cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age and older
* Subjects requiring elective radical or total cystectomy for bladder cancer
* Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

Exclusion Criteria:

* Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin
* Subjects with sepsis or undergoing laparoscopic surgery
* Subjects with impaired renal function (serum creatinine \>2.5 mg/dL or 221 micromoles/liter)
* Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have
* Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of \<24% or hemoglobin of \<8 g/dl)
* Subjects who have participated in an investigational drug study within the past 30 days
* Subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception
* Planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid
* Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)
Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pathological complete response (pCR) in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC).

As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.

IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pCR in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC).

The primary endpoint will be evaluated on surgical specimen using the residual cancer burden (RCB) index.

Thirty patients with clinical stage T1-2 Luminal B BC, suitable for conservative surgery and with a clinical indication for NAC, will be enrolled in two years. An observation cohort will also be created with patients fulfilling inclusion criteria who refuse enrollment in the interventional cohort and for patients where SBRT boost appears not feasible after enrollment for technical issues.

As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.

After the completion of neoadjuvant treatments, surgery and adjuvant therapies (endocrine therapy and whole breast irradiation) will be performed as for clinical practice

Eligibility Criteria:
Inclusion Criteria:

* Luminal B-like BC, cT1-2
* Indication for neoadjuvant chemotherapy

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Patient not available for follow up
Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy

Prospectively Investigate the effectiveness and safety of neoadjuvant Bevacizumab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS mutant-type locally advanced rectal cancer


Eligibility Criteria:
Inclusion Criteria:

1. A biopsy proven histological diagnosis of rectal adenocarcinoma；
2. An ARMS-PCR proven KRAS, NRAS mutation, excluding BRAF mutation or microsatellite instablility-High;
3. No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
4. MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
5. Age between 18-75 years;
6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
7. Has sufficient organ function:

   * Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L,
   * neutrophils ≥ 1.5 × 109/L
   * Liver function: ALT and AST \< 2.5 × ULN;
   * Renal function: serum creatinine \< 1.5 ULN;
8. Willing to participate and informed consent signed；

Exclusion Criteria:

1. An ARMS-PCR proven RAS wild type, BRAF mutation and microsatellite instablility-High;
2. Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;
3. Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;
4. Female patients who are pregnant or breastfeeding;
5. Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;
6. Patients with active infection;
7. Poor overall health status, ECOG ≥ 2;
8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;
9. Known hypersensitivity reactions to any investigational drugs;
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.


Eligibility Criteria:
Inclusion Criteria:

1. women 18-89 years of age
2. admitted for surgery lasting \>1 hour and requiring urinary catheter,
3. have normal urine analysis within 24 hours pre-surgery, and
4. able to provide informed consent.

Exclusion Criteria:

1. currently on dialysis,
2. chronic urinary infection,
3. hyperthyroidism,
4. current infection,
5. a history of allergy or sensitivity to iodine.
6. women who are pregnant or breast feeding
7. men due to their lower incidence of UTIs compared to the female population.
Enstilar in Combination With Biologic Agents

Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.

A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults ≥ 18 years of age.
2. Diagnosis of chronic plaque-type psoriasis.
3. Able to give written informed consent prior to performance of any study related procedures.
4. Treated with a biologic agent for a minimum of 24 weeks at baseline.
5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
6. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
7. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

1. \>5% Body Surface Area
2. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
3. Pregnant or breast feeding, or considering becoming pregnant during the study.
4. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
5. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
6. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
7. Patient received UVB phototherapy within 2 weeks of Baseline.
8. Patient received PUVA phototherapy within 4 weeks of Baseline.
9. Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
Hypoxia and Exercise in the Elderly

Ageing is the primary risk factor for most chronic diseases including type 2 diabetes mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic disease and frailty, which limits physical mobility as well as quality of life, share common cellular mechanisms.

The investigators will test the hypothesis that a combination of normobaric hypoxia and exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle dysfunction and the investigators will address the molecular mechanisms. In a randomized clinical study, the investigators will compare normoxic and hypoxic training conditions in elderly subjects. Outcome measures will focus on whole body insulin sensitivity and mitochondrial responses in skeletal muscle before and after the 8-week training intervention.


Eligibility Criteria:
Inclusion Criteria:

* 55 to 75 years of age
* body mass index: 20 - 35 kg/m2
* weight stable during last 6 months before screening (weight change \< 2% body weight)
* HOMA-index of insulin resistance ≥ 2 to 4 units

Exclusion Criteria:

* more than 1 hour of scheduled exercise training per week
* known diagnosis of type 2 diabetes or measured HbA1c \> 6,5%
* known drug or alcohol abuse
* any contraindication to perform exercise training
* acute or chronic infections
* increased bleeding risk by history, INR \> 1,3, use of anticoagulants
Safety and Efficacy of Pulmonary Vein Isolation Using Pulsed-field Ablation (PFA) Combined with Either PFA-based Left Atrial Posterior Wall Isolation or Vein of Marshall Ethanol Ablation in Patients with Persistent Atrial Fibrillation

This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with Persistent AF.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic persistent AF; 1st or redo ablation with PVI-only in the earlier procedure
* Willing to provide informed consent
* Age: 18-85 years

Exclusion Criteria:

* • Previous PWI or VoM ablation procedure

  * Left ventricular ejection fraction \<40%
  * Left atrial thrombus
  * Myocardial infarction within last 60 days
  * Cardiac surgery in the last 6 months
  * Advanced renal failure
  * Life expectancy \<1 year
  * Pregnant women
  * Unable or unwilling to provide informed consent
Self-sampling for Non-participants in an Organised Cervical Cancer Screening Programme

The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.

The CHOice trial is a parallel randomised controlled, open label trial. Participants will be equally randomised into three arms: 1) Directly mailed a second reminder including a HPV self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be ordered by e-mail, by text message, by phone, or by website; and 3) Mailed a second reminder for a conventional practitioner-collected sample (control group).

Eligibility Criteria:
Inclusion Criteria:

* Women resident in the Central Denmark Region who have not participate in cervical cancer screening after an invitation and one reminder

Exclusion Criteria:

* Women younger than 30 years are not included due to the lower specificity of HPV DNA tests in younger women
Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution

This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
* Planned removal of cataract
* Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception

Exclusion Criteria:

* Uncontrolled systemic disease
* History of incisional/refractive corneal surgery
* Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliation, or pigmentary glaucoma
* History of incisional glaucoma surgery or intraocular injections
* Other ocular diseases, pathology, or conditions
Single Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia

single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations

preoperative endoscopy was done and if hiatus hernia was present the patient is undergo single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures
Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?

Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.


Eligibility Criteria:
Inclusion Criteria:

* Patients in this study must have a resectable tumor of the head of the pancreas, and no evidence of distant metastasis or local vascular involvement. At the beginning of the study it's not necessary to have an accurate histologic diagnosis, the tumor might be malignant or benign. The patients also have jaundice with a total serum bilirubin level of 40-250µmol/l, and are fit enough to be considered for an early surgery.

Exclusion Criteria:

* Patients with ongoing cholangitis, neoadjuvant treatments or previous biliary drainage with stenting by means of ERCP or PTC (Percutaneous Transhepatic Cholangiogram) are excluded.
Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia

The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia.

This is a prospective, multi-center, non-randomized, observational registry designed to collect real world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia, including Singapore, Thailand and Vietnam. The primary objective of this registry is to assess clinical outcomes associated with the use of these devices in patients experiencing AIS due to large intracranial vessel occlusion within 8 hours of symptom onset. This registry may enroll up to 500 patients.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility Criteria:
Inclusion Criteria:

1. Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements.
2. Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries.
3. Subject has been or will be treated with a Medtronic market-released neurothrombectomy device as the initial device used to remove the thrombus.
4. Subject is willing to participate in a 90-day follow-up visit.
5. Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).

Exclusion Criteria:

1. Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis.
Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus

The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples.

Women accessing the Colposcopy Centres for a colposcopy examination and fulfilling the selection criteria will be asked, after written informed consent, to self-collect a first-void urine (with the Colli-Pee device) and a vaginal sample (with the FLOQSwab device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also take a cervical sample (with a Cervex-Brush using the same procedure normally adopted for cervical cytology and/or HPV testing. During colposcopy, a colposcopy-targeted biopsy may be taken if appropriate. When according to colposcopy and biopsy results, an excisional treatment of a cervical precancer lesion is needed, the histology of the excised tissue will complete the end point of the study. The colposcopy and histological findings will be used as the gold standard if biopsies are taken.

In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome.

Three new PCR-based HPV 'in vitro diagnostic devices' (Papilloplex, HPV Oncopredict RNA, HPV Oncopredict DNA) developed as part of the SME Instrument Project 'HPV OncoPredict (GA-806551)' will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Women referred to colposcopy evaluation for any reason \[i.e. previous history of abnormal cervical screen test results (cytology, HPV test), previous abnormal colposcopy\]
* Ability to understand and sign the informed consent
* Informed consent given

Exclusion Criteria:

* Age \< 25 or \> 65 years
* Past history of hysterectomy
* Women with known pregnancy
* Pregnancy within last 3 months
* Vulnerable patient: a patient who is or may be for any reason unable to take care of him or herself, or unable to protect him or herself against significant harm or exploitation
* Simultaneous involvement in any other research project
Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.

Objectives:

Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.

Secondary:

* To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in subjects with asthma.
* To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a requirement for emergency treatment of asthma, hospital admission for asthma or treatment with three or more days of oral corticosteroids (OCS) for asthma worsening.
* To assess the safety and tolerability of reslizumab in subjects with asthma.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* male or female subjects aged ≥ 18 to 75 years at time of screening
* female if she is of non-childbearing potential, or of childbearing potential and willing to use specific barrier methods specified in protocol
* confirmation of asthma
* symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥ 1.5
* requirement for treatment with high dose daily fluticasone and at least one other agent for the treatment of asthma not specifically excluded in the protocol
* requirement for \>/= 3% eosinophils in induced sputum at Screening

Exclusion Criteria:

* a clinically important event that would interfere with study schedule or procedure or compromise subject safety
* a diagnosis of hypereosinophilic syndrome
* an underlying lung disorder
* a current smoker
* use of systemic immunosuppressive agents within 6 months of study
* current use of systemic corticosteroids
* received attenuated live attenuated vaccines within three months prior to study entry
* expected to be poorly compliant with study drug, procedures, visits
* aggravating factors that are inadequately controlled
* participation in any investigational drug or device study within 30 days prior to study entry
* participation in biologics study within 3 months prior to study entry
* receipt of anti-human interleukin-5 (hIL-5) antibody within 6 months of study entry
* female subjects who are pregnant or nursing
* concurrent infection or disease that may preclude assessment of eosinophilic esophagitis
* concurrent immunodeficiency (human immunodeficiency \[HIV\], or acquired immunodeficiency syndrome \[AIDS\] or congenital immunodeficiency).
* current suspected drug and/or alcohol abuse