Kornimate/medical-research-clean huggingface dataset:
a long-term follow-up study of participants with sickle cell disease or transfusion dependent β-thalassemia who received edit-301

Conditions: Sickle Cell Disease; Transfusion-dependent Beta-Thalassemia; Hemoglobinopathies

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of edit-301 in participants with severe sickle cell disease (scd) or transfusion-dependent β-thalassemia (tdt) who have received edit-301.

this is a non-interventional, multicenter study evaluating the long-term safety and efficacy of edit-301 in participants with severe sickle cell disease (scd) or transfusion dependent b-thalassemia (tdt) who received edit-301 in parent studies em-scd-301-001 (nct04853576) or edit-301-bthal-001 (nct05444894). no investigational drug product will be administered in the ltfu study.

Eligibility criteria:
inclusion criteria: * participant must have received an edit-301 infusion as part of a clinical study. * participant or legal representative/guardian (if applicable) must sign and date the informed consent form (icf) or assent, if applicable for this long-term follow-up study. exclusion criteria: * participant is still actively enrolled in an edit-301 treatment study and has not yet met eligibility for long term follow-up in this study.

Keywords: sickle cell disease sickle cell anemia sickling disorder due to hemoglobin s beta-thalassemia thalassemia major thalassemia intermedia hemoglobinopathies crispr-cas12a autologous cd34+ genetic diseases, inborn hematologic diseases anemia anemia, hemolytic, congenital anemia, hemolytic
radiation therapy in treating patients with stage ii or stage iii oropharyngeal cancer

Conditions: Head and Neck Cancer; Radiation Toxicity

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. purpose: phase i/ii trial to study the effectiveness of radiation therapy in treating patients who have stage ii or stage iii oropharyngeal cancer.

objectives: * assess target coverage and major salivary gland sparing in patients with stage ii or iii oropharyngeal cancer treated with intensity-modulated radiotherapy. * determine the nature and prevalence of acute and late side effects of this treatment in these patients. * determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment. outline: this is a multicenter study. patients receive 3-d conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: approximately 57-64 patients will be accrued for this study over 27 months.

Eligibility criteria:
disease characteristics: * histologically proven stage ii or iii (t1-t2, n0-n1) squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or palate) * lymph nodes in both sides of neck at risk of metastatic disease and require radiotherapy * patients upstaged by imaging to n2 are eligible * measurable or evaluable disease * greater than 1 cm in one dimension or with necrotic regions if by ct or mri scan * surgery of the primary tumor or lymph nodes limited to incisional or excisional biopsies * no distant metastases patient characteristics: age: * over 18 performance status: * zubrod 0-1 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no active untreated infection * no other malignancy within the past 5 years except nonmelanoma skin cancer or a carcinoma not of head or neck origin * no concurrent major medical or psychiatric illness that would preclude study prior concurrent therapy: biologic therapy: * not specified chemotherapy: * more than 3 months since prior chemotherapy * no concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * no prior head or neck radiotherapy surgery: * see disease characteristics other: * no other concurrent treatment for head and neck cancer * no prophylactic amifostine or pilocarpine

Keywords: stage ii squamous cell carcinoma of the oropharynx stage iii squamous cell carcinoma of the oropharynx radiation toxicity
assess extent of agreement between online 24-hr dietary recall and interviewer-administered 24-hr dietary recall on the same day for 2 non-consecutive 2 days 1 wk apart to adults and school age children

Conditions: Dietary Habits

Summary: hypothesis: the online 24 hour dietary recall will be comparable to interviewer-administered 24 hour dietary recall considering the limits of agreement in the reporting of energy and macronutrient intake. if the two methods of dietary assessment are comparable (i.e., if greater than 95% of the data plots will lie within the limits of agreement), the online dietary assessment tool could be used in future studies to collect dietary intake data and health data in larger sets of russian populations, in order to investigate the potential differences in anthropometric risk factors of non-communicable diseases (cancers, diabetes, obesity, hypertension, mortality, etc.) in people with different diet.

baseline assessments include a demographic questionnaire, including anthropometrics (height, weight), a heath status questionnaire, supplement intake, eating habits, and a food frequency questionnaire, and cardiovascular assessment (blood pressure and heart rate).

Eligibility criteria:
inclusion criteria: 1. participants will be male and female. 2. 7-65 years of age. 3. must be willing and able to record (via online questionnaire) the prior day's food intake according to the protocol. 4. understanding of the procedures to be undertaken as part of the study. 5. willingness to participate in research measurement and follow instructions provided by the investigator. 6. informed, voluntary, written consent to participate in the study. exclusion criteria: 1. currently have any disease or condition that required chronic therapeutic nutritional treatment (the use of specific nutrition services to treat an illness, injury, or condition). 2. currently dieting (currently on a diet to lose weight; currently on a diet for health reasons; currently on a diet to gain weight). 3. have any formal training in nutrition, or had prior experience completing dietary recalls. 4. participant is unable to complete computer-based dietary questionnaires, through a mental, physical or visual limitation that would preclude him/her from reporting their dietary intake.

Keywords: 24-hr dietary recall
rct: impact of preop video on patient preparedness for surgery

Conditions: Prolapse

Summary: this is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical trial at one institution evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient-centered outcomes. the aim of this study is to determine the impact of a preoperative patient educational video as an adjunct to the routine preoperative visit on patients' preparedness for surgery, perception of time spent with their healthcare team, and ultimately their satisfaction after surgery. the aim of this video is not to limit the doctor patient interaction (as all patients will still be granted their pre-allotted 30 minute visit with the physician regardless of their intervention allocation) but rather to augment the visit with additional educational information in an attempt to optimize the visit. objective: a. primary aim(s): • to determine if patients feel more prepared for surgery with addition of preoperative patient education video b. secondary aim(s): * to determine if addition of preoperative patient education video correlates with improved patient satisfaction after surgery * to determine if patients' perception of time spent with healthcare team in preparation for surgery increases with addition of patient educational video * to determine if actual patient-physician time spent counseling differs between groups * to determine if patient preparedness is correlated with objective surgical outcomes * to determine if patient preparedness is correlated with patient symptom improvement scores after surgery hypothesis: the addition of a preoperative patient education video enhances patient preparedness for surgery, increases perception of the amount of time patients spend with healthcare team, and improves patient satisfaction.


Eligibility criteria:
inclusion criteria: * women \>18 scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy * it is acceptable if concomitant procedures such as suburethral slings or additional vaginal repairs are planned * english speaking * willing and able to provide written and informed consent exclusion criteria: * women \<18 * not scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy * non-english speaking * unable or unwilling to provide written and informed consent

Keywords: preoperative counseling patient satisfaction prolapse sacrocolpopexy
motor representations in orthopedic patients

Conditions: Orthopedic Disorder; Motor Disorder; Perceptual Disorders

Summary: the aim of this study is to investigate the possible effects that a motor limitation at the peripheral level might have on the ability to visually discriminate others' actions. previous literature has shown that specific motor skills (motor expertise) facilitate the visual discrimination of domain-specific actions, and that these motor experts' superior abilities might be mediated by areas not only responsible for the visual recognition of movements (as it happens in non-expert subjects) but also involved in motor planning. similarly, impairment in the motor system due to neurological damage modulates not only the ability to perform movements but also the ability to discriminate and predict the temporal course of observed actions. based on these findings, it has been hypothesized that the motor representations of gait, despite being a hyper-learned motor pattern, might be subjected to modification as a result of an impairment of walking caused by a peripheral functional limitation in the lower limbs as the one characterizing orthopaedic patients who underwent a surgical operation for total knee arthroprosthesis. in this protocol, patients are thus required to perform visual discrimination tasks based on the observation of movements performed with either the upper or lower limbs, and their performance is expected to correlated with their functional impairments in movement execution. these results would indicate that the (in)ability to perform a movement might have an impact on its representation at the central level and on internal motion simulation capabilities, which also influence the ability to visual discriminate others' actions through action-perception transfer: this would suggest that rehabilitation in orthopaedic patients should take into account (and restore) such a central impairment in motor representations.


Eligibility criteria:
inclusion criteria: * participants must be able to understand instructions and have no history of neurological or psychiatric disorders. exclusion criteria: * history of neurological or psychiatric disorders.
comparison of 2 ovarian stimulation protocols for women with low ovarian reserve

Conditions: Infertility

Summary: the purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. number of mature eggs, number of embryos as well as pregnancy rates will be compared.

a prospective randomized trial will be carried out. the minimal stimulation (ms) protocol is based on low dose letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the letrozole at 150 units per day. gnrh antagonist wil be introduced to avoid premature lh surge when one or more of the growing follicles reached approximately 14 mm in size. the high dose stimulation protocol is based on high dose of gonadotropins (≥300 iu/day) throughout the cycle with the usage of gonadotropin-releasing hormone (gnrh) antagonist to avoid premature luteinizing hormone (lh) surge as described above.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of poor responder to ovarian stimulation exclusion criteria: * patients undergoing pregestational diagnosis (pgd) * patients using donor eggs

Keywords: low ovarian reserve poor responder infertility
treatment for hbv-mn patients in chinese: an open parallel controlled trial

Conditions: Proteinuria; HBVe-antigen

Summary: lamivudine treatment for hbv-dna negative hbv-gn patients.

lamivudine and predinisone treatment for hbv-dna negative hbv-gn patients.

Eligibility criteria:
inclusion criteria: * adult hbv-gn patients with biopsy-proven mn, heavy protinuria, hbsag or hbeag positive, hbv-dna negative exclusion criteria: * primary mn patients, hbv-dna positive

Keywords: remission of proteinuria hbve-antigen
sensory reeducation in peripheral nerve injuries of hand

Conditions: Median Nerve Disease; Ulnar Nerve Disease; Peripheral Nerve Disease

Summary: objectives: to develop a protocol for early treatment using sensory reeducation through the mirror after surgical reconstruction of the median nerve and / or ulnar hand, and its comparison with the evolution of the return of skin sensitivity after a not early rehabilitation which will be conducted by physiotherapists, with blinding of the evaluators.

changes in the cerebral cortex begins soon after peripheral nerve injury resulting in overlapping cortical areas on adjacent as a result of the absence of stimuli in the area of cortical representation of the injured nerve. sensibility reeducation is a process of reprogramming the brain through a progressive learning proposing feed the somatosensory cortex with alternative stimulus to preserve the cortical map of the hand and facilitate the sensory recovery. this study is based on the hypothesis that sensory reeducation starting in the first days after surgery by training with the mirror promotes greater preservation of the cortical map of the original hand, with better functional results. we also believe that sensory reeducation performed early with the mirror will enhance the return of sensibility, emphasizing functional reorganization with less alteration of the cortical map of the hand. metodology: will be included patients over 18 with injury of the median and/or ulnar nerve at the first week after surgery. patients will be randomized into an early group with the use of mirror and a classic group of sensory reeducation. in evaluating the rosen score will be used with motor, sensory and pain/discomfort components. the assessment instruments used were: semmes weinstein monofilaments, jamar® and pinch gauge® dynamometer, goniometry, shape and texture identification (sti), sollerman test, disabilities of the arm, shoulder and hand questionnaire (dash), two points discriminator and numeric pain scale.

Eligibility criteria:
inclusion criteria: * patients over 18 years * male or female * reconstruction of peripheral nerve or ulnar median * primary or secondary graft through the hospital of the medical school of ribeirão preto, university são paulo * possible associated tendon and skin lesions * flexor zones i, ii, iii, iv or v. exclusion criteria: * nerve damage that may associated with multiple complex lesions, bone or joint injuries * presence of central nervous system injury * chronic diseases metabolic and degenerative rheumatic diseases, leprosy and diseases affecting the peripheral nervous system.

Keywords: peripheral nerve injury sensory reeducation brain plasticity training with a mirror rehabilitation
ori2 : ori for hyperoxia reduction in icu

Conditions: Intensive Care Units

Summary: recently, hyperoxia has been recognized as being potentially deleterious for critically ill patients, with increased duration of mechanical ventilation and even with increased mortality rates. this could be related to pulmonary lesions (including notably atelectasis) but also to increased tissue damage and organ dysfunctions, secondary to increased/induced oxidative stress. at last higher fio2 led to "over-consumption" of oxygen and therefore to additional costs. usually, fio2 and oxygen flows are modified according to the monitoring of spo2. but, it has also been recognized that modifying fio2 (and oxygen flows) according to spo2 monitoring is not routinely (or easily) done. indeed, nurses (and doctors) are reluctant to reduce oxygen flows when everything appear under control. the ori (oxygen reserve index) is an index measured using non-invasive spo2 sensors (rainbow sensors- masimo) that evaluates non-invasively pao2 (partial pressure of oxygen). an ori ≤0 indicates that pao2 is less than 100 mmhg. when ori increases (i.e. ori≥0.01) pao2 is higher than 100 mmhg. this index increases up to 1. ori between 0.01 and 1 indicates that pao2 is probably between 100 and 200 mmhg. thus, monitoring critically ill patients using the ori, may help identifying when pao2 is high and when fio2 (or oxygen flows in non-intubated patients) may be reduced. this could help reducing the time with hyperoxia (i.e. pao2 ≥100 mmhg or ≥80 mmhg). the purpose of this feasibility study is to evaluate if the use of ori can help to decrease length of moderate hyperoxia (pao2\>100mmhg) in critically ill patients, in comparison with monitoring the spo2 only.


Eligibility criteria:
inclusion criteria: * patient hospitalized in icu of angers hospital * patient intubated and mechanically ventilated for an expected period of at least 2 days inclusion is to achieve within 6 hours after admission (for admitted patients intubated ) or at the time of intubation (for non- intubated patients on admission ) exclusion criteria: * pregnant woman

Keywords: hyperoxia mechanical ventilation oxygen reserve index
clinical efficacy of exosome in degenerative meniscal injury

Conditions: Knee; Injury, Meniscus (Lateral) (Medial); Meniscus Tear; Meniscus Lesion; Meniscus; Degeneration; Meniscus; Laceration; Meniscus Injury, Tibial; Knee Injuries; Knee Pain Swelling; Arthralgia

Summary: comparison of intra-articular administration of synovial fluid-derived mesenchymal stem cells-derived exosomes with synovial fluid-derived mesenchymal stem cells on the same patient.

mesenchymal stem cell-derived exosomes will be developed and patented as an advanced technology platform as an autologous treatment protocol to repair damaged cartilage tissue. the fact that this treatment is obtained from an autologous source will significantly contribute to the literature in the field of personalized therapy (personalized medicine) and will pave the way for discoveries. experiences from clinical trials may guide the use of msc exosomes in other tissue and cell damaged pathologies and immune pathologies or chronic inflammatory diseases. this study was supported by a grant (1004, 20ag031) from the scientific and technological research council of turkey (tubitak).

Eligibility criteria:
inclusion criteria: * accepting the informed consent form * degenerative meniscus damage grade 1, 2 or 3 on mri in both right and left knees, and also the patient does not want surgical treatment * patients with the same degenerative meniscus grade in both knees * patients with ongoing pain * patients without a history of malignancy * absence of signs of unstable meniscus tear such as snagging or locking * patients with stage 0, 1 or 2 gonarthrosis according to kellgren-lawrence gonarthrosis staging * patients without lower extremity malalignment exclusion criteria: * patients whose treatment method was explained and who did not accept the method * patients outside the working-age range * congenital lesion * patients requiring surgical treatment (e.g. bucket handle tear and locked knee) * active inflammatory or connective tissue disease is thought to affect the patient's pain (eg lupus, rheumatoid arthritis, fibromyalgia) * local or systemic infection * pregnant or breastfeeding women * active endocrine disorder that may affect the assessment of patient's pain (eg, hypothyroidism, diabetes) * active neurological disorder that may affect the assessment of the patient's pain (eg, peripheral neuropathy, multiple sclerosis) * active heart disease * presence of a pacemaker * conditions where mr-i is contraindicated * patients with stage 3 or 4 gonarthrosis according to kellgren-lawrence gonarthrosis staging * patients with lower extremity malalignment * patients with signs of unstable meniscus tear such as snagging or locking

Keywords: meniscal injury exosome mesenchymal stem cell synovial fluid regeneration
safety and tolerability study of rbet v1 slit tablets

Conditions: Birch Pollen-Related Rhinoconjunctivitis; Rhinitis, Allergic, Seasonal

Summary: the purpose of this study is to determine the safety and tolerability of several doses of r bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.


Eligibility criteria:
inclusion criteria: * written consent * male or female subject from 18 to 60 years old and in general good health * for woman of child bearing potential: * symptoms of birch pollen induced allergic rhinitis for at least the last 2 years. * sensitisation to birch pollen as demonstrated with a positive spt to birch pollen and specific ige level (birch pollen and r bet v1) \>0.70 ku/l at screening. * fev1 at least of 80% of predicted values at screening. * subject accepting to comply fully with the protocol. exclusion criteria: * past or current disease which as judged by the investigator, may affect the outcome of this study. * history of life-threatening asthma, * asthma requiring daily treatment (whatever the pharmaceutical class). * pregnant or lactating woman. * subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit. * subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study. * symptoms during the treatment phase due to a sensitivity to a second allergen. * subjects treated with ongoing immunotherapy with another allergen

Keywords: rbet v 1 birch pollen allergy sublingual immunotherapy