Kornimate/medical-research-clean huggingface dataset:
a research study examining the use of olanzapine for the prevention of migraine

Conditions: Migraine

Summary: olanzapine (o-lan-zah-peen) is a medication that has been approved by the food and drug administration (fda) for the treatment of patients with schizophrenia and/ or bipolar disorder. the trade name for this drug is zyprexa®. olanzapine has not been approved by the fda for the prevention of migraine and is experimental for the purposes of this research study. the jefferson headache center at thomas jefferson university has developed this clinical study to evaluate the safety and effectiveness of olanzapine in preventing migraine headaches.


Eligibility criteria:
inclusion criteria: * subjects who are male or female between the ages of 18 and 65, inclusive * subjects who have a history of migraine with or without aura as defined by ihs criteria, for at least one year prior to screening * subjects who experience between 3 and 10 migraine attacks per month, for the three months preceding screening * subjects who have no more than 15 headache days per month * subjects who have been on a stable dose (no clinically significant changes) of all daily medications, for any indication, from 28 days prior to screening through the duration of the trial. * women who are using, or agree to use for the duration of the study, a medically acceptable form of contraception (as determined by the investigator), if female of childbearing potential. * subjects who are able to understand and comply with all study requirements * subjects who provide written informed consent prior to any study procedures being performed. exclusion criteria: * women who are pregnant or lactating * subjects with an abnormal ecg that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability (subjects with qtc interval greater than 450ms will be excluded) * subjects currently taking, or have taken within the thirty days prior to screening, any neuroleptics \> 1 day per week (such as geodon, zyprexa, compazine, phenergan, seroquel and other drugs in the same class) * subjects currently taking or have taken within 4-weeks prior to screening any medication for the prevention of migraine * subjects who have failed more than two adequate trials of migraine prophylaxis, as determined by investigator * subjects who experience significant orthostatic hypotension, as determined by the investigator * subjects who, in the investigators opinion, have a history or have evidence of a medical condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial * subjects who, in the investigators opinion, have a history or have evidence of a psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial. * subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
evaluation of ibi302 injection in namd or dme

Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Summary: the purpose of this study is to determine the efficacy and safety of intravitreal ibi302 in the treatment of subjects with neovascular age-related macular degeneration (only in phase i) or diabetic macular edema.


Eligibility criteria:
inclusion criteria 1. willing and able to sign informed consent form and comply with visit and study procedures per protocol; 2. male or female patiensubjects ≥ 18 yrs. of age; 3. for amd subjects, active subfoveal or parafoveal cnv secondary to neovascular amd; the vision decreased by namd; 4. for dme subjects, type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of dme in the study eye; the cst measurement of ≥ 280 μm in the study eye; 5. bcva etdrs letter score of 24-73 in the study eye; exclusion criteria 1. concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; 2. presence of uncontrolled glaucoma in the study eye ; 3. presence of active intraocular or periocular inflammation or infection; 4. prior any treatment of following in the study eye: 1. anti-vegf therapy or anti-complement therapy; 2. laser photocoagulation; 3. history of vitreoretinal surgery; 4. glucocorticoid treatment(intravitreal or peribulbar) ; 5. bcva score \<19 letters in the fellow eye; 6. anti-vegf therapy in the fellow eye within 30 days of day 0; 7. presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) or malignant tumor; 8. history of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; 9. pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period; 10. participated in any clinical study of any other drug within 90 days of day 0, or attempted to participate in other drug trials during the study; 11. other conditions unsuitable for enrollment judged by investigatiors.
effect of different subcutaneous injection methods on pain and satisfaction

Conditions: Pain, Acute; Injection Site

Summary: this study; in patients treated with subcutaneous heparin a randomized controlled trial was planned to determine the effect of the injection time and the device called "palm stimulator" to reduce the pain felt during injection.


Eligibility criteria:
inclusion criteria: * above 18 years old * the one who is literate, * no physical, mental disabilities or communication difficulties, * low molecular weight heparin in the treatment plan, * no history of allergy, * agreeing to participate in the research, * there is no scar tissue, incision or infection in the area to be injected, * patients who will receive a 1-day injection and whose pain score is between 1-10 according to vas will be admitted. exclusion criteria: * who gave up participating in the research while continuing the research, * using subcutaneous insulin therapy, * there is an amputation in the right/left arm area where the study will be performed, * there is scar tissue, incision or signs of infection in the area to be injected, * patients who received injections for 1 day and whose pain score is 0 (zero) according to vas will not be admitted.

Keywords: pain low molecular weight heparin palm stimulator extended injection time
minimal invasive laser hemorrhoidoplasty vs conventional excisional hemorrhoidectomy in ii-iii grade hemorrhoidal disease

Conditions: Hemorrhoids

Summary: the study aims to evaluate the effectiveness and long term outcomes of laser hemorroidoplasty versus conventional milligan morgan hemorrhoidectomy in ii-iii degree hemorroidal disease.

background hemorrhoidal disease (hd) is a widespread condition and several surgical techniques have been proposed to date without achieving a definitive consensus. laser hemorrhoidoplasty (lhp) is a minimal invasive procedure for hd treatment determining the shrinkage of the hemorrhoidal piles by diode laser limiting the postoperative discomfort and pain. the aim of the current prospective randomized trial is to evaluate the postoperative outcomes of hd patients undergoing lhp vs conventional milligan-morgan hemorrhoidectomy (mm). methods. operative time, postoperative pain and complications, resolution of symptoms, patients 'quality of life, patients' evaluation of treatment and length of return to daily activity of ii-iii grade symptomatic hd patients undergoing lhp vs mm were prospectively evaluated. the patients were followed-up for 24 months looking for recurrence of prolapsed hemorrhoid or symptoms.

Eligibility criteria:
inclusion criteria: * ii-iii hemorrhoidal disease * failure of conservative treatment * asa i-ii exclusion criteria: * acutely thrombosed hemorrhoids * patients affected by ibd involving rectum or anus * patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol
impact of intravitreal faricimab on renal function in diabetic patients

Conditions: Renal Function Disorder; Diabetic Macular Edema (DME); Neovascular Age Related Macular Degeneration

Summary: this study aims to investigate the impact of intravitreal injection of anti-vascular endothelial growth factor (anti vegf) faricimab on renal function of diabetic patients. faricimab is a new anti-vegf drug which inhibits both vegf-a and ang-2 and it is used for the treatment of diabetic macular edema and neovascular age related macular degeneration. it is known that previous anti-vegf agents has systematic absorption and may cause deterioration in renal function of the patients. however, the effect of faricimab on kidney function has not been investigated yet. taking into account that ang-2 has destructive effect on kidneys, the investigation of the effect of its inhibition in diabetic patients who have already renal function deterioration may provide a valuable information in scientific community.

for the purposes of this study, 60 diabetic patients who need intravitreal injections of anti-vegf for either diabetic macular edema or neovascular age related macular degeneration will be enrolled. 30 patients will consist the study group and they will receive faricimab and the remaining 30 patients will receive aflibercept 2 mg. before the initiation of therapy, laboratory tests including hba1c, egfr, plasma creatinine, urine albumin to urine creatinine ratio (acr) will be ordered to investigate the glycemic control and the renal function of the patients.the best corrected visual acuity (bcva), the intraocular pressure (iop) and the anterior segments will be assessed on each visit. the optical coherence tomography (oct) will be used for the assessment of centra macular thickness (cmt). the results will be assessed at baseline and then at 6 months and 12 months from the initiation of therapy. the statistical analysis will be performed at the end of study period.

Eligibility criteria:
inclusion criteria: * patients with diabetes * patients with dme or namd or macular edema secondary to retinal vein occlusion * patients already receiving nephroprotective drugs exclusion criteria: * patients with end stage renal disease * pregnancy * patients with other retinal disorders * previous renal transplantation patients under hemodialysis

Keywords: renal function intravitreal injection of anti-vegf faricimab diabetic macular edema diabetes mellitus
selection of chronic low back pain patients for neurotomy surgery radiofrequency

Conditions: Pain;Back Low;Chronic

Summary: chronic low back pain is one of the leading causes of disability associated with significant health care costs. one possible management of chronic low back pain of facet origin is neurotomy-radiofrequency (nt-rf) intervention. currently, to determine whether a patient is eligible for nt-rf, two positive block tests are required. clinical examination with a homolateral extension-rotation-tilt maneuver of the spine (eri maneuver) would have the potential to identify subjects with pain of facet origin. it could therefore be a simple and effective diagnostic tool in the evaluation of a patient with low back pain and help in the decision whether or not to perform a test block by local infiltration of the zygapophyseal joint prior to an nt-rf procedure. the purpose of this longitudinal, prospective, observational, single-center study is to evaluate the performance of the combined extension-rotation-lateral tilt maneuver (eri maneuver) in predicting the response to neurotomy-radiofrequency intervention in patients with chronic low back pain. the included patients will answer 5 questionnaires, in addition to the usual clinical data: * hospital anxiety and depression scale (had) questionnaire, * quality of life questionnaire eq-5d-5l, * brief pain inventory - french version: questionnaire concis de la douleur (qcd), * functional impotence scale for low back pain: the quebec back pain disability scale * clinical global impression of change (cgi-c)


Eligibility criteria:
inclusion criteria: * patients admitted to the chronic pain service at the calot institute with chronic low back pain for at least three months, not responding to well-conducted conservative treatment * age 18 - 65 years * patient did not object to the use of their data * patient affiliated to a social security plan non inclusion criteria: * patient with a disorder of hemostasis * patient with a history of arthrodesis * patient with radiologically visible root damage * patient with instability of the spine * patient with an abnormality on dorso-lumbar mri: modic 1 * patient under legal protection : * person under guardianship, * person under curatorship, * person under legal protection, * person deprived of liberty, * pregnant or breastfeeding woman

Keywords: radiofrequency facet pain
predictive value of the dd4 questionnaire on depressive relapse after hospitalization

Conditions: Depressive Episode

Summary: this is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation.

patients in the study were hospitalized following a characterized depressive episode. the study is based on a review of these patients' medical records and data from the three-month assessment. no additional assessments are planned.

Eligibility criteria:
inclusion criteria: * patient 18 years of age or older, having been informed of the research * patient hospitalized at the auzon clinic for a characterized depressive episodé (isolated episode or recurrent depressive disorder) * discharged from hospitalization * considered in remission (total or partial) and with a madrs score \< 20 exclusion criteria: * patient hospitalized for \< 15 days * patient with bipolar depression * patient with a psychotic disorder * patient using narcotics with a "moderate to severe" severity * patient previously included in this study * patient under court protection, guardianship or curatorship * patient unablé to respond correctly to a depression self-assessment questionnaire
aveir dr real-world evidence post-approval study

Conditions: Cardiac Pacemaker; Arrythmia; Bradycardia

Summary: the purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber aveir dr leadless pacemaker using real-world evidence methods.

this is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from abbott and the center for medicare services to assess aveir dr leadless pacemaker safety in a large patient population. the results from this study will provide long-term safety data for the aveir dual chamber lp and the aveir atrial lp to fulfill the condition of approval requirements for the aveir dr device from fda. due to the rwe data collection methods used in this study, a central irb approved informed consent waiver has been granted. due to this waiver and the sponsor's use of the central irb, individual hospitals are not required to consent patients or complete local irb submissions for this rwe study.

Eligibility criteria:
eligibility criteria: * implanted with an aveir dr leadless pacemaker * continuous enrollment in medicare part a and part b for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period * ability to link with medicare fee-for-service data

Keywords: bradycardia sick sinus rhythm pacemaker av block vasovagal syncope
measuring levels of smn in blood samples of sma patients

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy (sma) is a disorder that affects the motor neurons. sma is caused by a mutation in a part of the dna called the survival motor neuron (smn1) gene, which normally produces a protein called smn. because of their gene mutation, people with sma make less smn protein, which results in the loss of motor neurons. sma symptoms may be improved by increasing the levels of smn protein. the purpose of this study is to determine whether a drug called a histone deacetylase inhibitor can increase smn levels. after undergoing a general medical and neurological evaluation, study participants will donate a blood sample. researchers will use this sample to measure smn levels. they will also isolate cells from the blood and treat the cells with various drugs that may increase smn levels.

spinal muscular atrophy (sma) is a currently untreatable, autosomal recessive motor neuron disease that is caused by deficiency of full-length survival motor neuron (smn) protein. one promising therapeutic approach to sma is to pharmacologically increase full-length smn protein levels. several compounds have been shown to increase smn levels in immortalized cell lines derived from sma patients. the objective of this study is to determine baseline smn levels in primary peripheral blood cells of sma patients and heterozygous carriers compared to unaffected controls and to investigate the effects in vitro of pharmacological compounds that are expected to increase smn levels. it is anticipated that these studies will provide further evidence to support the use of one or more of these compounds in a clinical trial for sma patients. the study population will include patients with genetically proven type i, ii, or iii sma and their family members. blood samples from anonymous, unaffected control patients will be obtained through the department of transfusion medicine (99-cc-0168). this is an investigative study that involves blood drawing only. no new therapy will be provided except the standard of care.

Eligibility criteria:
* inclusion criteria: diagnosis of sma with genetically proven mutations in the smn1 gene or unaffected family members (age greater than or equal to 2 years). no exposure to valproic acid or any other hdac inhibitors for a period of at least 2 weeks. written, informed consent (and assent, if applicable). exclusion criteria: history of valproic acid or other hdac inhibitor use within the past14 days. history of bleeding disorder, which would make a blood draw unsafe.

Keywords: motor neuron disease neuromuscular disease histone deacytelase inhibitors spinal muscular atrophy sma
a study to evaluate thr-149 treatment for diabetic macular oedema

Conditions: Diabetes Mellitus; Diabetic Retinopathy; Diabetic Macular Edema

Summary: part a of the study is conducted to select the thr-149 dose level. part b of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to month 3. as from month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or thr-149) will be evaluated when administered 1 month after the 3 monthly injections of thr-149 or aflibercept. in the other subjects, the durability of 3 monthly injections of thr 149 or aflibercept will be evaluated.


Eligibility criteria:
key inclusion criteria: * written informed consent obtained from the subject prior to screening procedures * male or female aged 18 years or older at the time of signing the informed consent * type 1 or type 2 diabetes * bcva etdrs letter score ≤ 73 and ≥ 39 in the study eye (for subjects in part a); bcva etdrs letter score ≤ 73 and ≥ 24 in the study eye (for subjects in part b) * central involved dme (ci-dme) with cst of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (sd-oct), in the study eye * received ≥ 5 anti-vascular endothelial growth factor (anti-vegf) injections for the treatment of ci-dme * bcva etdrs letter score ≥ 34 in the fellow eye key exclusion criteria: * macular edema due to causes other than dme in the study eye * concurrent disease in the study eye, other than central-involved dme, that could require medical or surgical intervention during the study period or could confound interpretation of the results * any condition that could confound the ability to detect the efficacy of the investigational medicinal product * previous confounding medications / interventions, or their planned administration * presence of neovascularisation at the disc in the study eye * presence of iris neovascularisation in the study eye * uncontrolled glaucoma in the study eye * any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye * untreated diabetes mellitus * glycated haemoglobin a (hba1c) \> 12% * uncontrolled hypertension
incb001158 combined with subcutaneous (sc) daratumumab, compared to daratumumab sc, in relapsed or refractory multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and antitumor activity of incb001158 in combination with daratumumab sc, compared with daratumumab sc alone, in participants with relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * prior diagnosis of multiple myeloma according to imwg diagnostic criteria. * measurable disease at screening. * has received at least 3 but not more than 5 prior lines of multiple myeloma treatment, including proteasome inhibitor, immunomodulatory drug, and anti-cd38 therapies. * eastern cooperative oncology group performance status of 0 or 1. * willing to avoid pregnancy or fathering children. * willing to provide fresh and archival bone marrow aspiration and biopsy tissue. exclusion criteria: * receipt of any of the following treatment within the indicated interval before the first administration of study drug: * anti-myeloma treatment within 2 weeks or 5 half-lives (whichever is longer). * investigational drug (including investigational vaccines) or invasive investigational medical device within 4 weeks. * autologous stem cell transplant within 12 weeks, or allogeneic stem cell transplant at any time. * plasmapheresis within 4 weeks. * radiation therapy within 2 weeks. * major surgery within 2 weeks, or inadequate recovery from an earlier surgery, or surgery planned during the time the participant is expected to participate in the study or within 2 weeks after the last dose of study treatment. * toxicity ≥ grade 2 from previous anti-myeloma therapy except for stable chronic toxicities (≤ grade 2) not expected to resolve, such as stable grade 2 peripheral neuropathy. * known additional malignancy (other than multiple myeloma) that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry. * laboratory values at screening outside the protocol-defined range. * significant concurrent, uncontrolled medical condition including but not limited to known chronic obstructive pulmonary disease (copd), persistent asthma, or history of asthma within the past 2 years; chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment; acute diffuse infiltrative pulmonary disease; clinically significant or uncontrolled cardiac disease. * plasma cell leukemia, waldenström's macroglobulinemia, poems syndrome, or amyloidosis.

Keywords: arginase inhibitor multiple myeloma daratumumab