cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

The purpose of this clinical study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants must provide signed informed consent.
* Participants must be in good general health.
* Body mass index (BMI) 18 to ≤ 30 kg/m2.
* Contraception use by men or women .

Key Exclusion Criteria:

* Clinically significant liver, kidney disease or cardiac disease.
* Active malignancy and/or history of malignancy in the past 5 years.
* Serious local or systemic infection within 30 days prior to Screening
* Any acute illness within 30 days prior to Day 1.
* Surgery, bone fracture or major musculoskeletal injury within the 3 months.
* Abnormal screening laboratory tests.
* Positive for human immunodeficiency virus (HIV) antibody or antigen.
* Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
* Positive result indicating active SARS-CoV-2 infection on Day -1.
* Positive urine drug screen/alcohol breath test at Screening.
* Positive Quantiferon Tuberculosis (TB) test.
* Systolic blood pressure (BP) \> 150 mmHg or \< 90 mmHg or diastolic BP \> 90 mmHg or \< 50 mmHg. Heart rate \< 40 beats per minute (bpm) or \> 100 bpm.
* Prolonged QT interval corrected by Fridericia's formula (QTcF) (\> 450 ms for males and \> 470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the Investigator.
* All prescription and over-the-counter medications (including herbal medications), except for contraceptives and hormonal replacement therapy (HRT), are prohibited within 7 days prior to the first study intervention administration and throughout the entire duration of the study.
* All vaccines within 30 days prior and throughout the entire duration of the study.
* Administration of investigational product in another study within 30 days prior to the first study intervention administration, or five half-lives, whichever is longer.
* Blood donation within 30 days prior to the first study intervention administration.
* Females who are pregnant or breastfeeding.
* Failure to satisfy Investigator of fitness to participate for any other reason.
* Cigarette smokers and users of nicotine-containing products.
A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)

The purpose is to assess the overall survival of patients receiving either UFT/LV + radiotherapy (RT) or UFT/LV + Cetuximab + RT after neo-adjuvant chemotherapy.

Locally advanced pancreatic cancer carries a poor prognosis with no survival advantage of CRT over chemotherapy alone. 4 Phase II- III studies patients without disease progression after 3 months of systemic chemotherapy and CRT had a longer survival than those continuing on chemotherapy. Therefore chemotherapy followed by CRT may be a better approach. Also the effect of blocking EGFR will be evaluated in locally advanced pancreatic cancer. Gemcitabine and capecitabine combination will be used as neo-adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas.
* Considered to be unresectable based on following: extensive peri-pancreatic lymph node involvement, encasement or occlusion of the SMV or SMV/portal vein confluence, direct involvement of SMA, coeliac axis, inferior vena cava or aorta.
* Performance status 0-2
* No evidence of metastatic disease as determined by CT scan/ other investigations
* Adequate bone marrow function with platelets\>100\^9/l; WBC\>3x10\^9/l;neutrophils\> 1.5x10\^9/l
* Serum bilirubin ,1.5 x ULN and transaminases \< 2.5 x ULN
* Calculated/measured GFR \>50ml/min
* No concurrent uncontrolled medical condition
* No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix over the last 10 years
* Life expectancy \> 3months
* Adequate contraceptive precautions
* Informed written consent

Exclusion Criteria:

* medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Presence of met. disease
* Concurrent uncontrolled medical conditions
* Any previous chemo/RT or any investigational treatment for advanced pancreatic cancer.
* Adjuvant chemo + fluoropyrimidine or gemcitabine within 12months of trial entry
* Adjuvant RT with/without chemo for pancreatic cancer.
* Pregnancy/breast feeding
* Patients with known malabsorption syndromes ro a lack of physical treatment of the upper GI tract.
* Patients with a known hypersensitivity to 5-FU or with a DPD deficiency.
* Clinically significant CVD
A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using Da Vinci 5 Robot

The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.


Eligibility Criteria:
Pre-Operative Inclusion Criteria:

1. Age 22 years or older
2. ASA ≤ 3
3. The clinical decision has been made to perform multi-port robotic assisted surgery with da Vinci 5 with Force Feedback instruments for the study specified procedure as primary procedure prior to enrollment in the study
4. Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study
5. Subject is willing and able to comply with the study protocol requirements including follow up schedule

Pre-operative Exclusion Criteria:

* Subject receiving an emergent procedure
* Subject planned to undergo major concomitant surgery for the treatment of a different medical condition than was originally planned
* Subject with previous ipsilateral surgery (open, endoscopic or robotic) with the same surgical indication
* Subject with past or ongoing medical conditions (for example: inflammatory bowel disease) which, in the judgment of the Investigator, puts them at high risk for surgery and not appropriate for the study
* Subject is pregnant or suspected to be pregnant or breastfeeding
* Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data
* Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months
* Subject belongs to a vulnerable population.
* Subject is contraindicated for anesthesia or surgery.
* Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for the treatment of the cancer to be resected within the past 6 months

Intra-operative Exclusion Criteria

* Subject with hemodynamic or respiratory instability, which precludes the Investigator from performing the RAS.
* Subject in whom inadequate visualization makes a minimally invasive approach not feasible, as determined from the investigator assessment prior to docking the robot.
* Subject with adhesions, scarring and disease status in the body which in the opinion of the investigator limits the ability to perform the minimally invasive procedure.
Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction

The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in patient with ST-segment elevation acute myocardial infarction.

Study objective :

To investiage whether nicorandil treatment reduce infarct size measured by cardiac MRI at 6 months after primary PCI

Allocation :

1. Nicorandil arm :

   Recieve nicorandil 4 mg i.v. before undergoing PCI, additionall 2mg i.c. just before 1st ballooning, additionall 2mg i.c. just before stenting, After successful PCI, 10 mg/day (or 5 mg/day) p.o. for 6 months.
2. Control arm :

Recieve standard treatment including PCI, but avoid nicoranil and adenosine.

Follow-up and Measurement :

Cardiac MRI scans are scheduled at 5 days and 6 months after primary PCI. Clinically followed upto 6 months after parimary PCI.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients presenting within 12 hours after symptom onset
* Undergoing primary PCI

Exclusion Criteria:

* Previous myocardial infarction
* Atrial fibrillation
* RV infarction
* Cardiogenic shock
* Serum creatinine \>2.0 mg/dL
* Narrow angle glaucoma
* Taking PDE-5 inhibitors
A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
4. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
5. There is at least one measurable lesion according to RECIST V1.1 criteria

Exclusion Criteria:

1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
2. Has received HER2 antibody drug conjugates,
3. Central nervous system metastasis or meningeal metastasis with clinical symptoms
4. Has active infection requiring systemic treatment.
Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients

Evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients

Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis in the upper limb. The diagnostic and therapeutic stakes are major as it concerns the functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis.

In some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the ischemic condition appears to be rather the result of uncompensated arteriatory of the upper limb or limbs. Echo-doppler exploration is usual for assessing vascular access but without validated formal criteria for arterial disease in the upper limbs, with fistula flow calculation and analysis of FAV hemodynamics. Compression manoeuvres on or under the FAV can also be performed. The pressures of the digital arteries are also indicated with non-consensual values found in the literature for the diagnosis of digital ischemia but with varying tools in terms of collection of measurements.

The main objective of this study is to collate the characteristics of arterial condition of the upper limbs of medium or severe renal patients, medium- or short-term candidates for kidney dialysis. The data collected will match the data of the arterial echodoppler as well as measures of pressures doppler laser and plethysmography. Candidates for dialysis tend to be older and polyvascular. A better assessment of the vascular condition of their upper limbs, including the diagnosis of advanced arterial disease, could eventually guide the choice of type of dialysis (compared to an indication of FAV).

Prospective, monocentric study

The main objective of the research Description of the arterial condition of the upper limbs of kidney failure patients candidates for dialysis Primary Search Judgment Criterion: Description of the ultrasound characteristics of the arterial echo-doppler of the upper limbs.

Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure patient with nephrologist's decision to pre-dialysis Or Chronic renal insufficient patient with arteriovenous fistula of the upper limb and sign of digital ischemia (cold hand, digital ulcer, digital necrosis) Agreement on the study's non-opposition form Age above or equal 18 years Patient affiliated with a social security plan

Exclusion Criteria:

* Subject under guardianship or subject deprived of liberty Failure to obtain patient's consent
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.

Meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. In one out of five patients, standard first line medical treatment is not effective in controlling vertigo attacks. For these incapacitated patients, gentamicin injections through the ear drum is a well established minimally invasive treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. As hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. On the other hand, steroids are drug of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without any known side effects during local treatment in ear. We will compare the two in this randomised, double blind trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral Ménière's disease (definite or probable, according to Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. There should be normal, age appropriate hearing in the contralateral ear.

Exclusion Criteria:

* Patients with Ménière's disease in later stages (not having vertigo attacks).
* Age: patients older than 70 years at the start of the trial.
* Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
* Active additional neuro-otological disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the objective follow up difficult.
* Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active middle ear disease).
* Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
* History of known adverse/allergic reaction to steroids or gentamicin.
Princess® RICH for the Correction of Fine Lines

Eligible subjects deemed by the treating physician to have sufficient severity to merit treatment of either their lateral canthal lines (LCL) or perioral rhytids (PR) or both will be treated with Princess® RICH at the Baseline visit and at week 3 and 6.


Eligibility Criteria:
Inclusion Criteria:

* Subjects deemed by the treating physician to have LCL and/or PR of sufficient baseline severity to merit treatment with Princess® RICH to be corrected
* A negative urine pregnancy test at Visit 1 and commitment to use an adequate method of birth control for the duration of the clinical investigation (for women of childbearing potential only.)
* Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
* Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
* Written signed and dated informed consent

Exclusion Criteria:

* Tendency to hypertrophic scars, pigment disorders or keloid formation.
* History of autoimmune disease or receiving therapy for modification of immune response
* Hypersensitivity to hyaluronic acid or glycerol.
* Permanent fillers in the areas to be treated.
* Subjects who are pregnant or breast feeding.
* Subjects who are anticoagulated or with history of bleeding disorder.
* Daily treatment with platelet aggregation inhibitors unless previously cleared by their primary care physician.
* Cutaneous, inflammatory and/or infectious processes present at V0, recurrent herpes simplex or (pre) cancerous lesions in the areas to be treated
* Known Diabetes mellitus or uncontrolled systemic diseases in the assessment of the investigator.
* Laser therapy, chemical peeling, dermabrasion or botulin toxin treatment in the area to be treated within less than three months prior to and during the course of the study.
* Current participation in another clinical investigation
* Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g, persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)
Stroke Prevention and Rhythm Control Therapy STEEER-AF

A prospective trial with hospitals/health centres across 6 different European countries, being randomised to either a structured education programme as the intervention or no additional education as the control. To determine whether a comprehensive educational programme for healthcare professionals will increase the rate of appropriate stroke prevention and rhythm control therapy in patients with atrial fibrillation (AF) and adherence to Guidelines.

Prospective, parallel group, two-arm, unblinded, international, cluster-randomized controlled trial.

Intervention arm: A 16-week blended learning programme targeting stroke prevention and rhythm control therapy at the healthcare professional level, with controlled assessments, a commitment to change plan, and reinforcement actions Control arm: No added education of healthcare professionals 70 centres with a cluster size of 25 patients; total estimated number of patients 1750.

8-12 weeks patient recruitment period at each centre; 16 weeks educational intervention period; primary \& secondary outcomes at 6-9 months post-randomisation; remote follow-up for clinical events (no new patient contact) at 18 months from randomisation.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with AF
* Patient consents to data collection at baseline and follow-up.

Exclusion Criteria (patients only):

* Patients aged under 18 years of age,
* Pregnant or planning pregnancy,
* Participating in another clinical trial of an investigational medicinal product or device,
* Life expectancy of less than 2 years.

Patient assessment: Baseline (time of recruitment) and at follow-up routine appointment (6-9 months), plus remote follow-up at 18 months.
A Study of Observation and Follow-up in People With Basal Cell Carcinoma

The purpose of this study is to find out more about how Basal Cell Carcimonas/BCCs grow and to learn more effective ways to monitor and treat these common cancers. This study will not provide any type of treatment for the participants' cancer; it is a 3-year observational study to monitor participants' cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Diagnosed with at least 1 BCC based on clinical, dermoscopy, RCM and OCT
* Patients with BCCs that have a diameter smaller or equal to 1.5cm, allowing for 0.5cm growth before reaching the cutoff for stage 2 BCC, which would require removal of the BCC.
* Patients with BCCs that have a depth smaller or equal to 0.6mm, to allow for tumor growth of 0.2mm before reaching the depth limitation of OCT imaging (0.8mm)
* Treatment naiive lesions
* Ability to sign informed consent

Exclusion Criteria:

* Immunosuppressed patients, such as those with a primary immunodeficiency caused by a genetic abnormality and a secondary immunodeficiency caused by AIDS, cancer, chemotherapy and other immunomodulating drugs, solid organ transplant recipitents, CLL, aspelenia, and pregnancy).
* Patients with cancer genetic syndromes that increase risk of BCC (such as basal cell nevus syndrome, xeroderma pigmentosum, epidermolysis bulosa, oculocutaneous albinism, bazex-dupre-christol syndrome, rothmund-thomson syndrome, and epidermodysplasia verruciformis).
* Patients with BCCs that are clinically suspected as high risk histopathologic subtypes, i.e. indented or sclerotic lesions that are suspected as morpheaform or infiltrative BCCs.
* Patients with BCCs that have a diameter larger than 1.5cm\\
* Patients with BCCs that have a depth greater than 0.6mm
* Patients with BCCs in high risk locations, i.e. "H" area of the face. (is located in the mid-face at the site of the embryologic fusion plates and is generally believed to be associated with more aggressive skin cancers).
* Patients with BCCs on locations that may compromise an organ function should the tumor enlarge (for example, eyelid).
* Tumor located on a site that precludes attachment of the RCM device or inability to tolerate imaging procedure (i.e. remain relatively still for multiple short durations of 3- 4 minutes over a total time of 20-30 minutes)
* Lesions that previously received therapeutic intervention
* Inability to give informed consent
Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes

The patients who have achieved LDL-C levels below the currently recommended targets may still experience cardiovascular events. To reduce further the risk of coronary heart disease (CHD), raising HDL-C and lowering TG may be the secondary therapeutic target. However, increased HDL-C levels do not mean increase in functional HDL-C. It also remains controversial whether functional HDL is more important than total circulating levels of HDL-C in reducing CHD.

Actually, the increased concentration of HDL alone might be ineffective indicating that qualitative changes in HDL levels in response to drug interventions are required to result in clinical benefit.

The investigators set up a clinical trial investigating effect of (rosuva)statin treatment on functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.

1. Study design Study subject Number of Subjects (N = 30)
2. Study outcome

   Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol
3. Evaluation of functional aspect of HDL Cholesterol efflux from macrophages LDL-induced monocyte chemotactic activity (MCA) Assay Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1)

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. HbA1c ≥ 7.5%
3. Age ≥ 30
4. low HDL-C (\<40 mg/dl in men or \<50 mg/dl in women) and having 1 or more risk factors: 1) Body mass index (BMI) ≥ 25 kg/m2 (overweight); 2) LDL-C level ≥ 130 mg/dl; 3) TG level ≥150 mg/dl; 4) Systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥140/90 mmHg or taking antihypertensive medication; 5) Current smoker; 6) Family history of CHD.

Exclusion Criteria:

1. Contraindication to rosuvastatin
2. Pregnant or breast feeding women
3. Reproductive-age women who refuse contraception
4. Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
5. Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
6. Renal failure (Cr \> 2.0)
7. Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment)
8. Not appropriate for lipid lowering treatment
9. Medications which affect glycemic control
10. Diseases which affect efficacy and safety of statin
11. Other clinical trial within 30 days