cyrilzakka/clinical-trials huggingface dataset:
The POWERED Study: Prophylaxis With Metformin to Prevent PTDM

PrOphylaxis With mEtformin to pREvent PTDM: a single site, placebo controlled, double blind randomised clinical trial evaluating the effectiveness of metformin to prevent post-transplant diabetes in a cohort of patients undergoing renal transplantation.

Renal transplantation is the optimal form of renal-replacement therapy in end-stage kidney disease. However, up to 30% of new renal transplants develop post-transplant diabetes mellitus (PTDM). The development of PTDM is associated with adverse graft and patient survival outcomes and represents an increased financial burden. There is an urgent clinical need to discover therapies which could decrease the risk of developing PTDM. Metformin offers a safe and cheap therapeutic option which has been demonstrated to reduce the incidence of type 2 diabetes in a high-risk non-transplant patient group. The investigators propose to study its safety and efficacy in preventing the development of PTDM.

POWERED is a single site, placebo-controlled, double- blind randomised clinical trial of metformin in patients without pre-existing diabetes mellitus who have received a new renal transplant. Eligible, consented patients are randomised to a 3 month course of either active drug or placebo within 10 days post-transplant. All patients will receive the usual standard of care for transplant patients. Clinical and laboratory data will be collected and assessed at baseline and throughout their participation in the study. The primary endpoint is the development of PTDM as defined by a positive oral glucose tolerance test (OGTT). Secondary endpoints include graft outcomes, pancreatic b-cell function and safety endpoints. The study began recruitment in January 2019 and plans to enrol 60 patients. There are no interim analyses planned.

Ethical approval was obtained from the London - Brighton and Sussex Ethics Committee (REC 18/LO/0958) prior to commencing the study. All study-related data will be used by the Sponsor in accordance with local data protection law. Results of the trial will be submitted for publication in a peer-reviewed journal.

Eligibility Criteria:
Inclusion Criteria:

1. Patients (male or female) undergoing renal transplantation under the care of the Barts Health NHS Trust Renal Department
2. Aged 18-75 inclusively
3. Willing to comply with study schedule

Exclusion Criteria:

1. History of Type 1 or type 2 diabetes
2. Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
3. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug
4. Subject with a known hypersensitivity or contraindication to Tacrolimus
5. Subject with a known hypersensitivity or contraindication to Metformin
6. Pregnant or breast feeding
Improving Ultrasound Images in Brain Tumor Surgery With the Use of Brain Mimicking Fluid

Prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains unfavourable. Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival.

Ultrasound is currently used as a tool for providing 2D or 3D images for the purpose of tumor localization and resection control. For the use in resection control the resection cavity is filled with saline to provide acoustic coupling between the ultrasound transducer and tissue. However, attenuation of acoustic waves is very low in saline compared to the brain and this difference in attenuation is the cause of artifacts that may severely degrade the ultrasound images. Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond, potentially masking small tumor remnants and generally making the interpretation of images more difficult.

This research group has developed an acoustic fluid intended for use in the resection cavity instead of saline. Tests in laboratory measurements have shown that the fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery. The investigators expect that the acoustic fluid will make it easier to detect small tumor remnants near the end of an operation, thus increasing success of glioma surgery. The purpose of this study is to test the fluid during surgery for histopathologically proven glioblastoma to assess safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* A glioblastoma is suspected when there is a solitary brain tumour with ring-like contrast enhancement and oedema with no recent history (last 3 years) of primary tumour elsewhere
* In cases where histopathology is not known from previous biopsy or resection (i.e. diagnosis is suspected based on MRI findings and not from previous surgery) a tissue sample for frozen section is necessary. The fluid will only be used in cases where glioblastoma is suggested from this preliminary histopathological assessment.

Exclusion Criteria:

* Intended biopsy only (meaning: cases not suitable for resection)
* Other entities than glioblastoma is suspected
* Allergy to diary products and marine products
* Hypersensitvity to egg protein
* Hypersensitivity to soya or peanut protein
* Hypersensitvity to glycerol
Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors

Evaluation of the efficacy of the combination of olaparib and trabectedin in adult patients with locally advanced/metastatic solid tumors that failed standard treatment and whose molecular sequencing tumor profiles show homologous recombination repair (HRR) defects. The primary objective is to show superior disease control rate in patients with HRR-deficient tumors treated with olaparib and trabectedin compared to treatment according to current guidelines (physician's choice). This trial aims to establish whether the PARP-dependency of HRR-deficient tumors across entities can be exploited for therapeutic benefit.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Progressive locally advanced or metastatic malignancy
* Prior administration of standard treatment for primary and relapsed malignancy
* Eastern Cooperative Oncology Group Performance Status ≤1
* Patients with central venous access device in place (central venous catheter or porta-cath)
* Age ≥18 and ≤70 years
* Identification of defective DNA repair via HR
* Adequate bone marrow, renal, and hepatic function
* Hemoglobin ≥10 g/dl
* Neutrophil count ≥1,500/mm3
* Platelet count ≥100,000/µl
* Bilirubin ≤1.5 x upper limit of normal (ULN)
* ALT and AST ≤2.5 x ULN (≤5 x ULN in patients with hepatic tumor involvement)
* Alkaline phosphatase ≤2.5 x ULN
* PT-INR/PTT ≤1.5 x ULN
* Albumin ≥25 g/l
* Creatine kinase ≤2.5 x ULN
* Serum creatinine 1.5 mg/dl or creatinine clearance 51 ml/min

Main Exclusion Criteria:

* Hematological malignancies and primary brain tumors.
* Concurrent treatment in another interventional clinical trial
* Prior treatment with PARP Inhibitors
* Patients with platinum-refractory disease, defined as progressive disease during or immediately after treatment with platinum based chemotherapy
* Persistent toxicity (\> Grade 2 according to CTCAE 5.0)
* Dementia or significant impairment of cognitive state
* History of HIV infection
* Clinical signs of active infection (\>Grade 2 according to CTCAE 4.03)
* History of viral hepatitis (HBV or HCV)
* Epilepsy requiring pharmacologic treatment
* Pregnancy
* Major surgical intervention 4 weeks prior to study inclusion
* Known hypersensitivity to any of the study drugs
* Hematologic malignancy
* QTc time prolongation \>500 ms or history of familial long-QT-syndrome
* Heart failure NYHA III/IV
* Severe obstructive or restrictive ventilation disorder
* Concomitant use of known strong CYP3A Inhibitors
* Concomitant use of known strong CYP3A inducers
Early rhBNP on Myocardial Work in Patients With STEMI

The study intends to evaluate the efficacy of early rhBNP on myocardial work in patients with anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention


Eligibility Criteria:
Inclusion Criteria:

* 1. Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;

  2. No contraindication for rhBNP;

  3. Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.

Exclusion Criteria:

* 1.Cardiogenic shock (systolic BP \<90mmHg after fluid infusion or systolic BP\<100mmHg after vasoactive drugs);

  2. History of myocardial infarct;

  3.Severe arrhythmia: with III degree A-V block ,atrial fibrillation,ventricular fibrillation,ventricular tachycardia;

  4. Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia or thrombocytopenia; known acute pancreatitis;

  5. Pregnant or lactating;

  6. life expectancy≤12 months;

  7. Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk;
Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female \>/= 18 years
* Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy
* BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters

Exclusion Criteria:

* Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib \[Nexavar®\], sunitinib \[Sutent®\], bevacizumab \[Avastin®\])

Study eye:

* Active ocular inflammation or infection (ocular or periocular)
* Uncontrolled intraocular hypertension or glaucoma (IOP\> 30 mmPIg) despite treatment with anti-glaucoma medication
* Predominantly-scarred PCV lesions
* Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period
* Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
* Prior treatment with any anti-VEGF compound or any investigational treatment
* Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days
Endorectal Coil Magnetic Resonance Images (ERC-MRI)

When we acquired MR images of the prostate gland using a coil (receiver antenna) inside the rectum, we can see areas with tumour in the prostate gland, and well as details of the anatomy. The coil inside the rectum changes the shape of the prostate gland. In order to use this images to help target radiation therapy to the tumour better, we need to deform the images to the original shape of the prostate gland without the coil. In this study, we will develop a way to deform the images accurately.


Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the prostate
* patient undergoing dose escalated conformal EBRT
* low or intermediate risk prognostic factors: PSA \< or equa to20, gleason score \<8, T \<T3, N category 0 or X, M category 0 or X
* \> or equal to 18 years of age
* ECOG performance status 0 or 1

Exclusion Criteria:

* contraindications to MRI
* bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding insertion of fiducial markers
* IFB or collagen vascular disease
* previous colorectal surgery
* previous pelvic RT
Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Primary Objective:

- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.

Secondary Objectives:

* PSA response rate;
* Descriptive assessment of CTC (circulating Tumor Cells);
* Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;
* Description of the Health Quality of Life of the patients;
* Incidence of adverse events.

Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months

Eligibility Criteria:
Inclusion criteria :

* Histologically proven Castration-Resistant Prostate Cancer (stage IV only);
* Prior failure of treatment with docetaxel; o Documentation of metastasis by imaging.
* Performance status 0 or 1;

Exclusion criteria:

* Previous treatment with chemotherapy, except for docetaxel;
* Previous use of abiraterone;
* Inability to maintain treatment with androgen deprivation if no previous history of orchiectomy;
* Presence of any other active malignancy or history of any tumor diagnosed in the last 5 years, except basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the skin, bladder or anal canal (these tumors do not prevent participation if they have been treated, even in the last 5 years);
* Hypersensitivity or known allergy to any of the treatments under study, including history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to polysorbate 80 containing drugs
* History of congestive heart failure or myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmias, angina pectoris or uncontrolled hypertension;
* Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
* Presence of severe comorbidity, which in the opinion of the investigator, puts the patient at risk or impairs compliance to the protocol;
* Known seropositivity for HIV;
* Presence of significant psychiatric or neurological disease, in the investigator's opinion;
* Presence of uncontrolled hypercalcemia;
* Refusal to use appropriate contraception during the study period;
* Participation in any clinical trial in the last 12 months, unless there is benefit to the patient to be justified by the principal investigator
* Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
* Inadequate organ and bone marrow function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Is Deltoid Ligament Repair for Ankle Fracture Necessary?

The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.

The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.

Eligibility Criteria:
Inclusion criteria:

* Supination-external rotation ankle fracture with deltoid ligament incompetency
* Minimum of 2 year clinical follow up

Exclusion criteria:

* Non-supination-external rotation ankle fracture
* Medial malleolus fracture
* Incomplete clinical or radiographic followup.
Safety Study of the Rapid System for Acute Ischemic Stroke

This is a safety study of the Rapid System for acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 to \<85 years old
* Pre stroke modified Rankin Scale (mRS) of ≤2
* A signed informed consent by patient or a legally acceptable representative

Exclusion Criteria:

* Pre-stroke life expectancy of less than 6 months
* Current participation in another investigational drug or device study
* Pregnancy
Prevalence of Gastroesophageal Reflux Disease in Peritoneal Dialysis and Hemodialysis Patients

The purpose of this study is to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.

Gastroesophageal reflux disease is a common upper gastrointestinal disorder in chronic kidney disease. But, little is known about the prevalence in dialysis patients. The aims of this study were to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.

Eligibility Criteria:
Inclusion Criteria:

* peritoneal dialysis and hemodialysis patients

Exclusion Criteria:

* a history of abdominal surgery or with a proton pump inhibitor before 1 month and a eradication of H. pylori were excluded
Effects of Virtual Reality Hypnosis on Anxiety, Pain and Comfort in Oncology Patients During a Port-catheter Placement Procedure

The port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. Virtual reality hypnosis (VRH) is an innovative technique delivering clinical hypnosis to patients through virtual reality (VR). The clinical applications of VRH are still little known. We will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a PAC. The patients will be randomly divided into two groups. Thefirst group will benefit from the usual care for the placement of the PAC (i.e., local anaesthesia), while the second will benefit from the VRH in addition to the usual care. Pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Low auditory and/or visual acuity precludes the use of the device.
* Head or face wounds precluding the use of the device.
* Schizophrenia, dissociative disorder or any other psychiatric disorder.
* Non-proficiency in French (Research language).
* Patient under 18 years old.
* Phobia of deep water.
* Dizziness.
Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence

Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients will be enrolled and equally randomized to bright light or dim-red light treatment. Objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the baseline and intervention phases of the study. The primary outcome measure will be the change in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT), global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS) score, and actigraphy measures. A variety of exploratory analyses will examine the effects of bright light treatment on fatigue, depression, quality of life, cognition, and motor disability.

Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time sleep in PD patients with daytime sleepiness.

See above.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic PD as defined by the United Kingdom Parkinson's Disease Society Brain Bank Criteria
2. Hoehn and Yahr stage of 2 to 4 in the "on" state
3. Excessive daytime sleepiness as defined by the Epworth Sleepiness Scale (ESS) score of greater than or equal to 12 points
4. Stable PD medication regimen for at least 4 weeks prior to study screening
5. Willing and able to give written informed consent

Exclusion Criteria:

1. Atypical parkinsonian syndromes
2. Significant sleep disordered breathing (defined as an apnea-hypopnea index \>15 events/hr of sleep on screening PSG)
3. Significant periodic limb movement disorder (defined as a PLM arousal index\>10 events/hr of sleep on screening PSG) and REM sleep behavior disorder (based on the presence of both clinical symptomatology as well as intermittent loss of REM atonia on screening PSG)
4. Cognitive impairment indicated by the mini-mental status examination (MMSE) score of less than 24
5. Presence of depression defined as the Beck Depression Inventory (BDI) score \>14
6. Untreated hallucinations or psychosis (drug-induced or spontaneous)
7. Use of hypno-sedative drugs for sleep or stimulants during the daytime
8. Use of antidepressants unless the patient has been on a stable dose for at least three months
9. Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness
10. Travel through 2 time zones within 90 days prior to study screening
Longitudinal Study to Investigate Different Transcranial Electrical Stimulation

This research investigates the effect of different frequencies of tACS (0 Hz, 30 Hz, 50 Hz, 70 Hz, 90 Hz) and tRNS with cognitive exercises in a regimen protocol of weeks, everyday. The study design is a longitudinal study design in which participants receive different tES randomly ordered. Treatments occur for 4 weeks, then 12 weeks of no treatment (wash-out period), repeated for each tES treatment type. Participants have the option of having their choice of music in the background while they perform cognitive exercise.

This research will investigate the effect of applying transcranial electrical stimulation (tES) with different parameters when paired with cognitive exercises with optional background music on older adults in a longitudinal study. In addition, the investigators will investigate and explore novel technological methods not only to monitor the plausible changes due to intervention. Since most technological intervention on dementia have a demanding and costly protocol, it would be of great interest to personalized optimum treatment strategy. The investigators will use Egocentric Spatial Assessment using our Virtual Reality Navigation (VRN) and functional near infrared spectroscopy (fNIRS) measurements and analysis to develop the monitoring technologies. VRN measures how people orient themselves in a non-familiar environment; the investigators hypothesize it is deteriorated significantly in Alzheimer's even at its onset. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention.

Eligibility Criteria:
Inclusion Criteria:

* ability to read, write and speak English fluently
* MoCA score between 5 and 24

Exclusion Criteria:

* Being diagnosed with Parkinson's, Parkinsonian dementia, Huntington disease, speech significant aphasia and intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder.
* Having a Hhistory of epileptic seizures or epilepsy
* Inability to adequately communicate in English
* Impaired vision or hearing severe enough to impair performance in cognitive tests
* Current substance abuse disorder
* Currently participating in another therapeutic study for dementia
* Plan to change the medication during any treatment period (5 weeks including the pre-post assessments)