Kornimate/medical-research-clean huggingface dataset:
clinical study of vascular imaging evaluation of computed tomography photoacoustic breast imaging system

Conditions: Breast Tumor; Ultrasonography

Summary: using color doppler ultrasound to screen people with breast masses. for the patients who show only a single mass on either side of the breast in color doppler ultrasound, computer tomography photoacoustic breast imaging will be performed. by comparing the two modalities, the blood vessel imaging performance of the computer tomography photoacoustic breast imaging system developed by union photoacoustic technologies co., ltd is evaluated. the evaluation index of this experiment is the percentage of blood vessel pixels in the same region of interest (region of interest, roi) to the total area of the roi.

screening of people with breast tumors, through breast color doppler ultrasound examination, the results showed that there is only a single tumor on either side of the breast. the computer tomography photoacoustic breast imaging system was used to perform breast examination again. by comparing ultrasound and photoacoustic vascular imaging, the vascular imaging of the computer tomography photoacoustic breast imaging system developed by union photoacoustic technologies co., ltd was evaluated. this test does not evaluate the diagnosis or treatment performance of two imaging modalities. it only compares the vascular imaging of two different imaging systems. therefore, the evaluation index of this experiment is the percentage of blood vessel pixel number in the same region of interest (roi) to the total pixel number in roi. by comparing the percentages of blood vessel pixel number to the total pixel number in the same roi in ultrasound and computerized tomography photoacoustic breast imaging system, the vascular imaging of the computerized tomography photoacoustic breast imaging system is evaluated.

Eligibility criteria:
inclusion criteria: 1. female subjects aged ≥18 years old; 2. those who have undergone breast color doppler ultrasound examination in this hospital, and the results show that there is only a single tumor on either side of the breast; 3. able to comply with the research procedures specified in this program; 4. those who have fully understood the study before the experiment, volunteered to participate in the study and signed a written informed consent. exclusion criteria: 1. those with incomplete skin (such as scratches, open wounds, ulcers, etc.) in the assessment side breast area; 2. those who have a history of surgery in the assessment side breast area; 3. those with persistent or active breast and/or axillary infection on the assessment side; 4. those who have a history of mental illness and cannot cooperate to complete the trial at present; 5. subjects deemed unsuitable by the investigator to participate in this study.

Keywords: photoacoustic imaging ultrasonography breast tumor
a study of the safety and anesthetic effect of ag-920 topical ophthalmic solution

Conditions: Anesthesia, Local

Summary: this is a phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the us. it is designed to evaluate the safety and anesthetic efficacy of ag-920 sterile topical ophthalmic solution.

this is a phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the us. it is designed to evaluate the safety and anesthetic efficacy of ag-920 sterile topical ophthalmic solution. in this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of ag-920 or identical looking placebo into the study eye. subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent prior to any study-related procedures being performed. 2. is male or a non-pregnant, non-lactating female aged 18 years or older. 3. willing and able to follow instructions and be present for the required study visits. 4. have an early treatment diabetic retinopathy study (etdrs) best correct visual acuity (bcva) of 20/200 or better in each eye. 5. have an intraocular pressure (iop) between 7 and 30 mmhg. 6. certified as healthy by clinical assessment. 7. verbal communication skills adequate to participate. 8. able to tolerate bilateral instillation of over-the-counter artificial tear product based on investigator judgement. exclusion criteria: 1. have participated in an investigational study within the past 30 days. 2. have a contraindication to local anesthetics. 3. have known decreased corneal or conjunctival sensitivity. 4. have had ocular surgery in either eye within the past 90 days. 5. have had an intravitreal injection in either eye within 14 days. 6. have ocular disease requiring punctual plugs or ocular inflammation. 7. are currently using a systemic opioid or opiate analgesic or topical nsaid. 8. cannot withhold their over the counter (otc) artificial tear lubricant products for one hour preceding or following study medication. 9. any condition, including alcohol or drug dependency, that would limit the subject's ability to comply with the procedures of the protocol.

Keywords: ag-920 articaine septocaine intravitreal injection
lipiodol-tace with idarubicin for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this real-world study is to evaluate the safety and efficacy of lipiodol-tace with idarubicin for hepatocellular carcinoma.

idarubicin is a dna topoisomerase ii inhibitor that promotes dna strand breakage, trapping cells in the g2 phase of the cell cycle and inducing dna cleavage and cell apoptosis. at the same time, it can be inserted between the dna base pairs and produce free radicals, thus breaking the dna double helix structure and inhibiting the extension, replication and transcription of dna strands. preclinical studies have shown that idarubicin has higher antitumor activity than epirubicin, especially against sun-449 human hepatoma cells. in recent years, domestic and foreign scholars have conducted a series of explorations in the treatment of hepatocellular carcinoma with lipiodol-idarubicin emulsion, and have obtained positive results. this proepective， multicenter real-worldstudy aims to evaluate the efficacy and safety of lipiodol-tace with idarubicin in chinese hcc patients.

Eligibility criteria:
inclusion criteria: 1).18-75 years old; no gender limit; 2).confirmed diagnosis of hcc according to histopathology or cnlc guidelines (2019 edition); 3）life expectancy≥3 months; 4).child-pugh class a or b; 5).ecog ps of 0 or 1;6).one of the following cases: cnlc stage iib and iiia; cnlc stage ib and iia patient who is unable or unwilling to receive surgical treatment due to other reasons (such as advanced age, severe liver cirrhosis, etc.); the main portal vein has not been completely obstructed, with abundant collateral vessels, or restore the blood flow by portal vein stent placement; 7). at least one measurable lesion (the length diameter≥10mm); 8).laboratory indices: wbc≥3.0×109/l; plt≥50×109/l; hb≥70g/l; cr≤1.5×unl(upper limit of normal); bil≤2.0×unl, alt≤5.0×unl, ast≤5.0×unl. exclusion criteria: 1).the coagulation function is severely decreased and cannot be recovered; 2).the main portal vein is completely embolized by cancer embolism, with few collateral vessels; 3).with active hepatitis or severe infection that cannot be treated at the same time; 4). with cachexia or multiple organ failure; 5). with uncontrollable neurological and mental disorders, or poor compliance; 6.) primary brain tumors or central nervous system metastasis has not been controlled, with obvious intracranial hypertension or neuropsychiatric symptoms; 7). pregnant or breast feeding women; 8). received drug treatments in other clinical trial in the past 4 weeks; 9). other situations where the investigators judge that the patient should not participate in.

Keywords: hepatocellular carcinoma transarterial chemoembolization idarubicin real-world study
treatment of keratosis pilaris with 810 nm diode laser

Conditions: Keratosis Pilaris (KP)

Summary: the investigators hope to establish whether or not the diode laser, a longer-wavelength laser, is effective in treating keratosis pilaris, and hopefully opening a door into the discussion and management of this skin condition. the primary outcome of interest is the difference in the overall blind rater severity scores of the treated versus the untreated sites. the secondary outcome of interest is the change in the patient's self-rated severity score of the treated site. to account for potential natural disease progression or regression, the investigators will also compare patient mean changes to the mean changes in severity scores of the untreated site.


Eligibility criteria:
inclusion criteria: * subject is age 18 to 65 * subject has diagnosis of keratosis pilaris involving both arms * subject has fitzpatrick skin type i - iii * subject is in good health * subject has the willingness and ability to understand and provide informed consen exclusion criteria: * under 18 or over 65 years of age * subjects with fitzpatrick skin type greater than iii * subjects who have received any laser therapy to the armsin the past year * subjects with concurrent diagnosis of another skin condition or malignancy * subjects with tan or sunburn over the upper arms in the past month * subjects with open, non-healing sores or infections at any skin site * subjects who are unable to understand the protocol or give informed consent * subjects who take oral photosensitizing medications or who apply topical photosensitizing medications to either arm

Keywords: keratosis pilaris (kp)
predictive factors of outcome of mechanical thrombectomy after acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: predictive factors of outcome of mechanical thrombectomy after acute ischemic stroke

acute ischemic stroke is one of the most common causes of disability, dementia and death in developing world. in egypt, the total lifetime prevalence of ischemic stroke was 7.2/1,000 in the population aged 20 years and more . although the intravenous thrombolysis is a treatment option within ≤ 4.5 hours after stroke onset, the mechanical thrombectomy can be performed within a more extended time window. a positive results of 5 recent randomized clinical trials are driven mainly from patients treated by mechanical thrombectomy within 6 hours from onset and they demonstrated a clear benefit for mechanical thrombectomy in combination with intravenous thrombolysis. more recent two randomized clinical trials dawn and defuse 3 demonstrated an overall benefit in functional outcome at 90 days in patients treated with mechanical thrombectomy within 6 to 24 hours or 6 to 16 hours form onset respectively with special criteria. a major issue remains as to identifying patients which likely to benefit from mechanical thrombectomy to improve selection and subsequently clinical prognosis . these factors include:- 1. time of presentation. 2. age. 3. clinical presentation. 4. risk factors include hyperglycemia, peripheral vessel disease, atrial fibrillation, coronary heart disease, hyperlipidemia, smoking, and history of pervious stroke, 5. socioeconomic status. 6. collateral and stroke core. in this study the investigators will evaluate prognostic factors influencing angiographic and clinical outcomes at discharge and at three months after mechanical thrombectomy of acute ischemic stroke within 24 hours.

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. cerebral infarction in the anterior or posterior circulation (intracranial internal carotid artery, m1 or m2 middle cerebral artery, basilar or vertebral arteries) proven by computed tomography angiography 3. with or without intravenous thrombolysis 4. access to endovascular treatment within 24 hours from onset. 5. in selected patients with acute ischemic stroke within 6 to 24 hours of onset must meet dawn or defuse 3 eligibility criteria. exclusion criteria: 1. proven occlusion of the cervical carotid artery 2. disability prior to the stroke (modified ranking scale \>3) 3. opposition of the patient or their family
eculizumab in adult participants with paroxysmal nocturnal hemoglobinuria (pnh) in china

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this is a phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of eculizumab in adult participants with paraxysmal noturnal hemoglobinuria (pnh) in china.

this is a phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of eculizumab in adult participants with pnh in china who previously have not been treated with complement inhibitors. approximately 25 eligible participants in china will be enrolled.

Eligibility criteria:
inclusion criteria: * adult c5 inhibitor naïve pnh patients (age\>=18), which is confirmed by flow cytometry evaluation * must be vaccinated against n meningitidis exclusion criteria: * meningitidis infection or unresolved meningococcal disease * significant bone marrow failure * other significant systemic diseases that might have impact on efficacy and safety assessment

Keywords: paroxysmal nocturnal hemoglobinuria pnh
the vascutek custom fenestrated anaconda post-market surveillance study

Conditions: Abdominal Aortic Aneurysms (AAA)

Summary: this is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the vascutek anacondatm custom fenestrated stent graft in patients with a short infrarenal neck of \<15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the anacondatm custom fenestrated stent graft and for whom a customised medical device is required.

anacondatm custom fenestrated devices (cfd) are designed for the endovascular repair of abdominal aortic aneurysms (aaa) for cases where the aneurysm extends superiorly very close to or involving the renal arteries, leaving insufficient neck length for infrarenal device sealing. the non-ce marked devices are custom designed based on ct scan data of the patient's aorta and regulated in accordance with the medical device directive (93/42/eec) and associated country specific regulations as applicable. the proximal end of the anacondatm fenestrated body device is positioned suprarenally, where it seals and fixates in the vessel by means of rings comprised of multiple turns of fine nitinol wire, attached to the fabric with polyester sutures, creating a self-expanding stent which provides a conformable seal with the vessel wall and assists in anchoring of the device. nitinol hooks provide secure fixation within the suprarenal aorta. the saddle shape of the rings allows the superior mesenteric artery (sma) or celiac artery to be accommodated in the valley of the top ring saddle in some cases. the objective of the registry is to provide long term (5 year) safety and effectiveness data of all patients who consent to their data to be used in the registry. this data aims to demonstrate that the vascutek anacondatm custom fenestrated stent graft is safe and effective in patients with a short infrarenal neck of \<15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the anacondatm custom fenestrated stent graft.

Eligibility criteria:
inclusion criteria: a patient with juxta renal abdominal aortic aneurysms (aaa) who, in the opinion of the treating physician, is anatomically suitable for the anaconda fenestrated graft and for whom a customised medical device is required. exclusion criteria: 1. ruptured or symptomatic aneurysm 2. clinically significant concomitant medical disease or infection 3. connective tissue disease (e.g. marfan's syndrome) 4. known allergy to nitinol, polyester or contrast medium 5. excessive tortuosity of access vessels (femoral or iliac arteries) 6. landing zone of less than 10mm in the visceral segment of the aorta 7. inability to comply to follow up protocol 8. access vessels less than 6mm in diameter 9. diseased or excessively tortuous access to target vessels 10. target vessels of less than 5mm in calibre 11. excessive calcification or thrombus at the intended landing zone which could affect sealing
recombinant human serum albumin/interferon alpha2a fusion protein phase ib study in chronic hepatitis b patients

Conditions: Chronic Hepatitis B

Summary: this is an open label study that will be conducted at a single site in china to evaluate the safety,tolerability and pk/pd profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis b patients.the total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-75 years * chronic hbv infection (serum hbsag detectable for \> 6 months) * serum hbeag positive with hbv dna \>10\^6copies/ml (or \>20,000 iu/ml),orserum hbeag negative with hbv dna \>10\^5copies/ml (or \>2,000 iu/ml) * serum alt must be \> 2 x uln but below 10 x uln exclusion criteria: * steroid treatment or immunosuppression 3 months prior to entry. * interferon therapy or nucleotides analogues therapy in 6 months prior to entry. * active lung disease or history of interstitial lung disease. * hb\< lln or, and anc \< 750/mm3 or , and platelet count \< 75,000 mm3 ,or wbc\<3000/mm3 . * significant chronic medical conditions other than chronic hepatitis b which in the opinion of the investigator preclude enrollment into the study. * evidence of hepatic decompensation (i.e., child-pugh score of b or c). * seropositive for hiv, hcv, or hdv (hepatitis delta virus). * history of thyroid disease or current treatment for thyroid disease. other protocol-defined inclusion/exclusion criteria may apply
ankle-foot orthoses for night splinting in children with cp: impact on passive stiffness in plantarflexors muscles

Conditions: Cerebral Palsy

Summary: children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. in order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic cerebral palsy (cp). however, there's a lack of proof about efficacy by using this modality of treatment. moreover, impact on quality of life for children and families, cost for society were high. principal purpose of this study was to assess impact of night splint ankle foot orthoses on passive stiffness in plantarflexors muscles in children with cp.

children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. in order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic cp. however, there's a lack of proof about efficacy by using this modality of treatment. moreover, impact on quality of life for children and families, cost for society were high.

Eligibility criteria:
inclusion criteria: * children diagnosed spastic cerebral palsy * children wearing night splint ankle foot orthoses all night long during 1 week minimum * children with a level of spasticity in the gastrocnemius muscle greater than or equal to x1, vii, on the tardieu scale and 2 on the ashworth scale. * children able to understand and respect the simple instructions of the study * children and parents who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study. exclusion criteria: * children who do not tolerate ankle foot orthoses all night long. * children who had botulinum injection in gastrocnemius or soleus muscles during last three months. * children benefiting from an injection of botulinum toxin or the setting up of new equipment during the protocol. * children who do not tolerate ankle foot orthoses all night long. * children having benefited from plaster lengthening for less than three months.

Keywords: night splinting stiffness ankle foot orthoses teenager
physiological flow of liquids in head and neck cancer patients: a pilot study

Conditions: Deglutition Disorders; Oropharynx Cancer

Summary: this study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing. the focus of this study is to evaluate the flow of liquids of varying consistency in the head and neck cancer population.

thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). however, the field lacks a clear understanding of how liquids of different consistencies behave during swallowing. in order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx. this study explores this question in individuals who have undergone radiation treatment for head and neck cancer, specifically located in the oropharynx. participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, and mildly thick) using commercially available food thickeners. swallowing will be observed under videofluoroscopy.

Eligibility criteria:
inclusion criteria: * an initial cancer diagnosis of cancer in the base of tongue region of the oropharynx (tumor staging t2,t3 \& t4; nodal staging n0 orn1; human papilloma virus + or -). * completion of bilateral radiation therapy to the neck 3 months prior to enrollment * no longer requiring primary enteral feeding for nutrition. exclusion criteria: * prior history of swallowing, motor speech, gastro#esophageal difficulties, chronic sinusitis or taste disturbance. * previous radiation to the head and neck (prior to current illness); * previous cancer diagnosis; * prior or planned neck dissection; * trachestomy in situ; * neurological difficulties unrelated to spinal disorder (e.g. stroke, parkinson disease, etc). * cognitive communication difficulties that may hinder ability to participate. * current use of mechanical ventilation * type 1 diabetes (due to the requirement to swallow stimuli containing starch based thickeners, which carry a significant carbohydrate load). * known allergies to latex, food coloring or dental glue (due to the probability that these items will come into contact with the oral mucosa during data collection). * occupational exposure to radiation exceeding 10 msv in the past 6 months. * current pregnancy.

Keywords: swallowing