Kornimate/medical-research-clean huggingface dataset:
preliminary assessment of the efficacy of the vascuactive™ device on diabetic peripheral neuropathy

Conditions: Diabetic Neuropathy, Painful

Summary: the purpose of this study is to assess the safety and the preliminary efficacy of treatment by the vascuactive device on peripheral diabetic neuropathy, and to correlate this effect with physiologic changes. patients will undergo a 4-week period of home treatment by the vascuactive device, and will be monitored during this period and during a two-month follow-up period for the efficacy of the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.


Eligibility criteria:
inclusion criteria: * diabetes mellitus (type 1 or 2) * age 18 years or older * no changes within the last 3 months in diabetes medications, pain management medications, and symptoms associated with diabetes * painful diabetic neuropathy \> 3 months, but not more than 5 years * pain level ≥ 4 on an 11 point numerical pain rating scale in both feet (average of two measurements, at least 1 week apart, during the 2 weeks prior to first treatment) * loss of protective sensation by the 5.07 semmes-weinstein monofilament (swm, 10gr.) monofilament test (in both feet, at least at 3 out of 10 points in each foot) exclusion criteria: * known or suspected radiculopathy (based on patient's record and anamnesis) * any painful condition that is difficult to distinguish from painful diabetic peripheral neuropathy * women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive * severe cardiac disease or surgery within last 3 months, e.g., acute myocardial infarction, congestive heart failure grade 3 or higher * any major infectious, malignant or other severe systemic disease, including but not limited to acquired immune deficiency syndrome (aids), hepatitis, creutzfeldt-jakob disease * patient is incompetent to comply with study requirements (in the investigator's opinion)
comparison of piezoelectric and conventional surgery for germectomy of the lower third molar

Conditions: Tooth Disease; Piezoelectric Technique; Tooth Impacted; Tooth Extraction Status Nos; Tooth Avulsion; Facial Swelling; Germectomy

Summary: the main objective of the study is to compare the effects of the piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars

the main objective of the study is to compare the effects of piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars. post-operative swelling is analyzed using a photogrammetry facial scanner (marathon mt-4000).

Eligibility criteria:
inclusion criteria: * patients aged between 14 and 24 years, with both lower third molars in the developmental stage (with incompletely formed roots) and requiring extraction of both for prophylactic, therapeutic or strategic reasons * good quality of radiographic investigations (cbct) * good health status

Keywords: third molar surgery facial swelling 3d facial swelling evaluation piezoelectric technique tooth impacted piezosurgery germectomy
a prospective study of the nuvance facial rejuvenation system for mid-face, neck and jowl rejuvenation procedures

Conditions: Ptosis of the Neck, Mid-face and/or Jowl

Summary: the objective of this study is to evaluate the clinical tolerability of the nuvance™ facial rejuvenation system for correcting neck, mid-face and/or jowl ptosis.

this is a multicenter, prospective, single-arm study. the primary tolerability endpoint will be evaluated up to 30-days post-operatively. secondary endpoints will be evaluated at 6-months. extended follow-up will be conducted at 12-months, 24-months, and 36-months.

Eligibility criteria:
inclusion criteria: * male or female subject older than 18 years. * subject is a candidate for minimally invasive, bilateral facial rejuvenation procedure using nuvancetm facial rejuvenation system according to the device instructions for use (ifu). * subject is willing and able to provide informed consent and follow study-related requirements. exclusion criteria: * subject who previously received surgical facial cosmetic treatment (procedure involving an incision): 1. within the last 12 months under the area of the forehead; 2. within the last 3 months within the area of the forehead where forehead is defined as the area above the imaginary anatomical line between the lateral canthus of the eye and the upper pole of the ear. * subject who previously received a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within the last 9 months. * subjects with a permanent facial implant. * subjects planning on a cosmetic procedure with a permanent implant within 6-months of procedure. * subjects planning on a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within 6-months of procedure. * subjects with significant ptosis where skin excision would be necessary. * subject has an active infection (e.g. acne, herpes zoster) or inflammation (e.g. psoriasis, pemphigus vulgaris, cutaneous lupus erythematosus) affecting facial skin. * subject has a history of a disorder that can affect wound healing (e.g. subjects pre-disposed to infection or history of keloid formation). * subject with pre-existing facial abnormalities (e.g. deformities, bell's palsy, scarring) * subject with a significant psychiatric disorder judged by the clinical investigator that will interfere with the procedure * any pre-operative findings that the surgeon identifies that makes the subject not a candidate for a minimally invasive facial cosmetic surgical procedure.

Keywords: facelift rhytidectomy ptosis
observational study of adherence to laba / lama in chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of the study is to observe the effect of adherence to once-daily administered long-acting bronchodilators (long-acting ß2-agonists \[labas\] / long-acting muscarinic antagonists \[lamas\]) on patients health related quality of life (hr-qol) and to assess the relation between symptoms improvement and adherence to chronic obstructive pulmonary disease (copd) maintenance therapy


Eligibility criteria:
inclusion criteria: 1. male or female, above 40 years of age 2. patients clinically diagnosed of copd with no history suggestive of asthma: 1. by scores \>=5 in the copd population screener, 2. by a clinical diagnosis of copd made by pulmonologists or internists, 3. by a forced expiratory volume (fev1)/ forced vital capacity (fvc6) ratio of \<=0.70 and a fev1 \<=80% of the predicted value as assessed by copd-6 (vitalograph, uk); 3. maintenance treatment-naïve copd patients who have been prescribed once daily long-acting bronchodilators (labas / lamas) for the first time at enrolment into the study 4. patients who are able to provide signed informed consent 5. patients who agree to be contacted for telephone/ sms reminders via call center exclusion criteria: 1. patients with contraindications to the prescribed medication 2. patients with any disorder that would prevent the patient from being able to complete questionnaires either verbally or by self-completion 3. pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception
nlr and prl in neurocognitive disorders

Conditions: Neurocognitive Disorders; Neutrophil-Lymphocyte Ratio; Platelet-Lymphocyte Ratio

Summary: preliminary evidence suggest a possible relationship between neutrophil-lymphocyte ratio (nlr) and platelet-lymphocyte ratio (plr) and perioperative neurocognitive disorders (ncd). we are going to investigate whether the values of nlr and plr in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative ncd.

it is estimated that approximately 10% of elderly undergoing surgery will develop cognitive changes perioperatively, while in some reports the incidence rises up to 80%. despite the reported high prevalence of perioperative neurocognitive disorders (ncd), their exact etiology is still largely unknown. preliminary evidence suggest a possible relationship between neutrophil-lymphocyte ratio (nlr) and platelet-lymphocyte ratio (plr) and perioperative neurocognitive disorders (ncd). we are going to investigate whether the values of nlr and plr in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative ncd.

Eligibility criteria:
inclusion criteria: * 45 - 80 years * american society of anesthesiologists physical status i to iii * elective general, urological, gynecological and orthopedic surgery under general anesthesia * native speakers of the greek language exclusion criteria: * refused to participate or sign the informed consent form * had undergone surgery or anesthesia within the last 30 days * had any prior or current history involving an affliction of the central nervous system * were diagnosed with severe cognitive decline based on the 16 - item informant questionnaire on cognitive decline (iqcode - 16) * suffered from severe hearing or visual impairment * any psychiatric disorder * had a score \>5 in the geriatric depression scale (gds - 15) * or a score in females \< 4 males \< 2 in the lawton - brody instrumental activities of daily living scale (i.a.d.l.) * reported alcohol consumption \> 35 units/week * drug dependence * had undergone previous neuropsychological testing * diabetes mellitus type ii with \> 10 years of diagnosis * diabetes mellitus type i * hemoglobin a1c (hba1c) \> 7.5% * suffered from hemodynamical instability (\> 20% alterations of blood pressure perioperatively) * or desaturation (one or more events of spo2 \< 80% for more than 2 minutes) peri-operatively * or blood loss of more than one unit

Keywords: neurocognitive disorders neutrophil-lymphocyte ratio platelet-lymphocyte ratio
sphenopalatine ganglion block for postdural puncture headache

Conditions: Postdural Puncture Headache

Summary: background: postdural puncture headache (pdph), which is one of the complications of spinal anesthesia, is a condition that negatively affects the quality of life of patients, causes late mobilization and prolonged hospital stay. sphenopalatine ganglion block (sgb) has created a minimally invasive, easy, and safe treatment alternative. objective: evaluating the effectiveness of topical sgb on pdph treatment. design: retrospective observational study setting: single center tertiary level of care hospital study. the files of pdph patients between jan 2018 and jan 2020 were scanned. patients: pdph patients aged 18-65 are included and any patients with primary/secondary headache history are excluded. main outcome measures: patients were divided into 2 groups. the group that given only conservative treatment was named as group c, and the group of patients who had additionally been applied sgb was named as group sgb. headache severity was measured with visual analogue scale (vas) at the 1st,3rd, 12th and 24th hours of the treatment, in supine and upright position.


Eligibility criteria:
inclusion criteria: * 18-65 years-old * not having any headache diagnosis (g44 and subgroup according to the international classification of diseases-10 classification), * developed pdph according to the international headaches classification after the neuraxial procedure exclusion criteria: * history of primary headaches such as migraine, cluster type, tension type * secondary headache such as preeclampsia / eclampsia, cerebral venous thrombosis, stroke, ruptured aneurysm, hypertensive encephalopathy, pituitary apoplexy, meningitis and subarachnoid hemorrhage * any local or systemic infection

Keywords: sphenopalatine ganglion block postdural puncture headache
higher dose weekly topotecan in the treatment of patients with extensive stage small-cell lung cancer

Conditions: Small Cell Lung Cancer; Carcinoma, Small Cell

Summary: this proposed phase ii trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. to help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. this trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage sclc.

all patients will receive weekly topotecan. topotecan 6mg/m2 iv weekly x 6 consecutive weeks followed by a 2 week break. cycles are repeated every 8 weeks, for 3 cycles. restaging studies will be performed every cycle (or 8 weeks.)

Eligibility criteria:
inclusion criteria: * extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen * measurable or evaluable disease * able to perform activities of daily living with minimal assistance * adequate bone marrow, liver and kidney function * may have received no more than 3 previous courses of radiation therapy * give written informed consent prior to study entry exclusion criteria: * patients with limited stage disease * history of a prior malignancy within three years * female patients who are pregnant or are breast feeding * significant history of uncontrolled cardiac disease * myocardial infarction or stroke within six months * symptomatic peripheral vascular disease * cns involvement * serious active infection or underlying medical condition

Keywords: lung cancer extensive stage small cell lung cancer
influence of sodium intake in spondyloarthrites

Conditions: Spondyloarthritis, Axial; Arthritis, Psoriatic

Summary: the aim of the salt study is to analyze the relationship between dietary sodium intake and disease activity in patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis.


Eligibility criteria:
inclusion criteria: * patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis * women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potentiale, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches) exclusion criteria: * catient treated by cyclosporine, diuretics, angiotensin-converting enzyme inhibitors or angiotensin ii receptor antagonists. * current treatment with an anti-il-17a agent (secukinumab or ixekizumab or bimekizumab or brodalumab) or with an anti-il23 agent (ustekinumab, guselkumab, risankizumab or tildrakizumab) or previous treatment less than 6 months old. * patients on systemic corticosteroids with corticosteroid therapy \> 10 mg prednisone equivalent * pregnant woman

Keywords: sodium intake
poem versus pneumatic dilatation in achalasia cardia

Conditions: Achalasia Cardia

Summary: the aim of this study is to compare efficacy of poem and pneumatic dilatation in treatment of achalasia cardia.

achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (les). achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. endoscopic treatments of achalasia can be provided in the form of dilatation of the les or cutting of muscle fibers (myotomy) of the esophagus and of the les under endoscopic viewing. dilatation in this trial is accomplished with rigiflex balloons and myotomy via per oral endoscopic myotomy (poem). the effectiveness of treatment of achalasia using each method will be compared in this trial.

Eligibility criteria:
inclusion criteria: 1. achalasia with eckardt score at least 3 (0-12 scale achalasia least-most severe) 2. age 18-75 years 3. willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study exclusion criteria: 1. severe comorbid illness 2. previous esophageal or gastric surgery 3. pseudo achalasia 4. achalasia with esophageal diverticula 5. pregnancy or lactation

Keywords: achalasia poem pneumatic dilatation eckardt score
biomed 101 and interleukin-2 in treating patients with kidney cancer

Conditions: Drug Extravasation; Kidney Cancer

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. biomed 101 may protect normal cells from the side effects of interleukin-2. purpose: phase i trial to study the effectiveness of biomed 101 in treating patients receiving interleukin-2 for kidney cancer.

objectives: i. evaluate the safety and maximum tolerated dose of biomed 101 in patients with renal cell cancer currently treated with interleukin-2 (il-2). ii. evaluate the effect of different doses of biomed 101 on the incidence and severity of il-2 related toxicities and on the incidence and frequency of il-2 dose reduction due to il-2 induced toxicity. outline: this is a dose escalation study of biomed 101. patients receive oral biomed 101 three times daily, followed by interleukin-2 iv on days 1-5 and 16-20. cohorts of 5 patients receive escalating doses of biomed 101 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicities. patients are followed for 1 month. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed renal cell cancer no cns metastases patient characteristics: age: 18 and over performance status: ecog 0-1 life expectancy: at least 12 weeks hematopoietic: wbc at least 2,000/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9 g/dl hepatic: no hepatic failure no encephalopathy bilirubin no greater than 2.5 times upper limit of normal (uln) ast or alt no greater than 2.5 times uln renal: no renal dysfunction requiring dialysis for greater than 72 hours creatinine no greater than 2.0 mg/dl cardiovascular: no history of sustained ventricular tachycardia (greater than 5 beats) no uncontrolled cardiac rhythm disturbances no recurrent chest pain with echocardiogram changes no angina no myocardial infarction no pericardial tamponade no moderate or severe coronary artery disease (new york heart association class 3 or 4) other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no significant neurological dysfunction including seizure or clinical signs of other significant neurological disease no gastrointestinal bleeding requiring surgery no concurrent infection requiring antimicrobial therapy no bowel ischemia or perforation prior concurrent therapy: at least 30 days since prior investigational drugs no other concurrent investigational drugs no intubation required for greater than 72 hours no prior enrollment in this study

Keywords: stage i renal cell cancer stage ii renal cell cancer stage iii renal cell cancer stage iv renal cell cancer recurrent renal cell cancer drug extravasation
effect of dexmedetomidine on the prevention of emergence agitation in children undergoing day surgery

Conditions: Ambulatory Surgical Procedures

Summary: emergence agitation/delirium (ea/ed) is a common complication in pediatric surgery patients, which increases the risk of developing postoperative airway obstruction and respiratory depression. in infants, there is a high incidence of emergence agitation (ea) after desoflurane anesthesia. the aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (dex) that would prevent postoperative ea and ed in children undergoing day surgery with desoflurane anesthesia

subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years group, and 3-12 years group. then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0, 0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.

Eligibility criteria:
inclusion criteria: 1. patients who undergo elective unilateral inguinal hernia or hydrocele testis day surgery 2. patients who are american society of anesthesiologists classification i and ii 3. patients who are 4 months through 15 years of age exclusion criteria: 1. children with history of respiratory tract infection 1 week preoperatively. 2. patients with preoperative liver and/or kidney dysfunction, or with mental abnormalities. 3. patients with any congenital malformation or acquired disease that could increase the risks of anesthesia and the dose of anesthetics (such as, but not limited to, congenital heart disease, hydronephrosis, nutrition dysplasia). 4. patients with long-term use of sedative or analgesic drugs.

Keywords: emergence delirium desoflurane general anesthesia
a pilot study to explore the role of gut flora in lupus

Conditions: Lupus Erythematosus; Lupus Erythematosus, Systemic

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to lupus.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. may be signed by parent or legal guardian in the case of minor or adult unable to provide consent 2. male or female of all ages. (interest is given to children who present with autism or crohn's and whose parents wish to analyze their children's gut flora. also of interest analysis of development of the child's microbiome. in the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) 3. diagnosis of lupus by a physician exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition
pain quality study

Conditions: Low Back Pain; Headache; Fibromyalgia

Summary: one way to better understand how various treatments for pain differ is to determine the effects of these treatments on different pain qualities or characteristics. for example, pain can be described as "hot", "electrical", "cold", "achy", and "piercing." in order to determine which pain quality/qualities that a pain treatment affects, researchers must develop measures of these pain qualities or characteristics. the purpose of this study is to learn more about the different pain qualities individuals who have low back pain, headaches and fibromyalgia experience. identifying the common qualities of pain experienced by these groups will help researchers evaluate and develop more comprehensive pain quality measures, which will ultimately help them to be able to test the effectiveness of treatments for these different pain qualities.


Eligibility criteria:
inclusion criteria: * speaks and understands english; * at least 18 years of age; * confirms a diagnosis from a physician or certified medical provider of one of the three medical conditions (low back pain, headache, fibromyalgia), and that pain related to this diagnosis is still bothersome. * has experienced bothersome pain associated with their diagnosis in the past three months of a sufficient intensity; * english is their first and primary language. exclusion criteria: * individuals would be excluded if they have more than one of the three pain diagnoses to be studied.