Kornimate/medical-research-clean huggingface dataset:
priming effects of ultra-high frequency quattro pulse transcranial brain stimulation prior to hand motor function training in children with unilateral spastic cerebral palsy

Conditions: Cerebral Palsy, Spastic; Transcranial Magnetic Stimulation, Repetitive

Summary: unilateral spastic cerebral palsy (uscp) leads to life-long impairment with a hemiparesis of the affected side of the body. rehabilitation efforts combine evidence based methods such as constrained induced movement therapy (cimt) or hand-arm bimanual intensive therapy (habit) as well as training in daily life activities and psychological support in order to improve participation. it has been tried to enhance hand motor function trainings with non-invasive brain stimulation. however, evidence of this promising approach is limited. this might be due to a non-consideration of the individually different types of cortico-spinal projections to the paretic hand that demonstrated to be of highly relevant for the therapy of these children. approximately one third of such patients control their paretic hands via crossed projections from the affected hemisphere (contra), while one third uses ipsilateral projections from the contralesional hemisphere (ipsi). this study aims - for the first time - to enhance the effects of the training by priming the primary motor cortex (m1) of the paretic hand with a newly established high frequency quadri-pulse theta burst stimulation (qtbs) in a randomized, patient and evaluator blind, sham-controlled approach, for the first time taking the individual type of cortico-spinal reorganization (contra vs ipsi) into account. this promising and neurophysiologically motivated approach is likely to ameliorate hand function in children with uscp.


Eligibility criteria:
inclusion criteria: 1. assured diagnosis of uscp. 2. children aged 6 to 18 years with uscp 3. dated and signed informed consent of legal guardian, informed assent from minor exclusion criteria: 1. therapy refractory epilepsy 2. seizures within the last 2 years 3. more than 1 anti epileptic drugs 4. implanted shunt system 5. if singular primary motor cortex cannot be identified by tms, e.g. because of bilateral cortico-spinal reorganization or resting motor threshold above 80% maximum stimulator output (mso) 6. severe mental retardation 7. psychiatric diseases 8. pregnancy 9. uncooperative patients

Keywords: unilateral spastic cerebral palsy cortico-spinal reorganization transcranial magnetic stimulation sham-controlled trial intensive hand function training
efficacy of topical mitomycin c for complex benign esophageal anastomotic strictures

Conditions: Esophageal Stenosis; Anastomotic Stenosis

Summary: this study evaluates mitomycin c as treatment for dysphagia in adult subjects with documented complex esophageal anastomotic strictures. patients will be randomized in a double-blinded fashion to topical application of normal saline (ns) or mitomycin c (mmc) at the time of time of index procedure.


Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign a written informed consent and hipaa consent document * patients must have symptomatic (dysphagia ≥2), treatment naïve complex esophageal anastomotic stricture (length \>2 cm or diameter ≤9mm). * age ≥ 18 * esophago-gastro or esophago-jejunal anastomosis with or without having undergone neoadjuvant or adjuvant radio-chemotherapy * any patient taking antiplatelet agents such as plavix, effient, brilinta, aggrenox must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation. * any patient on vitamin k antagonists such as warfarin must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation. inr should be checked for such patients at least 24 hours before dilation and it must be \< 1.5 * patients taking direct thrombin inhibitors such as pradaxa, angiomax must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation * patients taking factor xa inhibitors must be able to hold the drugs 2 days prior to dilation and may resume 3 days after dilation * patients taking giib/iiia inhibitors must be able to hold the drugs1 day prior to dilation and resume 3 days after the dilation. * patients taking unfractionated heparin must be able to hold the drug 6 hours before dilation and low molecular weight heparin must be held 24 hours before dilation. unfractionated heparin may resume immediately after the dilation while low molecular weight heparin may resume 3 days after dilation exclusion criteria: * patients with malignant strictures * patients with non-complex benign strictures. * patients with anastomosis creation within ≤ 2 weeks * patients with suspected gastrointestinal perforation or leak that could result in extraluminal extravasation of mitomycin c * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant or breast feeding. refer to section 4.4 for further detail. * patients receiving systemic chemotherapy during the treatment of esophageal stricture.

Keywords: complex
a study to investigate progression-free survival with sonrotoclax plus obinutuzumab or sonrotoclax plus rituximab compared with venetoclax plus rituximab treatment in patients with relapsed and/or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (celestial-rrcll)

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: the goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (r/r) chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll). the study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with r/r cll/sll. the safety of these treatments will also be assessed.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cll/sll that meets the international workshop on chronic lymphocytic leukemia (iwcll) criteria * received one or more prior therapies for cll/sll. for each line of therapy, participants must have received at least 2 cycles of the therapy * participants with prior bcl2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last bcl2i intake * eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2 * adequate organ function exclusion criteria: * known active prolymphocytic leukemia or currently suspected richter's transformation * prior autologous stem cell transplantation or chimeric antigen receptor t-cell therapy within 3 months before first dose of study drug * prior allogeneic stem cell transplant with active graft-versus-host disease (gvhd), requiring immunosuppressive drugs for treatment of gvhd, or have taken calcineurin inhibitors within 4 weeks prior to consent * known central nervous system involvement by cll/sll * severe or debilitating pulmonary disease * clinically significant cardiovascular disease note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: b-cell lymphoma 2 inhibitor (bcl-2i) cll-rr1 german cll study group
effects of aromatherapy massage on lactation in non-breastfeeding mothers with premature newborns in neonatal intensive care unit

Conditions: LACTATION IN MOTHERS WITH PREMATURE NEWBORNS

Summary: this study was planned as a randomized controlled experimental study to investigate the effects of aromatherapy massage on lactation in non-breastfeeding mothers with premature newborns in neonatal intensive care unit. the population of the research, was consisted of all mothers who gave birth preterm in a city hospital in istanbul between october 2022- april 2023. the sample of the study included a total of 36 mothers (18 in aromatherapy group, 18 in the massage group) who were randomly selected among the mothers who were over 18 years of age, had preterm (\<37 weeks) cesarean section, had a single pregnancy, were on the first postpartum day, were asked to express their milk because of the baby's condition, and volunteered to participate in the study. the data of the study were collected with participant characteristics form, depression-anxiety-stress scale (das-21), lactation onset symptoms evaluation form, milking follow-up form and visual analog scale (vas) satisfaction evaluation form. the participant characteristics form and the depression anxiety stress scale were administered to all mothers within the first 6-8 hours post-operatively, and manual milking training was given. for three days, twice a day (15 minutes each), aromatherapy massage was applied with a mixture of lavender, fennel and frankincense essential oils in almond oil as a carrier oil, while mothers in the massage group were only massaged with almond oil, which is only the carrier oil. lactation symptoms were evaluated after the massage in both groups and the expressed milk amount was recorded after milking both breasts for at least 15 minutes. in addition, all mothers expressed their milk 8 times a day and recorded the total amount of milk in 24 hours. after the last application, their satisfaction with the application was evaluated with vas. descriptive statistical methods, chi-square, mann whitney and friedman tests were used to evaluate the data.


Eligibility criteria:
inclusion criteria: * the mothers who were over 18 years of age, had preterm (\<37 weeks) cesarean section, had a single pregnancy, were on the first postpartum day, were asked to express their milk because of the baby's condition, and volunteered to participate in the study. exclusion criteria: * those with breast problems, * who have allergic reaction to aromatherapy oils, * using supplements for milk production, * those who do not like aromatherapy oils or massage * mothers who do not want to continue tthe study, * developing postpartum health problems * and mothers who cannot adapt to manual milking

Keywords: aromatherapy massage lactation breastfeeding
clinic study of 18f-al-nota-prgd2 in cancer diagnostics

Conditions: Tumors; Carcinoma, Bronchogenic; Breast Carcinoma; Cancer of Head and Neck; Lymphoma, Malignant; Soft Tissue Neoplasms

Summary: the purpose of this study is to determine whether 18f-al labeled rgd is safety and effective for cancer diagnosis and therapy response.

observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.

Eligibility criteria:
inclusion criteria: 1. volunteers or patients with age more than 18 yeas; 2. the patients have been diagnosed with cancer or suspected with cancer; 3. it must fulfill the ethical requirements and subjects have signed an informed consent. exclusion criteria: 1. pregnancy or nursing mothers; 2. having drugs or alcohol dependence; 3. hypersensitive to the active or inactive ingredients of the study drug; 4. having attended other drug clinical trials within three months; 5. cardiac functional insufficiency; 6. hepatic and renal function insufficiency; 7. hypertensive patients with serious complications; 8. endangering the safety of life.
effect of medium chain fatty acids on cognitive function during acute hypoglycemia in patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: at present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. the aim of this study is to determine whether the human brain is able to use medium chain fatty acids (mcfa) and/or their metabolites as an alternative fuel source during acute hypoglycemia in patients with type 1 diabetes mellitus (t1dm). the hypothesis is that medium chain fatty acids will provide a rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during episodes of hypoglycemia (low blood sugar.)

twelve subjects between the ages of 18 years and 55 years who have had type 1 diabetes mellitus for more than five years and have had tight control of their diabetes as determined by screening blood work will be invited to participate. each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) in these hypoglycemic clamp studies, cognitive testing will be performed during 90 minutes of normal blood glucose followed by 90 minutes of hypoglycemia. during the hypoglycemic period, either the mcfa or a placebo will be administered. each subject will experience both conditions. the order in which the mcfa is given will be randomized.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for greater than 5 years (c-peptide negative) * age 18-55 years * subject is on intensive insulin therapy resulting in a hemoglobin a1c of less than 7.5% * history of frequent hypoglycemic events as defined as having at least one blood glucose of less than 60 mg/dl in the last four weeks exclusion criteria: * history of hypoglycemia induced seizures * pregnancy * significant baseline anemia (hemoglobin \< 11.0g/dl or hematocrit \< 33%) * a history of liver cirrhosis or porto-caval shunt surgery

Keywords: diabetes mellitus, type 1 medium chain fatty acid hypoglycemia
evaluating the use of thromboelastography to diagnose coagulopathy after traumatic brain injury

Conditions: Traumatic Brain Injury; Coagulation Disorder

Summary: the investigators will obtain thromboelastography (teg) on pediatric patients admitted to the rady children's hospital icu after traumatic brain injury on admission to our icu and after 24 hours of care. the investigators hypothesize that teg will identify abnormalities of coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time (pt), activated partial thromboplastin time (aptt), and international normalized ratio (inr).


Eligibility criteria:
inclusion criteria: * less than 15 years of age * evidence of intracranial bleed on ct scan or gcs \<12 exclusion criteria: * no intracranial hemorrhage or * gcs 13 - 15
treatment of balance disorders in parkinson's patients using spoton balance glasses

Conditions: Parkinson Disease

Summary: an open-label study to evaluate the effect of spoton balance glasses in non-demented parkinson's patients with balance disorders.


Eligibility criteria:
inclusion criteria: 1. female or men 2. diagnosed with parkinson's disease (according to brain bank uk criteria) 3. non-demented 4. age: ≥ 30 years 5. gait disturbances 6. patients who are able to perform questionnaires and physical tests (including computerized tests) 7. gave informed consent for participation in the study exclusion criteria: 1. unstable (less than 1 month) use of concomitant medications that might affect the balance system 2. change of pd medications during the past month 3. any medical condition or disorder that could produce gait or balance disturbances unless well controlled for at least 3 months 4. blindness 5. currently taking part in a clinical trial or within 30 days prior to screening 6. any known condition which in the opinion of the investigator may impair gait or balance and/or limits the successful trial completion
an open label study of itacitinib administered orally in patients with myelofibrosis

Conditions: MPN (Myeloproliferative Neoplasms)

Summary: this is a study of itacitinib (incb039110) in patients with myelofibrosis. this study will evaluate safety and efficacy parameters of itacitinib (incb039110).


Eligibility criteria:
inclusion criteria: * must be diagnosed with pmf, ppv-mf or pet-mf as confirmed by bone marrow biopsy. * must score at least 1 point on the dynamic international prognostic scoring system (dipss) for prognostic risk factors and have peripheral blast count \<10% at both screening and baseline hematology assessments. * subjects must discontinue all drugs used to treat underlying mf disease no later than day -14. * subjects must have hemoglobin value \>/= 8.0g/dl and be willing to receive blood transfusions, have a platelet count \>/=50x10\^9/l and absolute neutrophil count (anc) \>/= 1x10\^9/l. * subjects must have palpable spleen or history of splenectomy * active symptoms at the screening visit exclusion criteria: * women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively. * subjects with impaired liver function, end stage renal disease on dialysis or clinically significant concurrent infections requiring therapy. * subjects with unstable cardiac function or invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.

Keywords: primary myelofibrosis pmf post polycythemia vera fibrosis ppv-mf post essential thrombocythemia myelofibrosis pet-mf
non randomized humerusshaft fracture

Conditions: Humerusshaft Fractures

Summary: the aim of the study is to radiologically compare the fracture healing as well as the functional treatment outcome of conservative and operative treatment of defined humerusshaft fractures after 6w./12w./and 12 month based on the modified "constant score".

radiologically compare the fracture healing as well as the functional treatment outcome of conservative and operative treatment of defined humerusshaft fractures after 6w./12w./and 12 month based on the modified "constant score".

Eligibility criteria:
inclusion criteria: * over age 16 * fracture according to ao classifications 12a2, 12a3, 12b2 * have to be available for the fu's exclusion criteria: * open fractures * polytraumatized patients * multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing * pseudoarthrosis * pathological and refractures

Keywords: fractures humerus conservative treatment operative treatment
a powered ankle foot rehabilitation orthosis

Conditions: Stroke; Ankle Injuries

Summary: ankle rehabilitation training becomes a tough question for the patients with ankle joint injuries especially with the hemiplegia after stroke. here a novel powered ankle foot orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric motor is proposed in this paper. the mechanical structure of the orthoses includes wearing parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. this study provides a new method for ankle foot orthoses design and has great significance for ankle rehabilitation.


Eligibility criteria:
inclusion criteria: * ankle joint injuries about dorsiflexion and plantar flexion * ability to keep balance independently exclusion criteria: * ankle joint injuries about varus and valgus rehabilitation * two assistants needed while walking

Keywords: powered ankle-foot orthosis mechanical structure optimization dorsiflexion plantar flexion gait servomotor ankle rehabilitation
multi-center clinical evaluation of two reusable soft contact lenses

Conditions: Myopia

Summary: the purpose of this study is to compare the subjective performance of comfilcon a lens against samfilcon a lens after 4 weeks of reusable lens wear.

this will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon a versus samfilcon a lenses over 8 weeks of daily wear (2 x 4-weeks). both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. subjects will be masked to lens type and investigators will be masked to the lens codes.

Eligibility criteria:
inclusion: * spherical distance contact lens prescription between -1.00 and -6.00d or +1.00 to +4.00d in both eyes (inclusive) * adapted soft contact lens wearers (i.e. \>1 month), daily disposable and reusable lens wearers. * spectacle cylinder 0.75d in both eyes. * correctable to 6/9 (20/30) in both eyes * be between 18 and 50 years of age (inclusive) * able to read, comprehend and sign an informed consent * own a mobile phone and be willing to respond to short message service (sms) survey * willing to comply with the wear and study visit schedule exclusion: * existing biofinity or ultra wearers * any active corneal infection, injury or inflammation * systemic or ocular allergies, which might interfere with contact lens wear * systemic disease, which might interfere with contact lens wear * ocular disease, which might interfere with contact lens wear * strabismus or amblyopia * subjects who have undergone corneal refractive surgery * subjects with keratoconus or other severe corneal irregularity contraindicating lens wear * pregnant or lactating * use of systemic/topical medication contraindicating contact lens wear * diabetic * site employees or family members of site employees
phase 3 study of alxn1850 in pediatric participants with hpp previously treated with asfotase alfa

Conditions: Hypophosphatasia

Summary: the primary purpose of this study is to assess the safety and tolerability of alxn1850 versus asfotase alfa in pediatric participants with hpp previously treated with asfotase alfa.


Eligibility criteria:
inclusion criteria: * diagnosis of hpp documented in the medical records * presence of open growth plates by x-ray during screening period * tanner stage 2 or less during the screening period * must have been treated with 6 mg/kg/ week of asfotase alfa via sc injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6 months before day 1. note: participants currently treated with 9 mg/kg (eg, 3 mg/kg 3 times per week) will not be allowed in the study. exclusion criteria: * history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the investigator. * diagnosis of primary or secondary hyperparathyroidism * hypoparathyroidism, unless secondary to hpp * any new fracture within 12 weeks before day 1 (excluding pseudofractures) * planned surgical intervention which may impact the results of study assessments (in the opinion of the investigator) during the randomized evaluation period * history of allergy or hypersensitivity to any ingredient contained in asfotase alfa or alxn1850 * body weight \< 10 kg during the screening period

Keywords: hypophosphatasia hpp asfotase alfa alxn1850