cyrilzakka/clinical-trials huggingface dataset:
The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis

In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily practice. The hypothesis is that Pirfenidone will decrease cough and increase quality of life.

Rationale: Idiopathic Pulmonary Fibrosis (IPF) is a progressive fibrotic lung disease of unknown cause with a median survival of 3-5 years. No curative treatment exists, though in 2011 Pirfenidone was approved for the treatment of IPF as it appeared to slow down the decline in lung function. In patients with IPF, the most common symptoms are cough and breathlessness. Cough is not only a major distressing and disabling symptom but also an independent predictor of disease progression and death in IPF. Recent preliminary data suggest a possible effect of Pirfenidone on cough.

Objective: In this study we want to objectively measure the effect of Pirfenidone on cough in patients with IPF that are treated with Pirfenidone in daily practice .

Study design: This is a prospective, observational, international multicenter study.

Intervention: Objective 24-hour cough frequency will be recorded using the Leicester Cough Monitor (LCM), a validated ambulatory cough monitoring system, prior to starting with Pirfenidone treatment. The cough recording will be repeated at 4 weeks and at 12 weeks during treatment with Pirfenidone. At the days of cough recording, patients will be asked to fill in questionnaires related to cough and to quality of life. Patient will be treated according to normal clinical practice at their Physician's discretion.

Main study parameters/endpoints: The primary endpoint is change in cough frequency measured by the Leicester cough monitor at week 12 compared to baseline. Secondary endpoints look at the relationships between cough, change in cough, quality of life and clinical parameters.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPF according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria (5), definite and probable patients will be eligible
* Written informed consent
* Daily cough related to IPF (exclusion of other causes) present \> 8 weeks
* cough score on visual analogue scale of ≥ 40 mm.
* Carbon monoxide transfer capacity corrected for hemoglobin (TLCOc) ≥ 30% and Forced Vital Capacity (FVC) ≥ 50%
* Pirfenidone therapy about to be initiated
* if a history positive for Gastro Esophageal Reflux (GER), using proton pump inhibitor (PPI) \> 4 weeks

Exclusion Criteria:

* Opiates, antitussive medication, antihistamines, steroids \> equivalent of 10 mg prednisone or N-acetylcysteine (NAC) within two weeks before study
* Change of steroid \< 10 mg, inhalation steroids within 2 weeks of the study - History of bronchial hyper responsiveness or asthma or relevant airway obstruction (FEV1/FVC \< 0.7)
* within 6 weeks of the start signs of respiratory tract infection, change of sputum production and fever.
Using Text Messages to Boost COVID-19 Vaccine Booking Rate

This study is a nationwide randomised controlled trial (RCT) to test the impact of behavioural science-informed text messages notifying patients of their eligibility for the COVID-19 vaccine on vaccination rates.


Eligibility Criteria:
Inclusion Criteria:

* (i) satisfying the age criteria as defined above;
* (ii) recorded in the National Immunisation Management System (NIMS);
* (iii) with a valid mobile phone number;
* (iv) who had not already received or been invited for the COVID-19 vaccine via NIMS at the time of the study.

Exclusion Criteria:

* Participants with invalid phone numbers
Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients

This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy.

Phase 1b open label, single-arm, dose-escalating investigation of safety and efficacy of a gadolinium (Gd) and peptide based MRI contrast agent (MT218) as an extradomain-B fibronectin (EDB-FN) targeted molecular MR contrast agent to detect aggressive prostate cancer with comparison of its results with the standard-of-care mutliparametic MRI (mpMRI) and PSMA PET/CT and histopathology validation in preprostatectomy patients diagnosed with prostate cancer in their clinical care.

Eligibility Criteria:
Inclusion criteria

* Male subjects aged \>18 years.
* Patients with confirmed Gleason score of 8 - 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy.
* Ability to lie still for MRI scanning.
* Patients must be able to provide written informed consent.
* Glomerular filtration rate (GFR) \> 60 mL/min within a 30 days of the research MRI.

Key exclusion criteria

* Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease.
* Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections.
* Patients with uncontrolled diabetes or hypertension.
* Patients with active non-prostate malignancy.
* Patients with contraindications for MRI including implantable pace makers, cochlear implants.
* Patients with uni- or bilateral hip prosthesis.
* Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments.
* Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy.
* Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result.
* Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection.
* Is determined by the investigator that the patient is clinically unsuitable for the study.
* Is incapable of understanding the language in which the information for the patient is given.
* Participation in a concurrent clinical trial or in another trial within the past 30 days.
3D Time-of-Flight Magnetic Resonance Angiography in Hemodialysis Patients With Arteriovenous Fistula

This study is aimed to assess the value of three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) in hemodialysis patients with occlusive disease in arteriovenous fistula (AVF). All participants will receive 3D-TOF-MRA and ultrasound to detect the stenosis degree of AVF.

The Principle of 3D-TOF-MRA is based on the "flow effect" of MR. In the GE sequence of MRA imaging, the effect of RF pulses makes the protons in the stationary tissue in the active layer in a saturated state, and the longitudinal magnetization disappears. When the inflow blood appears, its protons are in an unsaturated state and have a high degree of longitudinal magnetization. In this way, a clear difference is formed between saturated tissue and unsaturated flowing blood to display blood vessels. Therefore as a non-invasive and safe method for diagnosing vascular diseases, 3D-TOF-MRA is used widely in cerebrovascular diseases. However, there are currently no studies using 3D-TOF-MRA to diagnose arteriovenous fistula (AVF) stenosis in hemodialysis patients. This project plans to use 3D-TOF-MRA to detect AVF stenosis in hemodialysis patients to provide a safe and effective diagnostic method for patients with end-stage renal failure.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patients suspected of occlusive disease in arteriovenous fistula (AVF);
* persistent edema of the limb with the fistula;
* decreased pulse or fremitus in anastomotic astium
* increase in venous pressure; blood flow at the access of less than 200 mL/min;

Exclusion Criteria:

* previous endovascular recanalization with stent or graft placement;
* contraindications to magnetic resonance imaging (MRI) examination;
* platelet(PLT)\<60\*10\^9/L or international normalized ratio (INR)\>1.5; 4. important organ function failure or other serious illness; 5. Allergic to antiplatelet drug, anticoagulant drug, anaesthetic drug and contrast material.
Analysis of Screen-detected Lung Cancers' Genomic Traits

Prospective, observational cohort study of patients undergoing surgical resection for low dose CT (LDCT) screen-detected lung cancer (detected through the SUMMIT study- ClinicalTrials.gov Identifier: NCT03934866/ lung screening programmes), in which translational research is a fundamental aspect.

The ASCENT study seeks to examine the genomic signatures of screen-detected cancers, in order to categorise the biological behaviour of such lesions and correlate this against non-invasive biological and radiological parameters. From these data, the plan is to explore strategies to characterise LDCT-detected cancers through non-invasive means, which the researchers believe may prove key in mitigating potential screening-associated harms.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with confirmed lung cancer or probable lung cancer via LDCT screening.
2. Planned for, or completed primary surgical resection either for histologically confirmed lung cancer, or strongly suspected lung cancer.
3. Able to provide written informed consent (or verbal informed consent for participants consenting to retrospective diagnostic samples and data collection only).

Exclusion Criteria:

1. Treatment with neoadjuvant therapy for current lung malignancy as per local MDT treatment decision.
2. Known Active Human Immunodeficiency Virus (HIV), Hepatitis B virus, Hepatitis C Virus or Syphilis.
The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study

Worldwide, colorectal cancer is the 3rd most common cancer; risk increases with age and is modified by lifestyle factors notably diet, physical activity and obesity. The BORICC Follow-Up (BFU) Study is a 12+ year follow-up of participants recruited to the Biomarkers of Risk of Colon Cancer (BORICC) Study. This longitudinal study will investigate associations between ageing and lifestyle factors and a panel of molecular biomarkers linked with colorectal cancer risk.

The BORICC Follow-Up (BFU) Study builds on the findings from the BORICC Study where the investigators observed associations between age and nutritional factors, including selenium and folate, and biomarkers of colorectal health.

The BFU Study will investigate the relationships between ageing (12+ years) and such biomarkers longitudinally. It is anticipated that the project will produce novel data on (i) changes in biomarkers of colorectal cancer risk with age and (ii) the effects of obesity and lifestyle factors on biomarkers of colorectal cancer risk. These biomarkers include differentially expressed proteins, DNA methylation markers and inflammation markers.

Eligibility Criteria:
Inclusion Criteria:

* Took part in the BORICC Study at baseline (recruited 2005/6)

Exclusion Criteria:

* Unable to travel to the hospital to attend study visit
* Unable to provide informed written consent
Testing Gender-based Violence Response in Family Planning and Antenatal Care Services in Nigeria

To pilot and evaluate the integration of first-line response to gender- based violence (GBV), particularly intimate partner violence (IPV), sexual violence and reproductive coercion, within family planning (FP) and antenatal care (ANC) services at public health facilities in Ebonyi and Sokoto states in Nigeria.

GBV first-line response in the health setting includes screening , empowerment counseling, safety planning, and support to connect to additional services needed.

This study seeks to:

1. Assess effectiveness of an integrated service delivery model (integration of GBV first-line response and empowerment counseling in standard of care FP or ANC services) in reducing on-going experience of intimate partner violence (IPV) and increasing utilization of modern contraceptive methods among clients.

1a. Assess effectiveness of the intervention in reducing IPV, increasing utilization of modern contraceptive methods, and improving safety and self-efficacy among clients seeking interval FP services.

1b. Assess effectiveness of the intervention in reducing IPV and improving safety and self-efficacy to seek GBV care among clients seeking ANC services.

2. Explore factors influencing feasibility, acceptability and ability to implement GBV first-line response as part of FP and ANC services.

Eligibility Criteria:
Inclusion Criteria:

* Woman of reproductive age (18 to 49 years) seeking FP or ANC services at study sites
* Women who believe they are able to conceive (i.e. who have not undergone a tubal ligation, hysterectomy, or oophorectomy, or are menopausal) (for FP clients)
* Have a male partner they currently have sex with
* Have a mobile phone that can be safely used for re-contacting for follow-up surveys
* Do not have any accompanying male partners or family members aged 5 or above present

Exclusion Criteria:

* Any individuals that do not meet all of the above inclusion criteria or do not agree to participate in the study will be excluded from data collection.
* In addition, individuals with impaired cognitive abilities (I.e. unable to make decisions/respond to questions on their own without assistance by someone else)will also be excluded from the data collection.
* Finally, women who share a mobile phone with their partner/husband or another family member will also be excluded.
The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study

To enhance understanding of the risk factors for AMN, improve lesion assessment and prediction of submucosal invasive cancer, improve endoscopic resection efficacy, reduce complications of WF-EMR and improve the understanding of the progression of large lesions to cancer

The Australian Colonic Endoscopic Mucosal Resection study (ACE), is a multicentre prospective observational study which examined WF-EMR of colonic AMN (Ethics approval No. HREC JH/TG 2008/9/6.1(2858)). This project now has an extensive dataset from 8 leading colonic endoscopic resection centres in Australia on more than 1500 lesions resected over 4 years since June 2008.

The ACE study has been successful in addressing several aspects of the resection of AMN, resulting in several high profile papers in internationally recognised journals. The collection of this data has produced robust information on the efficacy of the procedure4, recurrence rates7, bleeding complications8 and mortality when compared to surgery5. Single centre analysis of the ACE dataset at Westmead has also allowed insights into how to refine the procedure to improve outcomes. The target sign is now a recognised indication for the placement of clips to prevent perforation9, CO2 insufflation for WF-EMR has been shown to be superior to air insufflation10 and succinylated gelatin (Gelofusine®) has been shown to be superior to normal saline as a submucosal lifting agent11.

There remain a number of unanswered questions regarding the endoscopic resection of large sessile lesions and expanding the ACE dataset in a new cohort of patients will allow these to be addressed. Enhancing the prediction of submucosal invasive cancer, advanced lesion classification, refinement of the assessment of deep injury, submucosal injectate constituents, the optimum electrosurgical resection methods, prevention and prophylaxis of bleeding, and subtype analyses of the different histological groups comprising AMN will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for endoscopic resection of a large sessile colonic polyp or laterally spreading tumour ≥20mm in size.
* Age \> 18 years
* Able to give informed consent to involvement in the clinical study

Exclusion Criteria:

• Unable to provide informed consent for involvement
Clinical Study of FRC Implant to Treat Skull Bone Defects

Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects and orbital floor defects.

Functional and aesthetic outcome is assessed by patient and doctor.

Development phase: Clinical trial Objectives: Assessment of functional and aesthetic outcome Methodology: Intervention study Sample size: 35+20+25 Main criteria for inclusion: Skull bone defect OR orbital floor fracture

Investigational drug/treatment, dose and mode of administration: FRC implant Comparative drug(s)/placebo/treatment, dose and mode of administration: -

Duration of treatment: 2 years of follow-up

Assessments:

Clinical outcome and radiologic assesment Functional and aesthetic outcome with Visual Analog Scale (VAS). Pain assessment with VAS.

Statistical methods:

Adequate statistical methods for publishing in international peer-reviewed journals.

Eligibility Criteria:
Inclusion Criteria:

Study arm 1:

* patients with skull bone defect
* reconstruction indications fullfilled

Study arm 2:

* patients with orbital floor defect
* reconstruction indication fullfilled

Exclusion Criteria:

* if informed consent cannot be obtained
PSG and Neuroendocrine Hormones in Subjective Cognitive Impaired Patients With Transformed Migraine

Transformed migraine is the most common and challenging subtype of chronic daily headache disorders35. Patients with transformed migraine often report an evolutionary process that occurs over months or years in which headaches increase in frequency, change characteristics and ultimately result in patterns of daily or near-daily headaches resembling a mixture of tension-type headache and migraine.

The present study aimed to investigate the presence and frequency of cognitive affection in patients with transformed migraines, as well as to analyze the association of cognitive affection with clinical features and headache impact, anxiety, depression, and quality of sleep.

Eligibility Criteria:
Inclusion Criteria:

-Patients included were adults with clinically confirmed of chronic migraine

Exclusion Criteria:

* Primary headache disorder other than migraine
* Secondary headache disorders other than medication-overuse headache or unclassified headache, or
* Aged under 18 years or older than 65 years
The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study

The purpose of this study is to determine whether high ligation of spermatic vein by open operation and microsurgery for patients with are effective in the treatment of varicocele and to determine which surgical option is better.


Eligibility Criteria:
Inclusion Criteria:

* 1.infertile patient suffering from varicocele 2.severe varicocele patient with obvious symptoms 3.adolescents suffering from severe varicocele with or without orchiatrophy

Exclusion Criteria:

* 1.varicocele patient with abdominal infection 2.varicocele patient who has massive adhesion of pelvic tissue due to pelvic surgery history 3.mild varicocele 4.varicocele patient has no obvious symptoms if has have born children, suffer from idiopathic azoospermia，or their partner can't bear children
Additional Effect of Subthreshold Micropulse Laser to Intravitreous Injection of Bevacizumab on Diabetic Macular Edema

In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose.

A subthreshold micropulse laser will be performed after the third injection in group A and a sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.

The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years diabetic patients
* Center-involved diabetic macular edema
* Mean central subfield thickness \>300 micrometers
* Best-corrected visual acuity between 20/40 and 20/400

Exclusion Criteria:

* hemoglobin A1c \> 8
* High-risk proliferative diabetic retinopathy
* Prior treatment with intravitreal or peribulbar injections within the preceding 3 months
* History of panretinal photocoagulation within the former 4 months
* History of macular photocoagulation
* Hx of Intraocular surgery (except cataract extraction)
* cataract extraction less than 6 months ago
* Macular edema due to a cause other than diabetic retinopathy
* Any other ocular condition that visual acuity would not improve from the resolution of the edema (eg, foveal atrophy)
* Substantial cataract estimated to have reduced visual acuity by \>3 lines
* uveitis, neovascular glaucoma, exudative age-related macular degeneration, high risk proliferative diabetic retinopathy
* vitreomacular traction or epiretinal membrane
* uncontrolled glaucoma ( \> 30 millimeters of mercury with anti-glaucoma medications)
* Not having: Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis

Phase Ib trial including investigating the combination of nab-paclitaxel and cisplatin in patients diagnosed with peritoneal carcinomatosis related to pancreatic, oeso-gastric, ovarian cancer or primitive peritoneal mesothelioma.

Phase Ib trial investigating the combination of intraperitoneal Cisplatin (10.5 mg/m2) and Nab-paclitaxel (escalated dose from 7.5 mg/m2 to 70 mg/m2) administered by pressurized intraperitoneal aerosol chemotherapy (PIPAC) every 4-6 weeks for 3 cycles.

Eligibility Criteria:
Inclusion criteria:

* Informed consent as documented by signature
* ≥18 years,
* psychologically able to follow the trial procedures
* with peritoneal carcinomatosis from pancreatic, oesogastric, epithelial ovarian cancers or primitive peritoneal mesothelioma,
* ECOG 0, 1 or 2,
* Life expectancy \> 3 months,
* Not candidate for surgical cytoreduction and IP/HIPEC based on expert multidisciplinary board
* who received at least one line of chemotherapy and for whom standard therapies have been exhausted or not feasible. patients with residual disease following the first line of therapy or Following secondary debulking are eligible.

Exclusion criteria:

* Predominant extra-peritoneal metastases at the discretion of the study team after discussion at the multidisciplinary board,
* Bowel obstruction, active gastro-duodenal ulcer or ongoing abdominal infection (bacterial, viral or fungal),
* Chemotherapy or surgery within the last two weeks prior to enrollment,
* Previous intra-abdominal chemotherapy,
* General or local (abdominal) contra-indications for laparoscopic surgery
* Known allergy to cisplatin or other platinum-containing compounds or to nab-paclitaxel,
* Severe renal impairment (calculated GFR (CKD-EPI) \< 60 mL/min/1.73 m2), myelosuppression (platelet count \< 100.000/μl, hemoglobin \< 9g/dl, neutrophil granulocytes \< 1.500/ml), International Normalized Ratio (INR) \> 2, severe hepatic (Serum total bilirubin \> 1.5 mg/dl), respiratory or neurologic impairment (grade 3), severe myocardial insufficiency (NYHA class \> 2), recent myocardial infarction, severe arrhythmias,
* Pregnancy or breastfeeding, women who can become pregnant must ensure effective contraception.
* Known or suspected non-compliance, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.