cyrilzakka/clinical-trials huggingface dataset:
High Dose I-131 Metaiodobenzylguanidine(MIBG) for Metastatic Neuroendocrine Tumors

The goal of this clinical research study is to learn if I-131 Metaiodobenzylguanidine (MIBG) can shrink or slow the growth of the tumor(s) in patients with metastatic neuroendocrine tumors. The safety of this treatment will also be studied.

MIBG is used to visualize a group of specific cells in the body. It has been known to deliver the radioactive iodine to the tumor (cancer) cells selectively and result in their destruction.

Before treatment starts, patients will be evaluated with a tracer scan, using either I-131 MIBG or I-123 MIBG to locate the tumor site(s). If no MIBG accumulation can be found within tumor sites, the patient will not be able to continue on this study. Patients will also have CT scans and urine and blood tests. Women able to have children will have a pregnancy test.

If tumor sites are found and patients are fully eligible, they will receive a therapeutic (treatment) dose of I-131 MIBG by vein over 120 minutes. Some patients may have to receive a lower dose of MIBG. Patients will require hospitalization for treatment and will remain hospitalized for about 3-6 days.

Eligibility Criteria:
Inclusion Criteria:

* Age: 2 years of age and older
* Sex: male or female; female patients with child bearing potential must have a negative serum HCG pregnancy test within 72 hours prior to treatment;
* Diagnostic criteria- Patients must meet all of the following:

  1. Histologically documented neuroendocrine tumor.
  2. Labeled MIBG concentration in the tumor site(s) on diagnostic scan.
  3. good to excellent performance status.
* A patient for whom written voluntary informed consent has been obtained prior to study and participation.
* Patients can have had prior chemotherapy, as long as hematological parameters meet specifications.
* Please refer to Appendix D Drugs and Other Interactions for list of medications patient needs to cease 2 weeks prior to therapy. Patient should check with primary physician after therapy about resuming these medications.
* Patients with treatment refractory or relapsed advanced or disease not amendable to significant response (\>25% to available chemotherapy) or metastatic disease not amenable to standard therapy.

Exclusion Criteria:

* Patients with inadequate hematopoietic bone marrow function: ANC\<1000 cells/mm3, or platelets\<75k cells/mm3 or hemoglobin\<10g/dL.
* Patients with impaired renal function: creatinine\>1.5mg/dL.
* Patients with impaired hepatic function: AST or ALT \> 3.0 X upper limit of normal or total bilirubin \> 2.0 mg/dL.
* Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry.
* Female patients who are breast-feeding.
* Children less than 2 years of age.
* Patients with previous total body irradiation.
Phase I Study of Liposome-Mediated Gene Transfer in Patients With Cystic Fibrosis

OBJECTIVES:

Evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis transmembrane conductance regulator gene to nasal epithelium in patients with cystic fibrosis.

PROTOCOL OUTLINE: Cystic fibrosis transmembrane conductance regulator (CFTR) gene complexed with lipid is administered intranasally to the right inferior turbinate. Lipid without CFTR is administered to the left nostril as a control.

Cohorts of 3 patients are given successively lower doses of CFTR, each dose complexed with 500 micrograms of lipid.

Patients are followed at days 2-12, 15, and 21, then every 3-4 days for 3 weeks, every 2-3 weeks for 10 weeks, and every 3 months thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Cystic fibrosis (CF), i.e.: Sweat chloride greater than 60 mEq/L Clinical manifestations of CF Homozygous delta F508 mutation preferred Compound heterozygotes for F508 mutation with pancreatic insufficiency eligible FEV1 greater than 40% of predicted PO2 at least 60 mm Hg on room air No acute or recurrent sinusitis No obstructive nasal polyposis No pneumothorax or hemoptysis, e.g., more than 250 mL blood within 24-hour period, within past year No unstable lung disease with worsening pulmonary symptoms, arterial blood gas, or pulmonary function tests within 2 weeks prior to entry No pulmonary exacerbation within 4 weeks prior to entry --Prior/Concurrent Therapy-- At least 2 months since participation in any other clinical study At least 2 months since DNase At least 4 months since corticosteroids --Patient Characteristics-- Cardiac: No severe cardiac disease Other: No other severe organ system disease, e.g., juvenile-type diabetes mellitus No pregnant women
Robotic Assisted Hand Rehabilitation Outcomes in Adults After COVID-19

Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Therefore, assessing the efficacy of robotic-assisted rehabilitation is crucial for post-COVID-19 fatigue syndrome patients, aiming to improve motor function and overall recovery. The study focuses on evaluating rehabilitation effectiveness in individuals with upper-extremity impairment using a hand exoskeleton-based robotic system.


Eligibility Criteria:
Inclusion Criteria:

* Over 30 years old
* Patients infected with COVID-19 and has received care at the Centro Hospitalario Benito Menni
* Patients with acute or limited functional or strength impairment in at least one of the upper extremities
* Patients who would complete a rehabilitation program and a series of patient reported outcome questionnaires and a follow up evaluation
* Patients who give inform written consent.

Exclusion Criteria:

* Presence of behavioral disorders
* Dementia (loss of memory of cognitive functions)
* Disorders of consciousness (confusional states and drowsiness)
* Uncontrolled or severely limiting delusions and hallucinations
* Infectious skin diseases
* Rrisk of epileptic seizures due to COVID itself or prior to it
* Severe visual impairments
* Severe spasticity with a Modified Ashworth Scale \>2, joint stiffness in the wrist and fingers
* Pain with a score \>8 on the Visual Analog Scale (VAS) during mobilization of the affected hand.
A Randomized Study Evaluating the Incidence of Post Lumbar Puncture Headache With Atraumatic Needles in Hematology

Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional symptoms such as nausea. Some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for post lumbar puncture headache while using atraumatic needles as compared to standard needles. In this context, it is necessary to better document the incidence of post lumbar puncture headache with the use of atraumatic needles in hematologic patients.

Lumbar punctures (LP) are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache (PLPH) is a common complication in around 30% of patients. PLPH is characterized by the occurrence of a headache with an orthostatic component within 12-72 hours after LP with additional symptoms such as nausea. Even if this phenomenon spontaneously resolves within 3 to 5 days, symptoms can immobilize the patient and can interfere with his daily activities. Technical procedures largely influence the incidence of PLPH. Indeed, some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for PLHP while using atraumatic needles as compared to standard needles. So far, few data are available for hematology. In this context, it is necessary to better document the incidence of PLPH with the use of atraumatic needles in hematologic patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic syndromes undergoing a diagnostic lumbar puncture
* Signed written informed consent form
* Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria:

* Any known contraindication for the lumbar puncture procedure: increased intracranial pressure, blood clotting disorder, thrombocytopenia
* Any known infection
* Patient with a Body Mass index \< 18 or Body Mass index \> 40
* Any patient that requires an ultrasound guided lumbar puncture
* Patient that underwent a lumbar puncture within 6 months
* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)
* Refusing participation
* Pregnancy or breastfeeding women
Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery

The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* male and female 18 to 70 years
* patient alert and capable of self-administering an opioid anaglesic
* Patient is scheduled for orthopedic surgery under general anesthesia
* Patient has normal laboratory values
* Physical examination with no clincially relevant findings
* Patient in general good health based on medical history and clincially acceptable
* Patient is able to understand the requirements of the study
* Patient is able to communicate effectively with study personnel _Patient voluntarily gives written approval.

Exclusion Criteria:

* During Part 2 (randomized period) which involves the use of placebo, patients who are undergoing a major orthopedic procedure that normally requires multimodal analgesia to achieve adequate postoperative pain control (e.g. major spine surgery, total knee arthoplasty) will be excluded.
* Patient is taking opioid or non-opioid analgesics on a chronic basis at doses which in the opinion of the investigator would interfere with evaluations of post-operative fentanyl efficacy.
* History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, gastrointestinal (GI), or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study.
* Patient has documented or self-reported medical history of sleep apnea.
* Patient has a documented hypersensitivity to fentanyl or other opioid analgesics.
* Patient has a documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation, including hypersensitivity to soya lecithin or related food products such as soya bean and peanut.
* Patient is currently receiving treatment, or has received treatment in the previous two weeks, with monoamine oxidase inhibitors.
* Patient has a history of malignancy within the past 5 years, with the exception of successfully treated non?metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
* Patient was dosed with another investigational drug within 30 days prior to the Screening Visit.
* Patient has current therapy with CNS-depressant medications (other than stable doses of analgesics and drugs used with surgical anesthesia).
* Patient has current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
* Patient has a history of abuse of licit or illicit drug substances.
* Patient, who in the opinion of the Investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit

The purpose of this study is to evaluate the role of lung sonography during different PEEP settings in ICU patients with ARDS.

Acute respiratory distress syndrome (ARDS) is a clinical syndrome that often occurs in critically ill patients.

Patients with ARDS invariably require mechanical ventilation to improve oxygen transport. An improvement in oxygenation can be obtained by an increase in positive end-expiratory pressure (PEEP).

In critically ill patients with ARDS, lung imaging is been held by the use of chest radiography and the "gold standard" technique, Computed Tomography (CT).

We designed an observational study in which we included patients under mechanical ventilation admitted in our ICU. In all patients PEEP changes were applied and lung sonography was performed.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with ARDS admitted in ICU of Evangelismos Hospital
* length of stay \> 48 hours

Exclusion Criteria:

* age \< 18 years
* emphysema fractures or skin lesions that do not allow the implementation of lung sonography
* BMI \> 35 kg/m2
* length of stay \< 48 hours
Multicomponent Exercise in People With Dementia

People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Previous studies reported that multicomponent exercise improved EF in people with mild cognitive impairment and independence of ADL in those with Alzheimer's disease. However, few studies investigated whether multicomponent exercise improved EF, memory, and ADL in people with dementia. Therefore, the purposes of this study are to examine 1) the effect of multicomponent exercise on EF, memory, and ADL in people with mild to moderate dementia; 2) the correlation between change in EF and ADL; 3) the correlation between change in memory and ADL.


Eligibility Criteria:
Inclusion Criteria:

* Age: 60-80 y/o
* Mini-Mental State Examination: 10-26
* Clinical Dementia Rating: 1-2
* Walk at least 6 meters independently (with or without walking aids)

Exclusion Criteria:

* Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia)
* Physical or psychological comorbidities that affect performance during assessment or intervention
* Already participating in other physical training in the last 1 month
Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy

The aim of this study is to compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy.

Surgical repair of inguinal hernia is one of the most common day-case surgeries in the pediatric population. It is associated with significant postoperative pain and discomfort.

Caudal block analgesia is a popular and reliable technique for lower abdominal surgeries and found to be safe and effective for providing intra and postoperative analgesia in pediatric patients.

transversal fascia plane block (TFPB) aims to provide analgesia for invasive procedures of the inguinal and sublingual areas by blocking the subcostal (T12), ilioinguinal (L1) and iliohypogastric (T12-L1) nerves. Several studies have reported TFPB as the analgesic method of choice for procedures involving the T12-L1 dermatome region, including iliac bone graft harvesting, cesarean section, and inguinal hernia repair

Eligibility Criteria:
Inclusion Criteria:

* Age from 1 to 7 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for inguinal herniorrhaphy under general anesthesia (GA).

Exclusion Criteria:

* Repeated surgeries.
* Known allergic reactions to any of the study's drugs.
* Infection at the site of block needle entry.
* Bleeding diathesis.
* Neurological disorders.
Lidocaine and Analgesia After Laparoscopic Cholecystectomy

The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy

Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct.

Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* Age ≥ 18 years old
* BMI ≤ 35

Exclusion Criteria:

* Allergy in local anesthetics
* History of liver, kidney or heart failure
* Existence of chronic pain history or daily analgesics
* Psychiatric disorders
* Inability to understand pain assessment
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Immunosuppressant therapy.
* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.
* Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

* Radiation therapy for mucocutaneous Kaposi's sarcoma.

Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.

* Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans.
* Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
* Each individual patient must be approved by Pfizer Central Research prior to study entry.

Prior Medication:

Allowed:

* Immunosuppressant therapy.
* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.
* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles or azoles.
* Moderate or severe liver disease.

Concurrent Treatment:

Excluded:

* Lymphocyte replacement.

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles or azoles.
* Moderate or severe liver disease.
* Satisfactory response to amphotericin B and have received a total amphotericin B dose of 15 mg/kg or more since CSF culture documentation of the current episode of acute cryptococcal meningitis.
* Life expectancy of \< 2 weeks.

Prior Medication:

Excluded:

* Coumadin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications.

Prior Treatment:

Excluded:

* Lymphocyte replacement.
A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with BCG in participants with BCG-unresponsive high-risk NMIBC.

The study plans a similar evaluation of eciskafusp alfa in monotherapy following a positive interim analysis of the combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed high risk non muscle invasive transitional cell carcinoma classified according to World Health Organization (WHO) grading system
* Absence of resectable disease after transurethral resection of bladder tumor (TURBT) procedures
* The most recent cystoscopy/TURBT must have been performed within 12 weeks and up to 14 days of the first dose of study treatment
* Presence of BCG-unresponsive disease defined as persistent or recurrent carcinoma in situ \[CIS\] (± recurrent Ta/T1 disease) within 12 months of receiving adequate BCG therapy
* The participant is considered ineligible for radical cystectomy or has elected not to undergo the procedure.
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Positive hepatitis B surface antibody (HBsAb) test at screening
* Negative hepatitis C virus (HCV) antibody test at screening

Exclusion Criteria:

* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Active infections (both systemic and local urinary)
* Congenital or acquired immune deficiencies resulting in immunosuppression
* Known human immunodeficiency virus (HIV) infection
* History of radiotherapy of the bladder
* History of perforation of the bladder
* Major surgery or significant traumatic injury within 28 days prior to first administration of study treatment or anticipation of the need for major surgery during treatment
* Participants currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, and supportive care therapies for active disease
* Any intervening intravesical immunotherapy or chemotherapy from the time of the most recent cytoscopy/TURBT to the start of study treatment
* Systemic immune-modulating and systemic immunosuppressive agents/medication
* Administration of a live, attenuated vaccine within 28 days prior to first administration of study treatment
* Recurrence of BCG unresponsive CIS \> 12 months after last BCG instillation
* Concurrent second malignancy
Newborn Brain Test (NBT)

The aim of the overall project is to develop the Newborn Brain Test (NBT), a novel platform to detect abnormal brain activity in infants at birth through an automated AI assessment. Easy to interpret results, provided in less than 15 minutes, will allow for immediate follow up by a medical team when abnormal brain function is detected.

NBT has been developed by INFANT's study partner CergenX (UCC Spinout company), who sponsors the study. INFANT is responsible for the clinical aspect of the project and will conduct a feasibility study of the device as well as a larger pivotal investigation.

EEG activity will be recorded using the standard CE marked portable EEG amplifier with four electrodes on the scalp. The test will be controlled using a tablet. The captured waveforms will be sent to the cloud where the NBT Artificial Intelligence (AI) algorithm analyses EEG activity, analyses the data and decides whether the test was or was not completed successfully. The test takes approximately 15 minutes to complete. The device has been trained with EEG data from full term infants. It is not a diagnostic test, simply a screener.

The EEG and anonymised patient data collected during the NBT test will be processed and stored in the NBT secure AWS infrastructure. During the feasibility study, the result (EEG reading or result of AI algorithm) from the device will not be available to the research team so as not to influence clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* All neonates≥ 37 and ≤45 weeks gestational age
* Parental informed consent

Exclusion Criteria:

* Any Infant with head trauma or broken skin on the scalp
* Informed consent not obtained.