Kornimate/medical-research-clean huggingface dataset:
trial of efficacy and safety of sirolimus in tuberous sclerosis and lam

Conditions: Tuberous Sclerosis; Lymphangioleiomyomatosis

Summary: the purpose of this study is to determine the safety and efficacy of the mtor inhibitor sirolimus as a treatment for renal angiomyolipomas in patients with tyberous sclerosis complex or sporadic lymphangioleiomyomatosis.

inherited mutations of the tsc1 or tsc2 gene cause tuberous sclerosis while acquired (somatic) mutations of either gene are associated with sporadic lymphangioleiomyomatosis (lam). renal angiomyolipomas are a feature of both disorders. tsc1 and tsc2 regulate signalling through the mammalian target of rapamycin (mtor) pathway. inhibition of mtor may result in a decrease in size of tsc 1/2 assciated lesions. we are treating patients with tuberous sclerosis or sporadic lam with the mtor inhibitor rapamycin in a non-randomised, open label pilot study of safety and efficacy. change in size of renal angiomyolipomas is the primary end point

Eligibility criteria:
inclusion criteria: * if female, documentation of negative pregnancy test prior to enrolment. * participants, including males, must use an effective form of contraception, whilst taking sirolimus and for twelve weeks after stopping the drug * one or more renal angiomyolipomata of at least two centimetres or greater in largest diameter * adequate renal function :glomerular filtration rate \> 40 ml/min * clinically definite diagnosis of tuberous sclerosis (modified gomez criteria) or sporadic lam (biopsy-proven or compatible high resolution chest ct scan and respiratory function tests.) * signed and dated informed consent exclusion criteria: * history of non-compliance or inability to give informed consent * significant haematological or hepatic abnormality (i.e. transaminase levels \> 150 i.u./l serum albumin \< 30 g/l, haematocrit\< 30%, platelets \< 100,000/ mm3, adjusted absolute neutrophil count \< 1,500/mm3, total wbc \< 3,000/ mm3) * greater than 1 g proteinuria daily * multiple bilateral amls, where individual lesions cannot be distinguished * renal haemorrhage within preceding year * in those who have had a renal haemorrhage, known conservatively managed renal aneurysm(s) greater than 10mm * patients who have had embolisation for aml(s) within the preceding 6 months * patients who are unable to walk 100 metres on the flat * continuous requirement for supplemental oxygen * patients who have had or are being considered for organ transplant * uncontrolled hyperlipidaemia * intercurrent infection at initiation of sirolimus * surgery within last 2 months * pregnant or lactating women * use of an investigational drug within the last 30 days * change in anti epileptic drug medication within the last 3 months * likely to need vaccination e.g. for travel during the course of the trial (except for influenza vaccine in patients with lam) * current usage of strong inhibitors of cyp3ae ( such as ketoconazole, voriconazole, itraconazole, tilithromycin or clarithromycin) or strong inducers (such as rifampicin or rifabutin)

Keywords: tuberous sclerosis lymphangioleiomyomatosis sirolimus angiomyolioma rapamycin mtor
a phase 2a open-label study to evaluate the efficacy and safety of morf-057 in adults with uc

Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative

Summary: this is an open-label, single arm, multicenter, phase 2a study evaluating the efficacy, safety, and tolerability of morf-057 in adult patients with moderately to severely active ulcerative colitis (uc)

the main part of this phase 2a study will consist of 3 study periods: a screening period, a treatment period and a safety follow-up period. all participants who complete the open-label treatment period will have the opportunity to continue their treatment in an optional 26-week long-term extension study after completing the week 52 assessments.

Eligibility criteria:
inclusion criteria: * has signs/symptoms of moderately to severely active uc for at least 3 months prior to screening * has evidence of uc extending at least 15 cm from the anal verge * is bio-naïve or had an inadequate response, loss of response, or intolerance to other uc drugs * agrees to abide by the study guidelines and requirements * capable of giving signed informed consent exclusion criteria: * diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or crohn's disease or has clinical findings suggestive of crohn's disease * has positive findings on a subjective neurological screening questionnaire * has a concurrent, clinically significant, serious, unstable comorbidity * primary non-responder to vedolizumab or other integrin inhibitors * participation in any other interventional study or received any investigational therapy within 30 days * previous exposure to morf-057 and/or a known hypersensitivity to drugs with a similar mechanism to morf-057 * unable to attend study visits or comply with study procedures

Keywords: ulcerative colitis (uc) inflammatory bowel disease (ibd) a4b7 moderately to severely active ulcerative colitis integrin
the effect of hpv vaccination on recurrence rates in hiv patients with condylomata

Conditions: HIV Positive; Anal Condylomata; Anal Warts; HIV Infections

Summary: the primary objective of this pilot study is to evaluate the effect of the hpv vaccine gardasil on anal condylomata recurrence and persistence rates in hiv positive patients.

a quadrivalent human papilloma virus (hpv) vaccine called gardasil had recently (at start of study) been developed and approved by the fda for the prevention of cervical hpv infection and cervical cancer, which is associated with infection from this virus. it is unknown whether the same vaccine could also be of benefit in treating anogenital warts, which are caused by the same virus. this is an important and clinically relevant question which needs to be answered. anal warts have a high prevalence and recurrence and usually require extended lengths of treatment and follow-up, especially in the hiv population. at times, treatment of anal warts requires multiple surgeries to excise them if the burden of disease is high. therefore, this disease represents a significant expense to patients and the health care system. further, the hpv virus that causes anal warts has been associated with anal cancer and with its preliminary lesion known as anal intraepithelial neoplasia (ain). this study touches on two important, relevant and costly healthcare issues: finding a better treatment for the most common sexually transmitted disease in our country, and helping to prevent anal cancer, which is often a fatal disease.

Eligibility criteria:
inclusion criteria: * ≥18 years of age; * hiv positive status; * cd4 \> 200 and viral rna \ 350 if not on harrt; * the presence of anal warts that require surgical excision/ablation. exclusion criteria: * cd4 \ 400 on haart or cd4 \< 350 and not on haart ; * low burden of anal warts that would not require surgical excision/ablation; * previous vaccinations against hpv or allergic reactions to any vaccine component; * patients who are currently pregnant; * patients with a previous diagnosis of anal cancer; * patients who are incarcerated; * patients who have taken immunomodulators (i.e. interferon, interleukin, corticosteroids, etc.) within the last 90 days; * patients who have had an opportunistic infection in the last 90 days or who have another intercurrent illness that precludes their safe enrollment in this study; * patients who, in the judgment of the investigators, are unlikely to adhere to the protocol, either because of a substance abuse or psychiatric diagnosis, or other factors that would affect compliance; * failure to strictly comply with the vaccination schedule.

Keywords: hiv hpv anal condylomata vaccine hiv positive patients anal condylomata or anal warts
assessment of knowledge, attitude and practice of primary care doctors towards common dermatologic conditions in sudan

Conditions: Dermatological Disorders

Summary: the goal of this observational study is to assess the knowledge, attitude, and practice of primary care physicians regarding the common dermatologic conditions in sudan. the main question it aims to answer is: what is the level of knowledge of primary healthcare doctors regarding common dermatological conditions in sudan? what is the attitude and practice of primary healthcare doctors regarding common dermatological conditions in sudan?

dermatological conditions represent a major global health burden and significant portion of primary healthcare visits. primary healthcare physicians are the backbone of medical care and they are usually the first responders to deal with skin diseases. therefore, it is essential for primary care doctors to possess the sufficient knowledge and the best practice to achieve the best possible outcomes. assessing the knowledge, attitude and practice of doctors will help identify the areas of weakness and address the gaps. our online based cross-sectional study involved primary healthcare doctors across the 18 states of sudan. the study utilized multistage sampling to select the participants to fill the online questionnaire that is intended to assess the knowledge of the participants using a photo quiz, the attitude using likert's scale based assessment and the practice. the study explored the factors which may affect the knowledge attitude and practice of doctors like the age, sex, years of clinical experience, and number of cases seen per day.

Eligibility criteria:
inclusion criteria: * primary care doctors above 23 years of age * work in primary healthcare settings in sudan during the period of the study. exclusion criteria: * doctors less than 23 years of age * not located in sudan * didn't work in primary care facilities

Keywords: dermatological conditions skin disorders attitude knowledge primary care physicians sudan
long term follow-up of patients on children's cancer group protocols- (ccg-ltf1) follow-up data

Conditions: Pediatric Cancers; Oncology

Summary: this protocol is not an independent research study, but rather a means to aggregate children's cancer group protocols that are closed to patient entry for the purpose of collecting current status information on those patients treated under those protocols.

children's cancer group clinical trials are conducted to improve understanding of the biology and treatment of childhood cancers. protocols are developed by expert committees and distributed from the group operations center to the member institutions. before a protocol can be opened to patient accrual at a ccg institution, the protocol, consent form and any activation amendments are reviewed and approved by the local institutional review board qrb). protocols remain open to patient accrual until sufficient evaluable patients have been entered to answer the study questions. during this time, the protocol and any new amendments are reviewed annually by the irb. when the study has been closed to patient accrual it remains open solely for the purpose of collecting life status and occurrence of adverse events. the irb must continue its annual review as long as a patient treated on the protocol is alive and follow-up data are being collected. the ccg long term follow-up protocol (ccg-ltf1) is meant to allow continued collective review of all protocols that meet the following criteria: (a) it is closed to patient accrual, (b) all patients have completed treatment, and (c) there are patients who are alive and being followed. the protocols that meet these criteria will be listed as being aggregated under ccg-ltf1 such that an irb review of ccg-ltf1 will constitute a review of that protocol.

Eligibility criteria:
inclusion criteria: * the patient must have completed anti-cancer treatment according to a ccg protocol, or must have been declared off protocol therapy, but not off study. * the data to be collected on the patient must include only those data that are documented in the medical record or included on the follow-up forms. exclusion criteria: * n/a

Keywords: pediatric cancers oncology
full disclosure observational cardiac rhythm documentation follow-up after surgical atrial fibrillation therapy

Conditions: Atrial Fibrillation

Summary: 24 hour holter monitoring (24hm) is commonly used to assess cardiac rhythm after surgical therapy of atrial fibrillation. this "snapshot" rhythm documentation leaves a large diagnostic window of non recorded atrial arrhythmias and as such a large amount of uncertainty in follow-up result assessment. to improve accuracy of rhythm surveillance thus gaining a more "real-life" scenario of post surgical ablation therapy cardiac rhythm a new insertable cardiac rhythm monitor device (reveal® xt 9525, medtronic inc., minneapolis, mn, usa) with full observational continuous heart rhythm documentation is implanted. in order to verify different follow-up strategies after surgical atrial fibrillation therapy, a comparison of different follow-up scenarios (symptoms, different cardiac documentation devices i.e. ecg and 24 hour holter monitor, at different follow-up time points) is performed intraindividually. thus the reliability of these devices and follow-up strategies to define success after ablation therapy is evaluated.


Eligibility criteria:
inclusion criteria: * patients in atrial fibrillation (af duration \>4 months)being scheduled for cardiac surgery * patients with lone atrial fibrillation being scheduled for surgical af treatment exclusion criteria: * failure to provide informed consent * current participation in another clinical trial * organic cause of atrial fibrillation (hyperthyroidism etc.)

Keywords: heart rhythm surveillance follow-up atrial fibrillation success
using ultrasound to predict response to intraarticular corticosteroids in knee osteoarthritis

Conditions: Osteoarthritis

Summary: a study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. the hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.


Eligibility criteria:
inclusion criteria: * knee pain * diagnosis of osteoarthritis in affected knee exclusion criteria: * intraarticular corticosteroids in affected knee within past three months * primary inflammatory connective tissue disease (ie rheumatoid arthritis) * currently taking oral corticosteroids

Keywords: osteoarthritis knee corticosteroids ultrasound
ear-seizure detection (earsd) study

Conditions: Seizures; Epilepsy

Summary: the proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device (ear-seizure detection device (earsd)) by simultaneous recording with conventional video-eeg (electroencephalogram) on patients with epileptic seizures in the epilepsy monitoring unit of the hospital.

a wearable seizure detection and prediction device (earsd) is worn by patients with epileptic seizures. in this study, the goal is to validate the accuracy of a newly developed portable seizure detection device by examining if the ear-sd device can (1) provide more comfort, (2) be unobtrusive to the subject during daily activities, and (3) be able to provide additional insight on a patients' seizure control.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patients admitted to umass memorial epilepsy monitoring unit (emu) for long term video-eeg monitoring as part of standard care of both focal and generalized epilepsy. 3. willing to wear the wearable device. 4. ability to provide informed consent exclusion criteria: 1. subjects wearing other ear devices such as hearing aids. 2. inability or unwillingness to provide informed consent. 3. irritation of the skin where the device is to be placed. 4. patients with intracranial electrodes placement. 5. prisoners 6. cognitive impaired individuals 7. pregnant women 8. children (age 0-17)

Keywords: seizure detection central nervous system diseases nervous system diseases
evaluation of the informational content of setup verification images for patients receiving breast radiation therapy (anterior epi)

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if an alternative imaging protocol done at the time of radiotherapy treatments for patients with breast cancer can improve accuracy in patient set-up.

accurate patient positioning is critical in radiation therapy. electronic imaging is used to compare a patient's actual treatment position, with that which was planned from an initial ct scan. radiation therapists compare planned and actual images using analysis software to determine if differences are within acceptable tolerances. at the vic, we use 3 different breast imaging protocols depending on the patient set-up and treatment technique. findings from our recent retrospective planning study show that our current electronic imaging protocols miss some clinically significant patient set-up errors, particularly in the medial/lateral direction, and that these errors can be better detected with the use of an anterior image. the purpose of this study is to test these findings prospectively in clinical practice, through the direct comparison of our current protocols with a proposed new protocol, which would include an anterior electronic portal image (epi).

Eligibility criteria:
inclusion criteria: * all patients (male or female) receiving tangential breast/chest wall radiotherapy only, or three or four field breast/chest wall and nodal radiotherapy will be eligible. exclusion criteria: * those patients receiving partial breast treatment, those patients requiring an electron match field, those on another breast cancer radiotherapy trial, those who require radiotherapy using deep inspiration breath hold or multi-field intensity modulated radiotherapy, and all non-breast cancer patients will be excluded.
safety and efficacy of adalimumab in patients with moderate to severely active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis


Eligibility criteria:
inclusion criteria: * subject completed study m02-518 or m02-570 exclusion criteria: * subject prematurely discontinued study m02-518 or m02-570 * female subject who is pregnant or breast-feeding or considering becoming pregnant * subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
studying dna in patients with stage i, stage ii, stage iii, or stage iv ovarian epithelial cancer

Conditions: Ovarian Cancer

Summary: rationale: studying tissue and blood samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients respond to treatment. purpose: this laboratory study is evaluating dna to see how well it predicts response to treatment in patients with stage i, stage ii, stage iii, or stage iv ovarian epithelial cancer.

objectives: * to determine if dna methylation patterns and expression of differentially methylated genes taken before chemotherapy can predict patient outcome with regard to progression-free survival. * to evaluate whether dna methylation can predict response assessed by recist criteria and ca 125 response. * to evaluate the specificity and sensitivity of predicting methylation changes in tumor from the changes at the corresponding cpg islands in plasma. outline: tumor samples are collected at the time of initial laparotomy and blood is drawn prior to surgery for dna methylation and biomarker studies. changes in dna methylation will be examined globally using dna methylation hybridization to microarrays and methylation specific pcr, as well as expression of genes shown to be differentially methylated.

Eligibility criteria:
1. clinically suspected figo stages ic-iv epithelial ovarian cancer that are about to undergo surgery for confirmatory biopsy and attempted cytoreductive surgery 2. given written informed consent 3. female and \>18 years of age

Keywords: stage ic ovarian epithelial cancer stage iia ovarian epithelial cancer stage iib ovarian epithelial cancer stage iic ovarian epithelial cancer stage iiia ovarian epithelial cancer stage iiib ovarian epithelial cancer stage iiic ovarian epithelial cancer stage iv ovarian epithelial cancer
impact of non-invasive brain stimulation, associated with upper limb robot-assisted therapy, on motor recuperation

Conditions: Stroke

Summary: tdcs (transcranial direct current stimulation) and robot assisted therapy (rat) will be used in chronic stroke patients to improve a variety of functions with upper limb.

tdcs and rat will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb. tdcs will be applied in a placebo-controlled, double-blind, randomised fashion. a session of rat will be associated with tdcs/placebo. behavioural data will be collected before and after tdcs, associated with rat.

Eligibility criteria:
inclusion criteria: * stroke with at least slight deficit in upper limb exclusion criteria: * epilepsy * contraindication to tdcs * presence of metal in the head * inability to understand/complete behavioural tasks * chronic intake of alcohol or recreative drugs * major health condition (e.g. terminal renal failure, instable heart failure etc ...) * pregnancy
obtaining and storing standard of care wound biopsies for immediate or future wound-related scientific study

Conditions: Diabetic Foot; Leg Ulcer; Decubitus Ulcer

Summary: the objective of this study protocol is to use wound biopsies that have been obtained during standard of care management for further scientific evaluation after standard evaluation by a pathologist. further imaging and molecular analyses would closely evaluate the presence, architecture, and interaction of wound biofilm and human host tissues.

the criteria for considering a wound biopsy in a given patient are a chronic wound (venous leg ulcer, diabetic foot ulcer, decubitus ulcer) that has been present for over two (2) months and has failed to progress towards healing (less than 20% decrease in size over 2-week period of time). also any suspicious wound in which cancer is strongly considered on a clinical basis should be biopsied immediately without any arbitrary timeline being imposed.

Eligibility criteria:
inclusion criteria: * the subject must have a wound, which requires a biopsy for at least one of the following reasons: * the wound is clinically suspicious (raised fibrotic edges, patchy discoloration of the edges, "invasive appearance", or an appearance substantially different from normal chronic wound appearance). * the wound has been present for over 3 months that has been under standard of care management for at least 1 month and shows no progression towards healing. no progression towards healing is defined as less than 20% reduction in the size of the wound over a 2-week period of time. * the subject must be at least 18 years of age. * the ulcer to be biopsied must be greater than 3 centimeters in area. exclusion criteria: * unacceptable risk of bleeding as determined by the investigator. * medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator. * note: vulnerable populations will not be excluded from the study as they are over represented in the chronic wound population, but care will be taken to explain the study to family members and caretakers and other stakeholders in the subject's care, so that concerned parties are in agreement as to the subject's enrollment in the study.

Keywords: venous leg ulcer