cyrilzakka/clinical-trials huggingface dataset:
Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM

We aim to demonstrate that oral administration of glibenclamide stimulates pancreatic glucagon secretion during hypoglycemia in insulin-deficient (C-peptide negative) patients with type 1 diabetes when compared to type 1 diabetic patients with residual insulin secretion (C-peptide positive).

The glucagon response during insulin induced hypoglycemia and rate of glucose recovery will be monitored in 10 C-peptide positive and 10 C-Peptide negative patients with type 1 DM following the application of glibenclamide and placebo in a randomized, single-blind, cross-over study.

Cognitive function during hypoglycemia with and without glibenclamide pretreatment will be a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 50 years
* Patients diagnosed with C-peptide negative diabetes type 1 (C-peptide \<200 pmol/L 6 min after 1 mg glucagon i.v. at plasma glucose concentrations between 5 and 11 mmol/l)
* Patients diagnosed with C-peptide positive diabetes type 1 (C-peptide \> 500 pmol/l 6 min after 1 mg glucagon i.v. at plasma glucose concentrations between 5 and 11 mmol/l)
* Stable metabolic control; HbA1c levels \<8.0 % and without episodes of antecedent severe hypoglycemias in the past four weeks

Exclusion Criteria:

* Patients treated with medications potentially interfering with glucose metabolism, such as systemic steroids, immunosuppressive drugs (cyclosporine, tacrolimus, sirolimus), highly active antiretroviral therapy
* History coronary artery disease
* History of epilepsy or seizures
* Current smokers
* Any significant or unstable hepatic, cardiac, pulmonary, renal, neurological, musculoskeletal, hematological or endocrine disease.
* Pregnant or breast feeding women
* Woman of childbearing potential not using a reliable method of birth control such as oral contraceptives or IUD.
* Subjects refusing or unable to give written informed consent
Bone Density in Voluntary Apheresis Blood Donors

A longitudinal, randomized, controlled, single-center Phase IV clinical trial will be performed to assess changes in bone mineral density (BMD) among voluntary apheresis blood donors. The primary outcome measure will be clinically significant decline in BMD at the lumbar spine assessed by dual-energy x-ray absorptiometry (DXA).

Apheresis blood donation maximizes an individual's donation by selecting specific blood components that are used to save patient lives. Dramatic increases in the number of apheresis procedures performed each year are apparent both domestically and internationally. Apheresis requires the use of citrate anticoagulation, a substance that confers its anticoagulant effect through chelation of cations, like calcium. A small number of cross-sectional studies have reported that intermittent exposure to citrate through apheresis is associated with significant declines in donor bone mineral density (BMD). In contrast, oral potassium citrate of much lower dose has been used to treat low bone density with well-documented efficacy. The impact of citrate exposure during apheresis, either positive or negative, is important given that BMD is a significant risk factor for low trauma fracture, a problem that affects more than 2M people in the U.S. annually. It is ultimately unknown what effect repeated apheresis has on skeletal health. To address this knowledge gap, we will perform a Phase IV clinical trial of apheresis blood donors using a cross-disciplinary, multi-institutional team. As apheresis blood donation continues to affect more people, the importance of understanding the effects of repeated exposure to citrate on donor skeletal health is essential in protecting this precious community resource.

Eligibility Criteria:
Inclusion Criteria:

* male
* eligible volunteer blood donor
* ≥ 18, and, ≤ 65 years of age at enrollment
* ≥ 1, and, ≤ 5 prior apheresis blood donation procedures

Exclusion Criteria:

* female
* age \< 18 or \> 65 years at enrollment
* ineligible for whole blood donation
* BMD Z-score \<(-2.0) or \>(2.0) at any measurement site upon baseline assessment
* metal prosthesis at measurement site
* weight \> 300 lbs (136 kg)
* previous fracture of the lumbar spine or femoral neck
* any fragility fracture, defined as a fracture resulting from a fall of standing height or less, during adulthood (specifically ≥18 years of age at the time of fracture)
* previous lumbar spinal fusion surgery
* cystic fibrosis
* emphysema
* celiac disease
* Crohn's disease
* Current or past (\>1 month duration) use of medications known to affect BMD including, not limited to: (phenytoin, phenobarbital, corticosteroids)
* Current Osteoporosis Medication use including, but not limited to: (Forteo, oral biphosphonates, Reclast, Prolia, calcitonin)
* Unable or unwilling to donate high frequency apheresis
Traumacel FAM Trium in the Post-market Surveillance Phase

The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. It can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. The wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic).

The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. The partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18.
* Surgical intervention.
* Negative pregnancy test of women in fertile age.
* Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
* Informed consent

Exclusion Criteria:

* Hypersensitivity or a known reaction to oxidized cellulose.
* Age under 18
* A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
* The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
* Pregnancy or lactation.
* If during the procedure itself, there was no need to use the test agent
* Application of any other topical haemostatic product prior to application of the test agent to the same site.
Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury

During open cardiac surgery, cardiopulmonary bypass (CPB) is used to temporarily replace the function of the heart and lungs. Renal ischemia resulting in acute kidney injury is common after cardiac surgery. The renal oxygenation is impaired during CPB, but the oxygenation may be improved by increasing the CPB blood flow. In this randomized study, two CPB flow rates will be compared regarding renal outcome (biomarkers and renal oxygenation/renal blood flow), as well as markers of inflammation and hemolysis. Additionally, urine oxygen tension will be measured during CPB and the early intensive care phase and compared to renal oxygenation. Regional oxygen saturation assessed with near infrared spectroscopy from the brain and kidneys will be monitored during and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Written, signed informed consent
* Male and female subjects ≥18 years
* Left ventricular ejection fraction ≥30 %
* Estimated GFR ≥30 ml/min using the CKD-EPI equation (Levey 2009)
* Scheduled open cardiac surgery with CPB
* Planned normothermia during CPB
* Expected CPB time \> 60 minutes

Exclusion Criteria:

* Emergency surgery
* Cardiac transplantation
* Advanced grown-up congenital heart disease corrections
* Previous cerebral infarction, verified with computed tomography or magnetic resonance imaging
* Body mass index \> 32 kg/m2
* Use of hypothermia \< 32 °C during CPB
* Inability of the patient to give based opinion
* In the investigator´s opinion, the patient has a condition that could be adversely affected by study participation
Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* History of bronchial asthma
* FEV1 \> 1.20 L
* Positive Skin Prick Test
* Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit

Main Exclusion Criteria:

* Clinically relevant abnormal laboratory values
* Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
* Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
* One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
* Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
* Positive response to saline challenge at baseline visits
* Positive bronchial hyperresponsiveness
Autoimmunity in Inner Ear Disease

The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.


Eligibility Criteria:
Inclusion Criteria:

* Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed.
* Are in good general health.
* Are sterile or use contraception (if a woman of child-bearing age).
* Are able to speak and understand English or Spanish.

Exclusion Criteria:

* Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids.
* Have used corticosteroids for more than 30 days within the past 90 days. Patients who have been off corticosteroids for at least 30 days may be eligible.
* Have any significant heart, lung, digestive, blood, or neurologic disorders.
* Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus, active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease, kidney failure, history of shingles, or known (other) autoimmune disease.
* Have had a positive test for HIV, hepatitis C or B.
* Have any type of middle ear disorder.
* Are breast-feeding or pregnant.
Efficacy and Safety Study of SCT800 for On-demand Treatment With in Patients With Hemophilia A

In this trial safety and efficacy of SCT800 (B-domain deleted recombinant factor VIII) is being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe Hemophilia A. These subjects will receive open label treatment with SCT800 for approximately 6 months for on-demand treatment.


Eligibility Criteria:
Inclusion Criteria:

* 12 to 65 years old;
* The activity of the coagulation factor VIII (FVIII:C) ≤5%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
* Bleeding state need to be treated with FVIII;
* Negative assays for FVIII inhibitors (\<0.6 BU/mL);
* The platelet count is normal；
* Normal prothrombin time or INR ≤1.5；
* Given informed consent

Exclusion Criteria:

* Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
* Family history or history of FVIII inhibitors (≥0.6 Bethesda Units \[BU\] mL-1);
* Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days prior to study entry (including rFVIII, plasma-derived factor VIII \[pdFVIII\], cryoprecipitate and whole blood);
* Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
* HIV seropositive;
* Abnormal hemostasis from causes other than hemophilia A；
* Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level);
* Patients who received any anticoagulant or antiplatelet therapy within one week (including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials;
* Alcoholism, drug abuse, mental disorders and mental retardation;
* Elective surgery planned during the process of study;
* Patients who previously participated in the other clinical trials prior to study entry;
* The patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol;
* Other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;
Correlation of Metabolic Imaging With Immune Markers in NSCLC Candidate to Immunotherapy.

The purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on FDG-PET before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a NSCLC patients candidate to immunotherapy.

This is an interventional prospective study without medication lasting 36 months, including an estimated period of 18 months for the enrolment and max 18 months of follow-up. All consecutive patients affected by NSCLC and referred for immunotherapy with the anti-PD-1 agent nivolumab, or other checkpoint inhibitors that may become available in the future, will be prospectively enrolled. The study cohort will consist of 40 patients.

All patients will undergo the following steps: 1) selection based on eligibility criteria and informed consent; 2) baseline examinations (ceCT and 18F-FDG PET/CT); 3) tumor biopsy and blood sampling; 4) Immunotherapy with check-point inhibitors; 5) response evaluation after 8 weeks of treatment (ceCT and 18F-FDG PET/CT) and second blood sampling; 6) follow up.

Eligibility Criteria:
Inclusion Criteria:

* patients with pathological diagnosis of NSCLC eligible for immunotherapy;
* obtained informed consent.

Exclusion Criteria:

* age \<18 years;
* pregnancy or breast-feeding.
Life-long Monitoring of COPD in Veneto Region

The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.

The study is designed to evaluate the impact of telemonitoring on the management of COPD compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to improve COPD patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* COPD GOLD class 3-4
* Life expectance \> 12 months

Exclusion Criteria:

• Patient unable to use the equipment provided (alone or assisted).
Comparison of Two Marketed Lenses in a Controlled Environment

This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be 18 years of age and less than 51 years of age;
2. The subject must have read and understood the Participant Information Sheet;
3. The subject must have read, signed and dated the Informed Consent;
4. The subject must be a current planned replacement soft contact lens wearer;
5. The subject must be a regular user of devices (computer, tablet and/or smart phone) for a minimum average of 5 ± 1 hours per day in a typical week
6. The subject must have a refractive error within the range of correction of both study contact lenses;
7. The subject must have a best-corrected visual acuity of 6/9 (20/30, 0.18 LogMAR) or better in each eye;
8. The subject must demonstrate an acceptable fit with both study contact lenses;
9. The subject must agree to wear their contact lenses as directed for the duration of the study (every day or for at least a minimum of five days per week for a minimum of six hours per day and be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule;
10. The subject must have normal eyes with the exception of the need for visual correction.

Exclusion Criteria:

1. Any known sensitivity or intolerance to any of the contact lenses or adjunct products to be used.
2. Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses).
3. Use of systemic or ocular concomitant medications which, as determined by the investigator, might contraindicate or interfere with contact lens wear.
4. Ocular anterior segment infection, inflammation, abnormality, or active disease, which would contraindicate contact lens wear.
5. Any moderate or severe ocular condition observed during slit lamp examination at the enrollment visit.
6. A history of herpetic keratitis, ocular surgery or irregular cornea(s).
7. Known pregnancy or lactation during the study period.
8. Enrollment of investigator's office staff, relatives, or members of their respective households.
9. Participation in any clinical trial within 30 days of the enrollment visit.
Surgical Staging in Cervical Cancer Prior to Chemoradiation

The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.

The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.

To this end, 250 patients with histologically verified cancer of the cervix uteri of the stages IIB-IV shall be randomised to a standard arm (ARM B), whereby the therapy shall be conducted on the basis of the clinical FIGO stage.

The patients randomised to the test arm (Arm A), after determining the clinical FIGO stage, shall initially receive an operative staging in the form of a pelvine paraaortal lymphadenectomy (laparoscopic or open). On the basis of the operatively obtained findings, a ("surgically") modified tumour stage shall be determined. This "surgical" tumour stage, which shall take into account the affection of the lymph nodes, the infiltration of the neighbouring organs and the intraperitoneal spread, shall serve as the basis for the execution of primary, combined radio-chemotherapy. The primary end-point is the disease-free survival of both groups, the secondary endpoints are overall survival, the local control of both groups, as well as the determination of toxicity and the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky-Index =/\> 70,
* age between 18 - 70 years
* histological assured cervical cancer (by biopsy)
* FIGO stages II B - IV
* written informed consent
* patient's ability to cooperate

Exclusion Criteria:

* neuroendocrine tumors or histological mixed types containing neuroendocrine fractions
* pregnancy, lactation,
* distant metastases, except paraaortal metastases
* other malignant diseases in anamnesis
* pelvic radiotherapy in anamnesis
* severe internal diseases
* psychiatric diseases which might query the trial attendance or follow-up
* HIV-Infection or AIDS
* drug addiction
* existing motoric or sensoric polyneuropathy \> CTC Grad 1
A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

It is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of NSCLC patients with multiple metastases. At the same time, by using multimodal omics data, machine learning will be employed to construct a prediction model for the abscopal effect, and explore the immunoregulation of organ-specific radiotherapy and biomarkers of the abscopal effect. The main objective is to find the optimal organ combination and the best radioimmunotherapy combination pattern.


Eligibility Criteria:
Inclusion Criteria:

* Patient must meet all of the following inclusion criteria to be enrolled in this study:

  1. Non-small cell lung cancer diagnosed initially through pathological histology.
  2. There are 3-6 metastatic lesions.
  3. No brain metastasis or the lesions are stable.
  4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names).
  5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months.
  6. Aged between 18 and 75 years old.
  7. Evaluated by PET-CT (including FDG and FMISO, not mandatory).
  8. No contraindications for immunotherapy and radiotherapy.
  9. The informed consent form has been signed.

Exclusion Criteria:

* Patients with any of the following criteria are not eligible for enrollment in this study:

  1. Those with severe dysfunction of vital organs (heart, liver, kidney).
  2. Those accompanied by other malignant tumors.
  3. Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.
  4. Those with a history of mental illness.
  5. And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.