Kornimate/medical-research-clean huggingface dataset:
rbm-007 in treatment naïve exudative age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: this study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of rbm-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular amd. up to 5 subjects will be randomized to receive study medication. study treatment will be administered by intravitreal injections.


Eligibility criteria:
inclusion criteria: • general inclusion criteria: 1. male or female patients, 50 years of age or older at baseline 2. patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits. • ocular inclusion criteria: 3. best corrected visual acuity (bcva) 5 - 73 etdrs letters (20/800-20/40 snellen equivalent), inclusive, in study eye 4. presence of choroidal neovascularization secondary to amd 5. clear ocular media and adequate pupil dilation to permit good quality photographic imaging. exclusion criteria: • general exclusion criteria: 1. females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception. 2. history or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator. 3. participation in any investigational drug or device study within 30 days prior to baseline 4. history or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study. • ocular exclusion criteria: 5. active ocular or periocular infections, malignancy 6. aphakia 7. history of pars plana vitrectomy in the study eye 8. history of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days 9. history of significant ocular disease other than exudative amd that may confound results 10. uncontrolled glaucoma (defined as intraocular pressure \>21mm hg despite treatment with ocular hypotensive medications at baseline).
effect of segmental muscle vibration on upper extremity functional ability post stroke

Conditions: Stroke

Summary: background and objective: upper extremity functional impairments are common consequences post stroke. the aim of this study was to investigate the influence of segmental muscle vibration (smv) application along with supervised physical therapy (spt) on improving activities of daily living (adl) and motor recovery on the hemiparetic upper extremity in patients with stroke. methods: a sample of 37 patients post stroke (29 males) was randomly assigned to either supervised physical therapy (spt) control group (n=18) or supervised physical therapy and segmental muscle vibration (spt-smv) experimental group (n=19). all patients received 3 sessions per week of spt for 8 weeks. the spt-smv experimental group received smv at the end of each spt session. outcome measures used were barthel index (bi), modified ashworth scale (mas), manual muscle testing (mmt), and goniometry for range of motion (rom) assessment.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of stroke exclusion criteria: * if they had any serious orthopedic injury/disease, cardiopulmonary problems or suffered from a neurological disease (other than stroke).
an ex-us study to assess treatment persistence with risankizumab in adult participants with psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: psoriatic arthritis (psa) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. it is caused by an overactive immune system where the body attacks healthy tissue by mistake. this study aims to describe the long term usage and effectiveness with risankizumab (rzb) relative to other advanced therapeutic options for the management of psa in daily clinical practice. risankizumab is an approved drug for the treatment of psoriatic arthritis. the study will not be conducted in the united states, however it will be conducted in approximately 15 countries and include at least 900 and up to 1200 participants with a 2 to1 ratio of participant allocation between participants receiving risankizumab and participants receiving other advanced therapeutic agents. the therapy is prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. all study visits will occur during routine clinical practice and participants will be followed for 24 months. there is expected to be no additional burden for participants in this study.


Eligibility criteria:
inclusion criteria: * participant with a clinical diagnosis of psoriatic arthritis (psa) with symptom onset at least 6 months prior to the screening visit and fulfillment of classification for psoriatic arthritis (caspar) at baseline visit to confirm that the participant has active disease. * participant must have demonstrated an inadequate response to at least 1 disease-modifying antirheumatic drug (dmard) (with max 50% biologic dmard-inadequate response); alternatively, participant must have demonstrated an intolerance to or contraindication for csdmards as determined by the investigator. exclusion criteria: - participants demonstrated an inadequate response to three or more bdmards/targeted synthetic dmards (tsdmards).

Keywords: risankizumab, skyrizi
dry needling for shoulder pain in stroke patients

Conditions: Stroke

Summary: spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. there is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. few data exists on the effects on shoulder pain. in addition, it has been shown that application of dry needling induces post-needling soreness in individuals with musculoskeletal pain. no previous study has investigated the presence and the duration of post-needling soreness in individuals who had experienced a stroke.


Eligibility criteria:
inclusion criteria: * first-ever unilateral stroke; * hemiplegia resulting from stroke; * age between 30 and 60 years old; * presence of hypertonicity in the upper extremity; * pain symptoms in the shoulder * active trigger points in the shoulder muscles reproducing the shoulder pain symptoms exclusion criteria: * recurrent stroke; * absence of active trigger points in the shoulder muscles reproducing shoulder symptoms * previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time; * previous treatment with botulinum toxin-a in the 6 months prior the study; * severe cognitive deficits; * other neurologic diseases, * underlying complex medical conditions, e.g., heart conditions, unstable hypertension, fracture * fear to needles; * any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
quantifying and developing countermeasures for the effect of fatigue-related stressors on automation use and trust during robotic supervisory control

Conditions: Sleep Deprivation

Summary: this project proposes to both develop and test adaptive automation countermeasures for the effects of stressors such as sleep deprivation (sd) on human performance related to robotic tasks, and investigate the relationship between human trust and appropriate use of these countermeasures.


Eligibility criteria:
inclusion criteria: * healthy by history, physical exam, laboratory evaluations of urine and blood, electrocardiogram (ecg), psychological screening, and self-reported sleep quality. * engineering or computer programming experience exclusion criteria: * color blind * pregnant or nursing * using any prescription or non-prescription medications, caffeine, alcohol or tobacco for the three weeks prior to beginning the inpatient experiments
dumping syndrome and esophageal atresia

Conditions: Oesophageal Atresia; Dumping Syndrome

Summary: dumping syndrome (ds) is frequent in oesophageal atresia (29%). in causing hypoglycaemia, it can be dangerous for neonates. mechanisms of ds are actually partialy understood. this is also an affection difficult to diagnose, because it only occurs after meals and can be inconstantly present. to date, their is only symptomatic treatment for ds. this study aims to understand its pathological mechanisms so as to better treat it and avoid its consequences. oesophageal atresia patients enrolled in this study will benefit from a continuous glycemic monitoring, a continuous cardiac monitoring, and an a gastric emptying scintigraphy at the age of 3 months


Eligibility criteria:
inclusion criteria: * patients operated at birth for oesophageal atresia type c * aged from 2 to 3 months at inclusion * off prokinetic treatment (suspended for at least 72 hours) before monitoring exclusion criteria: * history of dumping syndrome of other cause (microgastria, fundoplication, dysautonomia..) * history of any disease that can modify glycemic regulation (hyperinsulinism, neonatal diabete) * treatment that can modify gastric motility

Keywords: oesophageal dysmotility oesophageal atresia post prandial hypoglycaemia gastric emptying troubles
safety and tolerability of varenicline in schizophrenia (satova)

Conditions: Schizophrenia; Schizoaffective; Psychosis

Summary: this is a 15 week trial to determine (1) the safety and tolerability of varenicline when used for smoking cessation/reduction in individuals with schizophrenia; (2) if treatment with varenicline affects the symptoms of schizophrenia.

researchers are looking to recruit a total of 50 subjects at riverview and forensic psychiatric hospitals who would like to reduce or quit smoking cigarettes. this open label pilot study will gather information regarding the safety and tolerability of varenicline in subjects who have been diagnosed with schizophrenia or schizoaffective disorder. consenting subjects will be prescribed varenicline as follows: varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily through week 12. the research team will meet with the subject once a week for twelve weeks and the subject will be interviewed and asked to complete questionnaires about his/her psychiatric symptoms, tobacco use and nicotine dependence. the measures used include the ftnd, panss, cgi-i, cgi-s, esrs, uku, bars, wsws, qsu-brief, mceq, and the oas-m. the cgi-ss will also be completed throughout the study as well as once weekly for three weeks following the completion of the study (post-study follow-up visits 1-3).

Eligibility criteria:
inclusion criteria: * inpatients with a diagnosis of schizophrenia or schizoaffective disorder * individuals between the ages of 19 and 65 years of age * individuals that had smoked 10 cigarette/day or more during the previous year, and had no period of smoking abstinence longer than 3 months in the past year * individuals that are not expected to be discharged from hospital within 4 months. exclusion criteria: * clinically significant allergic reactions to the study medication * clinically significant abnormalities in the screening laboratory values * subjects at significant risk of self-harm * previous treatment with varenicline * women who are pregnant, breast-feeding, or of child-bearing potential not using adequate contraception * men not using adequate contraception * use of medications that might interfere with the study medication evaluation * nicotine replacement * nortriptyline * clonidine

Keywords: smoking cessation schizophrenia schizoaffective psychosis varenicline champix chantix nicotine dependence
dose range study of anamorelin in patients with non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.

cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. anamorelin hcl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. this placebo controlled dose range study will evaluate the safety and efficacy of anamorelin hcl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.

Eligibility criteria:
inclusion criteria: * stage iiib or iv nsclc * eligible for treatment of nsclc with paclitaxel and carboplatin +/- bevacizumab exclusion criteria: * mixed large and small cell histologies for lung cancer * significant obesity, bmi \> 30

Keywords: nsclc
moderate hypofractionated radiotherapy for lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the incidences of grade iii and above radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung cancer treated with moderate hypofractionated (3gy/f) radiotherapy, and their predictors. efficacies are also evaluated.

radiotherapy plays an irreplaceable role in lung cancer. however, due to the long duration of conventional fractionation irradiation, tumor cells will accelerate repopulation after 3 to 4 weeks during radiotherapy, resulting in decreased efficacy. hypofractionated radiation is increasingly used in radiotherapy of lung cancer. it can shorten the overall treatment time, and can potentially reduce the effect of tumor accelerated repopulation. compared with conventional radiotherapy, hypofractionated radiotherapy can theoretically obtain a higher biological effective dose (bed). the application of stereotactic body radiation therapy (sbrt) or stereotactic ablative radiotherapy (sabr) in advanced or central lung cancer is restricted when the tumors are adjacent to important organs. moderate hypofractionated radiotherapy can not only shorten the overall total treatment time, but also reduce the severe toxicities. it is widely used in lung cancer nowadays. however, most data of the tolerated doses for normal tissue and organs comes from conventional radiotherapy. whether or not it is suitable for hypofractionated radiotherapy has not been determined. in our study, the incidences of grade iii and above radiation-reduced esophagitis and radiation-reduced pneumonia, as well as their predictors, were obtained by retrospective analysis of patients received moderate hypofractionated radiotherapy of 3gy/f. at the same time, the efficacies of this scheme are also evaluated.

Eligibility criteria:
inclusion criteria: 1. patients with previously untreated advanced lung cancer were recruited, who were confirmed pathologically or cytologically. 2. the karnofsky performance status (kps) score ≥60. 3. the expected survival time was≥3 months. 4. the laboratory examination results showed a neutrophil count ≥2.0 × 109, a hemoglobin level ≥100 g/l, a platelet count ≥100 × 109, and enough liver and kidney functions. 5. the patients did not show abnormal electrocardiogram (ecg) results. 6. they did not have other combined diseases that required hospitalization. 7. informed consent required before enrollment. exclusion criteria: 1. patients who were pregnant or breastfeeding. 2. patients who had another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years), could not receive concurrent chemotherapy due to medical reasons. 3. superior vena cava syndrome. 4. syndrome and severe lung diseases that affected lung function were excluded.

Keywords: hypofractionated radiotherapy; radiation-reduced esophagitis; radiation-reduced pneumonitis;predictor
accessory joint and neural mobilizations in shoulder after breast cancer surgery. randomized clinical trial.

Conditions: Breast Cancer

Summary: the potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. global kinesitherapy has been shown to be effective at increasing shoulder range of motion restriction. however, literature does not consider specific manual therapy techniques, which means peripheral nerves and articular capsule have not been taken into account. these two tissues are potentially damaged structures during surgery and they are main responsible for shoulder range of motion restriction the main objective of this study is to pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the articular capsule and nerve dysfunctions involvement in shoulder motion restriction.

background: the potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. design: prospective randomized and double-blind pilot trial. objective: to pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the joint capsule and nerve involvement in shoulder motion restriction. participants: 18 women who were undergoing unilateral breast cancer surgery and axillary lymph node dissection. setting: women´s health research group at physical therapy department of university of alcala, madrid, spain. intervention: accessory joint mobilization versus neural mobilization. follow-up: six-month follow-up. key outcomes: range of motion, sensitive disorder, pain and upper limb functionality.

Eligibility criteria:
inclusion criteria: * unilateral breast cancer diagnosis * breast cancer with axillary lymph node dissection * be willing to sign the informed consent form exclusion criteria: * bilateral breast cancer diagnosis * loco-regional recurrence * systemic disease * had not undergone the axillary lymph node dissection approach * to present any contraindication for physical therapy.

Keywords: accessory mobilization, nerve mobilization.
a phase 4, observational field study to evaluate tpoxx in patients with smallpox

Conditions: Smallpox

Summary: phase 4, observational field study in patients treated with tpoxx for smallpox disease

phase 4, observational field study to evaluate safety and clinical benefit of tpoxx (tecovirimat) in patients treated with tpoxx following exposure to variola virus and a clinical diagnosis of smallpox disease.

Eligibility criteria:
inclusion criteria: * able to provide informed consent or assent themselves or through a guardian or legally authorized representative, receiving or initiating treatment with tpoxx, and willing and able to adhere to the recommended procedures in the protocol. * determined, per the clinical definition of smallpox, that the patient presenting with a case of acute, generalized vesicular/pustular rash meets centers for disease control and prevention (cdc) criteria of having confirmed, suspected, or probable smallpox and/or is at high or moderate risk for developing smallpox. * the cdc in coordination with the department of health and human services/assistant secretary for preparedness and response (aspr) has released tpoxx to the physician or designated health authorities for patient treatment, and the cdc has provided physician contact information to ppd, the contract research organization. exclusion criteria: • known allergy to tecovirimat and/or excipients of tpoxx.
respiratory outcomes after early vitamin d supplementation in infants born extremely preterm

Conditions: Prematurity; Extreme

Summary: this is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin d dose recommended during the first 14 days after birth.


Eligibility criteria:
inclusion criteria: * gestational age of 28 weeks or less exclusion criteria: * major congenital anomalies and infants * terminal illness in whom decisions to withhold or limit life support have been made
mediterranean diet and endothelial function

Conditions: Cardiovascular Diseases

Summary: to assess the effect of mediterranean diet and some of its specific components (olive oil, non fried fish and nuts) on endothelial function in overweight and obese patients

abdominal obesity is well known to increase the risk of cardiovascular disease (cvd), since it is commonly associated with hypertension, dyslipidemia, impaired fasting glucose, type 2 diabetes, metabolic syndrome, insulin resistance, systemic inflammation and endothelium dysfunction. abnormal endothelial function, expressed as lower vasodilatation through flow-mediated vasodilatation (fmd) of brachial artery in response to an increase in blood flow, is considered an index of subclinical atherosclerosis, and an early hallmark of cardiovascular disease, with a strong prognostic value for future cardiovascular events. changes in diet, level of physical activity and behavior are well known key elements influence endothelial function. recent studies seem to show that mediterranean diet has beneficial role on cardiovascular risk. it could protect against the development of coronary heart disease also through a possible effect on body weight and obesity. at the best of our knowledge, the effect of mediterranean diet on endothelial function in obese subjects has not been definitely established. therefore, the aim of this study was to evaluate the impact of mediterranean diet on anthropometric parameters (body weight, bmi and waist circumference), lipid profile \[total cholesterol (tc), high density lipoprotein cholesterol (hdl-c), low density lipoprotein cholesterol (ldl-c)\], triglycerides (tg), fasting glucose and endothelium function, evaluated by fmd, in a group of obese and overweight subjects. in particular, subjects were invited to follow a standard mediterranean diet for a short (3 months) or a longer (18 months) period. the specific role of some components of mediterranean diet (olive oil or non fried fish or nuts) was also investigated.

Eligibility criteria:
inclusion criteria: bmi: \> 25.0 kg/m2 age between 18-70 years exclusion criteria: bmi \ 70 years low left ventricular ejection fraction (lvef \< 50%) symptomatic cardiac disease in advanced stage or poorly controlled by medication cerebral disorders major liver and kidney diseases cancer excessive alcohol intake use of drugs addressed to lose weight.

Keywords: mediterranean diet; fmd; obesity; cardiovascular risk.