Kornimate/medical-research-clean huggingface dataset:
neural mobilization and cerebral palsy

Conditions: Cerebral Palsy; Neurologic Disorder

Summary: objective: to assess the effect of neural mobilization applied to the lower limbs, compared to conventional physical therapy, in children diagnosed with cerebral palsy. using the international classification of functioning, disability and health, the investigators will try to evaluate the impact of the intervention in aspects related with structure, activity, and participation.this project will mainly focus on the structure dimension. more specifically, the investigators aim to observe if a treatment protocol designed to modify the structure (e.g.,the sciatic nerve using neural mobilization techniques), will evoke changes not only in the structural dimension, but also will be able to modify the activity and participation dimensions. design: a single blinded randomized clinical trial (the evaluator will remain blinded to treatment allocation group) will be conducted. the experimental group will receive an intervention consisting on the use of neurodynamic mobilization procedures of the lower limb and participants in the control group will undergo a conventional physical therapy intervention (stretching, mobilization), without the use of neural mobilization. subjects: participants will be aged between 5 and 18 years, and with a confirmed diagnosed of cerebral palsy with the presence of spasticity in the lower limbs. methods: participants will be randomly allocated into two groups: experimental or control group. the primary outcome will be the range of motion (flexion and extension) of the hip, knee and ankle. secondary outcomes will include gross motor function, pain intensity, muscle stiffness, muscle tension, and functional measures.


Eligibility criteria:
inclusion criteria: * children and adolescents diagnosed with cerebral palsy or presence of spasticity and aged between 5 and 18 years. * level i to v in the gross motor function classification system, which denotes that the participant should be able to walk with or without using assistive devices. * increased muscle tone in the lower extremities, represented by a score greater than 0 on the tardieu clinical scale and a positive response in the duncan ely test. * ability to communicate pain. * ability to follow simple commands. exclusion criteria: * have ankle joint arthrodesis or any surgical operation that prevents joint mobilization of the lower limb to some degree. * any significant change in medication treatment during the study period that may influence (increase or decrease) muscle tone. * experience uncontrolled epileptic seizures despite medication. * have received botulinum toxin treatment in the lower limb within the 6 months prior to the study. * undergo a different physical therapy treatment parallel to that developed in the study.

Keywords: range of motion pain intensity gross motor function neural mobilisation quality of life muscle stiffness muscle tension
muscle mri outlining of neuromuscular diseases using artificial intelligence

Conditions: Becker Muscular Dystrophy; FSHD - Facioscapulohumeral Muscular Dystrophy; Hypokalemic Periodic Paralysis

Summary: background and aim: neuromuscular diseases encompass a range of conditions affecting muscle cells, nerves, or the interaction between the two. a common pathological feature of these conditions is the pro-gressive replacement of muscle tissue with fat, which can be visualised using magnetic reso-nance imaging (mri). mri-based fat quantification serves as a key biomarker for disease characterisation, progression tracking, and treatment assessment. currently, manual segmenta-tion of mri scans for fat quantification is very time-consuming, requiring individual muscle delineation. therefore, an artificial intelligence (ai) model is being developed to automate the segmentation. the aim of this study is to validate this ai model and assess its possibilities and limitations. method: the study is ongoing. retrospective mri scans of patients with four different muscle diseases (anoctaminopathy, becker muscular dystrophy, facioscapulohumeral muscular dystrophy, and hypokalemic periodic paralysis) are collected and manual delineation used for training the ai-model is being performed. the intramuscular fat fraction of individual muscles of the pelvis, thigh, and calf will be analysed using the ai model. the performance of the ai model will be compared to manual segmentation. the ai will be evaluated on metrics such as segmentation accuracy and time efficiency.


Eligibility criteria:
inclusion criteria: * genetically verified diagnosis of neuromuscular diseases. * age above 18 years exclusion criteria: * contraindications to perform an mri * competing disorders and other muscle disorders, which may alter measurements. the investigator will decide whether the competing disorder can significantly influence the results

Keywords: ai muscle delineation automated segmentation becker muscular dystrophy fshd hypopp
immersive virtual reality for the non-pharmacological management of parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of this clinical trial is to evaluate the feasibility, safety and efficacy of an immersive virtual reality (ivr) exergaming using a head-mounted display in parkinson's disease symptomatic control. this is a parallel-group, single-blinded, randomized controlled trial. the intervention group perform 12 weeks of physiotherapy and ivr, whereas the control group have 6 weeks of physiotherapy only, followed by 6 weeks of physiotherapy and ivr. the primary outcome is the symptomatic effect of the intervention as measured by the change from baseline in time up and go (tug) test with cognitive dual-task (tug cognitive).


Eligibility criteria:
inclusion criteria: * patients diagnosed with parkinson's disease according to mds criteria; * hoehn and yahr stages between i-iii (med on); * ability to perform the time up and go test in normal pace and without assistance, in less than 11,5 seconds in on state; * stable medication for the past 1 month; * ability to communicate with the investigator, to understand and comply with the requirements of the study; * able to provide written informed consent to participate in the study. exclusion criteria: * postural instability or freezing of gait in med on representing an increased risk of fall, according to the best clinical judgement; * a montreal cognitive assessment (moca) score \< 21; * presence of severe visual loss that could interfere with the ability to see the vr simulation as well as vertigo, epilepsy and psychosis; * unstable medical condition, including cardiovascular, pulmonary or musculoskeletal, that according to the clinician's judgment affect patients' ability to participate in the study; * inability to correctly respond to the assessment protocol according to the clinician's judgment or lack of support from caregiver for this effect.

Keywords: immersive virtual reality neurorehabilitation
safety and efficacy of the percutaneous transvenous mitral annuloplasty device to reduce mitral regurgitation

Conditions: Heart Failure; Mitral Regurgitation

Summary: improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.


Eligibility criteria:
inclusion criteria: * symptomatic heart failure * moderate to severe mitral regurgitation * 20 - 50% lvef exclusion criteria: * mitral regurgitation of organic origins * recent interventions * severe comorbidities

Keywords: heart failure mitral regurgitation
study the safety and efficacy of "compont medical glue" in the treatment of esophagogastric varices

Conditions: Esophageal and Gastric Varices

Summary: to observe the safety and efficacy of compont medical glue in the treatment of esophagogastric varices.

"compont medical glue" is a kind of histoacryl producted by compont company. it has been used to treat esophagogastric varices for several years. this study is a prospective multicenter,open study on the safety and efficacy of compont medical glue in the treatment of esophagogastric varices. weather the patient receiving injection of compont medical glue is according to the degree of esophageal-gastric varices and is decided by the experienced endoscopic physicians. no additional intervention will be given to the patients, no matter whether patients are participated in the study.

Eligibility criteria:
inclusion criteria: * esophagogastric varices caused by portal hypertension with or without history of bleeding and no matter whether emergency bleeding. * patients may need to receive injection of histoacryl. * have signed informed consent. exclusion criteria: * allergic to formaldehyde or cyanoacrylate. * women who are pregnant or breast-feeding. * with contraindications of endoscopic exam. * computed tomography(ct)/computed tomography angiography(cta) shows that patient with severe portosystemic shunt. * large amount of blood accumulated in the stomach severely affects the endoscopic vision clarity. * other reasons that researcher think the patient is unsuitable for participating in the study.

Keywords: enbucrilate esophageal and gastric varices endoscopy safety efficacy
effect of intraperitoneal insulin administration after laparoscopy in insulin-resistant patients on prevention of postoperative adhesion recurrence: a randomized controlled trial

Conditions: Prevention of Postoperative Adhesions

Summary: adhesion formation following laparoscopic pelvic surgery remains a significant cause of chronic pelvic pain, infertility, and surgical complications. patients with insulin resistance (ir) may have heightened inflammatory responses and impaired tissue healing, contributing to a higher risk of adhesion formation. intraperitoneal administration of insulin has shown promising results in animal models by modulating inflammatory mediators and enhancing fibrinolysis. this trial aims to evaluate the efficacy and safety of intraperitoneal insulin instillation at the end of laparoscopy in women with insulin resistance.

this is a prospective, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy of intraperitoneal insulin administration at the end of laparoscopic surgery in women with insulin resistance, aiming to reduce postoperative adhesion formation. the study will be conducted at a dr saed hospital and will enroll 100 female patients diagnosed with insulin resistance undergoing laparoscopy for infertility or chronic pelvic pain.

Eligibility criteria:
inclusion criteria: * women aged 18-40 years * diagnosed insulin resistance (e.g., homa-ir \>2.5 or fasting insulin \>15 uiu/ml) * indicated for laparoscopy for infertility or pelvic pain * bmi 20-35 kg/m² * able and willing to give informed consent exclusion criteria: * diabetes mellitus requiring pharmacologic treatment * history of peritonitis or major abdominal surgery in the past 6 months * known allergy or sensitivity to insulin * chronic steroid or immunosuppressive use * pregnancy or lactation * participation in another clinical trial within the last 3 months
nicotine virtual reality conditioned place preference

Conditions: Nicotine Addiction; Nicotine Use Disorder

Summary: in this between-subjects, placebo controlled, double-blind study, the investigators will examine the effects of low oral doses of nicotine on the learning and extinction of a conditioned place preference acquired in a virtual reality environment by healthy human subjects. physiological and subjective responses to the drug will also be monitored.

external cues and contexts contribute to the development of smoking and the use of other drugs, and drugs themselves can alter the value of conditioned cues. interestingly, nicotine increases the acquisition of new learning, and has been considered as a "cognitive enhancer". nicotine also prolongs responding when responding is no longer rewarded, during extinction. although many studies have examined the effects of drugs on learning (acquisition) and unlearning (extinction) in laboratory animals, few have investigated drug effects on learning in humans. recently, novel procedures have been developed to study conditioning in humans, pairing initially neutral places with food, money or drugs. the investigators will use one of these procedures, a virtual place conditioning procedure, to study how nicotine affects the acquisition and extinction of conditioned behaviors in humans.

Eligibility criteria:
inclusion criteria: * subjects must have at least a high school education and be in good physical and mental health. exclusion criteria: * individuals with current medical conditions, and/or a history of serious medical problems (e.g., cardiac, kidney, liver, and neurological). additional exclusion criteria include: * regular medication, * pregnancy, * color blindness, * left-handedness, * consumption of 5 or more cigarettes per day, * english non-fluency and current dsm-iv axis 1 diagnosis excluding nicotine dependence.

Keywords: nicotine
neural mechanisms of dialectical behavioral therapy in patients with borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: this research examines the behavioral and neural mechanisms of dialectical behavior therapy (dbt) effect in patients with borderline personality disorder (bpd).

this project aims to evaluate the behavioral and neural mechanisms of dialectical behavior therapy (dbt) effect in patients with borderline personality disorder (bpd). the project includes three subject groups: patients with bpd undergoing the dbt program (bpd-dbt), control patients with bpd on the waiting list for the program (bpd-control), and healthy controls (hc). patients in the bpd-dbt group undergo a 24-week dbt program in an outpatient setting. all participants undergo a test battery comprising of self-report measures, clinical evaluation and fmri and eeg measurement in the week before the dbt program beginning (t1), after 24 weeks (follow-up, t3), and at 24 weeks after t3 (follow-up, t4). the bpd-dbt group undergoes another assessment at t2 (after 12 weeks) to monitor selected symptoms during the dbt program by a short set of questionnaires.

Eligibility criteria:
bpd-dbt group: inclusion criteria: * diagnosis of borderline personality disorder according to diagnostic and statistical manual 5th edition (dsm-5) criteria (rated by structured clinical interview for dsm-5 for personality disorders, bpd section) * minimum age 16, informed consent of the patient * informed consent of patient's legal representative in case of patients under age 18 * more than one self-injury incident and/or suicidal attempt in the past six months exclusion criteria: * neurological disorder * comorbid affective disorder or schizophrenia-related disorder * intelligence quotient\<70 * contraindications for mri measurement * pregnancy * body mass index under 15 bpd-c group: inclusion criteria: * diagnosis of borderline personality disorder according to diagnostic and statistical manual 5th edition (dsm-5) criteria (rated by structured clinical interview for dsm-5 for personality disorders, bpd section) * minimum age 16, informed consent of the patient * informed consent of patient's legal representative in case of patients under age 18 * more than one self-injury incident and/or suicidal attempt in the past six months exclusion criteria: * completing a dbt program or attending dbt-based therapy * neurological disorder * comorbid affective disorder or schizophrenia-related disorder * intelligence quotient\<70 * contraindications for mri measurement * pregnancy * body mass index under 15 hc group: inclusion criteria: * minimum age 16, informed consent of the patient * informed consent of patient's legal representative in case of patients under age 18 exclusion criteria: * mental health problems * history of self-injury or/and suicidal attempt * neurological disorder * intelligence quotient\<70 * contraindications for mri measurement * pregnancy * body mass index under 15

Keywords: dialectical behavior therapy borderline personality disorder therapy effectiveness
a phase ib study of prj1-3024 for treatment of advanced or metastatic melanoma

Conditions: Melanoma

Summary: this is a phase ib, open-label study to determine the safety and preliminary efficacy of prj1-3024 in china subjects with unresectable local advanced or metastatic melanoma

the study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of prj1-3024 and will determine the recommended dose in china subjects with unresectable local advanced or metastatic melanoma. prj1-3024 is a small molecular hematopoietic progenitor kinase (hpk-1) inhibitor. it will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.

Eligibility criteria:
inclusion criteria:• histologically or cytologically confirmed locally advanced (unresectable) or metastatic melanoma (with the exception of ocular uveal melanoma). patients who have progressed or relapsed after at least 1st-line systemic standard therapy. * male or non-pregnant, non-lactating female subjects aged ≥18 years. * ecog performance status 0\~1. * has at least 1 measurable lesion as defined by recist 1.1 criteria. * life expectancy of ≥3 months, in the opinion of the investigator. * able to take oral medications and willing to record daily adherence to investigational product. * adequate hematologic parameters. * adequate renal and hepatic function * able to understand and willing to sign a written informed consent form. * consent to provide archived tissue specimen or tissue sample. exclusion criteria:• history of another malignancy. * known symptomatic brain metastases requiring \>10 mg/day of prednisolone. * significant cardiovascular disease. * known active hbv, hcv, aids-related illness. * has received a live vaccine within 30 days. * history of active autoimmune disorders, or ongoing immunosuppressive therapy. * continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \< grade 2. * receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome p450 3a (cyp3a) . * prior treatment with other hematopoietic progenitor kinase 1 (hpk1) inhibitors. * allergy to the ingredients of study drug, or a history of other allergies which were judged by the investigator to be unsuitable for participation in the study.

Keywords: hpk-1 inhibitor;melanoma;prj1-3024;recommended phase 2 dose
study evaluating on-demand treatment of xyntha in chinese subjects

Conditions: Hemophilia A

Summary: this study will evaluate the safety and efficacy of on-demand treatment with xyntha in chinese hemophilia a subjects.


Eligibility criteria:
inclusion criteria: * subjects equal or more than 6 years of age with mild, moderate or severe hemophilia a (fviii activity: more than 5%, 1-5%, or less than 1%, respectively) * subjects with previous exposure to fviii replacement therapy * if human immunodeficiency virus (hiv) positive, documented cluster of differentiation (cd4) count more than 200/µl within 6 months of study entry exclusion criteria: * diagnosed with any bleeding disorder in addition to hemophilia a * current fviii inhibitor or history of fviii inhibitor (defined as positive result of the reporting laboratory) * subject has no history of exposure to fviii products (previously untreated patient \[pup\]) * subject is currently utilizing primary fviii prophylaxis * subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry * treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation * participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation * subjects with a known hypersensitivity to hamster protein * significant hepatic or renal impairment (alanine aminotransferase \[alt\] and aspartate aminotransferase \[ast\] \>5 x upper limit of normal \[uln\], bilirubin \>2 mg/dl or serum creatinine \>1.25 x uln) * prothrombin time \>1.5 x uln * platelet count \<80,000 / µl * pregnant or breastfeeding women * unwilling or unable to follow the terms of the protocol * any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the investigator or sponsor

Keywords: on-demand treatment; hemostatic efficacy assessments; factor viii recovery; factor viii inhibitor; chinese
a clinical trial to assess the potential of leo 130852a gel to reduce steroid induced skin atrophy on healthy skin

Conditions: Skin Tissue Diseases; Connective Tissue Diseases

Summary: the purpose of this study is to assess the effect of leo 130852a gel 1% in maintaining skin thickness in healthy skin treated with steroid.


Eligibility criteria:
inclusion criteria: * healthy male volunteers, 25 to 50 years old inclusive * healthy skin on volar arms with a hairless area sufficient for measurements exclusion criteria: * clinical skin atrophy, telangiectasia or striae on volar arms * presence of any skin condition or colouration that would interfere with test sites or the response or assessment * fitzpatrick skin type iv - vi * history or current evidence of infection, eczema or other relevant skin disease
the effect of nighttime dialysis on the inflammation of kidney failure

Conditions: End-Stage Renal Disease

Summary: this study will determine whether a new form of home hemodialysis carried out at night during sleep reduces blood levels of hormone-like substances called cytokines that may cause fatigue and increase blood fats and sugar. participants will stay twice in the rockefeller hospital and receive a standard diet and blood testing. training for nocturnal hemodialysis will be provided at the nearby manhattan dialysis center of the rogosin institute, affiliated with the rockefeller university.

patients treated with conventional hemodialysis for at least 3 months and interested in learning home nocturnal hemodialysis will be screened in the rockefeller outpatient research center. if eligible, during the first 8 day hospital stay, participants will receive a standard diet and dialysis treatment nearby at the rogosin institute dialysis center. during the last 2 days, their blood will be frequently sampled for cytokines, fats and sugar. dialysate will also be sampled. they will have the same diet and tests repeated during a second admission after either 4 months of conventional dialysis or 1 month training for nocturnal dialysis followed by 3 months of home nocturnal dialysis (randomized 1:1). after the second admission, patients treated with conventional dialysis will be discharged from the study and trained in nocturnal hemodialysis. off-site computer monitoring will be utilized when patients dialyze themselves at home or during the admission in the rockefeller university hospital.

Eligibility criteria:
inclusion criteria: men and women at least age 18 who receive hemodialysis three times a week for at least 3 months and meet the criteria for home instruction in nocturnal dialysis - exclusion criteria: no diabetes, any unstable clinical condition, chronic infection (including hepatitis, hiv), endocrine disorders or serious digestive problems, lipid-lowering medication , ldl cholesterol \ 10.0, no cholesterol-lowering medicine, able to change from renagel (has lipid effects) to phoslo for the duration of the study, cigarette smoking no more than half a pack per day

Keywords: dialysis cytokines triglycerides insulin