Kornimate/medical-research-clean huggingface dataset:
pmcf study on smile treatment of myopia with and without astigmatism

Conditions: Myopia; Astigmatism

Summary: the primary objective of this pmcf investigation is to systematically collect safety and effectiveness data with the visumax 800 laser in clinical daily routine smile use for the purpose of post market surveillance.

the present pmcf study is a prospective, non-randomized, international multi-center study without control group including patients with myopia or myopia combined with astigmatism undergoing smile with the visumax 800 femtosecond laser in daily routine use. in this pmcf study, at maximum 474 eyes of consecutive subjects will be consented, enrolled, treated and followed up to 6 months postoperatively at 4 to 5 sites. the treatments, which will be done bilateral, shall be equally distributed between the sites as far as possible. the subjects will be 18 years of age or older, who suffer from myopia of up to -10 d with or without astigmatism of up to 5 d, and are suitable for smile treatments, fulfil all inclusion criteria and not fulfil any of the exclusion criteria. the expected duration of the is 16 months (site initiation to closeout visit).

Eligibility criteria:
inclusion criteria: * myopia up to -10 d with and without astigmatism up to 5 d * age of 18 years or older * pre-operative cdva of 20/25 or better in each eye * patient shall be willing to comply with all follow-up visits and the respective examinations * patients should be able to understand the patient information and willing to sign an informed consent. * contact lens wearers must stop wearing their contact lenses at least 2 weeks before baseline measurements in case of hard contact lenses and 2 days before baseline measurements in case of soft contact lenses exclusion criteria: * no monovision treatments (target sphere may not be more negative than -0.25 d) * the patient may not participate in other ophthalmologic studies except in vemos study at site aarhus. * any impaired person (minors, pregnant or breast-feeding women or persons incapable of giving consent) are definitely excluded from the study. * the patients presenting at least one of the contraindications stated in user manual of the visumax 800 option relex smile must not be included in this clinical investigation

Keywords: smile myopia astigmatism
individualized telemedical assistance for lifestyle modification in the treatment of obesity and cardiometabolic risk prevention

Conditions: Obesity Type I and II

Summary: this project is based on the contribution that could offer a technological system for a continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic complications in high risk population. the main objective of predircam study is to evaluate the benefits obtained with the use in high cardiometabolic risk individuals of a telemedical platform integrating applications for monitoring and providing recommendations to improve lifestyle habits (diet and physical activity) in a healthier way. the study population are obese subjects (type i or ii) aged between 25 and 65 years with a 12 month follow-up. in this population it will be analysed the cost-effectiveness of a telemedic assistance with a technological system and its ability to modify lifestyle habits, reduce weight and cardiovascular risk associated parameters. previously to the clinical implementation, a pilot study for testing the telemedical system will be made. efficacy and security variables will be evaluated along the study.


Eligibility criteria:
inclusion criteria: preclinical phase: 1. people over 18 years with or without obesity and with ability for technology management clinical phase: 1. people between 18 and 65 years. 2. obesity defined as a body mass index (bmi) greater than or equal to 30 kg/m2: 1. grade i or ii without sleep apnea syndrome and ischemic heart disease 2. absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study. 3. people with ability for technology management exclusion criteria: preclinical phase: 1. serious illness and / or disabling clinical phase: 1. diabetes defining according to american diabetes association (ada) criteria. 2. subjects with moderate to severe active disease at the time of inclusion in the study protocol 3. impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism. 4. cardiovascular disease 5. dyslipidemia or hypertension requiring drug treatment. 6. alcohol consumption 7. pregnancy 8. serious illness and / or disabling
combined ultrasound guided bilateral rectus sheath and erector spinae plain blocks versus erector spinae plain block for intra and postoperative analgesia in elective abdominoplastic surgeries. a randomized controlled double blinded trial.

Conditions: Abdominoplasty; Perioperative Analgesia

Summary: the goal of this clinical trail is to determine if bilateral erector spinae plane block alone can provide good perioperative analgesia for abdominoplastic surgery patients or it is better to give combined bilateral rectus sheath and erector spinae plane blocks to achieve effective intraoperative and postoperative analgesia with minimal morphine consumption in such operations in which there is an extensive surgical dissection and a high risk of respiratory problems.

this study is randomized controlled trail in which 40 adult patients (male or female) scheduled for elective abdominoplastic surgeries during the study duration will be randomized into to equal groups to investigate the efficacy of erector spinae plane block alone versus the efficacy of combine use of erector spinae and rectus sheath plane block for intra and postoperative analgesia in abdominoplastic surgery patients.

Eligibility criteria:
inclusion criteria: * patients age from 21 to 60 years ,male and female patients ,asa i, ii patients scheduled for elective abdominoplastic surgeries during the study duration. exclusion criteria: * patient refusal, age less than 21 and above 60 years old, asa iii, iv patients., infection at the site of injection, opioid addiction, allergy to any used substances (lidocaine, bupivacaine)., preexisting severe or uncontrolled respiratory, renal or cardiac disease. , inr more than 1.5 and platelets less than 100000.

Keywords: rectus sheath block erector spinae plane block
the accumulative effect of cold water immersion in football athletes

Conditions: Athletic Performance

Summary: football is a sport with congested calendars, which requires muscle recovery strategies such as cold water immersion (cwi). this recovery technique is well spread through football clubs, although it lacks a profound physiologic investigation to understand its effects on athlete's body. objectives: the main objective of this study is to evaluate the effect of a long-term cwi exposure in football athlete's. study hypothesis: h0: the application of cold water immersion doesn't amend the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample. h1: the application of cold water immersion amends the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.

in order to answer this question, the investigators performed a randomized clinical trial in 23 sub-20 football athletes. all subjects were randomly divided into two groups; a control group (10 minutes seated rest) and a cwi group (10 minutes in a 10 degree c) during seven days in a row. the investigators evaluated creatine kinase (ck) and lactate dehydrogenase (ldh) as molecular biomarkers for muscle damage. the blood samples were collected on the first, second, ninth and tenth days. yet, the investigators assessed the peak of muscle activity and isometric strength of the knee flexors and extensors, potency of lower limbs, perceived exertion (pe) and total quality recovery perceived (tqrper) in order to understand the treatment physiological effect on the subjects on the first and last day of experiments (before and after training).

Eligibility criteria:
inclusion criteria: * healthy subjects * soccer players exclusion criteria: * neurological, vascular or systemic muscle disease
phase 3 extension study to evaluate long-term safety of ianalumab in participants with systemic lupus erythematosus (sirius-sle extension).

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two sirius-sle core studies (cvay736f12301 or cvay736f12302).

the purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ana)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either cvay736f12301 (sirius-sle 1) or cvay736f12302 (sirius-sle 2) core studies.

Eligibility criteria:
key inclusion criteria: * signed informed consent prior to participation in the extension study. parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study informed consent form (icf) at the next study visit. * participants must have participated in either one of the two sirius-sle core studies, cvay736f12301 or cvay736f12302, and have completed the treatment period through week 60 without treatment discontinuation. * in the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment. key exclusion criteria: * use of prohibited therapies. * active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation. * plans for administration of live vaccines during the study period. * pregnant or nursing (lactating) women. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications). * united states (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: systemic lupus erythematosus sle b cell depletion sledai-2k bilag-2004 sri-4, ana ianalumab vay736
treatment of plantar fasciitis with platelet rich plasma

Conditions: Plantar Fasciitis

Summary: the purpose of this investigator-initiated study is to clinically evaluate the efficacy of a new treatment for plantar fasciitis. this treatment consists of a platelet rich plasma injection into the origin of the plantar fascia. it is thought that plasma rich plasma injection will dramatically improve outcomes for patients suffering from plantar fasciitis. subjects will be randomized by choosing a slip of paper from an envelope. this process will randomize 25 patients to the experimental group, and 25 patients to the control. the experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma into the origin of the plantar fascia. the control group will undergo a corticosteroid injection into the plantar fascia as the sole treatment. patients will be followed for three months for pain, and will fill out questionnaires at the initial visit prior to receiving the injection, as well as six and twelve weeks post injection. these questionnaires will give insight into functionality and pain changes that the plantar fascia is experiencing due to treatment. subjects will be outpatients. subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed. subjects will be between 18 and 89 years of age. in total, subject participation will last approximately 3 months.


Eligibility criteria:
inclusion criteria: * patients presenting with complaints of plantar heel pain, worse with rising in morning and/or after periods of sitting or lying presenting for at least 4 weeks * examination reveals maximal tenderness at the attachment of the plantar fascia on the medial tubercle of the calcaneus * willingness to participate in an investigational technique * willingness to forgo any other concomitant conservative treatment modality; nsaids and orthotic devices during the study period exclusion criteria: * previous surgery for heel pain * nerve related symptoms (radiculopathy, tarsal tunnel syndrome, tarsi sinus syndrome) * patient with complex regional pain syndrome * achilles tendon pathology * ra, dm, local or systemic infection, pvd, metabolic disease such as gout, clotting disorder, anticoagulation therapy * patients that are pregnant or breastfeeding * patients with metastatic cancer * dysfunction of the knee, ankle, or foot * work related or compensable injury * previous treatment: corticosteroid injection in the last 6 months or nsaids treatment within the last 7 days

Keywords: plantar fasciitis prp platelet rich plasma
identification of predictive biomarkers of mood relapses in patients with bipolar disorder

Conditions: Bipolar Disorder

Summary: relapses in bipolar disorders are associated with a significant proportional functional impact, as well as worsening of the course of bipolar disorder, with impairment of the quality of functional remission, as well as the development of addictive, anxiety and suicidal comorbidities.the functional deficit and the instability of the mood disorder increase with thymic relapses. currently, these relapses (transition from the state of remission, to a depressive or hyperthymic state) are difficult to predict and to treat because of the absence of correlation between the degree of severity of the stressful event (intensity associated stress) and the occurrence of relapse, taking into account the mediation of this relationship by the stress compensation / adaptation capacities, which are very individual. this project proposes to develop tools based on artificial intelligence technologies to monitor the level of stress and adaptation to life events as well as identifying relapse predictive factors of a patient by using portable and connected devices recording different physiological signals in order to alert him/her when there is a risk of relapse, thus anticipating therapeutic strategies.


Eligibility criteria:
inclusion criteria: * voluntary subjects responding to the diagnosis of bipolar i or ii disorder according to the criteria of the dsm-5 * agreement to benefit from connected objects required for study and able to understand their use * age between 18 and75 years old * affiliated to the social security system (beneficiary or entitled) * no opposition signed exclusion criteria: * subject included in clinical and/or therapeutic experimentation with exclusion period * primary psychiatric pathology other than bipolar type i or ii disorder * patient hospitalized without consent * subject deprived of liberty by judicial or administrative decision * pregnant, parturient, breastfeeding woman * known allergy to one of the materials of the bracelets
a study of the safety and efficacy of pimavanserin (acp-103) in patients with parkinson's disease psychosis

Conditions: Parkinson's Disease Psychosis

Summary: this study will evaluate the safety and efficacy of two dose levels of pimavanserin (acp-103) compared to placebo in patients with parkinson's disease psychosis.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of parkinson's disease with a minimum duration of 1 year * presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening * psychotic symptoms must have developed after pd diagnosis was established * subject must be on stable dose of anti-parkinson's medication for 1 month prior to study day 1 (baseline) and during the trial * subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to study day 1 (baseline) and must remain stable during the trial * the subject is willing and able to provide consent * caregiver is willing and able to accompany the subject to all visits exclusion criteria: * subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of parkinson's disease including, but not limited to, schizophrenia or bipolar disorder * subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat parkinson's disease * subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder * subject has had a myocardial infarction in last six months * subject has any surgery planned during the screening, treatment or follow-up periods patients will be evaluated at screening to ensure that all criteria for study participation are met. these evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).

Keywords: parkinson's disease, psychotic disorders
microbiome alterations in il10ra-deficient patients after hsct

Conditions: Inflammatory Bowel Diseases; Microbiota

Summary: to elucidate the longitudinal development of intestinal microbiota in patients with il10ra deficiency after hematopoietic stem cell transplantation (hsct). the investigators planned to collect fecal samples from il10ra-deficient patients who received hsct. samples were collected more than once every three days after engraftment in lamina flow ward and at least once a week before discharge. microbial dna was extracted from the fecal samples. and all analysis was based on the next generation sequencing data.

hematopoietic stem cell transplantation is considered the only curative therapy for patients with interleukin-10 receptor-a(il10ra) deficiency. the investigators aimed to collect the fecal samples of these patients throughout the conditioning, transplantation until discharge, providing a dense insight into the longitudinal development of intestinal microbiota.

Eligibility criteria:
inclusion criteria: * il10ra gene mutations; * eligible for hematopoietic stem cell transplantation. exclusion criteria: * unwilling to participate.

Keywords: interleukin 10 receptor alpha gene
effects of imt on respiratory, diaphragmatic and balance functions, exercise capacity and qol in people after stroke

Conditions: Stroke

Summary: this is a randomized controlled trial. this current rct study will be a continuing project based on the optimal imt intensity identified from our ongoing study. this ongoing study (registered on clinicaltrials.gov with the registration number nct06267768) aims to explore the optimal imt intensity for the recruitment of diaphragm muscles in people after a stroke. based on this intensity, the aim of this rct is to explore the effects of a 4-week protocol of imt on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.


Eligibility criteria:
inclusion criteria: * aged between 40 and 80 years; * breathing spontaneously; * clinically diagnosed with ischemic and/or haemorrhagic stroke; * stroke duration from onset between 1 and 12 months; * no history of thoracic or abdominal surgery within the last 6 months; * able to understand and follow verbal instructions; * no facial palsy, or mild facial palsy without limitation of labial occlusion; * capable of maintaining a resting sitting posture without feet support for at least 30 seconds; * no cognitive impairment, as indicated by a montreal cognitive assessment (moca) score of ≥ 26; * able to independently walk at least 10 meters with or without an assistive device. exclusion criteria: * acute myocardial infarction or acute heart failure; * acute pain in any part of the body; * with respiratory illness or positive clinical signs of impaired respiratory function, such as shortness of breath, hypoxemia, chronic cough, or sputum retention; * with chronic cardiovascular dysfunction; * trunk impairment scale (tis) score ≥ 20; * presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedure.

Keywords: stroke inspiratory muscle training diaphragm balance control exercise capacity
breast cancer after ovarian cancer during and/or after therapy: genomic evaluation

Conditions: BRCA-Associated Breast Carcinoma

Summary: this study will investigate, in patients with germline brca-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with parp-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue.


Eligibility criteria:
inclusion criteria: * written informed consent. * age older than 18 years. * germline brca1/2 mutation. * histologically confirmed ovarian cancer treated with platinum-based chemotherapy and/or parp inhibitors. * histologically confirmed breast cancer occurred during or after therapy with platinum-based agents and/or parp-inhibitors for ovarian cancer. * availability of ffpe breast and ovarian tumor samples. exclusion criteria: * other malignancies in the last 2 years. * prior chemotherapy or radiation therapy for other malignancies.

Keywords: brca1/2 breast cancer ovarian cancer platinum salts parp inhibitors
how to predict post-surgical bleeding and hemoglobin in liposuction?

Conditions: Bleeding; Surgery

Summary: to evaluate the effect of using a mathematical model developed through pre- and post-surgical hemoglobins to predict the volume to aspirate in patients undergoing primary body liposuction.

postoperative anemia is a significant risk associated with liposuction, yet the scientific literature lacks detailed data on blood loss relative to the volume of fat removed. to address this, the investigators aimed to develop a mathematical formula predicting the decrease in postoperative hemoglobin (hb post) based on preoperative hemoglobin (hb pre), body mass index (bmi), and the volume of fat suctioned. an observational, analytical, non-experimental, prospective study was conducted on liposuction patients to validate this predictive formula. statistical analysis using spearman's test showed that the results were statistically significant (p \< 0.05).

Eligibility criteria:
inclusion criteria: * patients of indistinct gender, operated on at the centro médico nacional de occidente for primary liposuction. * age between 18 to 60 years old * liposuction technique used: super wet or tumescent. * surgical procedure on any area of the body * large volume liposuction (\> 5 l) * use of regional anesthesia exclusion criteria: * presence of any of the following comorbidities: systemic arterial hypertension or diabetes mellitus type 2. * performance of 2 or more procedures * use of medications (nsaids and/or coadjuvants that modify coagulation times).

Keywords: bleeding abdominoplasty liposuction hemoglobin