cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate SPI-1005 in Adults With Meniere's Disease

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo. During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing including electrocochleography will be performed at baseline, at the end of SPI-1005 treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will be performed over a 7-week period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12 months of study enrollment;
* Voluntarily consent to participate in the study;
* Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:

  * Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or
  * IUD in place for at least 3 months prior to study through study completion; or
  * Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or
  * Stable hormonal contraceptive for at least 3 months prior to study through study completion; or
  * Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
* Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.

Exclusion Criteria:

* Current use or within 90 days prior to study of ototoxic medications such as aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide);
* History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma;
* History of middle ear or inner ear surgery;
* Current conductive hearing loss or middle ear effusion;
* Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease;
* History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen;
* Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes;
* Participation in another investigational drug or device study within 90 days prior to study enrollment;
* Female patients who are pregnant or breastfeeding.
Acute Effects of E-Cigarette Aerosol Inhalation

This study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.

Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.

Eligibility Criteria:
Inclusion Criteria:

• BMI of 18.5 - 30

Exclusion Criteria:

* Cancer
* HIV
* Mental illness
* Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
* Serious arrhythmias
* Bronchospastic disease
* Upper respiratory tract infection within the past six weeks
* Chronic medication or antibiotics
* Claustrophobia / contraindications for MRI
Prazosin for Smoking Cessation

The most likely outcome of smoking cessation attempts is relapse, underscoring the need to advance novel treatments. Preclinical research shows that the noradrenergic system is critical for modulating drug-seeking behavior and recent findings indicate that the α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement. Presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. An efficient method for screening novel smoking cessation medications is to integrate human laboratory paradigms in the context of brief, randomized trials of smoking cessation that include smokers motivated to quit. This study aims to provide an initial test of prazosin for smoking cessation by implementing a brief, randomized trial that will include both human laboratory and clinical phenotypes. This approach will allow an efficient but sensitive method for medication screening that maximizes clinical validity.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 10 cigarettes per day for past year
* Baseline Fagerstrom Test for Nicotine Dependence (FTND) score of greater than or equal to four
* Willing to engage in two practice quit attempts
* Willingness to forgo other medication based treatments during the trial

Exclusion Criteria:

* Current illicit drug use
* Current treatment with psychiatric medications other than selective serotonin re-uptake inhibitors (SSRIs)
* Lifetime diagnosis of post-traumatic stress disorder (PTSD)
* Significant medical/neurological illness
* Baseline BP outside of normal range
* Current use of tobacco aids
* Current use of medications that could interact with prazosin
* Pregnancy or nursing
Use of 81 vs 325mg of ASA in Treatment of BCVI

Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.

Currently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.

This project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Diagnosed with BCVI via CT angiography (CTA) within 72 hours of injury at a Level I Trauma Center

Exclusion Criteria:

1. ≤18 years old
2. Known Pregnancy
3. Diagnosis of BCVI made based on imaging from another hospital (non-LTH)
4. Known pre-existing carotid/vertebral artery disease
5. Stroke on presentation/before BCVI diagnosis
6. Determined to require immediate surgical or interventional management of BCVI
7. Known allergy to ASA
8. Unable to consent OR absence of a Substitute Decision Maker (SDM)
Shock Indices Use for Early Mortality From Septic Shock

Background and Rationale:

Sepsis is a universal healthcare problem with a high incidence and mortality. Improvement in early sepsis recognition and management has reduced the 28 day- and in-hospital mortality in the last two decades. Mortality rates from sepsis ranges from 20% to 30% of which one-third occurs within 3 days of ICU admission.

Identifying patients with sepsis or septic shock who are at increased risk of early death can direct the priority of care for these patients and assist in predicting who is most likely to benefit from higher levels of care. In addition, this can encourage for direct future clinical trials to investigate new therapeutic interventions. Despite the large body of research on biomarkers (e.g. Serum lactate, interlukins) and clinical prediction tools (e.g. mSOFA score, APACHE II) for rapid risk stratification and in-hospital mortality of septic patients, the early identification of patients at increased risk for clinical deterioration remains challenging and the data on predictors of early death in septic patients remains deficient.

Persistently low MAP or DAP have been related to worse outcomes in septic shock, this was aggravated by the new-onset prolonged sinus tachycardia which occur as a result of sympathetic activity. This associated tachycardia has been linked to increased major cardiovascular events, prolonged length of stay and higher mortality rates The recent study by Ospina-Tascón et al. presented a novel index, the "diastolic shock index" (DSI), defined as the ratio of heart rate (HR) and diastolic arterial pressure (DAP). They studied the diastolic shock index relation to clinical outcomes in patients with septic shock. In their study, this index represented a very early identifier of patients at high risk of death within 28 days and 90 days after admission, while isolated DAP or HR values did not clearly identify such risk.

A few previous studies focused on the comparison between shock indices for prediction of sepsis outcomes and their results had a preference for DSI and MSI over SI.In this study we defined early mortality as that will occur within 3 days from admission or start of septic shock. This definition was based on previous works performed in patients with septic shock, for whom trends in organ failures during the first 3 days in the ICU were found accurate predictors of outcome .

However, almost no study focused on the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission. So, this study aims to fill this gap in the literature.

Objectives : to investigate the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission


Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>18 years) with septic shock

Exclusion Criteria:

* Age \< 18 years
* arrythmia
* History of ischemic heart disease
* cardiomyopathy
* pregnant women
* liver cirrhosis (Child B or C)
* renal impairment
* shock other than septic shock.
Efficacy and Safety of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir in HIV-Infected Patients

This trial is aimed at studying the antiviral activity, toxicity and pharmacokinetic (PK) interactions of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to HIV patients with multiple failure, under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir.

When licensed, new drugs are widely used in patients failing antiretroviral therapy, including patients with multiple failures. In such patients, having multi-resistant virus, the introduction of one new drug only in the salvage regimen will infrequently result in undetectable virus load in the plasma. Tenofovir DF and atazanavir appear promising because of their pharmacokinetic profile, activity, safety and resistance properties. In addition, pharmacokinetic data in healthy volunteers suggest that atazanavir could be optimized by adding ritonavir at low dose. Thus, one may speculate that atazanavir pharmacokinetic and antiviral activity could be optimized by adding ritonavir at low dose in patients exhibiting high rate of protease inhibitor mutations.

This protocol is aimed at studying the antiviral activity, toxicity and PK interactions, of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to patients with multiple failure, under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir.

EKG abnormalities (increased PR and QTc intervals) were observed in normal volunteers treated with atazanavir, therefore EKG safety monitoring will be performed on all subjects during this study

Eligibility Criteria:
Inclusion Criteria:

* Males and non pregnant females 18 years of age and older who have confirmed laboratory diagnosis of HIV infection and documented failure (plasma HIV RNA level over 10,000 copies/ml) to at least two protease inhibitors (ritonavir \[RTV\] must have been given at a dose over 400 mg twice a day (bid), in order to qualify for a protease inhibitor in this study) and one non-nucleoside reverse transcriptase inhibitor (NNRTI)
* Ongoing antiretroviral therapy at inclusion without change within the last month
* No threshold of CD4 cell count
* Patients naive of atazanavir and tenofovir DF

Exclusion Criteria:

* Cardiomyopathy
* QTc interval over 450 msec and pause length over 3 seconds on screening EKG
* Heart rate below 40 bpm
* Third degree heart block, and clinical symptoms potentially related to heart block
* Ongoing immunotherapy including IL2, interferon or HIV specific vaccine
* Ongoing opportunistic infection
CD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, We launch such a clinical trial using CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Leukemia and Lymphoma to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cell therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Diagnose as Relapsed and Refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
4. Evidence for cell membrane CD19 and CD22 expression；
5. All genders ，ages: 2 to 75 years；
6. The expect time of survive is above 3 months;
7. KPS\>60；
8. No serious mental disorders ;
9. Left ventricular ejection fraction ≥50%
10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
11. Sufficient renal function defined by creatinine clearance≤2 x ULN;
12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
13. With single or venous blood collection standards, and no other cell collection contraindications;
14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD；
5. The patients treatment by inhibitor of T cell；
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Why in Hospital After VATS Lobectomy

The study aims to identify specific or potential reasons that prolong the length of hospital stay after video-assisted thoracoscopic surgery lobectomy.

The hypothesis is that patients who are still in hospital after video-assisted thoracoscopic surgery lobectomy are associated with prolonged air leak, infection, pneumonia, atrial fibrillation or other complications or social factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to elective VATS lobectomy
* Speaks and understands Danish
* Informed consent obtained

Exclusion Criteria:

•Age \< 18 years
Bladder Cancer and ExeRcise Training During IntraVesical ThErapy

Bladder cancer is the fifth most common cancer in Canada and has the eighth highest cancer mortality rate. The treatment for the most frequent type of bladder cancer is surgically removing the tumour followed by six weeks of medication placed within the bladder. There are physical and psychosocial challenges from bladder cancer and its treatment that may affect how patients feel and function, and consequently their quality of life. Moreover, bladder cancer patients are at a high risk of their bladder cancer coming back and getting worse. Exercise is a low-cost intervention that may lower the chances of bladder cancer coming back or getting worse, manage side effects related to treatment, help patients feel better, and improve quality of life. To date, however, no study has examined if it is safe or even possible for bladder cancer patients to exercise when they are receiving drugs placed into their bladder. The Bladder cancer and exeRcise trAining during intraVesical thErapy (BRAVE) Trial will be the first study to test the safety, feasibility, and efficacy of exercise in bladder cancer patients during this drug therapy. The investigators will ask some patients to do a supervised exercise program during their drug treatment while other patients will be asked not to exercise. The investigators will compare the 2 groups on how they fare with their bladder cancer treatment. This study will provide information on whether exercise may help patients feel better, function better, and possibly even lower their chances of the disease coming back or getting worse.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will include men and women that (1) are ≥ 18 years old, (2) have a confirmed diagnosis of non-muscle invasive bladder cancer (clinical stage cis, Ta or T1), and (3) are scheduled to receive induction intravesical therapy with chemotherapy (e.g., Gemcitabine or Mitomycin) or immunotherapy (e.g., BCG) agents.

Exclusion Criteria:

* Exclusion criteria for participants include: (1) not being medically cleared to participate in the exercise intervention by their treating urologist and a certified exercise physiologist using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), (2) having contraindications for cardiopulmonary stress and/or physical fitness tests, (3) already exercising according to the Godin Leisure-Time Exercise Questionnaire (GLTEQ), (4) not having the ability to read and comprehend English, and (5) not willing to be randomized to a supervised exercise training program or usual care (no exercise) for 12 weeks.
Eszopiclone Treatment & Cortisol Responsivity

This study was designed to use a sensitive neuroendocrine probe, the Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults with insomnia. The primary aim was to assess cortisol reactivity before and after long-term (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone would result in a significant reduction in plasma cortisol response to the DEX/CRH test following treatment of insomnia with standard dose of eszopiclone.

see above

Eligibility Criteria:
Inclusion Criteria:

* Mild to Moderate Insomnia

Exclusion Criteria:

* Any acute or chronic medical condition involving function of HPA axis (e.g., Cushing's or Addison's Disease, adrenal or pituitary gland disorders)
* Currently taking, or unable to be free of, antidepressant, neuroleptic, anxiolytic, or thymoleptic drugs for at least 2 weeks preceding the DEX/CRH test (free of fluoxetine for at least 6 weeks)
* Current use of psychotropic medication or medication (prescribed or over the counter) thought to affect HPA axis function or glucocorticoid synthesis/release (e.g., prednisone, anabolic steroids, DHEA, ketoconazole, metyrapone)
* History of a significant adverse reaction to eszopiclone
* Meets DSM-IV criteria for any Axis I psychiatric disorder, including substance abuse presently, or substance dependence within the past 6 months
* Pregnancy, lactation, or unable/unwilling to use reliable methods of contraception during the study procedures
* Limited mental competency and the inability to give informed, voluntary, written consent to participate.
A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours

The purpose of the study is to evaluate the safety and biodistribution of \[I-124\]-CPD-1028 Injection in cancer patients with solid tumours.

Up to 18 adult participants will be enrolled in this Phase 1a study to evaluate the safety and biodistribution of \[I-124\]-CPD-1028 Injection in patients with Insulin-like Growth Factor-1R (IGF-1R) upregulated solid tumours. All eligible subjects who have given written informed consent and qualify based on the study's inclusion/exclusion criteria will be enrolled in the study. Each enrolled subject will take part in six visits consisting of a screening visit, an Investigational Product administration visit, 3 assessment visits involving 2-3 Positron Emission Tomography/Computed Tomography (PET/CT) scans, and a follow-up safety telephone call. At Visit 2, subjects will start a course of treatment to protect the thyroid from radioactivity and may receive a pre-targeting dose of an additional investigational agent, CPD-1061.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old with life expectancy \> 12 weeks with confirmed metastatic or unresectable malignancy
2. Patients must have progressed after at least first-line chemotherapy and have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1 or 2.
3. All patients must have archival tumour samples available and must have verification of IGF-1R expression.
4. Patients must have adequate organ and marrow function, vital signs and ECG.
5. Females of childbearing potential must not be pregnant and both males and females must use adequate forms of contraception.
6. Signed informed consent form
7. Subject must be compliant and have a high probability of completing the study.

Exclusion Criteria:

1. Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from previous treatment.
2. Patients who have received a therapeutic radiopharmaceutical in the past year or who are currently receiving any other investigational agents.
3. Previous treatment with IGF-1R inhibitors.
4. Patients who are currently taking antithyroid medications and lithium or potassium sparing diuretics.
5. Subjects with known or suspected allergies or contraindications to the investigational agents and iodine
6. Subjects with uncontrolled intercurrent illness
7. Female subjects who are pregnant, planning to become pregnant or are lactating and/or breast-feeding.
8. Patients with diabetes requiring therapy unless controlled through diet or metformin.
9. Subjects who are undergoing monitoring of occupational ionising radiation exposure.
10. Subjects with hypothyroidism requiring thyroid supplementation