Kornimate/medical-research-clean huggingface dataset:
study to demonstrate the efficacy and safety of adapalene/benzoyl peroxide topical gel in subjects with acne vulgaris

Conditions: Acne Vulgaris

Summary: this was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. efficacy and safety evaluations were performed at screening (safety only), baseline and weeks 1, 2, 4, 8 and 12. all investigator's global assessment evaluators and lesion counters must be trained and approved by galderma. the evaluator of a participant should remain the same during the study. the primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of acne vulgaris with facial involvement. * a minimum of 20 but not more than 50 inflammatory lesions * a minimum of 30 but not more than 100 noninflammatory lesions * a score of 3 (moderate) on the investigator's global assessment scale

Keywords: acne vulgaris adapalene benzoyl peroxide
a community health worker home intervention to improve pediatric asthma outcomes

Conditions: Asthma

Summary: the investigators propose to test the hypothesis that a home-based asthma intervention, the wee wheezers program, delivered by the community health workers and tailored to the needs of the investigators community, will improve anti-inflammatory medication adherence, parental asthma knowledge and management behaviors, which in turn will reduce asthma morbidity (defined as days with asthma symptoms) and health care utilization (defined as asthma-related emergency department visits) among low-income, minority children with persistent asthma in the bronx.

asthma disproportionately burdens low-income inner city and minority children residing in inner cities. daily use of inhaled corticosteroids (ics) control symptoms and reduce asthma morbidity. less then 50% of children with persistent asthma adhere to such therapy. poor adherence to ics medications is one of the major contributors to asthma morbidity. one way to reduce asthma disparities is to work in partnership with communities. community health workers (chws) share the ethnic, cultural, social, and environmental experiences of the people in the community. although, chw home interventions have been successful in reducing asthma allergens, no studies using chws to deliver a previously identified evidence-based home intervention to improve ics adherence and health outcomes in a population of inner-city, minority children with persistent asthma have been found. objective: to evaluate the effectiveness of an evidence-based asthma home intervention, the wee wheezers program, tailored to the needs of the community and delivered by chws, in improving medication adherence, health outcomes and parental management behaviors among low-income, minority children with persistent asthma in the bronx.

Eligibility criteria:
inclusion criteria: * children 2-9 years of age with persistent asthma * children being currently prescribed ics in the metered dose inhaler (mdi) form * if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists * primary caregiver speaks english or spanish * family has a phone. exclusion criteria: * children with other chronic pulmonary diseases (e.g, cystic fibrosis, bronchopulmonary dysplasia) or presence of tracheostomy

Keywords: asthma children community health workers home intervention
the global en bloc resection of bladder tumour registry

Conditions: Bladder Cancer

Summary: the study aims to collect data on erbt globally in order to clarify its role in the management of bladder cancer over a 5-year observation period.

bladder cancer is a prevalent disease globally, and it is the 9th most commonly diagnosed cancer in men worldwide. it has a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. this disease represents a significant burden to the healthcare system. bladder cancer is classified into non-muscle-invasive bladder cancer (nmibc) and muscle-invasive bladder cancer (mibc) according to its depth of invasion. conceptually, nmibc is amenable to complete resection by transurethral resection of bladder tumour (turbt) alone, while mibc requires more aggressive treatment in the form of radical cystectomy. the gold standard in local staging is by histology, and this can be achieved by turbt. however, conventional turbt creates charred tissue chips in a piecemeal manner which may hinder pathologists' judgment of the tumour base clearance. second-look turbt has been shown to detect residual disease in 33-55% of the patients, and upstaging of disease in 4-45% of the patients following the first turbt; it has also been shown to improve recurrence-free survival in patients with t1 non-muscle-invasive bladder cancer. in addition, tumour fragmentation and reimplantation may lead to early disease recurrence. all these highlighted the limitations of the conventional turbt procedure. transurethral en bloc resection of bladder tumour (erbt) represents a novel surgical technique in which the bladder tumour is resected in one piece. theoretically, erbt may prevent recurrence by minimizing the risk of tumour reimplantation and ensuring complete resection based on proper histological assessment. although erbt has been practised in many centres worldwide, there is a lack of high quality evidence in proving its superiority over conventional turbt. also, the optimal indications, best energy modality, the need for routine tumour base biopsy, intravesical chemotherapy, second-look turbt and the optimal follow-up protocol remain uncertain for this technique. therefore, there is a need for a well-planned prospective multi-centre study to evaluate the role of erbt in the management of bladder cancer. investigators propose to conduct a prospective, multi-centre, registry study to expedite understanding of erbt and to establish its role in management of bladder cancer.

Eligibility criteria:
inclusion criteria: * adult patients \>=18 years old with informed consent * presence of bladder tumour undergoing transurethral erbt exclusion criteria: * presence or previous history of upper tract urothelial carcinoma * presence of other active malignancy * pregnancy

Keywords: en bloc resection of bladder tumour
preoperative stomach cancer induction chemotherapy and radiation therapy

Conditions: Locally Advanced Gastric Carcinoma

Summary: based upon rtog 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * patients with potentially resectable adenocarcinoma of the stomach with histologic proof. * eus or mri stage t3-4, any n, m0. * adequate bone marrow (defined as peripheral absolute granulocyte count of \> 2,000/μl, and platelet count of\>100,000/μl), liver (bilirubin \< 1.5 mg/dl), and renal functions (creatinine \< 1.5 mg/dl). * absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion. * no prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason. * patients must have a life expectancy of at least 16 weeks. * performance status of \< 2 (zubrod scale). * no biopsy proof of lymph node metastases outside the study field. * no evidence of metastatic disease to distant organs. * no presence of concurrent or previous malignancies \< 5 years, other than noninvasive skin cancer. * no uncontrolled or severe cardiac disease, diabetes or hypertension. * signed study-specific consent form prior to study entry. exclusion criteria: * evidence of metastatic disease * prior chemotherapy or radiotherapy * patients with a past history of cancer * patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled * pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures * cardiac failure or sever pulmonary disease * patients with impaired gastrointestinal absorption for whatever reason * patients medically unfit for cisplatin or taxol chemotherapy
the effect of virtual reality glasses on dental anxiety control

Conditions: Periodontitis; Dental Anxiety; Dental Fear; Gingivitis; Calculus, Dental

Summary: in this clinical study, it was aimed to evaluate whether there is a decrease in patient anxiety by applying virtual reality glasses, which are the product of new technology, during scaling and root planing treatment. patients who required scaling and root planing treatment and also scored 9 or above according to the dental anxiety scale were included in our study. scaling and root planing was performed in a randomly selected intraoral quadrant of the patients, in the same way, with or without the use of virtual reality glasses. in the virtual reality glasses application, a video consisting of images of nature landscapes developed for patient rehabilitation was projected onto the screen in front of the patient's eyes. the dental anxiety scale was reapplied after the completion of the treatment. in the intraoral quadrant where virtual reality glasses were used, it is expected that lower corah dental anxiety scale scores may be obtained after the treatment is completed, compared to the intraoral quadrant where the treatment is performed without glasses, thus reducing anxiety.


Eligibility criteria:
inclusion criteria: * being over 18 years old * being systemically healthy * needing treatment in at least two quadrants of the mouth * at least five teeth in each quadrant and at least one region with a terminal pocket depth ≥4 mm * having a score of 9 or higher on the dental anxiety scale exclusion criteria: * having a history of seizures or a convulsive disorder * balance disorders such as nystagmus, vertigo * use of psychotropic drugs * getting treatment for anxiety * presence of dermatological lesions on the face and especially around the eyes * the presence of a lesion in the eye that will prevent the use of virtual reality glasses
nivats versus igavats: a pilot trial addressing biopsy quality in undetermined interstitial lung diseases

Conditions: Lung Diseases, Interstitial

Summary: the main objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease (ild) in terms of diagnostic confidence as determined by histologists.

the primary objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease (ild) in terms of diagnostic confidence as determined by histologists. the experimental arm will be operated under a neoteric non-intubated video assisted thoracic surgery (nivats) technique and the comparator arm under a usual intubated general anaesthesia video-assisted thoracic surgery (igavats) technique. secondarily, the two groups will also be compared in terms of: (i) further variables associated with histology, biopsy quality and size; (ii) surgical performance, (iii) patient trajectories and lung function; (iv) quality of life, and (v) harms.

Eligibility criteria:
inclusion criteria: * patient with purported interstitial lung disease * patient requiring a surgical lung biopsy to reinforce diagnosis according to current recommendations and validated by a multidisciplinary assessment * minimum age: 18 years exclusion criteria: * contra-indication for surgery * uncontrolled oesophageal gastric reflux despite optimal treatment * thoracic deformation (for example, pectus excavatum/carinatum or major scoliosis) * risk of pleural adhesion (for example, patient who has already undergone thoracic surgery) * history of abnormal bleeding * predictable risk of difficult intubation * body mass index (bmi) \> 30 * severe cardiovascular comorbidity (for example, instable ischemic cardiomyopathy) * unable to comply with all trial procedures/visits (for example, language barriers, upcoming move of household to another region, unwillingness to schedule the required followup visits.) * protected populations according to the french public health code articles l1121-5,6,8 (for example, pregnant, parturient or lactating women, prisoners, adults under guardianship or otherwise unable to consent.) * potential interference from another study (the patient is participating in another interventional study, or has done so in the past month, or is affected by an exclusion period stipulated by a previous study.) * non-beneficiary of the french single-payer national medical insurance system * lack of signed informed consent
nebulized dexmedetomidine versus oral sumatriptan in treatment of post dural puncture headache in cesarean section

Conditions: Post-Dural Puncture Headache

Summary: comparison between oral sumatriptan and nebulized dexmedetomidine in post dural puncture headache in cesarean section

a total of 48 patients will be randomly chosen to receive either inhaled dexmedetomidine (group d, n= 24) or oral sumatriptan (group s, n= 24) by a random sequence number generated by the computer kept in sealed envelopes. those envelopes will be opened once the patient is recruited and participants will receive either inhaled dexmedetomidine or oral sumatriptan as per the envelope. data collectors will be blinded to the type of used medication (dexmedetomidine or sumatriptan).

Eligibility criteria:
inclusion criteria: 1. pregnant female aged between 18 and 40 years old. 2. asa ii and iii undergoing elective caesarean section. 3. diagnosed with postdural puncture headache with visual analogue score (vas) ≥ 4 and lybecker classification score ≥ 2. exclusion criteria: 1. patient refusal. 2. history of primary headaches such as migraine, cluster and tension headaches. 3. hypersensitivity of dexmedetomidine or sumatriptan. 4. hypertensive disorders of the pregnancy. 5. contraindication to spinal anesthesia as coagulopathy or infection at site of injection. 6. symptoms of ischemic heart disease (ihd) e.g. angina. 7. cerebrovascular disease e.g. stroke or transient ischemic attacks (tias). 8. using of monoamine oxidase inhibitors (maois) in the last 24h.
sii and palbi is associated with the prognosis of pancreatic cancer surgery(sii,palbi)

Conditions: Pancreatic Cancer

Summary: chronic inflammation and immune dysfunction play a key role in the development of tumors. the aim of the study is to investigate the predictive value of sii and palbi grade for the patients with pancreatic cancer surgery.

the systemic immune-inflammation index(sii), based on the counts of platelets, neutrophils, and lymphocytes,was first found to be related to the prognosis of patients in melanoma12, and was subsequently confirmed in malignant tumors such as hepatocellular carcinoma13,and lung cancer12. a retrospective multicenter cohort study showed that bilirubin levels can interfere some inflammation index'prognosis of pdac7.the platelet-albumin-bilirubin (platelet-albumin-bilirubin, palbi) grade as a prognostic indicator of inflammation has been found in recent years, and its role has been confirmed in patients with liver cirrhosis14,15 and hepatocellular carcinoma 16, but there is no research to verify its role in patients with pancreatic cancer. this study aims to verify the predictive value of systemic immune inflammation index (sii) and platelet-albumin-bilirubin grade (palbi) for the prognosis of patients with pancreatic cancer surgery, and to explore the significance of other inflammatory indicators in the overall survival(os) and disease-free survival (dfs).

Eligibility criteria:
inclusion criteria: age ≥ 18 years old; it was diagnosed as pancreatic cancer by clinical manifestations, laboratory examination indexes, and pathology, and then surgically removed; agree to participate in this study and sign an informed consent form; exclusion criteria: all kinds of acute or chronic inflammation, infectious diseases and blood system diseases; metastasis of tumors in other parts; benign pancreatic diseases such as chronic pancreatitis and autoimmune pancreatitis; periampullary tumors without pancreatic cancer; suspicious pancreatic cancer patients who cannot be diagnosed; refuse to follow up.

Keywords: pancreatic cancer systemic immune inflammation index platelet-albumin-bilirubin grade
video head impulse test and seasickness susceptibility

Conditions: Sea Sickness

Summary: this a case control study on seasickness susceptibility. 86 healthy maritime personal were divided to seasickness susceptible and non susceptible groups based on a seasickness questionnaire (golding) and motion sickness score. all subjects from both groups underwent video head impulse testing (vhit). vhit parameters - gain, asymmetry ect were compared between both groups.


Eligibility criteria:
inclusion criteria: * 18-40 healthy military naval subjects * at least six month of active sailing. exclusion criteria: * a history of hearing loss * ear pathology observed at otoscopic examination * a neck injury precluding head movement. * abnormal otoneurological examination findings * subject's withdrawal of informed consent. * failure to complete the video head impulse test.

Keywords: motion sickness video head impulse test vestibular testing seasickness susceptibility
clinical efficacy and safety of subcutaneous immunotherapy with gpasit+™ in patients with grass pollen-induced allergic rhinoconjunctivitis

Conditions: Hay Fever

Summary: this is a randomised, double-blind, placebo-controlled, international, multicentre, confirmatory phase iii study in patients with grass pollen-related allergic rhinoconjunctivitis. after having given written informed consent, the patients will be examined to establish eligibility according to inclusion/exclusion criteria. the eligible patients will be randomised to placebo or gpasit+™ treatment according to a 1:1 ratio. study treatment will be administered before the start of the pollen season in 2019


Eligibility criteria:
inclusion criteria: * allergy diagnosis: * a clinical history of moderate to severe grass pollen-induced seasonal allergic rhinoconjunctivitis (sarc) for at least 2 pollen seasons, requiring treatment with either antihistamines or nasal corticosteroids during the 2017 and 2018 grass pollen seasons and with symptoms interfering with usual daily activities or with sleep, as defined according to allergic rhinitis and its impact on asthma (aria) classification of rhinitis (bousquet et al. 2001) * a positive skin prick test (spt) (wheal diameter ≥3 mm) to grass pollen mixture, histamine wheal ≥3 mm, sodium chloride (nacl) control reaction \<2 mm and * specific ige against grass pollen ≥0.7 ku/l. 6) * for asthmatic patients, confirmed diagnosis of controlled asthma according to global initiative for asthma (gina; 2018) exclusion criteria: * diagnosis of mastocytosis; * previous (within the last 5 years) immunotherapy with grass allergens; * ongoing immunotherapy with grass allergens or any other allergens; * patients with any history of anaphylaxis due to any cause; * patients with a history of hypersensitivity to the excipients of the investigational product; * patients with a forced expiratory volume in 1 second (fev1) \<80% of the predicted value (european community for steel and coal) or with a peak expiratory flow (pef) \<70% of the individual optimum value at the screening visit; * history of being intubated with mechanical ventilator support or in intensive care unit for asthma at any point in the patient's life; * history of emergency visit or hospital admission for asthma in the previous 12 months; * clinical history of moderate to severe allergic rhinitis, as defined according to the aria classification of rhinitis, due to tree pollen near or overlapping the grass pollen season; * clinical history of moderate to severe allergic rhinitis as defined according to the aria classification of rhinitis caused by an allergen to which the participant is regularly exposed;
surfactant versus nasal continuous positive airway pressure (ncpap) for respiratory distress syndrome in the newborn ≥ 35 weeks of gestation

Conditions: Acute Respiratory Distress Syndrome

Summary: term and near term newborns can present acute respiratory distress syndrome (rds). surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen treatment durations in the preterm newborn. whether surfactant treatment is beneficial for term and near term newborns is unknown. the purpose of this study is to compare surfactant treatment vs. nasal continuous positive airways pressure in the newborn between 35 and 41 weeks of gestation with rds within the first 24 hours of life. the study's primary endpoint is "survival with no oxygen treatment at 72 hours of life". the secondary endpoints are: death, surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension, inhaled nitric oxide treatment, fluid loading treatment, vasopressive amines treatment, mechanical ventilation duration, ncpap treatment duration, oxygen treatment duration, oxygen treatment at 28 days of life, hospitalization duration and treatment strategy cost.

newborn between 35 and 41 weeks of gestation with rds within the first 24 hours of life, treated with ncpap and a fio2 ≥ 30% are eligible. randomisation is stratified by centre and 2 age groups (35-36 weeks of gestation and 37-41 weeks ogf gestation). one arm will receive surfactant treatment after tracheal intubation. the second arm will continue ncpap. a rescue treatment is used in the second arm if fio2 \> 60%. in each arm the newborn is weaned from mechanical ventilation and oxygen treatment as soon as possible. the primary outcome of the study is the success of the procedure defined as "survival without any oxygen treatment" at 72 hours of life.

Eligibility criteria:
inclusion criteria: * gestational age between 35 and 41 weeks of gestation * \< 24 hours of life * nasal continuous positive airways pressure (ncpap) for more than 1 hour * fio2 ≥ 30% with ncpap and a target post-ductus arteriosus spo2 \>92% * written consent of the parents exclusion criteria: * fio2 \> 60% with ncpap, ou fio2 \> 40% for 3 consecutives hours whatever the respiratory support * life threatening congenital pathology * congenital cardiopathy (except patent ductus arteriosus) * shock defined as systemic hypotension (mean blood pressure \ 160 beats/min); 2) abnormal peripheral pulses; 3) modified extremities coloration; 4) prolonged capillary refill time \> 3 seconds; 5) urine output \< 1 ml/kg/h * blood gas ph \ 65 mmhg * apgar score ≤ 3 at 5 minutes of life

Keywords: infant newborn infant preterm acute respiratory distress syndrome surfactant hyaline membrane disease newborn acute respiratory distress syndrome (ards)