cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study


Eligibility Criteria:
Inclusion Criteria:

* Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp
* Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control
* Free of any systemic or dermatological disorder
* Any skin type or race, providing the skin pigmentation will allow discernment of erythema

Exclusion Criteria:

* Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)
* History of cutaneous hyperreactivity or facial irritation to topical products
* Engaging in activities involving excessive or prolonged exposure to sunlight
* Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry
* Currently using or have used systemic steroids 2 months prior to study
* Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization
* Pregnant or nursing mothers
* History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation
* Taking immunosuppressant medication
ETI During Spinal Trauma

The aim of this study was to compare time, success rates of different tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized manikin model.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
The IMPACT PAD Study

Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment

Endovascular treatment for peripheral arterial disease is commonly performed for claudication or critical limb threatening ischaemia (ischaemic rest pain, foot ulcer or gangrene). Disease is generally identified using Ankle Brachial Pressure Index or Toe Brachial Pressure Index and then lesions delineated using Doppler ultrasound or CT angiography. Clinical severity is staged using absolute walking distance (metres) in claudicants or the Society for Vascular Surgery wIfI (wound, ischaemia, foot infection) score in critical limb threatening ischaemia patients.

Intra-procedural lesion assessment and quality control is currently performed anatomically using angiography alone, with a few centres using pullback pressures across a lesion to give supplementary trans-lesional gradients or intravascular ultrasound (IVUS) to give pre and post intervention diameter and vessel area measurements. No direct or quantitative assessment of flow, or pressure normalisation across lesions is currently performed during interventions to improve blood flow to the leg.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Peripheral arterial stenosis scheduled for endovascular treatment

Exclusion Criteria:

* \< 18 year of age
* Unable to give informed consent
* Estimated GFR ≤30 mL/min
* Dialysis dependent
* Unable to receive antiplatelets or periprocedural anticoagulation
* Pregnancy or breastfeeding
* Contraindication to adenosine (severe asthma or COPD)
* WIfI ulcer score \<2 (no exposed bone)
* WIfI infection score \<2 (skin and subcutaneous tissues only)
* WIfI gangrene score \<3 (limited to digits)
* COVID-19 positive
* NYHA IV heart failure
* Contra-indication to adenosine including arrhythmia, asthma or allergy
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have failed or are intolerant to anti TNFs
* hsCRP greater or equal to 5.0 mg/L
* Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening

Exclusion Criteria:

* Pregnant or breastfeeding women
* Crohn's Disease with active fistulae or abscess
* History of diverticulitis or symptomatic diverticulosis
* Abnormality in hematology or chemistry profiles at screening
Glucolipotoxicity and Type 2 Diabetes

Elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory function of the pancreas. This is known as glucolipotoxicity. However, few studies have examined this in detail. This investigation will examine pancreatic insulin secretory function in physiological models of glucolipotoxicity such as obese and type 2 diabetic individuals. Furthermore, healthy subjects will undergo 24 hour infusion of glucose or Intralipid to induce experimental models of glucolipotoxicity. Insulin secretion in response to intravenous infusions of glucose, GLP-1, GIP, and arginine and in response to meal ingestion, will be examined. the investigators hypothesize that experimental glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that seen in type 2 diabetics.


Eligibility Criteria:
Inclusion Criteria:

* normal glucose tolerance based on screening OGTT or
* diagnosed type 2 diabetic (confirmed with OGTT)

Exclusion Criteria:

* insulin dependent diabetes
* age \<18 or \>65 years
* BMI \<20 or \> 35 kg/m2
* evidence of hematological, pulmonary, hepatic, renal, or cardiovascular disease
* actively undergoing weight-loss (\>2kg change in last 6 months)
* bariatric surgery (gastric by-pass or banding)
* pregnancy
* smoking
A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

To demonstrate the efficacy of dinoprostone vaginal insert (DVI) for cervical ripening success (either bishop score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at term (≥ 41 weeks 0 day and ≤ 41 weeks 6 days of gestation) at the Baseline visit
* Candidate for pharmacologic induction of labour
* Singleton pregnancy with live infant in vertex presentation
* Baseline BS ≤ 4 at the Baseline visit
* Parity ≤ 3 (parity is defined as one or more births live or stillbirths after 22 weeks 0 day gestation)
* Written informed consent

Exclusion Criteria:

* Women in labour
* Presence of uterine or cervical scar including scar from previous caesarean section, and previous cone biopsy of the cervix and loop electrosurgical excision procedure (LEEP)
* Uterine abnormality e.g. bicornuate uterus
* Administration of oxytocin, any cervical ripening or labour inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to IMP administration. Magnesium sulfate is permitted if prescribed as treatment for preeclampsia or pregnancy induced hypertension
* Presence of the following conditions/symptoms:

Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 110 mmHg. Platelets \< 100,000/µL. Increased liver function tests (2x upper limits of normal range). Severe, persistent right upper quadrant/epigastric pain. Progressive renal insufficiency: Creatinine \> 1.1 mg/dL, Doubling of creatinine in the absence of other renal disease. Pulmonary edema. New onset cerebral or visual disturbances

* Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation
* Diagnosed congenital abnormalities, not including polydactyly
* Suspected or confirmed intrauterine growth retardation (≤ 1.5 SD of mean normal estimated fetal weight for dates)
* Any evidence of fetal compromise at baseline visit (e.g., non-reassuring fetal heart rate pattern, meconium staining, history of non-reassuring fetal status or abnormal umbilical artery Doppler wave form)
* Intake of medication with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) at baseline visit
* Ruptured membranes
* Suspected clinical chorioamnionitis
* Current pelvic inflammatory disease, unless adequate prior treatment has been instituted
* Fever (axillary temperature ≥ 38.0 °C) at the Baseline visit
* Any condition in which vaginal delivery is contraindicated (eg., placenta previa or any unexplained vaginal bleeding at any time after 24 weeks 0 day during this pregnancy)
* Known or suspected allergy to, dinoprostone other prostaglandins or any constituent of IMP
* Any condition urgently requiring delivery
* History of asthma or glaucoma
* Unable to comply with the protocol
* Any other medical condition which in the judgement of the investigator would impair participation in the trial
IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery

IV and included steroids have produced the same length of block prolongation in adults as if the steroid was given with the nerve block. Clinically, this has not be noticed in children. The objective of this study is to examine this in young patients. The investigator will blindly give the steroid either in the IV or in the block solution (perineural). This is a prospective double blind study.

The subject has a 50/50 chance of receiving either cohort. After the subject is randomized to receive either steroid given IV or with the nerve block, the subject is anesthetized and the subject will receive either an IV injection of 5 cc steroids or placebo, and 20 cc local anesthetic plus placebo or steroid in the nerve block, the block will be placed under ultrasound to insure proper placement of block, the dose of steroid is based on weight, 0.1 - 0.15 mg/kg. The investigator will record the time of block and IV injection. The subjects will be called by the study PI after 24 hours to determine the time of duration and again at 48 hours if needed. This is a randomized, double blind study, neither the subject or the anesthesiologist giving the injection will know what is being given. The medications will be prepared and dispensed by the Research pharmacist, a randomization chart will be obtained by the research pharmacist.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to have a lower limb Orthopedic surgical procedure.
* Scheduled to have a nerve block placed for post operative analgesia.
* American Society of Anesthesiologist (ASA) Class I - III.

Exclusion Criteria:

* Not scheduled to have a nerve block placed for post operative analgesia.
Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.


Eligibility Criteria:
Inclusion Criteria:

* A clinical decision has been made, prior to study enrolment, to prescribe Esbriet
* Participants who are newly prescribed Esbriet therapy
* Initiation of Esbriet therapy is not more than 30 days prior to study enrolment

Exclusion Criteria:

* Participants receiving an investigational agent defined as any drug that has not been approved for marketing for any indication in the country of the participating site
* Participant has received Esbriet therapy 30 days or more prior to current treatment course (e.g., prior participation in clinical trials)
* Participant has any contraindication for the use of Esbriet, according to the current local version of the Summary of Product Characteristics (SPC)
Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter

Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma which is cleaned by filtration. This study comprises the recording of safety and efficacy data from patients treated either with the DALI or MONET-system over a period of 2 years.

Data were recorded from patients suffering from familial hypercholesterolemia and treated by lipid apheresis using one of the two systems investigated for at least 3 months prior to inclusion in the study. Only those treatments were documented in which routine blood samples for laboratory analysis were taken, or in which adverse or serious adverse device effects occur.

Eligibility Criteria:
Inclusion Criteria:

* given informed consent
* 18 years or older
* patient compliant to therapy as prescribed
* at least two therapy sessions per month
* treatment with DALI or MONET system for at least 3 months before inclusion
* last severe invasive intervention in hospital more than 3 months ago

Exclusion Criteria:

* earlier participation in the study
* unconscious patient/persons without capacity to contract
* for DALI: intake of ACE-inhibitors
Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
* Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

Exclusion Criteria:

* Small cell lung cancer (SCLC) or mixed SCLC and NSCLC
* Central nervous system (CNS) metastases
* Malignancy other than NSCLC
* Palliative radiotherapy for bone lesions inside the thorax
* Prior radiotherapy of bone marrow
* Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Life expectancy \< 6 months
* Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
* Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
* Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
* Other inclusion/exclusion criteria may apply
Epidemiology of Schizophrenia in Bulgaria

The purpose of this study is to provide accurate, reliable information on schizophrenia clinical management in order to detect unmet medical needs of this disease in terms of:

* Patient characteristics.
* Diagnostic and treatment approaches: initial and subsequent.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia
* Above 18 years
* Signed Informed consent

Exclusion Criteria:

* Below 18 years
* Consent refused
RWE of Brentuximab Vedotin Consolidation in Patients With RR HL Who Receive Salvage Chemotherapy and ASCT

This is a multicenter, observational real world study with prospective follow up that will evaluate the treatment approach in patients with relapsed/refractory cHL who undergo ASCT in Argentina.

The purpose of the study is to gather real world evidence of the proportion and characteristics of patients with relapsed refractory cHL who undergo ASCT, who receive consolidation with BV, and to study the factors that determine BV consolidation after ASCT in real world setting.

This study will evaluate the treatment approach in patients with relapsed/refractory cHL who undergo ASCT. All consecutive adult patients with relapsed/refractory cHL who undergo ASCT, regardless of the prior indication to receive or not BV consolidation therapy, will be included in this study and prospectively followed according to local practice.

Patients will be treated and monitored by their physicians according to local clinical practice and guided by the local approved label for patients receiving BV consolidation. Usual follow-up will be determined by the treating physicians' standards of care, and no scheduled patient visits are required for the conduct of this study. There are no visits or specific procedures planned by protocol, however, baseline and follow up data will be gathered every time the patient's response to treatment is assessed or has a medically important event.

All patients that undergo ASCT will be included in final analysis of the primary objectives (Full study population). Patients that receive BV consolidation or not (Non-BV consolidation) will be included in the analysis.

Patients included in the study are expected to be recruited during 24 months and followed up to progression, death, lost to follow or end of study (12 months after the inclusion of the last patient), whatever occurs earlier.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older.
* All patients with histologically confirmed cHL who are primary refractory or relapse and receive ASCT as part of their salvage therapy.
* Signature of the form consent for participation in the study.

Exclusion Criteria:

* Patients with Relapsed/Refractory cHL not suitable for ASCT.
Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy

DEEPLY aims to improve sarcoma therapy by the development of an innovative nanophotonic delivery approach to be applied in the future as an integrated local therapy for patients with inoperable tumors or with oligometastases. The major aim of the project is the development of innovative nanocarriers loaded with chemotherapeutic agents, whose delivery will be improved by the use of an optic fiber (optoporation). After the synthesis, and characterization of NPs, a prototype will be produced and preclinically validated on patient-derived biological material. This wide comprehensive methodological approach will ensure the obtainment of robust data to be faster exploited toward clinical applications.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for the study will be male or female, with an age ranging from 0- to 85 years, undergoing surgery or biopsy for STSs or BSs including osteosarcomas.
* Included patients may have undergone or may be still in treatment with chemotherapy (also neo-adjuvant settings), targeted therapy, radiotherapy, or combination therapy.
* IRST will enroll only adult patients (age \&gt; 18 years).
* Signed informed consent from all subjects enrolled in the study. IOR patients will have to sign both the specific project Informed Consent and the IOR Biobank Informed consent.

Exclusion Criteria:

* Patients not affected by STSs or BSs will be excluded from the study, as well as patients with multiple primary tumors.
The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection

The LIVER (Local Infiltration Versus Epidural after Liver Resection) and LIVER 2 (Local Infiltration Versus Epidural after Liver Resection 2) studies were randomised controlled trials that compared epidural analgesia with local anaesthetic wound infiltration as post-operative analgesia in patients undergoing open liver resection.

The overall findings of this trial were of similar rates of morbidity and pain control post-operatively but a reduced recovery time for the wound catheter group. As a result, wound catheter local anesthetic infiltration has become increasingly utilized in this unit and within other units throughout the country and worldwide.

Epidural use has been associated with improved long term outcomes following abdominal cancer surgery. This study is therefore a long term follow up study of the LIVER and LIVER 2 trials to assess survival between the two groups.

The LIVER and LIVER 2 studies were randomised controlled trials that compared epidural analgesia with local anaesthetic wound infiltration as post-operative analgesia in patients undergoing open liver resection.

The overall findings of this trial were of similar rates of morbidity and pain control post-operatively but a reduced recovery time for the wound catheter group. As a result, wound catheter local anesthetic infiltration has become increasingly utilized in this unit and within other units throughout the country and worldwide.

There has been some evidence however, that epidural analgesia post-operatively can have a positive impact on long term survival in patients undergoing abdominal surgery for cancer. The reasons for this are not well established but it is proposed that the protective effect against the immunosuppression following major surgery that epidural has can aid in the cancer prevention process. There remains no randomised controlled trials looking at this subject in open liver surgery.

The aim of this study is to assess the overall and disease free survival of the patients who participated in the LIVER and LIVER 2 trials.

The primary outcome is 5 year overall survival. Data will be observed from electronic (or non electronic) patient records, information and statistics department data and general practice records as required.

Overall survival at 1 and 3 years Disease free survival at 1, 3 and 5 years (Data will be observed from Lothian hepatobiliary multi-disciplinary team meeting data and follow up CT/MRI scan dates)

Median overall and disease free survival Survival according to individual pathology subgroups.

Participants will be identified from study records of the LIVER and LIVER 2 trials. This will be performed by the two study investigators.

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in the LIVER and LIVER 2 trials who had diagnoses of a malignancy and underwent liver resection for this malignancy.

Exclusion Criteria:

* Patients who had liver resection for benign disease. Patients who participated in the LIVER/LIVER2 trials but who did not undergo resection.