Kornimate/medical-research-clean huggingface dataset:
digital cognition in multiple sclerosis

Conditions: Multiple Sclerosis; Cognitive Decline

Summary: a digital therapeutic to improve thinking in multiple sclerosis who: 65 participants with a confirmed diagnosis of multiple sclerosis (ms) why: purpose of the study is to compare the effect of 2 tablet-based brain training digital tools on important components of thinking (cognition). what: complete a set of tests (physical and cognitive) at baseline, 6 weeks and 14 weeks, and use one of two brain training tools on an ipad in your home, for 25 minutes a day, 5 days a week, for 6 weeks. where: ucsf weill institute for neurosciences (675 nelson rising lane, san francisco, ca)

the purpose of this study is to begin to test a brain training video game in people with multiple sclerosis (ms). visit 1. after informed consent, you will complete a series of questions about your functioning and mood. you will then complete a series of tests (vision, hand tapping, walking). then, you will complete a set of thinking tests. the first set will be paper and pencil. the second set will be on a tablet or a computer. you will use your study code to sign into these tools and you won't provide any personal details for the digitized tests. finally, you will complete the "cognitive training tool". there are two versions of this digital, ipad based tool, which takes about 25 minutes to complete and is designed to be entertaining. you will be randomized into 1 of 2 groups: each group will play a version of the brain training game. you will not be told what group/game type you were randomized into. you will be given the tablet with the game on it to take home, and to practice this game 5 times a week for 6 weeks. visit 2. after the 6 weeks of at-home training, you will then come back to the research study unit to do a repeat of the initial visit (with physical and cognitive assessments). at this study visit, you will also be returning the ipad. visit 3. you will then return 8 weeks after visit 2, to do a repeat of the assessments. you will be compensated for each study visit (visit 1: $50, visit 2: $100, visit 3: $150).

Eligibility criteria:
inclusion criteria: * adult men or women diagnosed with multiple sclerosis (ms) or clinically isolated syndrome (cis) * sdmt z-score range (-2 to +1) * wifi available in home * able to use a tablet (ipad) * able to attend 3 study visits in person. exclusion criteria: * clinician's assessment of visual, cognitive, or motor impairment that would preclude participation. * a clinical relapse within the last 30 days. * steroid treatment for clinical relapse within the last 30 days.
selegiline for smoking cessation - 1

Conditions: Nicotine Dependence

Summary: the purpose of this study is designed to examine the effects of selegiline transdermal system and behavioral intervention in smoking cessation as compared to behavioral intervention alone.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * be in good general health * must meet diagnostic and statistical manual-iv (dsm-iv) diagnostic criteria for nicotine dependence * be currently smoking \> 15 cigarettes/day, and have smoked cigarettes for the past 5 years * subjects must be motivated to quite smoking * if female and of child bearing potential, agrees to use birth control and subject * subject must be able to understand and provide written informed consent. exclusion criteria: * please contact site for more information
treatment of melasma using q-switched nd: yag laser and fractional co2 laser separately and in combination

Conditions: Melasma

Summary: * all participants will be divided into 2 groups : group a \& group b. * group a will be subjected to 3 consecutive sessions of q-switched 1,064 nm nd: yag laser to one side of the face \& fractional co2 laser to the other side of the face with one month interval between sessions. * group b will be subjected also to 3 consecutive sessions of q-switched 1,064 nm nd: yag laser to one side of the face \& an additional fractional co2 laser to the other side of the face using the above mentioned parameters with one month interval between sessions. * response to treatment will be assessed using the melanin index (mi) score, melasma area and severity index (masi) score, spectrophotometer ( derma catch, colorix, neuchatel, switzerland ) and a subjective self-assessment method.


Eligibility criteria:
inclusion criteria: * melasma patients above 18 years exclusion criteria: * pregnancy. * usage of chemical peeling 1 month prior to the study. * isotretinoin intake 6 months prior to the study. * any laser procedure related to melasma lesions 1 month prior to the study. * active herpetic lesions. * any concurrent active skin disease within the treated area. * photosensitive skin conditions such as systemic lupus erythematous. * history of delayed wound healing. * keloid formation. * bleeding diathesis. * medical conditions such as diabetes mellitus \& autoimmune diseases.
a study of enzastaurin and erlotinib in participants with solid tumors and lung cancer

Conditions: Non-Small Cell Lung Cancer; Malignant Solid Tumor

Summary: phase i: a study to see what doses of enzastaurin and erlotinib are best tolerated by participants with solid tumor cancer. phase ii: a study to see how long participants with non-small cell lung cancer (nsclc) treated with enzastaurin and erlotinib live.


Eligibility criteria:
inclusion criteria: 1. phase 1: any incurable solid malignancy, with no more than 3 prior systemic treatment regimens. phase 2: histologic diagnosis of advanced nsclc, stage iiib with malignant pleural effusion or stage iv per american joint committee on cancer staging criteria for nsclc. participants must have failed 1 or 2 prior systemic treatment regimen(s). 2. performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) scale 3. prior chemotherapy must be completed at least 2 weeks prior to study enrollment, and the participant must have recovered from acute toxic effects (except alopecia) prior to enrollment. 4. prior radiotherapy is allowed to \<25% of the bone marrow. prior radiotherapy must be completed at least 2 weeks before study enrollment, and the participant must have recovered from acute toxic effects (except alopecia) prior to enrollment. 5. non-measurable or measurable disease as defined by response evaluation criteria in solid tumors \[recist, version (v) 1.0\]. exclusion criteria: participants who 1. are unable to swallow tablets. 2. unable to discontinue use of carbamazepine, phenobarbital, and phenytoin. 3. have previously been treated with an epidermal growth factor receptor (egfr) inhibitor, including erlotinib. 4. are receiving concurrent administration of any other antitumor therapy. 5. have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
connected scales to optimize the maintenance of weight lost after bariatric surgery and limit failures and reoperations

Conditions: Obesity, Severe; Surgery

Summary: in this research, we hypothesize that post-operative monitoring implemented with a connected scale after the 1st year (weight nadir period) post obesity surgery (i.e. sleeve and rygb) would reduce the percentage of patients with excessive weight regain (\>10% regain of lost weight) by improving the quality of follow-up and long-term results. to do this, we are carrying out a comparative study on 182 patients, controlled, randomized per patient, ratio 1/1, open, in two parallel arms. patients will be followed for 12 months and divided into one of the following two groups: * control group: standard follow-up * interventional group: standard follow-up + weekly weighing with the "body comp pro" connected scale during their follow-up period, patients in the intervention group will have to weigh themselves at least once a week using the "body comp pro" connected scale. the information will be transmitted to the investigation team via a secure platform available 24 hours a day. alerts will be generated from a weight regain \> 5% of the baseline weight, allowing early management of weight regain.


Eligibility criteria:
inclusion criteria: * adult patient aged 18 and over * patient operated by a sleeve or rygb at 1 year (+/- 1 month) from the inclusion visit * patient affiliated to a social security system (excluding ame) * patient having signed free, informed and written consent * patient speaking and reading french fluently exclusion criteria: * patient with medical-surgical complications during inclusion visit justifying specific and reinforced monitoring (at the discretion of the investigator) * patient with a pacemaker * patient with a pathology or disability preventing them from standing on the scale * patient participating in another interventional research at the time of inclusion * at the interview, pregnant patient or planning pregnancy during her period of participation in the research * patient deprived of liberty * patient subject to a legal protection measure (guardianship, curatorship)

Keywords: obesity surgery connected scale remote patient monitoring
pressure alternating shoes

Conditions: Foot Ulcer, Diabetic

Summary: the project is designed to develop and test pressure alternating shoes (pas), which will periodically off-load certain regions of the foot in order to prevent foot ulcers. an automated dual layer insole compromised of an active pressurized actuator array in combination with a passive compliant layer on top of each actuator to modulate and distribute the plantar surface pressure as desired will be tested. this device will allow us to simultaneously load and offload select areas of the foot using the active layer by inflating and deflating individual actuators using pressurized air. after offloading, the remaining load will be distributed to other areas with inflated actuators. automatic modulation will be provided through programmable control hardware which will cyclically relieve mechanical loading based on a prescribed duration and frequency.

the two-tier human subjects study will be conducted to assess the biomechanical characteristics of pas. in the first tier, we will test pas in healthy subjects and in the second tier, we will test pas in diabetic neuropathy patients (dn). subjects will walk on a treadmill in their usual daily shoes for 5 minutes, then with standard diabetic shoes with the pas insoles for 5 minutes. subjects will wear body worn sensors that assess position of the body. subjects will have the temperature of their feet measured via a special camera after walking. subjects will rest for 30 minute washout period and have the blood flow in the soles of the feet measured via a special camera. 1 healthy subject will undergo mri of the foot and ankle.

Eligibility criteria:
healthy controls: inclusion criteria: * age 18 or greater * ability to wear insoles in shoes provided * ability to walk unaided exclusion criteria: * diabetic neuropathy * charcot foot * knee pain * previous amputations * inflammatory diseases such as rheumatoid arthritis * open wounds, ulcers, sores or blisters on the feet; signs of infection in the feet diabetic population: inclusion: * age 18 or greater * ability to wear insoles in shoes provided * ability to walk unaided * diagnosis of diabetic neuropathy excluision: * charcot foot * knee pain * previous amputations * inflammatory diseases such as rheumatoid arthritis * open wounds, ulcers, sores or blistesr on the feet; signs of infection in the feet
edwards clasp tr efs

Conditions: Tricuspid Regurgitation

Summary: early feasibility study to assess the safety and performance of the edwards pascal transcatheter valve repair system in tricuspid regurgitation

the study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the edwards pascal transcatheter valve repair system

Eligibility criteria:
inclusion criteria: * severe functional or degenerative tr * symptomatic despite medical therapy * the local site heart team determines that the patient is appropriate for transcatheter tricuspid valve repair exclusion criteria: * unsuitable anatomy * previous tricuspid valve repair or replacement * co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Keywords: functional tr ftr transcatheter repair regurgitation degenerative
structural and molecular neuroplasticity in migraine

Conditions: Migraine

Summary: the main purpose of this study is to integrate novel mri techniques with positron emission tomography(pet) for the study of structural and molecular neuroplasticity in the brain of migraineurs, and its clinical association with changes in pain perception and modulation (e.g. allodynia). we will attempt to acquire images of the brain that may, in the future, assist doctors in better understanding how pain is felt and regulated in migraine sufferers.

to investigate interictal opioid receptor (mor) binding potential (bpnd) changes in migraineurs as compared to age/gender-matched healthy controls. to demonstrate that frequency of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced over multiple attacks are correlated with levels of mor bpnd in specific brain regions. to investigate whether dysfunction of the pain regulatory endogenous opioid system of migraineurs is correlated with changes in the gray matter thickness in cortical areas associated with pain perception and modulation.

Eligibility criteria:
inclusion criteria: * between 18-45 years of age * between 1-14 migraine attacks per month or healthy exclusion criteria: * cannot be taking daily migraine medication * healthy subjects cannot be taking hormonal birth control pills or other medication * cannot have chronic pain or a neurologic/psychiatric disorder such as: multiple sclerosis and bipolar disorder.

Keywords: migraine
the effect of an anti-inflammatory diet in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (ql). as a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option. the main objective of this parallel controlled randomized clinical trial is to check the effect of an anti-inflammatory dietary intervention, compared to a diet based on the principles of the mediterranean diet (control), on disease activity (ad) and improving ql. patients will be instructed to follow an anti-inflammatory diet (dai) or a control diet (dc) for 6 months. the ad and ql will be evaluated at the end of the intervention. as there are no dietary guidelines for ra, this study aims to provide scientific evidence about the impact of diet therapy on reducing ad and improving ql.

the main objective of this trial is to check the effect of an dai, compared to a dc, on reducing ad and improving ql. as secondary objectives, it is intended to investigate the relationship of dai with inflammatory markers and with the modulation of the composition / diversity of the intestinal microbiota, in comparison with a dc. this study combines all dietary components with an anti-inflammatory effect, thus allowing the possibility of evaluating the full potential of dietary treatment in the disease, including intestinal microbiota modulation. these results are intended to further contribute to clinical decision making and better evidence-based treatment.

Eligibility criteria:
inclusion criteria: * age over 18 years; * presence of active disease, (das28≥ 2.6), under adequate control and medication. * able to sign informed consent exclusion criteria: * any type of psychological deficiency, dementia or eating disorder; * presence of food allergies and / or intolerances; * be vegetarian or use phytotherapy or other supplements (namely, pre and probiotics); * use of antibiotics im the last 6 months; * have had previous nutritional monitoring or change in eating habits in the last 6 months.

Keywords: anti-inflammatory diet disease activity quality of life rheumatoid arthritis
study whose purpose is to find an optimal dose for the treatment with ak 3012 in patients with actinic keratosis

Conditions: Actinic Keratosis Olsen Grade I/II

Summary: in this three-armed dose-finding trial 3 ak 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation. the main objective of the trial is to determine the optimal concentration of the active agent in the topical formulation as quantified by the change of the number of skin alterations in pre-defined areas in a time period from inclusion in the trial until the end of treatment (3 months) or prior complete healing.


Eligibility criteria:
inclusion criteria: * age: ≥ 18 years * gender: male and female * actinic keratosis (olsen grade i/ii) * at least 5 actinic keratoses on the scalp, forehead, face, extremities, and/ or decollete * no treatment of the actinic keratoses within the previous 3 months before inclusion in the study * histologic confirmation of the diagnosis actinic keratosis by biopsy * good general condition * normal laboratory values (creatinine, urea, glutamate-oxalacetate transaminase (got),glutamate-pyruvate transaminase (gpt), gamma-glutamyl transferase (ggt), lactate dehydrogenase (ldh)) and blood count at study start not higher than 1.5 x upper norm limit * female patients must be tested negative for pregnancy before inclusion in the trial. during the trial, female patients have to apply a generally accepted form of birth control (i.e. oral estrogen- and gestagen containing contraceptives; estrogen containing skin plaster/ tape, hormone implant, hormone contraceptive coil, sterilisation; sexual abstinence) or being post-menopausal for at least 2 years. * willing and able to participate in the screening and all trial specific procedures in compliance with the protocol * signed written informed consent exclusion criteria: * known allergy against nonsteroidal antiphlogistics and/ or against excipients of the investigational medicinal product * presence of immunosuppression * treatment with 5-fluorouracil, cyclosporine, retinoids, glycolic acid, imiquimod, trichloroacetic acid during the trial or 12 weeks before inclusion in the trial * continuous treatment with nonsteroidal antiphlogistics with the exception of low-dose acetylsalicylic acid (100 mg) for inhibition of thrombocyte aggregation * planned treatment with photodynamic therapy during participation in the trial * pregnancy or lactation * participation in another clinical trial within 3 months before inclusion in the current trial
mirabegron for treatment of overactive bladder symptoms in patients with parkinson's disease

Conditions: Overactive Bladder; Parkinson Disease

Summary: the purpose of this study is to see the study drug, mirabegron, is safe and effective in treating symptoms of overactive bladder in patients with parkinson's disease.

this study is a randomized 1:1 placebo-controlled 12-week study of mirabegron in 144 parkinson's subjects the age of 40 to 80 with overactive bladder. active drug will be mirabegron 50mg daily. subjects will be enrolled based on response to an overactive bladder questionnaire at visit 1. enrolled subjects will have 3 study visits to the clinic as well as 1 phone visit.

Eligibility criteria:
inclusion criteria: * subject who signed a consent form approved from irb(institutional review board) or iec(independent ethics committee) * diagnosis of parkinson's disease by a neurologist * taking a parkinson's medications stably during 4 weeks preceding screening * 40 years to 80 years, male and female * patient has overactive bladder symptoms more than 4 weeks preceding screening. * oabss questionnaires total score≥ 3 and entries of urinary urgency score≥ 2 * the expanded disability status scale ≤ 7 exclusion criteria: * subjects who have any intervention and operation which can influence on study such as bladder augmentation, vesical sphincter, artificial sphincter, intravesical botulinum toxin treatment etc. * use of indwelling catheter or self-catheterization * acute urinary tract infection or urolithiasis at screening * history of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs * total volume urine \> 3l a day * screening post-void residual \> 200ml * nonpharmacological therapy within the previous 4 weeks of screening * screening blood pressure \>180 systolic or 110 diastolic * subjects who have orthostatic hypotension, syncope, hypokalemia, or angle-closure glaucoma * clinically significant ecg in recent year * screening estimated glomerular filtration rate (egfr) \ 2x upper limit of normal, γ-gt(gamma-glutamyl transferase) \> 3xuln * take following medication additionally or change the dose: previous 4weeks of screening to end of the study (tamsulosin/silodosin/terazosin, baclofen, diazepam, amitriptyline, ddavp/desmopressin) previous 12weeks of screening to end of the study (finasteride, dutasteride) * use β2- adrenoreceptor agonist, loop diuretic, cyp 3a4 inducer, cyp 2d6 narrow therapeutic index, cyp 3a4 inhibitor, antifungal agent, antiarrhythmic agent * history of allergy to mirabegron and beta-adrenergic receptor * use of one of the anti-cholinergic bladder medications such as propiverine / tolterodine / trospium / darifenacin / solifenacin / fesoterodine and mirabegron within 14 days of the screening visit. subjects who have used one of these medications in the past but discontinued it at least 14 days prior to the screening visit can be enrolled. * women who have potential to become pregnant during the course of the study

Keywords: overactive bladder parkinson disease