Kornimate/medical-research-clean huggingface dataset:
study designed to optimize the treatment of primary pneumothorax

Conditions: Primary Spontaneous Pneumothorax; Pleural Disease

Summary: knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.the aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.

* background knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial. typically, the first incidence is treated conservatively with simple chest tube drainage and only if the disease reoccurs is surgery considered. however, conventional treatment may be associated with increased morbidity, prolonged hospitalization and many young adults are concerned about the high recurrence of this disease. the latter has been reported in as many as 25-35% of patients. because spontaneous pneumothorax in young adults usually is associated with apical blebs, the investigators hypothesized that primary surgery (video-assisted thoracoscopic surgery = vats) with resection of such blebs at the time of the first episode of pneumothorax might be an effective first line treatment associated with lower morbidity and shorter hospital stays, and a definite decline in recurrence rate. * method from july 2009 the investigators conducted a nationwide study , where 300 consecutive patients admitted to a danish hospital with primary spontaneous pneumothorax undergo a high resolution ct of the thorax. based upon the ct the patients are randomised to conventional conservative treatment (chest tube drainage) or primary vats with bleb resection and mechanical pleurodesis. participants are followed for ten years. the primary endpoint is ipsilateral recurrence of pneumothorax. secondary endpoints are length of hospitalization, duration of chest tube drainage and miscellaneous complications. simultaneously, a research biobank containing blood samples and pulmonary tissue is created for future studies of biomarkers and possible genetic causes. finally, the investigators are conducting a national epidemiological study, where the incidence in the danish population is investigated. \*perspective this study contributes new knowledge on incidence, genetics and best treatment of primary spontaneous pneumothorax in young adults which will have an impact on the future strategy of both understanding and treatment of this disease on a global level.

Eligibility criteria:
inclusion criteria: * first incidence of primary spontaneous pneumothorax. * age between 18 and 40. * no known preexisting pulmonary disease. * patient must accept randomization. * able to read and understand information regarding the study. * the condition must require treatment with a chest-tube. exclusion criteria: * age above 40. * previously pulmonary og cardiac surgery. * pregnant or breastfeeding. * patients who do not tolerate anesthetics.

Keywords: primary spontaneous pneumothorax epidemiology genetics risk factors
trial of a novel family-based intervention to increase outdoor time and fitness

Conditions: Myopia; Obesity

Summary: this study aims to implement a new family-based health behavior community program to increase time spent outdoors and physical activity among singapore children aged 6 to 12 years in a 1-year randomized clinical trial. 300 children from 250 families will be randomly assigned to either a family-based intervention or no intervention. the family-based intervention comprises structured weekend outdoor activities organized by national parks and incentives for children to wear a pedometer and increase their daily steps. families who meet their monthly step and outdoor activity goals will receive a range of prizes and incentives. both groups will receive brochures on the national myopia prevention program and physical activity. the success of the intervention will be evaluated through light meters, 7-day outdoor diaries, questionnaires documenting outdoor time and myopia; as well as pedometer steps, walking tests, and body mass index. a community-based intervention will be developed to improve the health of singapore children by increasing outdoor time and physical activity to prevent myopia and obesity.

to develop, implement, and evaluate a novel incentive-based family intervention to increase time spent outdoors and physical activity among children aged 6 to 12 years in a 1-year randomized controlled trial.

Eligibility criteria:
inclusion criteria: * children between 6 and 12 years of age with no known health problems preventing them from staying outdoors or walking for physical activity will be included as long as they are singapore citizens or permanent residents. * both myopic and non-myopic children will be included exclusion criteria: * children with medical conditions such as type 1 diabetes, severe asthma, cancer or mental illness will be excluded.

Keywords: myopia outdoor activity physical activity randomized controlled trial pedometer behavior modification obesity
escitalopram for premenstrual syndrome (pms) in teens: a pilot study

Conditions: PMS

Summary: the purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe pms in young women ages 15-19 years.

the medication in this study is a serotonin reuptake inhibitor (ssri), a class that is considered the first-line treatment for severe pms at this time. although data indicate that young women who have pms in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for pms in teens.

Eligibility criteria:
inclusion criteria: * females 15-19 years of age * regular menstrual cycles of 22-35 days * in general good health * medically approved birth control method if sexually active * evidence of ovulation * meeting all symptom criteria for pms * signed informed consent * subjects under age 18 must also have signed parental consent exclusion criteria: * current use of any treatment for pms. * psychotropic or other medications that may compromise the study drug. * pregnancy, intending pregnancy or breast feeding. * not using a medically approved birth control method if sexually active. * significant medical or gynecological abnormalities. * irregular menses, any gynecologic disorder. * any severe or unstable medical illness. * any current major psychiatric diagnosis or any history of a major psychiatric diagnosis. * any current or history of alcohol abuse, drug abuse, suicide attempt, bi-polar disorder, psychosis or severe personality disorder. * use of triptans (imitrex, zomig, frova, maxalt, axert, amerge, relpax). * use of medicines that include dextromethorphan such as tylenol or vicks cough medicines. * use of the pain medication meperidine. * use of any herbal product such as st john's wort that may increase serotonin. * use of monoamine oxidase inhibitors (maois), pimozide or citalopram hydrobromide. * drugs metabolized by cyp2d6 or a combination of cyp3a4 and cyp2d6 inhibitors. * hypersensitivity to escitalopram or citalopram.

Keywords: premenstrual syndrome pms pmdd treatment ssri
effect of acupuncture on symptoms of diarrhea and pain in ibs

Conditions: Irritable Bowel Syndrome

Summary: acupuncture has been used for centuries in china in the treatment of diarrhea. our hypothesis is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients with diarrhea-predominant ibs

patients will complete a diary to determine if they qualify for the study. patients will be randomized to receive either acupuncture or sham acupuncture (needle insertion 1 cm away from acupuncture site). patients will be blinded to whether they are receiving acupuncture or sham acupuncture. the acupuncturist is blinded as to the patient response. the patients will undergo venupuncture to draw blood to determine sertotonin and beta-endorphin levels. they will receive treatment in 12 sessions over 4 weeks. they will maintain a diary during this time period to document level of pain and frequency of bowel movements. blood will be drawn at week 2 and 4 and, 6 weeks after cessation of treatment, subjects will again record abdominal symptoms and frequency of bowel movements for 2 weeks. blood will be drawn for hormone levels at 8 weeks after completion of study.

Eligibility criteria:
inclusion criteria: * frequence of bowel movement of at least 3/day * global disease severity of at least 3 exclusion criteria: * taking medications which will influence frequency of bowel movement * patient taking anticoagulants or suffering from coagulopathy * pregancy

Keywords: diarrhea-predominant irritable bowel syndrome acupuncture abdominal pain
testing the capability of the smart underwear device to detect increased microbiome activity following lactose consumption

Conditions: Lactose Intolerance, Adult Type

Summary: the goal of this interventional study is to validate the smart underwear device's ability to detect lactose intolerance by comparing its results to self-reported symptoms in adult participants aged 18 and above, divided equally between self-reported lactose-tolerant and lactose-intolerant individuals. the main questions it aims to answer are: can the smart underwear device reliably measure flatus events after lactose consumption? does the microbiome activity index differentiate between responses to lactose and sucrose consumption? researchers will compare participants consuming lactose (experimental arm) with their results after consuming sucrose (placebo arm) to see if the device detects increased flatus events and higher microbiome activity index values in the lactose arm. participants will: * follow a low-fiber/low-fodmap diet for four days. * record meals using a food log and a custom smartphone app. * wear the smart underwear device for 8 hours daily for three days. * fast for 12 hours overnight, consume 20 grams of either lactose or sucrose dissolved in water, and continue fasting for an additional 4 hours. * fast for 12 hours overnight, consume 20 grams of the carbohydrate they did not consume the first time (lactose or sucrose) dissolved in water, and continue fasting for an additional 4 hours. * complete digestive symptom surveys after each carbohydrate intake. the randomized crossover design ensures that participants consume both lactose and sucrose on separate days, with blinding maintained for both participants and researchers.


Eligibility criteria:
inclusion criteria: * has no gastrointestinal disorders * not consuming any prescribed medications * willing and able to consume sucrose and lactose * determined to be lactose tolerant or lactose intolerant after completing an eligibility survey exclusion criteria: * younger than 18 years old * diagnosed with or suspected to have the following conditions: diabetes, prediabetes, high blood sugar, ibd, sibo, or a food allergy to sucrose or lactose * experience gastrointestinal pain, bloating, or diarrhea when consuming garlic, onions, or leeks * routinely experience constipation or painful constipation * have ever had an anaphylactic reaction after eating or drinking anything
retrospective examination of initial care of severe bacterial infections of the child

Conditions: Bacterial Infection

Summary: the aim of the study is to determine the frequency of sub-optimal care in the initial care (before arrival at the intensive care unit) of children from "west france regions" suffering of severe bacterial infections.the characteristic "optimal or not" of the initial medical care will be determined by 2 independent experts, blinded from each other and blinded from the issue of the care. in case of a discordance between the two experts, a third expert will be demanded. three possibilities of conclusion will be proposed to the experts: "sure sub-optimal medical care", "possible suboptimal care" and "optimal care".


Eligibility criteria:
inclusion criteria: * child from west france regions * aged between 1 month and 16 years old, * admitted at the intensive care unit for a severe bacterial infection and with the first symptoms appeared when child was at home or hospitalized since less than 48h * children dead at home will also be included in this study via the mobil medical urgency help unit (french term : "samu") exclusion criteria: * patient not fulfilling inclusion criteria * child with a nosocomial infection * child dead or admitted at the intensive care unit following a pertussis- child not admitted at the intensive care or not dead at home in a context of infection. * child with viral or fungic infection admitted at the intensive care unit.

Keywords: severe bacterial infection
long-term renal prognosis of neonatal acute kidney injury

Conditions: Neonatal Acute Kidney Injury

Summary: the goal of this observational study is to conduct a multicenter, prospective neonatal acute kidney injury (aki) follow-up cohort to describe the clinical characteristics of chronic kidney disease (ckd) in aki cases within 1 year of follow-up and screen for effective biomarkers that can early warn of ckd progression. ultimately, a neonatal aki adverse prognosis warning model based on multidimensional data will be established to provide new data and new models for ckd management.


Eligibility criteria:
inclusion criteria: * delivered in this hospital and subsequently admitted to the nicu during the study period; * diagnosed with neonatal aki according to the 2015 kdigo neonatal aki criteria; * age \<28 days. exclusion criteria: * severe hydronephrosis diagnosed by prenatal renal ultrasound; * patients with congenital urinary malformations, including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal dysplasia, and obstructive uropathy; * newborns who required congenital heart surgery within the first 7 days after birth; * newborns whose mothers had a history of renal failure; * death within 48 hours after birth; * other genetic syndromes or medical conditions were not eligible for inclusion according to the attending neonatologist's judgment.

Keywords: neonatal acute kidney injury long-term prognosis prognosis and predictive factors biomarkers
real-world experience using nemolizumab in the treatment of moderate-to-severe atopic dermatitis in adolescents & adults

Conditions: Atopic Dermatitis

Summary: the main aim of the study is to assess real-world effectiveness of nemolizumab in atopic dermatitis (ad) as measured by physician assessment and patient reported outcome (pro) in clinical practice at month 6.

this prospective, multicenter, non-interventional study (nis) seeks to evaluate treatment with nemolizumab of moderate-to-severe ad in adolescents and adults over an approximately 12-month period using physician assessments in routine clinical practice and pro measures. treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. no additional visits, procedures, or laboratory tests are required outside of routine clinical practice. the visit structure is not defined by the study protocol but is determined by routine medical practice. the visit schedule is intended to facilitate a systematic data assessment according to clinical routine. a sub-study will be completed in germany and the uk at selected sites in which participants will complete the peak pruritus (pp) numerical rating scale (nrs), average pruritus (ap) nrs, sleep disturbance (sd) nrs, and pain nrs on a daily basis from day -1 to day 14. data collection will occur remotely, and no clinic visits will be required.

Eligibility criteria:
inclusion criteria: * participants who, according to the treating physician's decision and in line with the local package label, start treatment with nemolizumab (nemluvio®). * adolescent and adult participants aged \>=12 years with moderate-to-severe ad. * participants who signed the written informed consent form (icf) or had it signed by their legal representative. exclusion criteria: * have contraindication(s) for the use of nemolizumab (nemluvio®) according to the local package label. * participants who received treatment with a drug under clinical development/investigation within 3 months prior to baseline. * participants who received nemolizumab previously. * participants who are mentally, physically, or linguistically unable to understand the content of the icf and/or to complete the study questionnaires.
amphotericin-b and voriconazole for pulmonary blastomycosis

Conditions: Blastomycosis

Summary: all patients with pulmonary blastomycosis requiring mechanical ventilation will have their blood concentrations measured for the antifungal drugs, amphotericin-b and voriconazole; as well as an analysis of the susceptibility of their infecting species of blastomyces. this information will then be analyzed relative to their rate of clinical recovery from this serious fungal infection.

to evaluate six intensively studied patients admitted to medical intensive care with pulmonary blastomycosis requiring mechanical ventilation. interventionally, all patients will receive continuously infused amphotericin-b (1 mg/kg/d); and then stepped down to oral or i.v. voriconazole once clinically responding. blood will be sampled for amphotericin-b concentrations for the 3 first days (i.e. one blood sample per day); and when eventually changed over to voriconazole (i.e. generally after a total dose of 1 g has been reached of amphotericin-b; as per usual practice). once switched to oral or intravenous voriconazole, at the treating physicians discretion, then blood would once again be sampled for the next 3 days for voriconazole concentrations. mic's of the infecting blastomyces would also be analyzed. the fungal isolate would be sent off to the fungus testing laboratory at the university of texas in san antonio for susceptibility testing. clinical response to therapy relative to their initial pharmacokinetic and pharmacodynamic indices for amphotericin-b (i.e. daily free maximal concentration divided by the mic) would be assessed in these 6 intensively studied patients. clinical parameters assessed would be 1). time to fever defervescence; 2). time to white cell count resolution, and 3). improvements in respiratory gas exchange (i.e. specifically the rate of rise of the pressure of arterial oxygen (pa02) divided by the fraction of inspired oxygen (fi02) delivered through the ventilator (or pf ratio).

Eligibility criteria:
inclusion criteria: * all adult patients 18 years of age or older admitted to the intensive care units of st. boniface general hospital with a diagnosis of acute pulmonary blastomycosis requiring mechanical ventilation. exclusion criteria: * the patient's data will be excluded if they die within 3 days of hospital admission.

Keywords: amphotericin-b continuously infused voriconazole
emotional experiences in fathers of nicu infants

Conditions: Stress; Depressive Symptomatology

Summary: this study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)nicu setting. in addition, we will compare the emotional responses experienced by father of surgical nicu babies and fathers of medical nicu babies. our primary hypothesis is that paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical nicu compared with fathers of infants who are hospitalized in a surgical nicu. secondary hypotheses include: 1) stress levels for fathers of hospitalized infants will decrease over time; 2) depressive symptomatology modulates perceived stress in fathers of nicu infants.

it is well known that birth and hospitalization of a preterm infant is stressful for parents. numerous studies have evaluated emotional factors such as maternal stress, parental role alteration, and maternal depression. researchers have also investigated both maternal and paternal emotional responses in relation to their infant being hospitalized in the nicu. studies examining paternal response alone have received less research attention. to date, no studies have compared the emotional response of fathers of medical nicu babies and fathers of surgical nicu babies. the purpose of this study is to evaluate and compare perceived paternal stress and depressive symptomatology in fathers of preterm medical and surgical infants. fathers who agree to participate will be given a questionnaire that is comprised of two self-report tools. together these tools should take approximately 15-20 minutes to complete. fathers who participate will be asked to complete these tools at three different times throughout their infants' stay in the nicu.

Eligibility criteria:
inclusion criteria: * consenting fathers who are english speaking * fathers with preterm infants \< 30 weeks gestation and who are likely to survive * infants who lack congenital or genetic abnormalities likely to be associated with significant neurodevelopmental handicaps. exclusion criteria: * there are no specific exclusion criteria.

Keywords: emotional experiences fathers stress depressive symptomatology nicu preterm birth
the treatment of implant-retained mandibular overdentures for edentulous patients

Conditions: Edentulous

Summary: the purpose of this study is to investigate to what extent ios improve the functionality of edentulous patients and changes in quality of life and overall patient satisfaction following treatment with ios.

edentulous individuals will be selected from patients attending the prosthodontic clinic. then, new complete dentures will be provided; in a second stage half of these subjects (randomly selected) will receive ios. the effect of different treatment protocols on chewing ability, patient satisfaction and ohrqol will be investigated and assessed.

Eligibility criteria:
inclusion criteria: 1. being edentulous in the upper and lower jaw for at least 1 year 2. dissatisfied or cannot function with their complete lower denture 3. age between 40 and 75 4. suitable bone quality as assessed radiographically (cbct) according to zarb's classification。 exclusion criteria: 1. physical and mental disabilities which interfere with the maintenance of implants; 2. severe skeletal jaw discrepancies (class iii) 3. those who have already received or lost dental implants 4. those who abuse drugs or alcohol 5. smoking more than 10 cigarettes a day 6. having received radiotherapy to the head and neck region for malignancies 7. undergoing chemotherapy 8. on long-term therapy with steroids 9. immunosuppressants or biphosphonates 10. insulin-dependent diabetic patients and uncontrolled onset diabetic patients 11. those affected by chronic renal or liver disease 12. systemic and local bone disorders and pathology 13. serious cardiac and pulmonary disorders 14. haemophilic disorders who are susceptible for increased bleeding and tendency for post-operative infections 15. those who are at risk of developing bacterial endocarditis 16. immune system compromised patients, including those with hiv