Kornimate/medical-research-clean huggingface dataset:
single-use negative pressure wound therapy for free flap donor sites

Conditions: Surgical Wound

Summary: various management options for free flap donor sites that require split thickness skin grafting exist. none has proven superior from both a patient care and a cost standpoint. major complications occurring at these surgical sites include wound breakdown, tendon exposure, and loss of function. we seek to investigate the use of the pico single-use negative pressure wound therapy device in these surgical sites and determine if it can yield superior results to simpler methods.

many studies have addressed the use of negative pressure wound therapy (npwt) in free flap donor sites with mixed results. it is well established that npwt is safe and causes no harm, and no delay in healing. a previous study performed at uab showed that npwt in complex head \& neck surgery reconstruction is safe, including free flap donor sites. there have been studies that state the rate of tendon exposure is lower with npwt in free flap donor sites, and studies that conclude there is no difference in complication rates. current clinical practice is varied, often within a single institution. while no studies of npwt in free flap donor sites have noted inferior results with its use, a primary reason cited for not using it is cost. traditional npwt using canister-based vacuum devices adds significant cost. the pico single-use npwt device (smith \& nephew) is a relatively inexpensive, low-profile dressing that does not require attachment to an external canister. it is battery-powered and disposable. empiric use on our patients undergoing split-thickness skin-grafting to free flap donor sites shows good results with minimal intra-operative effort compared to traditional bandaging. we would like to prospectively investigate the use of this low-cost npwt device and compare it directly to the traditional post-op dressing method.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * participants are able to consent for themselves * undergoing reconstructive surgery requiring split-thickness skin graft coverage of a free flap donor site (i.e., radial forearm free flap or fibula free flap) exclusion criteria: * \< 18 years of age * participants are unable to consent for themselves * undergoing reconstructive surgery that does not require split-thickness skin graft coverage of a free flap donor site

Keywords: negative pressure wound therapy split thickness skin graft
cystic fibrosis blood neutrophils

Conditions: Cystic Fibrosis

Summary: the purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of pseudomonas aeruginosa chronic infection, treatment with cftr modulators and acute exacerbation on blood neutrophils phenotype and function.


Eligibility criteria:
inclusion criteria: * patient over the age of 18 who is not under legal protection * patients with cf according to the diagnostic criteria of the cystic fibrosis foundation including: * 15 patients with severe mutation but not chronically infected with pa and not treated with lumacaftor / ivacaftor * 15 patients homozygous phe508del, chronically infected with pa and not treated with lumacaftor / ivacaftor * 15 patients homozygous phe508del, chronically infected with pa and treated with lumacaftor / ivacaftor * 15 hospitalized patients for respiratory exacerbation * 40 patients initiating ivacaftor-tezacaftor-elexacaftor treatment. * no change in baseline treatment for 15 days (including antibiotic treatment). * patient affiliated to a social security system * free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study. exclusion criteria: * informed consent impossible to obtain * involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.

Keywords: blood neutrophils pseudomonas aeruginosa cystic fibrosis cftr modulators respiratory exacerbation airway chronic infection
desensitizers in reducing post tooth preparation sensitivity for a fixed dental prosthesis

Conditions: Dentin Hypersensitivity

Summary: the main purpose of the present study was to evaluate and compare the effectiveness of three kinds of commercially available desensitizing agents: gluma, sheildforce plus, and telio cs desensitizers in reducing the pre- and post-cementation sensitivity for full coverage restorations.

during the first visit, standard prosthodontic principles were followed to prepare the teeth for complete coverage restorations using high-speed handpiece and copious water-coolant spray. after the effect of local anesthesia was worn off, baseline sensitivity (first reading) was recorded on the vas using cold test and electric pulp test (ept) . final impression using addition silicon (virtual from ivoclar vivadent, amherst, ny) was made, and the provisional prosthesis was fabricated using protemp tm ii (3m espe, germany), by the direct method using polyvinyl siloxane putty (expresstm std, 3m espe) matrix. the first application of desensitizer was done then on the desensitizer group according to the manufacturer's recommendation. the fabricated provisional prosthesis was cemented with non-eugenol provisional cement tempbond ne (rely xtm tempne, 3m espe, germany) and the patient was recalled for the metal try-in. during the second visit, the provisional prosthesis was removed and the patient's response to cold test and ept was again recorded on vas (second reading) and the metal try-in was carried out. the second application of desensitizing agent was done, the provisional prosthesis was re-cemented, and the patient was recalled for final cementation. during the third visit, the provisional prosthesis was removed, the patient's response to cold test and ept was again recorded (third reading), and the third application of desensitizing agent was done before cementing the final prosthesis with g-cem resin cement. the control group had similar clinical steps except for the application of desensitizer, evaluation of sensitivity level subjective evaluation of pain produced by cold and electrical stimulus was done, for checking pre-cementation sensitivity. before starting the procedure, patients were explained about the cold test, ept, and the vas scores.

Eligibility criteria:
inclusion criteria: * the inclusion criteria were: minimum of one posterior tooth missing and patient in need of fixed dental prosthesis (porcelain fused to metal); abutment teeth with a vital pulp, normal apical periodontal ligament space, no history of hypersensitivity; and previous restorations not involving more than 50% of the coronal tooth surface. exclusion criteria: * the exclusion criteria were: patients with chronic diseases, gross oral pathology, or those undergoing any kind of medications; subjects with teeth that had extensive restorations, mobility or periodontal diseases; pregnant or lactating women; and individuals participating in any other clinical study.

Keywords: pre-cementation sensitivity, desensitizers
selective avoidance of sentinel lymph node biopsy after neoadjuvant chemotherapy in her-2 positive/triple negative breast cancer patients with excellent radiologic response to the breast and axilla, prospective, multi-center, single-arm (aslan) study

Conditions: Breast Cancer

Summary: the aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or her-2 positive breast cancer patients when physical examination expected complete remission. and radiological expected tumor size ≤ 2cm or non-mass enhancement ≤ 4cm.


Eligibility criteria:
inclusion criteria 1. 20≤age\<70 2. undergone neoadjuvant chemotherapy 3. her-2 or triple negative breast cancer 4. clinical stage t1-3, n0-1, m0 (ajcc 8th) 5. not inflammatory breast cancer 6. neoadjuvant chemotherapy should be done before surgery(sandwich method is not allowed) * least four times anthacycline or taxane-based regimens * no axilla lesion progression during chemotherapy * no period of adverse response during chemotherapy 7. undergone anti her-2 therapy in her-2 positive patient 8. no preoperative anti hormonal therapy 9. no preoperative radiation therapy 10. did not axillary lymph node biopsy before neoadjuvant chemotherapy 11. physical examination expected complete remission. and radiological expected tumor size ≤ 2cm or non-mass enhancement ≤ 4cm 12. no previous axilla surgery 13. no previous ipsilateral breast surgery for invasive cancer 14. no pregnancy-associated breast cancer 15. ecog performance status 0-1 16. serum or urine b-hcg negative 17. agree to the consent form exclusion criteria 1. during pregnancy 2. major depression or taking psychiatric medication 3. significant psychiatric disorder or history of taking antipsychotic drugs 4. any other lymph node metastasis than axillary lesion 5. undergoing total mastectomy 6. do not agree to the consent form

Keywords: aslan
a clinical trial of locally made titanium miniplate and screw in maxillofacial fractures management

Conditions: Maxillofacial Injuries; Maxillofacial Prosthesis Implantation; Fracture Fixation, Internal

Summary: the study is a blind randomized clinical study on patients with midface maxillofacial fractures coming to cipto mangunkusumo hospital. the subject is the fracture line who met the inclusion criteria and randomly allocated into the study (locally-made miniplate and screw) and control (biomet® miniplate and screw) group through a predetermined randomization list. the healing process is follow up using non-contrast head computed tomography immediately after surgery as a baseline, and 3 months post-op. afterward, a radiologist consultant as a blinded evaluator will evaluate the score of bone density, and screw loosening, while local tissue reaction after fixation evaluates during the patient's visit outpatient clinic. all scores from points of the evaluation group will be collected and going to statistically evaluated using independent t-test or mann whitney test depending on the distribution of the data


Eligibility criteria:
inclusion criteria: * midface fracture with the indication of surgery * midface fracture sustained within 2 weeks exclusion criteria: * comminuted and defect fracture * midface fracture on patients with systemic diseases affecting bone healing. * midface fracture in children * midface fracture in multiple trauma patients with neurological deterioration
effect of cupping therapy on nitric oxide level in patients with cervical spondylosis

Conditions: Cervical Spondylosis

Summary: this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis

cupping therapy is one of the oldest alternative medical procedures, along with acupuncture, with more than 3500 years of history to treat pain and various disorders. cupping induces various biological responses that could be evoked by suction of the skin, about 5 to 10 minutes of cupping causes extravascular blood within the subcutaneous tissue and creates bruise-like marks. therefore, cupping induces mild damage to a painful part of the body and accelerates healing by evoking the natural healing process. while this hypothesis is acceptable for some people, it might not be enough to change the minds of skeptics since cupping itself has no curative effects. suppose the healing process after cupping can be accelerated by merging cupping with scientifically proven techniques. in that case, this new form of therapy might help to persuade skeptics of the efficacy of cupping. integrative medicine, including acupuncture, dry needling, and cupping, is being used increasingly in the united states. evidence regarding their efficacy in the management of musculoskeletal conditions is heterogeneous and subject to several limitations. despite these limitations, acupuncture consistently is more effective than no treatment and is relatively safe. for chronic back pain, it is recommended as a first-line noninvasive therapy. for neck pain, acupuncture provides benefits when it is combined with other treatments. dry needling is similar to acupuncture and frequently is regarded as a form of acupuncture. sixty patients with cervical spondylosis will receive cupping therapy for three months.

Eligibility criteria:
inclusion criteria: * patients with (cervical spondylosis) from both sexes. * age range (24-60) in chronic stages. * bmi from20-25 kg/m2. exclusion criteria: * renal and hepatic patients. * anemia, hepatic disease, and dermatological diseases. * morbid obese patients if their bmi exceeds the 25 kg/m2 will be also excluded. * the patients are taking any medications known to affect the pain level * the patients have a systemic illness, dermatological problems, skin allergy, local ischemic problems

Keywords: cupping therapy cervical spondylosis
implementation of harmonized depression outcome measures in a primary care registry and a mental health registry

Conditions: Major Depression; Dysthymia

Summary: the purpose of this pilot project is to demonstrate feasibility and value of collecting harmonized outcomes measures for major depressive disorder (mdd) in two registries and combining the data to support patient-centered outcomes research.

the study is a longitudinal, multi-center observational feasibility study that will include data on eligible patients with a diagnosis of major depressive disorder (mdd). retrospective data on previous disease status and patient characteristics will be collected and combined with longitudinal data from these data sources on outcomes during the study timeframe. all data will be collected from institution electronic medical records (emrs), pro portals, and other existing data sources, as needed. two registries (psychpro and the prime registry) will participate in this feasibility study. a total of 20 sites participating in the registries (10 from each registry) will be recruited to participate in this study. to participate, sites must see adult patients with major depression or dysthymia and be willing to collect the phq-9 on a regular basis. sites will have the option of using the frequency, intensity, and burden of side effects ratings (fibser) scale to capture information on adverse events, but use of the fibser is not required.

Eligibility criteria:
inclusion criteria: * age \>=18 years * diagnosis of major depression or dysthymia as documented in the patient's emr exclusion criteria: * there are no exclusion criteria for this study.
long-term safety, tolerability and efficacy of idebenone in duchenne muscular dystrophy (delphi extension)

Conditions: Duchenne Muscular Dystrophy

Summary: the scientific aim of the present extension study is to monitor long-term safety and tolerability of idebenone in patients with dmd. furthermore, the long-term effect on respiratory, cardiac and motor functions, and skeletal muscle strength/function will be assessed.


Eligibility criteria:
inclusion criteria: * completion of study snt-ii-001 * body weight ≥ 25 kg * glucocorticosteroids and ace-inhibitors are allowed, if on stable dosage within 2 months prior to inclusion * eligibility to participate in the present extension study as confirmed by the investigator exclusion criteria: * safety or tolerability issues arising during the course of snt-ii-001 which in the opinion of the investigator preclude further treatment with idebenone * clinically significant abnormalities of haematology or biochemistry * abuse of drugs or alcohol * use of coenzyme q10 or idebenone within 30 days prior to inclusion * intake of any investigational drug within 30 days prior to inclusion * symptomatic heart failure * previous history of ventricular arrhythmias (other than isolated ventricular extrasystole); ventricular arrhythmias presented at baseline * known individual hypersensitivity to idebenone or to any of the excipients

Keywords: duchenne muscular dystrophy dmd duchenne idebenone
vitamin d and its metabolites quantification in adipose tissues of obese and non-obese patients.

Conditions: Obesity; Endocrine

Summary: vitamin d (vd) is a pleiotropic hormone, involved in many physiological processes including calcium and phosphorus absorption. the vd metabolism begin to be well-known and involves a hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome p450 family) leading to the production of the 25(oh)d, which corresponds to the circulating form of the vd. after circulation in blood, the 25(oh)d is submitted to a second hydroxylation in the kidney resulting to the generation of 1,25(oh)2d, the active metabolite of vd. numerous epidemiological studies reported an inverse relationship between obesity and circulation level of 25(oh)d. several mechanisms could explain the low level of 25(oh)d observed in obese subjects, the more classical evoked being based on sequestration and/or dilution of vd in adipose tissue (at), the main vd storage site. however, this mechanism has never been demonstrated. in order to confirm this hypothesis, the concentration of vd and its metabolites in adipose tissue need to be quantified. the objective of this study is to determine the concentration of vd and its metabolites in adipose tissue as well as adipose tissue mass quantification and distribution (visceral or subcutaneous) to highlight putative difference of vd and its metabolites quantities between obese and non-obese patients. a quantification of vd metabolism, inflammation and lipid metabolism gene expression will be realized on biopsies. correlations between gene expression and quantity of vd in tissue will be carrying out.


Eligibility criteria:
inclusion criteria: * subject with a bmi greater than 35 kg / m2 (group ob) or less than 30 kg / m² (group no) * subject undergoing bariatric surgery (ob group) or abdominal surgery (group no) exclusion criteria: * regular intake of dietary supplements or vitamin supplements in the last three months * for the subjects of the group no: * malnourished patient (bmi \<18.5 kg / m2, weight loss greater than 5% in 1 month or 10% in 6 months) * subject with an infection or inflammatory syndrome (crp\> 10 mg / l and / or white blood cells\> 12000 / mm3) * non-cancerous subject
a research study of how nnc0174-0833 behaves in japanese and caucasian volunteers who are normal weight, overweight or with obesity

Conditions: Obesity; Overweight

Summary: the aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. the study compares japanese and caucasian people who are normal weight, overweight or with obesity. the participants will either get nnc0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. participants will get 1 injection by a study nurse at the clinic. the injection will be with a needle in a skin fold in the participant's stomach area. the study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. the participants will have 8 clinic visits with the study staff.


Eligibility criteria:
inclusion criteria: * male, aged 18-55 years (both inclusive) at the time of signing informed consent. * for japanese subjects, both parents of japanese descent and both paternal and maternal grandparents of japanese descent. * for caucasian subjects, self-reported european descent or white latin-american descent. * body mass index (bmi) between 20.0 and 39.9 kg/m\^2 (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator. * body weight between 60 and 110 kg (both inclusive) at screening exclusion criteria: * male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner\[s\] of childbearing potential), who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (pearl index less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product. * any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
maintenance effect of clobex shampoo on participants with moderate to severe scalp psoriasis

Conditions: Scalp Psoriasis

Summary: the objective of the study was to assess the maintenance effect on scalp psoriasis of clobex® shampoo 0.05% when used twice weekly.

psoriasis was a chronic disease that was affecting skin, the scalp and joints. scalp psoriasis was very common and was having an important impact on people's life. primary objective of scalp psoriasis treatments was to gain initial and rapid control of the disease process with a minimum of side-effects and improve patient quality of life. still, one of the unmet needs of scalp psoriasis therapies was the maintenance of a long-term remission. for corticosteroids in particular, one of the drawbacks was the disease recurrences after cessation of the treatment. therefore, the establishment of a modified corticosteroid dosing regimen that would allow remission with minimal side-effects was suitable. the purpose of this study was to assess how long a patient successfully maintained in a good condition after use of clobex® shampoo only twice a week.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 years or older. * subjects with moderate to severe scalp psoriasis exclusion criteria: * subjects who needed systemic treatment for their body psoriasis * subjects with a washout period for topical treatment(s) on the scalp less than: * corticosteroids 2 weeks * all other anti-psoriasis medications 2 weeks * subjects with a washout period for systemic treatment(s) less than: * puva therapy 4 weeks * biological therapies 12 weeks * treatments other than biologicals with a possible efficacy on psoriasis 4 weeks * treatment known to worsen psoriasis 2 weeks

Keywords: maintenance scalp psoriasis galderma