cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Vardenafil and Carboplatin in Patients With Gliomas and Brain Metastases

This is a randomized pilot study to investigate the ability of a phosphodiesterase-V inhibitor (vardenafil) to increase the concentration of systemically delivered chemotherapy, carboplatin, in patients with recurrent malignant gliomas or metastatic brain cancer. This study will also determine the toxicity and tolerability of a phosphodiesterase-V inhibitor (vardenafil) in combination with intravenous carboplatin for patients with recurrent malignant gliomas or metastatic brain cancer.

Twenty patients (10 pts with recurrent malignant glioma and 10 pts with metastatic brain tumor) will be randomly assigned to receive either a phosphodiesterase-V inhibitor (vardenafil) followed by carboplatin or carboplatin alone. All patients will have tumor resection performed from 2 to 6 hours after administration of carboplatin. Using high performance liquid chromatographic (HPLC) or ELISA methodology, carboplatin levels will be determined from both serum and resected tumor tissue. Patients will be followed for four weeks after craniotomy for toxicity associated with the administration of carboplatin and a phosphodiesterase-V inhibitor plus carboplatin.

These data will provide quantitative measures of intratumoral carboplatin levels with and without alteration of blood/tumor barrier (BTB) permeability with vardenafil.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent malignant glioma or metastatic brain cancer requiring craniotomy for gross total resection, subtotal resection or biopsy
* Previously histopathologically proven glioma or radiographic appearance of metastatic lesion with a primary neoplasm that is known to metastasize to the brain
* Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
* Patients must have normal hematologic, renal and liver function (i.e. Hemoglobin \>10 gm/dl, Absolute neutrophil count ≥ 1500/mm3, Platelets ≥ 100,000/mm3, creatinine ≤ 1.5 mg/dl or Cr Clearance ≥ 60 mL/min, total bilirubin ≤ 1.5 mg/dl, transaminases ≤ 4 times above the upper limits of the institutional normal.
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
* Patients who are pregnant or breast-feeding
* Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents)
* Allergy to 5HT-(3) receptor antagonist including tropisetron, ondansetron
* Patients on enzyme-inducing anticonvulsants (Dilantin, Tegretol, Phenobarbital)
* Patients with unstable angina or serious cardiovascular disease
* Known HIV positivity or AIDS-related illness
* History of allergic reaction to platinum compounds or mannitol
* Medical conditions requiring the use of oral nitrates
* Patients on alpha-1 adrenergic blockers
Multicenter Evaluation in Patients With MEningiomas of the Response to Treatment With 177LUTEtium-oxodotreotide

Meningiomas are the most common primary tumors of the central nervous system, representing more than a third of tumors.Current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory regardless of their grade. Some meningiomas express somatostatin type 2 receptors and can be treated with lutathera. This study aims to evaluate the response to treatment in this pathology

In nuclear medicine, peptide receptor radionuclide therapy with 177Lu-oxodotreotide, deploys an octreotide-like effect and appears very promising, with a preliminary progression free survival at 6 months of 94% and overall survival at 12 months of 88% in grade 1 meningiomas, and 28% with an overall survival at 12 months of 65% in grades 2 and 3 meningiomas. These results are nevertheless the result of a meta-analysis obtained from series of patients limited in number and heterogeneous in terms of type of treatment modality.

At the request of healthcare professionals and in consultation with the Advanced Accelerator Applications laboratory, the Agency of the drug security has developed a compassionate prescribing framework aimed at securing the use of Lutathera in meningiomas of all grades, expressing type 2 somatostatin in imaging of nuclear medicine, after failure of the standard treatment (surgery, radiotherapy/radio-surgery) or impossibility of carrying it out (multiple lesions, inaccessible lesions), at the suggestion of the national comitee OMEGA (April 6, 2022). This cohort has the advantage of being consistent and homogeneous in terms of type of treatment and method of administration.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have benefited from treatment with Lutathera® within the framework of compassionate prescription in a refractory meningioma of any grade
* Patient informed via an information and non-opposition to the use of their pseudonymized data for research purposes (research objectives clearly explained in the letters)

Exclusion Criteria:

-Patient opposition to the use of their data for this research
Individual Patient Investigational New Drug (IND) Expanded Access Program of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Participant With Multiple Myeloma

The purpose of this individual-patient investigational new drug (IND) single patient request (SPR) is to provide participants treatment with JNJ-68284528, an investigational product prior to its marketing authorization. Such access may be considered for participants with serious/life-threatening diseases or conditions, where there exists no alternative treatments or where alternative treatments have been exhausted.


Eligibility Criteria:
A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer

This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=70 years of age;
* inoperable, locally advanced, metastatic non-squamous non-small cell lung cancer;
* \>=1 measurable lesion;
* ECOG performance status 0-1.

Exclusion Criteria:

* neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment;
* radical radiotherapy with curative intent within 28 days prior to enrollment;
* history of \>=grade 2 hemoptysis in 3 months prior to enrollment;
* evidence of CNS metastases;
* current or recent (within 10 days of first dose of Avastin)use of aspirin (\>325 mg/day)or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects

The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent.
* Normal physical examination, laboratory values, blood pressure and pulse
* Healthy male caucasian subjects

Exclusion Criteria:

* Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body.
* Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function
* Subjects must not have crystals or more than a trace of blood in their urine
The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients with Advanced Knee Osteoarthritis.

Genicular nerves chemical neurolysis in advanced osteoarthritis of the knee joint.

The study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the knee joint.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study
* patients with gonarthrosis who failed to achieve satisfactory pain control (NRS\>3) despite the use of NSAIDs, Paracetamol, and co-analgesics
* Age of patients: from 18 to 110 years of age.
* Caucasian patients can give informed, complete, written consent.

Exclusion Criteria:

* suspected or diagnosed opioid dependence syndrome
* active cancer
* dementia
Comparison of Epidural and TAP Block in Abdominal Surgery

This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but TAP blocks will decreased costs, urinary retention, and hypotension.

This study intends to examine this rational by comparing the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal surgery. The efficacy of the TAP block for abdominal surgery is well documented in the literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the primary outcome will demonstrate no difference between the two in terms of pain scores and opioid consumption. The investigators anticipate that patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension.

Eligibility Criteria:
Inclusion Criteria:

* subject \>/= 19 years of age
* Undergoing major abdominal surgery
* able to provide written informed consent

Exclusion Criteria:

* chronic opioid use
* allergies to amide anesthetics
* inability to undergo general anesthesia
* pregnancy
* any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs
* or evidence of gross neurological dysfunction of the lower extremity
TLR4 Polymorphisms and Risk of Skin Cancer

Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptor-4 (TLR4) in particular, appears to play a role in susceptibility to cancer. Of 44 identified SNPs (small nucleotide polymorphisms) in TLR4, the most common is an A-G substitution at nucleotide position +896, downstream of the cDNA start codon, a missense mutation which leads to an amino acid substitution Asp299Gly in the third exon of the TLR4 gene. Pre-clinical studies from our laboratory have shown an association of TLR4 with ultraviolet radiation induced skin cancer. Hence, in this study we will assess the pattern of TLR4 polymorphisms and susceptibility to skin cancer.

Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptors generally, and TLR4 in particular, appear to play a role in cancer susceptibility as well as tumor immunosuppression and stromal invasion. Of 44 identified SNPs (small nucleotide polymorphisms) in TLR4, the most common is an A-G substitution at nucleotide position +896, downstream of the cDNA start codon, a missense mutation which leads to an amino acid substitution Asp299Gly in the third exon of the TLR4 gene, and which was later shown to co-segregate with SNP Thr399Ile-also in the third exon of TLR4.1 This SNP, present in 10% of the general population, has been found associated with gastric cancer, prostate cancer, and nasopharyngeal cancer.2-4 Pre-clinical studies from our laboratory have shown an association of TLR4 with ultraviolet radiation induced skin cancer. Hence, in this study we will assess the pattern of TLR4 polymorphisms and susceptibility to skin cancer.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over the age of 50
* Fitzpatrick skin type I-IV

Exclusion Criteria:

* Tumor types other than basal cell carcinoma, squamous cell carcinoma and melanoma
* Chronic immunosuppression due to transplant antirejection regimen or HIV/AIDS
* Nevoid basal cell carcinoma syndrome, Cowden's syndrome, xeroderma pigmentosum or other syndrome with skin-cancer predisposition
* Known exposure to arsenic or ionizing radiation
Almond for Physical Performance

Investigators specific aims are to compare the effects of consuming daily snacks of raw, shelled, unsalted almonds (2.0 ounces) versus an isocaloric amount of another commonly consumed snack food (pretzels) on energy (vigor) perception and physical activity, exercise performance (VO2max and measures of strength), strength and power performance as well as muscle soreness recovery after strenuous eccentrically-biased exercise.

To accomplish these aims, investigators will examine whether regular consumption of almonds versus a common snack food over a period of 8 weeks impacts longer term metabolic, physiological and behavioral responses related to energy sensations and exercise capacity/performance.

Eligibility Criteria:
Inclusion Criteria:

* 30-50 years old
* BMI of 23-30

Exclusion Criteria:

* smoking,
* medications known to impact inflammation,
* musculoskeletal limitations and
* use of supplements within 1 month of participation that are known to impact antioxidant
* use of supplements within 1 month of participation that are known to impact inflammatory status
Pulmonary Rehabilitation Before Lung Cancer Resection

This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled to undergo a surgery for non small cell lung cancer
* Moderate to severe COPD
* Current or ex smoker of ten or more years

Exclusion Criteria:

* Unable to perform exercise due to active cardiovascular, musculoskeletal or mental problems Poorly motivated to attend the rehabilitation sessions or receive randomization.
Improving Breast Health Knowledge Among Women Using a Gamified Metaverse-Based Platform

This randomized controlled trial aimed to evaluate the effectiveness of Mammoverse, a gamified metaverse-based educational platform, in improving breast health knowledge among women in China. Participants were randomly assigned to either a gamified or non-gamified version of the platform. Both groups received identical educational content, but only the gamified group experienced interactive game elements such as avatars, progress feedback, and rewards. Knowledge was assessed at baseline, immediately post-intervention, and at 4-week follow-up. The study found that the gamified platform significantly improved knowledge retention and participant engagement compared to the non-gamified version.

This ClinicalTrials.gov registration reflects only the randomized controlled trial (RCT) portion of a broader mixed-methods study that was approved by the University of Malaya Research Ethics Committee (Ref: UM.TNC2/UMREC_3967). The full study protocol includes three methodological approaches, and this registration pertains specifically to the RCT component involving the Mammoverse platform. Other study components are not included in this registration.

Mammoverse is a 3D metaverse environment designed to promote breast health knowledge through immersive and interactive learning. The gamified version included user avatars, badges, tasks, and personalized feedback to increase motivation and engagement. The study recruited 72 women aged 18 and above, and used a pre-post-follow-up design. Outcome measures were based on an adapted 18-item Breast Health Literacy Questionnaire. The trial was conducted entirely online, with ethics approval from the University of Malaya Research Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* Female participants aged 18 years and above
* Able to read and understand Chinese
* Access to a digital device and stable internet connection
* Willing to provide informed consent

Exclusion Criteria:

* Cognitive impairment or mental health condition that affects participation
* Inability to complete the full intervention and follow-up sessions
* Incomplete baseline assessment
PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro-PvF)

Total hip arthroplasty is a major surgical procedure performed on a growing number of patients. Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation, thus expediting hospital discharge. Amongst the many peripheral nerve blocks, FIB (fascia iliaca block) has been recommended as the block of choice by many international guidelines since it offers the best pain control with a relatively low risk of motor block. PENG (pericapsular nerve group) and its association with LFCN (lateral femoral cutaneous nerve) has been proposed as an effective alternative that offers comparable, If not better, pain control with a considerably lower risk for motor block compared to FIB. Given the novelty of this block, there are few published papers on the subject, mostly case series or case reports thus justifying the need for retrospective study.

The primary outcome was the degree of residual quadriceps femoris muscle paresis assessed with the MRC (medical research council) scale at 6 hours between PENG and LCFN. The secondary outcomes were NRS (numeric rating scale) at 6,12, 24 hours, total opioid consumption expressed as milligrams of morphine equivalents (MME), time to first rescue opioid and time to first postoperative ambulation.

Eligibility Criteria:
Inclusion Criteria:

* elective total hip replacement surgery for non-traumatic hip disease,
* age over 18 years,
* complete clinical chart including type of peripheral nerve block performed,
* signed consent form for spinal anesthesia and peripheral nerve block.

Exclusion Criteria:

* preoperative opioid therapy,
* having received a peripheral nerve block other than PENG + LFCN or FICB,
* having received general anesthesia,
* incomplete chart,
* documented muscle weakness
* deviation from the established post-operative analgesia protocol.
Education Intervention on Vaccination Adherence Among Inflammatory Bowel Disease (IBD) Patients

A retrospective chart review and a six-month prospective outcome analysis aimed to evaluate the efficacy of a vaccination education intervention and vaccination adherence among IBD patients at Weill-Cornell Medical Center. It is hypothesized that a general vaccination education campaign will improve vaccination adherence rates for all IBD patients. Secondarily, it is hypothesized that an Human Papilloma Virus (HPV) vaccination intervention targeted at high-risk IBD patients will increase vaccination adherence among these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient at Weill-Cornell Medical Center with an in-person or virtual appointment between March 1 - August 30, 2021.
* Documentation of an IBD diagnosis (CD, UC, IC).

Exclusion Criteria:

* No documentation of an IBD diagnosis.
* Pregnant or breastfeeding.
* No scheduled appointment between March 1-August 30, 2021.
Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease.
* Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
* Must experience "wearing OFF" between doses of medication.

Exclusion Criteria:

* Diagnosed with atypical parkinsonism.
* Allergic or non-responsive to previous carbidopa-levodopa therapy.
* Active or history of narrow-angle or wide-angle glaucoma.
* History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures.
* Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
* Treatment with any dopaminergic blocking agent within the previous 3 months.