Kornimate/medical-research-clean huggingface dataset:
a prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of opko's glaucoma drainage device (aquashunttm) in patients with refractory chronic forms of open angle glaucoma (oag)

Conditions: Glaucoma

Summary: a prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of opko's glaucoma drainage device (aquashunttm) in patients with refractory chronic forms of open angle glaucoma (oag). the primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the aquashunttm after implantation in patients with refractory chronic forms of oag


Eligibility criteria:
inclusion criteria: patients of either sex will be eligible for the study if all of the following criteria are met: 1. patients must be aged 18 years or more. 2. patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery. 3. the patient's documented iop must be considered by the treating physician to be too high for their glaucoma status. 4. patients must have bcva of between 20/400 and light perception, or no light perception with pain, in the study eye. 5. patients must have a bcva in the fellow eye, which is better than that of the study eye. 6. patients must be mentally competent and willing to provide informed consent. 7. patients must be willing to return for all study visits and assessments for at least 3 years after surgery. exclusion criteria patients will not be eligible for the study if any of the following criteria are present: 1. patients with a diagnosis of glaucoma other than open angle glaucoma including active uveitic, active neovascular or recent traumatic glaucoma. 2. patients with clinically significant corneal disease including corneal dystrophy. 3. patients with iridocorneal endothelial syndrome. 4. any previous ocular surgery other than trabeculectomy, trabeculoplasty or cataract surgery and any surgery (including laser) within previous 3 months. 5. patients with an anterior chamber configuration that puts the patient at high risk for the development of angle closure glaucoma. 6. patients with any recent (within previous 30 days), or current, ocular/periocular inflammation or infection. 7. patients with a history of extensive keloid formation. 8. patients who will need ancillary procedures in the study eye at the time of implantation or during the initial one year study period. 9. patients who have any known intolerance or hypersensitivity to topical anesthetics, mydriatics or components of the device. 10. patients who are unable to interrupt their anti-coagulant, anti-platelet or nsaid (including aspirin) therapy for at least 3 weeks prior to surgery. 11. patients who have within the previous 3 months, are currently, or intend to participate in a study with any investigational agent (drug or device).

Keywords: refractory chronic forms of open angle glaucoma (oag) oag glaucoma
whole body vibration therapy in participants with ms related balance deficits

Conditions: Multiple Sclerosis

Summary: the purpose of this investigation is to determine the effect of whole body vibration therapy (wbv) on balance in participants with multiple sclerosis (ms) related balance deficits as measured by the neurocom balance master, the sapphire iime emg device and the kurtzke expanded disability status scale (edss) and the berg balance score.


Eligibility criteria:
inclusion criteria: * logan student, staff, or faculty or general public with a minimal of 2 year history of diagnosed multiple sclerosis (ms) exclusion criteria: * visual or vestibular condition that would affect balance * non-ms related systemic illness that would have an adverse effect on balance * local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes * any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates * acute thrombosis * severe migraine, epilepsy * serious cardiovascular disease, wearing a pacemaker * any spinal manipulation within 48 hours * acute disc herniation, discopathy or spondylolysis * prescription or herbal muscle stimulants, relaxants, etc. that could affect balance * any implanted device or prosthesis or intrauterine iud type of device * pregnancy

Keywords: ms balance multiple sclerosis
pharmacokinetic study of sct800 in previously treated patients with hemophilia a

Conditions: Hemophilia A

Summary: participants will be assigned to a or b groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse sct800 followed by xyntha (group a), or the alternate sequence (group b). all participants who completed the sct800ha1 study will enter the efficacy and safety study (protocol no.: sct800ha3).


Eligibility criteria:
inclusion criteria: * 12 to 65 years old; * the activity of the coagulation factor viii (fviii:c) ≤2%, and was previously treated with fviii concentrate(s) for a minimum of 50 exposure days (eds) prior to study entry * non-bleeding state (no clinical manifestations of active hemorrhage); * negative assays for fviii inhibitors (\<0.6 bu/ml); * the platelet count is normal； * normal prothrombin time or inr ≤1.5； * given informed consent exclusion criteria: * hypersensitivity to recombinant coagulation factor viii concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin); * family history or history of fviii inhibitors (≥0.6 bethesda units \[bu\] ml-1); * received an infusion of any fviii for on-demand therapy or prophylaxis within 4 days prior to study entry (including rfviii, plasma-derived factor viii \[pdfviii\], cryoprecipitate and whole blood); * significant hepatic or renal impairment (alt and ast ≥2×uln; bun and cr≥2×uln); * hiv seropositive; * abnormal hemostasis from causes other than hemophilia a； * patients with severe heart disease, including myocardial infarction, heart failure (iii or higher level); * patients who received any anticoagulant or antiplatelet therapy within one week (including nsaids) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials; * alcoholism, drug abuse, mental disorders and mental retardation; * elective surgery planned during the process of study; * patients who previously participated in the other clinical trials prior to study entry; * the patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol; * other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;
integrative approaches for cancer survivorship

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether a four-month manualized ayurvedic intervention will improve quality of life in recent breast cancer survivors.

cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. few effective treatment options exist for these symptoms. integrative medicine is rising in popularity in the united states; however, few integrative medicine modalities have been rigorously studied. ayurveda, a whole system of medicine that originated in the indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. we aim to perform a prospective single arm clinical study of a manualized ayurvedic approach in breast cancer survivors with impaired quality of life. specifically, we aim to develop the manualized ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.

Eligibility criteria:
inclusion criteria: * female breast cancer survivor who is over 1 month and less than 12 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) * having received chemotherapy as part of their primary therapy for breast cancer * be in a complete remission * aged 18 years or older * able to read, write, and understand english * karnofsky performance status (kps) 67 greater than 60. * ability to give informed consent exclusion criteria: * having received ayurvedic treatment within 2 months of study enrollment * receiving chemotherapy or radiotherapy at the time of study enrollment. trastuzumab therapy is not exclusionary. * being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). smaller surgical procedures such as implant exchange are not exclusionary. * patients on adjuvant hormone therapy for less than 1 month

Keywords: breast, cancer, survivorship, integrative, complementary
secondary cardiovascular prevention post-acute myocardial infarction (ami) through a web-based empowerment program

Conditions: Acute Myocardial Infarction

Summary: the aim of this study is to assess the efficacy of an innovative program of secondary cardiovascular prevention focused on patient empowerment. this program will be characterized by a blended interaction between healthcare workers and the patients: first, a face-to-face first encounter in-hospital for risk factors profiling, followed by remote interactions through a digital approach. the digital intervention is targeted at promoting the adoption and retention of virtuous behavior (e.g. smoking cessation, healthy eating habits, physical exercise, regular assumption of pharmacological therapies), improving cardiovascular risk factors control. moreover, an exploratory endpoint will be investigated: the reduction of the residual coronary risk.

the experimental intervention will consist of educational, motivational and coaching actions of patients post-ami through a web based interaction with the prevention team. this intervention will be: 1) personalized (based on a risk factor profile obtained in-hospital) 2) agreed (planned with the patient with shared decision making), 3) multidisciplinary (physician, nutritionist, psychologist, clinical research nurse), 4) blended, composed of a minimal initial interaction face-to-face and periodical reminders (educational, motivational and supportive) for secondary prevention, through email, a reserved website and a chat box. the intervention contents, targeted at patient empowerment, will take the behavioral change models into consideration as a theoretical basis. the participants of both groups will undergo conventional cardiology follow-up visits indicated (at 1- 3-12-36-48 months). blood tests or any other exam other than those indicated by routine clinical practice are not required in this study. patients with diabetes who already wear the abbot freestyle libre® glucose monitoring device will be asked access to device data within two periods of two weeks, before programmed cardiology visits at 1, 3 and 12 months. at 12 months and 48 months-follow-up visits, all participants will be assessed by the atherosclerosis prevention unit, and the lifestyle questionnaires administered at baseline will be repeated. the intervention group will also take a satisfaction survey at 12 months.

Eligibility criteria:
inclusion criteria: * stemi or nstemi * availability of digital communication devices (smart-phone, tablet or personal computer) and internet access exclusion criteria: * active malignancies (except for skin tumors other than melanoma) * life expectancy \<5 years * absolute clinical indication to undergo hospital rehabilitation cycles * cognitive status undermining digital communication devices use, even after proper training * low understanding of italian language, either oral or written, by clinician's judgement * patient not foreseeing to undergo cardiology follow-up at the site

Keywords: acute myocardial infarction secondary prevention atherosclerosis health empowerment
direct referral for apnea monitoring

Conditions: Obstructive Sleep Apnea (OSA)

Summary: the primary objective of this project is to compare a health care delivery model, direct referral for apnea monitoring (dream), with initial in-person (traditional) clinic appointments for veterans at risk for obstructive sleep apnea (osa). a secondary objective is to determine the negative predictive value (npv) of home sleep apnea testing (hsat).

patients referred to one of 3 participating va sleep medicine clinics (san francisco va, va portland or va pittsburgh) for osa will be assigned either to the traditional clinical pathway (which might include an initial encounter with a sleep care provider through in-person visits, telephone clinics, or video conferencing) or the dream pathway which will omit the initial encounter with a care provider. after a clinician conducts a chart review of medical records, patients in the dream pathway will be referred for sleep testing. all patients will be tracked from the time of referral until 90-days past the initiation of treatment. to determine the npv of hsat, results of sleep tests will be compared for patients who undergo both hsat and polysomnographic (psg) procedures. concurrent psg and hsat studies will be done at portland, pittsburgh, and san francisco.

Eligibility criteria:
inclusion criteria: age 18 years agrees to be seen by a va sleep program reason for referral to sleep clinic: new osa evaluation exclusion criteria: age \< 18 years declines to be seen by a va sleep program reason for referral to sleep clinic: anything other than a new osa evaluation

Keywords: sleep apnea syndromes polysomnography home sleep apnea testing
dahanca 28a: phase i/ii study on accelerated, hyperfractionated radiotherapy with concomitant cisplatin and nimorazole

Conditions: HNSCC,Larynx, Pharynx and Oral Cavity

Summary: p16 negative cancers continue to have a dismal prognosis despite advances in the treatment of head and neck cancer. acceleration, dose-escalation, hyperfractionation, chemotherapy and nimorazole has been shown to improve local control. the purpose of the study i to investigate the level of co-morbidity and performance status (ps) that allows the combination of all of the above means of treatment intensification


Eligibility criteria:
inclusion criteria: * squamous cell carcinoma head and neck cancer of the pharynx, larynx and oral cavity * p16 negative * t1-4 * n1-3 * m0 * organ function and performance status allowing radical chemo-radiotherapy exclusion criteria: * none
study to evaluate the efficacy of riluzole in children and young adults with spinal muscular atrophy (sma)

Conditions: SMA

Summary: this is a multicentric, randomized, double-blind study versus placebo, with two parallel groups treated to evaluate the efficacy and the tolerance of riluzole in children and young adults (6 to 20 years of age) with sma. (type ii and type iii).

asiri study should allow to evaluate the efficacy and the tolerance of riluzole in children and young adults (6 to 20 years of age) with sma. this is a multicentric, randomized, double-blind study versus placebo, with two parallel groups treated and followed during 2 years. it has been preceded by a 7 days pharmacokinetic phase, concerning 14 patients, aiming to provide information on the kinetic profile of riluzole in children. the drug could stabilize patients condition, and especially interrupt paralysis progression; those are the desired effects. there is an open-label study of the long term safety of riluzole therapy in spinal muscular atrophies types ii and iii, with patients previously enrolled in asiri double-blind study.

Eligibility criteria:
inclusion criteria: * patients afflicted with spinal muscular atrophy, type ii or iii, with genetic defect confirmed. * age between 6 and 20 years old. * score mfm at least 12 * negative pregnancy test for women of child-bearing age * signing of an informed consent form, after appropriate information has been provided (if the patient is under 18 years old, both parents are required to sign the form too; otherwise, only her (his) agreement is necessary). exclusion criteria: * patients already treated with riluzole * concomitant treatment with: gapapentine, dextromethorphane, amantadine, any hepatotoxic medication that cannot be stopped, any other experimental product * hepatic insufficiency: sgpt and/or sgot levels higher than or equal to twice the normal higher limit * renal insufficiency (creatinine above 115 micromoles/l) * severe cardiac insufficiency * current pneumopathy (clinical signs of an acute episode, confirmed by pulmonary x-ray, requiring specific treatment) * pregnancy or nursing for women; non-abstinence or absence of effective contraception for nubile women * any pathology or other circumstance likely to interfere with a regular follow-up * no affiliation to any social insurance system

Keywords: spinal muscular atrophies (sma) degeneration of the motor neurons anterior horn of the spinal cord riluzole
an rct comparing xenograft and allograft for ridge preservation

Conditions: Tooth Loss

Summary: to compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.

buccal bony wall loss is a common sequela following tooth extraction, and guided bone regeneration (gbr) is a common treatment for the regeneration of ridge form and volume preservation allowing dental implant placement. many bone augmentation biomaterials are employed to accomplish gbr, and both the medical/ dental community and, subsequently, patients benefit from understanding whether a given gbr biomaterial might be more efficacious. to this end, a randomized, case series comparison of allograft + x-linked collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to both the dental community and patients. the study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked collagen membrane with xenograft + non-x-linked collagen membrane for posterior region extraction socket ridge preservation.

Eligibility criteria:
inclusion criteria: 1. subjects 18 to 70-yrs of age 2. subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing) 3. subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket 4. subjects will have read, understood and signed an institutional review board (irb) approved informed consent form (icf). 5. subjects must be able and willing to follow study procedures and instructions. exclusion criteria: 1. subjects with a history of any tobacco use within the last six months. 2. subjects with healing disorders (i.e., diabetes mellitus, cancer, hiv, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. 3. subjects taking intramuscular or intravenous bisphosphonates. 4. subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic. 5. female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration 6. subjects participating in other clinical studies involving therapeutic intervention (either medical or dental). 7. subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
newbie validate: feasibility of a new test to measure glucose in newborn blood spots (nbs)

Conditions: Neonatal Diabetes

Summary: the aim of this feasibility laboratory study is to evaluate whether the laboratory testing pathway for glucose screening in newborn blood spots (nbs) can be done at scale, and that the glucose test has a carefully established cut-off to define what level glucose is abnormal at day 5 of life. the investigators aim to run this feasibility study for a period of 6 to 12 months to fully embed and test the process. this will equate to assessing glucose levels in approximately 10,000 nbs samples. the results from this study will inform a future large scale prospective screening study.


Eligibility criteria:
inclusion criteria: * babies having a routine nbs screening test. * routine maternity care team within the area served by the portsmouth regional screening laboratory (nhs trusts within hampshire, dorset \& parts of wiltshire) exclusion criteria: * parent decides to opt-out of the blood glucose test feasibility study.
effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection

Conditions: Lung Cancer

Summary: the purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. the investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.


Eligibility criteria:
inclusion criteria: * diagnosis confirmed or suspected of lung cancer (either primary or metastatic) * be on the waiting list for lung resection by video-assisted thoracic surgery * present at least one of the next conditions: forced expiratory volume in 1 second (fev1)\ 30 or/and \>80 years old and/or two or more comorbidities (arterial hypertension, chronic obstructive pulmonary disease, coronary disease, diabetes, renal failure and/or cancer. * no smoking at the time of recruitment * signed informed consent exclusion criteria: * chemotherapy or radiotherapy in the previous 6 months before the rehabilitation program. * thoracotomies or pneumonectomies.

Keywords: pulmonary rehabilitation lung cancer resection video-assisted thoracic surgery exercise tolerance quality of life