cyrilzakka/clinical-trials huggingface dataset:
Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)

This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* Is at least 50 years old
* Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or higher
* Has a QoL score of 3 or higher
* Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec
* Has a PRV of below 100mL
* Voluntarily decides to participate in this trial and sign with informed consent form

Exclusion Criteria:

* Has been administered silodosin
* Has been administered an α1A-adrenoceptor blocker within one month
* Has been prescribed antiandrogens except 5α-reductase inhibitors within a year
* Has had phytotherapy within 3 months
* Has had prostatectomy
* Has had intrapelvic radiation therapy
* Has had transurethral microwave hyperthermia of transurethral needle ablation
* Is suspected to have implications that are likely to affect urine passing such as neurogenic bladder, bladder calculus or active urinary tract infection (UTI).
* Is conducting self-catherterization
* Has a renal impairment with a serum creatinine of 2.0mg/dL or greater
* Has severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or has a total bilirubin of 2.5mg/dl or higher or has AST/ALT 2.5 times higher than the normal (upper) level
* Has suffered from a severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
* Has experienced allergy to α1 receptor blockers
* Has orthostatic hypotension around the time of Screening Visit
* Has participated in other clinical trials within 8 weeks prior to Screening Visit
* Has a Prostate specific antigen(PSA) of higher 10ng/mL or has been diagnosed with tumor identified by a biopsy even though he has a PSA of lower 10ng/mL (Patient who has been administered 5α-reductase inhibitors for more than 3 months are presumed to have 2 times higher than their actual PSA levels)
* Has been taking unstable dosing of 5α-reductase inhibitors like finasteride or dutasteride for the past 3 months or is expected to change the dosage during the trial.
To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom

30 untreated IgG4 related disease (IgG4-RD) patients with mild symptom are enrolled in this study, and will be treated with one dose of diprospan,then take Iguratimod 25mg, Bid orally. Patient's peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up. The clinical efficacy will be evaluated by the IgG4-RD responder index, serum immunoglobulin, IgG4 and IgE, cytokines, and peripheral blood T cell and B cell sub-populations will be measured at baseline and follow up.

Glucocorticoid is the recognized first-line medication for IgG4-RD, but it has many side effects. In order to avoid long time glucocorticoids intake, patients with mild disease will be treated with Iguratimod combined with one dose of diprospan. 30 untreated IgG4-RD patients with mild symptom will be enrolled in this study, and be treated with one dose of diprospan,then take Iguratimod 25mg, Bid orally. 5 ml of patients' peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up. At baseline and each follow-up, the clinical efficacy of treatment will be evaluated by IgG4-RD responder index, serum immunoglobulin, IgG4, immunoglobulin E (IgE), serum cytokines, such as interleukin 1, 6, and tumor necrosis factor, will be measured by ELISA, peripheral blood T cell sub-populations, B cell sub-populations and plasma cells will be measured by flow-cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Mikulicz disease, with/without nasosinusitis or lymph node swelling.
* Without internal organs affected,
* With slow disease progression.

Exclusion Criteria:

* Vital organs related:including autoimmune pancreatitis,retroperitoneal fibrosis, sclerosing cholangitis, lung related, kidney affected, IgG4 related castleman's disease and hypophysitis，
* Combined with other connective disease,
* With tumors,
* Pregnancy or to be pregnant,
* Active infection, including hepatitis B virus, hepatitis C virus, and tuberculosis.
* Leucocytopenia, impairment of liver and kidney function,
* Allergy of Iguratimod, or cannot tolerate Iguratimod.
Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil

Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on the determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators have demonstrated a significant and clinically relevant increase in CO and cerebral tissue oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more usual clinical practice of administrating classical vasoactive medication such as phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and SctO2. In previous research the investigators used standardized target controlled propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known that remifentanil has more intense haemodynamic side-effects compared to other opiates such as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid during anaesthesia of propofol combined with other opiates such as sufentanil.

Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep general anaesthesia, which is usually performed with the combination of drugs as mentioned above. Because these patients often experience severe haemodynamic fluctuations they need to be closely monitored.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years and older.
* Elective CABG surgery performed off-pump.
* Written informed consent to participate in this study.
* Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

Exclusion Criteria:

* Refusal to participate in this study.
* Age: younger than 18 years.
* Pregnant.
* BMI \> 35 kg/m2.
* Patients in which atropine is contra-indicated.
* Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.
* Urgent or emergency surgery.
Skin Cancer Screening Education Study

The overall aim of this population-based screening study is to assess whether the skin cancer screening training of family physicians and dermatologists leads to improved screening outcomes. The training course aims to increase the accuracy of detecting early stages of skin cancer. Screening outcomes of an intervention region (Calgary, Canada) in which physicians receive training will be compared with screening outcomes of a control region (Edmonton, Canada) where no physician training is administered.

The investigators will determine whether:

* clinical screening outcomes are more favorable in the group of trained physicians compared to non trained physicians
* there is an increase of knowledge about skin cancer screening among trained physicians, compared to non trained physicians
* skin cancer screenings are associated with psycho-social harms
* population-based screening has an effect on the overall incidence and stage-specific-incidence of skin cancer in Alberta

The investigators are aiming to recruit 100 physicians per region (total of 200 physicians) who will screen 40,000 to 80,000 individuals over a period of 20 months.


Eligibility Criteria:
Inclusion Criteria:

1. Screenees

   * Male and female residents of Alberta mainly living and receiving care in Edmonton or in Calgary
   * Age 20+
   * English-speaking
   * Individuals who consent to participate
2. Physicians

   * Registered dermatologists and family physicians administering care either in Edmonton or in Calgary
   * English-speaking
   * Physicians who consent to participate

Exclusion Criteria:

Physicians who have undergone special training in skin cancer screening within the last 2 years
Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting for Actively Smoking Family Members

The purpose of this pilot study is to examine, in an innovative setting, the potential for a lung cancer diagnosis in a loved one to represent a teachable moment for smoking cessation in family members or caregivers who are current smokers. The researchers will identify the willingness and preferred modality for smoking cessation among family members/caregivers in this setting. The researchers will estimate abstinence rates at 4, 8, 12, and 24 weeks..


Eligibility Criteria:
Patient Inclusion Criteria:

1. patient with newly diagnosed lung cancer within the last 6 months of initial diagnosis/confirmation of diagnosis at the study sites
2. Able to provide informed consent
3. Able to speak and read English

Family Member/Caregiver Participant Criteria:

1. Family member or caregiver (defined as first degree relative \[parent, sibling, child\] or person living in the same household)
2. Family member or caregiver must be a current, active smoker (defined as 10 cigarettes per day for 6 consecutive months).
3. At least 18 years of age at time of study consent
4. Able to provide informed consent
5. Able to speak and read English

Exclusion Criteria:

1. Currently receiving formal tobacco dependence treatment- Nicotine replacement of any kind, varenicycline or Bupropion.
2. Medical condition that precludes proposed pharmacotherapy for smoking cessation : Recent (≤ 2 weeks) myocardial infarction , history of underlying arrhythmias , history of serious or worsening angina pectoris, pregnancy and breastfeeding
A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer

Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.

All patients on this study will receive 4 intravenous injections of the chemotherapy drugs pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who complete 4 such injections and respond well to their treatment may continue to receive an injection of chemotherapy drug pemetrexed (approximately every 3 weeks). In general terms, treatment will last until either the patient or the doctor decides that there is no clear benefit in continuing with the treatment.

TS levels will be measured from the tumour sample used to make the original diagnosis of NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have Stage 3B or 4 Non-Small Cell Lung Cancer of the non- squamous type
* Patients must at least be able to be physically mobile, take care of yourself and be able to perform light activities such as light housework or office work
* Patients must not have had previous chemotherapy treatment for lung cancer
* Patients must not have had radiotherapy in the last 30 days
* Patients must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computed tomography (CT) scan
* Patients' test results assessing the function of their blood forming tissue, kidneys, liver and lungs are satisfactory
* Women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception

Exclusion Criteria:

* Patients cannot have received other investigational drugs within the last 30 days
* Patients cannot have any serious, uncontrolled medical condition that might compromise their ability to take part in the study safely
* Patients cannot have a current second primary malignant tumor
* Patients cannot be having current treatment with any other anti-tumor therapy
* Patients cannot have had a yellow fever vaccination within 30 days of enrolment
* Patients who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
* Patients who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
* Patients who are pregnant or breastfeeding
Minimal Residual Disease Evaluation on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation.

This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with AML
* At least one molecular marker identified at AML diagnosis
* Patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation.

Exclusion Criteria:

* Other diagnostic
* No marker available at AML diagnosis
* No bone marrow/ovarian fragment available at the time of complete remission
Evaluation of Whether Functional Strength Training Can Enhance Recovery of Mobility After Stroke

The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy

Neuromuscular weakness occurs frequently after stroke and the processes underlying recovery are still poorly understood. Accepted practice in UK physiotherapy is to avoid training of muscle strength after stroke but there is preliminary evidence that it might be effective.

An observer-blind randomised clinical trial. Subjects will be within 3 months of first stroke with some voluntary movement in the paretic lower limb. A power calculation estimated the sample size as 300. Research Physiotherapists, blinded to measurement, will recruit subjects, allocate subjects to one of the three intervention groups using sequentially numbered sealed envelopes containing previously randomised allocated intervention cards and provide interventions. The Research Assessors, blinded to intervention allocation will undertake all measurements. Conventional therapy (control) will be provided as normal for the clinical setting, the additional conventional therapy (experimental 1) or functional strength training (experimental 2) will be provided for one hour, four times a week, for six weeks. Subjects in the two experimental groups will also receive the conventional therapy standard in their clinical setting. Blinded measurement will be made before randomisation, at the end of intervention and 12-weeks thereafter. Primary outcomes are maximum torque around the knee joint, and gait velocity. The secondary outcomes include movement analysis, functional ability, corticospinal transmission (transcranial magnetic stimulation) and health related quality of life (Euroqol). The primary analysis will be analysis of covariance. A multiple comparison procedure (Gabriel's test) will be used to compare each pair of treatments. Euroqol data will be used to estimate the relative costs of the interventions and to calculate the incremental cost per QUALY gained. Every effort will be made to invite patients for assessment at outcome and follow-up even if they have withdrawn from therapy to allow the intention-to-treat principle to be applied.

Eligibility Criteria:
Inclusion Criteria:

Subjects in this study will:

* be aged over 50 years.
* be between one week and three months after stroke when recruited to the study;
* have been independently mobile indoors, with or without aids, before the stroke;
* have some voluntary movement in the paretic lower limb i.e. score above 28/100 on the lower limb section of the Motricity Index43;
* demonstrate adequate orientation and communication (be able to complete a one-stage command using the non-paretic upper limb e.g. point at the ceiling).

In addition those who agree to participate in TMS measurement will have no contraindications to TMS.
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in surgically menopausal women who are taking estrogen therapy.

Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on their use of oral or transdermal ET and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen throughout the study. Patients who completed the first 24 weeks of the study were given the opportunity to participate in a 3.5 year open-label (active treatment) study extension which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.

Eligibility Criteria:
Inclusion Criteria:

Eligible women must:

1. Be 20-70 years old and in generally good health
2. Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening
3. Be receiving a stable dose of estrogen replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
4. Be, in her own judgment, in a stable monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry.
5. Meet the criteria for having hypoactive sexual desire disorder.

Exclusion Criteria:

Eligible women must not:

1. Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
2. Be experiencing any chronic or acute life stress relating to any major life change
3. Be experiencing depression and/or receiving medication for such illness or disorder
4. Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
5. Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
6. Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
7. Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
8. Have abnormal laboratory test results upon initial screening for this study
9. Have previously participated in P\&GP study 1999068 or 1999092
10. Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.
Breast MRI Spectroscopy

The purpose of this study is to provide physicians with additional information not available with standard imaging methods for breast disease.

As part of the MRI examination ordered by your physician, a new method of analyzing the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence may look slightly different than the regular MRI pictures. Using spectroscopy data, it may be possible to distinguish benign conditions of the breast from malignant tumors and provide more precise information than can be obtained with regular MRI.

Our aim is to perform MR Spectroscopy (MRS) on 150 evaluable patients at the end of their routine breast MRI examination using a software package from General Electric Medical Systems Milwaukee, WI). This will add time to the routine examination but will not involve additional injections of contrast. We will analyze the spectroscopic data to determine if benign lesions can be reliably differentiated from malignant ones.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion

Exclusion Criteria:

* Patients who would be normally excluded from undergoing an MRI examination:

  * Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)

This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.

This Phase II randomized, placebo-controlled, double-blind study will assess whether topical GLS-1200 applied via nasal spray atomizer is well-tolerated and can reduce the incidence of confirmed SARS-CoV-2 infection. Subjects will be randomized to either the GLS-1200 or placebo group in a 2:1 ratio with a target enrollment of 225 subjects. Subjects will self-administer study drug three times daily for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Able to provide informed consent
* Able and willing to comply with study procedures
* Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential through to the end of treatment

Exclusion Criteria:

* Know allergy to quinine, quinidine, or mefloquine
* Confirmed prior positive test for SARS-CoV-2
* Treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir
* Pregnancy or documentation of pregnancy by pre-treatment urine test or breast feeding or plans to become pregnant during the course of the study
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1

Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.


Eligibility Criteria:
Inclusion criteria

* Age 18 years or more
* Hospitalized for the primary diagnosis of acute denovo or decompensated chronic heart regardless of ejection fraction
* AKI KDIGO any stage or urine NGAL ≥ 150 ng/mL
* Must be able to be enrolled into the trial ≤ 12 hours of diagnosis of AKI or elevated urine NGAL

Exclusion criteria

* Denied to participate in the study
* Cardiogenic shock or unstable hemodynamic (systolic blood pressure of at least 100 mmHg or required inotropic support within last 24 hours)
* Cardiac mechanical support (i.e. extracorporeal membrane oxygenation and intra-aortic balloon pump)
* Acute coronary syndrome
* Diagnosed with cause of AKI other than cardiorenal syndrome (eg. sepsis, nephrotoxic, dehydration)
* Anuria or requiring dialysis or expected to required dialysis within 24 hr
* Baseline eGFR ≤ 20 ml/min/1.73m2 with or without dialysis initiated
* Heart or kidney transplanted
* Previously received any SGLT2i in the last 3 months before admission
* Allergic to any SGLT2i
* Type 1 diabetes mellitus
* History of ketoacidosis, including diabetic ketoacidosis
* Pregnancy
* Comorbid conditions with an expected survival of less than 1 months such as end-stage liver or heart disease, or uncurable malignancy