Kornimate/medical-research-clean huggingface dataset:
a study to evaluate fixed dose carbidopa/levodopa/entacapone versus immediate release carbidopa/levodopa

Conditions: Parkinson's Disease

Summary: the purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early parkinson's disease (pd) by demonstrating that when used as initial levodopa therapy in early pd, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).

the purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early parkinson's disease (pd) by demonstrating that when used as initial levodopa therapy in early pd, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.

Eligibility criteria:
inclusion criteria: * aged 30 to 80 years, inclusive, at time of parkinson's disease diagnosis * idiopathic parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity * parkinson's disease impairment warranting treatment with a levodopa formulation according to the investigator's assessment exclusion criteria: * history, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases * history of stereotaxic brain surgery for pd (e.g., pallidotomy, deep brain stimulation, tissue transplant) * diagnosis of parkinson's disease for more than 5 years prior to screening * previous use of levodopa in any formulation, entacapone or tolcapone for more than 30 days or anytime within 4 weeks (28 days) prior to baseline * use of a dopamine agonist within 4 weeks (28 days) prior to baseline

Keywords: parkinson's disease, levodopa, dyskinesia
safety and efficacy of triple combination therapy with dorzolamide hydrochloride / brimonidine tartrate / timolol ophthalmic solution in patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will investigate the safety and efficacy of triple combination therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated iop on dorzolamide hydrochloride/timolol maleate combination therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of ocular hypertension or glaucoma in each eye * requires iop-lowering treatment in both eyes exclusion criteria: * use of dorzolamide or carbonic anhydrase within 4 weeks * any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye) * required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted) * use of oral, injectable or topical ophthalmic steroids within 21 days * any eye laser surgery within 3 months * any intraocular surgery (eg cataract surgery) within 6 months
path program for for severely frail or cognitively impaired patients scheduled for cancer surgery.

Conditions: Frailty; Oncology Problem; Cognitive Impairment

Summary: this is a single center, non-blinded randomized control trial taking place at the queen elizabeth ii hospital (qeii) in nova scotia. patients are eligible if aged 75 and older scheduled for elective cancer surgery (proven cancer or highly suspicious cancer) and screened to have mild or greater frailty (with cognitive impairments) or moderate to greater frailty (with medical/physical conditions). eligible participants will then be randomized to preoperative standard of care or geriatric assessment through the path clinic. primary outcome will assess time spend at home at 6 months after the surgery.

at nova scotia health authority (nsha), geriatric medicine colleagues developed a preoperative palliative and therapeutic harmonization (path) clinic with the following objectives: 1. assess medical conditions, health trajectory, and baseline frailty. 2. conduct an in-depth discussion with the patient (or their substitute decision maker) to review medical conditions and how frailty stage impacts decision-making about surgery. 3. co-develop a care plan, including ways to optimize health. the investigators have elaborated a single center randomized cohort trial for patients aged 75 and older, screened as severely frail or cognitively impaired scheduled for curative or palliative-intent surgery for bronchopulmonary, oropharyngeal, orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancers (proven or clinically highly suspicious cancer). patients enrolled in the trial will be randomized to standard of care preoperative assessment versus path geriatric care arm.

Eligibility criteria:
inclusion criteria: 1. patients must have a clinically highly suspicious or pathologically confirmed diagnosis of bronchopulmonary, oropharyngeal (including head and neck surgery), orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancer surgery. 2. patients must be scheduled and consented for curative or palliative intent surgery. 3. patients must be aged 75 or older. 4. patients must be screened by the cfs to have: 4a. mild or greater frailty (cfs equal or greater than 5) due to cognitive impairment. 4b. moderate or greater frailty (cfs equal or greater than 6) due to medical/physical conditions. 5. informed consent for participation must be received. exclusion criteria: 1. patients cannot be a resident in a long-term care facility prior to the cancer diagnosis. 2. urgent/ emergent cases are excluded.

Keywords: frailty cognitive impairment cancer surgery
clinical assessment of all ceramic single-retainer using upper canine as abutment with minimum preparation on the lingual surface, to replace the upper lateral incisor and will be compared with the all ceramic single-retainer using upper central incisor.

Conditions: Survival, Prosthesis

Summary: the intervention will be all ceramic single-retainer resin bonded fixed partial denture using the upper canine as abutment with minimum preparation on the lingual surface within the enamel providing maximum area for the retainer bonding, to replace the upper lateral incisor and will be compared with the control/comparator group which is the all ceramic single-retainer rbfpd using the upper central incisor. the participants in this study will be recruited by the researcher from the clinic of fixed prosthodontics department, clinic of orthodontics department and clinic of diagnosis department, cairo university without any financial or non-financial incentives.

the intervention will be all ceramic single-retainer resin bonded fixed partial denture using the upper canine as abutment with minimum preparation on the lingual surface within the enamel providing maximum area for the retainer bonding, to replace the upper lateral incisor and will be compared with the control/comparator group which is the all ceramic single-retainer rbfpd using the upper central incisor. this intervention will be done by one investigator in all study groups who has master degree in fixed prosthodontics with eight years of experience. the intervention will be carried out in the clinic of the department of fixed prosthodontics, cairo university under supervision of phd holder staff members. the self-adhesive dual cure resin cement will be used for cementation in all groups. in the first session, the participant will be informed about all steps from the beginning to the end. all participants will be encouraged to maintain good oral hygiene and attend the regular follow up visits and in case of any complain related to the investigated restoration.

Eligibility criteria:
inclusion criteria: * patients who have unilateral or bilateral missing upper lateral incisor and need to replace them with the following criteria: * from 14-30 years old and be able to read and sign the informed consent document. * physically and psychologically able to withstand conventional dental procedure * sound or minimally restored abutment with enough enamel surface area for bonding and no periodontal diseases. * if the patient had previously undergone orthodontic treatment, a stabilization period of at least 3 months before impression taking. * good oral hygiene. * able to return for follow-up examinations and evaluation. * no signs and symptoms of bruxism. exclusion criteria: * pregnant women * increased overbite * bruxism, clenching or abnormal habits like nail or pencil biting that create occlusal forces * any developmental anomaly affecting the enamel of upper central incisor or canine * uncontrolled caries and periodontal disease and uncooperative patients. 6- medically unfit for dental treatment and follow up.

Keywords: survival debonding resin bonded retainer
adenoid cystic carcinoma and carbon ion only irradiation

Conditions: Adenoid Cystic Carcinoma

Summary: adenoid cystic tumors are rare tumors of the head and neck region. despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. patients are usually irradiated with photons or, as here at the heidelberg university hospital, with a combination of carbon ions and photons. so far, there is no data from europe available for the sole irradiation with carbon ions. the present acco (adenoid cystic carcinoma and carbon ion only irradiation) study, a prospective, open-label, phase ii, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). in order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenoid cystic carcinoma in the head and neck area * indication for irradiation: * non-operable or * r1/r2 resected or * perineural sheat invasion (pn+) or * pt3/pt4 * informed consent * ki \> 60% or ecog 0/1 (minimum: self-sufficiency, normal activity or work not possible) * age 18-80 years exclusion criteria: * rejection of the study by the patient * patient is not able to consent * stage iv (distant metastases), except lung metastases \< 1cm * lymph node involvement (clinical or pathological) * previous radiotherapy in the head and neck area * active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...) * contraindication to mr imaging * simultaneous participation in another clinical study that could influence the outcome of this study or the other study * pregnancy

Keywords: carbon ion heavy ion salivary gland tumor acc radiation therapy
single center, prospective, randomized, controlled, non-significant risk

Conditions: Dry Eye

Summary: a randomized controlled trial to evaluate the efficiency of serum tears made with genius prp for improving signs and symptoms in dry eye disease (ded). single center, prospective, randomized, controlled, non-significant risk

genius prp is a class ii medical device with an 510(k)fda clearance for platelet and plasma separation for bone graft handling. subjects will sign the ic form within one week of being having been provided the form, at which time they will undergo the following assessments: * routine ophthalmology tests (biomicroscopy, bcva and iop) including corneal fluorescein staining and lissamine green conjunctival staining * measurement of tear break up time (tbut) in both eyes. these values will be used as baseline. * self-administration of the eye dryness scale; 0-100 visual analogue scale. this score will be used as baseline. * self-administration of visual analog pain scale * eligible subjects will be randomized with right eye to receive prp and left eye to receive vehicle eye drops in the same dosage. outcome measures will be assessed in both eyes.

Eligibility criteria:
inclusion criteria: * 1) able to read, understand and sign an informed consent (ic) form 2) 22-85 years of age 3) able and willing to comply with the treatment/follow-up schedule and requirements 4) tear break up time of less than 10 seconds in both eyes 5) spk in the conjunctiva and/or cornea of each eye 6) eye dryness scale of 40 or greater at baseline for each eye 7) self- reported ocular pain from dry eye disease exclusion criteria: 1) unwilling to discontinue use of contact lenses for the duration of the study 2) ocular surgery or eyelid surgery, within 3 months prior to screening 3) neuro-paralysis in the planned treatment area, within 6 months prior to screening 4) other uncontrolled eye disorders affecting the ocular surface, for example active allergies 5) punctal plugs placed within past 90 days 6) pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area 7) uncontrolled infections or uncontrolled immunosuppressive diseases 8) subjects with current ocular infections. 9) new prescription eye drops for dry eye or glaucoma or omega 3 supplements prescribed within 90 days prior to screening, excluding artificial tears 10) new topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management 11) change in dosage of any systemic medication, within 3 months prior to screening 12) anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period 13) legally blind in one or both eyes 14) first ipl treatment, within 3 months prior to screening 15) any condition revealed during the eligibility screening process whereby the investigator deems the subject inappropriate for this study -
stereotactic radiology versus chemotherapy for recurrent/progressive glioblastoma after second-line chemotherapy

Conditions: Recurrent or Progressive Glioblastoma

Summary: this clinical trial is a prospective study of radiosurgery treatment for progressive gbm to test 1)the efficacy of radiosurgery for recurrent/progressive gbm compared to chemotherapy , and 2) the role of diffusion-weighted image (dwi) to predict the early tumor progression and treatment response.


Eligibility criteria:
inclusion criteria: * histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens * initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma * history and physical exam, including neurologic examination, within 4 weeks prior to registration exclusion criteria: • warfarin or lmw heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding

Keywords: glioblastoma
a feasibility study of ketorolac treatment for cachexia in patients with advanced pancreatic ductal adenocarcinoma

Conditions: Pancreas Cancer; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Summary: the purpose of this study is to see if taking ketorolac, a nonsteroidal anti-inflammatory drug (nsaid), is reasonable, safe and can stabilize or increase weight along with quality of life in pancreatic cancer patients.

the main things that will happen in this study are: patients will be administered ketorolac for 5 days, blood draws, completion of questionnaires, monitoring physical activity and sleep by wearing a study-provided fitbit along with weight using a study-provided smart scale.

Eligibility criteria:
inclusion criteria: 1. diagnosis of advanced and refractory pancreatic ductal adenocarcinoma (pdac) referred to cedars-sinai medical center (csmc). 2. cachexia defined as ≥5% weight loss in the presence of chronic illness, within any 6-month period prior to screening or as documented by the medical physician based on standard diagnosis of cachexia. 3. eastern cooperative oncology group (ecog) performance status of ≤ 2 or karnofsky performance status \>50%. 4. patient must have adequate renal function per below lab values: * creatinine or measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or crcl) ≤1.5 × upper limit of normal or ≥30 ml/min for participant with creatinine levels \>1.5 × institutional uln. 5. patient must have access to wifi for the smart scale. exclusion criteria: 1. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator. 2. pregnancy, breastfeeding, or of childbearing potential and not willing to use adequate methods of contraception during the study. 3. has any known allergies or hypersensitivity to the study drug or allergic reactions to surgical steel or elastomer/rubber. 4. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 5. has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 6. concurrent use of any other nsaids while on study. 7. active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding. 8. have suspected or confirmed cerebrovascular bleeding, tendency to bleed or bruise easily, incomplete hemostasis (how you body stops bleeding), and at high risk of bleeding.

Keywords: ketorolac
risedronate for the treatment of osteoporosis for people with spinal cord injury

Conditions: Osteoporosis

Summary: the purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.


Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury of greater than 18 months * osteopenia or osteoporosis of the hip * must be able to swallow tablets and sit upright exclusion criteria: * bilateral heterotopic ossification * bilateral lower extremity metal implants * pregnant or lactating females * paget's disease * osteomalacia * steroid induced bone loss * untreated parathyroid or thyroid disease * symptomatic hypocalcemia or hypophosphatemia * treatment in the last year with calcitonin, fluoride or anabolic steroids * current treatment with prednisone

Keywords: spinal cord injury
effects of cuevas medek exercises children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorders (asds) describe a group of neurodevelopmental conditions in which the individuals face challenges with social engagement. this childhood disorder is characterized by core impairments in social/communication and repetitive behaviors. autism spectrum disorder (asd) is a lifelong disorder that occurs in approximately 1 in 68 children aged 8 years. it is primarily characterized by limited social interaction and communication, restricted interest, and stereotyped or repetitive behaviors. the motor deficits associated with asd can relate to impairments of motor planning and control processes. this randomized clinical trial will recruit the participants through non probability convenience sampling. participants will be randomly divided into 2 groups. two groups of children aged between 2 and 6 years, suffering from autism spectrum disorder, one for control and one for experiment. controlled will get conventional treatment while study group will get conventional treatment with cuevas medak exercises (cme). treatment duration is of 12 weeks. progress will be monitored every month. the frequency of recovery sessions will 3 sessions/week, and the duration of a session will 45 minutes. patient evaluation will be made at the beginning and the end of the treatment through pediatric balance scale and posture and postural ability scale. data will be analyzed through spss 25.

autism spectrum disorders (asds) describe a group of neurodevelopmental conditions in which the individuals face challenges with social engagement. this childhood disorder is characterized by core impairments in social/communication and repetitive behaviours. two groups of children aged between 2 and 6 years, suffering from autism spectrum disorder, one for control and one for experiment. controlled will get conventional treatment while study group will get conventional treatment with cuevas medak exercises (cme). treatment duration is of 12 weeks. progress will be monitored every month. the frequency of recovery sessions will 3 sessions/week, and the duration of a session will 45 minutes. patient evaluation will be made at the beginning and the end of the treatment through pediatric balance scale and posture and postural ability scale. data will be analyzed through spss 25.

Eligibility criteria:
inclusion criteria: * children with medical diagnosis of mild asd diagnosed by cars assessment tool with score ranges from 15 to 30. * children having postural and balance problems with scoring of 8 out of 14 items of pediatric balance scale. * age ranging from 2 to 6 years * parental/caregiver report of difficulty with motor planning, motor skills and/or postural control. * children who will able to follow verbal instruction and participate in exercise program. exclusion criteria: * children with planned surgical or medical surgeries during study period. * severe behavioral problems. * unstable medical condition. * history neurological disorder (seizures, epilepsy)

Keywords: autism spectrum disorder balance cuevas medek exercises(cme)
video-based, patient-focused opioid education in the perioperative period

Conditions: Opioid Use; Chronic Pain Post-Procedural

Summary: this is a pilot study designed to assess the feasibility of using a novel, video-based opioid education tool for opioid naïve ambulatory surgery patients in the perioperative period.

patients will be randomized to a video or no video prior to surgery then administered a phone questionnaire at post-op day 7, 30, and 90. the arkansas prescriptions drug monitoring database will also be accessed for information on opioid prescription refills. the overall goal of the study is to evaluate the effect that video-based opioid education has on narcotic intake after outpatient surgery. the duration of the study will be approximately 3 months, plus a single 1-hour long focus group if desired by the patient.

Eligibility criteria:
inclusion criteria: * men and women 18 years or older * not chronically receiving opioid analgesics * patients who have not taken opioids 30 days pre-operatively * undergoing surgical procedure not requiring overnight hospital stay exclusion criteria: * non-english speaking * legally deaf or blind * on opiate contract * has taken oral narcotic in the past 30 days * unable to operate a telephone