Kornimate/medical-research-clean huggingface dataset:
chidamide combined with clad/gem/bu with autosct in high risk hodgkin & non-hodgkin lymphoma

Conditions: Hodgkin Lymphoma; Non-hodgkin Lymphoma

Summary: this study is to explore the efficacy and safety of chicgb conditioning therapy in patients with high-risk hodgkin and non-hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * patients with primary refractory or recurrent diffuse large b cell lymphoma, mantle cell lymphoma, peripheral t cell lymphomas, hodgkin lymphomas that do not qualify for treatment protocols of higher priority. * relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment. * adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dl. * adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (sgot) and/or serum glutamate pyruvate transaminase (sgpt) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal. * adequate pulmonary function with forced expiratory volume at one second (fev1), forced vital capacity (fvc) and diffusing capacity of lung for carbon monoxide (dlco) \>/= 50% of expected corrected for hemoglobin. * adequate cardiac function with left ventricular ejection fraction \>/= 50%. no uncontrolled arrhythmias or symptomatic cardiac disease. * performance status 0-1. 10. negative beta diffusing capacity of the lung for carbon monoxide (hcg) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization exclusion criteria: * central nervous system lymphoma * patients relapsed after autologous stem cell transplantation * bone marrow was involved by lymphoma * patients with active hepatitis b or c(hbv dna \>/=10,000 copies/ml). * active infection requiring parenteral antibiotics * hiv infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (cd4) counts * evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis c or positive hepatitis c serology. * patients with a corrected qt interval(qtc) longer than 500 ms

Keywords: chidamide autologous stem cell transplantation
spirit 2: efficacy and safety study of relugolix in women with endometriosis-associated pain

Conditions: Endometriosis Related Pain

Summary: the purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (e2) and norethindrone acetate (neta) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

this study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral, once-daily relugolix (40 mg) co-administered with either 12 or 24 weeks of low-dose e2 (1.0 mg) and neta (0.5 mg), compared with placebo. approximately 600 women with endometriosis-associated pain were enrolled and randomized 1:1:1 to group a - relugolix plus low-dose hormonal add-back therapy, group b - relugolix monotherapy for 12 weeks followed by co-administration with low-dose hormonal add-back therapy, or group c - placebo (n = 200 per group). eligible participants were randomized on baseline day 1 to treatment group a, b, or c, in the double-blind period. eligible participants, including those randomized to placebo, were offered the opportunity to enroll in an 80-week open label extension study where participants received relugolix co-administered with low-dose e2 and neta. participants who did not enroll into the extension study had a follow-up visit approximately 30 days after the participant's last dose of study drug.

Eligibility criteria:
key inclusion criteria: 1. is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form. 2. has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these. 3. has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy. 4. during the run-in period (35 to 70 days prior to treatment period) has a dysmenorrhea nrs score ≥ 4.0 on at least 2 days and 1. mean nmpp nrs score ≥ 2.5, or 2. mean nmpp nrs score ≥ 1.25 and nmpp nrs score ≥ 5.0 on ≥ 4 days. key exclusion criteria: 1. has a history of chronic pelvic pain that is not caused by endometriosis. 2. has any chronic pain or frequently recurring pain condition, other than endometriosis that is treated with opioids or requires analgesics for ≥ 7 days per month. 3. has had surgical procedures for treatment of endometriosis within the 3 months prior to the screening visit. 4. has a history of or currently has osteoporosis or other metabolic bone disease. 5. has a clinically significant gynecologic condition, other than endometriosis, identified during screening or run-in period transvaginal ultrasound or endometrial biopsy.

Keywords: endometriosis pain dysmenorrhea
progenitor cells role in restenosis and atherosclerosis

Conditions: Coronary Artery Disease

Summary: the aim of this study is to prospectively investigate the relationship of circulating endothelial progenitor cells at time of percutaneous coronary intervention to the subsequent development of in-stent restenosis or progression of coronary atherosclerosis.

research on stem cells has identified a population of bone marrow-derived cells, called circulating endothelial progenitor cells (epcs), that incorporate into sites of neovascularization and are home to sites of endothelial denudation thus contributing to the maintenance of vascular homeostasis. although extensive work has been conducted to verify if epcs impairment plays a key role in coronary atherogenesis, it is still matter of debate if the extension and severity of coronary artery disease are associated with reduced or increased numbers of epcs, as it remains unclear if these cells exert favorable or unfavorable effects at sites of percutaneous coronary intervention (pci). one should consider, however, that most previous investigations have been hampered by discordant definitions of epcs and by different timing of epcs sampling, thus determining much uncertainty on the role of epcs in restenosis and atherosclerosis progression. furthermore, development of de novo lesions and post-pci restenosis, which are pathophysiologically dissimilar, have not been examined concomitantly and serially over time. accordingly, the aim of this study is to carry out the first prospective assessment of the significance of subpopulations of circulating epcs in the subsequent occurrence of restenosis or progression of coronary atherosclerosis after pci. to this end, a pool of epcs subtypes that are suggested to play some role in atherosclerosis is measured in a homogenous population of candidates to pci. at variance with previous work, counts of epcs are obtained in baseline conditions before pci in order to avoid the confounding effect that the procedure exerts on epcs.

Eligibility criteria:
inclusion criteria: * evidence of complete revascularization of clinically important stenoses by pci * willing to undergo 8-month control angiography. exclusion criteria: * in-hospital death after pci * myocardial infarction during follow-up to exclude potential subacute stent * unstable angina * any increase in creatine kinase-myocardial band, troponin i, myoglobin, or liver enzymes above upper normal limit before pci * left ventricular ejection fraction\<30% * renal failure with creatinine\>2 mg/dl * treatment with statins at referral

Keywords: coronary artery disease endothelial progenitor cells
penile injection anxiety

Conditions: Penile Injection Therapy; Erectile Dysfunction; Radical Pelvic Surgery

Summary: the purpose of this study is to help us understand more about your experience with penile injection therapy. many men become anxious when thinking about penile injections. we would like to understand more about this anxiety. you will be asked to fill out questionnaires before you start penile injection training, at each training visit, and then at your four month follow-up visit.

the treatment of erectile dysfunction (ed) following radical pelvic surgery has become an increasingly important issue. for many men, oral medications for ed will not be effective immediately postoperatively. these medications enhance the effect of nitric oxide secreted from the cavernous nerves, however these nerves are usually transiently injured intraoperatively diminishing the amount of nitric oxide available. consequently, oral medications are usually ineffective for up to 18 to 24 months postoperatively while the cavernous nerves are healing. as a result, penile injection therapy is the primary treatment for ed for those men. this treatment delivers intracavernosal vasodilators at the base of the penis with a 29 gauge needle. this direct application produces consistent results and has been found to be effective for 94% of injection users. despite common sense and clinical experience that indicates men become very anxious about penile injection therapy, anxiety has rarely been assessed in studies of penile injection therapy. we have observed that men who are initially reluctant about penile injection therapy are more likely to try this treatment when they hear that the injection anxiety dissipates quickly, after only a few injections. we unfortunately only have clinical observation to support our claim describing the course of injection anxiety. this study would provide empirical data to support this claim and this data will be used in describing the treatment and encouraging men to try injection therapy.

Eligibility criteria:
inclusion criteria: * history of a radical pelvic surgery (cystectomy, prostatectomy, low anterior resection) * participating in the injection therapy program * ability to provide informed consent * ability to converse, write and read english exclusion criteria: * history of or currently receiving radiation therapy, * history of or currently receiving chemotherapy, * history of or currently receiving hormone therapy.

Keywords: penile injection therapy erectile dysfunction radical pelvic surgery penile injection anxiety
supplementation in adolescent girls with endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to determine whether dietary supplementation with vitamin d or fish oil can help to reduce physical and emotional symptoms in adolescent girls with endometriosis.

this is a randomized controlled trial designed to evaluate the effect of dietary supplementation on endometriosis symptom remediation. adolescent and young adults females aged 12 to 25 years with a surgically-confirmed diagnosis of endometriosis will be eligible for study participation. subjects will be excluded if they have concurrent chronic illnesses that affect gastrointestinal absorption of nutrients (e.g., celiac disease, ibd, cystic fibrosis), a history of renal stones, are pregnant, or non-english speaking. once consented, subjects will be randomized to one of 3 treatment assignments: 1) vitamin d3 2000 iu daily (n=30), 2) fish oil 1000 mg daily (n=30), 3) placebo (n=30) and will take these daily for 6 months. baseline nutrient intake from food and supplements will be assessed using the food frequency questionnaire (ffq). the 142 item survey assesses usual dietary intake during the past year. validated rating scales including the visual analog scale (vas), sf-36, and the world endometriosis ephect questionnaires will be used to measure pain and overall quality of life. the sf-36 measures 8 health concepts relevant across disease groups, including limitations to physical or social activities because of health problems, vitality, and general health perception. patients will complete a full review of medication usage, past medical history, family history, and other lifestyle factors. anthropometrics will be measured, and vital signs obtained. measures will be repeated at 3-month intervals for a total of 6 months. blood will be drawn at baseline, and at 6 months to measure levels of fatty acids, vitamin d, parathyroid hormone (pth), and calcium.

Eligibility criteria:
inclusion criteria: * female * age 12 years -25 years * previously surgically diagnosed at boston children's hospital with endometriosis * at least 6 weeks following laparoscopy * minimum pain score within the 4 weeks preceding study baseline * must be able to swallow an empty 00 gelatin capsule at baseline * must be willing to stop all vitamins and nutritional supplements during trial exclusion criteria: * concurrent chronic illnesses that affect gastrointestinal absorption of nutrients (e.g., celiac disease, ibd, cystic fibrosis) * vitamin d level of greater than or equal to 100 ng/ml at study baseline * history of renal stones * no access to text messages or email * pregnancy * non-english speaking

Keywords: adolescent endometriosis diet nutrition pain
continuous monitoring and control of hypoglycemia

Conditions: Diabetes

Summary: evaluate safety of non-adjunctive cgm use in cgm naive participants.

the study comprises recruitment and consenting of pediatric and adult participants. at entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or dka events in the past 6 months and smbg testing frequency). there are 3 clinic visits: study entry, month 6 and month 12 . monthly phone contacts will be made to assess for any mild/severe hypoglycemic or dka events and any details surrounding an event. clinic visits at months 6 and 12 will capture frequency of smbg testing, a1c level and pro information. cgm data will be obtained during the study to assess for cgm adherence.

Eligibility criteria:
inclusion criteria: * naïve to real-time cgm * type 1 or insulin-requiring type 2 diabetes * ≥ 2 years old exclusion criteria: * use of rt-cgm, within the past 12 months * pregnancy * concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy. * known (or suspected) significant allergy to medical grade adhesives * dialysis
a study to assess the efficacy, safety, and pharmacokinetics of fnp-223 to slow progression of progressive supranuclear palsy (psp)

Conditions: Progressive Supranuclear Palsy

Summary: prosper trial is a trial to assess the efficacy of fnp-223 in slowing disease progression in participants with psp as measured by the psp rating scale (psprs) over 52 weeks and to assess the safety and tolerability of fnp-223 for 52 weeks in participants with psp.


Eligibility criteria:
inclusion criteria: * male or female participants aged 50 to 80 years, inclusive, at the time of informed consent. * diagnosis of possible or probable psp of the richardson's syndrome (psp-rs) phenotypes according to the movement disorders society's progressive supranuclear palsy (mds psp) clinical features criteria. at least 1 (either 1 or both) of the following 2 items must be met: 1. vertical supranuclear gaze palsy. 2. slowing of vertical saccades and postural instability with falls within the first 3 years of psp symptoms. * presence of psp symptoms within ≤3 years prior to screening. * moca score ≥23 * full 28-item psprs score ≤40. * able to ambulate independently or with minimal assistance defined as the ability to take at least 10 steps (stabilization of 1 arm \[ie, use of cane\]). * body weight range ≥43 kg/95 lbs to ≤120 kg/265 lbs. * reside outside a skilled nursing facility or dementia care facility, except for participants residing in an assisted living facility. * has a caregiver or study partner who will accompany them to the study visits. the caregiver or study partner must be a person who has frequent contact (at least 7 hours per week at 1 time or in different days) with the participant and is able to provide information about the participant's medication and overall condition. prior to the conduct of any study procedures, the caregiver or study partner must be willing to sign the independent ethics committee (iec)/institutional review board (irb) approved informed consent. exclusion criteria: non-psp- rs movement disorders or other central nervous system (cns) diseases * score of 3 on any functional domain in the psp-cds. * participants with known psp genetic mutation (based on familiar or clinical history). * evidence of other neurological disorder that could explain signs of psp (eg, parkinson's disease, alzheimer disease, etc.). * brain magnetic resonance imaging (mri) within 1 year of screening consistent with: * primary degenerative diseases other than psp. procedures * for the optional substudy only: contraindication or refusal to undergo 2 lumbar punctures for obtaining csf. * contraindication or inability to tolerate mri for screening mri and volumetric brain mri assessments throughout the substudy.

Keywords: progressive supranuclear palsy disease progression fnp-223
evaluation of emergency department visits and activity : study

Conditions: Dental

Summary: the main objective will be to evaluate the type of care performed and the main reasons for consulting patients for an odontological emergency in order to better adapt to the flow and expectations of patients.


Eligibility criteria:
inclusion criteria: - all adults (\>18years) consulting in the emergency department (montpellier university hospital) exclusion criteria: * person under 18 years old * patients who does not speak french

Keywords: dental emergencies emergency department patients coming to the chu adv montpellier for consultation
personalized feedback for distress intolerant smokers

Conditions: Anxiety Disorders; Depression; Psychological Distress; Tobacco Dependence; Smoking, Tobacco; Smoking, Cigarette

Summary: this project will develop and refine a computer-delivered integrated personalized feedback intervention (pfi) that directly addresses smoking and distress tolerance. the pfi will focus on feedback about smoking behavior, distress tolerance, and adaptive coping strategies.

the primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (pfi) that addresses smoking and distress tolerance to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, increase distress tolerance, reduce anxiety/depressive symptoms, and increase adaptive coping skills compared to a personalized feedback on smoking only control. to address this aim, the investigators will implement a randomized controlled trial that will employ a longitudinal experimental design and involve four stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (active pfi versus control pfi with no personalized feedback on distress tolerance), and a post-intervention assessment; (c) 2-week follow-up; (d) 1-month follow-up. assessments will include a multi-method approach, including biological, behavioral, and self-report methods.

Eligibility criteria:
inclusion criteria: * low distress tolerance defined as a dts mean score of 2.56 or lower * daily smoking for at least one year (minimum 5 cigarettes per day and biochemically confirmed via carbon monoxide \[co\] analysis at least 5 ppm) exclusion criteria: * currently engaging in treatment for an alcohol/drug problem including smoking cessation * legal status that will interfere with participating * not being fluent in english

Keywords: psychological distress tobacco smoking feedback stress anxiety disorders depression
patient-specific virtual reality rehearsal prior to evar: influence on technical and non-technical operative performance

Conditions: Infrarenal Aortic Aneurysm

Summary: ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. patient-specific image data are incorporated into these simulations, and transformed into a 3d model. this enables the practitioner and his/her team to perform and practice 'real' cases on a virtual patient prior to performing the real procedure on the actual patient. this new technology has been referred to as 'patient-specific' rehearsal, also 'mission' or 'procedure' rehearsal. research has already proven that simulated patient-specific rehearsal of a carotid artery stenting procedure may enhance surgical and team performance. the procedure rehearsal software can now also be used to practice patient-specific endovascular repair of infrarenal aortic aneurysms (evar). the ability to rehearse a challenging and complex procedure like evar may not only influence device selection based on preoperative planning, but also improve the technical performance of the surgeon/radiologist and the awareness and communication within the entire endovascular team. however, further research is needed to evaluate if this new technology may enhance clinical safety and efficiency, i.e. if patients actually benefit from physicians and team members conducting patient-specific rehearsals of evar interventions.


Eligibility criteria:
inclusion criteria: -infrarenal aortic aneurysm suitable for endovascular exclusion exclusion criteria: * adult patients who do not have capacity to consent. * previous stent-graft implanted in the abdominal aorta

Keywords: suitable for endovascular exclusion
study of daylight photodynamic therapy with aminolevulinic acid for actinic keratoses

Conditions: Actinic Keratosis

Summary: photodynamic therapy is an effective treatment for actinic keratoses. in the united states topical aminolevulinic acid (ala) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. this clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ala.

* initial visit: * study inclusion criteria reviewed * consent forms reviewed * creation of facial map for actinic keratoses * face cleansed with chlorhexidine soap * light curettage of precancerous skin lesions * application of topical aminolevulinic acid (ala) * application of sunscreen * patient then spends 2 hours outdoors in a shaded area * after treatment the patient is to remain indoors for 48 hours * 3 month follow up visit - facial map of actinic keratoses used to document treatment response * 6 month follow up visit * facial map of actinic keratoses used to document treatment response

Eligibility criteria:
inclusion criteria: * clinical diagnosis of \>10 actinic keratoses on head and neck * age ≥ 18 years (because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients \<18 years of age, children are excluded from this study) * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * patients currently undergoing anti-neoplastic therapy including but not limited to the following: * topical imiquimod * topical 5-fluorouracil * topical ingenol mebutate * topical diclofenac * topical retinoids * oral acitretin * history of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid * patients with a known photosensitivity disorder including but not limited to porphyria, lupus, polymorphous light eruption, or immunobullous disease. * patients taking known photosensitizing medications including but not limited to griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines. * pregnancy

Keywords: aminolevulinic acid pdt photodynamic therapy photochemotherapy