Kornimate/medical-research-clean huggingface dataset:
power morcellation systems for laparoscopic hysterectomy and myomectomy

Conditions: Leiomyoma

Summary: the purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the bags throughout and after insufflation and power morcellation. the hypothesis is the bags will remain in tact without leakage from the bags during and after power morcellation using the described contained system, confirming the safety and efficacy of the systems.

uterine leiomyoma (fibroids) are non-cancerous smooth muscle tumors that can cause heavy menstrual bleeding, pain, and pressure. common surgical treatment modalities are hysterectomy (removal of the uterus) or myomectomy (removal of the fibroid). minimally invasive surgical techniques (laparoscopy) are generally recommended due to improved recovery time, decrease infection risk, decreased bleeding risk and overall decreased morbidity and mortality risks. in order to remove a large uterus or large fibroids laparoscopically, a power morcellator is often used to cut the specimen into smaller pieces that can be removed through small incisions. due to the concern regarding spread of small amounts of tissue during power morcellation, many surgeons are advocating contained power morcellation, i.e. morcellation inside a specimen bag. this study will be evaluating the efficacy of contained morcellation using a specific specimen bag. morcellation will be performed in the designated bag. the bag will then be removed evaluated for any egg albumin leakage. if there is no leakage, it can be inferred that there is no tissue is spread during the contained morcellation process using this bag.

Eligibility criteria:
inclusion criteria: * adult premenopausal women (equal or greater than 18 years old) * no symptoms of menopause * undergoing robotic or laparoscopic total or supracervical hysterectomies or myomectomies for the indication of symptomatic uterine fibroids * not candidates for specimen removal via mini-laparotomy incision (as deemed by the study surgeon) or who have refused mini-laparotomy * endometrial biopsy with no suspicion for malignancy exclusion criteria: * known or suspected malignancy * peri- or post-menopausal women * specimen that can be removed without power morcellation (e.g., vaginally or through laparoscopic trocars) * adults unable to consent.

Keywords: morcellation myomectomy hysterectomy
pendulum d2d glucose control for adults with type 2 diabetes

Conditions: Type2 Diabetes; Gastrointestinal Symptoms

Summary: the study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with gi complaints using 1 or more oral or injectable anti-hyperglycemic agents to investigate if altering the microbiome though pendulum t2d dietary supplementation can further enhance the efficacy of the current treatment while reducing the gi associated symptoms in patients with type 2 diabetes.

a high prevalence of gastrointestinal (gi) symptoms exist in both type 1 and type 2 diabetes that affect the quality of life negatively and substantially, although the underlying pathophysiology and relationship with glycemic control remain unclear. the current study aims to investigate if altering the microbiome though pendulum t2d dietary supplementation can further enhance the efficacy of the current treatment while reducing the gi associated symptoms in patients with type 2 diabetes mellitus who are already on a stable dose of metformin alone and/or alongside other oral or injectable anti-hyperglycemic agents (sulfonylurea agents, dppiv inhibitor,glucagon-like peptide (glp)-1 agonist, sodium-glucose cotransporter (sglt)-2 inhibitor and/or insulin) and with present gi symptoms. the study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with gi complaints using 1 or more oral or injectable anti-hyperglycemic agent and an hba1c between 6.5% and 9.5%. the study will be 8 weeks in duration (2 weeks baseline and 6 weeks product intervention), with an option to continue to 6 months for those willing to continue taking the dietary supplement. as the study is observational and the data are to be used to for the purpose of evaluating improvement in gi symptoms during the intervention with pendulum t2d there is no specific method to determine sample size.

Eligibility criteria:
inclusion criteria: * body mass index ≤ 45 kg/m2. * subjects with type 2 diabetes that are on a stable dose of one or more injectable or oral antihyperglycemia agents for at least 8 weeks prior to screening. * hba1c ≥ 6.5 % and ≤ 9.5% obtained at the screening visit. * subjects with any gastrointestinal symptoms including but not limited to heartburn, indigestion, diarrhea, constipation. * must be willing and be able to give written informed consent. exclusion criteria: * type 1 diabetes * pregnant, nursing or planning pregnancy * planning elective surgery in the next 8 weeks * current or planned use of steroids, orally or injected * diagnosis of irritable bowel disease , diverticulitis, other significant gi illness * co-existing severe health condition, such as active cancer or unstable cardiovascular disease/congestive heart failure. * severe allergy to tape or any component of the cgm device
aprepitant for post-operative nausea

Conditions: Postoperative Nausea

Summary: anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. most patients are given two drugs, decadron and ondansetron, to try to minimize this. this study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. all laparoscopic cholecystectomy study patients will receive decadron and ondansetron. half the patients will receive aprepitant in addition. the other half will receive placebo. the study will be randomized and double-blind.


Eligibility criteria:
inclusion criteria: * laparoscopic cholecystectomy patients. * must be able to swallow a pill. exclusion criteria: * liver failure, * age less than 18. * pregnancy, breast-feeding. * pre-op vomiting. * allergy to aprepitant. * need for post-op gastric drainage. * use of drugs that interact with aprepitant.
effect of hemifacial spasm on intraocular pressure measurement

Conditions: Hemifacial Spasm; Intraocular Pressure

Summary: twenty-four consecutive patients with hemifacial spasm and 25 age and gender-matched randomly selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure measurements using goldmann applanation tonometer and non-contact tonometer. an interval of 15 minutes was maintained between goldmann applanation tonometer and non-contact tonometer measurements. intraocular pressure measurements were performed before (during hemifacial spasm) and 2 weeks after botox injections in hemifacial spasm patients and in healthy volunteers without botox injections. all the measurements with goldmann applanation tonometer were carried out by a single physician while those with the non-contact tonometer were done by another physician who was masked to the results of the goldmann applanation tonometer. all measurements were taken between 10:00 and 11:00 a.m.


Eligibility criteria:
inclusion criteria: * patients with hemifacial spasm exclusion criteria: * subjects will be excluded if they have allergies to botulinum toxin or any component of the drug, previous eyelid, refractive or intraocular surgery, any abnormality preventing reliable tonometry in either eye, strabismus, contact lens wear, pregnancy, glaucoma, ocular hypertension and patients using agents that could interfere with neuromuscular transmission.
saliva-based covid-19 dna aptamer test

Conditions: Covid19

Summary: this study aims to conduct formative usability and internal validation of the covid-19 rapid diagnostic test tool based on dna aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for clinical trials, and also assess initial accuracy by validating with the patient's pcr test results.

rt-pcr has several limitations that need to be considered in its role as a covid-19 diagnostic modality, especially in areas with limited health infrastructure. potential diagnostic tests are needed that are capable of detecting results that are fast to read, can be carried out in service locations with limited infrastructure, and have high accuracy. the dna aptamers-based diagnostic test has the potential to meet these criteria, as it allows the detection of infection quickly and without invasive procedures, where the examination is only on a person's saliva. the development of diagnostic tools must be well planned including the usability and internal validation of the tools to be studied before they can be used in clinical trial settings or diagnostic accuracy tests by involving patients in health services. this study aims to conduct formative usability and internal validation of the dna aptamer-based covid-19 rapid diagnostic test, involving 200 patients and also laboratory personnel to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for testing in clinical trials, and also assess early indications of instrument accuracy by validating with the patient's pcr test data.

Eligibility criteria:
inclusion criteria: * aged 18-59 years old * undertaking pcr swab test for screening, or * in-patients undertaking pcr swab test exclusion criteria: * unable to produce saliva * refusing to participate

Keywords: saliva-based test dna aptamer
the belgian molecular profiling program of metastatic cancer for clinical decision and treatment assignment

Conditions: Metastatic Cancer

Summary: precision 1 will enroll patients with metastatic solid tumors. the local pi will verify if the candidate patient fits the inclusion/ exclusion criteria. the participant will sign the precision 1 informed consent. ngs data will be collected from local panel testing on dna extracted from tissue samples or plasma. data will be collected from further molecular testing performed at the different laboratories: select rearrangements (fusion genes and translocations) by rt pcr, fish or ngs; copy number variations of selected genes via the ngs platform (if possible) or using fish or other technologies such as snp arrays in case the ngs technology is incapable of giving this information. results will be stored in the precision belgium section of the healthdata database. data on germline variants will also be collected in the healthdata database whenever this information is available. the cooperating clinical investigator will decide with the patient the treatment strategy, -guided by the best interest of the patient and the availability of respective options : * " empirical " available approved treatment (for example chemotherapy, immunotherapy) * genotype-driven standard of care * inclusion in a genotype-matched clinical trial (includes signing of trial-specific ic) * inclusion in precision 2 if options 2/3 not available. irrespective of treatment choice, the patient will be followed by the collaborating clinician and will have follow-up data collected every 6 months for determination of disease status and survival endpoints. clinical data will be collected and stored in the healthdata database. genomic data (somatic and germline whenever available) and clinical data (tumor type and stage, number of previous lines, treatment choice, response rate, pfs on chosen and previous treatments, ...) will be uploaded on the healthdata platform and can be consulted via password-protected web access by the local pi at each participating center. european regulation protecting patient privacy will apply ("gdpr").


Eligibility criteria:
inclusion criteria: * patients with metastatic solid tumors that are candidates for systemic therapy (early lines are preferred). * patient showing an eastern cooperative oncology group (ecog) performance status of ≤ 2. * patients able to provide written informed consent prior to enrollment into a subsequent clinical trial. * patients agrees to provide ngs data (somatic and/or germline) as well as clinical data baseline and during follow-up. exclusion criteria: * life expectancy of less than 12 weeks. * inability to comply with protocol procedures. * known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local pi). * targeted gene sequencing on dna extracted from decalcified bone biopsies is not accepted.
efficacy and safety of synthetic phosphoethanolamine in solid tumor patients

Conditions: Solid Tumor

Summary: synthetic phosphoethanolamine is a primary amine which has a critical role in the biosynthesis of cell membranes. pre-clinical models have shown potential anticancer activity.

phase ii multi-cohort study based on two-stage simon design. the primary goal of the study is response rate at 8 weeks in participants with advanced solid tumors treated with synthetic phosphoethanolamine, as defined by response evaluation criteria in solid tumors version 1.1 (recist v 1.1) or specific criteria for prostate cancer.

Eligibility criteria:
inclusion criteria: * histologically proven advanced solid tumor patients (recurrent or metastatic), not amenable to curative therapy. patients must have progressed to standard treatment proven to prolong survival or no standard treatment exists. tumor types include head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, breast cancer, cervix cancer, prostate cancer, melanoma, pancreas adenocarcinoma, gastric adenocarcinoma, hepatocellular carcinoma * no concurrent active systemic treatment * measurable disease by recist v1.1 * clinical or radiological progression in the last three months * eastern cooperative oncology group performance status 0-1 * ability to consent * adequate organ function * life expectancy greater than 12 weeks * ability to swallow * no previous malignancy in the last 5 years exclusion criteria: * pregnancy * corticosteroid therapy for prostate cancer * uncontrolled comorbidity * known hepatitis b, c and hiv * central nervous system involvement, except if controlled symptoms and without corticosteroids * previous use of phosphoethalonamine

Keywords: solid tumor phase ii phosphoethanolamine
re-exposure study of pegloticase intravenous (i.v.) in symptomatic gout patients

Conditions: Chronic Gout Refractory to Conventional Therapy

Summary: the purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry. this study is limited to four study centers in the us.


Eligibility criteria:
inclusion criteria: * previous treatment in studies of pegloticase i.v. * last exposure to pegloticase i.v. greater than one year prior to study entry * symptomatic gout * documented hyperuricemic (sua ≥ 7 mg/dl) exclusion criteria: * prior exposure to elitek® (rasburicase) * unstable angina * uncontrolled arrhythmia or hypertension * non-compensated congestive heart failure * end stage renal disease requiring dialysis * concomitant use of sua lowering agents and use of other investigational drugs

Keywords: gout gouty arthritis anti-gout preparations
solitaire aneurysm remodeling registry

Conditions: Intracranial Saccular Aneurysm, Either Rupture or Unruptured; Wide Neck Aneurysm

Summary: the objective of the registry is to evaluate the effectiveness and performance of the solitaire neurovascular remodeling device when used with embolic coils in the treatment of intracranial aneurysms.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of intracranial saccular aneurysms, either ruptured or unruptured * aneurysm requires current treatment with coils and a stent or aneurysm hs been previously treated with coils, but no prior placement of a stent. * aneurysm has a wide neck defined as having a neck equal to or greater than 4mm or a dome-to-neck ratio of \<2. * patient is 18 years or older. * patient has a hunt \& hess score of iii or less. exclusion criteria: * patient has a fusiform or dissecting aneurysm type. * patient is contraindicated for either heparin or anti-platelet therapy. * patient has severe allergy to iv contrast medium. * patient has a known hypersensitivity to nickel-titanium.

Keywords: intracranial aneurysms wide neck aneurysms
breast cancer molecular analysis protocol

Conditions: Metastatic Breast Cancer

Summary: this is a molecular testing study for patients with metastatic breast cancer. the purpose of this study is to find defects in the dna of the cancer that could potentially be treated with us food and drug administration (fda)approved or investigational drugs. for example, if your cancer has a mutation in the epidermal growth factor receptor (egfr) gene (a mutation is a change int he dna sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. if this genetic defect is not present in the cancer the same drug may not work. this egfr gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. what drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.


Eligibility criteria:
inclusion criteria: 1. all patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies. 2. patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. the final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy. 3. there is no age limit for this study. however, this study will not include children because metastatic breast cancer does not occur in children. 4. patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression. 5. patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. when the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis. exclusion criteria: 1. known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent

Keywords: metastatic breast cancer metastatic breast cancer breast biopsy molecular genetic
tdcs + ccfes-mediated functional task practice for post-stroke upper extremity hemiplegia

Conditions: Stroke; Upper Extremity Paresis; Hemiplegia

Summary: after a stroke, it is very common to lose the ability to open the affected hand. occupational and physical rehabilitation therapy (ot and pt) combined with non-invasive brain stimulation may help a person recover hand movement. the purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.

this study is a randomized clinical trail (rct) of stroke survivors with chronic (6 to 24 months) hemiplegia randomized to: 1) conventional transcranial direct current stimulation (tdcs), 2) unconventional tdcs, or 3) sham tdcs during contralaterally controlled functional electrical stimulation mediated occupational therapy. the treatment will last 12 weeks and be followed by a 6-month follow-up period. assessors, therapists and participants will be blinded to which tdcs treatment is received. this will be the first rct of tdcs + ccfes.

Eligibility criteria:
inclusion criteria: 1. age ≥ 21 and ≤ 90 2. ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke 3. able to follow 3-stage command 4. able to remember 2 of 3 items after 30 minutes 5. full volitional elbow extension/flexion and hand opening/closing of unaffected limb 6. adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice 7. patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment 8. medically stable 9. ≥ 10° finger and wrist extension 10. skin intact on hemiparetic arm, hand and scalp 11. muscle contraction can be elicited with transcranial magnetic stimulation 12. unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the medical research council (mrc) scale 13. score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity fugl-meyer assessment 14. while relaxed, surface nmes of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain. exclusion criteria: 1. co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, pd, sci, tbi, ms). 2. uncontrolled seizure disorder 3. use of seizure lowering threshold medications and the discretion of the study physician 4. cardiac pacemaker or other implanted electronic device 5. pregnant 6. im botox injections in any ue muscle in the last 3 months 7. insensate arm, forearm, or hand 8. deficits in communication that interfere with reasonable study participation 9. severely impaired cognition and communication 10. uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) 11. severe shoulder or hand pain (unable to position hand in the workspace without pain)

Keywords: stroke rehabilitation therapy electrical stimulation brain stimulation hand ccfes motor cortex tms motor recovery central nervous system cva upper limb
evaluation of high dose methotrexate toxicity

Conditions: Methotrexate Toxicity

Summary: this study aims to: 1. evaluation of high dose methotrexate related toxicities among children admitted to sohag oncology centre. 2. role of methotrexate blood level in prediction of high dose methotrexate related toxicities. 3. role of cystatin c as a predictor for acute kidney injury in high dose methotrexate related toxicities. 4. factors affecting outcome of high dose methotrexate related toxicities.

it is a prospective observational study will be carried out on children receiving high dose methotrexate in sohag oncology centre with one-year observation starting from january 2024. all children receiving high dose methotrexate in sohag oncology centre and fulfill the study inclusion criteria with one-year observation starting from january 2024. informed consent will be taken from the parents/guardians. a prepared sheet to collect data related to this study that include: 1. socio-demographic data: e.g. age, sex, residence in addition to dose of mtx and tumor type. 2. general and systemic manifestations: gastrointestinal manifestations, neurological manifestations, respiratory and hematological manifestations. 3. investigations: blood samples will be collected for cbc, urea, creatinine, alt, ast, methotrexate level and cystatin c. 4. treatment lines: fluid, folinic acid, alkalinization of urine, blood elements, hemodialysis and colony stimulating factors. 5. outcome: complete recovery, residual effects, complications or death.

Eligibility criteria:
inclusion criteria: * children admitted to sohag oncology centre, age from 1 to 18 years * receive high dose methotrexate therapy equal to or more than 1 gm/m2 surface area. exclusion criteria: * wbcs less than 1000 / microliter * platelet count less than 50000 / microliter * renal affection * hepatic affection * respiratory affection * diabetes mellitus * cardiovascular disease