cyrilzakka/clinical-trials huggingface dataset:
Trial of TG4023 Combined With Flucytosine in Liver Tumors

This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of 5-fluorocytosine in patients with primary or secondary hepatic tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced disease without any other standard of care treatment options:

  * hepatic metastases of colorectal cancer (CRC) or of other cancers
  * Hepatocellular carcinoma (HCC)
* At least one unresectable target tumor located in the liver, measuring 2-5 cm and accessible to IT administration of TG4023 and amenable to radiological measurement using RECIST,
* Weight ≤ 100 kg,
* Patients with stable disease, who have to discontinue chemotherapy because of intolerance,
* ECOG performance status ≤ 2,
* Life expectancy ≥ 3 months,
* Hematology:

  * Absolute neutrophil count \> 1,500/mm3,
  * Hemoglobin \> 9g/dL,
  * Platelet count \> 100,000/mm3,
  * Prothrombin time international normalized ratio (INR) ≤ 2; partial thromboplastin time ≤ 1.66 times upper limit of normal (ULN),
* Biochemistry:

  * Total bilirubin ≤ 3 x ULN,
  * Aspartate amino-transferase (AST), alanine amino-transferase (ALT), alkaline phosphatase

    * 5.0 x ULN,
  * Creatinin clearance ≥ 40 mL/min,
  * Total albumin ≥ 30 g/L,
* Anti-vitamin K anticoagulants should have been switched for low-molecular weight heparin prior to TG4023 injection,
* Signed, written Independent Ethics Committee (IEC)-approved informed consent.

Exclusion Criteria:

* Child-Pugh stage C hepatic insufficiency,
* Impaired renal function (creatinin clearance \< 40 mL/min),
* Known deficiency in dihydropyrimidine dehydrogenase (DPD) or total DPD deficiency diagnosed at baseline in those patients not previously treated with 5-FU-related compounds,
* Ascites,
* Brain metastases,
* Significant impairment of gastro-intestinal (GI) tract absorption capacity, such as total gastrectomy, gastric mucosal atrophy, extensive intestinal resections or malabsorption disease will not be treated by oral 5-FC,
* History of bleeding disorders,
* Pregnant or breast-feeding women,
* Human Immunodeficiency Virus (HIV) positive,
* Chronic use of immunodepressants within 4 weeks prior to TG4023 injection or immune-depressed patients,
* Hypersensitivity to 5-FC,
* Hypersensitivity to egg proteins,
* Concomitant or previous chemotherapy or targeted therapy within 4 weeks prior to TG4023 injection and last treatment with bevacizumab (Avastin®) within 2 months prior to TG4023 injection,
* Concomitant treatment with anti-inflammatory drugs: systemic cortico-steroids and non-steroidal anti-inflammatory drugs (NSAIDs),
* Prior gene therapy,
* Prior participation in any other research protocol involving an IMP within 2 months prior to TG4023 injection,
* Major surgery within 6 weeks of TG4023 injection,
BASIC Study: Bone Age Study In Children

This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.

The study of left wrist/hand Xrays can help children's doctors to ascertain the age of a child's skeleton, know how much growing they still have to do and predict how tall they will be as an adult. The Xray requires the child to keep their hand flat and still and in the correct orientation. Some children, especially young ones, find this difficult and therefore the quality of the Xray can mean that aging the skeleton is difficult and may require the Xray to be taken again.

This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.

Eligibility Criteria:
Inclusion Criteria:

* Children who are having a bone age Xray as part of their endocrinological hospital management.

Exclusion Criteria:

* Patients who do not give informed consent to be included in the study.
* As this study is very small and non externally funded, we will not be able to produce translations of the information sheets and consent/assent forms. This means that where patients are unable to fully give informed consent due to language barriers, they will be excluded from the study.
* )Any child with a left hand abnormality making them unable to place their hand flat e.g. contractures will be excluded.
* Any child too young or with significant enough learning difficulties making their compliance with the instructions too problematic. This will be at the discretion of the medical professional consenting the patient and the radiographer.
Walking and Balance Related to Sagittal Spinal Posture Alignment

This study aims to improve understanding of the relationship between spinal alignment and walking and balance in people who have degenerative spinal conditions.

This prospective cohort study will include people who are attending physiotherapy to address a degenerative spinal condition and measure them longitudinally. The investigators will measure spinal alignment, walking capacity and pattern, dynamic balance, and back muscle strength along with self-reported measures that reflect the person's functional self-efficacy, quality of life, and general health. Physical and self-reported outcome measures will be assessed at baseline before the physiotherapy-led exercise class commences, after completion at 6 weeks, and 6 months post baseline.

Eligibility Criteria:
Inclusion Criteria:

* Participant is diagnosed with a degenerative spinal condition.
* Participant is willing and able to give informed consent for participation in the study.
* Men and women aged 18 years or older.
* Participant is able to understand and participate safely in a physiotherapy measurement assessment.
* Participant is enrolled in physiotherapy.

Exclusion Criteria:

* Participant is unable to stand independently.
* Participant has a neurological condition which alters motor function and/or postural control.
Impact of Nicotinamide Riboside (NR) on Kidney Function in Patients Undergoing Cardiac Surgery

Acute kidney injury (AKI) associated with cardiac surgery is the most important complication in adult patients undergoing open heart surgery and is associated with increased mortality and morbidity. In patients in intensive care units, it is the second most common type of AKI after AKI secondary to sepsis. There is currently no specific treatment for AKI. Supportive measures include renal support therapy for patients with severe AKI, and mortality in this subgroup of patients exceeds 50%. Increasing NAD+ with niacinamide has been shown to prevent various etiologies of experimental AKI in mice, and an early pilot study has shown both increased NAD levels following administration of nicotinamide riboside with pterostilbene NPRT and the safety of niacinamide in patients undergoing cardiac surgery.

AKI associated with cardiac surgery is a condition with a high incidence of morbidity and mortality, without pharmacological interventions approved for its prevention or treatment. As far as we know, there is no study that evaluates the impact of the administration of nicotinamide riboside on renal function in patients undergoing cardiac surgery.

Implementation of this relatively low-cost intervention and adequate safety profile would reduce in-hospital complications in risk patients undergoing cardiac surgery.

Nicotinamide adenine dinucleotide (NAD+) is a cellular factor related to metabolism and longevity. NAD+ is a required cofactor of SIRT1, a nuclear deacetylase that modulates chromatin structure, gene expression, prolongs lifespan in organisms, and ameliorates age-related diseases. Experimental AKI in mice rapidly leads to reduced NAD+ levels in the kidney resulting from a combination of decreased NAD+ biosynthesis and increased NAD+ consumption. Likewise, mice deficient in SIRT1 are more susceptible to AKI and when there is overexpression of SIRT1 they are protected from AKI. These studies describe the modulation of NAD+ and SIRT1 as a potential therapeutic approach in AKI. Similarly, in subjects with AKI, there is evidence of a 50% reduction in plasma NAD. Increasing NAD+ with niacinamide has been shown to prevent various etiologies of experimental AKI in mice, and an early pilot study has shown both increased NAD levels following administration of nicotinamide riboside with pterostilbene NPRT and the safety of niacinamide in patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Heart valve replacement surgery
* Sign of informed consent

Exclusion Criteria:

* Allergy to any of the components
* Platelet count less than 100,000
* Weight less than 50Kg or over 100Kg
* Any type of infectious disease (e. g, Endocarditis)
* GFR less or equal to 15ml/min/m2 or with renal replacement therapy
* IV or oral contrast medium 72 hrs prior recruitment
* LRA 7 days prior to surgery
Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.

The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

* Aged 2 - 12 Years.
* Need for tonsillectomy / adenotonsillectomy.
* Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3.
* Anestesia geral com sevoflurano.
* Use of Intraoperative dipyrone, 30-50mg/Kg, IV.

Exclusion Criteria:

* Changes in consciousness.
* Neurological Deficit.
* Use of another drug as medication before anesthesia.
Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies

This study assesses neurocognitive outcomes after receiving radiation therapy to the brain (whole brain radiation therapy) in patients with blood cancers (hematologic malignancies). This may help researchers learn more about the effects of whole brain radiation therapy on memory and thinking in patients with blood cancer.

PRIMARY OBJECTIVE:

I. Record patients' cognitive outcomes after whole-brain radiation therapy (WBRT) for hematologic malignancies using standard-of-care neurocognitive function testing.

SECONDARY OBJECTIVES:

I. Assess patients' quality-of-life after WBRT for hematologic malignancies, based on a validated questionnaire.

II. Explore magnetic resonance imaging (MRI) changes in the brain after WBRT for hematologic malignancies, based on standard-of-care imaging studies.

III. Study the role of Memantine in patients' cognitive outcomes during and after WBRT for hematologic malignancies, based on standard-of-care use, utilizing standard-of-care neurocognitive function testing.

OUTLINE:

Patients undergo neurocognitive function assessments, complete questionnaires over 8-10 minutes and undergo standard of care MRI at baseline (within 4 weeks before the first day of WBRT), 2, 6, 12 months after RT completion, then annually for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Treatment with radiation therapy to the brain for a hematologic malignancy (ex. primary central nervous system lymphoma \[PCNSL\], secondary central nervous system lymphoma \[SCNSL\], leukemia, myeloma)
* Proficient and capable of completing tests in English
* Patients with claustrophobia are eligible if the claustrophobia is managed with medication
Effects of Cognitive Versus Task Oriented Training on Balance, Gait and Daily Activity in Chronic Stroke Patients

To determine effects of cognitive sensorimotor exercises versus task oriented training on balance, gait and activities of daily living in chronic stroke patients.

This study will be randomized clinical trial with total of 40 participants with chronic stroke. Patients will be recruited from Riphah rehabilitation centre and National Hospital Lahore. The sampling technique will be non probability convenience sampling technique. The patients will be randomized by lottery method and allocated into two intervention groups.

Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Patients in group B will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Intervention will be applied for 8 weeks it includes taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks. The assessment tools used will be berg balance test for balance, Dynamic gait index for gait and Modified Barthel index to assess activities of daily livings. Data will be analysed by using SPSS 25 version.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic stroke (6 months to 2 years)
* Patients with the ability to walk independently using aids or orthotics with or without supervision.
* Ability to communicate and follow instructions.
* No problem walking due to ankle contracture.
* No sensory deficiencies of the lower extremities.
* Patients cognition level on MMSE ≥ 24

Exclusion Criteria:

* Recent injuries- Patients having musculoskeletal or surgical problems of lower extremity.
* Co-morbid conditions- Cardiovascular (uncontrolled high blood pressure, diabetes), respiratory problems like dyspnoea.
* Neurological conditions- like brain tumour, demyelinating disease, Parkinson's disease, multiple sclerosis).
* Subjects with auditory and vestibular disorders.
* Cerebellar related problems.
Internet-based MOTOmed Exercise to Reduce Spasticity and Improve Physical Function in Persons With Multiple Sclerosis

In an RCT, the effect of the MOTOmed movement trainer (Reck, Germany) on spasticity and physical function in pwMS with EDSS score between 4,5 and 7 is investigated. All subjects exercise at home and are supervised and supported by an exercise therapist via an online platform.

We compare the effect of a 12 week passive, motor-driven movement therapy (VG1) to an intermittent active and passive training (VG2). After 12 weeks, VG1 continues with an active training including strengthening exercises for another 12 weeks. VG2 does not receive any intervention in the second study phase.


Eligibility Criteria:
Inclusion Criteria:

diagnosed Multiple Sclerosis (McDonald criteria) EDSS score between 5,5 and 7 diagnosed spasticity access to the internet

Exclusion Criteria:

lack of medical certificate for physical activity cognitive impairment clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
A Registry for People With T-cell Lymphoma

The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.
* Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):

  * T-cell prolymphocytic leukemia
  * T-cell large granular lymphocytic leukemia
  * Chronic lymphoproliferative disorder of NK cells
  * Aggressive NK-cell leukemia
  * Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood
  * Chronic active EBV infection of T- and NK-cell type, systemic form
  * Hydroa vacciniforme-like lymphoproliferative disorder
  * Adult T-cell leukemia/lymphoma
  * Extranodal NK/T-cell lymphoma, nasal type
  * Enteropathy-associated T-cell lymphoma
  * Monomorphic epitheliotropic intestinal T-cell lymphoma
  * Intestinal T-cell lymphoma, not otherwise specified (NOS)
  * Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract
  * Hepatosplenic T-cell lymphoma
  * Subcutaneous panniculitis-like T-cell lymphoma
  * Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)
  * Sézary syndrome
  * Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)
  * Primary cutaneous Gamma-Delta T-cell lymphoma
  * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma
  * Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)
  * Peripheral T-cell lymphoma, not otherwise specified
  * Angioimmunoblastic T-cell lymphoma
  * Follicular T-cell lymphoma
  * Nodal peripheral T-cell lymphoma with TFH phenotype
  * Anaplastic large cell lymphoma, ALK-positive
  * Anaplastic large cell lymphoma, ALK-negative
  * Breast-implant associated anaplastic large cell lymphoma.
* NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and/or primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.

Exclusion Criteria:

* Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and/or primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.
* Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.
Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer

Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated doses of paclitaxel, cisplatin, and topotecan administered together with or without filgrastim (G-CSF) in patients with newly diagnosed advanced ovarian cancer.

II. Describe and quantitate the clinical toxic effects of combination chemotherapy with paclitaxel, cisplatin, and topotecan with or without G-CSF.

III. Assess preliminary evidence of antitumor activity of this combination chemotherapy in these patients.

OUTLINE: This is a dose escalation study of topotecan.

Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed as clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial ovarian carcinoma

  * No borderline ovarian carcinoma
  * Stage III/IV disease that has been suboptimally or optimally debulked
* The following histologies are eligible:

  * Adenocarcinoma (unspecified)
  * Mucinous cystadenocarcinoma
  * Clear cell adenocarcinoma
  * Serous cystadenocarcinoma
  * Endometrioid adenocarcinoma
  * Transitional cell carcinoma
  * Malignant Brenner's tumor
  * Undifferentiated carcinoma
  * Mixed epithelial carcinoma
  * Extraovarian papillary serous cystadenocarcinoma
* Measurable or evaluable disease
* Performance status - GOG 0-1
* Enabling completion of at least 2 courses of therapy
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No myocardial infarction within 6 months
* No congestive heart failure
* No unstable or uncontrolled angina
* No history of cardiac arrhythmia requiring anti-arrhythmia medication
* No uncontrolled hypertension
* No hypersensitivity to E. coli-derived drug preparation
* No active infection
* No sensory neuropathy
* No other malignancies within the past 5 years except nonmelanomatous skin cancer
* No prior chemotherapy
* No prior radiotherapy
* Recovered from any recent surgery
Esthetic and Clinical Assessment of Injectable Resin Composite Technique

injectable resin composite technique will show a better clinical and esthetic performance compared to conventional layering resin composite technique in patients with multiple spacing in the maxillary anterior teeth area or not.

The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation. The injection molding technique has the advantage of replicating the excellent anatomy defined by a lab-made diagnostic wax-up whereby it would be used for the fabrication of direct restorations, so excellent anatomy results, verifies aesthetics, phonetics, and occlusion, avoids misunderstandings, as it is easy to implement and repair.

Eligibility Criteria:
Inclusion Criteria:

* Sound and vital upper anterior teeth.
* Spacing in the maxillary anterior teeth area ranging from .5mm to 2mm.
* Minor misalignment, correction of peg laterals.

Exclusion Criteria:

* Non-vital, fractured, or cracked teeth.
* Teeth with caries or in need of replacement of existing restorations.
* Rampant caries, atypical extrinsic staining of teeth.
* Heavy occlusion and occlusal contacts or history of bruxism.
* Severe periodontal affection.
Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis

This study aims to determine the daily rate of endogenous synthesis of oxalate using fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use a low-oxalate controlled diet, repeat fasted urine collections and 24-hr urine collections on a low-oxalate diet, to determine the daily rate of endogenous oxalate synthesis in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* History of MASLD, with liver fat content \> 5%
* Normal kidney function
* Stable medication for at least 1 month for diabetes mellitus if any
* Willingess to ingest fixed diets and stop dietary supplements for the study and come to UAB for visits

Exclusion Criteria:

* Age \< 18 years
* Inaccurate 24-hour urine collections
* Liver fat content \<5%
* Liver cirrhosis
* Evidence of other chronic liver disease, viral hepatitis
* history of alcoholism within 2 years of enrollment
* Contra-indication to Magnetic Resonance Imaging
* Chronic kidney disease with estimated Glomerular Filtration rate \< 60 ml/min/1.73m2
* Type 1 Diabetes Mellitus or treatment with insulin
* Uncontrolled diabetes
* Pregnancy, lactation or intention to be
* Uncontrolled hypertension
* Use of weight loss medication, SGLT2 inhibitors, GLP-1 receptor agonists, osteoporosis medication, chronic NSAID
* History of gastric or intestinal surgery or resection that could potentially alter oxalate absorption
* Chronic fat malabsorption
* Use of immunosuppressive medications
* Known immuno-compromised status
* Active malignancy or treatment for malignanacy within the last 12 months