Kornimate/medical-research-clean huggingface dataset:
reducing involuntary movements in participants with tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: the purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of sd-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. the purpose of part b is to establish the durability of effect of sd-809 following 1-week period of randomized withdrawal (sd-809 and placebo), followed by 12 weeks of maintenance with sd-809.

participants who complete study sd-809-c-18 (nct02195700), sd-809-c-23 (nct02291861), or any other sd-809 study will be enrolled in this study. this study include a screening period (part a), a titration period (part a), a long-term treatment period (part a), a double-blind, randomized withdrawal period (part b), treatment after completion of the randomized withdrawal period (part b), and a post-treatment safety follow-up period (part a and part b). eu participants who complete part b will be invited to participate in part c.

Eligibility criteria:
inclusion criteria: * history of using a dopamine receptor antagonist for at least 3 months * clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening * participant has successfully completed a controlled study of sd-809 for treatment of moderate to severe tardive dyskinesia * participants with underlying psychiatric diagnosis are stable and have no change in psychoactive medications * have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months * history of being compliant with prescribed medications * able to swallow study drug whole * be in good general health and is expected to attend all study visits and complete study assessments * female participants must not be pregnant and agree to an acceptable method of contraception exclusion criteria: * currently receiving medication for the treatment of tardive dyskinesia * have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias * have a serious untreated or undertreated psychiatric illness * have recent history or presence of violent behavior * have unstable or serious medical illness * have evidence of hepatic impairment * have evidence of renal impairment * have known allergy to any component of sd-809 or tetrabenazine * has participated in an investigational drug or device trial (other than study c-18, study c-23, or any other eligible tev-50717 parent study) and received study drug within 30 days * have acknowledged use of illicit drugs * have a history of alcohol or substance abuse in the previous 12 months

Keywords: dyskinesias movement disorders central nervous system diseases nervous system diseases neurologic manifestations signs and symptoms
autologous platelet rich plasma (prp) intra ovarian infusion in perimenopausal women

Conditions: Infertility, Female; Perimenopausal Disorder; Menstrual Cycle Abnormal

Summary: autologous prp intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.

this triple-blind randomized controlled trial (rct) aims to investigate the effectiveness of autologous prp intra ovarian infusion on improving ovarian tissue functionality and hormonal profile of perimenopausal women. prp is blood plasma prepared from fresh whole blood that has been enriched with platelets. it is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (vegf), epidermal growth factor (egf), platelet derived growth factor (pdgf), transforming growth factor (tgf) and other cytokines all of which stimulate tissue proliferation and growth. prp has been employed in several medical conditions in orthopedics, dermatology, and ophthalmology for wound healing. it's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. this study aims to investigate the effect of autologous prp intra ovarian infusion on improving ovarian tissue functionality in perimenopausal women.

Eligibility criteria:
inclusion criteria: * women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles or, presence of a menstrual cycle duration over sixty days and progressive elevation of fsh levels. * discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment. * willing to comply with study requirements exclusion criteria: * any pathological disorder related to reproductive system anatomy * amenorrhea * endometriosis * adenomyosis * fibroids and adhesions * infections in reproductive system * current or previous diagnosis of cancer in reproductive system * history of familiar cancer in reproductive system * severe male factor infertility * prior referral for pgt * ovarian inaccessibility * previous poi diagnosis -endocrinological disorders (hypothalamus- * pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome) * bmi\>30 kg/m2 or bmi\<18.5 kg/m2 * systematic autoimmune disorders
a comparative study: non-surgical spinal decompression and spinal manipulative therapy- utilizing a quantifiable musculoskeletal functional assessment risk analysis tool (msdr®) in patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: to administer the msdr® (musculoskeletal disorder reporting) instrument to document the musculoskeletal profile of patients with chronic low back pain, a prospective, non-randomized, multicenter treatment trial


Eligibility criteria:
inclusion criteria: * must have informed consent signed * lumbar disc herniations under 5mm without sequestered fragments * lumbar disc bulging * lumbar degenerative disc disease (mild and moderate severity) * non-pregnant females and males suffering from chronic low back pain from 18 to 65 years of age * segmental dysfunction secondary to dyskinesia * unresolved nerve entrapment syndrome * patients must be able to comply with study protocol * joint fixation syndrome * premenopausal female patients, excluding patients who have undergone a hysterectomy, oophorectomy, or tubal ligation, must have one of the following methods of contraception and must have a negative serum or urine b-hcg pregnancy test performed within 48 hours before initiating protocol specified treatment. exclusion criteria: * contraindications to spinal manipulative therapy * lumbar canal stenosis resulting in significant neurological comprimise * any spinal cord compression resulting in significant neurological comprimise * cauda equina syndrome * infection * osteomyelitis -\>65 years of age * history of back or neck surgery * acute arthritis * signs or symptoms of arterial aneurysm * history of active cancer with bone metastasis * widespread staphyloccal and/or strepococcal infection * acute gout * serious unstable medical illness such as cardiovascular, renal, respiratory, endocrine, gastrointestinal, or psychiatric. * unstable spondylosis, spondylolisthesis, or spondylolysis * prior adverse experience with spinal manipulation therapy * uncontrolled diabetic neuropathy * gonorreal spinal arthritis * tuberculosis to the bone * maligancy with metatasis to bone * excessive spinal osteoporosis * osteomalacia * ankylosis * syphlitic articular or peri-articular lesions * active low back injury resulting from a motor vehicle accident or work related injury
a post-marketing study of the immunogenicity of somatropin (ribosomal deoxyribo nucleic acid [rdna] origin) injection (nutropin aq®) in children with growth hormone deficiency

Conditions: Growth Hormone Deficiency

Summary: this is a phase iv, multicenter, open-label, single-arm study of somatropin (rdna origin) (nutropin aq v1.1) in pre-pubertal children with growth hormone deficiency (ghd) naïve to prior recombinant human growth hormone (rhgh) treatment. the study is designed to characterize the immunogenicity profile of somatropin (rdna origin) injection when administered daily subcutaneously for 12 months. the clinical impact of immunogenicity will also be assessed.


Eligibility criteria:
inclusion criteria: * bone age less than equal to (\</=) 9 years (females) or \</= 11 years (males) as determined by x-ray of the left hand and wrist using greulich and pyle method and obtained within the 12 months prior to enrollment * prepubertal (tanner i) males and females by physical examination * diagnosis of ghd (stimulated gh less than \[\<\] 10 nanograms per milliliter \[ng/ml\]) by two standard pharmacologic tests obtained up to 12 months prior to informed consent/assent * normal thyroid function test within the 12 months prior to informed consent/assent * normal complete blood counts within 12 months prior to informed consent/assent * documentation of prior height and weight measurements, with height standard deviation score (sds) \</= 5th percentile for idiopathic isolated ghd participants exclusion criteria: * any previous rhgh treatment * short stature etiologies other than ghd * acute critical illness or uncontrolled chronic illness, which in the opinion of the investigator and medical monitor, would interfere with participation in this study, interpretation of the data, or pose a risk to participant safety * chronic illnesses such as inflammatory bowel disease, celiac disease, heart disease, and diabetes * bone diseases such as achondroplasia or hypochondroplasia, intracranial tumor, irradiation, and traumatic brain injury * participants receiving oral or inhaled chronic corticosteroid therapy (greater than \[\>\] 3 months) for other medical conditions other than central adrenal insufficiency * participants who require higher (2 times or greater than maintenance) doses of corticosteroids for more than 5 days in the 6 months prior to enrollment in the study * participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhgh were initiated * females with turner syndrome regardless of their gh status * prader-willi syndrome regardless of gh status * born small for gestational age regardless of gh status * presence of scoliosis requiring monitoring * previous participation in another clinical trial or investigation of gh, treatment for growth failure, or treatment with a biologic agent * participants with closed epiphyses * participants with a known hypersensitivity to somatropin, excipients, or diluent
long-term safety study of bhv-3500 (zavegepant*) for the acute treatment of migraine

Conditions: Acute Migraine

Summary: the purpose of this study is to evaluate the long-term safety of bhv-3500/vazegepant intranasal in the acute treatment of migraine. \* bhv-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). the world health organization (who) international nonproprietary names (inn) expert committee revised the name to "zavegepant" which was accepted by the united states adopted names (usan ) council for use in the u.s. and is pending formal adoption by the inn for international use.


Eligibility criteria:
inclusion criteria: * 2-8 moderate to severe migraines/month within the last 3 months * migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age * migraine attacks, on average, lasting about 4-72 hours if untreated * less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit * ability to distinguish migraine attacks from tension/cluster headaches * participants with contraindications for use of triptans may be included provided they meet all other study entry criteria exclusion criteria: * history of human immunodeficiency virus disease * history of basilar or hemiplegic migraine * current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder * history of nasal surgery in the 6 months preceding the screening visit * history of gallstones or cholecystectomy * history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etcetera), or other disease or condition (for example, chronic pancreatitis, ulcerative colitis, etcetera) that causes malabsorption. * body mass index ≥ 33 * hemoglobin a1c ≥6.5%

Keywords: migraine, headache, intranasal
xeroderma pigmentosum patient experiences

Conditions: Xeroderma Pigmentosum

Summary: xeroderma pigmentosum (xp) is a rare skin condition that causes extreme sensitivity to the sun and an increased incidence of skin cancers. the purpose of this study is to find out more about xp patient experiences and their quality of life.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of xeroderma pigmentosum * any age * access to a public or private computer exclusion criteria: * patients who do not have a confirmed diagnosis of xp * patients under 18 who do not have a parent/guardian able to read or speak english * patients who are unable to read or speak english

Keywords: xeroderma pigmentosum quality of life dlqi cdlqi
novel treatment for rotator cuff tears

Conditions: Supraspinatus Tear

Summary: the focus of this study is to examine changes in pain scores, strength, and range of motion over time following an ultrasonic tenotomy on a partial tear (\<50%) of the supraspinatus tendon of the rotator cuff.


Eligibility criteria:
inclusion criteria: - evidence of partial tear (\< 50%) of the supraspinatus tendon on mri. exclusion criteria: * a tear of the supraspinatus tendon greater \> 50% and any areas of full thickness tearing, concomitant tears \> 25% of other rotator cuff tendons (infraspinatus, teres minor or subscapularis), or acute tear of the glenoid labrum. * evidence of systemic illness/infection requiring oral or iv antibiotics during the recruitment period. * evidence of overlying skin infection or lesion at the proposed device insertion point on the shoulder. * previous corticosteroid injection within three months. * those individuals less than 25 and greater than 75 years of age will be excluded.

Keywords: ultrasonic tenotomy
worksites, occupational nurses and cholesterol change

Conditions: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia

Summary: to study the relative effectiveness of teaching occupational nurses to conduct cholesterol screening, counseling and referral events (scores) in their own worksites versus using an external organization to implement these programs. also. to study the relative effectiveness of face-to-face behavior change counseling following the cholesterol measurement versus automated feedback of essentially the same individualized educational material.

design narrative: the research design was a 2 x 2 design with repeated measures at six and 12 months after the baseline measurement and treatment application. the investigators tested the relative effectiveness of two major dimensions of blood cholesterol change programming in worksites of 250 - 800 employees with at least one occupational nurse. the overall design was 2 x 2 with 10 of 25 worksites randomly assigned to an internal condition and 10 worksites assigned to an external condition. in the internal condition, occupational nurses were trained by project staff to implement the scores and were given reflotron portable dry chemistry analyzers to measure cholesterol. in the external condition, the score was conducted by an external organization (project staff). five (5) worksites from each of the above conditions had the educational session of the score delivered face-to-face \[face-to-face condition (ff)\] by either the nurse or project staff, depending on the condition (internal + ff or external + ff). the other 10 worksites had this education delivered by a microcomputer/optical scanner (the rt 2000) that read the participant's risk factor and self-reported eating pattern information and delivered a print-out with recommendations that were prioritized and individualized for the participant (rt intervention was delivered by the nurse or project staff depending on the condition (internal + rt or external + rt). all score participants in the above 20 worksites also received a self-help nutrition change kit. this cross design allowed testing for possible interaction effects. another group of five worksites was also included which served as a comparison group for the external condition. the employees in this group received a screening and education experience similar to the usual type of program offered by external, commercial screeners with minimal written education materials and no individualized feedback (usual care external condition). the primary dependent variables included measured blood cholesterol, weight, other chd risk factors, and self-reported eating pattern. change were assessed six and 12 months after the scores were conducted. a wide range of other variables including process, cost and mediating variables were assessed through the project period. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
fluid responsiveness evaluation in patients with acute circulatory failure and arrhythmia with atrial fibrillation: indice delta itv / delta rr

Conditions: Arrhythmia Atrial

Summary: fluid therapy is often used as first line treatment of acute circulatory failure, aiming an increase in cardiac output (by improving preload) and in tissue perfusion. depending on left ventricular systolic function, fluid challenge could lead to an increase in cardiac ouput and tissue perfusion, or only detrimental consequences (by fluid overload and aggravation of lung and tissues oedema, increase of morbi-mortality). patients are defined as responders to fluid therapy if one can observe an increase of cardiac output up to 15% after fluid therapy (500ml of crystalloids): gold standard test used in most of the studies on the subject. literature reports on heterogenous populations a reproductible and constant response rate to this fluid challenge of 50%. it seems reasonable to dispose of indices allowing to predict fluid responsiveness without resulting in fluid intake. statics markers have been abandonned for several years and dynamics methods have been developped. in front of arrythmia, validated methods are scarce. passive leg rising method appears to be the only one and it's validity seems to be less well documented than in sinusal patients. the purpose of this study is to determine a new method to assess fluid responsiveness in arrythmic patients. in atrial fibrillation, rr interval varies widely between cardiac cylces. systolic interval remain constant. variations will occure at expense of diastolic interval, or ventricular filling interval. one can reliably assume that when rr is longer, preload is rising. if the patient is on the ascendant part of the franck-starling curve, a longer rr should cause au greater vti (vitess time integral, surrogate of cardiac output). the evaluation by transthoracic echocardiography of the indice delta itv / delta rr should determine the degree of fluid responsiveness in arrhythmic patients. after decision of fluid expansion, patients will have haemodynamic and echocardiographic data measured, delta itv / delta rr indice assessed, then passive leg rising and fluid expansion with 500 ml of cristalloids administered, with evaluation of vti (as surrogate of cardiac output) at each time. fluid responders will be compared to non-responders to evaluate the diagnostic performances of the indice delta itv / delta rr.


Eligibility criteria:
inclusion criteria: * hospitalized patients in the units of surgical icu and cardiothoracic icu of the universatory hospital of poitiers * with atrial fibrillation * with spontaneous ventilation * with acute circulatory failure and medical decision to fluid therapy (systolic arterial blood pressure \< 90 mmhg and/or vasopressors agents) * with no left or right ventricular dysfunction exclusion criteria: * patients \< 18 yrs * contraindictions to passive leg rising * clinical evidence of hemorrhagic shock * cardiogenic shock * necessity of fluid expansion in emergency * no echographic windows
pelvic floor muscle contraction in response to different verbal instructions in women with urinary incontinence

Conditions: Urinary Incontinence

Summary: the aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles (pfm) in patients with urinary incontinence. and to examine whether correct pfm contraction can be taught by transabdominal ultrasound, which is used as biofeedback. pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.

a self-controlled clinical trial is planned for patients who receive physiotherapy for pelvic floor rehabilitation at one of the meuhedet institutes' physiotherapy clinics. each participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating". those who will not be able to contract will be taught by the ultrasound as biofeedback. the assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. a curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. an on-screen caliper and measurement tool will be used to measure bladder displacement.

Eligibility criteria:
inclusion criteria: * diagnosis of urinary incontinence * understand the language and simple instruction * willing to participate in the study exclusion criteria: * has been treated before for pelvic floor rehabilitation by a physiotherapist * received medication or surgery for the problem

Keywords: urinary incontinence pelvic floor muscle contraction transabdominal ultrasound verbal instructions