Kornimate/medical-research-clean huggingface dataset:
an open-label extension trial to assess the long-term safety of zx008 (fenfluramine hydrochloride hcl) oral solution in children and young adults with dravet syndrome

Conditions: Dravet Syndrome

Summary: this is an international, multicenter, open-label, long-term safety study of zx008 in subjects with dravet syndrome.

this is an international, multicenter, open-label, long-term safety study of zx008 in pediatric and young adult subjects with dravet syndrome who participated in one of the core studies (zx008-1501 and zx008-1502) and are candidates for continuous treatment for an extended period of time. this trial will consist of a 36-month open-label extension (ole) treatment period and a 2-week post-dosing period.

Eligibility criteria:
key inclusion criteria: * male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day of the core study screening visit. * satisfactory completion of the core study in the opinion of the investigator and the sponsor. * subjects who are \>18 to ≤35 years of age at the time of screening and did not participate in one of the core studies may be eligible for participation. * a documented medical history to support a clinical diagnosis of dravet syndrome, where convulsive seizures are not completely controlled by current antiepileptic drugs. * parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability. * subject's parent/caregiver has been compliant with diary completion during the core study, in the opinion of the investigator (eg, at least 90% compliant). key exclusion criteria: * current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke. * current cardiac valvulopathy or pulmonary hypertension that is clinically significant and warrants discontinuation of study medication. * current or past history of glaucoma. * moderate or severe hepatic impairment. * receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or cytochrome p450 (cyp) 2d6/3a4/2b6 inhibitors/substrates. * currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days, as maintenance therapy. * a clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness at visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.

Keywords: seizure tonic clonic epilepsy myoclonic encephalopathy
role of the spouse/partner of persons treated with chemotherapy for colon cancer

Conditions: Colon Cancer

Summary: altered quality of life in patients with stage iii or iv colon cancer is well known. at their sides, their spouse/partner must also cope with the suffering caused by the disease and the upheavals that it engenders, with the treatments, in the organization of their everyday life. the physical, emotional, social and financial impact of cancer in general and its treatment on care-givers has already been studied. however, there are no data concerning the "objective burden", that is to say the nature and the magnitude of the care weighing on the spouse of persons with colon cancer. objective is to develop and validate a questionnaire that can be completed by the spouse/partner of patients with stage iii or iv colon cancer so as to evaluate the burden of the disease in everyday life. it will allow medico-social professionals to identify spouses/partners in difficulty and the needs of patients so as to offer the best support.


Eligibility criteria:
inclusion criteria: inclusion criteria for patients: men or women : * able to understand written and spoken french ; * who have been informed about the study; * with stage iii or iv cancer of the colon or recto-sigmoid junction (code c18 and c19 of the icd 10), operated or not with curative intent; treated with chemotherapy in one of the study centres (adjuvant or 1st-line chemotherapy or palliative chemotherapy); * currently living with a spouse or partner; * who has consented to his/her spouse/partner taking part in the study. inclusion criteria for the spouse/partner: men or women: * able to understand written and spoken french ; * who have been informed about the study; living at the home of the spouse/partner; * able to take part in an interview of approximately one hour; * who has provided consent to take part in the study. exclusion criteria: exclusion criteria for patients: men or women : * under guardianship; * with a severe disease resulting in a major handicap; * with severe mental retardation affecting ability to understand; * with rectal cancer; * with stage i or ii cancer of the colon or recto-sigmoid junction; * with a history of treated cancer (colorectal or other); * with another cancer under treatment exclusion criteria for the spouse: men or women: * under guardianship; * with a severe disease resulting in a major handicap; * with severe mental retardation affecting ability to understand
the therapeutic effect of targeted intrinsic foot muscles exercises in plantar fasciitis

Conditions: Plantar Fasciitis, Chronic; Pain

Summary: a reduction of intrinsic foot muscle sizes has been identified in patients with chronic plantar fasciitis. weaker intrinsic foot muscles has been suggested to decrease the medial longitudinal arch height and subsequently increase extra tensile stress in the plantar fascia, resulting in the chronicity of the condition. therefore, it is speculated that atrophic intrinsic foot muscles may be a significant risk factor of developing chronic plantar fasciitis. the purpose of this study is to investigate the effect of an 8-week targeted intrinsic foot muscles exercise regimen on the intrinsic foot muscle size, symptomatic relief, and foot function improvement in long-distance runners with chronic plantar fasciitis.

distance runners are defined as running with more than 20km per week for more than 2 years. all recruited participants have \> 1 year of plantar fasciitis. the diagnosis were made based on clinical symptoms and the thickness of plantar fasciitis \> 4.0mm at the medial tubercle of heel by ultrasound imaging. arm 1: the purpose of this arm of the study is to determine if a 8-week targeted foot muscle exercise regimen, instructed with real-time ultrasound, affect the intrinsic foot muscle size, symptomatic relief, and foot function improvement of distance runners with plantar fasciitis. 32 participants will be recruited in this arm. arm 2: this group will not engage in any training, but will serve as a comparator for the intervention arm.

Eligibility criteria:
inclusion criteria: 1. a weekly mileage of at least 20km 2. have running experience of at least 2 years prior to the experiment 3. if they reported tenderness on palpation of the medial calcaneal tuberosity and exhibited one of the following complaints: * plantar heel pain \> 1 year * pain on visual analog scale of equal to or greater than 4 out of 10 * pain on the first step in the morning or after prolonged sitting, * pain on prolonged standing and/or walking * pain when running exclusion criteria: 1. contraindications to mri scans 2. had undergone surgery to the plantar fascia or 3. local steroid injection within the last 3 months or 4. any of the following conditions: * systemic arthritis, * neurologic conditions * any coexisting painful musculoskeletal condition of the lower limb.

Keywords: strengthening training intrinsic foot muscle
the effect of renal impairment on the pharmacokinetics of oral treprostinil

Conditions: Pulmonary Arterial Hypertension; Renal Dysfunction

Summary: this is a single-center, open-label, single-dose evaluation of 1 mg ut-15c sr pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (esrd; on dialysis). subjects in the esrd group will receive 2 doses of ut-15c sr, separated by 14 days. one dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis. pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. additionally, subjects with esrd will have a sample taken at 60 hrs post dose.


Eligibility criteria:
male and female volunteers with esrd (requiring dialysis), moderate (creatinine clearance; crcl = 30-50 ml/min), mild (crcl = 50-80 ml/min) and normal renal function (control group; (crcl \>80 ml/min)) may be enrolled. eligible subject will be 18-79 years of age with a bmi between 18 - 40 kg/m2 and not taking chronic nonsteroidal antiinflammatory drugs (nsaids)
the role of endothelin 1 as a marker of renal impairment in sickle cell disease

Conditions: Sickle Cell Disease

Summary: sickle cell disease (scd) refers to a group of hemoglobinopathies that include mutations in the gene encoding the beta subunit of hemoglobin. within the umbrella of scd, many subgroups exist, namely sickle cell anemia (sca), hemoglobin sc disease (hbsc), and hemoglobin sickle-beta-thalassemia (beta-thalassemia positive or beta-thalassemia negative). several other minor variants within the group of scds also, albeit not as common as the varieties mentioned above. it is essential to mention the sickle cell trait (hbas), which carries a heterozygous mutation and seldom presents clinical signs or symptoms. sickle cell anemia is the most common form of scd


Eligibility criteria:
inclusion criteria: * the patients fulfilling all the following criteria will be included: * patients with sickle cell disease in the age range of 1-18years. exclusion criteria: * patients diagnosed to have coexistent renal disease before the study
a study of evorpacept (alx148) with enfortumab vedotin for subjects with urothelial carcinoma (aspen-07)

Conditions: Bladder Cancer; Urothelial Carcinoma

Summary: at148007 is a phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of alx148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma. 2. must have received prior treatment with an immune checkpoint inhibitor (cpi). 3. subjects must have received prior treatment with platinum-containing chemotherapy. 4. subjects must have had progression or recurrence of urothelial cancer. 5. subjects must have measurable disease according to recist (version 1.1). 6. adequate bone marrow function. 7. adequate renal function. 8. adequate liver function. 9. adequate eastern cooperative oncology group (ecog) performance status. exclusion criteria: 1. preexisting sensory or motor neuropathy grade ≥2. 2. presence of symptomatic or uncontrolled central nervous system (cns) metastases. 3. prior treatment with enfortumab vedotin or other monomethylauristatin (mmae)-based antibody-drug conjugate (adcs) 4. prior treatment with any anti-cd47 or anti-signal regulatory protein-α (sirpα) agent. 5. known active keratitis or corneal ulcerations. subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated. 6. history of uncontrolled diabetes mellitus within 3 months of the first dose of study drug.
prevention of postoperative nausea and vomiting after bariatric surgery

Conditions: Bariatric Surgery Candidate; Postoperative Nausea and Vomiting; Morbid Obesity

Summary: postoperative nausea and vomiting are common occurrences following bariatric surgery, occurring in up to 80% of patients and contributing to increased healthcare utilization and delays in discharge. this study aims to evaluate the impact of a high-protein liquid diet on postoperative nausea, vomiting, and length of stay after laparoscopic or robotic sleeve gastrectomy.

patients with obesity or morbid obesity who are scheduled to undergoing robotic or laparoscopic sleeve gastrectomy will be screened at their preoperative visit. if they meet inclusion/exclusion criteria, they will be invited to participate in the study and written informed consent will be obtained. if the patient consents to participation, they will be randomized to either the control arm or intervention arm. all patients will undergo sleeve gastrectomy in a standard fashion, either laparoscopically or robotically, as discussed with their bariatric surgeon. post-operative diet will be initiated 4 hours after surgery. the specific diet received will depend on which arm the patient is randomized into. post-operative assessments will be completed at various time points for all patients. these include a verbal rating scale of nausea and vomiting, rhodes index survey, and quality of recover-15 survey. all patients will track their oral intake on a spreadsheet which will be provided. additional demographic and clinical data will be collected from the electronic medical record. after hospital discharge, patients will follow up in the clinic one week and one month after surgery, per routine. after the one-month visit, the patient's study participation will be considered complete.

Eligibility criteria:
inclusion criteria: * adult patient undergoing robotic or laparoscopic sleeve gastrectomy * patient able to provide written informed consent * patient able to understand and comply with study guidelines exclusion criteria: * inability to provide consent * previous history of bariatric or gastroesophageal surgery * chronic nausea/vomiting * hemoglobin a1c 9 or higher * therapeutic anticoagulation * celiac disease or gluten sensitivity/intolerance/allergy

Keywords: bariatric surgery sleeve gastrectomy postoperative diet postoperative nausea and vomiting
safety and efficacy of vsj-110 in the treatment of allergic conjunctivitis in adults with a history of ocular allergies

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to determine the safety and efficacy of vsj-110 compared to placebo in the treatment of allergic conjunctivitis using an antigen challenge model


Eligibility criteria:
inclusion criteria: * at least 18 years of age of either gender and any race * able to provide written informed consent and sign the hipaa form * willing and able to follow all instructions and attend all study visits exclusion criteria: * able and willing to avoid all disallowed medications during washout and study period
study of dasatinib (bms-354825) in patients with advanced estrogen/progesterone receptor-positive (er+/pr+) or her2/neu-positive (her2/neu+)breast cancer

Conditions: Breast Cancer; Metastasis

Summary: this study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced er+/pr+ or her2/neu+ breast cancer


Eligibility criteria:
inclusion criteria: * females, 18 or older * recurrent, locally advanced, or metastatic breast cancer with expression of er/pr receptor and/or overexpression of her2/neu * paraffin-embedded tissue block must be available * measurable disease * prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting) * 0, 1 or 2 chemotherapies in the metastatic setting * adequate organ function exclusion criteria: * metastatic disease confined to bone only * symptomatic central nervous system (cns) metastasis * concurrent medical condition which may increase the risk of toxicity * unable to take oral medication

Keywords: recurrent, locally-advanced, or metastatic breast cancer
effect of genetic polymorphisms on response to beta blocker therapy in egyptian patients

Conditions: Acute Coronary Syndrome; Hypertension

Summary: beta-blockers represent a cornerstone for the treatment of coronary artery disease (cad). their protective effect is based on the negative inotropic and chronotropic features, which have been tested in a large number of randomized controlled trials, both in patients with myocardial infarction (mi) and in those with stable angina, demonstrating a reduction of adverse cardiovascular events, a relief of symptoms and a reduction of myocardial ischemia however, considerable interpatient variability in response to β-blockers has been reported which indicates that a considerable proportion of β-blocker-treated patients do not achieve the warranted cardio protection with β- blockers. this highlights the importance of identifying biomarkers associated with variability in response to β-blockers to improve the current approach for β- blocker selection, which seems to be suboptimal. this study aims to study the effect of polymorphism in adrenergic beta receptors on beta-blocker response in egyptian patients.


Eligibility criteria:
inclusion criteria: 1. beta-blockers naïve patients 2. patients been on beta-blocker therapy for at least 4 weeks. 3. age (18-75) years old. exclusion criteria: 1. non-egyptians. 2. kidney failure of any stage. 3. liver failure of any stage. 4. malignancy. 5. pregnancy. 6. hr \< 55 beats/min (in the absence of b-blocker therapy). 7. presence of a cardiac pacemaker.
basal cell carcinomas treated with ablative fractional laser and ingenol mebutate

Conditions: Carcinoma, Basal Cell

Summary: a prospective clinical, uncontrolled, open-label, explorative phase 2a trial on patients with histologically-confirmed superficial and nodular basal cell carcinoma (bcc). the study assesses tolerability and tumor clearance after laser-assisted topical delivery of topical ingenol mebutate.

patients will receive ablative fractional laser (afxl)-assisted ingenol mebutate (im) as a treatment for their cutaneous basal cell carcinoma (bcc). treatment areas consisting of tumors and a 5 mm margin will undergo afxl exposure (co2 laser) followed by im 0.015% or 0.05% under occlusion for 2-3 days. . local skin reactions are monitored at baseline (day1), day 3/4, day 8, day 15, day 29, day 90, and tumor response monitored at baseline, day 29, and day 90. an additional repeat afxl-im treatment on day 29 will be offered if tumors persist, based on clinical evaluation and imaging on day 30. primary outcome: 1. severity and duration of clinical local skin reactions including erythema, scaling, edema, blistering, erosion/ulceration and crusting using a 0-4-point scale at all visits from baseline to day 90. 2. to monitor bcc tumor response on clinical assessments supported by non-invasive imaging techniques including optical coherence tomography (oct) and reflectance confocal microscopy (rcm) at baseline, day 29 and day 90.

Eligibility criteria:
inclusion criteria: subjects who meet all of the following criteria are eligible to participate in this study * patients with histologically verified, low-risk, previously untreated superficial or nodular bccs on the scalp, face, extremities or trunk * \> 18 years of age at baseline * legally competent, able to give verbal and written consent * communicate in danish verbally as well as in writing * subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements. * fitzpatrick skin phototype i-iii * female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. exclusion criteria: subjects meeting any one of the following criteria are not eligible to participate in this study * patients with o high-risk bcc * tumors on the following anatomical locations: * midface region * orbital areas * ears * ii. size: * \> 20 mm in facial/scalp areas * \> 50 mm in non-facial/non-scalp areas * subtype: * morpheaform * medical history * gorlin syndrome o immunosuppressive medication * subjects with a known allergy to im. * individuals with other skin diseases in the area of research interest * subjects with tattoo in the treatment area which may interfere with or confound evaluation of the study * subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator * subjects with fitzpatrick skin phototype iv-vi * lactating or pregnant women
microbiome test for the detection of colorectal polyps and cancer

Conditions: Colorectal Neoplasms; Colorectal Cancer

Summary: the purpose if this study is to measure the sensitivity, specificity and accuracy of the metabiomics colon polyp and colorectal cancer assay for the non-invasive detection of colon polyps or colorectal cancer.

the purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. in this study patients will supply samples of their gut microbiome prior to scheduled colonoscopy; the relative abundance of microbes from those samples will be used to predict the presence or absence of colon polyps or colorectal cancer. microbiome based predictions from blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity, specificity and accuracy (reported as %) of the metabiomics colon polyp and colorectal cancer assay for colon polyps. the limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer.

Eligibility criteria:
inclusion criteria: * male or female, * age: 45-80 years, * patients undergoing polyp surveillance or screening colonoscopy who are asa class 1-3. no asa class 4 or 5 will be included.footnote * all ethnic and racial groups will be included, * able to comprehend, sign, and date the written informed consent form (icf), * able to give informed consent in english. exclusion criteria: * history of inflammatory bowel disease * inability to schedule the colonoscopy within 60 days of the initial stool sample * colonic pathology that in the opinion of the endoscopist could interfere with the accuracy of the colonoscopy. examples include: colonic stricture, poor preparation, obstructing tumor. * asa class 4 or greater * vulnerable subjects. students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity.

Keywords: cancer colon cancer colorectal cancer neoplasm colorectal neoplasm intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms by site neoplasms colonic diseases digestive system diseases gastrointestinal diseases intestinal diseases rectal diseases
color fundus photograph with experts labelling

Conditions: Retinal Disease; Diabetic Retinopathy

Summary: this trial aims to provide a digital retinal image dataset from pakistan, graded by three specialists according to the severity of diabetic retinopathy. the dataset aims to improve research and patient care.

this clinical trial aims to address the scarcity of retinal image datasets in pakistan by providing a comprehensive digital fundus photograph dataset, accompanied by expert grading. the dataset will encompass retinal images from pakistani individuals, meticulously labeled by three vitreo retinal specialists. these specialists will assess the presence and severity of common retinal disorders, including no diabetic retinopathy (no dr), mild, moderate, severe, proliferative diabetic retinopathy, clinically significant macular edema (csme), and advance diabetic eye diseases (aded). each image will also be evaluated for diagnostic clarity and the presence of any additional findings. final grading decisions will be reached through unanimous consensus among the graders, ensuring the dataset's reliability and accuracy. this initiative holds promise for advancing ophthalmic research and improving patient care in pakistan and beyond.

Eligibility criteria:
inclusion criteria: * patients with type i or type ii diabetes. * patients of age of 20 years or above exclusion criteria: * the participant is unable or unwilling to comply with study procedures. * vulnerable participants (minors, legally detained individuals). * prisoners or subjects who are involuntarily incarcerated.