cyrilzakka/clinical-trials huggingface dataset:
LiverPAL: A Pilot Study of Inpatient Palliative Care for Patients With Advanced Liver Disease

Frequently patients with advanced liver disease experience physical and emotional symptoms during their hospitalization that can may cause a level of discomfort to both the patient and the family members that surround them.

This study involves the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these discomforting symptoms. This team of clinicians is called the palliative care team and they focus on ways to improve pain and other symptom management and to assist patients and their families in coping with the physical, emotional and social issues associated with a diagnosis of advanced liver disease. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness and their caregivers.

The investigators are studying the feasibility of delivering this program, the acceptability and satisfaction with the program, and changes in the quality of life, illness understanding, and symptoms of hospitalized patients who receive the program and their caregivers. The study will use a series of questionnaires to measure the study participants' quality of life, physical symptoms, illness and prognostic understanding, and mood. Study questionnaires will be completed in the hospital, home or clinic. Qualitative interviews will be conducted with hepatology and palliative care clinicians as well as patients and caregivers.


Eligibility Criteria:
Patient Inclusion Criteria:

1. Adult (≥ 18 years old) with advanced liver disease defined as cirrhosis complicated by one of the following (new or ongoing) clinically-evidence decompensating events

   1. Ascites (requiring diuretics or large volume paracenteses)
   2. Hepatic encephalopathy (requiring medical therapy)
   3. History of variceal bleed episode within 1 year of enrollment
2. Admitted to the general medicine service
3. Ability fo communicate in English and provide informed consent
4. Have a score ≥ 7 on the Short Portable Mental Status Questionnaire

Patient Exclusion Criteria:

1. Patients with severe hepatic encephalopathy or any other comorbid condition which the primary medical team believes prohibits compliance with study procedures
2. Patients with advanced malignancies being treated with palliative intent
3. Patients already receiving specialty palliative care and/or hospice care

Caregiver Eligibility Criteria

1. A relative or friend of eligible patient, who lives with them and has in-person contact with them at least twice per week
2. Verbally fluent in English or able to complete questionnaires with the help of an interpreter
3. Age 18 or older

Clinician Selection: All palliative care clinicians who deliver the LiverPal intervention will participate in qualitative interviews. Inpatient clinicians who provided direct care to enrolled patients in either the inpatient or outpatient setting will also be eligible to participate in the qualitative interviews.
Diagnostic Instruments for Autism in Deaf Children Study

The trial is in three stages and will translate and validate screening and assessment instruments for use with deaf children.

The first stage is modifying the screening and assessment instruments (ADI-R and ADOS-2) for use with deaf children. This will involve choosing the most promising screening instrument (SRS-2) based on the systematic review and the expertise of a review panel, which contains experts and public and patient involvement (PPI). This phase of the study seeks a wide range of user (parents/ carers and young people) views and experiences about the symptomatology and presentation of deaf children with autism, comparing this to hearing children with autism, and deaf children without autism.

The second stage is to ensure that the newly modified instruments are accessible to deaf children and deaf parents by making any necessary translations from English into British Sign Language. This involves a strict translation and back translation methodology with reiterations until successful translation is achieved.

For stage three in order to ensure that the new questionnaires are successfully identifying children and young people with Autism Spectrum Disorder, the modified instrument will be validated using a 'gold standard'. The current 'gold standard' for the mental health screening of Deaf children is a clinical interview administered by experienced senior multidisciplinary deaf child mental health clinicians.


Eligibility Criteria:
Inclusion Criteria:

For the purposes of this study, children and young people will be recruited if they have a chronological age of ≥18 months old, up to 18 years.

Deaf children will have a hearing loss of at least 40dB

Exclusion Criteria:

This is a pragmatic trial which recognises the frequency and complexity of co-morbidities in children with Autistic Spectrum Disorders (ASD) and deafness. We will therefore not exclude on the basis of co-morbidity in the groups where a diagnosis of ASD already exists, since these tools would be used with this population if adopted more widely in the NHS.

We will not exclude children or young people with language delay as children with ASD may have severe language delay. Families where the parents do not have either a signed language being studied here, or a language in which the ADI-R is available, will not be included.
Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients

The primary aim is to establish whether breastfeeding is associated with lowering blood pressure in hypertensive women.

Patients included in this study will have chosen to breastfeed.

1. The investigators will identify patients that are planning to breastfeed from their intake questionnaire that all patients receive upon admission to labor and delivery. They will also identify breastfeeding patients while performing our postpartum rounding.
2. The investigators will perform a chart review to determine their co-morbidities and current medications. Specifically, the patient information recorded will be age, parity, gestational age, delivery route, vital signs, medications, race, whether they are breastfeeding. Of note, all of the individuals listed to participate in this study have routine access to the patient's charts since they will be working with the patients regardless of their participation in the study.
3. Only hypertensive women will be included. Hypertension is defined as persistent Systolic blood pressure \> 140 and or persistent diastolic blood pressure \> 90.
4. Once it has been determined that they have met the inclusion criteria for the study the investigators will ask the patient's attending physician if we can approach the patient and explain the study and obtain consent.
5. Once consent is obtained, the investigators will inform the nurse. The patient will have her blood pressure taken prior to breastfeeding, during breastfeeding, and 1-2 hours after breastfeeding. This will occur 3 times in the postpartum period.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria include hypertensive women in the first 72 hours postpartum. The gestational age at delivery must be greater or equal to 34wk and the patient must be breastfeeding and/or pumping milk. The study will include patient's on anti-hypertensive. The study will also include patients receiving postpartum IV magnesium but they will have their blood pressure taken two times while on magnesium and two times after the magnesium has been discontinued.

Exclusion Criteria:

* The study will exclude patient's on dopamine agonist medications or HIV positive.
DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke

The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from television series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia. Patients will be treated individually in 40-minute sessions twice a week for 8 weeks. In each session, a speech therapist and an actor will select the clips with muted words or sentences that have been detected as functionally meaningful for each patient. Outcomes will be assessed as significant differences in two aphasia tests.

The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from TV series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia from the departments of Neurology and Rehabilitation from La Paz University Hospital and also from the "Afasia Activa" association. After meeting all inclusion and none of the exclusion criteria and signing informed consent, patients will be randomised (1:1) in two different treatment groups. The first group will receive therapy within the first 3 months of their inclusion with a subsequent period of another 3 months without therapy (thus, serving as group 2 controls). Group 2 will initiate therapy after 3 months since their inclusion (serving as group 1 controls during the first 3 months). Therapy consists of 17 sessions performed in a eight week period (1 baseline session and 16 dubbing sessions), each lasting 40 minutes, in which the patient will be asked to dubb words or sentences previously selected and considered as functionally meaningful for them. These words will be chosen through an online survey performed by a representative group of aphasic patients and the study patients´own relatives in the baseline treatment session. Outcomes will be assessed as significant differences in two aphasia tests (CAL questionnaire and the BDAE).

Eligibility Criteria:
Inclusion Criteria:

* nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere.
* the patient should have received a standard program of conventional speech therapy after stroke, remaining with aphasia with the following characteristics: severely restricted language, poor repetition (even for single words), not exceeding the 70th percentile in the Boston Diagnostic Aphasia Examination (BDAE) for repetition. Moderately preserved language comprehension: listening comprehension exceeding the 15th percentile of BDAE (average score obtained in three areas: word comprehension, commands and complex ideational material).
* Signed informed consent.

Exclusion Criteria:

* Any clinical condition (short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up.
* Participation in any therapeutic trial evaluating poststroke recovery.
Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated

This study is to evaluate the efficacy of a mobile app for monitoring the quality of life of patients but also on detection delay of side effects and/or complications linked to the therapeutic management. This allow to adapt their care more quickly, through a prospective randomized study. The impact of this connected monitoring of patients' anxiety will also be evaluated in this study as well as the time taken by the medical team to manage alerts generated by this application.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old without upper age limit.
* Subject operated for a non-recurrent glioma (grade II or III or IV glioma / glioblastoma) according to the WHO classification 2016;
* Subject with a connected support (smartphone,...) to download the connected tracking application.
* Unprotected adult within the meaning of the law
* Subject affiliated to a health insurance scheme
* Subject having signed an informed written consent

Exclusion Criteria:

* Minor subject, pregnant or breastfeeding woman;
* Subject under a measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
* Antipsychotic treatment (neuroleptic or lithium)
* Subjects with documented cognitive disorders (Alzheimer, other dementia)
* Subject with a personal medical history of psychiatry
* Subject unable to complete a questionnaire on his own (inability to read French language , severe cognitive disorders)
* Medical contraindication to performing an MRI (pace-maker) or scanner;
* Subject refusing to sign informed consent.
Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.

The program should not be improved by introducing new subjects such as circadian rhythm.

Respiratory diseases are a leading cause of death in developed countries. To avoid complications and recurrences, secondary prevention in patients with respiratory diseases is essential. Pulmonary rehabilitation (PR) is a well-established and effective treatment that is supervised by medical professionals and conducted in dedicated centres. It has been shown to reduce hospital readmissions, secondary events, and patient mortality.

The timing of reconditioning is crucial. Previous studies have indicated that training times affect strength and power gains. Additionally, the time of day for training can significantly impact progress in aerobic capacity.

Disturbances to the biological clock can have consequences for people with respiratory pathologies, particularly an alteration in muscular function.

Therefore, studying the temporal specificity of exercise re-training in patients with respiratory diseases is of interest.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with chronic obstructive pulmonary disease (COPD)
* Registered for respiratory re-education and rehabilitation at the Clinique de la Mitterie
* Number of rehabilitation sessions at least 18 over 4 weeks
* Written informed consent signed by the patient
* Membership of a social security

Exclusion Criteria:

* - cardiovascular contraindications to exercise
* unstable respiratory status (uncompensated respiratory acidosis)
* conditions interfering with the pulmonary rehabilitation process (progressive neuromuscular disease, psychiatric illness)
RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration

This study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.


Eligibility Criteria:
Inclusion Criteria:

• General Inclusion Criteria:

1. Male or female patients, 50 years of age or older at baseline
2. Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.

   • Ocular Inclusion Criteria:
3. Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye
4. Presence of choroidal neovascularization secondary to AMD
5. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.

Exclusion Criteria:

• General Exclusion Criteria:

1. Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
2. History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
3. Participation in any investigational drug or device study within 30 days prior to baseline
4. History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.

   • Ocular Exclusion Criteria:
5. Active ocular or periocular infections, malignancy
6. Aphakia
7. History of pars plana vitrectomy in the study eye
8. History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days
9. History of significant ocular disease other than exudative AMD that may confound results
10. Uncontrolled glaucoma (defined as intraocular pressure \>21mm Hg despite treatment with ocular hypotensive medications at baseline).
A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)

A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years.


Eligibility Criteria:
Inclusion Criteria

* Participants with histologically confirmed B-cell malignancy including:

  * Mantle cell lymphoma (MCL) treated with a prior Bruton's tyrosine kinase (BTK) inhibitor containing regimen;
  * CLL/SLL treated with a prior BTK inhibitor containing regimen;
  * Other types of B-cell NHL
* All participants must have disease requiring treatment, for CLL/SLL participants, at least 1 indication for treatment consistent with IWCLL 2018 criteria is required
* Eastern Cooperative Oncology Group 0-2
* Adequate hematologic status, coagulation, hepatic and renal function

Exclusion Criteria

* Lack of adequate wash-out period for investigational agent or anticancer therapy, major surgery, and radiotherapy prior to the first dose of study treatment
* Participants requiring therapeutic anticoagulation with warfarin
* Known central nervous system (CNS) involvement by systemic lymphoma. Primary CNS lymphoma is excluded
* Significant cardiovascular disease
* Prolongation of the QT interval
* Test positive for human immunodeficiency virus (HIV)
* Current treatment with certain strong cytochrome P450 3A4 (CYP450 3A4) inhibitors or inducers and/or strong p-glycoprotein (P-gp) inhibitors
* Pregnancy or lactation
* Active second malignancy
* Prior treatment with LOXO-305
* Known hypersensitivity to any component or excipient of LOXO-305
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer

This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic non-small cell lung cancer. Blood samples will also be collected for research purposes.

This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically verified stage IV non-small cell lung cancer with measurable lesions (On CT: longest diameter of tumoral lesion \>=10 mm, shorted diameter of lymph node \>=15 mm; measurable lesions should not have been irradiated)
* Progressed after all standard treatment
* Performance score: 0-1
* Expected life span: \>= 6 months
* Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
* Major organs function normally
* Women at pregnant ages should be under contraception
* Willing and able to provide informed consent

Exclusion Criteria:

* Pathology is mixed type
* Emergent treatment of tumor emergency is needed
* Poor vasculature
* Coagulopathy, or ongoing thrombolytics and/or anticoagulation
* Blood-borne infectious disease, e.g. hepatitis B
* History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
* With other immune diseases, or chronic use of immunosuppressants or steroids
* Compliance cannot be expected
* Other conditions requiring exclusion deemed by physician
Objective Brain Function Assessment of mTBI/Concussion in College Athletes

This study (Part 1) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).

Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.

Eligibility Criteria:
Inclusion Criteria:

* Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.

  1. If loss of consciousness, total duration less than \<20 minutes
  2. No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
  3. No hospital admission due to either head injury or collateral injuries for \>24 hours.
  4. GCS is between 13-15.

Exclusion Criteria:

1. Evidence of illicit drug usage
2. Do not speak or read English
3. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
4. Skull abnormalities, e.g. metal plate
5. History of brain surgery or neurological disease.
Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3

This study will determine the renoprotective effect of febuxostat in prevention of contrast induced acute kidney injury in chronic kidney disease patients Stage 3 undergoing percutaneous coronary intervention.

In this randomised non blinded clinical trial, Investigators will study 120 CKD patients undergoing PCI to determine the renoprotective effect of febuxostat in prevention of contrast induced acute kidney injury . So, the patients will be divided into two arms based on block randomization. Each arm compromise 60 patients. The first arm will receive IV hydration and N-acetylcysteine (ctrl arm) . The second arm will receive IV hydration, N-acetylcysteine and Febuxostat (F arm).

Block randomization will be used in this clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years old .

Patients under treatment of high dose statin(Atorvastatin (40-80 mg/day) .

Glomerular filtration rate=30-59ml/min.

Undergoing coronary PCI.

Exclusion Criteria:

Patients under treatment with febuxostat. Known allergy to febuxostat. High osmolar contrast media during the procedure .