Kornimate/medical-research-clean huggingface dataset:
the utility of peri-operative arnica montana for reduction of ecchymosis in rhinoplasty surgery

Conditions: Ecchymosis

Summary: arnica montana is a homeopathic drug that is made in accordance with the official methods of the homeopathic pharmacopoeia of the united states (hpus) and is commonly used by cosmetic surgeons throughout the world, although there is no study proving its benefit after rhinoplasty surgery. the purpose of the research is to see if arnica montana will reduce the amount of bruising and the intensity of the bruising after surgery. photographs of the subject's face will be taken and used to analyze bruising after rhinoplasty surgery in subjects who receive arnica montana and compare them to photographs of subjects who take a placebo (sugar pill).

subjects will receive either oral arnica montana or placebo without any identifying labels or markers on the drugs. during the post-operative period, the patients will be seen back in surgery clinic on post-operative days 3, 7 and 10. during the first two visits, the subject will receive routine post-operative care with no difference from patients not enrolled in the study. this includes routine sets of photographs. the participant will then return for a third post-operative visit lasting under ten minutes only for study photos using the left and right "three-quarters" view. again, the subject will hold a measurement marker so length measurements can be made, and this marker will be held under the ear to not interfere with the routine cosmetic analysis of the photographs. the digital photographs will be used to analyze the bruising for the study. the ratio was calculated by dividing the number of pixels of bruised area over number of pixels of standard area.

Eligibility criteria:
inclusion criteria: adult patients who are deemed candidates for rhinoplasty surgery at uw transformations will be eligible to participate in the study. - exclusion criteria: * patients who are prisoners * patients who are pregnant and breast-feeding women * patients taking anti-coagulants (such as blood thinners), anti-platelet drugs (such as nsaids), or other homeopathic remedies during the peri-operative period * patients with a bruising or bleeding disorder * patients who take oral corticosteroid therapy * patients who suffer from severe liver or kidney disease * patients with malignancy, infection, immunodeficiency, metabolic syndrome, infectious or inflammatory gastrointestinal disease * patients with oral or contact allergies to arnica montana or to any other member of the asteraceae family of plants such as ragweed, chrysanthemums, marigolds, and daisies

Keywords: ecchymosis bruising rhinoplasty nose job arnica arnica montana
aralast alpha1-proteinase inhibitor surveillance study

Conditions: Alpha1-antitrypsin Deficiency

Summary: the primary objectives of this phase 4, open label, prospective u.s. surveillance study are to evaluate the health outcomes of alpha 1-antitrypsin (aat)-deficient subjects who are initiating treatment with aralast on patient-related outcomes (pro), i.e., health-related quality of life (hrqol), healthcare resource utilization (hcru), and various laboratory analyses to evaluate the safety of long-term administration of aralast. up to 120 subjects will be enrolled and assessed for hrqol and hcru at baseline and every 6-months thereafter, for 2 years. a subset of subjects will be enrolled into the blood draw portion of the study, which will also include assessments of antibodies to aralast, and chemistry panel. subjects will be treated according to the prescribing (attending) physician's instructions based on the prescribing information given in the aralast package insert.


Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older * diagnosis of aat deficiency associated emphysema * active prescription for augmentation therapy with aralast * on service with coram (a speciality pharmacy provider) * signed and dated informed consent exclusion criteria: * clinically significant medical (other than copd), psychiatric, or cognitive illness that, in the opinion of coram or the sponsor or the investigator, may compromise subject safety or compliance (such as end stage renal or hepatic or heart disease, or metastatic cancer or any difficulty in communicating over the telephone lines) * previous treatment with aralast (i.e. subjects who had previously received and then discontinued aralast augmentation therapy and are now restarting aralast will be excluded from the study)
effect of creatine monohydrate on functional muscle strength in children with fshd

Conditions: Facio-Scapulo-Humeral Dystrophy; FSHD2; FSHD1

Summary: this multi-centre, randomised, double-blind, placebo-controlled crossover trial will compare changes in strength-related motor function following treatment with creatine monohydrate to treatment with placebo, as measured by the motor function measure, from baseline to 12 weeks. eligible subjects will undergo baseline assessments then will be randomised to either creatine monohydrate therapy or placebo for three months, followed by a six week wash-out period, then crossover to a further three months of therapy with either placebo or creatine. subjects will undergo clinical assessments and study safety assessments at the beginning and end of each treatment period. the study will begin recruitment in early 2017.


Eligibility criteria:
inclusion criteria: * is between the ages of 5 and 18 years inclusive at the time of randomisation; * has a confirmed genetic diagnosis of facioscapulohumeral muscular dystrophy (fshd) types 1 or 2; * has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. exclusion criteria: * has clinically significant elevation in plasma creatinine level or unexplained hypertension at screening; * has a prior diagnosis of chronic renal failure; * has a known hypersensitivity to creatine monohydrate of maltodextrin placebo; * patients already taking any medications to increase muscle bulk or strength or concomitant use of regular sodium valproate, corticosteroids of alpha agonists such as salbutamol.

Keywords: fshd creatine monohydrate children pediatrics facio-scapulo-humeral dystrophy
a phase iv vaccine study under the national cohort study of effectiveness and safety of sars-cov-2 (covid-19) vaccines.

Conditions: SARS CoV 2 Infection

Summary: a phase iv study to assess if the sars-cov-2 vaccine from johnson \& johnson/janssen (j\&j) results in change in number and activation of platelets and anti-pf4 level. as well as compare whether the vaccine is causing a greater activation of platelets and anti-pf4 than the mrna vaccines. the danish medicines agency has approved the vaccine from j\&j for use in denmark, however it is not currently part of the national vaccine programme. the design is an open-labelled, non-randomised, parallel group, phase iv study with historical controls. a sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).

participants will have 3 specific study visits and will hereafter be followed for 2 years after the vaccination with regular visits after 3, 6, 12 and 24 month. in this way the participants will be offered an extra close follow up on vaccine effectiveness. safety data will be collected at study visits until 3 months after the first vaccination,, with additional safety data collected under this protocol during the first month after vaccination. research samples will be collected at each study visit during the two-year follow-up.

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained before any trial related procedures are performed 2. male or female eligible for sars-cov-2 immunization (as defined by sst in the 'tilvalgsordningen') 3. the subject must be willing and able to comply with trial protocol (re-visits and biological samples) exclusion criteria: 1. male and female under the age of 18 2. any subgroup of individuals for which the vaccine is contra-indicated 3. previous sars-cov-2 vaccination specific for the johnson \& johnson vaccine: 4. experience of a serious allergic reaction after injection of any other vaccine 5. serious infection with high fever (\> 38 0c) a temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. mild fever or upper airway infection like a cold is not a problem 6. problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots) 7. immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)

Keywords: covid-19 vaccination
hysteroscopic guided versus ultrasound guided extraction of retained iud

Conditions: Contraceptive Device; Complications

Summary: the aim of this randomized controlled study is to compare the pain experienced during extraction of retained iud by office hysteroscopy with the pain experienced during extraction of retained iud under ultrasound guidance . moreover, the success of both procedures was compared. various subgroups (patients who delivered only by caesarean section, patients who delivered virginally, nulliparous women and menopausal patients) in both groups are compared.

the intrauterine device (iud) is a commonly used long-acting, effective and reversible method of contraception. the recommended way to remove a iud is by grasping the threads with forceps and applying gentle traction until the iud is extracted from the external os. absent of the threads at the time of iud removal is reported in 4.5 to 18% of cases. if the iud is present in the uterus and threads are not visible , its removal in the office setting can still be achieved in about 80% of patients with the use of alligator forceps or string retrieval devices, hooks or clamps. however, blind manipulation may cause uterine perforation . in cases where such devices have failed (retained iud ), if in office extraction of iud by these instruments failed, removal of this retained iud in the operating room is often employed because cervical dilatation and regional or general anesthesia are needed. in the last decade, several studies reported in office extraction of retained iud by office hysteroscopy or under ultrasound guidance. no studies compared the efficacy or safety of these procedures

Eligibility criteria:
inclusion criteria: * patients with retained iud exclusion criteria: * active pelvic infection * viable intrauterine pregnancy * cervical pathology

Keywords: iud office hysteroscopy ultrasound pain
cardiovascular risk reduction program aimed at african american women (the hher lifestyle program)

Conditions: Cardiovascular Diseases

Summary: cardiovascular disease (cvd) is a serious health problem among african american women. this study will evaluate a health care center-based program that aims to encourage african american women to eat a low fat diet and increase their physical activity levels to reduce the risk of developing cvd.

cvd is the leading cause of death for women in the united states. it affects african american women at a higher rate than it does white women. people at risk for cvd are encouraged to maintain a healthy weight, eat a healthy diet that is low in fat and cholesterol, and increase their physical activity. heath care centers are excellent places to provide counseling to people on ways to reduce their risk of cvd. in this study, researchers will evaluate the effectiveness of a community health care center-based counseling program aimed at reducing cvd risk factors among african american women from financially disadvantaged backgrounds. this study will enroll african american women. participants will be randomly assigned to one of two groups-either a basic program or a comprehensive program. during a routine, scheduled visit with their health care providers, all participants will learn about the importance of increasing physical activity and eating a low fat diet. all participants will also receive educational materials and a community resource guide. in addition to this, participants in the comprehensive program will receive a pedometer and will be asked to keep a daily log of their physical activity and eating habits. once a month, these same participants will receive telephone calls from a health counselor and a newsletter by mail that encourages them to maintain a healthy lifestyle. all participants will receive home visits from study staff at baseline and months 6 and 12. during these visits, participants will undergo blood pressure, weight, height, and waist measurements and a blood collection. participants will complete questionnaires to assess their medical history, diet, and physical activity habits. for 1 week after each visit, participants will wear a physical activity monitor and keep an activity diary.

Eligibility criteria:
inclusion criteria: * african american women * able and willing to complete survey instruments and assessment procedures exclusion criteria: * physical disability or orthopedic problem that limits physical activity * elevated blood pressure (i.e., greater than 160/95 mm hg) * insulin-dependent diabetes * pregnant or planning to become pregnant during the study period

Keywords: primary care diet physical activity
phase 3 efficacy study of lnz101 for the treatment of presbyopia

Conditions: Presbyopia; Near Vision; Miosis; Eye Diseases

Summary: phase 3 efficacy study to evaluate the safety and efficacy of lnz101 for the treatment of presbyopia

a multi-center, double-masked phase 3 evaluation of the safety and efficacy of lnz101 for the treatment of presbyopia

Eligibility criteria:
inclusion criteria: subjects must: 1. be able and willing to provide written informed consent and sign a health information portability and accountability act (hipaa) form prior to any study procedure being performed; 2. be able and willing to follow all instructions and attend all study visits; 3. be 45-75 years of age of either sex and any race or ethnicity at visit 1; 4. have +1.00 to -4.00 diopter (d) of sphere calculated in minus cylinder (so that spherical equivalent (se) results in myopia no more severe than -4.00 d mrse) in both eyes determined by manifest refraction documented at visit 1; 5. have ≤2.00 d of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at visit 1; 6. be presbyopic as determined at visit 2 baseline exclusion criteria: subjects must not: 1. be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy; 2. have known contraindications or sensitivity to the use of any of the study medications or their components; 3. have an active ocular infection at visit 1 or at visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye; 4. have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at visit 1; 5. have clinically significant abnormal lens findings including early lens changes during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of visit 1 or at visit 1;

Keywords: pharmaceutical solutions opthalmic solutions eye drops clarity presbyopia miotic
cervical spinal cord stimulation for the prevention of cerebral vasospasm

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: the study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (scs) in prevention of cerebral arterial vasospasm following aneurysmal subarachnoid hemorrhage (asah). it is postulated that 2 week long stimulation of the cervical spinal cord using an implanted epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following asah.

continuous stimulation of the cervical spinal cord for 14 days after electrode implantation (within 3 days after aneurysmal subarachnoid hemorrhage). the single-arm single-institution non-randomized prospective study evaluates effects of cervical spinal cord stimulation on prevention of cerebral arterial vasospasm. the patients are followed for 12 months after completion of stimulation.

Eligibility criteria:
inclusion criteria: * age 18-65 * subarachnoid hemorrhage (sah) within 72 hours * ruptured aneurysm confirmed by angiography of ct angiography * fisher grade 2-4 * hunt \& hess grade 2-4 * aneurysm is secured * ability to obtain informed consent exclusion criteria: * pregnancy * allergy to iv contrast or to any component of scs system * non-aneurysmal sah * previous cervical spine surgery or any anomaly of cervical spine that would prevent electrode insertion * coagulopathy

Keywords: vasospasm spinal cord stimulation aneurysm subarachnoid hemorrhage
"conducting a study on video observed therapy in the management of tuberculosis"

Conditions: Tuberculosis

Summary: the aim of this study is to measure the effectiveness usage of vot in the treatment of tb in terms of treatment adherence. the study will be a randomized controlled trial and will involve 240 tb patients. the study is aimed to commence by december 2023. the study period will be for 4 months.

there is an urgent need to produce an integrated e-health system in tackling the issue of remote monitoring for patient adherence. for example, in tb infection which requires close monitoring for better treatment outcomes. the usage of digital health products replacing the traditional dots will be a cost-effective method and will also bode convenient for patients and staff. video observed therapy (vot) usage as the alternative digital health method replacing traditional dots will be more effective in tackling adherence issues. this method has already been tried in many countries like the united states of america (usa), the united kingdom (uk), italy, and moldova, and has proven to be more effective than traditional dots. for instance, a study by story et al. reveals that a total of 70% of patients on vot successfully completed ≥80% of a 2-month observation compared with only 31% of those on traditional dots (95% ci 3.10 to 9.68). a proposed intervention of adapting vot in tb treatment is a practical move, as it can improve treatment compliance and also has the added benefit of being cost-effective. 1.4 research question what is the effectiveness of video observed therapy (vot) in the management of tuberculosis (tb) compared to the traditional directly observed treatment short course strategy (dots)? 1.5 study objectives 1.5.1 general objective the general objective of this study is to compare the effectiveness of vot with traditional dots in the management of tb. 1.5.2 specific objectives i. to develop vot intervention in the management of tb. ii. to compare the effectiveness of vot as compared to traditional dots. iii. to measure patient satisfaction using vot.

Eligibility criteria:
inclusion criteria: i. all ptb smear-positive patients. ii. patients aged 18 years and above. iii. possess a digital phone or other equivalent gadget equipped with a whatsapp application. iv. able to accurately identify each tb medication. exclusion criteria: i. recurrent ptb infection. ii. patients who are extremely ill, have no proper social support, no caretakers, and are hospitalized. iii. patients in prison during the time of diagnosis or treatment.

Keywords: tuberculosis digital health video observed therapy treatment adherence
intercostal nerve block with local anesthesia administered via incision-specific multi-site injection for thoracic surgery

Conditions: Intercostal Nerve Block

Summary: the goal of this clinical trial is to test analgesic effect of intercostal nerve block in different range. the main question it aims to answer are: question 1: whther incision-specific multi-site injection (ismsi, from the 3rd to 8th intercostal nerve) can improve the analgesic benefits . the participants will be divided into three groups to compare the analgesic effects of different intercostal nerve blocks

postoperative pain after thoracic surgery is usually severe, and potentially leads to worse outcomes. it is well known that the use of intercostal nerve block (icnb) analgesia with local anesthesia is common in thoracic surgery. compared with the traditional standard of epidural analgesia, it has the advantages of less effect on respiratory or circulation system and less postoperative complications such as hypotension and hematoma. however, the details of icnb form different hospital are in different ways. and it is unclear how many intercostal nerves should be blocked. and it is unknown which area should be payed more attention either, like the incision area or the chest tube port. it is hypothesized that the incision-specific multi-site injection (ismsi, from the 3rd to 8th intercostal nerve) can improve the analgesic benefits due to cover area of both incision and chest tube port. to test this hypothesis, the investigators did this study to evaluate the analgesic effect of different icnb methods. the participants will be divided into three groups. a(incision-specific multi-site injection, received intraoperative 3-8 intercostal nerve block ) b(single injection, received intraoperative 3-5 intercostal nerve block ) and c(received no intercostal nerve block). then compare the analgesic effects of the three groups.

Eligibility criteria:
inclusion criteria: 1. patients undergoing surgery for small pulmonary nodules in the department of thoracic surgery, china-japan friendship hospital in beijing 2. age≥ 18 years old 3. lung small nodules with a diameter of ≤ 2cm, pure ground-glass/mixed/solid nodules 4. permanent residents can be followed up for a long time 5. sign informed consent. exclusion criteria: 1. refusal to sign informed consent 2. damaged heart, lung, liver and kidney function 3. contraindications to surgery, such as inability to tolerate anesthesia, distant metastasis, bleeding tendency, etc c(4) combined with severe emphysema, tuberculosis, pneumothorax, pleural effusion (5) patients have other conditions that are not suitable for interventional surgery, such as pregnancy, lactation, long-term use of immunosuppressants, and serious infections