Kornimate/medical-research-clean huggingface dataset:
mechanical vs chemomechanical method for calcium hydroxide removal

Conditions: Necrotic Pulp; Chronic Apical Periodontitis

Summary: type of study: randomised clinical trial to compare the effectiveness of mechanical and chemomechanical methods in the removal of water-based calcium hydroxide medicament from endodontic system. participants allocated in group a and b should be appointed for endodontic treatment of single rooted teeth diagnosed with necrotic pulp and chronic apical periodontitis. in group a, calcium hydroxide medicament will be removed by using mechanical method while in group b, calcium hydroxide will be removed by using chemomechanical method.

this study is aimed at comparing the effectiveness of mechanical and chemomechanical methods for removal of intracanal medication. water-based calcium hydroxide is used as an intracanal medicament in this study. participants aged 18 years and above presenting to the outpatient department of operative dentistry and endodontics, school of dentistry, shaheed zulfiqar ali bhutto medical university, islamabad diagnosed with necrotic pulp with chronic apical periodontitis will be randomly allocated in two groups a and b. on first visit, root canal treatment will be initiated under rubber dam isolation. after locating canals, periapical radiograph for the working length will be taken. after working length has been confirmed, canal preparation will be done using rotary file system. after canal has been prepared till working length, intracanal medicament is placed using lentulospiral. patient is recalled after 2 weeks. on next visit, calcium hydroxide medicament will be removed by mechanical method from group a. mechanical method involves the use of rotary file system for removal of medicament. in group b, calcium hydroxide will be removed by using chemomechanical method. chemomechanical method involves the use of sonic or ultrasonic activation of irrigants for removal of medicament. after the removal of intracanal medicament, periodical radiograph will be taken. data will be taken on proforma and evaluation will be done for the effective removal of calcium hydroxide using a 4- point scoring system.

Eligibility criteria:
inclusion criteria: * single-rooted maxillary and mandibular teeth * necrotic teeth with chronic apical periodontitis * straight to moderately curved root canals exclusion criteria: * patients with systemic disease * pregnant and immunocompromised patients * teeth with compromised periodontal health * teeth unable to be restored or isolated by rubberdam

Keywords: mechanical method chemomechanical method calcium hydroxide intracanal medicament
prospective observational epidemiologic study of maraviroc's safety

Conditions: Human Immunodeficiency Virus

Summary: the study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

all patients meeting the study eligibility criteria at participating sites will be invited to participate.

Eligibility criteria:
inclusion criteria: * treatment experienced, hiv-1 infected patients * 18 years or older * receive an approved assay for determination of hiv-1 tropism exclusion criteria: * pregnant or lactating * using ccr5 inhibitor other than maraviroc

Keywords: maraviroc hiv-1 safety non-interventional
a real-world evidence study of goniotomy with the c-rex™ instrument in patients with primary open angle glaucoma

Conditions: Primary Open Angle Glaucoma (POAG)

Summary: this study enrolls adults with primary open angle glaucoma (poag) who underwent goniotomy intraocular pressure (iop)-lowering surgery with the c-rex instrument. patients are consented prior to surgery and followed for 12 months postoperatively. data regarding iop, use of glaucoma medications, and any device-related complications are collected during the study time period.

this a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (poag) in whom ab-interno goniotomy surgery with the c-rex instrument was performed. data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively. specific data collected includes c-rex instrument goniotomy surgical details, preoperative and postoperative iop and use of ocular hypotensive medications, and device-related safety events.

Eligibility criteria:
inclusion criteria: * primary open angle glaucoma * goniotomy surgery performed using the c-rex instrument exclusion criteria: * history of intraocular surgery within 8 weeks prior to c-rex surgery * preoperative iop higher than 33 mmhg * presence of a glaucoma type other than poag * presence of clinically significant intraocular pathology other than cataract or glaucoma

Keywords: ocular hypertension eye diseases glaucoma goniotomy
a study of the life changes experienced by patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to better understand what types of transitions people with pancreatic cancer face when they receive chemotherapy. again, this study defines transition as a change in a life situation or a status that causes a change in a person's identity, role, behavior, or personal relationships. examples of transitions include changes in sleeping habits, anxiety, employment, relationship with a higher power, and treatment goals.


Eligibility criteria:
inclusion criteria: * adult patients 18 years of age and older * primary language listed as english in electronic medical record * biopsy proven diagnosis of pancreatic cancer * within three months after initiating a chemotherapy regimen at the rockefeller outpatient pavilion at mskcc (patient may have previously received chemotherapy at an outside institution or may have received previous chemotherapy regimens at mskcc). exclusion criteria: * previous history of cancer within the past five years, except for non-melanoma skin cancer, ductal carcinoma in situ breast cancer, and thyroid cancer.

Keywords: quality of life health-illness transition 20-038
high-intensity strength training in myositis

Conditions: Myositis; Dermatomyositis; Polymyositis; Immune-Mediated Necrotizing Myopathy

Summary: this study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (sf-36). the study is designed as a parallel group randomised controlled trial with an intervention group and a control group.

overall aim: to investigate the effect of high-intensity strength training on quality of life, muscle strength, physical function, and disease activity in patients with myositis study design: 60 myositis patients will be included in a 16-week high-intensity strength training study. patients will be randomly allocated into 2 groups (strength training and control) in a 1:1 ratio. user involvement: myositis patients has been recruited to a patient advisory board. the advisory board's objective is to give patient-oriented project feedback, thus improving the overall research project. intervention: two training session per week for 16 weeks. sessions consists of 3 sets of each exercise corresponding to 10 rm. training progression will be accounted for and training loads will be evaluated weekly. the training protocol will be a full-body protocol, i.e. all major muscle groups will be engaged during each training session. outcomes: the primary outcome is the physical component summary measure from the quality of life questionnaire (sf-36). secondary outcomes include strength measures, functional tests, disease activity measures, questionnaires (e.g. international physical activity questionnaire), dexa whole body scans, blood samples and muscle biopsies.

Eligibility criteria:
inclusion criteria: * fulfilling the criteria for myositis by eular/acr (bottai et al., 2017; lundberg et al., 2017) * ≤ 5 mg/day prednisolone * stable dosage of immunosuppressive treatment for at least 1 months prior to inclusion in the study * myositis diagnosis at least 6 months prior to inclusion in the study exclusion criteria: * patients with sporadic inclusion body myositis and overlap myositis (myositis combined with another autoimmune rheumatic diseases, except sjögren's syndrome) * co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic \> 160mmhg, diastolic \> 100mmhg), severe knee/hip arthritis) * alcohol- and/or drug abuse. defined by the guidelines issued by the danish health authority
evaluation of a digital therapy of auditory training

Conditions: Hearing Loss, Age-Related

Summary: the aim of the study is to evaluate the efficiency of the medical device audissee in improving the perception in noise ability of presbycusis patients with hearing-aids.

audissee is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal (especially musical) stimuli. this therapy is designed improve the comfort of life of people fitted with hearing aids by improving the observance of the wearing of their hearing aids. it is designed for the greatest number of people regardless of age or type of hearing aids and adapts to all levels of hearing loss (mild to severe). in this study, 240 patients will be randomized in four groups. the first group will be trained with audissee-verbal, audisse-non-verbal then with the placebo therapy. the second group will be trained with audissee-non-verbal, audissee-verbal, then with the placebo therapy. the third group will be trained with the placebo therapy then audissee-verbal, and audisse-non-verbal. the fourth group will be trained with the placebo therapy then audissee-non-verbal, and audisse-verbal. each training session will last 20 minutes. 3 sessions are planned per week, for 5 weeks for each sub-training. the protocol lasts 20 weeks in total for each patient.

Eligibility criteria:
inclusion criteria: * age over 18 * no neurological or psychiatric background * no major cognitive deficit, able to understand and apply the recommendation * motivated to participate * have given its written consent * affiliated to a social security system * diagnostic of presbycusis by a health professional * hearing-aids since less than 2 years (no cochlear implants) * no tinnitus * with a possible access to a personal computer, tactile tablet or smart-phone to perform the training exclusion criteria: * age below 18 * pregnant or breastfeeding women

Keywords: hearing aid presbycusis auditory training hearing in noise
asthma l-citrulline pilot study

Conditions: Asthma

Summary: this study will evaluate whether treatment with l-citrulline, which is an amino acid found in some foods, can increase levels of l-arginine and thereby restore the concentration of nitric oxide (no) in the airways.

research has shown that some obese asthmatics have a metabolic imbalance in which l-arginine levels are reduced. l-arginine is an amino acid that is used to make no, a gas that is normally made in the bronchi and ensures that the lungs function properly. in this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of l-citrulline for two weeks. study participants will be asked to do lung function testing and donate blood before and after taking the supplement. l-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects.

Eligibility criteria:
inclusion criteria: * adequate completion of informed consent process with written documentation * male and female patients, 18 - 70 years old, inclusive * physician diagnosis of asthma (for medical records, icd 10 coding for physician's diagnosis) * all racial/ethnic backgrounds may participate * bmi ≥ 30 * treatment of controller asthma medication(s) ≥ 4 weeks * smoking history ≤10 pack years and no smoking in the last year * v1 eno ≤ 30ppb (may be repeated 3x during visit; lowest ppb will be kept) exclusion criteria: * respiratory tract infection within the 4 weeks prior to the study (may re-enroll after 4 weeks). * oral or systemic corticosteroid burst (for any indication) within the 4 weeks * one-time doses, such as intra-articular injections into a shoulder or knee joint, require a 2-week washout. * asthma-related er visit within the previous 4 weeks of visit 1 * significant concomitant medical illness, including (but not limited to) * heart disease * cancer * uncontrolled diabetes, * chronic renal failure (creatinine \> 2.0) at visit 1 (associated with higher adma levels) * untreated sleep apnea * other chronic lung/respiratory diseases (copd, ipf, etc.) * high dose inhaled steroids (\> 1000 mcg/day of fluticasone or equivalent) * current statin use (statins lower adma levels); patients may stop statins with approval from their primary physician and enroll after a 6-week washout * positive urine pregnancy test at visit 1 or at any time during the study * intolerance or allergy to l-arginine or l-citrulline * concomitant use of pde5 drugs or oral mononitrates * participation in an intervention study, use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study * unable or unlikely to complete study assessments in the opinion of the investigator * study intervention poses undue risk to patient in the opinion of the investigator * breastfeeding

Keywords: obesity l-citrulline
mederma to reduce appearance of post surgical scars

Conditions: Scars

Summary: this is a single-center, 20-subject, investigator-blinded study to evaluate the effect of mederma n\&i to mederma ultra gel on the appearance of post-surgical scars.

this is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. the subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest. inclusion criteria: * healthy male and non pregnant female subjects ≥18 years of age * have seborrheic keratoses on the right and left chest and/or back exclusion criteria: -subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and lidocaine.

Eligibility criteria:
inclusion criteria: * subjects must be 18-70 years of age, of any race or sex. * subjects must be fitzpatrick skin type i-vi. * subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study. exclusion criteria: * subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and lidocaine. * subjects with known history of keloids or hypertrophic scars.

Keywords: surgical scars mederma
effect of curcumin on systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this investigator initiated study is to determine the efficacy of curcumin on disease activity of subjects with systemic lupus erythematous. curcumin has been found to have anti-inflammatory effects and has been found to improve disease activity in lupus patients. in addition, subjects with rheumatoid arthritis as well as osteoarthritis have also found benefit for their disease activity.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged 18 or older * diagnosed with systemic lupus erythematous according to the 2012 systemic lupus international collaborating clinics classification criteria. * sledai score of 6 or higher * ability to take oral medication and be willing to adhere to the study drug regimen exclusion criteria: * inability to provide written consent for study participation * use of curcumin supplements within 30 days of enrollment of study * liver function disorders (ast/alt \> 2.5x upper limit of normal) * pregnancy or lactation * known allergic reactions to turmeric * subjects who are admitted for recent hospitalization within past 60 days * treatment with another investigational drug or other intervention within past 60 days * subjects with end stage renal disease on dialysis * subjects who lack the ability to provide consent
healthy habits, happy homes: an intervention to improve household routines for obesity prevention

Conditions: Obesity

Summary: while childhood obesity rates may have plateaued in some us population subgroups, such as whites and those of higher socioeconomic status, overall rates of obesity remain high and racial/ethnic and socioeconomic disparities appear to be widening. among the most promising approaches for childhood obesity prevention and management are interventions that begin early in life and that support change at the individual and community levels. the goal of this project is to develop and test an intervention delivered to racial/ethnic minority and low income parents of 2-5 year old children in their homes, designed to promote adoption of household routines and parenting strategies that are preventive of obesity. to achieve this goal, the investigators will work with community health centers in boston, cambridge, and somerville to recruit families to participate in an individual-level randomized controlled trial. the investigators partner community health centers include the roxbury comprehensive community health center, dimock community health centers, and the cambridge health alliance (cha). participants will be randomized to receive either 1) mailed educational materials for the duration of the 6-month program (control), or 2) home-based health coaching visits and phone calls with a health educator, text messages, and educational materials promoting the adoption of household routines and target behaviors (intervention). the investigators goal is to evaluate the feasibility and effectiveness of the investigators designed intervention (as compared to the control condition) using baseline and post-intervention data. in order to do so, the investigators will assess change from baseline to post-intervention in the investigators key behavioral outcomes of interest, including adoption of three household routines: 1. regularly eating meals together as a family 2. obtaining adequate sleep 3. limiting screen-viewing time


Eligibility criteria:
inclusion criteria: * parent with child between 2-5 years old * child has a tv in the room where s/he sleeps * parent is comfortable reading, writing and having conversations in english or spanish * child was seen for a well-child care visit at one of collaborating community health centers in the last 90 days exclusion criteria: * parent is not 18 years or older * family is planning to move from the boston area in the net 6 months * child has a physical/mental health condition which requires chronic care

Keywords: obesity overweight
laparoscopic-guided tap block vs epidural analgesia

Conditions: Post Operative Pain

Summary: the laptap trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.

in most previous studies tap-block has been inserted by anesthesiologist under ultrasound guidance. tap blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. there is lack in studies comparing laparoscopic guided tap-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.

Eligibility criteria:
iinclusion criteria * patients who undergo elective laparoscopic colorectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectosigmal area * patients able to provide informed written consent * patients capable of completing questionnaires at the time of consent exclusion criteria * documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone * contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (inr), anticoagulation, patient refusal, etc.) or tap block (patient refusal) * urgent or emergent surgery precluding epidural catheter placement or tap block * systemic infection contraindicating epidural catheter placement or tap block * rectal surgery * pregnant or suspected pregnancy * age \< 18 years * planned open surgery * planned bowel stoma (protective diversion and/or permanent stoma) * unwillingness to participate in follow-up assessments * patients with severe chronic pain * known sensibility for opioid side effects * i.v.-pca is contraindicated (for example drug abuse) * no informed consent
mechanisms behind microvascular dysfunction in inoca

Conditions: Coronary Microvascular Dysfunction; Ischaemia With Non Obstructed Coronary Arteries

Summary: the purpose of the study is to identify the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart.

a significant number of patients with ischemic heart disease do not exhibit coronary obstruction, leading to their symptoms being attributed to coronary microvascular dysfunction, a condition known as ischemia with no obstructive coronary artery disease (inoca). despite a considerable patient population affected by inoca, the specific mechanisms underlying this microvascular dysfunction are not fully understood, often resulting in a lack of targeted treatment. there is evidence to suggest that exercise capacity is linked to coronary microvascular function, an area yet to be explored. this study aims to identify mechanisms underlying coronary microvascular dysfunction (cmd) in angina and to assess whether exercise training can improve the condition. in study part i 30 patients with impaired coronary microvascular function and 30 asymptomatic controls will be studied to identify vascular and related molecular mechanisms underlying inoca by investigating microvascular function in the heart and in cutaneous tissue, skeletal muscle, and adipose tissue.

Eligibility criteria:
inclusion criteria: only for angina patients: have cmd, defined as myocardial bloodflow re-serve (mbfr) \< 2.5 or hyperemic myocardial blood flow (hmbf) \< 2.3ml/g/min exclusion criteria: * females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). the female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile * heart failure, defined as left ventricular ejection fraction of less than 40% * uncontrolled hypertension defined as blood pressure above target 140/90 for all * co-morbidity resulting in \<1 year expected survival * considered by the investigator, for any reason, to be an unsuitable candidate for the study. * unable or unwilling to exercise, e.g. due to arthritis or injury\* * already are regularly physically active and/or have a maximal oxygen uptake \>45 ml/kg/min * the subject has a known allergy to either: norepinephrine, adenosine, ketorolac, and or ascorbic acid (vitamin c).