Kornimate/medical-research-clean huggingface dataset:
what are the clinical factors associated with a significant pain reduction following physiotherapy in patients with temporomandibular disorders?

Conditions: Temporomandibular Disorders

Summary: rationale of the observation study: this study aims to observe which patients with temporomandibular disorder improve more following a physiotherapy program of four sessions. knowing the characteristics of patients who have the most significant improvements could help clinician advise or advise against physiotherapy for the treatment of temporomandibular disorders. study procedures the study will be conducted at the istituto stomatologico italiano. patients diagnosed with temporomandibular disorder will be recruited in the gnathological and neuromuscular gnathological departments. the physiotherapists of the craniomandibular physiotherapy service will perform physiotherapy therapy, which consists of four physiotherapy sessions \[lasting 30 minutes, about once a week\] over a month. before starting the treatment, participants will be asked to answer some questions concerning their state of health (e.g. pain intensity) with particular reference to temporomandibular disorder (e.g. location and duration of pain). the intensity of pain and the level of function will then be monitored at baseline, after 4 weeks and after 8 weeks from baseline. expected benefits from the study and expected benefits for the patient the benefits are the discovery of new knowledge in the field of therapeutic choice for patients with temporomandibular disorder.

additional information: in this study protocol, the variables reported in the section "other pre-specified outcomes" are the predictors that will be included in the prediction model. the total "enrollment" is 180 participants (100 for the development phase and 80 for the validation phase).

Eligibility criteria:
inclusion criteria: * (1) adults aged ≥18 years; * (2) tmd diagnosis according to the axis i of the diagnostic criteria for tmds (dc/tmd) (shiffman et al., 2014); * (3) no therapeutic interventions reported (for their tmd) in the past six months (wahlund et al., 2015); * (4) capacity to use and understand written and verbal italian language; * (5) mental capacity to provide informed consent. exclusion criteria: * (1) tmd pain related to rheumatoid/inflammatory arthritis; * (2) any physical or mental condition that could potentially influence the study; * (3) they commence another treatment for their tmd (pharmacology, oral appliance, others) throughout the duration of the study.

Keywords: temporomandibular joint dysfunction syndrome manual therapy prediction pain
bay1002670, fibroids, safety and efficacy eu,us,can, jap

Conditions: Leiomyoma

Summary: the study is performed to assess the efficacy and safety of different doses of bay1002670 in subjects with uterine fibroids. the dose-response relationship will be evaluated. further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for bay1002670 in subjects with uterine fibroids. to assess the efficacy of bay1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent * diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm * 18 to 50 years of age at the time of screening * heavy menstrual bleeding \>80 ml documented by mp during the bleeding episode following the screening visit * normal or clinically insignificant cervical smear not requiring further follow-up * an endometrial biopsy performed at the screening visit 1 (visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology * use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (visit 1) until the end of the study * good general health (except for findings related to uterine fibroids) exclusion criteria: * pregnancy or lactation * uterine fibroid with largest diameter \>10.0 cm * hypersensitivity to any ingredient of the study drug * laboratory values outside inclusion range before randomization and considered as clinically relevant * hemoglobin values \<6 g/dl or any condition requiring immediate blood transfusion (subjects with hemoglobin values \<10.9 g/dl will receive iron supplementation) * any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug

Keywords: uterine fibroids
posterior capsule opacification (pco) with acrysof single-piece iol

Conditions: Posterior Capsule Opacification

Summary: the purpose of this study what to evaluate if axial myopia might influence the development of pco.

we sought to prospectively compare pco in eyes with myopia in relation to axial length with pco in eyes with normal axial length, to decipher the role of axial myopia in pco 4 years after surgery for senile cataract.

Eligibility criteria:
inclusion criteria: * local residency and presence of a cataract in an otherwise normal eye. * patients older than 50 years * a dilated pupil after mydriasis * patients with retinochoroidal atrophy, retinal laser prophylaxis, * hypertension exclusion criteria: * nondilating pupil after maximal dilation; * pseudoexfoliation; mature, traumatic, black, or complicated cataracts; * previous intraocular surgery; * previous surgery for glaucoma; * uveitis * diabetes mellitus * patients who did not give consent preoperatively

Keywords: pco poco
epi-collect: data collection during video eeg monitoring and at patient's home

Conditions: Epilepsy

Summary: epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. about 0.7-1% of the world population suffers from seizures. the most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. however, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication. in this study eeg and other physiologic signals are collected using wearable sensors, from epilepsy patients who are at risk of experiencing seizures. the collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.


Eligibility criteria:
inclusion criteria: * age \>18 * known diagnosis of epilepsy * expected to experience seizures during the period of the study as determined by the pi. * able to meet with the sponsor representative at home exclusion criteria: * trauma/broken skin on forehead. * patient can not follow or comply with instructions * patients who are unable to independently provide an informed consent * patients with major psychiatric co-morbidities * patients with psychogenic non-epileptic seizures
microaspiration in pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: hypothesis 1: microaspiration, as diagnosed by bronchoalveolar lavage (bal) pepsin, is common in patients with ipf. hypothesis 2a: baseline clinical variables and co-morbid conditions are risk factors for microaspiration in patients with ipf. hypothesis 2b: baseline biological variables reflecting alveolar epithelial injury and inflammation are markers of microaspiration in ipf. hypothesis 3a: microaspiration will lead to a more rapid rate of decline in pulmonary function. hypothesis 3b: microaspiration will lead to higher rates of urgent medical care use (i.e. unscheduled clinic visit, emergency room visit, or hospitalization).


Eligibility criteria:
inclusion criteria: * diagnosis of ipf * ability ot provide informed consent exclusion criteria: * history of fundoplication or other gastroesophageal surgery * too ill to undergo bronchoscopy in the opinion of the investigator
treatment of depression in patients with ptsd

Conditions: PTSD; Depression

Summary: post-traumatic stress disorder is a mental health problem of enormous proportion within the va system for both male and female veterans. the 40 percent of veterans with ptsd and concurrent clinically significant depression are particularly difficult to treat. effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.

background: post-traumatic stress disorder is a mental health problem of enormous proportion within the va system for both male and female veterans. the 40 percent of veterans with ptsd and concurrent clinically significant depression are particularly difficult to treat. effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans. objectives: well-validated treatments of ptsd and its complications are rare. there are no studies of treatment addressing the sequelae of chronic ptsd, including depressive symptomatology. our study is the first randomized, controlled study of group psychosocial interventions for the combination of ptsd and depression in male and female veterans. the purpose of the study is to evaluate the impact of two psychosocial interventions on clinical outcomes and on the use of hospital resources by veterans with these co-existing disorders. methods: male and female veterans with both ptsd and depressive diagnoses will be recruited for the study. male veterans must have combat-related ptsd, and female veterans will have trauma related to sexual assault. veterans will be randomly assigned to either self-management therapy (rehm, 1984), a cognitive-behavioral treatment program for depression, or to a psychoeducational group therapy (dunn, et al., 1998). both programs involve short-term group therapies that teach veterans about their disorders, and provide them with new strategies and skills for overcoming them. these therapy groups will be in addition to other standard care that veterans receive within the trauma recovery program at the houston va medical center. approximately 120 male veterans and 60 female veterans will be enrolled in the program. participants will be assessed at pretest, posttest, and at 3-, 6-, and 12-month follow-up periods, utilizing various clinician-administered and self-report instruments of psychiatric symptomatology, psychosocial functioning, constructs targeted by the therapy groups, treatment compliances, and satisfaction. status: final report preparation.

Eligibility criteria:
inclusion criteria: to be accepted in the study, patients must (a) meet criteria for combat-related (men's cohort) ptsd and either major depressive disorder of dysthymic disorder, (b) not meet criteria for current or past psychosis, score 24 or greater on a mini-mental state examination cognitive screen, (d) not exhibit active suicidality or severity that would preclude participation in the groups, and (e) agree to random assignment and sign informed consent forms. for the women's groups, patients have ptsd related to sexual trauma. exclusion criteria:
sdc for lung cancer patients treated with curative primary or postoperative radiotherapy or chemoradiation

Conditions: Lung Cancer

Summary: introducing standardized data collection (sdc) for lung cancer patients to improve the performance of the prediction models.

all patients planned for curative primary or postoperative radiotherapy can be included. patients will be treated according to the institutional protocol. it is optional to collect a saliva sample for genetic profiling. follow up at five time points: * 2 weeks after rt * 3 months after rt * 6 months after rt * 12 months after rt * 24 months after rt at these time points, toxicity will be assessed. in addition, patients will receive a short questionnaire by mail at eight time points.

Eligibility criteria:
inclusion criteria: * all patients planned for curatively intended radiotherapy or postoperative radiotherapy * recurrent disease exclusion criteria: * all patients planned for palliative radiotherapy
natural history protocol for movement disorders

Conditions: Movement Disorder; Tremor; Parkinson's Disease

Summary: background: a movement disorder is a condition that causes a person s body to move in ways that are not normal. there are different types. some disorders cause movements people can t control, such as tics or shaking. some cause reduced or slow movements. movement disorders can cause disability in people. sometimes members of the same family will have the same disorder. researchers want to learn more about how people develop these disorders. this research could lead to better treatments. objective: this natural history study will collect data on people with different types of movement disorders. it will also collect data on their family members. the data will support further research. eligibility: children and adults aged 2 years and older who have a movement disorder. family members of people with movement disorders are also needed. design: participants will undergo screening. they will have a physical exam. researchers will look at their existing medical images. any photographs or videos of their movements will also be reviewed. most participants will come to the nih clinic for only 1 visit. they will answer questions about their condition. they will have normal tests used to diagnose their condition. they may have blood tests and different types of imaging scans. they may have tests to see how well their nerves function. the tests used will depend on the type of disorder they have. family members will have some of the same tests as people with disorders. participants will not receive any new treatments. some participants may be asked to return for a follow-up visit. up to 4000 people may participate.

study description: this is a natural history and screening protocol for movement disorders, no research procedures will be done but the resulting data will be used for research. objectives: primary objective: to collect data as part of standard of care evaluation of patients who have or are suspected to have a movement disorder and their family members for use in future secondary research. endpoints: collection of data from clinical/routine care that will contribute to/be used for future research.

Eligibility criteria:
* inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged 2 and above * either one of these: * have or suspected to have a diagnosis of a movement disorder. * family member of someone who has or is suspected of having a diagnosis of a movement disorder. * ability of subject or legally authorized representative (lar) to understand and the willingness to sign a written informed consent document. exclusion criteria: an individual who meets the following criteria will be excluded from participation in this study: -being \< 2 years old.

Keywords: movement disorder tremor parkinson's disease natural history
assessment of rosacea patients' clinical trial experiences

Conditions: Rosacea

Summary: taking part in medical trials usually favors a particular demographic group. but there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. this study will admit a wide range of data on the clinical trial experience of rosacea patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future rosacea patients.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * diagnosis of rosacea * ability to understand the study procedures, benefits and risks, and sign a written informed consent document. exclusion criteria: * inability to perform regular electronic reporting * women who are pregnant, intend to become pregnant, or are lactating * enrolled in another research study

Keywords: rosacea
neurogenic dysphonia/dysphagia registry

Conditions: Neurogenic Dysphonia; Neurogenic Dysphagia

Summary: the neurogenic dysphonia/dysphagia registry is designed to be purely observational (i.e. non-interventional, exploratory). patient data collected from the registry is expected to be consistent with any information which can be obtained during usual care of patients with dysphonia/dysphagia treated with vocal fold augmentation.

the neurogenic dysphonia/dysphagia registry is a 510k post-clearance multicenter, observational, open-label registry of the benefits and risks of management and outcomes of patients with neurogenic dysphonia/dysphagia who have received vocal fold augmentation (vfa). enrollment is open to all eligible patients meeting all of the inclusion and none of the exclusion criteria, with a target of 400 patients. up to 100 sites in the us and abroad will be a part of the registry. sites will provide retrospective data for active patients who have undergone vfa within the past 24 months at the site and also begin to prospectively enroll patients who are receiving vfa as a part of their usual care. patients will be followed for up to five years prospectively, until lost to follow-up, or death.

Eligibility criteria:
inclusion criteria: * males and females, ≥18 years of age * diagnosis of neurogenic dysphonia/dysphagia * under active treatment with vfa and follow-up care exclusion criteria: • patients with: * vocal fold scar * laryngeal cancer defect * irradiation to the larynx * laryngeal trauma * end-stage cancer

Keywords: dysphonia dysphagia neurogenic vocal fold augmentation vfa vocal fold insufficiency prolaryn radiesse coaptite voice parkinson's disease multiple sclerosis amyotrophic lateral sclerosis als ms calcium hydroxylapatite hyaluronic acid
the effect of a comprehensive rehabilitation program using robotic walking and functional electrical stimulation technologies on balance and walking in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of this study was to investigate the effect of a comprehensive rehabilitation program using robotic walking and functional electrical stimulation technologies on balance and gait in children with cerebral palsy. this study was planned as a prospective observational study. a total of 30 patients in two groups were planned to be included in the study. patients in both groups were planned to receive a 6-week conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. the case group was planned to consist of patients who received a comprehensive rehabilitation program using high-tech devices including functional electrical stimulation (fes) and robotic rehabilitation applications in addition to the conventional rehabilitation program.


Eligibility criteria:
inclusion criteria: * being between the ages of 2-18 * being diagnosed with cerebral palsy * walking independently with or without an assistive walking device * having a gmfcs score between 1-3 * lack of seizure history * showing consent to participate in the study (signing the informed consent by the legal guardian of the patient) exclusion criteria: * presence of contracture in lower extremities * being administered botulinum toxin within the last one month before treatment or during the 6-week treatment period * being unable to cooperate with clinical assessments
safety and efficacy of azd4547 in combination with fulvestrant vs. fulvestrant alone in er+ breast cancer patients

Conditions: FGFR Inhibition, Pharmacokinetics, Biomarkers; ER+ Breast Cancer

Summary: the purpose of this study is to assess the safety and effectiveness of azd4547 in combination with fulvestrant vs. fulvestrant alone in er+ breast cancer patients with fgfr1 polysomy (fish4/5) or gene amplification (fish 6)


Eligibility criteria:
inclusion criteria: * post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months) * histological confirmation of breast cancer with documented er+ receptor status * safety run-in: relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal ai and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal al * rand phase iia: received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal ai or tamoxifen or a combination of both). chemotherapy administered in the adjuvant setting is permitted. * rand phase iia: mandatory provision of tumour sample to confirm fgfr1 polysomy or gene amplification. at least one measurable lesion that can be accurately assessed by ct/mri/x-ray at baseline and follow up visits exclusion criteria: * prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase iia), or any agent known to inhibit fgfrs. * more than 1 prior regimen of chemotherapy for breast cancer * ecg recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction * history of hypersensitivity to active or inactive excipients of azd4547 or exemestane (safety run-in ) or fulvestrant (randomized phase), including castor oil, or drugs with a similar chemical structure or class to azd4547 or exemestane or fulvestrant. * randomized phase iia: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks

Keywords: breast cancer er+ fgfr1 exemestane azd4547 fulvestrant