Kornimate/medical-research-clean huggingface dataset:
artoss prospective spine registry outcomes

Conditions: Spinal Fusion

Summary: this prospective registry was designed as an observational study to ascertain how commercially available nanobone bone graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.

this multicenter prospective patient registry was developed with the aim of documenting how spine and neurosurgeons are utilizing the nanobone products along with relevant patient outcomes. these outcomes include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments. the primary objective of this study is to document and analyze the use of nanobone products in spine fusion surgery (as a stand-alone bone graft, or in combination with local bone only, no other bgs or biologic product used) and determine both radiographic success and clinical outcomes. all product related adverse events will be documented, tabulated, and summarized.

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older * patient is diagnosed with a degenerative spine disorder requiring spinal fusion, has failed conservative treatment, and has decided to undergo surgery. * the surgeon has determined that a nanobone product is or was clinically indicated, and will use or have used the product as a stand-alone bone graft substitute or in combination with local autograft only (no iliac crest harvesting, other bgs, or biologic {defined as containing growth factors, cytokines, proteins, or cells} used). * patient capable of understanding the content of the informed consent form * patient willing and able to participate in the registry protocol including soc follow-up visits and clinical evaluations. * patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of helsinki. exclusion criteria:• severe vascular or neurological disease * uncontrolled diabetes * severe degenerative disease (other than degenerative disc disease) * severely impaired renal function * hypercalcemia, abnormal calcium metabolism * existing acute or chronic infections, especially at the site of the operation * inflammatory bone disease such as osteomyelitis * malignant tumors * patients who are or plan to become pregnant. * uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol.

Keywords: bone graft substitute spinal fusion degenerative disc disease scoliosis spine deformity
acute undifferentiated fever in ethiopia

Conditions: Acute Febrile Illness

Summary: a cross-sectional study on acute undifferentiated fever and the utility of biomarkers in differentiating bacterial from viral infection among acute febrile patients in gondar, northwest ethiopia.

general objective: to assess the causes of acute undifferentiated febrile illness and evaluation of biomarkers for differentiation of bacterial and viral infections among outpatients at university of gondar (uog) hospital, northwest ethiopia specific objectives 1. to determine the number of malaria cases, bacterial infections (by blood culture and polymearase chain reaction (pcr) for rickettsia and borrelia), and arboviral infections (denv, yfv, chikv) among all acute febrile patients 2. to evaluate the diagnostic performance different assays (rdt, rt-(reverse transcriptase)pcr, elisa) for the diagnosis of denv 3. to evaluate the qualitative detection of c-reactive protein (crp) and myxovirus resistance protein (mxa) (by febridx rdt) and quantitative crp detection for differentiating bacterial and viral infections study design, population, materials and methods: a cross-sectional cohort study on febrile patients presenting with acute fever at the emergency ward of the uog hospital from june to august 2019. clinical and epidemiological data will be recorded in a pseudo-anonymized and collected using an electronic data collection tool (kobotoolbox). blood will be collected for rdt testing, blood culture, pcr and serum for elisa and rt-pcr. sample size: 200 acute febrile patients expected results and relevance: evaluation of the causes of acute febrile illness and the role of biomarkers in differentiating viral and bacterial infections will increase the awareness of circulating pathogens and improve patient management. this evidence will contribute to a more rational use of laboratory diagnostic tests, antibiotics and antimalarial treatment.

Eligibility criteria:
inclusion criteria: * patients presenting with acute fever (an axillary temperature of ≥37.5°c; symptom duration ≤7 days) * ≥ 15 years old * signed informed consent exclusion criteria: * pregnant woman \& children (\<15 y) * febrile patient suspected of urinary tract infection or acute respiratory tract infection * individuals who had taken antimicrobial and antimalarial drug in the last 2 weeks * patients with acute injury or trauma or for which participation in the study implies an unacceptable health risk as determined by the physicians

Keywords: biomarkers bacterial infection viral infection malarial infection
a retrospective study on the treatment of intermediate and advanced liver cancer.

Conditions: Carcinoma, Hepatocellular

Summary: to evaluate the effectiveness of tace combined with immunotherapy and targeted therapy versus tace alone in patients with intermediate and advanced liver cancer.

to evaluate the efficacy and safety of tace combined with immunotherapy and targeted therapy in patients with intermediate and advanced liver cancer. explore the factors affecting the prognosis of liver cancer treated with tace combined with immunotherapy and targeted therapy and establish a specific individualized prognostic score and risk stratification model.

Eligibility criteria:
inclusion criteria: * ≥18 years old, both men and women * primary liver cancer confirmed by liver biopsy or history of hepatitis b, afp, and typical imaging findings * patients with liver function child-pugh a or b (≤8 points) * bclc stage b and stage c * expected survival time ≥8 weeks * patients with generally good performance status (ecog ps score 0 or 1) exclusion criteria: * the patient's key data is missing * liver metastatic cancer confirmed by histology or cytology * patients who interrupt treatment due to intolerance of adverse drug reactions * combined with primary malignant tumors of other organs within 5 years; combined with other serious diseases, such as severe heart disease, renal insufficiency, severe infection, bleeding, etc. * combined with systemic infection, autoimmune disease, or other types of tumors; previous allogeneic bone marrow transplantation or solid organ transplantation * study participants known to have mental illness * situations such as drug use or substance abuse
living well after breast surgery

Conditions: Breast Cancer Female; Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Ductal Carcinoma in Situ; Ductal Breast Carcinoma; Lobular Breast Carcinoma

Summary: decision making about whether to have breast reconstruction after mastectomy can be difficult, and previous studies have found that many women are not well informed about their options. patient decision aids can improve decision quality for a variety of health conditions. this pilot randomized study seeks to determine how a patient decision aid about breast reconstruction affects the quality of decisions about reconstruction including patient knowledge, concordance between preferences and treatment, and decisional regret.

enrolled participants will be randomized to 1 of 2 arms; participants may receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. participants will complete up to three surveys; a baseline survey before viewing the decision aid or website, a second survey immediately after viewing the decision aid or website, and a third survey six months after surgery. tablets will be made available to participants at the study site through which they can complete the surveys and view the decision aid or website. participants will have the options of viewing the decision aid or website outside of the study site, and completing the three surveys electronically or on paper. the baseline survey and second survey will each take approximately 45 minutes for participants to complete. the third survey will take approximately 30 minutes for participants to complete.

Eligibility criteria:
inclusion criteria: * female * adult (18 years or older) * new diagnosis of incident or recurrent stage i-iii ductal or lobular carcinoma, or ductal carcinoma in situ (dcis) * not yet had mastectomy * considering or planning to have mastectomy * able to read and speak english * competent to make health care decisions exclusion criteria: * male * age less than 18 years * diagnosis of stage iv breast cancer, inflammatory breast cancer, phyllodes, or sarcoma * already had mastectomy for this diagnosis * planning to have breast conservation therapy * not being treated by a texas oncology surgeon or oncologist * not able to read and speak english * not competent to make health care decisions
treatment of patients with donor lymphocytes sensitized by antigens expressed by the host

Conditions: Hematological Malignancy; Neoplasm Metastasis

Summary: allogeneic stem cell transplantation is the only effective treatment to patients resistant to conventional chemotherapy. donor lymphocytes infusion (dli) serve as a routine treatment of choice for patients relapsing following allogeneic stem cell transplantation. the present proposal is presented for introducing the use of immune rather than naive donor lymphocytes for patients with resistant relapse and resistant to dli. dli primed in-vitro against tumor cells of host origin or against host alloantigens presented by parental alloantigens in one way mixed lymphocytes culture can induce much more than potent graft-vs-leukemia and graft-vs-tumor effects, while down-regulating graft-vs-host disease (gvhd).


Eligibility criteria:
inclusion criteria: * patients with hematologic malignancy or metastatic solid tumor relapsing following allogeneic bone marrow or blood stem cell transplantation (allobmt) or non-myeloablative stem cell transplantation resistant to dli with no gvhd when taken off anti-gvhd prophylaxis. * patients with documented chimerism to confirm induction of host-vs-graft transplantation tolerance. exclusion criteria: * patients not consenting to participate in the study, or minors without approved parental consent. * patients with other diseases or complications that may limit their life span other than their basic disease. * pregnant or lactating women. * non-compliant patients or patients with poor performance status with life expectancy, e.g. 6 weeks.

Keywords: metastatic solid tumor
morphometric, clinical and histological study on one stage bone augmentation using boneceramic (bcp) and collagen membranes

Conditions: Dehiscent Type of Alveolar Bone Defect; One Stage Bone Augmentation

Summary: prospective randomized assessment of alveolar ridge alterations after augmenting dehisced areas by applying principles of guided bone regeneration (gbr) subsequently to implant installation. ossix as cross-linked and biogide as non cross-linked degradable collagen membranes, both used in combination with biphasic calcium-phosphate (boneceramic) as bone substitute. clinical measurements and impressions from the sites of interest are to be taken at the stage of augmentation and 6 months after. at six months re-entry non-standardized biopsies from augmented sites will be taken to determine newly grown tissue in quality and quantity. due to different degradation characteristics of the two collagen membranes used as barrier, amount of newly formed mineralized tissue is suspected to vary in tests and controls, respectively.


Eligibility criteria:
inclusion criteria: * alveolar ridge deficiences after tooth loss exclusion criteria: * systemic disorders (diabetes mellitus, morbus crown, etc.) * pregnancy or lactating period

Keywords: lateral augmentation gbr boneceramic collagen membrane histomorphometry morphometry reentry biopsy
a mobile health intervention among hispanics

Conditions: Cancer of Skin

Summary: hypothesis: more than 80% of the participants (n=40) will complete the intervention at three month (intervention completion) and the six month follow-up (retention rate as feasibility). more than 70% of the participants will report high overall study satisfaction (acceptability) with the intervention and study. this pre-pilot will inform intervention and procedural refinements for the pilot. hypothesis: participants who receive the intervention (n=57) will report more skin cancer-related preventive behaviors (e.g., mean of summed score of sun protection behaviors such as use of sunscreen, etc.) at three month and six month follow-up compared to those in the control condition (n=57, who will receive general information about physical activity and nutrition).

aim 1: the investigator will conduct individual interviews among key stakeholders such as health care providers and community leaders to plan a mobile skin cancer intervention among hispanics. data will be collected from individual interviews (n=10-12) among key stakeholders and triangulated with data from a funded pilot grant (focus groups and surveys with hispanic community members) to gather information regarding hispanics perceptions and behaviors related to skin cancer and suggestions for a whatsapp intervention. aim 2: employing a user-centered approach to develop a whatsapp intervention to promote skin cancer risk-reduction behaviors among hispanics and encourage engagement in the intervention. use an iterative qualitative (focus groups with hispanics, n=32; individual interviews with key stakeholders e.g., health care providers and community leaders, n=10-12) process to incorporate input from hispanics and relevant stakeholders to develop a mobile whatsapp intervention that is theory- and culturally-guided. aim 3: the investigators will evaluate the feasibility and acceptability of this mobile intervention in a single-arm pre-, post-test pilot study among at-risk hispanics. aim 4: refine the intervention and conduct a pilot rct (n = 114) using this mobile program among hispanics at risk for skin cancer and assess the preliminary effects of the mobile intervention at 3-month (intervention completion) and 6-month follow-ups.

Eligibility criteria:
inclusion criteria: * self-report as hispanics * 18 years or older * no personal history of skin cancer * report more than one skin cancer risk factor * do not engage in sufficient sun protection behaviors * have not conducted a sse in the past three months * own a smartphone and will be willing to use whatsapp exclusion criteria: * currently being treated for melanoma or nonmelanoma skin cancer

Keywords: mobile health
an ascending dose, single/multiple dosing, food effect clinical trial to evaluate pharmacokinetics, safety and tolerability in healthy subjects after oral administration of gemigliptin (phase i)

Conditions: Type 2 Diabetes Mellitus

Summary: to determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of gemigliptin and food effect in healthy chinese subjects.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects (aged 19\~45 years at the time of screening) * subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (bmi) of 17.1～25.8 (inclusive of limits). * subjects with a fasting plasma glucose (fpg) of 70～110mg/dl (inclusive of limits) at the time of screening * subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). subjects who can sign the written informed consent form after being informed of the study procedures. exclusion criteria: * those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies. * those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases. * those with a medical history of gastrointestinal diseases (ulcers, crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.
effect of helfer skin tap and cold application on pain and hemodynamics during vaccination

Conditions: Pregnant Women

Summary: the purpose of this study is to investigate the effect of local cold application using the helfer skin tap technique on pain levels during the intramuscular injection of the tetanus vaccine in pregnant women. the study will also record vital signs, which are among the physiological effects of pain.

this randomized controlled study aims to evaluate the effects of the helfer skin tap technique and local cold application on pain intensity and hemodynamic parameters during intramuscular tetanus vaccination in pregnant women. the sample size will be calculated prior to data collection using the g\*power 3.1.9.2 software. pregnant women included in the sample will be randomly assigned to three groups using the research randomizer program. according to the randomization: group 1 (intervention) will receive the tetanus vaccine using the helfer skin tap technique, group 2 (intervention) will receive the vaccine with local cold application, group 3 (control) will receive the standard im injection without additional intervention. data will be collected from pregnant women who are followed by soma no. 5 family health center and who apply to the institution for tetanus vaccination during pregnancy. the data collection tools include a personal information form, numeric pain rating scale (nprs), the helfer skin tap im injection procedure guideline, cold compress gel im injection guideline, and standard im injection guideline. injections will be administered to participants in all groups according to the respective guidelines. vital signs (such as heart rate, blood pressure, peripheral oxygen saturation (%), and respiratory rate) will be measured before injection, immediately after injection, and 15 minutes post-injection. pain levels will be assessed immediately and at the 15th minute following the injection. additionally, to evaluate the longer-term effects of pain, participants will be contacted via a follow-up link and asked to report their pain levels at the 24th and 48th hours after vaccination.

Eligibility criteria:
inclusion criteria: pregnant women who meet the following criteria will be included in the study: * over the age of 18, * scheduled to receive a tetanus vaccine, * able to speak and communicate in turkish, * willing to participate in the study, * not experiencing any pain for any reason prior to the injection. exclusion criteria: pregnant women who meet any of the following criteria will be excluded from the study: * under the age of 18, * received a tetanus vaccine for reasons other than pregnancy, * received a vaccine other than tetanus, * experiencing pain for any reason prior to the vaccine, * have circulatory disorders or peripheral vascular disease, * have bleeding or clotting disorders, * have a local infection, * used painkillers at least 6 hours prior to the procedure, * underwent a painful procedure within the last hour, * have cold sensitivity, * have cognitive or psychological issues.

Keywords: immunization pain hemodynamic parameters pregnant women local cold application helfer skin tap tecnique
phase ii doubleblind exploratory study of gsk2402968 in ambulant subjects with duchenne muscular dystrophy

Conditions: Muscular Dystrophies

Summary: the purpose of this study is to determine whether gsk2402968 given as a continuous dose and as an intermittent dose is effective and safe in the treatment of duchenne muscular dystrophy.

this is a phase ii, double-blind, exploratory, parallel-group, placebo-controlled clinical study in ambulant subjects with dmd resulting from a mutation that can be corrected by exon skipping induced by gsk2402968. the study aims to randomise 54 subjects. there will be 2 parallel cohorts. each cohort will include subjects on gsk2402968 and matched placebo in a 2:1 ratio.

Eligibility criteria:
inclusion criteria: * ambulant subjects with duchenne muscular dystrophy resulting from a mutation in the dmd gene, confirmed by a state-of-the-art dna diagnostic technique covering all dmd gene exons, including but not limited to mlpa (multiplex ligation-dependent probe amplification), cgh (comparative genomic hybridisation) or h-rmca (high-resolution melting curve analysis), and correctable by gsk2402968-induced dmd exon 51 skipping, * males, at least 5 years of age and with a life expectancy of at least 1 year * able to rise from floor in ≤7 seconds (without aids/orthoses), * able to complete the 6mwd test with a distance of at least 75m * receiving glucocorticoids for a minimum of 6 months immediately prior to screening, with no significant change in total daily dosage or dosing regimen for a minimum of 3 months immediately prior to screening and a reasonable expectation that total daily dosage and dosing regimen will not change significantly for the duration of the study * qtc \<450msec * on adequate contraception * able to comply with and complete all protocol requirements exclusion criteria: * any additional missing exon for dmd * current of history of liver or renal disease or impairment * acute illness within 4 weeks of the first dose * use of prohibited meds within 6 months of fist dose * current participation in any other investigational clinical trial * positive hepatitis b surface antigen, hepatitis c antibody test, or human immunodeficiency virus (hiv) test at screening * symptomatic cardiomyopathy * children in care

Keywords: 968 muscular dystrophy duchenne dmd
a study in subjects with otoferlin mutation-related hearing loss using rna base-editing therapy(sound)

Conditions: Congenital Hearing Loss

Summary: the purpose of the study is to determine whether hg205 as crispr/cas13 rna base-editing therapy is safe and effective for the treatment of hearing loss caused by p.q829x mutation in otof gene.


Eligibility criteria:
inclusion criteria: * male or females between 1 and 16 years of age at the time the subject/parent/legal guardian signs the informed consent form. * willing to adhere to the protocol as evidenced by written informed consent or parental permission and subject assent. * molecular diagnosis of biallelic mutations in the otof gene with at least one mutation being p.q829x through collected blood samples at screening; * based on auditory brainstem response (abr), clinically diagnosed sensorineural hearing loss (snhl) with the following hearing thresholds: severe (65 db ≤ hearing threshold \< 80 db) or profound (80 db ≤ hearing threshold \< 95 db) or complete (hearing threshold ≥ 95 db) hearing loss in both ears. * acceptable hematology, clinical chemistry, and urine laboratory parameters. exclusion criteria: * pre-existing other hearing-loss conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints or complications of surgery. * presence of cochlear implants in the study ear. * complicating systemic diseases or clinically significant abnormal baseline laboratory values. * complicating systemic diseases would include those in which the disease itself, or the treatment for the disease, can alter hearing function. * prior participation in clinical study with an investigational drug within the past six months. * prior gene therapy treatments. * any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.

Keywords: congenital hearing loss otof q829x hg205 crispr