cyrilzakka/clinical-trials huggingface dataset:
Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.

Eligibility Criteria:
Inclusion Criteria:

* Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
* Patients with type I reactions defined by skin testing, antibody measurement, etc.
* Age over 6 years old

Exclusion Criteria:

* Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
* Subjects needed to wear contact lenses during treatment period on a testing eye
* Subjects complicating an eye infection
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a condition with several causes of which some remain unknown. It is believed that some types of CP may be genetic or passed down (inherited) from one generation to the next.

In this study, we are collecting genetic material and medical information to try to determine if genetic factors play a role in CP/CPPS. We will be collecting DNA (from Blood/Saliva sample) and urine from each participant. Bladder tissue from affected individuals will also be collected. Individuals and families with CP/CPPS will be enrolled. Family members of an individual with CP/CPPS are eligible whether or not they also experience CP/CPPS symptoms.

We would like to determine if chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has a genetic cause. We will be attempting to further describe the symptoms of CP/CPPS and to correlate them with changes in your genes. We will use several types of genetic testing; linkage analysis, whole exome sequencing and candidate gene studies. Each individual participant will be required to give a DNA sample (via Blood/Saliva), a urine sample and answer questionnaires. Affected participants will also be asked to provide a bladder sample from a clinical biopsy. All samples will be stored. Travel to Boston NOT required.

Eligibility Criteria:
Inclusion Criteria:

* Have symptoms for at least 3 months within the preceding 6 months:
* Pain in the pelvic area
* Urinary frequency and/or
* Urinary urgency and/or
* Sexual dysfunction (erectile dysfunction)
* Have CP/CPPS, Interstitial Cystitis (IC), Bladder Pain Syndrome BPS, or Bladder Fasciculation Syndrome (BFS)
* Be willing to provide a blood/saliva, bladder tissue (from previous biopsy) and urine sample
* Agree to complete several brief questionnaires
* Family member of someone with CP/CPPS, BPS, IC or BFS
* Live in the USA or Canada

Exclusion Criteria:

* Major structural/anatomical urinary tract abnormalities
* Underlying inborn or congenital conditions which affect the urinary tract
* Surgery/chemotherapy in the pelvic area
* Bacterial cause to CP/CPPS or recurrent Urinary tract infections (UTI)
* Traumatic cause to CP/CPPS
The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients (RIC-HD)

Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease. However, factors such as hemodynamic instability can lead to gradual loss of residual renal function (RRF) in HD patients. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patients' quality of life and survival. Unfortunately, there are currently no effective methods to protect RRF. The purpose of this study is to validate the protective effect of remote ischemic conditioning (RIC) on RRF in HD patients. This will provide evidence for the application of RIC in protecting RRF in HD patients.

Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease. However, factors such as hemodynamic instability can lead to gradual loss of residual renal function (RRF) in HD patients. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patients' quality of life and survival. Unfortunately, there are currently no effective methods to protect RRF. Remote ischemic conditioning (RIC) is a simple, safe, non-invasive, and non-pharmacological intervention. It induces the remote organs to develop an anti-ischemic injury capacity through repeated and brief ischemic stimuli on limbs, thereby reducing ischemic damage. RIC is a clinically feasible method that is easy to implement and promote. It has been widely used in the treatment and research of cardiovascular and cerebrovascular diseases, as well as in the prevention of acute kidney injury related to thoracoabdominal surgery and contrast agents. Studies have also found that RIC significantly reduces myocardial ischemic injury in HD patients. Theoretically, RIC can also be used to protect the RRF in HD patients. This study aims to validate the protective effect of RIC on RRF in HD patients. This will provide evidence for the application of RIC in protecting RRF in HD patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* First-time initiators of hemodialysis treatment for end-stage renal disease patients;
* Urine output \> 500ml/day or GFR \> 3ml/min/1.72m2;
* Hemodialysis access as a central venous catheter.
* Signed and dated informed consented is obtained;

Exclusion Criteria:

* Active infection;
* Infectious disease;
* Expected dialysis duration \< 6 months;
* Presence of vascular access dysfunction (blood flow rate \< 180ml/min);
* Patients who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities;
* Pregnancy or lactation women;
* Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
* Unwillingness to be followed up or poor adherence to treatment;
* Other circumstances that the investigator considers unsuitable for enrolment.
Internet-Behavioral Cough Suppression Therapy

The goal of this randomized, placebo-controlled, clinical trial is to develop and test the efficacy of an Internet-based behavioral intervention for refractory chronic cough. The main questions it aims to answer are:

* What are the best recruitment pathways to find people living with refractory chronic cough in Montana?
* Is Internet-Behavioral Cough Suppression Therapy (iBCST) efficacious?
* Do iBCST participants find it satisfactory?
* Is using Hyfe research app to monitor cough frequency feasible in rural areas?

Participants will complete iBCST or a placebo treatment virtually. Some participants will take part in qualitative interviews and use Hyfe research app for ambulatory cough frequency monitoring.


Eligibility Criteria:
Inclusion Criteria:

* No barriers to using a computer or smartphone (e.g., no significant fine motor or visual problems).
* Internet and e-mail access and the ability to use it.
* Suffering from a cough lasting at least eight weeks that is:
* Largely unproductive (cough up no more than a few teaspoons worth of clear or white sputum or mucus in a 24-hour period).
* Report of cough triggered by identifiable stimuli including and not limited to any combination of the following: cold air, talking, laughing, taking a deep breath, exercise, crumbly foods, strong smells or odors, fumes from paint or cleaning sprays.
* Often preceded by the sensation of an urge-to-cough (e.g., tickle or itch) at the level of the throat.
* Self-report of receiving the following assessments for current cough symptoms with unremarkable results:
* Physical evaluation by at least one physician.
* Chest x-ray.
* Willingness to avoid other potential cough treatments during the course of the study (or alert study personnel if alternative treatment is implemented out of necessity).

Exclusion Criteria:

* Current smoker of any substance.
* Diagnosis of any of the following:
* Respiratory disease (e.g., chronic obstructive pulmonary disease, asthma)
* Neurogenic disease (e.g., Parkinson's disease, cerebrovascular disease)
* Head and neck cancer
* Self-report of difficulty swallowing since having chronic cough
* Use of the following medication:
* Angiotensin-converting enzyme inhibitor (ACE-I) in the past four weeks: benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik).
* Use of a neuromodulator medication in the past 48 hours: Neurontin (Gabapentin) and amitriptyline.
* Individuals with dysphonia (abnormal voice; either self-reported or perceived by study personnel during enrollment interview) will be excluded unless they have had a normal laryngoscopy (endoscopic assessment of the larynx) by an otolaryngologist (ENT) within the past year specifically for their cough.
Intraoperative Hyperspectral Imaging for Fluorescence Guided Surgery in Low Grade Gliomas

The purpose of this study is to obtain images of brain tumours during surgery using a new type of surgical camera. The study will assess how the information obtained from the images during surgery matches the removed tissue. Data will also be used to develop the system's key computer-processing features. This will enable real-time information to be given to the surgeon whilst they are performing the procedure and has the potential to make neurosurgery safer and more precise.

High grade gliomas (HGG) and low grade gliomas (LGG) are the commonest CNS cancers, with LGGs accounting for 6.4% of all adult cases (Ostrom 2019). Despite LGGs typically being slow-growing, over 70% of them transform into higher-grade tumours or become aggressive within a decade (Jooma 2019). Median survival for LGG patients spans 5.6 to 13.3 years (Brown 2019). Gross total resection (GTR) improves 5-year LGG survival rates from 60% to 90% when compared to subtotal resection. However, GTR (\>96% tumour removal) is frequently not achieved because despite advanced techniques being available, surgeons are unable to clearly visualise the tumour and its boundaries in real-time during surgery.

There is an acute need to improve outcomes for affected brain tumour patients. Patients undergoing surgery have significantly improved outcomes and increased life expectancy if complete tumour removal is achieved. However, close to 30% of patients are left with residual tumour tissue after surgery. Successful surgery indeed mandates maximal safe tumour removal: surgeons need to avoid damaging sensitive areas that undertake vital functions and preserve crucial nerves and blood vessels. Even with the most advanced current techniques, it is not possible to always identify tumour and critical structures reliably during surgery. Furthermore, because one cannot objectively measure the blood supply and oxygenation of brain tissue during surgery, it is difficult to judge if injury is being caused during the operation.

To address the pressing clinical need of improved surgical precision and patient safety during low grade glioma surgery, we aim to develop an imaging system capable of quantitative wide-field fluorescence imaging for seamless real-time surgical guidance. This project aims to improve patient survival by delivering a precise assistive tool for neurosurgeons performing LGG surgery by evaluating this device in patients undergoing glioma surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and over
* Patients with a diagnosis of a probable glioma (any grade), who are scheduled for elective surgery
* Patients able to provide written informed consent

Exclusion Criteria:

* Patients under 18 years of age
* Patients who have previously had brain surgery
* Patients unable to provide written informed consent
Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital

The "Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest (IVIO)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. The intraosseous group will be further randomized to humeral vs. tibial access. The trial will be conducted in the Central Denmark Region. The primary outcome will be sustained return of spontaneous circulation, and 762 patients will be included. Key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Out-of-hospital cardiac arrest
2. Age ≥ 18 years
3. Indication for intravenous or intraosseous vascular access during cardiac arrest

Exclusion Criteria:

1. Blunt or penetrating traumatic cardiac arrest
2. Prior enrollment in the trial
3. Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site
RCT of Health-promoting Intervention for Older Foreign-born Adults

The overarching aim with this study was to develop, implement and evaluate a health promoting programme for people from Finland or the Western Balkan region, who were 70 years of age or older and independent daily activites (1). The aim of the programme was to prevent or delay dependence in daily activities, health decline, and frailty. The study focused on both evaluation and implementation and the data collection finished in 2016

The study has developed tools for collaboration between the target group, staff and researchers, as well as with tools to bridge barriers to health promotion. For example, alternative ways to recruit participants and to collect and analyse data in studies with and for people who are ageing in a migration context.

The findings describe how a person-centred approach could be used to make use of the resources of the target groups, and visualise methods to bridge linguistic barriers. The education material from Older people in the risk zone has also been translated to Bosnian Serbo-Croatian and Finnish.

Eligibility Criteria:
Inclusion Criteria:

* Foreign-born from Finland or any of five countries in the Western Balkans (Bosnia-Herzegovina, Croatia, Macedonia, Montenegro, and Serbia)
* 70 years of age or older
* Living in Angered, Gothenburg
* Living in their ordinary housing
* Not dependent on informal or formal help in daily activities

Exclusion Criteria:

* Impaired cognition, Mini Mental State Examination (MMSE) below 80% of administered items
Validation of Novel BTE and SP Hearing Aid Models

Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super power) BTEs.

During this study each participant will be asked to wear a set of BTE hearing aids home and wear them daily. We will be assessing their evaluation of the BTEs during and after their home field trial. They will be asked to report on their use with different apps/accessories. Subjective performance ratings will be collected.

Eligibility Criteria:
Inclusion Criteria:

* hearing aid candidacy (N2-N7 hearing loss)
* healthy outer and middle ears
* ability to complete questionnaires
* willingness to use smartphone
* informed consent documented by a signature
* willingness to wear a binaural BTE fitting
* willingness to use app and accessories
* willingness to adhere to COVID protocols

Exclusion Criteria:

* contraindications to the MD in this study: known hypersensitivity or allergy to investigational product/earmold
* limited mobility/not able to attend appointments
* limited ability to describe listening impressions/experiences
* inability to produce a reliable hearing test result
* limited dexterity - to point that participant cannot manage hearing aid insertion/removal
* known psychological disorders
Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)

RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer

OBJECTIVES:

Primary

Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.

Secondary

Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.

Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically.

After completion of study therapy, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were required to have histologically or cytologically documented
2. NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
3. No previous history of radiotherapy and surgery of brain
4. good response( CR/PR) to Erlotinib or Gefitinib.
5. Agree to radiotherapy
6. age \> 18 and \<75 years,ECOG performance status 1 or less
7. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB\>=80g /DL) functions
8. Have provided informed consent

Exclusion Criteria:

1. Seizure cannot be controled by the drugs
2. Combined with other disease of the brain such as tumour or infarction
3. Hypersensitivity to MR enhancer -
Comparative Study for the Validity of Various Severity Scoring System

Scoring systems for use in intensive care unit (ICU) patients have been introduced and developed over the last 30 years. They allow an assessment of the severity of disease and provide an estimate of in-hospital mortality

Severity scoring systems that are commonly used in critical care settings include Acute Physiology and Chronic Health Evaluation (APACHE), which was developed in the 1980s for predicting mortality, Simplified Acute Physiology Score (SAPS), and Mortality Probability Model (MPM). Although these scoring systems use different variables and weights for the classification of disease severity, they commonly monitor parameters such as heart rate, blood pressure, neurological state, and clinical data as these factors significantly deviate from physiological normality in the progression of critical disease. Old age and chronic disease are also captured by the scoring systems. Sequential Organ Failure Assessment (SOFA) score, which is based on organ failure over time to evaluate morbidity and multiple organ dysfunction is also used.

Eligibility Criteria:
Inclusion Criteria:

* newly admitted patients to the Surgical Intensive Care Unit with head trauma multiple trauma craniotomy sepsis preeclampsia - eclampsia postop. for vascular surgery

Exclusion Criteria:

less than 16 years old, readmitted to the ICU during the study period as only the first admission will be considered, ICU length of stay (LOS) less than 24 h
Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma

This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven renal cell carcinoma with metastases
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

Exclusion Criteria:

* Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma
* History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan
Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia

This study will explore whether ZIKV is currently responsible for neurological complications, and particularly microcephaly, in Aedes-infested regions of Sub-Saharan Africa (SSA) and Asia. This will inform regional public health strategies, such as vaccination of women of child-bearing age. It will also demonstrate the public health impact of ZIKV infection and increase the understanding of other regional infectious (e.g. cytomegalovirus) causes of microcephaly.

This study will last for 2 years, and will include only new cases of microcephaly.

Surveillance will take place in large maternities in urban areas (standard procedure)

* In each city, \~3000 live births per month will be monitored, so that on average one microcephaly will be diagnosed per month per city (i.e., 24 per city in 2 years)
* Microcephaly is defined as less than -3 standard deviation (SD), according to the INTERGROWTH standards by age and sex with abnormal ultrasound and/or clinical examination.

Data collection (study activity)

* A questionnaire with demographic, exposure and pregnancy details for all mothers Clinical exam and laboratory testing (standard procedure and study activity)
* Various biological samples (e.g. blood, placenta) will be collected from mothers and newborns/fetuses and tested for presence of ZIKV, and for other infectious (e.g. rubella, cytomegalovirus) causes of microcephaly
* Physical, neurological, hearing and visual examinations for all live births will be performed where possible.

Analysis and reporting (study activity)

o All results will be shared publically through conferences and peer-reviewed publications.

Eligibility Criteria:
Inclusion Criteria:

* All infants or fetuses with microcephaly, (defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex, detected during the mother's pregnancy, or at the end of the mother's pregnancy at one of the participating maternities)
* and with abnormal ultrasound and/or clinical examination findings for newborns.

Exclusion Criteria:

* Infants/fetuses with microcephaly whose mothers are under the age of 18 years,
* or inability or refusal of mothers/ guardians to give informed consent.