cyrilzakka/clinical-trials huggingface dataset:
Noise Exposure and Near-Infrared Light

The primary objective of this work is to determine the effect noise has on the auditory system (both auditory health and performance) and also the degree to which the effect of pre-noise therapy such as Near Infrared (NIR) light can mitigate the effects of noise exposure.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old, male or female
* Pass hearing exam with a threshold of 25 decibels (dB) hearing or less, for each ear, for all frequencies tested from 500 Hz to 8000 Hz
* Normal otoscopic exam, otoacoustic emissions (OAEs), and middle ear function as demonstrated by a normal tympanogram
* Completion of a hearing history questionnaire

Exclusion Criteria:

* Screening hearing test failure
* Pregnant females
* Adults unable to provide consent
* History of significant ear surgery
Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature

The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).

The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects over 22 years of age
* Ability to provide signed informed consent, and/or have a legally authorized representative (LAR) willing to provide informed consent on behalf of the subject
* ESI score of 3-5

Exclusion Criteria:

* Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure
* Recent immunization within seven days of the study procedure
* Pregnancy
* ESI score of 1-2
Guided Self-help for Anxiety - a Patient Preference Trial

Supporting patients in exerting choice over their treatment is a central aspect of modern healthcare. In Improving Access to Psychological Therapies (IAPT) services, then patients treated at step 2 are only and always offered cognitive-behaviourally informed guided self-help (GSH), when they are deemed suitable for treatment at step 2 of IAPT services (termed CBT-GSH). Step 2 interventions are guided self-help (GSH) delivered by Psychological Wellbeing Practitioners (PWPs). Recently, a new type of GSH has been developed and found to be feasible and effective in IAPT services - this is called cognitive-analytic guided self-help (CAT-GSH). This research aims to test the efficacy of CAT-GSH by comparing outcomes over time achieved in both types of GSH and interviewing participants about their experience of the GSH. The methodology to support patient choice is a patient preference trial. In this method, then patients that meet inclusion criteria for the trial are offered and choose between either CAT-GSH and CBT-GSH. Those patients that are unconcerned with the type of treatment are randomised to either CAT-GSH or CBT-GSH. The primary outcome measure is the Beck Anxiety Inventory. No changes to the standard practice of the PWPs will occur during the trial, the trial will be situated in a standard IAPT service and be a therefore conducted in a routine practice setting.


Eligibility Criteria:
Inclusion Criteria:

* patients have self-referred or been referred by their GP or other health or social care professional for a step 2 intervention for treatment of a common mental health problem,
* patients meet criteria for an anxiety disorder on MINI screening interview assessment and also met caseness on the BAI (as defined by a score of \>10 on the BAI at assessment).
* Patients want to engage in GSH to address the anxiety disorder
* patients are motivated to engage in treatment and can attend six sessions of face-to-face GSH.

Exclusion Criteria:

* engaging in any another IAPT step 2 interventions.
* Do not meet criteria for an anxiety disorder as defined by the MINI and the BAI score.
* Meet criteria for depression and a comorbid anxiety disorder, as identified by the BAI and MINI, where the depression is more severe and is the patient's main concern.
* Have a severe/chronic mental health problem and are already involved in psychiatric or secondary care mental health services.
* Have substance misuse issues that would interfere with engagement with the GSH.
* Have a diagnosed learning disability that precludes engagement in GSH.
* Have a diagnosis of social phobia or PTSD
Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease

Determine how much voriconazole is absorbed when the product is given by mouth to children with extensive graft versus host disease after a stem cell transplantation and determine the correct dosing of voriconazole in this population.

Hypothesis: Children with gastrointestinal graft versus host disease will have decreased absorption of oral voriconazole and require higher doses of voriconazole in order to prevent or treat fungal infections.

Disseminated fungal infections are a leading cause of mortality in children who receive hematopoietic stem cell transplantation (SCT). Therefore, children routinely receive prophylactic and empirical antifungal therapy after SCT. The most commonly used antifungal agent in this population is voriconazole. Voriconazole can be given via intravenous or oral routes and children who are post SCT are routinely switched from the intravenous to oral formulation at the time of hospital discharge. However, the absorption and systemic exposure of oral voriconazole has not been well-described in children. Furthermore, many children who undergo transplantation develop gastrointestinal graft versus host disease and this likely impacts oral absorption. The magnitude of effect resulting from graft versus host disease on absorption of voriconazole and subsequent blood concentrations in children is unknown. Thus children with graft versus host disease are at a particularly high risk of inadequate absorption with subsequent sub-therapeutic levels of voriconazole. They may need higher or more frequent dosing to achieve therapeutic levels. The purpose of my research project is to define the pharmacokinetics of oral voriconazole and establish dosing guidelines in children following SCT.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 18 years, sufficient venous access to permit administration of voriconazole, ability to take oral medications, written informed consent provided by the parent or legally authorized representative, and Grade II or higher (extensive) gastrointestinal graft versus host disease for those patients in the graft versus host disease patient subset.

Exclusion Criteria:

* History of anaphylaxis attributed to voriconazole or other triazole compounds, any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study, or previous participation in this study.
A Research Study Looking at How the Medicine NNC0385-0434 Works in the Body of Healthy Japanese Men

The aim of this study is to look at how the study medicine works in the body and how it is removed from the body.

We are testing the study medicine to make a medicine that can help people lower their cholesterol level.

Participants will either get

1. NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg.
2. placebo (a dummy medicine which looks like the study medicine but without any medicine).

Which treatment participants get is decided by chance. NNC0385-0434 is a new medicine and has not been approved by the Health Authorities (Centre for Drug Evaluation).

Participants will get 1 tablet per day for 10 days. The tablet will be handed out by a study doctor or site staff at the clinic and the study will last between 62 and 98 days.

Participants will have 7 clinic visits. One of these visits will be a 13-day, 12-night stay (V2) and the rest will be 1-day visits (V1 and V3 to V7).

At all visits, except the information visit, participants will have blood drawn along with other clinical checks.

Participants will be asked about their health, medical history and habits including mental health.


Eligibility Criteria:
Inclusion Criteria:

* Body weight greater than or equal to 54.0 kg.
* Body mass index (BMI) between 20.0 and 34.9 kg/m\^2 (both inclusive).

Exclusion Criteria:

* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
A Study to Assess the Efficacy of WSD0922-FU in Patients with C797S+ Advanced Non-small Cell Lung Cancer

This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.

WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.

Eligibility Criteria:
Inclusion criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
* Male or female aged ≥18 years old.
* Histological or cytological confirmation diagnosis of NSCLC.
* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
* Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
* Documented EGFR mutation .
* Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.
* At least one lesion, not previously irradiated and not chosen for biopsy during the study.
* Females should have evidence of non-childbearing potential.

Exclusion criteria:

* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
* Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
* Symptomatic brain complications that require urgent neurosurgical or medical intervention.
* Any evidence of severe or uncontrolled systemic diseases.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
* Past medical history of ILD.
* Inadequate bone marrow reserve or organ function as demonstrated.
* Males and females of reproductive potential.
* Known intracranial hemorrhage which is unrelated to tumor.
* Seizures requiring a change in anti-epileptic medications.
Analysis and Evaluation of Smoking Treatment With Cytisine

The lack of clinical studies on the use of Cytisine in the treatment of the cessation of smoking, the need to find effective therapeutic alternatives and the opportunity to reduce costs related to the complications of cigarette smoking, represent the main reasons that led to the design of this study.

The study is observational, retrospective and monocentric, and aims to evaluate patients who performed an initial pneumological examination at the Anti-Smoking Center of the National Institute Regina Elena tumors due to smoking cessation in the reference period. To such patients, affected of moderate or severe tobacco use disorder, drug therapy was prescribed with Cytisine 1.5 mg, with the aim of evaluating treatment adherence, efficacy and tolerability of Cytisine as monotherapy in the treatment of moderate or moderate tobacco use disorder serious. Responding patients will be taken into consideration for the study consecutively to the criteria established and pertaining to the Anti-Smoking Center of the National Cancer Institute Regina Elena in the period between 02/01/2023 and 11/30/2023 on first and subsequent visits controls.

Eligibility Criteria:
Inclusion Criteria:

* patients aged \> 18 years;
* patients suffering from moderate or severe tobacco use disorder;
* prescription of pharmacological therapy with Cytisine;
* patients returned to the 1st check-up on schedule;

Exclusion Criteria:

* Patients with contraindications to taking Cytisine and partial receptor agonists nicotinic cholinergics;
* Patients undergoing pharmacological or physical treatment for neoplastic pathology;
* Pregnant or breastfeeding women;
* Patients for whom specific information for objective assessments is not available;
Microbiome in Lung Cancer and Other Malignancies

To characterize the fecal, skin, nasal and oral microbiome and metabolome in patients with lung cancer and other malignancies, and correlate to treatment response and toxicities of various therapies including immunotherapy, chemotherapy and targeted therapy, etc.

Patients will be asked to provide nasal, oral and skin swabs, as well as stool samples during their regular clinic visits, at the baseline before desired therapy is given, and at the time when treatment is changed due to either disease progression or unbearable toxicities leading to treatment stop/change. If treatment stop/held is due to toxicities, a 3rd set of samples will be collected when toxicities reduce to less than grade 1. The samples will be subjected to DNA extraction followed by 16S rRNA and/or shotgun sequencing metagenomic analysis. The data will be correlated to clinical response from treatments, toxicities, clinical data (use of antibiotics, PPIs, lab parameters, etc.) and tissue genetic/immunological characteristics (mutations, PDL1 expression, etc.) for review of response. This is not data to be used for treatment of these subjects.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with lung cancer and other malignancies who are candidates for systemic therapies such as immunotherapy and chemotherapy

Eligibility criteria for studying microbiome in patients receiving immunotherapy:

* Patients with advanced/recurrent lung cancer (including both NSCLC and SCLC) and other solid tumors of our study interest (e.g. GU cancer and melanoma, etc.) that initiate a new line of immunotherapy (can be 1st or later line), either alone or in combination with chemotherapy, targeted therapy or other immunotherapy.
* Patients can be in other clinical trials as long as they meet criteria 1.
* Prior treatment with immunotherapy is acceptable as long as criteria 1 is met. For example, a new line therapy with pembrolizumab plus pemetrexed after failing pembrolizumab is considered eligible.
* Patients who are to start immunotherapy maintenance after chemoradiation therapy are eligible (e.g. NSCLC patients who will be on durvalumab maintenance)
* Patients who are to start immunotherapy after local therapies (e.g. radiation, ablation, etc.) are eligible.
* Immunotherapy must have component of anti-PD-1/PD-L1 agents (e.g. nivolumab, pembrolizumab, atezolizumab, durvalumab and avelumab, etc.) or anti-CTLA4 (e.g. ipilimumab)

Exclusion Criteria:

* Patients \< 18 years of age
* Patients that are pregnant
* Patients taking more than 2 alcoholic drinks per day and those using non-medical drugs such as marijuana, cocaine, heroine, etc.
A Prospective Observational Study to Evaluate the Quality of Life and the Costs in a Real Life Setting in Patients Who Are Treated With 90Y-Zevalin

The objective of this study is to compare hematological toxicity, costs, health-related quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement on the basis of a clinical trial in heavily pre-treated NHL.


Eligibility Criteria:
Inclusion Criteria:

* Advanced cancer of the lymph nodes of follicular type at study inclusion
* The patient has relapsed or has refractory disease, after previous treatment with rituximab
* Treating physician has decided to treat the patient with a 90Y-Zevalin regimen
* The patient is \>= 18 years of age
* Patient has given informed consent

Exclusion Criteria:

* Patient is unwilling or unable to give informed consent
* Patient is participating in another clinical trial
Nefazodone in the Treatment of Social Phobia

The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).

The purpose of this study is to examine the efficacy of the 5HT2 receptor antagonist nefazadone in SAD, and to explore regional cerebral blood flow in patients with SAD when confronted with a personal phobic stimulus, using positron emission tomography (PET). Changes in cerebral blood flow were correlated with self-rated anxiety measures.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of generalized social anxiety disorder, males and females between the ages of 18-65

Exclusion Criteria:

* A history of bipolar disorder, psychotic illness, or any other anxiety disorders, organic brain disease or active drug or alcohol abuse within one year as assessed by the SCID-P and interview, or a concurrent medical condition that would not be compatible with the study in the opinion of the principal investigator. Patients required to be free of psychotropic or beta-blocker medication for 2 weeks prior to study. Pts taking fluoxetine required to be drug-free for 6 weeks.
Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer

This is a randomized phase II study, aimed at evaluating the efficacy (through progression free survival at 6 months) and safety of 5 different treatments involving atezolizumab, bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian cancer patients in order to select the optimal treatments for further development in Phase III.


Eligibility Criteria:
Inclusion Criteria:

Recurrent, histologically proven, platinum-resistant, epithelial ovarian, fallopian tube and primary peritoneal cancer in advanced or metastatic stage. Histological diagnosis by image guided biopsy, laparoscopy or laparotomy. Tumors diagnosed on cytology only and borderline tumors are excluded.

At least one lesion accessible to biopsy without putting patient at risk

WHO PS: 0-2 for patients having received no more than two previous lines of therapy. WHO PS: 0-1 for patients having received \>2 previous lines of therapy

Prior chemotherapy or bevacizumab:

Any number of platinum-based chemotherapy lines are allowed but a maximum of 2 previous non-platinum containing lines

Prior treatment with bevacizumab or other targeted agents against Vascular Endothelial Growth Factor (VEGF) or VEGF receptor is allowed, but at least 18 weeks must have elapsed since their last administration

Eligible patients with ≤ 2 previous treatment lines must have been previously exposed to bevacizumab or other targeted agents against VEGF or VEGF receptor

Patients may have had prior therapy providing the following conditions are met:

Radiation therapy: wash-out period of 14 days prior to the first study treatment; exception: single fraction radiotherapy with the indication of pain control

Systemic anti-tumor therapy: wash-out period of 21 days prior to the first study treatment

Recovery from any toxic effects of prior therapy to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) except fatigue or alopecia.

Exclusion criteria:

Age \<18 years

Life expectancy of \< 12 weeks

No adequate hematologic and end organ function

Use of acetylsalicylic acid, NSAIDs or other COX-2 inhibitors that cannot be stopped at baseline and for the whole duration of the study.
Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

The purpose of this research study is to perform serial magnetocardiographs (MCG)and cardiovascular risk factor assessments on individuals with no symptoms or history of heart disease. This small sized study of MCG in healthy individuals will allow for data collection for power analysis for a larger prospective trial.

Volunteers are not compensated or paid.

The Magnetocardiography (MCG) has been approved by the U.S Food and Drug Administration (FDA) as a tool to measure the heart's magnetic field.However, it is not yet approved for the specific diagnosis of coronary artery disease.

The MCG scan is entirely non-invasive, rapid and no risk, since it does not require stress provocation, radiation, or use of medication or contrast.

In this study, the MCG will be used to compare the scans of normal, healthy volunteers to those which have been previously or are currently being collected in subjects with known heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects without chest pain and known heart diseases.
* Subjects \> or = 18 years of age.

Exclusion Criteria:

* Heart disease patients
* Patients with chest pain
* Subjects with magnetic metal fragments in the head or torso
* Subjects unable to consent
* Minors \< 18 years of age
* Subjects unable to lie flat for the examination
Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery.

Abdominal surgery is usually associated with severe postoperative pain. The transverse abdominal plane (TAP) block is considered an effective means for pain control in such cases. The quadratus lumborum (QL) block is another option for the management of postoperative pain.

The aim of this study is to evaluate the efficacy and safety of quadrates lumborum blocks and Transversus abdominis plane blocks for pain management after abdominal cancer surgery.

Postoperative pain is severe in patients undergoing abdominal surgery, and severe pain not only affects the rate of recovery of patients but also induces a series of pathophysiological reactions. Therefore, it is very important for perioperative patients to have a safe and effective pain management model. Although classic postoperative analgesia methods can provide effective pain relief after surgery, their administration has a well-defined risk of side effects. Recently, with the rise in enhanced recovery after surgery, nerve blocks have become the key link in multimodal analgesic regimes.

As effective constituents of multimode analgesia, quadratus lumborum (QL) block and transversus abdominis plane (TAP) block are mainly used for postoperative analgesia in abdominal surgery.

Aim of this study is to compare between the analgesic effecacy of quadrates lumborum block and transverses abdominal plane block

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the study, aged 20-60 years,
* with ASA Physical Status Class I and II,
* scheduled for abdominal cancer surgery under general anesthesia

Exclusion Criteria:

* infection at injection site,
* allergy to local anesthetics,
* coagulation disorders,
* physical or mental diseases which could interfere with the evaluation of pain scores
* kidney failure or liver failure.