Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of medi0457 and durvalumab in participants with human papilloma virus (hpv) associated recurrent/metastatic head and neck cancer

Conditions: Head and Neck Cancer; Human Papilloma Virus

Summary: this is a phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of medi0457 (also known as ino 3112) a hpv deoxyribonucleic acid (dna) vaccine in combination with durvalumab (also known as medi4736) which is a human monoclonal antibody directed against programmed death ligand 1 (pd-l1), which blocks the interaction of pd-l1 with pd-1 and cluster of differentiation 80 (cd80). an initial three to 12 participants (safety analysis run-in participants) will be enrolled and assessed for safety before additional participants are enrolled. the initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (hnscc) will be enrolled in this study and evaluated also for anti-tumor efficacy to medi0457 in combination with durvalumab.


Eligibility criteria:
inclusion criteria: 1. male and female participants 18 years and older 2. histologically or cytologically confirmed diagnosis of hnscc associated with hpv by a p16 immunohistochemistry (ihc) assay or hpv-16 or hpv-18 positive by nucleic acid testing. 3. recurrent or metastatic disease that has been treated with at least one platinum-containing regimen and lacking a curative treatment option. 4. participants who are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential. exclusion criteria: 1. any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment active or prior documented autoimmune disease with some exceptions. 2. current or prior use of immunosuppressive medication within 14 days prior to first study dose, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed. 3. no prior exposure to immune-mediated therapy defined as prior exposure to t-cell and natural killer cell directed therapy (e.g., anti-pd-1, anti-pd-l1, anti-cd137, and anti-ctla4, etc).

Keywords: head and neck squamous cell carcinoma oropharyngeal cancer hpv human papilloma virus cancer immunotherapy check point inhibitors pd-l1 inhibitor recurrent or metastatic cancer durvalumab medi0457 antineoplastic agents neoplasms
functional study of the hypothalamus in magnetic resonance imaging (mri) in polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: the aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in pcos is associated with transient microstructural and metabolic changes in the female hypothalamus using mri approaches to assess water diffusion and measure proton magnetic resonance spectra.


Eligibility criteria:
inclusion criteria: for all subjects * aged from 19 to 30 years * body mass index : 18-25 * informed consent before inclusion * do not smoke the 3 days before the mri for healthy volunteers subjects : * regular cycles (between 25 and 35 days) and ovulatory. * no signs of hyperandrogenism. * subjects desirous of taking oral contraceptives (estrogen/progestin combination). * for the realization of the 2nd mri: to be during the 3rd month of a treatment well followed by oestro-progestative monophasic minidose to 0,02mg of ethinyl-oestradiol / 0,1mg levonorgestrel. pcos women: * pcos defined by rotterdam criteria * needing a treatment with cyproterone acetate * to carry out the 2nd mri: to be in progress during the 3rd month of a treatment well followed by 50 mg of cyproterone acetate in association with 2mg / day of natural estradiol. exclusion criteria: * hormone treatment within 3 months prior to inclusion (including birth control pill ) * on-going pregnancy (determined before each mri scan visit) * claustrophobia * any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators) * diabetes or known dysthyroidism. * current substance abuse (including smoking more than 5 cigarettes/day; determined using drug screening at the screening visit) * pregnancy or breastfeeding the last 3 months. * practice of intense physical exercise (ex jogging\> 10km) the day before the mri. * person incapable of consenting, or enjoying legal protection (guardianship / curatorship). * unability to understand the treatment protocol

Keywords: hypothalamus diffusion magnetic resonance imaging magnetic resonance spectroscopy
treatment of surgical scars following breast augmentation, abdominoplasty or face lift

Conditions: Surgical Scar; Breast Augmentation; Abdominoplasty; Face Lift

Summary: evaluator-blinded study of the safety and performance of fractional radiofrequency (frf) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift. the study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following facelift surgery. subjects will receive a total of 3 treatments of their surgical scars at 1-month intervals. subjects will be followed up at 10 months after their last treatment (12 months after the first treatment).


Eligibility criteria:
inclusion criteria: 1. healthy, female, subjects 20-60 years of age who are seeking treatment for their breast augmentation or abdominoplasty surgical scars or male and female patients 40-75 years of age who are seeking treatment for their face lift surgical scars. 2. a minimum of four weeks since surgery. 3. able to read, understand and voluntarily provide written informed consent. 4. able and willing to comply with the treatment/follow-up schedule and requirements. 5. willing to avoid direct sunlight for the duration of the study. 6. women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative urine pregnancy test at baseline. exclusion criteria: * 1. fitzpatrick skin types 5-6. 2. implantable defibrillators, cardiac pacemakers, and other metal implants 3. subjects with any implantable metal device in the treatment area 4. pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 5. permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. 6. current or history of any kind of cancer, or pre-malignant moles. 7. severe concurrent conditions, such as cardiac disorders. 8. pregnancy or intending to become pregnant during the study and nursing. 9. impaired immune system due to immunosuppressive diseases, such as aids and hiv, or use of immunosuppressive medications. 10. history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime. 11. poorly controlled endocrine disorders, such as diabetes. 12. any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 13. history of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 14. history of bleeding coagulopathies, or use of anticoagulants. 15. use of isotretinoin (accutane®) within six months prior to treatment. 16. treating over tattoo or permanent makeup. 17. excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks. 18. as per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Keywords: fractional radiofrequency
safety and effectiveness study for pleurodesis with silver nitrate in malignant pleural effusion

Conditions: Malignant Pleural Effusion

Summary: the primary purpose of this study is to determinate the degree of chest pain on patients with malignant pleural effusion submitted to pleurodesis with silver nitrate in three different dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). our secondary purpose is to evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for pleurodesis in the aforementioned dosages/concentrations.

malignant pleural effusion is a frequent complication in advanced neoplasia. pleurodesis is the procedure of choice for symptomatic control, with talc as the sclerosing agent of choice. however, the occurrence of severe adverse effects associated with its use has led to the search for other agents. silver nitrate poses an option, presenting excellent results in animal models and having successful usage in pleurodesis in the past. although important, the current literature on the effective use of silver nitrate for pleurodesis is still too scarce, and a deeper knowledge on the occurrence of adverse side effects, especially pain, is still necessary to allow the substance to be considered as an effective alternative to talc, as well as for the definition of an adequate dosage.

Eligibility criteria:
inclusion criteria: * malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleural biopsy. * recurrent and symptomatic malignant pleural effusion. * full pulmonary expansion (\>90%) post thoracocentesis, confirmed via chest x-ray. * karnofsky performance status \>30 * agreement to participate of the study by signing of the informed consent term. exclusion criteria: * coagulopathies (prothrombin activity \<50%) and/or thrombocytopenia (\<80000 count). * active pleural or systemic infection. * massive skin neoplastic infiltration. * inability of understanding the pain scale. * previous pleural procedures (except for thoracocentesis and/or pleural biopsy). * refusal to participate of the study.

Keywords: pleurodesis malignant pleural effusion silver nitrate pain
the utility of 18f-dopa-pet in the treatment of recurrent high-grade glioma

Conditions: Glioma

Summary: this proposal is for a pilot study comparing volumes of 18f-dopa-pet avidity with contrast enhancement and t2 flair on mri. investigators then plan to compare patterns of failure with target volumes, pre-treatment mri changes and pre-treatment 18f-dopa-pet.


Eligibility criteria:
inclusion criteria * age \> or equal to 18 years * ecog ps \< or equal to 3 * histologically confirmed or radiographic evidence of recurrent/progressive glioma. * history of radiation therapy to the brain for prior diagnosis of glioma * planned radiation treatments at mayo clinic rochester * provide informed written consent * willing to sign consent onto the mayo clinic radiotherapy patient outcomes registry and biobanking study, irb number 15-000136 (blood draw optional) * willing to return to enrolling institution for follow-up during active monitoring phase of the study. exclusion criteria * more than one prior course of radiotherapy or prior prescription doses exceeding 60 gy to re-irradiation target volumes * unable to undergo mri scans with contrast * unable to undergo an 18f-dopa-pet scan (e.g., parkinson's disease, taking anti dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists.) note: other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline). if a patient is on any of these drugs, list which ones on the on-study form. -any of the following: * pregnant women * nursing women * men or women of childbearing potential who are unwilling to employ adequate contraception
personalized tacs to reduce rumination in patients with active suicidal ideation

Conditions: Suicidal Ideation Active; Depression Disorders

Summary: the goal of this clinical trial is to determine whether modulating default mode network (dmn) alpha connectivity using transcranial alternating current stimulation (tacs) can reduce rumination and, in turn, mitigate feelings of entrapment and suicidal ideation in individuals with active suicidal ideation and depression. the main questions it aims to answer are: 1. is personalized tacs stimulation of the dmn associated with reduced rumination 24 hours after stimulation? 2. does a reduction in rumination result in lower feelings of entrapment and suicidal ideation? 3. does personalized tacs stimulation of the dmn lead to a reduction of dmn alpha connectivity? researchers will compare active tacs stimulation to sham stimulation to assess whether modulating alpha connectivity has a specific effect on rumination, entrapment, suicidal ideation, and dmn alpha connectivity. participants will: * receive either active or sham tacs stimulation during stimulation sessions, but all participants will receive active tacs at least once. * complete self-report measures of rumination, entrapment, and suicidal ideation before and after stimulation. * undergo eeg recordings to assess changes in dmn alpha connectivity. this clinical trial will be preceded by a pilot study in healthy participants with an anticipated completion of data collection in august 2025.


Eligibility criteria:
inclusion criteria: * active suicidal ideation defined by a score ≥3 on item #10 of the montgomery-asberg depression rating scale (madrs) and a combined score of ≥2 on items #4 + #5 of the beck scale for suicide ideation (bss) * clinical diagnosis of a mild to severe depressive episode without psychotic symptoms * voluntary patients at inpatient, outpatient, or day-clinic units of mental health care settings in the greater zurich area * aged 18-65 years * fluent in german * ability to give written informed consent exclusion criteria: * mental disorders due to known physiological conditions * schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders * intellectual disabilities * concurrent vagus nerve stimulation, transcranial magnetic stimulation, electro-convulsive therapy, or treatment with nitrous oxide * pregnancy or breast-feeding * chronic migraines * metal implants or any other factor that - in the investigators' judgment - would unduly affect patient safety or compliance during this study

Keywords: tacs suicidal ideation rumination entrapment depression non-invasive brain stimulation suicidal thoughts and behavior
serratus posterior superior intekcostal plane block vs serratus anterior plane block for postoperative analgesia in vats: a randomized trial"

Conditions: Video Assisted Thoracoscopic Surgery; Postoperative Analgesia

Summary: thoracotomy is known as one of the most painful surgical procedures, with up to 65% of patients developing chronic post-thoracotomy pain syndrome (ptps), and approximately 10% experiencing pain that significantly impacts quality of life. video-assisted thoracoscopic surgery (vats) has become increasingly common over the past decade and offers reduced postoperative pain, morbidity, and length of hospital stay compared to open thoracotomy. however, vats can still cause moderate to severe postoperative pain and a high risk of chronic pain. optimizing analgesia after vats remains critical. with advances in ultrasound technology, several regional anesthesia techniques such as serratus anterior plane block (sapb), erector spinae plane block (espb), and thoracic epidural analgesia (tea) have shown comparable efficacy. in 2023, tulgar et al. described the serratus posterior superior intercostal plane block (spsipb), which demonstrated dermatomal coverage from c3 to t10. this randomized controlled trial aims to compare the analgesic efficacy of spsipb and sapb in patients undergoing vats procedures.

the patients will be divided into two groups and all will receive general anesthesia. before extubation, one group will receive a serratus anterior plane block, and the other group will receive a serratus posterior superior intercostal plane block. the randomization of the study will be performed by a physician who will not be involved in the patient follow-up, using a computer-generated randomization code (generated by the computer). the interfascial plane block (serratus anterior plane block or serratus posterior superior intercostal plane block) will be given to the anesthesiologist in a sealed envelope by an independent assistant personnel outside the study. the patient will not be aware of which block is being applied. the anesthesiologist performing the block will not participate in the patients' pain monitoring. postoperative pain assessment and data collection will be performed by another anesthesiologist who is unaware of the study. for standardization purposes, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 successful and uncomplicated procedures before.

Eligibility criteria:
inclusion criteria: * bmi \< 35 kg/m² patients with asa scores i, ii, iii exclusion criteria: * patients who do not want to be included in the study psychiatric and neurological disease with blurred consciousness patients with asa \> 3 bmi \> 35 kg/m² abnormality in coagulation parameters history of allergy to local anesthetic drugs infection at the injection site patients whose surgical procedure time exceeds 150 minutes

Keywords: serratus posterior superior intercostal plane block video-assisted thoracoscopic surgery serratus anterior plane block
effect of high power laser on radiotherapy induced trismus.

Conditions: Trismus

Summary: this study randomized controlled study will be conducted to study (the effect of high power laser therapy on radiotherapy induced trismus in head and neck cancer patients). the study group will receive high power laser therapy in combination with conventional tempromandibular joint exercises. the control group will receive conventional tempromandibular joint exercises.


Eligibility criteria:
inclusion criteria: * head and neck cancer patients who complain of decreased mouth opening and received or receiving radiotherapy. * patients who complain from pain and inflammation in the tempromandibular joint due to radiotherapy. * radiotherapy should be above 40 gy. * patient ages between 20 to 65 years old. exclusion criteria: * patients with poor general health. * patients with difficulties in filling questionnaire. * patients who are complaining of other tempomandibular problems other than trismus such as (disc discplacement and trumatic mandibular fractures.
a study of probiotics administration in the immunotherapy of urothelial bladder carcinoma

Conditions: Bladder Urothelial Carcinoma

Summary: a study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.

to evaluate the progression free survival of intestinal probiotics in immunotherapy for urothelial carcinoma. changes in fecal flora abundance before and after treatment were assessed to identify subjects most likely to benefit from enteric probiotics treatment.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with urothelial carcinoma and undergoing immunotherapy ; 2. age ≥ 18 years; 3. expected survival time is greater than 12 weeks; 4. eastern cooperative oncology group (ecog) performance status of 0 1 or 2; 5. organ function level must meet the following requirements: hematological indexes: neutrophil count \>= 1.5x10\^9/l, platelet count \>= 100x10\^9/l, hemoglobin \>= 9.0 g/dl (can be maintained by symptomatic treatment); liver function: total bilirubin \<=1.5 uln, alanine aminotransferase and aspartate aminotransferase \<=2.5 uln (can be maintained by symptomatic treatment); 6. the subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up; 7. willing and able to provide written informed consent. exclusion criteria: 1. receive live attenuated vaccine within 4 weeks before treatment or during the study period; 2. active, known or suspected autoimmune diseases; 3. cannot take orally or are allergic to probiotics ; 4. history of primary immunodeficiency ; 5. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 6. pregnant or lactating female patients; 7. untreated acute or chronic active hepatitis b or hepatitis c infection. under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions; 8. uncontrolled concurrent diseases, including but not limited to: hiv infected (hiv antibody positive); severe infection in active stage or poorly controlled; evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \[hypertension greater than or equal to conmon terminology criteria for adverse events （ctcae） grade 2 after drug treatment\]); patients with active bleeding or new thrombotic disease.

Keywords: immunotherapy probiotic
a dose-ranging study of valdecoxib 5 mg, 10 mg, and 20 mg once daily versus placebo in patients with osteoarthritis of the knee (japan)

Conditions: Osteoarthritis, Knee

Summary: to determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptoms of osteoarthritis of the knee. to assess safety and tolerability of multiple doses of valdecoxib in patients with osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * patients diagnosed with symptomatic oa of the knee by the american college of rheumatology (acr) criteria and a functional capacity classification (fcc) of i - iii at screening visit and were walking * at the baseline visit, eligible patients were to have patient's assessment of arthritis pain vas ≥ 40 mm and patient's \& physician's global assessment of arthritis of "poor" or "very poor" exclusion criteria: * patients unable to walk generally

Keywords: knee osteoarthritis; japan
transversus abdominis plane block versus quoadratus lumborum block on infants

Conditions: Transversus Abdominis Plane Block; Quoadratus Lumborum Block

Summary: we aimed to compare the effects of tapb and qlb on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.

infants are more sensitive to the side effects of general anesthesia than older children. this may be associated with the incomplete maturation of organ systems effective in pharmacodynamics. regional anesthesia applications provide safe and effective analgesia by reducing the need for opioids. regional anesthesia applications in infants require experience and complication rates due to central blocks are high. however, in recent years, the use of ultrasound (usg) has increased the use of safe and effective trunk blocks. there are studies on the use of transversus abdominis plan block (tapb) and quadratus lumborum block (qlb) in children. however, there is no comparative study on its use in infants. in our study, we aimed to compare the effects of tapb and qlb on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.

Eligibility criteria:
inclusion criteria: * 1 month to 1 year * who were scheduled for unilateral inguinal hernia operation * american society of anesthesiologists (asa) physical score i-ii exclusion criteria: * patients with asa ii-iv * coagulopathy * skin infection at the block application site * bupivacaine allergy * bilateral inguinal hernia operation * additional operation in different region * laparoscopic inguinal hernia operation * younger than 1 month * with a history of prematurity

Keywords: infant analgesic efficiency regional anesthesia