Kornimate/medical-research-clean huggingface dataset:
determinants of efficacy of esophyx treatment in gastro-esophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: esophyx is a promising endoscopic treatment for gastro-esophageal reflux disease. it is not known whether there are some pre- or per-operative anatomic or pathophysiological findings which may influence outcome. the aim of this trial is to study a series of parameters acquired during the pre-therapeutic work-up or during the procedure and their influence on the outcome of the procedure.


Eligibility criteria:
inclusion criteria: * patients being considered for esophyx treatment of gerd
a study of [14c]gb491 in male healthy subjects

Conditions: Breast Cancer; Nonsmall Cell Lung Cancer

Summary: this is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of gb491 in 4-8 healthy male subjects receiving a single oral 150mg dose of gb491 containing approximately 50 uci of \[14c\]gb491. this study will help understand how the drug appears in the blood, urine, and feces after it is administered. in addition, this study will also evaluate the safety of a single dose of \[14c\]gb491 when given to healthy subjects.


Eligibility criteria:
inclusion criteria: * a healthy male volunteer between 18 and 50 years of age inclusive * a total body weight \>=50kg, and a bmi of 19.0-26.0 kg/m2 * a signed informed consent document exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * subjects with hbsag-positive, or hcv-ab-positive, or tppa-positive, or hiv infection * subjects with a history of habitual constipation/diarrhea, irritable bowel syndrome, or inflammatory bowel disease
the role of optic nerve sheath fenestration in leukemic patients having increased intracranial pressure

Conditions: Leukemic Patients With Increased Intracranial Pressure; Optic Nerve Sheath Fenestration

Summary: optic nerve sheath fenestration (onsf) first described by de wecker in 1872 for the treatment of neuroretinitis. since then, optic nerve sheath fenestration has become well established procedure for treatment of papilledema in medically uncontrolled patients of idiopathic intracranial hypertension.

optic nerve sheath fenestration (onsf) first described by de wecker in 1872 for the treatment of neuroretinitis. since then optic nerve sheath fenestration has become well established procedure for treatment of papilledema in medically uncontrolled patients of idiopathic intracranial hypertension. indications for onsf in cancer patients are not well established, but a few case reports have shown success of onsf in patients with perineural metastasis of breast cancer, increased intracranial pressure with papilledema due to a brain tumor, leukemia and optic nerve sheath meningioma. this study is conducted to establish the role of optic nerve sheath fenestration in leukemic patients mainly those suffering from acute lymphoblastic leukemia.

Eligibility criteria:
inclusion criteria: * evidence of progressive visual loss and papilledema did not improve despite the maximal medical therapy prescribed. * informed written consent was obtained from the parents/care providers of the study participants. exclusion criteria: * can not get the informed consent
aspirate: novel intervention to acoustically detect silent aspiration in acquired dysphagia.

Conditions: Dysphagia, Oropharyngeal

Summary: this study will investigate whether silent aspiration during swallowing can reliably be detected using acoustic signal processing plus pulse oximetry.

this proof of concept trial, involving original research from a multicentre, multidisciplinary team, aims to establish whether silent aspiration can be detected in patients with dysphagia (swallowing difficulties), using a microphone array attached to the neck (to capture acoustic respiratory changes), pulse oximetry (to detect reduction in blood oxygen levels) and respiratory rate analysis, with data combined and analysed via post-capture signal processing techniques. the project aims to develop equipment and signal processing algorithms to a point where a novel intervention has been established that allows semi-automated detection of safe versus unsafe (aspiration) swallows. the intervention will be trialled in patients with dysphagia within standard videofluoroscopy clinics under clinical supervision. there will be on-going development of the intervention and signal processing algorithms during this process. public and patient involvement work will feed back into the design process. if the intervention performs successfully in this proof-of-concept study, the investigators aim to proceed to a larger clinical trial to determine its sensitivity and specificity as a screening tool for aspiration, before final development into a commercial product.

Eligibility criteria:
inclusion criteria: * dysphagia ± aspiration, * age 18 and above exclusion criteria: * not competent for consent, * previous neck surgery (not including thyroid surgery) * cervical skin infection or defect * pregnant (or unknown pregnancy status).

Keywords: swallowing disorders instrumental swallow assessment acoustic analysis respiratory changes
development and translation of generator-produced pet tracer for myocardial perfusion imaging-dosimetry group

Conditions: Coronary Artery Disease

Summary: this study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68ga-galmydar for pet/ct imaging.

the objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single 68ga-galmydar injection in normal healthy volunteers. healthy adult normal volunteers (n=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group). healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous ga-68 galmydar administration of 8 mci ± 20% (6.4-9.6 mci) with a mass of ≤ 10 µg followed by whole-body pet/ct imaging.

Eligibility criteria:
inclusion criteria: • healthy men and women, 18-99 years of age and any race exclusion criteria: * inability to receive and sign informed consent; * positive urine screen for drugs of abuse at screening or before dosing or over-the- counter drug use or herbal preparations within the 2-week period prior to enrollment; * participation in another research study with a study drug, including a diagnostic or therapeutic radiopharmaceutical, to be administered during this study or which was or will be administered within 10 hall-lives of the radiopharmaceutical. * severe claustrophobia; * pregnant or breastfeeding. * body mass index \ 40 kg/m2.

Keywords: myocardial perfusion imaging pharmacological stress biodistribution positron emission tomography myocardial blood flow
telemedicine for optimized collection of clinical data in patients with suspicion of acute stroke

Conditions: Stroke

Summary: observational prospective single-center study on the discriminatory value of the unassisted telestroke scale for differentiation between patients with lacunar stroke and those with other acute stroke syndromes.

assessment of stroke severity and differentiation between large-artery and small-artery stroke is pivotal for adequate treatment decision taking. patients with small vessel stroke tend have a better prognosis than those with large artery disease. further, patients with small artery infarction (lacunar stroke) have shown to respond well to treatment with intravenous recombinant tissue plasminogen activator (iv rt-pa), but are poor candidates for endovascular recanalization. conversely, iv rt-pa may be less effective at restoring perfusion of large artery occlusion, a stroke subtype that may benefit from intra-arterial thrombolysis or embolectomy. similarly, patients with large intracerebral hemorrhage or cerebellar hemorrhage may require neurosurgical interventions, such as intracranial pressure monitoring, ventricular drainage, surgical evacuation, or hemicraniectomy. the purpose of teleclass is to evaluate the discriminatory value of the unassisted telestroke scale (utss) obtained through in-hospital telemedicine for differentiation between patients with lacunar stroke and those with other acute stroke syndromes (nonlacs).

Eligibility criteria:
inclusion criteria: * age \> 18 years * suspicion of acute stroke with symptom onset \< 72 h before teleconsultation * nihss score \> 0 * informed consent exclusion criterion: * patients for whom telestroke consultation would delay any diagnostic or therapeutic intervention

Keywords: telemedicine emergency medicine stroke stroke syndromes
a study to assess the hypersensitivity to tak-880 compared to gammagard s/d in blood of children, teenagers and adults

Conditions: Drug Hypersensitivity

Summary: the aim of this study is to find out whether tak-880 creates hypersensitivity reactions compared to gammagard s/d by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin products. this study is about collecting data available in the participant's medical record. no study medicines will be provided to participants in this study. each participant will fill out a study questionnaire during a routine doctor visit. blood will be taken from participants who have a higher risk of developing hypersensitivity reactions to immunoglobulin products.


Eligibility criteria:
inclusion criteria: * at least 2 years of age except pid participants with selective iga deficiency (the lower age limit in this group of participants is 4 years of age). * participant has previously received at least one infusion of gammagard s/d prescribed for any approved indication (pid, b-cell chronic lymphocytic leukemia, idiopathic thrombocytopenic purpura, kawasaki syndrome) or pid participant with iga deficiency (serum iga level of \< 7 mg/dl (0.07 g/l) or below the detectable limit in participants older than 4 years) and has received other therapies (prophylactic antibiotics or immunoglobulin treatment other than gammagard s/d). * participant/legally authorized representative is willing to sign an informed consent form or assent form as applicable and is able to comply with the requirements of the protocol. exclusion criteria: -there are no applicable exclusion criteria for this study.
barriers to care and qol for ccca patients

Conditions: Scarring Alopecia; Central Centrifugal Cicatricial Alopecia; Central Centrifugal Scarring Alopecia

Summary: the purpose of the current project is twofold; first to determine what personal, historical, logistical, and environmental factors preclude women from obtaining medical care for ccca hair loss. because damage from ccca is irreversible, early identification and treatment is paramount to limiting the negative ramifications of the disease. second, to investigate how ccca hair loss, a common occurrence in the black population, can be a significant psychological impediment to lives of affected black women. based on previous research on the psychosocial impact of generalized hair loss in black women, it is fair to consider that ccca hair loss also leads to problems with self-esteem and participation in daily life activities. this research, the first of its kind, will add to existing knowledge of ccca by investigating the quality of life and barriers to care of patients with this condition. the goal of this study is to illuminate what stands in the way of secondary and tertiary prevention of ccca patients and tailor treatment strategies to address their needs. the results of this study will be instrumental in modifying dermatology resident training, adding to existing dermatology management guidelines, and even developing public health advocacy programming.


Eligibility criteria:
inclusion criteria: * evaluated in the northwestern dermatology department between october 1, 2015 and september 30, 2017. * evaluated by any faculty physician. * diagnosed with ccca. * age 18 or older. * all subjects must have given signed informed consent prior to participation in study. exclusion criteria: * non-english speakers (interpreters not available)
semi-automatic measurement of renal volume at ct angiography to plan repair of aortic aneurysms in patients with horseshoe kidney.

Conditions: The Horseshoe Kidney

Summary: the horseshoe kidney (hk) is a congenital anomaly in which the kidneys are fused in front of the anterior aortic wall in its most common form. the association of abdominal aortic aneurysm (aaa) and horseshoe kidney (hk) is a rare and challenging condition, occurring in less than 0.2% of all aaa cases. in these cases, open surgery is still widely practiced in many centers, with either a transperitoneal or retroperitoneal approach. typically, several polar arteries arise from the distal abdominal aorta or the iliac arteries to perfuse the hk. a key consideration for the surgery is whether or not to preserve the vascularization of the variant kidney. preserving them can be challenging, but removing them can lead to a significant reduction in renal volume and subsequent loss of function. in open surgery repair, it is recommended to reanastomose as many arteries as possible to the prosthesis, even though this introduces additional technical challenges, especially in emergency situations. computed tomography angiography (cta) is the best diagnostic test for performing a preoperative vascular assessment. the purpose of the present study is to develop a semi-automated model on preoperative ccta to measure the volume of parenchyma perfused by each artery to determine whether or not these should be preserved. the model will be validated on post-surgical ccta in patients with hk treated for aaa. customized use of this tool could be a valuable method in surgical decision making, determining which arteries can be made safe during surgery and addressing a rare but complex clinical need.


Eligibility criteria:
inclusion criteria: * adult subjects (≥18 years old) surgically treated for aaa with hk at san raffaele hospital between january 2019 and december 2023, with appropriate pre- and postoperative cta, pre- and post ct. exclusion criteria: * pediatric patients (age \<18 years) * absence of pre- and postoperative ct images * performance of surgery other than open surgery.
brain activity by magnetoencephalography for children

Conditions: Brain Activity

Summary: investigate the differences in activation of brain networks during performing functional tasks for children with attention deficit hyperactivity disorder with developmental delays and typical development

a total of 12 children with attention deficit hyperactivity disorder with developmental delays and12 children with typical development will be enrolled. the following evaluations will be evaluated by the investigator who is blinded to the group's classification. working task-related functions, such as beery-buktenica visual-motor integration, sensory profile, the chinese version of swanson, nolan and pelham version iv, and chinese version of wechsler intelligence scale for children-iv) non-working memory-related functions, such as pediatric outcome data collection instrument (podci), child health questionnaire- parent form (chq-pf 28), pediatric quality of life inventory (pedsql), and physical function (10 meters normal and fast walking, stair ascent, stair descent, and 5 times chair rising and timed up and go test) all participants will be investigated by magnetoencephalography and eye-tracking system to identify the difference of brain network activation during resting and performing tasks and between-group differences. brain magnetic resonance image study will be performed for matching of brain localization.

Eligibility criteria:
inclusion criteria: * children with attention deficit hyperactivity disorder with development delays * intelligence quotient 70 or greater exclusion criteria: * age less than 4 or greater than 10 of children * intelligence quotient less than 70

Keywords: attention deficit hyperactivity disorder networks magnetoencephalography developmental delay children
the management of systemic-pulmonary collateral blood flow in cyanotic children during cardiopulmonary bypass - pilot study

Conditions: Heart Defects, Congenital

Summary: the purpose of the study is to determine whether it is possible to manage the flow of blood through blood vessels using varying levels of carbon dioxide during cardiac surgery, and what effect this has on how well the major organs of the body work.

a great number of studies have shown that mapcas are a real issue for these patients, who require far higher blood flows than previously suggested. however, the optimal method of cpb is still unknown. recent research by sakamoto et al., showed that a raised carbon dioxide (pco2) increased brain blood flow in cyanotic patients, suggesting a noticeable decrease in aorto-pulmonary blood shunting. however, the mechanism of this action is not understood and it is unclear if this observation is an associated or causative one. whilst the vasoconstrictive (narrowing of vessels) effect of hypoxia has been well documented, with and without high carbon dioxide, there are no reports indicating that pco2 alone increases the narrowing of blood vessels in the lung. we hypothesize that a rise in pco2 could cause a shift in blood flow from pulmonary to systemic circulation, either through direct constricting action on mapca vessels, or through a vasoconstriction of blood vessels in the lung. furthermore, we predict the phenomenon could potentially be used to optimize the method of treatment, ensuring that vital organs receive the correct amount of blood flow during the surgical correction of these rare congenital heart diseases.

Eligibility criteria:
inclusion criteria: * patients whose parents/guardians are willing and able to provide written informed consent for participation in the study * patients undergoing elective tcpc surgery * mri proven presence of mapca vessels * patients between 1 day and 5 years of age exclusion criteria: * emergency surgery * documented history of cognitive impairment (may have an effect on biochemical markers of cerebral injury) * documented history of major organ dysfunction
semi-occluded vocal tract exercise in velopharyngeal dysfunction in patients with cleft palate

Conditions: Cleft Palate

Summary: analyze the effect of sovte (semi-occluded vocal tract exercise), with high resistance tube, on the velopharyngeal mechanism, for speech rehabilitation of twelve patients with cleft palate with vocal alterations, after four weeks. the study was developed in the city of porto alegre, southern brazil. the hypothesis of the study is that after four weeks of exclusive therapy with exercise it will be improvement in the voice of patients with cleft palate.

the study is an uncompared before-after clinical trial. all patients were submitted to videonasoendoscopy and had their vocal emissions recorded before and after the four weeks of speech therapy. these individuals were submitted to multidimensional evaluation comprised of analysis of images generated by specialized videonasoendoscopy software, analysis of speech emissions by perceptual-auditory evaluation and acoustic analysis, and vocal self-assessment.

Eligibility criteria:
inclusion criteria: * individuals with surgically repaired clp (cleft lip and palate), regardless of gender and regardless of the type of clef palate. * the sample only included patients aged 6+ because this is the ideal age to be submitted to videonasoendoscopy. * these patients attended four speech therapy sessions. * all individuals agreed to participate in this research voluntarily. exclusion criteria: * individuals with cleft lip and palate associated with genetic syndromes or other congenital malformation * individuals who proved unable to do sovte (semi-occluded vocal tract exercise), * no condition to be submitted to videonasoendoscopy examination, * patients who did not attend the four sessions of therapy or who did not do exercise at home were excluded from the sample.

Keywords: cleft palate velopharyngeal sphincter velopharyngeal insufficiency speech therapy rehabilitation
the effect of qvar on lung functioning in chronic obstructive pulmonary disease

Conditions: COPD

Summary: this is an investigator-sponsored research study to evaluate if treatment with hfa-134a beclomethasone (qvar) has an effect on peripheral (or outer) airway inflammation and airway "remodeling" or scarring in subjects with copd. approximately 20 subjects with copd will participate for approximately 7 weeks, with 10 receiving an active (bdp) inhaler with hfa-134a and 10 receiving a placebo.


Eligibility criteria:
inclusion criteria: * copd diagnosis * fev1/fvc\<70% * fev1 50-80% predicted * albuterol response of \ 8mg/ml * rv \> 120% predicted * dlco \< 80% * smokers and nonsmokers * lower age limit 45 years exclusion criteria: * asthma * other chronic airway or parenchymal lung disease * other comorbid illness (including but not limited to dm, mi or cad-related intervention in 6 months, neurologic disease, syncope) * use of any steroid (oral, iv, nasal, pulmonary) within 12 weeks * use of theophylline, leukotriene modifiers within 12 weeks * use of long-acting beta-agonists (formoterol, salmeterol) or anticholinergic (tiotropium)

Keywords: copd chronic obstructive pulmonary disease emphysema chronic bronchitis
study of mgcd0103 (mg-0103) in patients with relapsed or refractory hodgkin's lymphoma

Conditions: Hodgkin's Lymphoma

Summary: mgcd0103 is an experimental drug that belongs to a class of drugs known as the histone deacetylase inhibitors, which may restore normal control in cancer cells by affecting the genes and proteins that are being made. laboratory tests show that this new investigational anti-cancer drug can slow down the growth of human cancer cells in mice; two clinical research studies are currently being performed in humans with cancer and a similar study is being performed in patients with the same disease. the purpose of this study is to find out what effect the experimental drug mgcd0103 has on patients with relapsed and refractory hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria: * pathologic confirmation of relapsed or refractory classical hodgkin's lymphoma. * the patient has at least one site of measurable disease (≥ 2.0 cm) as measured by conventional techniques such as ct or mri. * prior treatment: there is no limit to number of prior therapies. patients who had prior allogeneic stem cell transplants and do not have evidence of graft versus host disease and are not receiving immunosuppressive agents are eligible if they meet all other inclusion criteria. * ecog performance status of 0 or 1. * aged 18 years or older (no safety data yet for ages \< 18). * laboratory requirements (must be done within 7 days prior to study initiation). exclusion criteria: * patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia \[cin/cervical in situ\] or melanoma in situ). prior history of cancer is allowed, as long as there is no active disease. * pregnant or lactating women. women of child-bearing potential (wocbp) must have a negative serum pregnancy test documented within 7 days prior to start of study drug. * wocbp and men whose partners are wocbp must use an acceptable method of contraception while enrolled in this study, and for a period of 3 months following study drug treatment. * patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever \> 38.5°c (not due to tumor fever) on the day of scheduled dosing.

Keywords: relapsed or refractory hodgkin's lymphoma phase ii