Kornimate/medical-research-clean huggingface dataset:
evaluating the impact of telehealth-based asd assessments and supports on child and caregiver outcomes

Conditions: Autism Spectrum Disorder

Summary: the overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about asd in their infants. in this study, we will gather exploratory data related to the potential of two telehealth tools: 1) the telehealth evaluation of development for infants (tedi); and 2) "help is in your hands" (hiiyh), a set of video materials and information on interactive strategies parents can use to support their child's communication development. we will recruit families participating in an ongoing study using the tedi (r21 hd100372, pi: talbott) to evaluate infants' behavioral development. as families exit the parent tedi study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (hiiyh) for parents or no additional materials. after 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. when children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.


Eligibility criteria:
inclusion criteria: previous enrollment in the parent r21 project (r21 hd100372, pi: talbott). exclusion criteria: no previous enrollment in the parent r21 project (r21 hd100372, pi: talbott).

Keywords: autism telehealth
open-label, multi-center, phase 1b/2a clinical trial designed to evaluate the safety and efficacy of iontophoretic dexamethasone phosphate ophthalmic solution in patients having undergone cataract surgery with implantation of a posterior chamber intraocular lens (iol)

Conditions: Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal

Summary: to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, egp-437®, using the eyegate® ii drug delivery system (egds) in patients having undergone cataract surgery with implantation of a posterior chamber intraocular lens (iol)

this will be a phase 1b/2a, open-label, multi-site study, in which a total of up to 20 eyes of up to 20 patients will be enrolled. patients having undergone unilateral cataract surgery with implantation of a posterior chamber monofocal intraocular lens (iol) who are interested in participating in the study will be provided an informed consent form prior to screening. screening/baseline procedures which include best corrected visual acuity (bcva), slit lamp examination, conjunctival injection, and intraocular pressure (iop) by tonometry will be used to determine eligibility just prior to cataract surgery on day 0. eligible subjects will undergo iontophoresis treatment immediately post-cataract surgery on day 0 and day 7, and will return to the clinic for examination on days 1, 14, and 28.

Eligibility criteria:
inclusion criteria: 1. have undergone unilateral cataract extraction and implantation of a monofocal iol at the time of enrollment 2. age 18 to 85 years 3. receive, understand, and sign a copy of the written informed consent form 4. be able to return for all study visits and willing to comply with all study-related instructions exclusion criteria: -
three-dimensional effects of bracing in adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: this study intends to investigate the three dimensional (3d) effect of bracing on the adolescent idiopathic scoliosis (ais). in particular, it will look at the relationship between frontal deformity correction and changes in the sagittal profile and apical vertebral rotation (avr) during bracing. the investigators hypothesise that if the thoracic frontal deformity can be controlled with bracing, there will be spontaneous correction of the sagittal plane and rotation deformity through coupling.

scoliosis is a 3d deformity of the spine with curvatures occurring in three planes. the efficacy of bracing in correcting the frontal deformity is now well-accepted after the bracing in adolescent idiopathic scoliosis trial (braist). restoration of the sagittal alignment is one of the fundamental goals in scoliosis treatment. the investigators have previously demonstrated on fulcrum bending radiographs that there is coupling between the frontal deformity, thoracic kyphosis and apical vertebral derotation. the investigators' findings suggest that there may be natural coupling of the frontal and sagittal deformities towards "self-normalisation" during correction of the curves. the effect of bracing on the sagittal alignment and 3d deformity in scoliosis is currently not well-understood. if there is a tendency for the natural curve behaviour to return towards a more normal sagittal alignment, then bracing may exert a similar effect on the 3d profile. understanding how the 3d deformity is affected by bracing allows further insight into curve progression and brace effectiveness. few studies in the literature have addressed the sagittal profile and 3d correction by bracing. of those, the findings were based on vertebral reconstructions obtained from ct-scan, finite element analysis modelling, or studying the changes in the rib cage rotation. however, the investigators propose to measure the 3d profile using the modern eos ® system, which allows biplanar radiography and 3d calculations and a more accurate measurement of vertebral wedging.

Eligibility criteria:
inclusion criteria: -diagnosis of lenke type 1 ais who fulfil the normal criteria for bracing exclusion criteria: * if the aetiology of the scoliosis is not idiopathic * does not belong to lenke type 1 * previous treatment with a brace * severe presentation requiring surgical intervention * unavailable for regular follow-up * parents are unable to give informed consent

Keywords: ais
management of cervical intraepithelial neoplasia grade 2

Conditions: Cervical Intraepithelial Neoplasia

Summary: the aim of this study was to compare two management options for cin 2. this randomized clinical trial performed between 2003 and 2006. a series of 90 brazilian women diagnosed as cin2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.

pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy. the researchers purpose was to make some comments about the over treatment and the misclassification of cin 2.

Eligibility criteria:
inclusion criteria: * histological cin2 diagnosis exclusion criteria: * previous cin treatment

Keywords: cin2 management
a south african pilot worksite parenting program to prevent hiv among adolescents

Conditions: Parent-Child Relations

Summary: the investigators hypothesize that participants in the worksite parenting program intervention will show significantly better parent-child communication than will participants in the no-treatment (wait-list) control group.

in south africa, \>5 million people, including many adolescents, are living with hiv. prevalence is increasing throughout south africa, most precipitously in the western cape, the site of our proposed study. the investigators propose to pilot test a multisession worksite-based program to help parents learn how to take an active role in rearing sexually healthy youth. our specific aims are to: (1) culturally adapt our us-developed worksite-based program for parents of adolescents to the south african context; (2) examine whether a worksite-based program for parents of adolescents in south africa improves the parent-child relationship, including general parent-child communication and communication about sexual health and hiv risk-reduction, as perceived by parents and adolescents; (3) explore program effects on parents' hiv testing and sexual behaviors; and (4) explore program effects on theoretically important psychosocial mediators of behavior change (e.g., greater self-efficacy for refusing sex and using condoms, and more perceived disadvantages of unprotected sex). the proposed research is a unique opportunity to adapt and pilot test an innovative hiv prevention intervention that promotes the health of families in a culturally acceptable and sustainable setting. the research is being conducted in three phases. in phase 1, the investigators conducted formative qualitative interviews with south african community members who work with adolescents and parents, who work on hiv prevention, and who hold relevant positions at worksites. the investigators used this information from key community members to culturally adapt the program. in phase 2, the investigators are conducting a process evaluation of one intervention group of 15 parents using qualitative debriefing interviews and quantitative data. in phase 3, the current phase, the investigators aim to conduct a pilot intervention to refine the program even further and test the evaluation methods with 60 xhosa and afrikaans-speaking parents and their 11-15-year-old adolescents (who will participate in the evaluation but not the program). their outcomes will be compared to a wait-list control group of 60 xhosa and afrikaans-speaking parents and their 11-15-year-old adolescents.

Eligibility criteria:
inclusion criteria: * parents: work for city of cape town; are xhosa-speaking or afrikaans-speaking; have a child between the ages of 11-15 (self report); spend at least 3 days/week with their adolescents * children: eligible if they are between the ages of 11-15 (self report) and have a parent or legal guardian who works in the city of cape town who is enrolled in the program.

Keywords: hiv
pre-approval single-patient expanded access for ritlecitinib (pf-06651600)

Conditions: Alopecia Areata

Summary: provide pre-approval single patient expanded access (compassionate use) of ritlecitinib for patients.

in expanded access, treating physicians are the sponsors. expanded access requests from treating physicians may be submitted to www.pfizercares.com. availability will depend on location and country.

Eligibility criteria:
must have ≥ 50% hair loss on scalp due to alopecia areata (aa) and be intolerant or have inadequate response to all commonly used aa therapies accessible in the country. additional eligibility criteria may be required.

Keywords: alopecia areata (aa) alopecia patchy aa alopecia universalis (au) alopecia totalis (at) ophiasis eyelash loss eyebrow loss hair loss
program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack: a multi-site rct

Conditions: Transient Ischemic Attack; Non-disabling Stroke

Summary: the objective of the program of rehabilitative exercise and education to avert vascular events after non-disabling stroke and transient ischemic attack (prevent) trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived nds or tia. one group will receive a comprehensive education and exercise program (prevent); the other group will receive usual care (usual care). we will measure modifiable vascular risk factors in both groups. we will also compare the effects of prevent vs usual care on exercise capacity, walking endurance, and daily physical activity. in addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. finally, we will compare outcomes in urban and rural settings as well as costs of the prevent program and usual care in order to assess sustainability of the prevent program.


Eligibility criteria:
inclusion criteria: * males and females * over 17 years of age. * diagnosis of first probable or definite tia or non-disabling stroke (national institutes of health stroke scale \< 6) * post-event interval of \<90 days. * residence within 75 km of intervention site. * orientation to time, place and person and ability to follow simple 3-step commands. * ability and willingness to provide informed consent. exclusion criteria: * evidence of intracranial hemorrhage on mri or ct scan. * presence of contraindications to exercise testing and training, in accordance with american college of sports medicine guidelines. * participation in another study that could potentially confound the outcomes of this trial.

Keywords: stroke secondary prevention vascular risk behavioral change exercise lifestyle modification
current exercise approaches in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study was conducted to examine the effects of exercises performed with mechanical hippotherapy device and cawthorne-cooksey exercises on balance, dizziness, fatigue and quality of life in patients with multiple sclerosis.

the research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. in order to provide a homogeneous distribution, the patients were divided into two different exercise groups using the double-blind method from the minimization method. the sample of the study consisted of definitively diagnosed multiple sclerosis (ms) patients who volunteered to participate in the study. patients who voluntarily agreed to participate in the study; while they were informed about the aims of the study, the duration of the study, the evaluation methods and the applications to be made, the informed consent form was signed by these patients and their consent was obtained. the study sample was divided into two groups by randomization method. the first group was given 35 minutes of traditional physical therapy program and 15 minutes of exercises with a mechanical hippotherapy device, while the second group was given 15 minutes of cawthorne-cooksey exercises in addition to the 35-minute traditional physical therapy program. both exercise groups were given a 50-minute physical therapy program. patients diagnosed with multiple sclerosis in the study; it was classified according to the expanded disability status scale score. tinetti balance rating scale was used to assess balance. the dizziness disability inventory was used to assess dizziness, the fatigue severity scale and the fatigue impact scale to assess fatigue, and the ferrans \& powers quality of life index ms adaptation to assess quality of life.

Eligibility criteria:
inclusion criteria: * being cooperative and oriented, * being 25 - 64 years * having a definite diagnosis of ms, * being able to sit dependent/independently and stand supported/unsupported, * not having an attack in the last 1 month or not currently in the attack period, * volunteering to participate in the study. exclusion criteria: * having another neurological disease or musculoskeletal system problems in addition to the diagnosis of ms, * being on cortisone treatment in the last 1 month or still ongoing, * having a mental, cardiovascular, pulmonary or orthopedic disease that will prevent exercise.

Keywords: dizziness cawthorne-cooksey hippotherapy simulator balance multiple sclerosis
functional exercise training with adolescents with cerebral palsy

Conditions: Cerebral Palsy

Summary: this cross-over study analyzes a novel and inclusive approach in how therapy for adolescents with cp is administered, with the main goal of examining the effects of a functional exercise intervention on motor capability and motor capacity. it is to investigate the effects of a functional movement-based exercise intervention in a group setting on motor capacity, motor capability and quality of life in adolescents with cp compared to standard therapy.

cerebral palsy (cp) is a permanent disorder which affects the development of movement and posture. it causes activity limitation and is oftentimes accompanied by secondary musculoskeletal problems, disturbances of sensation, perception, cognition, communication and behavior. in regard of the complex interplay between physical restrictions, motor disabilities, sedentary lifestyles and low participation in physical activity, an innovative exercise intervention study for adolescents with cp is intended in order to break the stated vicious cycle. this study aims at providing a novel and inclusive approach in how therapy for adolescents with cp is administered, with the main goal of examining the effects of a functional exercise intervention on motor capability and motor capacity.

Eligibility criteria:
inclusion criteria: * diagnosis of cp. * adolescents between 12 and 18 years of age. * gross motor functional classification system (gmfcs): i-iii. * cognitive abilities must include: ability to actively engage in a training session of 60 min. duration; ability to verbally or non-verbally communicate pain or discomfort; ability to attend training, testing and follow-up sessions. all included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations. exclusion criteria: * any surgery or botulinum toxin treatment within 6 months prior to the start of the study or surgery/serial casting / botulinum toxin injection scheduled during the study period. other medications can be continued as prescribed by the participants' physician. * known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the physical exercise intervention. * uncontrolled seizures or epilepsy

Keywords: adolescents with cerebral palsy functional exercise intervention motor capability motor capacity gross motor function measure (gmfm-66)
effect of ibuprofen sustained release on intraoperative and postoperative pain in mandibular molars

Conditions: Anesthesia

Summary: the study is conducted to evaluate the effect of ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis


Eligibility criteria:
inclusion criteria: 1. systemically healthy patients (asa i or ii). 2. patients with mandibular molar teeth diagnosed with: * pre-operative sharp pain marked on vas scale by reading not less than 6. * vital exaggerated response of pulp tissue to cold pulp tester (ethyl chloride spray) and electric pulp tester. * normal periapical radiographic appearance or slight widening in lamina dura. * positive response and pain provoked by percussion. exclusion criteria: 1. allergy to ibuprofen 2. medically compromised patients having significant systemic disorders. (asa iii or iv). 3. history of intolerance to nsaids. 4. patients with two or more adjacent teeth requiring endodontic treatment. 5. pregnant or nursing females. 6. teeth that have: * periodontal affection (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade i mobility) * no possible restorability.
the impact of torasemide on hemodynamic and neurohormonal stress, and cardiac remodeling in heart failure

Conditions: Heart Failure

Summary: the aim of the study is to compare the effects of torasemide and furosemide on clinical and biochemical parameters of hemodynamic and neurohormonal compensation and myocardial remodeling in patients with chronic heart failure with indications for use of loop diuretics. the study protocol 100 patients with heart failure nyha (new york heart association) ii-iv (stable or exacerbation aligned cardiopulmonary at the time of enrollment, with a fixed-dose loop diuretics\]) treated with optimal medical therapy as clinically indicated for use loop diuretics. patients will be randomized to treatment with furosemide and torasemide (randomization 1 : 1). after randomization, furosemide will continue in its current fixed-dose or will be replaced by equipotential dose of torasemide (4:1). the minimal follow-up of patients in the study will be at least six months.

according to current guidelines, angiotensin converting enzyme inhibitors and beta-adrenolytics are the first-line treatment agents in patients with heart failure. in case of fluid retention, diuretics, as a part of symptomatic treatment, should be administered. in practice, the most common diuretic used in patients with heart failure is loop diuretic - furosemide. what is important, furosemide has no effect on patients' outcomes. some studies showed unfavourable influence of this drug on rennin-angiotensin-aldosterone system. alternative loop diuretic, which may be administered in patients with heart failure is torasemide. its longer elimination half-life time, similar diuretic effects, lower influence on electrolyte disorders and additional pleiotropic effects could make torasemide more beneficial than furosemide. accordingly, only direct comparison of furosemide and torasemide could present similarities and differences of these two agents. the hypothesis of this study is that torasemide may present more favourable effects on some clinical parameters in patients with heart failure, than furosemide (e.g. clinical symptoms, biochemical parameters, activity of rennin-angiotensin-aldosterone system, side effects).

Eligibility criteria:
inclusion criteria: * heart failure nyha ii-iv * previous treatment with diuretics * age\>18 years exclusion criteria: * uncontrolled hypertension * uncontrolled diabetes * creatinine \> 2,5 mg/dl * potassium \> 6 mg/dl * acute coronary syndrome * hypertrophic cardiomyopathy

Keywords: heart failure diuretics furosemide torasemide
study on the quality of life and functional/oncological outcome of testicular cancer patients

Conditions: Testicular Cancer

Summary: the research aims to collect data in order to report the main problems related to the testicular cancer; to reach this aim, this study proposes to create a database of the testicular cancer condition. from this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient.

testicular cancer constitutes 1% to 1.5% of male tumors, 5% of urological tumors. in the western society to which we belong, the incidence is between 3 and 6 new cases per 100,000 inhabitants per year. in particular, this incidence has recorded continuous growth over the last thirty years. different histologies of this disease are known, with a clear prevalence of germ cell tumors (90-95%). from these general epidemiological coordinates it can be deduced that this pathology could affects a young segment of the population; it must be underlined that a pathology is peculiar due to the impact it has on the affected individual, who must be treated not only from an oncological point of view but also with regards to the sexual, reproductive and psychological-relational aspects. such complexity requires a systematic and detailed approach to examine all aspects. the creation of this database let to have a follow up above all an extension over time that is not present in the literature, especially towards the functional aspects of this condition. the database will represent a resource for future research.

Eligibility criteria:
inclusion criteria: * subjects suffering from suspected neoplastic testicular pathology candidates for testicle removal surgery * patients suffering from neoplastic testicular pathology requiring removal of the retroperitoneal lymph nodes * subjects \> 18 years old * subjects with at least elementary education * signature of informed consent exclusion criteria: * subjects \< 18 years * presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol

Keywords: testicular cancer