Kornimate/medical-research-clean huggingface dataset:
effect of hand arm bimanual intensive technique including lower extremity (habit-il) on hemiplegic cerebral palsy

Conditions: Hemiplegic Cerebral Palsy

Summary: the aim of this study is to determine the functional status of upper extremity using habit \& habit-ile. and to compare the effects of habit with and without lower extremity technique on functional status of hemiplegic cerebral palsy

hemiplegic cerebral palsy children have impairments in bimanual coordination above and beyond their unilateral impairments .hand-arm bimanual intensive therapy tends to show a constructive impact on hand function in children with hemi paretic cerebral palsy. hand-arm bimanual intensive therapy (habit) designed for children with unilateral cp, which when combines bimanual upper extremity training with activities involving the trunk and lower extremities making it habit-ile. a bimanual training program that continuously focusses on postural control and lower limb functional activity is all covered in habit-ile hand-arm bimanual intensive therapy including lower extremities (habit-ile) involves the concepts of motor skill learning and intensive training to both the ue and le. however it is not known that whether combined upper and lower extremity training in an intensive protocol is more efficacious or not thus rationale of this study would be to figure out that if an intensive protocol is devised involving upper and lower extremities both would it be more product full or not. this study would be significant in a way that we know cerebral palsy is a lifelong challenging condition for both children and their caregivers thus new and emerging treatments can be fruitful for progression.

Eligibility criteria:
inclusion criteria: * diagnosed cases of hemiplegic cerebral palsy * gmfcs level 2,3,4 * ashworth scale 0-2 exclusion criteria: * history of recent orthopedic surgery * history of seizures * visual impairment

Keywords: hand arm bimanual intensive technique hemiplegic cerebral palsy functional status
abt-888 and temozolomide for liver cancer

Conditions: Hepatocellular Carcinoma

Summary: this study is for people with liver cancer (also called hepatocellular carcinoma, or hcc in abbreviation). the purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, abt-888 and temozolomide for patients with liver cancer. temozolomide acts by damaging deoxyribonucleic acid (dna) in rapidly dividing cells, in other words, cancer cells. abt-888 inhibits an enzyme called "parp" which helps to fix damaged dna. by inhibiting this enzyme, abt-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. abt-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the food and drug administration (fda) for use in liver cancer. this study will help find out what effects (good and bad) the combination of drugs, temozolomide and abt-888, has on liver cancer. this research is being done because it is not known if abt-888 will increase the effectiveness of temozolomide in liver cancer.

patients with hepatocellular carcinoma seen at lombardi cancer center were evaluated for the eligibility of this study. the georgetown lombardi comprehensive cancer center was responsible for the data and safety monitoring of this trial. as this study is an investigator initiated study phase ii study utilizing a non-fda approved drug for which the pi held the ind it was considered a high risk study which had real-time monitoring by the pi and study team and quarterly reviews by the lccc data and safety monitoring committee (dsmc).

Eligibility criteria:
inclusion criteria: * pathological confirmation of hcc or noninvasive criteria following aasld guidelines * measurable or evaluable disease based on recist criteria * progressive disease on sorafenib or intolerance to sorafenib * ecog performance status 0-2 * child pugh class a or b * adequate hepatic, bone marrow, and renal function exclusion criteria: * prior abt-888 or other parp inhibitor treatment * anticipation of need for major surgery during the study * any of the following within 6 months before enrollment: myocardial infarction, severe/unstable angina, congestive heart failure, or severe pulmonary disease * women who are pregnant or lactating * women and men of child-bearing potential who are not using a reliable form of contraception * history of allergic reactions attributed to compounds of similar chemical or biologic composition to abt-888 and temozolomide * concurrent malignancy (i.e. malignancy other than hepatocellular cancer) unless 1) the subject has been curatively treated and disease free for at least 2 years or 2) the cancer was non-melanoma skin cancer or early cervical cancer. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding active hepatitis b or c) or psychiatric illness/ social situations that would limit compliance with study requirements

Keywords: liver cancer hepatocellular temozolomide veliparib
lha510 proof-of-concept study as a maintenance therapy for patients with wet age-related macular degeneration

Conditions: Exudative Age-Related Macular Degeneration

Summary: the purpose of this study is to evaluate the efficacy of 84 successive days of topically administered lha510 compared to vehicle in reducing the number of patients requiring intravitreal (ivt) anti-vascular endothelial growth factor (vegf) therapy (lucentis®) for recurrence of active choroidal neovascularization (cnv).

on day -1, patients will receive an ivt lucentis® injection in the study eye, and then will be randomized to receive either topical lha510 ophthalmic suspension or vehicle in a 1:1 ratio for 84 days. patients with recurrence of active cnv in the study eye during the study will receive rescue ivt lucentis® injections. following the treatment period, subjects will return for a follow-up visit and a disposition visit. only one eye (designated as the study eye) will be dosed with either topical lha510 or vehicle per patient.

Eligibility criteria:
inclusion criteria: * sign written informed consent form; * wet amd; * ivt anti-vegf therapy for at least 6 months and a maximum of 7 years since the 3rd loading dose; * bcva 50 letters (approximate snellen equivalent 20/100) or better in the study eye; * demonstrate ability to administer eye drops (subject or care-giver); * cnv recently demonstrated high need for frequent anti-vegf therapy and a sustained functional and clear anatomical response to the therapy in the study eye; * other protocol-specified inclusion criteria may apply. exclusion criteria: * any active ocular or periocular infection or intraocular inflammation; * current or history of macular or retinal disease (if visually significant) other than wet amd in the study eye; * current clinically significant vitreous hemorrhage or history of rhegmatogenous retinal detachment affecting the macula in the study eye; * history of hypersensitivity to any of the study drugs or clinically relevant sensitivity to fluorescein dye or povidone iodine; * women of child-bearing potential; * history of a medical condition that, in the opinion of the investigator, would preclude scheduled study visits, completion of the study or a safe administration of investigational product; * other protocol-specified exclusion criteria may apply.

Keywords: lha510 poc age-related macular degeneration
blended reality immersion for geriatric head trauma: the bright study

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is a major public health concern, particularly among older adults (oas) ≥ 65 years of age. each year in the united states, tbi results in over 600,000 emergency department visits and hospitalizations among oas. mild tbi (mtbi) accounts for 80% of all tbi in oas and is quite understudied in this rapidly growing population. mtbi, is mild in name only, as it can result in dysfunction in multiple cognitive domains, including attention, processing speed, executive functioning and memory and has been shown to be associated with progressive brain atrophy and increased susceptibility to neurodegenerative disorders. cognitive rehabilitation therapy is an evidence-based approach that can successfully improve cognitive impairment following tbi. virtual reality (vr) is emerging as a technology that can assess cognitive impairment and provide a neurorehabilitation modality (nrm) to improve cognitive decline post tbi. not only can vr provide a variety of environments like those encountered in real life and be adapted to varying levels and types of cognitive disability, but it can also be used safely in a patient's home with minimal equipment. yet, despite the promise of cognitive rehabilitation using vr among oas, very few studies to date have assessed the efficacy of vr cognitive rehabilitation in tbi. the aim of this study is to assess the effect and collect data on the efficacy and feasibility of a virtual reality application as a neurorehabilitation modality on executive functioning (attention, immediate memory, and visual-spatial skills) in oas with mtbi. the hypothesis is that the use of vr mediated cognitive exercises post mtbi will be associated with improved executive function at 6-weeks post-randomization compared to the control group.


Eligibility criteria:
inclusion criteria: * 65 years of age or older * diagnosed with a mild traumatic brain injury * community dwelling * english speaking * live within a 30 mile radius from the trauma center * active phone number * able to provide informed consent exclusion criteria: * known history of cognitive impairment * known history of functional impairment * history of seizure disorders * medical implantable devices ( pacemaker \& defibrillator) * substance use disorder * other severe traumatic injuries to the neck, chest, abdomen, spine and pelvis
defining normal citrulline levels as a diagnostic tool for screening of gastrointestinal disease in premature infants

Conditions: Premature Newborn; Necrotizing Enterocolitis

Summary: since the first description of citrulline as a potential marker for intestinal function in 1998, its use has been investigated in a variety of disease processes including short bowel syndrome, celiac disease, chemotherapy and radiation induced intestinal injury, infections producing intestinal cytopathic effects like adenovirus, and predicting rejection in intestinal transplantation. the use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed. the introduction of enteral nutrition in the premature infant is a process of trial and error, knowing that the immaturity of the gastrointestinal system may lead to frequent episodes of feeding intolerance. this is augmented by the fear of the development of necrotizing enterocolitis (nec) once feeds are commenced. nec is a condition characterized by disruption of the intestinal epithelial barrier, a pathogenic process shared with some of the conditions mentioned above for which citrulline has proven clinically useful. a normal pattern of citrulline production has not been established in the premature population. previous studies have shown decreased levels of glutamine and arginine in premature infants up to 10 days prior to the development of necrotizing enterocolitis. glutamine and arginine are two amino acids closely involved in the synthesis and catabolism of citrulline. the investigators therefore hypothesize that defining a normal pattern of citrulline production in the premature population may prove to be a clinically useful diagnostic tool to screen for gastrointestinal disease.

the use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed.

Eligibility criteria:
inclusion criteria: 1. premature infants with gestational age between \<32 weeks regardless of birth weight exclusion criteria: 1. inborn errors of metabolism 2. need for exchange transfusion 3. multiple congenital anomalies 4. renal failure (defined as urine output \ 24h, creatinine \>1.8, or diagnosis of "non-oliguric renal failure" as determined by pediatric nephrology)

Keywords: prematurity necrotizing enterocolitis feeding intolerance
safety of soluble beta-glucan (sbg) in treatment of patients with non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to assess the safety of soluble beta-glucan (sbg) in combination with antibody and chemotherapy treatment in patients with non-hodgkin-s lymphoma.


Eligibility criteria:
inclusion criteria: 1. cd20 positive b-cell non-hodgkin's lymphoma 2. treatment with rituximab and chop or cop 3. performance status 0 or 1 according to the who scale (appendix) 4. expected lifetime of more than 12 weeks 5. age ≥ 18 years 6. the patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained exclusion criteria: 1. women who are pregnant or breast-feeding. for fertile women, a negative pregnancy test must be provided during the screening test. women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation 2. lymphoma involvement of central nervous system 3. reduced bone marrow function defined by leukocyte counts \< 3.0 x 109/l, neutrophil counts \< 1.5 x 109/l, thrombocyte counts \< 100 x 109/l or hemoglobin \< 10 g/dl 4. reduced liver function defined by bilirubin \> 1.5 x upper limit of normal (uln) or asat/alat ≥ 3 x uln 5. reduced renal function defined by serum creatinine ≥ 2 x uln
sigmoid colon organ motion in radiotherapy

Conditions: Sigmoid Cancer; Sigmoid Colon Cancer

Summary: radiotherapy is used in cancer treatment to eradicate microscopic cancer cells to lower the risk of recurrence. the radiotherapy plan must account for organ movement inside the body to ascertain adequate dose is delivered to the target. knowledge of the magnitude is crucial to radiotherapy treatment planning. this study aims to quantify the movement of the sigmoid colon between different fractions of radiotherapy treatment (interfraction motion) and within the same fraction (intrafraction motion). this knowledge will help us determine the optimal margin to use in radiotherapy treatment planning.

day-to-day positioning variations contribute to uncertainty in radiotherapy. the international commission on radiation units and measurements (icru) report 62 recommended a margin added to the clinical target volume (ctv) to produce the planning target volume (ptv). in icru report 83, this concept is further extended and refined to yield the internal target volume (itv), which is defined as ctv plus a margin to account for uncertainty within the patient. image-guided radiotherapy (igrt) has been developed as a method to lower the margin required in ptv expansion. in current practice, igrt methods mostly rely on bony anatomy alignment. due to its nature, internal organ motion cannot be compensated by igrt. therefore, an itv expansion is still required. the optimal itv expansion margin depends on the magnitude of internal organ motion; the smallest margin that provides adequate coverage is preferred. in this study, we aim to quantify organ motion of the sigmoid colon anastomosis site during radiotherapy treatment, including movement between fractions (interfraction) and movement within the same fraction (intrafraction).

Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed sigmoid colon cancer, who have received surgical excision (ar or lar). * anastomosis of the colon must be performed with a surgical stapler, with the staple visible on ct imaging. exclusion criteria: * gross recurrent disease (defined as visible mass on ct imaging) in the pelvis. * other malignancy within the pelvic cavity. * previous surgery to the pelvic cavity other than ar/lar. * pregnant or lactating females. * subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Keywords: sigmoid colon cancer internal organ motion radiotherapy
the impact of 3d anal fistula models on patient understanding and decision making

Conditions: Fistula in Ano; Ano Fistula

Summary: an anal fistula is an abnormal communication between the luminal surface of the anorectal canal and the perianal skin. fistulas can vary in their complexity and can be challenging to treat, due to the anatomical relation to the anal sphincter complex that controls continence. in addition, fistulas can display complex features such as branches, cavities and horseshoes; where the tract travels radially around the anal canal. all these features have a role in determining the most appropriate surgical treatment option, and are key to understanding the surgical decision-making process. this study will determine patient understanding of fistula anatomy, their perception of their own understanding, their rating of how good their clinician's explanation is and how this impacts the decision-making process using standard explanation with 2d images, versus a 3d printed model of a fistula.

previous work has established a method of using traditional two-dimensional mr images to construct and print 3d models of perianal fistula, however the clinical utility of these models in the outpatient setting and their impact on patient knowledge of disease have not yet been assessed. this study is aimed at understanding how the use of 3d printed models can influence patient understanding of disease and support them in making decisions regarding treatment. participants attending routine outpatient appointments will have their fistula explained to them using either a standard explanation, or a 3d printed model of a fistula. they will complete a short series of questionnaires and their answers will be analysed to determine if there is any benefit of using 3d models in a clinical consultation.

Eligibility criteria:
inclusion criteria: * male and female patients * aged ≥18 years old * patients who are new referrals to complex fistula clinic * patients with an idiopathic or crohn's perianal fistula * patients with an intersphincteric or transsphincteric fistula according to park's classification * patients who have had mr imaging of their anal fistula prior to consultation * able to give full informed consent exclusion criteria: patients \< 18 years * patients with a rectovaginal or pouch fistula * fistula secondary to malignancy or radiation * suprasphincteric or extrasphincteric fistulas * follow up patients * patients who have no prior mr imaging of their fistula patients who do not have the capacity to consent
comparison of effectiveness of virtual reality with mirror therapy in improving motor function of upper limb of stroke patients

Conditions: Stroke

Summary: the purpose of the study is to compare the effectiveness of virtual reality and mirror therapy in stroke patients. different studies has been done to find out the best therapy for stroke patients. use of virtual reality in medical field is becoming more popular now-a-days. different devices and applications are available to treat various conditions. research has been done to find the clinical applications of virtual reality for upper limb motor rehabilitation in stroke. in another study, mirror therapy with bilateral arm training was used for hemiplegic upper extremity motor functions in patients with chronic stroke. after doing literature review, it was found that no research has been done to compare the effectiveness of mirror therapy with virtual reality in improving motor function of upper limb of stroke patients. so, in this study these two therapies are compared. for virtual reality oculus quest 2 has been used. patients were allowed to use beat saber game on oculus.


Eligibility criteria:
inclusion criteria: * stroke affecting upper limb exclusion criteria: * mental problem cognitive problem

Keywords: virtual reallity mirror therapy
the effect of virtual reality glasses on anxiety level and breast milk amount

Conditions: Anxiety; Amount of Breast Milk

Summary: pain, anxiety, nausea, vomiting, etc. in coping with symptoms, virtual reality glasses are recommended as a distraction application. the study was planned to examine the effect of virtual reality glasses applied to mothers whose babies were in the neonatal intensive care unit, on the level of anxiety and the amount of breast milk.

although milk is expressed early and frequently, milk volume and milk production may be lower in some mothers in the first few weeks.for this reason, pharmacological and non-pharmacological methods have been focused on to increase prolactin secretion and breast milk production in mothers with premature babies. it is emphasized that practices such as breast massage, hot application, nutrition and fluid consumption of the mother, thinking about her baby or looking at her picture, and psychological relaxation during milk expression with a pump increase the amount of milk. it is thought that the mother's stress and anxiety negatively affect the amount of breast milk in preterm births, and that methods that provide relaxation and relief will contribute to breast milk production by reducing stress and anxiety. pain, anxiety, nausea, vomiting, etc. in coping with symptoms, virtual reality glasses are recommended as a distraction application.

Eligibility criteria:
inclusion criteria: * are between the ages of 18-45, * those who gave birth at a gestational age of 30 weeks or more, * whose baby is still in intensive care, * whose baby has started breastfeeding, * giving breast milk to her baby by expressing, * not using any medication that will affect milk supply, * not diagnosed with a psychiatric disease that will affect breastfeeding in the postpartum period, * those who have not had any breast-related surgery before, * understands turkish and can communicate, * mothers who sign the informed volunteer consent form will be included in the research. exclusion criteria: * those who are younger than 18 years of age or older than 45 years of age, * the gestational age is less than 30 weeks, * whose baby was discharged from intensive care, * whose baby has not started breastfeeding, * those who do not express breast milk to their babies, * using medication that will affect milk supply, * diagnosed with a psychiatric disease that will affect breastfeeding in the postpartum period, * have had any breast-related surgery before, * cannot communicate in turkish, * mothers who do not sign the informed volunteer consent form will not be included in the research.

Keywords: anxiety breast milk breastfeeding premature virtual reality glasses