Kornimate/medical-research-clean huggingface dataset:
hiv reservoir dynamics after switching to dolutegravir in patients on a pi and 2 nrti based regimen

Conditions: HIV-1

Summary: the purpose of this study is to assess changes in viral reservoir after changing ip/r to dolutegravir in hiv-1 infected patients maintaining undetectable viral load on antiretroviral therapy (art).


Eligibility criteria:
inclusion criteria: * adult patients infected with hiv-1 * hiv rna \<50 copies / ml for ≥ 1 year with stable art regimen (≥ 3 months) based on 2 nrti and pi (fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir, if the 2 nrtis are abacavir + lamivudine * cd4 + lymphocytes \> 200 / mm3 * signature of voluntary informed consent * a woman may be eligible to enter and participate in the study if: 1. no reproductive potential-defined as post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of getting pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy. 2. it is in childbearing age with a negative pregnancy test on the day of screening and on day 1 and agrees to use one of the following contraceptive methods to prevent pregnancy: * complete abstinence from penis-vaginal from 2 weeks prior to administration of investigational product, throughout the study, and for at least 2 weeks after discontinuation of all study drugs; * double barrier method (male / spermicidal condom, male condom / diaphragm, diaphragm / spermicide); * any intrauterine device (iud) with published data showing that the expected failure rate is \<1% per year (not all iuds meet this criterion) * male sterilization confirmed before the entry of the female subject in the study, and that this man is the only sexual partner for women * approved hormonal contraception * any other method with published data show that the expected failure rate is \<1% per year. exclusion criteria: * prior virologic failure with an integrase inhibitor * acquired immune deficiency syndrome (aids)-defining illness in the last 48 weeks * glomerular filtration rate \<50 ml / min, estimated by chronic kidney disease epidemiology (ckd-epi) formula * alanine aminotransferase (alt) ≥5 times the upper limit normal (uln) or alt ≥3 x uln and total bilirubin ≥1,5 uln (with\> 35% direct bilirubin) and / or unstable liver disease (with the presence of ascites, hepatic encephalopathy, hypoalbuminemia, esophageal varices or persistent jaundice) or known biliary disorders excluded gilbert syndrome or asymptomatic lithiasis) . * positive for hepatitis b (hbsag +) or need for hepatitis c virus (hcv) treatment during the study . * subjects with severe hepatic impairment (child pugh class c). * patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol * pregnant or breast-feeding * history or presence of allergy to any of the study drugs or their components
comparison of btds (buprenorphine transdermal system) and placebo in low back pain

Conditions: Low Back Pain

Summary: the primary objective of this study is to evaluate the efficacy and safety of btds compared to placebo in subjects with moderate to severe low back pain.

the primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (btds) compared to placebo in subjects with moderate to severe low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Eligibility criteria:
inclusion criteria: * males or females age 20 years or older. * clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology. exclusion criteria: * subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to low back pain, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis and diabetic neuropathy).
comparison between two techniques of capsulotomy during capsulorrhaphy in cases of developmental dysplasia of the hip

Conditions: Developmental Dysplasia of the Hip

Summary: comparison of the outcome between using u-shaped incision and t-shaped incision for capsulorrhaphy in management of developmental dysplasia of the hip

developmental dysplasia of the hip: developmental dysplasia of the hip is a spectrum of abnormalities of the developing hip joint that ranges from shallowness of the acetabulum to capsular laxity and instability to frank dislocation . developmental dysplasia of the hip is relatively common, occurring in 1 of 1000 live births. when surgical intervention is decided, open reduction is needed to remove any obstacle that hinders hip reduction. capsulorrhaphy is an essential step for minimizing instability of the hip after reduction the classic t-shaped capsular incision is done by two incisions: vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two layers . suturing them back is somewhat cumbersome after femoral head reduction. therefore, the suggested technique utilizes a u-shaped incision to make re-suturing of the capsule easier with multiple stitches, and this study compares the outcome between using t-shaped incision and u-shaped incision for capsulorrhaphy after open reduction femoral osteotomy or pelvic osteotomy can be used in certain circumstances.

Eligibility criteria:
inclusion criteria: * patients older than 1 year and younger than 4 years * unilateral or bilateral cases exclusion criteria: * patients younger than 1 year and older than 4 years old * secondary hip dislocation ,neuromuscular disorders (as cerebral palsy, myelodysplasia or arthrogryposis). * patients who will undergo femoral shortening.
iga nephropathy registration initiative of high quality (insight)

Conditions: IgA Nephropathy

Summary: the investigators are registering all biopsy-proven primary iga nephropathy (igan) patients at recruited hospitals and developing a igan database in china. patients will be follow-up every one year, and both baseline and follow-up information will be entered into the registration system. all-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and end stage renal failure (esrd, defined as initiation of dialysis or kidney transplantation) of igan patients will be compared using the igan database.

the investigators are registering all biopsy-proven primary iga nephropathy (igan) patients, and developing a igan database in china. patients' demographic characteristics (including age, gender, height, weight, bmi, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of esrd, and lab measurements of serum and urine), complications, drug information at the baseline will be collected. patients will be follow-up every one year, the demographic and clinical characteristics, complications and drug information of patients will be collected at each visit. the investigators also record the clinical events at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), esrd (defined as initiation of dialysis or kidney transplantation) and hospitalization for any cause. all-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and esrd for igan patients will be compared using the igan database.

Eligibility criteria:
inclusion criteria: 1. biopsy-proven primary igan patients; 2. age ≥14 years old 3. adequate biopsy sample containing ≥8 glomeruli. exclusion criteria: secondary causes of mesangial iga deposition, such as henoch-schonlein purpura nephritis, systemic lupus erythematosus, liver cirrhosis and et al; egfr≤15ml/min/1.73m2 at biopsy.

Keywords: iga nephropathy all-cause mortality cardiovascular mortality a composite renal outcome
study of culturelle in the prophylaxis of infection and diarrhea

Conditions: Pediatric Burns

Summary: the primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients.


Eligibility criteria:
inclusion criteria: * acute burn injury * consented within 10 days of injury * feeding tube present- exclusion criteria: * gi disorder prior to burn * milk allergy or insensitivity * non-burned
evaluating the impact of psoas muscle size, composition, and clinical frailty on long-term outcomes following elective endovascular aneurysm repair

Conditions: Endovascular Aneurysm Repair (EVAR)

Summary: sarcopenia, which is characterized by the progressive loss of skeletal muscle mass and strength, has emerged as a significant prognostic biomarker in the field of vascular surgery, particularly regarding endovascular aneurysm repair (evar). this article delves into the implications of sarcopenia on the outcomes of evar, emphasizing its predictive value for long-term survival and potential as a tool for patient risk stratification. recent research suggests that sarcopenia could be used as a biomarker for prognosis. a systematic review and meta-analysis have underscored sarcopenia's negative prognostic value for survival during long-term follow-up post-evar. the presence of sarcopenia, as determined by decreased core muscle area in axial abdominal computed tomography (ct) scans, has been widely discussed as a predictor of outcomes in patients undergoing evar.1 moreover, studies have consistently reported an association between sarcopenia and increased mortality and adverse outcomes following evar.2 for instance, a retrospective review investigating sarcopenia as a method to predict 1-year survival in patients undergoing evar found a significant increase in overall mortality among patients with the lowest quartile of normalized total psoas cross-sectional area (ntpa).2 therefore, researchers suggested that physicians can use sarcopenia for risk stratification and patient selection before an evar. the evaluation of sarcopenia from preoperative ct scans can assist clinicians in identifying evar candidates who may be less likely to benefit from the procedure.2 this objective radiographic finding offers a standardized method for patient selection, which could be particularly useful in telemedicine and remote patient evaluation. the integration of sarcopenia assessment into the preoperative evaluation of patients considered for evar can revolutionize the approach to managing abdominal aortic aneurysms (aaa). by providing a reliable biomarker for risk stratification, sarcopenia can enable a more personalized treatment plan, potentially improving patient outcomes and optimizing healthcare resources. nonetheless, the majority of the studies were conducted among western populations. the implications are questionable for taiwan patients. this study aims to fill the gap and to analyze the sarcopenia and its impact on patient outcomes following evar in taiwan


Eligibility criteria:
inclusion criteria: * the aaa patients undergoing evar procedures exclusion criteria: * the aaa patients undergoing open surgery procedures

Keywords: endovascular aneurysm repair (evar) sarcopenia myosteatosis frailty
daptomycin pharmacokinetics in continuous veno-venous hemodiafiltration

Conditions: Bacteremia

Summary: the purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.


Eligibility criteria:
inclusion criteria: * male or female of 18 years or older * females: negative pregnancy test * hospitalisation in the medical icu * high suspicion or evidence of gram-positive infections requiring antibiotic therapy * subjects receiving standard antibiotic treatment for gram-positive infection * evidence of renal failure * clinical necessity for continuous renal replacement therapy * written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign. exclusion criteria: * skeletal muscle disorders or cpk levels of \> 2 x uln * history of hypersensitivity to the drug * participation in another study * subjects with a history of muscle disease * patients with severe liver function impairment (child c) * life expectancy of less than 5 days

Keywords: pharmacokinetics
china registration study in patients with skin infections

Conditions: Skin Diseases; Infectious

Summary: the objectives of this study is to evaluate the safety and efficacy of intravenous daptomycin (cubicin®)compared with that of comparator (vancomycin or vancomycin followed by semi-synthetic penicillin-cloxacillin) in the treatment of chinese subjects with complicated bacterial skin and skin structure infection due to gram-positive pathogens.


Eligibility criteria:
inclusion criteria: * provision of inform consent * a diagnosis of of complicated skin and skin structure infection known or suspected to be due to gram-positive bacteria * diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing exclusion criteria: * subjects known to have any bloodstream infection (including bloodstream infection caused by s. aureus). subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including s. aureus ) should be discontinued from study * minor or superficial skin infections, infected "decubitus"ulcer, perirectal abscess, hidradenitis suppurativa, myositis, multiple infected ulcers at distant sites, infected burn wounds of a large area, * conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation) * conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)

Keywords: skin infections complicated bacterial skin and skin structure infection due to gram-positive pathogens
docosahexaenoic acid in the treatment of autism

Conditions: Autism

Summary: the purpose of this study is to test the hypothesis that dietary supplementation with the omega-3 fatty acid docosahexaenoic acid (dha) improves the behavior of children with autism.

autism is a neurodevelopmental disability with an increasing prevalence. traditional medicine does not offer any cures for autism; thus, many parents of children with autism are attracted to complementary and alternative therapies, one of which is dietary supplementation with the long chain polyunsaturated omega-3 fatty acid, docosahexaenoic acid (dha). dha is a critical structural lipid of brain cell membranes and differences in brain dha content may influence synaptic function, particularly in nutritionally-sensitive areas of the brain, such as the cerebellum and hippocampus, which may be brain structures involved in the etiology of autism. this study is a randomized, double-blind, placebo-controlled trial investigating whether dha supplementation is an effective treatment for children with autism. eighty children with autism will be randomized to receive 200mg of dha or placebo for 6 months. outcome variables will include total plasma fatty acid patterns and scores on parent and investigator-completed behavioral and developmental rating scales at baseline and after 3 and 6 months of supplementation. differences between groups after 6 months will be evaluated using regression methods. regression analysis will be used to detect correlations between plasma total fatty acid dha contents and scores on the various outcome measures. results from this study will either provide evidence for a breakthrough biomedical treatment alternative for children with autism or evidenced-based advice to desperate parents in regard to their choices of potential treatments for their children with autism

Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for autistic disorder * age 3 to 10 years exclusion criteria: * use of a dietary supplement containing dha within 90 days of study inclusion * medical history of a disorder of lipid metabolism

Keywords: autism omega-3 fatty acids docosahexaenoic acid
risk stratified multidisciplinary ambulatory management of malignant bowel obstruction in gynecological cancers

Conditions: Gynecologic Cancer

Summary: management of malignant bowel obstruction (mbo) in patients with advanced gynecological cancers

guidelines for the management of patients with malignant bowel obstruction(mbo) are not available and as such, there remains an urgent need for a collaborative approach to streamline patient care and optimize use of hospital resources. this study will focus on management of mbo in advanced gynecological cancers.if patients with mbo can be effectively managed in an ambulatory setting, this may improve quality and consistency of patient care, and help reduce volume and duration of bed occupancy.

Eligibility criteria:
inclusion criteria: histologically and /or cytologically confirmed gynecological cancer, including ovarian, fallopian tube, endometrial, cervical or primary peritoneal cancer deemed to be at risk of developing or have a clinical diagnosis of mbo as defined using the following criteria: clinical evidence of bowel obstruction (history/physical/radiological examination; and bowel obstruction beyond the ligament of treitz. exclusion criteria: there are no specified exclusion criteria for this study
prevalence and description of fire (food induced immediate response of the esophagus) in the pediatric population with eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: a new clinical entity of eosinophilic esophagitis, food induced immediate response of the esophagus or fire, has been described since 2020. diagnostic criteria are not clearly established. specific questioning is necessary for differential diagnosis, such as the oro-pharyngeal syndrome notably described in pollinics, or a mechanical blockage strictly speaking linked to esophagitis. the aim is to obtain epidemiological data on this entity.


Eligibility criteria:
inclusion criteria: * patients over 6 and under 18 years of age at the time of inclusion * follow-up in the allergology unit of angers university hospital for eosinophilic esophagitis exclusion criteria: * patients or legal representative with severe communication or language comprehension difficulties * patients or legal representatives objecting to study participation
gene-environment interaction in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether certain environmental factors, namely occupational exposures and diet, have a greater effect on prostate cancer risk in the presence of selected inherited genetic factors.


Eligibility criteria:
men diagnosed with prostate cancer before age 70 and race/age frequency matched healthy controls

Keywords: gene environment occupation diet interaction
structured treatment of gastroesophageal reflux in a company health care setting, -effect on quality of life, symptoms and productivity

Conditions: GERD

Summary: the study aims to evaluate if a gerd treatment programme, in accordance with current regional recommendations, in a company health care setting, has an impact on health related quality of life (hrqol), symptoms, and productivity in gerd patients.


Eligibility criteria:
inclusion criteria: * female and/or male aged \> 18 years * diagnosis of gerd confirmed * prescription of gerd treatment or already receiving gerd treatment exclusion criteria: * any symptom suggesting a need for further investigation * previous participation in the present study * current participation in a clinical study or participation in a clinical study during the last 30 days

Keywords: gerd quality of life structured treatment
(right heart iii study - right ventricular hemodynamic evaluation and response to treatment)

Conditions: Pulmonary Arterial Hypertension (PAH)

Summary: pilot study to determine the therapeutic effect of two prarallel groups treated with either riciguat or macitentan, evaluated by the change in systolic and diastolic rv function within 12 weeks after first drug intake in order to plan a larger phase ii study.

in this multi-center, randomized, open pilot study the therapeutic effect of two prarallel groups treated with either riciguat or macitentan shall be determined by evaluating the change in systolic and diastolic rv function within 12 weeks after first drug intake in order to plan a larger phase ii study.the method used to determine the rv function will be the "conductance method".

Eligibility criteria:
inclusion criteria: * female and male patients, 18 years ≤ age ≤ 85 years * diagnosis of pulmonary hypertension group 1 according to nizza definition (pah) confirmed by invasive methods, who functional class ii and iii * existing clinical need to repeat a right ventricular catheter examination (as recommended by the current "kölner konsensuskonferenz") * ability to understand study goals and agree to study participation * hemodynamic criteria of ventricular catheter examination: * pulmonary vascular resistance (pvr)\> 240 dyn x sec x cm-5 * mean pulmonary arterial pressure (mpap) ≥ 25 mmhg * clinical need to receive treatment with a drug approved for the treatment of pah for the first time * potentially fertile women must agree to use highly effective methods of contraception, either through abstinence or the use of at least two methods of contraception from the date of consent until one month after the end of the study. an effective pregnancy protection consists in the combination of a hormonal contraceptive (oral, injectable or implant) and a barrier method (condom or diaphragm with a vaginal spermicide) * written consent to the clinical trial exclusion criteria: existing therapy with positive inotropic drugs such as catecholamines (including norepinephrine, dobutamine, suprarenin) * pregnancy or breastfeeding * general contraindication for examinations to be performed during the study * hypersensitivity to the active substances or to a constituent of the study medication (in particular lactose and soya) * simultaneous participation in another medical therapy study * simultaneous participation in another non-drug study that would preclude participation in this study * participation within one month after completing another therapy study * heavy liver function disorders * existing increase in liver aminotransferases (aspartate aminotransferase (ast) and / or alanine aminotransferase (alt))\> 3 × uln * systolic blood pressure \<95 mmhg * pulmonary hypertension associated with idiopathic interstitial pneumonia (ph-iip) * anemia (hb \<10 g / dl) * concomitant medication with potential interaction to macitentan and/or riociguat according to the ib * severe kidney dysfunction * severe hemoptysis * history of bronchial artery embolization * smoker