Kornimate/medical-research-clean huggingface dataset:
influence of silicone hydrogel contact lens neophyte wear on corneal sensitivity

Conditions: Cornea

Summary: soft contact lenses can affect the ocular surface and sometimes cause intolerance. the aim of this study is to measure corneal sensitivity using the swiss liquid jet aesthesiometer at baseline, after one and after six weeks, in novice daily contact lens wearers.

contact lens discomfort is described by many wearers. wearing contact lenses can influence corneal sensitivity through three mechanisms: hypoxic, mechanical and inflammatory. a change in corneal sensitivity can be considered an indicator of a change in corneal physiology. corneal sensitivity plays a major role in maintaining eye health. the interest of this study is to test the variability of the corneal sensitivity threshold during a new adaptation of silicone hydrogel contact lenses, and to verify whether there is a correlation with the wearer's comfort. for that, corneal sensitivity threshold measurements are taken at the baseline and then after one and six weeks of daily contact lens wear. the measurement is performed with the swiss liquid jet aesthesiometer for corneal sensitivity (slacs). after one week and six weeks of daily lens wear, participants complete a contact lens dry eye questionnaire (cldeq-8) for comfort analysis.

Eligibility criteria:
inclusion criteria: * the ocular surface disease index questionnaire (osdi) score for dry eye classification is ≤ 13 * participants must be candidates for contact lens wear. * corneal radius between 7.4mm and 8.0mm * if the corneal radius is \> 8.0mm, the corneal diameter must be greater than 12.0mm. * if the corneal radius is \<7.4mm, the required corneal diameter is less than 12.0mm. * participants have a cl cylindrical ametropia ≤ -1.25 d. * participants will not have worn cl for 7 days prior to the start of the study. * participants do not wear cl regularly (no more than 1 days per week) prior to the start of the study. * during the study, the participant wore the cl a minimum of 5 days per week for a minimum of 8 hours. * the person being tested is in good health. this means that he or she does not suffer from any systemic diseases, such as diabetes or rheumatism, which could have an influence on eye health. he or she also has no eye disease and has not previously undergone corneal (refractive) surgery. exclusion criteria: * the participant is a minor. * the participant has worn cl within the last 7 days. * the radius of the cornea is not within the prescribed range. in addition, the corneal diameter is not within the prescribed range either. * the participant's ametropia is not within the prescribed range. * the participant has worn the lenses for less than 8 hours for less than five days. * the participant has no diagnosis of dry eye. * the osdi questionnaire score for the dry eye classification is greater than 13. * the participant suffers from a systemic disease (diabetes or rheumatism) that could influence ocular health, an ocular disease or has already undergone refractive surgery. * vulnerable participants

Keywords: silicone hydrogel contact lens daily contact lens wear corneal sensitivity esthesiometry
effect of glp-1 on insulin-dose, risk of hypoglycemia and gastric emptying rate in patients with type 1 diabetes

Conditions: Diabetes Mellitus

Summary: the aim of the study is to investigate the effect of victoza (a glp-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * age 18-50y, * bmi 18-27, * caucasian origin, * type 1 diabetes diagnosed between age 5 and age 40, * no known diabetes complications or cardiovascular diseases, * no medication known to influence glucose homeostasis, * no pregnancy exclusion criteria: * diabetes complications, * autonomous nerve dysfunction, * anaemia, * hba1c \< 8.5% at screening, * estimated by the investigator to be incapable of completing the trial.

Keywords: patients with type 1 diabetes mellitus
wx-0593 combined with concurrent chemoradiotherapy in unresectable locally advanced nsclc

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the aim of this trial is to evaluate the safety of wx-0593 combined with concurrent chemoradiotherapy in unresectable, locally advanced non-small cell lung cancer (nsclc) with activating mutation of alk or ros1. this trial consists of two parts. in part 1, approximately 8 patients will be included and receive wx-0593 maintenance until disease progression or unacceptable toxicity. in part 2, approximately 32 patients will be included and receive wx-0593 monotherapy for 1-2 cycles and subsequently with concurrent chemoradiation, followed by wx-0593 maintenance until disease progression or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older; * pathologically confirmed nsclc who present with investigator-assessed previously untreated, unresectable, locally advanced (stage ii、iii) disease (according to tmn staging of ajcc version 8); * has active mutation of alk or ros1; * eastern cooperative oncology group (ecog) performance status (ps) 0-1; * has at least one evaluable lesion (according to recist 1.1); * have adequate pulmonary function test as a forced expiratory volume in 1 second (fev1) \>50% of predicted normal volume and carbon monoxide lung diffusing capacity (dlco) \>40% of predicted normal value; * have adequate organ and marrow function; * if participant is a woman of childbearing potential (wocbp), must agree to follow the contraceptive guidance from written informed consent until at least 180 days after the last dose of study treatment. the female participant should have negative serum pregnancy test within 7 days prior to the first dose of study drug, and not breastfeeding; * a male participant must agree to use contraception from written informed consent until at least 180 days after the last dose of study treatment. exclusion criteria: * diagnosed other malignant tumor besides nsclc within 5 years prior to study entry; * mixed small cell and non-small cell lung cancer histology; * has received prior therapy with any alk tki; * has a history of extensive diffuse/bilateral interstitial fibrosis, or grade 3 or 4 pulmonary fibrosis or interstitial lung disease prior to the first dose of study drug. has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry; * history of primary immunodeficiency; * active or prior documented autoimmune disease within the past 2 years. note: patients with vitiligo, grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.

Keywords: nsclc, unresectable , radiochemotherapy, wx-0593
three month efficacy/safety study with a 3-month safety extension of brinzolamide 1%/brimonidine 0.2% vs. brinzolamide 1% or brimonidine 0.2%

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (brinz/brim) in lowering intraocular pressure (iop) relative to its individual active components in subjects with open-angle glaucoma and/or ocular hypertension.

this study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 4 on-therapy visits conducted at week 2, week 6, month 3, and month 6. a washout period based on previous ocular medication preceded eligibility visit 1. subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. the study was designed to evaluate the efficacy and safety of brinzolamide/brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.

Eligibility criteria:
inclusion criteria: * sign informed consent document. * diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s. * other protocol-specified inclusion criteria may apply. exclusion criteria: * females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. * any form of glaucoma other than open-angle glaucoma. * severe central vision loss in either eye. * chronic, recurrent, or severe inflammatory eye disease. * ocular trauma within the preceding 6 months. * ocular infection or ocular inflammation within the preceding 3 months. * clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. * best-corrected visual acuity score worse than 55 letters using the early treatment diabetic retinopathy study chart. * other ocular pathology (including severe dry eye) that may, in the opinion of the investigator, preclude the administration of study product. * ocular surgery within the preceding 6 months. * ocular laser surgery within the preceding 3 months. * any abnormality preventing reliable applanation tonometry. * any other conditions, including severe illness, which could make the subject, in the opinion of the investigator, unsuitable for the study. * other protocol-specified exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension brinzolamide brimonidine intraocular pressure
safety study of dacarbazine and bortezomib in melanoma and soft tissue sarcoma

Conditions: Melanoma; Soft Tissue Sarcoma; Parathyroid Carcinoma; Small Cell Carcinoma of the Lung; Carcinoid Tumors

Summary: bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.

the primary objective is to determine recommended phase ii doses for the combination dacarbazine and bortezomib administered weekly. secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).

Eligibility criteria:
inclusion criteria: * histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (sts), or an apud (amine precursor uptake and decarboxylation) tumor. apud tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma. * measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy. * age 18 years or greater * ecog performance status 0 or 1 * women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. men also must agree to use a medically accepted form of birth control for the duration of study treatment. exclusion criteria: * uncontrolled brain metastatic disease * platelet count \<100 * absolute neutrophil count \<1.5 * blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment. * calculated or measured (cockcroft and gault formula) creatinine clearance \<30 ml/minute * ast \> 3 times the upper limit of normal, unless elevation due to metastatic disease, in which case ast \> 5 times the upper limit of normal * bilirubin \> 2 mg/ml * grade 2 or greater peripheral neuropathy * hypersensitivity to bortezomib, boron, mannitol, or dacarbazine * pregnant or nursing * other investigational drugs within 14 days of enrollment * other medical or other condition(s) that in the opinion of the investigator/sub-investigator might compromise the objectives of the study

Keywords: melanoma soft tissue sarcoma apud tumor dacarbazine bortezomib velcade
a prospective study on the efficacy of magnifying endoscopy with narrow-band imaging in diagnosing gastric lesions

Conditions: Stomach Neoplasms

Summary: magnifying endoscopy with narrow-band imaging (me-nbi) can emphasize surface pattern and microvascular architecture of the gastric mucosa.however,the usefulness and criteria of nbi for differential diagnosis among early gastric cancers (egc) have not been fully established.the study is based on the hypothesis: 1. me-nbi is useful in distinguishing egc from other gastric lesions 2. me-nbi is useful in further differential diagnosis among egcs.


Eligibility criteria:
inclusion criteria: * patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy. exclusion criteria: * advanced gastric cancer or any other malignancy; * patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc; * inability to provide informed consent; * inability to provide histology of resected specimens after endoscopic treatment or surgery.

Keywords: early gastric cancer stomach neoplasms magnifying endoscopy narrow band imaging
high flow nasal cannula for safe apnea

Conditions: Anesthesia, General; Apnea

Summary: this is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.

this is a prospective randomized controlled trial comparing two oxygenation methods for prolongation of apnea time in children aged 0 to 10 years old. this study measures time for the pulse oximetry drop from 100% to 92% after oxygenation with 100% oxygen, applying high flow nasal cannula or buccal oxygen insufflation via an oral ring-adair-elwyn endotracheal tube connected to oxygen.

Eligibility criteria:
inclusion criteria: * children under 11 years old undergoing general anesthesia with american society of anesthesiologists physical status 1 or 2. exclusion criteria: * refusal of enrollment from one or more legal guardians of the patient * plan of usage of supraglottic airway device as airway maintenance device * presence of upper respiratory tract infection of lung disease * premature infants younger than postconceptual age of 40 weeks * anticipation of difficult bag-mask ventilation due to facial anomaly or micrognathia * other conditions that are considered inappropriate for the study

Keywords: oxygenation high-flow nasal cannula
preclinical project on the traitment of acute lymphoblastique leukemia with nvp-bep800, an inhibitor of the heat shock protein hsp90

Conditions: Acute T Lymphoblastic Leukemia (T-ALL); Acute B Lymphoblastic Leukemia (B-ALL)

Summary: nvp-bep800, a new hsp90 inhibitor, has particularly interesting therapeutic potential and represents hope in cancer pathologies. while it is currently being tested for solid cancers, no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia (all). the investigators wish to study the effects of nvp-bep800 on two different types of all (t and b-all).


Eligibility criteria:
inclusion criteria: * patient suffering from acute lymphoblastic leukaemia whose biological samples are kept at the biology technical platform. exclusion criteria: * patient over 80 years of age
amniotic membrane associated with conjunctival autograft versus conjunctival autograft for recurrent pterygia

Conditions: Recurrent Pterygia

Summary: the purpose of this study is to compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia.

patients with recurrent pterygia without symblepharon were randomly assigned to undertake pterygium excision followed by amniotic membrane associated with a small conjunctival autograft (2x3mm) or conjunctival autograft (approximately 5x8mm) alone. the patients were examined after 1, 7, 30, 90, 180 and 360 days after the surgery. recurrence was considered as a fibrovascular ingrowth of 1.5 mm or more beyond the limbus with conjunctival drag.

Eligibility criteria:
inclusion criteria: * recurrent pterygium exclusion criteria: * less than 15 year of age * symblepharon * glaucoma, * ocular allergy * ocular surface disorders

Keywords: amniotic membrane conjunctival autograft recurrent pterygia compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia
impact of capsular tension ring implantation on intraocular lens position

Conditions: Cataract; High Myopia

Summary: this is a randomized controlled trial to investigate the effect of capsular tension ring (ctr) implantation on intraocular lens (iol) tilt and decentration in cataract patients with high myopia.

exact positioning and alignment of the iol with the visual axis are the prerequisites of high-quality visual performance after cataract surgery. a certain degree of iol tilt and decentration occur after uneventful cataract surgery, most of which are clinically tolerant. however, the relatively large capsular bag volume, zonular weakness, and vitreous liquefaction in cataract patients with high myopia may increase the iol position instability, such as tilt, decentration and even dislocation, leading to the deterioration of visual function. thus, how to improve the long-term stability of iol position in high myopic cataract patients is an urgent issue to be addressed. previous studies have shown that ctr implantation during cataract surgery can increase the iol stability in patients with normal axial length; however, its impact on iol position of cataract patients with high myopia remains unclear. in this randomized clinical trial, patients who meet the inclusion criteria will be divided into three layers according to the axial length: (1)26mm≤al\<28mm (2)28mm≤al\<30mm (3)al≥30mm we are going to recruit 186 patients in total, with 62 patients in each layer. patients on each layer will be randomly divided into experimental group (ctr implantation) and control group (only iol implantation). if both eyes of a patient meet the inclusion criteria, only the first operated eye is included in the statistics analysis. all included patients will be followed up at 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. visual acuity, iol tilt, iol decentration, posterior capsule attachment with iol, anterior capsule contraction, posterior capsular opacification, and visual quality will be measured and compared between the experimental group and the control group at different timepoints.

Eligibility criteria:
inclusion criteria: 1. \> 18 years old; 2. axis length≥26mm; 3. visually significant cataract; 4. the patient is willing and able to complete all necessary follow-ups and examinations. exclusion criteria: 1. intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.; 2. other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.; 3. history of intraocular surgery; 4. severe systemic diseases: such as severe hypertension, diabetes, heart disease, alzheimer's, parkinson, etc.; 5. any condition that the study physician considers to be an impediment to the clinical trial.
school-based physical education program and its effects on motor fitness in malaysian children

Conditions: Physical Fitness; Child Development; Exercise Intervention; Childhood Obesity; Physical Inactivity in Children

Summary: the objective of this randomized controlled trial was to compare the effects of a standard school physical education program (spep) and a rhythmic and gymnastic activities-based school physical education program (rgpep) on the physical and motor fitness parameters of malaysian primary school children.

this randomized controlled trial evaluates the impact of two distinct physical education programs on the physical and motor fitness of malaysian primary school children. the intervention group participates in a rhythmic and gymnastic activities-based physical education program (rgpep), designed to enhance balance, coordination, flexibility, and agility through structured, progressive activities. the control group follows the standard school physical education program (spep) in line with the national curriculum, which emphasizes general fitness and physical activity without specific rhythmic or gymnastic components.

Eligibility criteria:
inclusion criteria: * children aged 8 years at the time of enrollment. * both boys and girls. * regular school attendance during the academic year. * no diagnosed health conditions or chronic diseases that could interfere with physical activity. * not involved in extracurricular sports activities outside the school environment. * not engaged in extra traveling to and from school on foot or by bicycle. * parents or legal guardians provided written informed consent. * the child provided verbal assent to participate in the study. exclusion criteria: * children missing more than 20% of scheduled physical education classes. * overweight children with a bmi ≥ 23 kg/m². * underweight children with a bmi \< 18.5 kg/m². * children involved in regular sports training or participation in extracurricular sports activities during the intervention period. * children with any pre-existing medical conditions or injuries that could limit participation in physical activities. * children with developmental or motor impairments affecting their ability to perform the required fitness activities. * children on any medication that could interfere with their performance or physical fitness evaluation.

Keywords: physical education motor fitness exercise program