Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of pi3k inhibitors in relapsed/refractory large granular t lymphocytic leukemia

Conditions: Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Summary: this is a prospective, multicenter, single-arm, pilot study. the aim of this study is to evaluate the efficacy and safety of linperlisib, the pi3k delta inhibitor for patients with relapsed/refractory large granular t lymphocytic leukemia.


Eligibility criteria:
inclusion criteria: * male or female age ≥ 18 years * diagnosis of t-cell large granular lymphocytic leukemia (t-lgll) * meet any of the following indications for treatment： 1. hemoglobin \< 100g/l or rbc transfusion dependence 2. neutrophil count \<0.5×10\^9/l or neutrophil count decreased with recurrent infection 3. progressive splenomegaly and/or massive splenomegaly 4. combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc. 5. severe b symptoms * failure or intolerance to a first-line therapy * ecog performance status ≤2 * expected survival ≥ 6 months * willing and able to comply with the requirements for this study and written informed consent. exclusion criteria: * history of other lymphoproliferative neoplasms * had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors * previously received organ or stem cell transplantation. * patients with active infection within 2 weeks before giving the first dose of medication * patients with hbv, hcv, hiv or other infections that require treatment * history of immunodeficiency, or congenital immunodeficiency disorders * any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract. * abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that alt and ast are 2.5 times higher than the upper limit of normal values * renal impairment: creatinine clearance \<60ml/min * history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc. * received attenuated vaccine 4 in weeks before enrollment * participation in another clinical trial within 4 weeks before the start of this trial * have an allergy to linperlisib or any other part of this medicine. * previously treated with other pi3kδ inhibitor. * pregnant or breast-feeding patients * patients considered to be ineligible for the study by the investigator for reasons other than the above
pilot test of a community-based buprenorphine treatment intervention

Conditions: Opioid Dependence; Injection Drug Use

Summary: the main goal of this study is to pilot test the community-based buprenorphine treatment (cbbt) intervention, examining buprenorphine treatment initiation, opioid use, and hiv risk behaviors. two groups of participants will be followed for 60 days, with 3 research visits. one group will be enrolled prior to the cbbt intervention (pre-intervention), and one group after the cbbt intervention (post-intervention). data sources will include questionnaires, urine toxicology tests, and medical record data. investigators hypothesize that compared to the participants in the pre-intervention group, participants in the post-intervention group will be more likely to initiate buprenorphine treatment, reduce opioid use, and reduce high-risk hiv risk behaviors.


Eligibility criteria:
inclusion criteria: * at least 18 years old * english or spanish fluency * ever injected drugs * not receiving buprenorphine treatment (no prescribed buprenorphine in the previous 6 months) * clients of our collaborating community-based organization * interested in buprenorphine treatment exclusion criteria: * pregnant * taking more than 60mg of methadone daily in the previous 30 days

Keywords: opioid dependence injection drug use buprenorphine opioid agonist treatment access to care hiv risk behaviors opioids
different maxillary sinus 3d shapes assessment using cbct volumetric segmentation

Conditions: Cone-beam Computed Tomography; Maxillary Sinus; Anatomical Variations

Summary: the study aims to assist the different 3d shapes of maxillary sinus in adult individuals among egyptian population,the data collection will be obtained from the data base available at the department of oral and maxillofacial radiology, faculty of dentistry, cairo university. cbct images will be obtained from egyptian patients who were referred to the cbct unit in oral and maxillofacial radiology department for different purposes. the following radiographic examination will be done in oral and maxillofacial radiology department, faculty dentistry, cairo university. semiautomated segmentation will be performed for the maxillary sinus in both side and then linear and 3d volume will be assessed for each sinus.


Eligibility criteria:
inclusion criteria: * cbct scans of adult egyptian patients, males and females, with age range between 18 and 50 years old. patients will be divided into two age groups (group 1 less than or equal 30 years old, group2 more than 30 years old). * cbct scans of patient without previous orthodontic treatment. * cbct scans without any other treatment that might interfere with the natural course of maxillomandibular growth and development. exclusion criteria: -scans with maxillary pathologies like (tumors, odontogenic lesions, bone lesions). * patients with traumatic injuries or fractures affecting the maxillary sinus. * patients with missing upper premolar or molar teeth in one side or both sides. * patients with skeletal asymmetries, craniofacial traumas and developmental anomalies such as palatal cleft. * images of low-resolution quality. * distortion of images or presence of any artifacts.
liposomal doxorubicin and docetaxel in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: evaluation of safety and efficacy of a treatment associating pegylated liposomal doxorubicin + docetaxel in patients with metastatic breast cancer

evaluation of safety and efficacy of a treatment associating pegylated liposomal doxorubicin + docetaxel in patients with metastatic breast cancer. patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.

Eligibility criteria:
inclusion criteria: * first metastatic chemo line * presence of measurable or bone lesion * at least one lesion outside the radiated areas * can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks exclusion criteria: * only local tumoral progression * symptomatic cerebral metastasis * neuropathy \> nci-ctc 2 * previous cancer within 10 years _ previous cancer within 10 years
comparison of efficacy and safety of 0.1% tacrolimus and 0.1% mometasone furoate for adult vitiligo

Conditions: Vitiligo

Summary: vitiligo has remained a difficult disease to treat. previous available therapies are often ineffective. it usually takes several months or years for complete repigmentation and some areas of the body get at best only partial repigmentation. the desire of the patient to undergo therapy varies from patient to patient and needs to be assessed individually. several factors should be considered when planning the treatment strategies including type of vitiligo, site and degree of involvement, skin color, psychological effect, patient compliance, ease to assess to therapy, cost of treatment and social association of the disease. topical corticosteroids are still be the standard treatment of localized vitiligo. however, the adverse effects such as skin atrophy, striae, pigmentary change and hypothalamic-pituitary adrenal axis suppression can occur if we use inappropriate strength of topical steroids for a long period of time. tacrolimus (fk-506) is a new immunosuppressive agent that acts by inhibiting t-cell activation and cytokine release. it offers a safe and efficacious alternative for many skin conditions. it minimizes the need for topical glucocorticoids and does not cause skin atrophy. tacrolimus was first reported for treatment of vitiligo in 2002. the underlying mechanism was shown in an in vitro study that topical tacrolimus promoted proliferation of melanocytes and melanoblasts. this study purpose is to evaluate the efficacy and safety of 0.1% topical tacrolimus ointment comparing to 0.1% mometasone furoate cream in the treatment of adult vitiligo.

at first visit, patients will be randomized to receive 0.1% tacrolimus ointment for apply to vitiligo lesion on one side of the body. the lesion on the other side of the body will be treated with 0.1% mometasone furoate cream. patients are instructed to apply 0.1% tacrolimus ointment and 0.1% mometasone furoate cream twice a day for 6 months patients will be follow up at 2, 4 and 6 months for clinical improvement, side effects and photographs

Eligibility criteria:
inclusion criteria: 1. patients must be above 18 years old 2. patients must have symmetrical vitiligo lesion on both sides of the body. total vitiligo area is not exceeded 5% of the body surface area 3. discontinue any previous systemic medication or phototherapy for at least 3 months and discontinue any topical medication for at least 1 month before starting the study exclusion criteria: 1. patient who have the lesion on acral area (hands or feet) 2. pregnancy or lactation patient

Keywords: vitiligo tacrolimus mometasone furoate
effect of pregabalin on post operative pain in abdominal hysterectomy under spinal anesthesia with intrathecal morphine

Conditions: Post Operative Pain

Summary: this study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.

the participants are randomized into two groups by computer randomization. the patient undergo spinal anesthesia with 0.5% heavy bupivacaine with morphine 0.2 mg. iv pca morphine is initiate in the post-anesthetic care unit. we compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.

Eligibility criteria:
inclusion criteria: 1. asa classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine 2. patient can use patient-controlled analgesia (iv pca) exclusion criteria: 1. history of drug allergy to gabapentinoid and related drug 2. history of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient 3. renal disease (creatinine clearance \< 60), liver disease, seizure disorder and psychiatric disorder

Keywords: pregabalin postoperative pain abdominal hysterectomy
casting versus percutaneus pinning treatment of pediatric overriding distal forearm fractures

Conditions: Pediatric Overriding Distal Metaphyseal Radius Fractures

Summary: this is a randomized controlled trial comparing casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in under eleven years old children.

overriding pediatric distal radius fractures have been managed with anatomical reduction performed under anesthesia with or without percutaneous pinning. this research protocol was developed due to good results reported on leaving the fractures in an overriding position. in this randomized controlled trial, we will compare objective outcomes between casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in children. inclusion criteria are patients younger than 11 years old (tanner 0) with completely overriding distal radius fractures. at the emergency department patients are randomized into two groups: finger trap traction and cast immobilization (experimental group) and anatomic reduction and percutaneous pin fixation (control group). the current controversy is whether cast immobilization alone is an adequate stabilization or whether percutaneous pin fixation is more appropriate for displaced, complete, distal forearm (overriding) metaphyseal fractures. the objectives of this trial are to compare the outcomes between conservative treatment with finger trap method for completely displaced distal radius fractures and surgical treatment with percutaneous pinning. our null hypothesis is that there are no radiological or clinically relevant differences in outcome measures between the two treatment groups. we consider non-inferiority proven if there is no clinically significant difference at 6 months between the two treatments groups in the primary outcome: ratio (%) of forearm rotation and wrist extension-flexion range of motion (rom) compared to the non-affected side at 6 months (non-inferiority margin 10%).

Eligibility criteria:
inclusion criteria: * child with open epiphysis with closed overriding metaphyseal distal radial fracture with or without an associated fracture of the ulna * normal communication development (languages finnish, swedish, english) exclusion criteria: * bilateral forearm injuries * gustillo-anderson grade ii or iii open fracture * galeazzi fracture-dislocation * polytrauma * neurovascular injury of the ipsilateral upper extremity * history of a displaced forearm fracture * underlying disease affecting fracture healing

Keywords: bayonet fracture paediatric fracture distal forearm fracture overriding fracture
newly-diagnosed pediatric t-cell all protocol

Conditions: Acute Lymphoblastic Leukemia; Childhood Leukemia, Acute Lymphoblastic; T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

Summary: this is a prospective, multicenter study conducted within the chinese children's cancer group (cccg). the study aims to evaluate whether the addition of three novel agents, dasatinib, venetoclax and homoharringtonine, can improve the minimal residual disease (mrd)-negative remission rate, enhance event-free survival (efs), and reduce the cumulative incidence of relapse (cir) in pediatric patients with newly diagnosed t-cell acute lymphoblastic leukemia (t-all).

the cccg-t-all-2025 protocol will be modified as following based on the above analysis of the cccg-all-2020 protocol. 1. all t-all patients will receive 8 mg/m2/day dexamethasone in induction therapy. 2. all non-etp t-all patients will receive dasatinib after initial window phase in induction therapy. 3. non-etp t-all patients with mrd ≥ 0.01% on day 46 will be stratified and randomized to receive different doses of homoharringtonine during early intensification. 4. for all etp/near-etp t-all patients, venetoclax will replace daunorubicin in induction therapy. 5. for all etp/near-etp t-all patients, venetoclax will replace daunorubicin in interim therapy 2 and 4. 6. cat will replace cat+ during early intensification, and will be administrated to all etp/near-etp patients, as well as non-etp patients with mrd\< 0.01% on day 46. 2.11.7 in maintenance therapy 2, the ctx+ara-c treatment cycles are reduced to 5, in order to minimize the impact of alkylating agents on fertility. 2.11.8 add drug sensitivity testing for t-all.

Eligibility criteria:
inclusion criteria: 1. age older than 1 month to younger than 18 years. 2. diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3. diagnosis of t-all by immunophenotyping. exclusion criteria: 1. b-all 2. aml 3. acute leukemias of ambiguous lineage diagnosed according to who or egil criteria. 4. all evolved from chronic myeloid leukemia (cml). 5. down's syndrome, or major congenital or hereditary disease with organ dysfunction 6. secondary leukemia 7. known underlying congenital immunodeficiency or metabolic disease 8. congenital heart disease with cardiac insufficiency. 9. treated with glucocorticoids for ≥14 days, or abl kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression) 10. any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. in such cases, all participating sites must report directly to the pi to determine whether the patient meets exclusion criteria. 11. severe malnutrition, active infections, heart failure, or chemotherapy intolerance.

Keywords: dasatinib venetoclax homoharringtonine
leptospermum scoparium honey and wound care for pressure ulcers

Conditions: Pressure Ulcers

Summary: the investigators hypothesize that the use of leptospermum scoparium honey as a type of dressing and/or debridement agent on stage iii or iv pressure ulcers has an increased efficacy and safety compared to the current treatment protocol that includes the use of hydrogel/vaseline, collagenase, and silver alginate dressings as the standard of care. utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as a treatment for stage iii and stage iv pressure ulcers will not be inferior to the comparison treatment of standard of care wound dressings. moreover, this research design will enable the research team to determine if the honey based dressings are equivalent to or superior to the comparison treatment. therefore, the investigators specific study objectives are as follows: 1. primary objectives: determine if the use of honey as an alternative treatment will reduce site inflammation/irritation and pain associated with pressure ulcers compared to the standard treatment options. specifically, the investigators will monitor patient push scores, braden risk scale scores, granulation and/or epithelial tissue progression, length of time to heal, patient pain assessments via the wong baker face or numeric scale, wound odors, and incidence of adverse events (measured by allergies, stinging sensations, bacterial infections that warrant antibiotic intervention, etc.). 2. secondary objective: patients in the honey treatment group will have lower costs per healed ulcer than patients in the standard collagenase treatment group.

design: non-inferiority trial. this design is intended to demonstrate that leptospermum scoparium honey treatment is no worse than the standard treatment for pressure ulcers. data collection procedures: members of the research team will administer all wound care treatments on all of the patients in this research project. after initial evaluation and documentation of the presence of pressure ulcers, patients with stage iii and stage iv ulcers are randomized into the two groups; treatment and control. patients that develop nosocomial stage iii and stage iv pressure ulcers will also be included in this study and randomly placed into one of the groups. the following protocol will be followed.

Eligibility criteria:
inclusion criteria: * adult (18 years old and older) * newly admitted patients with a diagnosis pressure ulcers (stages iii and iv) or patients who develop nosocomial pressure ulcers stage iii and stage iv * ability to provide written informed consent (either patient or legal personal representative) exclusion criteria: * patient/representative refuses to give written informed consent * patient diagnosed with terminal illness

Keywords: wound care medical grade honey pressure ulcers
morbidity rate for uti through use of pcr-based diagnosis and management

Conditions: Urinary Tract Infections

Summary: this retrospective study is to determine if the use of pcr for detection and identification of pathogens in uti along with antimicrobial susceptibility information, affords more efficacious treatment of uti, as compared to traditional urine culture for patients served by house call physicians.

the objective of this study is to determine if retrospective data will show that use of pcr for detection and identification of pathogens in uti, and antimicrobial susceptibility information, affords more efficacious treatment of uti, thereby reducing uti-related morbidity and costs in a patient population that is served by house call physicians. house call physicians attend elderly and other adults patients who are suffering from illness or chronic conditions in the safety, privacy, and comfort of their home or assisted living location. in making house calls, physicians ease the burden and difficulty of these chronic patients from traveling to the doctor's office.

Eligibility criteria:
inclusion criteria: * all patients that the house call physician suspects the patient has a uti and are tagged with the following codes within the medical record exclusion criteria: * records where the npi does not match a known provider or the office listed is not a specific population * hospice patients * records for which dx codes of "x" and "nodx" where there isn't a diagnostic description.

Keywords: uti home care
modafinil treatment for sleep/wake disturbances in older adults

Conditions: Insomnia; Sleep Initiation and Maintenance Disorders; Alzheimer Disease

Summary: modafinil, trade named provigil, is a medication approved by the food and drug administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. modafinil is prescribed during the day to counteract this sleepiness. the idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. this study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of alzheimer's disease or mild cognitive impairment * subjective complaint of sleep disruption, unsatisfactory sleep, early morning awakening, early bedtime, or excessive daytime sleepiness. such complaint can be made by either the potential participant or by the caregiver. exclusion criteria: * participation in any other clinical drug trial * liver failure * believed by the investigator to be unwilling or unable to follow the protocol * active liver or coronary disease

Keywords: mild cognitive impairment (mci) sleep fatigue memory