Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of ar08 for the treatment of vasomotor symptoms (vms)

Conditions: Vasomotor Symptoms (VMS)

Summary: the purpose of this study is to determine the effective dose or dose range of ar08 in the treatment of vms in menopausal females.


Eligibility criteria:
inclusion criteria: 1. generally healthy female \> 40 years of age with a body mass index (bmi) ≤ 40; 2. has undergone menopause defined as any of the following: at least 12 months of spontaneous amenorrhea; or at least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (fsh) levels \> 40 miu/ml; or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy); 3. experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week exclusion criteria: 1. resting systolic blood pressure (sbp) \<110 mmhg, resting diastolic blood pressure (dbp) \<50 mm hg, or a resting heart rate (hr) \<60 beats per minute while awake; 2. subjects with pre-existing orthostatic hypotension at screening; 3. use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (serm) -containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening; 4. history of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of screening: antihypertensives or prophylactic antimigraine medications

Keywords: ar08, vasomotor symptoms
effectiveness of physical exercise in women with fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia (fms) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. exercise training is commonly recommended as a treatment. the purpose of this study is to determine whether a supervised resistance muscular exercise (rme) and walking program (wp) are effective in the treatment of fms on decrease of pain. the practical of the rme reduces the pain of participants with fms.

this study will evaluate and compare the effectiveness of a supervised resistance muscular exercise (rme) , walking program (wp)and control group (just observation) in women with fms during 16 weeks, on decrease of pain. participants will undergo an assessment including medical some questionnaires to assess their fms symptoms at baseline, after 8 weeks, 16 weeks and 28 weeks.

Eligibility criteria:
inclusion criteria: * criteria diagnosis according acr 1990 * wash-out of medication specific for fibromyalgia for 1 month * only paracetamol 750mg will be allowed during the period of study. exclusion criteria: * alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation

Keywords: exercise rehabilitation strength exercise aerobic exercise pain
international crds registry

Conditions: Calcium Release Deficiency Syndrome

Summary: calcium release deficiency syndrome (crds) is a newly discovered genetic arrhythmia syndrome that confers a risk of life-threatening arrhythmias secondary to ryr2 loss-of-function. the international crds registry has been designed to facilitate large-scale evaluation of crds, including its phenotypic spectrum, approaches to risk stratification, and optimal treatment strategies.

calcium release deficiency syndrome (crds) is a recently discovered inherited arrhythmia syndrome that predisposes to malignant ventricular arrhythmias and sudden cardiac death (scd). the underlying genetic culprit of crds is ryr2, which encodes the cardiac ryanodine receptor. in contrast to catecholaminergic polymorphic ventricular tachycardia (cpvt), which stems from pathogenic ryr2 gain-of-function, crds manifests secondary to ryr2 loss-of-function. enrolment into the crds registry requires that the putative disease causing ryr2 variant is confirmed to result in a loss-of-function on in vitro functional analysis. individuals possessing an ryr2 truncating variant or large copy number variant will be eligible for enrolment into a second registry arm. patients with a suspected crds diagnosis whose ryr2 variant is found not to impact function will be entered into a control arm of the registry. given its recent discovery, our understanding of crds remains in its infancy. the international crds registry has been designed to facilitate evaluation of large numbers of crds patients and enable robust insights to hopefully improve management of affected patients and families.

Eligibility criteria:
crds cohort inclusion criterion: - presence of a rare\* ryr2 variant that is characterized to be loss-of-function based on in vitro testing# ryr2 truncating and large cnv cohort inclusion criterion: - presence of a rare\* ryr2 truncating variant and/or large copy number variant involving the ryr2 gene. carriers of a non-functional ryr2 variant inclusion criterion: - presence of a rare\* ryr2 variant that is characterized to be neither loss- nor gain-of-function based on in vitro testing# \*rare defined as gnomad prevalence \< 0.1% #ryr2 in vitro functional testing will be performed in the laboratory of dr. wayne chen (university of calgary)
the efficacy of emdr in youngsters with autism

Conditions: Autism Spectrum Disorder

Summary: rationale: currently, for youngsters there is no treatment available that directly targets the core symptoms of autism. emdr is hypothesized to improve the core symptoms of asd by reducing the generally high stress levels experienced during social interactions, and increasing the functional connectivity in neuronal networks associated with executive functioning and limbic circuitry. objective: the primary objective of the study is to determine if emdr reduces the core symptoms of asd and daily experienced stress in youngsters diagnosed with asd. study design: longitudinal multiple single case studies. study population: youngsters aged 12-21 years who are diagnosed with asd and have a full-scale iq of 80 or more (n=20). intervention: 10 weekly emdr sessions. main study parameters/endpoints: the main endpoint of the study are autism symptoms, which will be assessed using the social responsiveness scale (srs-a) and the autism diagnostic observation schedule (ados 2). the srs-a will be administered prior, during and after treatment. the ados 2 will be administered prior to treatment and after treatment completion. in addition, we will also administer the trauma symptom investigation form in autism spectrum disorders (tif-asd) questionnaire prior to, during, and after treatment. furthermore, to answer more fundamental questions concerning the working mechanism of emdr in asd, other secondary outcome measures (i.e. pss-10, awma-2) will be included. nature and extent of the burden and risks associated with participation, benefit and group relatedness: participants are expected to benefit from treatment. the risks associated with study participation are considered negligible and the burden associated with participation is estimated as low.


Eligibility criteria:
inclusion criteria: * diagnosed with asd (with or without comorbid psychiatric disorders, except ptsd and anxiety disorders) * full-scale iq of 80 or more * able to understand and speak dutch exclusion criteria: * receiving other treatments than medication on a stable dosage. * ptsd or other comorbid psychiatric disorders that require immediate and continuous treatment.

Keywords: autism, emdr; children
effect of continuous positive airway pressure (cpap) therapy on changes of blood pressure between day and night

Conditions: Obstructive Sleep Apnea; Diurnal Blood Pressure

Summary: to test whether using cpap can restore the normal pattern of drop of blood pressure during sleep.

objective: to investigate the effect of cpap therapy on the restoration of the normal diurnal blood pressure pattern. possible improvement of the circadian dipper pattern after cpap therapy, with or without a decrease in the mean blood pressure, might constitute an additional potential benefit of cpap therapy in reducing cardiovascular risk in patients with osa. study design and methods: patients diagnosed with osa at the sleep center will undergo blood pressure monitoring by measuring the blood pressure every half hour during sleep study. patients with normal circadian bp changes are treated with cpap as indicated. patients with non-dipping bp pattern will be approach to join our study. the patients will receive cpap therapy. the trial period will be 6 weeks. at the end of the trial, the patients from both treatment arms will undergo a second bp monitoring according to our above-mentioned protocol (systolic, diastolic and mean bp) to determine the circadian bp changes. apnea-hypopnea index will be calculated to reflect on the compliance with our therapy. thus, patients could be divided into two study groups according to their objective compliance. baseline population characteristics between the placebo group and cpap group will be noted. these include apnea-hypopnea index (ahi), medications, other co morbidities and other factors that might affect the normal circadian bp dipping pattern including factors affecting the volume status i.e. diabetes, renal failure, uncontrolled diabetes. any new medications added during the 6 weeks trial period will be noted. statistical analysis: the difference in daytime and nighttime bp pattern will be noted between the treated (cpap) and the non-compliant groups. the circadian bp variation will be recorded in both groups. changes in the circadian bp pattern will be assessed on an intention-to-treat basis. the odds ratio, p value and confidence interval will be calculated. correlation between the dipping/non-dipping pattern with cpap compliance, severity of osa and number of antihypertensive drugs will be studied as well

Eligibility criteria:
inclusion criteria: 1. all patients with osa who don't meet the above mentioned exclusion criteria exclusion criteria: 1. patients who have a normal diurnal sleep pattern (i.e. decrease of more than 30% of the systolic bp at night time) 2. patients who are on three or more antihypertensives whose blood pressure is not controlled. 3. patients previously treated with cpap therapy within the past 3 months

Keywords: cpap diurnal blood pressure obstructive sleep apnea 24 hour blood pressure monitor
efficacy of swallowing function after early postoperative oral exercise among patient with oral cavity cancer underwent flap reconstruction

Conditions: Oral Cavity Cancer

Summary: efficacy of swallowing function after early postoperative oral exercise among patient with oral cavity cancer underwent flap reconstruction: a randomized controlled trial


Eligibility criteria:
inclusion criteria: * patient with ca tongue and tumor size 2 cm exclusion criteria: * previous treatment * history of head and neck cancer

Keywords: dysphagia oral cancer oral exercise
chf management using telemedicine

Conditions: Congestive Heart Failure (CHF)

Summary: the overall objective of this study is to improve clinical outcomes and quality of life for congestive heart failure (chf) patients by integrating a readily available, low cost technology - the telephone - into coordinated chf care.

strong patient-provider communication and vigilant home-based monitoring can be critical elements of successful chronic disease management. among chf patients, automated clinical data acquisition via the telephone can improve insight into inappropriate use of medications and onset of fluid overload or edema - indicating deteriorating heart function (notably worsening ejection fraction). routine, timely monitoring of this data can direct a nurse case manager to the subset of chf patients likely to benefit from a clinic visit, evaluation, diagnosis, and counseling. this should result in: significantly increased medication compliance, significantly lower emergency department (ed) visits and hospital admissions (both those related to chf and other conditions related to diminished physical capacity of patients with chf), and improved physical function. this study is intended to answer three questions. first, do potentially avoidable acute events (measured by ed visits and hospital admissions) decrease when chf management is accompanied by systematic telephone-based monitoring as compared with usual care? second, does medication compliance improve when chf management is accompanied by systematic telephone-based monitoring as compared with usual care? third, does perceived health status (physical and emotional function) improve when chf management is accompanied by systematic telephone-based monitoring as compared with usual care?

Eligibility criteria:
inclusion criteria: * physician diagnosed chf * member of kaiser permanente georgia
study of the sudden heart failure participant population in the us

Conditions: Heart Decompensation

Summary: an observational study using data from a large us electronic health record database to find participants hospitalized with adhf who do not have a concurring heart attack


Eligibility criteria:
inclusion criteria: * age 18 years or older on the index date * at least 6 months of activity in the database * an inpatient visit with at least one of the following icd-9 or icd-10 diagnosis codes (icd-9 diagnosis codes: 428.xx, 785.51 or icd-10 diagnosis codes: i50.xx, r57.0) in the primary or secondary position or mention of "heart failure" on the admission record exclusion criteria: * an average lvef ≥ 40 during the hospitalization * any code for myocardial infarction (icd-9 diagnosis code: 410.xx, icd-10 diagnosis code: i21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization other protocol defined inclusion/exclusion criteria could apply
the influence of axial length on visual quality following smile surgery in patients with high myopia

Conditions: Visual Quality; Axial Length; High Myopia

Summary: this retrospective study aimed to investigate the subjective and objective visual outcomes following small incision lenticule extraction (smile) surgery in high myopic patients with varying axial lengths (al).

the study enrolled 113 highly myopic patients (202 eyes) who underwent smile surgery at shanghai's tenth people's hospital. patients were classified into three groups based on the axial length before surgery: group a (al \< 26 mm, 62 eyes), group b (26 mm ≤ al \< 27 mm, 88 eyes), and group c (al ≥ 27 mm, 52 eyes). preoperative and postoperative evaluations included uncorrected distance visual acuity (udva), corrected distance visual acuity (cdva), equivalent spherical error(se), and corneal high order aberration. subjective visual quality was assessed using the quality of vision (qov) questionnaire.

Eligibility criteria:
inclusion criteria: * manifest refraction spherical equivalent refraction exceeding -6.00d; * stable myopia for a duration of at least 2 years; * corrected distance visual acuity of at least 20/25; * annual myopic spherical equivalent increment less than - 0.50 d. exclusion criteria: * a history of moderate to severe dry eye as well as any ocular or systemic disease.

Keywords: axial length high myopia smile higher-order aberration visual quality
cryopneumatic device after shoulder surgeries

Conditions: Shoulder Injuries; Shoulder Disease

Summary: this study randomize patients to receive either a cryopneumatic device or standard care (ice and ice packs) following open or arthroscopic shoulder surgeries. the primary objective is to determine the impact of the cryopneumatic device on post-surgery pain management, while secondary objectives are to detemine the effect on pain, patient eperience, quality of life, narcotic consumption and time to stop narcotic usage. patients who do not wish to participate in the randomized portion of the trial will be invited to participate in an observational cohort who will all receive the cryopneumatic device. patients who wish to enter this cohort will not have the device provided to them for free, and will either use their insurance or pay for the device, in order to determine if patients who pay demonstrate different outcomes from the patients receiving the device for free in the rct.


Eligibility criteria:
inclusion criteria: 1. men or women aged 18 years and older; 2. undergoing a unilateral primary or revision shoulder surgery (total shoulder replacement or arthroscopic surgery \[rotator cuff repair, subacromial decompression, bankart repair, latarjet repair, debridement\]). exclusion criteria: 1. patients undergoing bilateral surgery; 2. patients who are pregnant or nursing; 3. patients that do not believe they can comply with the study protocol; 4. patients generally unfit for surgery; 5. patients with specific treatment preferences; 6. patients who are unable to complete questionnaires due to language barriers, decreased mental capacity, neuro-psychological problems; 7. social factors precluding follow-up; 8) inability or unwillingness to provide informed consent.
open-label non-inferiority study evaluating the efficacy and safety of xeomin® in subjects with cervical dystonia flex

Conditions: Cervical Dystonia

Summary: this study will compare xeomin®, a botulinum toxin medication, in shorter treatment intervals (short flex dosing) to the standard interval dosing (long flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. xeomin® is approved by the united states food and drug administration (fda) for the treatment of cervical dystonia (cd). the use of xeomin® is investigational in regards to shorter treatment intervals. an investigational use is one that is not approved by the fda.

dystonia is a movement disorder which is characterized by sustained, involuntary muscle contractions which frequently causes twisting and repetitive movements or abnormal postures of the trunk, neck, face, or arms and legs. in focal dystonia, the abnormal movements involve a single area of the body. a commonly described form of focal dystonia is cervical dystonia (cd). botulinum toxin treatment can be offered as a treatment option for the treatment of cd. the current practice for botulinum toxin injection treatment is to inject patients every 3 months. however, not all patients receive continuing benefit from botulinum toxin injections for an entire 3 months. in a recent survey, approximately 45% of patients report that they would prefer a treatment cycle of less than 10 weeks.this study will compare xeomin®, a botulinum toxin treatment, in shorter treatment intervals (short flex dosing) to the standard interval dosing (long flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. xeomin® is approved by the united states food and drug administration (fda) for the treatment of cd. the use of xeomin® is investigational in regards to shorter treatment intervals. an investigational use is one that is not approved by the fda. the purpose of this research study is to evaluate the efficacy of the short flex dosing of xeomin® compared to the long flex dosing regimen of xeomin®, using a standard scale completed by the doctors and subjects as well as questionnaires that ask subjects to rate symptoms of cd.

Eligibility criteria:
inclusion criteria: * documented clinical diagnosis of idiopathic or genetic cervical dystonia exclusion criteria: * current treatment with botulinum toxin of any type for any other indication (including aesthetic indications) and for any body region during the study.
phase ii study of a b7-1 gene-modified autologous tumor cell vaccine and systemic il-2

Conditions: Kidney Cancer

Summary: rationale: vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. interleukin-2 may stimulate a person's white blood cells to kill cancer cells. combining vaccine therapy with interleukin-2 may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage iv kidney cancer.

objectives: * determine the percentage of patients with stage iv renal cell carcinoma with a reduction in tumor size after treatment with b7-1 gene-modified autologous tumor cell vaccine and interleukin-2. * determine the immunogenicity of this regimen in these patients. * determine the overall survival of patients treated with this regimen. * determine the local and systemic toxicity of this regimen in these patients. outline: tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis. at approximately 3-6 weeks after surgery, patients receive b7-1 gene-modified autologous tumor cell vaccine subcutaneously (sc) once on days 1, 29, and 57. at 6 weeks after the first vaccination, patients receive interleukin-2 (il-2) sc five days a week for 6 weeks (days 43-82). patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity. patients are followed at 3 weeks after the last dose of il-2. projected accrual: approximately 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed stage iv renal cell carcinoma * symptomatic primary tumor or resectable metastasis * measurable disease post resection * no symptomatic brain metastases patient characteristics: age: * 18 and over performance status: * eastern cooperative oncology group (ecog) 0-1 life expectancy: * not specified hematopoietic: * wbc greater than 4,000/mm\^3 * platelet count greater than 100,000/mm\^3 * hemoglobin greater than 10 g/dl * hematocrit greater than 30% hepatic: * bilirubin less than 2 times normal * sgot less than 3 times normal renal: * creatinine less than 1.5 mg/dl or * creatinine clearance greater than 60 ml/min cardiovascular: * no evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no contraindications to surgical resection * no history of immunodeficiency disease * no known allergy to penicillin prior concurrent therapy: biologic therapy: * prior interleukin-2, interferon alfa, or other biologic agent allowed chemotherapy: * not specified endocrine therapy: * no concurrent corticosteroids (except for replacement doses for adrenal insufficiency) radiotherapy: * not specified surgery: * see disease characteristics other: * no concurrent immunosuppressants

Keywords: stage iv renal cell carcinoma