cyrilzakka/clinical-trials huggingface dataset:
A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis

Randomized, double blind, placebo controlled study. The study has two parts:

Dose-finding part, followed by longer term follow-up (6 months)

Part 1: Randomized, double blind, placebo controlled dose-finding. Patients will be assigned to 1 of 3 doses OligoG, or to placebo, on top of Standard of Care. Patients will be treated for 12 weeks, followed by 4 weeks washout.The primary endpoint is relative change in % predicted FEV1. Secondary endpoints include additional spirometry parameters, exacerbation rate, Quality of Life, sputum rheology and microbiology, safety laboratory tests and adverse event reporting.

Part 2: Randomized double-blind 6 -month study, for longer term follow-up of the dose identified in Part 1. New patients will be recruited in part 2, in addition to patients who received placebo in Part 1. In addition to the endpoints studied in Part 1, Part 2 will include Lung Clearance Index (LCI), chest imaging by MRI or CT, and pharmaco-economic parameters.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF
* FEV1 at screening \>40 and \< 90% of predicted normal
* History of PA infection in last 12 m
* History of antibiotic treatment due tp PA infection (not for eradication) during last 12 m
* Concomitant inhaled tobramycin, colistin, aztreonam, or levoflaxin (cycled or continuous)
* Stable CF disease
* Willing to remain on stable CF medication (Standard of care)
* Women of child-bearing potential must habe negative urine pregnany test
* Males \& females must use acceptable contraception
* Capable of inhaling dry powder
* willing to sign informed consent
* willing and able to follow study procedures

Exclusion Criteria:

* Use of hypertonic saline \> twice daily
* Clinically significant abnormal lab findings, except CRP. In case of high GGT values, case will be discussed by experts before deciding
* History of comorbidity that may distort results or cause additional risk
* pulmonary exacerbation within 28 days prior to randomisation
* Change in CF therapy within 28 days prior to randomisation
* Burkholderia spp. finding within 12 m prior to screening
* pregnant or breast feeding females
* History of allergic reactions to IMP ingredients, incl milk protein
* Inability to perform lung function tests according to ATS/ ERS criteria
* Uncontrolled or unstable diseases that might limit compliance
* History of, or planned organ transplantation
* Allergic ABPA in the last 12 months prior to the screening visit
* Requirement for continuous oxygen supplementation
* Current participation in another clinical study
* medical condition, other than CFwhich exposes the patient to an unacceptably high risk
* Concurrent mlignant disease, except BCC and cervical neoplasia
* Clinically significant alcohol or drug abuse
A Trial of an Audit and Feedback Report to Improve Colonoscopy Performance

This project aims to measure the impact of a physician report card (also called an audit \& feedback report) on colonoscopy performance. Endoscopists in Ontario will be randomly assigned to either receive the endoscopist report card or to no feedback. Using Ontario health administrative data, the quality of colonoscopy will be compared between those who received the report card and those who do not. The investigators will also measure the effect of receiving endoscopist report card on colonoscopy performance amongst endoscopists who perform poorly at baseline compared to those who do not. Further, the acceptability of two educational interventions that aim to improve the quality of colonoscopy will be evaluated by conducting one-on-one interviews with select participants. This study is critical to ensure that Canadians have access to the highest quality colonoscopy possible.


Eligibility Criteria:
Inclusion Criteria:

* All practising endoscopists in Ontario who performed at least 5 colonoscopies in 2014

Exclusion Criteria:

-
Estimation of the Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in the Nîmes Administrative Detention Center

People in Administrative Detention Centers often come from areas of medium or high HIV, hepatitis C \& B endemic, and are often unaware of their serological status. Currently, HIV, hepatitis C \& B screening is not systematically performed at the CRA of Nîmes, and when performed, serological tests are used. The main disadvantage of this method is the length of time it takes to obtain the results, with subjects frequently discharged before receiving their results.

To improve the care of these vulnerable persons, the aim of this study is to estimate the prevalence of HIV, hepatitis C and hepatitis B in the detainees of the administrative detention center of Nîmes, by systematically screening with a rapid diagnosis test. In case of a positive rapid diagnosis test test, a serology test will confirm the rapid diagnosis test result.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed oral consent
* Patient detained in the Nîmes Administrative Detention Center

Exclusion Criterion

• It is impossible to give the subject informed information
Single-sided Deafness and Cochlear Implantation

This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.

Cochlear implant (CI) technology has been widely used for individuals with bilateral sensorineural hearing loss to improve the ability to perceive sound by bypassing the damaged portion of the inner ear. Recently in the U.S., Cochlear implantation has also been approved by the FDA for treatment of single-sided deafness. By restoring binaural hearing, cochlear implantation in unilateral hearing loss may improve hearing in noise and sound localization, however its audiologic outcomes and quality of life impact for patients remain incompletely understood.

This study aims to establish a prospective database to track and quantify the change in general health status, tinnitus severity, spatial hearing ability, and difficulty with communication in noise after unilateral cochlear implantation in patients with SSD undergoing routine medical and audiologic evaluation at the Johns Hopkins Cochlear Implant Center. Study participants will complete survey questionnaires and undergo standard-of-care audiological evaluation before and after cochlear implantation. Data collected in this study will be invaluable in gaining an in-depth understanding of the effects of cochlear implantation in patients with SSD in the context of current FDA guidelines, and lead to better counseling and patient selection for this treatment modality.

Eligibility Criteria:
Inclusion Criteria:

* For individuals ages 18 years-old and above, limited benefit from unilateral amplification is defined by test scores of 5% correct or less on monosyllabic consonant-nucleus-consonant (CNC) words in quiet when tested in the ear to be implanted alone.
* Before implantation with a cochlear implant, individuals with SSD or AHL must have at least 1-month experience wearing a Contra Lateral Routing of Signal (CROS) hearing aid or other relevant device and not show any subjective benefit.
* Medical and surgical clearance for cochlear implantation.

Exclusion Criteria:

* Not meeting FDA candidacy criteria for cochlear implantation in SSD
* Inability to perform audiologic tasks (e.g. non-English speaking)
* Medical or surgical contraindication to general anesthesia or cochlear implant surgery
* Does not wish to participate
Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals

The overall goals of this project are to determine the impact of an implicit priming intervention, designed to alter food perceptions, on both brain responses to food and on food intake behaviors in overweight/obese individuals. The investigators hypothesized that this bottom-up sensory-level conditioning approach would effectively result in reduced preference for high-calorie foods.

One factor that may contribute to susceptibility to obesity is a high responsivity to high-calorie foods in terms of cognitive factors such as emotional associations, reward value or reinforcing properties of food. Many of these processes involve learned associations thought to develop via classical conditioning through repeated pairings with external stimuli, which can influence food preferences and intake. As such, improving our understanding of the neuronal mechanisms underlying these processes and attempting to modify them may be a useful strategy to promote weight loss and maintenance. Therefore, the proposed study aims to investigate the effects of altering food perception on neuronal responses and food intake behaviors by using implicit priming, in which positively or negatively valenced images are presented immediately prior to food images, but are not consciously perceived.

The project goals are to determine the impact of the implicit priming intervention on both brain responses to food cues and on food intake behaviors in overweight/obese individuals. Food image ratings were assessed before and after either (a) an active implicit priming intervention or (b) a control intervention. One group of participants (n = 47; "MRI sample") completed the intervention during an fMRI scan and completed a visual food cues task both before and after the intervention (during fMRI), to assess intervention-related change in neuronal responses to food cues. In this group, food intake measures were also taken following fMRI. In a separate group of participants (n = 45; "Behavioral-only sample"), the primary outcome measure was the change in food image ratings from pre- to post-intervention; fMRI and measures of food intake were not assessed in this group.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese adults
* Healthy weight adults

Exclusion Criteria:

* Vegetarian, vegan, or having other wide-ranging food restrictions
* Currently dieting
* MRI exclusion criteria, if in MRI sample (e.g., claustrophobia, metal in the body)
Comfort Evaluation of a New MPS vs. Replenish in Contact Lens Patients

To compare corneal staining after contact lens instillation with a new MPS vs. RepleniSH


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 yrs or older
2. Males or females
3. Any race or ethnic background
4. CL patients using MPS products currently
5. Patients using Contact Lenses habitually (at least 1 month)

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Contact lens use on day of examination.
3. Corneal ectasia.
4. Current use of Restasis
A Feasibility Study of a Guided Self-help Programme for Male Offenders Serving a Long-term Prison Sentence

Background: Prisoners have complex mental health needs, and there is a disproportionately higher incidence of mental health problems compared with the general population. Although research indicates that psychological interventions are effective in treating prisoners with anxiety and depression, medication is often the only treatment available in prisons. Living Life To The Full (LLTTF) is a life skills programme teaching skills to cope with life stresses, and has been shown to reduce anxiety and depression in individuals in the community.

Research Questions

1. Will prisoners take part in and engage with LLTTF?
2. Do LLTTF booklets need to be adapted for prisoners?
3. Does LLTTF show an effect of reducing anxiety and/or depression?
4. Does history of HI reduce responsivity to LLTTF?
5. Does LLTTF reduce number of breaches of prison rules?

What did the study involve?: Prison Officers in HMP Shotts were invited to take part and attend LLTTF training. Male prisoners aged 21 and above in HMP Shotts were recruited using posters. Assessment of anxiety, depression, perceived functioning, and history of head injury was carried out. Prisoners' work attendance and breaches of prison rules for the month prior to and month during LLTTF was collected. Prison Officers and prisoners provided feedback of LLTTF at end of treatment.

Results: Six (6%) Prison Officers attended LLTTF training and two (33%) withdrew prior to prisoner recruitment. 6% (n=15) of prisoners invited to take part volunteered and were eligible. Seven prisoners completed LLTTF.

There was a sign of a treatment effect with reductions in depression following LLTTF. Anxiety reduced at the last session and increased at post-treatment, which reflects the deterioration in a minority of prisoners. Due to the small sample size, history of HI and responsivity was not explored. Prisoners were not on report the month prior to LLTTF, therefore impact on breached rules was not explored.

Feedback from Prison Officers and prisoners indicated materials required adaptation for prison, such as including activities feasible in prison. Prison Officers highlighted practical barriers to delivery of LLTTF, including limited time.

Conclusions: Guided self-help in prison is worth pursuing. Revision of materials with Prison Officers and prisoners is recommended, and evaluated in future research. Due to practical barriers reported by Prison Officers, designated guided self-help workers may be better placed to deliver this intervention.


Eligibility Criteria:
Eligible prisoners were adult males (aged 21+) at HMP Shotts who experienced mild-severe levels of psychological distress (defined as PHQ score of 5+), were prepared to attend four sessions of the guided self-help, able to read and write, and able to engage in the guided self-help.

Prisoners were excluded if deemed, by Prison Officers or healthcare staff, to pose a direct risk of harm to the field researcher (or were at risk of imminent and significant self-harm).
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.

Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75
* candidate for laparoscopic surgical intervention during the period of the study were included.

Exclusion Criteria:

* Patient has immunodeficiency disorder.
* Patient receiving anti-cancer / immunosuppressive therapy.
* Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.
Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors.

This is a multi-center, open-label, single-sequence, crossover, drug-drug interaction (DDI) study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on the PK of dovitinib in patients with advanced solid tumors, excluding breast cancer. The purpose of this study is to evaluate the effect of a CYP1A2 inhibitor, 100 mg fluvoxamine, on the PK of dovitinib when administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. The study will consist of 2 phases: a Pharmacokinetic (PK) phase and a clinical treatment phase. The DDI test will be conducted in the PK phase. The DDI test will assess the steady state PK profile of dovitinib when administered alone and in the presence of the CYP1A2 inhibitor, fluvoxamine (AUC 0-24h, AUC 0-72h and Cmax parameters). During the clinical treatment phase patients may continue to receive treatment with TKI258 until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.


Eligibility Criteria:
Inclusion Criteria:

Patients with a cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer which has progressed despite standard therapy or for which no standard therapy exists - ECOG performance status 0 or 1 and an anticipated life expectancy of ≥3 months- Patient must meet protocol-specific laboratory values

Exclusion Criteria:

- Patients with brain metastases - Patients who have received or who are expected to receive any prohibited medications and therapies - Patients who have received CYP1A2 or CYP3A inhibitor medications within 5 days prior to start study treatment or are expected to receive during the first 28 days after starting the study treatment - Patients who have received CYP1A2 or CYP3A inducer medications within 30 days prior to start study treatment or are expected to receive during the first 28 days after starting the study treatment - Patients who are actively taking antidepressants, benzodiazepines, serotonergic drugs, and/or monoamine oxidase inhibitors (MAOIs) - Patients who have not recovered from previous anti-cancer therapies - Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TKI258 - Patients who have concurrent severe and/or uncontrolled concomitant medical conditions that could compromise participation in the study - Female patients who are pregnant or breast-feeding - Fertile males or women not willing to use highly effective methods of contraception - Other protocol-defined inclusion/exclusion criteria will apply
Melanoma Molecular Profiling Analysis

There is a significant need to develop new and more effective ways to treat melanoma that will decrease patient morbidity and mortality. This protocol intends to collect and process a portion (\< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and appropriate lineage control tissue will be collected. Material only from already-indicated and planned procedures as part of standard medical care will be used. The main goal of this study will be to properly collect and process material to be analyzed and explore the molecular features melanoma biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Primary melanoma with the following Breslow thickness and stage

  * ≥ 2 mm with ulceration, T3b
  * ≥ 4 mm without (T4a) or with (T4b) ulceration
  * Patients with a biopsied tumor that has not been widely resected will also be eligible for study according to the above-specified criteria for tumor thickness and stage.
* Age 12 years or older.
* Patients must have documented hemoglobin level of 10g/dL or higher. This can be drawn on the day of consent, or be documented from a previous visit within the past 30 days
* Subjects must have provided written, informed consent prior to any study procedures: collection of blood and LN tissue specimens for this protocol.

Exclusion Criteria:

* Serious illnesses that may be considered a contraindication to surgery as determined by the physician investigator. If a subject is cleared for surgery as clinically indicated (wide excision of the primary melanoma and sentinel lymph node biopsy), subject would be eligible.
* Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the Principal Investigator or Co-Investigators, could prevent adequate informed consent or compromise participation in the clinical trial.
* Active infection or antibiotics within one-week prior to study
* Systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.
Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID).

The project aims to compile clinical and laboratory data of patients with primary immunodeficiencies (PID) in order to improve diagnosis, classification, prognosis and therapy. The online technology offers features not available in former databases such as access control,security functionality, and maintenance of data integrity during transactions and system errors, online back up, online optimization, scalability and online SQL-queries as well as a long term documentation of patients.

Furthermore the database can be used for the submission and storage of molecular diagnostic results and thus allow the compilation of genotype and phenotype observations, which is of essential and immediate use for the patient himself and patient care. An attending physician may gain information on similar cases of a rare PID disease in Switzerland and European countries and use these insights for therapy. In addition, it will be possible to obtain an insight on side effects. Thus, the system also meets the requirements of an optimal platform for Phase IV studies of post-licensing drug surveillance-programs.

Eligibility Criteria:
Inclusion Criteria:

* Primary Immunodeficiency Disease (PID)

Exclusion Criteria:

* None
A Comparison of Static and Dynamic PET/CT (HYPOTHESIS Generation Study)

The general purpose of this initial study is to evaluate whether parametric PET/CT improves diagnosis and treatment monitoring in select diseases. The specific aim of the HYPOTHESIS GENERATION study is:

1. To obtain and compare parametric as well as traditional static PET/CT images and determine the number of lesions identified on each type of scan.

The hypothesis generating study will include a wide range of patients scheduled for PET/CT as part of either pre-therapy staging or treatment response.

Most scans will be performed with FDG, with indications for PET/CT including hematological, urogenital, thoracic and gynecological malignancies as well as patients with suspected infections and inflammation. We will also include patients referred for PET/CT using other radiotracers, such as tumour markers (68Ga-DOTATOC, 18F-FDOPA, 68Ga-PSMA, 18F-PSMA).

Instead of the usual procedure of having the injection of the radiotracer in the waiting room and having to wait 60 minutes before being moved to the scanner room for imaging, the study participants will be injected with the radiotracer already laying on the scanner bed and the scan will commence immediately.

Therefore, in this study the patients are still only being scanned once, but we are gathering PET information in a different way.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a planned clinical standard PET/CT as part of pre-therapeutic staging, response assessment scanning or evaluation of infection/inflammation.
* Good performance status, which permits patients to lay still in the scanner for ca. 70 min.

Exclusion Criteria:

* Age \< 18 or \> 85 years
* Patients that can not tolerate a PET scan (f.ex: claustrophobia).