Kornimate/medical-research-clean huggingface dataset:
hematopoietic stem cell transplantation for mucopolysaccharidosis

Conditions: Mucopolysaccharidosis

Summary: the purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic cells using chemotherapy regimen without total-body irradiation in children undergoing a hematopoietic stem cell transplant for mucopolysaccharidosis. the blood stem cells will be derived from either related donor or unrelated umbilical cord blood or haploidentical donor.


Eligibility criteria:
inclusion criteria: * diagnosis of mucopolysaccharidosis type 1, 6 and 7 confirm by leukocyte enzyme assay * age up to 8 year old * have suitable donor exclusion criteria: * creatinine clearance ≤ 40ml/min/1.73m\^2 * bilirubin ≥ 3mg/dl * sgpt ≥ 500 u/l * current severe infection * evidence of cns involvement * morbidity such as blindness or deafness

Keywords: mucopolysaccharidosis hsct
a phase 1b/2 study of omp-59r5 (tarextumab) in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage iv pancreatic cancer

Conditions: Stage IV Pancreatic Cancer

Summary: the study consists of a phase1b lead-in portion to determine the maximum tolerated dose (mtd) of omp-59r5 in combination with nab-paclitaxel and gemcitabine followed by a phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of omp-59r5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage iv pancreatic cancer.


Eligibility criteria:
inclusion criteria: subjects must meet all of the following major inclusion criteria to be eligible for the study: 1. 18 years of age or older 2. histologically or cytologically documented stage iv ductal adenocarcinoma of the pancreas. 3. performance status (ecog) 0 or 1 4. ffpe tumor tissue from metastatic site(s 5. adequate organ function 6. written consent on an irb/iec-approved informed consent form prior to any study-specific evaluation. 7. for women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration. 8. male subjects must be surgically sterile or must agree to use physician-approved contraception from 30 days prior to the first study drug administration to 30 days following the last study drug administration. exclusion criteria: subjects who meet any of the following major exclusion criteria will not be eligible for participation in the study: 1. neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas. 2. known brain metastases. 3. prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage iv pancreatic cancer. 4. presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism). 5. any disorder that would significantly compromise protocol compliance. 6. prior non-pancreatic malignancy treated with chemotherapy. prior malignancies treated with surgery and/or radiotherapy alone must be in remission ≥3 years. the following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer. 7. known human immunodeficiency virus (hiv) infection. 8. females who are pregnant or breastfeeding.

Keywords: newly diagnosed stage iv pancreatic cancer
evaluation of tadalafil combined with lipus for treating erectile dysfunction

Conditions: Erectile Dysfunction

Summary: this study aims to evaluate the clinical efficacy and histological changes of tadalafil combined with low-intensity pulsed ultrasound (lipus) in patients with erectile dysfunction (ed) through a randomized controlled trial.

erectile dysfunction (ed) is defined as the persistent inability to achieve and maintain a sufficient erection for satisfactory sexual performance for more than six months. low-intensity pulsed ultrasound (lipus), a non-invasive therapy, improves the pathological changes in the corpora cavernosa and penile hemodynamics by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation. this study will recruit 114 patients diagnosed with ed and use simple random sampling to allocate them into a treatment group and a control group in a 1:1 ratio. the treatment group will receive daily 5mg tadalafil combined with lipus therapy twice a week for 4 weeks, followed by a 4-week interval without lipus treatment, and then repeat the treatment. the control group will receive only daily 5mg tadalafil. efficacy will be evaluated primarily through the minimal clinically important difference (mcid) of the international index of erectile function-5 (iief-5) at each follow-up point, combined with erectile hardness score (ehs), penile blood flow parameters, and elasticity values for comprehensive assessment. this trial may provide additional clinical evidence for the efficacy, safety, and cost-effectiveness of tadalafil combined with lipus in treating ed patients. the inclusion of penile blood flow parameters and two-dimensional shear wave elastography will help establish a comprehensive evaluation system combining ed symptoms with histological assessment, providing new methods for efficacy evaluation.

Eligibility criteria:
inclusion criteria: * age between 21 and 65 years old. * an international index of erectile function-5 (iief-5) score of 21 or less. * first-time diagnosis of erectile dysfunction (ed) without prior treatment from traditional chinese or western medicine. * a stable heterosexual relationship for at least 3 months. * agreement to attempt sexual intercourse at least four times every four weeks during the study period. * signing of an informed consent form. exclusion criteria: * erectile dysfunction caused by spinal/neural injury or radical prostatectomy. * history of priapism or penile anatomical abnormalities. * use of a penile prosthesis. * severe and poorly controlled psychological disorders. * untreated endocrine disorders, such as hypogonadism, hypothyroidism, or pituitary dysfunction. * history of myocardial infarction, stroke, life-threatening arrhythmias, or potential cardiovascular risks during sexual activity within the six months prior to enrollment. * inability to complete the participant records required for the trial. * allergic constitution and multiple drug allergies.

Keywords: tadalafil lipus randomized controlled trial protocol
pet image exploration of novel tracer [68ga]-fapi-jnu imaging studies in patients with malignant tumors

Conditions: Cancer; Solid Malignancies

Summary: to investigate the biological distribution of a new tracer 68ga-fapi-jnu in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68ga-fapi-jnu with standardized uptake values.

pet/ct imaging was performed about 1 hour after the patient was injected with the novel tracer 68ga-fapi-jnu. suvmax and suvmean values of the area of interest were mapped by two diagnostic physicians with more than 5 years of experience after the imaging was completed.

Eligibility criteria:
inclusion criteria: 1. the subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements; 2. age 18-85 years old, male or female; 3. clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as ct and mri; 4. ecog score is 0-3 points; exclusion criteria: 1. patients with a history or allergic constitution to any component of the developer, including alcohol; 2. pregnant or lactating women; 3. patients with mental illness or related history; 4. patients who cannot or cannot undergo a pet/ct scan;

Keywords: fap fapi pet cancer
effect of dietary components on gastrointestinal side effects induced by orlistat, a lipase inhibitor

Conditions: Obesity

Summary: the objective of the orlifat trial is to investigate if dietary fibres from linseeds and dairy calcium (capolac ®) may reduce gastrointestinal side effects related to increased fecal fat content, induced by treatment with alli® (orlistat). secondly, effect on food intake, anthropometry, quality of life and cardiovascular risk markers will be evaluated. the trial is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in which 72 obese participants will be randomised to supplementation with flaxseed fibres and/or dairy calcium concentrate (capolac) in addition to treatment with alli ®: 1. alli® (60 mg t.i.d) plus placebo (rice flour) 2. alli® plus 5 g flaxseed fibers 3. alli® plus 1200 mg ca from capolac 4. alli® plus 5 g flaxseed fibers and 1200 mg ca from capolac


Eligibility criteria:
inclusion criteria: * 20-60 years of age * men and women * bmi 30-40 kg/m2 exclusion criteria: * dairy allergy and/or intolerance, allergy to orlistat * infectious and metabolic diseases * gastrointestinal diseases (previous and current) * troubles swallowing tablets and capsules * dietary supplement use during the trial and 1 month prior to the trial * postmenopausal (selfreported) * pregnancy and lactation * treatment with oral anticoagulation medications, ciclosporin, levothyroxin, antiepileptika, acarbose and amiodaron * prescription medication will be considered on an individual basis at the screening visit according to sop * dieting or other changes of diet within 3 months * participation in other trials

Keywords: obesity orlistat fat excretion fiber dairy calcium
effect of mitomycin c on urethral stricture recurrence after internal urethrotomy

Conditions: Urethral Stricture

Summary: the aim of this study is to evaluate the efficacy of local injected mitomycin c at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.


Eligibility criteria:
inclusion criteria: * male urethral stricture suitable for internal urethrotomy * stricture length less than 10 mm exclusion criteria: * stricture length over 10 mm * benign prostate enlargement

Keywords: urethral stricture mitomycin c internal urethrotomy
asthma, a disease due to a lack of bacterial infections in childhood.

Conditions: Food Allergy; Atopic Dermatitis; Asthma; Rhinitis

Summary: the degree of th1-skewing by mycobacteria is controlles by nramp1 gene polymorphisms and related to the degree of inhibition of th2-mediated disease.

a randomised single blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with bcg or placebo. inclusion: high-risk was defined as either a mother or a father and a sibling with present or past atopic disease. exclusion: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother), the use of antibiotics directly post-partum (newborn)

Eligibility criteria:
inclusion criteria: high-risk was defined as either a mother or a father plus a sibling with present or past atopic disease. exclusion criteria: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother) or directly post partum (newborn)

Keywords: prospective randomised intervention bcg atopy
photobiomodulation on major salivary glands in children with caries activity

Conditions: Caries,Dental

Summary: the purpose of this trial is to evaluate the efficacy of photobiomodulation of the major salivary glands on salivary parameters in children with caries activity.

dental caries represents one of the most prevalent diseases among children around the world. saliva plays a preponderant role in the process of demineralization- remineralization of the dental surface. patient salivary characteristics, such as flow rate, ph, and buffering capacity, provide relevant information about patient's risk for developing carious lesions. photobiomodulation has shown promising results to improve salivary flow rate, as well as buffer capacity in the adult population. the purpose of this trial is to evaluate the efficacy of photobiomodulation of the major salivary glands on salivary parameters in children with caries activity. methods: this protocol details a randomized, double-blind, parallel-group, controlled trial evaluating salivary parameters through photobiomodulation in children. seventy-eight 6- to 12-year-old participants will be randomly divided in two groups: 1) the photobiomodulation experimental group (g1) (n=39), 2) the photobiomodulationn placebo group (g2) (n=39). infrared light will be applied in 16 intra and extraoral points and the placebo, respectively. the unstimulated salivary sample will be taken before and immediately after the application once a week, for three consecutive weeks. salivary samples will be analyzed for flow rate, ph and buffering capacity. the primary outcomes are difference in salivary flow rates between the g1 and the g2. the secondary outcomes are difference in salivary ph and buffering capacity between the g1 and the g2 group.

Eligibility criteria:
nclusion criteria * individuals of both sexes, between 6 and 12 years old with mixed dentition. * participants diagnosed with the presence of at least one active caries lesion * good general health, without systemic or local diseases that affect salivary secretions. exclusion criteria * participants with severe active cavitated lesions with pulpal symptoms. * plans of the family nucleus to move for the duration of the study. * patients with a diagnosis of hyposalivation or xerostomia * presence of fixed appliances. * physical disability that interferes with oral or intellectual hygiene to answer the questionnaire.

Keywords: dental caries photobiomodulation salivary flow
study of swaddling on tactile learning in premature infants

Conditions: Premature Newborn

Summary: explore the sensorially of the premature newborn that is fundamental to adapting the care environment to these hospitalized babies

indeed, the challenge is to offer them an environment adapted to their sensory skills, so as not to alter their development. this is in line with the customized care development, better known as the anglo-saxon term of neonatal individualised developmental care and assessment program. the aim is thus to promote later the cognitive development of these children

Eligibility criteria:
inclusion criteria: * children born prematurely and aged 28 to 35 weeks of amenorrhoea, regardless of their postnatal age exclusion criteria: premature newborns with * associated anomalies syndrome * abnormal cranial ultrasonography with stage iii or iv intraventricular hemorrhage or periventricular cavitary leukaemia * those receiving sedative or convulsive treatment during the experiment * those whose grasping reflex is absent
intravenous levodopa for the diagnosis of parkinson's disease

Conditions: Parkinson Disease

Summary: patients with parkinson's disease have low levels of the neurotransmitter dopamine. dopamine is responsible for motor function and normal physical activity. patients with parkinson's disease typically suffer from tremors, rigid muscles, stooped postures, and walk with a shuffle. the drug levodopa acts as a replacement for dopamine and has been has been used effectively for over 30 years as treatment for parkinsons disease. because of its effectiveness, levodopa has been used to distinguish parkinson's disease from other conditions that may resemble parkinson's disease. traditionally, levodopa has been given as a pill. in this study, researchers would like to inject levodopa directly into a vein (intravenous) in order to diagnose cases of parkinson's disease. this method provides immediate results and allows doctors to adjust the dose of levodopa very carefully. because the intravenous method of giving levodopa is less practical than oral medication, it is not an available alternative for the routine treatment of parkinson's disease. however, it may be useful for faster diagnosis of the disease and for determining effective doses of oral medication.

a positive response to levodopa is now considered a condition sine qua non for the diagnosis of idiopathic parkinson's disease. under this protocol, patients with parkinsonism of uncertain etiology will be tested for their motor response to intravenous levodopa to aid in the diagnosis of parkinson's disease. this protocol regulates and stipulates the acute administration of intravenous levodopa and associated safety issues.

Eligibility criteria:
all patients will have parkinsonism of undetermined etiology. males and females between the ages of 18 and 85 are eligible for the study. no presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risks, specifically those who have the following: a history of convulsive, hepatic, or renal disorders; currently receiving treatment for myocardial infarction, arrhythmia or cardiac failure; and pregnant women or anyone not practicing an effective means of birth control.

Keywords: diagnosis infusion parkinsonism
evaluation of rocker soles in diabetis

Conditions: Diabetic Neuropathy

Summary: the purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.

diabetes is a public health problem. the functional prognosis is partly conditioned by the occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy. preventive measures are necessary to avoid such complications: education, pedicure, suitable footwear, insoles. there are many types of orthopedic shoes, standard or custom-made. a key objective is to avoid excessive pressure found at the level of the front-foot, favoring the appearance of lesions like ulcers. in this context, the anglo-saxons have developed a type of shoe ( "rocker sole"), allowing to decrease the pressures on the front-foot with a rigid sole system associated with an elevation of the front-foot. some, however, have shown that this type of shoe may be responsible for disorders of equilibrium to the healthy subject, what about at the diabetic patients, already at higher risk of postural disorders and falls?

Eligibility criteria:
inclusion criteria: * patient with type 2 diabetes * patients suffering from diabetic neuropathy diagnosed by the test in the monostrand * can walk without technical assistance * age from 18 to 75 * having made his non-opposition exclusion criteria: * presence of ulceration of the foot (or a history of this type) * history of pathologies that could disturb the balance and walking independently of diabetes: vestibular diseases, ophthalmic diseases with decreased of visual acuity, neurological, musculoskeletal and rheumatic diseases.

Keywords: type 2 diabetes diabetic neuropathy disorders of equilibrium "rocker sole" shoes walking
eeg objectification in neuropsychiatry

Conditions: Personality Disorder; Depression; Neurodegeneration; Alzheimer's Disease; Epilepsy

Summary: the main objective of the study is to evaluate the use of eeg in the management and follow-up of neuropsychiatric disorders. secondary objectives are therefore better understanding of the pathological activations in neural network during neuropsychiatric disorders, their clinical evolution and response to therapies.

patients are having eeg recordings as a routine part of their clinical evaluation and diagnosis. eeg recording is harmless, has no side effects, any radiation or any mechanical or electrical influence. it is of short duration and may be done in the eeg institute or the patient's room.

Eligibility criteria:
inclusion criteria: * diagnosis of the investigated neuropsychiatric disease exclusion criteria: * other co-existing neuropsychiatric conditions * refusal to participate in the study
effect of early limited formula use on breastfeeding outcomes

Conditions: Breastfeeding

Summary: the aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. the investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). both groups will receive intensive lactation support. outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. the hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.


Eligibility criteria:
inclusion criteria: * healthy term infants (37 to 42 weeks gestation) * infants who have lost 5% of their birth weight at \<36 hours of age exclusion criteria: * infants who have received formula or water * mothers who are producing mature milk supply * infants receiving level ii or level iii care other than healthy term infants with routine complete blood count and blood tests pending

Keywords: breastfeeding outcomes breastfeeding self-efficacy infant weight loss
energy metabolism in patients with short bowel syndrome

Conditions: Short Bowel Syndrome

Summary: this study proposes to verify the total energy expenditure in patients with short bowel syndrome using the doubly labeled water method, as well as determining the rate of oxidation of nutrients, aiming to assist the management of nutritional therapy for these patients.


Eligibility criteria:
inclusion criteria: * short bowel syndrome: short bowel syndrome patients with gastrointestinal transit time less or equal 30 minutes. * control group: patients with the same gender, presenting age and chronic diseases similar with volunteers from the group with short bowel syndrome. exclusion criteria: - short bowel syndrome: time of bowel resection surgery less than 1 year.

Keywords: energy metabolism stable isotopes short bowel syndrome doubly labeled water