Kornimate/medical-research-clean huggingface dataset:
implementation of out-of-hospital administration of the long-acting cabotegravir+rilpivirine

Conditions: HIV-1 Infection

Summary: hola is a prospective, randomized (1:1), hybrid type (implementation-effectiveness), phase iv, double arm, open label, multicentric study including virologically suppressed hivinfected subjects who start or are currently under treatment with the la antiretroviral combination cab+rpv, to evaluate the out-of-hospital administration of this combination in terms of acceptability, appropriateness, feasibility and satisfaction.

randomized patients will receive long acting (la) cabotegravir (cab) + rilpivirine (rpv) administration in the hospital (standard of care) or out-of-hospital administration every 2 months (m2, m4, m6, m8,m10, m12). medical visits, routinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, m1 (if patient has not previously receiving la cab+rpv), m6 and m12.

Eligibility criteria:
inclusion criteria: 1. patients equal or older than 18 years old 2. chronic hiv infection 3. hiv patients in whom la cab+rpv is prescribed 4. recommended triple or dual therapy for at least 12 months, including cab+rpv la. 5. virologically suppression for at least 6 months: 2 consecutive determinations of undetectable viral load (plasma hiv-1 rna levels \< 50 copies/ml ) for ≥ 6 months preceding the study randomization. 6. post-menopausal or fertile females that agree to avoid pregnancy during the study. if sexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (iud), or anatomical sterility in self or partner) from 14 days prior to the first imp administration until at least 13 months after the last investigational medicinal product (imp) administration;all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol. 7. patients which have access to an out of hospital center in which can be treated without inconvenience 8. patient who agrees to participate in the study and signs the informed consent. exclusion criteria: 1. hepatitis b infection (section 6.2). 2. history of virological failure or mutations to insti or nnrti. 3. previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month. 4. contraindication for intramuscular injections 5. pregnancy or breastfeeding women, or with the desire to become pregnant in the near future. 6. current use of any concomitant treatment as indicated in section 5.6.

Keywords: hiv-1 long acting primary center community center out-of-hospital by implementation cabotegravir + rilpivirine (cab+rpv)
cervical preparation for same-day dilation & evacuation

Conditions: Abortion, Second Trimester; Procedural Pain; Procedural Complication

Summary: this is a noninferiority randomized control trial of two cervical preparation methods prior to same-day dilation \& evacuation (d\&e). cervical preparation is a process that softens and dilates the cervix prior to a procedure. the primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in d\&e operative time. secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.


Eligibility criteria:
inclusion criteria: * between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period) * able to provide informed consent * english- or spanish-speaking * singleton intrauterine pregnancy exclusion criteria: * allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators * fetal demise or known fetal anomaly * bmi \>45 * incarceration or other inability to give informed consent * decide to undergo cervical preparation overnight prior to next-day d\&e

Keywords: cervical dilation and evacuation (d&e) transcervical single-balloon catheter osmotic dilators adequate dilation patient satisfaction
a prospective study on the long-term vascular burden in thrombotic thrombocytopenic purpura patients

Conditions: Thrombotic Thrombocytopenic Purpura

Summary: a prospective cohort study of thrombotic thrombocytopenic purpura and atypical hemolytic uremic syndrome patients who have presented with their acute episode and are in remission within the last 30 days. they will be followed for 12 months from the time of their initial scan, followed by a long-term follow up study.

the investigators will conduct a prospective cohort study at the london health sciences centre, ontario, canada. the investigators will identify 15-30 idiopathic thrombotic thrombocytopenic purpura and atypical hemolytic uremic syndrome patients who are in remission within the last 30 days. they will be followed for 12 months from the time of their remission. study procedures include routine laboratory monitoring, biomarker assessments, cardiovascular and neurocognitive functional assessments, and non-invasive imaging studies. the long-term follow-up thrombotic thrombocytopenic purpura and atypical hemolytic uremic syndrome study will help to assess the mechanisms of vascular injuries, evaluate cardiovascular and cerebrovascular monitoring tools, and generate novel ideas to prevent further vascular injuries.

Eligibility criteria:
inclusion criteria: * adults (=18 years) with a recent diagnosis of their first episode of idiopathic ttp, who have been treated with plasma exchange with or without other therapies, and who are in remission. remission is defined as the normalization of platelet counts and lactate dehydrogenase levels with no clinical signs or symptoms of microvascular injury for more than 30 days. the patients will be included in the study within 30 days of remission of their symptoms. the patients will all meet the following diagnostic criteria for idiopathic ttp: (1) thrombocytopenia with platelet count \ 1.25 x of the upper limit of normal, and (4) adamts13 activity \< 10% exclusion criteria: * patients will be excluded if they have diagnoses of typical hus (diarrhea-associated hus), atypical hus, and disseminated intravascular coagulation, have abnormal international normalized ratio at the time of presentation, have diagnoses of malignant hypertension at the time of presentation, are on the following drugs within 90 days prior to their presentation: ticlopidine, clopidogrel, mitomycin c, gemcitabine, cyclosporine, and quinine, have a history of hematopoietic stem cell transplantations prior to their presentation, have a history and/or diagnosis of vasculitis, systemic lupus erythematosus, scleroderma, rheumatoid arthritis, antiphospholipid antibody syndrome, or hiv/aids, have a history of solid organ malignancy within 5 years prior to presentation, i.e. lung, breast, gastric, colon, pancreatic, prostate, or liver, are pregnant at the time of presentation, have severe bronchospasm, unstable angina, and severe ischemic heart disease, have advanced kidney failure (estimated glomerular filtration rate \< 30 ml/min/1.73m2), and have history of allergic reaction to contrast dye.
the role of values, acceptance, and mindfulness strategies in long term weight management

Conditions: Obesity

Summary: obesity is a prevalent, destructive, and costly chronic disease. in 2008, 37% of canadian adults were measured as overweight, and 25% as obese. obesity is a risk factor for a number of serious health problems, including type 2 diabetes, asthma, gallbladder disease, osteoarthritis, chronic back pain, several types of cancers (i.e., colorectal, kidney, breast, endometrial, ovarian and pancreatic cancers) and cardiovascular disease (i.e., hypertension, stroke, congestive heart failure and coronary artery disease). in 2008, it was estimated that the annual economic burden of obesity in canada was $4.6 billion. given the economic strain and widespread health risks of obesity, there is a clear need to provide effective interventions for obesity. the purpose of the proposed study is to examine the role of act-based interventions in long-term weight maintenance. the proposed study will examine the role of value consistent behaviour, acceptance skills, and mindfulness skills in promoting long-term weight-related health behaviours. acceptance and commitment therapy (act) is an empirically supported psychological intervention that emphasizes value consistent behaviours, acceptance skills and mindfulness skills.

participants will be recruited from the weight loss surgery waitlist and randomly assigned to a brief (5 sessions) act intervention or to waitlist control group. a mobile app will be used to encourage daily act skill practice and track health behaviours over time. the primary objective of the proposed project is to test whether a brief act intervention can result in sustained weight management (at 6 months and 1 year) compared to a waitlist control group. if this brief format of act intervention for obesity proves to be effective in encouraging health behaviours and weight loss, it may provide a low cost, sustainable option to enhance much needed obesity management services in nova scotia.

Eligibility criteria:
inclusion criteria: * bmi above 30 who are participating in weight loss surgery program at the nova scotia health authority exclusion criteria: * none
rare glycogen storage diseases natural history study

Conditions: Glycogen Storage Disease; GSD Type 0A; GSD Type 0B; GSD VII; Tarui Disease; GSD X; GSD XII; GSD XIII; GSD XV; Polyglucosan Body Myopathy 2; PGBM2; PRKAG2; Danon Disease

Summary: the purpose of this study is to collect and study key medical data about several ultra-rare gsds (glycogen storage diseases) including, but not limited to, gsd types 0a, 0b, vii, x, xii, xiii, xv, prkag2 syndrome and danon disease.

the immediate goal of this research is to create a natural history database to collect information from individuals who have a rare gsd. a repository of clinical, laboratory, and biochemical information on individuals with a rare gsd will allow a more definitive description of the different subtypes to be developed, which will permit development of treatment strategies in the future. duke will be the only site where this study takes place. however, since these are rare disorders, participants who receive care at other institutions will be included. the investigators will collect retrospective data from patient charts on diagnosed individuals, as far back as necessary to capture the clinical course of their disorder. prospective data collected from patient charts after enrollment will be captured as well. participant's medical records will be continually reviewed for the duration of the study. data will be collected from medical records and will only pertain to clinically relevant information, including, but not limited to: demographic and diagnostic information, tissue biopsy results, medical and family history, review of systems, imaging studies, results of liver, muscle, and nerve function testing, and urine and blood laboratory results.

Eligibility criteria:
inclusion criteria: * diagnosis of a rare gsd, including 0a, 0b, vii, x, xii, xiii, xv, prkag2 syndrome or danon disease * two variants in the gene associated with the specific gsd type (for autosomal recessive diseases) * one variant in the gene associated with the specific gsd type (for autosomal dominant or x-linked diseases) * deficient enzyme activity in liver, muscle, skin fibroblast or other tissue * one variant in causative gene with evidence of disease, per a clinician * histology as confirmed by a clinician * able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative) * able to provide consent for release of medical records * pregnant women with a diagnosis of a rare gsd will be included exclusion criteria: * unable to provide informed consent for participation for one's self or by legally authorized representative/legal guardian/parent

Keywords: glycogen storage disease gsd tarui disease polyglucosan body myopathy 2 pgbm2 prkag2 danon disease
fast mapping during atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia worldwide with a prevalence of 8% in the elderly. af is responsible for frequent hospitalizations, stroke, heart failure and mortality. af catheter ablation is an important treatment strategy for patients suffering from af, but the success rate remains low after conventional pulmonary vein isolation (pvi). the mechanism perpetuating af is poorly understood. focal electrical sources and triggers (fast) may sustain af in some patients, which makes them a potential therapeutic target for ablation. however, finding fast is very challenging due to complex nature of af electrical signals. in this study, the investigators will attempt to localize focal electrical sources and triggers (fast mapping) in patients undergoing af ablation using custom software that evaluates periodicity and waveform morphology. patients will be randomized to one of two af ablation strategies, namely fast mapping/ablation + pvi vs. pvi alone. the investigators will determine which strategy leads to better clinical outcome postablation.


Eligibility criteria:
inclusion criteria: * all patients must be over the age 18 and have a clinical indication for their first catheter ablation of af because of symptomatic af. * this will include patients with either high burden paroxysmal (\>4 self-terminating episodes of af within the last 6 months with two episodes lasting at least 6 hours within the last year) or persistent af (lasting ≥7 days, but which can still be converted to sinus rhythm). exclusion criteria: * the major exclusion criteria will include: * long-standing persistent af (ie. af which cannot be converted to sinus rhythm, or where multiple attempts at restoring sinus rhythm have failed) * rheumatic valvular disease * hypertrophic cardiomyopathy * uncorrected cardiac shunts (eg. secundum asd) * severe mitral regurgitation or mechanical mitral valve * left atrial size \>55 mm (echo derived parasternal long axis view).
double trigger in patients with low proportion of mature oocytes

Conditions: Infertility, Female

Summary: the aim of this randomized controlled trial is to determine whether co-administration of gnrh agonist and hcg for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous ivf cycle triggered by hcg.


Eligibility criteria:
inclusion criteria: * patients with history of low proportion of mature oocytes in previous ivf attempt (triggered by hcg). * patients with 6 to 15 mature follicles on the day oocyte trigger in the current ivf-et attempt exclusion criteria: * endometriosis * pcos

Keywords: ivf hcg gnrh agonist trigger
first-in-human study of bay2287411 injection, a thorium-227 labeled antibody-chelator conjugate, in patients with tumors known to express mesothelin

Conditions: Advanced Recurrent Malignant Pleural Epithelioid Mesothelioma; Advanced Recurrent Malignant Peritoneal Epithelioid Mesothelioma; Advanced Recurrent Serous Ovarian Cancer; Advanced Pancreatic Ductal Adenocarcinoma (Optional, Dose Expansion, Not Initiated)

Summary: the purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of bay2287411 injection: * safety (to identify, assess, minimize, and appropriately manage the risks associated to the study drug) * tolerability (the degree to which side effects can be tolerated by your body) * maximum tolerated dose * pharmacokinetics (the effect of your body on the study drug) * anti-tumor activity * recommended dose for further clinical development


Eligibility criteria:
inclusion criteria: * signed informed consent * male or female subjects ≥ 18 years of age * ecog ps (eastern cooperative oncology group performance status) of 0 or 1 * patients with advanced malignant epithelioid mesothelioma or advanced recurrent serous ovarian cancer, who have exhausted available therapeutic options; in addition, in the dose expansion part of the study, patients with metastatic pancreatic adenocarcinoma, who have exhausted available therapeutic options * availability of fresh or archival tumor tissue samples * adequate bone marrow, liver and renal function, as assessed by pre-defined laboratory requirements (within 28 days before start of study drug treatment) * a negative serum pregnancy test in women of childbearing potential (wocbp) performed within 7 days before the start of study drug administration. women and men of reproductive potential must agree to use highly effective methods of contraception, when sexually active. exclusion criteria: * impaired cardiac function, clinically significant cardiac disease or cardiac arrhythmias * pericarditis (any ctcae grade) or pericardial effusion (ctcae grade ≥ 2) * left ventricular ejection fraction (lvef) \< 50% (as measured at screening by echocardiogram). * history of anaphylactic reactions to monoclonal antibody therapy * history of myelodysplastic syndrome (mds)/treatment-related acute myeloid leukemia (t-aml) or with features suggestive of mds/aml * infections of ctcae (common terminology criteria for adverse events) version 5.0 grade 2 not responding to therapy or active clinically serious infections of ctcae grade \>2; known human immunodeficiency virus (hiv) infection; active hepatitis b virus (hbv) or hepatitis c virus (hcv)infection requiring treatment. patients with chronic hbv or hcv infection are eligible at the investigator's discretion provided that the disease is stable and sufficiently controlled under treatment * known brain, spinal or meningeal metastases

Keywords: malignant mesothelioma malignant pleural epithelioid mesothelioma malignant peritoneal epithelioid mesothelioma
investigate the safety tolerability and pharmacokinetics of multiple doses of azd1236

Conditions: Healthy Volunteer

Summary: the purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of azd1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.


Eligibility criteria:
inclusion criteria: * provision of signed informed consent prior to any study specific procedures * body mass index (bmi) between 19-27 kg/m2 exclusion criteria: * receipt of another investigational drug in the 4 months before dosing in this study * acute illness which requires medical intervention within 2 weeks of visit 2. * abnormal resting bp and pulse rate (after resting for 10 minutes). supine blood pressure \> 140 mmhg systolic or \>90 mmhg diastolic, pulse\ 90 beats per minute

Keywords: healthy volunteer safety tolerability pharmacokinetics azd1236
role of 18f-fdg pet/ct in gastric cancer

Conditions: Gastric Cancer

Summary: the objective of the study is to assess the value of pet/ct in diagnosis, staging, response evaluation, and relapse monitoring of gastric cancer.

gastric cancer (gc) is the fifth most common malignancy and the third leading cause of cancer mortality worldwide (1) it carries a poor prognosis, with a 5-year survival of only 20%-30% (2) clinical staging, based mainly on imaging, is critical in determining the best treatment.there is a widely accepted consensus of the usefulness of fdg pet/ct in staging and restaging of gastric cancer. according to evidence-based data, this modality can evaluate gastric cancer more accurately and is helpful for evaluation of tumor biologic characteristics, detection of lymph node and distant metastases, assessment of tumor response to therapy(9). retrospective and prospective study will conducted at sohag oncology hospital, nuclear medicine unit\& assuit university hospital, nuclear medicine unit including 50 patients in 12 months .

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as gc on surgically resected specimens; 2. patients with gastric and extragastric metastasis. 3. patients with gastric cancer either operated or not. exclusion criteria: 1. patients with second malignancy. 2. patient without proven pathology of cancer stomach. 3. severely ill patient (patient with disturbed conscious level, or couldn't lay supine during the imaging). 4. uncontrolled diabetic patient with blood glucose level more than 200mg\\dl. 5. pregnant women
comparison of the effects of synchronous and asynchronous telerehabilitation in patients with juvenile familial mediterranean fever

Conditions: Familial Mediterranean Fever (FMF ); Exercise; Telerehabilitation

Summary: our study will be randomized controlled. familial mediterranean fever patients between the ages of 12-18 will be included in the study and will be divided into 2 groups. the first group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist, and the second group will be applied an asynchronous video-based exercise program. the exercise program will be carried out for 8 weeks, 2 days a week. there will be 3 sets, 8 repetitions in 1 set in the exercise program and will be progressed according to tolerance. in the exercise program, the synchronous group will perform the exercises with the supervision of a physiotherapist via the zoom application, while the asynchronous video-based group will upload the exercises to the system asynchronously via a channel on youtube that only patients can access. feedback will be received from the asynchronous group by phone. our exercise program will be organized with the progression of exercises such as squat, lunge, stepping, running in place and jumping. the primary outcome measures of the study are the evaluation of fatigue (vas) and functional capacity (6-minute walking test). our secondary outcome measures are the evaluation of pain, balance, physical fitness and walking. for the assessment of fatigue: visual analog scale (vas), pedsql multidimensional fatigue scale, fatigue severity scale; for the assessment of functional capacity: 6 minute walk test, 30 sec sit-to-stand test, 10-step climbing test, pacer aebonic fitness test, half squat test; for the assessment of balance: one-leg stand test, functional forward reach test, kinvent (k-plate)-k force measurement evaluation set, digitsole smart insole system for the assessment of walking; for the assessment of physical fitness: fitnessgram test battery; for the assessment of pain: vas will be used.


Eligibility criteria:
inclusion criteria: * being between the ages of 12-18 * the parent's willingness to have their child participate in the study * being diagnosed with fmf at least 6 months ago * being in an attack-free period * have an internet access * being able to use a computer, tablet or smartphone * have access to a technological device with a camera, microphone and speaker output * being willing to participate in the study exclusion criteria: * having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise * acute pain for any reason * development of amyloidosis