Kornimate/medical-research-clean huggingface dataset:
inbrx-106 in combination with pembrolizumab in first-line pd-l1 cps≥20 hnscc

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary: this seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent ox40 agonist antibody inbrx-106 combined with the anti-pd-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (r/m hsnscc) incurable by local therapies, expressing pd-l1 with a combined proportion score (cps) ≥20.


Eligibility criteria:
inclusion criteria: * has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (hnscc) that is considered incurable by local therapies. * has tumor pd-l1 expression of cps ≥20. tumor tissue must be provided for pd-l1 biomarker analysis. * has human papilloma virus (hpv) testing results for oropharyngeal cancer by p16 immunohistochemistry (ihc) testing. * has measurable disease per recist 1.1 guidelines. * has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx. * has an eastern cooperative oncology group (ecog) performance status of 0 or 1. * female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding. * male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception. exclusion criteria: * has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site. * has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic hnscc. * prior systemic therapy completed \>6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no pd/recurrence occurred within 6 months of its completion. prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-pd-(l)1 agents, is allowed if pd/recurrence occurred ≥12 months after its completion. * has clinically active central nervous system metastases and/or carcinomatous meningitis. * has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. * rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain. * current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.

Keywords: ox40 receptor agonist pd-l1 positive pembrolizumab immunotherapy chemotherapy-free hnscc head and neck cancer keytruda oropharyngeal cancer hypopharyngeal cancer laryngeal cancer oral cancer inbrx-106
training methods for a doctrine of life with healthy heart

Conditions: Heart Diseases

Summary: this study is an interventional study which was conducted in the field. the investigators intended to develop an efficient and economically valuable method which can decrease the risk factors for prevention of cardiovascular diseases. effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and cheap methods to decrease risk factors. in this study, the aim of preparing the group ii training material was to enable the individual to see his or her risks as unique, and to proceed with life by adapting personal behaviors. group ii's training material was formatted as a prescription. because giving a prescription for a doctor is very important in low socioeconomical group person. this study showed that social programs oriented towards individual behavioral changes assume an important role in decreasing cardiovascular risk factors.

background: effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and economical methods to decrease risk factors. methods: this study was conducted in three stages in a semi-rural region of eskisehir, turkey. in the first stage, individuals selected by random sampling were evaluated in terms of social-demographic characteristics and the risk factors present for cardiovascular diseases. a scale comprised of 19 questions was implemented for data assessment. in the second stage, training materials were randomly distributed. group i's training material consisted of a brochure containing pictures and general information on heart disease; group ii members additionally received a personalized letter that further explained their individual risk factors and suggested measures for increased protection and prevention - in short, group ii's training material was formatted as a prescription. in the third stage, the subjects were screen against the cardiovascular risks factors one year later to assess and determine if there had been any changes in their attitudes towards the dangers of the cardiovascular diseases.

Eligibility criteria:
inclusion criteria: * over 40 years of age were contacted. * individuals who were literate or had at least one literate person in the household were selected through random sampling via the records of local health care units. exclusion criteria: * under 40 years of age and immigrants

Keywords: risk factors; coronary arterial hearth disease
effect of inpatient pulmonary rehabilitation on frailty in candidates for lung-transplantation

Conditions: Advanced Lung Disease; COPD; ILD

Summary: frailty in lung transplant candidates increases the risk of delisting and adverse transplantation outcome \[1\]. furthermore, preoperative frailty is associated with a higher one-year-mortality rate after transplantation in frail compared to non-frail candidates. mortality increases with severity of frailty \[2,3\]. decreasing the frailty-status of a ltx-candidate is therefore an approach to improve the pre- and also posttransplant situation. there is some evidence that frailty in ltx-candidates can be decreased by a homebased rehabilitation \[5\]. however, at the moment these possible benefits are unknown for an inpatient rehabilitation. therefore the aim of this study is to observe the effect of a three-week inpatient rehabilitation on frailty in lung transplant candidates.

rationale: frailty is a complex clinical syndrome describing a loss of physical and/or cognitive functionality which leads to a decreased resistance to stressors such as operations or illness. it is associated with increased number of falls, exacerbations, adverse health outcomes and a higher mortality \[6-9\]. frail ltx-candidates have a higher risk of being delisted before transplantation, adverse transplantation outcomes and a higher one-year-mortality compared to non frail candidates. however, studies show that frailty can be decreased by physical training \[10-12\]. a recent prospective cohort study in the uk observed a significant decrease of frailty in patients with copd participating at an inpatient rehabilitation programme \[4\]. singer et al. (usa) could detect a significant decrease of frailty by a homebased training for ltx-candidates \[5\]. aim of this study is to investigate the effects of a three-week inpatient rehabilitation programme on physical frailty (measured by short physical performance battery) in lung transplant candidates. additionally, other functional measures as well as the cognitive, social and psychological state will be assessed in order to better understand the complex syndrome of frailty and the effects of rehabilitation. design: this study is a prospective observational trial. the number of 32 participants is based on a sample size calculation. asssessments will take place in the beginning of rehabilitation programme and at discharge.

Eligibility criteria:
inclusion criteria: * participation in an inpatient pulmonary rehabilitation programme (schön klinik bgl, germany) * lung transplant candidates (already listed or listed during rehabilitation) * indication: copd or ild * written informed consent exclusion criteria: * non compliance at assessments

Keywords: frailty lung transplant candidates rehabilitation
post-endodontic pain survey

Conditions: Postoperative Pain; Endodontic Disease; Obturation

Summary: as part of root canal treatment, canals should be sealed to prevent further contaminations. there are multiple accepted techniques to fill-obturate canals. in the past, different obturation techniques have been compared. the most current technique used, a single cone with bioceramic sealer, has not been compared. this clinical investigation will compare the postoperative pain of this technique to another common technique used in our clinic. postoperative pain after one-visit root-canal treatment on teeth with vital pulps: comparison of three different obturation techniques.


Eligibility criteria:
inclusion criteria: * diagnosis of asymptomatic or symptomatic irreversible pulpitis according to aae consensus. the diagnosis was based on clinical examinations and confirmed upon accessing the teeth. * consenting adults age 18 years and older * non-contributory medical history (asa class i \& ii) * included patients were given oral and written information agreed for participation and signed the informed consent exclusion criteria: * non-consenting patients and patients below 18 years of age * medical history with asa class iii \& iv * non-restorable teeth * teeth with a non-vital pulp * periodontal probing depths were more than 4mm * pre-medication with antibiotics and/or analgesics 24 hours before the treatment * patients taking analgesics routinely for non-dental reasons

Keywords: postoperative pain bioceramic root canal filling
a clinical trial to assess subjects with dry eye disease.

Conditions: Dry Eye

Summary: a multi-center randomized, double-masked, parallel design, vehicle-controlled phase 2 clinical trial to assess the efficacy and safety of 0.25% reproxalap ophthalmic solution compared to vehicle in subjects with dry eye disease


Eligibility criteria:
inclusion criteria: 1. 18 years of age (either gender and any race); 2. reported history of dry eye for at least 6 months prior to visit 1; 3. reported history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1. exclusion criteria: 1. clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; 2. diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; 3. contact lens use within 7 days of visit 1 or anticipate using contact lenses during the trial; 4. eye drop use within 2 hours of visit 1; 5. previous laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; 6. cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of visit 1; 7. be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of visit 1 or anticipate such therapy throughout the study period; 8. planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of visit 1; 9. temporary punctal plugs during the study that have not been stable within 30 days of visit 1.
restoration of microbiota in neonates

Conditions: Atopic Dermatitis; Atopic Asthma; Immunologic Activity Alteration

Summary: the aim of the study is to examine the effect of exposure of cesarean section (cs) delivered neonates to a natural condition of birth, i.e. to the microbiota of the birth canal, on the acquisition of microbial genes during development of the microbiome at multiple body sites, immune system maturation and allergy risk in childhood

the primary outcome is to examine if exposure to the maternal vaginal and fecal microbiota directly after birth will halfen the cumulative incidence of immunoglubulin e (ige)-associated allergic disease at 2 years of age in cs delivered infants, compared with non-treated cs-delivered infants. the secondary outcomes are to compare the community structure of microbes from mothers and their infants and immunological programming of infants delivered via scheduled cs, with or without exposure to the maternal vaginal and fecal microbiota, from birth until two years of age. the primary and secondary outcomes will also be compared with a reference group of vaginally delivered infants. sex differences in the incidence and prevalence of allergic diseases have been described. the anticipated benefit of the intervention can be implemented in clinical practice regardless of sex, so that improved conditions for good health are created.

Eligibility criteria:
inclusion criteria: * infants of healthy mothers with uncomplicated pregnancies at term, mothers of any ethnic or social background that can speak, read, and understand swedish to the extent that they can consent in swedish. an additional inclusion criterion for mothers in the cs groups is vaginal ph ≤ 4 at the time of birth. exclusion criteria: * infants of mothers with pre-eclampsia or complicated pregnancies, mothers \ 40 years of age, genital herpes simplex, genital warts, hiv, hepatitis b or complications during delivery, infants delivered prior to 37 weeks of gestation. additional exclusion criteria for mothers in the cs group: mothers positive to group b streptococcus, group a streptococcus, bacterial vaginosis, vaginal ph \> 4 at the time of birth. mothers with fecal samples positive for salmonella, shigella, campylobacter or yersinia.

Keywords: microbiota cesarean section vaginal delivery allergy immunological programming
reconstruction flaps for nasal surgical wounds rct

Conditions: Surgical Wound

Summary: the purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction. this is a randomized clinical trial. approximately 32 participants who are undergoing nasal tip wound reconstruction surgery will be invited to participate and randomized to receive either the nasalis sling repair or the lobed flap repair. patients will be asked to complete a few questionnaires including a vas scale, the surgical outcomes scale, the nose instrument, and the nasal appearance and function evaluation questionnaire (nafeq). this study was a pilot study designed to determine the feasibility of these procedures.


Eligibility criteria:
inclusion criteria: * all patients \>18 years * defect located on the nasal tip, infratip, or supratip of the nose * longest length of the wound should be no greater than 15mm * participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study exclusion criteria: * active infection * age \<18 * investigator judgement that patient is not suitable for randomization (preexisting scars or architecture that would make one repair option less likely to be successful) * current cigarette smoking * patients that have a disease or are taking medication that would severely impair wound healing in the opinion of the investigator
intraorbital dermoid/epidermoid cyst

Conditions: Dermoid Cyst of Orbit

Summary: intraorbital epidermoid and dermoid cyst (dc) has been reported in the literature rarely. the current study evaluates clinicopathologic, radiologic, and management of intraorbital dc cases over ten years.


Eligibility criteria:
inclusion criteria: * those who had an excision biopsy with histology indicative of dermoid/epidermoid cyst exclusion criteria: * other cystic lesions
white matter pathology in parkinson's disease (pd)

Conditions: White Matter Lesions; Postural Instability Gait Disorders

Summary: the relationship between wm lesions (wm) and postural instability gait disorders (pigd-pd)in parkinson's disease patients is largely unknown. we hypothesize that sub-clinical wm pathology may be a major contributing factor to pigd-pd. we will compare two groups of patients with parkinson's disease (pd): those with pigd and patients with dominant tremor (n=120)to assess the role of brain wm changes.

to compare brain wm burden using mri in pd patients with and without pigd. diffusion tensor imaging (dti) analysis techniques will be applied.we will quantify pigd-related symptoms including cognitive function, balance and gait and their associations with mri findings.

Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic pd, as defined by the uk brain bank criteria 2. age between 50 and 80 years 3. hoehn and yahr stage ii-iii 4. on anti-parkinsonian medications 5. mini-mental state exam score ≥ 25 exclusion criteria: 1. brain surgery in the past including implanted deep brain stimulation 2. clinically significant co-morbidities likely to affect gait e.g., acute illness, significant rheumatic, orthopedic disease, dementia, or major depression 3. unable to walk independently 4. inability to comply with the protocol

Keywords: pigd tremor falls white matter
typing of human papilloma virus (hpv) from female genital warts

Conditions: Genital Warts; Human Papilloma Virus

Summary: this is a longitudinal observational study of women presenting to groote schuur hospital with genital warts. the study will evaluate the socio-demographic characteristics of the women using a structured questionnaire. it will also document the site and extend of the genital warts and genotyping will be performed on the warts. hiv status will be determined with patient consent, treatment modalities will be documented as will the outcome of treatment over a 6 month's period. risk factors for recurrence or failure of treatment will be analysed as will the costs of treating women with genital warts.

genital human papillomavirus (hpv) infection is the most common sexually transmitted viral disease in the world.1,2 hpv infection on genital epithelia is associated with a range of disease spectra, from visible lesions such as genital warts, cervical, vaginal, vulval, anal and penile intraepithelial cancers and their precursors, or they may co- exist in the latent form in apparently normal epithelium.3,4 it is established that genital warts are associated with low-risk hpv genotypes, with the causative agents being hpv-6 and hpv-11 in almost 100% of cases.5 however, recent studies have shown that 20 to 50% of lesions also contain co-infection with high-risk hpv types.6,7 although genital warts are not life-threatening, they cause significant psychosocial morbidities resulting in low self-esteem, negative self-perception, embarrassment and anxiety.8,9 genital warts also represent not only a health problem for the individual, but also an economic burden for society as they carry a high and immediate financial burden and health care cost due to their generally recalcitrant response to conventional therapies.9 with this in mind, immunization with hpv 6/11/16/18 recombinant vaccine holds promise for reducing overall burden on clinical hpv-related diseases. genital warts are a common cause for referral to the colposcopy clinic of groote schuur hospital, cape town which is a tertiary hospital serving the wider cape town area and the western cape province. with an increasing number of cases seen requiring multiple clinical visits for treatment and a high number of recurrent and persistent cases, we undertook this study to examine the nature of the disease from a clinical point of view, response to various therapies, the impact of hiv and the types of hpv causing or associated with genital warts in women referred to our clinic.

Eligibility criteria:
inclusion criteria: * all female patients with genital warts exclusion criteria: * patients who are pregnant, too frail or ill for gynaeoclogical examination and refusal to participate

Keywords: female genital warts hpv typing hiv status treatment modalities and recurrence socio-economic burdens
laparoscopic combined hypo gastric neural plexus block and uterosacral nerve block for patients with chronic idiopathic pelvic pain

Conditions: Chronic Idiopathic Pain Syndrome

Summary: often the etiology of chronic pelvic pain is not clear, as there are many disorders of the reproductive tract, gastrointestinal system, urological organs, musculoskeletal system, and psych neurological system that may be associated with chronic pelvic pain. an effective treatment for this condition has evaded the medical profession for centuries. even today only 20-25% patients respond to conservative management.5 when such treatment fails, a diagnostic laparoscopy is performed.1, 3, 6 the cause of the pain is not always obvious as no pathology is seen in 40-60% of the cases.1

this prospective randomized controlled study will be conducted at eldemerdash hospital. 60 patients will be included with the following criteria: . intraoperatively, all patients were monitored by standard monitoring. all patients will be assigned randomly by using computerized program to one of the two equal groups. patients will be (thirty patients per group): group a ; thirty patients will do laparoscopy for diagnosis of the causes of chronic pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the sacral promontory then30 ml (14 ml marcaine +14 ml normal saline+2ml betamethasone) are injected. group b; thirty patients will do laparoscopy for diagnosis and conventional surgical treatment of the causes of pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the promontory followed by 30 ml (14 ml marcaine +14 ml normal saline+2ml betamethasone) then injecting 5 ml ( 2.5 marcaine+1ml betamethasone +1.5 ml normal saline) 2 cm away from the cervix at the uterosacral ligament on each sides. pain score ( visual analogue score) was assessed before surgery (basal) and after completion of laparoscopy 4hr, 12hr, 24hr, 48hr, 1, 4, 8,12, 16,20 and 24 weeks. visual analogue scale: no pain moderate worst pain 0 1 2 3 4 5 6 7 8 9 10 duration of pelvic pain relieve after laparoscopy up to 16 weeks,side effects like urinary retention, constipation were recorded after completion of laparoscopy 4hr, 12hr, 24hr, 48hr, 1week, 4weeks, 8 weeks, 12 weeks and 16 weeks. urinary retention will be treated by reassuring the patients and catheterization as it usually resolves after 2-3 days, constipation will be treated by reassuring the patients and purgatives as it usually resolves after 2-3 days. postoperatively, all patients were transferred to postoperative care unit (pacu) and monitored every 10 min until discharge.

Eligibility criteria:
inclusion criteria: * • age 18 to 50 years old. * american society of anesthesiologists physical status (asa-ps) i and ii patients. * sex: female. * patients scheduled for elective laparoscopy for diagnosis of the cause of chronic pelvic pain. exclusion criteria: * • patient refusal. * patients on chronic pain medications. * asa iii or worse clinical condition. * intra-abdominal infection. * allergy to any of the study medications.