Kornimate/medical-research-clean huggingface dataset:
effect of dry needling multifidus on thickness of transversus abdominis in healthy individuals

Conditions: Back Pain

Summary: intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of musculoskeletal pain. the mechanisms of action remain unknown, and this study will examine for a neurophysiological effect.

consenting adults will be taught how to contract their abdominal muscles, and to contract transversus abdominis in particular. they will then have real time ultrasound measurements of the resting and contracted thickness of their left transversus abdominis muscle. after this, they will receive actual or sham needling to their left multifidus muscle by another researchers blinded to the real time ultrasound measurements. after needling or sham intervention is complete, the original researchers will return to re-measure transversus abdominis. they will be blind to intervention allocation.

Eligibility criteria:
inclusion criteria: * age, absence of back pain or symptoms for greater than 6 months and ability to perform dcc. subjects must also report they are comfortable with being 'needled'. exclusion criteria: * presence of back pain or symptoms within the last 6 months, history of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis. if a subject reports a fear of needles.

Keywords: back pain
culturally enhancing a motivational interviewing intervention for latinx adolescents

Conditions: Underage Alcohol Use; Smoking, Non-Tobacco Products

Summary: the purpose of this study is to compare two versions of an intervention focused on teaching 10-14-year-old latina/o adolescent's skills that will decrease the likelihood that they will use tobacco, alcohol, and other drugs. we are also interested in determining how cultural context is related to substance use and whether additional information about other tobacco products should be added to the gmit intervention.

all adolescents will receive the group motivational interviewing for teens (gmit) intervention. gmit is an evidence-based group intervention that has been shown to prevent substance use among adolescents. in this project, gmit will be delivered virtually in a group setting to multiple latina/o adolescents. in addition, some parents will virtually participate in a parent-only support group; the other parents will not participate in any group. in this study, participants will be randomly assigned (like flipping a coin) to receive one of two versions of an alcohol, drug, and tobacco program. as part of the program teen participants will virtually attend six 30-min intervention sessions with other teens. parents may also participate in virtual group sessions. participants will be asked on three separate occasions (before, immediately after, and 3 months after the sessions) to complete forms (phone/online) that ask questions about teens behavior at home, school, and in the community.

Eligibility criteria:
inclusion criteria: * adolescents must be between 10 and 16 years of age - parents can be any age * parent and adolescent must consent/assent to participate as dyad * self-identify as latina/o or hispanic exclusion criteria: * under the age of 10 or over the age of 16 * parent or adolescent refuses * identify as non-latina/o or non-hispanic
treatment of advanced gastrointestinal tumors with albumin taxol

Conditions: Advanced Gastrointestinal Tumors

Summary: the purpose of this study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.in order to provide more effective chemotherapeutic drugs, prolong survival time and improve quality of life for patients with advanced digestive tract tumors.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen; 2. ecog ps 0-2； 3. expected survival time ≥3 months; 4. according to recist1.1, at least one measurable lesion exists； 5. the level of organ function must meet the following requirements（1）blood routine examination standards must be met：hb≥90 g/l；anc≥1.5×109/l； plt≥80×109/l；（2）liver function should meet the following criteria tbil≤1.5×uln；ast≤2.5×uln；（3）renal function should meet the following criteria: crcl≥60 ml/min； exclusion criteria: 1. pregnant or lactating women； 2. had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer; 3. active brain metastasis or severe disease; 4. grade 1 peripheral neuropathy (judged according to ncictc standard for adverse reactions); 5. patients with allergy to research drugs, albumin or previous allergies; 6. severe mental or neurological disorders affecting the presentation or observation of adverse reactions; 7. the investigator considers that there is any condition that may impair the subject or cause the subject to fail to meet or perform the study requirements.
effects of marine n-3 fatty acids on heart rate variability and arrhythmias in patients receiving chronic dialysis

Conditions: Kidney Failure Chronic; Arrhythmias Cardiac

Summary: background: end stage renal disease (esrd) patients have an extremely high mortality and the leading cause of death is cardiovascular disease which accounts for 50% of all deaths. it is estimated that about one third is due to arrhythmias. previous studies reveal a higher risk of various arrhythmias in dialysis patients but the prevalence is uncertain. atrial fibrillation is the most common arrhythmia among patients with esrd. the arrhythmia is often asymptomatic, but the risk of stroke increases dramatically and the annual mortality doubles. autonomic cardiac dysfunction is often seen in patients with esrd, and this is expressed by attenuated heart rate variability (hrv) which is a measure of the variation in the time interval between heart beats. attenuated 24 hours hrv is associated with an increased risk of sudden cardiac death in the general population and among patients with esrd. n-3 polyunsaturated fatty acids (pufas) in fish or fish oil supplements have been shown to increase hrv and reduce the risk of various ventricular and supraventricular arrhythmias in some but not all studies, but this effect has only been sparsely investigated in the high risk patients with esrd, who has a very low intake of n-3 pufas. objective: the purpose of this study is to investigate the effects of n-3 pufa supplementation on hrv and arrhythmias in dialysis patients. hypothesis: n-3 pufa supplementation increases 24 hours hrv in dialysis patients. n-3 pufa supplementation reduces the level of supraventricular tachycardia, premature atrial complexes (pacs) and premature ventricular complexes (pvcs) in chronic dialysis patients. design: randomized double-blind, placebo controlled trial study participants: 140 dialysis patients at aalborg university hospital and vendsyssel hospital, hjørring in denmark. inclusion time: summer 2014 to fall 2015 methods: the patients are allocated to 3 months treatment with supplements of 2 g n-3 pufas or placebo (olive oil). the following data are registered at baseline and after 3 months treatment: demographics and medical history, standard ecg-12, blood pressure, blood samples, 48 hours ambulatory ecg holter recordings, intake of n-3 pufas (assessed by questionnaires and blood measurements). perspective: a positive result of this study might make it possible to achieve a reduction in arrhythmias and mortality in these high risk patients by a cheap and well tolerated nutritional supplement.


Eligibility criteria:
inclusion criteria: * dialysis \> 3 months * age \> 18 years * signed informed consent exclusion criteria: * patients who is not able to consent. * known allergy to contents of the olive or fish oil capsules. * remaining life expectancy \< 3 months. * pregnancy (positive s-hcg) - test only performed in cases of doubt.

Keywords: renal dialysis arrhythmias cardiac death sudden cardiac fatty acids omega 3
safety and efficacy of a topical scalp treatment for dry scalp conditions in children and adult

Conditions: Dermatitis, Seborrheic; Dry Skin; Eczema

Summary: the purpose of this study is to evaluate the safety and efficacy of a novel topical treatment for dry scalp conditions, including dandruff, seborrheic dermatitis, and atopic dermatitis. the study investigates clinical improvements in symptom severity, participant experience with the treatment, and changes in the scalp microbiome before and after use. by studying this treatment, the investigators aim to provide children and adults with a natural, effective option for managing dry scalp conditions.

this study evaluates the safety and efficacy of a novel topical scalp treatment for dry scalp conditions, including dandruff, seborrheic dermatitis, and atopic dermatitis. the treatment contains lactobacillus sp., honey, and turmeric in an emollient base, hypothesized to alleviate symptoms by addressing microbial imbalances, reducing inflammation, and promoting scalp hydration. the study will enroll 15-40 pediatric participants aged 1-17 years and 20-40 adults aged 18 and older, all clinically diagnosed with dry scalp. all participants will apply the treatment over a 14-day period. adults will use the treatment daily, while pediatric participants will apply it 2-3 times weekly. other scalp therapies will be discontinued during the study period. the study aims to explore the treatment's potential to improve clinical severity, enhance quality of life, and positively impact the scalp microbiome, providing a natural, effective option for managing dry scalp conditions.

Eligibility criteria:
inclusion criteria: 1. age 1 year (or corrected age of 1 year, for those born prematurely) to 17 years for children, and adults 18 and older 2. patients with dry scalp and dandruff symptoms as determined by a board-certified dermatologist, allergist, or pediatrician 3. good general health 4. participant and/or their parents are able to read, write, and understand study materials in english exclusion criteria: 1. infants younger than 1 year old 2. patients diagnosed with other scalp diseases such as psoriasis, tinea capitis, and pediculosis capitis 3. systemic steroid or oral antibiotic use during the past two months 4. allergy to any of the preparation components
to determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days

Conditions: Infections, Fungal

Summary: to determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.


Eligibility criteria:
inclusion criteria: * subjects must be willing and able to provide informed consent. * subjects must be willing and able to be confined at the clinical research unit as required by the protocol. exclusion criteria: * subjects with any condition affecting drug absorption.

Keywords: pharmacokinetics voriconazole magnetic resonance spectroscopy
single injection of faricimab for namd with persisting fluid despite frequent aflibercept treatments

Conditions: Neovascular Age-related Macular Degeneration

Summary: the goal of this retrospective single-center chat review is to establish the efficacy and safety of a single dose of intravitreal faricimab (vabysmo®) injection in patients with neovascular age-related macular degeneration (amd), who were previously treated with aflibercept (eylea®) and had persisting intraretinal or subretinal fluid despite frequent treatments.


Eligibility criteria:
inclusion criteria * presence of neovascular age-related macular degeneration (amd) in the study eye * \>50 years of age * previous intravitreal anti-vegf treatment with aflibercept (eylea®) or with aflibercept and ranibizumab (lucentis®) in the study eye * minimum of 6 monthly aflibercept injections * persisting intraretinal or subretinal fluid or both, despite at least 3 consecutive monthly aflibercept injections in the study eye before switching to faricimab exclusion criteria * neovascular conditions other than amd (e.g., choroidal neovascularisation due to other causes) or co-existence of other retinal disease in the study eye * significant optical media opacities that would result in poor imaging quality on oct scans in the study eye * intraocular surgery in the study eye 3 months before or within 1 month after the treatment switch
dme and vegf trap-eye [intravitreal aflibercept injection (iai;eylea®;bay86-5321)] investigation of clinical impact

Conditions: Diabetic Macular Edema

Summary: this is a phase 2, doubled-masked, randomized study of the efficacy and safety of intravitreal aflibercept injection (iai;eylea®;bay86-5321) in subjects with diabetic macular edema (dme). approximately 200 subjects will be randomized in the us, canada, australia and eu.

qualified subjects will be randomized to one of 5 treatment arms. the active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up

Eligibility criteria:
inclusion criteria: * patients with clinically significant dme with central involvement * adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema * etdrs bcva: 20/40 to 20/320 (letter score of 73 to 24) in the study eye exclusion criteria: * history of vitreoretinal surgery in the study eye * panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening * previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening * previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening * uncontrolled diabetes mellitus * uncontrolled hypertension defined as systolic \> 180mmhg or \> 160 mmhg on 2 consecutive measurements or diastolic \> 100 mmhg on optimal medical regimen * ocular disorders in the study eye, other than dme, that may confound interpretation of study results
nanatinostat plus valganciclovir in advanced ebv+ solid tumors and in combination with pembrolizumab in ebv+ rm-npc

Conditions: Nasopharyngeal Carcinoma; EBV-Related Gastric Carcinoma; EBV-Related Leiomyosarcoma; EBV Related Carcinoma; EBV-Related Sarcoma

Summary: this study will evaluate the safety and efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory ebv-positive solid tumors and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma

this is an open-label, multicenter phase 1b/2 study evaluating nanatinostat in combination with valganciclovir alone and in combination with pembrolizumab. nanatinostat is a selective class i hdac inhibitor which induces ebv early lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. the phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended phase 2 dose (rp2d) in patients with ebv+ rm-npc followed by a project optimus \| fda (https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus) cohort to confirm the rp2d. up to 60 patients with ebv+ rm-npc will be randomized 1:1 to receive nanatinostat in combination with valganciclovir at the confirmed rp2d with or without pembrolizumab to evaluate safety, overall response rate, and potential pharmacodynamic markers in the phase 2 dose expansion part of the study. additionally, patients with other ebv+ solid tumors will be enrolled to receive nanatinostat in combination with valganciclovir at the rp2d in a phase 1b cohort. the study was prematurely terminated after the end of phase 1b and did not proceed to phase 2.

Eligibility criteria:
key inclusion criteria: * recurrent or metastatic ebv+ nasopharyngeal carcinoma (rm-npc) for whom no potentially curative options are available, who have received at least 1 prior line of platinum-based chemotherapy and no more than 3 prior lines of therapy for rm-npc. * phase 1b exploratory proof-of-concept cohort only: advanced/metastatic ebv+ non-npc solid tumors with no available curative therapies. * measurable disease per recist v1.1 * ecog performance status 0 or 1 * adequate bone marrow and liver function key exclusion criteria: * anti-tumor treatment with cytotoxic drugs, biologic therapy, immunotherapy, or other investigational drugs within 4 weeks or \>5 half-lives, whichever is shorter * active cns disease * inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir * active infection requiring systemic therapy * active autoimmune disease that has required systemic therapy with modifying agents, corticosteroids, or immunosuppressive agents * positive hepatitis b or hepatitis c
effect of topical calcipotriene/betamethasone (taclonex) in managing localized breakthrough in moderate to severe plaque psoriasis in patients receiving efalizumab (raptiva)

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of lmb (mild localized breakthrough) in patients recieving efalizumab (raptiva) for moderate to severe plaque psoriasis. it is hypothesized that calcipotriene/betamethasone (taclonex) could be used to manage lmb and thus allow patients to continue efalizumab without interruption.

lmb (localized mild breakthrough)is one of two psoriasis adverse events commonly seen in efalizumab treated patients. it is generally papular in nature and does not involve existing lesions. clinical experience suggests that lmb may not have a clinical impact in patients responding to efalizumab and therefore may be treated without interrupting efalizumab therapy. to relieve discomfort topical therapy may be indicated until the symptoms are resolved. this is a single arm, open label study. fifteen patients who are receiving efalizumab before entrance into this study and who develop lmb wil be enrolled. topical calcipotriene/betamethasone (taclonex) will be applied to the areas (except face, axillae or groin) once a day for two weeks. the pi may choose to continue two more weeks if needed for a total of four weeks of therapy. all patients will continue with efalizumab without dose modification for the duration of the study. patients will return for follow up visits at weeks 2, 4 and 6. topical desonide may be used for lmb involvement of the face, groin or axillae.

Eligibility criteria:
inclusion criteria: * ability to provide written, informed consent and comply with study assessments for the full duration of the study. * age 18 years or older. * moderate to severe plaque psoriasis being treated with efalizumab. * develop lmb during efalizumab treatment. * pga of lmb at least mild (2) excluding face, axillae and groin. exclusion criteria: * patients with known hypersensitivity to efalizumab, calcipotriene/betamethasone or any of its components. * pregnant or lactating women. * known or suspected disorders of calcium metabolism. * erythrodermic, exfoliative and/or pustular psoriasis. * concomitant use of topical thaerapy, phototherapy or immunosuppressive agents. * lmb (in areas other than face, axillae or groin) constitutes more than 30% of total body surface area. * patients with generalized inflammatory flare which is defined as widespread worsening of psoriasis characterized by erythematous and and edematous lesions within exisiting plaques. * any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.

Keywords: localized mild breakthrough
letrozole and sequential clomiphene to improve the outcome of embryo transfer

Conditions: Female Infertility Due to Nonimplantation of Ovum

Summary: the purpose of this study is to study the effects of letrozole and sequential clomiphene in ovulation and pregnancy in pcos patients.

to evaluate the efficacy of letrozole and clomiphene in pcos patients is important,especially in resistent pcos patients. although most medications prove the effectiveness of letrozole and clomiphene,the subjects of letrozole and sequential clomiphene in pcos patients are rarely.the trial may provide further basis for this medication in pcos patients in ovulation. if the medication demonstrates efficacy, the method would help the patients with pcos to deal with the problem of infertility.

Eligibility criteria:
inclusion criteria: * women with pcos exclusion criteria: * •women more than 38 years or less than 20 years * with infectious diseases or endocrine diseases * who refuse to participate in the experiment

Keywords: pcos letrozole clomiphene
gcsf injection in women with repeated implantaiton failure

Conditions: Repeated Embryo Implantation Failure

Summary: the purpose of the study is to see the impact of intrauterine injection of recombinant gcsf on pregnancy and implantation rate during ivf-icsi (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. in addition, following the injection, the level of g-csf in the bloodstream will be verified.

recently, scientists have been interested in g-csf (granulocyte - colony stimulating factor) and the latter has seen its use grow in reproductive pathology. g -csf, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving: * immune tolerance * the self-healing of oocyte chromosome abnormalities * the adherence of the embryo the injection of g-csf molecule has been used in different circumstances. one of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.

Eligibility criteria:
inclusion criteria: * women between the ages of 18 and 37 * indication of the antagonist ivf protocol or indication of a substituted frozen embryo transfer * subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger * subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37. * negative repetitive implantation failure work up exclusion criteria: * renal failure or cardiac failure * chronic neutropenia * past or present cancer history * sickle cell anemia * lithium treatment * voluntary withdrawal from the study * use of concomitant medication: dhea (dehydroepiandrosterone ), coq10 (coenzyme q10), growth hormone and viagra

Keywords: infertility ivf embryo transfer