Kornimate/medical-research-clean huggingface dataset:
patient experience comparing tonic vs. burst spinal cord stimulation for chronic pain

Conditions: Chronic Pain

Summary: researchers are evaluating if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation.

the study is a controlled trial with subjects that have an already-implanted scs device (eon mini™) and are not satisfied with their pain relief status. as part of medical standard of care, patients with already-implanted eon family tonic implantable pulse generators (ipgs) have the opportunity to experience burst stimulation for 30-day trial fda approved. the aim of the study record patients experience during the 30-day trial using standard questionnaires.

Eligibility criteria:
inclusion criteria: * males and females ≥18 years-old * diagnosed with chronic pain * have an already-implanted eon family ipg for a minimum period of 6 months * are interested in trying burst technology by reprograming their ipg for 2-3 weeks according to the 30-day trial standard of care * signed informed consent exclusion criteria: * subject's overall beck depression inventory ii score is \>24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; if subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they will be subjects to baker's act * subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation * subject has an infusion pump or any other implantable neurostimulator device * subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment * subject's pain originates from peripheral vascular disease * subject is immunocompromised * subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection * subject has history of cancer requiring active treatment in the last 6 months * pregnancy

Keywords: spinal cord stimulator (scs)
influence of polishing after bleaching on color change and enamel morphology

Conditions: Tooth Discoloration; Morphologic Change; Tooth Sensitivity

Summary: this trial evaluated the influence of polishing on enamel color change after in-office bleaching treatment. it also evaluated the influence of polishing on tooth morphology and sensitivity.


Eligibility criteria:
inclusion criteria: * individuals aged 18 to 30 years old of both sexes; * with good oral hygiene; * with no sensitivity to tactile and evaporative stimuli; * who have not undergone previous bleaching treatment, and with no caries lesions. exclusion criteria: * patients undergoing fixed orthodontic treatment; * patients allergic to the bleaching product; * drug users or pregnant women; * patients with carious lesions, defective restorations and/or periodontal disease, patients with systemic diseases, pulpitis or patients using analgesics.
amh for the identification of pcom in pcos diagnosis

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to validate the anti-müllerian hormone (amh) cut-off established and validated in the aphrodite study, for the determination of pcom as part of the diagnosis of pcos, using the elecsys amh plus immunoassay.

the study participants will be women born july 1985-dec 1987 in northern finland; the study partially links to the northern finland birth cohort 1986. female subjects included in this cohort will be invited to participate in the study with the aim to enroll up to 1800 subjects. each enrolled subject will have one study visit, where the clinical data required for assessing their pcos status will be recorded, including a gynecological examination by transvaginal ultrasound to determine polycystic ovarian morphology (pcom) status (antral follicle count and ovarian volume). study subjects will also have blood drawn for serum collection, where hormonal parameters relevant for pcos will be measured. the collected serum will also be used to measure the amh levels using the roche elecsys amh test.

Eligibility criteria:
inclusion criteria: * female * born july 1985-dec 1987 in northern finland * signed informed consent regarding roche collaboration exclusion criteria: * unwilling to undergo gynecological examination including transvaginal ultrasound (tvus) * unwilling to have blood drawn * pregnancy

Keywords: polycystic ovary syndrome pcos anti-müllerian hormone amh antral follicle count polycystic ovarian morphology
effect of incidental findings information on lung cancer screening intent

Conditions: Neoplasm of Lung; Decision Support Techniques; Mass Screening

Summary: this online randomized controlled trial seeks to determine if inclusion of incidental findings information in a lung cancer screening decision aid affects screening intent among screening-eligible individuals. participants will view either a decision aid with incidental findings information or without and indicate their intent to pursue lung cancer screening. hypothesis: inclusion of incidental findings in a decision aid will decrease intent to screen among participants.


Eligibility criteria:
inclusion criteria: * 55-80 year old male or female * current or former smoker who quit within the last 15 years * at least 30 pack years of smoking exclusion criteria: * n/a

Keywords: incidental findings
comparing im vs. vaginal progesterone for pre-term birth

Conditions: Infant, Premature; Premature Birth

Summary: this is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes. our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

this study is intended as a randomized controlled trial. women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups. those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days. while those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. vaginal progesterone to last between clinic visits will be provided to subject. those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.

Eligibility criteria:
inclusion criteria: * singleton pregnancies * history of spontaneous preterm brith (between 20 weeks and 36 weeks 6 days) * gestational age between 16 weeks 0 days and 20 weeks 6 days. * signed consent to participate in the trial exclusion criteria: * multiple gestation * prior elective fetal reduction or planned termination * known spontaneous reduction to singleton * major fetal anomaly or known fetal chromosomal abnormalities * progesteone used this pregnancy

Keywords: pre term pre term birth premature birth premature baby high risk pregnancy progesterone im progesterone vaginal progesterone
endoscopy for bleeding situations in surgical patients

Conditions: Hemorrhage

Summary: retrospective analysis of surgical patients with relevant gastrointestinal bleeding situations and indication for endoscopy for bleeding

we performed an analysis of all adult, surgial patients with indication for emergency endoscopy because of relevant gastrointestinal bleeding situations. a retrospective analysisof the incidence, causes, endoscopic findings and therapy and the outcome of bleeding situations during a 24-mounths interval in the years 2017, 2018 and 2019 was performed at our tertiary centre. informed consent was obtained from all participants. patient records as well as database were analyzed for therapy-specific items.

Eligibility criteria:
inclusion criteria: * patients of the university hospital of tübingen department of general, visceral and transplantation surgery with gastrointestinal bleeding situations exclusion criteria: * younger patients * patients without indication for emergency endoscopy for bleeding situations

Keywords: surgical patients, gastrointestinal bleeding
effect of chromium picolinate on insulin sensitivity in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the effect of chromium to improve glucose levels in diabetes is controversial. the hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps

detailed description: the primary clinical strategy to improve metabolic control in patients with type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. however, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. as such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities. one supplement that has attracted considerable clinical interest is chromium (cr). however, routine use of cr in subjects with diabetes is not currently recommended. in part, the controversy surrounding cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations. as such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning cr supplementation. in order to provide a comprehensive clinical evaluation of cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with type 2 diabetes. individuals had baseline measures consisting of oral glucose tolerance testing, body fat and adiposity assessed, and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps. individuals were evaluated for 6 months at which time repeat testing was done.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * on no meds to alter glucose metabolism * age greater than 25 years old * fasting glucose greater than 125 mg/dl at screening exclusion criteria: * subjects on insulin * sujbects on meds that alter glucose metabolism * use of glitazones * c0-existing disorders in major organ systems such as heart, kidneys, liver

Keywords: insulin glucose chromium
car-t re-treatment for refractory/relapsed multiple myeloma

Conditions: Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma Progression

Summary: this is a single arm, open-label, single-center, phase 1 study, to determine the safety and efficacy of autologous reinfusion of car-t cells targeting bcma in the treatment of refractory/relapsed multiple myeloma (r/r mm) who get recurrence and progression after previous car-t cell therapy.


Eligibility criteria:
inclusion criteria: 1. patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated imwg criteria. 2. patients with refractory multiple myeloma. clear bcma expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry. 3. refractory disease：1) at least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors. 4. relapse criteria in nccn clinical practice guidelines in oncology: multiple myeloma (2016.v2). exclusion criteria: 1. women of child-bearing potential or who are pregnant or breastfeeding. 2. have any active and uncontrolled infection: hepatitis b, hepatitis c, hiv, or other fatal viral and bacterial infection. 3. systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen. 4. patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder. 5. patients with cns metastases or symptomatic cns involvement (including cranial neuropathies or mass lesions and spinal cord compression). 6. history of allogeneic stem cell transplantation. have active acute or chronic graft-versus-host-disease (gvhd), or require immunosuppressant medications for gvhd, within 6 months of enrollment. 7. patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis. 8. other conditions that excluded by clinicians.
transient elastography in hepatectomy for hepatocellular carcinoma

Conditions: Surgery; Hepatocellular Carcinoma

Summary: the purpose of this study is to determine whether liver transient elastography performed before the surgical procedure is able to predict liver failure in patients undergoing hepatectomy for hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * patients already scheduled to undergo liver resection fo hepatocellular carcinoma

Keywords: hepatocellular carcinoma cirrhosis liver resection fibroscan
drug therapy induced weight loss to improve blood vessel function in subjects with obesity

Conditions: Obesity; Metabolic Syndrome X

Summary: obesity is common (\>30% of us adults), contributes to substantial morbidity and mortality, but is difficult to treat. partly this is due to the transient, arduous and modest nature of lifestyle interventions. partly it is due to the limited efficacy and safety problems of existing pharmacotherapy. only one drug, orlistat, is approved for long-term use in obesity; but its effects on weight are relatively small. there are drugs that have been approved for other diseases but which also reduce weight. one promising approach to treating obesity is combination therapy with orlistat and one or more of these other agents. the investigators propose an innovative approach to developing new therapies for obesity coupling the use of combination therapy with rigorous assessment of cardiovascular safety. vascular function is a quantitative surrogate clinical endpoint that has been strongly and independently linked to future cardiovascular events. our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular function in obese human subjects. the co-primary endpoints will be weight and vascular function.


Eligibility criteria:
inclusion criteria: * age 40 to 75 years * male or postmenopausal female * bmi ≥ 30 kg/m2 * one or more major cardiovascular (cv) risk factors (hypertension, dyslipidemia, impaired glucose tolerance or metabolic syndrome) exclusion criteria: * congestive heart failure * renal impairment * history of bariatric surgery (i.e. lap-band, roux-en-y or biliopancreatic diversion) * type i diabetes mellitus * weight loss \> 10% in the past 6 months * recurrent nephrolithiasis * current treatment for seizure disorder * hepatic cirrhosis * current use of study medications * current use of oral estrogen * history of smoking cessation in the past three months * current cholestasis or malabsorption syndrome * planned use of any herbal or over-the-counter supplements for weight loss * history of allergic reactions to metformin, topiramate, orlistat or any of ingredients * medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours * participation in another clinical drug study within four weeks prior to this investigation. * participation in any other weight loss or rigorous exercise program. * any disease or condition that in the opinion of the investigator may interfere with completion of the study

Keywords: obesity metabolic syndrome x hypertension dyslipidemia impaired glucose tolerance
use of cognitive stimulation software for patients over the age of 70 followed for breast cancer: cog-tab-age feasibility study

Conditions: Breast Cancer

Summary: numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. elderly patients also seem to be at higher risk of developing cognitive impairment. these disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. however, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. it is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. stimulation programs of this type have been developed in electronic format. however, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.the happyneuron® software, developed by a french team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).for this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface.


Eligibility criteria:
inclusion criteria: * patient with breast cancer, aged 70 and over, * during treatment with chemotherapy, targeted therapy or radiotherapy. * whatever the stage of the disease, * hospitalised in a week hospital, in traditional hospitalisation for an intercurrent episode or day hospitalisation, or undergoing radiotherapy * absence of major cognitive impairment preventing cognitive tests (compliance with the moca score threshold based on the patient's age and educational level according to grecogvasc standards), * patient with education level 3 "end of primary education" minimum (barbizet scale), * mastery of the french language, * patient who signed the consent to participate in the study. exclusion criteria: * hospitalization for neurological reasons (e.g. confusion), or psychiatric, * documented brain metastases, * history of brain radiation therapy, * progressive psychiatric pathology or known dementia, * abuse of alcohol or drug use, * severe visual and / or hearing loss, * patient's refusal to participate, * patient deprived of liberty or under guardianship.

Keywords: cognition
effectiveness of core-needle us guided biopsy as primary tool for diagnosis of thyroid nodules

Conditions: Thyroid Nodule; Thyroid Diseases; Thyroid Gland; Node

Summary: the study aimed to determine the best intervention between core biopsy and fine needle aspiration in diagnosis of thyroid malignancy.


Eligibility criteria:
inclusion criteria: * patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with tirads category iii or higher. exclusion criteria: * patients with a history of hemodynamic instability or inadequate coagulation profile were excluded

Keywords: thyroid nodule core needle biopsy fnb
effective high aerobic intensity endurance training regimes in chronic obstructive pulmonary disease (copd) patients

Conditions: Pulmonary Disease, Chronic Obstructive; Hyperoxia

Summary: 4 times 4 minutes interval training with and without hyperoxia is more effective than low intensity endurance training.


Eligibility criteria:
inclusion criteria: * copd exclusion criteria: * heart disease * walking or cycling inabilities * other diseases

Keywords: copd training vo2peak performance ventilation high aerobic intensity treadmill walking one leg training by cycling
prebiotic effects on gut microbiota, gut comfort and immune function

Conditions: Healthy; Gastrointestinal Diseases

Summary: human milk oligosaccharides (hmos) are the third most abundant class of nutrients in human milk. studies investigating the effects of dietary hmos in infants have shown various health and developmental benefits such as the development of the early gut microbiome (by favouring colonisation of beneficial bifidobacterium, lactobacillus, and bacteroides), the development of the immune system, general infant growth, protection against infectious diseases and allergies, and stimulation of cognitive development. only a limited number of studies have been conducted in adults, showing intake of hmos stimulates the growth of gut bifidobacterium in healthy adults.

the current study aims to investigate the effects of a 4-week intervention with two hmos on gut microbiome composition, immune function and gastrointestinal symptoms in healthy adults with mild to moderate gastrointestinal complaints. the study will be conducted as a partially decentralized, double-blind, randomized, placebo-controlled, parallel group design.

Eligibility criteria:
inclusion criteria: * age ≥ 40 and ≤ 55 years * male/female * total score of \>2 on the gastrointestinal symptom rating scale (gsrs) * body mass index 18-30 kg/m2 * stable body weight (± 5%) for at least 6 months * stable lifestyle and dietary habits within the 4 weeks prior and during study period * owns device (computer, smartphone, tablet) with access to the internet * adequate fluency in the english language to understand the inform consent process, study instructions and study assessments * sufficient vision and hearing to complete study procedures * willing and able to participate, follow the study procedures and to give written informed consent exclusion criteria: * history (\< 6 months prior to the study) or presence of severe gastrointestinal, metabolic, immunological, psychiatric disorder, or major surgery * current or past (\< 4 weeks) use of prescription, over-the-counter, or traditional medication, or dietary supplements with a relevant impact on gi system or on visceral motility * having received antibiotic treatment \< 4 weeks prior to study * alcohol intake \>1 units/day * currently pregnant or pregnancy in past 6 months * use of pro/prebiotics \< 4 weeks prior to study start * fully vegetarian/vegan diet \< 4 weeks prior to study start * high habitual vegetable and fruit intake (\> 2 servings of fruits and \>2 servings of vegetables per day) \< 4 weeks prior to study start * lactose intolerance * maltodextrin allergy * members of the research team or their immediate family members. immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted

Keywords: prebiotics