekinumab according to the following criteria-:

* Ustekinumab administered at a dose equal or higher than that on the label for at least 24 weeks. The last administration must be at least 12 weeks before randomization
* absolute PASI score of 1-10 at Screening
* Presence of at least 1 refractory skin plaque, defined by a TCS of at least 6 and severity score of at least 2 or 3 (moderate) for each individual item, with an area ≥ 10 cm2 at screening.

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline
* Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at Baseline
* Previous treatment with more than one TNFα inhibitor or with IL-17A (including secukinumab), IL-17R or IL-23 (including guselkumab) inhibitors
* Use of other investigational drugs within 4 weeks before enrolment, or within a period of 5 half lives of enrollment/initiation of the study treatment, whichever is longer
* Ongoing use of prohibited treatments (see Section 6.2.2)
* Known immunosuppression (e.g., AIDS) at Screening
Better Understanding Slow Language Impairment

This study was designed to examine the development of children aged 6 to 10 with slow language impairment (SLI). The aim was threefold: (1) to investigate language skills of children with SLI at different levels - formal, semantic, pragmatic- in comparison with those of control children; (2) to test a procedural deficit hypothesis: abnormal development in the procedural memory system could account for some language deficits; (3) to make genotype-phenotype comparisons, focusing on the different levels of language development and on procedural skills. The main hypothesis is that genetic mutations, contingently epistatique, will lead to procedural learning deficit, which will have a negative impact on language skills at the formal level and consequently on semantic and pragmatic levels.

To test the main hypothesis, 60 SLI children and 100 controls children will be included on the protocol. Due to the lack of specific standardized tests, the diagnostic of specific language-impaired French children is a challenge. Thus, both a battery of standardized and non-standardized language tests (assessing the different levels: formal, semantic and pragmatic) will be administered to children to establish a profile of weaknesses for each child with SLI and to examine the relationships between SLI and procedural learning. DNA sampling will be conducted on each child, SLI and control, to allow subsequently the molecular analyses in order to run the association comparisons between behavioral data and genetic profiles.

The protocol includes as verbal standardized tests: the Echelle "Vocabulaire en Images Peabody" (EVIP;), the "Epreuve de COmpre´hension Syntaxico-SEmantique" (ECOSSE), two specific subtests (lexicon and grammar) of the "Evaluation du Langage Oral" (ELO;), and as non-standardized tests: a semantic inference task (drawing the meaning of new words from the context, and the meaning of predicative metaphors), and a pragmatic inference task (understanding of indirect requests, on speakers' intention meaning and on irony). The procedural learning skills will be assessed thanks to a serial reaction task, specifically adapted for children).

The complete sequencing of FoXP2 gene, as well as the genotyping of the 44 single nucleotide polymorphisms (SNPs), located in the risk haplotypes identified in ATP2C2, CMIP, CNTNAP2 genes and in the KIAA0319/TTRAP/THEM2 locus, will be conducted.

Eligibility Criteria:
Inclusion Criteria:

For SLI group, the inclusion criteria are:

* To present a slow language impairment
* To speak French

For control group, the inclusion criteria are:

* Being at elementary French school
* Speak French

Exclusion Criteria:

* Child with a neuro-motrice pathology or psychopathology
* Child with a neurological medication
* Child who have a score inferior to percentile 20 on the "Coloured Progressive Matrices" (Raven, 1998)
Optimizing Engagement in Services for First-Episode Psychosis

This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.

After an initial pre-screen, screening, and pre-intervention assessment, enrolled participants will be randomized to either BA or TAU. The study intervention phase will last up to 6 months, during which time BA participants will receive up to 12 one-on-one BA sessions and TAU participants will receive the usual care (e.g., medication management and any other service \[e.g., group counseling\]). Participants will be assessed at post-intervention, 1-month-post-intervention, and 6-month-post-intervention. The primary objective of aim 1 is to examine whether BA for FEP improves engagement in services better than TAU among Latinos with FEP and their families. Secondary objectives of aim 1 are to examine whether BA participants show greater improvements in quality of life, symptoms (e.g., psychosis, depression), functioning, and recovery compared to TAU participants, and whether BA participants have greater remission rates than the TAU group at 1- and 6-month post-intervention. Additionally, the association between potential BA mediators and engagement will be examined to identify mechanisms of engagement. Potential predictors of engagement will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* Self-identification as Latino
* Age 15 to 35
* Diagnostic \& Statistical Manual of Mental Disorders-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, other specified schizophrenia spectrum, affective psychosis, and other psychotic disorder criteria
* Ability to speak English or Spanish
* Caregiver willing to consent to participate in the study and care
* Ability to provide fully informed consent

Exclusion Criteria:

* Diagnosis of psychotic disorder due to another medical condition or substance/medication-induced psychotic disorder
* Presence of a serious medical condition
* 3≤ years after the onset
Geriatric Psychiatry and Pharmacovigilance

The purpose of this observational multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment.

The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises.

To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites.

At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed.

Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system.

In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually.

2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.


Eligibility Criteria:
Inclusion Criteria:

1. Age 65+ years old
2. Inpatients treated at one of the geriatric psychiatry study sites.
3. Signed consent form ( Patient and/or legally authorized custodian)

Exclusion Criteria:

1. Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
Schizophrenic Patients Taking Part in Integrated Care Program

Purpose of this non-interventional study (NIS) is to assess the effect of the participation in an integrated care program on treatment outcomes in patients treated with Seroquel for schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients suffering from schizophrenia, schizoaffective disorder, schizophreni-form disorder, delusional disorder or psychotic disorder not otherwise specified
* Age 18 - 65 years
* Current stable treatment with Seroquel according to SmPC since at least 2 months
* Given consent to take part in an integrated care program prior to study startWritten informed consent to take part in this NIS

Exclusion Criteria:

* Presence of any contraindication as described in the SmPC
* Cancellation of participation in the integrated care program
Comparison of Onset and Duration of Rocuronium Between 2nd Trimester Pregnant and Non-pregnant Women

Pregnancy is associated with major changes of the body's physiological status and composition.

These changes may modify the pharmacologic and/or pharmacokinetic profile of some drugs. Pharmacodynamic and pharmacokinetic changes in the 1st trimester during pregnancy are attributed to the following factors; Increase in plasma volume, heart rate and cardiac output; decrease in blood pressure due to decrease of systemic resistance and relative decrease of hepatic circulation and the aggravation of hepatic dysfunction. These changes intensify as pregnancy progresses into the 3rd trimester and take their effect on the onset time and duration of muscle relaxants.

Rocuronium and the steroidal non-depolarizing muscle relaxant like vecuronium is mostly excreted with bile by hepatic metabolism and classified as the FDA pregnancy category B, and is widely used in general anesthesia of pregnant women. Previous studies reported onset time of rocuronium is affected by cardiac output, blood circulation time of the whole body, and muscle perfusion. Accordingly, many researches were conducted under the assumption of onset time and duration being affected by physiologic changes during pregnancy. For example, in the research where vecuronium was used as muscle relaxant for pregnant woman undergoing C-sec, onset of vecuronium was significantly shorter than that of the control group and duration was longer. In a study investigating rocuronium used for patients right after delivery, onset time was shorter and duration was longer than that of the control group.

However, previous research mostly focused on the 3rd trimester, while there have been only a few studies of onset time and duration of rocuronium in non-obstetric surgery such as the transabdominal cervicoisthmic cerclage (TCIC) or Mcdonald surgery which are performed under general anesthesia during 2nd trimester. In this research, onset time and duration of rocuronium, which is widely used for general anesthesia in 2nd trimester pregnant females, will be compared with those of patients in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for Transabdominal cervicoisthmic cerclage under general anesthesia or patients scheduled for elective open abdominal surgery.
* The American Society of Anesthesiologists physical status class one or two
* female between 20 and 45

Exclusion Criteria:

* Patients with liver disease
* Patients with kidney disease
* Patients with Diabetes mellitus or heart disease
* Patients with asthma or Bronchial hypersensitivity
* Patients with a drug allergy
* Patients BMI under 18.5 or over 27
Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)

The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans. The study will also assess the safety profile and tolerability of MK-6183 in healthy participants, participants with varying degrees of renal impairment (RI), or participants with end-stage renal disease (ESRD) requiring hemodialysis (HD), based on estimated glomerular filtration rate (eGFR).


Eligibility Criteria:
Inclusion Criteria:

* Participants who are healthy; or who have mild, moderate, or severe RI; or who have ESRD requiring HD. Participants with ESRD requiring HD should have been receiving HD 3 times per week for at least 3 months preceding the initial dose in this study

Exclusion Criteria:

* For healthy participants (Group A): history or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, including clinically significant anemia, which in the opinion of the investigator would jeopardize the safety of the participant or the validity of the study results
* For participants with RI (Groups B to E): as above, except that RI and other medical conditions commonly associated with renal impairment (eg, hypertension, diabetes, which should be stable for at least three months preceding the initial dose of study medication in this study) are allowed
* Clinically significant abnormalities on physical examination, medical history, 12-lead electrocardiogram (ECG), vital signs, or laboratory values, as judged by the investigator or designee. Subjects with renal impairment should have clinical laboratory values consistent with their disease and approved by the investigator
* Evidence of clinically significant hepatic impairment including alanine aminotransferase or aspartate aminotransferase \>1.5 × upper limit of normal (ULN) or bilirubin \>1 × ULN
* Hemoglobin \<8 g/dL, unless considered stable and not clinically significant in the opinion of the investigator in subjects with ESRD and on HD
* Participants with renal impairment who are not on a chronic stable drug regimen, defined as starting a new drug or changing dosage within 14 days prior to administration of study medication, except for drugs administered in relationship to HD
* Participants with fluctuating or rapidly deteriorating renal function (assessment of the stability of the subject's renal function will be determined by the investigator)
* Participant has a currently functioning renal transplant and/or has been on significant immunosuppressant therapy, as determined by the investigator, within the last 6 months
Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses

The aim of this study is to assess the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.

Prospective, double-masked, crossover, bilateral wear, dispensing clinical trial where participants will wear multiple prototype (test) and commercial (control) lenses.

Multiple prototype contact lens designs will be assessed against commercial control lenses during the study, where each design will be worn for up to a week. There will be a minimum 1 night washout period between lens designs.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
* Be at least 18 years old, male or female.
* Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
* Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses.
* Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
* Be suitable and willing to wear contact lenses.

Exclusion Criteria:

* Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
* Use of or a need for concurrent category S3 and above ocular medication at enrolment. Ocular medication can be prescribed during the course of the trial as per standard optometric practice.
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. Note: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
* Eye surgery within 12 weeks immediately prior to enrolment for this trial.
* Previous corneal refractive surgery.
* Contraindications to contact lens wear.
* Known allergy or intolerance to ingredients in any of the clinical trial products.
The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts \<= 100 cells/mm3.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 count \<= 100 cells/mm3.
* No evidence of MAC.
* Life expectancy of at least 6 months.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Certain restricted drugs (details not available).

Patients with the following prior conditions are excluded:

History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.
Impact of the Coronavirus (COVID-19) on Patients With Cancer

The purpose of this study is to understand the impact of COVID-19 on patients with cancer through a survey.

The global spread of coronavirus (COVID-19) is affecting cancer patients and their treatments. Cancer patients are among those at high risk of developing serious illness from an infection because their immune systems are often weakened by cancer and its treatments. Due to the growing coronavirus outbreak, patients clinic visits are being cancelled and many are facing social isolation and strict restrictions on their daily lives. We want to evaluate the impact of the coronavirus on the patient's well-being and their cancer care by assessing the delays in their medical care and any other unmet needs. We have created a survey that is available online for any patient with cancer to fill out voluntarily regarding their experiences to date. The survey is available at: https://stanforduniversity.qualtrics.com/jfe/form/SV_ctKS6ZSMYdEYoXX

Eligibility Criteria:
Inclusion Criteria:

1. The patients must be 18 years or older.
2. Patients who opt in to complete the survey.
3. Patients must have the capacity to verbally consent for the interview.

Exclusion Criteria:

1.Patients who under the age of 18 years old.