Kornimate/medical-research-clean huggingface dataset:
obstructive sleep apnea in obese children and teenagers - occurrence and importance of intervention

Conditions: Sleep Apnea, Obstructive; Pediatric Obesity

Summary: the prevalence of childhood obesity has increased at an alarming rate over the last decades, both globally and in denmark. there are a number of serious sequelae related to obesity, such as hypertension, hypercholesterolemia, fatty liver and prediabetes. obesity is found to be a risk factor for obstructive sleep apnea (osa). osa in childhood is known to be associated with cardiovascular complications, neurocognitive problems and reduced quality of life. the correlation between obesity and osa is still poorly understood. early detection and intervention is of great importance as the health consequences related to osa as well as obesity are severe. adenotonsillectomy is recommended as first-line therapy in children with osa. however, only around 25% of obese children benefit from this treatment compared to around 75% of normal-weight children suggesting that there might be other structural factors predisposing to osa in obese children. in this study the investigators aim to clarify the impact of obesity in the development of osa. the prevalence of osa in obese children will be investigated. furthermore the purpose is to assess the effect of weight loss on osa.


Eligibility criteria:
inclusion criteria: * age: 7-18 years * bmi \> 90th percentile for age and gender exclusion criteria: * neuromuscular disorders * craniofacial syndromes / malformations * laryngeal and tracheal malformations

Keywords: sleep apnea, obstructive pediatric obesity
efficacy and safety of clascoterone cream 1% in facial acne vulgaris

Conditions: Acne Vulgaris

Summary: the primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.


Eligibility criteria:
inclusion criteria: * diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an investigator's global assessment (iga) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones); * male or female, 12 years of age or older; * subjects aged 18 years or older are required to provide informed consent and sign the written informed consent. a subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of consent signing. exclusion criteria: * subject has greater than two (2) facial nodules; * subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug; * subject has used topical and systemic anti-acne medications or therapies; * subject has received hormonal therapy for acne treatment; * subject has used a skincare product with acne removal effect; * subject has other serious underlying diseases such as mental illness or malignant tumors; * subject has any of the clinically significant laboratory test indicators at screening; * subject has known hypersensitivity or previous allergic reaction to multiple drugs, or any of the active or inactive components of the test articles; * subject engaged in drug abuse or excessive alcohol intake; * subject has uncontrolled hypertension; subject has poorly controlled diabetes; * subject is pregnant, lactating, or is planning to become pregnant during the study (both male and female); subject has positive pregnancy test result; subject is unable to practice highly effective contraception methods during the trial and within 3 months after the end of the trial; * subject is currently enrolled or was enrolled in other clinical trials within 3 months prior to the initiation of treatment; * subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this clinical trial.

Keywords: acne vulgaris
an exploratory study of changes in synovial immune responses following bms-188667 therapy in subjects with active rheumatoid arthritis on background dmards who have failed anti-tnf therapy

Conditions: Rheumatoid Arthritis

Summary: study to assess changes in synovial tissue before and after treatment with abatacept in subjects with ra who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-tnf (tumor necrosing factor)blocking agents.


Eligibility criteria:
inclusion criteria: * ra for at least 1 year * clear clinical signs of active ra in 1 knee joint * meet ara (1987) criteria for diagnosis of ra and acr (1991) criteria for ra functional classes i, ii, or iii * inadequate clinical response to a minimum of 3 months of therapy with anti-tnf-blocking agents * taking background dmards for a minimum of 3 months and at stable doses for at least 28 days exclusion criteria: * serious bacterial infection in last 3 months * history of tb * history of cancer within 5 years * evidence of latent or active bacterial or viral infection * intra-articular corticosteroids within 3 months * exposure to live vaccines * exposure to ctla4ig or bms-188667 * treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, d-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents
predictors of disease progression in primary focal segmental glomerulosclerosis

Conditions: Glomerulonephritis; Focal Segmental Glomerulosclerosis

Summary: focal segmental glomerulosclerosis (fsgs) is one of the most common primary glomerular diseases leading to end stage renal disease. in this study, our aim is to evaluate the effects of histopathological, clinical, and laboratory features of patients with primary fsgs on the disease progression.

focal segmental glomerulosclerosis (fsgs) is one of the most common primary glomerular diseases leading to end stage renal disease worldwide. numerous studies have been conducted in order to identify the etiology of this debilitating disease. beyond the etiological research, however, few studies managed to demonstrate the possible predictors of disease progression in patients. therefore, we aim to evaluate the effects of histopathological, clinical, and laboratory features of patients with primary fsgs on the disease progression.

Eligibility criteria:
inclusion criteria: * patients with biopsy-proven primary focal segmental glomerulosclerosis. * patients who have a renal biopsy available for reviewing including 8 or more glomeruli. * patients who have been followed-up for at least 6 months or have progressed to primary outcome regardless the duration of follow-up. exclusion criteria: * patients who have secondary focal segmental glomerulosclerosis attributable to any other condition (e.g., obesity, hiv, relevant drug exposure). * patients who have a genetic mutation or variation creating a tendency for developing focal segmental glomerulosclerosis. * patients who are unwilling or unable to consent.

Keywords: focal segmental glomerulosclerosis disease progression
referred pain areas in subjects with a recovered radius fracture

Conditions: Radius Fractures

Summary: the purpose of the present study is to investigate pressure algometry and pressure-induced referred pain areas in pain free individuals with a history of distal radius fracture (fully recovered) compared with age and gender matched healthy controls without history of fracture. it is hypothesized that individuals with a recovered radius fracture will have a facilitated referred pain patter towards the wrist but normal pressure pain sensitivity.

musculoskeletal injuries, nociception and pain can increase the sensitivity of the central pain mechanisms, which can be extended even after tissue recovery. however, little is known about the status of these central pain mechanisms once subjects are fully recovered from the tissue injury and pain. this information would help to explain pain conditions in which recurrence of the pain episodes is common (e.g low back pain or shoulder pain). pressure-pain thresholds have been widely used in pain research to test the sensitivity of the pain system. additionally, referred pain has been shown as a valid biomarker for the sensitization of the pain system. the aim of the present study is to investigate pressure pain sensitivity and referred pain patterns of individuals with a history of recovered fracture, compared with healthy controls.

Eligibility criteria:
inclusion criteria: * subjects with a history of distal radius fracture without pain at the moment of the study. exclusion criteria: * subjects with symptoms (e.g pain), functional limitations, history of other fractures in the upper limb or any other pathology.

Keywords: referred pain pressure algometry pain mapping
active lifestyle intervention in anorexia nervosa: a comprehensive study

Conditions: Anorexia Nervosa

Summary: the goal of this study is to perform a comprehensive analysis of varied health markers and analyze the impact of lifestyle interventions on the prognosis of anorexia nervosa (an) patients. in addition, this study aims to determine if biomarker analysis can be used as clinical outcomes for disease prognosis long-term and support individualized treatment strategies in female patients with an during the post-hospitalization phase. the main questions it aims to answer are: * what are the mirs and microbiota profiles associated with an, and how are they linked to other clinical markers? * how does a lifestyle intervention (exercise with nutritional support) affect biomarkers and clinical markers during the first three months after hospitalization? * what are the dynamics and associations of biomarkers, including gut microbiota, and how do they relate to critical events during the six months after hospitalization? * what is the perceived effect of participating in a healthy lifestyle program for patients, families, and professionals involved in the care of these patients? participants will: * undergo analysis of biomarkers and gut microbiota associated with an. * participate in a lifestyle intervention program involving exercise during the first three months post-hospitalization. * provide samples for biomarker and gut microbiota mapping over a six-month period. * share feedback on their perceived experience in the lifestyle program through interviews or surveys. researchers will compare biomarker and gut microbiota and the effects of the intervention to determine if a lifestyle exercise intervention can lead to better outcomes, and analyze its potential to individualized care strategies.


Eligibility criteria:
inclusion criteria: a) patients: * patients with a diagnosis of an (any subtype) * bmi \>14kg/m2 * under treatment at the regional eating disorders unit at the area iv and v of the principality of asturias * after acute treatment (total or partial hospitalization or other acute treatment regime following the recommendation of the medical team) b) healthy controls: - meet the physical activity recommendations of the world health organization for the age group and sex. exclusion criteria: a) patients: * contraindications to perform the evaluations proposed in this project * unmanaged dysfunctional or compulsive exercise * other criteria that, in the opinion of the medical team, prioritize the patient's health (i.e., psychological instability, substance abuse) . b) healthy controls: * suffer from metabolic, pulmonary or cardiovascular disease * suffer from serious organic disease * taking prescribed medications while participating in the project * have contraindications to perform the proposed assessments or intervention.

Keywords: anorexia nervosa microrna gut microbiota exercise physical fitness mental health body composition
coseal in liver and biliary surgery in prevention of denovo hepatic adhesion

Conditions: Patient With Hepatic Metastasis

Summary: study of phase ii: clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 study of phase iii: clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.


Eligibility criteria:
inclusion criteria: * major patients. * hepatic carriers of metastases. * eligible with a procedure of surgical eradication in two brought closer times (time lower than 3 months). * strategy validated in multidisciplinary meeting of cancerology. * enlightened assent given and signed before the intervention. exclusion criteria: * anaesthetic counter-indications with a procedure in two times * carcinose péritonéale, reached metastatic not éradicable * over-sensitiveness or allergy known to polyethylene coseal glycol * concomitant use of another antiblocking agent * immunodéprimés patients or taking drugs immunodépresseurs with the long court like the corticosteroids, * impossibility of subjecting itself to the medical monitoring imposed by the study for reasons geographical, social, psychic or medical. * concomitant participation in another clinical trial
environment effect on six-minute walk test performance

Conditions: Chronic Obstructive Pulmonary Disease; Alpha-1 Antitrypsin Deficiency

Summary: the purpose of this research study is to determine the effect of the environment on six-minute walk test performance in individuals with chronic obstructive pulmonary disease due to alpha-1 antitrypsin deficiency. the aim of the study is to determine the environmental impact on physical performance in this population to determine if any factors influence quality of life. this study was developed to evaluate the efficacy of the using the indoor six-minute walk test to determine eligibility for ambulatory oxygen therapy.

participants will be asked to come to the clinical research center (crc) for a visit lasting about one hour. participants will be asked to review and sign an informed consent document to participate in this trial. if participants agree to participate and sign the consent, the following procedures will be done. if they have not had pulmonary function testing performed in the past 18 months, standard spirometry testing will be performed. participants will perform two six-minute walk tests, one indoors and one outdoors. first, they will be randomly assigned to perform either the indoor or outdoor testing first. then participants will have their vital signs taken, perform the first six-minute walk study and immediately after have their vital signs taken again. participants will have a rest period between the two six-minute walk tests of at least 30 minutes. participants will then perform the second six-minute walk test with the same above procedures for the first test.

Eligibility criteria:
inclusion criteria: 1. age above 18 years. 2. have a diagnosis of congenital alpha-1 antitrypsin deficiency with an allelic combination of zz. 3. have a forced expiratory volume in 1 second (fev1)\< 50% of predicted and fev1/forced vital capacity (fvc) \< 70% (global initiative for chronic obstructive lung disease \[gold\] stage ii, iii, or iv). 4. not currently prescribed oxygen replacement at a rate of greater than 2 liters. 5. willing and able to perform two six-minute walk tests. 6. willing and able to provide written informed consent. exclusion criteria: 1. subject has had a moderate or severe pulmonary exacerbation during the 4 weeks before the study visit. 2. history of lung transplant. 3. severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease \[with the exception of skin cancers other than melanoma\], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis). 4. unwilling or unable to perform six-minute walk testing. 5. mentally challenged adult subjects who cannot give independent informed consent. 6. in the opinion of the investigator the subject may have compliance problems with the protocol and the procedures of the protocol. 7. american thoracic society listed absolute contraindications to six-minute walk test: unstable angina or myocardial infarction during previous month.

Keywords: six-minute walk
comparing the therapeutic efficacy and safety of da-9701 with domperidone in patients with parkinson's disease

Conditions: Parkinson's Disease,Idiopathic

Summary: this study will evaluate the therapeutic efficacy and safety of da-9701 with domperidone in patients with parkinson's disease

to prevent nausea and vomiting induced by anti-parkinsonian drugs, prokinetic drugs are frequently prescribed in patients with parkinson's disease (pd). additionally, there has been some evidence that prokinetics might improve pd symptom fluctuations. from this background, the investigators will evaluate the therapeutic efficacy and safety of da-9701 in pd patients. in this study, 40 patients will be enrolled and randomly allocated 1:1 to receive either domperidone or da-9701. the gastric function of each study participant will be evaluated using the mri technique before and after 4 weeks of the treatment. the study participants will also be subjected to complete the gastrointestinal symptom diary before and during the treatment period. in addition, plasma levodopa concentrations will be determined 30 minutes after dose administration before and after treatment.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with spontaneous parkinsonism by the united kingdom(uk) parkinson's disease society brain bank criteria * subjects who are able to explain symptoms they experience and to complete relevant assessment and exams including questionaires * subjects who understand the purpose and protocols of the study and agree to participate on the study exclusion criteria: * subjects who experience psychiatrical disorders such as cognitive or behavioral disorders * subjects who are on prokinetics or who are unable to cease such medication * subjects who present neurological disorders which influence gastrointestinal mobility * subjects who present gastrointestinal conditions which influence gastrointestinal mobility * subjects with a history of gastrectomy or colectomy * subjects who are unable to receive and complete the course of medication due to other metabolic disorders * subjects diagnosed with parkinson plus syndrome * subjects who are unable to undergo mri scan for safety reasons due to claustrophobia or certain devices such as cardiac pacemakers or aneurysm clips

Keywords: motilitone
stereotactic ablative radiotherapy for oligo-progressive non small cell lung cancer

Conditions: Lung Cancer Metastatic

Summary: a registry-based randomized screening phase ii trial. a total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.


Eligibility criteria:
inclusion criteria: * age ≥18 years * metastatic nsclc enrolled in our crchum lung cancer registry and co-enrolled to the pera registry * ability to provide written informed consent * eastern cooperative oncology group (ecog) performance status 0-3 * oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. progression at the primary tumor site should be counted within the total of 5 lesions. for patients with lymph node metastases, each node is counted as one site of metastasis. * oligoprogression while on ici or tki (any line) * patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care * all sites of disease can, in the opinion of the investigator, be safely treated and targetable with sabr (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.) * patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible. exclusion criteria: * any lesion beyond 5 cm * pregnancy or breastfeeding * any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy. * presence of spinal cord compression metastatic disease that invades the gi tract (including esophagus, stomach, small or large bowel)

Keywords: non small cell lung cancer oligoprogression steretactic body radiotherapy
allopregnanolone regenerative therapeutic for mild alzheimer's disease

Conditions: Alzheimer Dementia; Late Onset Alzheimer Disease; Neurodegenerative Diseases

Summary: a phase 2, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of allopregnanolone as a regenerative therapeutic for alzheimer's disease.

this is a proof-of-concept phase 2 clinical trial to investigate the long-term safety and efficacy of allo to function as a regenerative therapeutic to restore structural integrity and cognitive function of the brain in participants with mild alzheimer's disease (ad) dementia. study participants will be male and female, apoe ε4 positive diagnosed with probable ad, mini-mental state exam (mmse) 20 to 26, ages 55 to 80 years old. after a 2-4-week screening period, participants will be randomized to 4 mg allo (administered intravenously over 30 minutes, once per week, in clinic) or matching placebo, 1:1 allocation, for a period of 12 months. after 12 months, all participants in the placebo group will be crossed-over to receive allo for the remainder of the study (6 month open-label phase). brain imaging to evaluate the primary endpoint will be conducted at baseline, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * men and postmenopausal women * age 55 to 80 years old * meets nia-aa criteria for probable ad dementia * mmse of 20-26 * apoe ε4 positive * geriatric depression scale short form (gds-s) score of ≤ 6 * no medical contraindications to participation * capacity to provide informed consent at screening exclusion criteria: * dementia other than probable ad * use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the gaba-a receptor complex * history of stroke with a modified hachinski ischemic scale score \>4 * history of seizure disorder, focal brain lesion, traumatic brain injury * history within the last 5 years of a primary or recurrent malignant disease * unstable or clinically significant cardiovascular, kidney or liver disease * mri indicative of any other significant abnormality, including but not limited to one or more significant aria-e or macro-hemorrhage findings, or multiple microhemorrhages (\>8), or fazekas score of 3; encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions * any conditions that would contraindicate mri studies.

Keywords: mild alzheimer disease regenerative therapeutic apoe ε4 neurogenesis allopregnanolone