Kornimate/medical-research-clean huggingface dataset:
a study of oral atogepant tablets to assess adverse events and change in disease activity to prevent migraine in participants aged 12 to 17 years

Conditions: Chronic Migraine

Summary: migraine is a disease that most often causes moderate to severe headache on one side of the head. a migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. the goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. atogepant is a medicine currently approved in the united states and europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. this study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility criteria:
inclusion criteria: * history of chronic migraine with or without aura consistent with a diagnosis according to the international classification of headache disorders, 3rd edition (ichd-3) (2018) for at least 6 months as of visit 1. * during the last 28 days of the screening/baseline period, and as per ediary: * participant must have completed the ediary for a minimum of 20 out of 28 days. * participant has \>= 15 headache days. * participant has \>= 8 migraine days. exclusion criteria: * clinically significant hypertension per investigator's judgment. * history of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.

Keywords: migraine chronic migraine atogepant qulipta aquipta
combining virtual reality and hypnosis to alleviate chronic pain in elderly patients with hand arthritis

Conditions: Arthritis; Arthritis/Arthrosis; Arthritis, Rheumatoid; Elderly

Summary: the goal of this pilot randomized clinical trial is to test the efficacy of an intervention combining virtual reality and hypnosis on decreasing pain and improving quality of life in elderly patients with hand arthritis. the main questions it aims to answer are: * does the intervention allow for an improvement of patient reported outcomes related to pain and quality of life? * does the intervention allow for an improvement of physiological variables related to pain? researchers will compare intervention group to a passive control group (i.e., waiting list with treatment as usual). participants in the intervention group will be provided a virtual reality headset allowing them to beneficiate from the virtual reality and hypnosis modules.


Eligibility criteria:
inclusion criteria: * fluent in french * being diagnosed with hand arthrisis * reporting an invalidating chronic pain in hand related to the condition exclusion criteria: * experiencing a medical condition altering the ability to consent or participate in the study * experiencing cognitive disorders; experiencing sensory disorders (deafness, blindness)

Keywords: virtual reality hypnosis arthritis pain quality of life elderly
safety and tolerability of twp-201 in healthy female subjects

Conditions: Infertility

Summary: this study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase i clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone fc fusion protein injection (twp-201) in healthy female subjects. the objective of the trial is to evaluate the safety and tolerability of twp-201 in healthy female subjects.


Eligibility criteria:
inclusion criteria: * body weight ≥ 45 kg, 19 ≤ body mass index (bmi) ≤ 28 kg /m2; * women with sexual experience, potential fertility and regular menstrual cycle (25-34 days) (including boundary value); * the levels of sex hormones were normal or abnormal without clinical significance at the time of screening; * the physiological structure of uterus and bilateral ovaries was normal or abnormal by ultrasound examination, without clinical significance; exclusion criteria: * known the history of stage iii / iv endometriosis, submucosal myoma and endocrine abnormality within 6 months before enrollment; * known the history of ovarian hyperstimulation syndrome (ohss); * premature ovarian failure, decreased ovarian reserve function (antral follicle counting \< 3), high ovarian response, polycystic ovary syndrome, unexplained vaginal bleeding or endometrial hyperplasia; * any fsh or hmg preparations were used within 3 months before the first study; * pregnancy or lactating women.
the turkish version of the shanghai elbow dysfunction score

Conditions: Elbow Fracture; Stiffness of Elbow, Not Elsewhere Classified; Orthopedic Disorder; Assessment, Self

Summary: the shanghai elbow dysfunction score (sheds) is originally developed in english to evaluate elbow function in patients with elbow stiffness. the purpose of this study is to translate and cross-culturally adapt the sheds instrument into turkish and investigate its psychometric properties.

the shanghai elbow dysfunction score (sheds) is originally developed in english to evaluate joint function in patients with elbow stiffness. the purpose of this study is to translate and cross-culturally adapt the sheds instrument into turkish and investigate its psychometric properties. approximately seventy patients with elbow limitation will be included. for cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. within a 3-to-5-day period after the first assessment, the participants will complete the turkish version of sheds (sheds-t) to evaluate test-retest reliability. cronbach's alpha (α) will use to assess internal consistency. the correlation with the turkish version of the disabilities of the arm, shoulder and hand (dash) questionnaire, the turkish version of mayo elbow performance score, and short form-12 will be determined to check the validity. responsiveness and floor and ceiling effects will be detected.

Eligibility criteria:
inclusion criteria: * aged between 20 and 55 years * elbow fracture in the six months before the study * elbow limitation in flexion or extension * fractures should be managed with surgically * being able to follow simple instructions * being able to read and write in turkish exclusion criteria: * malunion or nonunion fracture * the occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing * non-healing wound or infection * previously received physiotherapy for elbow limitation * having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases * shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity

Keywords: elbow reliability validity function fracture
conservative treatment versus operative plate fixation for acute, displaced fractures of the distal clavicle

Conditions: Clavicle Fracture; Fractures

Summary: this is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (type ii) clavicle fractures.


Eligibility criteria:
inclusion criteria: * men or women aged 16 to 60 years of age * completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (type ii) confirmed by radiograph * fractures within 28 days post injury * provision of informed consent exclusion criteria: * pathological fractures * non-displaced (cortical contact) distal clavicle fractures * open clavicle fractures * presence of vascular injury * fractures more than 28 days post-injury * limited life expectancy due to significant medical co-morbidity * medical contraindication to surgery * inability to comply with rehabilitation or form completion * likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Keywords: clavicle fractures distal
a prospective cohort study of myasthenia gravis

Conditions: Myasthenia Gravis; Myasthenia Gravis Crisis

Summary: the average annual incidence of myasthenia gravis is up to (8.0-20.0) / 100,000 people. myasthenia gravis is an acquired autoimmune disease. all skeletal muscles of patients may be involved. when ocular muscles are involved, ptosis, diplopia and other symptoms may occur. when the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. however, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed. this study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. the purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.


Eligibility criteria:
inclusion criteria: * meeting the diagnosis of myasthenia gravis exclusion criteria: * malignant tumor or other serious chronic disease

Keywords: myasthenia gravis prognostic prediction
emotion regulation group therapy for bipolar disorder

Conditions: Bipolar I Disorder

Summary: psychoeducation has been the only group treatment developed for bipolar disorder thus far. deficits in emotion regulation, a core impairment among patients with bipolar disorder, are not directly addressed in this treatment. the objective of this study is to develop a group treatment for bipolar disorder that focuses on emotion regulation strategies (enhancing emotion regulation; eer). this study will examine the efficacy of this treatment using an open trial design. it is hypothesized that patients who receive eer will show a reduction in mood symptoms and improvement in well-being. reductions in emotion regulation difficulties will predict improvements.


Eligibility criteria:
inclusion criteria: 1. diagnosis of bipolar i disorder. 2. able to provide written informed consent. 3. men or women aged 18-65. 4. able to read and understand english. 5. psychiatrist prescribing mood-stabilizing medication. 6. participates in bimonthly individual psychotherapy exclusion criteria: 1. subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. these patients will be immediately referred to appropriate clinical treatment. 2. history of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as als, parkinson disease and any movement disorders, etc). 3. history or current diagnosis of the following diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months. 4. patients who currently meet criteria for a major depressive episode, a manic episode, or a mixed episode. excluded participants may remain on a waiting list to partake in a future group dependent on mood stabilization. 5. patients who have had electroconvulsive therapy (ect) within the 6 months preceding enrollment.

Keywords: bipolar disorder depression mania emotion regulation dialectical behavior therapy group therapy mindfulness
effect of foot reflexology on blood pressure and pulse rate: a randomized clinical trial

Conditions: Reflexology, Hypertension, Acupressure, Traditional Medicine

Summary: hypertension (ht) has been known for its prominent risk of cardiovascular events. although there are various pharmacological choices, many patients fail to adhere with them. therefore, adjunctive non-pharmacological treatment is a promising approach. foot reflexology is one of a complementary therapies that has been proved for its ability to decrease blood pressure (bp), however, there is limited data in patients with stage-2 ht. we aimed to examine the effectiveness of foot reflexology as adjunctive therapy for bp lowering. this was a single-center randomized clinical trial. hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). foot reflexology was performed in the intervention group during a clinical visit. office bp and pulse rate (pr) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.

background hypertension (ht) has been known for its prominent risk of cardiovascular events. although there are various pharmacological choices, many patients fail to adhere to them. therefore, adjunctive non-pharmacological treatment is a promising approach. foot reflexology is one of the complementary therapies that has been proved for its ability to decrease blood pressure (bp), however, there is limited data in patients with stage-2 ht. objective to examine the effectiveness of foot reflexology as adjunctive therapy for bp lowering. methods this was a single-center randomized clinical trial. hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). foot reflexology was performed in the intervention group during a clinical visit. office bp and pulse rate (pr) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.

Eligibility criteria:
inclusion criteria: * diagnosed stage-2 ht (defined by office sbp≥140 mmhg and/or dbp ≥90 mmhg at first hospital visit) * on stable anti-ht drugs for at least 3 months before enrollment. exclusion criteria: * pregnant women * history of foot surgery or bone fracture * skin disease of the foot * diabetes neuropathy

Keywords: hypertension reflexology acupressure traditional medicine
magnetic resonance imaging (mri) brachytherapy applicator study

Conditions: Cervical Cancer

Summary: the goal of this clinical research study is to learn if computed tomography (ct) and magnetic resonance imaging (mri) images can better help to plan internal radiation treatment.

treatment planning for patients with cervical cancer treated at md anderson is usually performed based on x-ray films taken while the patient is under anesthesia in the operating room. in this study, you will have an mri and ct scan performed after recovering from anesthesia in addition to the standard x-rays. in order to allow mri images to be taken, special mri compatible applicators will be used. the ct and mri images will be reviewed by the doctor in charge of radiation treatment and will also be used for research purposes. study procedures: if you agree to take part in this study, an applicator made of a material that can be used during an mri will be used. you will have a ct scan and an mri scan performed after the implant is placed in the operating room. the ct scan should take about 20 minutes and the mri about 55 minutes. these scans will be performed after you wake up from general anesthesia. pain medicine will be given if you feel any discomfort from the placement of the implant. the additional scans will be used to confirm appropriate placement of the applicator and may result in small adjustments to your radiation treatment plan. length of study: your active participation on this study will be complete once you have the ct and mri scans. your medical record may be reviewed after the scans for the purposes of the study, but you will not be contacted in the future. this is an investigational study. the applicator that best fits your personal anatomy will be used in this study. a selection of mri compatible applicators are available. many of the mri applicators that will be used are fda approved. however, in some cases you may have a novel device with a moveable shield placed. this applicator is not fda approved or commercially available. up to 57 patients will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1) women with stage greater than or equal to ib2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy. exclusion criteria: 1. patient or tumor anatomy that requires use of a non-mri-compatible applicator. 2. patients who require interstitial brachytherapy. 3. patients whose treating physician feels that they require additional 3d imaging at the time of implant based on physical exam or initial findings. 4. patients with implantable cardioverter-defibrillator, pacemaker or other implanted device, which precludes mri acquisition.

Keywords: cervical cancer radiation therapy xrt external beam therapy brachytherapy intracavitary brachytherapy icbt mri compatible intracavitary applicators computed tomography ct magnetic resonance imaging mri mri compatible applicators 3d image guided treatment planning 2d treatment planning
invasive coronary angiography early in ischemic heart failure

Conditions: Acute Heart Failure

Summary: to compare the outcomes of patients with acute heart failure who undergo early coronary angiography vs. usual care


Eligibility criteria:
inclusion criteria: adult patients with acute heart failure, hospitalized in ontario, canada, with evidence of possible ischemic heart disease, defined as at least one of: a) prior myocardial infarction, b) troponin elevation, or c) angina. exclusion criteria: * recent myocardial infarction * coronary angiogram or revascularization within previous 3 months before admission * nonresidents of ontario, invalid health card number * hf diagnosed after admission * admission bnp or nt-probnp not diagnostic of hf * died within 14 days of admission * palliative within 6 months prior to hospital admission * elevated creatinine concentration * documented anaphylactic contrast allergy * ischemic or hemorrhagic stroke within 3 months prior to admission * highest category of hospital frailty risk score * active severe bleeding at time of hospital admission * absolute platelet count \< 20 * metastatic cancer

Keywords: coronary angiography invasive strategy myocardial infarction troponin heart failure
hypertension, ethnicity and exercise trial

Conditions: Hypertension

Summary: the main aim of this study is to investigate the acute effects of a single bout of isometric handgrip exercise (ihg) and a single bout of aerobic endurance exercise (aex) on blood pressure, both immediately after exercise and during the subsequent activities of daily living in patients with high-normal to grade 1 hypertension of south-asian or african descent living in suriname.


Eligibility criteria:
inclusion criteria: * • age 18 - 65 years * patients with high- normal bp (sbp: 130 - 139 mmhg or and dbp: 85 - 89 mmhg) or stage i hypertension (sbp: 140 - 159 mmhg or dbp: 90 - 99 mmhg) according to the esc/esh guidelines \[15\] * asian or african descent * do not meet the level of physical activity recommended by the who based on self-report \[15\] * non-medicated patients or patients using a maximum of 2 antihypertensive drugs exclusion criteria: * • functional or mental limitation limiting the correct execution of an exercise bout * history of ischemic stroke, autonomic neuropathy, cardiovascular, renal, or pulmonary disease by self-report * diabetes type i or ii * pregnancy * the presence of exercise induced signs of myocardial ischemia or complex ventricular arrhythmia during cpet * patients using three or more antihypertensive drugs or patients with resistant hypertension
complex aneurysm registry - real-world evidence data collection intracranial aneurysm treatment devices

Conditions: Aneurysm Cerebral

Summary: to collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available microvention devices used for the endovascular treatment of intracranial aneurysms (ia) at the direction of the treating physician.


Eligibility criteria:
inclusion criteria: 1. patient must have a single ruptured or unruptured ia for which endovascular treatment has been determined appropriate. 2. patient's ia will be treated using a commercially available microvention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the car study and prior to enrollment. note: for the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices. 3. patient or patient 's legally authorized representative (lar) has provided written informed consent prior to treatment or no later than 48 hours post procedure for emergent treatment of a ruptured aneurysm. 4. patient must be considered by the treating physician to be available for and able to complete study follow-up visits. exclusion criteria: 1. target aneurysm has been previously treated via surgical or endovascular means. 2. patient is enrolled in another device or drug study in which participation could confound study results. 3. patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm). 4. patient has been previously enrolled into this study.
developing affective health to improve adherence to health behaviors in diabetes (dahlia ii)

Conditions: Diabetes Mellitus, Type 2

Summary: participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires before, during, and after the 8-week program, as well as at 3 months, 6 months, and 12 months after the end of the program.

participants will be randomly assigned to either the diabetes positive affect skills intervention or a psychoeducation control group. both programs last 8 weeks and take place on a simplified research version of the happify platform. participants assigned to the diabetes positive affect program will have full access to happify, with a track that focuses on building skills for greater happiness, reducing stress, and coping better with diabetes displayed as the feature track. participants assigned to the psychoeducation (control) condition will be asked to complete a series of polls on various wellbeing topics, and then provided with some social comparison data about how their responses compared with the responses of other users, as well as information about why the well being topic is important. participants will be asked to complete questionnaires before, during, and after the 8-week program as well as 3 months, 6 months and 12 months follow-up questionnaires after the program is complete, at which point study participation will end.

Eligibility criteria:
inclusion criteria: * adults with type 2 diabetes * elevated hba1c levels (7 or greater) * no prior experience on the happify platform (new user registration) * phq-8 score of 13 or higher * us resident * under the care of a medical professional for the treatment of their diabetes * be willing and able to obtain hba1c every 3 months exclusion criteria: * none