Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of esflurbiprofen hydrogel patch in the treatment of local acute pain

Conditions: Soft Tissue Injuries; Contusions; Strains; Sprains; Bruises

Summary: objective of this study is: to determine efficacy and safety of a esflurbiprofen hydrogel patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries. to demonstrate that the esflurbiprofen hydrogel patch is superior to placebo, and that the patch has acceptable local tolerability.

study design randomized (1:1) (stratified by center and 2 subgroups), controlled, double-blind, multi-centric study in parallel groups. patient population/sample size/study sites the clinical trial population will consist of male or female patients, 18 - 60 years suffering from acute; strains, sprains or bruises of the extremities following blunt trauma, and meeting all clinical trial entry criteria. 200 patients will be enrolled (assumes a drop-out-rate of ≤10%). the study will be performed in germany in 3 sites

Eligibility criteria:
inclusion criteria 1. acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb 2. location of injury such that pain-on-movement (pom) is elicited on by specified exercises 3. enrollment within 6 hours of the injury 4. baseline vas score for pom of injured extremity \> 50 mm on a 100 mm vas 5. size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2 6. adult male or female patients 7. age 18 to 60 years 8. having given written informed consent 9. satisfactory health as determined by the investigator based on medical history and physical examination. exclusion criteria 1. significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound 2. excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion 3. current skin disorder or shaving hair at application site 4. history of excessive sweating/hyperhidrosis inclusive of application site 5. intake of nsaids or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study 6. intake of long-acting nsaids or application of topical medication since the injury (rice allowed) 7. participation in a clinical study within 30 days before inclusion in the study or concomitantly 8. drug or alcohol abuse in the opinion of the investigator 9. pregnant and lactating women 10. women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as: * surgical sterilization * hormonal contraception * intra uterine device * double barrier method * total abstinence throughout the study at the discretion of the investigator.

Keywords: blunt trauma
public health nurse-peer co-led group cognitive behavioral therapy for postpartum depression

Conditions: Postpartum Depression

Summary: the purpose of this study is to determine the effectiveness of an online 9-week group cognitive behavioural therapy (cbt; a type of talking therapy) intervention that is co-led by public health nurses (phns) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (ppd) for treating ppd when delivered in addition to treatment as usual (tau) compared to tau alone. the study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of ppd and whether it is cost-effective.

the primary objective of the randomized controlled trial (rct) is to determine if a 9-week group cognitive behavioral therapy (cbt) intervention delivered online and co-led by public health nurses (phns) and peers added to treatment as usual (tau) can improve postpartum depression (ppd) more than tau alone. peers are individuals who have previously recovered from ppd and received training to deliver the intervention. the secondary objective of the rct is to determine if the intervention can effectively treat its common comorbidities (anxiety) and complications (parenting stress, social support, mother-infant relationship, and infant temperament) and whether the intervention is cost-effective. 170 mothers/birthing parents will take part in the study with 50% being randomly assigned to the intervention group. all participants complete online questionnaires at 3 time points: baseline (t1), 9 weeks later (t2-immediately post-intervention in the experimental group to assess effectiveness) and 6 months later (t3-intervention durability).

Eligibility criteria:
inclusion criteria: mothers or birthing parents, 18 years old, have an infant under 12 months of age at recruitment, fluent in written/spoken english, have a edinburgh postnatal depression scale (epds) score ≥10 and live in ontario, canada. exclusion criteria: bipolar, psychotic, or current substance use disorders and borderline personality disorder as assessed during screening when study coordinator administers the mini international neuropsychiatric interview (mini).

Keywords: postpartum depression, ppd cognitive behavioural therapy public health nurse peer
effect of enzymatic-containing mouth spray (oral7®) on xerostomia symptoms, salivary flow rate, and oral health-related quality of life in older patients

Conditions: Xerostomia; Geriatric

Summary: background: xerostomia, or dry mouth, is a prevalent condition among older adults and has significant implications for oral and systemic health. it is associated with impaired chewing, swallowing, and speech, and increases the risk of oral infections, dental caries, and gum disease. xerostomia may also contribute to malnutrition and aspiration pneumonia. objective: this study aims to evaluate the effectiveness of an enzymatic-containing mouth spray (oral7®) on xerostomia symptoms, unstimulated salivary flow rate, and oral health-related quality of life (ohrqol) in older patients with xerostomia. methods: a single-center, randomized, double-blind, placebo-controlled trial will be conducted at hospital universiti sains malaysia from august 2025 to july 2026. eligible participants aged 60 and above with self-reported xerostomia will be randomly assigned to receive either oral7® mouth spray or a placebo spray for four weeks. the primary outcome is the mean change in summated xerostomia inventory (sxi) scores between groups from baseline to post-intervention. secondary outcomes include changes in unstimulated salivary flow rate using the sialometry technique and ohrqol measured by the geriatric oral health assessment index (gohai) at baseline and three months post-intervention. data will be analyzed using spss version 29. conclusion: this trial will provide evidence on the efficacy of oral7® mouth spray in alleviating xerostomia symptoms and improving salivary function and oral health-related quality of life in older adults, potentially guiding future clinical management of this condition.


Eligibility criteria:
inclusion criteria: * aged 60 years and above * patients with often or always having dry mouth/xerostomia by asking single-item xerostomia question: "how often does your mouth feel dry?" (adakah mulut anda sering merasakan kekeringan?). the response options were "never (tidak pernah)," "sometimes (kadang-kadang)," "often (kerap)," or "always (sentiasa/sepanjang masa)." * patients who are taking nutrition orally * patients who are able to speak * patients who are physically fit to take oral spray on their own. exclusion criteria: * • patients on salivary substitutes for the past one week * oral condition that required immediate attention such as mucosal or gingival bleeding, orofacial swelling, oral pain and oral ulcer. * patients who are deaf and mute * those with mental disabilities or documented cognitive deficits that would impair their ability to answer questions independently.

Keywords: xerostomia dry mouth geriatric older patient
comparison of anwar and melles techniques in deep anterior lamellar keratoplasty (dalk) for keratoconus patients

Conditions: Keratoconus

Summary: this study will be performed on patients who come to labbafinejad ophthalmic clinic from 20 march 2008. keratoconus diagnosis will be determined by clinical finding in slit lamp, keratometery and topographic characteristics. patients will be randomly placed in group a and b. in group a, anwar surgical method and in b, melles surgical method, will be done. this is not a blind study due to surgeons' knowledge. all patients will receive btamethazone drop and chloramphenicol every 6 hours and will be tapered in two months. in the end anatomical results, complications, bcva, ucva, astigmatism, endothelial cell numbers will be compared in two groups by using specular microscopy. contrast sensivity, central corneal diameter, interface wrinkling and opacity will be measured by metrovison, confoscan, photoslit in months 3, 6, 12, respectively and will be evaluated afterwards.


Eligibility criteria:
inclusion criteria: * patients with keratoconus * 15\<age\<45 * contact lens intolerance exclusion criteria: * having a history of any other ophthalmic or systemic problem * central corneal scar * descemet's membrane detachment

Keywords: anwar melles keratoconus
integrated e-health (electronic health) for hiv and substance use disorders in justice involved women

Conditions: HIV; Opioid Use Disorder; eHealth

Summary: the purpose of this 2-site (ct, al) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (prep) and opioid use disorder (oud) care continua in women involved in the criminal justice system (wicj). this study evaluates a newly validated prep decision aid and ehealth for integrated prep and moud compared to a decision aid-only for wicj with oud.

problem: there is urgent need to reach women involved in criminal justice (wicj) for lifesaving, evidence-based prep and medications for oud (moud), using innovative healthcare delivery models that surmount existing social and structural barriers to engagement. purpose: this study uses a newly validated decision aid and ehealth to remotely deliver integrated prep and moud to community-based wicj with oud in new haven, connecticut (ct) and birmingham, alabama (al). methods: 250 prep-eligible wicj with oud will undergo randomization to: a) the "athena" strategy, which includes the decision aid + ehealth for remote integrated prep/moud with a provider using outputs from the decision aid; or b) decision aid-only with referral to community-based prep/moud. randomization will be stratified by site; past 6-month use of any stimulants; and baseline receipt of moud. follow-up study assessments occur at months 1, 3, and 6. to understand implementation, the investigators will conduct population modeling and engage with relevant stakeholders through focus groups using nominal group technique and in-depth individual interviews. aims: the aims of the project are: 1) to compare the athena strategy to decision aid-only in terms of patient-level engagement in the prep and oud care continua, considering key site differences; and 2) to assess scale-up potential of the athena strategy in terms of modelled long-term outcomes and how stakeholders interact with ehealth for integrated prep/moud in wicj in two diverse epidemiological and implementation contexts (ct and al), using standardized definitions of implementation outcomes.

Eligibility criteria:
inclusion criteria: * cis-women * have access to a working mobile or landline phone * lifetime cj-involvement (probation, parole, intensive pretrial or community supervision, or release from prison/jail) * are confirmed hiv-negative by point-of-care 3rd generation hiv antibody test * meet clinical criteria for prep * have opioid use disorder (regardless of baseline treatment status) exclusion criteria: * unable or unwilling to provide informed consent * pregnant or breast-feeding * currently taking prep at the time of study enrollment * not comfortable conversing in english or spanish.
quality of life after conservative oncoplastic surgery in breast cancer patients (irony: life after oncoplastic surgery)

Conditions: Breast Cancer

Summary: evaluation of quality of life after conservative oncoplastic surgery in patients with breast cancer

the aim of the study is the evaluation of the oncological, aesthetic and functional results after conservative oncoplastic breast surgery using unilateral or bilateral remodeling techniques in a prospective sample of 250 patients. endpoints: * evaluation of post-surgical histopathological data with a selective focus on the achievement of oncological radicality in relation to the surgical technique ( resection volume, locoregional extension / tnm / multifocality and tumor biological profile) and any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).this data will be collected through the compilation of a database by the health personnel. * evaluation of aesthetic and functional results related to the quality of life after oncoplastic conservative surgery (unilateral or bilateral), as data perceived by the surgeon (technical analysis), and by the patient (psychosocial well-being, physical discomfort, adverse effects of radiotherapy). this data will be collected through the administration of a questionnaire whose data will be entered into the database by the healthcare personnel.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of breast cancer * must be able for conservative oncoplastic surgery with type 1 and 2 procedures who give informed consent to the study. exclusion criteria: * patients who are pregnant or breastfeeding * patients in emergency situations * subjects unable to understand and want

Keywords: oncoplastic breast surgery therapeutic mammoplasty chest wall perforated flaps quality of life
treatment of chronic pain after spinal cord injury (sci) or amputation

Conditions: Spinal Cord Injuries; Amputation, Traumatic; Pain

Summary: pain is a major problem for people after spinal cord injuries and amputations. this is a study to test how pain is affected by adding methadone to a six-week program of weekly physical therapy, relaxation training and counseling. individuals who qualify for this study will receive a comprehensive medical and physical therapy evaluation.

pain has a major impact on the functioning of individuals with spinal cord injuries and individuals with amputations. this double-masked randomized trial to evaluate the utility of a combination of psychological intervention and physical therapy in order to improve pain reduction, increase physical functioning and quality of life for patients with pain associated with spinal cord injuries or amputations will compare the effect of a 6 week program of physical therapy and cognitive-behavioral therapy with methadone to one without methadone (n = 400). secondary outcomes are to evaluate the maintenance of effects of the combined intervention and to evaluate the usefulness of a course of opioid therapy compared to active placebo medication. based on the sample size, all measures have greater than 0.7 power to detect major within group differences at posttreatment, 6-month follow-up, and 12-month follow-up (taking into account a 15% attrition rate, alpha .05). patients who qualify for this study will receive a comprehensive medical and physical therapy evaluation at baseline. outcome will be assessed by the physician, psychiatrist and physical therapist who are all masked both to the treatment condition and therapy. pain is assessed through self-report (measures include pain inventories) and clinical interview.

Eligibility criteria:
inclusion criteria: * individuals with spinal cord injury or amputation, who have persistent pain of three months or longer duration. exclusion criteria: * pregnant women * allergy to latex, methadone, or diphenhydramine * surgery planned * history of substance abuse in past two years * history of major psychiatric disorder

Keywords: spinal cord injury amputation pain management
early access to art for all in swaziland: effects on economic outcomes

Conditions: HIV/AIDS

Summary: the purpose of this study is to evaluate the impact of offering early antiretroviral therapy to hiv-positive individuals in government-managed health facilities in swaziland on a range of economic outcomes

the maxart study is a three-year stepped-wedge randomized trial with open enrollment for all adults 18 years and older across 14 rural health facilities in swaziland's hhohho region. the main trial registration is accessible at: https://clinicaltrials.gov/ct2/show/record/nct02909218. this registration is specific to the economic evaluation of the maxart study which aims to quantify the causal impacts of early art initiation (compared to national standard care) on a range of key economic outcomes, including healthcare expenditures, productivity, and household wealth.

Eligibility criteria:
inclusion criteria: * all hiv-positive individuals who are aged 18 years or older, are art naïve and attend the health facilities included in the study exclusion criteria: * all hiv-positive individuals who are \<18 years of age * all hiv-positive pregnant or breastfeeding women * all hiv-positive individuals who did not consent to participate

Keywords: antiretroviral treatment
effect of different head positions during endotracheal intubation on postoperative sore throat

Conditions: Endotracheal Intubation; General Anesthesia

Summary: the goal of this \[ randomized clinical trial\] is to \[effect of different head positions on the incidence of postoperative sore throat \] in \[patients with endotracheal intubation \]. the main question it aims to answer is: the rate of postoperative sore throat will be reduced or not with the patients' head position changed during intubation.

objective: to investigate the effect of tracheal intubation in different head positions on the incidence of pharyngeal pain 1, 6 and 24h after operation;effect of tracheal intubation in different head positions on the incidence of hoarseness 1, 6 and 24h after operation

Eligibility criteria:
inclusion criteria: 1. patients undergoing endotracheal intubation abdominal or lower extremity surgery under general anesthesia 2. age 18\~65 years old, 3. asa grade i or ii exclusion criteria: 1. patients with pre-existing sore throat or hoarseness before anesthesia; 2. patients with cervical spine disease; 3. patients with upper respiratory infection or a history of tracheostomy; 4. mallampati score ≥ 3; 5. participation in other clinical trials within the past three months.
a worldwide pregnancy safety study to assess maternal, fetal, and infant outcomes following exposure to efgartigimod during pregnancy and/or breastfeeding.

Conditions: Myasthenia Gravis; CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Summary: this is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod ph20 sc any time within 25 days prior to conception or any time during pregnancy. women exposed to efgartigimod or efgartigimod ph20 sc only during breastfeeding will also be eligible to enroll. background rates of major congenital malformations (mcms) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod ph20 sc exposed pregnancies were reported.


Eligibility criteria:
inclusion criteria: * women with exposure to efgartigimod or efgartigimod ph20 sc any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod ph20 sc during breastfeeding. the timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days. * written/verbal informed consent or econsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or econsent by the pregnant minor (where applicable) and written/verbal informed consent or econsent by the parent/legal guardian). exclusion criteria: * none
construction of ct radiomics model for predicting the efficacy of immunotherapy in patients with stage iii nsclc

Conditions: Stage III Non-small Cell Lung Cancer

Summary: consolidation immunotherapy of immune checkpoint inhibitor (ici) following chemoradiotherapy (crt) is the current standard of care for patients with unresectable locally advanced non-small cell lung cancer (nsclc) as it improves both progression-free survival and overall survival. however, a substantial proportion of patients still experience disease recurrence despite consolidation ici. it is important for personalized treatment to predict the efficacy of consolidation ici. pd-l1 expression is used as a predictive biomarker for ici response and efficacy in advanced nsclc, but its role in patients with stage iii disease is unclear. one important reason is pd-l1 testing performed on pre-crt tissue may not reflect changes in pd-l1 expression after crt. ct-based radiomics approaches have been successfully applied to generate imaging biomarkers as decision support tools for clinical practice. the hypothesis of this study is that ct radiomics model can assess pd-l1 status after crt and predict the efficacy of crt combined with ici in unresectable locally advanced nsclc.

this is an observational longitudinal prospective study. ct scan is performed before radiotherapy, during radiotherapy and at the end of radiotherapy in patients with unresectable locally advanced nsclc who undergo crt. radiomic features were extracted from ct images and baseline pd-l1 expression is assessed. ct-based radiomics models is developed to assess pd-l1 expression and predict the efficacy of ici.

Eligibility criteria:
inclusion criteria: * histological or cytological proven non-small cell lung cancer * unresectable stage iii according to american joint committee of cancer stage (the eighth edition) * 18 years or older exclusion criteria: * previous thoracic radiotherapy * palliative treatment

Keywords: non-small cell lung cancer radiomics immunotherapy chemoradiotherapy