Kornimate/medical-research-clean huggingface dataset:
co2-laser treatment for caesarean section scars

Conditions: Cicatrix

Summary: fractional co2-laser for treatment of mature caesarean section scars.

randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.

Eligibility criteria:
inclusion criteria: * mature caesarean section scar exclusion criteria: * systemic uncontrolled disease * recent or current cancer * smoking * keloid formation * wounds or local disease int treatment area * pregnancy or lactation
tumor local excision +postoperative adjuvant chemoradiotherapy for t1-2n0m0 low/ultra-low rectal cancer

Conditions: Rectal Cancer Stage I

Summary: this study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low/ultra-low rectal cancer. the study plans to enroll 60 patients with t1-2n0m0 low/ultra-low rectal cancer.

baseline examnation: all enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (incl. cea, ca-199, ca-724 β2-microglobulin, ferroprotein), chest ct, abdominal and pelvic mri, etc., were required to undergo kras, nras, bref, pd-l1, mmr/mss testings before surgery, and blood lymphocyte subgroups were analyzed before surgery. all enrolled patients will first undergo local tumor resection. adjuvant therapy will be initiated 4-6 weeks postoperatively based on pathological staging: for pt1n0m0 patients without high-risk features: active surveillance or radiotherapy alone (prescription: pelvic field irradiation 45gy in 25 fractions) for pt2n0m0 or pt1n0m0 patients with adverse prognostic factors (including poorly differentiated histology, lymphovascular invasion, positive margins\*, tumor infiltration beyond the outer third of the submucosal muscle layer（sm3 level）, or submucosal invasion \>1mm): adjuvant chemoradiotherapy (prescription:pelvic field irradiation 45gy in 25 fractions plus local tumor bed boost 5.4gy in 3 fractions；concurrent chemotherapy: oral capecitabine 825mg/m² twice daily)；for patients with positive margins after local excision: re-excision followed by adjuvant chemoradiotherapy or dose-escalated chemoradiotherapy (prescription: pelvic field irradiation 45gy in 25 fractions plus local tumor bed boost 14.4gy in 8 fractions)； for patients with staging \> pt2n0m0: total mesorectal excision (tme) following treatment completion, patients will enter clinical follow-up surveillance.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years, regardless of gender 2. ecog performance status 0-1 3. biopsy-proven rectal adenocarcinoma 4. distal margin of primary tumor ≤8 cm from anal verge 5. clinical stage i (ct1-2n0m0) 6. strong organ preservation preference with refusal to undergo abdominoperineal resection (miles operation) 7. the surgeon determined a local resection was feasible 8. no contraindications to chemoradiotherapy exclusion criteria: 1. failure to meet the above inclusion criteria 2. patients refusing to sign informed consent 3. impaired cognitive function or psychiatric disorders 4. patients deemed ineligible by investigators

Keywords: adjuvant chemoradiotherapy local excision low/ultra-low rectal cancer early rectal cancer
pilot feasibility study with patients who are at high risk for developing invasive candidiasis in a critical care setting (mk-0991-067)

Conditions: Invasive Candidiasis

Summary: this is a pilot feasibility study that investigates antifungal therapy with caspofungin in patients at high-risk for developing invasive candidiasis in a critical care setting.

hypothesis: in high-risk non-neutropenic participants in the icu, the proportion of participants discontinued from study therapy in order to be empirically treated with antifungal therapy for suspected candidiasis outside of the context of this protocol is less than 20% (i.e., the upper bound of the 95% confidence interval for the observed proportion is less than 20%).

Eligibility criteria:
inclusion criteria: * hospitalization for a minimum of 3 days in an icu and expectation to stay in the icu for at least another 48 hours * meets the following high-risk criteria: requires mechanical ventilation at the time of study entry; and has a central venous catheter in place at the time of study entry; and is receiving broad spectrum antibiotics at the time of study entry; and meets at least one of the following criteria: required parenteral nutrition during the current icu admission; or required renal dialysis during the current icu admission; or had major surgery during or within the 7 days before the current icu admission; or was diagnosed with pancreatitis during or within the 7 days before the current icu admission; or required systemic steroids or other immunosuppressive agents during or within the 7 days before the current icu admission * meets at least one of the following criteria of suspected infection at the time of study entry or within the 24 hours before study entry: temperature ≥38° c or ≤36° c (oral equivalent); or hypotension (systolic blood pressure of \<90 mm hg) or significant drop in blood pressure (40 mm hg) from the participant's normal baseline; or elevated white blood cell count of ≥12,000/mm\^3 * candida is growing in at least one non-sterile culture site collected during the current icu admission * female of childbearing potential has a negative serum or urine pregnancy test before enrollment exclusion criteria: * females pregnant or breast feeding * history of allergy, hypersensitivity, or any serious reaction to caspofungin or another member of the echinocandin class (e.g., micafungin, anidulafungin) * neutropenia or expected to develop neutropenia during study therapy * diagnosis of acquired immune deficiency syndrome (aids), aplastic anemia, or chronic granulomatous disease * diagnosis of moderate or severe hepatic insufficiency * patient not expected to survive at least 24 hours * received systemic (iv or oral) antifungal therapy within 10 days before study entry * active diagnosis of proven or probable invasive fungal infection (ifi) * currently on or has received an investigational agent within 10 days before study entry * any condition or concomitant illness which might confuse the study results or pose additional risk in administering the study therapy

Keywords: candidiasis invasive candidiasis fungal infection empirical therapy
biomarkers of food intake using a cross-over feeding study

Conditions: Diet Habit

Summary: assessment of dietary intake is key for understanding the links between diet and health. here, researchers will study molecules in urine samples to give them an insight into what people have eaten. these new molecules are called dietary biomarkers. this study will help to identify new molecules that can act as biomarkers of commonly consumed foods. these can then be used in the assessment of diet, identification of diet-related diseases and used how to explain how a dietary intervention (programme) will work, thereby adding to scientific knowledge.

for biomarker discovery a cross-over study where participants will visit the human intervention centre (in ucd) on 3 occasions (3 study days) with a minimum one week between each visit. the order of consumption of the test foods will be randomized. the test foods are mixed vegetables (spinach and lettuce), green beans and mixed berried (strawberries and blueberries). for each study day, the participants will arrive fasting and provide a urine sample (0h sample). for 24h prior to the study day participants will avoid the test foods. participants will consume the food and urine samples will be taken at 2, 4, 6 and 24 h post consumption . standard portions of the test food will be eaten on each occasion. between the visits, participants will consume their habitual diet. the samples will be analysed using the metabolomics platforms lc-ms and nmr spectroscopy. both nmr and lc-ms data generated will undergo statistical analysis such as principal component analysis (pca) and supervised analysis such as partial least squares-discriminant analysis (pls-da). validation of such models will be performed using permutation testing.

Eligibility criteria:
inclusion criteria: 1. healthy adults aged 18-50 years old 2. bmi\<30. exclusion criteria: 1. smokers 2. diagnosed health condition (chronic or infectious disease) 3. taking medication (oral contraceptive pill is allowed) 4. pregnant, lactating 5. allergies/intolerances to any of specified test foods

Keywords: metabolomics dietary biomarkers personalized nutrition
gene transfer clinical trial for krabbe disease

Conditions: Krabbe Disease

Summary: this is a nonblinded, non-randomized dose escalation study of intravenous aavrh10 after hematopoietic stem cell transplantation (hsct) in which subjects will receive standard of care hematopoietic cell transplantation for krabbe disease, followed by a single infusion of an adeno-associated virus gene therapy product. extensive natural history subjects will be used to compare as control group.


Eligibility criteria:
inclusion criteria: 1. diagnosis of infantile krabbe disease, characterized by the following criteria outlined below: * galactocerebrosidase (galc) activity levels in leukocytes compatible with the diagnosis of krabbe disease; and at least one of the following: * elevated psychosine levels predictive of infantile disease onset by dbs; or * imaging or neurophysiological findings consistent with krabbe disease (csf, mri, ncv, abr); or * two galc mutations predictive to result in infantile onset phenotype. 2. age at the time of screening: 1 day to 12 months 3. participant has been deemed eligible for treatment with hsct (standard of care) and a fully myeloablative reduced intensity/toxicity conditioning regimen (ric/rtc) is/has been used 4. participant's parents or legal guardian consents to participate in the study and provides informed consent according to irb guidelines prior to any study procedures being performed 5. parent(s) and/or legal guardian able to comply with the clinical protocol 6. participant must have adequate organ function at time of screening as measured by: * creatinine ≤ 1.5x upper limit of age appropriate normal and creatinine clearance ≥ 60 ml/min/1.73 m2 * hepatic transaminases (alt/ast) ≤ 2x age related upper limit of normal * ejection fraction of \> 50% by echocardiogram or other appropriate study without evidence of pulmonary hypertension * pulmonary evaluation testing demonstrating resting pulse oximeter \> 95% on room air * coagulation tests within 110% of normal ranges for age. (pt/inr and ptt) exclusion criteria: 1. history of prior treatment with a gene therapy product 2. presence of major congenital anomaly or any other condition that affects neurodevelopmental function 3. presence of any neurocognitive deficit or brain damage not attributable to krabbe disease 4. active aspiration 5. signs of active infection or disease from cytomegalovirus, adenovirus or other viruses 6. hiv positive 7. uncontrolled and progressive bacterial or fungal infection 8. presence of any contraindication for mri 9. use of any investigational product prior to study enrollment or current enrollment in another study that involves clinical interventions 10. any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the pi, would preclude participation in the study 11. ongoing veno-occlusive disease (vod) as determined by liver ultrasound (moderate ascites and static or retrograde portal vein flow) the day before fbx-101 infusion.

Keywords: lysosomal storage disorder globoid cell leukodystrophy leukodystrophy galc
physical activity level, aerobic capacity and dietary habits among a cohort of females with premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: the aim of the study is to investigate the physical activity level, aerobic capacity and dietary habits among a cohort of females with premenstrual syndrome

premenstrual syndrome can be defined as a recurrent disorder that occurs every month in the luteal phase of the menstrual cycle, and subside with the onset of menstruation. it is characterized by a complex set of symptoms, which include physical, psychological and behavioral changes with varying severity. this can interfere with the lives of females. physical exercise improves pms through rising endorphin levels, reducing adrenal cortisol symptoms, leading to lesser anxiety, depression and greater pain tolerance, as previous studies showed that it was effective in decreasing pain as well as mental and physical symptoms of pms. recently, lifestyle changes have gained more importance than pharmacotherapy. lifestyle changes include many methods including diet regulation and exercise. 30 minutes of aerobic exercise is recommended for at least 3 days per week to contribute to the regulation of both body composition, mood and to improve physical symptoms. evidence suggests that it can be helpful in reducing symptoms.

Eligibility criteria:
inclusion criteria: * 1-suffering from pms (as determined by pms scale) 2-their ages range from 20 to 35 years 3-having regular menstrual cycle exclusion criteria: * 1-smoking 2-following any special diet 3-taking any medication 4-history of chronic disease 5-having any psychiatric or gynecological problems

Keywords: physical activity level, aerobic capacity and dietary habits in pms
a trial of shr-1707 infusion in patients with mild cognitive impairment due to alzheimer's disease and mild alzheimer's disease

Conditions: Alzheimer's Disease (AD)

Summary: to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of shr-1707 in patients with mild cognitive impairment (mci) due to alzheimer's disease (ad) and mild ad for 26 weeks.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial, 2. male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form. 3. total body weight of 45\~100 kg (inclusive), with a body mass index (bmi) of 19\~32 kg/m2 (inclusive)at screening or baseline. 4. the subjects must meet the following clinical criteria for mild cognitive impairment (mci) due to alzheimer's disease (ad) or criteria for mild ad. 5. the subjects should have a stable caregiver who will help the patients to participate in the whole study process. exclusion criteria: 1. cognitive impairment due to other medical or neurological factors (non-ad). 2. history of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year. 3. any psychiatric diagnosis that may interfere with the subject's cognitive assessment. 4. inability to tolerate mri examination or have contraindications to mri examination. 6. exclusion criteria related to previous or concomitant diseases, as listed in the protocol. 7. exclusion criteria related to general or laboratory tests, as listed in the protocol. 8. the subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period. 9. severe visual or hearing impairment, unable to cooperate in the scale examination. 10. patients suspected to be allergic to aβ antibody drugs and their excipients. 11. women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating. 12. history of drug abuse and/or drug addiction within 1 year prior to screening. 13 use of dual antiplatelet or anticoagulant drugs within 3 months prior to the randomization period or planned during the trial. 14.have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization. 15. those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening. 16. investigators and site-related personnel or other persons directly involved in the implementation of the protocol. 17. other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.
a study of prt7732, an oral smarca2 degrader, in patients with advanced or metastatic solid tumors with a smarca4 mutation

Conditions: Advanced Solid Tumor; Metastatic Solid Tumor; Non-small Cell Lung Carcinoma; SMARCA4 Mutation

Summary: this is a phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of prt7732 in patients with select advanced or metastatic solid tumors with a smarca4 mutation.

this is an open-label, multi-center, first-in-human, phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of prt7732 an oral smarca degrader in patients with select advanced or metastatic solid tumors with a smarca4 mutation. approximately 104 participants will be enrolled.

Eligibility criteria:
inclusion criteria: * willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures * histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mutation of smarca4 by local testing that has either progressed on or is ineligible for standard of care therapy * must have measurable or non-measurable (but evaluable) disease per recist v1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * willing to provide either archival or fresh tumor tissue sample * adequate organ function (hematology, renal, and hepatic) exclusion criteria: * participants with solid tumors with known concomitant smarca2 mutation or loss of protein expression * clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (cns) metastases or leptomeningeal disease * history of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study * receipt of any targeted therapy directed against brm/brg1 (smarca2/smarca4).

Keywords: advanced solid tumors brg1 brm degrader metastatic solid tumors non-small cell lung cancers nsclc prt7732 smarca2 smarca4
the effects of varenicline on cognitive function in patients with schizophrenia

Conditions: Schizophrenia

Summary: the primary objective of this project is to examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. the secondary objective is to evaluate the effect of this combination therapy on smoking in people with schizophrenia. this study will be a randomized, double blind, parallel group, placebo controlled 8 weeks trial.

cognitive deficits have been considered as a core symptom domain of schizophrenia. amelioration of or improvement in cognitive impairments is becoming an important focus of clinical treatment development. varenicline is a potent and selective alpha 4 beta 2 nicotinic acetylcholine receptor partial agonist that has been developed for smoking cessation. in animal studies, alpha 4 beta 2 receptor agonists significantly improve working memory and attention function. subjects will be assigned in 1:1 ratio to receive varenicline or placebo respectively. assessments will be done using several neuropsychologic tests, clinical rating scale including assessment of nicotine withdrawal scales.varenicline has been found to be efficacious for smoking cessation in the general population and animal studies have demonstrated the cognitive benefits of this agent. however, no published work is available evaluating the cognitive effects in humans. thus, patients may experience improvements in cognitive function and in people who are smokers, these people may be able to achieve abstinence in smoking. this will in turn improve long-term functional outcomes and health outcomes in people with schizophrenia. this is an exciting opportunity for discovery if indeed cognitive abilities could be improved with this adjunctive treatment.

Eligibility criteria:
inclusion criteria: * clinically stable patients with schizophrenia exclusion criteria: * refractory schizophrenia * mental retardation * serious medical illness

Keywords: schizophrenia cognition varenicline
improving hiv prevention among heterosexual cisgender men seeking sti services in malawi

Conditions: HIV Infection; Sexually Transmitted Infections; Pre-exposure Prophylaxis; Systems Navigation

Summary: to evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered hiv prevention intervention in promoting and supporting persistent use of evidence-based hiv pre-exposure prophylaxis (prep) among heterosexual cisgender men receiving care for sexually transmitted infections (stis) in lilongwe, malawi.


Eligibility criteria:
inclusion criteria: 1. cisgender adult and adolescent cisgender men who meet all of the following criteria are eligible for inclusion in this study as a participant initiating prep: * age ≥18 years, or age 15-17 (with assent and parent/guardian consent) * able to provide informed consent * no plans to move outside study area for at least 26 weeks after study enrollment * willing to provide contact/locator information, including phone number, to facilitate tracing * willing to participate in study activities, including specimen collection * willing to participate in study activities, including systems navigation, counseling, and point of contact sti testing * sought sti clinic services within 7 days of enrollment * initiated on prep at sti clinic within 7 days of enrollment * reports at least one cisgender female sex partner in the 6 months prior to enrollment * self-identifies as heterosexual 2. individuals who meet all of the following criteria are eligible for inclusion in this study as other key stakeholders: * age ≥18 years at the enrollment visit * able to provide informed consent * involved in provision of clinical service navigation, systems navigation, sti or hiv care or prevention (including clinic management or oversight), or development of hiv prevention policy or programs at local or national level exclusion criteria: 1. cisgender adult and adolescent men who meet any of the following criteria are ineligible for inclusion in this study as a participant initiating prep: * appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators * any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the conduct of the study * current participation in any hiv prevention study or other study considered to interfere the interpretation of study outcomes (see section 4.4). 2. individuals who meet any of the following criteria are ineligible for inclusion in this study as other key stakeholder: * appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators * any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the study activities

Keywords: hiv sti prep cisgender heterosexual lilongwe malawi systems navigation