Kornimate/medical-research-clean huggingface dataset:
endocrinological profile in patients with medication-overuse headache before and after withdrawal therapy

Conditions: Endocrine Disorder; Deficiency; Medication Overuse Headache; Migraine

Summary: the project will be conducted to investigate the hormonal homeostasis in men and women, with a special emphasis on sex hormones in men and amh level in women, before and after withdrawal of the overused analgesics among moh patients. additionally, a more broad endocrine profile will be explored before and after withdrawal. it is hypothesized that patients with moh have disturbed hormone levels, which is normalized after withdrawal of the medication-overuse.


Eligibility criteria:
inclusion criteria: * confirmed moh diagnosis according to the ichd-iii (1). * capable of completing headache diary and headache calendar * age 18-60 years old for men and 18-50 years old for women * signed informed consent * bmi 19-30 exclusion criteria: * severe physical illness * severe psychiatric disorders requiring pharmacological treatment * addiction to alcohol or other drugs * pregnancy or breastfeeding * menopause, either natural or surgical (only women) * inability to provide reliable information about medical history
raltegravir switch study: effects on endothelial recovery

Conditions: HIV Infection; Endothelial Dysfunction

Summary: treatment with hiv-infection with protease inhibitors is associated with high blood lipids and higher chance for cardiovascular complications. the rasster study aims to investigate the effect of switching the protease inhibitor lopinavir/ritonavir to raltegravir on vessel wall function and inflammation,and activation of the immune system. we hypothesize that with this intervention these parameters will improve. since decreased vessel wall function and inflammation are initial steps in the process of atherosclerosis, it is important to know this data when treating hiv-infected patients.

fixed dose combination lopinavir/ritonavir (lpv/r) is a widespread used antiretroviral drug belonging to the class of protease inhibitors (pis). pis are associated with an increased risk of myocardial infarction. however, data is available suggesting increased levels of plasma lipids are not the sole explanation for this observation. treatment with lpv/r might lead to a decrease of endothelial function as well, thus explaining the increased risk of myocardial infarction besides increased plasma lipids. raltegravir is a registered antiretroviral drug with no known cardiovascular side effects. we hypothesize that switching lpv/r to raltegravir in hiv-infected patients with suppressed plasma viral load (\<50 copies/ml) will lead to an improvement of endothelial function. objective: * first, to assess the effect of the switch of lopinavir/ritonavir to raltegravir on endothelial function. * second, to assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on plasma hiv-rna below the cut-off of 50 copies/ml.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hiv-1 infection * treatment with antiretroviral regimen containing lopinavir/ritonavir for at least the previous 3 months * no other protease inhibitors besides lopinavir/ritonavir in antiretroviral regimen * subjects must have a minimum period of viral suppression (plasma hiv-rna \< 50 copies/ml) of 6 months * subjects will not have a history of virological failure on antiretroviral therapy * results of previous resistance testing allowing replacement of lopinavir/ritonavir by raltegravir * cd4+ cell count \> 200 cells/µl * signed informed consent exclusion criteria: * pregnancy * breastfeeding * raltegravir hypersensitivity * treatment of underlying malignancy * renal insufficiency requiring dialysis * acute or decompensated chronic hepatitis (child-pugh score c) * modification of antiretroviral regimen in the previous 3 months

Keywords: anti-hiv agents anti-retroviral agents antiviral agents anti-infective agents lopinavir/ritonavir
multi dimensional precise exploration of immunoconsolidation therapy for locally advanced nsclc after chemo-radiotherapy

Conditions: NSCLC; Chemoradiotherapy; ctDNA

Summary: the purpose of this study is to carry out a prospective observational study in patients with locally advanced nsclc receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. by detecting ctdna and tils of the patients, we explored the value of blood dynamic monitoring of ctdna in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy the characteristics of dna, rna, t cells and other biomarkers were correlated with the efficacy and prognosis.


Eligibility criteria:
inclusion criteria: 1. non small cell lung cancer patients confirmed by pathology; 2. they were 18-80 years old; 3. the tumor could not be resected or could not tolerate surgery; 4. planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy; 5. clinical stage iii (ajcc, 8th edition, 2017); 6. after systematic detection of non-small cell lung cancer core indicators including egfr, alk, ros1, kras, ntrk, tmb, etc; 7. patient informed consent. exclusion criteria: 1. after radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out 2. it can not cooperate with the completion of baseline mutation screening and subsequent sample detection 3. factors judged by other researchers not suitable for further study
stem cell therapy combined hormone replacement therapy in patients with premature ovarian failure

Conditions: Premature Ovarian Failure，

Summary: premature ovarian failure (pof) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40. it has important physical and psychological consequences/impact in those patients. premature ovarian failure (pof) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics. human umbilical cord mesenchymal stem cells (hucmscs) and human cord blood mononuclear cells (hcbmncs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for pof. in this study, the safety and efficacy of hucmscs and hcbmncs transplantation combined with hormone replacement therapy will be evaluated in patients with premature ovarian failure. participants will be followed for an expected average of 48 weeks.


Eligibility criteria:
inclusion criteria: * between age 18- 39 years, female only. * diagnosed with premature ovarian failure，and currently receiving hormone replacement therapy; * willing to sign the informed consent form. exclusion criteria: * fragile x chromosome. * polycystic ovary syndrome. * hiv+. * autoimmune disease, e.g. lupus erythematosus, multiple sclerosis. * severe pulmonary and hematological disease, malignancy or hypo-immunity. * currently undertaking other treatment that may affect the safety/efficacy of stem cells. * pregnancy or lactation * enrollment in other trials in the last 3 months. • other criteria the investigator consider improper for inclusion.

Keywords: hormone replacement therapy， premature ovarian failure， stem cell therapy
validity of a home respiratory polygraphy for the diagnosis of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea (OSA)

Summary: to assess the diagnostic validity and cost-effectiveness of a apnia device, a home respiratory polygraphy (hrp).

to assess the diagnostic validity and cost-effectiveness of a apnia device, a home respiratory polygraphy (hrp), performed at home compared with the standard polysomnography (psg) in adults with clinically suspected obstructive sleep apnea (osa). methodology: design: randomized, prospective, multicenter, and crossover trial. the study will include 240 adults, both sexes, with clinical suspicion of obstructive sleep apnea (osa). measurements: to all patients with clinical suspected osa and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinical history; b) anthropometric variables: weight, height, body mass index, neck circumference and percentile; c)epworth sleepiness scale; osa questionnaire, quality of life and clinical questionnaires and comorbidity; d) psg in the sleep laboratory; e) hrp at home; f) cost-effectiveness variables. analysis: data from hrp and from full psg will be compared as follows: 1) agreement of results according to the different apnea-hypopnea index by using the receiver operating characteristic (roc) curve; 2) the concordance of the diagnosis and treatment decisions when using clinical findings and data from psg or hrp at home; 3) all data will be analyzed independently; 4) a cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.

Eligibility criteria:
inclusion criteria: * men and women over 18 years to 75 years old, with clinical suspicion of osa * written informed consent signed exclusion criteria: * psycho-physical inability to perform the study at home * presence of insomnia or depressive syndrome * patient with malformation syndromes, down syndrome and neuromuscular diseases * cardiovascular, cerebrovascular or respiratory disease exacerbated. * previous positive continuous pressure (cpap ) treatment or surgery for osa

Keywords: home respiratory polygraphy standard polysomnography validity cost-effectiveness
sertraline in generalized social phobia with co-occurring anxiety and mood disorders

Conditions: Phobia, Social; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder; Anxiety Disorders; Major Depressive Disorder

Summary: selective serotonin reuptake inhibitors (ssris) including sertraline have been found to be effective in the treatment of generalized social phobia (gsp). however, virtually all of the current treatment studies with medicines, including the ssris, have excluded patients with social phobia who have other co-occurring conditions. in fact, 80% of individuals suffering with primary social phobia have at least one other anxiety. this study will evaluate the safety and efficacy of sertraline in the treatment of generalized social phobia with co-occurring anxiety and mood disorders.


Eligibility criteria:
inclusion criteria: * outpatient with primary diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) gsp plus at least one of the following comorbid dsm-iv anxiety disorders: * panic disorder with agoraphobia * obsessive compulsive disorder * major depressive disorder * generalized anxiety disorder * score on lsas \> 50 * score on madrs \< 25 exclusion criteria: * any other primary axis-i diagnosis * criteria for alcohol/substance abuse/dependence * history (hx) of bipolar disorder, schizophrenia or other psychotic disorder * a comorbid axis ii cluster a personality disorder * current increased risk of concomitant suicide * allergy/previous intolerance during an adequate trial (50mg/day for minimum of 4 weeks) of sertraline * participation in any clinical trial 30 days prior to entering the study * unable to tolerate being free of/shows signs of withdrawal from benzodiazepines for 4 weeks * hx of seizures * thyroid problems

Keywords: generalized social phobia comorbid panic disorder with agoraphobia comorbid obsessive compulsive disorder comorbid generalized anxiety disorder comorbid major depressive disorder/dysthymia
trial comparing dual probe ultrasonic lithotripsy to a single probe ultrasonic lithotripsy

Conditions: Kidney Stones

Summary: percutaneous nephrolithotomy (pnl), in conjunction with intracorporeal lithotripsy, allows for the rapid removal of any kidney stone regardless of size. currently, the choice of intracorporeal lithotripters includes ultrasonic, pneumatic, and combined ultrasonic/pneumatic energy sources. recently, a novel dual probe design as been introduced by cybersonics of erie, pennsylvania. this dual probe intracorporeal lithotrite is called the cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 hz. as this new design has the potential to revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

percutaneous nephrolithotomy (pnl) is used to remove large and complex stones from the upper urinary tract. intracorporeal lithotripsy is an integral part of pnl. commercially available intracorporeal lithotripsy modalities include ultrasonic, pneumatic, and combined ultrasonic and pneumatic models. each modality has its inherent advantages and disadvantages. ultrasonic lithotrites are capable of fragmenting stones while concomitantly suctioning out fragments. unfortunately some stones are hard enough to resist fragmentation from ultrasonic lithotripsy. pneumatic lithotrites are able to fragment all stones regardless of hardness, but this modality is unable to suction out stone pieces at the same time fragmentation is occurring. the newest lithotrite which combines both ultrasonic and pneumatic components is capable of fragmenting any stone, but also has some inherent limitations. the handpiece of the lithotripsy device is somewhat cumbersome, the suction component can clog, and the device has overheated at the maximal settings (kuo et al). current intracorporeal lithotrites, while functional, can certainly be improved. recently, a novel dual probe design has been introduced by cybersonics of erie, pa. this dual probe intracorporeal lithotrite is called the cyberwand and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 hz. as this new design has the potential to revolutionalize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Eligibility criteria:
inclusion criteria: * patient of methodist urology in indianapolis, in * undergoing percutaneous nephrolithotomy for calculi greater than 2 cm * age 18 years or older * stone easily visible/measurable on kidney, ureters and bladder (kub) or computed tomography (ct) scan preoperatively exclusion criteria: * radiolucent stones * size of largest stone less than 2 cm * pregnancy * inability to give informed consent * multiple percutaneous access anticipated * active urinary tract infection * recent (within last 3 months) extracorporeal shock wave lithotripsy

Keywords: kidney stones renal calculi
combination chemotherapy plus oblimersen in treating patients with previously untreated extensive-stage small cell lung cancer

Conditions: Extensive Stage Small Cell Lung Cancer

Summary: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. oblimersen may make tumor cells more sensitive to chemotherapy drugs. phase i trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer

primary objectives: i. determine the maximum tolerated dose of oblimersen when combined with standard dose carboplatin and etoposide in patients with previously untreated extensive stage small cell lung cancer. ii. determine the toxicity and feasibility of this regimen in these patients. iii. determine potential antitumor activity of this regimen as assessed by objective response in these patients. outline: this is a multicenter, dose-escalation study of oblimersen (g3139). patients receive g3139 iv continuously on days 1-8, carboplatin iv over 30 minutes on day 6, and etoposide iv over 1 hour on days 6-8. treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression. cohorts of 3-6 patients receive escalating doses of g3139 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: approximately 6-12 patients will be accrued for this study within 5 months.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed extensive stage small cell lungcancer * no active cns disease * cns metastasis allowed provided patient completed 1 course of cns radiotherapy * performance status - ecog 0-2 * performance status - karnofsky 60-100% * more than 2 months * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin normal * ast and alt no greater than 2.5 times upper limit of normal (uln) * pt and ptt no greater than 1.5 times uln * creatinine normal * creatinine clearance at least 60 ml/min * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior allergic reactions to compounds of similar chemical or biologic composition to study agents * no other uncontrolled concurrent illness * no ongoing or active infection * no psychiatric illness or social situation that would preclude study compliance * see disease characteristics * at least 1 week since prior cns radiotherapy and recovered * no prior radiotherapy to more than 25% of skeleton * no other prior anticancer therapy * no other concurrent investigational agents * no other concurrent anticancer therapy * no concurrent anticoagulation therapy * no concurrent combination antiretroviral therapy for hiv-positive patients
motivational interviewing to increase parent engagement in preventive parenting programming

Conditions: Behavior Problems; Parent-Child Relations

Summary: evidence-based programs aimed at enhancing parenting skills are effective, and pediatricians identify many parents who could benefit from such programs. low-income children have high rates of behavior problems and their family system and environmental exposures often lead to cumulative and daunting levels of risk for poor functional outcomes; their parents are highly likely to benefit from parenting supports. however, low-income families are the most likely to drop out of parenting interventions, meaning the families and children with the greatest need receive the least support. fewer than 25% of low-income families recruited to parenting programs will participate in even one session, and only about half of these parents will participate in more than half of the sessions offered. the aims of this trial are: aim 1: to test the hypothesis that the provision of motivational interviewing (mi), as compared to an attention control (ac) condition, will increase the engagement of low-income parents of preschoolers in an evidence-based parenting skills group (the incredible years series (iys)). for this study, the outcome of engagement is operationally defined as intention to attend iys sessions, attendance, and satisfaction with the iys program. aim 2: to test the hypothesis that the effect of mi on engagement in iys will be impacted by the following moderators: parenting self-efficacy, child behavior problems, and maternal depression. the investigators hypothesize that the effect of mi on engagement will be greater among parents with lower parenting self-efficacy and parents of children with more behavior problems, but less among parents with more maternal depressive symptoms. the investigators will use a stratified, randomized controlled trial (rct) design to evaluate the impact of mi on parent engagement in a well-validated preventive parenting skills intervention, the incredible years series (iys).


Eligibility criteria:
inclusion criteria: * all children enrolled in the head start agencies involved in this study, who were randomized to the study arm involving the incredible years series exclusion criteria: * child is a foster child * parent or child cannot communicate in english
assessing the impact of the covid-19 lockdown on metabolic control and access to health care in patients with diabetes

Conditions: Diabetes Mellitus; Coronavirus Infection; Metabolic Disease; Glucose Metabolism Disorders

Summary: the outbreak of the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) and the covid-19 (coronavirus disease-2019) in december 2019 has led to an unprecedented international health situation. exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. in france, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. hospital routine care appointments have been cancelled, in order to reallocate medical resources towards covid-19 units and limit contacts between patients within hospitals or waiting rooms. while the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes. the french regional confi-diab study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to covid-19 in patients with a chronic condition such as diabetes. special attention will be given to metabolic control and access to health care. this cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.


Eligibility criteria:
inclusion criteria: * adult patients * patient with diabetes known for at least 6 months before inclusion * patient followed by a specialist physician from the university hospital of nancy for routine care within the 6 months prior to the lockdown. * patient who was assessed for prioritization of care following the end of the lockdown by the department of endocrinology, diabetology and nutrition exclusion criteria: * subjects opposed to the use of their data * minors, adults under guardianship, protected persons

Keywords: diabetes mellitus lockdown covid-19