Kornimate/medical-research-clean huggingface dataset:
surgical intervention and lymphatic diseases.

Conditions: Lymphedema

Summary: supermicrosurgical lva has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (db) and even severe lymphatic fluid leakage. therefore, the use of lva should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. among all surgical procedures for lymphedema, lva is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

lymphatic-related diseases such as lymphedema often result from damage to the lymphatic system due to tumor removal and lymph node dissection surgeries, as well as tissue fibrosis caused by post-operative radiation therapy. this can lead to obstruction in the proximal channels of lymphatic flow, resulting in swelling, deformity of the distal limbs, poor wound healing, or cellulitis. in the case of lymphatic-related diseases like lymphedema, improvement can be achieved through surgical interventions. surgery can be categorized into physiologic reconstruction and volume reduction procedures. among them, supermicrosurgical lymphaticovenous anastomosis (lva) is a form of physiologic reconstruction. lva involves the separation of lymphatic vessels in the affected limb and their anastomosis with nearby small veins to alleviate limb swelling and reduce the risk of cellulitis. when using lymphaticovenous bypass surgery to treat lymphedema, the ideal scenario is to use veins for anastomosis that do not have venous blood reflux. this is because veins generally have higher blood pressure than lymphatic fluid, and if venous blood flows into the lymphatic vessels over the long term, it can reduce the patency of the lymphaticovenous anastomosis site. the choice of anastomosis technique, based on the size and position of the lymphatic vessels and veins, can also impact the post-operative outcomes. therefore, factors such as lymphatic vessel size, flow rate, function, vein size, pressure, and the presence of reflux are closely related to the success of lymphaticovenous bypass surgery. supermicrosurgical lva has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (db) and even severe lymphatic fluid leakage. therefore, the use of lva should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. among all surgical procedures for lymphedema, lva is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

Eligibility criteria:
inclusion criteria: * this study including patients diagnosed with lymphatic-related diseases at kaohsiung chang gung memorial hospital from september 1, 2015, to august 31, 2022. exclusion criteria: * patients under the age of 20. * patients with incomplete medical records.
realization of sequencing of all known human genes in case of detection of cerebral, renal or ophthalmological fetal malformations during pregnancy in order to make an etiological diagnosis and to precise the fetal prognosis

Conditions: Fetal Malformation; Pregnancy Related; Rare Genetic Disease

Summary: congenital malformations concern 3% of pregnancies; most of them can be seen during pregnancy. for some malformations, an invasive sample (trophoblast biopsy or amniocentesis) is proposed to search a chromosomal abnormality by the technique of dna chip. however, some strongly suggestive signs of a genetic (and not chromosomal) pathology have a very low diagnostic rate with this technique. in the absence of an etiological diagnosis, the prognosis for the unborn child is very difficult to assess, as we can't know if the fetal malformation is really isolated or associted to other unseen features as part of a syndromic condition. for some malformations strongly suggestive of a genetic condition, we propose to realize an exome (i.e. all coding parts of the genome) sequencing of the trio (child and the 2 parents) with a delivery time compatible with the emergency situation of a pregnancy (6 weeks maximum). we will apply bioinformatics filters to analyse only genes known to be involved in the malformation present in the unborn child and thus avoid the identification of variants in unrelated genes. these lists of genes have been previously validated by the rare disease health sectors and the affiliated diagnostic laboratories. the selected malformations are: 1) anomalies of the central nervous system (microcephaly (\<- 2ds) with anomalies of gyration, anomalies of the posterior fossa, anomalies of the midline except agenesis of the corpus callosum), 2) ophthalmological anomalies (microphthalmia, hyperplasia vitreous) and 3) renal abnormalities (large hyperechoic kidneys).


Eligibility criteria:
inclusion criteria: * father and mother of an unborn child past the age of majority * consent dated and signed by the mother and by the father * father and mother able to understand the objectives and risks of the study * for the mother, pregnancy in progress (between 12 and 34 weeks) * for the mother, pregnancy with the presence of a malformation on ultrasound, confirmed by a doctor from the multidisciplinary diagnostic prenatal center, entering into the indications retained for this study * clinical validation of the couple's eligibility by an expert for some of selected indications * father and mother affiliated to a social protection health exclusion criteria: * identified genetic or chromosomal abnormality explaining the observed malformation * inability to give informations to the father and / or mother (father or mother in emergency or life-threatening situation) * father and / or mother under the protection of justice * father and / or mother under guardianship or curatorship * nursing woman

Keywords: fetal malformations exome sequencing antenatal cerebral malformations antenatal ocular malformations antenatal large hyperechoic kidneys
assessing the polygenic burden of rare disruptive mutations in parkinson's disease

Conditions: Parkinson Disease

Summary: the project intends to assess the polygenic burden of rare disruptive mutations in parkinson's disease (pd) and how they influence the phenotype/pathological heterogeneity of disease.

the investigators intend to extend the genetic analysis to a cohort of 300 pd cases and 300 healthy subjects (wife / husband of the patients) that will be recruited at scientific institute for research, hospitalization and healthcare (irccs) neuromed. after signed informed consent patients will be assessed for disease progression (hoehn and yahr stadium, movement disorder society-unified parkinson's disease rating scale part iii (mds-updrs), montreal cognitive assessment (moca) test, no motor symptoms, therapy and levodopa induced dyskinesia (lid) occurrence). each patient and control will be subjected to peripheral blood sampling for the isolation of dna, rna, plasma and serum. the investigators will use a disease-specific gene panel including about 100 genes related to parkinson's disease, autophagy and levodopa induced dyskinesia (lid). bioinformatics analysis will allow to catalog in a database the identified variants/mutations according to their frequency and characteristics. the investigators will specifically assess if the inheritance of multiple rare deleterious variants in parkinson's disease genes is predictive of disease risk. the presence of one or more variants will be tested for association with phenotypic manifestation of parkinson's disease (motor, non-motor, and cognitive signs, as well as age at onset, lid and neuroimaging changes) to assess the variant burden effect on progression, and prognosis of the disease.

Eligibility criteria:
inclusion criteria: * presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to l-dopa (levodopa). exclusion criteria: * previous thalamotomy on the implanted sides; * significant brain atrophy or structural damage seen on ct or mri; * marked cognitive dysfunction; * active psychiatric symptoms; * concurrent neurological disorders; * other uncontrolled medical disorders.
a study of a new drug treatment for acne

Conditions: Acne Vulgaris

Summary: a study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.

approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (jnj 10229570-aaa) or color-matched vehicle. subjects will apply the study medication once daily on the face for 12 weeks. safety will be monitored throughout the study duration. efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at baseline and at weeks 2, 4, 6, 8, 10, and 12. approximately 50 subjects from one investigational site also will have serums collected at weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of jnj 10229570-aaa cream.

Eligibility criteria:
inclusion criteria: * 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol * if female of childbearing potential, must take a pregnancy test and have a negative result * females of childbearing potential must also agree to use an adequate method of birth control, which would include: * systemic birth control (subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study) * condom with spermicide * iud. females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods exclusion criteria: * known sensitivity to any of the ingredients in the study medication * more than 3 nodulocystic acne lesions * use of acne treatments, therapies or medications within protocol-specified timeframes * presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety * excessive facial hair that may interfere with application of the medication and/or evaluations

Keywords: acne irritation safety sebum
evaluation of the efficacy and safety of zinc in viral infections

Conditions: SARS-CoV2 Infection

Summary: the main objective of the clinical study is to evaluate the efficacy of zinc supplementation in non-critically ill covid-19 patients..

the vizir study is a national, longitudinal, multi-centre study conducted over a 3-month follow-up period. the priori hypothesis was that supplementation with zinc would reduce 30-day mortality and need to intensive care unit (icu) admission among non critically ill patients with covid-19. the vizir study will be carried out in tunisia at the level of consultations of general practitioners of both sectors : public and liberal, as well as in the emergency services of monastir and sousse.

Eligibility criteria:
inclusion criteria: * age 18 years and over . * sars-cov2 infection diagnosed with rt pcr , rapid test or chest ct-scan performed within the less than 5 days of symptoms. exclusion criteria: * patients who received zinc before the start of the protocol. * heart, liver, malignancies, or renal failure (estimated glomerular filtration rate ≤30 ml/min/1.73 m2); * mental disorders . * chronic dialysis. * hospitalisation in icu (use of respiratory or cardiovascular organ support (oxygen delivered by high-flow nasal cannula, noninvasive or invasive mechanical ventilation, or the use of vasopressors or inotropes). . * known hypersensitivity to zinc. * unsuitability for oral administration
recalling and anticipating specific positive events to boost resilience in adolescents

Conditions: Specific Positive Memories; Specific Positive Future Events; Resilience; Mental Wellbeing

Summary: many young people are experiencing stress-related mental health problems, with some recent studies suggesting this number is increasing. especially now, in the context of the covid-19 pandemic, there is a significant increase in depression and anxiety in adolescents. an important way to help address this challenge is not so much to focus on trying to repair what makes young people vulnerable but to focus on building resilience. resilience refers to the ability to successfully deal with stressful experiences. recent research shows that being able to vividly remember and imagine positive events can buffer the negative consequences of stress, and makes a convincing case that training adolescents in recalling and anticipating positive events would promote resilience and thereby improve their mental wellbeing. and this is exactly what the current project sets out to do for the very first time. adolescents will receive a playful group-training in school to make them better at recalling and anticipating positive events, which is expected to help them to bounce back more swiftly from challenging or otherwise stressful life events. the investigators predict that youngsters who follow our positive event training will experience more positive emotions, will show improved resilience and report better mental wellbeing. the investigators will also develop a free online training protocol for teachers so that schools can provide this resilience program on their own, without the need of external professional trainers.


Eligibility criteria:
inclusion criteria: * all adolescents of the selected classes of the participating schools (12-16 years; 1st and 2nd grade of secondary school) who want to take part in the study and give informed consent (own informed consent and active parental informed consent) will be allowed to take part in the study. * to minimize the risk of too much heterogeneity in our final sample, for instance due to context factors related to the type of education, the investigators will first recruit classes of adolescents that follow general secondary education. future studies (after pet has been properly evaluated in this study) should also be conducted in samples of adolescents following other types of secondary education. exclusion criteria: -

Keywords: adolescents anhedonia dampening episodic future thinking memory specificity positive emotions resilience savoring wellbeing
safety study of bms-903452 in healthy subjects (panel 1-7) & relative bioavailability of the crystalline and amorphous forms of bms-903452 [panels 4, 6, 11 & 12(part a)], and subjects with type 2 diabetes mellitus (part b)

Conditions: Diabetes

Summary: the purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of bms-903452 compared to placebo in healthy subjects \& relative bioavailability of the crystalline and amorphous forms of bms-903452 \[panels 4,6,11 \& 12(part a)\] ; and subjects with type 2 diabetes mellitus (part b). the study will also determine the amount of bms-903452 in the blood.


Eligibility criteria:
inclusion criteria: * clinically healthy or clinical diagnosis of type 2 diabetes on a stable dose of metformin monotherapy exclusion criteria: * type 1 diabetes * history of significant heart disease * prior bariatric surgery * women of childbearing potential
study the safety and efficacy of ptk 0796 in patients with complicated skin and skin structure infection (csssi)

Conditions: Skin Diseases, Infectious

Summary: a phase iii trial to demonstrate the safety and efficacy of ptk 0796 in the treatment of complicated skin and skin structure infections (csssi).

the pharmacologic profile of ptk 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. data from in vitro and animal studies support this hypothesis. in ptk 0796-cssi-0804 the safety and efficacy of ptk 0796 in the treatment of csssi will be compared to an antibiotic approved for this indication by fda. initial treatment will be administered intravenously with the option for subsequent oral treatment.

Eligibility criteria:
inclusion criteria: * patients, ages 18 years or older * is expected to require ≥4 days of iv antibiotic therapy * has an acute complicated skin and skin structure infection with findings of systemic inflammatory response * female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug exclusion criteria: * has received an investigational drug within past 1 month * has been previously enrolled in this protocol * has received \>24 hr of a potentially effective systemic antibiotic immediately prior to study drug * is nursing

Keywords: cssi abscess wound cellulitis complicated skin and skin structure infections (csssi)
a study in adults with ulcerative colitis (uc) or crohn's disease (cd) receiving vedolizumab in real-world practice in poland

Conditions: Inflammatory Bowel Disease (IBD); Crohn's Disease; Ulcerative Colitis

Summary: the primary reason of this study is to observe current treatment options in participants receiving vedolizumab, intravenous (iv) or subcutaneous (sc), for ibd in poland. there is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to vedolizumab induction and maintenance treatment for ibd \[including ulcerative colitis (uc) and crohn's disease (cd)\].

this is a non-interventional, prospective study of participants with moderately to severely active ibd (uc or cd) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting. the study will enroll approximately 160 participants: 100 participants with uc and 60 participants with cd. the data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: •participants with ibd this single center study will be conducted in poland at public hospitals and institutions that treat uc and cd. the overall duration of the study will be at least 24 months. data will be collected at baseline, every 3 months within the first year and every 6 months within the second year, and at the time of switch, discontinuation and/or at routine follow-up visits.

Eligibility criteria:
inclusion criteria: 1.participants with moderately to severely active ibd (uc or cd), initiating or ongoing iv induction treatment with vedolizumab in accordance with the current smpc and national drug program (ndp) at baseline or ibd participants receiving ongoing/maintenance iv vedolizumab treatment, with the option to switch to sc vedolizumab maintenance treatment. exclusion criteria: 1. prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy) to vedolizumab therapy as defined in the current smpc. 2. current or planned participation in an interventional clinical trial for cd or uc. 3. cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. .

Keywords: drug therapy
can ultrasound be used as a measure of muscle quality? a validation study comparing ultrasound with mri and mrs in older and younger persons.

Conditions: Muscle Atrophy

Summary: this study aims to see if ultrasound can be used as a reliable and valid method to measure fatty infiltration, muscle thickness and muscle architecture to provide a quick, cheap and mobile alternative measure of muscle quality to mri. the mrs and mri images will be used to validate the ultrasound images.

a key hallmark of the natural biology of ageing is a progressive loss of skeletal muscle mass, strength and aerobic capacity, termed 'sarcopenia' (cruz-jentoft et al. 2019a). the association between muscle loss (mass and quality) and increased incidence of falls, fractures, metabolic disease and other health complications is well established. despite exercise and physiotherapy, recovery from these is often incomplete and studies have failed to identify fully effective countermeasures (reeves et al, 2005). ways to objectively measure the clinical effectiveness of the countermeasures are also limited. muscle quality can be measured in terms of muscle thickness, architecture (pennation angle and fascicle length) and fatty infiltration. at present ultrasound muscle thickness and architecture have been shown against mri to be a reliable and valid but fatty infiltration can only be measured reliably using mri. mri is an expensive, time consuming and immobile technique limiting its use as a clinical tool in a rehabilitative setting. finding a cheaper, quicker and mobile alternative, such as ultrasound, would enable clinicians to gather useful information on patient muscle quality in an objective manner and use this information to tailor treatment accordingly. 15 old (\>50y) and 15 young (\<40y) will be recruited. mri, mrs and ultrasound will be measured in each participant in calf and thigh muscle, at the same location within a 1 hour time frame. mri and mrs will provide the validation to ultrasound fatty infiltration.

Eligibility criteria:
inclusion criteria: - age \ 50yrs exclusion criteria: 1. significant cognitive deficits and the inability to follow directions during assessment. 2. neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. cp, muscular dystrophy or sci 3. prosthesis with metalwork, eg. metal work from surgery 4. aneurysm clip in situ 5. no metal work anywhere, history of metal fragments in eyes, spinal cord or brain. 6. previous exposure to metal flakes and metallic injury. 7. no external implants; cochlear implant, spinal cord simulator, pacemaker or other implanted electronic devices. 8. non-removal hearing aids 9. female only not pregnant 10. not claustrophobic

Keywords: ultrasound mri
pharmacokinetics/ pharmacodynamics and safety of da-4001 in healthy male subjects with androgenic alopecia

Conditions: Androgenic Alopecia

Summary: an open-label, randomized, multiple-dose, crossover study to evaluate the pharmacokinetics/ pharmacodynamics and safety of da-4001 in healthy male subjects with androgenic alopecia.


Eligibility criteria:
inclusion criteria: * male, aged between 19 and 65 years, clinically healthy * bmi between 18.5kg/m2 and 27kg/m2 * clinical history of androgenic alopecia exclusion criteria: * subject has any dermatological disorders of the scalp * subject has a history of hair transplants, hair weaves * subject has hypersensitivity to previously prescribed minoxidil or finasteride * subject who is considered inappropriate to participate in the study due to any conditions including screening results at the investigator's discretion