Kornimate/medical-research-clean huggingface dataset:
the role of ureteral stenting following uncomplicated ureteroscopy for ureteral and renal stones: a randomized, controlled trial

Conditions: Ureteroscopy

Summary: it is well established that uncomplicated distal ureteroscopy can be safely performed without leaving a ureteral stent. however, many urologists continue to leave ureteral stents following uncomplicated ureteroscopy, regardless of stone location, due to concerns for post-operative complications, patient symptoms and to reduce unplanned medical visits. there is a paucity of data regarding the utility of stent placement for proximal ureteral or renal stones following ureteroscopy. we have designed a prospective, randomized controlled trial to evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in proximal and renal stones.


Eligibility criteria:
inclusion criteria: * adult patients age ranges 18-89 with solitary or multiple proximal ureteral or renal stones 1.5cm or smaller measured in the longest dimension on preoperative imaging (ct or xray). proximal ureteral stones are those proximal to the pelvic brim in the ureter. exclusion criteria: * stone size greater than 1.5 cm on preoperative imaging * pregnancy * stent placement prior to ureteroscopy ("pre-stented patients") * patients with solitary kidney
5-hydroxytryptophan and creatine for treatment resistant depression associated with hypoxia in females

Conditions: Major Depressive Disorder

Summary: the investigators hypothesize that the administration of two widely available, naturally occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the severity of depression in individuals exposed to chronic hypoxia by living at altitude. the purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-htp twice daily reduces hypoxia-related depressive symptoms measured by the 17-item hamilton depression rating scale (ham-d) in women with ssri or snri-resistant depression.

serotonin and creatine are processed separately in the brain, and deficits in these brain biochemicals lead to distinct clinical problems. therefore, investigators believe that treatment with a combination therapy, which could correct both deficits, would have a synergistic effect in the treatment of hypoxia-related depression and possibly other forms of treatment-resistant depression. thus, investigators propose to investigate antidepressant efficacy of dietary 5-hydroxytryptophan (5-htp) and creatine, as a means to restore the brain neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude residence.

Eligibility criteria:
inclusion criteria: * female gender, ages 18-64 years inclusive * current diagnosis of major depressive disorder identified by the scid-5-ct * current ham-d17 score of \> 15 * adequate adherence to any fda approved ssri or snri for at least 8 weeks exclusion criteria: * diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the scid-5-ct * history of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease * diabetes type i or ii * colitis or diverticulitis * history of pulmonary disease * history of fibromyalgia, lupus, eosinophilia myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition * seizure disorder * current serious suicide risk identified by the columbia severity suicide rating scale * current treatment with an antipsychotic, mood stabilizer, or non-ssri antidepressant * positive pregnancy test * previous diagnosis of serotonin syndrome * use of any excluded drugs or medications including serotonergic drugs or medications
trial comparing pla to higrt (prove-hcc)

Conditions: Hepatocellular Carcinoma

Summary: this phase ii, randomized trial compare quality of life for patients with hepatocellular carcinoma (hcc) who are not surgical candidates or decline surgery and are treated with percutaneous local ablation (pla) or hypofractionated image-guided radiation therapy (higrt).

administrative clarification: this clinical trial was terminated due to poor enrollment and was replaced by a separate non-randomized trial (nct04933435).

Eligibility criteria:
inclusion criteria: * hcc diagnosed either by histology/pathology or liver imaging reporting and data system (lirads 5 per the acr's lirads criteria) by ct or mri * patient is 18 years or older * ecog performance status of 0-2 * child pugh score a5, a6, b7 or b8 * lesions less than or equal to 5cm in size * less than or equal to 3 lesions in the liver to be treated on protocol * lesion amenable to treatment with both pla and higrt; for pla treatment this requires the lesion be visible via ultrasound and/or non-contrast ct or feasible per treating physician exclusion criteria: * child pugh score b9 or class c * fluctuating ascites * inability to complete baseline qol forms * concurrent administration of systemic therapy for hcc * prior liver rt is an exclusion unless subject participation is approved by the pi * positive serum pregnancy test

Keywords: unresectable
long-term follow-up of children born in the petn studies

Conditions: Intrauterine Growth Restriction; Pentaerithrityl Teratnitrate in Pregnancy; Long-Term Effects to Children

Summary: in every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. this occurs when the child cannot reach its growth potential due to an undersupply in the uterus. this inadequate supply is considered a developmental cause for the later development of physical diseases like cardiovascular diseases, sugar metabolism disorders and obesity as well as mental developmental problems (for example problems in cognitive skills, deficits in language development, concentration and attention). from 2002 to 2008, 111 patients with impaired placental blood flow were included in a small study and treated with pentalong or placebo. from 2017 to 2022, the positive effects of the study treatment were tested on a larger number of patients. a total of 317 pregnant women were included at 14 participating study centers in germany. in this follow-up study, the development of the children born in the two studies will be examined. the study consists of two independent parts: firstly, questionnaires are answered by the former participants and secondly, an on-site visit is carried out to check the physical and mental health of the child.

pregnancies in which impaired uterine blood flow is detected by doppler measurements during routine examinations in the second trimester are at high risk of developing fetal growth restriction (fgr). fgr affects 10% of pregnancies and is the leading cause of perinatal mortality and morbidity. in addition, intrauterine growth restriction places a lifelong burden on the physical and mental health of affected children. epidemiological studies have shown that children with fgr have an increased risk of developing type 2 diabetes mellitus, hypertension, dyslipidemia and a high bmi. in addition, the affected children show disorders in hormonal balance and pubertal development as well as specific impairments of various cognitive and neurocognitive functions. there is also a link between fgr and lower cognitive ability in preschool children, school-age children and young adults, as well as lower communication, language and reading skills in school-age children. neuronal development (e.g. eeg frequency spectra, resting-state networks) and executive functions are also impaired by fgr. in the follow-up study, the children will be examined from the age of 6. here, the effects of petn on the development of children of women with high-risk pregnancies can be further investigated and a comparative study of growth-retarded and normal-growth children can also be carried out.

Eligibility criteria:
inclusion criteria: * mothers participation in one of the petn studies * age above 5 years * completion of questionnaires for self reported data * written consent for physical examination exclusion criteria - only physical examination: * physical and mental states preventing physical examination
does the mesh have to be fixed in laparoscopic etep repair of bilateral inguinal hernia?

Conditions: Migration of Implant; Pain; Postoperative Complications; Relapse

Summary: inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. as with many open surgical methods, this repair is also performed laparoscopically. among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (etep). the benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate. one of the recent debates regarding the laparoscopic technique is mesh fixation. fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. however, it has been reported that this fixation may increase postoperative pain. several studies have reported that recurrence may be due to inadequate mesh fixation technique. in contrast, other prospective randomized studies have found relapse unrelated to mesh fixation. there are studies in the literature on mesh fixation related to the total extraperitoneal repair (tep) technique. these studies are generally planned for unilateral hernias. it is a controversial issue among surgeons that the possibility of mesh migration is higher in bilateral hernias since there is a larger dissection area. this discussion is the starting point of this study. there were no studies in the literature regarding mesh fixation in bilateral inguinal hernias. the aim of this study is to compare bilateral inguinal hernia patients with and without mesh fixation in the etep technique in terms of both mesh migration and clinical features.


Eligibility criteria:
inclusion criteria: * patients with bilateral inguinal hernias. * patients aged 18-65. exclusion criteria: * younger than 18 years, and older than 65 years * incarcerated or strangulated inguinal hernias, * recurrent hernias. * patients with unilateral inguinal hernias. * patients who are contraindicated to receive general anesthesia. * pregnancy
endothelial function in lower extremity bypass grafts

Conditions: Peripheral Arterial Disease

Summary: this study will determine whether or not saphenous vein \[arterial\] bypass grafts in the leg relax in response to increases in blood flow.

subjects who have undergone saphenous vein \[arterial\] bypass grafts from the femoral to above-knee popliteal artery will undergo ultrasound imaging at rest, and again after 5 minutes of blood pressure cuff occlusion of the calf. (at 1 minute and 15 minutes) subjects will then be given sub-lingual nitroglycerin, and repeat ultrasound will be performed 3 minutes later. following 10 minutes of rest, subjects will be given intravenous l-nmma, a specific nitric oxide inhibitor, to help determine the responsible agent of the vein graft flow mediated dilation.

Eligibility criteria:
inclusion criteria: * adults who have undergone femoral artery to above-knee popliteal artery saphenous vein bypass grafts exclusion criteria: * amputation beyond the toes * critical limb ischemia defined as rest pain, non-healing ulceration or gangrene * pregnancy

Keywords: saphenous vein bypass grafts flow-mediated vasodilation
training executive functions to facilitate recovery following traumatic brain injury

Conditions: Traumatic Brain Injury; Brain Injuries, Traumatic

Summary: the purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury.


Eligibility criteria:
inclusion criteria: * if you have had a traumatic brain injury (tbi)or no history of neurological disease/damage. * if you are between the ages of 19 and 65. exclusion criteria: for participants with traumatic brain injury: * if you have a history of prior neurological disorders (e.g., stroke, seizures, or brain tumor). * if your brain injury is less than 6 months ago. for healthy participants: -if you have a history of prior neurological disorders (e.g., head injury, stroke, seizures, or brain tumor). for all participants: * if you have significant psychiatric history (such as schizophrenia or bipolar disorder.) * if you have a alcohol or drug abuse history. * if you are currently taking certain types of medications, which the study doctor will review. * if you do not have a working knowledge of the english language.
the therapeutic value and mechanism of recombinant human interleukin-2 on children with rheumatic diseases

Conditions: Systemic Lupus Erythematosus

Summary: the study aims to explore the therapeutic value and mechanism of interleukin-2 on children with rheumatic diseases (systemic lupus erythematosus, primary sjögren syndrome, juvenile idiopathic arthritis).

the investigators designed a single center, open-label, prospective study that routinely administered low-dose il-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines. methods: patients were divided into two groups. one received standard therapy, while another one administrate with low-does il-2 plus standard therapy.

Eligibility criteria:
inclusion criteria: 1. age \<18 years old 2. meet the diagnostic criteria of disease classification 3. hiv negative;negative for hepatitis b virus and hepatitis c virus. exclusion criteria: 1. heart failure (cardiac function ≥ grade iii nyha) 2. liver insufficiency (upper limit of normal range of transaminase \> 2 times) 3. renal insufficiency (creatinine clearance ≤30ml/min) 4. acute or severe infections such as bacteremia and sepsis 5. malignant tumor 6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month;rituximab, infliximab or other biological agents were used 7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information 8. inability to comply with il-2 treatment regimen.
assessing the clinical performance of two frequent replacement silicone hydrogel multifocal toric contact lenses

Conditions: Refractive Errors; Presbyopia; Astigmatism

Summary: the purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Eligibility criteria:
key inclusion criteria: * requires add (additional power for near vision); * currently wears multifocal soft contact lenses in both eyes during the past 3 months; * manifest cylinder power between -0.75 diopter (d) and -1.00 d; * best corrected visual acuity (bcva) of logmar 0.10 (snellen 20/25) or better in each eye. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator; * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; * current or history of pathologically dry eye in either eye that, in the opinion of the investigator, would preclude contact lens wear; * monovision contact lens wear. * other protocol-specified exclusion criteria may apply.

Keywords: contact lenses
multiple-dose nicotine pharmacokinetics with a new oral nicotine replacement product.

Conditions: Tobacco Dependence

Summary: a comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

this study compares a new oral nicotine replacement therapy (nrt) product with niquitin™ lozenge 4 mg and nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. the study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility criteria:
inclusion criteria: * healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and bmi between 17.5 and 30.0 kg/m2. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication. * prior regular use of nicotine mouth spray

Keywords: smoking cessation, nicotine pharmacokinetics
an open-label, phase 1 study in healthy adult subjects to examine the effects of multiple-dose ciprofloxacin on ivacaftor and vx-661 in combination with ivacaftor

Conditions: Cystic Fibrosis

Summary: to evaluate the effect of ciprofloxacin on the pharmacokinetics (pk) of ivacaftor and on the pharmacokinetics of vx-661 when administered in combination with ivacaftor


Eligibility criteria:
inclusion criteria: * willing and able to comply with scheduled visits, treatment plan, study restrictions,laboratory tests, contraception guidelines, and other study procedures * healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ecg, and clinical laboratory tests. * body mass index (bmi) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg * female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the day -1 visit. exclusion criteria: * history of any illness, clinical condition, or other factor that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject * inability to swallow capsules, or inadequate venous access. * history of febrile illness within 5 days before the first study drug dose * a screen positive for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus 1 or 2 antibodies. * for female subjects: pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. for male subjects: subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose. * any condition possibly affecting drug absorption * abnormal renal function at screening
study comparing cubicin with vancomycin in treatment of participants with complicated skin and skin structure infections in a home infusion setting

Conditions: Complicated Skin or Skin Structure Infection

Summary: this is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous (iv) daptomycin and iv vancomycin administered in a home infusion setting for the treatment of complicated skin and skin structure infections (csssi) due to gram-positive bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive vancomycin in a home-infusion setting.

this is a randomized, open-label, multi-center, phase 4 study. the overall goals of this study are to compare intravenous (iv) daptomycin and iv vancomycin administered in a home infusion setting for the treatment of csssi due to gram-positive bacteria in participants who are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home infusion setting. study objectives include evaluation of clinical and resource utilization endpoints and economic analysis from the perspective of the home infusion provider.

Eligibility criteria:
inclusion criteria: * complicated skin or skin structure infection (csssi) * intravenous vancomycin home infusion ordered for 7-14 days exclusion criteria: * pregnant or lactating female * concurrently receiving other systemic antibiotics with gram positive activity * known or suspected allergy or hypersensitivity to daptomycin or vancomycin * known or suspected vancomycin-resistant enterococci (vre) * known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection * known or suspected human immunodeficiency virus (hiv), cancer, or autoimmune disease such as lupus * receiving systemic concomitant immunosuppressive agents such as chemotherapy, corticosteroids, tacrolimus, sirolimus, or cyclosporine, during the duration of the study * requirement for non-study gram positive systemic antibiotics * known to be allergic or intolerant to intravenous vancomycin or daptomycin * participants with known or suspected creatinine clearance (clcr) \< 30 milliliters per minute (ml/min) * in skilled nursing facility * in hospice or admission to hospice is planned