cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)

Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.

Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug), lenvatinib, or sorafenib. Approximately 120 adult participants will be enrolled in the study across 60 sites worldwide.

In arm 1 (control), participants will receive the investigator's choice: lenvatinib as an oral capsule or sorafenib as an oral tablet, once daily. In arm 2, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab, every 3 weeks. In arm 3, participants will receive intravenously (IV) infused livmoniplimab (dose B) in combination with IV infused budigalimab, every 3 weeks. The estimated duration of the study is up to 2 years

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh A classification.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Received an immune checkpoint inhibitor in first-line (1L) hepatocellular carcinoma (HCC) treatment regimen.
* Adequate hematologic and end-organ function.
* Tissue biopsy at screening.
* Disease that is not amenable to surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
* Prior treatment with an approved tyrosine kinase inhibitor (for example sorafenib or Lenvatinib) in 1L HCC treatment regimen.
* History of malignancy other than hepatocellular carcinoma (HCC) within 5 years prior to screening.
* Hepatic encephalopathy or requirement for medications to prevent or control encephalopathy.
* Moderate or severe ascites requiring recurrent non-pharmacologic intervention to maintain symptomatic control.
* Coinfection with active HBV infection and active HCV infection.
* Prior history of grade 3 or higher immune-mediated adverse event or discontinuation due to immune-mediated adverse events.
* Prior history of recurrent grade 2 or higher interstitial lung disease/pneumonitis.
A Study of Tor Kinase Inhibitor in Advanced Tumors

The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma Part A only)
* Cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria) can be recruited to Part A
* Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients

Exclusion Criteria:

* Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug.
* Patients with abnormal fasting glucose, have type I or II Diabetes or have uncontrolled blood fats and cholesterol
* Patients with a history of neurological disease, peripheral or central neuropathy, brain metastases or family history of myopathy are excluded
* Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions
Localizing the Epileptogenic Zone With High Resolution Electroencephalography

Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.


Eligibility Criteria:
Inclusion Criteria:

* medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures.
* Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure.
* full informed consent of the patient (or of his/ her legal representative)
* 15 year or older patient

Exclusion Criteria:

* contraindication to cortectomy
* contraindication to depth-EEG
* indication of epilepsy surgery without depth-EEG monitoring
* high grade glioma, arterio-veinous malformations

  * pregnancy
  * history of severe cardio-vascular event (coronaropathy, stroke)
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon

The proposed trial is a multi-centre prospective randomized controlled trial comparing outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or with open operative tendon repair. All patients will undergo accelerated functional rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.

Equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects through elimination of a surgical repair; reduction of cost to patients by eliminating need for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Complete mid-substance rupture of the Achilles tendon as diagnosed on clinical exam
* Present for initial assessment and treatment with application of a plantar-flexed cast within 48 hours of their injury.
* Referred to one of the participating orthopaedics surgeons in a timely fashion so as to allow for further treatment (operative repair or initiation of the rehabilitation protocol) within 14 days of their injury.

Exclusion Criteria:

* Open Achilles injury
* Achilles injury that is not a mid-substance tendon injury
* Any additional injury to the ipsilateral lower extremity
* Contraindication to surgery or anesthetic
* (Physical or mental) that may interfere with compliance with the rehabilitation protocol
* Any known factor for increased risk of Achilles tendon rupture (i.e. diabetes mellitus, immunosuppressive therapy including local or systemic steroids, and fluoroquinolone use).
Functional Relining Versus Digital Altered Cast Using Digitally Fabricated Distal Extension Frameworks

This clinical study will be done to compare between functional relining and digital altered cast of selective pressure impression techniques for constructing mandibular distal extension removable partial dentures using digitally fabricated frameworks by measuring the abutment alveolar bone height changes.

According to the functional impression techniques, all patients will be classified into two equal groups:

Group A: Functional relining of processed RPD base at insertion:

•After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast.The finished removable partial denture is relined using the functional relining impression technique.

Group B : Digitally obtained altered cast :

Selective pressure impression technique will be made.

Digital altered cast will be done according to J. Wu, Y. Cheng (20) as follow :

All patients will be informed about the follow up and evaluation recalls.

Evaluation of abutment alveolar bone height changes:

Alveolar bone height changes of abutment teeth will be evaluated radiographically at insertion (T0), and after 6 (T6) \& 12 months (T12) after RPD insertion.

Eligibility Criteria:
Inclusion Criteria:

* 1. All patients having completely edentulous maxilla opposing class I Kennedy mandible.

  2. Sufficient restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane). This will be detected by a tentative jaw relation.

  3. Well formed residual ridge covered by healthy firm mucosa. 4. All patients are of angel's class I maxillo-mandibular relationships. 5. Abutment teeth must fulfil certain criteria:
  1. Abutment teeth should be healthy with good periodontal and bone support.
  2. Should not show a pronounced degree of mobility or advanced gingival recession.
  3. Crown Root Ratio of abutment teeth not more than 1:2

     Exclusion Criteria:
* 1. Sever soft tissue undercuts. 2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.

  3. History of radiotherapy in the head and neck region.
Trial Comparing Two Techniques of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas

Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better visualization of the plexus. There are limited data comparing the two modalities.The patients are on follow-up for 6 months post neurolysis.

Carcinoma pancreas patients with abdominal pain requiring daily analgesics for more than 4 weeks were included.we are randomising about 100 patients into two groups to undergo either of the two procedures, i.e. celiac plexus neurolysis by percutaneous technique or by endoscopic ultrasound guided technique.The pain scores have been recorded by visual analogue scale for an average follow-up of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* all patients with carcinoma pancreas

Exclusion Criteria:

* patients below 18 years of age and who have not given consent
The Clinical Research of the Safety and Effectiveness Evaluation for Using Echocardiography-guided Liwen RF Radiofrequency Ablation System to Treat Hypertrophic Obstructive Cardiomyopathy

Objective to investigate the safety and effectiveness of Echocardiography-guided radiofrequency ablation in patients with Hypertrophic obstructive Cardiomyopathy (HOCM).

Percutaneous intramyocardial septal radiofrequency ablation (Liwen Procedure) is a safe and effective treatment approach for Hypertrophic obstructive Cardiomyopathy and results in sustained improvement in exercise capacity, persistent in reducing Left Ventricle Outflow Tract (LVOT) gradient, and sustained improvement in cardiac function.

In patients with disabling symptoms caused by Hypertrophic obstructive Cardiomyopathy (HOCM),Echocardiography-guided radiofrequency ablation could be a less invasive treatment option.

Percutaneous intramyocardial septal radiofrequency ablation (Liwen Procedure) is a new method for the diagnosis or treatment of heart disease by using a special diagnosis and treatment device to the heart target area under the guidance of image technology. The method breaks through the worldwide problem of the minimally invasive diagnosis and treatment of the myocardium on the beating heart, so as to avoid the X-ray radiation and contrast agent damage .

As a new pathway of cardiac disease intervention, Liwen Procedure can be used in congenital heart disease, myocardial biopsies, drug injection, cell implantation and instrument implantation in addition to Hypertrophic Cardiomyopathy and cardiac tumors. It has important clinical value and broad application prospect.

In this study, Liwen RF radiofrequency ablation system was used to treat HOCM , and evaluate its safety and effectiveness , in order to provide a new medical device for Liwen Procedure of HOCM.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with Systolic Anterior Motion）in the resting-state or after exercise stress test.
2. Subject with obvious clinical symptoms.
3. Subject with New York Heart Association (NYHA) cardiac function ≥ II grade.
4. Subject with adequate drug treatment is not effective or cannot tolerate side effects of the drug.
5. Subject was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed an informed consent form, and agreed to complete the following checks.

Exclusion Criteria:

1. Subject is pregnant, lactating, or planned to conceive during a clinical study.
2. Subject with Hypertrophic Non-obstructive Cardiomyopathy.
3. Subject with interventricular septal thickness ≥ 30mm.
4. Subject with Sudden Cardiac Death Index ≥ 10%.
5. Subject combined with other heart diseases requires surgical treatment.
6. Subject with heart failure(Defined as resting heart failure after intensive anti-heart failure therapy, left ventricular fraction of ejecting\< 40%).
Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects

This study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects.

Sleep is essential for well being and performance. Sleep disturbances by recurrent apnea and hypoxia in patients with obstructive sleep apnea syndrome impair quality of life, cognitive and cardiovascular functions. Similar consequences occur in healthy subjects exposed to hypoxia at altitude due to periodic breathing with recurrent central apnea. This project will investigate effects of altitude on sleep, breathing, psychomotor performance and on the cardiovascular system in healthy subjects and patients with sleep apnea. The results will help to better understand mechanisms of sleep disturbances and psychomotor impairment induced by hypoxia and to prevent adverse effects of altitude exposure.

Eligibility Criteria:
Inclusion Criteria:

* healthy men
* residence at \<800m

Exclusion Criteria:

* any active disease requiring treatment
* requirement for regular use of medication
* smoking, regular intake of alcohol or drugs
* body mass index \<18 or \>30 kg/m2
* previous intolerance of moderate altitude (\<3000m)
ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy

This is a single arm, single centre imaging study which will be offered to all consecutive, eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within Oxford University Hospitals.

Investigations

* Dynamic contrast enhanced magnetic resonance imaging (DCE MRI)
* Diffusion weighted magnetic resonance imaging (DWI MRI)
* MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI)
* MRI scan designed to measure the T2\* or produce T2\*-weighed images (T2\* MRI)
* Perfusion computed tomography (pCT)
* Fludeoxyglucose positron emission tomography (FDG PET/CT)

Study Design: Observational

Target Population: Patients undergoing radical CRT for anal cancer in Oxford University Hospitals National Health Service (NHS) Trust.

Duration on study: Patients should be on study for a maximum of 5 months.

Patient care post-trial: Follow up as per local standard.

No. of Study Site(s): Single Centre, United Kingdon (UK)

End of study: Last Patient, last assessment of response. Patients should be on study for a maximum of 5 months.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive primary squamous carcinoma of the anus.
* Patients must be fit and scheduled to receive radical CRT with curative intent.
* Any stage tumor 2-node 0 (T2N0)
* Male or female, Age 18 years+.
* The patient is willing and able to comply with the images and protocol for the duration of the study.
* Written (signed and dated) informed consent.

Exclusion Criteria:

* Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used.
* Previous pelvic radiotherapy
* Patients with a pacemaker or any other implanted metal which would preclude MRI scan.
* Patients with a prosthetic hip.
* Patients receiving radiotherapy with palliative intent.
* Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this study, at the discretion of the investigator

Additional criteria for optional oxygen breathing procedure:

* Patients with Chronic Obstructive Pulmonary Disease
* Any patient not felt to be suitable for supplementary oxygen as considered by an appropriately trained clinician
Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children

This study is expected to provide, for the first time, data on Cov2-SARS circulation in asymptomatic children and children with moderate respiratory symptoms in order to construct the severity pyramid of this novel pathogen. This information will be essential in the coming weeks to understand the dynamics of the transmission of this pathogen at the population level and to highlight the relevance of public health interventions, particularly with regard to the systematic closure of schools and childcare facilities.

Cov2-SARS is an emerging respiratory virus of the coronavirus family responsible for a global epidemic since November 2019. As of March 10, 2020, it had caused more than 160,000 cases of corona virus disease (COVID-19), including more than 6,500 deaths worldwide. France is one of the main epidemic outbreaks with more than 5,000 confirmed cases and the number of diagnosed patients is increasing every day.

The number of confirmed paediatric cases is relatively low, and the mortality rate in children is close to zero. This contrast suggests that children are more likely to present pauci-symptomatic or even asymptomatic forms of the disease, which are therefore undiagnosed in most cases. Given the rapid spread of this virus, and the fact that indigenous cases without an obvious chain of transmission now appear to be frequent in France, it is possible that the pauci-symptomatic or asymptomatic child may play a role in the transmission of the pathogen and the dynamics of the epidemic, as documented for other respiratory pathogens such as influenza. Based on this hypothesis, the closure of children's communities has been organized in France and other highly endemic countries.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic children:
* Age between birth and 15 years
* Carrying out a visit within the framework defined by the learned societies and professional organisations representative of paediatrics in France, i.e. :
* The consultation of the first month and all consultations involving compulsory vaccinations (2, 4, 5, 11, 12, 16 months).
* Consultations for acute pathologies, infectious or not.
* Monitoring of chronic diseases that warrant clinical examination (the majority of which can be carried out by telemedicine) or in the case of acute exacerbation.
* In one of the participating outpatient centres
* During the study period
* With a clinical examination that does not reveal any progressive infectious pathology

AND Pauci-symptomatic children

* Age between birth and 15 years,
* Consultant at one of the participating outpatient centres
* During the study period
* And presenting with a mild respiratory infection:
* Rhinopharyngitis, Acute otitis media, Angina, Bronchitis, etc.
* Acceptance to participate in the protocol by one of the holders of parental authority
* Affiliated to a social security

Exclusion Criteria:

* Refusal to participate in the study
Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial

This pilot study aims to evaluate the feasibility of a non-blinded randomized controlled trial with a parallel group design of an invitation to an evaluation of liver disease (intervention) compared to standard care with no invitation, among individuals in alcohol abuse treatment.

Alcohol-related liver disease (ALD) is responsible for about 80% of all liver disease in Denmark. The prognosis for ALD is good, if detected early and abstinence is obtained. Unfortunately ALD is often diagnosed at a late state and the 1-year survival is only 30%.

Currently there is no available systematic screening for fibrosis/cirrhosis among patients with longterm abuse of alcohol and thereby high risk for developing ALD.

Transient elastography (TE) is a non-invasive, risk free and quick method of detecting fibrosis. TE is validated for diagnosing fibrosis and ruling out cirrhosis.

40 patients will be enrolled in the study with a 1:1 randomization. Baseline data is collected and informed concent is obtained at the local alcohol abuse treatment center, Novavi Køge. The fibroscan and blood samples are done at Zealand University Hospital, Køge. Follow-up is done after 6 months, by a project nurse, blinded to the intervention.

If the study proves to be feasible, our aim is to extend the study in order to investigate wether the interventions described above, could help decrease alcohol consumption/maintain abstinence for patients in alcohol treatment. Moreover the prevalence of fibrosis and cirrhosis found by fibroscan is examined.

Eligibility Criteria:
Inclusion Criteria:

* must be enrolled at alcohol treatment center Novavi Koege, Denmark
* Maximum 6 months of treatment at Novavi Koege

Exclusion Criteria:

* known severe liver disease
* life expectancy less than 6 months
* unable to give informed written consent
A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea

This is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of THX-110 (Dronabinol (synthetic Δ9-THC) and PEA) for the treatment of adults with Obstructive Sleep Apnea.

This is a 30-day sponsor-initiated, open-label trial of the therapeutic treatment THX-110 (a combination of Dronabinol and PEA) in 30 adults with Obstructive Sleep Apnea (OSA). Participants will receive THX-110 for the duration of the trial. The goal for this pilot study is to provide initial safety, feasibility and tolerability data on THX-110 in an OSA population.

Eligibility Criteria:
Inclusion Criteria:

* OSA diagnosis; OSA severity AHI: 15-30
* Population aged 20-65
* Gender: Males and Females
* BMI \< 30
* OSA patients that cannot tolerate CPAP
* OSA patients who use CPAP will not use the device during the entire duration of the study

Exclusion Criteria:

* Minors
* Severity of OSA outside the determined boundaries
* Pregnancy
* BMI \> 30
* Medical history of narcotic dependency