cyrilzakka/clinical-trials huggingface dataset:
A Study of the PK Interaction of CXA-10 With Pravastatin and Vytorin® in Healthy Males

This is an exploratory study in a small, well controlled group of healthy subjects to explore the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and ezetimibe).

This is an exploratory study in a small, well controlled group of healthy subjects to explore the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and ezetimibe).

The overall design of the trial is to administer drugs that are metabolized through these transporters to quantify the impact CXA-10 may have on the exposure of these drugs.

The study will also examine the 24-h urine total creatinine excretion prior to and following administration of CXA-10 to examine the effects of CXA-10, if any, either directly on creatinine transporters or through enhanced creatinine production.

To reduce the potential variability in drug exposure levels, the study population will only include male subjects between 19 to 25 years of age.

Eligibility Criteria:
Inclusion Criteria:

* In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities for this population and may exceed the limits of the reference ranges, including hematology, clinical chemistry and urinalysis except as noted below.
* Resting HR greater than or equal to 45 beats per minute (BPM) after 5 minute rest at screening.
* QTcF interval must be less than or equal to 430msec at screening and pre-dose.

Exclusion Criteria:

* Any clinically relevant abnormality for this population identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study.
* Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations, personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason.
* Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements) within 7 days or 5 half-lives, whichever is longer, prior to dosing and until collection of the final PK sample.
* History of smoking, including e-cigarettes, or use of nicotine-containing products within 1 month of screening.
* Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study.
Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure

In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.

COVID-19 is a novel coronavirus that was initially outbreak in Wuhan, China. Severe acute respiratory infection with COVID-19 causes severe acute respiratory failure with substantial mortality. Currently, the standard care is supportive care, and no treatment is proven to be effective for this condition.

Glucocorticoid therapy is widely used among critically ill patients with other coronavirus infection such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). However, whether glucocorticoid improved the outcome of COVID-19 remains unknown. We hypothesized that glucocorticoid would improve the prognosis of patietns with COVID-19.

In this study, critically ill patients with COVID-19 were enrolled and randomized to receive ether standard care or standard care in combination with methylprednisolone therapy. The primary outcome is the difference of Murray lung injury score between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* PCR confirmed COVID-19 infection
* Symptoms developed more than 7 days
* PaO2/FiO2 \< 200 mmHg
* Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours
* Requiring ICU admission

Exclusion Criteria:

* pregnancy;
* patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent);
* Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease;
* Severe adverse events before ICU admission, i.e. cardiac arrest;
* Underlying disease requiring corticosteroids;
* Contraindication for corticosteroids;
* Recruited in other clinical intervention trial
Far Infrared Irradiation for the Management, Control and Treatment of Frontotemporal Dementia

Pick's disease, also known as Pick disease,or FTD is a rare fronto-temporal neurodegenerative disease. This study will investigate the use of far infrared radiation for the control, management and treatment of Pick's disease.

This disorder causes progressive destruction of nerve cells in the brain and causes tau proteins to accumulate into the "Pick bodies" that are a defining characteristic of the disease. Tau proteins are microtubule-associated proteins that are abundant in neurons in the central nervous system and are less common elsewhere.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have FTD.

Eligibility Criteria:
Inclusion Criteria:

* People with Pick's Disease

Exclusion Criteria:

* None
Antenatal Depression Help-seeking Trial in Eswatini

The goal of this trial to test if a web-based psychoeducation will work in improving depression help-seeking intention and behavior among antenatal women with probable depression in Eswatini. The main question it aims to answer is:

• Does the web-based psychoeducation improve depression help-seeking intention and help-seeking behavior in antenatal women with probable depressive symptoms?

Researchers will compare this web-based psychoeducation to a waitlist control, to see if the program works in improving depression help-seeking intention and behavior during pregnancy.

* The psychoeducation program will have a total of 4 sessions, which will be given to participants over a two-week period. two sessions will be delivered each week.
* Participants will be asked questions before the intervention starts, immediately the intervention ends as well as after a month of completing the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Less than 30 weeks of gestation,
* Aged 18 or above
* With probable depression (Edinburg Postnatal depression scale; EPDS \> 10)
* Has access to a smart phone
* Fluent in spoken and written Siswati or English (with at least secondary school education)
* Planning to remain in the country for the next 2 months
* Willing to share her dominant phone number with the study team
* Willing to participate in the intervention study

Exclusion Criteria:

* Antidepressants or other depression treatments
* Currently enrolled in another trial
A Pilot Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope

The purpose of the study is to compare the effect of acupuncture to the standard of care (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay in post-mastectomy patients at Abbott Northwestern Hospital.

About 40 subjects will be participating in this study. Following qualification for the study, participants will be randomly assigned by chance to receive either acupuncture or to receive the standard of care without an integrative medicine session.

* One group will receive acupuncture after surgery. Acupuncture involves inserting thin, sterile needles at certain points on your body.
* The other group will receive the standard of care without an acupuncture session.

Before surgery participants will complete a demographics questionnaire. After surgery, participants will be visited in their hospital room by either an acupuncturist or another member of the research team. For those assigned to the acupuncture group, participants will receive up to two sessions of acupuncture, at least twelve hours apart. For those assigned to the control group, a research team member will visit the participant in their room up to two times, at least twelve hours apart. During those visits, participants will be asked about pain, nausea, anxiety, and ability to cope at the beginning and end of each treatment or visit.

Additional information will be gathered from participants hospital charts, such as the type of surgery that was performed, length of hospital stay, and the costs associated with the hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Women
* 18 years or older
* Undergoing mastectomy surgery

Exclusion Criteria:

* Non-English speaking
* Pregnant
* Also undergoing an oophorectomy, TRAM or Latissimus flap surgery
Transbronchial Lung Biopsy Guided by ENB

The purpose of this study is to evaluate the performance and safety of electromagnetic navigation bronchoscopy (ENB) system and system kit (iLungTM SuperNavigator) .

This is prospective, randomized, multicenter, superiority study. 8 top centers in China was chosen. Subject which has peripheral lung lesions (PLLs) detected by chest CT scan, requires biopsy diagnosis, and meets all inclusion and exclusion criteria, will be included in this trial. Firstly physician determines the lesion biopsied, then the subject will be randomized to experimental or control group. The experimental group is treated with ENB guided transbronchial lung biopsy (TBLB)(ENB-TBLB): Under ENB guidance, the location sensor reaches the edge of the lesion, and X-ray is used for actual distance confirmation, if physician determines the distance is enough for biopsy, TBLB will be conducted. The control group will be treated with TBLB using X-ray guidance.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older;
* Subject presents with PLL(s) detected by chest CT scan and biopsy diagnosis is needed;
* Subject is willing to receive bronchoscopy voluntarily, and meets relevant requirements;
* Subject or their guardian understands the purpose of this trial, and willing to participate in the trial voluntarily and sign Informed Consent Form (ICF).

Exclusion Criteria:

* Subject has participated in a drug or device study (drug study within 3 months or device study within 1 month);
* Female subject who is pregnant or nursing;
* Allergic to anesthetic;
* Bronchoscopy contraindications, include: Active hemoptysis; Newly developed myocardial infarction or unstable angina attack; Severe cardiac and pulmonary dysfunction; Severe hypertension and arrhythmia; Uncorrectable bleeding tendency (Such as severe clotting dysfunction, uremia, and severe pulmonary hypertension, etc.); Severe superior vena cava obstructive syndrome; Suspected aortic aneurysm; Multiple lung bullae; Extremely exhausted systemic conditions;
* Subject with serious lung disease (Such as: severe bronchiectasis, severe emphysema, etc) ,which investigator considers not appropriate for this examination;
* Subject with implanted pacemaker or defibrillator;
* Lack of patient cooperation for bronchoscopy, such as patient with mental disorders, dysgnosia, psychological disorder etc;
* Conditions investigator considers not appropriate for this trial.
Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"

To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.

This is a special drug use surveillance with an observation period of 12 months designed to investigate the safety and efficacy of pioglitazone (Actos) in the routine clinical setting in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy (planned sample size, 1000).

The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 45 mg.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
2. Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
3. Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment

Exclusion Criteria:

1. Patients who have received Actos Tablets within the past 3 months.
2. Patients who started treatment with biguanides and Actos Tablets simultaneously
3. Patients who discontinued biguanides and switched to Actos Tablets treatment.
4. Patients who received additional biguanides after the start of Actos Tablets treatment
5. Patients with contraindications to Actos Tablets treatment
Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk

This study seeks to develop an explanatory framework for breast MRI utilization to inform future interventions. The Health Services Utilization Model (HSUM) will guide the selection of specific participant-level factors for examination, including predisposing characteristics (knowledge, health/cultural beliefs), enabling resources (social support, cost/insurance coverage), and perceived need (perceived susceptibility, provider recommendation).


Eligibility Criteria:
Inclusion Criteria:

* Ability to speak/read English
* Within 2 years of last screening mammogram
* Pathogenic BRCA1/2 mutations OR estimated lifetime risk ≥20% per the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool (BCRAT)

Exclusion Criteria:

* Women who have received a prior diagnosis of breast cancer
A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer

The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.

Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.

In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 75 years with histologically proven NSCLC
* No severe major organ dysfunction
* WHO performance status of 0 or 1
* No prior cancer chemotherapy
* A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.

Exclusion Criteria:

* Age ≥ 76
* Severe major organ dysfunction
* WHO performance status of \>1
* Prior cancer chemotherapy
* Stage IV
Effect of Simethicone on Eustachian Tube Dysfunction

This study is designed to measure the effects of a chewable Simethicone tablet taken by mouth on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear pressure. In children and adults, middle-ear diseases such as otitis media (the buildup of fluid within the middle ear) and a form of temporary hearing loss occur if the Eustachian tube does not open, does not open often enough or is always open. Simethicone, available over-the-counter under several brand names including Gas-X, may help break up the bubbles that may block the opening of the Eustachian tube in the back of the nose during a cold, allowing air to pass between the nose and middle ear. This study requires a single visit to the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If eligible for the study, Eustachian tube function testing will be done; the Simethicone tablet or placebo (a tablet that looks and tastes like the Simethicone tablet but has no active ingredient) will be given and Eustachian tube function testing repeated.

For the Eustachian tube function testing, the subject and a technician are seated comfortably within a pressure chamber, a room-like chamber in which the air pressure can be varied much like in an airplane or submarine. Middle ear pressure will be measured in each ear by tympanometry, a test done by inserting a small probe (an earplug attached to a rubber or plastic tube that measures ear pressure) half-way into the ear canal and changing the pressure in the probe. Then, microphones will be placed in the ear canals and a sound source placed into one nostril. The chamber pressure is then decreased and increased to various pressures and middle ear pressure is measured at these various pressures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50 years
* Healthy subjects other than current upper respiratory tract infection ("cold")
* Jackson Score of 6 on screening
* Subject reports symptom onset within 4 days of entry visit
* Unilateral or bilateral middle-ear pressure \<-50 mmH2O

Exclusion Criteria:

* Otoscopic diagnosis of unilateral or bilateral otitis media
* Presence of tympanostomy tubes or tympanic membrane perforations bilaterally
* Asthma or any chronic medical disease or condition
* Use of an "over the counter" medicine within 24 hours of study or prescription within 4 weeks of the study day (except birth control)
* Use of an experimental drug within 3 months of study
* An unusual or allergic reaction to simethicone, food dyes, or preservatives
* Pregnancy or breast feeding
* Ear surgery other than tympanostomy tube insertion
Validation Study of the Feasibility of an Integrated Diagnostic System of Anatomo-pathological Lesions - Including Rejections - Appearing in Renal Grafts in the First Year of Transplant for Applicability in Routine Clinical Practice : KTD Innov-2 Study

The main objective of the present study (KTD Innov-2) is to validate the feasibility of SDI within a limited time frame to ensure its clinically relevant use, with a high level of evidence to consider its labelling as a medical device by health authorities prior to routine transfer and/or future marketing.


Eligibility Criteria:
Inclusion Criteria :

* Male and female patients, age ≥ 18 years at time of transplantation.
* Patients with a minimum weight of 40 kg in order to allow blood samples to be taken safely in accordance with the table published in the Order of 12 April 2018 setting the list of research mentioned in 3° of Article L. 1121-1 of the Public Health Code.
* Patients receiving a kidney transplant from a living or brain-dead donor.
* Patients expressing their non-opposition and ready to comply with the study procedures.

Exclusion Criteria :

* Patients who have received a previous transplant with an organ other than the kidney
* Patients unable or unwilling to perform study procedures or who do not speak French
* Vulnerable patients (minors, adults, pregnant women, under guardianship)
Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

Current evidence on tapering of tumor necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) is still hampered by heterogeneity in tapering regimens, selection and performance biases, and lack of data on optimized treatment dosing strategies especially in real-world clinical settings. This study aims to contribute to the ongoing investigation of disease-activity-guided tapering of TNFi in axSpA in the form of a prospective, randomized controlled trial.

This is a 48-week randomized, controlled, open-label, non-inferiority trial of patients with radiographic or non-radiographic axial spondyloarthritis. The study will include 156 patients with inactive disease or low disease activity (LDA) for at least 6 months on a TNFi at the time of randomization.

Participants will be randomized using a 1:1 ratio to either the tapered-dose arm or the standard-dose arm of TNFi. Progressive tapering of TNFi according to a predefined protocol will be allowed as long as the patient is able to maintain inactive disease or LDA during the study period. We hypothesize that, in patients with 6 months or more of inactive or low-activity axial spondyloarthritis, tapered-dose TNFi are non-inferior to standard-dose TNFi in sustaining the disease state for at least 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Adult axSpA patients satisfying the 2009 Assessment of SpondyloArthritis International Society (ASAS) Classification Criteria
* Currently enrolled in the SPARCC Program with successful completion of standard data collection protocol in the Spondylitis Clinic of UHN-Toronto Western Hospital
* Have sustained inactive disease or LDA with an ASDAS of \<2.1 or BASDAI \<4 for at least 6 months
* On a stable dose of a TNFi (infliximab, etanercept, adalimumab, certolizumab pegol, or golimumab)
* Must not be pregnant

Exclusion Criteria:

* Adults axSpA patients with active extra-articular manifestations such as inflammatory bowel disease, psoriasis, and/or uveitis
* Have comorbidities that may preclude clinical assessment (i.e. fibromyalgia or other chronic pain syndromes; chronic inflammatory diseases other than axSpA)
* Have diagnosed psychiatric or personality disorders
* Pregnant
* Not enrolled in the Spondyloarthritis Research Consortium of Canada (SPARCC) Program