cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

The study is designed to approve non-inferior efficacy and safety of Insulin Lispro Biphasic 25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients.


Eligibility Criteria:
Inclusion Criteria:

* Signed written consent
* Clinical diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
* Glycosylated hemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive)
* Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive)
* Stable doses OADs for at least 3 months prior to treatment of experimental drug
* Female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion

Exclusion Criteria:

* Acute inflammation disease for 3 weeks prior to screening
* Deviation of the laboratory results conducted during the screening:

Hemoglobin value \< 9,0 g/dl; Hematocrit value \< 30 %; ALT and AST value \> 2 folds as high as maximal normal value; Serum bilirubin value \> 1.5 folds as high as maximal normal value

* History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.)
* Serious blood loss for 3 months prior to screening (blood donation, surgery procedure, etc.)
* Contraindication to the use of insulin Lispro Biphasic 25
* Insulin resistance over 1.5 U/kg insulin pro day
* Presence of insulin antibodies in the blood at the screening ˃10 U/ml
* Use of 3 or more oral antidiabetic drugs (OAD)
* Presence of severe diabetes complications
* History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
* Deviation of vital signs, which can influence to results
* History of administration of glucocorticoids for 1 year prior to screening
* History of autoimmune disease, except controlled autoimmune thyroid disease
* Pregnant and breast-feeding women
* History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions
* Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexatum)
* Incomplete recovery after surgery procedure
High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study

This is a randomized study aiming to assess the feasibility of a phase II randomized controlled trial of different high-intensity training interventions and usual care (UC) in men with prostate cancer (PCa) undergoing active surveillance (AS).

Primary objectives:

The primary objective of this study is to assess the feasibility of conducting a three-armed randomized controlled trial comparing high-intensity interval training (HIIT), high-intensity resistance training (HIRT), and usual care (UC) in men with PCa on AS.

The secondary exploratory objective of this study is to assess changes in cardiorespiratory fitness, musculoskeletal strength, body composition, circulating blood markers, and participant-self-reported outcomes (e.g., quality of life, anxiety, fear of disease progression) after 8 weeks of HIIT, HIRT, or UC.

Methods:

Participants will be randomized in a 1:1:1 ratio to HIIT, HIRT or UC group.

Participants in the HIIT and HIRT group will undergo training 3 times per week (two supervised and one home-based/unsupervised training session) for 8 weeks.

The UC group will be directed towards publicly available literature on physical activity (e.g., Cancer Care Ontario's physical activity guidelines for cancer survivors) and will receive an individualized exercise program upon completion of their final fitness assessment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* initiating or currently on AS for PCa;
* not currently engaging in high-intensity aerobic and/or resistance training at 85%HRmax or ≥9 RPE in the Borg 0-10 RPE scale;
* willing and able to travel to the study-designated facilities;
* proficient in English;
* able to provide written informed consent;
* pass the screening CPET by achieving volitional exhaustion (rate of perceived exertion (RPE) ≥ 9 using the Borg 0-10 RPE scale) in the absence of any cardiorespiratory abnormalities.

Exclusion Criteria:

* uncontrolled hypertension (≥2/3 of readings of \> 160/90), regardless of whether on a regimen of anti-hypertensive therapy or not;
* been diagnosed with congestive heart failure (New York Heart Association Class II, III or IV);
* a history of serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI);
* a medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the study physician, would make this protocol unreasonably hazardous for the patient;
* a history of a psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol;
* serious or non-healing wound, ulcer, or bone fracture;
* experience shortness of breath, chest discomfort, or palpitations when performing activities of daily living;
* ongoing restriction of physical activity;
* developed chest pain in the past month
The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler

Growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological treatment for neuropathic pain. The objective of this study is to explore the pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler, (i.e. CannaHALER) for cannabis in a cohort of 12 healthy volunteers. In a single escalating dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg / 20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the Kite Systems cannaHALER cannabis Inhaler device. Blood samples will be taken at baseline and up to 30 minutes. Adverse events will be monitored following the inhalation.


Eligibility Criteria:
Inclusion Criteria:

* aged 30-70 years;
* healthy
* if applicable, negative pregnancy test (β human chorionic gonadotropin pregnancy test).

Exclusion Criteria:

* significant cardiac or pulmonary disease,
* history of a psychotic or anxiety disorder,
* pregnancy, pregnancy attempt or breastfeeding,
* presence of a neuropathic or non-neuropathic pain,
* low blood pressure, below 90 mm Hg (systolic)
* Diabetes is diagnosed,
* first degree family history of psychotic or anxiety disorder,
* history of drug addiction,
* history of drug misuse,
* using the following drugs: Rifampicin, Rifabutin, Carbamazepine, Phenobarbital, Primidone,
* using the following plants: Hypericum perforatum, troglitazone,
* Alcohol consumption up to 12 hours before the study,
* abnormal parameters such as Heart Rate above 100 BPM, Blood pressure, below 90 mm Hg (systolic), Saturation below 91 percent,
* Cannabis use up to 12 hours before the study,
* health condition which could affect or alter the experiment results,
* Volunteer has a legal guardian.
* Chronic use of drugs,
* age less than 30 or more than 70,
* a health condition that could affect the outcome of the trial or constitutes a risk factor for participation in the trial.
* The experiment will not include special populations such as pregnant women, children and without judgement.
Immune Regulation in Multiple Sclerosis: The Effect of Glatiramer Acetate on MicroRNA Expression in Antigen-Presenting Cells

MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis.

MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis. The expression of microRNA will be analysed in cell subsets separated from peripheral blood mononuclear cells.

Eligibility Criteria:
Inclusion Criteria:

18-60 year-old healthy subjects or patients with RRMS/CIS

Exclusion Criteria:

1. Any treatment with steroids in the last 30 days prior to the blood draw or any immunosuppressive or Disease-modifying treatment (DMT) other than Glatiramer Acetate in the last 90 days
2. Presence of other disorders that may be associated with immune-deficient or autoimmune process (e.g., HIV, lymphoma, lupus) or demyelinating disease other than MS (e.g., Lyme, B12 deficiency)
3. Pregnancy
4. Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting (Expanded Disability Status Scale (EDSS) score greater than 5.5)
Validation of Neurokeeper's Algorithm on Patients Undergoing Cardiac Surgery.

The primary objective of the study is to check the ability of Neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery.

The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS ThiS study is a prospective, open label, single arm, self control, single center study.

This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Patients undergoing cardiac surgery .

Exclusion Criteria:

* Previous major hemispheric stroke.
* Any known major hemispheric lesion.
* Significant movement disorder.
* Local skull or skin affliction which prevents electrodes application.
* Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling

The incidence and severity of hot weather and extreme heat events (heat waves) is increasing. As such, there is an urgent need to develop heat-alleviation strategies that can provide targeted protection for older adults who are at an elevated risk for heat-induced illnesses or death due to impaired body temperature and cardiovascular regulation. While air-conditioning provides the most effective protection from extreme heat, it is inaccessible for many individuals and cannot be used during power outages (e.g., heat-related rolling blackouts). Immersion of the lower limbs in cold water and/or the application of cold towels to the neck have been recommended as simple and sustainable alternatives to air-conditioning. However, empirical data to support the efficacy of these interventions for mitigating physiological strain and discomfort in older adults is lacking. To address this knowledge gap, this randomized crossover trial will evaluate the effect of lower limb immersion with and without application of cold towels to the neck on body core temperature, cardiovascular strain and autonomic function, dehydration, and thermal comfort in adults aged 65-85 years exposed to simulated heat wave conditions (38°C, 35% relative humidity) for 6 hours.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults.
* Aged 65-85 years.
* Non-smoking.
* English or French speaking.
* Ability to provide informed consent.

Exclusion Criteria:

* Physical restriction (e.g., due to disease: intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
* Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, etc.)
* Cardiac abnormalities identified via 12-lead ECG during an incremental exercise test to volitional fatigue (performed for all participants).
* Peak aerobic capacity (VO2peak), as measured during an incremental exercise test to volitional fatigue, exceeding the 50th percentile of age- and sex-specific normative values published by the American College of Sports Medicine (ACSM).
EXtendedAnalysis for Cancer Treatment

The purpose of this study is to prospectively validate treatment benefit of an individualized treatment concept based on molecular profiling (MP) from paraffin-embedded tumor tissue sections obtained before the start of treatment (real time biopsy).

The treatment concept will be considered to be of clinical benefit for the individual patient if a progression-free survival (PFS) ratio (PFS on MP-based therapy / best PFS achieved by prior therapy) will be \> 1.0 thus generating a patient cohort with this very property. Thereby, the null hypothesis (that ≤ 40 % of this patient population would have a PFS ratio of \> 1.0) will be evaluated with each patient being his own control. For tumor types with high numbers of patients per cohort, the overall response rate (ORR) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Consenting patients of \>19 years with advanced cancer fulfilling the criteria of having:

* an advanced malignancy with metastatic spread refractory to conventional treatment
* a life expectancy of \>4 months,
* the possibility to access and biopsy tumour material within 4 weeks before onset of individualized treatment,
* a malignancy amenable to further treatment options with either cytotoxic drugs, tyrosine kinase inhibitors, monoclonal antibodies or related molecules with anti-proliferative potential to cancer cells, as assessed by the ex vivo analysis and a likelihood of treatment response according to the mathematical model (all outlined in detail above),
* agreed to participate by their signature on an informed consent form are eligible.

Exclusion Criteria:

* Presence of further treatment options, as defined by NCCN guidelines which are available in Austria representing a possible further treatment-related response by conventional therapies according to generally accepted medical evidence.
* No fresh and viable tumor material available.
* Current use of therapeutic warfarin.
* Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia.
* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
* A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
* A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* History of other malignancy. Subjects who have been disease-free for 5 years or those with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol)
* unwillingness or inability to follow the procedures required in the protocol.
* pregnant or lactating females.
* History of alcohol or drug abuse within 6 months prior to screening.
* No informed consent available.
Validation in a Non-targeted Population of Single Ultrasound Doppler Signs of Liver Fibrosis

The diagnosis of liver fibrosis lesions remains an important issue in patients with chronic liver diseases. The early detection of fibrosis is important for determining disease progression and postponing the evolution of chronic hepatitis into cirrhosis via the implementation of prompt and specific treatment. However, as chronic liver disease can remain asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly, when life-threatening complications start appearing.

Noninvasive methods for liver fibrosis diagnosis have been developed over the last decade. In this setting, blood fibrosis tests and transient elastography have been shown to be accurate, and are now commonly used as first-intention tests for liver fibrosis diagnosis in chronic liver diseases. However, these tests are usually performed by a hepatologist to whom the patient has been referred following the appearance of symptoms suggestive of chronic liver disease. Thus the number of patient diagnosed early by these new tools, that is in the period before symptoms start appearing and during which preventative measures may be particularly beneficial, remains quite low in relation to the prevalence of the disease. This prevalence has been estimated to 0.5 to 2.8 % in general population.

Many studies have identified the value of hemodynamic and morphological ultrasound parameter in providing information on liver fibrosis degree. Moreover, abdominal ultrasound is widely used for various symptoms, and thus could be an excellent way to detect patients with signs evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. To be feasible during a nonspecific US examination, and by any radiologist, these signs should be easy and quick to collect. Addition of a quick measure of hepatic stiffness could increase the screening interest of ultrasound examination.

The main aim of the present study was thus to validate 3 simple US signs in patients referred for ultrasound abdominal examination for reasons other than suspicion of liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to an ultrasound unit for abdominal US examination, whatever the indication.
* Patient with Social Security

Exclusion Criteria:

* Age \<18 years
* Previously identified chronic liver disease
* Hematological disease
* Patient under guardianship
Endothelial Function in Young Hispanic Adults at Risk for Type 2 Diabetes

Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk for type 2 diabetes. The function of the endothelium has played a key role in the understanding of vascular complications in people with diabetes. Endothelial function and vascular reactivity are impaired not only in white adults with type 2 diabetes but also in those at risk for the disease by virtue of having impaired glucose tolerance or parental history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The investigators plan to assess the endothelial function and vascular reactivity in young Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging to a minority population.


Eligibility Criteria:
Inclusion Criteria:

* Group 1:

  1. Age between 18-40 years;
  2. Hispanic (we will consider a subject being Hispanic if both parents are reported as Hispanics when asked the following question: "What ethnic group do you consider that you belong to?");
  3. History of type 2 diabetes in one or both parents;
  4. BMI above 27;
  5. Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Group 2:

1. Age between 18-40 years;
2. Hispanic (same criteria as above );
3. No history of type 2 diabetes in any first degree relative;
4. BMI under 25;
5. Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Exclusion Criteria:

* diabetes, glucose intolerance, pregnancy, smoking, cardiovascular disease, uncontrolled hypertension, renal disease, proteinuria, cancer, infectious diseases, severe GI diseases, lung disease, electrolyte abnormalities, anemia, endocrine disorders, severe dyslipidemia, peripheral vascular disease, medications: beta-blockers, any diuretic, calcium channel blockers, ACE inhibitors, angiotensin receptor blockers, niacin, glucocorticoids, any antineoplastic agent, antibiotics, psychoactive agents, bronchodilators or insulin.
A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.

One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.

The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.

The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a live twin living in the same household who is also enrolled in this study.
* Born after a gestation period of ≥32 weeks,
* Discharged from hospital neonatal care stay,
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parent or guardian of the subjects.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Any clinically significant history of chronic gastrointestinal disease.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Contact with an immunosuppressed individual.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Chronic administration of immunosuppressants since birth.
* Gastroenteritis within 7 days preceding the first study vaccine administration.
* Documented HIV-positive subject.