Kornimate/medical-research-clean huggingface dataset:
adenovirus-specific cytotoxic t-lymphocytes for refractory adenovirus infection

Conditions: Adenovirus; Primary Immune Deficiency Disorder

Summary: related donor adenovirus (adv) specific cytotoxic t cells (ctls) manufactured with the miltenyi clinimacs prodigy cytokine capture system will be administered intravenously in in children, adolescents and young adults with refractory adv infection post allogeneic hematopoietic stem cell transplantation (allohsct), with primary immunodeficiencies (pid) or post solid organ transplant. funding source: fda oopd


Eligibility criteria:
1. patients with adenovirus infections post allogeneic hsct, with primary immunodeficiencies or post solid organ transplant with: * increasing or persistent quantitative adv rt-pcr dna copies despite two weeks of appropriate anti-viral therapy and/or * clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis and/or * medical intolerance to anti-viral therapies including: * grade 2 renal insufficiency secondary to cidofovir consent: written informed consent given (by patient or legal representative) prior to any study-related procedures. performance status \> 30% (lansky \ 16 yrs) age: 0.1 to 79 years females of childbearing potential with a negative urine pregnancy test 2. donor eligibility related donor available with a t-cell response to the viral macs® gmp peptivator antigen(s) of adenovirus. a. third party related allogeneic donor: if original donor is not available or does not have a t-cell response: third party allogeneic donor (family donor \> 1 hla a, b, dr match to recipient) with a t-cell response at least to the viral macs® gmp peptivator antigen(s) of adenovirus. and allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (appendix 1). and obtained informed consents by donor or donor legally authorized representative prior to donor collection. 3. patient exclusion criteria: a patient meeting any of the following criteria is not eligible for the present study: . patient with acute gvhd \> grade 2 or extensive chronic gvhd at the time of ctl infusion patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of ctl infusion patient treated with donor lymphocyte infusion (dli) within 4 weeks prior to ctl infusion patient with poor performance status determined by karnofsky (patients \>16 years) or lansky (patients ≤16 years) score ≤30% concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s) any medical condition which could compromise participation in the study according to the investigator's assessment known hiv infection female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment. known hypersensitivity to iron dextran patients unwilling or unable to comply with the protocol or unable to give informed consent. known human anti-mouse antibodies -

Keywords: adenovirus primary immune deficiency disorder cytotoxic t-lymphocytes
treatment use of domperidone for gastroparesis

Conditions: Gastroesophageal Reflux Disease; GERD; Gastroparesis

Summary: domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (gerd), with upper gi symptoms, gastroparesis, and chronic constipation. this is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.

the treatment use of domperidone program is also available at the cleveland clinic florida/weston gastroenterology department. this is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. because of this, this study is enrolling patients via invitation only, and as such, all expenses associated with the drug, initiation and follow up of treatment are the responsibility of the patient or the patient's third party payer.

Eligibility criteria:
inclusion criteria: * male or female * age 18 and older * symptoms or manifestations secondary to gerd (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy. * patients must have a comprehensive evaluation to eliminate other causes of their symptoms. * patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including: * increased prolactin levels * extrapyramidal side effects * breast changes * cardiac arrhythmias including qt prolongation and death * there is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum. exclusion criteria: * history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and torsade des pointes. patients with minor forms of ectopy (pacs) are not necessarily excluded. * clinically significant bradycardia, sinus node dysfunction, or heart block. prolonged qtc (qtc\> 450 milliseconds for males, qtc\>470 milliseconds for females). * clinically significant electrolyte disorders. * gastrointestinal hemorrhage or obstruction * presence of a prolactinoma (prolactin-releasing pituitary tumor). * pregnant or breast feeding female * known allergy to domperidone

Keywords: gastroesophageal reflux disease gerd gastroparesis domperidone
fecal microbiota transplantation for epilepsy

Conditions: Epilepsy

Summary: increasing evidences showed the microbiota effects on neuropsychiatric disorders. this clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation for epilepsy.

very few literatures reported the clinical use of microbiota or bacteria for brain diseases. the most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (fmt). this study aims to evaluate the efficacy and safety of fmt for epilepsy. patients were diagnosed as epilepsy by electroencephalogram (eeg) and mri and clinical data when the study began and thent received repeated fmt with fecal from healthy donors.the antiepileptic medication regimen of patients remained unchanged after fmt. the primary outcome measure was the frequency of the seizures. secondary outcome measure were the 50% response rate. .

Eligibility criteria:
inclusion criteria: had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before wmt ; exclusion criteria: had other severe diseases, including other intestinal disorders (e.g., clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure or serious liver or kidney disease, had undergone previous fmt or wmt, had taken antibiotics within three months before starting wmt

Keywords: fecal microbiota transplantation gut microbiota brain-gut axis epilepsy
study of a topical formulation for the treatment and prevention of raynaud's phenomenon symptoms

Conditions: Raynaud Disease

Summary: the purpose of this study is to determine if vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with raynaud's phenomenon.

raynaud's phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. current therapies for raynaud's are suboptimal because they are associated with significant side effects. in this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers * a history of at least two raynaud's events during a typical winter day * must be willing to apply creams to fingers * must be willing to undergo cold temperature exposure * must be willing and able to stop certain medications * must be willing to use effective contraception, if applicable exclusion criteria: * had a raynaud's attack that required hospital or clinic intervention * has allergies to nitroglycerin or topical medication ingredients * has a history of migraine or chronic pain * has an unstable medical problem that could interfere with the study * had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months * used any investigational drug in the past 4 weeks * has significantly abnormal laboratory tests * had certain major surgeries in the past 6 months * has skin lesions on certain parts of the fingers * women who are pregnant or nursing

Keywords: raynaud's scleroderma nitroglycerin mqx-503 treatment
to evaluate the immunogenicity and safety of inactivated hepatitis a vaccine in healthy children aged from 24mons-15yrs

Conditions: Hepatitis A; Hep A

Summary: the purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis a vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).

the purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis a vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval). this study is a two-group comparative study using a marketed inactivated hepatitis a vaccine (havrix®, manufactured by gsk) as a control. the study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.

Eligibility criteria:
inclusion criteria: 1. healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination 2. subjects with no history of hepatitis a and no previous vaccination against hepatitis a 3. written informed consent obtained from the subject's legal representative (parents or representative) 4. children who no health issues based on medical history and physical examination as judged by the investigator exclusion criteria 1. tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination 2. uncontrolled epilepsy or neurological disorder 3. history of thrombocytopenia or has a risk of bleeding 4. history of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine 5. severe acute or chronic infectious disease on the day of vaccination 6. congenital / acquired immunodeficiency or receiving immunosuppressive therapy 7. received immunosuppressive dose of systemic corticosteroids within 12 weeks prior to the first vaccination with the ip (investigational product) (equivalent potency of ≥ prednisolone 20 mg/day or equivalent potency of ≥ prednisolone 2.0 mg/kg/day in \< 10kg of body weight for ≥ 14 consecutive days) 8. administration of any other vaccine within 4 weeks prior to screening 9. planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product 10. administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to screening 11. currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to screening 12. ineligibility for participate in the study for other reasons as determined by the investigator

Keywords: hepatitis a hepatitis a vaccine vaccine hep a hav
biomarkers of spontaneous recovery from traumatic spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of the study is to profile biochemical responses and measure functional recovery in parallel, throughout the 1st year after spinal cord injury (sci), within the same participants. these responses and recovery will be evaluated in samples from people who have had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first year after sci. specifically, the investigators will test the hypothesis that a subset of inflammatory biomarkers correlate inversely with functional recovery. the investigators will use these data to build a predictive model of functional recovery after sci that incorporates biomarkers that can be easily quantified in the clinic. total anticipated enrollment will be 100 participants with sci across three different sites (northwell health system (ny), the kessler institute for rehabilitation (nj), university of louisville (ky) and may enroll up to 30 participants without sci.

at all study visits, a member of the study team (investigator) will collect basic demographic and health information from the participant or the participant's medical record. study participants will have blood drawn at each study visit (approximately 2 tablespoons). the participant will be asked to partake in 4 study visits over the course of 1 year. the first visit will be within the first 0-14 days of sci. the 2nd, 3rd, and 4th visits will be 3, 6, and 12 months after their spinal cord injury. at study visits 2, 3 and 4, a study investigator will also perform some clinical evaluations for research purposes to test how the participant is recovering the ability to perform activities of daily living and move after spinal cord injury.

Eligibility criteria:
inclusion criteria: sci subject inclusion criteria: to be eligible for prospective enrollment, participants are required to meet the following inclusion criteria: * ≥18 years old with traumatic sci * injury within 0-3 days post injury prior to enrollment * all american spinal injury association (asia) grade classification a-d. * neurological injury level c4-t10 exclusion criteria: to be eligible for prospective enrollment, sci subjects are required to not meet the following exclusion criteria: * stage iii-iv pressure ulcers * cancer, chemotherapy, neutropenia * pregnancy (all female trauma patients of childbearing years are given a pregnancy test on admission as part of routine admitting labs) or lactation * no known previous sci * autoimmune disease * pre-existing neurological disease
progrip ventral study for sublay repair

Conditions: Primary Ventral and Incisional Hernia Repair

Summary: a novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. progrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (pla) micro-grips, which provide self-gripping properties during the first few months after implantation. the self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair. case series confirmed that parietex progrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. on this basis, larger sizes parietex progrip™ meshes have been developed for larger incisional hernia defect treatment. in order to assess the clinical outcomes following the use of progrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.


Eligibility criteria:
inclusion criteria: * all patients at participating hospital undergoing incisional hernia repair by using retromuscular placement by open approach. * defect size: 5cm ≤ width\*, 10 cm ≤ length ≤ 20 cm
efficacy of continuous erector spinae plane block to reduce postoperative pain in patients undergoing unilateral thoracotomy

Conditions: Continuous Erector Spinae Plane Block; Unilateral Thoracotomy

Summary: the goal of this clinical trial is to learn if continuous erector spinae plane block (espb) reduces postoperative pain in patients undergoing unilateral thoracotomy. it will also evaluate the safety and effectiveness of continuous espb. the total participants needed will be 30 persons. the main questions it aims to answer are: * does continuous espb lower the intensity of postoperative pain compared to multimodal intravenous analgesia? * does continuous espb increase the time to first analgesic request? * does continuous espb reduce the amount of intravenous opioids required in the first 48 hours after surgery? * does continuous espb improve the overall recovery quality within 48 hours post-surgery? participants will: * receive continuous espb or multimodal intravenous analgesia after the surgery. * undergo routine pain assessments, and recovery evaluations using tools like the visual analogue scale (vas) and quality of recovery-15 (qor-15). * participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.

for the continuous espb group, patients will receive continuous espb, nsaids, paracetamol, and morphine using patient controlled analgesia (pca) with a demand only mode. for the intravenous opioid, patient will receive non-steroidal anti-inflammatory drugs (nsaids), paracetamol, and morphine using patient controlled analgesia (pca).

Eligibility criteria:
inclusion criteria: * patients of 21-65 years of age * undergoing unilateral thoracotomy operation exclusion criteria: * patients with asa physical status \> iii * obese or underweight patients with bmi of less than 18.5 or more than 29.99 * patients with contraindications to be given local anesthesia drugs * patients with contraindications to be given opioid drugs * patients refused to participate

Keywords: erector spinae plane block unilateral thoracotomy regional anesthesia continuous peripheral nerve block
parallel group trial to evaluate the efficacy and safety of loion® compared to 10% salicylic acid in patients with chronic psoriasis capitis

Conditions: Scalp Psoriasis

Summary: the study will be conducted to evaluate the efficacy and safety of a topical dimeticone formulation (loion®) compared to 10% salicylic acid in octyl-dodecanol with 15% macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis (scalp psoriasis).


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * having a diagnosis of chronic psoriasis capitis (scalp psoriasis) with or without the involvement of other body areas and with or without psoriatic arthritis. * pssi ≥5 (range 0-72) * scaling ≥2 (on an scale from 0 to 4) * at least 10% of scalp area affected * if a women: * postmenopausal * premenopausal and using an established oral, injected or implanted hormonal method of contraception, intrauterine device (iud) or intrauterine system (ius) * negative pregnancy test at inclusion * patients with no concomitant systemic psoriasis medication. * willingness and adherence to the prohibitions and restrictions specified in the study protocol. * willingness to self-administer the drug. * signed informed consent document indicating that the patient to be included understands the purpose of and the procedures for the study and is willing to participate. exclusion criteria: * patients having a solely non- plaque form of psoriasis (e.g. erythrodermic, guttate, pustular). * patients with uncontrolled psoriasis under the current treatment. * patients having received topical keratolytic agents for the scalp within the past 2 weeks and topical steroids for the scalp within the past week (prior to inclusion). * patients receiving systemic antipsoriatic drugs, immunosuppressants or systemic corticosteroids (within 4 weeks prior to inclusion). * women who are pregnant or breastfeeding or planning to become pregnant during the observational period. * patients participating in another study using an investigational agent or procedure during participation in the study observation period. * known hypersensitivity to any ingredient in the investigational products' formulations. * having any condition that in the opinion of the investigator makes the participation not be in the best interest of the subject. * employees and staff of the investigator or study site with direct involvement in the study as well as family members of the employee or the investigator.

Keywords: psoriasis capitis scaling salicylic acid dimethicone plaque removal
multisession radiosurgery in large meningiomas

Conditions: Intracranial Meningioma

Summary: this is a prospective observational trial consisting of robotic multisession radiosurgery (cyberknife ®) for large and medium size and/or located at critical site benign intracranial meningiomas.

to date, the treatment of choice for intracranial meningiomas is surgical removal. radiotherapy, especially the radiosurgery (srs), in exclusive, adjuvant or salvage setting represents an alternative or complementary viable treatment to the neurosurgery. despite being a well-established treatment for intracranial meningiomas, srs might be associated with significant morbidity when large volumes or critical sites are treated. hypofractionated stereotactic radiotherapy has the potential to deliver sharply focused high doses per fraction without increasing the risk of toxicity. the aims of our study are toxicity and symptom control evaluation of radiosurgery treatment delivered in multisession, for large or medium size intracranial meningiomas and/or for intracranial meningioma located at the critical sites (perichiasmatic area, perioptic area, pca). we will evaluate also the efficacy of the treatment by volumetric analysis of treated meningiomas carrying out a volumetric comparison between pre- and post-radiosurgery treatment (every 6 month after treatment). the neurological and clinical assessment before and after s-srs will be based on ctcae v4.0 and bpn bsn house-brackman and sensorineural internation scale assessment.

Eligibility criteria:
inclusion criteria: * either histologically confirmed or imaging-defined benign meningioma diagnosis; * large or medium lesion size and/or in critical area (e.i. perichiasmatic area); * signed specific informed consent; * age ≥ 18 years; * for female patients, execution of pregnancy blood test; * karnofsky performance status (kps) ≥ 70. exclusion criteria: * histologically confirmed diagnosis of atypical or malignant meningiomas; * patients who had received prior radiotherapy in the same site; * pregnancy; * allergy for contrast medium; * neurofibromatosis diagnosis.

Keywords: intracranial benign meningioma radiosurgery large meningioma critical site multisession radiosurgery