Kornimate/medical-research-clean huggingface dataset:
efficacy of probiotic lactobacillus crispatus m247 in promoting high-risk human papillomavirus (hr-hpv) infection clearance and modifying vaginal microbiota

Conditions: Human Papillomavirus Infection

Summary: this clinical trial evaluates the efficacy of the probiotic strain lactobacillus crispatus m247 in promoting the clearance of genital high-risk human papillomavirus (hr-hpv) infection and restoring the balance of the vaginal microbiota. the study adopts a multicenter, randomized, single-blind, longitudinal, prospective design involving hr-hpv-positive patients. primary outcomes include hr-hpv clearance rates and microbiota composition changes.

this study investigates the potential benefits of lactobacillus crispatus m247, a probiotic strain with proven ability to promote vaginal health, in the management of hr-hpv infections. lactobacillus crispatus m247 has demonstrated superior probiotic properties, including the ability to produce lactic acid and hydrogen peroxide, which contribute to maintaining a stable vaginal microbiota and potentially inhibiting hr-hpv persistence. participants will be randomized to receive either lactobacillus crispatus m247 or a placebo over a specified study period. the primary aim is to evaluate the probiotic's efficacy in enhancing hr-hpv clearance rates and restoring a balanced vaginal microbiota. secondary objectives include assessing changes in cervical cytology and participant-reported outcomes on vaginal health. by focusing exclusively on the role of lactobacillus crispatus m247, the study seeks to establish its clinical relevance in hr-hpv management and its potential as a therapeutic intervention.

Eligibility criteria:
inclusion criteria: * women aged 18-69 years. * first diagnosis of hr-hpv infection via dna-hpv screening. * cytology results showing asc-us or lsil. * negative colposcopy or biopsy (absence of lesions). * ability to provide written informed consent. exclusion criteria: * prior hpv vaccination. * history of cervical treatments for pre-neoplastic pathology. * cytology showing hsil (high-grade squamous intraepithelial lesion) requiring treatment. * current treatment with antibiotics, immunomodulatory, or immunosuppressive therapies. * diagnosed immune system or neoplastic diseases requiring chemotherapy. * pregnancy, lactation, or planning to become pregnant within 6 months. * known hypersensitivity to product components.
burden of disease and functional impairment in xlh

Conditions: X Linked Hypophosphatemia

Summary: observational study comprising prospective follow up as well as retrospective chart review in order to evaluate the longitudinal course of the disease in xlh patients with a specific focus on functional impairment, physical performance and complications associated with the disease or respective treatment.

this is an observational / non-interventional study in order to assess the longitudinal course of xlh including disease related burden of disease and functional impairment. this is accomplished by both prospective follow up of affected patients as well as retrospective chart review. evaluation conducted as per clincal routine and specifically evaluated as part of this study will include * baseline documententation / demographic (as obtained from medical records) * general data on xlh-disease specific medical history * physical examination results * functional assessments * technical assessments * quality of life / questionnaires * laboratory evaluations

Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years, inclusive, at the time of enrollment * diagnosis of x-linked hypophosphatemia confirmed by * documented phex mutation in either the patient, or in a directly related family member * positive family history of xlh and symptoms of the disease or * phosphaturia + elevated serum levels of c-term fgf23 or ifgf23 and symptoms of the disease * written informed consent exclusion criteria: - suspected of confirmed diagnosis of another phosphate wasting disorder
a phase 1/2a, single dose study of pf-04383119 in japanese patients with moderate to severe pain from osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: to evaluate the safety and tolerability of single iv doses of pf-04383119 in japanese patients with moderate to severe pain from oa of the knee (part i). to evaluate the preliminary analgesic efficacy of pf-04383119 in japanese patients with moderate to severe pain from oa of the knee in comparison with placebo (part i and part ii).


Eligibility criteria:
inclusion criteria: * japanese male or female, age 35-65 (part 1), age 35-75 (part 2) * diagnosis of osteoarthritis (oa) of the knee based on american college of rheumatology criteria * knee pain, and radiographic evidence of knee oa (kellgren-lawrence x-ray grade ≥2) obtained within 1 year of enrollment * at least one of the following: age \>50, morning stiffness \<30 minutes in duration, crepitus, and oa of the knee must involve the index tibiofemoral joint and must have present for at least 6 months * patients who meet at least one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery * pain levels as required by the protocol at screening and baseline exclusion criteria: * diagnosis or history of ra, any inflammatory arthritis, gout, paget's disease or any other disease that in the investigator's opinion would interfere with the assessment of pain and other symptoms of oa * patients with regional pain syndromes suggestive of fibromyalgia or regional pain caused by lumbar or cervical compressions with radiculopathy or at risk of developing radiculopathy. * diagnosis or history of fibromyalgia * planned surgical procedure during the duration of the study

Keywords: monoclonal antibody
spd489 in adults aged 18-55 years with moderate to severe binge eating disorder

Conditions: Binge Eating Disorder

Summary: the primary objective of the study is to demonstrate the efficacy of spd489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe binge eating disorder at visit 8 (weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

not required

Eligibility criteria:
inclusion criteria: the subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met: 1. subject is between 18-55 years of age. 2. subject meets the following diagnostic and statistical manual of mental disorders fourth edition - text revision (dsm-iv-tr) criteria for a diagnosis of bed: 3. subject has a bed diagnosis. 4. subject's bed is of at least moderate severity with subjects reporting at least 3 binge eating days per week. 5. female subjects must have a negative serum b-hcg pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements. exclusion criteria: subjects are excluded from the study if any of the following exclusion criteria are met: 1. subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. 2. subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, weight watchers) for bed. 3. subject has used psychostimulants to facilitate fasting or dieting as a part of their bed. 4. subject has a lifetime history of psychosis, mania, hypomania, dementia, or adhd. 5. subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. 6. subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. 7. subject has a history of moderate or severe hypertension. 8. subject is female and pregnant or nursing. 9. subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
laparoscopic associating liver partition and portal vein ligation for staged hepatectomy

Conditions: Liver Tumor

Summary: the purpose of this research is evaluate the results with laparoscopic alpps procedure in a single center. the validity, feasibility and limitations were assessed objectively through our clinical prospective study.the investigators expect laparoscopic alpps is safe, effective and feasible.

background: associating liver partition and portal vein ligation for staged hepatectomy (alpps) is a breakthrough in the field of hepatobiliary surgery in recent years，which stimulates the remnant liver volume(rlv) grew by 74%-87.2% in 9 to 13 days。the published literature reported that the two stages of alpps are the conventional laparotomy surgery，patients need to undergo the injury of two open operations in a short time. the incidence of postoperative complications and mortality rate is as high as 53% -73% and 12%-27%.the aim of this study was to evaluate the results with laparoscopic alpps procedure in a single center, with special emphasis in validity, feasibility and limitations. results: clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, long-term curative effect and survival time were collected and analysed. statistical method:groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, cox survival analysis ，kaplan-meier survival analysis，log-rank survival curves were used.

Eligibility criteria:
inclusion criteria: * patients with marginally resectable or primarily non-resectable locally advanced liver tumors * insufficient future liver remnant (flr) either in volume or quality exclusion criteria: * unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases * severe portal hypertension * high anesthesiological risk * unresectable primary tumor

Keywords: liver tumor two stage hepatectomy hypertrophy laparoscopy alpps
an exploratory crossover clinical trial to compare the activity of reproxalap and lifitegrast in a dry eye disease chamber

Conditions: Dry Eye

Summary: an exploratory, single-center, double-masked, crossover clinical trial to assess safety and tolerability of 0.25% reproxalap ophthalmic solution compared to xiidra® in subjects with dry eye disease in a dry eye chamber


Eligibility criteria:
inclusion criteria: 1. eighteen (18) to70 years of age at the time of screening (either gender and any race). 2. ability to provide written informed consent. 3. reported history of dry eye for at least 6 months prior to visit 1. exclusion criteria: 1. diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at visit 1. 2. contact lens use within 7 days of visit 1 or anticipate using contact lenses during the trial. 3. a condition that the investigator feels may put the subject at significant risk may confound the study results or may interfere significantly with the subject's participation in the trial. 4. inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.
comparison of small bowel lesions associated with celecoxib versus ibuprofen plus omeprazole

Conditions: Bowel Diseases, Inflammatory

Summary: to evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole


Eligibility criteria:
inclusion criteria: inclusion criteria: * normal, healthy gastrointestinal tract (no small bowel mucosal breaks at day 14 according to endoscopic data * no history of gi ulcers, bleeding or surgery, or complete or partial stenosis of the small intestine * willing not to drink any alcohol during study period exclusion criteria: exclusion criteria: * has established delayed gastric emptying or diabetic gastroparesis * has active gastroesophageal reflux disease or requires anti-ulcer medications * has taken aspirin or nonsteroidal antinflammatory drugs (ibuprofen, naproxen) more than 3 times per week within 2 weeks prior to the screening visit; aspirin for cardiovascular prophylaxis is restricted

Keywords: bowel disease
effects of 5-methyltetrahydrofolate and vitamin b12 supplemetation on red cell membrane in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine whether 5 - methyltetrahydrofolate and vitamin b12 supplementation can ameliorate cell plasma membrane features in pediatric patients with cystic fibrosis

cystic fibrosis (cf) is one of the most common fatal autosomal recessive disorders in the caucasian population caused by mutations of gene for the cystic fibrosis transmembrane conductance regulator (cftr). new experimental therapeutic strategies for cf propose a diet supplementation to affect the plasma membrane fluidity and to modulate the cellular amplified inflammatory response in cf target organs. red blood cells (rbcs) were used to investigate plasma membrane, because rbcs share lipid, protein composition and organization with other cell types.

Eligibility criteria:
inclusion criteria: * cystic fibrosis exclusion criteria: * diabetes * chronic infections of the airways * regular antibiotics intake

Keywords: cystic fibrosis folate vitamin b12
can exercise improve therapeutic learning among women with posttraumatic stress disorder

Conditions: PTSD

Summary: this study aims to test whether aerobic exercise improves the consolidation and subsequent recall of the learned safety memories among adult women with ptsd related to interpersonal violence exposure and whether this effect is mediated by the ability of exercise to increase acute levels of brain-derived neurotrophic factor (bdnf) and endocannabinoids (ecb). participants can expect to be on study for up to 90 days, participating in 4 study sessions: day 1 of intake screening, day 2 of emotional learning, day 3 of fear extinction and exercise, and day 4 of recall of emotional learning.


Eligibility criteria:
inclusion criteria: * current diagnosis of ptsd where the index traumatic event includes physical or sexual assault * english speaking * medically healthy exclusion criteria: * any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the physical activity readiness questionnaire (par-q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise. * major medical disorders (such as cancer, aids) * physical discomfort or difficulty with blood draws * psychotic disorders * intellectual disabilities * developmental disorders * active substance use disorders * pregnancy * due to safety concerns, participants with these conditions will be ineligible to participate: * major medical disorders (e.g., hiv, cancer) * daily cannabis use * history of light headedness or fainting during blood draws or physical activity * history of chest pain during physical activity * abnormal ekg finding at intake visit screening, without follow-up clearance from their physician * bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be worsened by physical activity (e.g., chronic obstructive pulmonary disease (copd), diabetes, hypertension) that is not currently addressed via medication or lifestyle change. * a positive pregnancy test * a self-reported history of loss of consciousness (greater than 30 minutes) * physical disabilities that prohibit task performance (such as blindness or deafness) * psychotic disorders (e.g., schizophrenia) * any other condition that the investigator believes might put the participant at risk

Keywords: women, exercise, mental health
ric regimen for elderly or high comorbidity burden patients receiving haplo-hsct

Conditions: Acute Leukemia; Myelodysplastic Syndromes

Summary: this study aimed to evaluate the efficacy of reduced intensity conditioning (ric) regimen in elderly or high comorbidity burden patients who receive haploidentical hematopoietic stem cell transplantation (haplo-hsct). haplo-hsct is an effective treatment option for patients who did not have identical sibling donor (isd) or unrelated donor (urd). however, post-transplant transplant-related mortality (trm) is one of the major causes for transplant failure, and the risk of trm for old patients or those with high comorbidity burden was higher. ric regimen may decrease the risk of trm for haplo-hsct recipients. the study hypothesis: using ric haplo-hsct regimen in elderly patients or those with high comorbidity burden can reduce trm and improve survival.

ric regimen was given for elderly patients or those with high comorbidity burden who would receive haplo-hsct. the elderly patients were defined as older than 55 years. the burden of comorbidities in hsct recipients was assessed based on the hematopoietic cell transplantation-specific comorbidity index (hct-ci), and patients with score ≥3 were assigned as high burden. the primary end point was transplant-related mortality, and the secondary endpoints included overall survival, disease-free survival, relapse, engraftment, graft-versus-host disease (gvhd), and infections. following time is 1 years.

Eligibility criteria:
inclusion criteria: * patients older than 55 years or those with hct-ci scores of ≥3, without isd nor urd, receiving haplo-hsct exclusion criteria: * patients having identical sibling or unrelated donors; patients with active infection; patients having organ failure; patients with poor compliance.

Keywords: ric regimen comorbidity elderly haploidentical transplant-related mortality
share project define

Conditions: HIV

Summary: the overall goal of the current study is to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes - alcohol use and hiv - among young people living with hiv (yplwh). this is a correlational, longitudinal cohort study that will seek to evaluate the association of cumulative stress with self-management of alcohol (i.e. hazardous drinking) and hiv (viral suppression) among yplwh. the study will enroll up to 175 participants between the ages of 18-29 who currently reside in florida and are living with hiv. in the model phase, individuals will participate in two assessment timepoints, including baseline assessment with a two-week sleep diary completion and 9-month follow-up assessment with another two-week sleep diary completion. the aim of the model phase is to define key modifiable intervention targets by longitudinally evaluating multiple components of sleep health, and emotion and behavioral regulation among yplwh to determine potential pathways between cumulative stress and alcohol and hiv outcomes, in the context of individual factors relevant to yplwh (e.g., age, race/ethnicity, cannabis and other substance use, cognitive functioning, education), with an additional cross-project moderator aim to explore age, biological sex and gender, race/ethnicity, other substance use, and mental health as moderators. in the adapt phase, 42 of n=175 will participate in 60-90 minute focus groups, that will focus on adapting developmentally and culturally scalable measures of cumulative stress, sleep health, and emotion/behavior regulation for screening and intervention targeting, and creation of a community-informed toolkit of the adapted measures.


Eligibility criteria:
inclusion criteria: * 18 years and 0 months to 29 years and 11 months * currently reside in florida * report having had at least 1 alcoholic drink in the last 30 days * able to read and understand english * have internet access via smartphone, tablet or computer * be diagnosed as hiv positive and; * willing to provide informed consent. exclusion criteria: * adults unable to consent * individuals who are not yet adults * individuals who are not diagnosed as hiv+ * prisoners * pregnant women
turn up the heat - healthy eating and activity time in summer day camps

Conditions: Childhood Obesity

Summary: the investigators long-term goal is to increase the number of summer day camps (sdc) that meet the national afterschool association healthy eating and physical activity (hepa) standards. the objective is to evaluate the effectiveness of a multi-component intervention designed to increase children's pa levels and improve the quality of lunches and snacks children consume in sdcs. the hepa intervention is designed to target children, parents, staff, program leaders, and the sdc environment and uses a train-the-trainer model with sdc leaders to train their staff to deliver and integrate the intervention into routine practice. in the proposed study, the investigators will evaluate these hepa strategies, using a 4-year randomized controlled trial with 20 sdcs. an important feature of the study will be the evaluation of maintenance of the intervention after the removal of research support (e.g., training, boosters) during the final year, as well as costs associated with implementation. the investigators hypothesize that intervention sdcs will achieve significantly greater increases in hepa, compared to control sdcs. the investigators expect the study to support the cost-effectiveness and maintenance of our strategies for promoting hepa that will facilitate sdcs meeting newly-established hepa standards for this setting.

the investigators aim to: evaluate the impact of the hepa interventions on: 1.) the proportion of children meeting the pa standard (i.e., ≥60min mvpa/d) while attending summer day camp; 2.) the proportion of foods (e.g., fruit, vegetable, water) children and staff bring and consume at the summer day camp that meet the he standards; and 3/) changes in children's age-sex specific bmi percentile from the start to end of summer evaluate the cost-effectiveness of the hepa intervention evaluate the maintenance of the hepa intervention in summer day camps

Eligibility criteria:
inclusion criteria: * summer day camps will be eligible if: * they operate for at least 10 weeks during the summer * they do not have any primary focus such as sports, art, or tutoring (must be a general camp) * enrollment is at least 40 campers * operation hours are at least 8 hours. exclusion criteria: * children will be unable to wear an activity monitor if experience any physical and/or orthopedic impairment that limits the child's ability to participate in regular pa (e.g., wheelchair user)

Keywords: mvpa healthy eating children childhood obesity