Kornimate/medical-research-clean huggingface dataset:
dose-finding study of metformin with chemoradiation in locally advanced head and neck squamous cell carcinoma

Conditions: Head and Neck Cancer

Summary: the purpose of this research study is to test the safety of adding metformin to standard of care. the standard of care treatment will be cisplatin once every 3 weeks for 3 treatments and radiation for 7 weeks. metformin is a medication that is currently used to treat diabetes. increasing amounts of metformin will be given to groups of patients already receiving normal treatment for their cancer to see if metformin causes any good effects by killing your cancer or bad effects (side effects).

patients were registered by contacting the university of cincinnati clinical trials office. patients must be registered and consent obtained prior to initiation of any protocol therapy. treatment was administered on an outpatient basis. adverse events and potential risks for metformin and cisplatin and radiation were reported. patients must have screening labs performed within 2 weeks of start of treatment including a complete blood count, liver function tests, metabolic renal panel including magnesium, vitamin b12 level, lactate, and c-peptide. renal panel must be verified within 24 hours of cisplatin administration. they must fulfill inclusion criteria. the recommended starting dose of metformin in diabetic patients is 500mg orally twice a day which can be escalated by 500mg increments weekly as tolerated with the maximum recommended daily dose of 2550mg. cisplatin was given either before or after the radiation therapy fraction that is given on the same day. if radiation is held for more than 2 days (for any reason), cisplatin may be held as well until radiation resumes. the prescribed radiotherapy dose was be 70 gy in 2 gy once-daily fraction size (total of 35 fractions).

Eligibility criteria:
inclusion criteria: * locally advanced squamous cell cancer of the head and neck, stage iii or iv disease (t1-2, n2a-3 or t3-4). * measurable disease * no prior chemotherapy or radiation for head and neck squamous cell cancer * life expectancy of greater than 3 months. * adequate labs exclusion criteria: * known metastatic disease. * nasopharyngeal carcinoma * history of allergic reactions attributed to metformin or other agents used in study. * known diagnosis of diabetes requiring insulin for control. * administration of metformin within last 4 weeks.
efficacy of oral colchicine in prevention of proliferative vitreoretinopathy in rhegmatogenous retinal detachment

Conditions: Rhegmatogenous Retinal Detachment

Summary: this clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (pvr) in cases of rhegmatogenous retinal detachment


Eligibility criteria:
inclusion criteria: * rhegmatogenous retinal detachment exclusion criteria: * pvr grade c * duration of retinal detachment ≥ one month * history of cataract surgery * history of rd surgery

Keywords: retinal detachment proliferative vitreoretinopathy
catheter ablation for atrial fibrillation and heart failure

Conditions: Congestive Heart Failure; Atrial Fibrillation; Arrhythmia

Summary: to compare heart function, symptoms, exercise capacity and quality of life in patients with congestive heart failure (chf) and atrial fibrillation (af)before and after catheter ablation. hypothesis: restoration and maintenance of sinus rhythm by catheter ablation, without the use of antiarrhythmic drugs, in af and chf improves heart failure status.


Eligibility criteria:
inclusion criteria: * age 18 years to 80 years * clinical diagnosis of chf based on symptoms (shortness of breath, fatigue, peripheral edema) * systolic left ventricular dysfunction with ejection fraction 40% or less * nyha class i, ii or iii heart failure * paroxysmal af(2 or more episodes in one month) that terminate within 7 days:or persistent af (more than 7 days or less than 7 days but terminated with pharmacologic or electrical cardioversion). * willing and able to sign informed consent exclusion criteria: * previous ablation * left atrial size greater than 60mm(parasternal view on transthoracic echocardiogram) * af episodes triggered by another uniform arrhythmia(e.g.atrial flutter or atrial tachycardia) * active alcohol or drug abuse, which may be causative of af * severe valvular disease requiring surgical repair * myocardial infarction within 6 months of enrollment * abnormality that prevents catheter introduction * coronary surgical revascularization or other cardiac surgery within 6 months of enrollment * patients in whom heart transplant expected with 6 months * af deemed secondary to a transient or correctable cause (e.g.electrolyte imbalance ,trauma,recent surgery,,infection, toxic ingestion or endocrinopathy * pregnancy or women of child bearing potential \& not on reliable method of birth control * contraindication to warfarin therapy or other bleeding diathesis * participation in another clinical trial * inaccessable to follow-up * life expectancy of less than 24 months caused by reasons other than heart disease * renal failure requiring dialysis * decompensated chf within 48 hours of enrollment * second or third degree av block or sinus pause greater than 3 seconds, resting heart rate less 30 bpm without a permanent pacemaker * a history of drug induced torsades de pointes or congenital long qt syndrome * currently responding to antiarrhythmic drug therapy * uninterrupted af for more than 12 months prior to randomization unless sinus rhythm maintained for 24 hours or longer. * unwilling or unable to sign informed consent

Keywords: catheter ablation atrial fibrillation congestive heart failure
topical hyaluronic acid and recurrent aphthous stomatitis.

Conditions: Recurrent Aphthous Stomatitis

Summary: this study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis

recurrent aphthous stomatitis (ras) is a common and widely recognized disorder involving the oral mucosa. it occurs typically as a single or multiple well-defined painful self-limiting ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red halo. the prevalence of ras is up to 25% in the world population, with recurrence rate of 50% every 3 mouths. the exact cause of ras is uncertain, and accordingly numerous components are as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic, immunological, and psychological factors.

Eligibility criteria:
inclusion criteria: the inclusion criteria were as follows: * age 18-30 years. * minimum of 2 years of ras history, with active ulcer less than 48 hours of recurrent aphthous stomatitis. exclusion criteria: * known history of hypersensitivities to chlorhexidine or hyaluronic acid. * use of any medication as a treatment for the present active ulcer. * smoking and presence of systemic diseases such as behçet disease, anemia, crohn's disease, ulcerative colitis, acquired immune deficiency syndrome, and liver or kidney disease. * pregnant or breast-feeding women. * stomach ulcer, duodenal ulcer, and inflammation of the stomach or the esophagus. * treatment with systemic nonsteroidal anti-inflammatory drugs, systemic steroids or other immune modulatory agents, oral antihistamines, or systemic antibiotics in the previous 3 months.

Keywords: recurrent aphthous stomatitis chlorhexidine hyaluronic acid pain topical
study of individualized wound prevention instruction to prevent venous ulcer development

Conditions: Varicose Ulcer

Summary: the purpose of this study is to determine whether individualized wound prevention instructions will lengthen the ulcer-free period in veterans with recently healed venous ulcers.

venous ulcer disease is the most common form of lower extremity ulcer, and treatment requires months to years of costly intervention. preventing venous ulcers from recurring is ideal, however, healing time is variable, possibly due to inadequate patient/clinician communication and surveillance. an aftercare summary is a detailed set of self-care instructions designed to help patients understand and influence preventative factors under their control. they have successfully been used in patients with cardiac disease and are currently being tested to help prevent diabetic foot ulcers. we propose the use of an aftercare summary to help prevent ulcer recurrence in veterans with recently healed venous ulcers.

Eligibility criteria:
inclusion criteria: * confirmed venous ulcer (icd-9: 454.0, 454.2, 459.11, 459.13, 459.31, 459.33); * documented healing of all lower extremity ulcers; * ankle-brachial index (abi) \> 0.8 to rule out arterial insufficiency exclusion criteria: * unwilling or unable to sign informed consent; * no plans to seek care at va puget sound within 6 months; * limbs with ulcers or threatened viability

Keywords: varicose ulcer veteran recurrence aftercare
attentive eating for weight loss

Conditions: Overweight and Obesity

Summary: this trial examined whether a smartphone application designed to encourage a more attentive eating style could help people to lose weight, compared to a control group.

there is evidence that enhancing memory for recent eating and focusing attention on food being consumed influences later energy intake. studies have shown that attending to food being eaten can reduce food intake. this has since been implemented into a smartphone based 'attentive eating' application. in a feasibility trial of this mobile phone application, adults with overweight or obesity were encouraged to eat attentively by photographing their meals and making satiety ratings after they had eaten. participants were also required to review what else they had eaten that day before entering their next meal, with an overall aim of encouraging a more attentive eating style. adherence data and qualitative interviews suggested that the mobile phone app was generally acceptable to participants and easy to use. participants reported that they felt the application increased their awareness of what they had been eating. there was also an average weight loss of 1.5kg across the 4 week period that participants used the application for. given that the previous feasibility trial included no control condition, the aim of the current trial was to examine initial proof of concept for effectiveness of an attentive eating smartphone weight loss application. in the current study the investigators hypothesised that participants randomised to the attentive eating smartphone based condition (experimental condition) would lose significantly more weight than participants randomised to the control condition. the study is a single centre, parallel, two arm, individually randomised 8 week controlled trial in adults with overweight and obesity in the merseyside area of england.

Eligibility criteria:
inclusion criteria: * bmi ≥25.0 kg/m2 * self-report would like to lose weight by changing their dietary behaviour * 18-65 years * fluent english * own an android/apple smartphone exclusion criteria: * history of eating disorders or food allergies * medication that affects appetite * pregnant * scheduled for weight loss survey during the trial * currently on a structured weight loss programme (e.g. weight watchers)

Keywords: attentive eating e-health weight loss food intake
evaluation of a mind-body education program to enhance resiliency and reduce burnout in residents

Conditions: Resident Burnout

Summary: this prospective, waitlist-control study is evaluating the benefits of a stress management and resiliency training program for residents (smart-r). the primary aim of this study is to determine whether the smart-r is effective at increasing coping skills and reducing stress among residents, reflected by changes in constructs such as emotional growth, perceived stress, optimism, and coping styles. objective parameters (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy) measured with the basis health tracking device will help correlate objective signs to subjective report of stress.

the investigators adapted the benson-henry institute stress management and resiliency training program -- relaxation response resiliency program (smart-3rp) to create the smart-r resident wellness curriculum. the actual smart-3rp is both a clinical program and research intervention. the three prongs of the smart-r include 1) elicitation of the relaxation response through mind-body techniques 2) reducing overall stress reactivity and 3) increasing connectedness to self and others. in a waitlist-control design, the smart-r was implemented into multiple residents programs at mass general hospital, nyu langone medical center, and weill cornell medical college. the primary aim is to evaluate the effectiveness of the smart-r in increasing coping skills and reducing stress among residents in the participating programs. participants enrolled will be invited to complete 1) a brief questionnaire before, during (q3months) and after participation in the program (5 questionnaires total). the investigators will also collect continuous physiologic data using the basis peak health tracking device to correlate the physiologic data with self-report measures of stress. additionally, objective indicators of daily workload (page frequency, and quantity of notes authored by a resident during a given period) will help control for residents' schedules and busyness, in evaluating perceived stress, wellbeing and other outcomes.

Eligibility criteria:
inclusion criteria: * residents in the following participating departments: departments of psychiatry, pediatrics, or neurology at mgh, medicine or psychiatry at nyu, or medicine or psychiatry at cornell exclusion criteria: * not a resident in the participating departments
the effect of acupressure (gb30) on ventrogluteal intramuscular injection pain

Conditions: Acute Pain; Injection; Needle Phobia

Summary: acupressure is an ancient manual therapy which fingers are used to press key points on the body. these points are the same with acupuncture points but in contrast to acupuncture, acupressure uses gentle but firm pressure with fingers and hands. the purpose of this study is to investigate effect of acupressure onto gb30 poin for ventrogluteal intramuscular injection pain.the study was designed as a prospective, single-blind, crossover study. the study included 72 volunteer students attending faculty of health sciences, nursing department.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18.5 to 29.9kg/m2 * voluntariness exclusion criteria: * history of im injection within 2 weeks
maintenance hormonal therapy and dlbcl

Conditions: Diffuse Large B Cell Lymphoma

Summary: the study aims to detect the benefit of maintenance tamoxifen after achieving cr with conventional immuno-chemotherapy and/or radiotherapy in patients with dldcl

diffuse large b-cell lymphoma (dlbcl) is the most common form of aggressive non-hodgkin lymphoma. the standard immuno-chemotherapy (r-chop) markedly improves the prognosis of dlbcl, but up to 40% of patients still experience relapse or incomplete remission . so, there is a need for new targeted therapy for such malignancy. recent studies identified a potential novel target in dlbcl, the esr2 gene, which codes for the estrogen receptor beta (erβ) protein, a receptor that can be targeted with selective er modulators (serms) such as tamoxifen. recent data shows that exposure of dlbcl cell lines to tamoxifen (either alone or in combination with chop chemotherapy) results in apoptosis and growth inhibition in vitro and in vivo. these data suggest the potential importance of erβ in the pathogenesis of dlbcl as well as a potential role for tamoxifen in the treatment of dlbcl.50-100 patients with newly diagnosed dlbcl will be treated with standard immuno-chemotherapy according to disease stage with detection of erb and era on the tissue samples using ihc. after the end of chemotherapy treatment patients who achieve cr will be randomized to either receive tamoxifen maintenance (20 mg daily) versus follow up to evaluate possible tamoxifen effect on disease recurrence, dfs and os. pt who achieve cr after 2nd line chemotherapy versus post bmt will also be recruited.

Eligibility criteria:
inclusion criteria: adults 18-75 years old newly diagnosed dlbcl patients who achieve cr after conventional primary treatment can be included ps 0-2 exclusion criteria: less than 18 years or older than 75 years other types of lymphoid neoplasms cardiac comorbidity

Keywords: dlbcl maintenance hormonal therapy tamoxifen erb
single ascending-dose study of the efficacy, safety, tolerability, and pharmacokinetics of regn1908-1909 in allergic, adult participants

Conditions: Allergy

Summary: the purposes of this study are to assess the efficacy, safety and tolerability of a single dose of regn1908-1909 in allergic adult participants, to collect information about how much regn1908-1909 is in blood over time and to collect information about how the body reacts to regn1908-1909.


Eligibility criteria:
inclusion criteria: 1. healthy men and women between the ages of 18 and 55 2. positive allergen skin prick test 3. willing and able to comply with clinic visits and study-related procedures 4. provide signed informed consent exclusion criteria: 1. persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit 2. any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination 3. onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial 4. hospitalization for any reason within 60 days prior to the screening visit 5. participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of the investigational drug prior to the screening visit 6. any medical or psychiatric condition that in the opinion of the investigator or regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results the information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
efficacy and safety of 24 weeks of oral treatment with biil 284 bs in adult and pediatric patients

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine the effect of 24 weeks of treatment with biil 284 bs compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.


Eligibility criteria:
inclusion criteria: * male or female patients \>= 6 years pediatric 6-17 years inclusive; adult \>= 18 years) * body weight \>= 20 kg (determined at visit 1) * confirmed diagnosis of cf * able to perform acceptable spirometric maneuvers, according to american thoracic society standards . * fev1 25-85% predicted * clinically stable * the patient or the patient's legally acceptable representative must be able to give informed consent. * the patient must be able to swallow the biil 284 bs tablets whole. * patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study. exclusion criteria: * patients with a significant history of allergy/hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the investigator. "relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication; there are no specific issues of concern currently identified with respect to use of biil 284 bs in allergic patients per se. * patients who have participated in another study with an investigational drug within one month or 6 half-lives (whichever is greater) preceding the screening visit. * patients with known relevant substance abuse, including alcohol or drug abuse. * female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening (pregnancy tests will be performed for all females of child bearing potential). * female patients of child bearing potential who are not using a medically approved form of contraception. * patients who are unable to comply with food requirements prior to dosing. * patients with documented persistent colonization with burkholderia cepacia. * patients chronically using oral corticosteroids or high-dose ibuprofen. * patients with hemoglobin \ 2.5 times the upper limit of normal; creatinine \> 1.5 times upper limit normal. * clinically significant disease or medical condition other than cystic fibrosis or cystic fibrosis-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data.

Keywords: cystic fibrosis biil 284 boehringer ingelheim
scapholunate ligament reconstruction: early dart throwing motion versus motion in anatomical planes

Conditions: Scapholunate Ligament Rupture

Summary: patients undergoing scapholunate ligament reconstruction at balgrist university hospital are divided into two groups and receive two different types of mobilisation postoperatively. the investigators will compare the outcome (pain, strength, mobility) between the two groups 1 year after the operation.

the so-called 'dart-throwing motion' (dtm) plane of movement, from radial extension to ulnar flexion, has gained attention as it has been shown to be an important axis of wrist movement during activities of daily living. further studies have shown that during movement of the intact wrist in the dart throwing plane, most of the movement occurs in the mediocarpal joint, while the proximal row remains relatively immobile. in scapholunate (sl) ligament reconstruction using the flexor carpi radialis tendon, the sl interval is immobilised using 2 kirschner wires for 8-10 weeks to relieve the strain on the ligament and allow it to heal. from the 2nd postoperative week, mobilisation is started using dtm mobilisation or mobilisation in the anatomical plane. the aim of the study is to investigate in a randomised trial whether mobilisation in the anatomical plane produces the same postoperative results. in this project, the investigators will compare two types of mobilisation in the rehabilitation of sl ligament reconstruction. the participants will be randomised to two treatment groups. this procedure therefore corresponds to a risk category a in 'other' clinical trials according to chapter 4 clino.

Eligibility criteria:
inclusion criteria: * sl ligament reconstruction at balgrist university hospital * at least 18 years * written informed consent exclusion criteria: * age under 18 years * refusal of participation * pregnancy

Keywords: mobilisation scapholunate ligament recontruction