cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of glaucoma or ocular hypertension in both eyes
* Patient requires IOP-lowering in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* Contraindication to beta-andrenoceptor antagonist or brimonidine therapy
A Novel Functional Imaging Technique With FLT-PET/MRI For Staging, Response Assessment and Radiation Treatment Planning in Cervix Cancer

This pilot study aims to monitor early tumour response based on \[18F\]FLT-PET/MRI scans and to determine the feasibility of personalised radiotherapy to spare active bone marrow areas identified by \[18F\]FLT-PET/MRI. Bone marrow within the pelvis will be outlined by employing 18FLT PET to identify active BM within bony structures. Subsequently, treatment plans with various conformal radiotherapy techniques will be generated with different optimization approaches toward bone marrow while ensuring adequate tumor coverage.

Dosimetric comparison amongst plans will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice
* Histologically or cytologically confirmed cervical carcinoma
* FIGO staged IB to IVA
* Underwent MRI pelvis
* Underwent FDG-PET/CT or MRI abdomen or CT thorax and abdomen or Chest X ray for routine staging
* Planned for radical radiotherapy with or without chemotherapy
* No distant metastasis in staging work up
* ECOG 0-2
* Age 21 or over (no upper age limit)

Exclusion Criteria:

* Patients scheduled for neoadjuvant chemotherapy
* Patients with previous hysterectomy or radiotherapy to the pelvis
* Patients who are pregnant or lactating
* Patients who do not meet the above mentioned inclusion criteria
* Patients who refuse to give and/or sign the informed consent
* Patients who currently have a pacemaker
* Patients who have a history of serious adverse events related to a previous MRI or PET/CT
* Patients who are unable to undergo MRI scanning
* Patients with a known allergy against any component of the contrast enhancing agent
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the trial.
S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System

The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.

To overcome the potential drawback of the durable polymer a new generation of drug-eluting stent (DES) with a biodegradable polymer has been designed. The first-generation sirolimus-eluting or paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. More recently, second generation DES have been developed not only to improve long-term DES safety but also to facilitate the procedure by using a cobalt-chromium (Co-Cr) stent platform. Co-Cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform.

The Sahajanand Medical Technologies Pvt. Ltd. (SMT) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a Co-Cr stent platform. The purpose of this registry is to evaluate the Supraflex Family sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
3. Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care.
4. The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria:

1. Women with known pregnancy or who are lactating
2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
4. Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
Point of Care Ultrasonography In The Management of Shock: A Pilot Study

This project aims to determine the feasibility of conducting a randomized controlled trial investigating point of care ultrasound guided resuscitation compared with usual care in the management of shock at the Critical Care Trauma Centre (CCTC) in London Health Science Centre (LHSC).


Eligibility Criteria:
Inclusion Criteria:

Patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the following:

1. Lactate greater than or equal to 2.2 mmol/L
2. AKIN stage I or greater or Urine output less than 0.5 cc/hr
3. Altered level of consciousness due to shock or requiring invasive mechanical ventilation as a result of shock
4. Vasoactive agents required to maintain a mean arterial pressure greater than 65 mmHg.

Exclusion Criteria:

1. Pregnant patients
2. Participants who have already undergone a PoCUS study (as defined in the protocol for this study) within the past 48 hours
3. Participants who have restrictions on their goals of care at the time of ICU admission (including patients refusing blood products).
4. Patients post cardiac arrest who are not obeying commands
Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

This study sought to determine whether terbogrel was an effective treatment for primary pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.


Eligibility Criteria:
Inclusion Criteria:

* Primary pulmonary hypertension and New York Health Association (NYHA) chronic heart failure (CHF) functional class II-III
* Ability to walk \>= 50 meters on the 6 minute walk test
* Resting mean pulmonary artery pressure \> 25 mmHg
* Mean right atrial pressure \<= 20 mmHg
* Pulmonary capillary wedge pressure \<= 15 mmHg
* Cardiac index \> 2.5 L/min2
* SvO2 sat. \> 63%
* Male of female at least 18 years old
* Signed written informed consent

Exclusion Criteria:

* Secondary pulmonary hypertension due to lung or systemic diseases
* Pregnant of nursing women, or women of childbearing potential who are not using adequate methods of birth control
* Concurrent systematic use of aspirin, aspirin like drugs, or non-steroidal anti-inflammatory drugs (NSAIDs)
* Surgery of bleeding from gastrointestinal, genitourinary tract, cerebrum or retina within past 6 weeks
* History of bleeding diathesis or a platelet count less than 70,000/mm3
* Exercise limited by factors other than fatigue or exertional dyspnea, such as arthritis, claudication, angina, chronic obstructive pulmonary disease, or bronchial asthma
* Myocardial infarction, stroke, or transient ischemic attack within the preceding six months
* Systolic blood pressure \< 90 mmHg or \> 180 mmHg, or diastolic blood pressure \> 110 mmHg
* Known drug or alcohol dependency within one year of entry into the study
* Known hypersensitivity to any component of the study formulation, epoprostenol, nitric oxide, or adenosine
* Psychiatric or other illness or condition which, in the opinion of the principal investigator, may interfere with study participation, compliance, or other elements of the protocol
* Participation in an evaluation of an investigational drug within the past 30 days
* Portal hypertension or cirrhosis of the liver
* Congenital heart disease e.g., atrial septal defect; patent foramen ovale does not exclude patient from the study
* Appetite suppressants such as fenfluramine, dexfenfluramine, and inhibitors of serotonin uptake known to be associated with primary pulmonary hypertension, received within 3 months of entry into the study
* HIV positive
* Vasodilators. Patients will not receive Ca-channel blockers during the study unless the medication was started prior to the study and the patient has been on a stable dose for at least one month prior to entry
ICG and Blue Dye Guided Sentinel Lymph Node Biopsy in Patients Underwent Neoadjuvant Therapy

The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. The purpose of this study is to determine the detection rate and the false negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. This is a single arm clinical trial.

Patients indicated for neoadjuvant therapy would be recruited in this study. During the surgery, SLNB using the dual tracing method would be applied before axillary clearance. After the surgery, histological results of the SLN and non-SLN would be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for neoadjuvant therapy
* Have complete evaluation of the axillary status
* Planned for axillary clearance after neoadjuvant therapy

Exclusion Criteria:

* Sensitive to Iodine
* Inflammatory disease
* Patient's refusal to join the trial
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients prostatectomised (PT) due to histologically verified adenocarcinoma of the prostate gland who currently are not being treated, or expected within the next 8 months to be treated, with any anti-cancer treatment.
* ECOG performance status 0 or 1.

Exclusion Criteria:

* Patient has been treated with Androgen Deprivation Therapy (ADT), or expected to receive such treatment within the next 8 months from enrolment.
* Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator.
The Effects of Sandalwood Aromatherapy on Anxiety Levels of Pediatric

Aim of the study:

Evaluate the anxiety in the child before treatment. Detection of the sandalwood and lavender oil effect on dental anxiety.

Anxiety is a kind of emotional disorder associated with unexpected or considered dangerous situations. Physiological signs that can be observed are sweating, increased blood pressure, tachycardia, dry mouth, diarrhea, muscle tension, and hyperventilation. The prevalence of anxiety for worldwide dental patients is considered high, reaching 6-15% of the population and usually starting from childhood (51%) and adolescents (22%). A study showed that 25% of primary-school-age children undergoing dental treatment experienced severe anxiety, 50% moderate anxiety, and 20% mild anxiety.

Aromatherapy is a relaxation therapy media that uses aromatic essence extracts from plant parts. Aromatherapy is used to treat and improve physical and psychological health. Aromatherapy essential oil stimulates receptors in the nose, then the information is transmitted further to areas in the brain that control emotions and provide information to the hypothalamus, which is a regulator of the internal system of the body so that it reacts to stress.

Sandalwood is one of 22 species of the genus Santalum in the world and is a commercial species through Santalol oil that is widely used as a feedstock for aromatherapy. Sandalwood has a distinctive aroma. This aroma comes from the main content of sandalwood, Santa lol. The quality of sandalwood oil is determined by the content of a-santalol and P-santalol. a-santalol and P-santalol are sesquiterpene organic compounds. Through aromatherapy, sandalwood oil is widely used to relieve anxiety, stress, and depression. This oil has neuroleptic, calming, and bronchial dilatation effects.

This study aims to analyze sandalwood aromatherapy's effect on the anxiety level of pediatric patients undergoing dental treatment. The analysis was seen through three indicators of anxiety, namely systolic blood pressure, diastolic blood pressure, and heart rate per minute.

Eligibility Criteria:
Inclusion Criteria:

1. Egyptian children from 6 to 12 years old undergo primary tooth extraction.
2. Absence of any systemic problems, physical and mental disabilities.
3. Children intellectually sufficient to complete the anxiety scale and those whose parents were willing to participate in the study.
4. Frankel rating 3 in cooperation.

Exclusion Criteria:

1. Presence of dental or medical emergency and systemic disorders.
2. Special needs children.
3. Children with any respiratory tract illnesses, common cold, or allergy.
Prostate Cancer in Firemen: Early Diagnosis Because of Increased Diagnostic Pressure?

Firefighters, police, military personnel and pilots are all shown to have a higher incidence of prostate cancer than the general population. A possible explanation for this is that these four groups of employees need regular mandatory health-checkups. If these checkups increase the chances of having a PSA or DRE performed one could expect the workers in question to have a higher probability than the general population of being diagnosed with prostate cancer. If this is the case the four groups should have cancers that are lower grade and have better survival. The investigators wish to examine this by comparing the four groups with a control group made up of all other workers with regards to prognostic factors at the time of diagnosis and survival rates. This will be done by extracting data from the Cancer Registry of Norway, coupled with employment data from Statistics Norway. This study is also a part of a project on cancer in firefighters. If the prostate cancers in firefighters differ significantly from the other three specified groups, this could point to an exposure specific for firefighters, e.g. fire smoke, as an etiologic factor.


Eligibility Criteria:
Inclusion Criteria:

* All cases of prostate cancer as registered by the Cancer Registry of Norway

Exclusion Criteria:

* None
Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Growth Factor Receptor 2) Positive Gastric Cancer After Failure to Standard Care

BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Progressive or recurrent HER2/neu positive(IHC 1+≥) gastric cancer
* Received 1 or more chemotherapy or radiotherapy as prior therapy for progressive or recurrent tumor lesion
* At least 1 measurable lesion according to RECIST(ver 1.1)
* Ages above 19
* ECOG performance status between 0 to 2
* Patients meets the blood test standards in the screening test
* Patients meets the blood chemistry test standards in the screening test
* Patients who has agreed to a medically accepted contraceptive in this clinical trial
* Patients at least six months or more of survival can be expected
* Patients decided to participate in this clinical trial and signed written informed consent

Exclusion Criteria:

* Histopathology is a neuroendocrine or small cell carcinoma
* History of brain metastasis or signs of brain metastasis
* Clinical diagnosis of hepatitis C or hepatitis B
* Clinical diagnosis of human immunodeficiency virus (HIV)
* History of HIV infection
* Patients with heart failure, coronary artery disease(CAD) or Myocardial infarction in 6 month prior to screening. (LVEF is lower than 50% in screening visit)
* Administered the drug for other clinical trials within 4weeks before participate in this trial
* Administered any vaccines within 4weeks before participate in this trial (4 weeks for live vaccine, 2 weeks for other inactivated vaccine)
* Administered the granulocytes concentrates within 3 months before the screening visit
* Received chemotherapy or radiation therapy within 2 weeks before the 1st administration of investigational drug(BVAC-B)
* Received following formulation within 1 months before the screening visit : Chronic steroids(more than 5 days), immunosuppressant or immunomodulatory agents. G-CSF
* Patients who have participated in the clinical trial of a immunotherapeutic vaccine within 1 year or immunotherapy within 3 months before the screening visit
* Patients who is pregnant or breast-feeding
* Patients who researchers has determined that participation in the clinical trial is inappropriate
* Suspected to have other progressive cancer or malignant tumor needs treatment in 3 years. Completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma, cervical intraepithelial neoplasia are not included
Imaging Correlates of Renal Cell Carcinoma Biological Features

This pilot study is designed to evaluate imaging parameters indicative of underlying tumor biology. Patients with large renal masses (\>3 cm, or at the discretion of the investigator) who are planning to undergo nephrectomy will be identified, and recruited to undergo a contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography (MR-FDG-PET) scan.

This pilot study is designed to evaluate imaging parameters indicative of underlying tumor biology. Patients with large renal masses (\>3 cm, or at the discretion of the investigator) who are planning to undergo nephrectomy will be identified, and recruited to undergo a contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography (MR-FDG-PET) scan. Samples collected from their tumor after it is removed will undergo a variety of laboratory tests, including biomarker assessments and genotyping. By examining primary renal masses via a combination of MR and FDG-PET functional imaging in concert with tissue based tests, areas of hypermetabolism and hypervascularization will be evaluated as features of HIF activation or tumor subtype.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age (no upper age limit)
* Informed consent obtained and signed
* Clinically suspected RCC based on imaging performed prior to enrollment
* Planned nephrectomy schedule that can accommodate a MR-FDG-PET scan within 4 weeks prior to surgery
* Willing to undergo gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake by the tumor within 4 weeks prior to nephrectomy
* Willing to consent for genetic and proteomic analysis of tumor and germline nucleic acids
* Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI
* Breast feeding women cannot do so for 24 hours after FDG injection
* Patient is willing to fast for 4 hours, including avoiding any sugar-containing drinks.
* Patient is willing to drink at least 32 ounces of water (or other no-sugar-containing fluids) within 4 hours prior to arriving for scans.

Exclusion Criteria:

* History of severe reaction to gadolinium-enhanced MRI
* Poorly controlled diabetes mellitus
* Inability to tolerate PET and/or MRI
* Presence of pacemaker or intracranial aneurysm clip
* GFR \< 30mL/min as measured via Cockcroft-Gault equation
* Inability to lie flat for \>1 hour
* Pregnant female
* History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer, low risk prostate cancer, or other low risk tumor history at the discretion of the investigator.
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank

Generation of a common European database and biobank Continous assessment and implementation of guidelines and treatment protocols Establishment of a large observational cohort of chILD patients Determination the value of outcomes used in child Assess treatment variations used, deliver data from defined protocols and linked outcomes

Objective 1: Generation of a common European database and biobank. The existing national programmes to collect data on chILD in three countries (France, Germany, UK) will enable the consortium to swiftly adapt current frameworks to a functionally appropriate pan-European web-based database and biobank. Importantly, compatibility with ongoing United States chILD data base developments will be factored in.

Objective 2: Continuous assessment and implementation of guidelines and treatment protocols. Our Standards Working Group will convene regularly. Initial tasks will establish (a) specific diagnostic pathways, including detailed protocols for gathering clinical information, blood testing, imaging and pathology ("Best Practice Checklist"); (b) international panels of clinicians, geneticists, radiologists and pathologists who will review every diagnosis to quality control the data; and (c) detailed protocols for follow up to generate natural history data.

Objective 3: Recruitment of a carefully characterized cohort of chILD patients. European wide recruitment and interdisciplinary critical peer review of all diagnoses submitted from across Europe is imperative. Each case will be given a diagnosis independently; if no firm diagnosis is possible, we will review the case periodically as new information becomes available. During the first year of the study, clinicians´ decisions according to local practice and outcomes will be independently monitored and assessed.

Objective 4: Determine the value of outcomes used in chILD. We will systematically optimize and clarify the relative weight of a large spectrum of single and composite clinical outcomes (using both clinician and carer scoring), sequential limited chest CT (to minimise radiation exposure), lung function testing, histopathological categorization of lung biopsies, serum markers and genetic tests. Variability, reproducibility and the effects of training on reading images will be investigated.

Objective 5: Assess treatment variations used, deliver data from defined protocols and linked outcomes. This project will analyse in detail treatment and outcomes within and between subjects using data collected. Analysis of the collected data will enable us to support the definition of trial protocols planned in the future.

Eligibility Criteria:
Inclusion Criteria:

* all children with suspected or
* verified diagnosis of ILD or
* masquerading as ILD and
* those with rare localized parenchymal lung diseases

Exclusion Criteria:

* other indication as inclusion criteria