Kornimate/medical-research-clean huggingface dataset:
phase iii trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura

Conditions: Acquired Thrombotic Thrombocytopenic Purpura

Summary: the study was a phase iii, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis


Eligibility criteria:
inclusion criteria: 1. adult male or female ≥ 18 years of age at the time of signing the informed consent form (icf). 2. clinical diagnosis of acquired thrombotic thrombocytopenic purpura (attp) (initial or recurrent), which included thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes). 3. required initiation of daily pe treatment and had received 1 pe treatment prior to randomization 4. others as defined in the protocol exclusion criteria: 1. platelet count ≥100×10e9/l. 2. serum creatinine level \>200 µmol/l in case platelet count is \> 30×10e9/l 3. known other causes of thrombocytopenia 4. congenital ttp (known at the time of study entry). 5. pregnancy or breast-feeding. 6. subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown 7. others as defined in the protocol
home care in allogeneic haematopoietic stem cell transplantation

Conditions: Stem Cell Transplant Complications; Quality of Life; GVH - Graft Versus Host Reaction

Summary: mixed methods study with focus groups interviews and a prospective observational cohort study aimed to investigate the impact of advanced home care on transplant specific outcomes and quality of life in recipients of allogeneic hematopoietic stem cell transplantation

study of advanced home care after allogeneic haematopoietic stem cell transplantation (allo-hsct). the main objective is to investigate the impact of home care on transplant specific variables and quality of life (qol). the main hypothesis is that home care patients will home care patients will have significantly better measured qol than patients receiving in-hospital care during the first 6 weeks after allo-hsct. the study will be conducted as part of routine care at the departement of haematology, oslo university hospital. there are qualitative and quantitative aspects to the study. the qualitative part involves focus groups interviews with patients that have been treated with allo-hsct and have recieved home care and their caregivers. in the prospective observational cohort study data will be collected to compare patients receiving home care and patients treated in-hospital (control group). patients in both groups wil answer the questionnaire eortc qlq-c30 once weekly for 6 weeks. in addition transplant- and treatment-specific variables will be collected and compares between the groups.

Eligibility criteria:
inclusion criteria: * consent competency and written informed consent to participation * age ≥18 * understanding and willing to comply with written and oral instructions in norwegian * planned treatment with allo-hsct * ecog performance status 0-2 * caregiver (age ≥18) present 24 hours a day during the aplastic phase * travelling distance from residence to the hospital must be less than one hour. exclusion criteria: * not meeting inclusion criteria * uncontrolled infection or other medical condtion unsuitable for out patient care
pregabalin trial in hiv neuropathic pain

Conditions: HIV-1 Infection; Neuropathic Pain

Summary: this study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with hiv infection as an extension of another trial that tests the efficacy of pregabalin.

the parent double blind study was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated simultaneously on april 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Eligibility criteria:
inclusion criteria: * subjects who participated in the preceding a0081244 double-blind trial and completed at least through visit 9 of that trial. subjects with painful distal sensory polyneuropathy (dsp) interested in treatment based on investigator's clinical judgment. subjects who had acceptable tolerability of study drug in a0081244. exclusion criteria: * clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. this includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, psychiatric illness, and untreated endocrine disorders. * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. * active acquired immune deficiency syndrome (aids)- defining opportunistic infection (oi) that requires hospitalization.

Keywords: peripheral neuropathic pain pregabalin safety
the influence of raltegravir on pravastatin pharmacokinetics(grappa)

Conditions: HIV Infections

Summary: the purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.

pravastatin is a first choice statin for hiv-infected patients. therefore, raltegravir and pravastatin are expected to be co-administered frequently in hiv-infected patients.since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction. because co-administration will be indicated in many hiv-infected patients, it is essential to investigate this potential interaction.

Eligibility criteria:
inclusion criteria: * subject is at least 18 and not older than 55 years of age. * subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day. * subject has a quetelet index (body mass index) of 18 to 30 kg/m2. * subject is able and willing to sign the informed consent form prior to screening evaluations. * subject is in good age-appropriate health condition. * subject has a normal blood pressure and pulse rate. exclusion criteria: * documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients. * positive hiv test. * positive hepatitis b or c test. * pregnant female or breast-feeding female. * therapy with any drug. * relevant history or presence of pulmonary disorders (especially copd), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders. * fasting triglyceride levels \> 8.0 mmol/l * relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. * history of or current abuse of drugs, alcohol or solvents. * inability to understand the nature and extent of the trial and the procedures required. * participation in a drug trial within 60 days prior to the first dose. * donation of blood within 60 days prior to the first dose. * febrile illness within 3 days before the first dose

Keywords: interaction statins pharmacokinetics
trifecta™ long term follow-up (ltfu) study

Conditions: Aortic Valve Insufficiency; Aortic Valve Regurgitation; Aortic Valve Stenosis; Aortic Valve Incompetence

Summary: the trifecta™ ltfu study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the united states and canada to collect long-term safety and effectiveness data through 10 years after implant of the trifecta™ aortic bioprosthetic valve. the trifecta™ is a tri-leaflet stented pericardial valve designed for supraannular placement in the aortic position. the trifecta™ ltfu study is an extension of the trifecta™ investigational device exemption (ide) study (nct00475709) conducted to support united states food and drug administration (fda) approval of the trifecta™ valve. all trifecta™ ltfu study subjects received trifecta™ valve implants during participation in the trifecta™ ide study and subsequently consented to extended annual follow-up through 10 years under the trifecta™ ltfu protocol.

this clinical study was designed as an extension of the trifecta™ ide study supporting fda approval of the trifecta™ valve. a total of 11 trifecta™ ide study investigational sites in the united states (n=9) and canada (n=2) participated in the trifecta™ ltfu study. study enrollment included 329 subjects implanted from 2007 through 2009 at these 11 sites during the ide study who consented to participate in continued annual follow-up through 10 years post-implant. of these 329 subjects, 140 also participated in the fda-mandated trifecta™ post-approval study (pas, nct01514162) prior to consenting to additional annual follow-up under the trifecta™ ltfu protocol. the remaining 189 subjects entered the trifecta™ ltfu study directly from the trifecta™ ide study. the trifecta™ ltfu study database subsumes all data collected in the 329 participants under the trifecta™ ide and trifecta™ pas protocols and extends these data through 10 years from each subject's original date of implant in the trifecta™ ide study. the trifecta™ ltfu study data thus encompass 10 years of continuous annual post-implant follow-up in the 329 participants as well as their pre-implant baseline visit data. data collected includes adverse events, assessments of heart failure symptoms by new york heart association (nyha) functional classification, and echocardiographic assessments of trifecta™ valve function.

Eligibility criteria:
inclusion criteria: 1. patient currently has a trifecta™ aortic valve that was implanted at one of the u.s. or canadian investigational sites during the trifecta™ ide study. 2. patient met eligibility criteria prior to enrollment in the trifecta™ ide study. 3. patient agrees to complete all required follow-up visits. 4. patient provided written informed consent prior to any study related procedure, as approved by the governing institutional review board (irb) or the ethics committee (ec) of the investigational site. exclusion criteria: 1. patient is currently participating or planning to participate in any other study unless approved by the sponsor.

Keywords: aortic valve heart valve tissue valve bioprosthesis
effect of real-fire training on vascular function

Conditions: Vascular Function; Atherothrombosis

Summary: fire-fighters are at increased risk of death from heart attacks when compared to other emergency service professionals whose jobs involve similar components such as emergency call-outs and shift work. the unique risk to fire-fighters is likely to reflect a combination of factors including extreme physical exertion, mental stress, heat and pollutant exposure. in the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter deaths were classified according to the duty performed during the onset of symptoms or immediately prior to any sudden death. the majority of deaths due to a cardiovascular cause (i.e. heart attack) occurred during fire-suppression whilst this activity represented a relatively small amount of a fire-fighters professional time. fire simulation training centers offer a unique opportunity to assess the heart, blood and blood vessel response to fire suppression in a controlled environment. in this study the investigators will assess healthy career fire-fighters on two occasions: following a fire-suppression training exercise in a purpose built real-fire training center, and following a sedentary period as a control. the investigators will take blood samples to measure platelet activity (platelets are the particles in blood that help blood clot) and will examine how blood clots outside of the body. the investigators will then perform studies placing small needles in the arm to assess blood vessel function following fire suppression. by undertaking this comprehensive assessment of blood, blood vessel and heart function we hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire suppression. the investigators hypothesize that following the fire-suppression exercise firefighters blood will clot more readily and their blood vessels will not relax properly which are two of the main processes in the development of a heart attack.


Eligibility criteria:
inclusion criteria: * non-smoking healthy firefighters exclusion criteria: * current smoker * history of lung or ischaemic heart disease * malignant arrhythmia * systolic blood pressure \>190mmhg or \<100mmhg * renal or hepatic dysfunction * previous history of blood dyscrasia * unable to tolerate the supine position * blood donation within the last 3 months * recent respiratory tract infection within the past 4 weeks * routine medication including aspirin and nsaids

Keywords: firefighters fire-simulation training myocardial infarction endothelial function thrombosis
a study evaluating the efficacy and safety of vismodegib (gdc-0449, hedgehog pathway inhibitor) in patients with advanced basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: this was a phase ii, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (gdc-0449) in patients with advanced basal cell carcinoma. all patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * for patients with metastatic basal cell carcinoma (bcc), histological confirmation of distant bcc metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is response evaluation criteria in solid tumors (recist) measurable using computed tomography (ct) or magnetic resonance imaging (mri). * for patients with locally advanced bcc, histologically confirmed disease that is considered to be inoperable. * for patients with locally advanced bcc, radiotherapy must have been previously administered for their locally advanced bcc, unless radiotherapy is contraindicated or inappropriate. for patients whose locally advanced bcc has been irradiated, disease must have progressed after radiation. * for women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (gdc-0449). * for men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib. exclusion criteria: * prior treatment with vismodegib or other hedgehog pathway inhibitors. * pregnancy or lactation. * life expectancy of \< 12 weeks. * patients with superficial multifocal bcc who may be considered unresectable due to breadth of involvement. * concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy). * recent, current, or planned participation in an experimental drug study. * history of other malignancies within 3 years of the first day of treatment with vismodegib in this study (day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix. * uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.

Keywords: bcc hedgehog pathway inhibitor hedgehog basal cell cancer
voice prosthesis made in porous titanium after total laryngectomy or pharyngolaryngectomy

Conditions: Pharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma

Summary: the benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. this novel application is a step towards resolving the very real problems which still exist in the field today. the functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. the aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions


Eligibility criteria:
inclusion criteria: * age more than 18 * total laryngectomy or pharyngo-larynctomy exclusion criteria: * pregnant women-age less than 18 * major pulmonary bronchitis * major neurological disorders

Keywords: laryngeal or pharyngo-laryngeal's carcinoma, voice prosthesis tracheooesophageal shunt, titanium beads, cellular colonization laryngeal or pharyngo-laryngeal's carcinoma
clinical evaluation of bulk-fill alkasite restoration versus resin modified glass ionomer in adult with class v carious

Conditions: Cervical Lesion

Summary: cention n will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. evaluation of restorations will be done at baseline, six months, and one year according (usphs) criteria.

in this study, class v carious lesions were restored using two different restorative materials either resin modified glass ionomer or cention n restorative materials. this study will be held in the restorative clinic at future university in egypt. patients will be assessed for medical and dental histories first. then an examination of the patients will be done using visual inspection by using a dental mirror and probe. eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, 12 their signature on written informed consents will be obtained. eligible participants will be randomly divided into two groups according to the type of restoration they will be received. the first group (a) will be received resin modified glass ionomer restorative material and the second group (b) will be received cention n restorative materials. each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year. the restorations will be clinically examined according to modified usphs criteria in terms of marginal adaptation, anatomic form, color match, marginal discoloration, secondary caries, postoperative sensitivity and retention. the information that will be obtained will be collected and statistically analyzed

Eligibility criteria:
inclusion criteria: * patients with high caries risk. * patients with poor oral hygiene. * patients with untreated cervical caries lesion. * patient aging ≥18 years. * absence of tooth mobility * absence of abnormal occlusion. * patients with good likelihood of recall availability. exclusion criteria: * patients with cervical caries lesions need crown restoration. * non-vital teeth. * evidence of parafunctional habits. * teeth supporting removable prosthesis. * periapical abscess or fistula. * patients with systemic disease. * patients with xerostomia. * participants with a history of allergy to any component of restorations will be used in the study.
a study to evaluate the efficacy and safety of two dose strengths of dalfampridine extended release tablets.

Conditions: Post-Ischemic Stroke

Summary: the objective of this study is to determine the effect of two dose strengths of dalfampridine-extended release (er) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.

this was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (er) tablets on chronic walking deficits in subjects with post-ischemic stroke.

Eligibility criteria:
inclusion criteria: * clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the investigator, based on review of medical records and physical exam. such deficit was not present prior to the stroke and cannot be attributed primarily to other conditions (e.g. chronic obstructive pulmonary disease, arthritis). evidence of walking deficits is objectively supported by any one of the following findings on clinical examination: 1. obvious slowness of movement assigned primarily to the stroke 2. use of an assistive walking device such as a cane or walker 3. presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction * modified rankin scale score of 1 - 3, regardless of the cause(s) of the disability * sufficient ambulatory ability to independently complete the 2minwt and 10mwt * ≥ 6 months from occurrence of most recent stroke exclusion criteria: * woman who is not surgically sterile or is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product. * woman who is pregnant, breastfeeding, or planning to become pregnant * history of seizures, except simple febrile seizures * moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 ml/minute using the cockcroft-gault equation * suicide attempt within 1 year prior to the screening visit, or severe suicidal ideation within 6 months prior to the screening visit, or subject is at significant risk of suicidal behavior in the opinion of the investigator * previous use of ampyra, dalfampridine, fampridine or 4-aminopyridine (4-ap) * initiation of a serotonin reuptake inhibitor (ssri) within 3 months prior to the screening visit, or any change in dosing regimen within 3 months prior to the screening visit * botulinum toxin use within 2 months prior to the screening visit * orthopedic surgical procedures in any of the extremities within the past 6 months

Keywords: post stroke ischemic stroke
safety and efficacy study of albiglutide in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * bmi 20-45kg/m2 inclusive exclusion criteria: * females who are pregnant, lactating, or \<6 weeks post-partum * chf nyha class iii-iv

Keywords: placebo albiglutide monotherapy diabetes