Kornimate/medical-research-clean huggingface dataset:
neurodynamic study

Conditions: Sciatic Leg Pain

Summary: sciatica is a debilitating and costly condition. prognostically, patients presenting with leg pain often have a poor recovery and some go onto have spinal surgery. however, in the absence of nerve root compression on mri, no surgical option is viable and patients are often discharged and encouraged to self manage. neurodynamics offers a means to treat patients with non-compressive leg pain. to date, there is no research exploring which form of neurodynamic sliding technique offers the greatest therapeutic benefit in patients presenting with sciatica. the aim of this pilot study is to calculate how many patients would be needed to run a full scale trial evaluating therapeutic efficacy. moreover, the pilot will assess the overall workability of the study and the feasibility of patient recruitment.

patients who have given informed consent will be randomly allocated to one of three groups in a ratio of 1:1:1 (control group, intervention group 1, intervention group 2). randomisation reduces selection bias and controls for unknown variables that may affect the outcome. treatment allocation will occur through the use of sealed, opaque envelopes and will be implemented by the graves move more reception team as the patient attends the clinic. the reception staff will hand an opaque envelope to the subject for them to open. randomisation undertaken by an independent third party improves internal validity. patients will be treated according to the group they have been randomised to. data collection, analysis \& statistical opinion prior to undertaking the study, baseline socio-demographic data will be recorded (e.g. age, sex, weight, height, occupation and duration of symptoms). pre and posttest outcome data will also be recorded for the roland-morris disability questionnaire (rmdq) and oswestry disability index 2.0 (odi). long-term data (i.e. 6-12 months post-treatment) will not be recorded as treatment effect is not being analysed as part of the pilot study.

Eligibility criteria:
inclusion criteria: * patients presenting with sciatic leg pain or dysaesthetic symptoms into one leg, below the knee who have had lumbar/sacral nerve root compression excluded through mri * duration of symptoms greater than 12 weeks * reproduction of the patients symptoms with slr test + passive ankle dorsiflexion * patients aged between 18-75 years of age (both male and female participants) exclusion criteria: * any form of lower limb or spinal entrapment neuropathy * patients who have not had a lumbosacral mri * any contraindications to manual therapy including; cancer, cauda equina syndrome, active inflammatory arthropathies, rapidly deteriorating neurology, spinal fracture * previous lumbar spinal surgery * inability to undertake side lying * patients unable to give informed consent
evaluation of integrated versus parallel connection for renal replacement therapy in ecmo patients

Conditions: Venoarterial Extracorporeal Membrane Oxygenation; Renal Replacement Therapy; Acute Kidney Injury

Summary: extracorporeal membrane oxygenation (ecmo) is an extra-corporeal assistance used in case of respiratory or circulatory failure. in case of circulatory failure, ecmo is in the veno-arterial configuration (va-ecmo). va-ecmo patients are at high risk of developing acute kidney injury (aki) and renal replacement therapy (rrt) may be needed in 50% of ecmo patients. although the administration of rrt in ecmo patients has major implications, no specific recommendations are currently available. the 2020 kidney disease: improving global outcomes (kdigo) international conference identified the evaluation of rrt in these ecmo patients as a research priority. in 2023, the two main configurations used to administer rrt in ecmo patients are an independent delivery on a separate vascular access (parallel connection) or an integration of the rrt machine directly into the ecmo circuit (integrated connection). the integrated connection may reduce infectious and bleeding complications associated with the use of a second vascular access. however, it can expose the hemofilter and circuit to excessive positive pressures that can trigger pressure alarms in the rrt machine and expose the patient to a theoretical risk of air embolism or hemolysis. furthermore, there is currently no robust data comparing the hemofilter lifespan with the parallel or with the integrated connection, although the filter lifespan is a crucial parameter to assess the quality of the rrt delivery in the icu. the investigators recently performed a survey of practices in this context of ecmo patients. the investigators found that both strategies (parallel and integrated connection) are widely used and can be seen as common patient care. the hypothesis tested in this study is the following: when rrt is integrated to the ecmo circuit, the hemofilter lifespan is non inferior to the one when rrt is delivered on a separate vascular access. only va-ecmo patients will be enrolled in this trial.


Eligibility criteria:
inclusion criteria: * patients between 18 and 75 years of age * patient on va-ecmo who requires the initiation of continuous rrt during va-ecmo treatment * patient with a foreseeable length of stay in intensive care greater than 24 hours exclusion criteria: * patient who does not have a vascular capital allowing for the insertion of a new dialysis catheter to administer rrt and therefore cannot be randomized to the parallel connection group * high pressures monitored on ecmo not allowing direct rrt catherter on ecmo * pregnant, parturient, or breastfeeding women * patient deprived of liberty by a judicial or administrative decision * patient under psychiatric care * patient subject to a legal protection measure (guardianship, curators) * patient not affiliated to a social security system * patient participating in another interventional research study in the field of extra purification renal

Keywords: va-ecmo rrt connection integrated parallel hemofilter
ppi and mindfulness app for parents of children with a ndd

Conditions: Stress; Mental Health; Mental Well-being

Summary: an app based on positive psychology and mindfulness to support the mental well-being of parents of children with a neurodevelopmental disorder (ndd) was developed and will be evaluated on effectiveness.

this pragmatic randomized controlled trial aims to assess the effectiveness of the adappt app, an app developed to support the mental well-being of parents of children with a neurodevelopmental disorder (ndd), such as autism and adhd. this app was developed since research has shown that these parents experience higher stress levels than parents of typically developing children. furthermore, the app was developed in collaboration with parents of children with a ndd, mental health care professionals and scientists in europe.

Eligibility criteria:
inclusion criteria: 1. at least 18 years 2. parent of one or more children (\< 18 years) diagnosed with or suspected of a ndd 3. having access to internet 4. in possession of an e-mail address, 5. in possession of a smartphone or tablet 6. willing to use the digital intervention for a month, daily for approximately 15 minutes a day. exclusion criteria: 1. presence of severe anxiety symptoms 2. presence of moderately severe to severe depressive symptoms 3. being in treatment for mental health issues (the parent self)

Keywords: ability to adapt adappt
radiation therapy in patients with limited-stage small cell lung cancer in complete remission

Conditions: Lung Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. it is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain. purpose: this randomized phase iii trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.

objectives: * compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission. * evaluate the quality of life and late sequelae in this patient population treated with these regimens. outline: this is a randomized, multicenter study. patients are stratified according to participating center, age (60 and under vs over 60), and interval between the start of induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180 days). patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose. * arm i: patients receive standard-dose prophylactic cranial radiotherapy (10 fractions/12 days). * arm ii: patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center. * 18 fractions/24 days (conventional radiotherapy) or * 24 fractions/16 days (accelerated hyperfractionated radiotherapy) patients with isolated brain failure may undergo further radiotherapy. quality of life is assessed prior to randomization, at 6 months, at 1 year, and then annually thereafter. patients are followed at least every 6 months for 2 years and then annually thereafter. projected accrual: a total of 700 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * histologically proven limited stage small cell lung cancer * complete response to induction therapy (at least on chest x-ray) * normal brain ct scan or mri less than 1 month prior to study * no metastases (including ipsilateral lung metastases and malignant pleural effusion) patient characteristics: age: * 70 and under performance status: * who 0-2 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified cardiovascular: * no prior cerebrovascular disease other: * no epilepsy requiring permanent oral medication * no other prior malignancy except skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * no concurrent chemotherapy endocrine therapy: * concurrent steroids allowed radiotherapy: * concurrent thoracic radiotherapy allowed surgery: * not specified other * no other concurrent antitumoral agent

Keywords: limited stage small cell lung cancer
intestinal protozoal infections and sexual transmitted diseases among targeted cohorts

Conditions: HIV Infections; Protozoan Infections

Summary: in this two-year study, we will target two high risk groups, including msm of hiv-infected and those of non-hiv-infected. we will avail the serodiagnosis to detect the potential amebic carriers in both groups; and use microscopy to detect protozoas other than amebiasis. meanwhile we will also survey the patients' status of sexual transmitted diseases (std). for the amebic carriers, we will apply specific antigen and molecular biologic method to follow up the duration of the persistence of fecal amebas. we try to clarify the dynamic change of amebic carriage.

hiv-infected persons who are men having sex with men (msm) are prone to acquire invasive amebiasis. it would cast great threat for public health if the pathogens are spread by way of human to human transmission and food contamination. from 2000 to 2004, we assessed the seroprevalence of entamoeba histolytica infection using indirect hemagglutination antibody (iha) assay among 667 hiv-infected persons (group 1), 1311 asymptomatic hiv-uninfected persons seeking anonymous hiv testing (group 2), 616 hiv-uninfected controls with gastrointestinal symptoms (diarrhea and/or liver abscess) seeking medical care (group 3), and 2500 healthy controls undergoing health check-up (group 4). an iha titer greater than 128 was detected in 7.1% of group 1, 2.5% of group 2, 1.8% of group 3, and 0.1% of group 4 (p\<0.0001). the highest seroprevalence (11.2%) was noted among hiv-infected persons who were msm aged 30 to 39 years. compared with persons with gastrointestinal symptoms, the adjusted odds ratio for having high iha titers among hiv-infected persons was 3.206 (95% confidence interval, 1.433, 7.176) (p=0.005). these findings demonstrate that hiv-infected persons, especially msm aged 30 to 39 years, are at significantly higher risk of e. histolytica infection. in this two-year study, we will target two high risk groups, including msm of hiv-infected and those of non-hiv-infected. we will avail the serodiagnosis to detect the potential amebic carriers in both groups; and use microscopy to detect protozoas other than amebiasis. meanwhile we will also survey the patients' status of sexual transmitted diseases (std). for the amebic carriers, we will apply specific antigen and molecular biologic method to follow up the duration of the persistence of fecal amebas. we try to clarify the dynamic change of amebic carriage. we anticipate this study could outline the epidemiology and risk factors of protozoal infections and std in msm cohorts. we also hope to reduce the the infection rate (protozoa and hiv) and disease rate (std) through the repetitively effective health education and consultation during the conduct of this study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hiv-1 disease * clinical diagnosis of intestinal protozoal infections

Keywords: protozoa amoeba
a long-term follow-up study in subjects who received vmco-i administered via intravitreal injection

Conditions: Retinitis Pigmentosa; Retinal Disease; Retinal Degeneration

Summary: this study "a long-term follow-up study in subjects who received an adeno-associated viral vector serotype 2 containing the multi-characteristic opsin gene (vmco-i) administered via intravitreal injection" is an observational study and will be conducted following good clinical practice (gcp)- international conference on harmonization (ich) guidelines. eligible subjects satisfying all inclusion and none of the exclusion criteria will be enrolled. all subject who completed the parent clinical study (nsct/ct/18/01) will undergo safety and efficacy assessments up to 5 years post study drug injection

the observational study population comprises of individuals who received an adeno-associated viral vector serotype 2 containing the multi-characteristic opsin gene (vmco-i) administered via intravitreal injection in a parent study. enrolled subjects will undergo safety and efficacy assessments for up to 5 years from the vmco-i administration. at the visits, subjects will have safety and efficacy evaluations. subjects will have a final visit at 60 months post study drug administration.

Eligibility criteria:
inclusion criteria: * the subject population includes subjects who received an adeno-associated viral vector serotype 2 containing the multi-characteristic opsin gene (vmco-i), administered via intravitreal injection in a parent study. exclusion criteria: * subjects who will not consent for study.

Keywords: optogenetics gene therapy aav vectors multicharacteristic opsin (mco)-i
the role of gut hormones and hepcidin in type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this study aims to investigate the potential of the gut hormones glp-1, pp, pyy and the iron regulatory hormone hepcidin as biomarkers for progression to complications in diabetes mellitus.

iron overload and mechanisms inducing insulin resistance are reciprocally linked. dietary iron absorption, and iron uptake in liver and adipose tissue, are regulated through the hormone hepcidin. iron is implicated in microvascular and macrovascular disease pathways and therefore hepcidin may represent a biomarker for progression to complications in type 2 diabetes mellitus. serum pancreatic polypeptide levels correlate with visceral adiposity and may therefore contribute to the diagnosis of, and risk stratification in, the metabolic syndrome. hypothesis: measuring iron status, incretin hormones and serum pancreatic polypeptide will facilitate discrimination of patients at risk of vascular complications of t2dm and clinically significant non-alcoholic fatty liver disease. statistical analysis: serum/plasma level of hormone under investigation corrected for age, sex, bmi, diabetes duration, blood pressure, lipid profile, smoking status, treatment for diabetes, hypertension and dyslipidaemia, and hba1c using multinomial logistic regression and cox regression models.

Eligibility criteria:
inclusion criteria: * all exclusion criteria: * lack of capacity for informed consent; vulnerable individuals
moses vs. thulium laser study

Conditions: Urinary Tract Stone

Summary: the incidence of urinary tract stone disease is increasing. according to the national health and nutrition examination survey, as of 2012, 10.6% of men and 7.1% of women in the united states are affected by renal stone disease. this has led to an increased demand on urologists for efficient and safe surgical treatment of stone disease. over the past two decades, ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and renal stones globally. the holmium laser is considered the gold standard for laser lithotripsy. holmium laser lithotripsy with moses and the thulium laser are new technologies meant to improve the efficiency of laser lithotripsy. both are fda approved treatment modalities for stone disease. two in vitro studies have compared moses versus thulium and shown that thulium has higher ablative volumes then the holmium laser with moses, but no clinical trials have compared the two treatment modalities. in this study, investigators are going to conduct a prospective, randomized clinical trial to determine whether there is a difference in procedural time, intraoperative parameters or stone free rate between the holmium laser with moses and the thulium laser. this is significant as this may lead to shorter overall operative times, which may result in decreased operative costs and complications.


Eligibility criteria:
inclusion criteria: * participants with renal or ureteral urinary stones who require endoscopic treatment in the outpatient operating room * participant's stone size in a single renal unit of 3-10 mm and 11-20 mm. stone size is defined as the largest diameter of a single stone on pre-operative ct. participants with multiple stones will be included as long as their largest stone size falls within the above parameters. exclusion criteria: * participants under 18 years of age and over 89 years old. * pregnant participants * participants with transplant kidneys * participants with irreversible coagulopathy * participants with known ureteral stricture disease * participants who do not have a pre-operative ct. * non-english speaking, vulnerable participants such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.

Keywords: lithotripsy holmium laser
imm01+azacitidine vs placebo +azacitidine in patients with newly diagnosed chronic myelomonocytic leukemia (cmml1-2)

Conditions: Chronic Myelomonocytic Leukemia

Summary: this study is a randomized, controlled, double-blind, multicenter, phase ⅲ clinical study to evaluate the efficacy of imm01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (cmml1-2).primary endpoint are complete remission rate and overall survival.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, regardless of gender; * eastern cooperative oncology group (ecog) performance status score of 0-1. * life expectancy ≥ 12 weeks; * patients with cmml diagnosed according to who 2016 criteria, including cmml-1 and cmml-2; * white blood cell count ≤ 13×10⁹/l before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed, but not within 3 days prior to the first treatment with the study drug). * patients must be treatment-naïve to any hypomethylating agents (e.g., azacitidine, decitabine), chemotherapy or allogeneic stem cell transplant for cmml. immunomodulators ( lenalidomide), immunosuppressants (antithymocyte globulin, cyclosporine), targeted agents (ruxolitinib), etc. are also excluded, as these agents are considered disease-modifying therapies. note: during screening and study participation, subjects may continue oral corticosteroids for diseases other than cmml (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mg prednisone. in addition, supportive care in the form of blood transfusions or growth factors is not considered prior therapy in this case and is permitted prior to and as needed during the study. exclusion criteria: * previous treatment with anti-cd47 monoclonal antibody/sirpα fusion protein; * history of allogeneic stem cell transplant and other organ transplants; patients who have undergone autologous haematopoietic stem cell transplant; * prior diagnosis of: therapy-related myelodysplastic syndrome(t-mds); mds evolved from a pre-existing myeloproliferative neoplasm (mpn) ;mds/mpn including atypical chronic myeloid leukemia (acml), juvenile myelomonocytic leukemia (jmml) and unclassifiable mds/mpn. patients positive for bcr-abl fusion genes, pdgfra, pdgfrb, and fgfr1 rearrangements need to be excluded; * current or history of central nervous system (cns) leukemia, extramedullary leukemia, or myeloid sarcoma; * diagnosis of other malignant neoplasms within 3 years prior to the first dose. exceptions: a. radically treated cervical carcinoma in situ or non-melanoma skin cancer; b. a second primary cancer that has been curatively treated and has no recurrence within three years;
comparison of different feeding appliances for cleft palate babies

Conditions: Cleft Palate

Summary: this study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

this study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate. the purpose of the present study will be explained to the patient's parents and informed consent will be obtained according to the guidelines on human research adopted by the research ethics committee, faculty of dentistry, tanta university.

Eligibility criteria:
inclusion criteria: * infants with age range from 1-15 days. * unilateral cleft palate. * medically free subjects. * both males and females. exclusion criteria: * patients older than 15 days. * syndromic patients with other defects in addition to cleft lip and palate. * patients with bilateral cleft lip and palate. * patients with previous presurgical infant orthopedic treatment. * medically compromised patients.-

Keywords: feeding appliance ,flexible, rigid