Kornimate/medical-research-clean huggingface dataset:
safety study of plasma treatment system to treat back acne

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate the safety of treating human skin with atmospheric plasma and get an initial evaluation of the efficacy of this treatment for acne.


Eligibility criteria:
inclusion criteria: 1. males and non-pregnant, non-nursing females age 18-40 years old. 2. presence of clinically-evident back acne. 3. minimum of 20 non-inflammatory lesions (open and closed comedones) 4. minimum of 30 total lesions (sum of inflammatory and non-inflammatory) 5. subject must have measurable sebum production. 6. subjects must be in generally good health. 7. must be able and willing to comply with the requirements of the protocol. exclusion criteria: 1. any nodulo-cystic lesions at baseline 2. pregnancy or breast feeding 3. use of acne devices or systemic therapy with antibiotics within four months prior to start and throughout the duration of the study 4. intake of any oral retinoids within four months prior to study start and throughout the duration of the study 5. topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study 6. topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study 7. use of an experimental drug or device within 30 days prior to study start; 8. intake of hormonal therapy within 3 months prior to study start 9. use of topical products on the back containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids. 10. concomitant use of mega-doses of certain vitamins, such as vitamin d (\>2000iu qd) vitamin b12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital. 11. procedures on the skin of the back such as chemical or laser peel, microdermabrasion, photodynamic therapy) within the past 2 weeks or during the study. 12. history or evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication 13. any significant medical conditions that could confound the interpretation of the study results. 14. history of/or current skin cancer cancer 15. use of tanning booths, sun lamps within the past 2 weeks or during the study 16. any metallic implants or prostheses in the vicinity of the treatment site (such as shoulders, back, spine, pacemakers, etc.). 17. any known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study. 18. history of significant post-inflammatory hyperpigmentation at the sites of acne lesions. 19. history of or is currently immunocompromised.
hexetidine and chlorobutanol for lesions due to prostheses

Conditions: Oral Mucositis

Summary: objectives: the study aimed at assessing the efficacy of a new mouthwash in treating oral lesions due to removable prostheses. methods: the present prospective randomized clinical trial was performed on 44 patients. the experimentation lasted for 4 weeks and 4 operators participated. the effects of the mouthwash were evaluated subjectively and objectively, with questionnaires, visual analogic scales and clinical examinations. the results were statistically analyzed. the following variables were recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of pain after rinsing.

the aim of the present prospective, randomized, triple-blind controlled clinical trial was to evaluate the efficacy of an innovative mouthwash (emulsion) in the treatment of lesions of oral mucosae due to removable prostheses. the tested preparation contained two active molecules: a topical antiseptic (0.1% hexetidine) and a local anesthetic (0.5% chlorobutanol).

Eligibility criteria:
inclusion criteria: * use of removable partial or complete dentures; * presence of lesions of oral mucosae due to dentures; * absence of any concomitant local or systemic pathology; * absence of pregnancy or breastfeeding; * negative allergic anamnesis; * negative anamnesis for recurrent aphthous stomatitis; * no taking medicines with potential pharmacologic interactions with molecules to be tested; * no taking antibiotics and/or painkillers for at least 6 months before entering the experimentation; * good oral hygiene with a full-mouth plaque score ≤25%; * non smoking or light smoking (≤10 cigarettes/day) status. exclusion criteria: missing one or more of the above described conditions automatically excluded a subject from the study.
enteral feeding and splanchnic nirs values in infants with neonatal encephalopathy (ne)

Conditions: Neonatal Encephalopathy

Summary: the research team plans to administer trophic enteral feeds to infants with neonatal encephalopathy that are undergoing therapeutic hypothermia. the team will monitor splanchnic nirs values and compare these values to a group of historic infants who underwent hypothermia but did not receive feeds, to investigate whether there may be a range of values that can predict safe feeding. the team will also look at some clinical outcomes including feeding tolerance, time to achieve full enteral feeds, infection rates, length of hospital stay.


Eligibility criteria:
inclusion criteria: * subjects greater than or equal to 35 completed weeks of gestation, on the first day of life * birth weight greater than or equal to 1800g * infants diagnosed with moderate-severe encephalopathy based on the modified sarnat scoring system * infants that qualify to receive therapeutic hypothermia as part of our unit protocol exclusion criteria: * premature infants \< 35 completed weeks of gestation * infants with birth weight \< 1800g * patients in whom th is contraindicated including those with major congenital anomalies, suspected chromosomal anomaly such as trisomy 13 or 18, significant / large intracranial hemorrhage, or severe coagulopathy with active bleeding. * parent or guardian unable or unwilling to provide consent * infants requiring high doses of vasopressors including dopamine \> 10mcg/kg/min or any 2 vasopressor agents simultaneously. * infants with evidence of gastrointestinal ischemia as evidenced by the presence of bloody stools. * infants with suspicion for gastrointestinal malformation, or obstruction as evidenced by bilious emesis or abdominal distension. * srso2 \< 45% within the first 24 hours of life, prior to initiation of enteral feeds.

Keywords: enteral feeds therapeutic hypothermia
rct comparing robotically-assisted vs. manually-executed total knee arthroplasties

Conditions: Osteoarthritis

Summary: this study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty.

although total knee arthroplasty (tka) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. contemporary designs have bolstered durability, but longer life expectancies have placed an even greater emphasis on survivorship. additionally, patient satisfaction remains an issue. a prospective randomized clinical trial (rct) is proposed to compare robotically-assisted versus manually executed primary (tkas). this study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. patients will be randomized to receive either a robotically-assisted or a manually-executed primary tka.

Eligibility criteria:
inclusion criteria: * include all patients who are surgical candidates for primary tka with unilateral osteoarthritis * all eligible male or female patients between the ages of 20 years to 100 years old * all included study participants must be able to give an informed consent. exclusion criteria: * significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella * the presence of infections, highly communicable diseases (e.g. aids), active tuberculosis, venereal disease, hepatitis. * significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing. * presence of previous prosthetic knee replacement devices (of any type) * metastatic disease * psychiatric illness * drug or alcohol abuse * body mass index (bmi) \> 40 kg/m2
household participants

Conditions: Type 2 Diabetes; Hypertension; Dyslipidemias; Overweight and Obesity

Summary: native hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. in this project, the investigators will adapt and test an evidence-based multilevel intervention entitled pili 'āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. the objectives of this project are to optimize the effectiveness and sustainability of pili 'āina, improve diet quality, cardiometabolic markers, promote traditional native hawaiian diets, and improve social cohesion.

the investigators will conduct a group-randomized controlled trial to test the effectiveness of pili aina for improving diet and health at the individual and household levels compared to a diabetes prevention program lifestyle intervention only group. the investigators will enroll 180 native hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition (type 2 diabetes, pre-diabetes, hypertension, pre-hypertension, dyslipidemia). these index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month pili aina intervention or to a control group. data collection will occur at baseline and 3, 9, and 12 months. other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects.

Eligibility criteria:
inclusion criteria: * current resident of the household in which an index participant lives * willing to complete data collection protocols * fluent in written and spoken english exclusion criteria: -
analysis of patterns of recurrence in head and neck cancer using clinicopathomic markers

Conditions: Head and Neck Neoplasm; Squamous Cell Carcinoma of Head and Neck

Summary: here, the investigators will develop a clinicopathomic assay from biomarkers obtained from digital pathologies of resected whole-mount oral cavity and oropharyngeal squamous cell carcinoma (ocscc and opscc) specimens with the goal of administering personalized novel image-guided therapies immediately after primary surgical management in ocscc and opscc patients. the primary aim is to determine the association between clinicopathomic biomarkers and lrr. the secondary aim is to develop a clinicopathomic risk score (assay) such that a decision-support tool can be used by physicians for measuring the benefit of additional therapies (i.e. conventional chemotherapy +/- radiation or administering dose-escalated chemoradiation) in the adjuvant setting to reduce lrr rates.

the proposed study is significant for developing personalized treatments. the proposed research will yield high rewards to patients by providing additional information to clinicians for better prognostication and potentially adapting adjuvant treatments to improve the survival of patients with ocscc or opscc.

Eligibility criteria:
inclusion criteria: * participants must be men and women age 18+ * confirmed diagnosis of oral cavity or oropharyngeal squamous cell carcinoma * participants must have received or will undergo surgery to excise the primary oropharyngeal tumor. exclusion criteria: * participants who had other primary cancers prior to oral cavity or oropharyngeal cancer

Keywords: radiomics pathomics head and neck cancer biomarkers machine learning artificial intelligence squamous cell carcinoma
effectiveness of resargin on adult's body composition and health

Conditions: Weight Loss

Summary: the goal of this clinical trial is to learn if the supplement resargin (a reservatrol-based supplement) works to slow down muscle loss during a period of fat loss. other related health outcomes such as sleep, mood, and activity will be assessed. the main questions it aims to answer are: does resargin improve muscle loss? does resargin improve sleep quality, activity, mood, and body satisfaction. researchers will compare resargin to a placebo (a look-alike substance that contains no active ingredients) to see if resargin works to improve muscle loss and related health outcomes. participants will: take resargin or the placebo every day for 3 months assessment will occur at baseline, day 30, day 60, and day 90. participants will complete a daily diary of their mood and health.

study purpose: examine the effectiveness of resargin in attenuating muscle loss during a period of fat loss in overweight and mildly obese men and women. outcomes: primary outcomes will be body composition. secondary outcomes will be physical activity, food cravings, health-related quality of life, body satisfaction, basal metabolic rate, sleep behaviors, mood, anxiety, and perceived stress. study design • randomized double-blind placebo-controlled trial o n = 60 men and women (30 adults in the resargin condition and 30 adults in the placebo condition).

Eligibility criteria:
inclusion criteria: * overweight and mildly obese adults * age range between 25 to 60 years exclusion criteria: * metabolic or endocrine related dysregulation including but not limited to: diagnosis of type i or type ii diabetes, liver, kidney, or pancreatic dysfunction. * history of seizures or epilepsy-related disorders * musculoskeletal issues that would prohibit them from engaging in spontaneous activity, * metabolic disorder * sleep disorder * psychiatric condition * dietary aversions or restrictions including any animal sources of protein, dairy, fruits/vegetables, nut/seed allergy, eggs, and wheat/gluten or are currently following a carbohydrate restricted (under 20%) habitual diet. * smokers * consume excessive amounts of alcohol (\>3 drinks/d) * actively intermittent fasting * actively trying to lose weight or have lost more than ± 3kg in previous 3 months * pregnant * nursing * trying to conceive * changed their birth control in the past 3 months.
alteplase treatment in elderly acute ischaemic stroke (ais) patients

Conditions: Stroke

Summary: the objective of this study is to find out if chinese acute ischaemic stroke (ais) patients older than 80 years benefit from intravenous (iv) recombinant tissue plasminogen activator (rt-pa) treatment within 4.5 hours of symptom onset in a real-world clinical setting.


Eligibility criteria:
inclusion criteria: * patients registered in the zhejiang stroke quality control centre (zsqcc) platform from jan 2017 to mar 2020 * \> 80 years of age * diagnosed with ais at admission * arrived or admitted to the hospital within 4.5 hours of symptom onset * if treated with iv rt-pa: received iv rt-pa within 4.5 hours of symptom onset exclusion criteria: * documented intravenous thrombolysis (ivt) contraindication except age to iv rt-pa treatment according to the summary of product characteristics (smpc) * missing any one of the key data (age, gender, baseline national institutes of health stroke scale \[nihss\], time of symptom onset, time of hospital arrival or admission, ivt or not, time of iv rt-pa treatment) * received thrombolysis agents other than rt-pa (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase) * received endovascular treatment * received iv rt-pa after 4.5 hours of symptom onset
pituitary function and spontaneous intracranial hypotension

Conditions: Hyperprolactinemia; Spontaneous Intracranial Hypotension

Summary: previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns. typical magnetic resonance imaging findings include subdural fluid collections, enhancement of pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the brain (seeps). because pituitary hyperemia has been documented in cases of spontaneous cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the investigators would like to like to assess the clinical manifestations and neuroimaging abnormalities of sih patients with regard to the pituitary gland. specifically, the investigators are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in sih patients.


Eligibility criteria:
inclusion criteria: * male or female patients * age 18 years and older * diagnosis of sih: * lp * brain mri (seeps) exclusion criteria: * pregnant and post-partum females * nursing mothers * patients with potential hyperprolactinemia due to: * hypothyroidism, * chronic renal disorder * liver disease (including cirrhosis) * primary or secondary amenorrhea * polycystic ovary syndrome * seizure disorder * illicit drug use
a study of epothilone d in combination with herceptin (trastuzumab) in patients with her-2 positive advanced or metastatic breast cancer

Conditions: Breast Cancer

Summary: this single arm study will determine the efficacy and safety of an epothilone d and herceptin combination regimen in patients with her-2 positive locally advanced or metastatic breast cancer. epothilone d will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. the anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * women \>=18 years; * locally advanced or metastatic breast cancer; * her-2 overexpression (fish + or ihc 3+); * \>=1 measurable lesion; * up to one prior anthracycline-based chemotherapy regimen in a metastatic setting. exclusion criteria: * pre-existing neuropathy \>=grade 2; * known cns metastases; * congestive heart failure, or myocardial infarction within the last 6 months; * previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.
the health promoting conversations for families with a critically ill relative

Conditions: Family Health

Summary: objective: we investigated the outcomes of a nurse-led family intervention, health promoting conversations, which focused on family functioning and wellbeing in families with a critically ill member. study design: this randomized controlled pilot study used a pre-test, post-test design with intervention and control groups to investigate the outcomes of the nurse-led intervention in 17 families. outcome measures: the health promoting conversations intervention was evaluated using validated instruments that measure family functioning and family wellbeing: the general functioning sub-scale from the mcmaster family assessment device; the family sense of coherence, the herth hope index, and the medical outcome short-form health survey. descriptive and analytical statistical methods were used to analyse the data.

this randomized control trial (rct) used a pre-test, post-test design with intervention and control groups. in the intervention group, there were 3 health-promoting conversations with each family after the discharge. the health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. a closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection. baseline data were collected to assess family functioning and wellbeing in the intervention group and the control group 1-2 months after the critical illness and before the start of the intervention. follow-up assessments were conducted 3 and 12 months after the intervention for both groups. additionally, background data, including health history, were collected using a self-administered questionnaire that asked about age; sex; education level; habits like smoking, alcohol consumption, and physical activity; psychosocial support; co-morbidity; and risk of mortality. the latter was calculated using the charlson comorbidity index (charlson et al., 1987). the main outcome variables in this study were family functioning and family wellbeing. the following instruments were used in this study: 1) general functioning (gf) sub-scale from the mcmaster family assessment device (fad); 2) family sense of coherence (f-soc/f-kasam); 3) herth hope index (hhi); and 4) medical outcome short-form health survey (sf-36).

Eligibility criteria:
inclusion criteria: * patient age \>18 years * patient treated in the icu for at least 96 hours * at least one family member (age \>15 years) interested in participating exclusion criteria: * dementia * or other severe psychiatric illnesses * drug abuse * difficulties in understanding or reading the swedish language

Keywords: family relations family health intervention study social support intensive care unit
dose escalation by boosting radiation dose within the primary tumor using 18fdg-pet/ct for unresectable thoracic esophageal cancer

Conditions: Esophageal Cancer

Summary: most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (gtv). and the metabolic active areas post-treatment were located in the high fdg uptake areas prior to the radiotherapy. the hypothesis is that selective dose boost to the esophageal gtv could be safely delivered using a simultaneous integrated boost (sib) technique, and that boosting the high 18f-deoxyglucose (fdg) uptake areas of the esophageal gtv defined prior to treatment may improve local tumor control.


Eligibility criteria:
inclusion criteria: 1. histopathologically proven diagnosis of esophageal squamous cell carcinoma. 2. ecog performance status 0-1. 3. able to swallow semifluid diet. 4. patients must not have received either radiotherapy or chemotherapy. 5. technically unresectable, medically inoperable, or surgery declined by the patient. 6. suvmax in the pre-treatment fdg-pet scan \> 5 for the primary tumor and the length of the primary tumor ≤10cm. 7. normal liver and renal function and adequate bone marrow reservation. 8. meet the requirements of the dose limitation to the critical organ: v20≤25%，dmean≤15gy for lung; dmax ≤45gy for spinal cord，dmean ≤20gy for liver. 9. written, signed informed consent. exclusion criteria: 1. other malignancy histology. 2. any evidence of visceral metastases. 3. prior radiotherapy to the thorax or systemic therapy for esophageal cancer. 4. evidence of deep esophageal ulcer or esophageal perforation. 5. weight loss ≥10% within half year or cachexia. 6. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 7. history of cardiac disease: congestive heart failure \> nyha class 2, active cad, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months. 8. concurrent uncontrolled medical conditions. 9. pregnant or lactating women. 10. drug addiction, alcoholism or aids. 11. uncontrolled seizures or psychiatric, behavioural disorders.