Kornimate/medical-research-clean huggingface dataset:
ne3107 in adults with neurological symptoms of long covid

Conditions: Long COVID

Summary: long covid is a condition where debilitating symptoms can persist for months after a covid-19 infection. this study aims to evaluate the effects of ne3107 on several neurological symptoms reported in people with long covid including difficulty concentrating or remembering things ("brain fog") and fatigue. researchers will compare ne3107 to a placebo (a look-alike substance that contains no drug) to see if ne3107 works to treat neurocognitive and fatigue symptoms of long covid. participants will: * take ne3107 or a placebo twice daily for 84 days * visit the clinic 5 times for checkups and tests and have a follow up phone call


Eligibility criteria:
inclusion criteria: * 18 years to 64 years of age * diagnosed with long covid with symptoms of fatigue and brain fog for at least 3 months * agree to use birth control measures * provide voluntary consent * willing to allow blood collection * pass all screening tests and procedures exclusion criteria: * has received a covid-19 vaccination within 30 days * previous admission to the intensive care unit for covid-19 * medical history of major mental or physical illness prior to covid-19 infection

Keywords: covid-19 neurocognition fatigue post-exertional malaise sleep sars-cov-2 brain fog
music to improve sleep quality in adults with depression and insomnia

Conditions: Insomnia; Depression

Summary: insomnia is a common sleep disorder for patients with depression. this has a major impact on the quality of life for the individual. the aim is to investigate, whether music intervention is effective in 1. improving sleep quality, 2. reducing symptoms of depression and 3. improving quality of life participants use a sound pillow and selected music in the the music star app at home as a sleep aid in 4 weeks.

depression is a common health problem in denmark with a prevalence for depression of 17-18%. depression has serious personal and social consequence. sleep disorders are common in patients with depression. resolving sleep disturbances in depression may prevent worsening of symptoms and relapse. music listening is widely used as a sleep aid. a study from the cochrane library shows consensus that music may be helpful to improve sleep quality in insomnia. it remains unclear if music listening is helpful to patients with depression as it is to a broader population. a randomized controlled trial address the use of music as a supplementary treatment to improve sleep in depression.

Eligibility criteria:
inclusion criteria: * out patients in treatment for depression in psychiatry, unit for depression, aalborg university hospital. * icd-10 diagnosis of unipolar depression f32 or f33. * sleeping problems identified by ham-d by a total score of 3 on sleep items 4-6, or a single score = 2 on at least one sleep item. * following treatment standards according to national guidelines.(pharmacological treatment, psychotherapy, psycho education, electro convulsive therapy). * 4 weeks of treatment and/or in stabilized pharmacological treatment exclusion criteria: * icd-10 diagnosis of depression f32 or f33 and psychotic episodes * substance or alcohol abuse * sentence to treatment by law * restless legs syndrome * obstructive sleep apnoea or other organic sleep disorders * hearing loss * dislike of music

Keywords: music depression sleep disturbances insomnia quality of life
prediction rules for low level laser on burn wounds

Conditions: Burn Wound; Clinical Prediction Rules

Summary: the purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to low level laser therapy in burn patients

it will be hypothesized that 1. age may significantly affect burn wound healing's response to low level laser therapy. 2. tbsa may significantly affect burn wound healing's response to low level laser therapy. 3. depth of wound may significantly affect burn wound healing's response to low level laser therapy. 4. wound healing stage may significantly affect burn wound healing's response to low level laser therapy. there will be only one intervention group. the duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). sixty patients (male and female) will be recruited from the burn units. low level laser therapy will be performed for 30 min 3 times per week for 8 weeks on the wound area. wound area was irradiated by a red 655 nm light, 150 mw, 2 j/cm2 at the bed of the wound.

Eligibility criteria:
inclusion criteria: * partial thickness burn wound depth. * age ranges from 20-50 years. * tbsa more than 15% * sufficient understanding to perform the test exclusion criteria: * diabetic patients. * burn wound with skin graft * infected wounds * patients receiving immunosuppressive drugs. * patients receiving irradiation or chemotherapy. * chronic circulatory diseases * severe associated injury with burn. * associated co-morbidities, such as neurological diseases, malnutrition, and other inﬂammatory and/or infectious diseases.
an investigational drug study evaluating a novel approach to treat dyslipidemia (0524a-032)

Conditions: Dyslipidemia

Summary: this is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach to treating dyslipidemia.

the duration of treatment is 7 days.

Eligibility criteria:
inclusion criteria: * males and females (ages 25-75) exclusion criteria: * a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
renal tolerance of amoxicillin and cloxacillin combination

Conditions: Endocarditis; Acute Kidney Injury

Summary: 2015 european society of cardiology guidelines have proposed the combination of ampicillin and cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identiﬁcation). yet this combination has never been studied in clinical trials. high dose penicillin treatments are associated with a risk of nephrotoxicity. the investigator's primary purpose is to describe patients treated with high dose amoxicillin and cloxacillin combination and to evaluate its renal tolerance.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years old) * hospitalized at the strasbourg university hospital and treated concomitantly with amoxicillin iv and cloxacillin iv for ≥48 hours between january 1, 2016 and december 31, 2020. * patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes. exclusion criteria: * subject having expressed opposition to participating in the study * subject under guardianship, curatorship or safeguard of justice

Keywords: endocarditis acute kidney injury amoxicillin cloxacillin
comparison of two growth hormone dosing methods in adults with growth hormone deficiency

Conditions: Hypopituitarism

Summary: this study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (dxa) scanning, performed at the beginning of the study and at the completion of the study eight months later.

dose regimen of growth hormone based on weight: starting dose was 4.0 micrograms/kg/day for four months, then increased to 8 micrograms/kg/day for two months, and then increased to 12 micrograms/kg/day for a further two months (eight months in total). dose regimen of growth hormone based on individual patient needs: starting dose was 200 micrograms/day, then increased by 200 micrograms/day every two months for an additional six months (eight months in total) as needed for optimal treatment results.

Eligibility criteria:
inclusion criteria: * have growth hormone deficiency that started in childhood or adulthood * have not received any growth hormone treatment in the last 12 months * have had a growth hormone stimulation test within the last two years showing abnormally low response * have received adequate and stable hormonal replacement for other hormone deficiencies during the last three months exclusion criteria: * presence of clinically significant diseases, such as cancer, lung, heart, liver, kidney, neuromuscular, genetic, or severe psychiatric diseases * recent growth of pituitary tumor or other intracranial tumor * history of acromegaly * taking medication to suppress appetite or reduce weight, or antidepressant drugs * poorly-controlled high blood pressure or diabetes
hvpg for rebleeding risk stratification

Conditions: Liver Cirrhosis; Portal Hypertension

Summary: background: in patients with cirrhosis on secondary prevention of variceal rebleeding with non-selective beta-blockers (nsbbs), the risk of rebleeding and death is markedly higher in those failing to achieve a good hemodynamic response (hvpg reduction ≥20% of baseline values or ≤12mmhg). however a substantial proportion of non-responders will never rebleed, thus appearing protected by nsbbs although non-detected by hvpg response. this low sensitivity hampers risk stratification and diminishes the cost-effectiveness of assessing the hemodynamic response to nsbbs. this is particularly relevant in prevention of rebleeding since in this scenario the risk of rebleeding and of other portal hypertension related complications is very high, which calls for early institution of effective therapy. baseline hvpg bears prognostic significance with regards to risk of developing varices, decompensation, hepatocellular carcinoma and death1,2,7,8,18-27. however, no studies have investigated whether adding data from baseline hvpg may improve the sensitivity of the criteria defining a good or poor hemodynamic response. hypothesis: adding data from baseline hvpg may improve the sensitivity of the criteria defining a good or poor hemodynamic response. objective: exploring the prognostic value of basal hvpg that better discriminate those non-responders who do not re-bleed under prophylactic treatment with nsbbs. methods: observational cohort study. training set: patients from two longitudinal studies conducted at the hepatic hemodynamic laboratory of the hospital clínic of barcelona to assess the prognostic value of hvpg changes during continuous therapy with nsbbs for preventing variceal rebleeding. validation set for chronic hemodynamic response: patients from two longitudinal studies conducted at the hepatic hemodynamic laboratory of the hospital de sant pau of barcelona to assess the prognostic value of hvpg changes during continuous therapy with nsbbs for preventing variceal rebleeding; a third cohort composed of patients undergoing acute hemodynamic response to intravenous propranolol will be studied. all patients received a preplanned follow-up in the outpatient clinic at 1, 3, and 6 months, and every 6 months thereafter in the original studies. end-point: bleeding from portal hypertensive sources (esophago-gastric varices or portal hypertensive gastropathy) (defined according to baveno criteria 32), death or liver transplantation. ethical aspects: all patients have given their written informed consent to use their data in the original studies.


Eligibility criteria:
inclusion criteria: liver cirrhosis admission for bleeding from esophageal varices in the previous 7 days baseline hvpg \>12 mmhg subsequent long-term treatment with nsbb (propranolol or nadolol) second measurement of hvpg after 1-3 months of therapy exclusion criteria: hepatocellular carcinoma portal vein thrombosis contraindications to beta-blockers cholestatic liver disease
cardiac mr (cmr) in cardiac resynchronization therapy non-responders

Conditions: Heart Failure

Summary: cardiac mr (cmr) will be used to assess myocardial activation and hemodynamics in patients with crt. goals are to demonstrate that * differences in left ventricle (lv)- right ventricle (rv) pacing delays cause differences in myocardial activation * differences in lv-rv pacing delays cause differences in lv/rv hemodynamics and to use these data to optimize crt.

cmr will be performed in patients under crt who are currently not responding to crt. different lv-rv delays will be programmed during cmr and lv function and different dyssynchrony parameters will be assessed. results will be used to determine the optimal lv-rv delay, and crt-devices will be reprogrammed accordingly. improvement in nyha-class/conversion to therapy responder will be determined clinically after 3 months.

Eligibility criteria:
inclusion criteria: * presence of crt device * crt non responder exclusion criteria: * pregnancy * end-stage renal failure

Keywords: crt heart failure cmr safety
an open label, safety study to assess the potential for adrenal suppression.

Conditions: Atopic Dermatitis

Summary: an open label, safety study to assess the potential for adrenal suppression following treatment with dsxs in patients with atopic dermatitis

to evaluate the potential of dsxs topical product to suppress hpa axis function in patients with moderate to severe atopic dermatitis.

Eligibility criteria:
inclusion criteria: * parent/legal guardian has signed informed consent form, which meets all criteria of current fda regulations. exclusion criteria: * females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy
validation of scales in reconstructive breast surgery

Conditions: Breast Cancer; Breast Hypertrophy

Summary: the main purpose of the project is to validate patient reported outcomes measures (proms) in reconstructive breast surgery. breast-q will be evaluated for swedish and sweden.hospital anxiety and depression scale (hads), euroqol 5d (eq5d), and sf-36 will be validated for reconstructive breast surgery. in addition, the complication classification system according to clavien-dindo will be validated for reconstructive breast surgery.


Eligibility criteria:
inclusion criteria: * women who have had or will have reconstructive breast surgery in sahlgrenska university hospital. exclusion criteria: * do not understand swedish.

Keywords: plastic surgery breast reconstruction patient reported outcome complication
post-marketing surveillance to assess the safety of boostrix vaccine given according to prescribing information in korea

Conditions: Diphtheria-Tetanus-acellular Pertussis Vaccines

Summary: the purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after boostrix vaccination is administered according to the approved prescribing information in korea.

protocol amendment 3 rationale was as follows: * age for analysis set is specified. * subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination. * pregnancy notifications must be done within 2 weeks

Eligibility criteria:
inclusion criteria: * written or signed informed consent obtained from the subject/ subject's parent(s)/legally acceptable representative(s) of the child. korean male or female subjects who were recently vaccinated or eligible to receive boostrix according to the locally approved prescribing information. exclusion criteria: * those who are not eligible for vaccination according to the local prescribing information. * child in care.

Keywords: korea post-marketing surveillance boostrix prescribing information safety
fecal transplantation in patients with ibs

Conditions: IBS - Irritable Bowel Syndrome

Summary: the study will characterize the biology of fmt in the context of ibs prior to wider clinical application of the method. given the ethical concerns of unknown and long-term adverse effects of fmt therapy, the study will include patients only with moderate to severe symptoms. ibs is a heterogenous disorder and it is important to characterize the patients, and study as homogeneous patient populations as possible. therefore the study will only include post-infectious ibs patients after the giardia outbreak.

primary aims: detailed characterisation of donor and recipient microbial community composition (by means of 16s rrna profiling) and determination of the kinetics of changes following fmt secondary aims: * determination of interactions of importance to persisting recipient gut microbiota. * evaluate safety of fmt in an ibs population * to evaluate the efficacy of fmt in relieving symptoms in selected patients with ibs in an open pilot trial in order to have the possibility to calculate number of patients needed when planning future controlled studies.

Eligibility criteria:
inclusion criteria: * age between 18-and 70 years * ibs-sss (ibs-symptom severity scale) score \>175 (175 - 300 represents moderate, \> 300 represent severe ibs). * all patients are required to have symptoms for at least 12 months, fulfilling the rome iii criteria with either diarrhoea-predominant irritable bowel syndrome (ibs-d) or alternating constipation and diarrhoea (ibs-a) with bloating or flatulence as predominant symptoms. only ibs considered post-infectious after the bergen giardia outbreak will be included. the severity of global ibs symptoms has to be either moderate ("cannot be ignored but do not influence daily activities") or severe ("influence daily activities"). a decrease of 50 points on the ibs-sss has been shown to correlate with improvement in clinical symptoms. all patients will undergo appropriate investigations to exclude organic disease. exclusion criteria: * history of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool or antibiotic use within 1 month prior to fmt, immunocompromised patient defined as taking immuno-suppressive medications, history of opportunistic infections within 1 year prior to fmt, oral thrush, or disseminated lymphadenopathy. * patients who are scheduled for abdominal surgery, pregnant women or patients taking probiotics or taking antibiotics within 4 weeks prior to installation are also excluded from the protocol.
hpv vaccination health-promotion programme on vaccine acceptance and uptake among female adolescents

Conditions: HPV Infection; Health Behavior; Health Attitude

Summary: the mdl-shpvp will be developed and a clustered randomised controlled trial will be conducted to evaluate the effects of the mdl-shpvp and to examine whether the effect of the mdl-shpvp on the rate of hpv vaccine uptake 1 year after intervention is mediated by parents'/guardians' and female adolescents' hpv knowledge, attitudes and beliefs, adolescents' intention to receive hpv vaccination and vaccine acceptance among their parents/guardians.

2520 adolescents and their parents or guardians from 18 local secondary day schools will be recruited. multicomponent interventions will be offered to the intervention schools. to build and strengthen the community capacity in health promotion, a team of volunteers will be established to raise awareness of hpv, cervical cancer and hpv vaccine. data will be collected at baseline, 1 month and 1 year after intervention. the mixed-effects model will be used to compare the differential changes for each of the primary and secondary outcomes across time between the two groups. the project is expected to instil a more accurate understanding of hpv and hpv vaccination and support the decision to undergo vaccination.

Eligibility criteria:
inclusion criteria: * female; * age 14-17 years; exclusion criteria: * have received the hpv vaccination before
clinical outcomes of joint arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

the purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

Eligibility criteria:
inclusion criteria: * all patients over 21 years of age who require a primary robotic-arm assisted unicompartmental knee arthroplasty or bicompartmental knee arthroplasty. these patients will have failed non-operative management of their joint disease and are candidates for partial joint replacement because of pain and stiffness that interferes with their performances or normal daily activities. exclusion criteria: * patient had an active infection * onlay implants were implanted without bone cement * patient does not have enough bone stock to allow for insertion and fixation of the components * patient does not have sufficient soft tissue integrity to allow for stability * patient has a neurological or muscular deformity that did not allow for control of the knee * patient will be excluded from participation in the study if they are cognitively unable to answer study questions * pregnant women are excluded.

Keywords: osteoarthritis medial unicompartmental lateral unicompartmental bicompartmental patellofemoral
efficacy and safety study of toremifene citrate for the reduction in the risk of new bone fracture occurrences in men with prostate cancer

Conditions: Risk of Bone Fracture Occurrences

Summary: the purpose of this study is to determine whether toremifene citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on androgen deprivation therapy.


Eligibility criteria:
inclusion criteria: * give voluntary signed informed consent * have histologically documented prostate cancer * have been on adt treatment for 6 months prior to randomization or intermittent lhrha for preceeding 12 months * expected to continue lhrha therapy uninterrupted for the next 12 months * have total testosterone levels less than 50 ng/dl * have bmd of lumbar spine or femoral neck at or below the bmd thresholds * have a zubrod performance status \<or equal to 1 * subject weight \<300 lbs(\<136 kg) * agree to complete a daily diary of medication intake * agree not to take excluded medications throughout the trial * agree to use an effective method of contraception * have adequate bone marrow, liver and renal functions exclusion criteria: * currently or previously exposed * within the past 5 years to intravenous bisphosphonates, strontium ranelate or denosumab * for more than 3 years to oral bisphosphonates * within the last 45 days to pth or pth derivative, anabolic steroids or testosterone, serms, calcitonin, calcitriol or oral gluccorticoids * have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic or lumbar spine * have \<8 evaluable vertebrae * have a bmd t score \<-4 at the lumbar spine or total hip or femoral neck * have any history of other carcinomas within the last 5 years * serum psa \> 5ng/ml at baseline under adt * have paget's disease, cushing's disease, chronic hepatitis or cirrhosis or rheumatoid arthritis * have active uncontrolled systemic viral, bacterial or fungal infections * have a clinically significant concurrent illness or psychological, familial, sociological, geograhical or other condition that would not permit adequate follow-up and compliance * received treatment with other investigational agents within 30 days * taking finasteride, dutasteride, danazol or testosterone like substances * taking herbal medicines or dietary supplements * have a history of thromboembolic disease including dvt or pulmonary embolus * have a qtcf of \> or equal to 450 msec or congenital or acquired qtc prolongation * have hiv * calcicum urolithiasis prohibiting the use of vitamin d

Keywords: fractures prostate cancer androgen deprivation therapy