Kornimate/medical-research-clean huggingface dataset:
prophylactic cranial irradiation in extensive-stage small cell lung cancer

Conditions: Extensive-stage Small-cell Lung Cancer

Summary: the prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. this experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.

this study is a prospective trial. this study included es-sclc patients who response after standard first-line treatment, and aimed to explore the safety and effectiveness of prophylactic cranial irradiation in this treatment modality. the primary endpoint is progression-free survival in the brain.the secondary endpoints includes os, pfs. the indicators for evaluating safety are the incidence and severity of adverse events.the exploratory endpoint is the molecular biomarkers for efficacy and toxicity predicting from tumor tissue and peripheral blood tmb. the trial was designed by the national cancer center/cancer hospital of the chinese academy of medical sciences and peking union medical college. the hypothesis is that preventive brain irradiation is safe and effective in the treatment of extensive sclc combined with chemotherapy and immunotherapy.

Eligibility criteria:
inclusion criteria: * sign written informed consent; * with extensive small cell lung cancer; * previously received first-line standard chemotherapy, with treatment response of cr or pr; * can tolerate the radiotherapy process; * be over 18 years old * life expectancy ≥ 12 weeks; * with the eastern cancer cooperative group (ecog) score 0-1 * after the systemic treatment was received, there was no brain metastasis on mr before brain preventive irradiation. exclusion criteria: * exclude subjects with central nervous system (cns) metastasis at the first diagnosis; * pregnancy or breastfeeding; * any other conclusive medical, psychiatric and/or social reasons determined by the researcher; * subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study; * researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.

Keywords: small-cell lung cancer radiation:prophylactic cranial irradiation
deep brain stimulation of nucleus accumbens for methamphetamine addiction

Conditions: Treatment Methamphetamine Addiction

Summary: the main objective of this study is to assess the efficacy of bilateral deep brain stimulation (dbs) of the nucleus accumbens(nac) as a novel treatment in severe methamphetamine addiction. our hypothesis is that bilateral dbs of the nac will significantly reduce the craving for methamphetamine.


Eligibility criteria:
inclusion criteria: * dsm-iv-tr diagnosis of drug addiction disorder; * age 18-65 years old; * proficiency in mandarin language; * failure to detox more than three times; * capacity to provide informed consent (understanding of the study purpose and methods); exclusion criteria: * multidrug abuse and formation of addiction; * serious and unstable organic diseases (e.g. unstable coronal heart disease); * any history of seizure disorder or hemorrhagic stroke; * past stereotactic neurosurgical intervention; * neurological disease (abnormal pet-ct, mri, eeg) * contraindications of mri-examination, e.g. implanted cardiac pacemaker/ heart defibrillator; * contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases); * hiv positive; * pregnancy and/or lactation;

Keywords: bilateral nucleus accumbens methamphetamine addiction
clinical results of a monofocal aspheric bitoric intraocular lens with plate haptics in hyperopic eyes (hiper-at-torbi)

Conditions: Astigmatism; Far Sightedness; Cataracts

Summary: observational post-marketing study with prospective follow-up of ce marked medical devices aimed at the treatment of hyperopia and astigmatism in patients with cataract. the objective is to evaluate the clinical results of the implantation of the monofocal aspheric bitoric intraocular lens (iol) with at-torbi 709 plate haptics in cataract surgery of hyperopic eyes with astigmatism.

all patients participating in the study will have the intraocular lens (iol) at torbi 709 implanted from carl zeiss meditec ag, jena, germany, with ce marking. all patients will be treated according to standard clinical practice. a preoperative and postoperative evaluation will be carried out one month, six and twelve months after the intervention where the following tests will be performed: refraction, corneal topography, measurement of visual acuity with and without correction, slit lamp examination, eye biometry using the iolmaster 700 carl zeiss meditec ag, jena, germany, ce marked optical non-contact biometer, contrast sensitivity with the cc-100 screen (topcon europe, the netherlands), and the catquest-9sf (european registry of quality outcomes for cataract and refractive surgery, founded by the european society of cataract and refractive surgeons). the sponsor has received an unrestricted research grant by zeiss.

Eligibility criteria:
inclusion criteria: 1. patients of 50 years of age or older to undergo cataract surgery with phacoemulsification 2. patient who signs the informed consent. 3. regular corneal astigmatism between 1.0d and 4.0d. 4. iol power between 21d and 26d 5. target-target distance measured with the iolmaster 700 biometer (carl zeiss meditec ag) greater than 11.6 mm. 6. patients with hyperopia between 1.0d and 4.0d. exclusion criteria: 1. patients who do not provide informed consent 2. patients who do not understand the study procedure 3. previous corneal surgery. 4. irregular cornea (eg keratoconus) 5. myopic patients 6. eye abnormalities or pathologies that could reduce the visual function or stability of the iol (eg severe amblyopia or macular degeneration)
high-dose accelerated theta burst stimulation for the treatment of alcohol addiction

Conditions: Alcohol Dependence

Summary: this is a two-arm randomized placebo-controlled trial in which 72 patients with alcohol addiction are treated with high-dose accelerated intermittent theta burst stimulation (tbs).


Eligibility criteria:
inclusion criteria: * alchohol dependence according to icd-10 (f10.2) * desire to reduce or abstain from alcohol drinking * male or female * 18-65 years * residency in germany, german speaking * written informed consent exclusion criteria: * contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker) * relevant neurological or internistic diseases according to study investigator * treatment with tms in the past * participation in other trials during treatment * pregnancy or breatfeeding * positive breath test for alcohol * legal care and placement in a psychiatric hospital * co-medication with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefene * acute psychiatric comorbidity that requires inpatient treatment or medication readjustment (\<1 month) * severe chronic psychiatric illness (schizophrenia, schizoaffective disorder, bipolar disorder) * patients who are unable to complete study questionnaires or follow-up questionnaires (in the opinion of the investigators)
indwelling pleural catheters with or without doxycycline in treating patients with malignant pleural effusions

Conditions: Pleural Neoplasm

Summary: this study is designed to obtain preliminary data comparing indwelling pleural catheters (ipcs) versus ipcs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (mpe). indwelling pleural catheters (ipcs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). doxycycline is an antibiotic that is also used to treat pleural effusions. the goal of this clinical research study is to learn if adding doxycycline to the use of an ipc can lead to shorter treatment times with ipcs.

primary objectives: i. to obtain preliminary data comparing indwelling pleural catheters (ipcs) versus ipcs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (mpe). outline: patients choose 1 of 2 groups. group i: patients undergo ipc placement and receive doxycycline via ipc 5 days later. group ii: patients undergo ipc placement. after completion of study treatment, patients are followed up at 10-14 days and then monthly for up to a year.

Eligibility criteria:
inclusion criteria: * outpatients with mpe undergoing ipc placement * sufficient mental capacity to provide informed consent and answer short-form six-dimension health index (sf-6d) and borg score questions * inpatients that are expected to be discharged within 5 days of receiving an indwelling pleural catheter exclusion criteria: * patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax) * inability or unwillingness to give informed consent * inability to perform phone call and clinical follow-up at md anderson cancer center (mdacc) * pregnancy * previous intrapleural therapy for mpe on the same side * eastern cooperative oncology group (ecog) of 4 and life expectancy =\< 2 weeks * doxycycline allergy * extensive loculations or hydropneumothorax or other contraindication to pleurodesis * chylous effusions associated with malignant disease
compression aided management of edema in patients with c3 venous disease

Conditions: Chronic Venous Disease

Summary: objectives: to quantify the clinical improvement and quality of life between patients wearing compression stockings versus anti-embolism stockings in patients with varicose veins and limb edema.

research design: pilot study of patients presenting to vascular clinic with chronic venous disease with varicose veins and/or edema will be randomized 1:1 in one of two compression garment groups. measurements of edema and the interface compression applied at the ankle will be determined. the venous clinical severity scoring system and quality of life are assessed. after 4 weeks of treatment patients will have repeat objective studies and clinical outcomes determined. methodology: patients with venous disease and edema and non-venous edema will be evaluated by clinical exam and venous duplex ultrasound. patients eligible for the study will be randomized to knee-high 20-30 hg graded compression stockings or anti-embolism (13-18 mm hg) compression stockings. patients will have limb quantitative edema assessment, a severity score and quality of life determination. compression will be assigned to each treatment group with instruction on proper wear and duration, and the interface pressure of compression at the skin surface at the ankle level determined. following 4 weeks of compression, patients will return for evaluation in the following areas: quantify limb edema, quantify compression at the ankle, venous clinical severity score, and venous disease specific quality of life. data will be analyzed and presented as mean±sd. data are analyzed using anova followed by scheffe's f test for comparison of multiple means. student's t-test for unpaired and paired data will be used for comparison of two means. differences are considered statistically significant if p \< 0.05. significance: utilizing objective measures of leg edema and applied interface pressure with two different compression garments, the data will provide the important relation between compression (mm hg) and function of an appropriate graded compression stocking in improving limb edema and symptoms. in addition, measuring clinical outcomes before and after compression will validate the usefulness of proper compression. this study is intended to identify important quantifiable parameters that may be useful in assessing treatment end point including: clinical improvement, length of treatment, daily treatment utilization, prognosis, and clinical guidelines for compression in a specific clinical setting.

Eligibility criteria:
inclusion criteria: * patients with varicose veins exhibiting lower leg edema * unilateral or bi-lateral edema exclusion criteria: * generalized leg edema from renal disease, heart failure, liver disease or other undetermined cause * acute infection * hepatitis * steroid use * immuno-deficiencies including hiv * acute deep venous thrombosis * have had leg surgery or other orthopedic procedure in past 6 months

Keywords: chronic venous disease c3 edema compression garments compression stockings bioimpedance
placebo and active comparator controlled dose response study of rivoglitazone in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to assess the efficacy response of rivoglitazone hcl compared to pioglitazone hcl on the placebo-corrected change from baseline in hba1c after 12 weeks of treatment in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c \>6.5% and \<10.0% * fpg \>126 mg/dl (7 mmol/l) and \< 270 mg/dl (15 mmol/l) exclusion criteria: * history of type 1 diabetes * history of ketoacidosis * current insulin therapy * c-peptide \<0.5ng/ml * imparied hepatic function * nyha class ii-iv cardiac status or hospitalization for chf or ef\<40% * uncontrolled hypertension

Keywords: rivoglitazone hcl pioglitazone hcl thiazolidinedione peroxisome proliferator-activated receptor gamma (ppar gamma) type 2 diabetes mellitus
effects of oral stimulation in preterm infants

Conditions: Premature Infant; Eating Disorder

Summary: preterm infants with gestational age inferior to 34 weeks were included in the study. a prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention. the study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.


Eligibility criteria:
inclusion criteria: * preterm infants with gestational age inferior to 34 weeks exclusion criteria: * instability caused by respiratory, cardiac or gastrointestinal issues * orofacial malformations.
norditropin nordiflex® device compared to the device previously used by patients or parents

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Foetal Growth Problem; Small for Gestational Age; Genetic Disorder; Turner Syndrome; Chronic Kidney Disease; Chronic Renal Insufficiency; Delivery Systems

Summary: this study is conducted in europe. the aim of this study is to compare the easiness of use of norditropin nordiflex® device to the device previously used by patients or parents.


Eligibility criteria:
inclusion criteria: * children who can receive norditropin® (somatropin) treatment according to the product labelling * treated with growth hormone for at least one year exclusion criteria: * contraindications to norditropin® growth hormone therapy * known or suspected hypersensitivity to somatropin or related products * the receipt of any investigational medicinal product within 3 months prior to study start * life threatening disease, for example cancer * pregnancy or the intention of becoming pregnant
a study to see if tolvaptan can delay dialysis in infants and children who at enrollment are 28 days to less than 12 weeks old with autosomal recessive polycystic kidney disease (arpkd)

Conditions: Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Summary: the primary objective of this study is to evaluate the effect of tolvaptan on the need for renal replacement therapy in pediatric subjects with autosomal recessive polycystic kidney disease (arpkd)

tolvaptan has been demonstrated to delay the decline of kidney function in adults with rapidly progressing adpkd (ckd stages 1 to 3), a closely related indication to arpkd, as measured by estimated glomerular filtration rate (egfr) and total kidney volume (tkv). the trial will be the first trial of tolvaptan in a pediatric arpkd population. participants in this study will be assigned to tolvaptan for 24 months and closely monitored over the course of the study.

Eligibility criteria:
inclusion criteria: 1. male or female subjects between 28 days and \< 12 weeks of age, inclusive at the time of enrollment. 2. must have clinical and imaging features that are consistent with a diagnosis of arpkd with all the following characteristics: * nephromegaly (\> 2 standard deviations from age appropriate standard via ultrasound) * multiple renal cysts * history of oligohydramnios or anhydramnios 3. ability for parent or guardian to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial. exclusion criteria: 1. premature birth (≤ 32 weeks gestational age) 2. anuria or rrt, defined as intermittent or continuous hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration or history of kidney transplantation 3. evidence of syndromic conditions associated with renal cysts (other than arpkd) 4. abnormal liver function tests including alt and ast, \> 1.2 × uln 5. parents with renal cystic disease 6. need for chronic diuretic use 7. cannot be monitored for fluid balance 8. has or at risk of having sodium and potassium electrolyte imbalances 9. has or at risk of having significant hypovolemia as determined by investigator 10. clinically significant anemia, as determined by investigator 11. severe systolic dysfunction defined as ejection fraction \< 14% 12. serum sodium levels \ 145 mmol/l 13. taking any other experimental medications 14. require ventilator support 15. taking medications known to induce cyp3a4 16. having an infection including viral that would require therapy disruptive to imp dosing 17. platelet count \<50,000 µl 18. significant portal hypertension 19. bladder dysfunction or difficulty voiding 20. taking vasopressin agonist 21. having concomitant illness or taking medications that are likely to confound endpoint assessments. 22. history of cholangitis 23. received or scheduled to receive a liver transplant

Keywords: arpkd tolvaptan polycystic kidney disease autosomal recessive polycystic kidney disease renal cysts nephromegaly oligohydramnios anhydramnios
connectomics in psychiatric classification of bipolar disorder and schizophrenia

Conditions: Bipolar Disorder; Schizophrenia

Summary: washington university early recognition center is conducting a research study to examine brain functional connectivity and network patterns in participants with bipolar disorder and schizophrenia.

this study extends the assessment of brain connectivity and function, being conducted in the human connectome project (hcp), to psychiatrically ill populations. the hcp consortium has made significant improvements in mri instrumentation, data acquisition, preprocessing, and analysis. these improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. this study will focus on individuals aged 18-40 years who have a diagnosis of either schizophrenia/schizoaffective disorder or bipolar disorder, or are healthy controls. additionally, similar to the hcp, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. dna will be collected non-invasively from saliva. furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.

Eligibility criteria:
inclusion criteria: * between ages 18-30 exclusion criteria: * head injury * unstable medical condition

Keywords: bipolar schizophrenia schizoaffective
the experience of living with polycystic ovary syndrome in the military

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to understand the experience of living with polycystic ovary syndrome (pcos) as an active duty service woman. as part of a budding research program, this proposed study will lay the groundwork for future intervention studies targeting the management of pcos in a military population.

using a qualitative descriptive approach with focus groups (fg) and individual interviews (ii), the investigators will seek to describe the experience of living with pcos as an active duty service woman (adsw). this method will allow the investigators to obtain a comprehensive summary of living with pcos in the every day terms of adsw. the discussion in the (fg) meetings will be an effective way to supply information about what people think, or how they feel, or on the way they act. advantages of this method include: (a) it can cover a large number of people in one session, (b) it is an efficient way of gaining a large amount of information in a short time, (c) it is comparatively easier to drive or conduct, and (d) it generates an opportunity to collect data from the group interaction, which concentrates on the topic of the researcher's interest \[64, 65\]. this proposed study will focus on six primary areas of inquiry: (a) experience of receiving pcos diagnosis (b) symptoms experienced and methods of coping with them, (c) military-specific experience of managing and living with pcos, (d) access to/availability of information related to pcos and how they have applied it, (e) experience of support, and (f) present and future concerns about having pcos.

Eligibility criteria:
inclusion criteria: * women, active duty or prior (within 5 years) in the army, navy, air force or marine corps * diagnosed with pcos * 18 years of age or over exclusion criteria: * reservist, coast guard, women who have separated or retired \> 5 years ago

Keywords: polycystic ovary syndrome military service women active duty