Kornimate/medical-research-clean huggingface dataset:
use of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives to the management of painful blind eye

Conditions: Blind Painful Eye; Refractory Glaucoma; Control of Pain Through Drug Injection

Summary: the purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of ocular pain in blind eyes.

the management of chronic eye pain is a constant challenge to ophthalmology. treatment varies with the intensity of pain, and topical eye drops and contact lens therapy are effective in many patients. in refractory cases, and without vision, surgical removal of the eye through enucleation is considered classical therapy. as less invasive alternatives we have cyclodestruction and neurolytic drug injection in order to promote analgesia for a prolonged period. the purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of this is a prospective study of patients with blind painful eyes not responsive to topical treatment and with no indication for evisceration seen at the department of ophthalmology, hospital governador celso ramos (hgcr) in 2010.

Eligibility criteria:
inclusion criteria: * patients treated in the period at hgcr who wanted to be part of the protocol by signing the consent form exclusion criteria: * patients whose follow-up period was less than three months

Keywords: triamcinolone chlorpromazine refractory glaucoma blind painful eye
electrical stimulation on erbs palsy infants

Conditions: Erbs Palsy

Summary: this study examined the effect of reciprocal electrical stimulation (res) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in erbs palsy infants. forty infants with erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (a) received standard physical therapy, the study group (b) received traditional physical therapy plus a 15-minute res through elbow flexors and extensors. for three months, interventions were carried out three times each week. the percentage of degeneration and motor function reaction were assessed pre-and post-treatment using electromyography and toronto active motion scale, respectively.

this study examined the effect of reciprocal electrical stimulation (res) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in erbs palsy infants. forty infants with erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (a) received standard physical therapy, the study group (b) received traditional physical therapy plus a 15-minute res through elbow flexors and extensors. for three months, interventions were carried out three times each week. the percentage of reaction of degeneration and motor function were assessed pre-and post-treatment using electromyography and the toronto active motion scale respectively.

Eligibility criteria:
inclusion criteria: * infants with obpi limited to nerve roots c5, c6, with/without involvement of c7, partial lesion as determined by electrophysiological examinations, age between two to five months, and willingness of the infant's family to take part in the study. exclusion criteria: * infants with clavicular or humeral fractures, complete transection of nerve roots, other neurological co-morbidities such cerebral palsy, congenital musculoskeletal deformities, or recommendation against electrical stimulation by the attending neuro-pediatrician.

Keywords: brachial plexus birth injury neuromuscular electrical stimulation active motion electroneurography motor function
evaluating the indego exoskeleton for persons with hemiplegia due to cva

Conditions: Cerebrovascular Accident (CVA); Stroke; Hemiplegia

Summary: the purpose of this study is to evaluate the safety and effectiveness of the indego exoskeleton as a gait training tool for individuals with hemiplegia due to cerebrovascular accident (cva).


Eligibility criteria:
inclusion criteria: * height 5'1" to 6'3" (acceptable height may vary by a few inches depending on femur length) * weight 250 pounds or less * history of one sided ischemic or hemorrhagic stroke with resultant hemiparesis * manual muscle test (mmt) 4/5 in at least upper extremity * no restrictions on time since stroke (acuity), but all subjects need to be cleared by md for locomotor training * no other brain abnormalities or neurological diseases/disorders * has not been diagnosed with more than one stroke * passive range of motion (prom) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait * skin intact where interfaces with indego device * modified ashworth scale (mas) for spasticity 3 or less in the lower extremities * absence of complicating physical or mental conditions as determined by md that would preclude the individual from safely participating in gait training * must be able to follow directions and communicate basic needs, demonstrated by a mini- mental state exam (mmse) score of 18 or greater exclusion criteria: * failure to meet all inclusion criteria * pregnancy * colostomy bag * uncontrolled/untreated hyper- or hypotension
a study of ak119 (anti-cd73 antibody), a treatment for covid-19, in healthy subjects

Conditions: Coronavirus Disease 2019 (COVID-19)

Summary: this is a first-in-human (fih), phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pk and immunogenicity of ak119, a humanized monoclonal antibody targeting the cd73. the study will consist of 4 cohorts of healthy subjects. eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug ak119 (n=6) or matching placebo (n=2). approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.


Eligibility criteria:
inclusion criteria: subjects must meet all the following inclusion criteria (as applicable) to be eligible for participation in this study: * adults between 18 and 55 years of age, inclusive, at screening. * must have a calculated body mass index (bmi, weight \[kg\]/height \[m2\]) within 18.0 to 30.0 kg/m2 (inclusive) at screening, and a total body weight ≥50 kg for men or ≥45 kg for women at screening and day -1 before randomization. * must, in the opinion of the investigator, be in good general health based upon medical history, physical examination (including vital signs), and 12-lead ecg; and clinical laboratory tests (up to 1 repeat permitted) must fall within the clinical laboratory"s reference normal ranges. exclusion criteria: subjects who meet any of the following exclusion criteria will not be enrolled in this study * have a history of latent or active granulomatous infection, including histoplasmosis, candidiasis, or coccidioidomycosis prior to screening, or a history of any other infectious disease within 4 weeks prior to screening that, in the opinion of the investigator, affects the subject"s ability to participate in the study. * have a history of multiple drug allergies or a known allergy or hypersensitivity to any biologic therapy at screening that is important in the opinion of the investigator. * have a known allergy or reaction to any component of the ak119 formulation. * have any known malignancy or have a history of malignancy within the previous 5 years. * have a 12-lead ecg demonstrating qtcf interval \> 450 msec for male subjects and \>470 msec for female subjects at screening and day -1 from average of 3 ecgs obtained after 5 minutes of supine rest. * blood pressure (bp) \>150 mmhg (systolic) or \> 95 mmhg (diastolic) at screening and day -1, following at least 5 minutes of supine rest. * have had a live vaccination within 12 weeks prior to the study dosing or intend to have a live vaccination during the course of the study or have participated in a vaccine clinical study within 12 weeks prior to the study dosing.

Keywords: anti-cd73 immunotherapy
the periviable birth plan

Conditions: Pregnancy, High Risk; Parturition Complication as Antepartum Condition; Anxiety; PTSD; PreTerm Birth

Summary: pregnant women who are at risk of delivering their infants in the periviable period can suffer a large amount of stress and anxiety. moreover, many women feel a loss of control over their own pregnancy. there is some evidence that more counseling and planning can help reduce maternal stress and anxiety. patients at risk of delivering in the periviable period will be randomized to either receive standard counselling or to complete the periviable birth plan.


Eligibility criteria:
inclusion criteria: * 18 years old. * currently pregnant * high risk of pre-term birth in the periviable period 20+0 to 25+6 wga exclusion criteria: * intrauterine fetal demise (prior to admission) * inability to read or communicate in english
effectiveness of the remedrugby program

Conditions: Schizophrenia; Social Cognition; Self Esteem; Empowerment; Recovery

Summary: remedrugby's objective is to strengthen the capacity of users to interact with others in an assertive way and to fight against stigma. it proposes to specifically target the processes of "social cognition". "social cognition" brings together the mental mechanisms that allow everyone to decipher the social situations, emotions and intentions of others and interact with others in the different contexts of everyday life. people with a psychic handicap frequently have difficulties in this area, which has often important consequences for their social and professional integration. the remedrugby program proposes to work specifically on these processes in the context of sport (+ role play and blog) to strengthen the ability to interact with others and to deal with the stigma that can be encountered on a daily basis.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, schizo-affective disorder (dsm-v criteria; apa, 2013). * french mother tongue. * psychotropic treatment unchanged during the month prior to inclusion. * patients who gave their informed consent to participate in the study. * affiliated with a social security scheme or beneficiary of such a scheme * subject suitable for the practice of sport. exclusion criteria: * recent dependence and abuse on cannabis or any other substance (dsm-v criteria), except tobacco. * neurological disorders of vascular, infectious or neurodegenerative origin. * taking of medicinal products with a cerebral or psychic impact (e.g., corticosteroids). * inability to practice sport * pregnancy planned or in progress * simultaneous participation in any other program of remediation of social cognition, training in social skills, self-esteem.
comparison of conventional with sonography assisted breast surgery

Conditions: Breast Cancer Surgery

Summary: aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse


Eligibility criteria:
inclusion criteria: * 18 to 70 years * female * presurgical validated breast cancer exclusion criteria: * sonographically not defined report * lobular breast cancer * extensive ductal carcinoma in situ
a study comparing denosumab vs. zoledronic acid for the treatment of bone metastases in breast cancer subjects.

Conditions: Bone Metastases

Summary: the purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.


Eligibility criteria:
inclusion criteria: * adults with histologically or cytologically confirmed breast adenocarcinoma * radiographic evidence of at least one bone mets * easter cooperative oncology group status of 0, 1 or 2; * adequate organ function exclusion criteria: * current or prior iv bisphosphonate administration * current or prior oral bisphosphonates for bone mets * life expectancy of less than 6 months

Keywords: fractures compressions bisphosphonates bone metastases breast cancer skeletal radiation surgery to bone
ethnic/racial variations of intracerebral hemorrhage (erich)

Conditions: Intracerebral Hemorrhage

Summary: the purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ich), among caucasians, african americans, and hispanics.


Eligibility criteria:
inclusion criteria: all cases must meet the following eligibility criteria: 1. age 18 years or greater, fulfillment of the criteria for intracerebral hemorrhage 2. resident for at least 6 months within 50 miles of the recruiting center 3. no evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of the hemorrhage 4. ability of the patient or legal representative to provide informed consent exclusion criteria: exclusion criteria: 1. malignancies leading to coagulopathy 2. hemorrhagic transformation of ischemic infarct 3. hemorrhage secondary to dural venous sinus thrombosis

Keywords: intracerebral hemorrhage ich stroke cerebrovascular accident
adjuvant treatment recommendation and oncotype dx® in early breast cancer

Conditions: Breast Cancer

Summary: oncotype dx® is likely to become more widely used in europe as well as in switzerland. the test is currently not reimbursed by the swiss health insurances. the proposed study will investigate to what extent adjuvant treatment recommendations in breast cancer patients with an er-positive tumor, made by swiss tumor boards, are based on conventional factors, and whether the recommendations would change, when rs results from the oncotype dx® test were available. in addition this study approaches the dilemma of adding adjuvant ct to adjuvant endocrine therapy in a systematic fashion. in this study, the st. gallen consensus 2009 (with a minor update from the 2011 consensus, is used to predefine the patients suitable for endocrine therapy or chemo-endocrine therapy. once results of this study are available they may help to better integrate oncotype dx® with other factors. currently, it is unclear how the different factors should be integrated into one recommendation. this study will provide data on the usefulness of this test for the two patient groups which are suitable for hormone therapy only and for those who are considered for hormone plus chemotherapy.


Eligibility criteria:
inclusion criteria: - patients screening criteria 1. ≥ 18 years old female patients. 2. resected primary breast cancer (r0 resection). 3. er-positive breast cancer (defined as at least 10% er-positive malignant cells). 4. her2 negativity by ihc (0 or 1+) or by fish (negative if ratio is ≤ 2.0). 5. pn0 or pn1a (1-3 positive nodes) by sentinel procedure or axillary dissection. all patients matching the screening criteria should be recorded consecutively in the patient screening and enrollment list. patients inclusion criteria for baseline data collection 1. signed informed consent form for participation to the baseline data collection. in addition, the following information must be available from the pathology report: 2. estimation of the pathologic maximum tumor diameter (in mm). 3. results of er positive tumor cells (in %) and of pgr positive tumor cells (in %) of the invasive component. 4. proliferation rate by ki-67 staining (mib-1 antibody) in %. 5. result of modified bloom-richardson-elston (bre) grading (grade 1, 2 or 3). patients eligibility criteria for participation to the study inclusion criteria 1. signed informed consent form for participation to the study sakk 26/10. 2. the patient is considered suitable to receive adjuvant chemotherapy (ie no medical contraindications to chemotherapy). 3. invasive breast cancer tissue is available to prepare 39 sections (35 unstained + 4 h\&e stained slides, thickness of 5 µm). 4. performance status: 0 or 1. exclusion criteria 1. pregnancy 2. bilateral invasive breast cancer 3. ct4 and pt4 tumors. 4. patient with a current psychiatric or medical diagnosis that would interfere with her ability to participate in this study. 5. known metastatic breast cancer (m1).

Keywords: adjuvant treatment recommendation early breast cancer oncotype dx genetic profiling
ultrasonic neuromodulation for treatment of ptsd

Conditions: PTSD

Summary: this study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (ptsd). low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. a well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. the trial will evaluate brain target engagement using magnetic resonance imaging and numerical scales of ptsd, cognitive performance, and mood.


Eligibility criteria:
inclusion criteria: * positive ptsd diagnosis; pcl-5 \> 20 exclusion criteria: * inability to complete mri * suicidal ideation
bicarbonate administration in kidney transplant recipients

Conditions: Kidney Transplant; Complications; Metabolic Acidosis

Summary: metabolic acidosis is associated with vascular endothelial dysfunction and is a common complication in patients who have received a kidney transplant. kidney transplant recipients (ktr) with lower serum bicarbonate levels, even within the normal range, have an increased risk of graft loss and mortality. the investigators propose a prospective, double-blind, randomized, placebo-controlled, 18-week crossover pilot study to examine the effects of sodium bicarbonate on vascular endothelial function, graft function, and cognitive function in 20 ktr patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * kidney transplant received at least 1 year ago * serum bicarbonate 20-26 meq/l on 2 separate measurements (at least 1 day apart) * egfr \>45 ml/min/1.73m2 * blood pressure \<140/90 mm hg prior to randomization * bmi \< 40 kg/m2 (fmd measurements can be inaccurate in severely obese patients). * able to provide consent * stable kidney transplant medication regimen for at least 1 month prior to randomization * stable anti-hypertensive regimen for at least one month prior to randomization * not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin). exclusion criteria: * significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) * uncontrolled hypertension * serum potassium \< 3.3 or ≥ 5.5 meq/l at screening * new york heart association class 3 or 4 heart failure symptoms, known ef ≤30%, or hospital admission for heart failure within the past 3 months · factors judged to limit adherence to interventions * current participation in another research study * pregnancy or planning to become pregnant or currently breastfeeding * chronic use of supplemental oxygen
safety and efficacy of nyx-783 in subjects with post-traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: to evaluate the safety, tolerability, and response profile of nyx-783 in a post-traumatic stress disorder population.

the study will be a 10 to 12-week study, including a 1 to 3-week screening period, followed by a double-blind, randomized, placebo-controlled, parallel-group treatment period, and a 1-week follow-up period. subjects eligible for the study will be randomized to receive either nyx-783 (4-weeks) or placebo (4 or 8-weeks).

Eligibility criteria:
inclusion criteria: * a primary diagnosis of ptsd \[post traumatic stress disorder, according to dsm-5 (diagnostic and statistical manual of mental disorders)\] with the primary traumatic event occurring ≥12 months prior to screening. * pcl-5 (ptsd checklist for dsm-5) ≥38 at screening. * caps-5 (clinician-administered ptsd scale for dsm-5) total score ≥30 at screening. exclusion criteria: * complex ptsd. * trauma focused psychotherapies. * primary traumatic event occurred prior to 2001. * primary traumatic event was followed by further major traumatic life episodes. * other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma) * current use of medications with primarily central nervous system activities * other clinically significant medical histories that may interfere with completing the study.
it-based training in obesity

Conditions: Obesity; Inactivity

Summary: though possibly cost-saving, there is little scientific evidence for the effectiveness and reasonable modality of internet-delivered physical activity interventions in primary prevention. the aim of the study is to compare the influence of different personal and it-based service levels on the activity outcome of obese, sedentary persons to evaluate the minimum level of service necessary for a maximum increase in activity and weight reduction.


Eligibility criteria:
inclusion criteria: * physical activity of less than once per week * body-mass-index 28-35 kg/m2 * age 35-65 * men and women exclusion criteria: * chd * diabetes * other chronic diseases with conditions prohibiting regular physical activity * drug abuse * bmi \ 35 * regular physical activity * pregnancy * mental illness
early advanced weight bearing for peri-articular knee and pilon injuries

Conditions: Distal Femur Fracture; Tibial Plateau Fracture; Distal Tibia Fracture; Pilon Fracture

Summary: the overall objective of this study is to compare outcomes following early advanced weight bearing (eawb) using the alterg antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.


Eligibility criteria:
inclusion criteria: * ages 18-55 * closed or open (gustilo type i, ii or iiia) fractures: distal femur (ao/ota 33b, 33c), tibial plateau (ao/ota 41b, 41c), or distal tibia/pilon (ao/ota 43b, 43c) * definitively treated with a plate * ambulatory prior to injury * able to participate in rehab starting 28 days after definitive fixation * meets alterg requirements (4'8- 6'4; 85-400lbs) exclusion criteria: * medical or psychological disease that would preclude safe functional testing (e.g., severe traumatic brain injury, stroke, heart disease, etc.) * prior joint trauma or disease of the operative extremity that resulted in pain, stiffness, or other limitation to mobility * injury to the contra-lateral limb, upper extremities or axial skeleton that would influence single limb weight-bearing or use of an assistive device * pregnancy * unable to speak english * severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have documented psychiatric disorders). * unable to provide informed consent.

Keywords: anti-gravity
effect of tranexamic acid on prevention of recurrence of hemoptysis

Conditions: Hemoptysis

Summary: hemoptysis is one of the serious complication of many pulmonary diseases. upto now, there is no proven medical treatment in recurrence of hemoptysis. the investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.


Eligibility criteria:
inclusion criteria: * age: \>=20 and \<=75 * er visit or admission for hemoptysis * no evidence of hemoptysis on screening exclusion criteria: * anticoagulation treatment * cr \>= 2.0 mg/dl or urinary protein \>= 2+ or who received renal replacement treatment * hepatic failure: total bilirubin \>= 1.5 mg/dl or ast or alt \>= 1.5 of upper normal limit level * hypersensitivity to tranexamic acid * pregnant woman * fertile female who don't use contraception

Keywords: hemoptysis recurrence